chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Dose 1, 2 and 4:Moderna; Dose 3: Pfizer BioNTech vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 3 (booster), single (Lot number: FK9893) at the age of 54 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Feb2021 as dose 1, single (Lot number: 024M20A), in left arm, on 24Oct2021 as dose 2, single (Lot number: 040a21a), in left arm and on 06Sep2022 as dose 4 (booster), single (Lot number: As7140c), in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; LORATADINE, stop date: 28Nov2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Apr2022, outcome "unknown", described as "Dose 1, 2 and 4:Moderna; Dose 3: Pfizer BioNTech vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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) from product quality group. The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ3277), 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 was not reported. The patient took concomitant medications. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine received and other medication in 2weeks was Yes. It was reported that patient received treatment with Paxlovid from 29Nov to 03Dec.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Moderna Dose 4 & 5; 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 38-year-old male patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: EL9269), on 02Mar2021 as dose 2, single (Lot number: EN6202) and on 25Sep2021 as dose 3 (booster), single (Lot number: 301307A) at the age of 37 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18May2022 as dose 4 (booster), single (Lot number: 059M21A) for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 27Sep2022 as dose 5 (booster), single (Lot number: 055F22B) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing). Concomitant medication(s) included: VENLAFAXINE, start date: Feb2022. Past drug history included: Minocycline, reaction(s): "Known allergies: Minocycline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Sep2022, outcome "unknown", described as "Moderna Dose 4 & 5". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2022) Negative, notes: two negative home tests on the evening of 05Dec2022; (07Dec2022) Negative, notes: two negative home tests on the evening of 05Dec2022 and morning of 07Dec2022; (10Dec2022) Positive, notes: on the morning of 10Dec2022 tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The patient also received other medication venlafaxine (Feb2022) in 2 weeks. The patient had known allergy with minocycline and also had other medical history of asthma, migraines.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; Tested positive after negative tests; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single, 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: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Tested positive after negative tests". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after negative tests; Positive, notes: Tested positive after negative tests.  Clinical course: Other medication in 2weeks product: Prednisone. Other medication in 2weeks start date: 29Nov2022. Other medication in 2weeks stop date: 07Dec2022  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: vaccination failure; COVID 19; This is a spontaneous report received from 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 03Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic Arthritis" (unspecified if ongoing); "Heart" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, stop date: 01Dec2022; CARVEDILOL; COSAMIN DS [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE;MANGANESE ASCORBATE]; ISOSORBIDE; FOLIC ACID; LUBIPROSTONE; METHOTREXATE; PANTOPRAZOLE; PEARLS PROBIOTICS; PRASUGREL; PRESERVISION AREDS; REMICADE; VITAMIN D3. Past drug history included: Naproxen, reaction(s): "known allergies: naproxen". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, the patient received paxlovid from 01Dec2022 to 06Dec2022.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough infections; breakthrough infections; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 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) all with onset May2022, outcome "unknown" and all described as "breakthrough infections". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Clinical course: The patient reported that the patient was fully vaccinated with Pfizer's Covid vaccine, including the inital series in Mar2021 (unspecified date), booster in Sep2021 (unspecified date), and updated (new variant) booster in Sep2022 (unspecified date). The patient work in clinical research and was not sure if the data of breakthrough infections would be liked, as the patient had then tested positive in three separate infections on May2022 (unspecified date), on Oct2022 (unspecified date) and on Dec2022 (unspecified date).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
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 (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Clinical course: Unknown if there are other medication in 2weeks. 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
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) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 16:00 as dose 1, single (Lot number: EN6205), in right arm, on 30Mar2021 at 14:00 as dose 2, single (Lot number: ER8733), in right arm and on 19Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FJ1611) at the age of 68 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "skin lupus" (unspecified if ongoing); "GERD" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Bactria" (unspecified if ongoing); "known allergies: shellfish" (unspecified if ongoing); "overweight" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EN6205, ER8733, FJ1611 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6205, fill lot EN5337, formulated drug product lot EN5326; finished goods lot ER8733, fill lot EP8685, formulated drug product EP8572; finished goods lot FJ1611, fill lot FH4344 formulated drug product FJ8502. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I had COVID-19; I had COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 27Nov2022, outcome "recovered" (05Dec2022) and all described as "I had COVID-19".  Clinical information: Patient just came off COVID. Patient had COVID-19 back in 27Nov2022 and was diagnosed clear on 05Dec2022. Stated never had any side-effects from any other vaccines of Pfizer was asking if one case still get vaccinated even though you have just gone through COVID-19, 5 days later.  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-202201369378 same patient/drug, different AE/dose;
Age: 70.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "known allergies: Bone" (unspecified if ongoing), notes: known allergies: Bone. Concomitant medication(s) included: MYLAN ATORVASTATIN, start date: 01May2022, stop date: 21Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about covid treatment was yes. Paxlovid, Other medication in 2weeks was yes. Anti Viral details was product: COVID 19 Treatment brand was Pfizer, treatment start date was 21Nov2022, reatment stop date was 25Nov2022 and indication was treatment of COVID-19.   Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9702. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CYMBALTA; DULOXETINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 08Dec2022 to 11Dec2022 for COVID 19 Treatment.  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-202201372206 Same patient, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer
Clinical narrative: Breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "lymph nodes swelled in her arm pit". The following information was reported: BREAST CANCER (medically significant) with onset Sep2022, outcome "unknown".  Clinical information: While reporting on her son, the caller mentioned that she has cancer. She stated that she also had the the same Pfizer Covid-19 Vaccine. Her cancer was diagnosed after her Pfizer doses and she believes that the vaccine showed them that she had cancer. She thinks the vaccine sped up her cancer. After her first vaccination, her lymph nodes swelled in her arm pit. She did not want to get a second dose, but was getting a new job and did not want to lie on the application so she got fully vaccinated. She was diagnosed with a very aggressive breast cancer in Sep2022.   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-202201374752 Same product, patient, different AEs, different dose;
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 36 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), on 22Apr2021 as dose 2, single (Lot number: ER8731) and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history included: "IUD" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; MIRENA; EMGALITY [GALCANEZUMAB]. The following information was reported: VACCINATION FAILURE (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: (11Dec2022) Positive, notes: four days after completing Paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient took paxlovid for COVID 19 treatment from 03Dec2022 to 08Dec2022. Return of covid symptoms/positive test results four days on 11Dec2022 after completing Paxlovid course. Patient had no known allergies and no other medical history.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective
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 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma linked to allergens" (unspecified if ongoing), notes: Asthma linked to allergens. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Body mass index: 29. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient took paxlovid 300 mg: 100mg dose for COVID 19 treatment from 11Dec2022 to 12Dec2022. Known allergies: No actually before taking Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: She also mentions that every after she gets the pfizer covid vaccine she experiences Guillain-Barre symptoms.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "She also mentions that every after she gets the pfizer covid vaccine she experiences Guillain-Barre symptoms.".  Clinical Course: Reported as, She mentioned that every after she gets the pfizer covid vaccine she experiences Guillain-Barre symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient 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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Clinical course: the reporter's brother and his brother's wife (patient) got Covid shots and went out to on the holiday with their kids and granddaughters and got Covid. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201372485 Same reporter, similar events in different patient;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient 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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Clinical course: the reporter's brother and his brother's wife got Covid shots and went out to Thanksgiving with their kids and granddaughters and got Covid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201372468 Same reporter, similar events in different patient;
Age: 74.0
Sex: F
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: G23277) at the age of 74 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Tetracycline, reaction(s): "Known allergies:Tetracycline"; Composine, reaction(s): "Known allergies: Composine". 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment medication from 04Dec2022 to 10Dec2022 for Covid-19.
Age: 33.0
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) (Nurse) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 03Feb2021 as dose 2, single (Lot number: EL3247), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF2985) at the age of 33 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "gastric bypass 2018" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Wellbutrin, reaction(s): "known allergies: wellbutrin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: the patient was treated with Paxlovid for Covid-19 from 12Dec2022 (also reported as 13Dec2022).; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Vaccination Failure and COVID-19 cannot be ruled out.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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. An 80-year-old male patient received BNT162B2, BNT162B2 OMI BA.4-5, on 08Sep2022 at 11:00 AM as dose number unknown (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; COVID-19 VACCINE, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "V Leiden blood clotting disorder" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN. Past drug history included: Morphine, reaction(s): "Known allergies- morphine"; Hydrocodone, reaction(s): "Known allergies- hydrocodone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Paxlovid treatment with start date on 28Nov2022 and treatment stop date on 03Dec2022, indication for treatment of COVID-19.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 19-year-old student dies 6 hours after receiving Covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 19-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "19-year-old student dies 6 hours after receiving Covid-19 Vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: 19-year-old student dies 6 hours after receiving Covid-19 Vaccine
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough infections; breakthrough infections; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 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) all with onset Oct2022, outcome "unknown" and all described as "breakthrough infections". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (Oct2022) Positive; (Dec2022) Positive.  Clinical course: The patient reported that the patient was fully vaccinated with Pfizer's Covid vaccine, including the inital series in Mar2021 (unspecified date), booster in Sep2021 (unspecified date), and updated (new variant) booster in Sep2022 (unspecified date). The patient work in clinical research and was not sure if the data of breakthrough infections would be liked, as the patient had then tested positive in three separate infections on May2022 (unspecified date), on Oct2022 (unspecified date) and on Dec2022 (unspecified date).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Maternal exposure during pregnancy, Oxygen saturation
Clinical narrative: 27 weeks pregnant at time of initial test; Tested positive for COVID-19; Tested positive for COVID-19; 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 (pregnant) 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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 27 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "27 weeks pregnant at time of initial test"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: 100'; Oxygen saturation: no lower than 92; SARS-CoV-2 test: Positive, notes: Tested positive for COVID-19; Negative, notes: Negative test achieved on day six. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: tested positive for COVID-19 on an unspecified date. The patient was 27 weeks pregnant at time of initial test. Symptoms included fever around 100' for several days, pulse ox measurements of no lower than 92% over the course of two weeks, chest cough with persistent congestion on-going. The patient then received PAXLOVID five-day course, which was started 30 hours post positive test. Negative test achieved on day six after start of anti-viral treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: 27 weeks pregnant at time of initial test; Tested positive for COVID-19; Tested positive for COVID-19; 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 (pregnant) 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; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient was 27 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant), outcome "unknown", described as "27 weeks pregnant at time of initial test"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: 100'; Oxygen saturation: no lower than 92; SARS-CoV-2 test: Positive, notes: Tested positive for COVID-19; Negative, notes: Negative test achieved on day six. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: tested positive for COVID-19 on an unspecified date. The patient was 27 weeks pregnant at time of initial test. Symptoms included fever around 100' for several days, pulse ox measurements of no lower than 92% over the course of two weeks, chest cough with persistent congestion on-going. The patient then received PAXLOVID five-day course, which was started 30 hours post positive test. Negative test achieved on day six after start of anti-viral treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 55.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 50.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT EXPRESSED A DESIRE TO RECIEVE A SHINGLES VACCINE.  UPON ADMINISTRATION, PATIENT SAID THAT MAYBE SHE HAS ALREADY RECEIVED ONE DOSE AT A DIFFERENT PHARMACY BUT IT WAS AN OLD VERSION (ZOSTAVAX).  UPON VERIFING INFORMATION USING STATE IMMUNIZATION WEBSITE, IT WAS DISCOVERED THAT PATIENT ALREADY HAD 2 DOSES OF SHINGRIX AT A DIFFERENT PHARMACY AND SHE HAS RECIEVED A 3RD DOSE WITH US.  PATIENT COMPLAINED OF A SWALLEN AND PAINFUL ARM.
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 7.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 68.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. Dose was given to patient. Offered a revaccination. No symptoms reported.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 39.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 14.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 28.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 78.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 73.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 18.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. dose was given to patient. offered a revax. no symptoms reported
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated, dose was given and no adverse reaction was reported, offered to revaccinate.