chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: Shaking/shivering violently for 2 hours; Shaking/shivering violently for 2 hours; Bad headache; Muscle aches; Fever finally broke at 3pm on the next day 17 hours after symptoms began; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular on the left arm on 09Jan2021 at 11:00, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), intramuscular on the left arm on 22Dec2020 at 11:00 for COVID-19 immunization. On 09Jan2021, the patient had shot at 11am with no reaction then at 10pm when started shaking/shivering violently for 2 hours and then developed very bad headache, muscle aches. The patient's fever up to 101 then the fever finally broke at 3pm on the next day (10Jan2021) 17 hours after symptoms began. As treatment, patient took Tylenol and Excedrin for headache, muscles aches and fever. No treatment was reported for the events shaking/shivering. The outcome of the event fever was recovered on 10Jan2021 15:00 while the rest of the events was recovered on Jan2021.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Nausea, Pain
Clinical narrative: Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had gastrointestinal issues; Nausea; Had allover muscle aches; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 10Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced dizziness that was bad the following morning, 11Jan2021. She said the dizziness was so bad, she had to have her husband take her to a dentist appointment because she did not feel safe driving. She said she was not feeling well, and was surprised her dentist even saw her that day. She said the dizziness resolved later that day by 7:00PM. Feeling Unwell Treatment: Reported she took 3 Equate brand Ibuprofen 200mg tablets (600mg dose) twice on 11Jan2021. Reported she didn't have a fever, but had a body temperature of 99 degrees Fahrenheit, saying her body temperature usually doesn't run that high. Reported she had gastrointestinal issues. She said she woke up yesterday, 11Jan2021, and was feeling bad. She said her symptoms hit all at once. She clarified she had diarrhea and nausea. She said the diarrhea remains as of this morning, 12Jan2021. She said as soon as she eats, the diarrhea is there. She said she is drinking PowerAde to keep her electrolytes going, but the diarrhea is wiping her out. She said she felt like she was hit by a Mack truck, or has a bad hangover. She said the nausea is gone, clarifying the nausea resolved this morning, 12Jan2021, upon waking up. Diarrhea Treatment: Reported she tried a generic Imodium, saying she took 2 generic Imodium tablets, and the generic Imodium didn't do anything. Reported she had allover muscle aches that started on 11Jan2021. She said her muscle aches improved, and she only has muscle aches remaining in her intestinal tract. Reported she told her doctor she felt horrible and was taking Ibuprofen for muscle pains and a slight fever. Outcome of event dizziness, Nausea was recovered, of Diarrhea was not recovered, of muscle aches was recovering, of others was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had gastrointestinal issues; Nausea; Had allover muscle aches; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 10Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced dizziness that was bad the following morning, 11Jan2021. She said the dizziness was so bad, she had to have her husband take her to a dentist appointment because she did not feel safe driving. She said she was not feeling well, and was surprised her dentist even saw her that day. She said the dizziness resolved later that day by 7:00PM. Feeling Unwell Treatment: Reported she took 3 Equate brand Ibuprofen 200mg tablets (600mg dose) twice on 11Jan2021. Reported she didn't have a fever, but had a body temperature of 99 degrees Fahrenheit, saying her body temperature usually doesn't run that high. Reported she had gastrointestinal issues. She said she woke up yesterday, 11Jan2021, and was feeling bad. She said her symptoms hit all at once. She clarified she had diarrhea and nausea. She said the diarrhea remains as of this morning, 12Jan2021. She said as soon as she eats, the diarrhea is there. She said she is drinking PowerAde to keep her electrolytes going, but the diarrhea is wiping her out. She said she felt like she was hit by a Mack truck, or has a bad hangover. She said the nausea is gone, clarifying the nausea resolved this morning, 12Jan2021, upon waking up. Diarrhea Treatment: Reported she tried a generic Imodium, saying she took 2 generic Imodium tablets, and the generic Imodium didn't do anything. Reported she had allover muscle aches that started on 11Jan2021. She said her muscle aches improved, and she only has muscle aches remaining in her intestinal tract. Reported she told her doctor she felt horrible and was taking Ibuprofen for muscle pains and a slight fever. Outcome of event dizziness, Nausea was recovered, of Diarrhea was not recovered, of muscle aches was recovering, of others was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature abnormal, Diarrhoea, Dizziness, Gastrointestinal disorder
Clinical narrative: Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had gastrointestinal issues; Nausea; Had allover muscle aches; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 10Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced dizziness that was bad the following morning, 11Jan2021. She said the dizziness was so bad, she had to have her husband take her to a dentist appointment because she did not feel safe driving. She said she was not feeling well, and was surprised her dentist even saw her that day. She said the dizziness resolved later that day by 7:00PM. Feeling Unwell Treatment: Reported she took 3 Equate brand Ibuprofen 200mg tablets (600mg dose) twice on 11Jan2021. Reported she didn't have a fever, but had a body temperature of 99 degrees Fahrenheit, saying her body temperature usually doesn't run that high. Reported she had gastrointestinal issues. She said she woke up yesterday, 11Jan2021, and was feeling bad. She said her symptoms hit all at once. She clarified she had diarrhea and nausea. She said the diarrhea remains as of this morning, 12Jan2021. She said as soon as she eats, the diarrhea is there. She said she is drinking PowerAde to keep her electrolytes going, but the diarrhea is wiping her out. She said she felt like she was hit by a Mack truck, or has a bad hangover. She said the nausea is gone, clarifying the nausea resolved this morning, 12Jan2021, upon waking up. Diarrhea Treatment: Reported she tried a generic Imodium, saying she took 2 generic Imodium tablets, and the generic Imodium didn't do anything. Reported she had allover muscle aches that started on 11Jan2021. She said her muscle aches improved, and she only has muscle aches remaining in her intestinal tract. Reported she told her doctor she felt horrible and was taking Ibuprofen for muscle pains and a slight fever. Outcome of event dizziness, Nausea was recovered, of Diarrhea was not recovered, of muscle aches was recovering, of others was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Dizziness; Diarrhea; She was not feeling well; Had a body temperature of 99 degrees Fahrenheit; Had gastrointestinal issues; Nausea; Had allover muscle aches; This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on 10Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included ongoing hypothyroidism for the last 15 years. The patient's concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN) and cetirizine hydrochloride (ZYRTEC ALLERGY). The patient experienced dizziness that was bad the following morning, 11Jan2021. She said the dizziness was so bad, she had to have her husband take her to a dentist appointment because she did not feel safe driving. She said she was not feeling well, and was surprised her dentist even saw her that day. She said the dizziness resolved later that day by 7:00PM. Feeling Unwell Treatment: Reported she took 3 Equate brand Ibuprofen 200mg tablets (600mg dose) twice on 11Jan2021. Reported she didn't have a fever, but had a body temperature of 99 degrees Fahrenheit, saying her body temperature usually doesn't run that high. Reported she had gastrointestinal issues. She said she woke up yesterday, 11Jan2021, and was feeling bad. She said her symptoms hit all at once. She clarified she had diarrhea and nausea. She said the diarrhea remains as of this morning, 12Jan2021. She said as soon as she eats, the diarrhea is there. She said she is drinking PowerAde to keep her electrolytes going, but the diarrhea is wiping her out. She said she felt like she was hit by a Mack truck, or has a bad hangover. She said the nausea is gone, clarifying the nausea resolved this morning, 12Jan2021, upon waking up. Diarrhea Treatment: Reported she tried a generic Imodium, saying she took 2 generic Imodium tablets, and the generic Imodium didn't do anything. Reported she had allover muscle aches that started on 11Jan2021. She said her muscle aches improved, and she only has muscle aches remaining in her intestinal tract. Reported she told her doctor she felt horrible and was taking Ibuprofen for muscle pains and a slight fever. Outcome of event dizziness, Nausea was recovered, of Diarrhea was not recovered, of muscle aches was recovering, of others was unknown.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial asymmetry, Facial paralysis, Fatigue, Headache, Myalgia
Clinical narrative: Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician.   A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face cannot be excluded, considering the plausible temporal relationship. 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: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician.   A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face cannot be excluded, considering the plausible temporal relationship. 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: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial asymmetry, Facial paralysis, Fatigue, Headache, Magnetic resonance imaging abnormal
Clinical narrative: Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician.   A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face cannot be excluded, considering the plausible temporal relationship. 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: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: Unable to move the left side of my face/I could quite noticeably see asymmetry in my face/I was provided with the diagnosis of Bells Palsy; I felt moderate tingling sensations associated with the distribution of the paralysis; Generalized muscle aches; I felt fatigue; Dizziness; This is a spontaneous report from a contactable Physician.   A 32-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246) on 07Jan2021 at 09:00 a.m. intramuscular on left deltoid, at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included omeprazole. The patient received first dose of BNT162B2 on 18Dec2020 at 09:00 on left arm (lot number: EK5730) and experienced headaches that started on the third day and ended on the tenth day. Following the second dose on 07Jan2021, patient experienced fatigue and generalized muscle aches within six to twelve hours, and these symptoms lasted for two days. On 10Jan2021, he noticed that was unable to move the left side of his face. He felt moderate tingling sensations associated with the distribution of the paralysis. When looked in the mirror, he could quite noticeably see asymmetry in his face. Patient immediately visited emergency department at the hospital where his primary care doctor was located. Patient was kept in the hospital into the next day for observation (as reported). After evaluation by a neurology team and an MRI, patient was diagnosed with Bells Palsy. He had never previously been diagnosed with Bells Palsy, and never previously had a hospital stay before. It was also informed that patient underwent Nasal Swab for SARS-CoV-2 test on an unspecified date in Dec2020 and on 10Jan2021, both resulted negative. At the time of the reporting, the symptoms continued.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of diagnosed Bells Palsy presented as unable to move the left side of his face/felt moderate tingling sensations associated with the distribution of the paralysis/asymmetry in his face cannot be excluded, considering the plausible temporal relationship. 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on shoulder, face and arms; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 12Jan2021 12:45 at a single dose on the left arm for COVID-19 immunization. Vaccine was administered on a hospital. The patient had no other vaccine in four weeks. Medical history included polycythemia vera, diabetic, bronchiectasis and allergies to penicillin and yellow dye #5. The patient was not tested for Covid prior and post vaccination. Concomitant medications included zolpidem tartrate (AMBIEN), empagliflozin (JARDIANCE), montelukast and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]).  The patient previously took acetylsalicylic acid (ASPIRIN) and ibuprofen (MOTRIN) and experienced allergies to both. The patient experienced hives on shoulder, face and arms on 12Jan2021 13:15. The patient had an emergency room/department or urgent care visit. The event was treated with Epi Pen, steroids and Benadryl. The outcome of the event was recovered on Jan2021.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives on shoulder, face and arms; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 12Jan2021 12:45 at a single dose on the left arm for COVID-19 immunization. Vaccine was administered on a hospital. The patient had no other vaccine in four weeks. Medical history included polycythemia vera, diabetic, bronchiectasis and allergies to penicillin and yellow dye #5. The patient was not tested for Covid prior and post vaccination. Concomitant medications included zolpidem tartrate (AMBIEN), empagliflozin (JARDIANCE), montelukast and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]).  The patient previously took acetylsalicylic acid (ASPIRIN) and ibuprofen (MOTRIN) and experienced allergies to both. The patient experienced hives on shoulder, face and arms on 12Jan2021 13:15. The patient had an emergency room/department or urgent care visit. The event was treated with Epi Pen, steroids and Benadryl. The outcome of the event was recovered on Jan2021.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Body temperature increased, Paraesthesia oral, Throat tightness
Clinical narrative: BP at 179/99; Tongue felt tingly; felt a tight sensation in her throat; Temp elevated at 99; This is a spontaneous report from a contactable other HCP. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9231), intramuscular in left arm on 13Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. The patient had no covid-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unknown date COVID-19 immunization. On 13Jan2021 10:15, the patient experienced tongue felt tingly, felt a tight sensation in her throat, temp elevated at 99, BP at 179/99, and HR 62. No hives, no wheezing, and no angioedema. The events recovered on an unknown date in Jan2021. The patient received Benadryl 50 mg as treatment and had ice pack behind neck, laid down for 30 mins. The patient was not tested for COVID-19 post vaccination.  Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Paraesthesia oral, Throat tightness
Clinical narrative: BP at 179/99; Tongue felt tingly; felt a tight sensation in her throat; Temp elevated at 99; This is a spontaneous report from a contactable other HCP. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9231), intramuscular in left arm on 13Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. The patient had no covid-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unknown date COVID-19 immunization. On 13Jan2021 10:15, the patient experienced tongue felt tingly, felt a tight sensation in her throat, temp elevated at 99, BP at 179/99, and HR 62. No hives, no wheezing, and no angioedema. The events recovered on an unknown date in Jan2021. The patient received Benadryl 50 mg as treatment and had ice pack behind neck, laid down for 30 mins. The patient was not tested for COVID-19 post vaccination.  Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dysgeusia, Headache, Hypoaesthesia
Clinical narrative: Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient).  A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date.  Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient).  A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date.  Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram normal, Dysgeusia, Headache, Hypoaesthesia
Clinical narrative: Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient).  A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date.  Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Magnetic resonance imaging normal, SARS-CoV-2 test
Clinical narrative: Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient).  A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date.  Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Diarrhoea, Dysgeusia, Headache, Hypoaesthesia
Clinical narrative: Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient).  A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date.  Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Numbness to the left side of my face from the bottom of my eye to the middle of my neck; headache; metal taste in my mouth; some soreness at the site; diarrhea; This is a spontaneous report from a contactable Other HCP (patient).  A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular in the right arm on 08Jan2021 12:30 at single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history was none. Concomitant medication included losartan (unknown manufacturer). On 09Jan2021 at 04:00 the patient experienced numbness to the left side of her face from the bottom of her eye to the middle of her neck, headache, metal taste in her mouth, some soreness at the site and diarrhea with outcome of not recovered. The events resulted in Emergency room/department or urgent care visit. The patient underwent sars-cov-2 test: negative on 11Jan2021, and computerised tomogram and magnetic resonance imaging with unknown results on unknown date.  Prior to vaccination, the patient was not diagnosed with COVID-19.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: 4 days after vaccine, developed shingles, left thorax; This is a spontaneous report from a contactable Physician (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek9321), on 08Jan2021 at 13:00 at single dose intramuscular in left arm for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was vaccinated at hospital. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 18Dec2020 at 13:00 at single dose intramuscular in right arm. Medical history included gastrooesophageal reflux disease and palpitations. The patient had no known allergies. Concomitant medications included famotidine (PEPCID), and metoprolol. On 12Jan2021 at 13:00, four days after vaccine, the patient developed shingles, left thorax. The event resulted in Doctor or other healthcare professional office/clinic visit. Treatment for the event included Valacyclovir. The event was resolving at the time of the report. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Office visit
Clinical narrative: 4 days after vaccine, developed shingles, left thorax; This is a spontaneous report from a contactable Physician (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ek9321), on 08Jan2021 at 13:00 at single dose intramuscular in left arm for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient was vaccinated at hospital. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 18Dec2020 at 13:00 at single dose intramuscular in right arm. Medical history included gastrooesophageal reflux disease and palpitations. The patient had no known allergies. Concomitant medications included famotidine (PEPCID), and metoprolol. On 12Jan2021 at 13:00, four days after vaccine, the patient developed shingles, left thorax. The event resulted in Doctor or other healthcare professional office/clinic visit. Treatment for the event included Valacyclovir. The event was resolving at the time of the report. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram normal, Chest discomfort, Echocardiogram abnormal, Electrocardiogram change, Left ventricular dysfunction
Clinical narrative: Patient received Moderna injection 1 in the morning and that afternoon developed  4/10 constant chest pain for 3 hours prior to presentation to the ER.  She did report associated palpitations but has a h/o paroxysmal afib.   Her troponin I was elevated at 1.14 which trended down.  EKG on admission demonstrated T wave changes in the anterolateral leads concerning for possible ischemia.   She was medically managed overnight with heparin, nitro, Brilinta, and beta blockers and taken to the cath lab the following day where she was found to have clean coronaries but with some wall motion abnormalities.   ECHO was performed and showed mildly reduced LVEF at 40-45%.   Cardiology felt that EKG changes, troponin elevation and non obstructive coronary artery disease was consistent with a potential diagnosis of myocarditis.  These tests were all on 1/12 or 1/13/21
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Left ventricular hypertrophy, Pyrexia, Troponin increased
Clinical narrative: Patient received Moderna injection 1 in the morning and that afternoon developed  4/10 constant chest pain for 3 hours prior to presentation to the ER.  She did report associated palpitations but has a h/o paroxysmal afib.   Her troponin I was elevated at 1.14 which trended down.  EKG on admission demonstrated T wave changes in the anterolateral leads concerning for possible ischemia.   She was medically managed overnight with heparin, nitro, Brilinta, and beta blockers and taken to the cath lab the following day where she was found to have clean coronaries but with some wall motion abnormalities.   ECHO was performed and showed mildly reduced LVEF at 40-45%.   Cardiology felt that EKG changes, troponin elevation and non obstructive coronary artery disease was consistent with a potential diagnosis of myocarditis.  These tests were all on 1/12 or 1/13/21
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Catheterisation cardiac abnormal, Chest pain, Condition aggravated, Echocardiogram abnormal
Clinical narrative: Patient received Moderna injection 1 in the morning and that afternoon developed  4/10 constant chest pain for 3 hours prior to presentation to the ER.  She did report associated palpitations but has a h/o paroxysmal afib.   Her troponin I was elevated at 1.14 which trended down.  EKG on admission demonstrated T wave changes in the anterolateral leads concerning for possible ischemia.   She was medically managed overnight with heparin, nitro, Brilinta, and beta blockers and taken to the cath lab the following day where she was found to have clean coronaries but with some wall motion abnormalities.   ECHO was performed and showed mildly reduced LVEF at 40-45%.   Cardiology felt that EKG changes, troponin elevation and non obstructive coronary artery disease was consistent with a potential diagnosis of myocarditis.  These tests were all on 1/12 or 1/13/21
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram T wave abnormal, Palpitations, Troponin I increased, Wall motion score index abnormal
Clinical narrative: Patient received Moderna injection 1 in the morning and that afternoon developed  4/10 constant chest pain for 3 hours prior to presentation to the ER.  She did report associated palpitations but has a h/o paroxysmal afib.   Her troponin I was elevated at 1.14 which trended down.  EKG on admission demonstrated T wave changes in the anterolateral leads concerning for possible ischemia.   She was medically managed overnight with heparin, nitro, Brilinta, and beta blockers and taken to the cath lab the following day where she was found to have clean coronaries but with some wall motion abnormalities.   ECHO was performed and showed mildly reduced LVEF at 40-45%.   Cardiology felt that EKG changes, troponin elevation and non obstructive coronary artery disease was consistent with a potential diagnosis of myocarditis.  These tests were all on 1/12 or 1/13/21
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood thyroid stimulating hormone, Cardiac arrest, Echocardiogram, Electrocardiogram
Clinical narrative: Vasovagal syncope with asystole; Vasovagal syncope with asystole; This is a spontaneous report from a contactable pharmacist (patient).  A 36-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1686), via an unspecified route of administration in the right arm on 11Jan2021 at 14:45 at 36-years-old at a single dose for COVID-19 immunization in a hospital.  Medical history included Wilms tumor from an unknown date and unknown if ongoing, Kidney resection and chemo from 1986 to an unknown date, sulfonamide allergy from an unknown date and unknown if ongoing, premature ventricular contractions (PVCs) from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899) for COVID-19 immunization on 21Dec2020. On 12Jan2021 at 04:00, the patient experienced vasovagal syncope with asystole (hospitalization, medically significant).  The patient was hospitalized for vasovagal syncope with asystole on unknown dates for 4 days (at the time of the report). It was reported that the patient did not receive any treatment due to the events. The clinical course was reported as follows: The patient experienced what was believed to be a vasovagal syncope with asystole; approximately 12 hours after receiving the second dose. The patient had been admitted to the hospital since all cardiac diagnosis tests were negative for structural or functional abnormalities. The patient remained in-patient at this time for initiation of therapy for frequent PVCs, which were diagnosis about one year ago; but chose not to treat at that time, as the symptoms were not affecting her lifestyle. The patient underwent lab tests and procedures which included cardiac diagnosis tests: negative for structural or functional abnormalities on an unknown date.  The clinical outcome of the events was recovering. The patient did not have COVID prior to vaccination; and was not tested for COVID post vaccination.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in the development of the vasovagal syncope with asystole cannot be excluded. The event is confounded by the patient's underlying premature ventricular contractions. 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.