chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Fatigue, Headache
Clinical narrative: The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; States she had no energy. She was in bed really sick; States she had no energy. She was in bed really sick; still tired; she still has Covid because she feels stuffy; Covid 19 after three doses of Pfizer Covid Vaccine; Covid 19 after three doses of Pfizer Covid Vaccine; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Lot number: FH8020) at the age of 63 years as dose 3, (booster) single, administration date 16Mar2021 (Lot number: FN6199) as dose 1, single and administration date 06Apr2021 (Lot number: FR8737) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 11Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Covid 19 after three doses of Pfizer Covid Vaccine"; COUGH (non-serious), OROPHARYNGEAL PAIN (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having"; ASTHENIA (non-serious), ILLNESS (non-serious), outcome "recovered" and all described as "States she had no energy. She was in bed really sick"; FATIGUE (non-serious), outcome "not recovered", described as "still tired"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "she still has Covid because she feels stuffy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; States she had no energy. She was in bed really sick; States she had no energy. She was in bed really sick; still tired; she still has Covid because she feels stuffy; Covid 19 after three doses of Pfizer Covid Vaccine; Covid 19 after three doses of Pfizer Covid Vaccine; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Lot number: FH8020) at the age of 63 years as dose 3, (booster) single, administration date 16Mar2021 (Lot number: FN6199) as dose 1, single and administration date 06Apr2021 (Lot number: FR8737) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 11Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Covid 19 after three doses of Pfizer Covid Vaccine"; COUGH (non-serious), OROPHARYNGEAL PAIN (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having"; ASTHENIA (non-serious), ILLNESS (non-serious), outcome "recovered" and all described as "States she had no energy. She was in bed really sick"; FATIGUE (non-serious), outcome "not recovered", described as "still tired"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "she still has Covid because she feels stuffy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having; States she had no energy. She was in bed really sick; States she had no energy. She was in bed really sick; still tired; she still has Covid because she feels stuffy; Covid 19 after three doses of Pfizer Covid Vaccine; Covid 19 after three doses of Pfizer Covid Vaccine; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 11Oct2021 (Lot number: FH8020) at the age of 63 years as dose 3, (booster) single, administration date 16Mar2021 (Lot number: FN6199) as dose 1, single and administration date 06Apr2021 (Lot number: FR8737) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 11Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Jan2022, outcome "unknown" and all described as "Covid 19 after three doses of Pfizer Covid Vaccine"; COUGH (non-serious), OROPHARYNGEAL PAIN (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "The caller mentioned that they are both feeling better, no longer coughing, no sore throat or headache like they were having"; ASTHENIA (non-serious), ILLNESS (non-serious), outcome "recovered" and all described as "States she had no energy. She was in bed really sick"; FATIGUE (non-serious), outcome "not recovered", described as "still tired"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "she still has Covid because she feels stuffy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: tested on 31Dec2021 and was positive; tested on 31Dec2021 and was positive; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset Sep2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "tested on 31Dec2021 and was positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) negative; (03Jan2022) negative; (31Dec2021) positive. It was reported that, the patient (caller's husband) has been vaccinated with Pfizer COVID 19 vaccine initial series and booster dose the end of Sep2021. Stated that, he began feeling tired but had no other symptoms. The patient was tested on 31Dec2021 and was positive. He was tested again on 03Jan2022 and was negative, as well as negative when tested on 06Jan2022. Enquired, if someone did test positive for Covid-19, they had to wait 3 months before getting a vaccine, was that right. The reporter details (reporter postal code and state) were added. The caller (name) mentioned that, patient (her husband) got tested positive and has no symptoms. The caller mentioned as well that, they took 2 Covid-19 tests and the result was negative. Any unaddressed medical questions referred or forwarded to Medical Information was reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia
Clinical narrative: her joint pain increase with covid vaccine; This is a spontaneous report received from contactable reporter (Other HCP).  A 56 year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), since 30Sep2021 (Batch/Lot number: unknown) at 11 mg. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "her joint pain increase with covid vaccine". The action taken for tofacitinib citrate was unknown.  The lot number for bnt162b2, tofacitinib citrate was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive/covid test result=Positive; Tested positive / covid test result=Positive; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 12:00 (Lot number: 3302500) at the age of 64 years as dose 3 (booster), single, administered in arm left, administration date 25Mar2021 12:00 (Lot number: EP6955) as dose 2, single and administered in arm left, administration date 04Mar2021 12:00 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. Relevant medical history included: "A fib" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; APIXABAN; FLECAINIDE. The following information was reported: IMMUNISATION (medically significant) with onset 11Jan2022 12:00, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant) with onset 17Jan2022, outcome "unknown", described as "Tested positive/covid test result=Positive"; COVID-19 (medically significant) with onset 17Jan2022, outcome "recovering", described as "Tested positive / covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Clinical Course: No other vaccine in four weeks. No covid prior vaccination. Tested covid positive post vaccination  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE, IMMUNISATION, COVID 19 and the suspect drug BNT162B2.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Cough; Sore throat; PCR test positive in Jan2022; PCR test positive in Jan2022; 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 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Sep2021 (Lot number: EW0196) at the age of 37 years as dose 2, single and administration date 17Aug2021 (Lot number: EW0196) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "PCR test positive in Jan2022"; COUGH (non-serious) with onset 14Jan2022, outcome "unknown", described as "Cough"; OROPHARYNGEAL PAIN (non-serious) with onset 14Jan2022, outcome "unknown", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: PCR test positive in Jan2022. Therapeutic measures were not taken as a result of vaccination failure, covid-19, cough, oropharyngeal pain.  Clinical course: No treatment for AE (adverse event), no COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Immunisation, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: covid test date: 11Jan2022 / covid test result: Positive; covid test date: 11Jan2022 / covid test result: Positive; sore throat; sinus headache; dry cough; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 19:15 (Lot number: FH8020) at the age of 60 years as dose 3 (booster), single, administered in arm left, administration date 23Feb2021 16:15 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 04Feb2021 10:30 (Lot number: EL3247) as dose 1, single for covid-19 immunisation at pharmacy or Drug Store. The patient had no relevant medical history. There were no concomitant medications. Known allergies: none. Other vaccine in four weeks: No. Other medications in two weeks: none. Covid prior vaccination: No and covid tested post vaccination: Yes. The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021 19:15, outcome "unknown", described as "dose number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "covid test date: 11Jan2022 / covid test result: Positive"; OROPHARYNGEAL PAIN (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "sore throat"; SINUS HEADACHE (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "sinus headache"; COUGH (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "dry cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Other. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain, sinus headache, cough.; Reporter's Comments; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events immunization, vaccination failure and covid-19 and BNT162B2.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus headache, Vaccination failure
Clinical narrative: covid test date: 11Jan2022 / covid test result: Positive; covid test date: 11Jan2022 / covid test result: Positive; sore throat; sinus headache; dry cough; dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 19:15 (Lot number: FH8020) at the age of 60 years as dose 3 (booster), single, administered in arm left, administration date 23Feb2021 16:15 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date 04Feb2021 10:30 (Lot number: EL3247) as dose 1, single for covid-19 immunisation at pharmacy or Drug Store. The patient had no relevant medical history. There were no concomitant medications. Known allergies: none. Other vaccine in four weeks: No. Other medications in two weeks: none. Covid prior vaccination: No and covid tested post vaccination: Yes. The following information was reported: IMMUNISATION (medically significant) with onset 09Nov2021 19:15, outcome "unknown", described as "dose number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "covid test date: 11Jan2022 / covid test result: Positive"; OROPHARYNGEAL PAIN (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "sore throat"; SINUS HEADACHE (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "sinus headache"; COUGH (non-serious) with onset 09Jan2022, outcome "recovered" (Jan2022), described as "dry cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive, notes: Other. Therapeutic measures were not taken as a result of covid-19, oropharyngeal pain, sinus headache, cough.; Reporter's Comments; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events immunization, vaccination failure and covid-19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: tested positive for Covid; tested positive for Covid; booster dose; 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 73 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "he had Covid" (unspecified if ongoing), notes: He had Covid 14 months ago and received a monoclonal infusion. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 16Jan2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive. The patient tested positive for Covid three days ago, who also received the Pfizer Covid-19 vaccines (2 dose series and a booster dose) over the last year.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fixed eruption, Gait inability, Impaired work ability, Pain
Clinical narrative: Diagnosed with "fixed drug eruption" by PCP. Painful and itchy erythematous patches on hands and feet. Lasted ~2 weeks, out of wokr because could not walk. Treated with benadryl and high dose steroids. Categorized as Type IV Hypersensitivity.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Diagnosed with "fixed drug eruption" by PCP. Painful and itchy erythematous patches on hands and feet. Lasted ~2 weeks, out of wokr because could not walk. Treated with benadryl and high dose steroids. Categorized as Type IV Hypersensitivity.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Pain, Product administered at inappropriate site, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA; been in pain 11 months; The vaccine was probably injected in the capsule of the joint; The patient is miserable.; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (005570).  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 was not reported. There were no concomitant medications. The following information was reported: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (non-serious), outcome "unknown", described as "SIRVA"; PAIN (non-serious), outcome "recovering", described as "been in pain 11 months"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "The vaccine was probably injected in the capsule of the joint"; DEPRESSED MOOD (non-serious), outcome "unknown", described as "The patient is miserable.". Therapeutic measures were taken as a result of shoulder injury related to vaccine administration, pain (The patient has had 3 steroid shots and a Medrol dose pack).  Additional information: Patient was suffering from this after getting the Pfizer covid 19 vaccine, she has been in pain for 11 months. The patient was a tall skinny person with skinny arms and the caller thinks the vaccine was injected in the capsule of the joint instead of the deltoid muscle. A couple of days after the dose, the patient started having pain and it got better. The patient has been working with an orthopaedic surgeon in doing therapy. The patient was miserable. The caller believes he reported this event to the CDC a few months ago but does not have a report number. Dates for Shoulder injury related to vaccine administration: (From: Unspecified To: Unspecified). Reporter seriousness for Shoulder injury related to vaccine administration: Unspecified. Reason for no lot number: of Pfizer covid 19 vaccine: Complainant hung up abruptly/transfer incomplete. Expiry date for the Covid-19 vaccine was not provided. Forwarded as an Adverse Event and Medical Inquiry by the Epsilon Escalation team on 19Jan2022. Reporter provided verification of contact address on 18Jan2022. CEP ID #5570 Subject: Patient Assistance, Customer Verbatim: Patient needs treatment options for post Pfizer vaccine SIRVA. Patient has been in pain for 11 months.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: he got Covid-19 2months after his 2nd PBCV purple cap formula shot; he got Covid-19 2months after his 2nd PBCV purple cap formula shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he got Covid-19 2months after his 2nd PBCV purple cap formula shot". The patient underwent the following laboratory tests and procedures: covid-19: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, Vaccination failure
Clinical narrative: Booster; COVID; have been fully vaccinated; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 (Lot number: FC3180) at the age of 49 years as dose 3 (booster), single, administered in arm left, administration date 08Apr2021 (Lot number: EW0151) as dose 2, single and administered in arm left, administration date 18Mar2021 (Lot number: EP7534) as dose 1, single for covid-19 immunisation. Indication: Nurse stated, "Ankylosing Spondylitis, it is also for my Ulcerative 'Proctitis', I mean it is helping both diseases (Further clarification Unknown hence not captured)."The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 16Aug2021, outcome "unknown", described as "Booster"; COVID-19 (medically significant) with onset 2021, outcome "unknown", described as "COVID"; DRUG INEFFECTIVE (medically significant) with onset 2021, outcome "unknown", described as "have been fully vaccinated".  She had a patient that is taking Xeljanz and she has COVID. Reassurance: Nurse stated, "No, I have been fully vaccinated (Pfizer COVID-19 Vaccine). I do not know if you guys want that info or not but including the booster." the first one is EP7534 and the second dose was EW0151 and the third was FC3180.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunization, Covid-19, Vaccination Failure and the suspect drug BNT162B2.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the first dose; tested positive with Covid; got the first dose; tested positive with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FK5618) at the age of 10 years 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "got the first dose; tested positive with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, sars-cov-2 test positive. It was reported that, reporter have her kids here got the first dose on 02Dec2021 and then 2 weeks ago they are tested positive with Covid. So she was wondering if is it okay to take the second dose. Reporter stated, it was for her kids. They are all between the age of 5 and 11 all four of them. They got their COVID shot on 02Dec201 and then they were due for their second dose but then they got Covid, tested positive for Covid on 03Jan2022 (Further clarification unknown). Reporter stated patient have not got the second test for it but they were positive on the 3rd. Reporter When probed if all the four patient received any Prior vaccination (4 weeks prior), Reporter stated as No. Other Patient suffering from any other medical conditions, Reporter stated, as No and stated they are pretty healthy. Reporter stated, They did take Tylenol medication when they had Covid all of them (Further clarification unknown), There is no other specific treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111074 same product and event, different patients
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Became sick/Positive with Covid-19 after being fully vaccinated; Became sick/Positive with Covid-19 after being fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 03Dec2021 (Lot number: FL0007) at the age of 6 years as dose 2, single and administered in arm right, administration date 10Nov2021 (Lot number: FK5127) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovering" and all described as "Became sick/Positive with Covid-19 after being fully vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.
Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Illness, Product administered to patient of inappropriate age
Clinical narrative: Became sick/Positive with Covid-19 after being fully vaccinated; Became sick/Positive with Covid-19 after being fully vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 03Dec2021 (Lot number: FL0007) at the age of 6 years as dose 2, single and administered in arm right, administration date 10Nov2021 (Lot number: FK5127) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history and no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "recovering" and all described as "Became sick/Positive with Covid-19 after being fully vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 41 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Nov2021 (Lot number: FH8027) at the age of 41 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 11Apr2021 (Lot number: EP6955) as dose 2, single and intramuscular, administered in arm left, administration date 20Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other medications in two weeks. The following information was reported: IMMUNISATION (medically significant) with onset 22Nov2021, outcome "unknown", described as "Dose number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jan2022, outcome "recovering" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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. Since the vaccination, the patient had been tested for COVID-19. The case was assessed as non-serious.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result=Positive, covid test date=12Jan2022; covid test result=Positive, covid test date=12Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Jun2021 (Lot number: EW0182) at the age of 14 years as dose 2, single and administered in arm left, administration date 21May2021 (Lot number: EW0176) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "covid test result=Positive, covid test date=12Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Nasal swab. Patient had not received any other vaccine in four weeks and had not received Other medications in two weeks. It was reported that reporters 14-year-old daughter had only two (2) menstrual full periods (30May2021 and 30Aug2021) since her first and second dose of COVID vaccine. Had 1 period with only cramps and a small spot of blood on one day in Oct2021. This was very concerning. Spoken with practitioner about their concerns. She had been fairly regular since onset in 2019. It was reported that patient not had covid prior vaccination and was tested to covid post vaccination. It was reported that patient had no known allergies.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient tested positive for Covid-19; patient tested positive for Covid-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 09Feb2021 (Lot number: EL3247) at the age of 30 years as dose 2, single and administered in left arm, administration date Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "recovered with sequelae" (Jan2022) and all described as "patient tested positive for Covid-19". The event "patient 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: (05Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Loss of Efficacy- The patient contracted Covid-19.; Loss of Efficacy- The patient contracted Covid-19.; administration date: Sep2021, dose number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Sep2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administered in arm left, administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy (post Graves disease)" (unspecified if ongoing), notes: Other medical history: Thyroidectomy (post Graves disease). Concomitant medication(s) included: SYNTHROID; CYTOMEL.  The following information was reported: IMMUNISATION (medically significant) with onset Sep2021, outcome "unknown", described as "administration date: Sep2021, dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "recovering" and all described as "Loss of Efficacy- The patient contracted Covid-19.". The event "loss of efficacy- the patient contracted covid-19." and "loss of efficacy- the patient contracted covid-19." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with monulpiravir.  Clinical course: No other vaccination was reported in 4 weeks. No known allergies were reported. Covid prior to vaccination was reported as no.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: The caller was allergic to the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, 30 ug single for covid-19 immunisation. Relevant medical history included: "cancer tumor on the bladder" (unspecified if ongoing), notes: Verbatim: cancer tumor on the bladder, It was removed in Dec2021 via surgery; "just had surgery" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "The caller was allergic to the vaccine".  Additional information: The patient was taking antibiotics (unspecified) as she just had surgery. The patient was allergic to the vaccine so she was hesitant but she did it anyways. The patient had the two doses of the vaccine. Received her second dose on 18Mar2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: I was infected with COVID-19 as confirmed by a home administered Antigen test and administered PCR test; I was infected with COVID-19 as confirmed by a home administered Antigen test and administered PCR test; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Oct2021 07:00 (Lot number: FF8839) at the age of 35 years as dose 3 (booster), single, administered in arm right, administration date 18Feb2021 13:45 (Lot number: EL3247) as dose 2, single and administered in arm right, administration date 28Jan2021 13:45 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SUPER B COMPLEX [VITAMIN B COMPLEX]; MAGNESIUM. The following information was reported: IMMUNISATION (medically significant) with onset 28Oct2021 07:00, outcome "unknown", described as "booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 12Jan2022 12:00, outcome "recovering" and all described as "I was infected with COVID-19 as confirmed by a home administered Antigen test and administered PCR test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Nasal Swab; (14Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Other medication in two weeks was reported as Multivitamin. Patient had no other vaccine in four weeks. Patient did not have covid prior vaccination. It was reported that patient was infected with COVID-19 as confirmed by a home administered. Antigen test and a (place)administered PCR test. The only symptom patient displayed was fatigue. Otherwise, patient would not have known patient had COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of soreness in the arm; 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 84 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date Mar2021 (Batch/Lot number: unknown) at the age of 84 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pernicious anaemia" (ongoing), notes: diagnosed over 40 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "little bit of soreness in the arm".  Additional Information: The patient was not related to any study or programme. Vaccination facility was reported as police combination building. Family Medical History Relevant to AE(s) was reported as none. She had spoken with her local health department where she got the first two Pfizer covid vaccine shots back in Mar. With the first dose she had no problems, aside from a little bit of soreness in the arm. First dose of Pfizer covid vaccine: Mar2021, in the morning around 10:00 or 11:00. She does not have the exact date or her vaccination card handy to provide lot number. She might had got the first dose in her right arm. No AE(s) following prior to vaccination. The patient was neither received any other additional vaccine within 4 weeks prior to vaccination nor on the same date of Covid-19 vaccination. No relevant tests or investigation assessment were reported. Events did not resulted in emergency room/physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Inappropriate schedule of product administration
Clinical narrative: hot flash; 26Dec2020 1st dose / 12Jan2021 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 12Jan2021 15:00 (Lot number: EK5730) at the age of 36 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Rupture" (not ongoing); "Appendectomy", start date: 1991, stop date: 1991, notes: Open appendectomy after rupture; "Seasonal allergies: Seasonal allergy" (ongoing); "Obesity", start date: 2019 (ongoing); "Frequent hypoglycemia" (ongoing), notes: Onset date: Childhood; "Suspected endometriosis" (unspecified if ongoing); "known allergies: Kiwi" (unspecified if ongoing); "known allergies: adhesive" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; FISH OIL; VITAMIN D [COLECALCIFEROL]. Past drug history included: Zantac, reaction(s): "drug allergy"; Prilosec, reaction(s): "drug allergy"; Pepcid, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (Dose 1; Batch/lot no.: CV19PF; Route of Administration: IM; Anatomical location: Left arm), administration date: 26Dec2020, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "Sore injection site", "hot flashes with no fever", "styes on both eyes". The following information was reported: HOT FLUSH (non-serious) with onset 13Jan2021 07:00, outcome "recovered" (13Jan2021 08:00), described as "hot flash"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Jan2021 15:00, outcome "unknown", described as "26Dec2020 1st dose / 12Jan2021 2nd dose".
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, COVID-19, Headache, Pyrexia
Clinical narrative: tested positive for COVID; tested positive for COVID; vomiting; headache; lower back pain; fever (101.7); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Nov2021 (Lot number: FK5127) at the age of 7 years as dose 2,(tris) single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=FK5127,, prev dose lot unknown=False,, prev dose administrator route=Intramuscular,, prev dose administration date=11Dec2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 11Dec2021, when the patient was 7 years old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "recovering" and all described as "tested positive for COVID"; VOMITING (non-serious) with onset 20Jan2022, outcome "recovering", described as "vomiting"; HEADACHE (non-serious) with onset 20Jan2022, outcome "recovering", described as "headache"; BACK PAIN (non-serious) with onset 20Jan2022, outcome "recovering", described as "lower back pain"; PYREXIA (non-serious) with onset 20Jan2022, outcome "recovering", described as "fever (101.7)". The events "tested positive for covid", "tested positive for covid", "vomiting", "headache", "lower back pain" and "fever (101.7)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 101.7; sars-cov-2 test: (20Jan2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, vomiting, headache, back pain, pyrexia. Symptoms on 20Jan were vomiting, headache, lower back pain, and fever (101.7). At the time of submitting this report, he has improved and no longer has any of the symptoms above (only congestion). Treatment received with Tylenol. No other vaccine in four weeks and no other medications in two weeks. No covid prior to vaccination and covid tested post vaccination. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.