chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Neuralgia, Spinal pain, Swelling
Clinical narrative: Hot pain spots on top and  back of head progressing to an intense nerve pain over two weeks moving from head down the back.; Hot pain spots on top and  back of head progressing to an intense nerve pain over two weeks moving from head down the back.; sleepness nights; a burning pain  at top of vertebrae with a swelling feeling inside the head; a burning pain  at top of vertebrae with a swelling feeling inside the head; This is a spontaneous report from a contactable consumer reporting for herself. This 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247) at single dose in left arm at age of 55-year-old on 02Apr2021 11:00 for COVID-19 immunization. The first dose was on 05Mar2021 11:00 in left arm, Lot number: EN6204, at age of 55-year-old. Medical history included endometriosis from 1999; trigeminal nerve neuralgia from 2011. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 15:00, patent had hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving from head down the back. Pain continued with similar intensity over the next 7 weeks causing sleepiness nights until treated with steroids at week 9 where sleeping became possible. Condition continued at week 10 but a burning pain at top of vertebrae with a swelling feeling inside the head. Steroid treatment was ongoing. The adverse events result doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The treatment received for the adverse events was gabapentin, acyclovir, prednisone. The outcome of events was not recovered.   Follow up attempts are needed. Additional information can be requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Feeling cold, Hypotension, Seizure, Syncope
Clinical narrative: Mild seizure; could not see; fainting; low blood pressure; Felt cold; This is a spontaneous report from a contactable consumer. A non-pregnant 13-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Jun2021 at 10:00 AM, at patient age of 13-year-old, as single dose (Lot number EwO191) for COVID-19 immunization. The patient had no COVID prior vaccination. The patient's medical history was none. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medications within 2 weeks of vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 25May2021 at 15:00 PM, at patient age of 13-year-old, as single dose (Lot number Ew175) for COVID-19 immunisation. The patient experienced the adverse events from 15Jun2021 at 22:15 PM. The patient experienced mild seizure, could not see and low blood pressure, fainting. The patient felt cold and could not see is what she said before sitting in the chair at the pharmacy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with laying down with propped up legs and water. The outcome of the events was resolved.  COVID was not tested post vaccination.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: Child diagnosed with appendicitis.; This is a spontaneous report from a contactable consumer (patient). A 15 years-old male patient received 2nd dose of covid vaccine lot number=EW0180, at the age of 15 years old, on 08Jun2021 04:00 PM on Left arm for covid-19 immunization. No known allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was multivitamin. Historical vaccine was the 1st dose of BNT162B2 (lot number=EW0177) on 18May2021 04:00 PM on Left arm for covid-19 immunization. No reaction on previous exposure to vaccine. On 14Jun2021 11:00 PM, Child diagnosed with appendicitis. AE resulted in Emergency room/department or urgent care, Hospitalization 1 day. Treatment was Appendectomy. Seriousness criteria-Caused/prolonged hospitalization. Prior to vaccination, patient was not diagnosed with COVID-19. Covid test post vaccination: covid test type post vaccination=Blood test on 15Jun2021, Negative. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced heart failure on an unspecified date due to vaccine according to preliminary investigations of symptoms. Event took place after use of product. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported event heart failure and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Chest X-ray, Musculoskeletal chest pain, Neck pain
Clinical narrative: Pain from neck down to bottom of rib cage on right side/extreme pain; Pain from neck down to bottom of rib cage on right side/extreme pain; A deep breath caused extreme pain; Pain continued across the stomach; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm, on 04Jun2021 16:30 (Batch/Lot Number: EW0182), as dose 2, single, at age 59 years old, for COVID-19 immunisation, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included migraine, thoracic disc degeneration, cervical dystonia, known allergies: cats, IV dye, tegaderm and "trednisone" (as reported), all from unknown dates. The patient was not diagnoswed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included ubrogepant (UBRELVY); zolmitriptan; galcanezumab (EMGALITY); gabapentin, and "tiza" (as reported), all taken for unspecified indications, start and stop dates were not reported. The patient previously took imipramine and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, received on 14May2021 16:30 (batch/lot number: EW0167), as dose 1, single, at age 59 years old, for COVID-19 immunisation and the patient had no reaction. On 04Jun2021 21:00, the patient experienced pain from neck down to bottom of rib cage on right side/extreme pain, a deep breath caused extreme pain, and pain continued onto the left side from the neck down to the bottom of the rib cage and across the stomach with the same symptoms. The patient used heat, flu and cold medicine, with Benadryl at night. Treatment was also reported as "doctor's visit, blood work and chest x-rays". The events resulted to physician's office visit. The patient had COVID-19 nasal swab on 29May2021 which was negative. The patient underwent blood work and chest x-rays on an unspecified date with unknown results. The outcome of the events was recovering. The reporter assessed the events as non-serious.  Follow-up attempts are needed. Further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Painful respiration, SARS-CoV-2 test
Clinical narrative: Pain from neck down to bottom of rib cage on right side/extreme pain; Pain from neck down to bottom of rib cage on right side/extreme pain; A deep breath caused extreme pain; Pain continued across the stomach; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm, on 04Jun2021 16:30 (Batch/Lot Number: EW0182), as dose 2, single, at age 59 years old, for COVID-19 immunisation, at a pharmacy/drug store. The patient was not pregnant at the time of vaccination. Medical history included migraine, thoracic disc degeneration, cervical dystonia, known allergies: cats, IV dye, tegaderm and "trednisone" (as reported), all from unknown dates. The patient was not diagnoswed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Concomitant medications included ubrogepant (UBRELVY); zolmitriptan; galcanezumab (EMGALITY); gabapentin, and "tiza" (as reported), all taken for unspecified indications, start and stop dates were not reported. The patient previously took imipramine and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm, received on 14May2021 16:30 (batch/lot number: EW0167), as dose 1, single, at age 59 years old, for COVID-19 immunisation and the patient had no reaction. On 04Jun2021 21:00, the patient experienced pain from neck down to bottom of rib cage on right side/extreme pain, a deep breath caused extreme pain, and pain continued onto the left side from the neck down to the bottom of the rib cage and across the stomach with the same symptoms. The patient used heat, flu and cold medicine, with Benadryl at night. Treatment was also reported as "doctor's visit, blood work and chest x-rays". The events resulted to physician's office visit. The patient had COVID-19 nasal swab on 29May2021 which was negative. The patient underwent blood work and chest x-rays on an unspecified date with unknown results. The outcome of the events was recovering. The reporter assessed the events as non-serious.  Follow-up attempts are needed. Further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood glucose abnormal, Colitis microscopic, Diabetes mellitus, Diarrhoea, Impaired gastric emptying
Clinical narrative: Gastroparesis; Colitis collagenous; Worsening of diabetes; Blood sugar abnormal; Nausea aggravated; Vomiting; Diarrhea aggravated; This is a spontaneous report from a non contactable consumer reported for self. This 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via Intramuscular on Mar2021 as 2nd dose, single for COVID-19 immunisation and ongoing pancreatin (CREON) from 04May2021 orally at 1 or 2 capsules with meals depending on the volume,1 capsule per snack for exocrine pancreatic insufficiency. Medical history included no tobacco use, no alcohol use, NSAIDS allergy, codeine allergy manifestated by nausea, vomiting, omeprazole allergy manifestated by full body rash, penicillin allergy manifestated by rash. Past medications include penicillin, codeine and omeprazole. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Feb2021 at age of 70-year-old for COVID-19 immunisation. blood sugar level was labile, worsened diabetes, worsened nausea and vomiting with creon (pancrea-tin). In May2021, the patient experienced Gastroparesis/ gastroparesis worsened, worsened diarrhea, Colitis collagenous, blood sugar level was labile, worsened diabetes and worsened nausea. On 10Jun2021, the patient experienced vomiting. Once patient was on Creon her husband noticed Gastroparesis worsened. Her diarrhea became worse. Prior to 10Jun2021, she was never vomited for at least a year. Physician wanted to switch Zofran to emend to manage severity of her nausea but it was not implemented yet due to financial reasons. Her husband did not have the time to provide the concomitant medications during the call. She had a shot of CoVid-19 vaccine before at least one symptom happened therefore CoVid-19 vaccine was considered as co-suspect product. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The patient was treated with ZOFRAN. Spontaneous report from a consumer of with events of non-serious gastroparesis worsened, worsened diarrhea, collagenous colitis. Action taken with pancreatin was dose not changed. Outcome of the events was not recovered. The reporter's causality for the events of gastroparesis worsened, worsened diarrhea, collagenous colitis onset in May 2021, blood sugar level was labile, worsened diabetes, worsened nausea, vomiting and worsened diarrhea, collagenous colitis onset in May2021 was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Vomiting
Clinical narrative: Gastroparesis; Colitis collagenous; Worsening of diabetes; Blood sugar abnormal; Nausea aggravated; Vomiting; Diarrhea aggravated; This is a spontaneous report from a non contactable consumer reported for self. This 70-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via Intramuscular on Mar2021 as 2nd dose, single for COVID-19 immunisation and ongoing pancreatin (CREON) from 04May2021 orally at 1 or 2 capsules with meals depending on the volume,1 capsule per snack for exocrine pancreatic insufficiency. Medical history included no tobacco use, no alcohol use, NSAIDS allergy, codeine allergy manifestated by nausea, vomiting, omeprazole allergy manifestated by full body rash, penicillin allergy manifestated by rash. Past medications include penicillin, codeine and omeprazole. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Feb2021 at age of 70-year-old for COVID-19 immunisation. blood sugar level was labile, worsened diabetes, worsened nausea and vomiting with creon (pancrea-tin). In May2021, the patient experienced Gastroparesis/ gastroparesis worsened, worsened diarrhea, Colitis collagenous, blood sugar level was labile, worsened diabetes and worsened nausea. On 10Jun2021, the patient experienced vomiting. Once patient was on Creon her husband noticed Gastroparesis worsened. Her diarrhea became worse. Prior to 10Jun2021, she was never vomited for at least a year. Physician wanted to switch Zofran to emend to manage severity of her nausea but it was not implemented yet due to financial reasons. Her husband did not have the time to provide the concomitant medications during the call. She had a shot of CoVid-19 vaccine before at least one symptom happened therefore CoVid-19 vaccine was considered as co-suspect product. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. The patient was treated with ZOFRAN. Spontaneous report from a consumer of with events of non-serious gastroparesis worsened, worsened diarrhea, collagenous colitis. Action taken with pancreatin was dose not changed. Outcome of the events was not recovered. The reporter's causality for the events of gastroparesis worsened, worsened diarrhea, collagenous colitis onset in May 2021, blood sugar level was labile, worsened diabetes, worsened nausea, vomiting and worsened diarrhea, collagenous colitis onset in May2021 was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Blood test, Computerised tomogram, Echocardiogram
Clinical narrative: My mother collapsed the morning after her second shot.; She was non responsive; blood pressure was very high; limp, could not walk; squeezing sensation around head; Fatigue; This is a spontaneous report received from a contactable consumer (Patient). A 96-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWo191) via an unspecified route of administration, administered in Arm Left on 09Jun2021 at 01:00 PM as single dose for covid-19 immunisation at Pharmacy/drug store. Medical history included renal insufficiency and Grave's Disease. Patient had no known allergies. The patient's concomitant medications were not reported but she received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ewo176) via an unspecified route of administration, administered in Left arm on an unspecified date in May2021 at 01:00 PM covid-19 immunisation. On 10Jun2021 at 09:00, the patient collapsed the morning after her second shot, she was nonresponsive, limp, could not walk, blood pressure was very high, squeezing sensation around head (stated did not know what year it was). Ambulance was called and she was hospitalized for two days. CT scans and blood work were normal. ER (emergency room) Doctor and floor Doctor both said it was an extreme reaction to the second dose of the vaccine. Fatigue, unresponsive episodes continued for two days after she was released to home. The patient underwent lab tests and procedures which included blood pressure measurement: high, blood test: normal, computerised tomogram: normal, echocardiogram: unknown, urine analysis: unknown. Therapeutic measures were taken as a result adverse event. The outcome of events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on close temporal relationship the causal role of the vaccine cannot be excluded for the reported events. Renal insufficiency and graves disease can be contributory to event
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Gait disturbance, Head discomfort, Loss of consciousness
Clinical narrative: My mother collapsed the morning after her second shot.; She was non responsive; blood pressure was very high; limp, could not walk; squeezing sensation around head; Fatigue; This is a spontaneous report received from a contactable consumer (Patient). A 96-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWo191) via an unspecified route of administration, administered in Arm Left on 09Jun2021 at 01:00 PM as single dose for covid-19 immunisation at Pharmacy/drug store. Medical history included renal insufficiency and Grave's Disease. Patient had no known allergies. The patient's concomitant medications were not reported but she received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ewo176) via an unspecified route of administration, administered in Left arm on an unspecified date in May2021 at 01:00 PM covid-19 immunisation. On 10Jun2021 at 09:00, the patient collapsed the morning after her second shot, she was nonresponsive, limp, could not walk, blood pressure was very high, squeezing sensation around head (stated did not know what year it was). Ambulance was called and she was hospitalized for two days. CT scans and blood work were normal. ER (emergency room) Doctor and floor Doctor both said it was an extreme reaction to the second dose of the vaccine. Fatigue, unresponsive episodes continued for two days after she was released to home. The patient underwent lab tests and procedures which included blood pressure measurement: high, blood test: normal, computerised tomogram: normal, echocardiogram: unknown, urine analysis: unknown. Therapeutic measures were taken as a result adverse event. The outcome of events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on close temporal relationship the causal role of the vaccine cannot be excluded for the reported events. Renal insufficiency and graves disease can be contributory to event
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: My mother collapsed the morning after her second shot.; She was non responsive; blood pressure was very high; limp, could not walk; squeezing sensation around head; Fatigue; This is a spontaneous report received from a contactable consumer (Patient). A 96-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWo191) via an unspecified route of administration, administered in Arm Left on 09Jun2021 at 01:00 PM as single dose for covid-19 immunisation at Pharmacy/drug store. Medical history included renal insufficiency and Grave's Disease. Patient had no known allergies. The patient's concomitant medications were not reported but she received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ewo176) via an unspecified route of administration, administered in Left arm on an unspecified date in May2021 at 01:00 PM covid-19 immunisation. On 10Jun2021 at 09:00, the patient collapsed the morning after her second shot, she was nonresponsive, limp, could not walk, blood pressure was very high, squeezing sensation around head (stated did not know what year it was). Ambulance was called and she was hospitalized for two days. CT scans and blood work were normal. ER (emergency room) Doctor and floor Doctor both said it was an extreme reaction to the second dose of the vaccine. Fatigue, unresponsive episodes continued for two days after she was released to home. The patient underwent lab tests and procedures which included blood pressure measurement: high, blood test: normal, computerised tomogram: normal, echocardiogram: unknown, urine analysis: unknown. Therapeutic measures were taken as a result adverse event. The outcome of events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on close temporal relationship the causal role of the vaccine cannot be excluded for the reported events. Renal insufficiency and graves disease can be contributory to event
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Atrioventricular block, C-reactive protein, Cardiac dysfunction, Inflammation
Clinical narrative: he indicated recent medical tests reading excessive levels of "CRT" inflammation; He has been suffering a decline in cardiac function since Feb2021 of this year - so far explained as new blockages; decline in cardiac function since Feb2021 of this year so far explained as new blockages; This is a spontaneous report from a contactable consumer. A 79-year-old male patient (reporter's father) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at the age of 79-year-old as single dose for covid-19 immunisation. Medical history included cardiac disorder from 2011, he had been a cardiac patient more than 10 years. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. In discussion with the patient on 15Jun2021, he indicated recent medical tests reading excessive levels of CRP (reported as "CRT") inflammation which he and doctors are trying to resolve by changing some meds. The reporting consumer recalled that the Cominraty vaccine did have some warnings about inflammation and so need to report this for review. Patient had been suffering a decline in cardiac function since Feb2021 of this year so far explained as new blockages. He had been a cardiac patient more than 10 years and experienced a shift in his condition and function during the 1st quarter of 2021. The adverse event result in doctor or other healthcare professional office/clinic visit. The adverse event result in emergency room/department or urgent care and hospitalization. Since the vaccination, it was unknown if the patient had been tested for COVID-19. Outcome of the events was unknown.   Information about lot/batch number was requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clot in left leg; This is a spontaneous report received from a contactable consumer or other non hcp.  A 59-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FL3302) via an unspecified route of administration in Arm Left on 22Jan2021 at 16:00 (age at vaccination 59-years-old) as dose 1, single for covid-19 immunization. The patient also received other Pfizer vaccine (batch number: EM9809) as dose 2 on 22Jan2021.The patient did not had any medical history. Concomitant medications included esomeprazole (ESOMEPRAZOLE), ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), ascorbic acid, calcium carbonate, calcium pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX WITH C). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19.On 06May2021, the patient experienced blood clot in left leg. The patient received treatment blood thinning medication x 3 months for the adverse events. The patient had not yet recovered from the events.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 06Jun21 came down with an unusual rash on stomach, face, and to both arms and hands; This is a spontaneous report from a contactable Healthcare professional (patient) reported for herself. A 49-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0179, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 12May2021 at 09:30 am (age at vaccination was 49 years) as 2nd dose, single for COVID-19 immunization. The patient did not have any medical history. The patient had known allergy to adhesive. Concomitant medications were not reported. The patient previously took Tetracycline and experienced allergy. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0170, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 21Apr2021 at 10:00 am (age at vaccination was 49 years) as 1st dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 06Jun21, the patient came down with an unusual rash on stomach, face, and arm. Rash spread within a week on stomach, face, and to both arms and hands and was still present. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment with internal steroid, benedryl, and medicated lotion. The event was reported as non-serious. The device date was reported as 16Jun2021. The outcome of the event was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on known drug safety profile and temporal association, there is reasonable possibility of causal association between the event rash and the suspect vaccine BNT162B2.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus after the second dose; This is a spontaneous report from a contactable consumer (reporting himself). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration in left arm on 29May2021 at 10:00 (age at the time of vaccination was 72-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient had no relevant medical history. The patient did not receive any other medications within 2 weeks of vaccination. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0164), via an unspecified route of administration in left arm on 29Apr2021 at 09:00 as a single dose for COVID-19 immunization. On 02Jun2021, the patient experienced tinnitus after the second dose and resulted in disability or permanent damage. The patient did not receive any treatment medication for the event. The outcome of the event was not resolved.  Information on Lot/Batch number is available; Further information has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blindness unilateral, Body temperature, Chills, Limb discomfort
Clinical narrative: Lose sight in my left eye; Weakness; Heaviness in my legs/feet; Chills; Low grade fever; Neuoromyelitis Optica; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 08Apr2021 at 10:00 as dose 2, single (at the age of 47-years-old) for covid-19 immunisation. Medical history included vitiligo and known allergies to some raw fruits & vegetables and known allergies to penicillin. Patient received no other vaccines in four weeks. Concomitant medications or other medications in two weeks included pantoprazole, pimecrolimus (Elidel) and boron, calcium, Cimicifuga racemosa extract, folic acid, glycine max extract, Magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin B12 NOS (Estroven). Patient was not diagnosed with COVID prior vaccination. Historical vaccination included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Mar2021at 09:30 hours as dose 1, single for covid-19 immunisation and had no reaction on previous exposure to drug. Patient was COVID tested post vaccination by nasal swab and result was negative. On 09Apr2021 (the day after the second dose), patient had chills, low grade fever. On 13Apr2021 (4 days after the second dose, patient began to had weakness and heaviness in her legs/feet and by 16Apr2021, patient began to lose sight in her left eye and had to be hospitalized for a week. Patient received high dose of steroids and had to have plasma exchange (plasmapheresis) for an antibody (Neuoromyelitis Optica) that was triggered in her system, as treatment for all the events. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Event lose sight in her left eye was considered as serious (hospitalization and disability) by the reporter. The outcome of all the event was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neuromyelitis optica spectrum disorder, Pyrexia, SARS-CoV-1 test
Clinical narrative: Lose sight in my left eye; Weakness; Heaviness in my legs/feet; Chills; Low grade fever; Neuoromyelitis Optica; This is a spontaneous report from a contactable consumer (patient). A 47-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER8729, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 08Apr2021 at 10:00 as dose 2, single (at the age of 47-years-old) for covid-19 immunisation. Medical history included vitiligo and known allergies to some raw fruits & vegetables and known allergies to penicillin. Patient received no other vaccines in four weeks. Concomitant medications or other medications in two weeks included pantoprazole, pimecrolimus (Elidel) and boron, calcium, Cimicifuga racemosa extract, folic acid, glycine max extract, Magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin B12 NOS (Estroven). Patient was not diagnosed with COVID prior vaccination. Historical vaccination included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 18Mar2021at 09:30 hours as dose 1, single for covid-19 immunisation and had no reaction on previous exposure to drug. Patient was COVID tested post vaccination by nasal swab and result was negative. On 09Apr2021 (the day after the second dose), patient had chills, low grade fever. On 13Apr2021 (4 days after the second dose, patient began to had weakness and heaviness in her legs/feet and by 16Apr2021, patient began to lose sight in her left eye and had to be hospitalized for a week. Patient received high dose of steroids and had to have plasma exchange (plasmapheresis) for an antibody (Neuoromyelitis Optica) that was triggered in her system, as treatment for all the events. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Event lose sight in her left eye was considered as serious (hospitalization and disability) by the reporter. The outcome of all the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion
Clinical narrative: bruising more easily; increase in joint pain; This is a spontaneous report from a contactable other HCP. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced bruising more easily during the past few months; md not aware. Patient is worried about the side effects of therapy, especially the risk for blood clots. Patient noticed in increase in joint pain, MD aware. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I had a period 21 days after first vaccine even though I am post menopausal and have been for 6 years.; This is a spontaneous report from a contactable consumer ( patient reported herself ). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number:ER8727, expiry date:unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 22May2021 at 09:15 (at age of 59-years-old) (DOSE 1, SINGLE for covid-19 immunization. The patient medical history included AC nodal re-entry tachycardia 1991/1993-Heart ablations corrected the rhythm issue and non-small cell adenocarcinoma in right lung 2015.Concomitant medication included calcium carbonate, cholecalciferol (VITAMIN D 2000). The patient previously took midazolam, epinephrine, diphenhydramine, levofloxacin, penicillin and dibromoglutaronitrile, c. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The most recent COVID-19 vaccine was administered at Hospital. The patient is not pregnant at time of vaccination. On 14Jun2021 at 15:45, the patient reported she had a period 21 days after first vaccine even though her post-menopausal and have been for 6 years.  The reporter assessed the event as non serious.The event outcome was recovering.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea, Ovarian cyst ruptured
Clinical narrative: Ruptured ovarian cyst one month after vaccine/Second ovarian cyst one month after the first ruptured cyst; Prolonged menstruation starting 2 days after vaccine.; Second prolonged menstrual cycle shortly after ruptured cyst; This is a spontaneous report from a contactable consumer (patient). A 17-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, in left arm on 19Apr2021 at 13:30 pm (at the age of 17-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Known allergies reported as to dairy products, Elidel. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, in left arm on 29Mar2021 at 13:30pm (at the age of 17-year-old) as dose 1, single for covid-19 immunisation and experienced no reaction. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 17May2021 at 07:00 am, the patient experienced prolonged menstruation started 2 days after vaccine. Ruptured ovarian cyst one month after vaccine. Second prolonged menstrual cycle shortly after ruptured cyst. Second ovarian cyst one month after the first ruptured cyst. She had no prior history of prolonged/irregular menstrual cycles or ovarian cysts. The patient did not receive any treatment for the event. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Outcome of all events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Synovitis, Thrombosis
Clinical narrative: blood clotted; had persistent synovitis in all knuckles; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ew0186 and Expiration date: unknown), via an unspecified route of administration, in arm left on 26May2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included amitriptyline hydrochloride (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at 10 mg and frequency for unknown indication; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took flu shot on an unspecified date in 2017 and experienced synovitis. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 28May2021, since his first Pfizer shot have had persistent synovitis in all knuckles. On an unspecified date in Jun2021, 12 days after first Pfizer shot donated blood and blood clotted in tubes before completion. He had donated about 40 times and that was the first time his blood has clotted. The case was assessed as non-serious. No treatment was received for events. The clinical outcome of had persistent synovitis in all knuckles, blood clotted were not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling hot, Flushing
Clinical narrative: I did have diarrhea the next morning; Panic attack; It was a near fainting episode; It was a near fainting episode; Feel a flush go through my chest and then up through my face; I had an antiseptic taste in my mouth; feel hot all over; Sweating beads of sweat on my forehead running down; Suddenly my hearing went muffled almost completely out; Heart was also racing; Felt very lightheaded and dizzy; My hands and fingertips were tingling and felt numb; My hands and fingertips were tingling and felt numb; I had extreme arm soreness on the arm with the injection; I felt extremely tired and sluggish for the rest of the evening; I felt extremely tired and sluggish for the rest of the evening; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0191 and Expiration date: unknown), via an unspecified route of administration, in left arm on 15Jun2021 at 15:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. Medical history included PCOS and thyroid nodules from an unknown date. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for oral contraception, start and stop date were not reported. The patient previously took erythromycin. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 15Jun2021 at 15:00, within about 30 seconds of receiving the vaccine she could feel a flush go through her chest and then up through her face. She had an antiseptic taste in her mouth. She began to feel hot all over, started sweating beads of sweat on her forehead running down, suddenly her hearing went muffled almost completely out, heart was also racing and felt very lightheaded and dizzy. She had to lean back in the chair and close her eyes for about 15 minutes until it stopped. Afterwards when she got up to leave, still felt dizzy and her hands and fingertips were tingling and felt numb. Either this was a panic attack or it was a near fainting episode. Afterwards she had extreme arm soreness on the arm with the injection. She felt extremely tired and sluggish for the rest of the evening. The next day (as reported) she felt better, just a little sluggish with arm soreness. On 16Jun2021 the patient experienced that, she did have diarrhea the next morning which was not normal for her. Hospitalization was not required for events. No treatment was received for events. Outcome of events was recovered on an unknown date in Jun2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoacusis, Hypoaesthesia, Palpitations, Panic attack
Clinical narrative: I did have diarrhea the next morning; Panic attack; It was a near fainting episode; It was a near fainting episode; Feel a flush go through my chest and then up through my face; I had an antiseptic taste in my mouth; feel hot all over; Sweating beads of sweat on my forehead running down; Suddenly my hearing went muffled almost completely out; Heart was also racing; Felt very lightheaded and dizzy; My hands and fingertips were tingling and felt numb; My hands and fingertips were tingling and felt numb; I had extreme arm soreness on the arm with the injection; I felt extremely tired and sluggish for the rest of the evening; I felt extremely tired and sluggish for the rest of the evening; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EW0191 and Expiration date: unknown), via an unspecified route of administration, in left arm on 15Jun2021 at 15:00 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. Medical history included PCOS and thyroid nodules from an unknown date. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for oral contraception, start and stop date were not reported. The patient previously took erythromycin. Patient did not receive any other vaccine within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 since the vaccination. On 15Jun2021 at 15:00, within about 30 seconds of receiving the vaccine she could feel a flush go through her chest and then up through her face. She had an antiseptic taste in her mouth. She began to feel hot all over, started sweating beads of sweat on her forehead running down, suddenly her hearing went muffled almost completely out, heart was also racing and felt very lightheaded and dizzy. She had to lean back in the chair and close her eyes for about 15 minutes until it stopped. Afterwards when she got up to leave, still felt dizzy and her hands and fingertips were tingling and felt numb. Either this was a panic attack or it was a near fainting episode. Afterwards she had extreme arm soreness on the arm with the injection. She felt extremely tired and sluggish for the rest of the evening. The next day (as reported) she felt better, just a little sluggish with arm soreness. On 16Jun2021 the patient experienced that, she did have diarrhea the next morning which was not normal for her. Hospitalization was not required for events. No treatment was received for events. Outcome of events was recovered on an unknown date in Jun2021.