chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Palpitations
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received.  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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Body temperature, Chills, Decreased appetite
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received.  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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Heart rate, Heart rate increased, Hot flush
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received.  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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Palpitations, Presyncope
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received.  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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received.  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: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Chest discomfort, Dizziness, Dry throat, Dyspnoea
Clinical narrative: heart arrhythmia; Cool limbs so blood circulation issues; Cool limbs so blood circulation issues; Tightness of throat; Hard to breathe; Dizzy and light-headed; prickly over the whole body; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 31Mar2021 05:00 PM, at age of 37 years old at single dose for COVID-19 immunization. Medical history included known allergies: Hives/Prickly/itchy/tight throat: Green Tea. Sensitive: Outdoor Maple & Boxelder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. There was no covid prior vaccination. No covid test post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient experienced tightness of throat, hard to breathe, dizzy and light-headed, prickly over the whole body, elevated heart rate, and heart arrhythmia. Cool limbs so blood circulation issues. Adverse event started date on 31Mar2021 05:15 PM. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. The seriousness criteria was reported as non-serious, no resulted in death, no Life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Received treatment for the adverse events, included two diphenhydramine hydrochloride (BENADRYL) and one after 6 hours. Since the vaccination, the patient had not been tested for COVID-19. Patient was recovered from the events.     Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Heart rate increased, Hypotension, Pain
Clinical narrative: heart arrhythmia; Cool limbs so blood circulation issues; Cool limbs so blood circulation issues; Tightness of throat; Hard to breathe; Dizzy and light-headed; prickly over the whole body; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 31Mar2021 05:00 PM, at age of 37 years old at single dose for COVID-19 immunization. Medical history included known allergies: Hives/Prickly/itchy/tight throat: Green Tea. Sensitive: Outdoor Maple & Boxelder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. There was no covid prior vaccination. No covid test post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient experienced tightness of throat, hard to breathe, dizzy and light-headed, prickly over the whole body, elevated heart rate, and heart arrhythmia. Cool limbs so blood circulation issues. Adverse event started date on 31Mar2021 05:15 PM. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. The seriousness criteria was reported as non-serious, no resulted in death, no Life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Received treatment for the adverse events, included two diphenhydramine hydrochloride (BENADRYL) and one after 6 hours. Since the vaccination, the patient had not been tested for COVID-19. Patient was recovered from the events.     Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Pruritus, Swelling face, Throat clearing, Throat irritation
Clinical narrative: heart arrhythmia; Cool limbs so blood circulation issues; Cool limbs so blood circulation issues; Tightness of throat; Hard to breathe; Dizzy and light-headed; prickly over the whole body; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 31Mar2021 05:00 PM, at age of 37 years old at single dose for COVID-19 immunization. Medical history included known allergies: Hives/Prickly/itchy/tight throat: Green Tea. Sensitive: Outdoor Maple & Boxelder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. There was no covid prior vaccination. No covid test post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient experienced tightness of throat, hard to breathe, dizzy and light-headed, prickly over the whole body, elevated heart rate, and heart arrhythmia. Cool limbs so blood circulation issues. Adverse event started date on 31Mar2021 05:15 PM. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. The seriousness criteria was reported as non-serious, no resulted in death, no Life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Received treatment for the adverse events, included two diphenhydramine hydrochloride (BENADRYL) and one after 6 hours. Since the vaccination, the patient had not been tested for COVID-19. Patient was recovered from the events.     Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: heart arrhythmia; Cool limbs so blood circulation issues; Cool limbs so blood circulation issues; Tightness of throat; Hard to breathe; Dizzy and light-headed; prickly over the whole body; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 31Mar2021 05:00 PM, at age of 37 years old at single dose for COVID-19 immunization. Medical history included known allergies: Hives/Prickly/itchy/tight throat: Green Tea. Sensitive: Outdoor Maple & Boxelder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. There was no covid prior vaccination. No covid test post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient experienced tightness of throat, hard to breathe, dizzy and light-headed, prickly over the whole body, elevated heart rate, and heart arrhythmia. Cool limbs so blood circulation issues. Adverse event started date on 31Mar2021 05:15 PM. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. The seriousness criteria was reported as non-serious, no resulted in death, no Life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Received treatment for the adverse events, included two diphenhydramine hydrochloride (BENADRYL) and one after 6 hours. Since the vaccination, the patient had not been tested for COVID-19. Patient was recovered from the events.     Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Dizziness, Dyspnoea, Heart rate increased, Paraesthesia
Clinical narrative: heart arrhythmia; Cool limbs so blood circulation issues; Cool limbs so blood circulation issues; Tightness of throat; Hard to breathe; Dizzy and light-headed; prickly over the whole body; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 31Mar2021 05:00 PM, at age of 37 years old at single dose for COVID-19 immunization. Medical history included known allergies: Hives/Prickly/itchy/tight throat: Green Tea. Sensitive: Outdoor Maple & Boxelder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. There was no covid prior vaccination. No covid test post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient experienced tightness of throat, hard to breathe, dizzy and light-headed, prickly over the whole body, elevated heart rate, and heart arrhythmia. Cool limbs so blood circulation issues. Adverse event started date on 31Mar2021 05:15 PM. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. The seriousness criteria was reported as non-serious, no resulted in death, no Life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Received treatment for the adverse events, included two diphenhydramine hydrochloride (BENADRYL) and one after 6 hours. Since the vaccination, the patient had not been tested for COVID-19. Patient was recovered from the events.     Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Poor peripheral circulation, Throat tightness
Clinical narrative: heart arrhythmia; Cool limbs so blood circulation issues; Cool limbs so blood circulation issues; Tightness of throat; Hard to breathe; Dizzy and light-headed; prickly over the whole body; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 31Mar2021 05:00 PM, at age of 37 years old at single dose for COVID-19 immunization. Medical history included known allergies: Hives/Prickly/itchy/tight throat: Green Tea. Sensitive: Outdoor Maple & Boxelder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. There was no covid prior vaccination. No covid test post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient experienced tightness of throat, hard to breathe, dizzy and light-headed, prickly over the whole body, elevated heart rate, and heart arrhythmia. Cool limbs so blood circulation issues. Adverse event started date on 31Mar2021 05:15 PM. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. The seriousness criteria was reported as non-serious, no resulted in death, no Life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Received treatment for the adverse events, included two diphenhydramine hydrochloride (BENADRYL) and one after 6 hours. Since the vaccination, the patient had not been tested for COVID-19. Patient was recovered from the events.     Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report from a contactable other healthcare professional. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727), intramuscular, administered in arm left on 31Mar2021 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The vaccine was administered at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient never had an adverse event following any previous vaccine. The patient experienced death on 02Apr2021. The outcome of the event was fatal. The patient died on 02Apr2021. Cause of death was unknown. It was unknown if an autopsy was performed.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes 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.; Reported Cause(s) of Death: Unknown cause of death
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Headache, Loss of consciousness, Muscular weakness, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation.  Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation.  Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscular weakness, Nausea, Pain in extremity, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation.  Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Syncope, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).   A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation.  Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Dysarthria, Facial paralysis, Headache
Clinical narrative: right sided facial paralysisBell's Palsy; dizzy; headache; feeling extreme fatigue; couldn't speak; This is a spontaneous report from a contactable consumer (patient). The 50-years-old female patient (age at vaccination was 50 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney donor. The patient was healthy with no medical issues. Concomitant medication(s) was not reported. The patient experienced right sided facial paralysisbell's palsy, dizzy, headache, feeling extreme fatigue on an unspecified date. Reported as: Within 8 hours of receiving the dose, she said "the room got dizzy" and she developed a headache and Bell's Palsy. She states she had right sided facial paralysis, couldn't speak, and exhibited other stroke like symptoms. Was admitted to the hospital, given Plavix, and a headache "cocktail" to treat her symptoms. She underwent an MRI, CT, and echocardiogram to rule out a stroke. She is still hospitalized and states her symptoms started to resolve today, 02Apr2021, at around 8 AM. She also reports feeling extreme fatigue after receiving the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: right sided facial paralysisBell's Palsy; dizzy; headache; feeling extreme fatigue; couldn't speak; This is a spontaneous report from a contactable consumer (patient). The 50-years-old female patient (age at vaccination was 50 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney donor. The patient was healthy with no medical issues. Concomitant medication(s) was not reported. The patient experienced right sided facial paralysisbell's palsy, dizzy, headache, feeling extreme fatigue on an unspecified date. Reported as: Within 8 hours of receiving the dose, she said "the room got dizzy" and she developed a headache and Bell's Palsy. She states she had right sided facial paralysis, couldn't speak, and exhibited other stroke like symptoms. Was admitted to the hospital, given Plavix, and a headache "cocktail" to treat her symptoms. She underwent an MRI, CT, and echocardiogram to rule out a stroke. She is still hospitalized and states her symptoms started to resolve today, 02Apr2021, at around 8 AM. She also reports feeling extreme fatigue after receiving the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Dizziness, Echocardiogram, Fatigue
Clinical narrative: right sided facial paralysisBell's Palsy; dizzy; headache; feeling extreme fatigue; couldn't speak; This is a spontaneous report from a contactable consumer (patient). The 50-years-old female patient (age at vaccination was 50 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney donor. The patient was healthy with no medical issues. Concomitant medication(s) was not reported. The patient experienced right sided facial paralysisbell's palsy, dizzy, headache, feeling extreme fatigue on an unspecified date. Reported as: Within 8 hours of receiving the dose, she said "the room got dizzy" and she developed a headache and Bell's Palsy. She states she had right sided facial paralysis, couldn't speak, and exhibited other stroke like symptoms. Was admitted to the hospital, given Plavix, and a headache "cocktail" to treat her symptoms. She underwent an MRI, CT, and echocardiogram to rule out a stroke. She is still hospitalized and states her symptoms started to resolve today, 02Apr2021, at around 8 AM. She also reports feeling extreme fatigue after receiving the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Magnetic resonance imaging, Speech disorder
Clinical narrative: right sided facial paralysisBell's Palsy; dizzy; headache; feeling extreme fatigue; couldn't speak; This is a spontaneous report from a contactable consumer (patient). The 50-years-old female patient (age at vaccination was 50 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included kidney donor. The patient was healthy with no medical issues. Concomitant medication(s) was not reported. The patient experienced right sided facial paralysisbell's palsy, dizzy, headache, feeling extreme fatigue on an unspecified date. Reported as: Within 8 hours of receiving the dose, she said "the room got dizzy" and she developed a headache and Bell's Palsy. She states she had right sided facial paralysis, couldn't speak, and exhibited other stroke like symptoms. Was admitted to the hospital, given Plavix, and a headache "cocktail" to treat her symptoms. She underwent an MRI, CT, and echocardiogram to rule out a stroke. She is still hospitalized and states her symptoms started to resolve today, 02Apr2021, at around 8 AM. She also reports feeling extreme fatigue after receiving the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Dramatic  loss of hearing in both ears; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 16Mar2021 13:30 (Batch/Lot Number: EP 7534) as single dose for covid-19 immunisation at a clinic. Medical history included depression and high blood pressure. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), losartan potassium (COZAAR) and lamotrigine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tinnitus and dramatic loss of hearing in both ears on 20Mar2021. The events resulted in emergency room/department or urgent care visit. The events were not treated. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain lower, Appendicectomy, Blood test, Computerised tomogram abnormal
Clinical narrative: having her appendix taken out.; stomach cramps; This is a spontaneous report from contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient got her 1st dose last Wednesday and on Thursday she started with stomach cramps. By monday she was in surgery having her appendix taken out. She stated she is nervous about getting the 2nd dose and has tried to address this with HCP, but they don't have any information. Outcome of events not reported.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: having her appendix taken out.; stomach cramps; This is a spontaneous report from contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient got her 1st dose last Wednesday and on Thursday she started with stomach cramps. By monday she was in surgery having her appendix taken out. She stated she is nervous about getting the 2nd dose and has tried to address this with HCP, but they don't have any information. Outcome of events not reported.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicectomy
Clinical narrative: having her appendix taken out.; stomach cramps; This is a spontaneous report from contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in 2021, the patient got her 1st dose last Wednesday and on Thursday she started with stomach cramps. By monday she was in surgery having her appendix taken out. She stated she is nervous about getting the 2nd dose and has tried to address this with HCP, but they don't have any information. Outcome of events not reported.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: On March 30, I was taken to the Emergency Room with severe chest pains and shortness of breath. (I had been experiencing shortness of breath on and off  for at least a week prior to this, but this is when it became severe and I was gasping for breath. Following the vaccine, I had also experienced a mild allergic reaction, nausea, and intense abdominal pain). At the ER, I was diagnosed with a massive pulmonary embolism (after having labs, an EKG, and a cat scan) with clots in both lungs (in all lobes and in my arteries). It was determined that my small rural hospital could not adequately care for me, and I was airlifted to another hospital, where I stayed for five days. While there, I also had an ultrasound of my legs and was told I also had large blood clots in both legs as well as in my lungs.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Electrocardiogram
Clinical narrative: On March 30, I was taken to the Emergency Room with severe chest pains and shortness of breath. (I had been experiencing shortness of breath on and off  for at least a week prior to this, but this is when it became severe and I was gasping for breath. Following the vaccine, I had also experienced a mild allergic reaction, nausea, and intense abdominal pain). At the ER, I was diagnosed with a massive pulmonary embolism (after having labs, an EKG, and a cat scan) with clots in both lungs (in all lobes and in my arteries). It was determined that my small rural hospital could not adequately care for me, and I was airlifted to another hospital, where I stayed for five days. While there, I also had an ultrasound of my legs and was told I also had large blood clots in both legs as well as in my lungs.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Laboratory test, Nausea, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: On March 30, I was taken to the Emergency Room with severe chest pains and shortness of breath. (I had been experiencing shortness of breath on and off  for at least a week prior to this, but this is when it became severe and I was gasping for breath. Following the vaccine, I had also experienced a mild allergic reaction, nausea, and intense abdominal pain). At the ER, I was diagnosed with a massive pulmonary embolism (after having labs, an EKG, and a cat scan) with clots in both lungs (in all lobes and in my arteries). It was determined that my small rural hospital could not adequately care for me, and I was airlifted to another hospital, where I stayed for five days. While there, I also had an ultrasound of my legs and was told I also had large blood clots in both legs as well as in my lungs.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: On March 30, I was taken to the Emergency Room with severe chest pains and shortness of breath. (I had been experiencing shortness of breath on and off  for at least a week prior to this, but this is when it became severe and I was gasping for breath. Following the vaccine, I had also experienced a mild allergic reaction, nausea, and intense abdominal pain). At the ER, I was diagnosed with a massive pulmonary embolism (after having labs, an EKG, and a cat scan) with clots in both lungs (in all lobes and in my arteries). It was determined that my small rural hospital could not adequately care for me, and I was airlifted to another hospital, where I stayed for five days. While there, I also had an ultrasound of my legs and was told I also had large blood clots in both legs as well as in my lungs.