chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Feeding disorder, Nausea, Vomiting
Clinical narrative: That night at 1:30 am started getting very nauseous and started vomiting. All of the next day I was extremely nauseous and unable to eat anything. I vomited up stomach acid. I have been taking Zofran; That night at 1:30 am started getting very nauseous and started vomiting. All of the next day I was extremely nauseous and unable to eat anything. I vomited up stomach acid. I have been taking Zofran; That night at 1:30 am started getting very nauseous and started vomiting. All of the next day I was extremely nauseous and unable to eat anything. I vomited up stomach acid. I have been taking Zofran; This is a spontaneous report from a contactable other healthcare professional (the patient).This 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), dose 2, single dose via an unspecified route of administration in the left arm  on 25Jan2021 at 09:00 AM for COVID-19 vaccination. The patient's medical history included type 2 diabetic. The patient had no allergies to medications, food, or other products. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK4176), single dose, dose 1 in the left arm on 07Jan2021 at 12:00 PM. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other medications within 2 weeks of vaccination. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021 at 1:30 AM, he started getting very nauseous and started vomiting. All of the next day, he was extremely nauseous and unable to eat anything. He vomited up stomach acid. He took  ondansetron (ZOFRAN) for the nausea. It is now two days later and the nausea is better but still can't work or eat. The events were reported as non-serious. Therapeutic measures taken as a result of nausea included ondansetron (ZOFRAN). The clinical outcome of nauseous, vomiting and unable to eat was recovering. The patient has not been tested for COVID-19 since having the vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Broke out in hives on my back and blood pressure was very high
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Urticaria
Clinical narrative: Broke out in hives on my back and blood pressure was very high
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram abnormal, Aphasia, Blood test, Cerebrovascular accident, Computerised tomogram thorax normal
Clinical narrative: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband.    A 71-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on  22Jan2021 17:00 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM).  The patient experienced DVT (deep vein thrombosis)  on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke)  on 26Jan2021 05:30 with outcome of unknown , right paralysis  on an unspecified date with outcome of unknown.  The patient was hospitalized for DVT (deep vein thrombosis) and stroke  from 26Jan2021 to 30Jan2021.  The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021   , blood pressure systolic: 141 mmhg on 30Jan2021   , body mass index: 26.4684 kg/m2   on 26Jan2021   , body temperature: 98.2 °F on 30Jan2021,  heart rate: 55 bpm   on 30Jan2021   , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT,  oxygen saturation: 95 % on 30Jan2021   , respiratory rate: 18 br/min   on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Echocardiogram, Hemiparesis, Intensive care, Magnetic resonance imaging abnormal
Clinical narrative: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband.    A 71-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on  22Jan2021 17:00 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM).  The patient experienced DVT (deep vein thrombosis)  on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke)  on 26Jan2021 05:30 with outcome of unknown , right paralysis  on an unspecified date with outcome of unknown.  The patient was hospitalized for DVT (deep vein thrombosis) and stroke  from 26Jan2021 to 30Jan2021.  The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021   , blood pressure systolic: 141 mmhg on 30Jan2021   , body mass index: 26.4684 kg/m2   on 26Jan2021   , body temperature: 98.2 °F on 30Jan2021,  heart rate: 55 bpm   on 30Jan2021   , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT,  oxygen saturation: 95 % on 30Jan2021   , respiratory rate: 18 br/min   on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oxygen saturation decreased, SARS-CoV-2 test, Speech disorder, Thrombosis, Venogram
Clinical narrative: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband.    A 71-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on  22Jan2021 17:00 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM).  The patient experienced DVT (deep vein thrombosis)  on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke)  on 26Jan2021 05:30 with outcome of unknown , right paralysis  on an unspecified date with outcome of unknown.  The patient was hospitalized for DVT (deep vein thrombosis) and stroke  from 26Jan2021 to 30Jan2021.  The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021   , blood pressure systolic: 141 mmhg on 30Jan2021   , body mass index: 26.4684 kg/m2   on 26Jan2021   , body temperature: 98.2 °F on 30Jan2021,  heart rate: 55 bpm   on 30Jan2021   , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT,  oxygen saturation: 95 % on 30Jan2021   , respiratory rate: 18 br/min   on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Deep vein thrombosis, SARS-CoV-2 test
Clinical narrative: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband.    A 71-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on  22Jan2021 17:00 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM).  The patient experienced DVT (deep vein thrombosis)  on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke)  on 26Jan2021 05:30 with outcome of unknown , right paralysis  on an unspecified date with outcome of unknown.  The patient was hospitalized for DVT (deep vein thrombosis) and stroke  from 26Jan2021 to 30Jan2021.  The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021   , blood pressure systolic: 141 mmhg on 30Jan2021   , body mass index: 26.4684 kg/m2   on 26Jan2021   , body temperature: 98.2 °F on 30Jan2021,  heart rate: 55 bpm   on 30Jan2021   , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT,  oxygen saturation: 95 % on 30Jan2021   , respiratory rate: 18 br/min   on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Blood pressure diastolic, Blood pressure systolic, Body mass index, Body temperature
Clinical narrative: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband.    A 71-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on  22Jan2021 17:00 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM).  The patient experienced DVT (deep vein thrombosis)  on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke)  on 26Jan2021 05:30 with outcome of unknown , right paralysis  on an unspecified date with outcome of unknown.  The patient was hospitalized for DVT (deep vein thrombosis) and stroke  from 26Jan2021 to 30Jan2021.  The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021   , blood pressure systolic: 141 mmhg on 30Jan2021   , body mass index: 26.4684 kg/m2   on 26Jan2021   , body temperature: 98.2 °F on 30Jan2021,  heart rate: 55 bpm   on 30Jan2021   , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT,  oxygen saturation: 95 % on 30Jan2021   , respiratory rate: 18 br/min   on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiovascular examination, Computerised tomogram, Deep vein thrombosis, Echocardiogram, Gastrointestinal examination
Clinical narrative: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband.    A 71-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on  22Jan2021 17:00 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM).  The patient experienced DVT (deep vein thrombosis)  on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke)  on 26Jan2021 05:30 with outcome of unknown , right paralysis  on an unspecified date with outcome of unknown.  The patient was hospitalized for DVT (deep vein thrombosis) and stroke  from 26Jan2021 to 30Jan2021.  The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021   , blood pressure systolic: 141 mmhg on 30Jan2021   , body mass index: 26.4684 kg/m2   on 26Jan2021   , body temperature: 98.2 °F on 30Jan2021,  heart rate: 55 bpm   on 30Jan2021   , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT,  oxygen saturation: 95 % on 30Jan2021   , respiratory rate: 18 br/min   on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Ischaemic stroke, Magnetic resonance imaging, Ophthalmological examination, Oxygen saturation
Clinical narrative: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband.    A 71-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on  22Jan2021 17:00 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM).  The patient experienced DVT (deep vein thrombosis)  on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke)  on 26Jan2021 05:30 with outcome of unknown , right paralysis  on an unspecified date with outcome of unknown.  The patient was hospitalized for DVT (deep vein thrombosis) and stroke  from 26Jan2021 to 30Jan2021.  The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021   , blood pressure systolic: 141 mmhg on 30Jan2021   , body mass index: 26.4684 kg/m2   on 26Jan2021   , body temperature: 98.2 °F on 30Jan2021,  heart rate: 55 bpm   on 30Jan2021   , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT,  oxygen saturation: 95 % on 30Jan2021   , respiratory rate: 18 br/min   on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paralysis, Respiratory rate, Skin test, Thermometry, Ultrasound joint
Clinical narrative: Lt parietal occlusion; DVT; Right paralysis; This is a spontaneous report from a contactable Nurse reporting for her husband.    A 71-years-old male patient  received the first dose of  bnt162b2 (BNT162B2; Lot # EL 1284) vaccine , intramuscular in the left deltoid on  22Jan2021 17:00 at  single dose for Covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included apixaban (APIXABAN), acetylsalicylic acid (ASPIRIN) atorvastatin (ATORVASTATIN), cyanocobalamin (CYANOCOBALAMIN), metoprolol tartrate (METOPROLOL TARTRATE) , pantoprazole (PANTOPRAZOLE), sumatriptan (IMITREX [SUMATRIPTAN]), triazolam (TRIAZOLAM).  The patient experienced DVT (deep vein thrombosis)  on 26Jan2021 with outcome of not recovered , left parietal occlusion (ischaemic stroke)  on 26Jan2021 05:30 with outcome of unknown , right paralysis  on an unspecified date with outcome of unknown.  The patient was hospitalized for DVT (deep vein thrombosis) and stroke  from 26Jan2021 to 30Jan2021.  The patient underwent lab tests and procedures including blood pressure diastolic: 84 mmhg on 30Jan2021   , blood pressure systolic: 141 mmhg on 30Jan2021   , body mass index: 26.4684 kg/m2   on 26Jan2021   , body temperature: 98.2 °F on 30Jan2021,  heart rate: 55 bpm   on 30Jan2021   , magnetic resonance imaging: acute left parietal lacunar infarct, Lower extremity ultrasound: left popliteal vein DVT,  oxygen saturation: 95 % on 30Jan2021   , respiratory rate: 18 br/min   on 30Jan2021. The reporter considered the reported events to be possibly related to BNT162B2 vaccine. Follow up information has been requested.; Sender's Comments: Based on the limited information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely excluded given the known suspect drug profile and/or implied temporal association. 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient felt fine that day and worked at the dental office.  She went with the other dental office staff at 2pm and received her Covid shot.  After work ,she went out with a coworker for dinner and to do their hot tubs.  She returned to her house and called me at 930 pm.  She felt fine. During the pandemic ,she would sleep at our house because of the curfew ,but she had an early case in the am so said she was going to stay at her house and go to bed at 10 pm.  She was suppose to get up at 530 am .  She brought her Glatiramer acetate shot with her as Thursday was one of her day's to take it.  I received a call from her office shortly before 9am ,because she never showed up for work.  My daughter would never miss work.  I called my wife and son and we raced over to her house and we found her on the floor near the couch with her head somewhat upright against the couch.  She had stooled in her pants and appeared to have been dead for awhile. On her table was the needle kit and the alcohol wipe with a slight bit of blood on it. The medical examiner estimated her time of death being between 10 and 11 pm jan 28. She was sent for the autopsy and no cause of death was identified.  He urine drug screen and toxicology tests were negative. There was no sign of PE,brain aneurysm,MI ,covid ,flu or rsv infection. The microscopic evaluation is still pending. My wife ,son ,and I are devastated. She was the light of our life. I don't think we will ever recover. I talked to her at 930 pm and she felt fine. I believe the last thing she did was inject herself with her MS medication. She had not had any previous problems with it. The medical examiner was concerned about a possible interaction between the MS medication and the Covid immunization. I was worried she may have had a seizure and had a poor airway with her head against the couch and didn't get enough oxygen. I also worried about a possible effect on her heart causing an arrhythmia .She has  never had a seizure or any arrhythmia in the past. There is no family history of epilepsy  or heart arrhythmia on either side of the family. She showed no sign of illness when I talked to her at 930 pm and died suddenly between 10 and 11 pm possibly within minutes after the Glatiramer injection and within 8 hours of Covid vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Death
Clinical narrative: Patient felt fine that day and worked at the dental office.  She went with the other dental office staff at 2pm and received her Covid shot.  After work ,she went out with a coworker for dinner and to do their hot tubs.  She returned to her house and called me at 930 pm.  She felt fine. During the pandemic ,she would sleep at our house because of the curfew ,but she had an early case in the am so said she was going to stay at her house and go to bed at 10 pm.  She was suppose to get up at 530 am .  She brought her Glatiramer acetate shot with her as Thursday was one of her day's to take it.  I received a call from her office shortly before 9am ,because she never showed up for work.  My daughter would never miss work.  I called my wife and son and we raced over to her house and we found her on the floor near the couch with her head somewhat upright against the couch.  She had stooled in her pants and appeared to have been dead for awhile. On her table was the needle kit and the alcohol wipe with a slight bit of blood on it. The medical examiner estimated her time of death being between 10 and 11 pm jan 28. She was sent for the autopsy and no cause of death was identified.  He urine drug screen and toxicology tests were negative. There was no sign of PE,brain aneurysm,MI ,covid ,flu or rsv infection. The microscopic evaluation is still pending. My wife ,son ,and I are devastated. She was the light of our life. I don't think we will ever recover. I talked to her at 930 pm and she felt fine. I believe the last thing she did was inject herself with her MS medication. She had not had any previous problems with it. The medical examiner was concerned about a possible interaction between the MS medication and the Covid immunization. I was worried she may have had a seizure and had a poor airway with her head against the couch and didn't get enough oxygen. I also worried about a possible effect on her heart causing an arrhythmia .She has  never had a seizure or any arrhythmia in the past. There is no family history of epilepsy  or heart arrhythmia on either side of the family. She showed no sign of illness when I talked to her at 930 pm and died suddenly between 10 and 11 pm possibly within minutes after the Glatiramer injection and within 8 hours of Covid vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anal incontinence, Death, Drug screen negative, Toxicologic test normal
Clinical narrative: Patient felt fine that day and worked at the dental office.  She went with the other dental office staff at 2pm and received her Covid shot.  After work ,she went out with a coworker for dinner and to do their hot tubs.  She returned to her house and called me at 930 pm.  She felt fine. During the pandemic ,she would sleep at our house because of the curfew ,but she had an early case in the am so said she was going to stay at her house and go to bed at 10 pm.  She was suppose to get up at 530 am .  She brought her Glatiramer acetate shot with her as Thursday was one of her day's to take it.  I received a call from her office shortly before 9am ,because she never showed up for work.  My daughter would never miss work.  I called my wife and son and we raced over to her house and we found her on the floor near the couch with her head somewhat upright against the couch.  She had stooled in her pants and appeared to have been dead for awhile. On her table was the needle kit and the alcohol wipe with a slight bit of blood on it. The medical examiner estimated her time of death being between 10 and 11 pm jan 28. She was sent for the autopsy and no cause of death was identified.  He urine drug screen and toxicology tests were negative. There was no sign of PE,brain aneurysm,MI ,covid ,flu or rsv infection. The microscopic evaluation is still pending. My wife ,son ,and I are devastated. She was the light of our life. I don't think we will ever recover. I talked to her at 930 pm and she felt fine. I believe the last thing she did was inject herself with her MS medication. She had not had any previous problems with it. The medical examiner was concerned about a possible interaction between the MS medication and the Covid immunization. I was worried she may have had a seizure and had a poor airway with her head against the couch and didn't get enough oxygen. I also worried about a possible effect on her heart causing an arrhythmia .She has  never had a seizure or any arrhythmia in the past. There is no family history of epilepsy  or heart arrhythmia on either side of the family. She showed no sign of illness when I talked to her at 930 pm and died suddenly between 10 and 11 pm possibly within minutes after the Glatiramer injection and within 8 hours of Covid vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Hyponatraemia, Immunomodulatory therapy, Laboratory test, Myocardial fibrosis
Clinical narrative: Patient felt fine that day and worked at the dental office.  She went with the other dental office staff at 2pm and received her Covid shot.  After work ,she went out with a coworker for dinner and to do their hot tubs.  She returned to her house and called me at 930 pm.  She felt fine. During the pandemic ,she would sleep at our house because of the curfew ,but she had an early case in the am so said she was going to stay at her house and go to bed at 10 pm.  She was suppose to get up at 530 am .  She brought her Glatiramer acetate shot with her as Thursday was one of her day's to take it.  I received a call from her office shortly before 9am ,because she never showed up for work.  My daughter would never miss work.  I called my wife and son and we raced over to her house and we found her on the floor near the couch with her head somewhat upright against the couch.  She had stooled in her pants and appeared to have been dead for awhile. On her table was the needle kit and the alcohol wipe with a slight bit of blood on it. The medical examiner estimated her time of death being between 10 and 11 pm jan 28. She was sent for the autopsy and no cause of death was identified.  He urine drug screen and toxicology tests were negative. There was no sign of PE,brain aneurysm,MI ,covid ,flu or rsv infection. The microscopic evaluation is still pending. My wife ,son ,and I are devastated. She was the light of our life. I don't think we will ever recover. I talked to her at 930 pm and she felt fine. I believe the last thing she did was inject herself with her MS medication. She had not had any previous problems with it. The medical examiner was concerned about a possible interaction between the MS medication and the Covid immunization. I was worried she may have had a seizure and had a poor airway with her head against the couch and didn't get enough oxygen. I also worried about a possible effect on her heart causing an arrhythmia .She has  never had a seizure or any arrhythmia in the past. There is no family history of epilepsy  or heart arrhythmia on either side of the family. She showed no sign of illness when I talked to her at 930 pm and died suddenly between 10 and 11 pm possibly within minutes after the Glatiramer injection and within 8 hours of Covid vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocardial ischaemia, Obesity, Pericardial effusion, Sudden death, Syncope
Clinical narrative: Patient felt fine that day and worked at the dental office.  She went with the other dental office staff at 2pm and received her Covid shot.  After work ,she went out with a coworker for dinner and to do their hot tubs.  She returned to her house and called me at 930 pm.  She felt fine. During the pandemic ,she would sleep at our house because of the curfew ,but she had an early case in the am so said she was going to stay at her house and go to bed at 10 pm.  She was suppose to get up at 530 am .  She brought her Glatiramer acetate shot with her as Thursday was one of her day's to take it.  I received a call from her office shortly before 9am ,because she never showed up for work.  My daughter would never miss work.  I called my wife and son and we raced over to her house and we found her on the floor near the couch with her head somewhat upright against the couch.  She had stooled in her pants and appeared to have been dead for awhile. On her table was the needle kit and the alcohol wipe with a slight bit of blood on it. The medical examiner estimated her time of death being between 10 and 11 pm jan 28. She was sent for the autopsy and no cause of death was identified.  He urine drug screen and toxicology tests were negative. There was no sign of PE,brain aneurysm,MI ,covid ,flu or rsv infection. The microscopic evaluation is still pending. My wife ,son ,and I are devastated. She was the light of our life. I don't think we will ever recover. I talked to her at 930 pm and she felt fine. I believe the last thing she did was inject herself with her MS medication. She had not had any previous problems with it. The medical examiner was concerned about a possible interaction between the MS medication and the Covid immunization. I was worried she may have had a seizure and had a poor airway with her head against the couch and didn't get enough oxygen. I also worried about a possible effect on her heart causing an arrhythmia .She has  never had a seizure or any arrhythmia in the past. There is no family history of epilepsy  or heart arrhythmia on either side of the family. She showed no sign of illness when I talked to her at 930 pm and died suddenly between 10 and 11 pm possibly within minutes after the Glatiramer injection and within 8 hours of Covid vaccination.
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: broke out with a terrible rash to his chest, groin and back with terrible itching; broke out with a terrible rash to his chest, groin and back with terrible itching; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3246 and Expiration Date unknown) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included heart burn. The concomitant medications were reported as omeprazole (PRILOSEC) for heart burn. Patient took the Pfizer vaccine on 13Jan2021 and 1 and a half days later (evening of 14Jan2021) he broke out with a terrible rash all over his body on his chest, groin and back with terrible itching. He reports that he went to Urgent care/clinic and was prescribed prednisone for 6 days and reports that there is still a little bit there but the rash appears much better and stopped itching. The rash, it practically eliminated the rash there are still some signs of it but at the height of it, it was very vibrant and red. Also the second day he started taking another pill, Prilosec 20 mg for heart burn and he doesn't know if the rash was caused by the vaccine or the Prilosec but his question is, is that going to deter him from taking the second dose on 03Feb2021. Patient thinks he started the Prilosec either on the 14Jan2021 or 15Jan2021 and he stopped, after 2 tablets he stopped taking it because he wasn't sure, he didn't want to aggravate anything if it was caused by the Prilosec.  Now asking for guidance of if he should receive the second dose. Treatment for events was prednisone. The outcome of itching was recovered in Jan2021. The outcome of rash was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 91.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: broke out with a terrible rash to his chest, groin and back with terrible itching; broke out with a terrible rash to his chest, groin and back with terrible itching; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3246 and Expiration Date unknown) via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included heart burn. The concomitant medications were reported as omeprazole (PRILOSEC) for heart burn. Patient took the Pfizer vaccine on 13Jan2021 and 1 and a half days later (evening of 14Jan2021) he broke out with a terrible rash all over his body on his chest, groin and back with terrible itching. He reports that he went to Urgent care/clinic and was prescribed prednisone for 6 days and reports that there is still a little bit there but the rash appears much better and stopped itching. The rash, it practically eliminated the rash there are still some signs of it but at the height of it, it was very vibrant and red. Also the second day he started taking another pill, Prilosec 20 mg for heart burn and he doesn't know if the rash was caused by the vaccine or the Prilosec but his question is, is that going to deter him from taking the second dose on 03Feb2021. Patient thinks he started the Prilosec either on the 14Jan2021 or 15Jan2021 and he stopped, after 2 tablets he stopped taking it because he wasn't sure, he didn't want to aggravate anything if it was caused by the Prilosec.  Now asking for guidance of if he should receive the second dose. Treatment for events was prednisone. The outcome of itching was recovered in Jan2021. The outcome of rash was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Eye pain, Head discomfort, Headache, Tinnitus
Clinical narrative: Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Head discomfort, Ophthalmic migraine, Tachycardia, Tinnitus
Clinical narrative: Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Head discomfort, Headache
Clinical narrative: Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Migraine, Tinnitus, Tremor, Vestibular function test
Clinical narrative: Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vestibular migraine
Clinical narrative: Migraine, head pressure, ringing ears, dizziness. Now I have Vestibular migraines, I am off balance. Still have dizziness, and head pressure. Headache comes and goes. First 2 days I also had inside vibration and energy zap in my whole body.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Gave her an entire vial instead of one dose; Giant red circle/rash; Really swollen; Inflamed; Painful; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 04Feb2021 (10:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). The patient did not have relevant medical history. Concomitant medication included ongoing amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previously took a flu shot a couple of months ago, and had no reaction. On 04Feb2021 (10:00), the pharmacy reportedly screwed up, and gave the patient an entire vial of BNT162B2 instead of one dose. The patient was not feeling any side effects then. In Feb2021, the patient had a giant red circle/rash; and she was really swollen, inflamed and in pain (reported as "painful"). The patient did not receive any treatment for the giant red circle/rash and pain. The outcome of the events was recovering for 'giant red circle/rash', 'really swollen', 'inflamed' and 'pain'; and was unknown for 'gave the patient an entire vial of BNT162B2 instead of one dose'. The reporter had asked about whether she should receive the second dose.  Follow-up (08Feb2021): New information received from a contactable consumer (patient) included: reporter information, suspect vaccine details and new events ('giant red circle/rash', 'really swollen', 'inflamed' and 'pain').
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Overdose, Pain, Rash erythematous, Swelling
Clinical narrative: Gave her an entire vial instead of one dose; Giant red circle/rash; Really swollen; Inflamed; Painful; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable consumer (patient) reported that a 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302; Expiration date was not reported) on 04Feb2021 (10:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store (not a military facility). The patient did not have relevant medical history. Concomitant medication included ongoing amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previously took a flu shot a couple of months ago, and had no reaction. On 04Feb2021 (10:00), the pharmacy reportedly screwed up, and gave the patient an entire vial of BNT162B2 instead of one dose. The patient was not feeling any side effects then. In Feb2021, the patient had a giant red circle/rash; and she was really swollen, inflamed and in pain (reported as "painful"). The patient did not receive any treatment for the giant red circle/rash and pain. The outcome of the events was recovering for 'giant red circle/rash', 'really swollen', 'inflamed' and 'pain'; and was unknown for 'gave the patient an entire vial of BNT162B2 instead of one dose'. The reporter had asked about whether she should receive the second dose.  Follow-up (08Feb2021): New information received from a contactable consumer (patient) included: reporter information, suspect vaccine details and new events ('giant red circle/rash', 'really swollen', 'inflamed' and 'pain').
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Induration, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: she had an allergic reaction to first dose; could not get warm; Facial swelling; lips got hard; nose got firm; tingling of both feet/tingling of both hands; lips were tingling/severe vaccine reaction; This is a spontaneous report from a contactable Physician (patient). A 65-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 at 17:00 at single dose in left arm for COVID-19 immunisation at the age of 65-year-old. Lot number was EL3247. Relevant medical history included ongoing Psoriatic arthritis since fall 2018. Concomitant medications included APREMILAST (OTEZLA) from 2018 and ongoing for Psoriatic arthritis. On 21Jan2021, the patient experienced Tingling lips (at 17:30), lips got hard (at 19:00), nose got firm (at 19:00), tingling of both feet (at 19:00), tingling of both hands (at 19:00), Facial swelling (at 19:00), could not get warm (at 21:00). Tingling lips were considered an important medical event. It was reported that on unknown date the patient had an allergic reaction to first dose. On unknown date, full blood count, chem 20 and temperature measurement were performed but results were unknown. The patient was treated for the event with benadryl. The patient was recovering from Tingling lips, the patient recovered from lips got hard on 24Jan2021, from nose got firm on 21Jan2021, from tingling of both feet/both hands on 21Jan2021, from facial swelling on 21Jan2021, could not get warm on 21Jan2021, the outcome of allergic reaction was unknown.; Sender's Comments: Based on a compatible temporal association and known product safety profile a causal relationship between events "lips were tingling/severe vaccine reaction", "facial swelling" and "allergic reaction to first dose" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)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.