chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Asthenia, Blood pressure measurement, Body temperature increased, Computerised tomogram head
Clinical narrative: vomiting; weakness; SOB; Palpitations; headache; body pain; high blood pressure; nausea; heart beat; pain heart; couldnt sleep all night; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 42-year-old on 18Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to penicillins, cat dander, dog dander. The patient's concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 18Jul2021. The patient was really disappointed the way vaccine was working. A lot of side effects from vaccine without knowing exactly side effects. The patient decided to take the vaccine on 18Jul2021 and was completely fine before the vaccine. Everything goes wrong that night 18Jul2021, the patient couldn't sleep at night and thought it was normal reaction. But on 19Jul2021 everything got worse and the patient going to emergency room because the symptoms was not normal such as headache, body pains, high blood pressure, nausea, heartbeat abnormal, pain heart. The doctor said it was normal reaction to the vaccine and said if the patient feels same after 5 days, they need to check. But all symptoms got worse in fact, the patient started vomiting with all symptoms that no was going away on 01Aug2021. The patient was back to the hospital again with headache, nausea, vomiting, high blood pressure, weakness. The patient received some medication that day and feel better.  But the next day the symptoms no was going away, the patient had a lot of headache, nausea, high blood pressure and pain heart. The patient was waiting for MRI test of head. The patient was not able to work because got side effects from vaccine Pfizer. The patient also experienced SOB (dyspnoea) and palpitations on 29Jul2021. The events were caused patient Emergency Room Visit. It is reported the patient under treatment with Acetaminophen (Tylenol), Metoclopramide HCL (REGLAN), sodium Chloride 0.9% 1000ml Bolus for all events. The patient underwent lab tests and procedures which included blood pressure measurement: 137/76, body temperature increased: 98 fahrenheit, CT head Brain W/O contrast: results awaiting, Culture Urine -Random: unknown, CBC with diierential: unknown, Pulse: 68, MRI: unknown, Basic Metabolic Panel: unknown, oxygen saturation: 99 %, Respiration: 18, POCT HCG Urine: unknown, POCT Urine Dipstick: unknown, Urinalysis: unknown, all on an unknown date. The outcome of the all events were not recovered.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Culture urine, Dyspnoea, Full blood count, Headache, Heart rate
Clinical narrative: vomiting; weakness; SOB; Palpitations; headache; body pain; high blood pressure; nausea; heart beat; pain heart; couldnt sleep all night; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 42-year-old on 18Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to penicillins, cat dander, dog dander. The patient's concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 18Jul2021. The patient was really disappointed the way vaccine was working. A lot of side effects from vaccine without knowing exactly side effects. The patient decided to take the vaccine on 18Jul2021 and was completely fine before the vaccine. Everything goes wrong that night 18Jul2021, the patient couldn't sleep at night and thought it was normal reaction. But on 19Jul2021 everything got worse and the patient going to emergency room because the symptoms was not normal such as headache, body pains, high blood pressure, nausea, heartbeat abnormal, pain heart. The doctor said it was normal reaction to the vaccine and said if the patient feels same after 5 days, they need to check. But all symptoms got worse in fact, the patient started vomiting with all symptoms that no was going away on 01Aug2021. The patient was back to the hospital again with headache, nausea, vomiting, high blood pressure, weakness. The patient received some medication that day and feel better.  But the next day the symptoms no was going away, the patient had a lot of headache, nausea, high blood pressure and pain heart. The patient was waiting for MRI test of head. The patient was not able to work because got side effects from vaccine Pfizer. The patient also experienced SOB (dyspnoea) and palpitations on 29Jul2021. The events were caused patient Emergency Room Visit. It is reported the patient under treatment with Acetaminophen (Tylenol), Metoclopramide HCL (REGLAN), sodium Chloride 0.9% 1000ml Bolus for all events. The patient underwent lab tests and procedures which included blood pressure measurement: 137/76, body temperature increased: 98 fahrenheit, CT head Brain W/O contrast: results awaiting, Culture Urine -Random: unknown, CBC with diierential: unknown, Pulse: 68, MRI: unknown, Basic Metabolic Panel: unknown, oxygen saturation: 99 %, Respiration: 18, POCT HCG Urine: unknown, POCT Urine Dipstick: unknown, Urinalysis: unknown, all on an unknown date. The outcome of the all events were not recovered.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Heart rate abnormal, Hypertension, Insomnia, Magnetic resonance imaging, Metabolic function test
Clinical narrative: vomiting; weakness; SOB; Palpitations; headache; body pain; high blood pressure; nausea; heart beat; pain heart; couldnt sleep all night; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 42-year-old on 18Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to penicillins, cat dander, dog dander. The patient's concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 18Jul2021. The patient was really disappointed the way vaccine was working. A lot of side effects from vaccine without knowing exactly side effects. The patient decided to take the vaccine on 18Jul2021 and was completely fine before the vaccine. Everything goes wrong that night 18Jul2021, the patient couldn't sleep at night and thought it was normal reaction. But on 19Jul2021 everything got worse and the patient going to emergency room because the symptoms was not normal such as headache, body pains, high blood pressure, nausea, heartbeat abnormal, pain heart. The doctor said it was normal reaction to the vaccine and said if the patient feels same after 5 days, they need to check. But all symptoms got worse in fact, the patient started vomiting with all symptoms that no was going away on 01Aug2021. The patient was back to the hospital again with headache, nausea, vomiting, high blood pressure, weakness. The patient received some medication that day and feel better.  But the next day the symptoms no was going away, the patient had a lot of headache, nausea, high blood pressure and pain heart. The patient was waiting for MRI test of head. The patient was not able to work because got side effects from vaccine Pfizer. The patient also experienced SOB (dyspnoea) and palpitations on 29Jul2021. The events were caused patient Emergency Room Visit. It is reported the patient under treatment with Acetaminophen (Tylenol), Metoclopramide HCL (REGLAN), sodium Chloride 0.9% 1000ml Bolus for all events. The patient underwent lab tests and procedures which included blood pressure measurement: 137/76, body temperature increased: 98 fahrenheit, CT head Brain W/O contrast: results awaiting, Culture Urine -Random: unknown, CBC with diierential: unknown, Pulse: 68, MRI: unknown, Basic Metabolic Panel: unknown, oxygen saturation: 99 %, Respiration: 18, POCT HCG Urine: unknown, POCT Urine Dipstick: unknown, Urinalysis: unknown, all on an unknown date. The outcome of the all events were not recovered.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nausea, Oxygen saturation, Pain, Palpitations, Respiratory rate
Clinical narrative: vomiting; weakness; SOB; Palpitations; headache; body pain; high blood pressure; nausea; heart beat; pain heart; couldnt sleep all night; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 42-year-old on 18Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to penicillins, cat dander, dog dander. The patient's concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 18Jul2021. The patient was really disappointed the way vaccine was working. A lot of side effects from vaccine without knowing exactly side effects. The patient decided to take the vaccine on 18Jul2021 and was completely fine before the vaccine. Everything goes wrong that night 18Jul2021, the patient couldn't sleep at night and thought it was normal reaction. But on 19Jul2021 everything got worse and the patient going to emergency room because the symptoms was not normal such as headache, body pains, high blood pressure, nausea, heartbeat abnormal, pain heart. The doctor said it was normal reaction to the vaccine and said if the patient feels same after 5 days, they need to check. But all symptoms got worse in fact, the patient started vomiting with all symptoms that no was going away on 01Aug2021. The patient was back to the hospital again with headache, nausea, vomiting, high blood pressure, weakness. The patient received some medication that day and feel better.  But the next day the symptoms no was going away, the patient had a lot of headache, nausea, high blood pressure and pain heart. The patient was waiting for MRI test of head. The patient was not able to work because got side effects from vaccine Pfizer. The patient also experienced SOB (dyspnoea) and palpitations on 29Jul2021. The events were caused patient Emergency Room Visit. It is reported the patient under treatment with Acetaminophen (Tylenol), Metoclopramide HCL (REGLAN), sodium Chloride 0.9% 1000ml Bolus for all events. The patient underwent lab tests and procedures which included blood pressure measurement: 137/76, body temperature increased: 98 fahrenheit, CT head Brain W/O contrast: results awaiting, Culture Urine -Random: unknown, CBC with diierential: unknown, Pulse: 68, MRI: unknown, Basic Metabolic Panel: unknown, oxygen saturation: 99 %, Respiration: 18, POCT HCG Urine: unknown, POCT Urine Dipstick: unknown, Urinalysis: unknown, all on an unknown date. The outcome of the all events were not recovered.
Age: 42.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urine analysis, Vomiting
Clinical narrative: vomiting; weakness; SOB; Palpitations; headache; body pain; high blood pressure; nausea; heart beat; pain heart; couldnt sleep all night; This is a spontaneous report from a contactable consumer (patient). A 42-year-old patient of an unspecified gender received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 42-year-old on 18Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to penicillins, cat dander, dog dander. The patient's concomitant medications were not reported. The patient received first dose of Pfizer vaccine on 18Jul2021. The patient was really disappointed the way vaccine was working. A lot of side effects from vaccine without knowing exactly side effects. The patient decided to take the vaccine on 18Jul2021 and was completely fine before the vaccine. Everything goes wrong that night 18Jul2021, the patient couldn't sleep at night and thought it was normal reaction. But on 19Jul2021 everything got worse and the patient going to emergency room because the symptoms was not normal such as headache, body pains, high blood pressure, nausea, heartbeat abnormal, pain heart. The doctor said it was normal reaction to the vaccine and said if the patient feels same after 5 days, they need to check. But all symptoms got worse in fact, the patient started vomiting with all symptoms that no was going away on 01Aug2021. The patient was back to the hospital again with headache, nausea, vomiting, high blood pressure, weakness. The patient received some medication that day and feel better.  But the next day the symptoms no was going away, the patient had a lot of headache, nausea, high blood pressure and pain heart. The patient was waiting for MRI test of head. The patient was not able to work because got side effects from vaccine Pfizer. The patient also experienced SOB (dyspnoea) and palpitations on 29Jul2021. The events were caused patient Emergency Room Visit. It is reported the patient under treatment with Acetaminophen (Tylenol), Metoclopramide HCL (REGLAN), sodium Chloride 0.9% 1000ml Bolus for all events. The patient underwent lab tests and procedures which included blood pressure measurement: 137/76, body temperature increased: 98 fahrenheit, CT head Brain W/O contrast: results awaiting, Culture Urine -Random: unknown, CBC with diierential: unknown, Pulse: 68, MRI: unknown, Basic Metabolic Panel: unknown, oxygen saturation: 99 %, Respiration: 18, POCT HCG Urine: unknown, POCT Urine Dipstick: unknown, Urinalysis: unknown, all on an unknown date. The outcome of the all events were not recovered.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus bilaterally ~24 hours from 2nd Pfizer COVID vaccine. persisting and does not appear to be waning at this time. has tried flonase with no benefit, referral placed to ENT
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood lactic acid, Blood sodium decreased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Injection was given on 08/03/21 after 2 negative COVID-19 tests, by 08/06/21 she was in bed not feeling well. On 8/10/21 she was taken to Urgent care and diagnosed with COVID but her primary physician Dr. would not authorize the Regeneron without a virtual visit. She was taken to the hospital on 8/11/21 before the visit with Dr., oxygen level was 76%. She was immediately placed on the BiPAP. By 8/16/21 they were talking about putting her on a ventilator and by 8/17/21 she was on the vent. Two days later on her birthday 8/19/21 we were all called and by 8/20/21 at 8:40 she died.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax normal, Cough, Dyspnoea, Exposure to SARS-CoV-2, Hypoxia
Clinical narrative: Injection was given on 08/03/21 after 2 negative COVID-19 tests, by 08/06/21 she was in bed not feeling well. On 8/10/21 she was taken to Urgent care and diagnosed with COVID but her primary physician Dr. would not authorize the Regeneron without a virtual visit. She was taken to the hospital on 8/11/21 before the visit with Dr., oxygen level was 76%. She was immediately placed on the BiPAP. By 8/16/21 they were talking about putting her on a ventilator and by 8/17/21 she was on the vent. Two days later on her birthday 8/19/21 we were all called and by 8/20/21 at 8:40 she died.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung consolidation, Lung opacity, Malaise, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: Injection was given on 08/03/21 after 2 negative COVID-19 tests, by 08/06/21 she was in bed not feeling well. On 8/10/21 she was taken to Urgent care and diagnosed with COVID but her primary physician Dr. would not authorize the Regeneron without a virtual visit. She was taken to the hospital on 8/11/21 before the visit with Dr., oxygen level was 76%. She was immediately placed on the BiPAP. By 8/16/21 they were talking about putting her on a ventilator and by 8/17/21 she was on the vent. Two days later on her birthday 8/19/21 we were all called and by 8/20/21 at 8:40 she died.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sick relative
Clinical narrative: Injection was given on 08/03/21 after 2 negative COVID-19 tests, by 08/06/21 she was in bed not feeling well. On 8/10/21 she was taken to Urgent care and diagnosed with COVID but her primary physician Dr. would not authorize the Regeneron without a virtual visit. She was taken to the hospital on 8/11/21 before the visit with Dr., oxygen level was 76%. She was immediately placed on the BiPAP. By 8/16/21 they were talking about putting her on a ventilator and by 8/17/21 she was on the vent. Two days later on her birthday 8/19/21 we were all called and by 8/20/21 at 8:40 she died.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bilevel positive airway pressure, Blood glucose normal, Blood potassium decreased, COVID-19, Death
Clinical narrative: Injection was given on 08/03/21 after 2 negative COVID-19 tests, by 08/06/21 she was in bed not feeling well. On 8/10/21 she was taken to Urgent care and diagnosed with COVID but her primary physician Dr. would not authorize the Regeneron without a virtual visit. She was taken to the hospital on 8/11/21 before the visit with Dr., oxygen level was 76%. She was immediately placed on the BiPAP. By 8/16/21 they were talking about putting her on a ventilator and by 8/17/21 she was on the vent. Two days later on her birthday 8/19/21 we were all called and by 8/20/21 at 8:40 she died.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mechanical ventilation, Oxygen saturation decreased
Clinical narrative: Injection was given on 08/03/21 after 2 negative COVID-19 tests, by 08/06/21 she was in bed not feeling well. On 8/10/21 she was taken to Urgent care and diagnosed with COVID but her primary physician Dr. would not authorize the Regeneron without a virtual visit. She was taken to the hospital on 8/11/21 before the visit with Dr., oxygen level was 76%. She was immediately placed on the BiPAP. By 8/16/21 they were talking about putting her on a ventilator and by 8/17/21 she was on the vent. Two days later on her birthday 8/19/21 we were all called and by 8/20/21 at 8:40 she died.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Computerised tomogram head abnormal, Emotional distress, Fatigue, Irritability
Clinical narrative: hemiparesis; acute disseminated encephalomyelitis; Has multiple brain demyelinating lesions; psychiatric problems; This is a spontaneous report from a contactable physician. A 61-year-old female patient (not pregnant) received an unknown dose of BNT162B2 via intramuscular on 19Jul2021 (Lot Number: EW0191) at the age of 61-year-old as single dose for COVID-19 immunization. Medical history included HTN and depression. Known allergy included PCN, flagyl and azithromycin. The patient didn't receive other vaccine in four week. The patient had received other medications in two weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient previously received Azithromycin, Flagyl and experienced allergy. On 06Aug2021, patient developed hemiparesis and psychiatric problems. She was hospitalized and diagnosed with acute disseminated encephalomyelitis. Has had 2 neurologic consultations. Has multiple brain demyelinating lesions.MS evaluation negative, negative LP. The events resulted in emergency room visit and physician office visit. The patient was hospitalized for three days. Treatment included IV steroids. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hemiparesis, Psychiatric disorder NOS, Acute disseminated encephalomyelitis and Demyelination cannot be totally excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: hemiparesis; acute disseminated encephalomyelitis; Has multiple brain demyelinating lesions; psychiatric problems; This is a spontaneous report from a contactable physician. A 61-year-old female patient (not pregnant) received an unknown dose of BNT162B2 via intramuscular on 19Jul2021 (Lot Number: EW0191) at the age of 61-year-old as single dose for COVID-19 immunization. Medical history included HTN and depression. Known allergy included PCN, flagyl and azithromycin. The patient didn't receive other vaccine in four week. The patient had received other medications in two weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient previously received Azithromycin, Flagyl and experienced allergy. On 06Aug2021, patient developed hemiparesis and psychiatric problems. She was hospitalized and diagnosed with acute disseminated encephalomyelitis. Has had 2 neurologic consultations. Has multiple brain demyelinating lesions.MS evaluation negative, negative LP. The events resulted in emergency room visit and physician office visit. The patient was hospitalized for three days. Treatment included IV steroids. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hemiparesis, Psychiatric disorder NOS, Acute disseminated encephalomyelitis and Demyelination cannot be totally excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Demyelination, Hemiparesis, Lumbar puncture, Mental disorder
Clinical narrative: hemiparesis; acute disseminated encephalomyelitis; Has multiple brain demyelinating lesions; psychiatric problems; This is a spontaneous report from a contactable physician. A 61-year-old female patient (not pregnant) received an unknown dose of BNT162B2 via intramuscular on 19Jul2021 (Lot Number: EW0191) at the age of 61-year-old as single dose for COVID-19 immunization. Medical history included HTN and depression. Known allergy included PCN, flagyl and azithromycin. The patient didn't receive other vaccine in four week. The patient had received other medications in two weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient previously received Azithromycin, Flagyl and experienced allergy. On 06Aug2021, patient developed hemiparesis and psychiatric problems. She was hospitalized and diagnosed with acute disseminated encephalomyelitis. Has had 2 neurologic consultations. Has multiple brain demyelinating lesions.MS evaluation negative, negative LP. The events resulted in emergency room visit and physician office visit. The patient was hospitalized for three days. Treatment included IV steroids. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hemiparesis, Psychiatric disorder NOS, Acute disseminated encephalomyelitis and Demyelination cannot be totally excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multiple sclerosis
Clinical narrative: hemiparesis; acute disseminated encephalomyelitis; Has multiple brain demyelinating lesions; psychiatric problems; This is a spontaneous report from a contactable physician. A 61-year-old female patient (not pregnant) received an unknown dose of BNT162B2 via intramuscular on 19Jul2021 (Lot Number: EW0191) at the age of 61-year-old as single dose for COVID-19 immunization. Medical history included HTN and depression. Known allergy included PCN, flagyl and azithromycin. The patient didn't receive other vaccine in four week. The patient had received other medications in two weeks. The patient didn't COVID prior vaccination. The patient didn't perform COVID test post vaccination. The patient previously received Azithromycin, Flagyl and experienced allergy. On 06Aug2021, patient developed hemiparesis and psychiatric problems. She was hospitalized and diagnosed with acute disseminated encephalomyelitis. Has had 2 neurologic consultations. Has multiple brain demyelinating lesions.MS evaluation negative, negative LP. The events resulted in emergency room visit and physician office visit. The patient was hospitalized for three days. Treatment included IV steroids. The outcome of events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hemiparesis, Psychiatric disorder NOS, Acute disseminated encephalomyelitis and Demyelination cannot be totally excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: developed shingles was reported as worsened; This is a spontaneous report from a contactable nurse (the patient), then from the same nurse via a Pfizer Sponsored Program. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485) via an unspecified route of administration in left arm on 27Jul2021 at age of 58-year-old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated that she had developed shingles on 08Aug2021 after the first dose of the Pfizer Covid vaccine, it was reported as worsened. The detailed description was as follow: On 08Aug2021 the patient went to the ER with blisters on her chest and left arm also a couple of spots on her abdomen, it goes from the middle of her chest to her left arm and down her left arm and in the middle of her back and she had some nerve pain, like she had acid pored on her. Was diagnosed with Shingles and was taking Acyclovir 1 gram three time a day for 10 days and gabapentin (NEURONTIN)for nerve pain 600MG three times a day. She hoped she would not have nerve pain after the blisters gone. Caller would like to know if the Acyclovir would affect the Pfizer COVID-19 vaccine she is due to get her Second dose tomorrow. She also thought people should get a piece of paper telling them that if they had the chicken pox as a kid they should get the shingles vaccine before getting the COVID vaccine. Caller was also thinking about asking her doctor for a steroid to help with the shingles, and asked if it would that be a problem with the vaccine. It also stated she had the blisters all over her and they were breaking. Caller clarified they started in the middle of her chest over to left arm, going down left arm, in middle of back over to left arm. She was going to the medical doctor appointment at 2:45 the reporting date, no clue if the antiviral medication effected the first dose of the vaccine and if she should get the second dose. Treatments for shingles, Valacyclovir 1 gram 3 times and gabapentin (NEURONTIN) 600mg three times a day, oxycodone 15mg every 6 hours and treating with ice. Caller stated she thought this is in between medically significant and disabling, stated it has not left her disabled yet but it could. The outcome of the event "shingles was reported as worsened" was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events Shingles and suspect drug BNT162B2 cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Faint; I passed out; I wasn't feeling good/Sat down and propped myself up in a corner of the room; My head started hurting really bad; started vomiting. Non stop; Felt super weird; Slumped down and back; Started dreaming; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included passed out. There were no concomitant medications. Within 2-3 minutes of getting it (they told me to stay for 15 minutes to just hang out) I felt super weird and then faint. I've passed out several times before and knew it was coming on quick. I sat down and propped myself up in  a corner of the room and knocked loudly on the back room to the pharmacy. I was in some small waiting room back there. The pharmacist came out and I told her I wasn't feeling good and needed water. She went to get water and that was all I remember. I passed out. Started dreaming then my head started hurting really bad and realized she was over me talking to me and my head was wedged in the corner as I had slumped down and back. I sat up and came to then started vomiting. Non stop. They called an ambulance. Paramedics came. Vitals all okay but continual vomiting has occurred still. Can't keep anything down not even water. The onset date for events reported as on 16Aug2021 16:15. Outcome of event vomiting was not recovered, of others was recovering. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received no treatment for events.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood glucose, Electrocardiogram, Feeling abnormal, Headache
Clinical narrative: Faint; I passed out; I wasn't feeling good/Sat down and propped myself up in a corner of the room; My head started hurting really bad; started vomiting. Non stop; Felt super weird; Slumped down and back; Started dreaming; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included passed out. There were no concomitant medications. Within 2-3 minutes of getting it (they told me to stay for 15 minutes to just hang out) I felt super weird and then faint. I've passed out several times before and knew it was coming on quick. I sat down and propped myself up in  a corner of the room and knocked loudly on the back room to the pharmacy. I was in some small waiting room back there. The pharmacist came out and I told her I wasn't feeling good and needed water. She went to get water and that was all I remember. I passed out. Started dreaming then my head started hurting really bad and realized she was over me talking to me and my head was wedged in the corner as I had slumped down and back. I sat up and came to then started vomiting. Non stop. They called an ambulance. Paramedics came. Vitals all okay but continual vomiting has occurred still. Can't keep anything down not even water. The onset date for events reported as on 16Aug2021 16:15. Outcome of event vomiting was not recovered, of others was recovering. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received no treatment for events.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope, Vomiting
Clinical narrative: Faint; I passed out; I wasn't feeling good/Sat down and propped myself up in a corner of the room; My head started hurting really bad; started vomiting. Non stop; Felt super weird; Slumped down and back; Started dreaming; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included passed out. There were no concomitant medications. Within 2-3 minutes of getting it (they told me to stay for 15 minutes to just hang out) I felt super weird and then faint. I've passed out several times before and knew it was coming on quick. I sat down and propped myself up in  a corner of the room and knocked loudly on the back room to the pharmacy. I was in some small waiting room back there. The pharmacist came out and I told her I wasn't feeling good and needed water. She went to get water and that was all I remember. I passed out. Started dreaming then my head started hurting really bad and realized she was over me talking to me and my head was wedged in the corner as I had slumped down and back. I sat up and came to then started vomiting. Non stop. They called an ambulance. Paramedics came. Vitals all okay but continual vomiting has occurred still. Can't keep anything down not even water. The onset date for events reported as on 16Aug2021 16:15. Outcome of event vomiting was not recovered, of others was recovering. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received no treatment for events.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dreamy state, Fall, Feeling abnormal, Headache, Loss of consciousness
Clinical narrative: Faint; I passed out; I wasn't feeling good/Sat down and propped myself up in a corner of the room; My head started hurting really bad; started vomiting. Non stop; Felt super weird; Slumped down and back; Started dreaming; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included passed out. There were no concomitant medications. Within 2-3 minutes of getting it (they told me to stay for 15 minutes to just hang out) I felt super weird and then faint. I've passed out several times before and knew it was coming on quick. I sat down and propped myself up in  a corner of the room and knocked loudly on the back room to the pharmacy. I was in some small waiting room back there. The pharmacist came out and I told her I wasn't feeling good and needed water. She went to get water and that was all I remember. I passed out. Started dreaming then my head started hurting really bad and realized she was over me talking to me and my head was wedged in the corner as I had slumped down and back. I sat up and came to then started vomiting. Non stop. They called an ambulance. Paramedics came. Vitals all okay but continual vomiting has occurred still. Can't keep anything down not even water. The onset date for events reported as on 16Aug2021 16:15. Outcome of event vomiting was not recovered, of others was recovering. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received no treatment for events.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Syncope, Vital signs measurement, Vomiting
Clinical narrative: Faint; I passed out; I wasn't feeling good/Sat down and propped myself up in a corner of the room; My head started hurting really bad; started vomiting. Non stop; Felt super weird; Slumped down and back; Started dreaming; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included passed out. There were no concomitant medications. Within 2-3 minutes of getting it (they told me to stay for 15 minutes to just hang out) I felt super weird and then faint. I've passed out several times before and knew it was coming on quick. I sat down and propped myself up in  a corner of the room and knocked loudly on the back room to the pharmacy. I was in some small waiting room back there. The pharmacist came out and I told her I wasn't feeling good and needed water. She went to get water and that was all I remember. I passed out. Started dreaming then my head started hurting really bad and realized she was over me talking to me and my head was wedged in the corner as I had slumped down and back. I sat up and came to then started vomiting. Non stop. They called an ambulance. Paramedics came. Vitals all okay but continual vomiting has occurred still. Can't keep anything down not even water. The onset date for events reported as on 16Aug2021 16:15. Outcome of event vomiting was not recovered, of others was recovering. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received no treatment for events.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: I began having episodes of irregular heart beats/palpitations around Feb. 14, lasting 10 seconds. These occurred 1-2 times a week through July, 2021.  On Aug. 6 I had a 30 minute episode of irregular heartbeats/palpitations which spontaneously resolved.  On Aug. 16 I become symptomatic of Covid and tested positive on Aug. 17.  I received monoclonal antibodies on Aug 19.  The evenings of August 19 and August 20 I experienced 20-30 minute episodes of continuous irregular heartbeats and presented to the ER on Aug 20.  I was kept as an outpatient overnight and had a cardiac monitor which picked up the one episode I experienced during the hospitalization, a run of 8 ventricular beats. I did feel the same sensations I experienced during those 30 minute episodes.  I have no previous cardiac history and these symptoms all developed since my vaccines.  I am wondering if they could be side effects.   I continue to have these episodes of palpitations daily, lasting about 20-30 minutes per episode.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactate dehydrogenase, C-reactive protein, COVID-19, Differential white blood cell count, Echocardiogram
Clinical narrative: I began having episodes of irregular heart beats/palpitations around Feb. 14, lasting 10 seconds. These occurred 1-2 times a week through July, 2021.  On Aug. 6 I had a 30 minute episode of irregular heartbeats/palpitations which spontaneously resolved.  On Aug. 16 I become symptomatic of Covid and tested positive on Aug. 17.  I received monoclonal antibodies on Aug 19.  The evenings of August 19 and August 20 I experienced 20-30 minute episodes of continuous irregular heartbeats and presented to the ER on Aug 20.  I was kept as an outpatient overnight and had a cardiac monitor which picked up the one episode I experienced during the hospitalization, a run of 8 ventricular beats. I did feel the same sensations I experienced during those 30 minute episodes.  I have no previous cardiac history and these symptoms all developed since my vaccines.  I am wondering if they could be side effects.   I continue to have these episodes of palpitations daily, lasting about 20-30 minutes per episode.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Fibrin D dimer, Full blood count, Heart rate irregular, International normalised ratio
Clinical narrative: I began having episodes of irregular heart beats/palpitations around Feb. 14, lasting 10 seconds. These occurred 1-2 times a week through July, 2021.  On Aug. 6 I had a 30 minute episode of irregular heartbeats/palpitations which spontaneously resolved.  On Aug. 16 I become symptomatic of Covid and tested positive on Aug. 17.  I received monoclonal antibodies on Aug 19.  The evenings of August 19 and August 20 I experienced 20-30 minute episodes of continuous irregular heartbeats and presented to the ER on Aug 20.  I was kept as an outpatient overnight and had a cardiac monitor which picked up the one episode I experienced during the hospitalization, a run of 8 ventricular beats. I did feel the same sensations I experienced during those 30 minute episodes.  I have no previous cardiac history and these symptoms all developed since my vaccines.  I am wondering if they could be side effects.   I continue to have these episodes of palpitations daily, lasting about 20-30 minutes per episode.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Malaise, Metabolic function test, Palpitations, Procalcitonin
Clinical narrative: I began having episodes of irregular heart beats/palpitations around Feb. 14, lasting 10 seconds. These occurred 1-2 times a week through July, 2021.  On Aug. 6 I had a 30 minute episode of irregular heartbeats/palpitations which spontaneously resolved.  On Aug. 16 I become symptomatic of Covid and tested positive on Aug. 17.  I received monoclonal antibodies on Aug 19.  The evenings of August 19 and August 20 I experienced 20-30 minute episodes of continuous irregular heartbeats and presented to the ER on Aug 20.  I was kept as an outpatient overnight and had a cardiac monitor which picked up the one episode I experienced during the hospitalization, a run of 8 ventricular beats. I did feel the same sensations I experienced during those 30 minute episodes.  I have no previous cardiac history and these symptoms all developed since my vaccines.  I am wondering if they could be side effects.   I continue to have these episodes of palpitations daily, lasting about 20-30 minutes per episode.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Prothrombin level, Serum ferritin, Troponin I, Urine analysis
Clinical narrative: I began having episodes of irregular heart beats/palpitations around Feb. 14, lasting 10 seconds. These occurred 1-2 times a week through July, 2021.  On Aug. 6 I had a 30 minute episode of irregular heartbeats/palpitations which spontaneously resolved.  On Aug. 16 I become symptomatic of Covid and tested positive on Aug. 17.  I received monoclonal antibodies on Aug 19.  The evenings of August 19 and August 20 I experienced 20-30 minute episodes of continuous irregular heartbeats and presented to the ER on Aug 20.  I was kept as an outpatient overnight and had a cardiac monitor which picked up the one episode I experienced during the hospitalization, a run of 8 ventricular beats. I did feel the same sensations I experienced during those 30 minute episodes.  I have no previous cardiac history and these symptoms all developed since my vaccines.  I am wondering if they could be side effects.   I continue to have these episodes of palpitations daily, lasting about 20-30 minutes per episode.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test normal, Dry eye, Dry mouth, Fatigue, Pain
Clinical narrative: blood clots on the outside of my legs and torso; dry mouth; dry eyes; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 04Feb2021 (at the age of 86 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date unknown), via an unspecified route of administration, administered on an unspecified date in Jan2021 (at the age of 86 years) as dose 1, single for COVID-19 immunization. It was reported that the patient had the second (dose) Pfizer Covid shot on 04Feb2021, the next week on an unknown date in Feb2021, she got dry mouth, dry eyes and then I got little blood clots on the outside of my legs and torso." The patient did not receive any treatment for the events. The outcome of events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: blood clots on the outside of my legs and torso; dry mouth; dry eyes; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 04Feb2021 (at the age of 86 years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date unknown), via an unspecified route of administration, administered on an unspecified date in Jan2021 (at the age of 86 years) as dose 1, single for COVID-19 immunization. It was reported that the patient had the second (dose) Pfizer Covid shot on 04Feb2021, the next week on an unknown date in Feb2021, she got dry mouth, dry eyes and then I got little blood clots on the outside of my legs and torso." The patient did not receive any treatment for the events. The outcome of events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.