chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid-19; Tested positive for Covid-19; Dose received:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 22Dec2021 (Lot number: 330258D) at the age of 44 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 24Mar2021 (Lot number: EK5730) as dose 2, single and intramuscular, administered in arm right, administration date 03Mar2021 (Lot number: EJ1685) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 22Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 22Dec2021, outcome "unknown", described as "Dose received:3"; VACCINATION FAILURE (medically significant) with onset 12Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 12Jan2022, outcome "recovering" and all described as "Tested positive for Covid-19". The event "tested positive for covid-19" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive. Therapeutic measures were not taken as a result of covid-19.  Clinical course: covid prior vaccination was reported as no.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Patient tested positive for Covid; Patient tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 17 year-old patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in deltoid left, administration date 11Apr2021 15:37 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Patient tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (03Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: vaccine booster; Patient got COVID-19 in December from her grandson. She tested positive; Patient got COVID-19 in December from her grandson. She tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.-  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 45 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENTRESTO. Vaccination history included: Covid-19 vaccine (Manufacture: Unknown, dose number unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION, outcome "unknown", described as "vaccine booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "Patient got COVID-19 in December from her grandson. She tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Clinical courses: The patient tested positive but did not show any side effects besides a cough. She thought she was ill due to the COVID-19 Vaccine booster.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: swelling under my arm pits and it's pretty significant. It's the size of a baseball; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "she did not experience with 1st and 2nd dose of the Pfizer COVID vaccine"; Bnt162b2 (Dose: 02), for COVID-19 Immunization, reaction(s): "she did not experience with 1st and 2nd dose of the Pfizer COVID vaccine". The following information was reported: SWELLING (non-serious), outcome "unknown", described as "swelling under my arm pits and it's pretty significant. It's the size of a baseball"; IMMUNISATION (non-serious), outcome "unknown", described as "booster".  Additional Information: Reporter stated that she received a Comirnaty dose and said "I have a swelling under my arm pits, and it was pretty significant. It was the size of a baseball" she wanted to know if she is "in danger or some sort" as she did not have a reaction with her first 2 doses of Comirnaty. This is her booster dose, and she did not experience with 1st and 2nd dose of the Pfizer COVID vaccine. PQC was not present. Reporter seriousness for Swelling under armpits that are the size of a baseball was unspecified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: she didn't die but she knows 2 people that did; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "she didn't die but she knows 2 people that did". The patient date of death was unknown. The reported cause of death was "she didn't die but she knows 2 people that did". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The information provided is limited for reasonable medical assessment.  There was no information provided regarding cause of death, autopsy results and diagnostic studies. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related to the suspect drug until the cause of death is clarified and re-assessed based on additional data. This case will be updated 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: she didn't die but she knows 2 people that did
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Additionally, she's reported on behalf of others in her community:  "I know several people who have had severe reactions and I've had severe reactions. It's clear now that the vaccine does not keep you from getting covid, it doesn't keep you from passing it on to someone else.  Some friends have been boosted twice, 8 members in their family have covid now.  Sometimes the vaccine will cause more harm than good, there's so many variants out there now, so it's not preventing you from passing it on". "I also know people who have gotten it and died from the vaccine, who were young and no other medical problems and just died. Several people in our family have died of the vaccine. They contacted attorneys because they've been so sick and they have so many medical problems now from taking it and some people have died.  This has been 25-30 people right in one area.  I think Pfizer needs to be aware of it. And other, Moderna some have had that and had problems, it's not just all Pfizer that's done it, but most of them had the Pfizer vaccine because it was safer to take it... my pharmacist and doctor said that would be the best one [Pfizer]."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid". Reporter reported on behalf of others in her community: She knew several people who have had severe reactions and she had severe reactions. It's clear now that the vaccine did not keep you from getting covid, it didn't keep you from passing it on to someone else. Some friends had been boosted twice, 8 members in their family had covid now. Sometimes the vaccine would cause more harm than good, there's so many variants out there now, so it's not preventing you from passing it on. She also stated that she also knew people who had gotten it and died from the vaccine, who were young and no other medical problems and just died. Several people in our family had died of the vaccine. They contacted attorneys because they've been so sick, and they had so many medical problems now from taking it and some people have died. This had been 25-30 people right in one area.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: 8 members in their family have covid now; 8 members in their family have covid now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "8 members in their family have covid now".  Additional Information: Additionally, she's reported on behalf of others in her community: 8 members in their family have covid now. . The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Arthralgia, Arthritis
Clinical narrative: severe joint pain and arthritis; severe joint pain and arthritis; Hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Sep2021 (Lot number: FD8448) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "neck issues" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; HYDROCHLOROTHIAZIDE; VITAMIN D NOS; FISH OIL. Vaccination history included: Bnt162b2 (Dose 1, Lot: FC3180), administration date: 09Aug2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), ARTHRITIS (non-serious) all with onset Oct2021, outcome "unknown" and all described as "severe joint pain and arthritis"; ALOPECIA (non-serious) with onset Oct2021, outcome "unknown", described as "Hair loss". Therapeutic measures were taken as a result of arthralgia, arthritis, alopecia. Additional information: Four weeks after the patient had the injection she started experiencing severe joint pain and hair loss, she was still on treatment for hair loss she was on Finasteride, she was also taking vitamin that's called Viviscal (Treatment) and she was also taking Nutrafol (Treatment) so for the bone and joints she had have neck issues (Intent: history) so she had already been taking Tizanidine which is muscle relaxant and also take Diclofenac then she was going to rheumatologist as well too so that appointment has gonna make. No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID - positive test on 13Jan2022; Contracted COVID - positive test on 13Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Jun2021 (Lot number: EW0180) at the age of 14 years as dose 2, single and administration date 16May2021 (Lot number: EW0173) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 13Jan2022, outcome "recovering" and all described as "Contracted COVID - positive test on 13Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Jan2022) positive. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Rheumatoid arthritis
Clinical narrative: Rheumatoid Arthritis Flare; Fatigue; Chills; Low grade fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4227695-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single and intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid Arthritis Flare"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "Low grade fever". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of Chills, Fatigue, Rheumatoid arthritis flare up and Low grade fever was not provided. Since no determination has been received, the case is managed based on the company causality assessment.  PFIZER BIONTECH COVID-19 VACCINE: The reporter causality for the event chills, fatigue and low grade fever was reported as possible and for event Rheumatoid arthritis flare up was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the events Fatigue, Pyrexia, Chills, Rheumatoid arthritis and the suspect drug BNT162B2. 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: Bone pain, Cough, Dry throat, Immunisation, Pruritus
Clinical narrative: third dose of Comirnaty; blood clot; itching on the side of her heart (further clarified that it was a sudden sensation on the left side of her chest, next to her breast); She also reports a dry throat; a cough; a lot of bone pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (COMIRNATY) (Lot number: 331308A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 13Jan2022, outcome "unknown", described as "third dose of Comirnaty"; THROMBOSIS (medically significant) with onset 13Jan2022, outcome "unknown", described as "blood clot"; PRURITUS (non-serious) with onset 13Jan2022, outcome "unknown", described as "itching on the side of her heart (further clarified that it was a sudden sensation on the left side of her chest, next to her breast)"; DRY THROAT (non-serious) with onset 13Jan2022, outcome "unknown", described as "She also reports a dry throat"; COUGH (non-serious) with onset 13Jan2022, outcome "unknown", described as "a cough"; BONE PAIN (non-serious) with onset 13Jan2022, outcome "unknown", described as "a lot of bone pain".  Clinical course: Caller was a 48 year old female who got her third dose of Comirnaty on Wednesday. Yesterday, she had the following side effects begin: itching on the side of her heart (further clarified that it was a sudden sensation on the left side of her chest, next to her breast). She reported that it comes and goes. She had a blood clot last year, and she was asking what she should do about this. She also reports a dry throat, a cough, and a lot of bone pain. The reporter considered events as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: third dose of Comirnaty; blood clot; itching on the side of her heart (further clarified that it was a sudden sensation on the left side of her chest, next to her breast); She also reports a dry throat; a cough; a lot of bone pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (COMIRNATY) (Lot number: 331308A) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 13Jan2022, outcome "unknown", described as "third dose of Comirnaty"; THROMBOSIS (medically significant) with onset 13Jan2022, outcome "unknown", described as "blood clot"; PRURITUS (non-serious) with onset 13Jan2022, outcome "unknown", described as "itching on the side of her heart (further clarified that it was a sudden sensation on the left side of her chest, next to her breast)"; DRY THROAT (non-serious) with onset 13Jan2022, outcome "unknown", described as "She also reports a dry throat"; COUGH (non-serious) with onset 13Jan2022, outcome "unknown", described as "a cough"; BONE PAIN (non-serious) with onset 13Jan2022, outcome "unknown", described as "a lot of bone pain".  Clinical course: Caller was a 48 year old female who got her third dose of Comirnaty on Wednesday. Yesterday, she had the following side effects begin: itching on the side of her heart (further clarified that it was a sudden sensation on the left side of her chest, next to her breast). She reported that it comes and goes. She had a blood clot last year, and she was asking what she should do about this. She also reports a dry throat, a cough, and a lot of bone pain. The reporter considered events as non serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 10Jan2022, outcome "recovered" (Jan2022), described as "he tested positive for Covid". Relevant laboratory tests and procedures included covid positive on 10 jan2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin papilloma
Clinical narrative: Large warty growth at injection sites; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Feb2021 12:00 (Lot number: EN3248) at the age of 74 years as dose 1, single and administered in arm left, administration date 09Mar2021 12:00 (Lot number: EN6199) as dose 2, single for covid-19 immunization. Relevant medical history included: "Vascular dementia" (unspecified if ongoing), notes: vacular dementia; "Cerebral amyloid angiopathy" (unspecified if ongoing), notes: CAA; "Acute intermittent porphyria" (unspecified if ongoing), notes: AIP (Acute Intermittent Porphyria). The patient took concomitant medications. Past drug history included: Bacitracin, reaction(s): "Drug allergy", notes: Known allergies: Bacitracin antibiotic. The following information was reported: SKIN PAPILLOMA (non-serious) with onset Mar2021, outcome "not recovered", described as "Large warty growth at injection sites". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of skin papilloma.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rheumatoid arthritis, Stress
Clinical narrative: Rheumatoid arthritis flare up; Fatigue; Stress; Pain in arm/sore arm;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA) (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "Rheumatoid arthritis flare up"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; STRESS (non-serious), outcome "unknown", described as "Stress"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Pain in arm/sore arm". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of fatigue was not provided. The reporter's causality for the event(s) of Rheumatoid Arthritis flare and pain in arm/sore arm and stressed with Humira (Adalimumab) was no reasonable possibility. Causality for Pfizer biontech covid-19 vaccine(Tozinameran) The reporter's causality for the event(s) of Fatigue and pain in arm/sore arm was possible, Stress and Rheumatoid arthritis flare up was not reported.  Clinical course: Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. She received COVID-19 Vaccine manufactured by Pfizer, Biontech.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information, there is reasonable possibility of causal association between the events PAIN IN EXTREMITY, Fatigue, Stress, Rheumatoid arthritis and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date=11Jan2022/covid test result=Positive; covid test date=11Jan2022/covid test result=Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 18:30 (Lot number: 3302680) at the age of 29 years as dose 2, single and administered in arm left, administration date 26Oct2021 18:45 (Lot number: 320308D) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Feb2020 (unspecified if ongoing), notes: if covid prior vaccination: Yes, Already had COVID-19 in Feb2020, with antibodies in T-cells, prior to vaccination. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "covid test date=11Jan2022/covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Nasal Swab.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store.Prior to vaccination, the patient was diagnosed with COVID-19.Device Date : 14Jan2022  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: covid test result: Positive; covid test result: Positive; dose Number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FF2589) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "covid test result: Positive". The event "covid test result: positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive. Therapeutic measures were taken as a result of covid-19. 09Jan2022 cough and really bad body aches and asthma dx seen by PCP 10Jan2022 and given 20 mg PDN daily as well as Albuterol known asthma. Prior to vaccination, unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID- 19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Immunisation, Drug ineffective, Covid-19 and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: lymph nodes are swollen; the whole side of her body is very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant), outcome "unknown", described as "lymph nodes are swollen"; PAIN (non-serious), outcome "unknown", described as "the whole side of her body is very sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood testosterone decreased, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 28 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 13Jan2021 09:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low testosterone", start date: 27Jan2021 (ongoing); "Skin disorder" (unspecified if ongoing). Family history included: "Low testosterone" (unspecified if ongoing), notes: Low testosterone, Father. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 25Sep2021; DEPO-TESTOSTERONE taken for blood testosterone decreased, start date: Jan2021 (ongoing); DEXAMETHASONE taken for surgery, start date: 29Dec2021, stop date: 29Dec2021; HYDROCODONE/ACETAMINOPHEN taken for pain, start date: 30Dec2021, stop date: 01Jan2022; IBUPROFEN taken for pain, start date: 30Dec2021, stop date: 06Jan2022; ONDANSETRON/ ZOFRAN taken for nausea, start date: 30Dec2021, stop date: 30Dec2021; CEFADROXIL taken for infection prophylaxis, start date: 31Dec2021, stop date: 07Jan2022; MUCINEX FAST MAX SEVERE CONGESTION AND COUGH taken for cough, start date: 31Dec2021, stop date: 07Jan2022; RETIN-A taken for skin disorder, start date: 2018 (ongoing); HUMAN CHORIONIC GONADOTROPIN taken for blood testosterone decreased, start date: Jan2021 (ongoing).The following information was reported: BLOOD TESTOSTERONE DECREASED (non serious) with onset 27Jan2021, outcome "unknown", described as "Low testosterone". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) negative; (04Jan2022) positive, notes: N/A; (04Jan2022) positive, notes: Second confirmatory positive test; (07Jan2022) positive, notes: N/A; (08Jan2022) positive, notes: N/A; (09Jan2022) negative, notes: N/A; (10Jan2022) negative, notes: Second confirmatory positive test. Therapeutic measures were taken as a result of blood testosterone decreased.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Neoplasm
Clinical narrative: marble sized lumps under her arm after the 1st shot; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM (non-serious) with onset 2021, outcome "unknown", described as "marble sized lumps under her arm after the 1st shot". The event "marble sized lumps under her arm after the 1st shot" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information:Calling about the Covid 19 Vaccine. Caller states that she got the shot last Mar and Apr. She got marble sized lumps under her arm after the 1st shot, and after the 2nd shot on 16Apr2021 she got a grapefruit sized lump and it's still there. States that she doesn't have any health insurance, but she did go to one doctor who looked at some cells under a microscope, and said that she didn't see any cancer or anything. Caller states that she has not had any blood tests done because she can't afford it. States that she has been trying to find information locally, and she has called the CDC but they just keep referring her to the internet. She has also been to the local health department, but this is the first time calling Pfizer. States that a friend of hers sent her something today talking about people that got lumps on their arms after getting the booster. It said she is 1 in 100 that got lumps after the 1st 2 shots. Caller explains that the lump got larger after the 2nd injection. Clarifies that she received both the 1st and 2nd dose in the same arm. States that the 2nd dose was significantly more painful. States that she is an anti-vaxxer, but she got the vaccine because she is a dog walker and was going to be around the children that owned the dogs and wanted to be responsible. States that when she got the 2nd dose, it started to burn and the pain went up and down her shoulder and then went over to her other shoulder and back. States that her husband got sick after his 2nd dose, but she did not.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Laboratory test, Neoplasm, Pain
Clinical narrative: after the 2nd shot on 16Apr2021 she got a grapefruit sized lump; 2nd dose was significantly more painful; It burned; the pain went up and down her shoulder, then went over to her other shoulder and back.; the pain went up and down her shoulder, then went over to her other shoulder and back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Mar2021, for COVID-19 immunization, reaction(s): "marble sized lumps under her arm after the 1st shot". The following information was reported: NEOPLASM (non-serious) with onset 2021, outcome "not recovered", described as "after the 2nd shot on 16Apr2021 she got a grapefruit sized lump"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "2nd dose was significantly more painful"; THERMAL BURN (non-serious) with onset 2021, outcome "not recovered", described as "It burned"; ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "the pain went up and down her shoulder, then went over to her other shoulder and back.". The events "after the 2nd shot on 16apr2021 she got a grapefruit sized lump", "2nd dose was significantly more painful", "it burned", "the pain went up and down her shoulder, then went over to her other shoulder and back." and "the pain went up and down her shoulder, then went over to her other shoulder and back." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller states that she got the shot last Mar and Apr. She got marble sized lumps under her arm after the 1st shot, and after the 2nd shot on 16Apr2021 she got a grapefruit sized lump and it's still there. States that she doesn't have any health insurance, but she did go to one doctor who looked at some cells under a microscope, and said that she didn't see any cancer or anything. Caller states that she has not had any blood tests done because she can't afford it. Caller explains that the lump got larger after the 2nd injection. States that the 2nd dose was significantly more painful. States that when she got the 2nd dose, it started to burn and the pain went up and down her shoulder and then went over to her other shoulder and back. States that her husband got sick after his 2nd dose, but she did not. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Thermal burn
Clinical narrative: after the 2nd shot on 16Apr2021 she got a grapefruit sized lump; 2nd dose was significantly more painful; It burned; the pain went up and down her shoulder, then went over to her other shoulder and back.; the pain went up and down her shoulder, then went over to her other shoulder and back.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 16Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Mar2021, for COVID-19 immunization, reaction(s): "marble sized lumps under her arm after the 1st shot". The following information was reported: NEOPLASM (non-serious) with onset 2021, outcome "not recovered", described as "after the 2nd shot on 16Apr2021 she got a grapefruit sized lump"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "2nd dose was significantly more painful"; THERMAL BURN (non-serious) with onset 2021, outcome "not recovered", described as "It burned"; ARTHRALGIA (non-serious), BACK PAIN (non-serious) all with onset 2021, outcome "not recovered" and all described as "the pain went up and down her shoulder, then went over to her other shoulder and back.". The events "after the 2nd shot on 16apr2021 she got a grapefruit sized lump", "2nd dose was significantly more painful", "it burned", "the pain went up and down her shoulder, then went over to her other shoulder and back." and "the pain went up and down her shoulder, then went over to her other shoulder and back." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller states that she got the shot last Mar and Apr. She got marble sized lumps under her arm after the 1st shot, and after the 2nd shot on 16Apr2021 she got a grapefruit sized lump and it's still there. States that she doesn't have any health insurance, but she did go to one doctor who looked at some cells under a microscope, and said that she didn't see any cancer or anything. Caller states that she has not had any blood tests done because she can't afford it. Caller explains that the lump got larger after the 2nd injection. States that the 2nd dose was significantly more painful. States that when she got the 2nd dose, it started to burn and the pain went up and down her shoulder and then went over to her other shoulder and back. States that her husband got sick after his 2nd dose, but she did not. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest, Immunisation, Myocardial infarction
Clinical narrative: booster; cardiac arrest; heart attacks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: IMMUNISATION (Death, medically significant), outcome "unknown", described as "booster"; CARDIAC ARREST (death, Medically significant), outcome "fatal", described as "cardiac arrest"; MYOCARDIAL INFARCTION (death, Medically significant), outcome "fatal", described as "heart attacks". The patient date of death was unknown. The reported cause of death was cardiac arrest, myocardial infarction. It was not reported if an autopsy was performed. Clinical course: Reporter friend after he received the booster shot he has passed away now. No heart complications, he had no heart issues at all, perfectly healthy and died of cardiac arrest after suffering multiple heart attacks in the hospital (further clarification unknown) with no heart history at all, young and healthy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cardiac arrest; heart attacks
Sex: F
Vaccine: COVID19
Symptoms: Crying, Hormone level abnormal, Menstrual disorder
Clinical narrative: Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying; Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying; Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), HORMONE LEVEL ABNORMAL (non-serious), CRYING (non-serious), outcome "unknown" and all described as "Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying". Additional Information: Patient menstrual cycle and hormones were severely impacted to the point of uncontrollable crying. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted COVID-19.; Contracted COVID-19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 13May2021 (Lot number: EW0167) as dose 2, single and administration date 22Apr2021 (Lot number: EW0175) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 18Jan2022, outcome "unknown" and all described as "Contracted COVID-19.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: Nasal Swab.  Clinical Course : Patient did not received other vaccine with in four weeks of covid vaccine. Patient did not have covid prior to vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, SARS-CoV-2 test
Clinical narrative: Shortness of breath; Tested positive to COVID; Tested positive to COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Lung disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Tested positive to COVID"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive. Caller mentioned her daughter tested positive to COVID in a over the counter test that she took on Saturday 15Jan2022. Caller mentioned she was exposed to her on Friday 14Jan2022. Caller asked how long should she quarantine for since the dates were always changing. Caller stated she had no symptoms, but shortness of breath, however she specified that she had a lung disease and this was not a new symptom for her.  Follow-up attempts have been completed and no further information is expected.