chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow; Fatigue; A slight cough; Her left arm began to ache and shake/left arm pain; Her left arm began to ache and shake/left arm shaking; She had arm pain when woke up the next day, and the 28th she had slight swelling; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 27Mar2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated on Sunday morning while taking a phone call her left arm began to ache and shake and she had to end the call. Caller states her arm hurts below the vaccination site in her left arm and the center area to an inch above her elbow. Caller states she can't use her left hand too much because it starts to ache and shake, says she was holding the phone talking to someone and after about 50 minutes her arm hurt, then 5 minutes later it started to shake and she had to stop using her hand to hold the phone. She says she had the same problem driving to work last night, she works night, she couldn't use her left arm driving for the trip because it was shaking. then she couldn't do as much of her usual work because it starts to shake and she needs two hands to do her job. She says today she also has a little bit of a cough and fatigue. The patient reported that since it was after her first dose that she had these problems she would like to know if it is safe for her to have her second dose that is scheduled for 24Apr2021. She could use her left arm now and was currently holding the phone in that hand to see if the event reoccurs. She says her arm aches above her injection site to two inches below her elbow, and when it shakes it was like her arm was having a seizure. She was used to having 4 hour phone calls to stay in touch with people and holding a phone for long periods of time was not unusual for her, but her arm could not hold it after that 50 minute call. She had arm pain when woke up the next day, and the 28th she had slight swelling by Saturday afternoon or evening, then she woke up more swelling the next day. She said this was at a mass vaccination site she got her first dose. She had a constant ache, and she hasn't taken any Ibuprofen for it. Since she has been holding the phone this call, it has begun aching more, she has been holding the phone 15 minutes, and it started to ache, but there was no shaking yet. States she is scheduled for the second dose on 24Apr2021. She would like to know if her side effects are normal and if she should receive the second dose. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: She said she is  past quarantine peroid  and fever free for a week now.; she was exposed to covid and tested positive; This is a spontaneous report from a contactable consumer via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via unspecified route of administration on 10Mar2021 as 1st single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient received her first dose of the Pfizer covid vaccine on 10Mar2021 and on 09Mar2021 she was exposed to covid and tested positive on 17Mar2021. On an unknown date, patient was past quarantine period and fever free for a week now. Patient was scheduled to get her 2nd shot tomorrow and wanted to know if she can already get her second dose. The outcome of event fever was resolved and COVID-19 was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer reported on behalf of a female patient (mother). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the second dose appointment on 06Apr, however tested positive to COVID-19 Virus on an unspecified date. Caller wanted to know if her mother can take the vaccine because her quarantine would almost be over. The patient underwent lab tests and procedures which included SAR-COV-2 test which was positive on an unspecified date.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller tested positive yesterday after getting his first covid vaccine; This is a spontaneous report from a non-contactable consumer (patient) reporting himself via Pfizer-sponsored program.  A male patient reported that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: not provided) via an unspecified route of administration on 26Mar2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, on 25Mar2021, patient tested positive after getting his first covid vaccine and he would like to know if he can still get his second covid vaccine. Transferred due to getting covid and being scheduled 4 weeks to get his second covid vaccine. The patient underwent laboratory tests and procedures which included SARS-CoV-2 test: positive on 25Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable Female consumer (patient). A 69-year-old (non-pregnant) female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unspecified), via intramuscular route, administered in left arm on 13Mar2021 at 11:15 (at the age of 69-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unspecified), via intramuscular route, administered in left arm on 24Feb2021at 15:45 as 1st dose, single dose for COVID-19 immunization. The patient medical history includes flu shots on unspecified date, the vaccine stopped the fractured sleep such bliss, bronchitis I had many times as child. Concomitant medications were not reported. No other vaccine taken 4 weeks prior. On 17Mar2021, after the vaccination, the patient experienced Tiredness/ suddenly exhausted, swollen lips after drinking green tea, Hay fever with little blooming in mountains, rashes, Welts on skin were brushed against things. On 18Mar2021, patient experienced mild headache, eyes and nose running, became allergic to nearly everything, On 20Mar2021, patient experienced Low Blood Oxygen when climbing Low hill 89% and 91%, On 22Mar2021 patient experienced Chest and upper back pain. on unspecified date patient experienced sneezing, shoulder started hurting, migraine and bad sleep. The patient continued to work around home but did not go down the hill again for another week all cleared up by 15 considered taking otc drug Benadryl but warred it might mess immune response of vaccine. Patient said he was migraine- free for about a month after 2nd vaccine had first migraine. Patient usually get 8 hrs of sleep fractured over a 12-hr period of trying to sleep the vaccine stopped the fractured sleep. Lab investigations include heart rate with reading 56 bpm and steady 56 bpm on unspecified dates and oxygen saturation 89% and 91 % on unspecified dates. Good effects were all pain in old injury in left shoulder is gone. Therapeutic measures were taken as a result of events sneezing, eyes and nose running, mild headache, Low Blood Oxygen when climbing Low hill 89+91%. The outcome of the events urticaria, pyrexia, lip swelling, hypersensitivity, chest pain, backpain, fatigue, rash, oxygen saturation and headache was recovered on unspecified date, whereas outcome of other events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypersensitivity, Inappropriate schedule of product administration, Insomnia, Lacrimation increased
Clinical narrative: This is a spontaneous report from a contactable Female consumer (patient). A 69-year-old (non-pregnant) female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unspecified), via intramuscular route, administered in left arm on 13Mar2021 at 11:15 (at the age of 69-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unspecified), via intramuscular route, administered in left arm on 24Feb2021at 15:45 as 1st dose, single dose for COVID-19 immunization. The patient medical history includes flu shots on unspecified date, the vaccine stopped the fractured sleep such bliss, bronchitis I had many times as child. Concomitant medications were not reported. No other vaccine taken 4 weeks prior. On 17Mar2021, after the vaccination, the patient experienced Tiredness/ suddenly exhausted, swollen lips after drinking green tea, Hay fever with little blooming in mountains, rashes, Welts on skin were brushed against things. On 18Mar2021, patient experienced mild headache, eyes and nose running, became allergic to nearly everything, On 20Mar2021, patient experienced Low Blood Oxygen when climbing Low hill 89% and 91%, On 22Mar2021 patient experienced Chest and upper back pain. on unspecified date patient experienced sneezing, shoulder started hurting, migraine and bad sleep. The patient continued to work around home but did not go down the hill again for another week all cleared up by 15 considered taking otc drug Benadryl but warred it might mess immune response of vaccine. Patient said he was migraine- free for about a month after 2nd vaccine had first migraine. Patient usually get 8 hrs of sleep fractured over a 12-hr period of trying to sleep the vaccine stopped the fractured sleep. Lab investigations include heart rate with reading 56 bpm and steady 56 bpm on unspecified dates and oxygen saturation 89% and 91 % on unspecified dates. Good effects were all pain in old injury in left shoulder is gone. Therapeutic measures were taken as a result of events sneezing, eyes and nose running, mild headache, Low Blood Oxygen when climbing Low hill 89+91%. The outcome of the events urticaria, pyrexia, lip swelling, hypersensitivity, chest pain, backpain, fatigue, rash, oxygen saturation and headache was recovered on unspecified date, whereas outcome of other events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Migraine, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Female consumer (patient). A 69-year-old (non-pregnant) female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unspecified), via intramuscular route, administered in left arm on 13Mar2021 at 11:15 (at the age of 69-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unspecified), via intramuscular route, administered in left arm on 24Feb2021at 15:45 as 1st dose, single dose for COVID-19 immunization. The patient medical history includes flu shots on unspecified date, the vaccine stopped the fractured sleep such bliss, bronchitis I had many times as child. Concomitant medications were not reported. No other vaccine taken 4 weeks prior. On 17Mar2021, after the vaccination, the patient experienced Tiredness/ suddenly exhausted, swollen lips after drinking green tea, Hay fever with little blooming in mountains, rashes, Welts on skin were brushed against things. On 18Mar2021, patient experienced mild headache, eyes and nose running, became allergic to nearly everything, On 20Mar2021, patient experienced Low Blood Oxygen when climbing Low hill 89% and 91%, On 22Mar2021 patient experienced Chest and upper back pain. on unspecified date patient experienced sneezing, shoulder started hurting, migraine and bad sleep. The patient continued to work around home but did not go down the hill again for another week all cleared up by 15 considered taking otc drug Benadryl but warred it might mess immune response of vaccine. Patient said he was migraine- free for about a month after 2nd vaccine had first migraine. Patient usually get 8 hrs of sleep fractured over a 12-hr period of trying to sleep the vaccine stopped the fractured sleep. Lab investigations include heart rate with reading 56 bpm and steady 56 bpm on unspecified dates and oxygen saturation 89% and 91 % on unspecified dates. Good effects were all pain in old injury in left shoulder is gone. Therapeutic measures were taken as a result of events sneezing, eyes and nose running, mild headache, Low Blood Oxygen when climbing Low hill 89+91%. The outcome of the events urticaria, pyrexia, lip swelling, hypersensitivity, chest pain, backpain, fatigue, rash, oxygen saturation and headache was recovered on unspecified date, whereas outcome of other events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea, Sneezing, Therapeutic response unexpected, Urticaria
Clinical narrative: This is a spontaneous report from a contactable Female consumer (patient). A 69-year-old (non-pregnant) female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unspecified), via intramuscular route, administered in left arm on 13Mar2021 at 11:15 (at the age of 69-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unspecified), via intramuscular route, administered in left arm on 24Feb2021at 15:45 as 1st dose, single dose for COVID-19 immunization. The patient medical history includes flu shots on unspecified date, the vaccine stopped the fractured sleep such bliss, bronchitis I had many times as child. Concomitant medications were not reported. No other vaccine taken 4 weeks prior. On 17Mar2021, after the vaccination, the patient experienced Tiredness/ suddenly exhausted, swollen lips after drinking green tea, Hay fever with little blooming in mountains, rashes, Welts on skin were brushed against things. On 18Mar2021, patient experienced mild headache, eyes and nose running, became allergic to nearly everything, On 20Mar2021, patient experienced Low Blood Oxygen when climbing Low hill 89% and 91%, On 22Mar2021 patient experienced Chest and upper back pain. on unspecified date patient experienced sneezing, shoulder started hurting, migraine and bad sleep. The patient continued to work around home but did not go down the hill again for another week all cleared up by 15 considered taking otc drug Benadryl but warred it might mess immune response of vaccine. Patient said he was migraine- free for about a month after 2nd vaccine had first migraine. Patient usually get 8 hrs of sleep fractured over a 12-hr period of trying to sleep the vaccine stopped the fractured sleep. Lab investigations include heart rate with reading 56 bpm and steady 56 bpm on unspecified dates and oxygen saturation 89% and 91 % on unspecified dates. Good effects were all pain in old injury in left shoulder is gone. Therapeutic measures were taken as a result of events sneezing, eyes and nose running, mild headache, Low Blood Oxygen when climbing Low hill 89+91%. The outcome of the events urticaria, pyrexia, lip swelling, hypersensitivity, chest pain, backpain, fatigue, rash, oxygen saturation and headache was recovered on unspecified date, whereas outcome of other events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive with COVID-19; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer Sponsored Program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No medical information was reported. On 29Mar2021, the patient reported that she tested positive with COVID-19. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Fatigue, Headache
Clinical narrative: tired; feeling dizzy; headaches; had slight flu like symptoms and was really dizzy and tired; lost the sense of smell and taste; lost the sense of smell and taste; This is a spontaneous report from a Pfizer-sponsored program received from a consumer (patient) reporting for herself. A 31-year-old female patient (31 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 23Mar2021 at 10:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the first dose of vaccination, she did not receive any vaccinations within 4 weeks. No additional vaccines were administered on same date of the suspect vaccine. The patient stated that 7 after vaccination on 30Mar2021, she noticed she had no smell or taste or anything and asked whether it was an allergic reaction and should she be tested for the virus. She felt very dizzy and tired, and it was a lot more severe. She added that she felt flu like symptoms and believed the event continued at the time of report. She did not require treatment or a visit to her HCP or the Emergency room. She did not receive the 2nd dose of the Pfizer vaccine at the time of report. The clinical outcomes of the events loss of smell and taste, dizziness, tiredness, headache, and flu like symptoms were reported as unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: tired; feeling dizzy; headaches; had slight flu like symptoms and was really dizzy and tired; lost the sense of smell and taste; lost the sense of smell and taste; This is a spontaneous report from a Pfizer-sponsored program received from a consumer (patient) reporting for herself. A 31-year-old female patient (31 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 23Mar2021 at 10:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the first dose of vaccination, she did not receive any vaccinations within 4 weeks. No additional vaccines were administered on same date of the suspect vaccine. The patient stated that 7 after vaccination on 30Mar2021, she noticed she had no smell or taste or anything and asked whether it was an allergic reaction and should she be tested for the virus. She felt very dizzy and tired, and it was a lot more severe. She added that she felt flu like symptoms and believed the event continued at the time of report. She did not require treatment or a visit to her HCP or the Emergency room. She did not receive the 2nd dose of the Pfizer vaccine at the time of report. The clinical outcomes of the events loss of smell and taste, dizziness, tiredness, headache, and flu like symptoms were reported as unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive with COVID-19 and he had some other symptoms; This is a spontaneous report from a contactable consumer (himself) to Pfizer-sponsored program.   A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 14May2021 as 1st dose, single dose for Covid-19 immunisation. The patient's medical history and concomitant medications are not reported. After vaccination, on 25Mar2021, he tested positive with COVID-19 and he had some other symptoms. His appointment for the second dose was on 04Apr2021 and he would like to ask whether he needs to get tested negative first before he gets the second shot or shall he proceed going for the second shot. He would like to know if he should proceed or not. However, the concern was, he has the adverse effect that's why caller was trying to transfer it to another program. The patient underwent lab test which included SARS-CoV-2 test positive on 25Mar2021. The outcome of event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got first dose and tested positive for Covid-19 virus; This is a spontaneous report from a contactable Consumer or other non-health professional. A contactable consumer reported for a female patient (grandmother).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as 1st dose, single dose for COVID-19 immunization. Patient's medical and concomitant medication history were not reported. On an unspecified date, the patient underwent lab tests and procedures which included SARS-CoV-2 test was positive. It was reported that, "reporter, grandmother (patient) got the first dose on 18Mar2021 and patient was supposed to get the second dose on 08Apr2021 however the patient tested positive the COVID-19 virus yesterday and caller wants to know if patient can take the second dose of the vaccine or what the best thing they could do or should do?" patient scheduled to receive the second vaccine in the series on (08Apr2021)."  Reporter was informed about Pfizer Medical Information Department.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore; this breakout was bad; This is a spontaneous report received from a contactable consumer. A 55-Year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown) via an unspecified route of administration, in arm left, on 25Mar2021 at 09:30 AM (at the age of 55 years, non-pregnant), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. There was no history of allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021, the patient had experienced Cold sore (I am so curious if you have ever heard this, have not had one in years and this breakout was bad). The treatment received for the adverse event was reported as anti-viral. Outcome of the event was reported as recovering/resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, COVID-19, Chills, Diarrhoea
Clinical narrative: States she felt like she had Covid; felt terrible; very sick to stomach; bad headache; chills; increased temperature; diarrhea; sore arm; she got too sick after the first dose; body aches; reaction; This is a spontaneous report from a contactable consumer (herself). A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 29Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that she had a reaction after receiving the first dose. On 15Apr2021, she did not want to get the 2nd dose because she was scared. the patient stated that she experienced adverse events like headache, chills, increased temperature, diarrhea, sore arm, and covid-like symptoms. States she felt like she had Covid, states she had Covid 19 around the end of November 2020 and now she knows exactly what it feels like. Started three hours after the first dose, had a bad headache and very sick to stomach, after that she got diarrhea, chills and body aches, felt terrible. Lasted for 7 days. She wanted to do the right thing and cancel the appointment instead of just not showing up. Patient asked she went on the computer and read that if you have had covid, you only need one vaccine, is this true. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Nausea, Pain
Clinical narrative: States she felt like she had Covid; felt terrible; very sick to stomach; bad headache; chills; increased temperature; diarrhea; sore arm; she got too sick after the first dose; body aches; reaction; This is a spontaneous report from a contactable consumer (herself). A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 29Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that she had a reaction after receiving the first dose. On 15Apr2021, she did not want to get the 2nd dose because she was scared. the patient stated that she experienced adverse events like headache, chills, increased temperature, diarrhea, sore arm, and covid-like symptoms. States she felt like she had Covid, states she had Covid 19 around the end of November 2020 and now she knows exactly what it feels like. Started three hours after the first dose, had a bad headache and very sick to stomach, after that she got diarrhea, chills and body aches, felt terrible. Lasted for 7 days. She wanted to do the right thing and cancel the appointment instead of just not showing up. Patient asked she went on the computer and read that if you have had covid, you only need one vaccine, is this true. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: States she felt like she had Covid; felt terrible; very sick to stomach; bad headache; chills; increased temperature; diarrhea; sore arm; she got too sick after the first dose; body aches; reaction; This is a spontaneous report from a contactable consumer (herself). A female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 29Mar2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The caller stated that she had a reaction after receiving the first dose. On 15Apr2021, she did not want to get the 2nd dose because she was scared. the patient stated that she experienced adverse events like headache, chills, increased temperature, diarrhea, sore arm, and covid-like symptoms. States she felt like she had Covid, states she had Covid 19 around the end of November 2020 and now she knows exactly what it feels like. Started three hours after the first dose, had a bad headache and very sick to stomach, after that she got diarrhea, chills and body aches, felt terrible. Lasted for 7 days. She wanted to do the right thing and cancel the appointment instead of just not showing up. Patient asked she went on the computer and read that if you have had covid, you only need one vaccine, is this true. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Alcohol test false positive
Clinical narrative: Had a urinalysis that tests for alcohol and he tested positive in that test; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 29Mar2021 as single dose for Covid-19 immunisation. Patient had to have a urinalysis this past Monday on 05Apr2021 due to having a DUI, urinalysis came back positive for alcohol, he stated he has not had any alcohol and the only other thing he has had are stool softeners. He wanted to know if the Pfizer COVID-19 vaccine could interfere with the urinalysis and He did not want another positive urinalysis. The outcome of the vent was unknown. A review of the Prescribing Information for Pfizer COVID-19 vaccine (LAB-1457-7.0; Revised: 06Apr2021) failed to find any information regarding interaction of the Pfizer COVID-19 vaccine to urinalysis and causing people to test positive for alcohol. Please consult with doctor or health care provider for further guidance, as doctor/healthcare provider is the most familiar with medical condition.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, SARS-CoV-2 test
Clinical narrative: she didn't feel good; she was feelin bad; she tested positive; This is a spontaneous report from a contactable consumer or other non-health care professional. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, caller reports that, his wife received her first dose on Sunday, 14 Apr The Tuesday after she received her first shot she didn't feel good and then wednesday "she was feeling bad" and Friday "I took her to the ER and she tested positive". The adverse event she was feeling bad and she tested positive was resulted in emergency room visit. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423380 same reporter/drug, different patient/AE
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Oral herpes
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program Pfizer RX Pathways. A contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot No: UNKNOWN) via an unspecified route of administration on 12Apr2021 at 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, "I received my first dose of the Pfizer vaccine on Monday 12Apr2021 well 5 days later(17Apr2021) I woke up to the worst cold sore outbreak and entire lip is swollen on unspecified date". The patient reported that, "I ever had normally I only get cold sores once per year during cold season when I have an active cold at the moment I have no other cold symptoms and I had never seen anything like this and asked why is this happening to me." The outcome of the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Suspected COVID-19
Clinical narrative: feel tired; covid symptoms; This is a spontaneous report from Pfizer program. This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had Covid vaccine on Monday and on Wednesday he started to feel tired and had Covid symptoms. He wanted to know if that was normal or not. Outcome of the event was unknown. No Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Infection; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine given to patient previously was dose 1 received bnt162b2 for COVID-19 immunisation. It was reported that patient had the second dose of the vaccine on 08Apr2021. After a week on an unspecified date in Apr2021, she had an infection and her doctor gave her Prednisone as a corrective treatment, "she started taking this medicine today". She wanted to know if the drug will interfere with the effectiveness of the vaccine. Were any unaddressed medical questions referred or forwarded to Medical Information reported as yes. The outcome of the event was reported as unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Feeling hot, Headache, Heart rate increased, Nausea
Clinical narrative: headache; like my throat was swelling; heart rate accelerated; I felt tight in my chest and throat; I felt tight in my chest and throat; I felt warm; nauseous; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 02:45 (Batch/Lot Number: EN6204) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included drospirenone, ethinylestradiol (NIKKI) taken for a contraception, LORATADINE taken for an unspecified indication and start and stop date were not reported. The patient previously took sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 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. The patient experienced headache, like my throat was swelling, heart rate accelerated, i felt tight in my chest and throat, i felt tight in my chest and throat, i felt warm, nauseous on 07Apr2021 03:30. The patient reported that patient was stayed almost 30 minutes on site with the emt and then on the car ride back home patient started feeling like her throat was swelling and she tried to brush it off but then her heart rate accelerated and she felt tight in her chest and throat and then patient felt warm. patient started feeling nauseous and developed a headache so patient drove to the ER. Her throat continued to swell and release for the next few hours. Therapeutic measures were taken as a result of events includes PREDNISONE. The outcome for all events was recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Throat tightness
Clinical narrative: headache; like my throat was swelling; heart rate accelerated; I felt tight in my chest and throat; I felt tight in my chest and throat; I felt warm; nauseous; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 02:45 (Batch/Lot Number: EN6204) as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included drospirenone, ethinylestradiol (NIKKI) taken for a contraception, LORATADINE taken for an unspecified indication and start and stop date were not reported. The patient previously took sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 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. The patient experienced headache, like my throat was swelling, heart rate accelerated, i felt tight in my chest and throat, i felt tight in my chest and throat, i felt warm, nauseous on 07Apr2021 03:30. The patient reported that patient was stayed almost 30 minutes on site with the emt and then on the car ride back home patient started feeling like her throat was swelling and she tried to brush it off but then her heart rate accelerated and she felt tight in her chest and throat and then patient felt warm. patient started feeling nauseous and developed a headache so patient drove to the ER. Her throat continued to swell and release for the next few hours. Therapeutic measures were taken as a result of events includes PREDNISONE. The outcome for all events was recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: COVID-19 PCR test positive; they had a sore arm that day that went away with no side effects.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8732) via an unspecified route of administration on 08Apr2021 at 07:00 pm on left arm as 1st dose, single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported that three out of four of her family got the first dose of the vaccine then tested positive for COVID-19 on 20Apr2021. Her husband went in related to his allergies to get tested. She says it was her mother-in-law that had passed, then Tuesday they all got tested and they were all negative. She says her husband started feeling like he had allergies Friday after he cut the grass, and her son is a crazy person about COVID, but he has asthma so he wanted them to all get tested again since allergies can be like COVID, and her husband's test was positive, so then she and her son got tested and they were positive, so they had three positives out of the four family members who got the first dose. She clarifies that her mother-in-law didn't get the vaccine, but she had passed away Tuesday, and they contracted COVID during that time after she passed away at home. They had not gotten any other vaccinations the day of the first dose of the COVID-19 vaccine or in the four weeks prior. Their second dose is scheduled on 29Apr2021, he would like to know if they need to get tested and test negative for Covid-19 before receiving the second dose of the vaccine. They told her May 4th was when they could get their second dose after quarantining. She says that they were all fine after they got the first dose of the vaccine, they had a sore arm that day that went away with no side effects. She says that her arm soreness began that night into the next day, then it went away without treatment the next day after that, so lasting about 24 hours. She says she felt like if she had been able to move her arm after instead of how she slept on it at night, it would have been less, but she didn't get to move it around much since they got it at night.   No follow-up attempts are needed. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, SARS-CoV-2 test
Clinical narrative: I developed a pretty severe outbreak of genital herpes. I had not had an outbreak like this since I contracted it 22 years ago.; This is a spontaneous report from a contactable consumer (patient).   A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in Left arm on 29Mar2021 at the age of 54-years-old as 2nd dose, single for covid-19 immunisation. Medical history included asthma, hypothyroidism from an unspecified date, Allergies to medications, food, or other products augmentin & CIPRO, genital herpes from an unspecified date and had not had an outbreak like that since she contracted it 22 years ago. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, on an unspecified date received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: En6199), via an unspecified route of administration, administered in Left arm on 08Mar2021 13:30 at the age of 54-years-old as single dose for covid-19 immunisation. The patient previously took augmentin [amoxicillin;clavulanic acid] and cipro [ciprofloxacin] and experienced drug allergy. The patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 08Apr2021, the patient developed a pretty severe outbreak of genital herpes. She had not had an outbreak like that since she contracted it 22 years ago and no treatment was received for the adverse event. The patient underwent lab tests and procedures which included COVID-19 (sars-cov-2 test): positive on an unspecified date. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number, expiration date: unknown), via an unspecified route of administration, administered in Left arm on 20Apr2021 18:00 as 2ND DOSE, SINGLE DOSE, for covid-19 immunization. Medical history included herpes simplex from an unknown date. Concomitant medication included sertraline HCL (SERTRALINE HCL), Ethinylestradiol, etonogestrel (NUVARING) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 30 Mar 2021 (Batch/Lot number was not reported) as for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. on 23Apr2021 05:00 the patient stated that patient developed a cold sore the day after my fever from the shot subsided, or three days following the shot. Patient had HSV1 since childhood, but only develop cold sores occasionally. It stood out to me because I had one in mid-March for the first time in a few years, which was normal. Having a second so close to the vaccine made me think it was a secondary effect, or potential reaction to the fever. The patient had no Allergies to medications, food, or other products. Outcome for the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Facial pain
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient got first dose of the vaccine and experiencing pain on half of her face and wanted to know if that was okay. There was no any unaddressed medical questions referred or forwarded to Medical Information. The outcome of event was unknown.  No Follow-up attempts are needed; information about lot/batch number cannot be obtained.