chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: platelets had dopped down to nothing; 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 male patient received BNT162b2 (BNT162B2), in Jul2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Jan2021, stop date: Jan2021. The patient's concomitant medications were not reported. Past drug history included: Regeneron treatment  for COVID-19. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Unknown manufacturer), administration date: Jan2021, for COVID-19 immunization. The following information was reported: PLATELET COUNT DECREASED (hospitalization, medically significant), outcome "unknown", described as "platelets had dopped down to nothing". The event "platelets had dopped down to nothing" required physician office visit. The patient underwent the following laboratory tests and procedures: Platelet count: dopped down to nothing. Therapeutic measures were taken as a result of platelet count decreased. Clinical information: Reporter stated that he and his wife both got covid 19 virus in Jan2021 and had the regeneron treatment right after that. They were vaccinated in Jul2021 and in Aug2021 he had a check up, fine looked great, then got booster 12Jan2022, another appt 2nd week of Feb2022 and platelets had dopped down to nothing. He has been in hospital 1-3 times a week since going into almost a year starting in Feb2022 for dealing with this. He was put on 2nd oral medication because 1st did not work, just had a check up yesterday and platelets down to a 1, obviously new oral med hasn't worked. Patient asked if there were any steps or what they have to do about this other than what his oncologist or hematologist has suggested.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300004954 same reporter/patient, different vaccine dose and event;
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, Chest pain, Myocardial infarction, Myocarditis, Pyrexia
Clinical narrative: high temperature/fever; severe chest pain; heart attack; myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Dec2022 as dose 3 (booster), single (Lot number: GJ3274) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history was not reported (no other medical history). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 13Dec2022 as dose number unknown, single. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FF2590), administration date: 31Oct2021, when the patient was 41-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FF2587), administration date: 15Nov2021, when the patient was 41-year-old, for COVID-19 immunization. There was no other medications in two weeks, no covid prior vaccination, no known allergies. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 24Dec2022, outcome "not recovered", described as "heart attack"; PYREXIA (hospitalization, life threatening) with onset 24Dec2022, outcome "not recovered", described as "high temperature/fever"; MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 24Dec2022, outcome "not recovered"; CHEST PAIN (hospitalization, life threatening) with onset 24Dec2022, outcome "not recovered", described as "severe chest pain". The patient was hospitalized for pyrexia, chest pain, myocardial infarction, myocarditis (hospitalization duration: 3 day(s)). The events "high temperature/fever", "severe chest pain", "heart attack" and "myocarditis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) high; SARS-CoV-2 test: (26Dec2022) Negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of pyrexia, chest pain, myocardial infarction, myocarditis.
Age: 42.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test
Clinical narrative: high temperature/fever; severe chest pain; heart attack; myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Dec2022 as dose 3 (booster), single (Lot number: GJ3274) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history was not reported (no other medical history). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 13Dec2022 as dose number unknown, single. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FF2590), administration date: 31Oct2021, when the patient was 41-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FF2587), administration date: 15Nov2021, when the patient was 41-year-old, for COVID-19 immunization. There was no other medications in two weeks, no covid prior vaccination, no known allergies. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 24Dec2022, outcome "not recovered", described as "heart attack"; PYREXIA (hospitalization, life threatening) with onset 24Dec2022, outcome "not recovered", described as "high temperature/fever"; MYOCARDITIS (hospitalization, medically significant, life threatening) with onset 24Dec2022, outcome "not recovered"; CHEST PAIN (hospitalization, life threatening) with onset 24Dec2022, outcome "not recovered", described as "severe chest pain". The patient was hospitalized for pyrexia, chest pain, myocardial infarction, myocarditis (hospitalization duration: 3 day(s)). The events "high temperature/fever", "severe chest pain", "heart attack" and "myocarditis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) high; SARS-CoV-2 test: (26Dec2022) Negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of pyrexia, chest pain, myocardial infarction, myocarditis.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Covid-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient used Paxlovid from 23Dec2022 to 27Dec2022 for COVID 19 Treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: CH9702) at the age of 30 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), on 20Apr2021 as dose 2, single (Lot number: EW0169) and on 19Nov2021 as dose 3 (booster), single (Lot number: EW0187) for covid-19 immunisation. The patient's relevant medical history included: "Mountain Cedar (seasonal) Known allergies" (unspecified if ongoing); "Dust allergy" (unspecified if ongoing); "Mold allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: KYLEENA, start date: Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4506816-00  An 86-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), on 15Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 86 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Non-tobacco user" (unspecified if ongoing); "No alcohol use" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Aug2022, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive, notes: have Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Had Covid in December; Had Covid in December; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: 057F22A) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 27Apr2022 as dose 4 (booster), single (Lot number: PK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Previous heart attack", start date: May2005 (not ongoing), notes: Previous heart attack, May2005, 1 stent placed; "1 stent placed" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: 25May2005; ATORVASTATIN, start date: 25May2005. Past drug history included:ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Had Covid in December". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 05Dec2022 to 09Dec2022.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 6 (booster), single (Lot number: GJ2524) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Treated for breast cancer until May2022; "Allergies" (unspecified if ongoing), notes: Known allergies: yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had Paxlovid from 19Dec2022 to 23Dec2022 as COVID 19 Treatment.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid positive after 4 doses of the Pfizer covid 19 vaccine; covid positive after 4 doses of the Pfizer covid 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure", start date: 2005 (unspecified if ongoing), notes: high blood pressure diagnosed in 2005 after she had a stroke.; "she had a stroke" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for hypertension; HYDROCHLOROTHIAZIDE oral taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "not recovered" and all described as "covid positive after 4 doses of the Pfizer covid 19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Over the weekend she had a negative test; (25Dec2022) Positive, notes: Result: positive; Unit: Not Provided; (03Jan2023) Positive, notes: She tested last night and it was a very faint positive for covid; (04Jan2023) Positive, notes: Today she tested a very bold positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Concomitant products included lisinopril taking for years, has been as high as 40mg in the past, currently taking 10mg (10mg tablet once a day by mouth); hydrochlorothiazide taking for years, 25mg tablet once a day by mouth. She had all the Pfizer covid 19 vaccines including the bivalent booster, clarifies she has had four doses. Her 4th dose was the bivalent booster and it was administered in Nov2022. She is 69 years old. She tested positive for covid on and started taking Paxlovid on Monday 26Dec2022, then tested negative this past weekend on Saturday. Then yesterday she started having a tickle on her throat and started having cold symptoms again. She tested last night and it was a very faint positive for covid. She tested a very bold positive. She knows what she read is that there can be false negative but unlikely to get a false positive.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient has no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures, Paxlovid from 28Dec202 to 02Jan2023, were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2022 at 18:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: asking any guidelines on repeat use for Paxlovid; asking any guidelines on repeat use for Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prescriber prescribed the patient Paxlovid 3 times in the past year. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "asking any guidelines on repeat use for Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Call was transferred from Medical Information Department Transferring agent stated, "I do have (redacted) (Further not clarified by the reporter. Hence, capture as consumer or other non health professional by default) on hold. Her first name is (name withheld), I think that was the spelling of (name withheld) (Not clarified with the reporter) and her last name is (name withheld). So, she was reporting, the product is for the Pfizer Covid-19 vaccine Bivalent, the adult formulation. She was reporting that a patient got the Pfizer bivalent vaccine instead of primary series and she also mentioned, the patient never had a vaccine yet." When requested to repeat the concern, Transferring agent stated, "She mentioned that the patient got the Bivalent instead of the primary series and also mentioned the patient never had the vaccine yet (Captured as unspecified vaccine). The next product was for Paxlovid, she mentioned that, there is a prescriber prescribed the patient Paxlovid 3 times in the past year and he is trying to prescribe it again (Event captured conservatively as per the verbatim). When paraphrased the concern: Transferring agent stated, "It is correct, so this the 4th time, that the prescriber gave or prescribed Paxlovid for this patient. That is all the information that I have and the caller disconnected the call already." Call back was done. However, it was unsuccessful as ther was a IVR response.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events drug ineffective and COVID 19  and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202201398131 Same reporter, same product, same patient, different event;
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart disorder; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart disorder".  Additional information: The reporter also had a nephew and a niece that had heart damages because of these shots, so no comments needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Illness
Clinical narrative: keep getting sick over and over again after getting these shots; keep getting sick over and over again after getting these shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890).  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "keep getting sick over and over again after getting these shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300001877 Same reporter/drug/events, different patient.;
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Illness
Clinical narrative: keep getting sick over and over again after getting these shots; keep getting sick over and over again after getting these shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "keep getting sick over and over again after getting these shots".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300001876 Same reporter/drug/events, different patient.;
Sex: F
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: My grandpa almost died from that vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant, life threatening), outcome "unknown", described as "My grandpa almost died from that vaccine".  Clinical information: During an open-ended question, reporter stated that my grandpa almost died from that vaccine. Age provided as 22.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: my mom who has every shot and booster got covid; my mom who has every shot and booster got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "my mom who has every shot and booster got covid".  Clinical course: Everyone reporter knew who had the vaccine has gotten very sick, not just a little sick. In fact, the reporter's mom, who had every shot and booster, got covid, reporter couldn't help but be around her. And yet reporter didn't got sick, neither did reporter girlfriend. reporter mom, who was supposed to be the most protected, got very sick, VERY. And yet we experienced nothing. NOTHING. This had happened to numerous other people reporter personally knew. Every person who got the vaccine got sick and then said that "it would have been so much worse if hadn't had the vaccine," but study psychology, this was justification, this was not reality. IF they knew anything about evolution and adaptation, they would recognize that the shots were of very fleeting interest as far as protection goes because the virus mutates with each body it enters."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: my sister got the shot and it made her sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "my sister got the shot and it made her sick". Additional information: Patient's age reported as "21" (no age units).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Immunodeficiency common variable
Clinical narrative: I have an immune disorder, CBID and I'm very high risk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY COMMON VARIABLE (medically significant), outcome "unknown", described as "I have an immune disorder, CBID and I'm very high risk".  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Nerve block
Clinical narrative: having a total knee surgery redone; the nerve blocked it.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHROPATHY (medically significant), outcome "unknown", described as "having a total knee surgery redone"; NERVE BLOCK (non-serious), outcome "unknown", described as "the nerve blocked it.". Therapeutic measures were taken as a result of arthropathy. Clinical course: patient said that she just came home from having a total knee surgery redone and the nerve blocked it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Fatigue, Illness, Irritability, Nasopharyngitis
Clinical narrative: The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4506816-00.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4, (booster) single (Batch/Lot number: unknown) at the age of 86 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 10Apr2021 (Lot number: 1164825) at 80 mg daily (80 mg, daily(80 mg day 15 citrate free pen, every 1 days)), second regimen (Lot number: 1164825) at 160 mg daily (160 mg, daily( 160 mg day 1 citrate free pen, every 1 days)) and third regimen since Feb2022 (ongoing) (Lot number: 1164825) at 40 mg (40 mg(40 mg citrate free, every 2 weeks)), all subcutaneous for crohn's disease.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gestational diabetes, Insomnia, Maternal exposure during pregnancy, Restless legs syndrome
Clinical narrative: The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4424759-003714030.  by a consumer of a 32 years old female with events of and non-serious Maternal exposure during pregnancy, restless leg syndrome after first covid-19 vaccine, gestational diabetes, Could not sleep after first covid-19 vaccine, and more tired with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. In 2022, the patient experienced gestational diabetes. On unknown date(s) in 2022, the patient experienced more tired, could not sleep after first covid-19 vaccine, restless leg syndrome after first covid-19 vaccine, maternal exposure during pregnancy. On unknown date, restless leg syndrome after first covid-19 vaccine recovered/resolved. On unknown date, could not sleep after first covid-19 vaccine recovered/resolved. Pfizer Biontech Covid-19 Vaccine was also considered suspect. The fetus was exposed to maternal use of Humira in utero. The patient was 35 weeks pregnant as of 21Nov2022. Maternal use of Humira was ongoing. This case was a follow-up to case 22K-163-4424759-00.  A 32-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), on 01Mar2016 as unk (40mg/0.4ml), citrate free (Lot number: 1160679) subcutaneous for Crohn's disease. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "non-serious maternal exposure during pregnancy/35 weeks pregnant", "gestational diabetes" and "more tired" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on limited information available, the causal association between the events maternal exposure during pregnancy, gestational diabetes, fatigue, restless leg syndrome, insomnia and suspect drug  BNT162b2 (BNT162B2) cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Arthralgia, Chills, Confusional state, Dyskinesia, Emotional disorder
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The event "seizures" required physician office visit (Ask Doctor for tests/record). Therapeutic measures were taken as a result of seizure, loss of consciousness, chills, confusional state, feeling abnormal, emotional disorder, headache, musculoskeletal stiffness, joint stiffness, nerve injury, myalgia, illness. Therapeutic measures were not taken as a result of dyskinesia, pain in extremity, arthralgia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Feeling abnormal, Headache, Illness, Interchange of vaccine products, Joint stiffness
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The event "seizures" required physician office visit (Ask Doctor for tests/record). Therapeutic measures were taken as a result of seizure, loss of consciousness, chills, confusional state, feeling abnormal, emotional disorder, headache, musculoskeletal stiffness, joint stiffness, nerve injury, myalgia, illness. Therapeutic measures were not taken as a result of dyskinesia, pain in extremity, arthralgia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Myalgia, Nerve injury, Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The event "seizures" required physician office visit (Ask Doctor for tests/record). Therapeutic measures were taken as a result of seizure, loss of consciousness, chills, confusional state, feeling abnormal, emotional disorder, headache, musculoskeletal stiffness, joint stiffness, nerve injury, myalgia, illness. Therapeutic measures were not taken as a result of dyskinesia, pain in extremity, arthralgia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, FLUX
Symptoms: Seizure
Clinical narrative: This is a spontaneous report received from contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The event "seizures" required physician office visit (Ask Doctor for tests/record). Therapeutic measures were taken as a result of seizure, loss of consciousness, chills, confusional state, feeling abnormal, emotional disorder, headache, musculoskeletal stiffness, joint stiffness, nerve injury, myalgia, illness. Therapeutic measures were not taken as a result of dyskinesia, pain in extremity, arthralgia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Autonomic neuropathy, Illness
Clinical narrative: autonomic neuropathy; I fell very sick; my stomach was bothering me; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 2, single (Lot number: EL9267) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 02Mar2021, outcome "recovering", described as "my stomach was bothering me"; AUTONOMIC NEUROPATHY (medically significant), outcome "recovering"; ILLNESS (non-serious), outcome "recovering", described as "I fell very sick".  Clinical course: She had a very bad reaction to the shot. On 02Mar2021 she noticed her stomach was bothering her. she was a healthy female and very much a COVID shot proponent. she fell very sick with which had now been diagnosed with autonomic neuropathy from the vaccine. This had been a year and half recovery and she want to offer to be studied by Pfizer to help.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: autonomic neuropathy; I fell very sick; my stomach was bothering me; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 2, single (Lot number: EL9267) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 02Mar2021, outcome "recovering", described as "my stomach was bothering me"; AUTONOMIC NEUROPATHY (medically significant), outcome "recovering"; ILLNESS (non-serious), outcome "recovering", described as "I fell very sick".  Clinical course: She had a very bad reaction to the shot. On 02Mar2021 she noticed her stomach was bothering her. she was a healthy female and very much a COVID shot proponent. she fell very sick with which had now been diagnosed with autonomic neuropathy from the vaccine. This had been a year and half recovery and she want to offer to be studied by Pfizer to help.
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Food intolerance, Near death experience, Pyrexia, Skin burning sensation
Clinical narrative: The individual was so dehydrated, her skin stayed red when pinched. This lasted 4-5 days and she said she felt near death; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 IMMUNIZATION. The following information was reported: NEAR DEATH EXPERIENCE (life threatening), PYREXIA (non-serious), FOOD INTOLERANCE (non-serious), DEHYDRATION (non-serious), SKIN BURNING SENSATION (non-serious), outcome "unknown" and all described as "developed a fever and couldn't keep any food down. The individual was so dehydrated, her skin stayed red when pinched. This lasted 4-5 days and she said she felt near death".  Clinical information: On 20Dec2022, it was reported that a patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine unspecified dose (reported as booster dose) for COVID-19 immunization. It was reported that about 24 hours after the booster dose, the patient developed a fever and couldn't keep any food down.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: gout; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOUT (non-serious), outcome "unknown".  Additional information: The patient having an adverse reaction to the past 2 Pfizer Covid-19 vaccinations and submitted my issues in the CDC VAERS reporting. Until after Apr2022 shot, gout attacks were at best mild and rare, maybe 1 attack in about a year. After Apr2022's shot, about 2mos/2wks. The patient had the worst attack lasted over 4wks in my foot/ankle. About 2.5 wks after Oct22 Pfizer shot, had a major attack in left hand/wrist. The patient felt like joints everywhere in body all the time now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: influenza A; Initial information received on 03-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp ( non-health care professional ) .  This case involves an unknown age and unknown gender patient who reported  influenza A after receiving  INFLUENZA VACCINE.  The patient's past medical history, concomitants, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown  dose of suspect INFLUENZA VACCINE ( with unknown strength, form, route, frequency, batch number and expiry date) at  unknown administration site for prophylactic vaccination.  On an unknown date the patient had a non-serious event  influenza A (influenza) (unknown latency)   No lab data included.  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (influenza A).  Outcome : Unknown.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: on day 3 of the flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult patient of an unknown age and gender who had flu on day 3 after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, strength, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event on day 3 of the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.