chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dysgeusia, Erythema, Gastrointestinal disorder
Clinical narrative: abdominal symptoms; very strange metallic taste in his mouth; had flare ups on a regular basis where the tip of his nose would get red and break out; had flare ups on a regular basis where the tip of his nose would get red and break out; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROINTESTINAL DISORDER (abdominal symptoms), DYSGEUSIA (very strange metallic taste in his mouth), ERYTHEMA (had flare ups on a regular basis where the tip of his nose would get red and break out) and CONDITION AGGRAVATED (had flare ups on a regular basis where the tip of his nose would get red and break out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Bacterial infection (he believed was MRSA.) since 2016.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (abdominal symptoms), DYSGEUSIA (very strange metallic taste in his mouth), ERYTHEMA (had flare ups on a regular basis where the tip of his nose would get red and break out) and CONDITION AGGRAVATED (had flare ups on a regular basis where the tip of his nose would get red and break out). At the time of the report, GASTROINTESTINAL DISORDER (abdominal symptoms) and DYSGEUSIA (very strange metallic taste in his mouth) outcome was unknown and ERYTHEMA (had flare ups on a regular basis where the tip of his nose would get red and break out) and CONDITION AGGRAVATED (had flare ups on a regular basis where the tip of his nose would get red and break out) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had a chronic bacterial infection in 2016, prior to vaccination, which was never cultured, but he believed was MRSA. He had flare ups on a regular basis where the tip of his nose would get red and break out, then resolve. Then Covid came, and the patient believed he had it, having abdominal symptoms and a very strange metallic taste in his mouth. However, he did not test for it, as he wasn't really that sick. The patient reported he got the J&J vaccine, followed with the Moderna COVID-19 vaccine booster a few months later. The patient reported he found that the infection on his nose vanished during this period.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for covid after being vaccinated.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (positive for covid after being vaccinated.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 032L20A and 011L25A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (positive for covid after being vaccinated.). At the time of the report, COVID-19 (positive for covid after being vaccinated.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient never received Pfizer vaccine. The patient was positive for Covid after being vaccinated thrice.  No treatment medications were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: About 1 week after vaccination I started having irregular heartbeats.; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE IRREGULAR (About 1 week after vaccination I started having irregular heartbeats.) in a 50-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced HEART RATE IRREGULAR (About 1 week after vaccination I started having irregular heartbeats.). At the time of the report, HEART RATE IRREGULAR (About 1 week after vaccination I started having irregular heartbeats.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2023, Heart rate: Irregular.         Concomitant medication was not provided. About 1 week after vaccination, patient started having irregular heartbeats. They had only gotten worse, and she just had to be put on heart medication. She never had this happen till after she got vaccine.   Company Comment: This is a spontaneous case concerning a 50-year-old, female patient with no reported medical history, who experienced the non-serious unexpected, AESI of Heart rate irregular. The event occurred approximately 1 week after a dose of SPIKEVAX 2023-2024 (dose number was not provided). As reported, the patient had only gotten worse and had to be put on heart medication. Clinical course, supportive diagnostic procedures and details about treatment medication were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: 8-9 hours following administration, became nauseous and started vomiting; 8-9 hours following administration, became nauseous and started vomiting; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (8-9 hours following administration, became nauseous and started vomiting) and VOMITING (8-9 hours following administration, became nauseous and started vomiting) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Feb-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 29-Feb-2024, the patient experienced NAUSEA (8-9 hours following administration, became nauseous and started vomiting) and VOMITING (8-9 hours following administration, became nauseous and started vomiting). At the time of the report, NAUSEA (8-9 hours following administration, became nauseous and started vomiting) and VOMITING (8-9 hours following administration, became nauseous and started vomiting) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bells palsy; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (bells palsy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 22-Feb-2021, the patient experienced BELL'S PALSY (bells palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (bells palsy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was unknown if the patient experienced any additional symptoms/events. The treatment medication was not reported by reporter. Company comment:  This spontaneous case concerns a 76-year-old female patient, with no medical history reported, who experienced the serious (medically significant) and unexpected AESI of BELL'S PALSY in the same year of vaccination, since the exact vaccination date with an unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine was not reported; hence, latency could not be properly assessed. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had no known allergies.   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, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: Patient had the Pfizer COVID vaccine prior to having COVID; Patient had the Pfizer COVID vaccine prior to having COVID; patient's 2nd time taking Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient had the Pfizer COVID vaccine prior to having COVID"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "patient's 2nd time taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. The patient and patient's wife were both ended up with it about the time the medication was approved and that is what doctor gave. The patient's wife applied for discount card, got the Paxlovid for patient yesterday (27Feb2024), went through boom, no problem. First time got it, patient was given monoclonal antibody treatment, where you lay down and they put stuff in IV. Had all of the vaccines and boosters, was fixing to get next dose. Clarified patient had the Pfizer COVID vaccines prior to having Covid, had 4 total doses, all were the Pfizer COVID vaccine. The patient's wife personally believes vaccine saved their life. Confirmed this patient's 2nd time taking Paxlovid as well.  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, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Patient had the Pfizer COVID vaccine prior to having COVID; Patient had the Pfizer COVID vaccine prior to having COVID; patient's 2nd time taking Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 73-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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient had the Pfizer COVID vaccine prior to having COVID"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "patient's 2nd time taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence. The patient and patient's wife were both ended up with it about the time the medication was approved and that is what doctor gave. The patient's wife applied for discount card, got the Paxlovid for patient yesterday (27Feb2024), went through boom, no problem. First time got it, patient was given monoclonal antibody treatment, where you lay down and they put stuff in IV. Had all of the vaccines and boosters, was fixing to get next dose. Clarified patient had the Pfizer COVID vaccines prior to having Covid, had 4 total doses, all were the Pfizer COVID vaccine. The patient's wife personally believes vaccine saved their life. Confirmed this patient's 2nd time taking Paxlovid as well.  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: COVID-19, Drug ineffective
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Date: Unknown, card with information is at home, NDC, lot, expiry: Unknown, card with information is at home, Time: Unknown, Route, anatomical location: In arm, unknown which arm, Administered at (withheld).), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Date: Unknown, card with information is at home, NDC, lot, expiry: Unknown, card with information is at home, Time: Unknown, Route, anatomical location: In arm, unknown which arm, Administered at (withheld).), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Date: Unknown, card with information is at home, NDC, lot, expiry: Unknown, card with information is at home, Time: Unknown, Route, anatomical location: In arm, unknown which arm, Administered at (withheld).), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  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-202400053096 same patient and drug, different dose and event;
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; recurrent positive Covid antigen test; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a Physician.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 73 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Feb2021 as dose 1, single (Lot number: 024M20A), in left arm, on 19Mar2021 as dose 2, single (Lot number: 002A21A), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: 048C21A), in left arm, on 05May2022 as dose 4 (booster), single (Lot number: 004M21A), in left arm, on 21Jun2023 as dose 6 (booster), single (Lot number: A57645B), in left arm and on 08Nov2023 as dose 7 (booster), single (Lot number: 3030342), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant) with onset Feb2024, outcome "recovered" (26Feb2024), described as "COVID 19"; COVID-19 (medically significant) with onset Feb2024, outcome "recovered" (26Feb2024), described as "recurrent positive Covid antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Feb2024) negative; (27Feb2024) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 19Feb2024 until 24Feb2024.; Sender's Comments: A causal relationship to the suspect drugs cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 69.0
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 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 03Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "arrhythmia" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ADVAIR. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID-19 treatment from 08Feb2024 to 12Feb2024.  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-202400053759 Same patient, different drug and event;
Sex: U
Vaccine: PNC20
Symptoms: Pyrexia
Clinical narrative: Mild fever after vaccine; This is a spontaneous report received from a Nurse from a sales representative.  An infant patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Mild fever after vaccine". It was unknown if therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: She had a reaction at the injection site: a red area at injection site; Little febrile; This is a spontaneous report received from a Physician from medical information team.  A 72-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 72 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension; ROSUVASTATIN taken for blood cholesterol increased; EFFEXOR taken for depression. The following information was reported: PYREXIA (non-serious) with onset 11Jan2022, outcome "unknown", described as "Little febrile"; VACCINATION SITE ERYTHEMA (non-serious) with onset 11Jan2022, outcome "unknown", described as "She had a reaction at the injection site: a red area at injection site". Therapeutic measures were taken as a result of pyrexia. Additional information: The reporter stated that she and her husband who are both retired physicians participated in Pfizer RSV vaccine. She thought she got the vaccine as she had a reaction at the injection site: a red area at injection site. She also reported she might have taken a dose of Tylenol because she felt a little febrile.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Heart rate irregular
Clinical narrative: developed an unspecified Cardiovascular disease; extremally variable heart rates, all over the place; This is a spontaneous report and received from Pharmacists from medical information team, Program ID.  A female patient (unknown if 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 and concomitant medications were not reported. The following information was reported: CARDIOVASCULAR DISORDER (non-serious), outcome "unknown", described as "developed an unspecified Cardiovascular disease"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "extremally variable heart rates, all over the place".  Additional information: A mother, her sister and her son received the Comirnaty vaccine. After this, these three patients developed an unspecified cardiovascular disease. Reporter believed it to be genetic, due to the three of them getting the same disease after vaccination. Reporter stated they did not have comorbidities, but after some time the reporter specified that the mother had postural orthostatic tachycardia syndrome. Their side effects were cardiac, with extremely variable heart rates, all over the place. The reporter found extremely interesting was the fact that not only that the mother had the severe reactions, so did her sister, who was still suffering as she was, and her son who milder case but again, a lot of the  symptoms, which may directly points to a genetic factor (further clarification Unknown, hence split not made).   Batch/lot number is not provided, and it cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "SVT (arrhythmia)" (unspecified if ongoing), notes: SVT (arrhythmia); "prostatectomy", start date: 2013 (unspecified if ongoing), notes: prostatectomy for treatment of prostate cancer in 2013; "known allergies: Sulpha drugs" (unspecified if ongoing); "SVT (arrhythmia)" (unspecified if ongoing), notes: SVT (arrhythmia). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 08Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 05Apr2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 08Oct2021, when the patient was 62-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 4, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 06May2022, when the patient was 62-year-old, for COVID-19 immunization; moderna (Dose Number: 5, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 09Sep2022, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, 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: 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 43-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Dec2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Alpha 1 antitrypsin deficiency" (unspecified if ongoing); "blood clot" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Batch/Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Batch/Lot number: unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN, Batch/Lot number: unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, which included nirmatrelvir, ritonavir (PAXLOVID) from 20Feb2024 to 24Feb2024.  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 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An adult male patient 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: Unknown, Vaccine lot unknown reason=Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot: Unknown, Vaccine lot unknown reason=Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot: Unknown, Vaccine lot unknown reason=Not available/provided to reporter at the time of report completion), for COVID-19 immunization. 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.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 54.0
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 Consumer or other non HCP.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL3302), in right arm, on 08Mar2021 as dose 2, single (Lot number: EN6201), in right arm and on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included treatment with Paxlovid from start date on 23Feb2024 and treatment stop date on 28Feb2024.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Has taken every other Covid shot/Never had reaction, only thing she ever had was just a little soreness.; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "Has taken every other Covid shot/Never had reaction, only thing she ever had was just a little soreness.".
Age: 55.0
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 Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hx of breast cancer" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LETROZOL, start date: 01Oct2019; LEVOTHYROXINE, start date: 01Jan1984. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 12Feb2024 to 17Feb2024.  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 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. It was unknown if patient had known allergies or other medical history. The following information was reported: 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 with Paxlovid.  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, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: pos Covid test; pos Covid test; 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), as dose 5 (booster), single (Lot number: Gj3295), in left arm and on 27Jun2023 at 12:15 as dose 6 (booster), single (Lot number: HJ3270), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's medical history included allergies with penicillin, some cholesterol meds cause myalgias, milk and fish together very serious allergy, diabetes type 2, Tuberculous pleurisy (A16. 5.5), moderate elevated BP, arthritis of spine knees, torn rotator cuff 2x spinal fusions, fibromyalgia, weight loss of 80 lbs in 14 years, leaky Heart valves, spring allergies, and kidney disease. Concomitant medication(s) included: CELEBREX; HCTZ; LOSARTAN; NEXIUM [ESOMEPRAZOLE SODIUM]; MG [MAGNESIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "recovered" (27Aug2023) and all described as "pos Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2023) Positive, notes: On 05Aug2023, returned from a cruise and had A pos Covid test that day; (27Aug2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400054933 same reporter/patient/prodcut, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood pressure abnormal, Dizziness, Fall, Hypoacusis
Clinical narrative: pos Covid test; pos Covid test; 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), as dose 5 (booster), single (Lot number: Gj3295), in left arm and on 27Jun2023 at 12:15 as dose 6 (booster), single (Lot number: HJ3270), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's medical history included allergies with penicillin, some cholesterol meds cause myalgias, milk and fish together very serious allergy, diabetes type 2, Tuberculous pleurisy (A16. 5.5), moderate elevated BP, arthritis of spine knees, torn rotator cuff 2x spinal fusions, fibromyalgia, weight loss of 80 lbs in 14 years, leaky Heart valves, spring allergies, and kidney disease. Concomitant medication(s) included: CELEBREX; HCTZ; LOSARTAN; NEXIUM [ESOMEPRAZOLE SODIUM]; MG [MAGNESIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "recovered" (27Aug2023) and all described as "pos Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2023) Positive, notes: On 05Aug2023, returned from a cruise and had A pos Covid test that day; (27Aug2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400054933 same reporter/patient/prodcut, different dose/event;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, Inappropriate schedule of product administration, Overdose, Presyncope, SARS-CoV-2 test
Clinical narrative: pos Covid test; pos Covid test; 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), as dose 5 (booster), single (Lot number: Gj3295), in left arm and on 27Jun2023 at 12:15 as dose 6 (booster), single (Lot number: HJ3270), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single) and as dose 4 (booster), single) for covid-19 immunisation. The patient's medical history included allergies with penicillin, some cholesterol meds cause myalgias, milk and fish together very serious allergy, diabetes type 2, Tuberculous pleurisy (A16. 5.5), moderate elevated BP, arthritis of spine knees, torn rotator cuff 2x spinal fusions, fibromyalgia, weight loss of 80 lbs in 14 years, leaky Heart valves, spring allergies, and kidney disease. Concomitant medication(s) included: CELEBREX; HCTZ; LOSARTAN; NEXIUM [ESOMEPRAZOLE SODIUM]; MG [MAGNESIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "recovered" (27Aug2023) and all described as "pos Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2023) Positive, notes: On 05Aug2023, returned from a cruise and had A pos Covid test that day; (27Aug2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400054933 same reporter/patient/prodcut, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Fall, Seizure
Clinical narrative: seizure; fell down after vaccination; This is a spontaneous report received from an Other HCP.  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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single, Unknown Manufacturer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Single, Unknown Manufacturer, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: SEIZURE (medically significant), outcome "recovered"; FALL (medically significant), outcome "recovered", described as "fell down after vaccination". The events "seizure" and "fell down after vaccination" required physician office visit. It was unknown if therapeutic measures were taken as a result of seizure, fall. Clinical course: Reported seizure after taking Pfizer vaccine. Person reported that she had a seizure after her first to vaccination. Also report daughter had the same issue. Additionally, her mother fell down after vaccination. Ages and of people are unknown. Timing of when vaccination is unknown. She said that her neurologist told her that it may be hereditary.  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: Based on the temporal relationship, the association between the events fall and seizure with COMIRNATY (2023-2024 Formula) can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Body height, Burning sensation, Investigation, Neuropathy peripheral, Weight
Clinical narrative: neuropathy; Burning sensation all over body; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Back issues" (unspecified if ongoing). Concomitant medication(s) included: MORPHINE taken for back disorder. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), outcome "not recovered", described as "neuropathy"; BURNING SENSATION (non-serious), outcome "not recovered", described as "Burning sensation all over body". The patient underwent the following laboratory tests and procedures: Body height: Unknown results, notes: Like 4, 11, has no idea; Test results: Unknown results, notes: Knows patient had a lot of them. Does not know specific ones, to be honest; Weight: Unknown results, notes: Maybe 165, 170, is just guessing. Therapeutic measures were taken as a result of neuropathy peripheral. Clinical Course: She said that did not know if that was true but, after she got Covid shot, vaccination, not sure if it was first one, thought it was second and, not 100 percent sure, was not going to ask all these questions in front of a bunch of people. After that, patient had this burning sensation all over her body. Going to say, she thought patient said, 2021 or 2022, did not remember. After completing initial report, caller stated she had separate report, regarding her sister for Covid vaccine. Patient still had it. Outcome: Had definitely persisted. Caller stated, she thought they told patient, she had neuropathy, was not sure what they gave her. She was on a lot of medication, was not really sure.  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
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Nurse.  A 58-year-old female patient (not 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: "Asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain / Chest was hurting as soon as patient got the shot; 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)), 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: CHEST PAIN (non-serious), outcome "unknown", described as "Chest pain / Chest was hurting as soon as patient got the shot".  Additional information: patient is having chest pain and started getting it shortly after the shot. The patient has a reaction to the Pfizer booster shot. The patient had a reaction to the shot and chest was hurting as soon as patient got the shot. it's been hurting and patient had to see a heart specialist.  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: MENB
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccines were administered; a temperature excursion happened; This is a spontaneous report received from a Nurse, Program ID.  A patient (age and gender not provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown", described as "Vaccines were administered"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "a temperature excursion happened".  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400028129 same reporter/events, different drug;US-PFIZER INC-PV202400028130 same reporter/events, different drug;
Sex: M
Vaccine: COVID19, COVID19, COVID19-2
Symptoms: Blood test, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer vaccine bivalent didn't work/ has contracted Omicron subvariant BAA; Pfizer vaccine bivalent didn't work/ has contracted Omicron subvariant BAA; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-761315, MOD-2024-761316.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 3 (booster), single) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Vitiligo" (ongoing), notes: He has an autoimmune disease vitiligo; "Does not smoke cigarettes, but used to over 2.5 years ago", stop date: 2021; "contracted Omicron in Dec2021", start date: Dec2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Jan2024, outcome "unknown" and all described as "Pfizer vaccine bivalent didn't work/ has contracted Omicron subvariant BAA". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; SARS-CoV-2 test: (26Jan2024) positive; Viral load: (17Feb2024) high viral load, notes: and still detectable. Clinical course: The patient had extremely high viral load as of 17Feb2024, has contracted Omicron subvariant BAA on 25Jan2024 and tested positive on 26Jan2024. Patient stated he had 2 monovalent Moderna vaccines, and a Moderna bivalent booster vaccine. He did not currently know the dates he received them, but he started the process 3.5-4 years ago so his mRNA waned over time. He gave permission for them to contact (withheld) to verify exact dates. Had a Pfizer bivalent vaccine about 2 years ago at (Withheld) in (Withheld). Done many blood tests. Agent asked to clarify when he was diagnosed with COVID, he said 3 days ago, 17Feb2024. Patient was also dispensed Paxlovid through (withheld) in (withheld), per his request when he contracted Omicron in Dec2021. He was diagnosed around 01Dec. It was a 5 day packet. It worked, got rid of his migraine headaches and runny nose after 7 days. He had previously received the first 2 Moderna monovalent and then Moderna booster shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : 202400053641 same patient/product, different events;