chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Lack of efficacy - positive COVID-19; Lack of efficacy - positive COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 42-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 10:00 as dose 1, single (Lot number: HF9275) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEXAPRO. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Dec2023 at 20:00, outcome "recovering" and all described as "Lack of efficacy - positive COVID-19". The event "lack of efficacy - positive covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Dec2023) Positive; (19Dec2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of  vaccination failure, covid-19 which included Paxlovid. Clinical course: No covid prior to vaccination. covid tested post vaccination: Yes. Patient had no known allergies. Other Medical History: Not applicable.    No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis, Respiratory syncytial virus infection
Clinical narrative: pericarditis; myocarditis; RSV infection; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), 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: PERICARDITIS (medically significant), outcome "unknown"; MYOCARDITIS (medically significant), outcome "unknown"; RESPIRATORY SYNCYTIAL VIRUS INFECTION (non-serious), outcome "unknown", described as "RSV infection". The events "pericarditis", "myocarditis" and "rsv infection" required physician office visit. Clinical course: Claimed pericarditis and myocarditis approximately 5 days after receiving COVID-19 vaccine; not diagnosed until 18 months later when had subsequent RSV infection. It was unknown if patient received treatment, had covid prior vaccination and tested covid post vaccination. It was unknown if patient had Known allergies and Other medical history.  The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result= Positive; Covid test result= Positive; This is a spontaneous report received from a Nurse from product quality group.  A 39-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 13:45 as dose 1, single (Lot number: HF9275) at the age of 38 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CSL H1N1 PANDEMIC INFLUENZA VACCINE taken for immunisation, on 13Sep2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Dec2023 at 16:30, outcome "recovering" and all described as "Covid test result= Positive". The event "covid test result= positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received more than 3 doses. It was reported that reporter did not know where he was exposed but sudden onsite 13Dec2023 at 04:30 pm severe symptoms fevers 103.1, cough, SOB (shortness of breath), fatigue and joint aches, got paxlovid. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. Covid tested post vaccination.  No follow-up attempts are possible.; Sender's Comments: Based on available information a contributory role of BNT162b2 omi xbb.1.5 to the reported events, vaccination failure and covid-19 cannot be totally excluded as efficacy of a drug varies from individual to individual.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cause cancer; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cause cancer".  Clinical information: Inquiry from the patient (reporter) included, Does the Pfizer vaccine for Covid cause cancer, Stated Many said yes and before reporter file a lawsuit, reporter was asking.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Palpitations
Clinical narrative: blood pressure had been high; blood pressure had been high and so was her pulse; When she lies down her heart pounds; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient (unknown if pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "calcium levels were high" (unspecified if ongoing); "liver enzymes high" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hctz; Losartan. The following information was reported: PALPITATIONS (non-serious) with onset 2023, outcome "unknown", described as "When she lies down her heart pounds"; HYPERTENSION (non-serious) with onset 2023, outcome "unknown", described as "blood pressure had been high"; HEART RATE INCREASED (non-serious) with onset 2023, outcome "unknown", described as "blood pressure had been high and so was her pulse". Therapeutic measures were taken as a result of hypertension. Additional information: She was taking HCTZ and Losartan prior to getting the covid vaccine. Her hcp took her off of the HCTZ  sometime after receiving the Pfizer covid vaccine because her calcium levels were high and liver enzymes were high. Patient received Pfizer covid vaccine in Oct2023 and since then her blood pressure had been high and so was her pulse.  When she lies down her heart pounds. Her hcp added Amlodipine to her medication regime on top of her Losartan. Patient stated she had a friend who started experiencing blood pressure problems and weight gain 2 weeks  after receiving Pfizer covid vaccine and another friend who has been in and out of hospital with high blood pressure after receiving Pfizer covid vaccine as well.  Patient stated and yet another friend died last month (as of 19Dec2023 ) from motor neuron disease (Lou Gherigs Disease). States her friends symptoms developed rapidly after receiving covid shot ( mfg unknown).  Patient was asking if increased blood pressure and increased pulse has been reported.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Nasal Swab:Positive; Nasal Swab:Positive; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in arm, as dose 2, single (Batch/Lot number: unknown), in arm, as dose 3 (booster), single (Batch/Lot number: unknown), in arm and on 02Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "If covid tested prior vaccination: Yes" (unspecified if ongoing), notes: If covid tested prior vaccination: Yes. Concomitant medication(s) included: ESCITALOPRAM; NEURYL [CLONAZEPAM]. The patient also took other concomitant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Nasal Swab:Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: nasal swab.  Clinical information: No known allergies and other medical history. Facility type vaccine was pharmacy or perfumery. No other vaccine in four weeks. Other medications in two weeks noted Escitalopram and neutral. No other vaccine in four weeks. The patient reported that the patient received 4 doses, two in each arm. Covid was tested post vaccination noted nasal swab test with positive result.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300451206 same reporter/patient/event, different dose;US-PFIZER INC-202300451205 same reporter/patient/event, different dose;US-PFIZER INC-202300451207 same reporter/patient/event, different dose;US-PFIZER INC-202300451208 same reporter/patient/event, different dose;
Age: 60.0
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 Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 9, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 8, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 7, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 6, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 5, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (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; Negative, notes: Covid rebound 2 days after testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. Anti-viral details included Paxlovid for COVID 19 Treatment started on 08Dec2023 stopped on 12Dec2023. Patient experienced Covid rebound 2 days after testing negative with Paxlovid.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had received antiviral covid 19 treatment with Paxlovid from 11Dec2023 to 15Dec2023. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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 Consumer or other non HCP.  A 78-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. 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: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (Dec2023) Negative, notes: Rebound covid within week of testing negative. Therapeutic measures were taken as a result of drug ineffective.  clinical course: COVID 19 Treatment (Pfizer) from 09Dec2023 to 14Dec2023,  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Single, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (Booster), Single, unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received anti viral covid 19 treatment with Paxlovid from 08Dec2023 to 13Dec2023. Other medical history: None.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 58.0
Sex: M
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 Consumer or other non HCP.  A 58-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Dec2023, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2023) Positive, notes: Tested positive for COVID on 10Dec2023;; (16Dec2023) Negative, notes: tested negative starting 16Dec;; (19Dec2023) Positive, notes: recurrence of COVID on 19Dec including positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Tested positive for COVID on 10Dec2023; Took Paxlovid for 5 days as prescribed from 10Dec2023 to 15Dec2023); tested negative starting 16Dec2023; recurrence of COVID on 19Dec2023, including positive test.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: I have had 4 of the initial shots and two other, 6 in all/all of the COVID vaccines were Pfizer vaccines she had them in 2020, 2021 and the last one 2023/they finally didn't work; I have had 4 of the initial shots and two other, 6 in all/all of the COVID vaccines were Pfizer vaccines she had them in 2020, 2021 and the last one 2023/they finally didn't work; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, 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, Single), administration date: 2020, for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization; Bnt162b2 (Dose 3 (Booster), Single), for COVID-19 immunization; Bnt162b2 (Dose 4 (Booster), Single), for COVID-19 immunization; Bnt162b2 (Dose 5 (Booster), Single), for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "I have had 4 of the initial shots and two other, 6 in all/all of the COVID vaccines were Pfizer vaccines she had them in 2020, 2021 and the last one 2023/they finally didn't work". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient husband and Patient had 4 of the initial shots and two other, 6 in all. Patient have been taking them since 2020 and they finally didn't work, Reporter thought we had gotten away with not getting COVID, but there seems to be an epidemic where we are in withheld. Caller states all of the COVID vaccines were Pfizer vaccines she had them in 2020, 2021 and the last one 2023, we just had the last one a couple months ago." Patient had COVID and picked these pills up 3 days ago.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient had not other medication in 2weeks. Patient had administered paxlovid for the treatment.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
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 Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 10:00 as dose 1, single at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Thyroid Disease" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Jan1995. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (dose 5, single; lot number=GH9697, location= right arm), administration date: 29Oct2022, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2 (dose 4, single; lot number=FJ5683, location=Right arm), administration date: 06Apr2022, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (dose 3, single; lot number=FH8027, location=Right arm), administration date: 10Oct2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (dose 2, single; lot number=ER2613, location=Right arm), administration date: 25Mar2021, when the patient was 62-year-old, for Covid-19 Immunization; BNT162b2 (dose 1, single; lot number=EB6198, vaccine location=Right arm), administration date: 04Mar2021, when the patient was 62-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant) with onset 05Dec2023, outcome "not recovered", COVID-19 (medically significant) with onset 05Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Dec2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid as COVID 19 Treatment from 05Dec2023 to 09Dec2023
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 08Dec2023 to 13Dec2023 for the treatment of COVID-19. No known allergies.  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.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 at 18:30 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "reactive airway disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Dec2023) Negative, notes: was testing negative Thursday and Friday; (15Dec2023) Negative, notes: was testing negative Thursday and Friday; (17Dec2023) Positive, notes: on Sunday tested positive again. I'm still positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Weight increased
Clinical narrative: blood pressure problems; weight gain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: BLOOD PRESSURE ABNORMAL (non-serious), outcome "unknown", described as "blood pressure problems"; WEIGHT INCREASED (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "weight gain". Additional information: she has a friend who started experiencing blood pressure problems and weight gain 2 weeks after receiving pfizer covid vaccine.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive for COVID; I tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years intramuscular, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Dec2023, outcome "recovering" and all described as "I tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: No other vaccine in four weeks. No other medication in two weeks. No covid prior to vaccination. No known allergies. The patient was tested after his daughters and wife tested positive, and the patient tested positive for COVID. His symptom are a mild sore throat, mild chills, and mild fatigue.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Migraine, Myalgia, Vaccination site pain
Clinical narrative: Soreness at injection site; achy muscles and joints; achy muscles and joints; migraine; This is a spontaneous report received from an Other HCP.  A 45-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Dec2023 at 14:45 as dose 1, single (Lot number: HG9497) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; AIRBORNE; MIDNITE. Past drug history included: Neosporin [neomycin sulfate;polymyxin b sulfate], reaction(s): "Allergy"; Aspirin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Dec2023 at 18:00, outcome "recovered", described as "Soreness at injection site"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 19Dec2023 at 18:00, outcome "recovered" and all described as "achy muscles and joints"; MIGRAINE (non-serious) with onset 19Dec2023 at 18:00, outcome "recovered". Therapeutic measures were taken as a result of migraine.  Additional information: the patient received Tylenol rapid release: 2 capsules for migraine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested positive for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Neck pain, Pain in extremity
Clinical narrative: Loss of full mobility of left arm. Can only lift arm about half-way. Have arm and neck pain.; Loss of full mobility of left arm. Can only lift arm about half-way. Have arm and neck pain.; Loss of full mobility of left arm. Can only lift arm about half-way. Have arm and neck pain.; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Feb2023 as dose number unknown (booster), single (Lot number: GL0447) at the age of 53 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: pfizer / biontech (Batch/Lot No: EN0217, Location of injection: Arm Left), administration date: 10Jul2021, when the patient was 51-year-old; pfizer / biontech (Batch/Lot No: FA7484, Location of injection: Arm Left), administration date: 31Jul2021, when the patient was 51-year-old, for COVID-19 immunisation. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious) all with onset 13Mar2023, outcome "not recovered" and all described as "Loss of full mobility of left arm. Can only lift arm about half-way. Have arm and neck pain.". Therapeutic measures were taken as a result of joint range of motion decreased, pain in extremity, neck pain. Additional information: Treatment with prednisone 10mg tablets, two rounds.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: faulty syringe separated from the needle; sprayed my daughter's face; sprayed my daughter's face; sprayed my daughter's face; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID: .  A female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 03Dec2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: SYRINGE ISSUE (non-serious) with onset 03Dec2023, described as "faulty syringe separated from the needle"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious), UNDERDOSE (non-serious) all with onset 03Dec2023 and all described as "sprayed my daughter's face".  Additional information: The parent reported that while the patient was receiving a covid vaccine booster on 03Dec2023, a faulty syringe separated from the needle and the vaccine sprayed into patient's face.   Causality for "faulty syringe separated from the needle" and "sprayed my daughter's face" was determined associated to device constituent of BNT162b2 omi xbb.1.5 (malfunction).  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities. This report includes also additional follow-up information received on 14Dec2023. Suspect updated to BNT162B2 OMI XBB.1.5 prefilled syringe (TOPPAC), Event syringe issue added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300434586 Same reporter, drug and event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Menstrual disorder, Premenstrual syndrome
Clinical narrative: it makes my periods and PMS a nightmare; it makes my periods and PMS a nightmare; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: MENSTRUAL DISORDER (non-serious), PREMENSTRUAL SYNDROME (non-serious), outcome "unknown" and all described as "it makes my periods and PMS a nightmare".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I was just diagnosed w Covid.; I was just diagnosed w Covid.; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Dec2023 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), SUSPECTED COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "I was just diagnosed w Covid." Clinical course: It was reported that patient didn't get the texts in follow up like initially did.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: still can't see very well; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2023NVX-US-000001809 (Novavax).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "corneal transplant", start date: 2022 (unspecified if ongoing); "corneal rejection" (unspecified if ongoing); "corneal transplant", start date: Jul2022 (unspecified if ongoing), notes: underwent surgery for another corneal transplant. The patient's concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "still can't see very well". Additional information: On 04Dec2023, it was reported that a patient started treatment on an unreported date with Pfizer BioNTech COVID-19 Vaccine unspecified dose for COVID-19 immunisation. It was reported that the patient received a corneal transplant 1 year prior to receipt of the Pfizer COVID-19 vaccine. In around May or June of 2022, she began experiencing symptoms of corneal rejection. In Jul2022, the patient underwent surgery for another corneal transplant. The patient reported that she still couldn't very well.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Got Covid 19; Got Covid 19; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RSV VACCINE taken for immunisation, in 2023 as dose number unknown, single; FLU VACCINE VII taken for influenza immunisation, in 2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 Immunisation, reaction(s): "Covid-19". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Got Covid 19". Clinical course: The patient received the latest Pfizer Covid 19 shot at PRIVACY about a month before the patient cruised. Along with the flu and SRV shot (all about a week apart from each other). About a week after patient returned and got Covid 19. Patient lived in PRIVACY and many here have had it as well. The patient had the other brand when lived in PRIVACY but got Covid as well there.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300450454 Same reporter/vaccine/event, different patient;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Atelectasis, COVID-19, Chest X-ray, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: Atelectasis; acute covid; acute covid; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 64-year-old female patient received BNT162b2 (COMIRNATY), on 11Mar2021 as dose 1, single (Lot number: EN6204), in arm, on 01Apr2021 as dose 2, single (Lot number: EN6207), in arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 64 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "I may have long covid" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breath overall off.; "Anxiety" (unspecified if ongoing); "get very tired" (unspecified if ongoing); "shortness of breathoverall off" (unspecified if ongoing); "scarring in lung" (unspecified if ongoing); "Syncope" (unspecified if ongoing), notes: had happened before. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Feb2022, outcome "unknown" and all described as "acute covid"; ATELECTASIS (medically significant) with onset 11Oct2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (11Oct2023) atelectasis, notes: 2 CT scans for unrelated reasons & I have < atelectasis bilateral upper lung base(L) Mild line or subsequential atelectasis in base Values in all 4 heart valves-varying degrees I believe I have lung covid; SARS-CoV-2 test: (22Feb2022) Acute Covid; Chest X-ray: (22Feb2022) Clear.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300274675 Same product/patient, different event/dose;US-PFIZER INC-202300274683 Same patient/product, different dose/events;
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Atelectasis; acute covid; acute covid; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 64-year-old female patient received BNT162b2 (COMIRNATY), on 11Mar2021 as dose 1, single (Lot number: EN6204), in arm, on 01Apr2021 as dose 2, single (Lot number: EN6207), in arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 64 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "I may have long covid" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breath overall off.; "Anxiety" (unspecified if ongoing); "get very tired" (unspecified if ongoing); "shortness of breathoverall off" (unspecified if ongoing); "scarring in lung" (unspecified if ongoing); "Syncope" (unspecified if ongoing), notes: had happened before. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Feb2022, outcome "unknown" and all described as "acute covid"; ATELECTASIS (medically significant) with onset 11Oct2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (11Oct2023) atelectasis, notes: 2 CT scans for unrelated reasons & I have < atelectasis bilateral upper lung base(L) Mild line or subsequential atelectasis in base Values in all 4 heart valves-varying degrees I believe I have lung covid; SARS-CoV-2 test: (22Feb2022) Acute Covid; Chest X-ray: (22Feb2022) Clear.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300274675 Same product/patient, different event/dose;US-PFIZER INC-202300274683 Same patient/product, different dose/events;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Incorrect dose administered, SARS-CoV-2 test
Clinical narrative: he did one of the home test and it came positive; he did one of the home test and it came positive; had two booster shots; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) and in 2023 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; Manufacturer unknown), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 2023, outcome "unknown", described as "had two booster shots"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "he did one of the home test and it came positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive.  Clinical course: Patient had two booster shots at (Facility name withheld) on 12th (unspecified, as reported), want it today because he did one of the home test and it came positive. Patient would like to know if he can get the booster today. Patient might have missed a dose for his medication since he tested positive for COVID.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: deceased; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: DEATH (death, medically significant), outcome "fatal", described as "deceased". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: Reported that My mother's husband is deceased. Please stop sending these mail errors to my home.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Reported Cause(s) of Death: deceased
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got a covid vaccine and she was tested positive now; got a covid vaccine and she was tested positive now; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID:.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular 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 2023, outcome "unknown" and all described as "got a covid vaccine and she was tested positive now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient called because she received a Paxlovid that the expiry date was scratch out lot# GJ7331. Caller got a covid vaccine and she was tested positive now (2023) and she was now experiencing adverse effect of the Paxlovid, she also wants to know if there is already a approve medication for covid 19. Caller got her covid vaccine before but now she tested positive.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; expiration date sticker 12/11/2023, given 12/15/2023
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; expiration date sticker 12/11/2023, given 12/20/2023
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; expiration date sticker 12/11/2023, given 12/20/2023
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered expired vaccine; expiration date sticker 12/11/2023, given 12/20/2023
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Mobility decreased, Myalgia
Clinical narrative: Muscle pain  arm fatigue  could hardly lift right arm
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Injection site reaction, Migraine
Clinical narrative: Headache then migraine Stiff very sore arm around injection site, Arm swollen, pink in color Chills, nausea, Sore muscles - legs, body Itchy face, specially right side of cheek & above & around right eye-brow. After 20 hrs, itchiness all over; face, neck, arms, sides of torso, legs, toes (yep), inside ears, scalp, fingers (!), eyes, nose (all night), back. The nausea was so strong, worked to stay relaxed & calm so not to vomit. Possibly ran fever. I wasn't connecting the physical reactions to the vaccine until day 3