chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Pulse absent, Resuscitation, Urine analysis
Clinical narrative: Passed out; Pulseless for 30 seconds; Feel dizzy and nauseous; Feel dizzy and nauseous; This is a spontaneous report from a contactable Other Health Professional (patient).  A 25-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown since not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 22Jan2021 11:45 at single dose for COVID-19 immunization at a Nursing Home/Senior Living Facility. The patient's medical history included known allergies: Sulfa and poppy seed. No other known medical history/conditions. For concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin, clarithromycin (BIAXIN) and cefaclor (CECLOR), and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. After receiving the vaccine, the patient was sitting in the observation area for about 10 minutes when she started to feel dizzy and nauseous. She raised her hand up and called for the nurse to come over. She passed out. She was pulseless for 30 seconds and they had to begin giving her CPR chest compressions. She woke up lying on the ground and was taken to the emergency room (ER) where they ran tests to see how she was doing and for observation for several hours. The patient was "discharged" this afternoon and was doing better. The events result in emergency room/department or urgent care. Treatment was received for the events, ER observation and care, and CPR chest compressions. The patient underwent lab tests and procedures which included test on 22Jan2021: unknown results. The outcome of events at the time of last observation was recovering. The reporter's assessment of the events was non-serious, no results in death, no life threatening, not causing/prolonging hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.; Sender's Comments: The reported passed out and pulseless for 30 seconds were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.   However, considering the clinical course and medical history, other cause(s)/confounding factors cannot be excluded.  The case will be reassessed should additional information become 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: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Pulse absent, Resuscitation
Clinical narrative: Passed out; Pulseless for 30 seconds; Feel dizzy and nauseous; Feel dizzy and nauseous; This is a spontaneous report from a contactable Other Health Professional (patient).  A 25-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown since not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 22Jan2021 11:45 at single dose for COVID-19 immunization at a Nursing Home/Senior Living Facility. The patient's medical history included known allergies: Sulfa and poppy seed. No other known medical history/conditions. For concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin, clarithromycin (BIAXIN) and cefaclor (CECLOR), and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. After receiving the vaccine, the patient was sitting in the observation area for about 10 minutes when she started to feel dizzy and nauseous. She raised her hand up and called for the nurse to come over. She passed out. She was pulseless for 30 seconds and they had to begin giving her CPR chest compressions. She woke up lying on the ground and was taken to the emergency room (ER) where they ran tests to see how she was doing and for observation for several hours. The patient was "discharged" this afternoon and was doing better. The events result in emergency room/department or urgent care. Treatment was received for the events, ER observation and care, and CPR chest compressions. The patient underwent lab tests and procedures which included test on 22Jan2021: unknown results. The outcome of events at the time of last observation was recovering. The reporter's assessment of the events was non-serious, no results in death, no life threatening, not causing/prolonging hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.; Sender's Comments: The reported passed out and pulseless for 30 seconds were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.   However, considering the clinical course and medical history, other cause(s)/confounding factors cannot be excluded.  The case will be reassessed should additional information become 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: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture, Paraesthesia
Clinical narrative: Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  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: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  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: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood calcium, Blood folate, Blood glucose, Blood immunoglobulin A, Blood magnesium
Clinical narrative: Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  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: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, Burning sensation, Electrophoresis protein, Full blood count, Glycosylated haemoglobin
Clinical narrative: Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  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: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hyperaesthesia, Liver function test, Lumbar puncture, Metabolic function test
Clinical narrative: Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  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: 40.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Vitamin B12, Vitamin D
Clinical narrative: Guillain Barre syndrome/Symptoms started with 2 fingers tingling; This is a spontaneous report from a contactable nurse reporting for a patient. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176), via intramuscular on 09Jan2021 at single dose in left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular on 22Dec2020 at single dose in left arm at the age of 39-year-old for COVID-19 immunization. Reported he was diagnosed with Guillain Barre syndrome. Symptoms started with 2 fingers tingling on 11Jan2021. Progressively increasing in severity. Now had numb fingers and toes. Initiating IV therapy on 22Jan2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  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: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Ultrasound scan, Urine analysis
Clinical narrative: Miscarriage; The mother reported she became pregnant while taking bnt162b2; The mother reported she became pregnant while taking bnt162b2; This is a spontaneous report from a contactable consumer reported for herself. A 27-year-old female patient (Pregnant) received first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left arm on 16Jan2021 16:30 at single dose for covid-19 immunization. Medical history included asthma, covid-19 from an unknown date and unknown if ongoing. The patient's concomitant drug included prenatal vitamins. The patient experienced miscarriage on 21Jan2021 with outcome of recovering. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. The mother was 8 weeks pregnant at the onset of the event.  The mother was due to deliver on 19Aug2021. Last menstrual date: 22Nov2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies to medications, food, or other products.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage; The mother reported she became pregnant while taking bnt162b2; The mother reported she became pregnant while taking bnt162b2; This is a spontaneous report from a contactable consumer reported for herself. A 27-year-old female patient (Pregnant) received first dose of bnt162b2 (lot number: EL3248), via an unspecified route of administration in left arm on 16Jan2021 16:30 at single dose for covid-19 immunization. Medical history included asthma, covid-19 from an unknown date and unknown if ongoing. The patient's concomitant drug included prenatal vitamins. The patient experienced miscarriage on 21Jan2021 with outcome of recovering. The event was reported as non-serious. The adverse event result in emergency room/department or urgent care. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. The mother was 8 weeks pregnant at the onset of the event.  The mother was due to deliver on 19Aug2021. Last menstrual date: 22Nov2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Not known allergies to medications, food, or other products.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: nausea; headache; lip fever blisters; severe body aches (as bad as when I had Covid 8 months ago); chills; fevers up to 101.9 (baseline 96); fatigue; This is a spontaneous report from a contactable physician (patient). A 58-year-old male receive first single dose of BNT162B2 (Solution for injection, lot number= EL1283, exp date not reported), via an unspecified route of administration on 16Jan2021 10:45 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Age at vaccination reported as 58-years-old. Medical history included autoimmune thyroiditis, and 'Covid Pneumonia' on Jun2020. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication/ other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 01:30, 15 hours after dose 1, the patient developed severe body aches (as bad as when he had Covid 8 months ago), chills, fevers up to 101.9 (baseline 96), and fatigue. This lasted for 46 hours. On 21Jan2021 (day 4), patient had nausea, headache, and lip fever blisters. The events were considered as non-serious by the reporter. The events required doctor or other healthcare professional office/clinic visit. The patient received treatment: ibuprofen, and oral fluids for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: nausea; headache; lip fever blisters; severe body aches (as bad as when I had Covid 8 months ago); chills; fevers up to 101.9 (baseline 96); fatigue; This is a spontaneous report from a contactable physician (patient). A 58-year-old male receive first single dose of BNT162B2 (Solution for injection, lot number= EL1283, exp date not reported), via an unspecified route of administration on 16Jan2021 10:45 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Age at vaccination reported as 58-years-old. Medical history included autoimmune thyroiditis, and 'Covid Pneumonia' on Jun2020. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication/ other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 01:30, 15 hours after dose 1, the patient developed severe body aches (as bad as when he had Covid 8 months ago), chills, fevers up to 101.9 (baseline 96), and fatigue. This lasted for 46 hours. On 21Jan2021 (day 4), patient had nausea, headache, and lip fever blisters. The events were considered as non-serious by the reporter. The events required doctor or other healthcare professional office/clinic visit. The patient received treatment: ibuprofen, and oral fluids for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: nausea; headache; lip fever blisters; severe body aches (as bad as when I had Covid 8 months ago); chills; fevers up to 101.9 (baseline 96); fatigue; This is a spontaneous report from a contactable physician (patient). A 58-year-old male receive first single dose of BNT162B2 (Solution for injection, lot number= EL1283, exp date not reported), via an unspecified route of administration on 16Jan2021 10:45 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Age at vaccination reported as 58-years-old. Medical history included autoimmune thyroiditis, and 'Covid Pneumonia' on Jun2020. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication/ other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 01:30, 15 hours after dose 1, the patient developed severe body aches (as bad as when he had Covid 8 months ago), chills, fevers up to 101.9 (baseline 96), and fatigue. This lasted for 46 hours. On 21Jan2021 (day 4), patient had nausea, headache, and lip fever blisters. The events were considered as non-serious by the reporter. The events required doctor or other healthcare professional office/clinic visit. The patient received treatment: ibuprofen, and oral fluids for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oral herpes, Pain, Pyrexia
Clinical narrative: nausea; headache; lip fever blisters; severe body aches (as bad as when I had Covid 8 months ago); chills; fevers up to 101.9 (baseline 96); fatigue; This is a spontaneous report from a contactable physician (patient). A 58-year-old male receive first single dose of BNT162B2 (Solution for injection, lot number= EL1283, exp date not reported), via an unspecified route of administration on 16Jan2021 10:45 for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Age at vaccination reported as 58-years-old. Medical history included autoimmune thyroiditis, and 'Covid Pneumonia' on Jun2020. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication/ other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021 01:30, 15 hours after dose 1, the patient developed severe body aches (as bad as when he had Covid 8 months ago), chills, fevers up to 101.9 (baseline 96), and fatigue. This lasted for 46 hours. On 21Jan2021 (day 4), patient had nausea, headache, and lip fever blisters. The events were considered as non-serious by the reporter. The events required doctor or other healthcare professional office/clinic visit. The patient received treatment: ibuprofen, and oral fluids for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Myalgia
Clinical narrative: Pain at injection site; muscle pain; fatigue; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient (unknown if pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on left arm on 23Jan2021 13:15 at single dose for covid-19 immunisation. Medical history included Migraines with aura, vasovagal syncope, PCOS, environmental allergies/hay fever, eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cefixime (FLEXERIL), ibuprofen (ADVIL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), inositol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site, muscle pain, fatigue, dizziness, all on 23Jan2021 1400. The events were assessed as non-serious.  Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Pain at injection site; muscle pain; fatigue; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient (unknown if pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on left arm on 23Jan2021 13:15 at single dose for covid-19 immunisation. Medical history included Migraines with aura, vasovagal syncope, PCOS, environmental allergies/hay fever, eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cefixime (FLEXERIL), ibuprofen (ADVIL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), inositol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site, muscle pain, fatigue, dizziness, all on 23Jan2021 1400. The events were assessed as non-serious.  Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pyrexia, Swelling face
Clinical narrative: Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Lip swelling, Pyrexia, Swelling face
Clinical narrative: Facial filler swelling in cheeks and lips; Facial filler swelling in cheeks and lips; fever; chills; coughing; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (also age at vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number Not available/provided to reporter at the time of report completion, dose number: 1), via an unspecified route of administration in left arm on 21Jan2021 09:30 at SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included prior to vaccination the patient was diagnosed with covid-19 on unspecified date. However, since the vaccination the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient's concomitant medications were not reported. The patient experienced Facial filler swelling in cheeks and lips, fever, chills and coughing on 21Jan2021 at 12:00 AM. No treatment was received for the events. The case was reported to be non-serious (not resulting to death, Caused/prolonged hospitalization, Congenital anomaly/birth defect, Disabling/Incapacitating or Life threatening). The outcome of the events was not recovered.    Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Hives at site, redness, swelling, hot, pain, itching at 10 days post vaccine.  18 days post vaccine developed PVCs, currently still experiencing PVCs.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Electrocardiogram, Erythema, Injection site urticaria
Clinical narrative: Hives at site, redness, swelling, hot, pain, itching at 10 days post vaccine.  18 days post vaccine developed PVCs, currently still experiencing PVCs.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Hives at site, redness, swelling, hot, pain, itching at 10 days post vaccine.  18 days post vaccine developed PVCs, currently still experiencing PVCs.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Headache, Malaise
Clinical narrative: body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 16Jan2021 at 18:15 at a single dose for COVID-19 immunization. The vaccination facility was a public health department. The vaccine was not administered at the Military facility. The patient had no additional vaccines administered on the same date of the Pfizer vaccine. Relevant medical history included gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. The patient had no family medical history. Concomitant medication included cimetidine for GERD, which she had been taking for years and years. The patient had no other vaccinations within four weeks prior to the first vaccination. The patient woke up on Tuesday, 19Jan2021, feeling off; she experienced body aches, joint pain, and fatigues. The symptoms (Sxs) were still ongoing. The patient had question regarding the side effects and duration: if these had been reported and was it normal to still feel the side effects and how long would it last for. The patient was also asking if these were indicative of something more serious. The patient added that her healthcare provider (hcp) told her to take 2 paracetamol (TYLENOL) every 6 hours; however, the Tylenol only lasted for 5 hours. The patient further asked that if she continued to have side effects, at what point should she be do something and wanting recommendations on management. The patient was also asking if the side effects would happen with the second shot. The patient further reported that she felt pretty good on Sunday and Monday (17Jan2021 and 18Jan2021), maybe just a little off, and stated that on Tuesday (19Jan2021), she woke up and started with the classic side effects body aches, joint pain, fatigue, and chills that had continued. She stated she was taking Tylenol 2 extra strength; it worked for about 5 hours and then the effects came back. The patient wanted to know if this was normal to last this long and had this been reported by others. She stated she had contacted her doctor and her doctor did not know. The adverse events did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of body aches/ body and legs aches, joint pain, fatigues, and chills. There were no relevant tests. The patient was not recovered from the events "body aches/ body and legs aches, joint pain, fatigues, and chills."
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 16Jan2021 at 18:15 at a single dose for COVID-19 immunization. The vaccination facility was a public health department. The vaccine was not administered at the Military facility. The patient had no additional vaccines administered on the same date of the Pfizer vaccine. Relevant medical history included gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. The patient had no family medical history. Concomitant medication included cimetidine for GERD, which she had been taking for years and years. The patient had no other vaccinations within four weeks prior to the first vaccination. The patient woke up on Tuesday, 19Jan2021, feeling off; she experienced body aches, joint pain, and fatigues. The symptoms (Sxs) were still ongoing. The patient had question regarding the side effects and duration: if these had been reported and was it normal to still feel the side effects and how long would it last for. The patient was also asking if these were indicative of something more serious. The patient added that her healthcare provider (hcp) told her to take 2 paracetamol (TYLENOL) every 6 hours; however, the Tylenol only lasted for 5 hours. The patient further asked that if she continued to have side effects, at what point should she be do something and wanting recommendations on management. The patient was also asking if the side effects would happen with the second shot. The patient further reported that she felt pretty good on Sunday and Monday (17Jan2021 and 18Jan2021), maybe just a little off, and stated that on Tuesday (19Jan2021), she woke up and started with the classic side effects body aches, joint pain, fatigue, and chills that had continued. She stated she was taking Tylenol 2 extra strength; it worked for about 5 hours and then the effects came back. The patient wanted to know if this was normal to last this long and had this been reported by others. She stated she had contacted her doctor and her doctor did not know. The adverse events did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of body aches/ body and legs aches, joint pain, fatigues, and chills. There were no relevant tests. The patient was not recovered from the events "body aches/ body and legs aches, joint pain, fatigues, and chills."
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: body aches/ body and legs aches; body and legs aches; joint pain; fatigues; chills; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the right arm on 16Jan2021 at 18:15 at a single dose for COVID-19 immunization. The vaccination facility was a public health department. The vaccine was not administered at the Military facility. The patient had no additional vaccines administered on the same date of the Pfizer vaccine. Relevant medical history included gastroesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. The patient had no family medical history. Concomitant medication included cimetidine for GERD, which she had been taking for years and years. The patient had no other vaccinations within four weeks prior to the first vaccination. The patient woke up on Tuesday, 19Jan2021, feeling off; she experienced body aches, joint pain, and fatigues. The symptoms (Sxs) were still ongoing. The patient had question regarding the side effects and duration: if these had been reported and was it normal to still feel the side effects and how long would it last for. The patient was also asking if these were indicative of something more serious. The patient added that her healthcare provider (hcp) told her to take 2 paracetamol (TYLENOL) every 6 hours; however, the Tylenol only lasted for 5 hours. The patient further asked that if she continued to have side effects, at what point should she be do something and wanting recommendations on management. The patient was also asking if the side effects would happen with the second shot. The patient further reported that she felt pretty good on Sunday and Monday (17Jan2021 and 18Jan2021), maybe just a little off, and stated that on Tuesday (19Jan2021), she woke up and started with the classic side effects body aches, joint pain, fatigue, and chills that had continued. She stated she was taking Tylenol 2 extra strength; it worked for about 5 hours and then the effects came back. The patient wanted to know if this was normal to last this long and had this been reported by others. She stated she had contacted her doctor and her doctor did not know. The adverse events did not require any visit to an emergency room or a physician office. Therapeutic measures were taken as a result of body aches/ body and legs aches, joint pain, fatigues, and chills. There were no relevant tests. The patient was not recovered from the events "body aches/ body and legs aches, joint pain, fatigues, and chills."
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Chest X-ray normal, Culture urine positive, Escherichia infection, Fall, Full blood count normal
Clinical narrative: This is what I was told by a nurse.  My mother twice tested positive for  COVID, in March and in late Nov /DEC, but never showed serious symptoms.  My mother received the first dose of the COVID Pfizer vaccine in late December 2020 or early January 2021. She collapsed after this shot, but they will have to tell you exactly how long after the vaccine this happened.  3 weeks later, in mid January (they can give you the dates) she received the next dose. She collapsed twice. She hit her head. She refused food and medication. My mother had a memory issue, but was robust physically and as far as our family knows, she had never fallen until she got the COVID vaccine. She died Jan 22, 2021.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Metabolic function test normal, Urinary tract infection
Clinical narrative: This is what I was told by a nurse.  My mother twice tested positive for  COVID, in March and in late Nov /DEC, but never showed serious symptoms.  My mother received the first dose of the COVID Pfizer vaccine in late December 2020 or early January 2021. She collapsed after this shot, but they will have to tell you exactly how long after the vaccine this happened.  3 weeks later, in mid January (they can give you the dates) she received the next dose. She collapsed twice. She hit her head. She refused food and medication. My mother had a memory issue, but was robust physically and as far as our family knows, she had never fallen until she got the COVID vaccine. She died Jan 22, 2021.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Death, Food refusal, Head injury, Refusal of treatment by patient, Syncope
Clinical narrative: This is what I was told by a nurse.  My mother twice tested positive for  COVID, in March and in late Nov /DEC, but never showed serious symptoms.  My mother received the first dose of the COVID Pfizer vaccine in late December 2020 or early January 2021. She collapsed after this shot, but they will have to tell you exactly how long after the vaccine this happened.  3 weeks later, in mid January (they can give you the dates) she received the next dose. She collapsed twice. She hit her head. She refused food and medication. My mother had a memory issue, but was robust physically and as far as our family knows, she had never fallen until she got the COVID vaccine. She died Jan 22, 2021.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: Increased blood pressure; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1288 and expiry date: unknown), via an unspecified route of administration on the left shoulder, on 14Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing acid reflux, atrial fibrillation, and cholesterol. Concomitant medication included omeprazole, apixaban (ELIQUIS), and atorvastatin. Patient previously took pneumonia vaccine. On Jan2021, patient noticed an increased blood pressure (usually his BP is around 120, now has consistently been around 150). Prior to the shot, he has not been on blood pressure medication. His blood pressure usually runs high 120s to 130s on the top, and mid 50-60 on the bottom. His blood pressure prior to the vaccine that day was 132/56. Then a couple of days after the first shot, the top number of his blood pressure was in the high 150s, but the same on the bottom. Patient was wondering if he has a problem, or is this a side effect. He went in as a senior. He didn't have a prescribing doctor. The blood pressure difference started a couple of days after his first shot. He was scheduled for his second shot 4Feb2021. He has had no other side effects or anything. There was no swelling, no fever, no chills and he felt good. Just his blood pressure has been an issue. Outcome of the event was not recovered.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Increased blood pressure; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1288 and expiry date: unknown), via an unspecified route of administration on the left shoulder, on 14Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing acid reflux, atrial fibrillation, and cholesterol. Concomitant medication included omeprazole, apixaban (ELIQUIS), and atorvastatin. Patient previously took pneumonia vaccine. On Jan2021, patient noticed an increased blood pressure (usually his BP is around 120, now has consistently been around 150). Prior to the shot, he has not been on blood pressure medication. His blood pressure usually runs high 120s to 130s on the top, and mid 50-60 on the bottom. His blood pressure prior to the vaccine that day was 132/56. Then a couple of days after the first shot, the top number of his blood pressure was in the high 150s, but the same on the bottom. Patient was wondering if he has a problem, or is this a side effect. He went in as a senior. He didn't have a prescribing doctor. The blood pressure difference started a couple of days after his first shot. He was scheduled for his second shot 4Feb2021. He has had no other side effects or anything. There was no swelling, no fever, no chills and he felt good. Just his blood pressure has been an issue. Outcome of the event was not recovered.