chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage, Malaise, Ocular discomfort
Clinical narrative: Blood vessel bursts in whites of eye; Feeling of pressure on eye; General ill feeling; eye discomfort; This is a spontaneous report received from a contactable consumer (patient). A 59-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in right arm, on 24Mar2021 (at the age of 59 years old) at 13:15, as a single dose, for COVID-19 immunisation. Medical history included Colon re-section surgery in 2020 due to diverticulitis. The patient did not have allergies to mediations, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162b2. On 24Mar2021 (at 4:00pm), the patient experienced blood vessel bursts in whites of eye, eye discomfort/feeling of pressure on eye and general ill feeling. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive treatment for the events. The clinical outcome of the events, blood vessel bursts in whites of eye, eye discomfort/feeling of pressure on eye and general ill feeling, was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Toothache
Clinical narrative: face hurts; Tooth hurts; This is a spontaneous report from a contactable consumer (patient).   A 41-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (Lot Number: ER8737; Expiration Date: 31Jul2021) at SINGLE DOSE in Left shoulder for covid-19 immunisation.  The patient medical history was not reported.   No Prior Vaccinations (within 4 weeks).  The patient's concomitant medications were not reported. The only medication she takes is cholesterol pills. She received her first dose of the Pfizer Covid 19 Vaccine this morning and ever since she came home, her tooth hurts and her face hurts on 1Apr2021.  She would like to know if teeth and face hurting are side effects from the vaccine. She reported her teeth at the top are hurting, teeth on the bottom are okay. Said its the both sides of mouth on the top that are hurting. The patient reported this is happening off and on.  The outcome of Tooth hurts was unknown, of face hurts was recovering.  No follow-up attempts possible. No further information expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to arthropod sting, Body temperature, Flushing, Nausea, Pyrexia
Clinical narrative: a bit of flushing/ face flushes/ face was flushed out like red; Feeling sick to stomach little bit; a fever/ temperature was 99.6; Shaky; Had an anaphylactic reaction to the bee sting/had bee sting allergy; This is a spontaneous report received from a contactable consumer (wife). This consumer reported for a 72-years-old male patient that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EP7534) at the age of 72-years, via an unspecified route of administration on 29Mar2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included clopidogrel bisulfate (PLAVIX) for blood thinner. The consumer reported that the patient seemed to be having a bit of flushing and a fever. Further stated, he seemed to be flushed, he was feeling sick to his stomach little bit and his temperature was 99.6, his was shaky and it was just he had an anaphylactic reaction to the bee sting (unclear) and they noticed that so, and so consumer was worried. Consumer further stated that actually talked to their doctor and they said this seemed to be a Pfizer reaction. Consumer stated, this was the first time, he just got this vaccine yesterday and he was having this reaction today and consumer was concerned because it was not normal for him to be shaky and he had face flushes. His face was flushed out like red. It was reported that adverse events started in the afternoon on 30Mar2021. No treatment recevied. The consumer also mentioned that expiration date seems to be 29Mar2021, but she was not sure. While inquiry patient still having the adverse events, the consumer stated that, yes, they kept him long because he had bee sting allergy and it may be related to that. Outcome of the events was not recovered/not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: a bit of flushing/ face flushes/ face was flushed out like red; Feeling sick to stomach little bit; a fever/ temperature was 99.6; Shaky; Had an anaphylactic reaction to the bee sting/had bee sting allergy; This is a spontaneous report received from a contactable consumer (wife). This consumer reported for a 72-years-old male patient that who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EP7534) at the age of 72-years, via an unspecified route of administration on 29Mar2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included clopidogrel bisulfate (PLAVIX) for blood thinner. The consumer reported that the patient seemed to be having a bit of flushing and a fever. Further stated, he seemed to be flushed, he was feeling sick to his stomach little bit and his temperature was 99.6, his was shaky and it was just he had an anaphylactic reaction to the bee sting (unclear) and they noticed that so, and so consumer was worried. Consumer further stated that actually talked to their doctor and they said this seemed to be a Pfizer reaction. Consumer stated, this was the first time, he just got this vaccine yesterday and he was having this reaction today and consumer was concerned because it was not normal for him to be shaky and he had face flushes. His face was flushed out like red. It was reported that adverse events started in the afternoon on 30Mar2021. No treatment recevied. The consumer also mentioned that expiration date seems to be 29Mar2021, but she was not sure. While inquiry patient still having the adverse events, the consumer stated that, yes, they kept him long because he had bee sting allergy and it may be related to that. Outcome of the events was not recovered/not resolved.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Dizziness, Drug ineffective
Clinical narrative: She feels like she has COVID all over again; She feels like she has COVID all over again; Her lips got super numb and she was light headed; Lightheaded and dizzy; She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; Unrelenting headache and her limbs are so fatigued she can't even get around.; Severe lower back pain; Unrelenting headache and her limbs are so fatigued she can't even get around./She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; This is a spontaneous report received from a contactable consumer. This 70-year-old female consumer, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: not reported) via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 Immunization. Patient medical history and concomitant medication were unknown. On 25Mar2021 (15 minutes later after vaccination), Patient experienced her lips got super numb and was very lightheaded. The patient received some apple juice and a gram cracker and after extra 30 minutes the numbness went away, and she felt lightheaded and dizzy. That night patient started getting chills and severe headache getting so bad she is thinking of going to the ER. On 26Mar2021 (next day of vaccination) patient had a fever and for next 2 days patient had fever of 101. After a week of vaccination her headache was unrelated since she had the vaccination, her limbs are so fatigued she could not even get around. The patient thought about going to the ER. She had severe lower back pain on an unspecified date. She had COVID in December she felt like she had COVID all over again and was worse than she did when she had COVID the first time. She thought about cancelling the second dose as it because she feels so horrible, people say the 2nd is worse than the first. The side effects are worse. The patient had an appointment with her doctor. The patient wanted to mention something that sounds weird. It tracks your pattern of sleep REM, the patient sleep since January she was getting 8 hours and getting 2 hours of REM sleep, the deep sleep which is needed for cell repair and such. Ever since she had the shot, she is getting enough sleep but, not enough REM sleep. Probably a very unusual reaction that she thought was kind odd but, thought we should know. Patient reported as a Product Complaint.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia oral, Pyrexia, Suspected COVID-19
Clinical narrative: She feels like she has COVID all over again; She feels like she has COVID all over again; Her lips got super numb and she was light headed; Lightheaded and dizzy; She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; Unrelenting headache and her limbs are so fatigued she can't even get around.; Severe lower back pain; Unrelenting headache and her limbs are so fatigued she can't even get around./She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; She had chills, a severe headache and the next day she had a fever and for the next 2 days she had a fever of 101; This is a spontaneous report received from a contactable consumer. This 70-year-old female consumer, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: not reported) via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 Immunization. Patient medical history and concomitant medication were unknown. On 25Mar2021 (15 minutes later after vaccination), Patient experienced her lips got super numb and was very lightheaded. The patient received some apple juice and a gram cracker and after extra 30 minutes the numbness went away, and she felt lightheaded and dizzy. That night patient started getting chills and severe headache getting so bad she is thinking of going to the ER. On 26Mar2021 (next day of vaccination) patient had a fever and for next 2 days patient had fever of 101. After a week of vaccination her headache was unrelated since she had the vaccination, her limbs are so fatigued she could not even get around. The patient thought about going to the ER. She had severe lower back pain on an unspecified date. She had COVID in December she felt like she had COVID all over again and was worse than she did when she had COVID the first time. She thought about cancelling the second dose as it because she feels so horrible, people say the 2nd is worse than the first. The side effects are worse. The patient had an appointment with her doctor. The patient wanted to mention something that sounds weird. It tracks your pattern of sleep REM, the patient sleep since January she was getting 8 hours and getting 2 hours of REM sleep, the deep sleep which is needed for cell repair and such. Ever since she had the shot, she is getting enough sleep but, not enough REM sleep. Probably a very unusual reaction that she thought was kind odd but, thought we should know. Patient reported as a Product Complaint.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Premature baby
Clinical narrative: delivered on 25Mar2021, 7 weeks before her due date; Patient's mother was pregnant at the time, subsequently developed pre-eclampsia; This is a spontaneous report received from a contactable other Health Care Professional. This other health care professional reported information for both mother and fetus/baby. This is a fetus/baby report. A fetus male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose transplacental on 22Jan2021 (Batch/Lot number was not reported) as single dose, second dose transplacental on 18Feb2021 (Lot Number: EN6201) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient's mother was pregnant at the time, subsequently developed pre-eclampsia, and delivered on 25Mar2021, 7 weeks before her due date. The event outcome for events was unknown.; Sender's Comments: Based on the plausible temporal association, a contributory role of suspect product to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021372132 maternal case
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Palpitations, Presyncope, Tremor
Clinical narrative: Felt very faint like I was about to pass out; Dizzy; I had really fast heartbeat; Shaking of hands; It was a wave that came over me; This is a spontaneous report from a contactable consumer. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 19Mar2021 (at the age of 36-years-old) (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from 2003 and ongoing, Seasonal Environmental allergy, Acid reflux. Concomitant medications included  (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; etonogestrel (NEXPLANON) taken for contraception, start and stop date were not reported. On 19Mar2021, the patient experienced some symptoms 9-10 min after receiving the vaccine some of which are listed on the severe allergic reactions possibility here so I just wanted to report that and if anybody could provide me any suggestion as to whether or not I should be receiving my second round which is due for next week and I am not sure to get that. Felt very faint like I was about to pass out. It was a wave that came over me, I was very dizzy and my heart rate was racing, I had really fast heartbeat. In couple of minutes my hands were shaking. The patient did not receive treatment for the events. The outcome of the event It was a wave that came over me was unknown while recovered for the other events.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Headache; Tiredness/Fatigue; Sore throat; weak; This is a spontaneous report from a contactable consumer for his wife.   A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 at SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received first  dose of bnt162b2 on unknown date at SINGLE DOSE for covid-19 immunisation. On the morning of 1Apr2021, she had a headache, tiredness, fatigue and a sore throat and he gave her a couple Tylenol and the sore throat went away. She was tired and weak and has a headache. She has no fever. She was fine yesterday. The headache, tiredness and she took a couple Tylenol for the sore throat and that went away and they went shopping and she was a little more tired and weak a little bit so they came home and she is sleeping now. The outcome of Sore throat was recovered, of other events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Seizure
Clinical narrative: Seizure; This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer-sponsored program. A 12-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as single dose for immunization; influenza vaccine (reported as flu shot) via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) at unknown dosing regimen for an unspecified indication. The patient's medical history and concomitant medications were not reported. Patient came in for annual flu shot and was behind on several of his shots. The patient received pneumococcal 13-val conj vac (dipht crm197 protein) along with the flu shot. He experienced a seizure (at home). The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: There is a reasonable possibility that the event seizure was related to PREVENAR 13 based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for coronavirus; This is a spontaneous report from a consumer(patient) via Pfizer Sponsored Patient Support Program. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 21Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had her 1st dose of COVID 19 Vaccine on 21Mar2021 and then tested positive for COVID 19 a week later on 28Mar2021 and she was asking if it was allowed to have the 2nd dose on the 11Apr2021 knowing that she is in that kind of situation. States she is due for her 2nd dose 11Apr2021 and she is wondering if she is supposed to do it or not now or how that works. Caller provides that it is the Pfizer Coronavirus vaccine. Caller clarifies she tested positive for Coronavirus 28Mar2021. States she had the rapid and the PCR and both came back positive. Caller states she was tested on 28Mar2021 and the rapid came back positive that day. Referred caller to her healthcare provider for medical information. Outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; 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 VACCINE), dose 1 via an unspecified route of administration on 12Feb2021 (Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient scheduled for the second dose 05Mar2021, however missed her second dose since she had a cardiac arrest on 04Mar2021. The outcome was unknown.  Information on Lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: bad headache; made her really tired; arm got sore; This is a spontaneous report from a contactable consumer (patient). This 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021), dose 1, via an unspecified route of administration on 02Mar2021 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Medical history included borderline high blood pressure from an unknown date and unknown if ongoing, heart flutter from an unknown date and unknown if ongoing and covid-19 from an unspecified date in Nov2020. Concomitant medication(s) included verapamil (VERAPAMIL) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication from 2020. On 02Mar2021, the patient experienced a bad headache, it made her really tired and then her arm got sore. When she arrived home after receiving the vaccination, she took Tylenol and had to lay down. Therapeutic measures included Tylenol. Clinical outcome of the events bad headache, made her really tired and her arm got sore was resolving.   No follow up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Said he had a headache after second dose of vaaccine; This is a spontaneous report from Pfizer Sponsored Patient Support Program from a non contactable male consumer (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient previously received  bnt162b2 (BNT162B2) for covid-19 immunization.The patient said he had a headache after second dose of vaaccine on an unspecified date.  Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Ecchymosis, Rash
Clinical narrative: ecchymotic appearance; rash on the buttocks or upper thigh; This is a spontaneous report  from a contactable nurse reporting same event under the same suspect product for #4 patients. This is one of the patient among four patients. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (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 developed a rash on the buttocks or upper thigh within a few days to a week after getting a Pfizer Covid-19 vaccine. The rash begins with an appearance similar to shingles. After about a week the lesions are flat with an ecchymotic appearance. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021375444 same drug, event, different patient;US-PFIZER INC-2021375445 same drug, event, different patient;US-PFIZER INC-2021375443 same drug, event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Ecchymosis, Rash
Clinical narrative: rash on the buttocks or upper thigh; After about a week the lesions are flat with an ecchymotic appearance; This is a spontaneous report  from a contactable nurse reporting same event under the same suspect product for #4 patients. This is fourth of the patient among four patients. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (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 developed a rash on the buttocks or upper thigh within a few days to a week after getting a Pfizer Covid-19 vaccine. The rash begins with an appearance similar to shingles. After about a week the lesions are flat with an ecchymotic appearance. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter
Clinical narrative: "flutter like" heart symptoms; This is a spontaneous report received from a non-contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "flutter like" heart symptoms. The outcome of event was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Immune thrombocytopenic purpura; ITP; acute bleeding and thrombocytopenia; uncontrollable bleeding that did not stop; This is a spontaneous report from a Pfizer-sponsored. A contactable physician (anesthesiologist) reported that an 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 25Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 27Mar2021, the patient developed immune thrombocytopenic purpura (ITP) after getting or receiving the COVID-19 vaccine. The physician would like to know the protocol of that. The patient got his vaccination, on Thursday before the reporting (25Mar2021). And the patient was admitted to the hospital 48 hours later on Saturday (27Mar2021) with acute bleeding and thrombocytopenia. The patient went to the hospital with uncontrollable bleeding that did not stop. The physician was interested if the company had any internal protocol for treatment of ITP occurring acute onset after the Pfizer COVID-19 vaccine. The physician was trying to get some information to help some rheumatologist who can't seem to be finding things on the information on treating this. The physician was not here to blame anybody for it and from what he/she read, there are like 150 cases around the world with thrombocytopenia after the COVID-19 vaccine from totally different manufacturers (further clarification unknown). The physician had read a many couple case reports of different individual, people have tried for that but he/she was just interested if the company had any inhouse information for the treatment protocols for acute thrombocytopenia after the Pfizer COVID-19 vaccination. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Based on the information provided and temporal association, a possible causal relationship cannot be excluded between the suspect product BNT162B2 and the reported event Immune thrombocytopenic purpura. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster
Clinical narrative: shingles after getting the first dose; she is experiencing lower left quadrant back pain; This is a spontaneous report received from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unknown date in Mar2021 after getting the first dose, the patient experienced shingles and lower left quadrant back pain. The clinical outcome of the shingles and lower left quadrant back pain was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles after getting the first dose; she is experiencing lower left quadrant back pain; This is a spontaneous report received from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number unknown) as a single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  On an unknown date in Mar2021 after getting the first dose, the patient experienced shingles and lower left quadrant back pain. The clinical outcome of the shingles and lower left quadrant back pain was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6204) via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Metoprolol, Atorvastatin, Gabapentin, Ondansetron, Norco; thrice a day, Cymbalta, Topiramate; 100mg and Zantac; 50mg. On 20Mar2021, patient experienced shingles. Patient contacted her Primary Care Physician, he confirmed it and patient was given Prednisone and Acyclovir as treatment. Patient was due to have second dose on 7April at 3 o'clock. Outcome of the events was unknown.   No follow attempts are needed. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer or other non-health care professional. A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6204) via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Metoprolol, Atorvastatin, Gabapentin, Ondansetron, Norco; thrice a day, Cymbalta, Topiramate; 100mg and Zantac; 50mg. On 20Mar2021, patient experienced shingles. Patient contacted her Primary Care Physician, he confirmed it and patient was given Prednisone and Acyclovir as treatment. Patient was due to have second dose on 7April at 3 o'clock. Outcome of the events was unknown.   No follow attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Facial paralysis/Bells palsy; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (COMIRNATY) (batch/lot number was not reported) via an unspecified route of administration on 02Mar2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced facial paralysis/Bells palsy observed at four weeks following the first dose, on an unspecified date in 2021 with outcome of unknown. The second dose was planned on 02Apr2021.  The event facial paralysis/Bells palsy occurred in a country different from that of the reporter.  This may be a duplicate if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support via a contactable consumer(patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced mild headache. The outcome was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: she's having a minor infection which is Urinary tract infection; This is a spontaneous report from a Pfizer Sponsored Program support via contactable Consumer (patient). A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route on 22Mar2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient had minor infection which is urinary tract infection, took antibiotics as prescribed by doctor. She wants to know if that affects a reaction while having the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pain in extremity
Clinical narrative: Sore arm; his heart rate is going up; This is a spontaneous report from Pfizer Sponsored Program COVAX US Support via a contactable consumer (parent) reported for her son. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Mar2021 (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 experienced sore arm and his heart rate was going up. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Has complaints of a headache; This is a spontaneous report received from Pfizer sponsored program COVAX US Support. A non-contactable consumer (patient) reported for a male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced has complaints of a headache on 01Apr2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, COVID-19, Hypersensitivity
Clinical narrative: tested positive for covid; she just had allergies; lost her taste and smell; lost her taste and smell; mild fever of 99; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program . A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 05Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that both she and her husband received their first vaccine doses on 5Mar2021. On 11Mar2021, the patient thought she just had allergies but then lost her taste and smell and tested positive for covid on March 11th (she reports that her test results came back and confirmed covid on 16Mar2021) and she also reports having a mild fever of 99. They were scheduled to get their second vaccine dose on 26Mar2021 but patient's husband (was tested since they live together) tested positive on 20Mar2021 even though he only had some mild sinus congestion. Caller reported that she was told by the health department to wait 90 days to get the second dose and her doctor told her 14 days. And she was also told that she would have to start the whole series over again. Seriousness of event Covid-19 was medically significant. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021379323 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for covid; she just had allergies; lost her taste and smell; lost her taste and smell; mild fever of 99; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program . A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 05Mar2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that both she and her husband received their first vaccine doses on 5Mar2021. On 11Mar2021, the patient thought she just had allergies but then lost her taste and smell and tested positive for covid on March 11th (she reports that her test results came back and confirmed covid on 16Mar2021) and she also reports having a mild fever of 99. They were scheduled to get their second vaccine dose on 26Mar2021 but patient's husband (was tested since they live together) tested positive on 20Mar2021 even though he only had some mild sinus congestion. Caller reported that she was told by the health department to wait 90 days to get the second dose and her doctor told her 14 days. And she was also told that she would have to start the whole series over again. Seriousness of event Covid-19 was medically significant. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021379323 same reporter/drug, different patient/AE
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nervousness, Ocular hyperaemia
Clinical narrative: Caller received vaccine on Sat next day had really really red eyes; still don't feel good and is shaky; still don't feel good and is shaky; This is a spontaneous report received from a Pfizer Sponsored Program via a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received vaccine on Saturday-next day had really really red eyes-still don't feel good and is shaky-wants to know if she should still be feeling like this. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nephrolithiasis
Clinical narrative: But he was hospitalized because of his kidney stones; This is a spontaneous report from a contactable male consumer (patient) via Covax Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history was not reported. The patient's concomitant medications were not reported. The reporter received his 1st dose of the Pfizer vaccine on 03Mar2021 and he is supposed to go back on 22Mar2021 for his 2nd dose. But he was hospitalized because of his kidney stones and he lost his vaccination card. He was asking how he can get his 2nd dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Insomnia, Migraine, Nausea
Clinical narrative: hallucinations; insomnia; nausea; migraine; This is a spontaneous report from Pfizer. A contactable consumer (patient) reported that a male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced insomnia, hallucinations, nausea and migraine 3 days after 1st dose on 06Feb2021. The event hallucinations was serious for being medical significant. He got the 1st dose last 03Feb 2021. He was scheduled for 2nd dose on April 5. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Vomiting
Clinical narrative: headache; vomiting; chills; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had COVID vaccine at Pfizer site - 5 hours later had headache, vomiting and chills. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: he is feeling cold; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support via a contactable consumer (patient) reported for himself. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the 1st dose at 11Mar2021. The 2nd dose is today (01Apr2021). He is feeling cold. Asking if he can still take the vaccine. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: not feel well after the first dose; Tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported for a male patient (son-in -law) received first dose of bnt162b2 (Covid 19 vaccine; solution for injection) via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunisation. The patient medical history and Concomitant medications were not reported. The patient tested positive for Covid-19 on 25Mar2021 after getting the first dose of Pfizer vaccine. The patient did not feel well after the first dose. The patient underwent lab tests and procedures which included Covid 19 positive on 25Mar2021. The outcome of the events was unknown.   Information about Lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dry eye, Headache
Clinical narrative: no sense of smell and taste; Bad headache; dry eyes; no sense of smell and taste; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient herself) reported that she received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number/Expiration date: unknown) via an unspecified route of administration on 13Mar2021 as single dose for covid-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date, after her first vaccination caller got exposed to Covid positive person and experienced with no sense of smell and taste, Bad headache, and very dry eyes. No lab data was recorded. Caller questioned whether she could take second dose if it was ok. Outcome of the event was unknown.  No follow-up attempts are possible, Information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, SARS-CoV-2 test
Clinical narrative: trouble breathing/shortness of breath; terrible headache; I had chest pains; This is spontaneous report from contactable consumer (patient). A 49-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW6H02, expiry date not reported), via an unspecified route of administration, administered in left arm on 25Feb2021 17:00 as single dose for covid-19 immunization. The patient medical history included allergies to IVP dye (reported as "die").  Prior to vaccination, the patient was not diagnosed with COVID-19.Concomitant medication included insulin taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took penicillin, codeine, and atorvastatin (LIPITOR) and experienced allergies to them.  On 26Feb2021, the patient had chest pains, and on an unspecified date in 2021, had trouble breathing, terrible headache, and shortness of breath which lead to surgery. The events were reported as serious life-threatening and had caused hospitalization on unknown dates. It was reported that for the event chest pains the patient was hospitalized for 5 days, while for the other events it was not provided how many days the patient was hospitalized. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has been tested for COVID-19 on 20Mar2021 which was negative nasal swab. Therapeutic measures were taken as a result of the event shortness of breath which included surgery, and chest pains. The outcome of the event chest pains was recovering while the outcome of the other reported events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test positive
Clinical narrative: consumer reports receiving her first dose of the Pfizer covid-19 vaccine on 22Mar2021 and then getting covid-19 disease later.; consumer reports receiving her first dose of the Pfizer covid-19 vaccine on 22Mar2021 and then getting covid-19 disease later.; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 22Mar2021 at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient received her first dose of the Pfizer covid-19 vaccine on 22Mar2021 and then getting covid-19 disease later in 2021. The patient experienced some covid-19 symptoms in 2021 (not specified what symptoms) and reported being recovered from them. The patient was scheduled to receive her second injection of the Pfizer covid-19 vaccine on 01Apr2021. The outcome of events was recovered on unknown date in 2021.  Information on the lot/batch number has been requested.