chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: dizzy; heavy headache; sweating; chilly; a little muscle pain (like flu symptoms); a little muscle pain (like flu symptoms); pain at injection site; This is a spontaneous report from a contactable pharmacist (patient herself). A 63-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 22Dec2020 14:15 in left arm at single dose for covid-19 immunization. Medical history included high blood pressure and high cholesterol. Concomitant medication included lisinopril, atorvastatin, hctz, ergocalciferol (VIT D) and vitamin b complex (VIT B COMPLEX). The patient previously took levetiracetam (KEPPRA) and experienced allergies. The most recent COVID-19 vaccine was administered at hospital. 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 had not been tested for COVID-19. 5 hours after Covid vaccinated, patient had sweating, chilly, a little muscle pain (like flu symptoms), and pain at injection site on 22Dec2020 19:00. The next day (23Dec2020), still moderate pain at injection site and she felt dizzy and heavy headache for 3 hours; after that, all symptoms were gone. She took paracetamol (TYLENOL) 500mg by mouth twice a day to relieve pain (muscle pain). No treatment was received for other events. All events were reported as non-serious. Outcome of all events were revered on Dec2020.   No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling cold, Head discomfort, Headache, Hyperhidrosis
Clinical narrative: dizzy; heavy headache; sweating; chilly; a little muscle pain (like flu symptoms); a little muscle pain (like flu symptoms); pain at injection site; This is a spontaneous report from a contactable pharmacist (patient herself). A 63-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 22Dec2020 14:15 in left arm at single dose for covid-19 immunization. Medical history included high blood pressure and high cholesterol. Concomitant medication included lisinopril, atorvastatin, hctz, ergocalciferol (VIT D) and vitamin b complex (VIT B COMPLEX). The patient previously took levetiracetam (KEPPRA) and experienced allergies. The most recent COVID-19 vaccine was administered at hospital. 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 had not been tested for COVID-19. 5 hours after Covid vaccinated, patient had sweating, chilly, a little muscle pain (like flu symptoms), and pain at injection site on 22Dec2020 19:00. The next day (23Dec2020), still moderate pain at injection site and she felt dizzy and heavy headache for 3 hours; after that, all symptoms were gone. She took paracetamol (TYLENOL) 500mg by mouth twice a day to relieve pain (muscle pain). No treatment was received for other events. All events were reported as non-serious. Outcome of all events were revered on Dec2020.   No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Injection site pain, Myalgia
Clinical narrative: dizzy; heavy headache; sweating; chilly; a little muscle pain (like flu symptoms); a little muscle pain (like flu symptoms); pain at injection site; This is a spontaneous report from a contactable pharmacist (patient herself). A 63-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 22Dec2020 14:15 in left arm at single dose for covid-19 immunization. Medical history included high blood pressure and high cholesterol. Concomitant medication included lisinopril, atorvastatin, hctz, ergocalciferol (VIT D) and vitamin b complex (VIT B COMPLEX). The patient previously took levetiracetam (KEPPRA) and experienced allergies. The most recent COVID-19 vaccine was administered at hospital. 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 had not been tested for COVID-19. 5 hours after Covid vaccinated, patient had sweating, chilly, a little muscle pain (like flu symptoms), and pain at injection site on 22Dec2020 19:00. The next day (23Dec2020), still moderate pain at injection site and she felt dizzy and heavy headache for 3 hours; after that, all symptoms were gone. She took paracetamol (TYLENOL) 500mg by mouth twice a day to relieve pain (muscle pain). No treatment was received for other events. All events were reported as non-serious. Outcome of all events were revered on Dec2020.   No follow up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Insomnia, Malaise, Pain, Pruritus
Clinical narrative: itchy; burning skin on my back; cannot sleep or get comfortable; I have been feeling really bad; Bad body aches; Feels like I am getting sick; This is a spontaneous report from a contactable Other-HCP. This 56-year-old male Other-HCP reported for himself that a 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685m Expiry Date Mar2021) , intramuscular at 08:15 on 22Dec2020 at the first single dose for covid-19 immunisation.  Anatomical Location was Arm Left. Medical history was none.  Concomitant medication included aspirin [acetylsalicylic acid], probiotics nos, nystatin (RIVOSTATIN), Multi- Vitamin.  The patient have been feeling really bad, bad body aches, feels like i am getting sick on 23Dec2020 17:00, itchy, burning skin on my back, cannot sleep or get comfortable on 25Dec2020.  The patient did not receive any treatment for the events.  The outcome of events was not recovered. The most recent COVID-19 vaccine was administered in Hospital. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin burning sensation
Clinical narrative: itchy; burning skin on my back; cannot sleep or get comfortable; I have been feeling really bad; Bad body aches; Feels like I am getting sick; This is a spontaneous report from a contactable Other-HCP. This 56-year-old male Other-HCP reported for himself that a 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685m Expiry Date Mar2021) , intramuscular at 08:15 on 22Dec2020 at the first single dose for covid-19 immunisation.  Anatomical Location was Arm Left. Medical history was none.  Concomitant medication included aspirin [acetylsalicylic acid], probiotics nos, nystatin (RIVOSTATIN), Multi- Vitamin.  The patient have been feeling really bad, bad body aches, feels like i am getting sick on 23Dec2020 17:00, itchy, burning skin on my back, cannot sleep or get comfortable on 25Dec2020.  The patient did not receive any treatment for the events.  The outcome of events was not recovered. The most recent COVID-19 vaccine was administered in Hospital. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Feeling abnormal, Pain, Pruritus
Clinical narrative: itchy; burning skin on my back; cannot sleep or get comfortable; I have been feeling really bad; Bad body aches; Feels like I am getting sick; This is a spontaneous report from a contactable Other-HCP. This 56-year-old male Other-HCP reported for himself that a 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685m Expiry Date Mar2021) , intramuscular at 08:15 on 22Dec2020 at the first single dose for covid-19 immunisation.  Anatomical Location was Arm Left. Medical history was none.  Concomitant medication included aspirin [acetylsalicylic acid], probiotics nos, nystatin (RIVOSTATIN), Multi- Vitamin.  The patient have been feeling really bad, bad body aches, feels like i am getting sick on 23Dec2020 17:00, itchy, burning skin on my back, cannot sleep or get comfortable on 25Dec2020.  The patient did not receive any treatment for the events.  The outcome of events was not recovered. The most recent COVID-19 vaccine was administered in Hospital. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Chills; vomiting; nausea; sore throat; fatigue; This is a spontaneous report from a contactable Nurse, the patient. This 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EI0140), intramuscularly in the right arm on 21Dec2020 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included sulfa allergy from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took codeine for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported and no other medications were received within 2 weeks of the vaccination. It was reported the patient received the vaccine on Monday (21Dec2020) and had a sore throat and fatigue at 48 hours, Wednesday (23Dec2020). She had chills on Thursday (24Dec2020) and began vomiting Thursday afternoon (24Dec2020) with persistent nausea. No therapeutic measures were taken as a result of the events. The clinical outcome of the sore throat, fatigue, chills, vomiting and nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Nausea, Oropharyngeal pain, Vomiting
Clinical narrative: Chills; vomiting; nausea; sore throat; fatigue; This is a spontaneous report from a contactable Nurse, the patient. This 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EI0140), intramuscularly in the right arm on 21Dec2020 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient's medical history included sulfa allergy from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took codeine for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported and no other medications were received within 2 weeks of the vaccination. It was reported the patient received the vaccine on Monday (21Dec2020) and had a sore throat and fatigue at 48 hours, Wednesday (23Dec2020). She had chills on Thursday (24Dec2020) and began vomiting Thursday afternoon (24Dec2020) with persistent nausea. No therapeutic measures were taken as a result of the events. The clinical outcome of the sore throat, fatigue, chills, vomiting and nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Feeling hot, Injection site pain, SARS-CoV-2 test, Vomiting
Clinical narrative: body temperature was 101.3; at 1030pm, it was 100.6; Not feeling well; Feels like I have a sunburn; Vomited; This is a spontaneous report from a contactable other HCP. A 23-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number EH9899), via an unspecified route of administration in right arm on 23Dec2020 08:00 at  single dose for covid-19 vaccination. Vaccine was administered in the hospital. There were no relevant medical history. Concomitant medication included ibuprofen. The patient received the vaccine on Wednesday, 23Dec2020 at 0800, then the patient worked from 7pm to 7am and was not feeling well. She felt like he had a sunburn. His joints ached. On Thursday, 24Dec2020 at 0830 the patient body temperature was 101.3; at 1030pm, it was 100.6; then on Friday, 25Dec2020, it was 100.1; then at 5pm 99.3; then vomited at 830pm; then at 11pm it was 101.3. On Saturday, 26Dec2020, the patient had Covid tested at 11am-pending result. The outcome of the events was not recovered. The patient visited emergency room and physician's office with regards to the events. The patient did not receive any treatment for the events. The reporter considered the events as non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Malaise, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: body temperature was 101.3; at 1030pm, it was 100.6; Not feeling well; Feels like I have a sunburn; Vomited; This is a spontaneous report from a contactable other HCP. A 23-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number EH9899), via an unspecified route of administration in right arm on 23Dec2020 08:00 at  single dose for covid-19 vaccination. Vaccine was administered in the hospital. There were no relevant medical history. Concomitant medication included ibuprofen. The patient received the vaccine on Wednesday, 23Dec2020 at 0800, then the patient worked from 7pm to 7am and was not feeling well. She felt like he had a sunburn. His joints ached. On Thursday, 24Dec2020 at 0830 the patient body temperature was 101.3; at 1030pm, it was 100.6; then on Friday, 25Dec2020, it was 100.1; then at 5pm 99.3; then vomited at 830pm; then at 11pm it was 101.3. On Saturday, 26Dec2020, the patient had Covid tested at 11am-pending result. The outcome of the events was not recovered. The patient visited emergency room and physician's office with regards to the events. The patient did not receive any treatment for the events. The reporter considered the events as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Headache, Tonsillar hypertrophy
Clinical narrative: headache; swollen tonsil on L side; L ear ache; This is a spontaneous report from a contactable Nurse (patient). A 35-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), intramuscular on 19Dec2020 at 12:15 at single dose in left arm for covid-19 immunization. Medical history was reported as none. Concomitant medication included ubidecarenone (COQ10), DHEA, minerals nos, vitamins nos (PRENATAL VITAMINS), and colecalciferol (VITAMIN D). The patient experienced headache, swollen tonsil on L (left) side and L ear ache; all on 20Dec2020. All events were reported as non-serious. The patient didn't receive treatment for all the events. The outcome of all the events was resolved on 24Dec2020.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nausea, Syncope
Clinical narrative: Headache severe for 9 days improving dizziness intermittent faintness
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache severe for 9 days improving dizziness intermittent faintness
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Pressure in center of chest, where the heart is; Loose stools; fever; chills; she slept for hours; Reaction to vaccine, not feeling well; Exhausted/ wiped out; This is a spontaneous report from a contactable nurse reporting for herself. A 65-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 17Dec2020, at 0.3 mL single, for COVID-19 immunisation. Medical history and concomitant medications were none. She has never had an issue receiving a vaccine in her life. The patient experienced reaction to vaccine, not feeling well on 17Dec2020 with outcome of not recovered, exhausted/ wiped out in Dec2020 with outcome of not recovered, pressure in center of chest, where the heart is on 18Dec2020 with outcome of not recovered, loose stools on 18Dec2020 with outcome of not recovered, fever on 17Dec2020 with outcome of recovered on 17Dec2020, chills on 17Dec2020 with outcome of not recovered, she slept for hours on 17Dec2020 with outcome of unknown. The patient reported that on 17Dec2020 night she started having symptoms of a reaction to the vaccine, and was not feeling well. Subsequently she was exhausted and totally wiped out. On 18Dec2020, when she takes a deep breath, right in the center of her chest, where the heart is, she feels a little bit of pressure. That happened everyday. She was visited by a cardiologist who listened to her lungs, and they were clear. On 18Dec2020 she had loose stools. On 17Dec2020 evening she had fever and chills and she slept for hours. She didn't know if she had viral infection because she may have been exposed to COVID-19 (nurse she worked with tested positive). On 21Dec2020 she still wasn't feeling good, the doctor said he doesn't think this is from the vaccine. He thought she was sick. He wants her to get tested. In Dec2020 the patient underwent 2 times COVID-19 PCR test, results were unknown. She knows her body well enough. This exhaustion is not normal. She feels like she will get a little better, and then all of the sudden she feels like again. Relatedness of drug to reaction/event (source of assessment: primary source reporter): for events exhausted/ wiped out, pressure in center of chest, fever, loose stools, drug result: unknown (Method of assessment: global introspection).  The information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Diarrhoea, Exposure to SARS-CoV-2
Clinical narrative: Pressure in center of chest, where the heart is; Loose stools; fever; chills; she slept for hours; Reaction to vaccine, not feeling well; Exhausted/ wiped out; This is a spontaneous report from a contactable nurse reporting for herself. A 65-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 17Dec2020, at 0.3 mL single, for COVID-19 immunisation. Medical history and concomitant medications were none. She has never had an issue receiving a vaccine in her life. The patient experienced reaction to vaccine, not feeling well on 17Dec2020 with outcome of not recovered, exhausted/ wiped out in Dec2020 with outcome of not recovered, pressure in center of chest, where the heart is on 18Dec2020 with outcome of not recovered, loose stools on 18Dec2020 with outcome of not recovered, fever on 17Dec2020 with outcome of recovered on 17Dec2020, chills on 17Dec2020 with outcome of not recovered, she slept for hours on 17Dec2020 with outcome of unknown. The patient reported that on 17Dec2020 night she started having symptoms of a reaction to the vaccine, and was not feeling well. Subsequently she was exhausted and totally wiped out. On 18Dec2020, when she takes a deep breath, right in the center of her chest, where the heart is, she feels a little bit of pressure. That happened everyday. She was visited by a cardiologist who listened to her lungs, and they were clear. On 18Dec2020 she had loose stools. On 17Dec2020 evening she had fever and chills and she slept for hours. She didn't know if she had viral infection because she may have been exposed to COVID-19 (nurse she worked with tested positive). On 21Dec2020 she still wasn't feeling good, the doctor said he doesn't think this is from the vaccine. He thought she was sick. He wants her to get tested. In Dec2020 the patient underwent 2 times COVID-19 PCR test, results were unknown. She knows her body well enough. This exhaustion is not normal. She feels like she will get a little better, and then all of the sudden she feels like again. Relatedness of drug to reaction/event (source of assessment: primary source reporter): for events exhausted/ wiped out, pressure in center of chest, fever, loose stools, drug result: unknown (Method of assessment: global introspection).  The information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypersomnia, Malaise, Pyrexia, Reaction to preservatives
Clinical narrative: Pressure in center of chest, where the heart is; Loose stools; fever; chills; she slept for hours; Reaction to vaccine, not feeling well; Exhausted/ wiped out; This is a spontaneous report from a contactable nurse reporting for herself. A 65-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 17Dec2020, at 0.3 mL single, for COVID-19 immunisation. Medical history and concomitant medications were none. She has never had an issue receiving a vaccine in her life. The patient experienced reaction to vaccine, not feeling well on 17Dec2020 with outcome of not recovered, exhausted/ wiped out in Dec2020 with outcome of not recovered, pressure in center of chest, where the heart is on 18Dec2020 with outcome of not recovered, loose stools on 18Dec2020 with outcome of not recovered, fever on 17Dec2020 with outcome of recovered on 17Dec2020, chills on 17Dec2020 with outcome of not recovered, she slept for hours on 17Dec2020 with outcome of unknown. The patient reported that on 17Dec2020 night she started having symptoms of a reaction to the vaccine, and was not feeling well. Subsequently she was exhausted and totally wiped out. On 18Dec2020, when she takes a deep breath, right in the center of her chest, where the heart is, she feels a little bit of pressure. That happened everyday. She was visited by a cardiologist who listened to her lungs, and they were clear. On 18Dec2020 she had loose stools. On 17Dec2020 evening she had fever and chills and she slept for hours. She didn't know if she had viral infection because she may have been exposed to COVID-19 (nurse she worked with tested positive). On 21Dec2020 she still wasn't feeling good, the doctor said he doesn't think this is from the vaccine. He thought she was sick. He wants her to get tested. In Dec2020 the patient underwent 2 times COVID-19 PCR test, results were unknown. She knows her body well enough. This exhaustion is not normal. She feels like she will get a little better, and then all of the sudden she feels like again. Relatedness of drug to reaction/event (source of assessment: primary source reporter): for events exhausted/ wiped out, pressure in center of chest, fever, loose stools, drug result: unknown (Method of assessment: global introspection).  The information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Pressure in center of chest, where the heart is; Loose stools; fever; chills; she slept for hours; Reaction to vaccine, not feeling well; Exhausted/ wiped out; This is a spontaneous report from a contactable nurse reporting for herself. A 65-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 17Dec2020, at 0.3 mL single, for COVID-19 immunisation. Medical history and concomitant medications were none. She has never had an issue receiving a vaccine in her life. The patient experienced reaction to vaccine, not feeling well on 17Dec2020 with outcome of not recovered, exhausted/ wiped out in Dec2020 with outcome of not recovered, pressure in center of chest, where the heart is on 18Dec2020 with outcome of not recovered, loose stools on 18Dec2020 with outcome of not recovered, fever on 17Dec2020 with outcome of recovered on 17Dec2020, chills on 17Dec2020 with outcome of not recovered, she slept for hours on 17Dec2020 with outcome of unknown. The patient reported that on 17Dec2020 night she started having symptoms of a reaction to the vaccine, and was not feeling well. Subsequently she was exhausted and totally wiped out. On 18Dec2020, when she takes a deep breath, right in the center of her chest, where the heart is, she feels a little bit of pressure. That happened everyday. She was visited by a cardiologist who listened to her lungs, and they were clear. On 18Dec2020 she had loose stools. On 17Dec2020 evening she had fever and chills and she slept for hours. She didn't know if she had viral infection because she may have been exposed to COVID-19 (nurse she worked with tested positive). On 21Dec2020 she still wasn't feeling good, the doctor said he doesn't think this is from the vaccine. He thought she was sick. He wants her to get tested. In Dec2020 the patient underwent 2 times COVID-19 PCR test, results were unknown. She knows her body well enough. This exhaustion is not normal. She feels like she will get a little better, and then all of the sudden she feels like again. Relatedness of drug to reaction/event (source of assessment: primary source reporter): for events exhausted/ wiped out, pressure in center of chest, fever, loose stools, drug result: unknown (Method of assessment: global introspection).  The information on the lot/batch number has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, COVID-19, Dizziness, Loss of consciousness, Occupational exposure to SARS-CoV-2
Clinical narrative: I had syncopal episode; I discovered to be Covid positive with no symptoms; I discovered to be Covid positive with no symptoms; sore arm; This is a spontaneous report from a contactable physician (patient).  A 39-year-old male patient received 1st dose of bnt162b2, lot number: EH9899, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The reporter is a pediatrician physician and works in the hospital. The patient received the Pfizer COVID vaccine on 18Dec2020, Friday. Apparently, the patient was also exposed to a positive COVID contact on Friday also. Now on 23Dec2020, Wednesday, the patient was working in the hospital and was rounding on patients and suddenly felt light headed, had to sit down and the next thing, he had a co-team top of him trying to resuscitate, apparently he had syncopal episode. There was a procedure on syncopal episode and they did a work up and the patient was sent straight to the ER and discovered to be COVID positive. At the time of report, the patient was still in the hospital and hope to be discharged that day. The physician asked if he is even allowed to take the second dose or not. The patient did not have any COVID symptoms. The patient added that he had a sore arm following night and day after the COVID 19 vaccine and that's it. Maybe just for one day and no treatment was given. The patient underwent standard COVID lab tests in 23Dec2020: echocardiogram, electrocardiogram (EKG), haematocrit (HCT), magnetic resonance imaging (MRI) and electroencephalogram (EEG) all with unknown results between admissions 2 days ago until today so span of 2 days. Outcome of the event sore arm was recovered in Dec2020, for the other events was not recovered. The reporter assessed the events syncopal episode and Covid positive with no symptoms as serious due to hospitalization on 23Dec2020.; Sender's Comments: 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: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Seizure, Syncope
Clinical narrative: I had syncopal episode; I discovered to be Covid positive with no symptoms; I discovered to be Covid positive with no symptoms; sore arm; This is a spontaneous report from a contactable physician (patient).  A 39-year-old male patient received 1st dose of bnt162b2, lot number: EH9899, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The reporter is a pediatrician physician and works in the hospital. The patient received the Pfizer COVID vaccine on 18Dec2020, Friday. Apparently, the patient was also exposed to a positive COVID contact on Friday also. Now on 23Dec2020, Wednesday, the patient was working in the hospital and was rounding on patients and suddenly felt light headed, had to sit down and the next thing, he had a co-team top of him trying to resuscitate, apparently he had syncopal episode. There was a procedure on syncopal episode and they did a work up and the patient was sent straight to the ER and discovered to be COVID positive. At the time of report, the patient was still in the hospital and hope to be discharged that day. The physician asked if he is even allowed to take the second dose or not. The patient did not have any COVID symptoms. The patient added that he had a sore arm following night and day after the COVID 19 vaccine and that's it. Maybe just for one day and no treatment was given. The patient underwent standard COVID lab tests in 23Dec2020: echocardiogram, electrocardiogram (EKG), haematocrit (HCT), magnetic resonance imaging (MRI) and electroencephalogram (EEG) all with unknown results between admissions 2 days ago until today so span of 2 days. Outcome of the event sore arm was recovered in Dec2020, for the other events was not recovered. The reporter assessed the events syncopal episode and Covid positive with no symptoms as serious due to hospitalization on 23Dec2020.; Sender's Comments: 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: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Dizziness, Echocardiogram, Electrocardiogram, Electroencephalogram
Clinical narrative: I had syncopal episode; I discovered to be Covid positive with no symptoms; I discovered to be Covid positive with no symptoms; sore arm; This is a spontaneous report from a contactable physician (patient).  A 39-year-old male patient received 1st dose of bnt162b2, lot number: EH9899, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The reporter is a pediatrician physician and works in the hospital. The patient received the Pfizer COVID vaccine on 18Dec2020, Friday. Apparently, the patient was also exposed to a positive COVID contact on Friday also. Now on 23Dec2020, Wednesday, the patient was working in the hospital and was rounding on patients and suddenly felt light headed, had to sit down and the next thing, he had a co-team top of him trying to resuscitate, apparently he had syncopal episode. There was a procedure on syncopal episode and they did a work up and the patient was sent straight to the ER and discovered to be COVID positive. At the time of report, the patient was still in the hospital and hope to be discharged that day. The physician asked if he is even allowed to take the second dose or not. The patient did not have any COVID symptoms. The patient added that he had a sore arm following night and day after the COVID 19 vaccine and that's it. Maybe just for one day and no treatment was given. The patient underwent standard COVID lab tests in 23Dec2020: echocardiogram, electrocardiogram (EKG), haematocrit (HCT), magnetic resonance imaging (MRI) and electroencephalogram (EEG) all with unknown results between admissions 2 days ago until today so span of 2 days. Outcome of the event sore arm was recovered in Dec2020, for the other events was not recovered. The reporter assessed the events syncopal episode and Covid positive with no symptoms as serious due to hospitalization on 23Dec2020.; Sender's Comments: 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: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit, Magnetic resonance imaging, Occupational exposure to SARS-CoV-2, Pain in extremity, Resuscitation
Clinical narrative: I had syncopal episode; I discovered to be Covid positive with no symptoms; I discovered to be Covid positive with no symptoms; sore arm; This is a spontaneous report from a contactable physician (patient).  A 39-year-old male patient received 1st dose of bnt162b2, lot number: EH9899, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The reporter is a pediatrician physician and works in the hospital. The patient received the Pfizer COVID vaccine on 18Dec2020, Friday. Apparently, the patient was also exposed to a positive COVID contact on Friday also. Now on 23Dec2020, Wednesday, the patient was working in the hospital and was rounding on patients and suddenly felt light headed, had to sit down and the next thing, he had a co-team top of him trying to resuscitate, apparently he had syncopal episode. There was a procedure on syncopal episode and they did a work up and the patient was sent straight to the ER and discovered to be COVID positive. At the time of report, the patient was still in the hospital and hope to be discharged that day. The physician asked if he is even allowed to take the second dose or not. The patient did not have any COVID symptoms. The patient added that he had a sore arm following night and day after the COVID 19 vaccine and that's it. Maybe just for one day and no treatment was given. The patient underwent standard COVID lab tests in 23Dec2020: echocardiogram, electrocardiogram (EKG), haematocrit (HCT), magnetic resonance imaging (MRI) and electroencephalogram (EEG) all with unknown results between admissions 2 days ago until today so span of 2 days. Outcome of the event sore arm was recovered in Dec2020, for the other events was not recovered. The reporter assessed the events syncopal episode and Covid positive with no symptoms as serious due to hospitalization on 23Dec2020.; Sender's Comments: 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: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Syncope
Clinical narrative: I had syncopal episode; I discovered to be Covid positive with no symptoms; I discovered to be Covid positive with no symptoms; sore arm; This is a spontaneous report from a contactable physician (patient).  A 39-year-old male patient received 1st dose of bnt162b2, lot number: EH9899, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The reporter is a pediatrician physician and works in the hospital. The patient received the Pfizer COVID vaccine on 18Dec2020, Friday. Apparently, the patient was also exposed to a positive COVID contact on Friday also. Now on 23Dec2020, Wednesday, the patient was working in the hospital and was rounding on patients and suddenly felt light headed, had to sit down and the next thing, he had a co-team top of him trying to resuscitate, apparently he had syncopal episode. There was a procedure on syncopal episode and they did a work up and the patient was sent straight to the ER and discovered to be COVID positive. At the time of report, the patient was still in the hospital and hope to be discharged that day. The physician asked if he is even allowed to take the second dose or not. The patient did not have any COVID symptoms. The patient added that he had a sore arm following night and day after the COVID 19 vaccine and that's it. Maybe just for one day and no treatment was given. The patient underwent standard COVID lab tests in 23Dec2020: echocardiogram, electrocardiogram (EKG), haematocrit (HCT), magnetic resonance imaging (MRI) and electroencephalogram (EEG) all with unknown results between admissions 2 days ago until today so span of 2 days. Outcome of the event sore arm was recovered in Dec2020, for the other events was not recovered. The reporter assessed the events syncopal episode and Covid positive with no symptoms as serious due to hospitalization on 23Dec2020.; Sender's Comments: 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: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Hypoaesthesia, Urticaria
Clinical narrative: 31-year-old female presents with warm feeling, itchiness on her chest, face and scalp approximately 5 minutes after getting her Covid vaccine.  Patient states that she received the vaccine around 12:15 PM and other staff members noticed that she was having hives.  She is not having any tongue swelling, lip swelling, wheezing or shortness of breath.  No difficulty swallowing.  Denies abdominal pain.  Patient denies any previous reactions to vaccines. Symptoms resolved and the patient was discharged with follow up by allergist for further testing.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Pruritus, Rash macular, Skin warm, Urticaria
Clinical narrative: 31-year-old female presents with warm feeling, itchiness on her chest, face and scalp approximately 5 minutes after getting her Covid vaccine.  Patient states that she received the vaccine around 12:15 PM and other staff members noticed that she was having hives.  She is not having any tongue swelling, lip swelling, wheezing or shortness of breath.  No difficulty swallowing.  Denies abdominal pain.  Patient denies any previous reactions to vaccines. Symptoms resolved and the patient was discharged with follow up by allergist for further testing.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Pruritus, Urticaria
Clinical narrative: 31-year-old female presents with warm feeling, itchiness on her chest, face and scalp approximately 5 minutes after getting her Covid vaccine.  Patient states that she received the vaccine around 12:15 PM and other staff members noticed that she was having hives.  She is not having any tongue swelling, lip swelling, wheezing or shortness of breath.  No difficulty swallowing.  Denies abdominal pain.  Patient denies any previous reactions to vaccines. Symptoms resolved and the patient was discharged with follow up by allergist for further testing.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature decreased, Burning sensation, Chills, Dyspnoea, Injection site rash
Clinical narrative: Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chest X-ray, Chills, Dyspnoea
Clinical narrative: Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: Shortness of breath Hives, Fever, chills joint pains. I was Tx in the ER with Pepcid IV Solumedrol IV, Benadryl IV ,Tylenol and IV fluids. I was discharged on prednisone , Benadryl and Tylenol.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram normal, Hot flush, Palpitations
Clinical narrative: after 5 minutes, warm Flushing feeling in body and then tachycardia and shortness of breath
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling hot, Flushing, Skin papilloma, Tachycardia
Clinical narrative: after 5 minutes, warm Flushing feeling in body and then tachycardia and shortness of breath
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: 10 minutes after receiving vaccination, a significant increase in HR was noted, along with a tingling sensation through out body. Also, scratchy throat was noted. Alert by patient made to staff at vaccination site. Sweating noted and shortness of breath at that time. Epi pen given via L thigh IM. PIV started and benadryl and solumedrol given. Relief of symptoms noted very shortly after Epi administration. Taken to ER for 4 hour observation. Sent home after 4 hours and given prednisone to be taken at home, 50mg daily for 4 days. No further adverse symptoms noted.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Hyperhidrosis, Paraesthesia, Throat irritation
Clinical narrative: 10 minutes after receiving vaccination, a significant increase in HR was noted, along with a tingling sensation through out body. Also, scratchy throat was noted. Alert by patient made to staff at vaccination site. Sweating noted and shortness of breath at that time. Epi pen given via L thigh IM. PIV started and benadryl and solumedrol given. Relief of symptoms noted very shortly after Epi administration. Taken to ER for 4 hour observation. Sent home after 4 hours and given prednisone to be taken at home, 50mg daily for 4 days. No further adverse symptoms noted.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest discomfort, Electrocardiogram, Flushing, Hypoaesthesia
Clinical narrative: Developed rash, tightness in throat and mild SOB. Epinephrine 0.3 mg IM and sent to ED at our facility. Observed for 2 hours and released to home.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Tachycardia, Throat tightness
Clinical narrative: Developed rash, tightness in throat and mild SOB. Epinephrine 0.3 mg IM and sent to ED at our facility. Observed for 2 hours and released to home.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Rash, Throat tightness
Clinical narrative: Developed rash, tightness in throat and mild SOB. Epinephrine 0.3 mg IM and sent to ED at our facility. Observed for 2 hours and released to home.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Immunodeficiency
Clinical narrative: experiencing flushing and she did say she is immunocompromised.; experiencing flushing and she did say she is immunocompromised.; experiencing flushing and she did say she is immunocompromised.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Rheumatoid arthritis since age of 7 (1990), Raynauds, Migraine since age of 5 (1988) and immunocompromised. Concomitant medications included ongoing hydroxychloroquine, atenolol, and topiramate (TOPAMAX) for Migraine. The patient received a Covid Vaccine Yesterday (21Dec2020) and was experiencing flushing and she did say she was immunocompromised. She approximately had 02:20 pm so that was 14:10 hours. The patient had a complete blood count (CBC), had complete lipid channel done, had a Covid done which was negative. She had a hepatitis panel done, had antibody screening done. The patient did not receive treatment for the event flushing. She had 'cold' circulation (not clarified) so her hands were always cold so she always put her hand on face trying to cool her face down but that was about it. The outcome of the event was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Full blood count, Hepatitis viral test, Lipids, SARS-CoV-2 test negative
Clinical narrative: experiencing flushing and she did say she is immunocompromised.; experiencing flushing and she did say she is immunocompromised.; experiencing flushing and she did say she is immunocompromised.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 21Dec2020 at single dose for COVID-19 immunization. Medical history included Rheumatoid arthritis since age of 7 (1990), Raynauds, Migraine since age of 5 (1988) and immunocompromised. Concomitant medications included ongoing hydroxychloroquine, atenolol, and topiramate (TOPAMAX) for Migraine. The patient received a Covid Vaccine Yesterday (21Dec2020) and was experiencing flushing and she did say she was immunocompromised. She approximately had 02:20 pm so that was 14:10 hours. The patient had a complete blood count (CBC), had complete lipid channel done, had a Covid done which was negative. She had a hepatitis panel done, had antibody screening done. The patient did not receive treatment for the event flushing. She had 'cold' circulation (not clarified) so her hands were always cold so she always put her hand on face trying to cool her face down but that was about it. The outcome of the event was unknown.