chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headaches".  Additional information: Description of Event: Withheld shared in the chat of a call that her husband and a staff member got the bivalent shot at withheld and they had splitting headaches for 12 hours. Optional Information: None given. Name of Product: Pfizer biontech COVID-19 bivalent vaccine.Event took place after use of product.  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-PV202200070297 same reporter/drug, event, different patients;
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colitis" (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 Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE, start date: Jul2009; LOSARTAN, start date: Jul2009. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid received from 15Sep2022-19Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer BioNTech COVID19 Vaccine 4th dose, and dose 1, 2 and 3 of the Moderna Vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 06Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 51 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Mar2021 at 16:00 as dose 1, single (Lot number: 018B21A), in right arm, on 25Apr2021 at 16:00 as dose 2, single (Lot number: 048B21A), in right arm and on 22Nov2021 at 14:00 as dose 3, single (Lot number: 033F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 06Apr2022, outcome "unknown", described as "Pfizer BioNTech COVID19 Vaccine 4th dose, and dose 1, 2 and 3 of the Moderna Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Negative; (21Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received "Paxlovid" to treat "drug ineffective", "covid-19",  treatment start date:14Sep2022, treatment stop date:18Sep2022. Clinical course: Rebound COVID symptoms and infection. Cold symptoms began 20Sep2022; symptoms worsened, tested positive for COVID again on 21Sep22. Had tested negative on 19Sep2022 following 5 days Paxlovid.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine dose number :3 (Moderna)/Vaccine dose number :2 (Pfizer); This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: EL9261), in left arm and on 10Feb2021 as dose 2, single (Lot number: EM9809) at the age of 58 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2021 as dose 3 (booster), single (Lot number: 022C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Chloresterol" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "neurocardiogenic syncope" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cephlosporin, reaction(s): "Known allergies: Cephlosporin"; Bactrim, reaction(s): "Known allergies: Bactrim"; Flagyl, reaction(s): "Known allergies: Flagyl". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2021, outcome "unknown", described as "Vaccine dose number :3 (Moderna)/Vaccine dose number :2 (Pfizer)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 11Sep2022 and 16Sep2022.; Sender's Comments: Based on the information in the case, an association between the reported events vaccination failure and covid 19 and suspect product bnt162b2 cannot be ruled out.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8733), on 23Apr2021 as dose 2, single (Lot number: EW0170), on 15Nov2021 as dose 3 (booster), single (Lot number: EW0191) and on 01Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 58 years for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. Concomitant medication(s) included: ALPRAZOLAM, start date: 05Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive, notes: Indication: Treatment of COVID-19; (Sep2022) Positive, notes: Covid-19 Rebound Infection. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 at 14:30 as dose 1, single (Lot number: EN6206), in left arm, on 19Mar2021 at 10:30 as dose 2, single (Lot number: EN6207), in left arm, on 26Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 18Apr2022 at 15:15 as dose 4 (booster), single (Lot number: FJ4991) at the age of 67 years, in left arm 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 05Sep2022 at 10:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Positive, notes: Positive COVID infection 05Sep2022 and Rebound COVID infection 19Sep2022; (19Sep2022) Positive, notes: Positive COVID infection 05Sep2022 and Rebound COVID infection 19Sep2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Off label use, Pain in extremity
Clinical narrative: Headache; sore arm; off label use; booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 18:00 as dose 5 (booster), single (Lot number: gh9694) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Sep2022 at 18:00, outcome "unknown", described as "booster"; OFF LABEL USE (non-serious) with onset 22Sep2022 at 18:00, outcome "unknown"; HEADACHE (non-serious) with onset 23Sep2022, outcome "recovered" (Sep2022); PAIN IN EXTREMITY (non-serious) with onset 23Sep2022, outcome "recovered" (Sep2022), described as "sore arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  Additional information: Patient have not received other vaccine in four weeks. No Covid prior to vaccination and no covid tested post vaccination.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: en6199), on 27Mar2021 as dose 2, single (Lot number: er2613), on 09Oct2021 as dose 3 (booster), single (Lot number: ff2950) and on 23Apr2022 as dose 4 (booster), single (Lot number: fj4989) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "copd" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing); "general allergies" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: off label use; Interchange of vaccine products; COVID-19; COVID-19; 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 72-year-old male patient received BNT162b2 (BNT162B2), on 09Apr2022 at 10:30 as dose 4 (booster), single (Lot number: FL3198) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Feb2021 at 12:00 as dose 1, single (Lot number: 006U20A), in left arm, on 16Mar2021 at 12:00 as dose 2, single (Lot number: 003A21A), in left arm and on 19Oct2021 at 10:30 as dose 3 (booster), single (Lot number: O35C21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Benign prostatic hyperplasia" (unspecified if ongoing), notes: BPH; "Penicillin allergy" (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 Sep2022, outcome "not recovered" and all described as "COVID-19"; OFF LABEL USE (medically significant), outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Sep2022) NEGATIVE; (15Sep2022) POSITIVE. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Petit mal epilepsy
Clinical narrative: Absence seizure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID: (159558).   A 14-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 11:20 as dose number unknown (booster), single (Lot number: GJ3277, Expiration Date: 31Jul2023) at the age of 14 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PETIT MAL EPILEPSY (medically significant) with onset Sep2022, outcome "unknown", described as "Absence seizure". The patient underwent the following laboratory tests and procedures: Blood test: (24Sep2022) Unknown results, notes had his blood taken out today, blood drawn today for the lot purpose.   Clinical Course: The caller said that they have gave the Bivalent vaccine confirmed as COVID-19 Bivalent Vaccine to a fourteen-year-old patient and it looks like the patient is having some absence seizure. When paraphrased the concern: Pharmacist stated Yes so after receiving the vaccine patient looks like he is having absence seizure is that one of the listed side effects. Pharmacist stated they said they had his blood taken out today blood drawn today for the lot purpose. No not within the past two-week no.  ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Petit mal epilepsy and suspect drug 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 RAs, Ethics Committees, and Investigators, as appropriate
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 12:00 as dose 1, single (Lot number: EN6202), in right arm, on 23Mar2021 at 13:15 as dose 2, single (Lot number: ER8727), in left arm, on 29Sep2021 at 17:15 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 19May2022 at 17:30 as dose 4 (booster), single (Lot number: FM0173) at the age of 46 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure and covid-19 included Paxlovid (lot numberGE4606) from 14Sep2022 to 18Sep2022.  Clinical course: It was unknown that the patient received other medications within 2 weeks to the COVID vaccine. Patient had a COVID-19 rebound and onset of symptoms from 24Sep2022 07:00 AM. Patient did not receive treatment for symptoms and not recovered from symptoms. The patient previously receive a COVID-19 Vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1 with Moderna vaccine, dose 2 with Pfizer vaccine and dose 3 with Moderna vaccine; Dose 1 with Moderna vaccine, dose 2 with Pfizer vaccine and dose 3 with Moderna vaccine; 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 2, single (Lot number: FJ1620) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: Mod011A21A), in right arm and on 31Mar2022 as dose 3 (booster), single (Lot number: Mod017B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: PCN" (unspecified if ongoing), notes: known allergies PCN; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 08Dec2021, outcome "unknown" and all described as "Dose 1 with Moderna vaccine, dose 2 with Pfizer vaccine and dose 3 with Moderna vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 10Sep2022 to 16Sep2022.
Sex: M
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).  An 84-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 was not reported. The patient took 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: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes. Antiviral details: product: Paxlovid, COVID 19 Treatment, treatment start date 22Sep2022.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: EW0178), in left arm and on 13Jul2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) Negative; (24Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 08Jan2021 as dose 2, single (Batch/Lot number: unknown), on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: PAROXETINE, start date: 01Jun1998; ATORVASTATIN, start date: 01Jan2005, stop date: 13Sep2022; LISINOPRIL, start date: 01Apr2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) negative; (21Sep2022) negative; (24Sep2022) strongly positive; (13Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: COVID positive anthem test on 13Sep2022. Symptoms started on 12Sep2022 and resolved on 21Sep2022. COVID negative antigen test x2 separated by 12 hours on 21Sep2022. Started having cough, congestion, mild myalgias 23Sep2022. Antigen test strongly positive 24Sep2022. Suspecting rebound case. Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 13Sep2022, treatment stop date: 18Sep2022, indication: Treatment of COVID-19 The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after four doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 1, single (Lot number: FE3590) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing), notes: Other medical history: Mild intermittent asthma; "Known allergies: Sulfa and tree nuts" (unspecified if ongoing), notes: Known allergies: sulfa and tree nuts; "Known allergies: Sulfa and tree nuts" (unspecified if ongoing), notes: Known allergies: sulfa and tree nuts. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was prescribed Paxlovid yesterday for positive COVID-19 home test. was called in to pharmacy in the evening and she took the first dose in the evening. Experienced lip swelling overnight and itching. Denied throat itching, swelling, or increased hoarseness.; Sender's Comments: As per the available information the events drug ineffective and covid-19 are possibly related to the suspect BNT162b2.
Age: 56.0
Sex: F
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Optic neuritis" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (17Sep2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Sep2022 to 18Sep2022. Had a negative test and all symptoms resolved by 17Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, the reported events DRUG INEFFECTIVE and COVID-19 cannot be excluded for the suspect drug BNT162b2.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm, in 2022 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Apr2020 as dose 1, single (Batch/Lot number: unknown), in left arm and (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (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 Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received paxlovid treatment from 13Sep2022 to 17Sep2022 for treatment of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient had other medications Amlodipine, Hydrochlorothiazide and Trazodone in 2 weeks. The patient had anti viral treatment Paxlovid which was started on 03Sep2022. On 03Sep2022 12:00 PM, the first dose was given to the patient after which the patient experienced felt queasy and after the second dose, the patient had bad taste in mouth. On 04Sep2022 the patient had the third dose which made the patient very sick to the stomach. So, the treatment with Paxlovid was discontinued on 04Sep2022. The adverse events were not treated. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm 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 Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 14Sep2022 to 18Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pfizer shot made her tired and she had a sore arm; Pfizer shot made her tired and she had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high diagnosed most of her life; "High cholesterol" (unspecified if ongoing), notes: High cholesterol diagnosed most of her life. Her liver produces too much but it is pretty even; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1, (SINGLE), Dose #1: Pfizer-MRN (lmp-s) PF.30mcg/0.3mL dose Date: 08Feb2021 Lot: unknown NDC: unknown Expiry: unknown Dose: 0.3mL), administration date: 08Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Pfizer shot made her tired and she had a sore arm", "Pfizer shot made her tired and she had a sore arm". The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Pfizer shot made her tired and she had a sore arm". Additional information:  Lisinopril HCTZ: 10mg/12.5mg tablets, she takes 2 now she used to only take 1 a day now she takes 2 a day.  The regular Pfizer shot made her tired and she had a sore arm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Pfizer shot made her tired and she had a sore arm; Pfizer shot made her tired and she had a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high diagnosed most of her life; "High cholesterol" (unspecified if ongoing), notes: High cholesterol diagnosed most of her life. Her liver produces too much but it is pretty even; "thyroid" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ taken for hypertension. Vaccination history included: BNT162b2 (Dose #1: Pfizer-MRN (lmp-s) PF.30mcg/0.3mL dose Date: 08Feb2021 Lot: unknown NDC: unknown Expiry: unknown Dose: 0.3mL), administration date: 08Feb2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "Pfizer shot made her tired and she had a sore arm"; BNT162b2 (Dose #1: Pfizer-MRN (lmp-s) PF.30mcg/0.3mL dose Date: 08Feb2021 Lot: unknown NDC: unknown Expiry: unknown Dose: 0.3mL), administration date: 08Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Pfizer shot made her tired and she had a sore arm"; BNT162b2 (Dose #2: Pfizer Date: 03Mar2021 Lot: unknown NDC: unknown Expiry: unknown), administration date: 03Mar2021, when the patient was 70-year-old, for Covid-19 Immunization, reaction(s): "Pfizer shot made her tired and she had a sore arm", "Pfizer shot made her tired and she had a sore arm". The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Pfizer shot made her tired and she had a sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; patient previously received dose 3 of Moderna vaccine; patient previously received dose 3 of Moderna vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 19Apr2022, outcome "unknown" and all described as "patient previously received dose 3 of Moderna vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of 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 included paxlovid.
Age: 47.0
Sex: M
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 contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 47 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Dec2020 as dose 1, single (Lot number: EH9899), on 11Jan2021 as dose 2, single (Lot number: EL1283), on 20Sep2021 as dose 3 (booster), single (Lot number: EW0167) and on 30Mar2022 as dose 4 (booster), single (Lot number: FL9729) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". 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. Clinical courses is as follows: Other medication in 2 weeks product was Carvedilol. The patient received completed treatment for tongue cancer in January 2022 (radiation/chemotherapy).; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events and suspect drug(s) cannot be excluded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tongue neoplasm malignant stage unspecified
Clinical narrative: Completed treatment for tongue cancer in Jan2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2021 as dose 3 (booster), single (Lot number: EW0167) at the age of 46 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARVEDILOL. Vaccination history included: BNT162b2 (DOSE 2, SINGLE,Vaccine brand: Pfizer / BioNTech,, Vaccine lot number: EL1283,), administration date: 11Jan2021, when the patient was 45-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE, Vaccine brand: Pfizer / BioNTech,, Vaccine lot number: EH9899), administration date: 20Dec2020, when the patient was 45-year-old, for Covid-19 immunization. The following information was reported: TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED (medically significant) with onset Jan2022, outcome "unknown", described as "Completed treatment for tongue cancer in Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: post-treatment rapid testing negative; Positive, notes: symptoms recurred on Day 11 and RAT positive. Therapeutic measures were taken as a result of tongue neoplasm malignant stage unspecified.  Clinical information: Reported as, patient received BNT162b2, on 30Mar2022 as dose 4 (booster), single (Lot number: FL9729) and received BNT162b2 on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694). Completed treatment for tongue cancer in January 2022 (radiation/chemotherapy). No Known allergies.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported event and the suspect drug 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
Age: 44.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 06Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amox, reaction(s): "Known allergies: amox", notes: Known allergies: amox. 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: (unspecified date) Positive; (23Sep2022) Negative; (24Sep2022) Negative; (25Sep2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment was given from 15Sep2022 to 19Sep2022. Patient was experiencing a rebound case of COVID after completing 5-day course on 19Sep2022. Symptoms came back 23rd and 24Sep and multiple negative COVID tests until evening of 25Sep.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Got long covid; Got long covid; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 60-year-old male patient received 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 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 "Got long covid". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown results; SARS-CoV-2 test: Negative, notes: already was starting to test negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: Fr8727), in left arm, on 04Oct2021 as dose 2, single (Lot number: Ff8841), in left arm and on 22Apr2022 as dose 3 (booster), single (Lot number: Ft9943) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies : tetracycline, reaction(s): "Known allergies : Tetracycline", notes: Known allergies : Tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment started from 14Sep2022 to 19Sep2022.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, SARS-CoV-2 test
Clinical narrative: Guillen Barre; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 2, single (Lot number: EL9267) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OZEMPIC. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Arm Left), administration date: 22Jan2022, when the patient was 71-year-old, for Covid-19 Immunization. No other vaccine in four weeks. No known allergies. No covid prior vaccination.  The following information was reported: GUILLAIN-BARRE SYNDROME (prolonged hospitalization, disability, life threatening) with onset 25May2021, outcome "not recovered", described as "Guillen Barre". The event "guillen barre" required emergency room visit. In June 2022. Hospital for Guillen Barre Aug2022 hospital again for Guillen Barre Sep2022 diagnosed with CIDP chronic form of Guillen Barre. Ae treatment included: lvlG. The event resulted in: Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of guillain-barre syndrome.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Date: 06Jan2022/Nasal Swab: Positive; Date: 06Jan2022/Nasal Swab: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 21Dec2021 as dose 2, single (Lot number: EL9267), in left arm and on 22Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 71 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OZEMPIC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Date: 06Jan2022/Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) Positive, notes: Nasal Swab.