chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Immediate post-injection reaction, Nausea
Clinical narrative: One and a half hours after vaccine shot, my mouth and face started to tingle.  This continued for two hours.; One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs.; very light headed right after the shot; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9261, expiry date: not reported), via an unspecified route of administration at left arm on 29Jan2021 12:45 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, gastrooesophageal reflux disease (GERD), and migraine. The patient also had known allergies to multiple antibiotics, kiwi, walnuts, and bee sting. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]), topiramate, vitamin D3, guaifenesin (MUCINEX), and clarithromycin (CLARITIC). The patient stated, "One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs. I had no trouble breathing. I was also very light headed right after the shot but that resolved quickly." All the events started on 29Jan2021 14:15 (reported as 02:15 PM). There was no treatment received for all the events. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient recovered from all the events.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: One and a half hours after vaccine shot, my mouth and face started to tingle.  This continued for two hours.; One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs.; very light headed right after the shot; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9261, expiry date: not reported), via an unspecified route of administration at left arm on 29Jan2021 12:45 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, gastrooesophageal reflux disease (GERD), and migraine. The patient also had known allergies to multiple antibiotics, kiwi, walnuts, and bee sting. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]), topiramate, vitamin D3, guaifenesin (MUCINEX), and clarithromycin (CLARITIC). The patient stated, "One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs. I had no trouble breathing. I was also very light headed right after the shot but that resolved quickly." All the events started on 29Jan2021 14:15 (reported as 02:15 PM). There was no treatment received for all the events. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient recovered from all the events.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Paraesthesia, Paraesthesia oral
Clinical narrative: One and a half hours after vaccine shot, my mouth and face started to tingle.  This continued for two hours.; One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs.; very light headed right after the shot; This is a spontaneous report from a contactable physician (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9261, expiry date: not reported), via an unspecified route of administration at left arm on 29Jan2021 12:45 at SINGLE DOSE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included arthritis, gastrooesophageal reflux disease (GERD), and migraine. The patient also had known allergies to multiple antibiotics, kiwi, walnuts, and bee sting. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]), topiramate, vitamin D3, guaifenesin (MUCINEX), and clarithromycin (CLARITIC). The patient stated, "One and a half hours after vaccine shot, my mouth and face started to tingle. This continued for two hours. The tingling spread to the skin on my chest. And briefly to my legs. I had no trouble breathing. I was also very light headed right after the shot but that resolved quickly." All the events started on 29Jan2021 14:15 (reported as 02:15 PM). There was no treatment received for all the events. The patient had no COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient recovered from all the events.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Arthralgia, Blood test, Computerised tomogram head, Dizziness
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Electromyogram, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Influenza like illness, Insomnia, Magnetic resonance imaging brain, Magnetic resonance imaging spinal
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Memory impairment, Middle ear effusion, Motor dysfunction, Muscular weakness, Nausea
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, Night sweats, Oropharyngeal pain, Otitis media, Pain
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pleural effusion, Pulmonary oedema, Rash, SARS-CoV-2 test negative
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder, Systemic lupus erythematosus, Vertigo
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cognitive disorder, Dizziness, Gait disturbance, Headache
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Memory impairment, Middle ear effusion, Muscular weakness, Nausea
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pleural effusion, Rash, SARS-CoV-2 test, Speech disorder
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient).  A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Anger, Belligerence, Crying, Hallucination
Clinical narrative: Patient has Parkinson's disease. In one hour after the infection, his personality changed to an angry, combative, belligerent, rude man, attitudes never seen before. This continued for 3 days. He was unruly, disrespectful to his care givers, calling them names to the people around them and then to their faces, storming away from those who tried to help him,  unpleasant  and frightening.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental impairment
Clinical narrative: Patient has Parkinson's disease. In one hour after the infection, his personality changed to an angry, combative, belligerent, rude man, attitudes never seen before. This continued for 3 days. He was unruly, disrespectful to his care givers, calling them names to the people around them and then to their faces, storming away from those who tried to help him,  unpleasant  and frightening.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Aggression, Anger, Belligerence, Personality change
Clinical narrative: Patient has Parkinson's disease. In one hour after the infection, his personality changed to an angry, combative, belligerent, rude man, attitudes never seen before. This continued for 3 days. He was unruly, disrespectful to his care givers, calling them names to the people around them and then to their faces, storming away from those who tried to help him,  unpleasant  and frightening.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accessory muscle, Aphasia, Appetite disorder, Bladder cancer, Blood gases normal
Clinical narrative: 2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax normal, Condition aggravated, Confusional state, Decreased appetite, Dehydration
Clinical narrative: 2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Depressed level of consciousness, Dyspnoea, Fluid intake reduced, Gait inability, Hypoxia
Clinical narrative: 2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incoherent, Intensive care, Laboratory test normal, Metabolic function test, Mobility decreased
Clinical narrative: 2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mouth breathing, Oxygen saturation decreased, Pyrexia, Restlessness, Somnolence
Clinical narrative: 2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli, Urinary tract infection, White blood cell count normal
Clinical narrative: 2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chest X-ray, Headache, Hypoxia, Lethargy
Clinical narrative: 2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: 2/17 - Headache; Temp of 100.2, 2/20 - Hypoxia, drowsiness, lethargy
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose decreased, Fatigue, Unresponsive to stimuli
Clinical narrative: became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose, Blood glucose decreased, Fatigue, Investigation, Unresponsive to stimuli
Clinical narrative: became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose, Blood glucose decreased, Fatigue, Hyporesponsive to stimuli
Clinical narrative: became almost non-responsive/nearly totally nonresponsive; her blood sugar went down to 25; she was tired; This is a spontaneous report from a contactable consumer. A 69-year-old female patient (reporter's wife) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) on 12Feb2021 on right arm at a single dose for COVID-19 immunisation. Medical history included diabetes diagnosed about 30 years prior. Concomitant medications were none. Patient got the 1st dose of bnt162b2 and 4 hours after getting it, her blood sugar went down to 25 (12Feb2021) and she became almost non-responsive. She took a lot of carbohydrates after the shot before she plummeted. Reporter asked if there had been any reports of this and should she take the 2nd shot. Reporter said that he is reporting the side effect of that approximately 4 hours after receiving the shot, which his wife is diabetic, she was tired and then her sugar dropped to 25 before he realized she had an issue. He says she was nearly totally nonresponsive (12Feb2021). He said this was very abnormal and her sugar has never been that low. He said after he realized her sugar dropped to 25, he got some ice cream into her and then some (brand name withheld), then he got her blood sugar which the next reading was 47, then the third reading was mid 90s, so then he took her to the emergency room and they ran tests. He says by then her blood sugar was 250-280, which they thought was good after it had been that low. He says that they did blood tests and did not find anything abnormal, and her blood sugar has been good since then. He said she was not admitted to the hospital, and they went home that night. He said that this had never occurred before, period. Reporter said that everything seems to be normal at this point, though it scared them. He said his wife has not gotten the second dose yet, and they have questioned if she should take the second dose since this happened, and he was wondering if Pfizer may have advice to provide them on getting the second dose for her. The outcome of events was recovered on an unspecified date.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site, after 12 day is a 2-1/4 inch light red circle.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema
Clinical narrative: Injection site, after 12 day is a 2-1/4 inch light red circle.