chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 57-year-old female patient (not pregnant) 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 included: "asthma" (unspecified if ongoing); "mild hypothyroidism" (unspecified if ongoing), notes: mild hypothyroidism; "lichen sclerosis" (unspecified if ongoing), notes: lichen sclerosis; "known allergies: PCN" (unspecified if ongoing), notes: known allergies: PCN; "known allergies: molds" (unspecified if ongoing); "known allergies:dust" (unspecified if ongoing); "known allergies:pollen" (unspecified if ongoing); "known allergies:sulfites in food" (unspecified if ongoing), notes: known allergies: sulfites in food. The patient's concomitant medications were not reported. Past drug history included: E-mycin, reaction(s): "known allergies", notes: known allergies:E-MYCIN. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: Report about covid treatment reported as Yes. If vaccine received and Other medication in 2 weeks reported as unknown.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 30Apr2021 as dose 2, single (Lot number: ER8736), in left arm, on 03Nov2021 at 12:45 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Feb2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Hypothyreosis" (unspecified if ongoing), notes: Hypothyreosis; "Vit B12 deficiency" (unspecified if ongoing); "Known allergies: Hazelnut allergy" (unspecified if ongoing), notes: Known allergies: Hazelnut allergy; "Known allergies: Apple" (unspecified if ongoing), notes: Known allergies: Apple; "Known allergies: Pear intolerance" (unspecified if ongoing), notes: Known allergies: Pear intolerance; "Known allergies: Pollen allergy" (unspecified if ongoing), notes: Known allergies: Pollen allergy; "Known allergies: Cat hair" (unspecified if ongoing), notes: Known allergies: Cat hair; "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites; "Known allergies: Adhesives/bandaids" (unspecified if ongoing), notes: Known allergies: Adhesives/bandaids. The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Negative; (12Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Other medication in 2 weeks was reported as yes. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Nov2021 as dose 3 (booster), 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. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Known allergies were reported as no. It was reported that the patient received Paxlovid from 08Jun2022 to 12Jun2022 as COVID-19 treatment. The patient had Diarrhea, metallic taste in mouth about an hour after taking the pills (Paxlovid), lasting several hours.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, 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). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 at 16:30 as dose number 1, single (Lot number: EN6201), in left arm, on 19Mar2021 at 16:30 as dose number 2, single (Lot number: ER8727), in left arm, on 23Oct2021 at 10:30 as dose number 3 (booster), single (Lot number: EW0202), in left arm and on 27Apr2022 at 09:15 as dose number 4 (booster), single (Lot number: FK9893) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis (currently inactive)" (unspecified if ongoing), notes: Ulcerative colitis (currently inactive). Concomitant medication(s) included: METHOTREXATE SODIUM, start date: 07Sep2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about COVID treatment: Yes; If vaccine received: Yes; Anti-viral details: Product: COVID 19 treatment, brand: Pfizer; The patient previously received a COVID-19 Vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: EB8733), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0170), in left arm, on 18Oct2021 as dose 3 (booster), single (Lot number: 30155 BA), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 55 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result; positive; negative. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Other medication in 2weeks: Yes Anti-viral details: Product- COVID-19 Treatment, Brand: Paxlovid, Treatment start date- 30May2022, Treatment stop date- 03Jun2022. New symptoms and positive PCR one week after finishing course of Paxlovid and testing negative at end of Paxlovid course. Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: fk9893) at the age of 72 years, in right 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: "Known allergies: yes-penicillin" (unspecified if ongoing). The patient had no other medical history. Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: 01Jan2021, stop date: 13Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "recovering" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) positive, notes: home test; (12Jun2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included nirmatrelvir, ritonavir (PAXLOVID).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history included: "high ANA" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: NP THYROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (11Jun2022) positive, notes: Rebound/return of symptoms and 2 positive covid-19 rapid tests on day 8 after finishing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course:  Patient received other medication in 2weeks: NP thyroid. Patient received COVID 19 Treatment (Paxlovid)  from 04Jun2022 to 09Jun2022 for the treatment of COVID-19. Rebound/return of symptoms and 2 positive covid-19 rapid tests on day 8 after finishing treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: testing positive; testing positive; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Batch/Lot number: unknown), on 05May2021 as dose 2, single (Batch/Lot number: unknown) and on 28Nov2021 at 12:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "not recovered" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jun2022) Positive, notes: Started packs love it within hours of testing positive; (08Jun2022) Negative, notes: I completed the 5 day course and tested negative; (11Jun2022) Positive, notes: 3 days later I once again had a scratchy throat and tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient started packs love it within hours of testing positive. Patient had no more than a scratchy throat. she completed the 5 day course and tested negative. 3 days later she once again had a scratchy throat and tested positive. Patient  had achy body and head congestion with yellow mucus, runny nose and a mild sore throat the first day. Patient still sick 3 days later.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: el3248), on 01Feb2021 as dose 2, single (Lot number: el9269) and on 12Oct2021 as dose 3 (booster), single (Lot number: ff2587) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Hypertension" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Chronic sinus problems" (unspecified if ongoing), notes: Chronic sinus problems; "Anxiety" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; TYLENOL; METFORMIN; ROSUVASTATIN; OZEMPIC; FAMOTIDINE; LEXAPRO; WELLBUTRIN; HYDROCHLOROTHIAZIDE; CALCIUM + VIT D; VITAMIN B12 [CYANOCOBALAMIN]. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor; Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex; Lisinopril, reaction(s): "Known allergies: Lisinopril", notes: Known allergies: Lisinopril; Dilaudid, reaction(s): "Known allergies: Dilaudid", notes: Known allergies: Dilaudid; Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim. The following information was reported: SUSPECTED COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.  Clinical Course: Anti-viral details: Product: COVID 19 Treatment, Paxlovid, from 31May2022 to 05Jun2022, Adverse event: Stopped Paxlovid 05Jun2022. COVID test had light line by 08Jun, then darker line 09Jun. Some symptoms resolved - low fever, productive cough, extreme fatigue. But sinus congestion symptoms continued and worsened a bit. Still positive with sinus symptoms as of 13Jun2022; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Indication as Reported by the Primary Source: COVID-19; Indication as Reported by the Primary Source: COVID-19; 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), on 10Feb2021 as dose 1, single (Lot number: EN6201), on 04Mar2021 as dose 2, single (Lot number: EN6198) and on 11Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Mar2022 as dose 2 (booster), single (Lot number: 0466214) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "Indication as Reported by the Primary Source: COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Tinnitus
Clinical narrative: The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line. My friend  also has the same thing.; The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line. My friend  also has the same thing.; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID:  This case refers to friend. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (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: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious), ILLNESS (non-serious) all with onset 13Jun2022, outcome "unknown" and all described as "The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line. My friend an NP also has the same thing." Additional information: I am an NP who had your 2 doses and one booster of COVID vaccine. The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line. My friend an NP also has the same thing. I think this happens more often than reported. I and others are very hesitant to get more vaccines and would like your scientists input. 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-PV202200001516 Same reporter/ drug/ event for different patient;
Age: 41.0
Sex: F
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 05:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 31Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATENOLOL; MONTELUKAST; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; METFORMIN; HYDROCHLOROTHIAZIDE. Past drug history included: Ace inhibitors, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were not taken as a result of covid-19, vaccination failure.  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, Vaccination failure
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) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7538), on 12Apr2022 as dose 2, single (Lot number: EP7538) and on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Mildly high cholesterol." (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jun2012, stop date: 31May2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, 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 64-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 64 years, in right 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: "MGUS" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Antigen home test 6 days after a negative antigen home test; Positive, notes: Antigen home test my antigen home test was positive 6 days after a negative antigen home test; Positive, notes: along with being positive; Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. I experienced all of the side effects of Paxlovid: diarrhea; "Paxlovid mouth" - extremely foul taste for the duration of the 5 day course; but most importantly, "Paxlovid Rebound" - my antigen home test was positive 6 days after a negative antigen home test. I had been in quarantine for 8 days at the time of the negative test. I still have nasal congestion and a cough, along with being positive.
Age: 65.0
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 (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: 039A21A), in left arm, on 26Apr2021 as dose 2, single (Lot number: 045B21A), in left arm, on 17Nov2021 as dose 3 (booster), single (Lot number: 027H21B), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: 049L21A) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. 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) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (Lot number: GA1189) from 03Jun2022 to 07Jun2022.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife; My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (172086).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, single (Batch/Lot number: unknown) and as dose 4, 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 "My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered./Pfizer however they were positive with Covid19, he and his wife". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical Information: He was a patient, and he was calling to ask if there was a correlation between Paxlovid and all of the vaccination they received. He mentioned that he was fully vaccinated with Pfizer however they were positive with Covid19, he and his wife. The Correlation between Paxlovid and all the other vaccination that he received that was his exact question. All the vaccination he had received, he mentioned that he was fully vaccinated with Pfizer (Later clarified as COVID-19 Vaccine hence captured as suspect and manufacturer checked Yes for Pfizer) and they still got positive with Covid. Consumer Stated, what is the correlation between Pfizer vaccinations and boosters My wife and I both had all the vaccinations Pfizer offered and all the boosters from Pfizer offered. What is the correlation between Paxlovid and all the vaccinations we had from Pfizer. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200836728 Same reporter/drug/AE, different patient;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 booster, single (Batch/Lot number: unknown) at the age of 67 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 1, single) and second regimen (Batch/Lot number: unknown) at single (dose 2, single) for Covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Gout" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Airborne, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant) with onset 12Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "started Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: positive; negative; positive. Therapeutic measures were not taken as a result of Covid-19. Patient stated that she started Paxlovid on day 4 after testing positive for Covid. She took it 5 days. On day 11, she tested neg for Covid on rapid and PCR test. She had been testing everyday since with a rapid test. On the 6th day after she finished Paxlovid, she developed symptoms and tested positive for Covid. She had rebound Covid on my 6th day after treatment and she want that recorded. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL9261), in right arm for covid-19 immunization. The patient's relevant medical history included: "Pancreatic cancer" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. The following information was reported: HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "not recovered", described as "Peripheral numbness feet, legs"; PARAESTHESIA (non-serious) with onset Mar2021, outcome "not recovered", described as "tingling in hands". The events "peripheral numbness feet, legs" and "tingling in hands" required physician office visit. Therapeutic measures were taken as a result of hypoesthesia, paranesthesia.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Peripheral numbness feet, legs; tingling in hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FF2588), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic carcinoma" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VIT D3; ASPIRIN [ACETYLSALICYLIC ACID]; PANTOPRAZOLE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL9261, Vaccine location= Right arm), for Covid-19 immunization, reaction(s): "Peripheral numbness feet, legs", "Peripheral numbness feet, legs", "tingling in hands"; Bnt162b2 (DOSE 2, SINGLE; Lot number: EN6200; Vaccine location= Right arm), for Covid-19 immunization, reaction(s): "Peripheral numbness feet, legs", "Peripheral numbness feet, legs", "tingling in hands". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "Peripheral numbness feet, legs"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in hands". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, peripheral numbness feet, legs and tingling in hands. Started after first dose but didn't equate it with vaccine until after the most recent booster. Initially in left foot/leg only about two three weeks after shot. A week after the 4th booster my right foot/leg and fingers were affected and right leg worse. Then connected the dots from beginning.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19, Weight
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4404009-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 23Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Weight: (unspecified date) 124 lbs; (2022) 105 lbs, notes: tremendous weight loss from 124 pound to 105 pound and was only weighing 102 pound. The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to BNT162b2. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect BNT162B2 cannot be denied for the reported events. ,Linked Report(s) : US-PFIZER INC-202101361686 Same patient/reporter/drug, different AE;
Age: 39.0
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 09Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cough-variant asthma" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: QVAR REDIHALER; FLOVENT; PANTOPRAZOLE, start date: 10Dec2021; POTASSIUM CITRATE, start date: 03Feb2022. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Negative, notes: Symptoms resolved and I tested negative multiple times; (14Jun2022) Positive, notes: symptoms returned and I tested positive again. Reboundexperienced. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details Product: COVID 19 Treatment,Brand: Paxlovid Treatment start date: 04Jun2022, Treatment stop date: 08Jun2022.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 44-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9265), in right arm, on 26Feb2021 as dose 2, single (Lot number: EN6200), in right arm and on 26Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; ALLERGAN; LEXAPRO. 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: Unknown results, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Vaccine received. Start date of treatment COVID-19 was 13Jun2022.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid symptoms were slight and tested pos; Covid symptoms were slight and tested pos; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, notes: Known allergies: No. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid symptoms were slight and tested pos". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid symptoms were slight and tested pos; Unknown results, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid from 03Jun2022 to 08Jun2022 for Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient. A 64-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), in Mar2021 at 12:00PM (as reported) as dose 1, single (Lot number: EP7534), in left arm, on 09Apr2021 at 13:00 as dose 2, single (Lot number: ER8729), in left arm and on 10Nov2021 at 16:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Patient received Paxlovid to treat "drug ineffective", "Covid-19". 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, Product administered at inappropriate site
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in left leg 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "Vaccine location: Left leg". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Patient received COVID-19 Treatment Paxlovid from 04Jun2022 to 08Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID 19 Treatment/mild upper respiratory infection (uri) symptoms; COVID 19 Treatment/mild upper respiratory infection (uri) symptoms; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 08Jan2021 at 09:00 as dose 1, single (Lot number: EK9231), in right arm, on 29Jan2021 at 08:00 as dose 2, single (Lot number: EL9261), in left arm, on 05Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 02May2022 at 10:00 as dose 4 (booster), single (Lot number: FJ9944) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "recovering", described as "COVID 19 Treatment/mild upper respiratory infection (uri) symptoms"; COVID-19 (medically significant) with onset 2022, outcome "recovering", described as "COVID 19 Treatment/mild upper respiratory infection (uri) symptoms ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (07Jun2022) Negative, notes: Negative home test 2 days after completion of Paxlovid; (13Jun2022) Positive, notes: Symptoms and positive home test 8 days after completion of Paxlovid; (Jun2022) negative, notes: Development of covid symptoms after use of Paxlovid and negative test results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient started Paxlovid within 48 hours of mild upper respiratory infection (uri) symptoms with total resolution of covid symptoms within 36 hours of starting Paxlovid. Similar symptoms with Paxlovid rebound. The product Paxlovid was a COVID 19 treatment.  Paxlovid was started on 01Jun2022 and stopped on 05Jun2022.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm and on 19May2022 as dose 4 (booster), single (Lot number: PL3198) at the age of 76 years, in right 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 was not reported. The patient had no known allergies. Concomitant medication(s) included: DONEPEZIL, start date: 25Aug2021; LOSARTIN, start date: 14Apr2021; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE], start date: 25Aug2021; PROZAC; SYNTHROID; WELLBUTRIN; ZOCOR; AZELASTINE HYDROCHLORIDE; ASPIRIN 81; CALTRATE [CALCIUM CARBONATE;COLECALCIFEROL]; NASACORT; VITAMIN D3; VITAMIN E [TOCOPHEROL]; CENTRUM WOMEN. The patient experienced Covid-19 on an unspecified date. The patient received Covid-19 treatment which included PAXLOVID taken from 28May2022 to 01Jun2022. The patient underwent the following laboratory tests and procedures: Covid-19 test: Unknown results. The outcome of the event was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Suspected COVID-19, Vaccination failure
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6202), on 01Apr2021 as dose 2, single (Lot number: Ep6955) and on 18Nov2021 as dose 3 (booster), single (Lot number: Ff2506) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 08Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Result. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Clinical Course: The patient had no known allergies, had a treatment with Paxlovid from 01Jun2022 to 05Jun2022.  No follow-up attempts are possible. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: she tested positive for Covid.; she tested positive for Covid.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team and product quality group, Program ID:  A 53-year-old female patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 19Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 08Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "not recovered" and all described as "she tested positive for Covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (12Jun2022) Positive, notes: diagnosed with COVID.  Clinical Course: It was reported that the patient was enquiring what will happen if she received the 4th booster shot while she tested positive for Covid. Caller states that she is seeking information on the fact the she had gotten the 4th dose of the Pfizer Covid 19 vaccine and tested positive for the Covid 19 virus days later. There is no information for that. Additional vaccines administered on same date of Pfizer suspect was reported as none. Prior vaccinations within 4 weeks was reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure and COVID-19 cannot be ruled out.