chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got infected with the Delta variant; got infected with the Delta variant; This is a spontaneous report from a contactable consumer or other non hcp via Contact Center. An 81-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported) on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient got infected with the delta variant. Now patient wanted to participate in Pfizer covid booster trial. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: My sister and brother-in-law both contracted COVID-19 after receiving their first dose of the Pfizer Covid-19 Vaccine; My sister and brother-in-law both contracted COVID-19 after receiving their first dose of the Pfizer Covid-19 Vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's brother-in-law).  A 91-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 26Jan2021 (age at vaccination: 91 years), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that my sister and brother-in-law both contracted COVID-19 after receiving their first dose of the Pfizer Covid-19 Vaccine on an unspecified date in 2021. The reporter would like to know if they could receive their second dose or would they need to repeat the series. The patient underwent lab test and procedure included Covid 19 with positive result on an unspecified date in 2021. There was a Product Complaint. Description of Product Complaint included Pfizer Covid 19 vaccine: Tested positive after getting first dose of Pfizer Covid 19 vaccine. Product strength and count size dispensed: Is a sample of the product available to be returned, if requested (Y/N): Packaging sealed and intact? Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Headache, Illness, Pyrexia, Suspected COVID-19
Clinical narrative: It was like I had a COVID; It was like I had a COVID; It made me sick; Headache; I ran a fever; This is a spontaneous report from a contactable consumer or other non health professional (patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: AWO198) via an unspecified route of administration on 02Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She has not done her second one because she said, she had a reaction and she did not tell me what that reaction was and her question was can she still get the second vaccine, she does have the medical information phone number. She stated they got that in the system, it was all there, she called in and reported it. On an unspecified date in Jul2021, it made her sick, it made her have a headache, she ran a fever. It was like she had a COVID. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID; patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date: not provided) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiration date: not provided) via unspecified route of administration on an unspecified date as DOSE 2, SINGLE both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient was fully vaccinated with Pfizer vaccine, had tested, through a PCR test, positive for COVID. Symptoms were mild including runny nose, stuffed up and were getting better. The patient underwent lab tests and procedure which included SARS-CoV-2 test/ PCR test was positive on an unspecified date. The events outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, SARS-CoV-2 test
Clinical narrative: Tested positive for the COVID Delta variant after being vaccinated; Tested positive for the COVID Delta variant after being vaccinated; He mentioned he is not feeling well.; This is a spontaneous report from a contactable consumer. This consumer reported for unknown male patient. A male patient of an unspecified age received bnt162b2 (COVID-19 VACCINE - manufacturer unknown; Solution for injection, Lot number: unknown, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. No medical and concomitant medication history were reported. The patient experienced tested positive for the COVID delta variant after being vaccinated and not feeling well. Reporter was unsure of which vaccine was administered (only info is that it was a 2-dose version, so Moderna or Pfizer). There were no adverse reactions, only actively symptomatic. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on an unspecified date. The outcome of the events were unknown.  Information about lot/batch number cannot be obtained. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Gait disturbance, X-ray
Clinical narrative: Problems with my thigh started about 6 weeks ago and finally they are getting worse; Something is going on with the back of my thigh it's  difficult to walk; This is a spontaneous report from two contactable consumers (Patient and another consumer).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EN6207), dose 2 via an unspecified route of administration, in Right arm on 16Mar2021 at 13:00 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: EL9267), dose 1 via an unspecified route of administration in right arm on 23Feb2021 at 13:00 for COVID-19 immunization. Patient did not receive prior vaccination within 4 weeks. On an unspecified date in 2021, Consumer stated that consumer was having side effects from the Pfizer vaccine. Consumer read online some of the problems were in your thighs and consumer thought consumer had formed hamstring in both thighs and consumer just went to have an x-ray in hamstrings were fine but there was something was going on with the back of thigh it's difficult to walk. The problems with thigh started about 6 weeks ago and finally they were getting worse on an unspecified date in Jun2021 and consumer went to doctor 3 days ago. Patient did not receive any treatment for side effects. The patient underwent lab tests and procedures on an unspecified date in 2021 which included x-ray: fine (x-ray in my hamstrings are fine). The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Pyrexia
Clinical narrative: positive for Covid19; positive for Covid19; fever; lost his sense of taste and smell; lost his sense of taste and smell; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose and dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 28Jul2021, the patient tested positive for Covid19, has a low grade fever, lost his sense of taste and smell. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: positive for Covid19; positive for Covid19; fever; lost his sense of taste and smell; lost his sense of taste and smell; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose and dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 28Jul2021, the patient tested positive for Covid19, has a low grade fever, lost his sense of taste and smell. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: passed out in her car and got into a car accident; passed out in her car and got into a car accident; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, passed out in her car and got into a car accident on an unspecified date. Reported as, after receiving the Pfizer COVID-19 vaccine, she passed out in her car and got into a car accident. Her doctor confirmed that it was a result of the vaccine. She stated that it happened right after she left the doctor's office where she received the Pfizer COVID-19 vaccine. She waited 20 minutes and immediately passed out. She got into an accident and was rushed to the emergency room. Outcome of the events were unknown.  Information on the lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. Caller states my cousin and his wife also got diagnosed a couple days earlier than I did. Especially when I found out my cousin and his wife had both doses and tested positive. The patient was positive for covid on Jul2021 considered as medically significant. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. A female patient (Cousin's wife) of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient pregnant information was unknown. The patient was tested positive for covid in Jul2021. Reporter stated my cousin and his wife also got diagnosed a couple days earlier than I did. I just wanted to make sure this got reported because I know you were still trying to figure all this out. Especially when I found out my cousin and his wife had both doses and tested positive. Reporter asked, "is there any more information about this". The patient underwent lab tests and procedures which included COVID-19 as positive on Jul2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller has since contracted COVID-19 as a "break through case" last week; Caller has since contracted COVID-19 as a "break through case" last week; This is a spontaneous report from a contactable consumer (patient). 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 an unknown date in Apr2021 as dose 1, single; and later received second dose of BNT162B2 (Batch/Lot number was not reported) via an unspecified route of administration on an unknown date in Apr2021 as dose 2, single; both for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date in Jul2021 (reported as last week), the patient experienced contracted covid-19 as a "break through case".  Batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Fatigue, Fear, Malaise
Clinical narrative: Heart attack; Caller states that he has been having a weird chest pain and tightening of the chest and does know if it is related to the vaccine or to his heart.; Caller states that he has been having a weird chest pain and tightening of the chest and does know if it is related to the vaccine or to his heart./He states its a pressure in his chest; Scared; he wasn't feeling well and needed to lie down; Sore arm; Tiredness; This is a spontaneous report from a contactable consumer. A 56-year-old male consumer (patient) reported that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number: not reported), dose 1 via unspecified route on 15Jul2021, as single dose for COVID-19 immunization (age at time of vaccination 56 years). The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021 the patient experienced Heart attack, he did not want to die of Corona or Delta virus. He wanted to know what he should do. He did not know if he was gone to die of a heart attack, he had been having a weird chest pain and tightening of the chest and does know if it was related to the vaccine or to his heart, Sore arm, and Tiredness. He was scared to get the second dose and is looking for guidance. agent states that the caller declined to fill out safety report because he stated he was not feeling well and needed to lie down. He had these chest pains for the last 3 or 4 days this week. He states that it seems like it is getting a little bit worse. All he could link it to is the vaccine, several people told him including his mailman that if you have a heart condition not to get the vaccine. He was questioning if he wants to get his second shot because it is a little scary what he is going through right now. It was unknown especially when it comes to your heart. He states when he gets off this phone call, he was gone to call his doctor. He states he did not know what to do but he is just concerned about his chest pain. He had been taking baby aspirin, twice a day one in the morning and one at night and that seems to be helping a little bit. He forgot to take it last night and all the sudden he felt the chest pain, he states he just took it a little while ago and he knows it takes time for it to kick in. He did not know. It was a pressure in his chest, so he was not sure if it could be his heart, he states the pain seems to be between the center and the right versus the left side. The outcome of event Scared was unknown, and rest of all events was not recovered.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Pain in extremity
Clinical narrative: Heart attack; Caller states that he has been having a weird chest pain and tightening of the chest and does know if it is related to the vaccine or to his heart.; Caller states that he has been having a weird chest pain and tightening of the chest and does know if it is related to the vaccine or to his heart./He states its a pressure in his chest; Scared; he wasn't feeling well and needed to lie down; Sore arm; Tiredness; This is a spontaneous report from a contactable consumer. A 56-year-old male consumer (patient) reported that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number: not reported), dose 1 via unspecified route on 15Jul2021, as single dose for COVID-19 immunization (age at time of vaccination 56 years). The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021 the patient experienced Heart attack, he did not want to die of Corona or Delta virus. He wanted to know what he should do. He did not know if he was gone to die of a heart attack, he had been having a weird chest pain and tightening of the chest and does know if it was related to the vaccine or to his heart, Sore arm, and Tiredness. He was scared to get the second dose and is looking for guidance. agent states that the caller declined to fill out safety report because he stated he was not feeling well and needed to lie down. He had these chest pains for the last 3 or 4 days this week. He states that it seems like it is getting a little bit worse. All he could link it to is the vaccine, several people told him including his mailman that if you have a heart condition not to get the vaccine. He was questioning if he wants to get his second shot because it is a little scary what he is going through right now. It was unknown especially when it comes to your heart. He states when he gets off this phone call, he was gone to call his doctor. He states he did not know what to do but he is just concerned about his chest pain. He had been taking baby aspirin, twice a day one in the morning and one at night and that seems to be helping a little bit. He forgot to take it last night and all the sudden he felt the chest pain, he states he just took it a little while ago and he knows it takes time for it to kick in. He did not know. It was a pressure in his chest, so he was not sure if it could be his heart, he states the pain seems to be between the center and the right versus the left side. The outcome of event Scared was unknown, and rest of all events was not recovered.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID test with symptoms; Positive COVID test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), on 22Feb2021 (batch/lot number: EL3247) as dose 1, single; on 15Mar2021 (batch/lot number: EL-3247, at the age of 54-year-old) as dose 2, single, both via an unspecified route of administration, administered in arm left for COVID-19 immunization. Medical history included T1 DM (type 1 diabetes mellitus), the patient was Known allergies to PCN and CDN. Prior to vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin aspart (FIASP) and desvenlafaxine succinate monohydrate (PRISTIQ); both drugs received within 2 weeks of vaccination. The COVID-19 vaccine was administered at workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jul2021, the patient experienced Positive Covid test with symptoms. The events was resulted at Doctor or other healthcare professional office/clinic visit. The patient underwent lab data and procedures included on 26Jul2021; he was tested Nasal swab with positive results. The events did not required hospitalization prolonged. The patient did not take the treatment for the events. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient had Pfizer Covid vaccine and contracted Covid-19.; Sars-Cov-2 infection; This is a spontaneous report form a contactable consumer (patient) via regulatory authority. A 20-year-old female patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient had Pfizer covid vaccine and contracted covid-19. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in spleen; This is a spontaneous report from a non-contactable consumer (patient reported for herself). An 82-year-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Lot Number: EW0177), dose 2 via an unspecified route of administration, administered in Arm Right on 19May2021 (at the age of 82-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient previously received her first dose of (BNT162B2, formulation: Solution for injection, Lot Number: EW0172), via an unspecified route of administration, administered on 28Apr2021 (at the age of 82-year-old) as DOSE 1, SINGLE for covid-19 immunisation. 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. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, a few days after 2nd dose of Pfizer vaccine, the patient was hospitalized with a blood clot in spleen. It was reported that the patient had no prior medical history. The seriousness criteria of the event reported as hospitalization. The outcome of the event was resolved on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood Clots in the Wrist; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on an unknown date, as dose number unknown, single, for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced blood clots in the wrist. The outcome of the event was unknown.   Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: Blood clot in the brain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included lupus. The patient's concomitant medications were not reported. The patient experienced blood clot in the brain on an unspecified date. It was reported that, consumer stated she had not an adverse reaction. Her sister in law had an adverse reaction, she had lupus and she was not sure if that had caused the blood clot in her brain. She enquired how did she find out if adverse reactions have been reported about this or not. She also enquired had anyone reported the reaction with lupus or lupus cerebritis or not. Cerebritis means that it was affecting the brain. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid vaccine and she tested positive for covid afterwards; Covid vaccine and she tested positive for covid afterwards; This is a spontaneous report from a contactable consumer. This is the second of three reports   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter mentioned his wife's co-worker (patient) also got the Covid vaccine and she tested positive for covid afterwards on an unspecified date, this was shortly after getting the vaccine. On an unspecified date, the patient underwent COVID-19 test with result positive. The outcome of the event was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100971123 same reporter/drug, different patients/AE
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: blood clots in her lungs; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program. A 86-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration on an unspecified date in 2020 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation; tofacitinib citrate (XELJANZ), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The reporter stated that his neighbor was taking Xeljanz and got the COVID 19 vaccine (unknown manufacturer) and died from blood clots in her lungs. She died on an unspecified date and the family was blaming Xeljanz. The patient was diagnosis with blood clots about a month ago. She got COVID Vaccine around Christmas 2020. She was in hospital for 5 days with blood clots. The reporter inquired if vaccine cause blood clots. Seriousness of the event was reported as death and hospitalization. The action taken in response to the event for tofacitinib citrate was not applicable. The outcome of the event was fatal. It was not reported if an autopsy was performed.  Follow-up attempts are needed. Information on the lot/batch number is expected.; Reported Cause(s) of Death: unknown cause of death
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Biopsy, Disease recurrence, Laboratory test, Neutropenia
Clinical narrative: patient states over the years she has had to hold medication various times due to neutropenia, a biopsy, both covid vaccines.; patient states over the years she has had to hold medication various times due to neutropenia, a biopsy, both covid vaccines.; This is a spontaneous report from a Pfizer-sponsored program received from a contactable Healthcare professional. A 50-years-old female patient received the first and the second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified dates, at 50 years of age, (Batch/Lot numbers was not reported for both doses) as single doses, for COVID-19 immunization and palbociclib (IBRANCE), oral from 2018 (over 3 years) (Batch/Lot number was not reported) and ongoing, at starting dose of 125 mg for breast cancer, then decreased after few cycles to 75 mg daily for 21 of 28 days due to neutropenia. Medical history included mouth sores, fatigue, joint pain, hair thinning, constipation, nausea and neutropenia, all ongoing at the time of the report. Concomitant medication included letrozole taken for an unspecified indication since an unknown date. The patient stated that over the years she has had to hold medication various times due to neutropenia, a biopsy and both COVID-19 vaccines. She reports her side effects did not go away while she was off medication. Neutropenia onset date was reported as 2021 and it was assessed as medically significant. The patient underwent lab tests and procedures which included biopsy: unknown results and lab test which showed neutropenia. The action taken with palbociclib in response to the event was unknown. At the time of the report the event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of neutropenia  due to temporal relationship. However, concomitant therapy with palbociclib represents an alternative explanation for the neutropenia. In addition, the patent has medical history of recurrent neutropenia. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including baseline CBC with differential, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Symptomatic of COVID infection despite vaccination; no test to confirm; Symptomatic of COVID infection despite vaccination; no test to confirm; This is a spontaneous report from a contactable consumer or other non health care professional. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient tested COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On an unspecified date in Jul2021, the patient was symptomatic of covid infection despite vaccination; no test to confirm. Patient did not receive treatment for the events. The outcome the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test, Urinary tract infection
Clinical narrative: Caller tested positive for COVID-19 with a "1287" result of antibodies on her test; Caller tested positive for COVID-19 with a "1287" result of antibodies on her test; a urinary tract infection; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via medical information team.  A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date not reported), via an unspecified route of administration, administered on an unspecified date in Feb2021(at the age of 70-year- old) as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date not reported), via an unspecified route of administration, administered on unspecified date (at the age of 70 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller wants to know if the high COVID-19 antibody levels that she presented on her physical test could be due to a urinary tract infection that she developed recently. Caller and her husband received the second dose of the Pfizer COVID-19 vaccine on Feb, shortly after receiving the vaccine caller had no antibodies against COVID-19 and now a year later she resulted with a high level of antibodies relatively closely after experiencing a urinary infection. Caller will have a new medical test performed on Sep. As far as she knows she never had COVID-19. Caller heard that the type O blood is more protective with the vaccine. Caller also read that according to Pfizer withheld after 6 months of receiving the second dose of the vaccine patients have less immunity. E-transmitting neglected probable lack of efficacy. The patient tested positive for covid-19 with a 1287 result of antibodies on her test on 29Jul2021, and a urinary tract infection in 2021. The outcome of event urinary tract infection was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: took COVID test and it came back positive; took COVID test and it came back positive; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EJ1685, Expiration Date was not reported), via an unspecified route of administration, administered in left arm like the shoulder on 03Mar2021 (at the age of 50-years-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EK5730, Expiration Date was not reported), via an unspecified route of administration, administered in left arm like the shoulder on 24Mar2021(at the age of 50-years-old) as dose 2, single for covid-19 immunisation at vaccination clinic. The patient medical history was none. There were no concomitant medications.  It was reported that, the patient had the vaccine in Mar. He was a little stuffy this week and had mild symptoms. Down the street has COVID test. He took COVID test and it came back positive. Patient clarified yesterday, 29Jul2021, he had rapid COVID test and it was positive. PCR test was also done, but he hasn't gotten the PCR results, that will take a couple of days. He took the test yesterday morning between 11:00AM or 11:30AM. His awareness date of testing COVID positive was yesterday, 29Jul2021. Patient states that he was stuffy, had a little cough, and didn't feel right on Sunday 25Jul2021. He went to a drive up testing site. He was feeling off and had a cough. The patient underwent lab tests and procedures which included PCR test: unknown results on 29Jul2021, Rapid COVID Test: positive on 29Jul2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Prolonged arrhythmia episodes starting after 1st dose; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left in Feb2021 12:00 (Batch/Lot Number: EL3247) (at the age of 67-years-old) as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Medical history included thyroiditis, non-specified atopic dermatitis and allergies: fragrances used in cosmetics/cleaning products. There were no concomitant medications. The patient previously took melaleuca alternifolia oil (TEA TREE OIL) and experienced allergies: tea tree oil. The patient experienced prolonged arrhythmia episodes starting after first dose on 12Mar2021. It was unknown if this will be permanent. The patient considered the report as serious. Did not results in death, not medically significant, not life threatening, did not cause/prolong hospitalization, not disabling/incapacitating, no intervention required and no congenital anomaly/birth defect. There was no treatment for the event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Cerebrovascular accident, Dysarthria
Clinical narrative: He may have had a stroke; His left hand, he had no control over it; Slurred speech; This is a spontaneous report from a contactable consumer. A male patient (Father) of an unspecified age received BNT162B2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. Reporter was calling on behalf of his/her father, patient took the Pfizer vaccine on Monday, his first shot and sounds like he may have had a stroke (event captured as per verbatim) the next day. He won't go to the doctor, he woke up 'next' morning and his left hand, he had no control over it on an unspecified date. On an unspecified date, he had slurred speech, reporter didn't notice, reporter just found this out today and reporter didn't even know that he has got the shot. The symptoms have gone better, and he didn't go to the doctor. So, one, he never goes to the doctor hardly ever and two, he was researching it online and said that, he thought that maybe those were symptoms like the side effects of getting the vaccine but reporter was concerned that maybe it was a stroke. Reporter have been trying to get him go to the hospital but since the symptoms have got better, he was not going. When asked for LOT of first shot reporter stated, that reporter don't know what that was he/she don't have that reporter can get that from him but he/she was not at his house right now. The outcome of the events was unknown.  Follow-up activities are closed. Batch/lot number is not available
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Parosmia, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: contracted covid; contracted covid; He still has the impaired sense of taste and smell unfortunately; He still has the impaired sense of taste and smell unfortunately; This is a spontaneous report from contactable consumer (patient) and from a Pfizer sponsored program. A 32-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date (at the age of 32-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient contracted COVID after the first dose of COVID-19 vaccine. He had been negative for a week now (at the time of report). He still had the impaired sense of taste and smell unfortunately. He has had that for 2 weeks. According to PCR test he was negative on an unspecified date. He had heard conflicting information about getting the second dose straight away or waiting 30 days. Outcome of the event impaired sense of taste and smell was not resolved and while contracted covid was resolved on an unknown date and drug ineffective was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: contracted covid; contracted covid; He still has the impaired sense of taste and smell unfortunately; He still has the impaired sense of taste and smell unfortunately; This is a spontaneous report from contactable consumer (patient) and from a Pfizer sponsored program. A 32-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date (at the age of 32-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient contracted COVID after the first dose of COVID-19 vaccine. He had been negative for a week now (at the time of report). He still had the impaired sense of taste and smell unfortunately. He has had that for 2 weeks. According to PCR test he was negative on an unspecified date. He had heard conflicting information about getting the second dose straight away or waiting 30 days. Outcome of the event impaired sense of taste and smell was not resolved and while contracted covid was resolved on an unknown date and drug ineffective was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Patient was fully vaccinated and got COVID after Memorial Day; Patient was fully vaccinated and got COVID after Memorial Day; This is a spontaneous report from a contactable consumer received via a Pfizer sales representative. A 61-year-old female patient received doses 1 and 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified routes of administration on unspecified dates (at the age of 61-years-old) as single doses for COVID-19 immunization. Medical history was unknown. It was unknown if the patient received any other vaccines prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. It was unknown if the patient had any allergies. On 02Jun2021, the patient was fully vaccinated and got COVID-19 after Memorial Day. The event was reported as non-serious. The patient was not hospitalized for the event. It was unknown if the patient received treatment for the event. The outcome of COVID-19 was recovered. It was unknown if the patient was tested for COVID-19 after the vaccination.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID; Patient tested positive for COVID; This is a spontaneous report from a contactable consumer. A 27-year-old male patient received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on Apr2021 (Lot: EW0179) and May2021 (Lot: EW0161), respectively, at the age of 27-years-old, intramuscular as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were none. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On Jul2021, the patient tested positive for COVID. Laboratory tests included COVID test post vaccination (nasal swab) in Jul2021: positive. The patient was not treated for the event. The clinical outcome of the event was resolved on Jul2021.  No follow-up attempts are possible. No further information is expected.