chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Inappropriate schedule of product administration, Myalgia
Clinical narrative: fatigue; Severe fever (104.6); chills; nausea; muscle soreness; first dose of BNT162B2 on 22Dec2020, second dose on 09Jan2021; This is a spontaneous report from a contactable nurse. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 09Jan2021 at 07:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other product. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) on 22Dec2020 at 02:00 pm on the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Jan2021 at 20:00, the patient experienced fatigue, severe fever (104.6), chills, nausea, and muscle soreness. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fatigue; Severe fever (104.6); chills; nausea; muscle soreness; first dose of BNT162B2 on 22Dec2020, second dose on 09Jan2021; This is a spontaneous report from a contactable nurse. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302), via an unspecified route of administration on 09Jan2021 at 07:30 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other product. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) on 22Dec2020 at 02:00 pm on the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Jan2021 at 20:00, the patient experienced fatigue, severe fever (104.6), chills, nausea, and muscle soreness. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Feeling jittery, Headache
Clinical narrative: Abnormal diuresis from 8am to 10pm; Urinating 1-2 time per hour; woke up for midnight trauma/woke up 4 times in between; woke up for midnight trauma; Felt very jittery, although HR was 75.; extremely nauseous; lightheaded; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0140), intramuscular at left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included 1 kidney stone in 2019. No known allergies to medications, food, or other products. There were no concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1685), intramuscular at left arm on 18Dec2020 07:15 for COVID-19 immunization at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. It was reported that the patient was vaccinated at 07:15. The events started on 08Jan2021 08:00. Detailed clinical course was reported das follows. Abnormal diuresis from 08:00 to 10:00. Urinating 1-2 time per hour, 300-500 ml per time. He went to sleep from 22:00 to 23:30, woke up for midnight trauma. He felt very jittery, although heart rate (HR) was 75. In the middle of surgical case, he became extremely nauseous and lightheaded. He left the operating room (OR) for 20 minutes and drank 50 oz of water and felt slightly better. He finished case at "an". He slept from 04:00 to 07:00. He woke up 4 times in between and urinated 300 500ml each time. He drove home from 07:00-08:00, felt nauseous. Laid in bed from 08:00 to 09:00 and urinated 3 times 300-500 ml each time. Slept from 09:00 to noon, felt better, urinating every 4-6 hours, appears back to normal routine. Treatment for the events included fluids. The outcome of the events was unknown. The reporter consider the events as non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Feeling jittery, Heart rate, Injury, Nausea
Clinical narrative: Abnormal diuresis from 8am to 10pm; Urinating 1-2 time per hour; woke up for midnight trauma/woke up 4 times in between; woke up for midnight trauma; Felt very jittery, although HR was 75.; extremely nauseous; lightheaded; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0140), intramuscular at left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included 1 kidney stone in 2019. No known allergies to medications, food, or other products. There were no concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1685), intramuscular at left arm on 18Dec2020 07:15 for COVID-19 immunization at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. It was reported that the patient was vaccinated at 07:15. The events started on 08Jan2021 08:00. Detailed clinical course was reported das follows. Abnormal diuresis from 08:00 to 10:00. Urinating 1-2 time per hour, 300-500 ml per time. He went to sleep from 22:00 to 23:30, woke up for midnight trauma. He felt very jittery, although heart rate (HR) was 75. In the middle of surgical case, he became extremely nauseous and lightheaded. He left the operating room (OR) for 20 minutes and drank 50 oz of water and felt slightly better. He finished case at "an". He slept from 04:00 to 07:00. He woke up 4 times in between and urinated 300 500ml each time. He drove home from 07:00-08:00, felt nauseous. Laid in bed from 08:00 to 09:00 and urinated 3 times 300-500 ml each time. Slept from 09:00 to noon, felt better, urinating every 4-6 hours, appears back to normal routine. Treatment for the events included fluids. The outcome of the events was unknown. The reporter consider the events as non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pollakiuria, Polyuria, Poor quality sleep
Clinical narrative: Abnormal diuresis from 8am to 10pm; Urinating 1-2 time per hour; woke up for midnight trauma/woke up 4 times in between; woke up for midnight trauma; Felt very jittery, although HR was 75.; extremely nauseous; lightheaded; This is a spontaneous report from a contactable nurse (patient).  A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0140), intramuscular at left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included 1 kidney stone in 2019. No known allergies to medications, food, or other products. There were no concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1685), intramuscular at left arm on 18Dec2020 07:15 for COVID-19 immunization at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. It was reported that the patient was vaccinated at 07:15. The events started on 08Jan2021 08:00. Detailed clinical course was reported das follows. Abnormal diuresis from 08:00 to 10:00. Urinating 1-2 time per hour, 300-500 ml per time. He went to sleep from 22:00 to 23:30, woke up for midnight trauma. He felt very jittery, although heart rate (HR) was 75. In the middle of surgical case, he became extremely nauseous and lightheaded. He left the operating room (OR) for 20 minutes and drank 50 oz of water and felt slightly better. He finished case at "an". He slept from 04:00 to 07:00. He woke up 4 times in between and urinated 300 500ml each time. He drove home from 07:00-08:00, felt nauseous. Laid in bed from 08:00 to 09:00 and urinated 3 times 300-500 ml each time. Slept from 09:00 to noon, felt better, urinating every 4-6 hours, appears back to normal routine. Treatment for the events included fluids. The outcome of the events was unknown. The reporter consider the events as non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Eye irritation, Malaise, Pain, Pain in extremity
Clinical narrative: Sore arm starting Friday night & through Saturday.  Saturday, apx 1830, I infused my Gammaguard uneventfully.  Slight chills Saturday 1 hr after infusion, which is unusual.  on waking Sunday, severe tremoring chills. no elevated temperature.  by 0830, severe headache, total body aches and tremors such that i could not write or keyboard.  left work. severe  chills continues until about noon Monday when they started to lesson.  they were gone by midafternoon.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tremor
Clinical narrative: Sore arm starting Friday night & through Saturday.  Saturday, apx 1830, I infused my Gammaguard uneventfully.  Slight chills Saturday 1 hr after infusion, which is unusual.  on waking Sunday, severe tremoring chills. no elevated temperature.  by 0830, severe headache, total body aches and tremors such that i could not write or keyboard.  left work. severe  chills continues until about noon Monday when they started to lesson.  they were gone by midafternoon.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Headache, Impaired work ability, Pain, Pain in extremity
Clinical narrative: Sore arm starting Friday night & through Saturday.  Saturday, apx 1830, I infused my Gammaguard uneventfully.  Slight chills Saturday 1 hr after infusion, which is unusual.  on waking Sunday, severe tremoring chills. no elevated temperature.  by 0830, severe headache, total body aches and tremors such that i could not write or keyboard.  left work. severe  chills continues until about noon Monday when they started to lesson.  they were gone by midafternoon.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Electrocardiogram, Heart rate increased, Laboratory test
Clinical narrative: 3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest X-ray, Electrocardiogram, Fatigue, Heart rate
Clinical narrative: 3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hot flush, Laboratory test, Myalgia, Paraesthesia
Clinical narrative: 3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: 3.5 hours after injection all of a sudden HR was at 161; Muscle pain around injection site and some fatigue, but not bad.; Muscle pain around injection site; Muscle pain around injection site and some fatigue, but not bad.; I was warmflush feeling; When HR jumped to 161 she had a weird sensation run down both of arms; This is a spontaneous report from a contactable consumer. This 40-year-old female (no pregnant) patient received first dose of BNT162B2 (lot# EL3249) on 08Jan2021 02:30 PM on arm Left for COVID-19 immunization. Medical history was Type 1 IDDM (Diabetes), Anxiety/Panic Disorder. Concomitant drug included desvenlafaxine succinate (PRISTIQ), Clonazepam, insulin lispro (HUMALOG), cetirizine hydrochloride (ZYRTEC), all received within 2 weeks of vaccination. Past drug was Allergies to levofloxacin (LEVAQUIN). It was reported that 3.5 hours after injection (08Jan2021 06:00 PM) all of a sudden HR was at 161, patient layed down and it came down a little to 115-125, for 4-5 thereafter it stayed around 110-115, and after about 6 hours it returned to normal. She was warm flush feeling but without a fever. When HR jumped to 161 she had a weird sensation run down both of arms but is subsided with kaying down and HR coming down a bit. No toher bad issues since. Muscle pain around injection site and some fatigue, but not bad. Emergency room/department or urgent care visit. Treatment: EKG, CXR, Labwork, very brief monitoring of HR/BP. Outcome of the event was recovered. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest X-ray, Electrocardiogram, Full blood count, Metabolic function test
Clinical narrative: anaphylactic reaction to seafood; tightness of throat; itchy red rash over entire body; This is a spontaneous report from a contactable nurse reported for herself. This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # Ek9231), via an unspecified route of administration at single dose in the right arm on 30Dec2020 02:45 PM, for Covid-19 immunisation. Medical history none. Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), estrogens conjugated, medroxyprogesterone acetate (PREMPHASE). On 09Jan2021 07:00 PM, the patient experienced anaphylactic reaction, tightness of throat, itchy red rash over entire body. Therapeutic measures were taken as a result of the events included H1H2 blockers steroids. The events were described as follows: On 09Jan2021 after eating seafood developed anaphylactic reaction requiring ER visit. No prior allergy to seafood. Developed itchy red rash over entire body with tightness of throat. After being treated and observed for a few hours without symptoms developed another reaction which was treated a second time. The outcome of the events was recovered on an unspecified date in Jan2021. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant.; Sender's Comments: Based on the available information the event "developed anaphylactic reaction after eating seafood" represents an intercurrent medical condition that was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Throat tightness, Troponin
Clinical narrative: anaphylactic reaction to seafood; tightness of throat; itchy red rash over entire body; This is a spontaneous report from a contactable nurse reported for herself. This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # Ek9231), via an unspecified route of administration at single dose in the right arm on 30Dec2020 02:45 PM, for Covid-19 immunisation. Medical history none. Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), estrogens conjugated, medroxyprogesterone acetate (PREMPHASE). On 09Jan2021 07:00 PM, the patient experienced anaphylactic reaction, tightness of throat, itchy red rash over entire body. Therapeutic measures were taken as a result of the events included H1H2 blockers steroids. The events were described as follows: On 09Jan2021 after eating seafood developed anaphylactic reaction requiring ER visit. No prior allergy to seafood. Developed itchy red rash over entire body with tightness of throat. After being treated and observed for a few hours without symptoms developed another reaction which was treated a second time. The outcome of the events was recovered on an unspecified date in Jan2021. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant.; Sender's Comments: Based on the available information the event "developed anaphylactic reaction after eating seafood" represents an intercurrent medical condition that was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Rash, Rash erythematous, Rash pruritic, Throat tightness
Clinical narrative: anaphylactic reaction to seafood; tightness of throat; itchy red rash over entire body; This is a spontaneous report from a contactable nurse reported for herself. This 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # Ek9231), via an unspecified route of administration at single dose in the right arm on 30Dec2020 02:45 PM, for Covid-19 immunisation. Medical history none. Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), estrogens conjugated, medroxyprogesterone acetate (PREMPHASE). On 09Jan2021 07:00 PM, the patient experienced anaphylactic reaction, tightness of throat, itchy red rash over entire body. Therapeutic measures were taken as a result of the events included H1H2 blockers steroids. The events were described as follows: On 09Jan2021 after eating seafood developed anaphylactic reaction requiring ER visit. No prior allergy to seafood. Developed itchy red rash over entire body with tightness of throat. After being treated and observed for a few hours without symptoms developed another reaction which was treated a second time. The outcome of the events was recovered on an unspecified date in Jan2021. The vaccine was administered at Hospital Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient was not pregnant.; Sender's Comments: Based on the available information the event "developed anaphylactic reaction after eating seafood" represents an intercurrent medical condition that was not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Patient arrived in the office in normal state of health, no previous reactions to vaccines or injectable medications reported. Vaccine was given at approximately 1:30 pm. Patient immediately reported a flushing sensation and felt anxious. Monitoring began at this time as below:  1:36p: BP 131/87, HR 99, O2 99%,  1:43: BP 131/85, HR 89. Continued flushed feeling. Examined by MD who noted hives around injection site and on contralateral arm and chest. MD called to assist. Decision was made to move her to a separate room to lie down on a bed. En route to new room patient developed diarrhea, given Benadryl 50 mg.  1:49p: patient reported shortness of breath and throat tightness. Epipen given and 911 called. O2 sat 99%, HR 133. Husband was brought in to be at bedside with patient.  1:55: BP 145/76, HR 137, O2 99% 2p: EMS arrived to transport patient to Hospital  Patient left the office in stable condition with vital signs within expected range and fully conscious.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Hot flush, Immediate post-injection reaction, Rash
Clinical narrative: Patient arrived in the office in normal state of health, no previous reactions to vaccines or injectable medications reported. Vaccine was given at approximately 1:30 pm. Patient immediately reported a flushing sensation and felt anxious. Monitoring began at this time as below:  1:36p: BP 131/87, HR 99, O2 99%,  1:43: BP 131/85, HR 89. Continued flushed feeling. Examined by MD who noted hives around injection site and on contralateral arm and chest. MD called to assist. Decision was made to move her to a separate room to lie down on a bed. En route to new room patient developed diarrhea, given Benadryl 50 mg.  1:49p: patient reported shortness of breath and throat tightness. Epipen given and 911 called. O2 sat 99%, HR 133. Husband was brought in to be at bedside with patient.  1:55: BP 145/76, HR 137, O2 99% 2p: EMS arrived to transport patient to Hospital  Patient left the office in stable condition with vital signs within expected range and fully conscious.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Patient arrived in the office in normal state of health, no previous reactions to vaccines or injectable medications reported. Vaccine was given at approximately 1:30 pm. Patient immediately reported a flushing sensation and felt anxious. Monitoring began at this time as below:  1:36p: BP 131/87, HR 99, O2 99%,  1:43: BP 131/85, HR 89. Continued flushed feeling. Examined by MD who noted hives around injection site and on contralateral arm and chest. MD called to assist. Decision was made to move her to a separate room to lie down on a bed. En route to new room patient developed diarrhea, given Benadryl 50 mg.  1:49p: patient reported shortness of breath and throat tightness. Epipen given and 911 called. O2 sat 99%, HR 133. Husband was brought in to be at bedside with patient.  1:55: BP 145/76, HR 137, O2 99% 2p: EMS arrived to transport patient to Hospital  Patient left the office in stable condition with vital signs within expected range and fully conscious.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Diarrhoea, Dyspnoea, Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Patient arrived in the office in normal state of health, no previous reactions to vaccines or injectable medications reported. Vaccine was given at approximately 1:30 pm. Patient immediately reported a flushing sensation and felt anxious. Monitoring began at this time as below:  1:36p: BP 131/87, HR 99, O2 99%,  1:43: BP 131/85, HR 89. Continued flushed feeling. Examined by MD who noted hives around injection site and on contralateral arm and chest. MD called to assist. Decision was made to move her to a separate room to lie down on a bed. En route to new room patient developed diarrhea, given Benadryl 50 mg.  1:49p: patient reported shortness of breath and throat tightness. Epipen given and 911 called. O2 sat 99%, HR 133. Husband was brought in to be at bedside with patient.  1:55: BP 145/76, HR 137, O2 99% 2p: EMS arrived to transport patient to Hospital  Patient left the office in stable condition with vital signs within expected range and fully conscious.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Patient arrived in the office in normal state of health, no previous reactions to vaccines or injectable medications reported. Vaccine was given at approximately 1:30 pm. Patient immediately reported a flushing sensation and felt anxious. Monitoring began at this time as below:  1:36p: BP 131/87, HR 99, O2 99%,  1:43: BP 131/85, HR 89. Continued flushed feeling. Examined by MD who noted hives around injection site and on contralateral arm and chest. MD called to assist. Decision was made to move her to a separate room to lie down on a bed. En route to new room patient developed diarrhea, given Benadryl 50 mg.  1:49p: patient reported shortness of breath and throat tightness. Epipen given and 911 called. O2 sat 99%, HR 133. Husband was brought in to be at bedside with patient.  1:55: BP 145/76, HR 137, O2 99% 2p: EMS arrived to transport patient to Hospital  Patient left the office in stable condition with vital signs within expected range and fully conscious.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chills, Cough, Fatigue, Headache
Clinical narrative: fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Cough, Fatigue
Clinical narrative: fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fatigue; headache; body aches; chills; cough; GI distress; high fever (102); This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the left arm, on 08Jan2021 at 17:00, at a single dose, for COVID-19 immunization. Relevant medical history included diabetes type 2, high blood pressure, hyperlipidemia, and glaucoma. Concomitant medications included orphenadrine (K-FLEX), empagliflozin (JARDIANCE), losartan, atorvastatin calcium (LIPITOR), and insulin. The previously took metformin and experienced allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient is not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 18:00, the patient experienced fatigue, headache, body aches, chills, cough, gastrointestinal (GI) distress, and high fever (102). The patient did not receive treatment for the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Dizziness, Fear, Throat tightness
Clinical narrative: Gave injection, patient set down to be observed for 15 minutes and did fine. Patient left and came back 10 minutes later saying she was having trouble breathing and swallowing. Looked in patients mouth and could see her throat closing up and tongue swelling. Administered Epi pen into left leg (left side of thigh). Patient was able to start taking breaths. Called 911 and spoke with them until EMS arrived and took over.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Swollen tongue, Throat tightness
Clinical narrative: Gave injection, patient set down to be observed for 15 minutes and did fine. Patient left and came back 10 minutes later saying she was having trouble breathing and swallowing. Looked in patients mouth and could see her throat closing up and tongue swelling. Administered Epi pen into left leg (left side of thigh). Patient was able to start taking breaths. Called 911 and spoke with them until EMS arrived and took over.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Polypectomy, Sinus polyp, Throat tightness
Clinical narrative: Gave injection, patient set down to be observed for 15 minutes and did fine. Patient left and came back 10 minutes later saying she was having trouble breathing and swallowing. Looked in patients mouth and could see her throat closing up and tongue swelling. Administered Epi pen into left leg (left side of thigh). Patient was able to start taking breaths. Called 911 and spoke with them until EMS arrived and took over.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Malaise, Palpitations, Throat irritation
Clinical narrative: Dizzy, shaking, runny nose, tachycardia, high blood pressure, nausea. Could not obtain IV access after multiple attempts. Benadryl given IM. Steroid course and pepcid prescribed.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypertension, Nausea, Rhinorrhoea, Tachycardia
Clinical narrative: Dizzy, shaking, runny nose, tachycardia, high blood pressure, nausea. Could not obtain IV access after multiple attempts. Benadryl given IM. Steroid course and pepcid prescribed.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Dizzy, shaking, runny nose, tachycardia, high blood pressure, nausea. Could not obtain IV access after multiple attempts. Benadryl given IM. Steroid course and pepcid prescribed.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Impaired work ability
Clinical narrative: I started feeling lightheaded, heart started beating fast, and I briefly felt like I might pass out. I raised my hand to tell the nurse, and she asked if I wanted to see the EMTs which I replied yes. I was able to walk to the EMTs with no issue, as the lightheadedness had subsided (felt lightheaded for maybe 1-2 min total time). The EMTs took my blood pressure and it was 160/100, with a high heartrate (they didn't tell me what that was). They gave me some water and I sat for a few minutes, starting to relax and feel better shortly thereafter. They took my blood pressure again, and it was down to 140/84 and they mentioned that the heartrate had gone down significantly as well. At that time I felt fine, and they felt I was ok to go home.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Dizziness, Palpitations
Clinical narrative: I started feeling lightheaded, heart started beating fast, and I briefly felt like I might pass out. I raised my hand to tell the nurse, and she asked if I wanted to see the EMTs which I replied yes. I was able to walk to the EMTs with no issue, as the lightheadedness had subsided (felt lightheaded for maybe 1-2 min total time). The EMTs took my blood pressure and it was 160/100, with a high heartrate (they didn't tell me what that was). They gave me some water and I sat for a few minutes, starting to relax and feel better shortly thereafter. They took my blood pressure again, and it was down to 140/84 and they mentioned that the heartrate had gone down significantly as well. At that time I felt fine, and they felt I was ok to go home.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Hypoaesthesia, Neck pain, Pain in extremity, Swelling face
Clinical narrative: Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included fluticasone propionate (FLONASE), pantoprazole.  The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Headache, Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included fluticasone propionate (FLONASE), pantoprazole.  The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw
Clinical narrative: Possible Bells Palsy; Arm/neck soreness; Arm/neck soreness/ neck are painful; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; travel up neck to side of face/around temple/ Side of head/face/cheeks/jaw; Feel numb; Sore-all on same side as injection; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received first dose of bnt162b2 (Pfizer COVID 19 vaccine, lot number: EL3246) , via an unspecified route of administration on 13Jan2021 17:00 at single dose on left arm for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included fluticasone propionate (FLONASE), pantoprazole.  The patient experienced arm/neck soreness, travel up neck to side of face/around temple; side of head/face/cheeks/jaw, neck are painful, feel numb, and sore-all on same side as injection; and possible Bells Palsy on 14Jan2021 02:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. No treatment was received for the events. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Malaise, Migraine, Pyrexia
Clinical narrative: Feeling migraine; Headache; This is a spontaneous report from a non-contactable other hcp (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history included covid-19 in Mar2020 to an unknown date (he had COVID19 last Mar2020 but with no visual disturbances). The patient's concomitant medications were not reported.  The patient received the first COVID19 Vaccine dose last 31Dec2020 and reported feeling migraine, headache. He had COVID19 last Mar2020 but with no visual disturbances. He had migraines in the next couple weeks from vaccination which persisted for more than 1 week (moderate-severe). The patient did not recover from migraine while the outcome of headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Migraine
Clinical narrative: Feeling migraine; Headache; This is a spontaneous report from a non-contactable other hcp (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization. Medical history included covid-19 in Mar2020 to an unknown date (he had COVID19 last Mar2020 but with no visual disturbances). The patient's concomitant medications were not reported.  The patient received the first COVID19 Vaccine dose last 31Dec2020 and reported feeling migraine, headache. He had COVID19 last Mar2020 but with no visual disturbances. He had migraines in the next couple weeks from vaccination which persisted for more than 1 week (moderate-severe). The patient did not recover from migraine while the outcome of headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Urticaria
Clinical narrative: 15 minutes after her shot c/o pins and needles  to her arms, feet followed by a flushed chest. Developed flushing to her face, arms.  Administered 50mg PO Benadryl (employee declined IM Benadryl). VS remained stable during observation period.  Hydration provided.  Also took 40 mg Pepcid.  Reported symptom relief, declined ER observation and obtained transport home.