Datasets:

chrisvoncsefalvay
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vaers-outcomes

id int32 25k 2.72M	text stringlengths 1 32k	label class label 8 classes
2,496,595	Vaccine was expired by one week	0No event
1,711,259	Continued joint pain; intestinal issues; continued very fatigued; heart palpitations; severe depression; very sensitive to chemicals; vaccine has magnified them severely; This is a spontaneous report from a contactable consumer (patient, self-reported). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 12Mar2021 (age at vaccination: 68 years), as a single dose for COVID-19 immunization at public health clinic/veterans. The patient's medical history included depression, MCS, and all chemicals allergy. Concomitant medications included alprazolam (XANAX) and metropropol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date, as a single dose for COVID-19 immunization at public health clinic/veterans. The patient received second dose of other vaccine in 4 weeks after vaccination in left arm on 03Apr2021. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. On 01Apr2021, the patient experienced continued joint pain, intestinal issues, continued very fatigued, heart palpitations, severe depression, very sensitive to chemicals. All these conditions he already have, but the vaccine has magnified them severely. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The patient underwent lab test and procedure included COVID (nasal swab) with negative result on 05Aug2021. Outcome of the events was not recovered. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.	0No event
812,436	c/o right arm pain at rest and movement	0No event
2,626,721	At approximately 11:15 am, the Patient, as mentioned above, returned to the nurse health assessment room, reporting she was having a reaction to the vaccines she had received. The Patient had received Pfizer Covid-19 bivalent, Tdap by GSK, Hepatitis B by Dynavax, and Influenza vaccine by ID Biomedical. The pt presented with generalized urticaria. Pt denied any SOB, difficulty swallowing, or chest pain. Vitals were immediately taken B/P 146/84 P: 64 Pulse Ox: 100% T: 98.4. 11:18 am Upon assessment from NP, Benadryl 25mg/0.5 ml was given IM. Generalized urticaria noted by NP. No angioedema or wheezing was noted on auscultation. A second set of vitals were taken B/P: 145/80 P: 66 Pulse ox: 100% T: 98.3. No acute distress was noted. 11:23 am Patient continues in observation. No acute distress was noted. Urticaria still noted. 11:35 am Vital retaken B/P: 135/76 P: 63 Pulse ox: 100% T: 98.2. No acute distress noted. Urticaria is subsidizing. 11:45 am Vital retaken B/P: 130/72 P: 60 Pulse ox: 100% T: 98.0. Urticaria localized to face, chest, and abdomen. Pt discharged at this time with discharge instructions and referral to PCP. Pt advised to seek immediate medical attention (911) should she present with any Urticaria, SOB, Chest pain, Angioedema, or difficulty swallowing. Pt verbalized understanding of all discharge instructions given. Pt left in stable condition, accompanied by family member.	0No event
2,075,806	new onset of rheumatoid arthritis in patient with no history of RA	0No event
2,614,503	Patient received expired vaccine. Office calling Pfizer to get stability data. Will revaccinate if recommended.	0No event
308,234	Information has been received from a physician concerning a 51 year old male who on 23-FEB-2006, 07-JUL-2006, 18-DEC-2006, 18-JUN-2007 was vaccinated with the first (Lot# 649260/0848R), second, third (Lot# 654018/0904F) and fourth (Lot# 0042U) 0.5 ml IM dose of RECOMBIVAX HB. On 17-AUG-2007, lab hepatitis titers showed he did not have seroprotection with a level of 3 mIU/ml. Medical attention was sought via the physician's office. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.	1ER_VISIT
1,549,532	Pt was brought the ED c/o bilateral numbness and weakness. CT angiography demonstrated focal occlusion of the left anterior cerebral artery and severe stenosis of the right anterior cerebral artery. No deficits noted. Pt was checked for COVID and it was positive. Pt is housed in our covid med/surg unit. Pt was discharged on 8/11/2021 with no further treatment.	4HOSPITAL
603,111	Legs felt as if I couldn't pick them up...weighed 500 pounds each. Headache, severe and progressed to worse. Tightness in chest and fever(ranging from 100.5 to 104.7) and all over aches and pain. Felt like I wanted to die.	1ER_VISIT
902,255	pt reports noticed after a few days from what he was saying some discomfort in left arm. no swelling no redness anywhere on arm or body. no warmth . no streaking reported. pt got vaccine on 11/3/2020 called clinic on 12/2/2020 for first time. pt reports no pain, no numbness, or tingling. able to use arm per pt. hadn't sought any tx or went anywhere. pt reports just notices some "discomfort" more in that arm with cerntain movements. when asked more about reporting like when turning sterring wheel of car notices sometimes. not worsening. was calling to look for suggestions. discussed if he had a PCP or ortho or PT. none per pt. told pt to let me look into further and call him back in meantime pt was going to try to see about assess with PT and get a PCP.	0No event
1,904,429	Menstrual cycle highly irregular after both vaccine doses. 12 days late after 1st dose. After second dose - 39 days late and heavy bleeding during cycle that lasted 19 days. Intermittent bleeding between cycle lasting 1-2 days at a time. Currently awaiting appointment at obgyn. Prior to vaccine, menstrual cycle was clockwork regular.	0No event
76,401	pt recv vax;swelling & redness in area of inject;very irritable; persistent inconsolable crying at intervals;to er 9jun95; atbs given & advil	1ER_VISIT
634,671	This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). The temperature excursion of the administered dose of vaccine was 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. There was no adverse effect report. This is one of several reports received from the same reported. Additional information has been requested.	0No event
2,538,040	1. Temperature of the fridge used to store the flu vaccine is not monitored, and the vaccine potentially may have been exposed to extreme temperatures and may have lost its potency. 2. Patient received flu shot that is approved for 65 yrs and older. pt is 42yrs	0No event
2,659,781	Headache, Sedation, Injection site discomfort, fatigue, and tiredness. Narrative:	0No event
2,699,933	22 y/o male came in the clinic for his TB skin test and JEV # 2. During check-in/screening, he mentioned that he has passed out previously after getting his immunizations in the past. Instructed to lean his back on the wall and raise his feet on the bed during vaccine administration. TB skin test placed on LFA and JEV # 2 administered on left deltoid without incident. Patient verbalized that he was "okay" after administration, talked to the patient for a couple more minutes then instructed him to seat in the waiting room and alert the immunization's staff if he starts to feel unwell, verbalized understanding. About 5 mins later, patient was observed to be very pale. Approached patient, observed to be in a sitting position very pale, cool to touch, diaphoretic, unresponsive, a code blue was called. While waiting for the code team, patient regained consciousness, became alert/oriented, assessed by PA and brought to acute care clinic for further evaluation.	0No event
1,271,305	Death within 60 days of vaccine	3DIED
637,401	Generalized pain, general inflammation, bruises on the left arm. Pain on cervical and lumbar zone, fever, fatigue, difficulty walking, high blood pressure, muscular aches, chest pain, and breathing problems. DOLOR GENERAL INFLAMACION HEMATOMAS EN EL BRAZO IZQUIERDO. DOLOR CERVICAL Y ZONA LUMBAR FIEBRE ,FATIGA ,DIFICULTAD PARA CAMINAR, PRESION ALTA, DOLOR MUSCULAR ,DOLOR EN EL PECHO Y PROBLEMA PARA RESPIRAR	1ER_VISIT
2,619,829	I noticed in late April that my ears started a low ringing, I consulted my doctor who referred me an ear doctor, I went in to get my ears checked also for my age to ensure that I did not need hearing aids, I was told I had a mild case of tinnitus. It has since cleared up. I also do not need hearing aids.	0No event
892,754	refrigerator temp out of range. Invalid vaccination.	0No event
1,156,625	Shaking - cold, Nauseated, Headache, fatigue	0No event
164,105	Fever, headache and cold sweats.	0No event
905,696	Felt hot, chest felt different, BP elevated	0No event
343,744	Pt arm Turned red and slightly raised the evening of the day the shot was given.	0No event
1,636,840	Every night I feel as though one side of my body was being shocked.	0No event
222,408	c/o left upper thigh edema with redness, no temp, no drainage.	0No event
1,609,297	Flu-like symptoms; Rash on legs; Body aches; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), RASH (Rash on legs) and MYALGIA (Body aches) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), RASH (Rash on legs) and MYALGIA (Body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), RASH (Rash on legs) and MYALGIA (Body aches) outcome was unknown. Not Provided Action taken with mRNA-1273 in response to the event was not applicable. No Concomitant medication were reported. No treatment medication were reported. This case was linked to MOD-2021-080601 (Patient Link).	0No event
365,177	frequent and heavy epistaxis	1ER_VISIT
1,155,538	skin under my mask turned red, splotchy, got very hot and slightly swollen. Eye sockets slightly swollen. Left side of face more severe in reaction than the right side. Throat slightly swollen. Left ear became plugged feeling. Scalp slightly numb, again more intense on the left side of head than right side. Even after I took my mask off symptoms continued and got slightly worse, not life threatening, but surprising. Pharmacist gave me 2 benadryl pills which I took with a 12 oz of water and symptoms began to lessen within a few hours. Came back the next day with moderate exercise. They were not nearly as pronounced but my face did turn red, get hot and my ear plugged up again. No medicine needed, I just rested and it went away. Same thing happened the third day but even less severe reaction and went away quickly when I stopped walking around and just rested. The shot was injected at the very top of my shoulder near the clavicle bone, it should have been administered lower in the deltoid and I think I might not have had such severe reactions. Perhaps nerves were interfered with due to the proximity of the injection.	0No event
1,001,635	Needle separated from the syringe during administration; Was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient; A spontaneous report was received from a nurse, concerning a 73-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and noted needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient. The patient's medical history was not reported. Concomitant medications were not specified. On 07-Jan-2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 07-Jan-2021, the nurse reported that, the needle got separated from the syringe during administration of the vaccine. Hence, the nurse was able to administer some of the vaccine but was unsure of how much of the dose was given to the patient. The patient has been monitored and no adverse event has been reported. Patient was on concomitant medications but the name of which was not known. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not reported. The events, needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient were considered to be resolved on 07-Jan-2021.; Reporter's Comments: This case concerns a 73 year old male who received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection and noted needle separated from the syringe during administration and was able to administer some of the vaccine before needle was separated from syringe and was not sure how much dose was given to the patient. There were no reported adverse events after the study drug was administered in this case of syringe connection issue and incorrect dose administered.	0No event
47,305	t104 started 7PM on 3NOV92; red rash down arm & acorss shoulders & back & also vomiting started 4NOV92; went to ER mom was told to keep cool packs on arm & observe pt; returned to school 6NOV92;	1ER_VISIT
281,425	fever, back ache, severe fatigue, desire to sleep, poor appetite, vomiting, sore throat	1ER_VISIT
1,827,825	Hot flashes; Leg pain; back again aching; I was confused; Chills/ mild shivers; Fever; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0164) via an unspecified route of administration on 26Apr as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included bnt162b2 as dose 1 for covid-19 immunisation. On an unspecified date, the patient experienced hot flashes, leg pain, back again aching, i was confused, chills/ mild shivers and fever. The patient stated that she had chills and hot flashes in the night and from morning she showed fever and it kind of went up to 103 and she took a Tylenol (treatment), fever and leg pain that was in the morning. So, after taking Tylenol she felt good. Again from an hour, one hour, one and half hour she experienced mild shivers and her back again aching and she had again showing 102. The patient reported that she was confused. The patient underwent lab tests which included body temperature: 103 fahrenheit and 102 fahrenheit on an unknown date. Therapeutic measures were taken as a result of fever. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.	0No event
2,407,139	As with prior two doses, this booster dose caused a flare up of symptoms consistent with CIDP exacerbation. This booster dose caused exacerbation of my neuropathy symptoms, balance issues/recurrence of falling, and new occurrence of tremors. The tremors and sensory exacerbations have not fully resolved. After further discussion with my neurologist, it has been concluded that this booster dose likely caused a significant flare up/relapse of my chronic condition resulting in unresolved damage from an episode of demyelination exacerbation.	0No event
952,400	Body aches and joint pain	0No event
857,138	Small hives on torso, neck, arms and legs. Itching but controllable.	0No event
1,108,587	Presents to PCP 2 days after 2nd covid vaccine with fevers, chest heaviness, palpitations, syncope (fell and hit head), swollen lymph node under arm, bilateral ear pain. Sncyope thought to be vasovagal and not related to vaccine. OTC treatment for symptoms.	0No event
1,164,256	I fell asleep for a full 24 hours after vaccine. I was too tired to stay up past 8:30 pm and woke up the next evening at 8:00pm. I lost a whole day! I continued to be unable to stay awake longer than 12 hours a day; always sleepy. Several days after vaccination itchy, red, swollen eyelids began and continue. They do not look infected as in conjunctivitis, just red. swollen and itchy with no discharge. I do not know if the itchy eyes are from the COVID vaccine, but assumed the extreme sleepiness was from the injection.	0No event
1,807,868	The first thing I noticed is the rash and then I noticed my heart was skipping. That is when I started calling the DR, and I started to become very worried. They told me that something was elevated, they did a test which usually indicates a heart attack or clot but that was in normal range so they sent me home in the same day. The symptom continued so I went to my Dr. and got a heart monitor for 24 hrs. My Dr. gave me medications to try and control my blood pressure but did not pay attention to my irregular heart rate. The medication gave me swollen legs so that medication was stopped. My blood pressure is continued to be monitored, I see the Dr. every 2-3 weeks. Up until this date, my BP was 159-96 which is not a normal BP. Right now, they increased all my medications - Losartan and Bystolic 10mg and I am taking an antidepressant which is nothing, but that is the story. My heart skip is somewhat under control when they increase the Bystolic. It has been a mission and I am still not comfortable with the meds I am taking.	0No event
381,501	The approximately 44 year old female consumer reported that she began CHANTIX starter pack in Apr2007, to stop smoking, ZOLOFT 50 mg daily, for depression, in Aug2007, and received two BIOPORT injections, while overseas, on unknown dates, prior to ZOLOFT and CHANTIX. At an unknown time, the consumer reports that she was depressed and felt like she had morning sickness with the CHANTIX. The consumer feels terrible, and her family and coworkers think she is nuts. On unknown dates, the consumer has had weight gain, and now weighs 148 pounds, anxiety, been frustrated, feels that something is neurologically wrong with her, and feels like a lunatic. The consumer's dose was increased to 100mg daily. In Sep2007, the consumer stopped taking ZOLOFT, because she felt the ZOLOFT was making things worse. The consumer feels the combination of the BIOTHRAX vaccine, CHANTIX and ZOLOFT has caused her events, since she feels that they all stimulate the nervous system. The consumer stopped taking CHANTIX, in May2007, because she was at a military training school and ran out of medication. The consumer smokes a half pack of cigarettes daily and her doctors want her to go for testing for her events, but the consumer refuses to go to the hospital. The consumer has had no relevant laboratory testing. As of 10Oct2007, the consumer is no longer taking ZOLOFT, CHANTIX, or BIOTHRAX vaccine. The consumer continues to be depressed, morning sickness, feels terrible, her family thinks she is nuts, has weight gain, anxiety, frustrated, something is neurologically wrong, feels like a lunatic, still hurts, and has motion sickness. Is unknown if the consumer has resolved from the ZOLOFT making things worse. The consumer works for a civilian company that is trying to go smoke free. She has five children and five grandchildren she used to take care of. The consumer gets her medications locally.	0No event
2,299,936	Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021 at 1:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 45.95 for dose administered on 15-Apr-2021. No concomitant medications were reported. Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).	0No event
81,733	hives	1ER_VISIT
1,175,180	excess vomiting about 10 times in 5 hours; Very high fever; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 19Mar2021 10:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunization at a clinic. Medical history included asthma, high blood pressure and allergy with Sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA) and apple cider vinegar. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 at 10:00 in the left arm for covid-19 immunisation. The patient experienced very high fever and excess vomiting about 10 times in 5 hours on 19Mar2021 at 22:00. No treatment was given for the events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.	0No event
1,123,529	Got the vaccine, she had no side effects and about 3/12/201 noticed a major rash from above the elbow, inner aspect of her arm down to her wrist. This was bright red. She put cortisone on it, and now it's brownish and rough in nature. It is 4" above the elbow and probably down to about 2-3" above the wrist, watch area. It runs up the outer aspect of the arm to the elbow. She put cortisone cream on it, the redness and inflammation was there for about 2 days, and now it has changed to the brownish/rough area. She did not go to the doctor, just took the OTC Cortisone cream. It is not itching, it did not itch, just red and inflamed.	0No event
1,674,957	Swollen lymph nodes Lump in neck near collar bone	0No event
1,314,467	16 hours after dose (10:15am Tuesday) I was dizzy and felt 'off balance'. This lasted for approximately 2 hours. I also endured muscle aches and mild fatigue. 30 hours after dose (10:00pm Tuesday) I began getting the 'chills'. This continued most of the night. I woke up at 6am Wednesday morning and my t-shirt was extremely wet with perspiration. The rest of Wednesday and Thursday I have had mild muscle aches and mild fatigue.	0No event
1,431,528	About 11 days after receiving the shot, I started experiencing chest tightness/pain. The pain persisted for four days and I went to urgent care. Urgent Care referred me to ER to screen for blood clots. After returning from ER, I started feeling sharp pains in multiple places all over my body?hands, fingers, toes, feet, calves, shins, forearms, back. Chest pain also continued. The chest pain has subsided, but I still experience shooting pains in arms, legs, hands, feet, toes, fingers, and occasionally my back. Pain is a 3-4/10 on average, but persistent. Some days are better than others. Some days the pain is mostly in a forearm (sometimes both) and the next day it's in a leg (sometimes both). Some pain seems to be in/along muscles, some in/along bones. It sort of feels like there's a small electrical storm in my body. Movement does not seem to have any effect on the pain.	1ER_VISIT
1,743,435	hurts like crazy; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to Shingles vaccine. Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient got a Shingles vaccine shot and stated it hurts like crazy. The follow-up could not be possible as no contact details were available.	0No event
906,806	Patient was done receiving vaccine at 0921, approximately 5-10 minutes later reported feeling flush, metallic taste in mouth (first symptom), heart racing. VS taken: 152/93, HR 120. Pt seated, calm, given water to drink, speaking full sentences, NAD and no difficulty breathing or swallowing. At 0948 VS: 132/91, HR 96, SpO2 98% room air. At 0955, patient continued to feel waves of heart racing, HR on monitor 90-108, SpO2 98%. At 1002, notified ED charge nurse that patient will be escorted for further monitoring, work up if necessary. Still no respiratory or swallowing symptoms. At 1002, patient escorted to ED by RN, ambulated without difficulty. Upon ED arrival, patient reported feeling "fine" without symptoms.	1ER_VISIT
959,807	Bellspalsy diagnosed in the ED 01/12/2021	1ER_VISIT
881,052	Pharmacist gave patient the vaccine in the left arm intramuscularly. Moments after the injection the patient felt a discomfort. Patient reported that there was swelling along the arm when she got home. Patient had a fever of 102. Patient took Tylenol 500mg three times a day to treat the fever and pain. Days after the pain still persists but the patient is able to return to work now.	0No event
697,215	This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# M040267 with expiration date on 14-MAY-2018; and lot # M025563 with expiration date on 06-NOV-2017) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015171: US-009507513-1705USA015170: US-009507513-1705USA015169: US-009507513-1705USA015168:	0No event
1,868,534	Patient has not reported any event. The wrong vaccine was administered. The Pediatric Pfizer was administered to an adult patient	0No event
2,717,014	Pt had an acute stroke 1 hour after treatment	2ER_VISIT, HOSPITAL
1,361,095	Prolonged emesis occurring day following vaccination. Patient was instructed to contact primary care provider or emergency department.	1ER_VISIT
1,024,464	I have hives on my chest, stomach, neck and back.	0No event
508,923	9/4/13 onset of rash, abdominal cramping diarrhea, headache. 9/5/13 total body itchy rash including hands palms of and feet bottoms - Seen in Occ Health states she was treated last week for sinus infection and was treated with Amoxicillin for which she says was allergic as a child. Tested by allergist - skin tested and blood work tested - No longer considered allergic. Seen by doctor, Infectious Disease, feels it is measles.	1ER_VISIT
1,792,043	This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EN6204), at the age of 50, via an unspecified route of administration, in the right arm, on Mar 11, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient has no medical history or known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any concomitant medications. On Mar 11, 2021 at 12:00, patient experienced underarm lymph lump in right arm pit. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, patient has not tested for COVID-19. The outcome of underarm lymph lump in right arm pit: unknown (at the time of this report). No follow-up attempts needed. No further information expected.	0No event
1,116,885	joint nerve pain in left shoulder/neck/elbow/back starting several hours after the first covid 19 vaccine was received in the right arm. started taking tylenol after 14 days because the pain was getting worse but switched to advil as tylenol was not helping with the pain. after a couple weeks, the pain was still present even with the advil. so went to my primary doctor today (3-19-21) who prescribed gabapentin for the pain as i am scheduled to receive the second covid 19 shot next week.	0No event
2,069,000	61-year-old male with a history of chronic intermittent dizziness/weakness/falls with related hospitalizations and clinic visits, severe episodes of recurrent MDD, chronic myofascial pain on narcotic pain agreement, type 2 diabetes, uncontrolled, with neuropathy, nephropathy and chronic left hallux amputation site ulceration, hypertension, HLD, PAD, CKD 3, IDA, presented to the ER with worsening dizziness/weakness and several falls over the last 24 hours. Felt this episode is the same as priors, except he experienced vomiting with this one. Completed stroke w/u negative for acute neurologic event. CXR and u/a negative for infection.	4HOSPITAL
1,322,051	None stated.	0No event
2,423,742	Received both doses and still get shingles/Suspected vaccination failure; Get shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Previously administered products included shingles vaccine (dose received on unknown date years before reporting date). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 19-AUG-2022. Reporter's Comments: This case was reported by patient via interactive digital media. The patient received the original shingles vaccine years ago from date of reporting, then two years ago. The patient received both the doses of Shingrix and still got shingles. The patient wanted to ask that, was there anything that he/she could do perhaps booster. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the completion of the time to onset for event and laboratory confirmation for herpes zoster were unknown. The follow up would not be possible as permission denied.	0No event
1,178,055	Patient administered 2.5mL	0No event
1,607,997	Dizziness; Pain in neck; Pain in legs; Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Pain in legs) and ARTHRALGIA (Pain in shoulder) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00121A) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Pain in legs) and ARTHRALGIA (Pain in shoulder). At the time of the report, DIZZINESS (Dizziness), NECK PAIN (Pain in neck), PAIN IN EXTREMITY (Pain in legs) and ARTHRALGIA (Pain in shoulder) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: unknown (Inconclusive) unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is skeptical about second dose because of the events. She stated she normally walks 4 miles a day. Patient wanted to knowthe effectiveness after one dose. No concomitant medical provided by the reporter. No treatment medication provided by the reporter.	0No event
2,457,961	Bruising at injection site - after the injection; Nasal congestion; Insomnia; Dry mouth in the night; Less but higher FRQ urine; Numbing in her fingers; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising at injection site - after the injection), NASAL CONGESTION (Nasal congestion), INSOMNIA (Insomnia), DRY MOUTH (Dry mouth in the night) and POLLAKIURIA (Less but higher FRQ urine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products DUPILUMAB for Nasal polyps and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication. No Medical History information was reported. On 19-Oct-2020, the patient started DUPILUMAB (Subcutaneous) 300 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) (unknown route) at an unspecified dose. On 19-Oct-2020, the patient experienced VACCINATION SITE BRUISING (Bruising at injection site - after the injection), NASAL CONGESTION (Nasal congestion), INSOMNIA (Insomnia), DRY MOUTH (Dry mouth in the night), POLLAKIURIA (Less but higher FRQ urine) and HYPOAESTHESIA (Numbing in her fingers). At the time of the report, VACCINATION SITE BRUISING (Bruising at injection site - after the injection), NASAL CONGESTION (Nasal congestion) and INSOMNIA (Insomnia) had not resolved and DRY MOUTH (Dry mouth in the night), POLLAKIURIA (Less but higher FRQ urine) and HYPOAESTHESIA (Numbing in her fingers) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. On 19-Oct-2020, the patient started taking subcutaneous dupilumab injection at a dose of 300 mg every other week (strength: 300 mg/2ml, lot number and expiration date: unknown) for nasal polyps delivered via dupilumab prefilled pen. In the context of COVID19 crisis, the batch number and expiration date were not requested. It was the first time use of the product. On 19-Oct-2020 (latency: same day), after the injection, the patient experienced bruising at the injection site (Injection site bruising). Upon follow up it was reported that patient had complained that dupixent caused dry mouth in the night (dry mouth), numbing in her fingers (hypoaesthesia), less but higher FRQ urine (pollakiuria) (onset and latency unknown for all events). The patient had nasal congestion for a few months (onset and latency unknown). The patient also had insomnia since starting dupilumab (insomnia) (onset and latency unknown). MD was aware. No lab tests reported. Action taken for dupilumab: no action taken for injection site bruising, unknown for all others. No corrective treatment was received for injection site bruising, unknown for all others. Reporter causality for dupilumab: Related for dry mouth in the night, numbing in her fingers and less but higher FRQ urine and not reported for injection site bruising. Additional information received on 20-oct-2021 from patient via specialty pharmacy: Added event, dry mouth, numbness in fingers, increased urinary frequency. Additional information received on 20-Nov-2021 from patient via specialty pharmacy: Added events of nasal congestion and insomnia. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.	0No event
309,563	A non-serious report of administration of expired FluMist has been received from a nurse concerning a 36-month old male. This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. Neither medical history nor concomitant medications were provided. The patient received FluMist on 12-Mar-2008. The FluMist had expired on 10-Jan-2008. The reporter stated that she received 100 doses of FluMist from the vaccines program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinical did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. No adverse events were reported. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006659; MEDI-0006669; MEDI-0006670; MEDI-0006671 MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.	0No event
260,659	Information has been received from a RN concerning a 78 yr old female with some food and environmental allergies and no medication allergies, who on 24Feb06 was vaccinated IM into the upper outer quadrant of right thigh with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651524/0605R). On 27Feb06 the pt presented to the office with right thigh pain, right thigh warmth and swelling at the injection site. The pt was treated with warm compress and oral diphenhydramine hydrochloride (Benadryl) as needed. The outcome was not reported. There was no product quality complaint involved. Additional information has been requested.	1ER_VISIT
1,530,599	Thyroiditis subacute; This is a spontaneous report received from a contactable consumer or other non-health care professional. A contactable consumer reported different events for 29 patients. This is 3 of 29 reports. A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 44-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thyroiditis subacute on an unspecified date. Calculated Time to onset: 2 Months. Summary: Subacute thyroiditis (SAT) was a typically painful inflammatory condition of the thyroid. A safety signal of subacute thyroiditis following vaccination with the novel mRNA and vector-based COVID-19 vaccines was found during a screening of the regulatory authority database of individual case safety reports. Subacute thyroiditis (SAT) was an inflammatory disease of the thyroid caused by viral infections or autoimmune reactions. Up to 08Jun2021, VigiBase, the regulatory authority database of individual case safety reports, contained 29 reports of SAT (MedDRA preferred term (PT): thyroiditis subacute) following immunisation with the novel COVID-19 vaccines. Furthermore, VigiBase comprised 50 cases reporting the PT autoimmune thyroiditis and another 50 cases reporting the PT thyroiditis following COVID-19 vaccination up to 08Jun2021. In 30 of the 50 cases reported the PT autoimmune thyroiditis. The cases reported the MedDRA PT thyroiditis subacute as it was the only PT found to be disproportionately reported. In-depth analysis of the other mentioned PTs can be made available on demand. The radioactive iodine uptake (RAIU) test was a reliable test to differentiate between causes of hyperthyroidism. Low uptake suggests thyroiditis and high uptake suggests Grave's disease. In the current case series, RAIU was performed in three cases confirming the diagnosis of SAT. The presented signal was aimed to increase patient's and healthcare professional's awareness of the will be necessary. The potential benefit of the COVID-19 vaccines was considered to outweigh the possible associated risk of subacute thyroiditis. The outcome of the event was reported as not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883	0No event
2,098,840	Positive COVID-19.	0No event
2,239,195	Adverse event: Mis-stored vaccine administered. Result: revaccinated.	0No event
958,150	Patient no adverse symptoms Patient was given too much vaccine 1mL instead of 0.5 mL	0No event
901,839	Patient reports 104 fever, cold sweats, achy back, headache, chills, insomnia, and loss of appetite. Left arm was hot to the touch and painful to move. Symptoms started 12/8/2020 8pm and continued until 12/11/2020 9am.	0No event
431,832	Information has been received from a physician concerning a 18 year old male patient who on 30-JUL-2010 was vaccinated with a dose of GARDASIL (Lot# unknown) and a dose of VAQTA (manufacturer unspecified). The physician reported that shortly after the patient received the dose of GARDASIL on 30-JUL-2010, the patient had fainted. The physician reported that the patient was given some Coke and something to eat and within a half hour the patient was fine and was able to leave the office (on 30-JUL-2010). There were no laboratory tests or diagnostic studies performed. The patient sought unspecified medical attention. Follow-up information has been received concerning the male patient with no preexisting allergies, birth defects or medical conditions and no illness at time of vaccination who on 30-JUL-2010 was vaccinated intramuscularly into his left deltoid with his first dose GARDASIL (lot number 663559/1178Y). Suspect secondary vaccination included a first dose IM of VAQTA (lot number 667262/0245Z) IM, in the right deltoid. Concomitant therapy included an IM first dose of ADACEL (lot number C3629BA) in the right deltoid. It was reported that immediately after receiving GARDASIL, the patient fainted. Fainting lasted about three seconds and the patient kept in office for 40 minutes. No laboratory tests were performed. On 30-JUL-2010 the patient recovered. Additional information is not expected.	0No event
529,981	This spontaneous report as received from a pharmacist via field representative refers to a female patient of unknown age. No details or demographics were provided for the patient. On an unknown date, the patient was vaccinated with ZOSTAVAX, dose (unknown) and router of administration (unknown). No concomitant medications were reported. On an unknown date (also reported as the next day), the patient developed rash at the injection site and pain in her neck. No details given for which pharmacist administered the ZOSTAVAX vaccine. No time frame was provided. No further symptoms or treatments provided. Action taken with respect to ZOSTAVAX was not applicable. No Product quality complaint was involved. The outcome of events was unknown. Causality was not provided. No further adverse event information was provided. Additional information has been requested.	0No event
1,268,604	Pt had first Pfizer vaccine on 4/10, 2nd dose give on 4/26/2021	0No event
433,210	Patient called next day (8/27). States that within 30 minutes of receiving FLUZONE, she got "real sick" with extreme diarrhea (soiled clothing), shakes/sweats went home and to bed. Sick all night. Better next day.	0No event
1,319,646	Small lump accompanied by medium to mild soreness going from left armpit to the back	0No event
242,418	Patients left arm was swollen, red, warm and hard to touch - no rash noted. Diagnosed with Cellulitis. Treated with Augmentin 600mg/5ml, UML twice a day for 10 days, Atarax as needed. Mom reports rash before this.	1ER_VISIT
946,495	Persistent Posterior headache at base of skull and neck pain, fatigue	0No event
535,751	This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. The healthcare worker reported that, on unknown date, ROTATEQ (dose, frequency, route, lot number and exp. date were not reported) that underwent a temperature excursion hs been administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.	0No event
2,275,541	The next day severe headache or Migraine. Could not get out of bed. Arm was unusually red and sore. Went to the doctor that week, symptoms lasted 2 weeks. Had an all over body rash, hot and inflamed. Vaccine site stayed red for months. No medication was given, only to take Ibuprofen.	0No event
588,206	All over body Aches, Left arm Quarter-sized redness & swelling, Sore Throat, pain reported in both arms but swelling occured in Lt arm where Tdap was given. No allergies reported on screening No history of reactions to Dtap as a child.	0No event
44,736	mom phone stating pt has been having pale & blue skin color; instructed to taken pt to ER;	1ER_VISIT
741,478	REDNESS, SWELLING, WARMNESS TO THE TOUCH. REDNESS EQUIVLAVENT TO THE SIZE OF PATIENTS HAND ON HIS LEFT BICEP. PATIENT WAS SEEN IN THE EMERGENCY ROOM. GIVEN ZYRTEC 10MG - 1 TAB EVERYDAY FOR 5 DAYS THEN PRN. CLARITIN 150 MG - 1 TAB BID FOR 5 DAYS.	1ER_VISIT
1,706,548	FATIGUE; HEADACHE; MUSCLE SORENESS ALL OVER; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and no drug abuse or illicit drug usage . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, expiry: 21-OCT-2021) dose was not reported, administered on 11-SEP-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 12-SEP-2021, the patient experienced fatigue. On 12-SEP-2021, the patient experienced headache. On 12-SEP-2021, the patient experienced muscle soreness all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, headache, and muscle soreness all over on 13-SEP-2021. This report was non-serious.	0No event
2,553,163	Error: Improper Storage (ex. temp./location)-	0No event
568,973	Case number PHEH2013US016402, is an initial spontaneous report received from the pharmacist on 31 JUL 2013. This report refers to an unspecified age and gender patient. Past medical history and concomitant medication were not reported. The patient received only MenCYW-135 liquid conjugate component of MENVEO (batch number: M12129) on an unspecified date. The patient did not receive Men A lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error. No additional information was available.	0No event
76,106	hand tremors 14JUL95-17JUL95 & loss of balance; vax given 19JUN95	0No event
374,434	Itchy abdomen on R side not itchy prior to vaccination. Given 50 mg BENADRYL elixir PO at 5:27 pm. By 6 pm no longer itchy. Will go home w/mom to eat. Call 911 if prob reoccurs.	0No event
1,259,297	The next day I got the vaccine, I started to feel acidic in my stomach. At first it was a very mild annoyance and now it is moderate. Apparently it is a gastroesophageal reflux.	0No event
1,939,136	Patient noticed red blotch on right eye at 5:10pm. He came back to us at around 5:39pm because he was worried the blotch has expanded the length of his lower lid. First thing the patient was asked if he wanted us to call 911. The patient refused. The pharmacist asked if he was okay, he stated he was fine & felt no different, just the spot on his eye. The pharmacist asked again if he wanted us to call 911, he refused a second time. The Pharmacist ask if he's ever gotten a red blotch in his eye and patient said he rarely gets them, about three times a year. He was asked if this has ever happened with getting vaccines, he said he doesn't get vaccines. He was asked if this has happened when he takes any medication, the patient said he doesn't take medication. The pharmacist asked if he has told his doctor about this, the patient stated he has not told his doctor because it goes away on its own	0No event
2,522,767	Patient received extra dose of primary series. Parent forgot they received 3rd dose while on vacation.	0No event
113,928	5min post vax pt was standing by doorway while cousin was being immunized;a thump was heard & pt was seen lying on back;ammonia inhalent strips were used & pt responded quickly to verbal stimuli & aware of surrounding;referred to ER;	1ER_VISIT
1,606,092	Inflammatory nodules; This spontaneous case was reported by a physician and describes the occurrence of NODULE (Inflammatory nodules) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Dermal filler injection (Restylane Lyft.). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NODULE (Inflammatory nodules). At the time of the report, NODULE (Inflammatory nodules) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient took moderna covid-19 vaccine. case is valid.	0No event
988,988	nausea; fever; chills/burning up, body aches and pain, headache	0No event
1,691,543	very mild malaise type of feeling; Soreness at the injection site; feeling of tiredness; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (very mild malaise type of feeling), VACCINATION SITE PAIN (Soreness at the injection site) and FATIGUE (feeling of tiredness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A OR 02C120A) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism, Hypertension (High Blood Pressuer), BPH, Sleep apnea and Atrial fibrillation. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), FLECAINIDE, AMLODIPINE BESILATE (NORVASC), TADALAFIL (CIALIS), HYDROCHLOROTHIAZIDE and NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (very mild malaise type of feeling) and FATIGUE (feeling of tiredness). an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, MALAISE (very mild malaise type of feeling) and FATIGUE (feeling of tiredness) outcome was unknown and VACCINATION SITE PAIN (Soreness at the injection site) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient took Dose-3 on 25-AUG-2021 and he had experience Hot, typical covid arm,giving him a little bit of problem. On 26-AUG-2021 he felt much better than 25-AUG-2021 and later itchiness and soreness is much better but the swelling and redness is a little bit better or the same. Other Treatment medicine: CBD Cream. This case was linked to MOD-2021-297029, MOD-2021-297099 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received contains no new information.	0No event
1,077,704	Hives and itching rash on both arms and chest, swollen face with hives, sore eyes	0No event
879,320	Headache; Feeling Sick; Body Aches; Chills; This case was reported by a other health professional via call center representative and described the occurrence of headache in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis. On 10th August 2020, the patient received Bexsero. In August 2020, less than a day after receiving Bexsero, the patient experienced headache, malaise, general body pain and chills. On an unknown date, the outcome of the headache, malaise, general body pain and chills were not recovered/not resolved. It was unknown if the reporter considered the headache, malaise, general body pain and chills to be related to Bexsero. Additional information was received as follows: The case was reported by the Clinical Supervisor. The patient experienced feeling sick, headache, body aches, and chills. Healthcare Professional noted the event began the night the vaccine was received. The events were ongoing, with no outcome at the time of this report. The reporter consented to follow up. This case was linked to case US2020158056, US2020158058 and US2020AMR159262 by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2020158056:same reporter US-GLAXOSMITHKLINE-US2020158058:same reporter US-GLAXOSMITHKLINE-US2020AMR159262:same reporter	0No event
2,573,939	Narrative: 48 Y F with PMH of, menorrhagia with uterine fibroids (home estrogen/progesterone-has been on for >10 years), HTN, asthma, allergic rhinitis, DJD, and iron deficiency anemia (baseline Hgb 8-9) who presented to ED from home on 4/10/21 with complaints of SOB, nausea, generalized weakness, bilateral leg swelling, and presyncope. No recent travel. Non-smoker. COVID-19 negative (4/10/21). No family hx of DVTs/PEs. The patient received her 1st Pfizer COVID-19 vaccine on 4/5/21. CT demonstrated distal L main pulmonary artery extensive PE (as well as smaller branches L, R lobar PA branches) and R heart strain. BLE DVT US on 4/11/21 notable for RLE DVT. She was admitted and heparin gtt was started, went for catheter directed thrombolysis on 4/11/21, received systemic alteplase. During the procedure, multiple PEA arrests and was cannulated for ECMO (4/11-4/20) with notable low flows (c/f RP bleed with RF sheath pull), vent dyssynchrony, high pressor requirements. Transferred to outside Hospital for ECMO management on 4/12/21. Course at outside hospital notable for AF w/ RVR s/p cardioversion, AKI on dialysis, small falcine subdural hematoma, right iliac artery stent, left leg weakness i/s/o L groin hemorrhage. On 4/22/21, Patient returned (extubated) to agency hospital ICU. HIT panel negative on 4/23/2021-patient transition back to heparin from argatroban. S/p emergent repair of left groin hemorrhage on 5/2/21. On 5/18/21, She was admitted to the acute rehabilitation unit. Per 7/29/21 Infectious Disease consult, "TTS can begin as early as 4 days post vaccination, and up to 42 days after. Some of the initial patients had prior risks for hypercoagulability. Thrombosis most often occurs in atypical locations (cerebral, abdominal) but can be pulmonary. There is almost always thrombocytopenia, and almost always a positive test for PF4 (platelet factor 4) antibodies, as with heparin-induced thrombocytopenia (but without exposure to heparin)--which turn out to be activating antibodies in this particular syndrome. Heparin should not be used in this syndrome, but rather IVIG and nonheparin anticoagulation. She could have had TTS (female, typical age, OCP use, documented major arerial thrombosis, and documented thrombocytopenia--albeit after receiving heparin. Unfortunately, it will be tough to know if she did--unless a lab saved some serum from the initial blood draw in ED before she received heparin. If so, a PF4 (HIT) antibody screen should be run on that saved sample. Without PF4 antibody confirmation TTS cannot be confirmed. A serotonin release assay would also be informative. If she did have TTS, there are very little data on which to base a decision about whether she should receive another dose of a COVID vaccine. Nearly all of the very limited experience with TTS has been with single dose vaccines. My sense about this however is that until it is better understood how to risk stratify individuals for COVID vaccine-associated TTS, I would not give her another dose of COVID vaccine. She may have risks (in addition to OCP) that we don't recognize that create a high likelihood of another post-COVID vaccine major thrombotic event. Given that she essentially died and was then resuscitated from the last one, I would not place her at repeated risk of the same until we understand more about how to predict or mitigate." On 8/3/2021, COVID-19 vaccine was added to the patient's allergy/adverse drug reaction coversheet in the electronic medical record system indicating that the patient should not receive a 2nd covid-19 per infectious disease and to re-evaluate for vaccine candidacy in the future once more data is available. Per 8/3/2021 Hematology consult, "Hypercoagulable work-up performed: APLS sceen at facility negative for ACA Abs, LAC (though on apixaban), aPS/PT Abs, B2G Abs Factor V Leiden negative on 6/7 Prothrombin negative on 6/7 antiphospholipid panel performed 7/22 was unremarkable (see imaging) Protein C returned elevated, though on apixaban. Protein S and ATIII not sent since on AC. A PF4 antibody was sent at hospital and was negative." "Given the severity of her pulmonary embolism with PEA arrest and requiring ECMO, would recommend that she remains on lifelong anticoagulation. Her hypercoagulable workup has been unrevealing thus far. LAC, protein C and S, and ATIII cannot be accurately assessed on anticoagulation however would not stop her anticoagulation to test for them at this time, since it would not change her management and put her at higher risk of worsening VTE." In terms of the relation to the COVID vaccine, it seems like the vaccine could be a provoking factor particularly in terms of the timing; however, there has not been a clear association between the mRNA vaccines and VTE. Vaccine-induced thrombotic thrombocytopenia has been described in relation to the adenovirus vector vaccines (JnJ, AstraZaneca) rather than mRNA vaccines, in which there has been sparse case reports and has not been found to be associated with VITT at this current time. This patient's platelets on admission were normal and only one reading was low at any time during her admission. In addition, her PF4 antibody was normal at hospital even after heparin exposure; this was positive in almost all patients diagnosed with VITT. Given that she had an mRNA vaccine with mostly normal platelet counts and negative PF4 antibody, this is unlikely to be vaccine-induced thrombotic thrombocytopenia. We would defer to infectious disease as to whether to pursue second dose of vaccine with this information."	1ER_VISIT
1,650,681	headache; legs and muscles felt like under a heavy blanket and stiff; heart rate shooting up by 30 points of 100 - 115/my heart rate was closer to the 80's and 90's; this was a terrible feeling - tachycardia and there was pain in left arm with shot; this was a terrible feeling - tachycardia and there was pain in left arm with shot; this was a terrible feeling - tachycardia and there was pain in left arm with shot; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 56-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Left arm on 16Apr2021 14:00 at the age of 56-years-old as dose 2, single for covid-19 immunisation. Medical history included thyroid issues from an unspecified date and COVID-19 on an unspecified date prior vaccination. The patient had no allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. Facility type vaccine was other. The patient was diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that after shot 2, on 17Apr2021, the patient experienced headache, legs and muscles felt like under a heavy blanket and stiff, and heart rate shooting up by 30 points of 100 - 115# Typically his heart rate is in the 70's so this was a terrible feeling - tachycardia and there was pain in left arm with shot, literally the next day it stopped and my heart rate was closer to the 80's and 90's, so a bit better. The patient received did not receive treatment for adverse events. Adverse events resulted in None of the above. The patient underwent lab tests and procedures which included heart rate: shooting up on 17Apr2021 (30 points of 100 - 115/my heart rate was closer to the 80's and 90's). The outcome of events was recovered on an unspecified date in 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained.	0No event