chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19 on 12Aug2021/he got tested positive for covid after getting the first dose/felt sick; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX Support. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Arm Left on 01Aug2021 17:30 (at the age of 40-years-old) as dose 1, single for Covid-19 immunization. No Patient history reported and Family history included diabetics- Reporter states his parents are diabetics. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with Covid-19. On 12Aug2021, the patient tested positive for Covid 19 on 12Aug2021/he got tested positive for covid after getting the first dose. Reporter states he tested positive for covid last week on Thursday 12Aug2021 and states he had the first dose of the Pfizer Covid vaccine administered to his left arm on 01Aug2021 and his patient card has lot number EW0169 and states there is not an expiry date or NDC written on the card. Reporter states he had no treatment but just stayed home. The patient underwent lab tests and procedures which included Covid-19 test: positive on 12Aug2021. The outcome of the event was unknown.  Follow-Up (20Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored Program. A 34-year-old female patient (consumer) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Aug2021 (age at the time of vaccination was not reported), as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Aug2021 (reported 17 days after vaccination), she patient experienced headache. The patient received the first dose 17 days ago and has had a headache ever since. She asked if this was normal. The outcome of the event was reported as unknown.  Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: passed away of COVID19; passed away of COVID19; This is a spontaneous report from a contactable consumer (patient's son). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included a little overweight but she was not big. The patient's concomitant medications were not reported. The patient had the COVID vaccine and she recently passed away of COVID19. Patient got tested for Covid-19 on 25Jul2021 and was negative at that time. But then 3 days to 4 days later (Jul2021) she was sick and he had to call the ambulance, that was on a Monday going into Tuesday morning, 27Jul2021 or so and she was admitted to the hospital with COVID. Then 3 days later patient stopped texting and answering and she passed away on 18Aug2021. Covid-19 tested positive in Jul2021. Reporter seriousness for COVID-19 was death. The outcome of the events was fatal. The patient died on 18Aug2021.  It was not reported if an autopsy was performed.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away of COVID19; passed away of COVID19
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Delayed Anaphalaxsis; This is a spontaneous report from a contactable consumer. A 17-year-old male patient (reporter's son) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an unspecified route of administration, administered in arm left on 15Aug2021 13:45 at the age of 17 years old, as single dose for covid-19 immunisation. Medical history included seasonal allergies (non medicated), covid-19, ADD (attention deficit hyperactivity disorder, non medicated). There were no concomitant medications. There was no other vaccine in four weeks or other medications in two weeks. The patient experienced delayed anaphalaxsis on 16Aug2021 17:45. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment Epi, IM Benadryl, IM Steroid IM anxiolytic, IV fluids was received for the event. The outcome of the event was recovering. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, at 67-year-old, as single dose(Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination the patient had not been diagnosed with COVID-19. It was unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. On 10Aug2021, the patient was tested positive for COVID. This event resulted in emergency room/department or urgent care and hospitalization, and the patient died. The patient got hospitalization for 7days from 10Aug2021 to 17Aug2021. The patient was on a ventilator for 5 days and died last night( on 17Aug2021). The outcome of events was fatal. It was unknown if an autopsy was performed.  The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: COVID; COVID
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clot  in left calf; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 03May2021 10:00 (Lot Number: EW0173) as dose 2, single at the age of 36-year-old for covid-19 immunization. No known allergies. No other medical history. No concomitant medications. No other medications in two weeks. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in left arm on 12Apr2021 11:00 (Lot Number: ER8731) as dose 1, single at the age of 36-year-old for covid-19 immunization. The patient experienced blood clot in left calf on 14Aug2021 08:00 and diagnosed on 16Aug2021. The aeriousness of event was hospitalized for 2 days (no hospitalization prolonged) and life threatening illness (immediate risk of death from the event). The patient underwent lab tests and procedures which included PCR -Nasal Swab: unknown results on 18Aug2021. Therapeutic measures were taken as a result of blood clot in left calf which included blood thinner. This event resulted in emergency room visit and physician office visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient had been tested for COVID-19. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest X-ray, Chest pain, Electrocardiogram, Inspiratory capacity
Clinical narrative: chest pain, which describes as a pressure between sternum and clavicle; impaired inspiration secondary to pain; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER COVID 19 VACCINE; solution for injection, lot number was not reported), via an unspecified route of administration, on an unspecified date, at dose number unknown, single for covid-19 immunization. Medical history included the patient is smoker. The patient's concomitant medications were not reported. The patient experienced chest pain, which describes as a pressure between sternum and clavicle since the vaccination and after the vaccination. The patient underwent lab tests and procedures which included stress test, chest x-ray, electrocardiogram with no abnormal findings and impaired inspiration secondary to pain on an unspecified date.  The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: chest pain, which describes as a pressure between sternum and clavicle; impaired inspiration secondary to pain; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER COVID 19 VACCINE; solution for injection, lot number was not reported), via an unspecified route of administration, on an unspecified date, at dose number unknown, single for covid-19 immunization. Medical history included the patient is smoker. The patient's concomitant medications were not reported. The patient experienced chest pain, which describes as a pressure between sternum and clavicle since the vaccination and after the vaccination. The patient underwent lab tests and procedures which included stress test, chest x-ray, electrocardiogram with no abnormal findings and impaired inspiration secondary to pain on an unspecified date.  The 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: Vaccination site abscess, Vaccination site mass
Clinical narrative: huge lump under the shot that came up on arm; feels like I have an abscess under there; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 18Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in 2021, as single dose for COVID-19 immunization. The patient stated that after receiving second dose of vaccine on 19Aug2021 she experienced huge lump under the shot that came up on arm and feels like she has an abscess under there. The reporter stated that her husband and she got their second dose of the Pfizer BioNTech covid vaccine yesterday on 18Aug2021 and she am having problems. When they got there, they were going to give her a dose of the Moderna, her husband witnessed it, so they went somewhere else and got the Pfizer dose. On next day she had a huge lump under the shot that came up on her arm and stated that it feels like she has an abscess under there. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Feeling abnormal
Clinical narrative: not feeling well; not feeling well; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 09Apr2021 as DOSE 2, SINGLE (at the age of 83-years-old) for covid-19 immunisation. The patient's medical history included hypertension, drug hypersensitivity (allergic to Penicillin). The patient's concomitant medications included lisinopril (LISINOPRIL) taken for blood pressure measurement. The patient had hip surgery 11 years earlier and was now an inch shorter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter's brother died after getting the second shot. It was reported that, the patient was not feeling well and the reporter talked to him on the 07Apr2021 and then on 11Apr2021. The patient didn't complain and didn't sound well and didn't feel well when the reporter spoke to him. By 15Apr2021 the patient died. It appears the patient had some kind of reaction to the vaccine. The patient was well before he took any vaccines. The patient had his blood pressure under control, low cholesterol, and walked every day. The reporter tried to get an autopsy but was unable because of the condition of the body. The reporter had a welfare check done on the patient on 06May2021 and that's when they found his body in his home. The patient was alive until the 15Apr2021. The reporter knew this because the patient wrote on his calendar daily but it abruptly stopped on 15Apr2021. They did not have the official cause of death for the patient, the reporter will have to look at the patient's death certificate. Everything about the patient was healthy and had his blood pressure under control for a while. The patient died on 15Apr2021. An autopsy was not performed. The outcome of the patient was reported as fatal.  Information about Lot/Batch number has been requested.; Reported Cause(s) of Death: not feeling well
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Taste disorder, Vaccination failure
Clinical narrative: little trouble with taste; positive COVID test; positive COVID test; This is a spontaneous report from Pfizer-sponsored program via contactable consumer or other non hcp. A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL3249), (age 58-year at the time of vaccination) via an unspecified route of administration, administered in Arm Right on 20Jan2021 14:00 as dose 1, and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9267), via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 as dose 2, single for COVID-19 immunization at hospital. Medical history included diabetes mellitus from 2011 to an unknown date Verbatim: Diabetes (Additional Information for Other Conditions: from 10 years), hypertension from 2011 to an unknown date (Verbatim: Blood pressure high Additional Information for Other Conditions: from 10 years). There were no concomitant medication reported. Prior vaccinations within 4 weeks was reported as none. The patient experienced positive covid test on 26Jul2021, little trouble with taste on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 26Jul2021 (More information available (Y/N): NO), sars-cov-2 test was negative on 05Aug2021 (More information available (Y/N): NO). AE(s) following prior vaccinations were none. Description of complaint: Consumer reporting an AE/PC for the Pfizer COVID 19 vaccine; reports she has been fully vaccinated with the Pfizer COVID 19 vaccine in Jan2021 and then tested positive for COVID on 26Jul2021. The outcome of the event positive covid test was recovered on unspecified date 2021 and the event little trouble with taste was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer Covid-19 vaccine on 02AUG2021 and was diagnosed with Covid-19 on 12AUG2021; fever for the past three days/ran a temperature for 7 days with a cough; ran a temperature for 7 days with a cough; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0170), dose 1 via an unspecified route of administration on 02Aug2021 (Age at vaccination: 62 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine on 02aug2021 and was diagnosed with covid-19 on 12aug2021 (covid-19), fever for the past three days and ran a temperature for 7 days with a cough in Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 12Aug2021. Reporter received the first dose of the Pfizer Covid-19 vaccine on 02Aug2021 and was diagnosed with Covid-19 on 12Aug2021 (caller stated "we got the vaccine" but did not specify the other person or persons). Reporter stated that she was previously running a fever but has no complaints of fever for the past three days. She was scheduled to get her second dose of the Pfizer Covid-19 vaccine on 25Aug2021. She was asking "should we get our second dose" of the Pfizer Covid-19 vaccine. The outcome of the event received the first dose of the pfizer covid-19 vaccine on 02aug2021 and was diagnosed with covid-19 on 12aug2021 (covid-19), ran a temperature for 7 days with a cough was unknown. The outcome of fever for the past three days was recovered in Aug2021.  Follow-up (19Aug2021): This is a follow-up spontaneous report from Pfizer Sponsored Pro-gram. Reporter says she and her husband got their first dose of the Pfizer COVID-19 vaccine on 02Aug2021, then they both tested positive on 12Aug2021 which is merge in above as combine follow up.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Photosensitivity reaction, Pruritus, Scratch
Clinical narrative: scratch and bleed; severe itching with sun exposure that started around the time of his second dose of the Pfizer BioNTech Covid-19 Vaccine/severe itching on his arms, neck, and legs within 15 minutes of sun exposure; severe itching with sun exposure that started around the time of his second dose of the Pfizer BioNTech Covid-19 Vaccine; scratch and bleed; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via unspecified route of administration on 02Feb2021 (age at the time of vaccination 72-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Patient had previously received first dose of BNT162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via unspecified route of administration on unspecified date (at age of 72-years-old) as single dose for COVID-19 immunisation and no adverse event was observed. On an unspecified date in 2021, the patient had severe itching with sun exposure that started around the time of his second dose of vaccine. Severe itching on his arms, neck, and legs within 15 minutes of sun exposure and not accompanying rash with the itching, but it itches so badly that he scratches and bleed. Patient can't pinpoint when exactly first started having this issue, but it dawned on him later that it could have been around the time of second shot. The timing seems to coincide. Patient saw a dermatologist in May2021 or Jun2021 about this and her opinion was that it was related to vaccine, but she believed it would go away on its own, and it had not. Patient did not yet reach out to his primary care physician, but he intends on consulting a different dermatologist as well and don't think it was definite that the vaccine did cause this. Patient stated, if this was permanent, he was prepared to live with it and stay out of the sun and wear SPF clothing and so forth, can deal with that and were to be able to do this all over again knowing this would happen, would still take the vaccine and would much rather have this than get severely ill or die from COVID. The patient stated that he will probably take the booster dose anyway. Even if he got a similar reaction it couldn't be much worse than what he had now. The outcome of events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Ocular hyperaemia, Pyrexia, Rash erythematous
Clinical narrative: experiencing fever; chest pains; difficulty breathing; painful red rash on body; red eyes; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (Pfizer COVID Vaccine), dose 2 via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient experienced experiencing fever, chest pains, difficulty breathing, painful red rash on body and limbs, red eyes early Monday morning on 16Aug2021. The patient was hospitalized for events from Aug2021. The outcome of 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: COVID-19, Drug ineffective
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non HCP. This consumer (patient) reported for himself that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: 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. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced tested positive for covid-19. The event was serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Event took place after use of product. The clinical outcome of 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, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non HCP. This consumer reported similar events for 37 patients. This report is for 7th patient of 37 patients. A 71-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL9266, expiry date was unknown), via an unspecified route of administration on 23Feb2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318, expiry date was unknown), via an unspecified route of administration, at an unknown administration site on 28Jan2021 as dose 1, single for covid-19 immunization, at physician's office. The patient medical history was not reported. The patient's concomitant medications were not reported. It was stated that, on 16Jul2021, the patient was tested positive for covid virus, after being fully vaccinated. Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Jul2021. The outcome of the event was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (BNT1 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EJ1686 and expiration date was not reported), dose 1 via an unspecified route of administration on 16Jan2021 as a single dose and dose 2 via an unspecified route of administration on 06Feb2021 (Lot Number: EN5318 and expiration date was not reported) as a single dose for covid-19 immunization. Medical history included ongoing Rheumatoid arthritis from unknown to ongoing. The patient's concomitant medications were not reported. On 27Jul2021, the patient experienced tested positive for covid virus, after being fully vaccinated (vaccination failure) and (sars-cov-2 test positive). The event was serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: positive (tested positive for Covid) on 27Jul2021. The outcome of all the events was unknown.  Follow-up (23Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer reported for 37 patients. This case is for 11th patient of 37 patients.  A 64-years-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 23Jan2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: EL9266) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes mellitus. The patient's concomitant medications were not reported. On 26Jul2021 the patient experienced tested positive for covid virus, after being fully vaccinated. Caller states that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Jul2021. Outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot Number: EN5318)), dose 1 via an unspecified route of administration on 26Jan2021 as dose 1, single, dose 2 via an unspecified route of administration on 22Feb2021 (Batch/Lot Number: EL9266) as dose 2, single (age at vaccination 57-year-old) for COVID-19 immunisation. The patient's medical history included ongoing hypertension and diabetes mellitus. The patient's concomitant medications were not reported. The patient experienced tested positive for covid virus, after being fully vaccinated on 28Jul2021. She states they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. Caller states that Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 28Jul2021. The outcome for all events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ event for different patients
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Circumstance or information capable of leading to medication error, Product use issue, SARS-CoV-2 test
Clinical narrative: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6203) via an unspecified route of administration on 23Feb2021 as DOSE 2, SINGLE, and first dose via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Aug2021, the patient tested positive for covid virus, after being fully vaccinated. It was reported that, patient has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. Reporter reclarified later in report that 15% of the breakthrough cases in her county had the same lot number, which was concerning. Reporter stated, she has 37 patients with partial identifiers. She cannot provide some identifying details and that she would need to check with her legal department first. Reporter provided the details she was allowed to identify. Reporter stated she can provide, age, gender, BMI, medical conditions, if reported, and date they tested positive for Covid, and the type of covid test utilized, she cannot provide the zip code. The patient underwent lab tests and procedures which included body mass index: 20 on 01Aug2021  and sars-cov-2 test: positive on 01Aug2021. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6203) via an unspecified route of administration on 23Feb2021 as DOSE 2, SINGLE, and first dose via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Aug2021, the patient tested positive for covid virus, after being fully vaccinated. It was reported that, patient has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. Reporter reclarified later in report that 15% of the breakthrough cases in her county had the same lot number, which was concerning. Reporter stated, she has 37 patients with partial identifiers. She cannot provide some identifying details and that she would need to check with her legal department first. Reporter provided the details she was allowed to identify. Reporter stated she can provide, age, gender, BMI, medical conditions, if reported, and date they tested positive for Covid, and the type of covid test utilized, she cannot provide the zip code. The patient underwent lab tests and procedures which included body mass index: 20 on 01Aug2021  and sars-cov-2 test: positive on 01Aug2021. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient tested positive for Covid virus, after being fully vaccinated; patient tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. This case is for 21st patient of 37 patients. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6203) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unspecified date to ongoing. The patient concomitant medications were not reported. The patient tested positive for Covid virus, after being fully vaccinated on 01Aug2021. The reporter stated they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Caller stated she has 37 patients with partial identifiers. Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The patient underwent lab tests and procedures which included NAAT Covid test (sars-cov-2 test): positive on 01Aug2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Testing positive for Covid virus, after both vaccines; Testing positive for Covid virus, after both vaccines; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 37 patients. This report is for 25th of 37 reports. A 71-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was not provided) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EJ1685) as DOSE 1, SINGLE for covid-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-CoV-2 infection on 02Aug2021. The reporter stated they were monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The reporter at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information. Reporter stated, reclarified later in report, she had 37 patients with partial identifiers, stated she could not provide some identifying details and that she would need to check with her legal department first. Reporter stated that Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. Description of complaint: Reporter was reporting on the Pfizer Covid 19 vaccine, reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. Some identifying details provided. Product strength and count size dispensed: not applicable. The patient underwent lab tests and procedures which included PCR Covid test (Sars-Cov-2 test): positive on 02Aug2021. The outcome of the events was unknown.  Information about lot/ batch number is available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Master case, same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Caller states that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses.; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from contactable consumer. This consumer reported similar events for 37 patients. This report is for 28th patient of 37 patients. A 38-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318, expiry date was unknown), via an unspecified route of administration on 13May2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318, expiry date was unknown), via an unspecified route of administration, at an unknown administration site on 22Apr2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was stated that, on 09Aug2021, the patient was tested positive for covid virus, after being fully vaccinated. Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included body mass index: 32.4 on an unspecified date, sars-cov-2 test: positive on 09Aug2021. There was an investigation assessment, and a product complaint was initiated. The outcome of the event was unknown at the time of report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Vaccination failure
Clinical narrative: Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This report is for 36th patient of 37 patients. This consumer reported for a 72-year-old male patient that:  A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318, Expiration date was not reported), dose 2 via an unspecified route of administration on 06Feb2021 as dose 2, single for covid-19 immunisation. Medical history included renal cancer from an unknown date and ongoing. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EJ1686, On 16Jan2021 for covid-19 immunization. The patient experienced tested positive for covid virus, after being fully vaccinated on 12Aug2021. Agent reports that Caller states 15% of breakthrough cases are from one Pfizer Covid 19 Lot number: EN5318.which was concerning. Covid positive is defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Description of complaint: Caller reporting on the Pfizer Covid 19 vaccine. Caller reports 37 breakthrough cases, for fully vaccinated patients testing positive for Covid.  Some identifying details provided. Product strength and count size dispensed: not applicable. Additional lot numbers: not applicable. Is a sample of the product available to be returned, if requested (Y/N): No, Packaging sealed and intact: unknown. The patient underwent lab tests and procedures which included body mass index was 29.8, NAAT Covid test was positive on 12Aug2021. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Irregular pain on the left side of chest; This is a spontaneous report from a contactable consumer via a company representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 as dose number unknown, single for covid-19 immunization.  Medical history included chest pain occasionally occur with her anxiety.  The patient's concomitant medications were not reported. Patient experienced irregular pain on the left side of chest in Aug2021. It was reported that the chest pain occasionally occur with her anxiety but the patient had the Covid vaccine over the last weekend and had heard of Cardiomyopathy side effect. The event chest pain has occurred prior to taking provost as a result of anxiety. The outcome of the event 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, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer reported events for three patients. This is the second of three reports. This report is for the son's friend.  A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration in 2021 (Batch/Lot number unknown) as a single dose; second dose via an unspecified route of administration in 2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient got COVID after getting the Pfizer vaccine. The patient tested positive for COVID-19 in 2021. The consumer thinks the patient got the Pfizer one, but was not 100% sure.  It was about 4 months ago. The outcome of the events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (parent) via Pfizer-sponsored program (program name not reported). A 16-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection, lot#, expiration date not reported), via an unspecified route of administration, on Aug 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On a week before the time of report, patient had the vaccination. About 24 hours later, she experienced a rash in armpit. It turned out as shingles on Aug 2021. The patient visited the doctor on the day before the time of report, because the rash was not getting any better. The outcome of the events: not recovered. The lot number for the vaccine BNT162B2: not provided and will be requested during follow-up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal
Clinical narrative: Got vaccine on Tuesday and following Sunday feel bad and had chest pain; Got vaccine on Tuesday and following Sunday feel bad and had chest pain; This is a spontaneous report from a contactable consumer (patient).  A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 29Jun2021 13:00 (Batch/Lot number was not reported), age at vaccination of 64-years-old, as single dose, for covid-19 immunisation.  Medical history was none.  The patient was not pregnant and was not pregnant at the time of vaccination   The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced got vaccine on Tuesday and following Sunday on 04Jul2021 14:00 she felt bad and had chest pain. The events resulted in Emergency room/department or urgent care, Hospitalization (2 Days Hospitalization). It was unknown if treatments were given. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The 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: 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 Pfizer-sponsored program. A contactable female consumer (patient) an unspecified age reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient tested positive for Covid on 13Aug2021. The patient missed her scheduled second dose (yesterday), on 19Aug2021. The patient wanted to know how and when she could get her second dose. The patient declined to make a report. Stated she was just trying to get information and had been on the phone awhile now. She was asking if making this call will prevent her from getting the 2nd dose. The patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID test): positive on 13Aug2021. Investigation assessment was not reported. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough positive case of COVID-19; Breakthrough positive case of COVID-19; This is a spontaneous report from a contactable consumer (patient, self-reported). A 25-Years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via an unspecified route of administration, in Right arm, on 16Feb2021 at 10:00 AM (age at vaccination: 25 years), as a single dose for COVID-19 immunization at workplace clinic. The patient's medical history was not reported. The patient did not have known allergies. Concomitant medications included iron, plantago ovata fibre (FIBER SUPPLEMENT), and emtricitabine, tenofovir disoproxil fumarate (TRUVADA). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN 5318 and expiry date was not reported), via an unspecified route of administration, in Right arm, on 26Jan2021 at 10:00 AM (age at vaccination: 25 years), as a single dose for COVID-19 immunization at workplace clinic. The patient did not received any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. On 20Aug2021 at 11:00 AM, the patient had breakthrough positive case of COVID-19. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included COVID-19 Antigen test: positive (Nasal Swab) on 20Aug2021. Outcome of the events was recovering.