chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tremor, Troponin I, Urine ketone body, Urine leukocyte esterase, Urobilinogen urine
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ventricular arrhythmia, Weight, White blood cell count, pH urine
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chills, Computerised tomogram, Defaecation urgency, Dizziness
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dry mouth, Fatigue, Headache, Heart rate, Malaise
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Micturition urgency, Palpitations, Pruritus, Specialist consultation, Tinnitus
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Heart racing; Itching; Ringing in ears; urgency to urinate; Dry mouth; shaking and shivering; shaking and shivering/dry flashes through the body; Dizzy; Does not feel well; strong headache; Had a sudden bowel movement; quite exhausted; The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on 16Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient had 3 visits to the emergency room on the first week after the second shot of the Covid vaccine on 09Mar2021, 13Mar2021 and 15Mar2021 (2 of them were overnight stays) as she was having very strange symptoms. Some day, but not every day, usually after breakfast, was having strange ringing in the ears, felt behind the ears and in the head. Could see on her device that her heart was racing. It would go down really fast and then go right back up. After the spike in heart rate, in a hour, was having dry flashes through the body. Had a sudden bowel movement and urgency to urinate. Had dry mouth and shaking. Felt very dizzy and had a strong headache. In bed, was shaking and shivering. Was itching but, not during the return of the event on Monday. Heart rate had gone down in 5 minutes to a half hour. Does not feel well.  It was a few hours. Then like a switch, was back to normal. The patient was quite exhausted. Has no clue what it is. It feels like a carbon released in the body. 2 CT scans and emergency blood work were performed and had not found pretty much anything; after that had 2 visits to the PCP. They ordered hormonal blood work. Took 2 hours to get everything done. Everything was perfectly normal. Had a visit to the cardiologist, not the one from the hospital visit, have not found anything either.  Placed a heart monitor for 3 weeks. The last event was recorded.  It spiked pretty much every day for the first 2 weeks. Then it decreased and disappeared. Had another one Monday and one today (15Apr2021). Patient went back to the emergency room, 15Apr2021, has been admitted to the hospital and is still there now. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Chest X-ray normal, Chills, Computerised tomogram head, Computerised tomogram normal
Clinical narrative: DEHYDRATION; PASSED OUT TWICE; COULDN'T SLEEP; VERY UNCOMFORTABLE; SUPER BAD CHILLS; REALLY, REALLY TIREDNESS; This spontaneous report received from a patient concerned a 29 year old white and not hispanic or latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, 1 total at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, patient experienced super bad chills for 7 to 8 hours after the vaccine for 10 minutes, subsided and got again 24 hours later, but not as bad as night before, could not sleep it was very uncomfortable.  On 16-MAR-2021, patient also felt really tired. On 17-MAR-2021, the patient experienced passed out twice back to back in about 10 minutes of each other and on same day patient went to emergency room. On 19-MAR-2021, the patient experienced dehydration. Patient had never tested for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out twice on 18-MAR-2021, couldn't sleep, and super bad chills on 17-MAR-2021, dehydration on 2021, and really, really tiredness on 20-MAR-2021, and the outcome of very uncomfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210454256-Covid-19 vaccine ad26.cov2.s-PASSED OUT TWICE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Differential white blood cell count normal, Electrocardiogram normal, Full blood count normal, Headache, Insomnia
Clinical narrative: DEHYDRATION; PASSED OUT TWICE; COULDN'T SLEEP; VERY UNCOMFORTABLE; SUPER BAD CHILLS; REALLY, REALLY TIREDNESS; This spontaneous report received from a patient concerned a 29 year old white and not hispanic or latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, 1 total at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, patient experienced super bad chills for 7 to 8 hours after the vaccine for 10 minutes, subsided and got again 24 hours later, but not as bad as night before, could not sleep it was very uncomfortable.  On 16-MAR-2021, patient also felt really tired. On 17-MAR-2021, the patient experienced passed out twice back to back in about 10 minutes of each other and on same day patient went to emergency room. On 19-MAR-2021, the patient experienced dehydration. Patient had never tested for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out twice on 18-MAR-2021, couldn't sleep, and super bad chills on 17-MAR-2021, dehydration on 2021, and really, really tiredness on 20-MAR-2021, and the outcome of very uncomfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210454256-Covid-19 vaccine ad26.cov2.s-PASSED OUT TWICE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Liver function test normal, Loss of consciousness, Metabolic function test normal, Nausea, Pain
Clinical narrative: DEHYDRATION; PASSED OUT TWICE; COULDN'T SLEEP; VERY UNCOMFORTABLE; SUPER BAD CHILLS; REALLY, REALLY TIREDNESS; This spontaneous report received from a patient concerned a 29 year old white and not hispanic or latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, 1 total at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, patient experienced super bad chills for 7 to 8 hours after the vaccine for 10 minutes, subsided and got again 24 hours later, but not as bad as night before, could not sleep it was very uncomfortable.  On 16-MAR-2021, patient also felt really tired. On 17-MAR-2021, the patient experienced passed out twice back to back in about 10 minutes of each other and on same day patient went to emergency room. On 19-MAR-2021, the patient experienced dehydration. Patient had never tested for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out twice on 18-MAR-2021, couldn't sleep, and super bad chills on 17-MAR-2021, dehydration on 2021, and really, really tiredness on 20-MAR-2021, and the outcome of very uncomfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210454256-Covid-19 vaccine ad26.cov2.s-PASSED OUT TWICE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Troponin I normal
Clinical narrative: DEHYDRATION; PASSED OUT TWICE; COULDN'T SLEEP; VERY UNCOMFORTABLE; SUPER BAD CHILLS; REALLY, REALLY TIREDNESS; This spontaneous report received from a patient concerned a 29 year old white and not hispanic or latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, 1 total at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, patient experienced super bad chills for 7 to 8 hours after the vaccine for 10 minutes, subsided and got again 24 hours later, but not as bad as night before, could not sleep it was very uncomfortable.  On 16-MAR-2021, patient also felt really tired. On 17-MAR-2021, the patient experienced passed out twice back to back in about 10 minutes of each other and on same day patient went to emergency room. On 19-MAR-2021, the patient experienced dehydration. Patient had never tested for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out twice on 18-MAR-2021, couldn't sleep, and super bad chills on 17-MAR-2021, dehydration on 2021, and really, really tiredness on 20-MAR-2021, and the outcome of very uncomfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210454256-Covid-19 vaccine ad26.cov2.s-PASSED OUT TWICE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dehydration, Discomfort, Fatigue, Insomnia
Clinical narrative: DEHYDRATION; PASSED OUT TWICE; COULDN'T SLEEP; VERY UNCOMFORTABLE; SUPER BAD CHILLS; REALLY, REALLY TIREDNESS; This spontaneous report received from a patient concerned a 29 year old white and not hispanic or latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, 1 total at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, patient experienced super bad chills for 7 to 8 hours after the vaccine for 10 minutes, subsided and got again 24 hours later, but not as bad as night before, could not sleep it was very uncomfortable.  On 16-MAR-2021, patient also felt really tired. On 17-MAR-2021, the patient experienced passed out twice back to back in about 10 minutes of each other and on same day patient went to emergency room. On 19-MAR-2021, the patient experienced dehydration. Patient had never tested for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out twice on 18-MAR-2021, couldn't sleep, and super bad chills on 17-MAR-2021, dehydration on 2021, and really, really tiredness on 20-MAR-2021, and the outcome of very uncomfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210454256-Covid-19 vaccine ad26.cov2.s-PASSED OUT TWICE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: DEHYDRATION; PASSED OUT TWICE; COULDN'T SLEEP; VERY UNCOMFORTABLE; SUPER BAD CHILLS; REALLY, REALLY TIREDNESS; This spontaneous report received from a patient concerned a 29 year old white and not hispanic or latino male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021, 1 total at left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, patient experienced super bad chills for 7 to 8 hours after the vaccine for 10 minutes, subsided and got again 24 hours later, but not as bad as night before, could not sleep it was very uncomfortable.  On 16-MAR-2021, patient also felt really tired. On 17-MAR-2021, the patient experienced passed out twice back to back in about 10 minutes of each other and on same day patient went to emergency room. On 19-MAR-2021, the patient experienced dehydration. Patient had never tested for COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out twice on 18-MAR-2021, couldn't sleep, and super bad chills on 17-MAR-2021, dehydration on 2021, and really, really tiredness on 20-MAR-2021, and the outcome of very uncomfortable was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210454256-Covid-19 vaccine ad26.cov2.s-PASSED OUT TWICE. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: my first dose I had in my right shoulder I hardly felt the pain, I waited for an  hour before leaving I had no side effects at all, little soreness in shoulder; I am feeling so weak; Severe chills; waves of chills; shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) on 18Feb2021 14:30 as single dose and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. Patient was 75-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. The patient had his second dose and his first dose he had in his right shoulder he hardly felt the pain, he waited for an hour before leaving, he had no side effects at all, little soreness in shoulder, he had no complaint about it but he had the second vaccine at 2:30 afternoon (statement incomplete). Patient experienced little soreness in shoulder, was feeling so weak,  had waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 this afternoon after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he does have injection site pain in shoulder but that's not a big deal. Patient visited hospital because he had severe chills accompanied with headache, feeling tired, some nausea, there was unwell feeling, little bit of fever was not actual fever but the injection site pain (reason of hospitalization was not clarified). The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021210764 similar report from same reporter
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Tremor, Vaccination site pain, Weight
Clinical narrative: my first dose I had in my right shoulder I hardly felt the pain, I waited for an  hour before leaving I had no side effects at all, little soreness in shoulder; I am feeling so weak; Severe chills; waves of chills; shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) on 18Feb2021 14:30 as single dose and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. Patient was 75-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. The patient had his second dose and his first dose he had in his right shoulder he hardly felt the pain, he waited for an hour before leaving, he had no side effects at all, little soreness in shoulder, he had no complaint about it but he had the second vaccine at 2:30 afternoon (statement incomplete). Patient experienced little soreness in shoulder, was feeling so weak,  had waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 this afternoon after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he does have injection site pain in shoulder but that's not a big deal. Patient visited hospital because he had severe chills accompanied with headache, feeling tired, some nausea, there was unwell feeling, little bit of fever was not actual fever but the injection site pain (reason of hospitalization was not clarified). The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021210764 similar report from same reporter
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: my first dose I had in my right shoulder I hardly felt the pain, I waited for an  hour before leaving I had no side effects at all, little soreness in shoulder; I am feeling so weak; Severe chills; waves of chills; shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) on 18Feb2021 14:30 as single dose and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. Patient was 75-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. The patient had his second dose and his first dose he had in his right shoulder he hardly felt the pain, he waited for an hour before leaving, he had no side effects at all, little soreness in shoulder, he had no complaint about it but he had the second vaccine at 2:30 afternoon (statement incomplete). Patient experienced little soreness in shoulder, was feeling so weak,  had waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 this afternoon after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he does have injection site pain in shoulder but that's not a big deal. Patient visited hospital because he had severe chills accompanied with headache, feeling tired, some nausea, there was unwell feeling, little bit of fever was not actual fever but the injection site pain (reason of hospitalization was not clarified). The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021210764 similar report from same reporter
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Tremor, Vaccination site pain
Clinical narrative: my first dose I had in my right shoulder I hardly felt the pain, I waited for an  hour before leaving I had no side effects at all, little soreness in shoulder; I am feeling so weak; Severe chills; waves of chills; shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) on 18Feb2021 14:30 as single dose and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. Patient was 75-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. The patient had his second dose and his first dose he had in his right shoulder he hardly felt the pain, he waited for an hour before leaving, he had no side effects at all, little soreness in shoulder, he had no complaint about it but he had the second vaccine at 2:30 afternoon (statement incomplete). Patient experienced little soreness in shoulder, was feeling so weak,  had waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 this afternoon after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he does have injection site pain in shoulder but that's not a big deal. Patient visited hospital because he had severe chills accompanied with headache, feeling tired, some nausea, there was unwell feeling, little bit of fever was not actual fever but the injection site pain (reason of hospitalization was not clarified). The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021210764 similar report from same reporter
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic Taste in my mouth; Nasal Drip; Nasal Drip with Nausea; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the right arm on 30Mar2021 at 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. Concomitant medications included atorvastatin, pantoprazole, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC) all from unknown dates for unknown indications. The patient previously received morphine on an unknown date for an unknown indication and experienced drug allergy, and the first dose of BNT162B2 (lot number EN6208) on 09Mar2021 at 13:15 (at the age of 45-years-old) for COVID-19 immunisation. On 30Mar2021 at 08:45 the patient experienced low grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, further reported as nothing tasted good yesterday (as of 31Mar2021), and nasal drip with nausea. No treatment was provided for the events. The outcomes of low-grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, and nasal drip with nausea were not recovered. It was also reported the patient had not been tested for COVID since vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: Low grade Fever; Arm so sore that you dont want to move it; Body Aches; Fatigue; Headache; Metallic Taste in my mouth; Nasal Drip; Nasal Drip with Nausea; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER8727) via an unspecified route of administration in the right arm on 30Mar2021 at 08:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included sarcoidosis from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4-weeks prior to the COVID vaccine. Concomitant medications included atorvastatin, pantoprazole, fluticasone propionate (FLONASE), and cetirizine hydrochloride (ZYRTEC) all from unknown dates for unknown indications. The patient previously received morphine on an unknown date for an unknown indication and experienced drug allergy, and the first dose of BNT162B2 (lot number EN6208) on 09Mar2021 at 13:15 (at the age of 45-years-old) for COVID-19 immunisation. On 30Mar2021 at 08:45 the patient experienced low grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, further reported as nothing tasted good yesterday (as of 31Mar2021), and nasal drip with nausea. No treatment was provided for the events. The outcomes of low-grade fever, arm so sore that you don't want to move it, body aches, fatigue, headache, metallic taste in their mouth, and nasal drip with nausea were not recovered. It was also reported the patient had not been tested for COVID since vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on face, neck, chest, and (lighter on abdomen); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in the left arm on 20Mar2021 at 09:30 (Batch/Lot Number: EN6206) at 51-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination.  The patient's medical history and concomitant medications were not reported. On 26Mar2021 at 21:00, the patient experienced: rash on face, neck, chest, and (lighter on abdomen) (non-serious). Therapeutic measures were not taken as a result of the rash. The clinical outcome of the event was recovering. The patient was not tested for COVID post vaccination.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Tinnitus
Clinical narrative: Loud ringing in ears; numb/tingle in left pointer finger; numb/tingle in left pointer finger; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm, on 18Mar2021 at 15:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no allergies to medications, food, or other products. The patient did not have any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced loud ringing in ears and numb/tingle in left pointer finger on 21Mar2021 at 17:00. The events were reported as non-serious. The clinical outcome of experienced loud ringing in ears and numb/tingle in left pointer finger was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Angioedema, Blood pressure increased, Blood test, Electric shock sensation, Flushing
Clinical narrative: body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart rate/rapid heart rate; Angioedema; having a hard time finding food to eat; water makes tongue swell and tingle; lip swelling; respiration changes from clothing; extreme hypersensitivity; heart racing; tongue tingling; rapid breathing/rapid respirations; nervousness; chills; burning sensation in her body; skin itches; bumps on back and abdomen; lock jaw at night; skin feels like it is thinning out; breathing stops and starts at night; electrical charges that were prickly in her body; warm flush; high blood pressure/blood pressure went up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On an unspecified date, the patient experienced body is responding to food, water and medicine like it is foreign and she is frustrated. On 17Mar2021, the patient experienced high blood pressure/blood pressure went up (which required an emergency room visit), electrical charges that were prickly in her body, and warm flush. On 18Mar2021, the patient experienced angioedema, extreme hypersensitivity, heart racing, tongue tingling (which required an emergency room visit), rapid breathing/rapid respirations (which required an emergency room visit), nervousness, chills, burning sensation in her body, skin itches, bumps on back and abdomen, lock jaw at night, skin feels like it is thinning out, breathing stops and starts at night, having a hard time finding food to eat, water makes tongue swell and tingle, lip swelling (which required an emergency room visit), and respiration changes from clothing, elevated heart rate/rapid heart rate (which required an emergency room visit). The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date, blood pressure measurement: had gone down on 17Mar2021, blood pressure measurement: 164/100 on 17Mar2021, blood pressure measurement: 176/100 on 17Mar2021, blood pressure measurement: went up on 17Mar2021, heart rate: rapid on 18Mar2021, heart rate: elevated on 18Mar2021, respiratory rate: rapid on 18Mar2021. Therapeutic measures were taken as a result of high blood pressure/blood pressure went up (hypertension). The outcome of electrical charges that were prickly in her body, body is responding to food, water and medicine like it is foreign, warm flush and frustrated was unknown. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427769 Pfizer
Age: 64.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Heart rate increased, Respiratory rate increased
Clinical narrative: body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart rate/rapid heart rate; Angioedema; having a hard time finding food to eat; water makes tongue swell and tingle; lip swelling; respiration changes from clothing; extreme hypersensitivity; heart racing; tongue tingling; rapid breathing/rapid respirations; nervousness; chills; burning sensation in her body; skin itches; bumps on back and abdomen; lock jaw at night; skin feels like it is thinning out; breathing stops and starts at night; electrical charges that were prickly in her body; warm flush; high blood pressure/blood pressure went up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On an unspecified date, the patient experienced body is responding to food, water and medicine like it is foreign and she is frustrated. On 17Mar2021, the patient experienced high blood pressure/blood pressure went up (which required an emergency room visit), electrical charges that were prickly in her body, and warm flush. On 18Mar2021, the patient experienced angioedema, extreme hypersensitivity, heart racing, tongue tingling (which required an emergency room visit), rapid breathing/rapid respirations (which required an emergency room visit), nervousness, chills, burning sensation in her body, skin itches, bumps on back and abdomen, lock jaw at night, skin feels like it is thinning out, breathing stops and starts at night, having a hard time finding food to eat, water makes tongue swell and tingle, lip swelling (which required an emergency room visit), and respiration changes from clothing, elevated heart rate/rapid heart rate (which required an emergency room visit). The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date, blood pressure measurement: had gone down on 17Mar2021, blood pressure measurement: 164/100 on 17Mar2021, blood pressure measurement: 176/100 on 17Mar2021, blood pressure measurement: went up on 17Mar2021, heart rate: rapid on 18Mar2021, heart rate: elevated on 18Mar2021, respiratory rate: rapid on 18Mar2021. Therapeutic measures were taken as a result of high blood pressure/blood pressure went up (hypertension). The outcome of electrical charges that were prickly in her body, body is responding to food, water and medicine like it is foreign, warm flush and frustrated was unknown. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427769 Pfizer