chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 94.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Dizziness, Fall, Immunisation, Off label use, Product administered at inappropriate site
Clinical narrative: I got dizzy; blurred vision; fainted and fell on the floor the next morning; fainted and fell on the floor the next morning; Other vaccine same date vaccine date 08Oct2021: Flu Shot; dose number=3 on 08Oct2021; dose number=3 on 08Oct2021; vaccine location=Left leg; This is a spontaneous report from a contactable consumer. A 94-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Leg Left at age of 94-years-old on 08Oct2021 10:30 (Lot Number: 30130A) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (reported as Flu Shot), via an unspecified route of administration on 08Oct2021 (Batch/Lot number was not reported), at single dose for immunisation. Medical history Afib, high blood pressure, history of bladder and breast cancer, osteoarthritis. Concomitant medication(s) included metoprolol tartrate; furosemide; tamoxifen; omeprazole; rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 at age of 93 year old on 27Jan2021 (Batch/Lot No: e3302) Arm Left and second dose of BNT162B2 at age of 93 year old on 17Feb2021 (Batch/Lot No: EN6200) Arm Left for COVID-19 immunization. The patient experienced adverse event: I got dizzy, blurred vision, fainted and fell on the floor the next morning. I was sent to the hospital by ambulance on 09Oct2021 09:30. The patient was hospitalized for events from 10Oct2021 for 3 days. Treatment of events was unknown. Outcome of events was unknown. Evens required Emergency room/department or urgent care.
Age: 94.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Product use issue, Syncope, Vision blurred
Clinical narrative: I got dizzy; blurred vision; fainted and fell on the floor the next morning; fainted and fell on the floor the next morning; Other vaccine same date vaccine date 08Oct2021: Flu Shot; dose number=3 on 08Oct2021; dose number=3 on 08Oct2021; vaccine location=Left leg; This is a spontaneous report from a contactable consumer. A 94-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Leg Left at age of 94-years-old on 08Oct2021 10:30 (Lot Number: 30130A) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (reported as Flu Shot), via an unspecified route of administration on 08Oct2021 (Batch/Lot number was not reported), at single dose for immunisation. Medical history Afib, high blood pressure, history of bladder and breast cancer, osteoarthritis. Concomitant medication(s) included metoprolol tartrate; furosemide; tamoxifen; omeprazole; rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 at age of 93 year old on 27Jan2021 (Batch/Lot No: e3302) Arm Left and second dose of BNT162B2 at age of 93 year old on 17Feb2021 (Batch/Lot No: EN6200) Arm Left for COVID-19 immunization. The patient experienced adverse event: I got dizzy, blurred vision, fainted and fell on the floor the next morning. I was sent to the hospital by ambulance on 09Oct2021 09:30. The patient was hospitalized for events from 10Oct2021 for 3 days. Treatment of events was unknown. Outcome of events was unknown. Evens required Emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots in abdomen the next day; This is a spontaneous report from a Pfizer sponsored Program, received from a non-contactable consumer via medical information team. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced blood clots in abdomen the next day of vaccination. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Culture urine, Diarrhoea
Clinical narrative: She passed out when the diarrhea started; Diarrhea; Her cheeks are flushed, right side is worse than the left; very weak; hot; chills; Fever of 105F; Sweating profusely; having to pee; every time she thought she could go back to sleep, she had to go back to the bathroom; Vomiting; This is a spontaneous report from a contactable consumer. This consumer reported for an 88-year-old female patient (her client) received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Right on 07Oct2021 12:00 (Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 88 years old.  Medical history included ongoing cardiac failure congestive. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 23Jan2021 in upper right arm (Lot: EL9262) and second dose on 13Feb2021 in right arm (Lot: EM9809) for COVID-19 immunisation, both at the age of 88 years old. The patient had the booster on Thursday and had a reaction. It started with her having to go to the bathroom to pee; every time she thought she could go back to sleep she had to go back to the bathroom; this started at 1am on Friday 08Oct2021 and she peed until about 7am. Next, she started vomiting. She went to the hospital at around 7am on Friday 08Oct2021. After she started throwing up and sweating profusely her sons called an ambulance to take her to the hospital. When she got to the hospital, they gave her an IV, and checked her heart and her pulse ox which were both normal. She did have a fever of 105F. They gave her Oxygen for about an hour even though her pulse ox was 96-98. This morning her pulse ox was 98. They released her from the hospital about 3:45-4pm on Friday. It was verified that the patient was not admitted, she was only in the ER. While at the hospital she had a 12 lead EKG and an x-ray, which were both normal. They also did a metabolic panel, CBC with complete blood count, urinalysis and urine culture, and all came back normal. After the patient got home the diarrhea started, and she continued to throw up. She passed out when the diarrhea started. She states that today she has been resting for the most part, she is still not doing great. Her cheeks are flushed, right side is worse than the left. She is still very weak, not as weak as she was, but she will be staying in the bed today because the aide doesn't want her to be stumbling around. States that she threw up more than 10 times, which was really hard on her body, so she needs to rest. The last time she threw up or had diarrhea was on Saturday. Her fever has subsided; she went in between chills, hot, and sweating; today (12Oct2021) her temperature was 95.6F. She is able to hold food down now. Caller states that she is about to take her medication, the aide just wanted her to have food on her stomach first. The outcome of her cheeks are flushed, right side is worse than the left was not recovered, outcome of weak was recovering, the outcome of other events was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Feeling hot, Flushing, Full blood count, Hyperhidrosis
Clinical narrative: She passed out when the diarrhea started; Diarrhea; Her cheeks are flushed, right side is worse than the left; very weak; hot; chills; Fever of 105F; Sweating profusely; having to pee; every time she thought she could go back to sleep, she had to go back to the bathroom; Vomiting; This is a spontaneous report from a contactable consumer. This consumer reported for an 88-year-old female patient (her client) received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Right on 07Oct2021 12:00 (Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 88 years old.  Medical history included ongoing cardiac failure congestive. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 23Jan2021 in upper right arm (Lot: EL9262) and second dose on 13Feb2021 in right arm (Lot: EM9809) for COVID-19 immunisation, both at the age of 88 years old. The patient had the booster on Thursday and had a reaction. It started with her having to go to the bathroom to pee; every time she thought she could go back to sleep she had to go back to the bathroom; this started at 1am on Friday 08Oct2021 and she peed until about 7am. Next, she started vomiting. She went to the hospital at around 7am on Friday 08Oct2021. After she started throwing up and sweating profusely her sons called an ambulance to take her to the hospital. When she got to the hospital, they gave her an IV, and checked her heart and her pulse ox which were both normal. She did have a fever of 105F. They gave her Oxygen for about an hour even though her pulse ox was 96-98. This morning her pulse ox was 98. They released her from the hospital about 3:45-4pm on Friday. It was verified that the patient was not admitted, she was only in the ER. While at the hospital she had a 12 lead EKG and an x-ray, which were both normal. They also did a metabolic panel, CBC with complete blood count, urinalysis and urine culture, and all came back normal. After the patient got home the diarrhea started, and she continued to throw up. She passed out when the diarrhea started. She states that today she has been resting for the most part, she is still not doing great. Her cheeks are flushed, right side is worse than the left. She is still very weak, not as weak as she was, but she will be staying in the bed today because the aide doesn't want her to be stumbling around. States that she threw up more than 10 times, which was really hard on her body, so she needs to rest. The last time she threw up or had diarrhea was on Saturday. Her fever has subsided; she went in between chills, hot, and sweating; today (12Oct2021) her temperature was 95.6F. She is able to hold food down now. Caller states that she is about to take her medication, the aide just wanted her to have food on her stomach first. The outcome of her cheeks are flushed, right side is worse than the left was not recovered, outcome of weak was recovering, the outcome of other events was unknown.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vomiting, X-ray
Clinical narrative: She passed out when the diarrhea started; Diarrhea; Her cheeks are flushed, right side is worse than the left; very weak; hot; chills; Fever of 105F; Sweating profusely; having to pee; every time she thought she could go back to sleep, she had to go back to the bathroom; Vomiting; This is a spontaneous report from a contactable consumer. This consumer reported for an 88-year-old female patient (her client) received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Right on 07Oct2021 12:00 (Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 88 years old.  Medical history included ongoing cardiac failure congestive. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 23Jan2021 in upper right arm (Lot: EL9262) and second dose on 13Feb2021 in right arm (Lot: EM9809) for COVID-19 immunisation, both at the age of 88 years old. The patient had the booster on Thursday and had a reaction. It started with her having to go to the bathroom to pee; every time she thought she could go back to sleep she had to go back to the bathroom; this started at 1am on Friday 08Oct2021 and she peed until about 7am. Next, she started vomiting. She went to the hospital at around 7am on Friday 08Oct2021. After she started throwing up and sweating profusely her sons called an ambulance to take her to the hospital. When she got to the hospital, they gave her an IV, and checked her heart and her pulse ox which were both normal. She did have a fever of 105F. They gave her Oxygen for about an hour even though her pulse ox was 96-98. This morning her pulse ox was 98. They released her from the hospital about 3:45-4pm on Friday. It was verified that the patient was not admitted, she was only in the ER. While at the hospital she had a 12 lead EKG and an x-ray, which were both normal. They also did a metabolic panel, CBC with complete blood count, urinalysis and urine culture, and all came back normal. After the patient got home the diarrhea started, and she continued to throw up. She passed out when the diarrhea started. She states that today she has been resting for the most part, she is still not doing great. Her cheeks are flushed, right side is worse than the left. She is still very weak, not as weak as she was, but she will be staying in the bed today because the aide doesn't want her to be stumbling around. States that she threw up more than 10 times, which was really hard on her body, so she needs to rest. The last time she threw up or had diarrhea was on Saturday. Her fever has subsided; she went in between chills, hot, and sweating; today (12Oct2021) her temperature was 95.6F. She is able to hold food down now. Caller states that she is about to take her medication, the aide just wanted her to have food on her stomach first. The outcome of her cheeks are flushed, right side is worse than the left was not recovered, outcome of weak was recovering, the outcome of other events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history was reported as none (never having any clinical history in the past). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced seizures on an unspecified date. The outcome of the event was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Confusional state
Clinical narrative: intermittent mental confusion; heart flutters; This is a spontaneous report from a contactable pharmacist. A 34-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 31Aug2021 10:28 (at the age of 34 years old) (Lot Number: FC3813; Expiration Date: 31Oct2021) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  Family medical history relevant to events and relevant tests were unknown. It was unknown if other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On an unspecified date in 2021, patient experienced heart flutters. On 21Sep2021 10:28, patient had intermittent mental confusion. The events were reported as serious, medically significant. Clinical course details: Patient had heart flutters at least twice day every day after he got the first dose of Pfizer Covid Vaccine on 31Aug2021; and that for the first probably 3-4 weeks after he got the first dose of Pfizer Covid Vaccine on 31Aug2021 had intermittent mental confusion. Patient asked if there are any recommendations on whether patient should or should not get any additional doses of Pfizer Covid Vaccine relative to these events. It was unknown if events required a visit to Emergency Room/Physician Office. It was unknown if patient was hospitalized (not hospitalized to reporter's awareness). The outcome of the events was Recovering/Resolving. Relatedness of drug to reactions/events - reaction assessed: Heart flutters and Intermittent mental confusion. Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Cardiac flutter, Confusional state and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac disorder, Drug ineffective, SARS-CoV-2 test
Clinical narrative: "re infected" with COVID; "re infected" with COVID; heart issues; This is a spontaneous report from a non-contactable consumer. A 17-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included "COVID naturally" over one year ago. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced "re infected" with COVID and now he has heart issues. He sees a cardiologist as well as a lung specialist. The patient underwent lab tests and procedures which included sars-cov-2 test: infected with covid on unspecified date (as reported). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Magnetic resonance imaging head, Nerve injury, Tinnitus
Clinical narrative: abrupt loss of hearing in left ear; Tinnitus; nerve damage; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 05Apr2021 11:30 AM (batch/lot number: ER8733) at the age of 73 years old, as DOSE 2, SINGLE for COVID-19 immunization. The vaccine was administered at the Doctor's office/Urgent care. The patient's medical history included HTN (hypertension), DM Type 2 (Type II Diabetes mellitus), and osteoarthritis, all from an unknown date. Patient had no history of hearing loss in either ear, and had no history of COVID-19 prior to vaccination. There were no known allergies. Concomitant medications included amlodipine (AMLODIPINE), atorvastatin (ATORVASTATIN), metformin (METFORMIN), and omeprazole (OMEPRAZOLE), indications and therapy dates for all were not reported. The patient did not receive any other vaccine within four weeks. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on Mar2021 02:15 AM (batch/lot number: EN6205) as DOSE 1, SINGLE for COVID-19 immunization. On 06Apr2021, 7:00 AM, the patient experienced tinnitus and abrupt loss of hearing in left ear. Symptoms became increasingly pronounced and patient had been told that the hearing loss is permanent. On 06Apr2021, patient had MRI of head to rule out organicity and had two hearing tests (acoustic stimulation tests), all confirmed nerve damage. The events resulted in Doctor or other healthcare professional office/clinic visit. All prescription meds are long-term, well-tolerated meds. Patient had also seen ENT for steroid injections to TM (tympanic membrane) two times which did not help at all. The outcome of the events was not recovered. The events were reported as serious causing disability, permanent damage. The patient has not tested for COVID-19 post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dairy intolerance, Lactose intolerance
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife) via Medical information team. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13Aug2021 (Lot Number: FC3180) as DOSE 1, SINGLE for COVID-19 immunization at the age of 42 years old in the Pharmacy/drug store; tilactase (LACTAID), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at UNK [take 1 tablet by mouth with meals as consuming dairy. taking it with anything having dairy] for lactose intolerance; and metformin hydrochloride (METFORMIN), oral from an unspecified date (Batch/Lot number was not reported) and ongoing, at 500 mg, 2x/day [(once in the morning and once at night)] for diabetes. Medical history diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes), obesity, diabetes and pre-diabetic all from an unknown date and ongoing lactose intolerance from an unknown date. There were no concomitant medications. The patient's wife stated, "my husband is having some side effects from his Pfizer Covid-19 vaccine, I wasn't sure if they are common or if you any remedies for them. After the first vaccine, he is lactose in-tolerant very very mild, generally doesn't have to take Lactate, he usually just drinks lactaid milk and is fine. He usually does not have to take Lactaid tablets unless he chugs a whole gallon of milk. His lactose intolerance has increased in severity and he has to take Lactate tablets now. He did have to call in sick to work one morning because the night before he had a dollop of sour cream and some cheese on a taco which used to be okay." The patient also experienced severe reaction to dairy in Aug2021. The patient's wife further stated, "Now he is taking Lactaid tablets at every meal, but he still has dairy issues and they are now worse after getting the vaccine". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The action taken in response to the events for tilactase and metformin hydrochloride was dose not changed. The outcome of severe reaction to dairy was not recovered and unknown outcome for the rest of events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Night sweats, Pain, Product use issue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 AM (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation.  Facility type vaccine was in hospital. Medical history included arthritis, high cholesterol and known allergies to shellfish. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm right on 22Mar2021 10:45 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC); metformin; hydrochlorothiazide; finasteride (FINASTERIDE), all taken for an unspecified indication, start and stop date were not reported.  There is other unspecified vaccine on 12Apr2021. 24 hours after 2nd shot on 13Apr2021, patient had 90 straight hours of high fever and constant bad chills. Next 2 weeks mostly severe aches and pains, next 2 weeks mostly difficult breathing, and 6 weeks of heavy night sweats. All events onset date was on 13Apr2021, with latency 24 hours. The patient underwent lab tests and procedures which included sars-cov-2 test (Blood test): negative in May2021.  The outcome of events was recovered in 2021 without treatment. Events was results in physician office visit. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 AM (Batch/Lot Number: ER8737) as DOSE 2, SINGLE for covid-19 immunisation.  Facility type vaccine was in hospital. Medical history included arthritis, high cholesterol and known allergies to shellfish. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm right on 22Mar2021 10:45 AM (Batch/Lot Number: EP7534) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included nebivolol hydrochloride (BYSTOLIC); metformin; hydrochlorothiazide; finasteride (FINASTERIDE), all taken for an unspecified indication, start and stop date were not reported.  There is other unspecified vaccine on 12Apr2021. 24 hours after 2nd shot on 13Apr2021, patient had 90 straight hours of high fever and constant bad chills. Next 2 weeks mostly severe aches and pains, next 2 weeks mostly difficult breathing, and 6 weeks of heavy night sweats. All events onset date was on 13Apr2021, with latency 24 hours. The patient underwent lab tests and procedures which included sars-cov-2 test (Blood test): negative in May2021.  The outcome of events was recovered in 2021 without treatment. Events was results in physician office visit. Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Flushing, Pruritus, Tongue blistering
Clinical narrative: This is a spontaneous report from a contactable other hcp. This other hcp (patient) reported that a 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 22-years, intramuscular, administered in right arm on 30Sep2021 at 14:30 (batch/lot number was not reported) as dose 1, single for COVID-19 immunisation, at workplace clinic. Medical history included asthma. The patient was not pregnant at time of vaccination. No other vaccine in four weeks, no COVID prior vaccination, no known allergies. Concomitant medications were not reported. On 30Sep2021, the patient experienced flush face, intense itching of the face and body, burning feeling of the face, dizzy and blisters on tongue. AE resulted in doctor or other healthcare professional office/clinic visit. Oral treatment for tongue and diphenhydramine hydrochloride (BENADRYL). Outcome of the events was recovered with lasting effects. No COVID tested post vaccination. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer. An adult female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took dose 1 of bnt162b2 on unspecified date (batch/lot number was not reported) for covid-19 immunization. The reporter informed that it was unknown if patient received other vaccine in four weeks and other medications in two weeks. On an unspecified date, the patient experienced stroke. The reporter informed that the patient had a stroke months ago after getting the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Breast cancer; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that the patient got breast cancer because of the vaccine on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Feeling abnormal, Gait inability, Illness, Inflammation
Clinical narrative: multi-system inflammatory syndrome; abdominal pain /abdominal cramping; unable to walk; muscle cramping; fever/ horrible fever; body was completely wiped out; she feels like shards of glass going down leg, she's in constant pain; she's been sick for the last 5 weeks; This is a spontaneous report from a contactable consumer (patient's spouse) via Pfizer-sponsored program.   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left shoulder on 24Aug2021 (at the age of 51-year-old) (Batch/Lot Number: FA6780) as single dose for COVID-19 immunisation, administered at Pharmacy.  Medical history was none.   The patient's concomitant medications were not reported. No previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No other prior vaccinations within four weeks prior to the first. No events following prior vaccinations. No relevant tests.0 The patient experienced abdominal pain (non-serious) on 25Aug2021 with outcome of not recovered and worsened, unable to walk (non-serious) on 25Aug2021 with outcome of not recovered and worsened, muscle cramping (non-serious) on 25Aug2021 with outcome of not recovered and worsened, fever/ horrible fever (non-serious) on 25Aug2021 with outcome of not recovered and worsened, multi-system inflammatory syndrome (medically significant) on an unspecified date with outcome of unknown, body was completely wiped out (non-serious) on 25Aug2021 with outcome of not recovered and worsened, she feels like shards of glass going down leg, she's in constant pain (non-serious) on 25Aug2021 with outcome of not recovered and worsened, she's been sick for the last 5 weeks (non-serious) on 25Aug2021 with outcome of not recovered, abdominal cramping (non-serious) on 25Aug2021 with outcome of not recovered. The events required a visit to Physician Office and Emergency Room. She has been in the emergency room. The clinical course of events was as follows: She received first dose of Pfizer Covid 19 vaccine last month, first she started getting abdominal pain and it continued to worsen, she was been unable to walk, had muscle cramping and fever, the symptoms have not worn off, they continue to get worse, they spoke to a provider, and the provider said it was normal after receiving the vaccine. All symptoms began the day after the shot, 25Aug2021, are ongoing, worsening. The doctor said she had multi system inflammatory syndrome. She had a horrible fever, abdominal cramping, her body was completely wiped out, still having trouble walking hasn't been able to go to work, it has been pretty horrendous, she's having muscle cramping, it was constant, one thing after another, she felt like shards of glass going down leg, she was in constant pain. She's been sick for the last 5 weeks.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pyrexia
Clinical narrative: multi-system inflammatory syndrome; abdominal pain /abdominal cramping; unable to walk; muscle cramping; fever/ horrible fever; body was completely wiped out; she feels like shards of glass going down leg, she's in constant pain; she's been sick for the last 5 weeks; This is a spontaneous report from a contactable consumer (patient's spouse) via Pfizer-sponsored program.   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left shoulder on 24Aug2021 (at the age of 51-year-old) (Batch/Lot Number: FA6780) as single dose for COVID-19 immunisation, administered at Pharmacy.  Medical history was none.   The patient's concomitant medications were not reported. No previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No other prior vaccinations within four weeks prior to the first. No events following prior vaccinations. No relevant tests.0 The patient experienced abdominal pain (non-serious) on 25Aug2021 with outcome of not recovered and worsened, unable to walk (non-serious) on 25Aug2021 with outcome of not recovered and worsened, muscle cramping (non-serious) on 25Aug2021 with outcome of not recovered and worsened, fever/ horrible fever (non-serious) on 25Aug2021 with outcome of not recovered and worsened, multi-system inflammatory syndrome (medically significant) on an unspecified date with outcome of unknown, body was completely wiped out (non-serious) on 25Aug2021 with outcome of not recovered and worsened, she feels like shards of glass going down leg, she's in constant pain (non-serious) on 25Aug2021 with outcome of not recovered and worsened, she's been sick for the last 5 weeks (non-serious) on 25Aug2021 with outcome of not recovered, abdominal cramping (non-serious) on 25Aug2021 with outcome of not recovered. The events required a visit to Physician Office and Emergency Room. She has been in the emergency room. The clinical course of events was as follows: She received first dose of Pfizer Covid 19 vaccine last month, first she started getting abdominal pain and it continued to worsen, she was been unable to walk, had muscle cramping and fever, the symptoms have not worn off, they continue to get worse, they spoke to a provider, and the provider said it was normal after receiving the vaccine. All symptoms began the day after the shot, 25Aug2021, are ongoing, worsening. The doctor said she had multi system inflammatory syndrome. She had a horrible fever, abdominal cramping, her body was completely wiped out, still having trouble walking hasn't been able to go to work, it has been pretty horrendous, she's having muscle cramping, it was constant, one thing after another, she felt like shards of glass going down leg, she was in constant pain. She's been sick for the last 5 weeks.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 with symptoms (patient tested positive for Covid); COVID-19 with symptoms (patient tested positive for Covid); This is a spontaneous report from a contactable consumer (patient's wife). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in Arm Right on 13Sep2021 (Lot Number: FB8448) at age of 46-year-old at single dose, dose 2 via an unspecified route of administration administered in Arm Right on 04Oct2021 (Lot Number: FB8448) at age of 46-year-old at single dose for COVID-19 immunisation. Medical history included ongoing thyroid disorder diagnosed maybe two years ago. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks prior to the first administration date of the suspect vaccine. The patient experienced covid-19 with symptoms (patient tested positive for COVID) on 06Oct2021. Caller stated because she and her husband got first vaccine on 13Sep2021 both got second dose on 04Oct2021 and late 06Oct2021 caller stated her husband was having what they thought were side effects, stated he had a high fever, was very sick, he was unable to get out of bed exhausted, coughing, thought it was side effects, caller stated he went to the doctor this morning and has tested positive for COVID, caller told him that because it was so soon after getting the vaccine he should call Pfizer to report. Caller clarified her husband tested this morning, 12Oct2021 at 10:15 AM. The AE(s) did not require a visit to emergency room. The outcome of the events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: About 1 1/2 weeks after 2nd dose of covid vaccine, patient began exhibiting symptoms of Parosmia, namely: consistently complaining of rancid smells when around certain foods (eggs, chicken, onions, garlic).  There is no available treatment in her local area.  Symptoms are ongoing.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular, Muscle spasms
Clinical narrative: Vaginal bleeding/spotting within 72hrs of second vaccine, two weeks before my normal menstrual cycle. Menstrual cycle was heavier, lasted a couple days longer, and cramps were more intense.   Second menstrual cycle came at the normal time, lasted a day or two longer than usual, bleeding was a little heavier. However, it is now two weeks after that period I started spotting again yesterday along with breast tenderness. No pregnancy, and no other symptoms.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding/spotting within 72hrs of second vaccine, two weeks before my normal menstrual cycle. Menstrual cycle was heavier, lasted a couple days longer, and cramps were more intense.   Second menstrual cycle came at the normal time, lasted a day or two longer than usual, bleeding was a little heavier. However, it is now two weeks after that period I started spotting again yesterday along with breast tenderness. No pregnancy, and no other symptoms.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin discolouration
Clinical narrative: Rash on my right knee first doses. Now with booster, I have rash and my skin is dark on both my inner thighs.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Condition aggravated, Dizziness, Heart rate increased, Orthostatic hypotension
Clinical narrative: Recurrence of orthostatic hypotension that had been in remission( a year or more since last notable instance).  Exact recurrence unsure, but steady increase following a week after vaccination.   On June 5th, noticeable symptoms started to occur, with head rushing, dizziness, and heart rate rising.  Above the norm  On June 8th, severe instance, near loss of consciousness when standing up in a public place.  Heart rate exceedingly high with moderate chest pain following after. Tingling and buzzing in head as dizziness set in.    Following afternoon of June 8th incident, Trip was made to emergency room, POTS was tested for and not found, told to monitor health and use compression socks and exercises to improve blood flow.    Moderate improvement of symptoms, but recurring episodes multiple times a week, as well as irregularly high heartbeat while relaxed( recorded over 120 via smartwatch and self measurement while simply in conversation at a table multiple times).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Presyncope, Tinnitus
Clinical narrative: Recurrence of orthostatic hypotension that had been in remission( a year or more since last notable instance).  Exact recurrence unsure, but steady increase following a week after vaccination.   On June 5th, noticeable symptoms started to occur, with head rushing, dizziness, and heart rate rising.  Above the norm  On June 8th, severe instance, near loss of consciousness when standing up in a public place.  Heart rate exceedingly high with moderate chest pain following after. Tingling and buzzing in head as dizziness set in.    Following afternoon of June 8th incident, Trip was made to emergency room, POTS was tested for and not found, told to monitor health and use compression socks and exercises to improve blood flow.    Moderate improvement of symptoms, but recurring episodes multiple times a week, as well as irregularly high heartbeat while relaxed( recorded over 120 via smartwatch and self measurement while simply in conversation at a table multiple times).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain radiating from tips of fingers to neck & shoulders. Numbness & parenthesis to left hand
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site erythema, Injection site warmth, Lymphadenopathy
Clinical narrative: Red circle at injection site that feels warm. Swollen lymph nodes extending into left breast and diarrhea.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Joint pain and inflammation. Headache; hot and cold flashes; restlessness; tiredness.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Restlessness
Clinical narrative: Joint pain and inflammation. Headache; hot and cold flashes; restlessness; tiredness.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Lymph node pain, Oedema peripheral
Clinical narrative: Had moderna booster following J&J vaccine back in March. Starting 7 hours after booster developed pain/tenderness in lymph nodes under arm on left side (same side as shot). By 12-15 hours there has been big swelling in this area. Pain and swelling still present 44 hours after injection.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Admitted to Hospital on Date of Adverse Event for treatment of Covid-19 Positive following completion of Covid Vaccine Series
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper storage (temperature).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Dysuria, Eye swelling, Renal pain
Clinical narrative: kidney pain- not like a UTI, pain in lower abdomen that wraps around back when urinating  swollen right eye- woke up swollen from a nap on 10/26 at 5:30pm and remained swollen throughout the evening/night and was still swollen on 10/27/21 once awake at 5:45am.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site discomfort, Loss of personal independence in daily activities, Pain in extremity, Sleep disorder
Clinical narrative: I had horrible joint pain beginning that evening.  So bad that I could not sleep.  My hands, hips, and feet were the worst.  The pain has subsided somewhat over time,  but is very bad certain days.   It really bothers me in that it has suddenly changed my daily activity, lifestyle and comfort level.  My hope was this would go away, but it is approaching 11 months with little change.  I also wish to denote that I received my booster a few days ago.  I received the Pfizer and had nearly no reaction to it.  I only had mild discomfort at the injection site...
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Headache, Hot flush, Nausea, Pain
Clinical narrative: fevers, nausea, achy, right side of face swollen, bilateral eyes swollen, rash on left arm, swollen left arm, headache flushed
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, Swelling face
Clinical narrative: fevers, nausea, achy, right side of face swollen, bilateral eyes swollen, rash on left arm, swollen left arm, headache flushed
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Chills, Dry mouth, Fatigue, Heavy menstrual bleeding
Clinical narrative: About two hours after vaccine, severe dry mouth continued for about 12 hours. At exactly 12 hours after vaccine, muscle aches, fatigue, chills, nausea all lasted for about 3 days. First menstrual cycle after vaccine, which occurred in august, was extremely heavy. It lasted about 10 days and was almost uncontrollable, accompanied by anemia. This is absolutely not normal while being on a well managed birth control regimen. September cycle was also heavier  and longer, but not as bad.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Myalgia, Nausea
Clinical narrative: About two hours after vaccine, severe dry mouth continued for about 12 hours. At exactly 12 hours after vaccine, muscle aches, fatigue, chills, nausea all lasted for about 3 days. First menstrual cycle after vaccine, which occurred in august, was extremely heavy. It lasted about 10 days and was almost uncontrollable, accompanied by anemia. This is absolutely not normal while being on a well managed birth control regimen. September cycle was also heavier  and longer, but not as bad.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Nausea, headaches, sore arm
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Pain and swelling in left arm. Pain in joints,  Pain in every joint has persisted for months. Left elbow swollen to  2 inches.  The swelling in the elbow still exist.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Admitted to Hospital on Date of Adverse Event [recorded in VAERS] for treatment of Covid-19 Positive following completion of Covid Vaccine Series.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Nausea, Somnolence
Clinical narrative: Starting about 2PM 20oct, I started to feel extremely fatigued.  I was falling asleep sitting down.  Through out the remainder of the work day, I struggled to stay awake.  Toward the end of the evening, 8PM or so, I developed a headache so I went to bed.  I woke up at 530AM on the 21st with an extreme headache.  I couldn't open my eyes longer than a few seconds, the room seemed to be moving in and out as if I was zooming in and out on a camera, and I was nauseous.  I called off work and went back to sleep. I woke up at 930am and the headache intensity had subsided.  I was still tired but got up and started moving around.  The headache gradually went away throughout the day and but the morning of the 22nd, was gone.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Starting about 2PM 20oct, I started to feel extremely fatigued.  I was falling asleep sitting down.  Through out the remainder of the work day, I struggled to stay awake.  Toward the end of the evening, 8PM or so, I developed a headache so I went to bed.  I woke up at 530AM on the 21st with an extreme headache.  I couldn't open my eyes longer than a few seconds, the room seemed to be moving in and out as if I was zooming in and out on a camera, and I was nauseous.  I called off work and went back to sleep. I woke up at 930am and the headache intensity had subsided.  I was still tired but got up and started moving around.  The headache gradually went away throughout the day and but the morning of the 22nd, was gone.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: Severe stiffness and muscle aches in back and neck