chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19; COVID 19; Pfizer - Dose Number: 4; Moderna - Dose Number: 5; This is a spontaneous report received from a Physician.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Nov2023 as dose 5 (booster), single), 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 had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown", described as "Pfizer - Dose Number: 4; Moderna - Dose Number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used for COVID 19 treatment, from 28Dec2023 to 02Jan2024.  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: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162b2, BNT162b2 omi ba.4-5 to the reported events drug ineffective, COVID-19, interchange of vaccine products cannot be ruled out.
Age: 57.0
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 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Dec2022 as dose 4 (booster), single (Lot number: GL2042) at the age of 57 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 22Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: EP7534), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE, start date: 01Nov2021, stop date: 29Dec2023. Past drug history included: Macrobid, reaction(s): "Drug allergy"; Erythromycin, reaction(s): "Drug allergy"; Iodine, reaction(s): "Drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2024) Negative. The patient tested negative for one day after 3 days of completing PAXLOVID course of treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included taking PAXLOVID from 31Dec2023 to 04Jan2024. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Physician. Patient is the reporter.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 as dose 5 (booster), single (Lot number: GJ3274) at the age of 66 years 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 relevant medical history included: "Known allergies: 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) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient received PAXLOVID from 26Dec2023 to 31Dec2023 as COVID-19 treatment and acetaminophen on 23Dec2023. Other medical history was no significant illnesses.; 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, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Mobility decreased, Pyrexia
Clinical narrative: had a temperature; i was sick for 7 days; couldn't get off the couch or nothing; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 85-year-old 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. The following information was reported: PYREXIA (medically significant), outcome "unknown", described as "had a temperature"; ILLNESS (medically significant), outcome "unknown", described as "i was sick for 7 days"; MOBILITY DECREASED (medically significant), outcome "unknown", described as "couldn't get off the couch or nothing". The events "had a temperature", "i was sick for 7 days" and "couldn't get off the couch or nothing" required physician office visit. Therapeutic measures were taken as a result of pyrexia, illness. Additional information: patient was sick for 7 days and had a temperature and then they sent her to the Hospital to give her antibodies. Patient stated she ran a temperature for 7 days, couldn't get off the couch or nothing. Then her doctor sent her for antibodies.  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-202400015965 same reporter/product, different event/patient;
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: MS; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: MULTIPLE SCLEROSIS (medically significant), outcome "unknown", described as "MS". 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-202400015897 same reporter/product, different event/patient;
Age: 73.0
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 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient had no relevant medical history. Patient did not have known allergies and other medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine as dose 1, dose 2, dose 3, dose 4 all from manufacture unknown all for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures including Paxlovid from 07Jan2024 to 11Jan2024 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.
Age: 23.0
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 24-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 23 years, 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 relevant medical history included: "IBS" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 03Feb2020. 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 with Paxlovid from 02Jan2024 to 06Jan2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: in the middle of recovering from covid right now; in the middle of recovering from covid right now; 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)), on 01Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovering" and all described as "in the middle of recovering from covid right now". Patient has been participating in research relating to RSV and flu vaccine and is still participating in research. And she wanted to know what dosage of the vaccine she was administered at the pharmacy.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Skin warm
Clinical narrative: his arm was warm the day after he was vaccinated; This is a spontaneous report received from a Physician from medical information team.  A 68-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "his arm was warm the day after he was vaccinated".  Additional information: Patient is a retired physician who was in an Abrysvo clinical trial about 2 years ago. He received actual vaccine and not placebo in the trial. He suspected this to be the case as his arm was warm the day after he was vaccinated.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from an Other HCP.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 07:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 84 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Jan2021 at 16:00 as dose 1, single (Lot number: 0251L20A), in left arm, on 05Feb2021 at 11:00 as dose 2, single (Lot number: 0133120A), in left arm, on 01Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 025D21A), in left arm and on 12Apr2022 at 15:00 as dose 4 (booster), single (Lot number: 002M21A), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Jan2024 to 08Jan2024.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 75.0
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 76-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 18Oct2023 at 11:00 as dose 1, single (Lot number: HG4675) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic fatigue syndrome", start date: 2016 (unspecified if ongoing), notes: since an Epstein-Barr virus infection in 2016; "Epstein-Barr virus infection", start date: 2016 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Pfizer/Biontech COVID-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Lot number: GJ3277, vaccine location; right arm), administration date: 30Sep2022, when the patient was 74-year-old, for COVID-19 Immunization; Moderna COVID-19 vaccine (DOSE 4 (BOOSTER), Lot number: 066K21A, vaccine location: right arm), administration date: 12Apr2022, when the patient was 74-year-old, for COVID-19 Immunization; Moderna COVID-19 vaccine (DOSE 3 (BOOSTER), Lot number: 032F21A, vaccine location: right arm), administration date: 08Nov2021, when the patient was 73-year-old, for COVID-19 Immunization; Moderna COVID-19 vaccine (DOSE 2, Batch/Lot number: unknown, vaccine location: right arm), administration date: 05Mar2021, when the patient was 73-year-old, for COVID-19 Immunization; Moderna COVID-19 vaccine (DOSE 1, Batch/Lot number: unknown, vaccine location: right arm), administration date: 25Feb2021, when the patient was 73-year-old, 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". Therapeutic measures were taken as a result of covid-19, which included nirmatrelvir, ritonavir (Paxlovid) from 04Jan2024 to 09Jan2024. Clinical course: The patient had no known allergies.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 47-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cypri, reaction(s): "Known allergies: Cypri", notes: Known allergies: Cypri. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid treatment from 03Jan2024 to 07Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulpha drugs" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Known allergies: walnuts" (unspecified if ongoing); "Known allergies: mango" (unspecified if ongoing); "Known allergies: wool" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 2, SINGLE, vaccine brand Other: Moderna, vaccine administration date: 24May2022, vaccine location: Left arm), administration date: 24May2022, when the patient was 64-year-old, 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), outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid were taken as a result of covid-19 from 14Jan2024.  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, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Pharmacist.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Lot number: H64677), in left arm for covid-19 immunisation. The patient's relevant medical history included: "angioplasty", start date: 2005 (unspecified if ongoing), notes: angioplasty 2005 no stent; "Known allergies: quinolone Antibiotics" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "hip replacement", start date: 2006 (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jun2005, stop date: 05Jan2024. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURE UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURE UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURE UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included: Paxlovid from 05Jan2024 to 09Jan2024.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event vaccination failure (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
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 75-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient received Paxlovid as COVID 19 treatment from 07Jan2024 to 12Jan2024.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxil, reaction(s): "allergies"; Keflex, reaction(s): "allergies"; Codein, reaction(s): "allergies"; Morphine, reaction(s): "allergies"; Penicillin, reaction(s): "allergies"; Diamatap pseudoephedrine, reaction(s): "allergies". Vaccination history included: moderna (DOSE 3, administration time: 09:00 AM,, lot unknown, Not available/provided, Vaccine location: Left arm), administration date: 11Oct2022, when the patient was 47-year-old, for COVID-19 immunization; moderna (DOSE 2, administration time: 09:00 AM,, lot unknown, Not available/provided, Vaccine location: Left arm), administration date: 10Apr2022, when the patient was 46-year-old, for COVID-19 immunization; moderna (DOSE 1, administration time: 09:00 AM,, lot unknown, Not available/provided , Vaccine location: Left arm), administration date: 10Jan2022, when the patient was 46-year-old, 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 04Jan2024 to 08Jan2024 as COVID 19 Treatment.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Physician.  A 76-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Lot number: HG4677) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Episode paroxysmal atrial fibrillation" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 7 (BOOSTER), SINGLE, Batch/Lot No: 069H22A, Location of injection: Arm Left), administration date: 28Apr2023, when the patient was 76-year-old, for COVID-19 Immunization; moderna (DOSE 6 (BOOSTER), SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 07Oct2022, when the patient was 75-year-old, for COVID-19 Immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 05Apr2022, when the patient was 75-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 025D21A, Location of injection: Arm Left), administration date: 07Oct2021, when the patient was 74-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, Batch/Lot No: 011M20 A, Location of injection: Arm Left), administration date: 15Feb2021, when the patient was 74-year-old, for COVID-19 immunization; moderna (DOSE 1, SINGLE, Batch/Lot No: 025L20A, Location of injection: Arm Left), administration date: 18Jan2021, when the patient was 73-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19,Paxlovid treatment from 06Jan2024 to 10Jan2024.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Antiphospholipid syndrome" (unspecified if ongoing); "essential tremor" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing); "Known allergies: sesame" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID], start date: 01Nov2020, stop date: 16Jan2024; CALCIUM & MAGNESIUM CITRAT, start date: 01Nov2020, stop date: 16Jan2024; VITAMIN D [VITAMIN D NOS], start date: 01Nov2020, stop date: 16Jan2024. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin"; Tramadol, reaction(s): "Known allergies: Tramadol", notes: Known allergies:. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used for COVID 19 treatment from 07Jan2024 to 11Jan2024.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 68.0
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 Physician.  A 69-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Lot number: HG4680) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos hypothyroidism" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 01Jan1984, stop date: 16Jan2024. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose 5 (booster), single, vaccine lot number=GL2042, vaccine location=Left arm), administration date: 26Apr2023, when the patient was 68-year-old, for Covid-19 Immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose 4 (booster), single, vaccine lot number=GH9694, vaccine location=Left arm), administration date: 12Sep2022, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (Dose 3 (booster), single, vaccine lot number=FK9895, vaccine location=Left arm), administration date: 05Apr2022, when the patient was 67-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, single, vaccine lot number=FC3184, vaccine location=Left arm), administration date: 18Sep2021, when the patient was 66-year-old, for Covid-19 Immunization; Covid-19 vaccine (Dose 1, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: rapid antigen test. Therapeutic measures including Paxlovid from 06Jan2024 to 10Jan2024 were taken as a result of vaccination failure, covid-19. Patient also took vit D from 01Jan2024 to 16Jan2024 with lot number 2497661.; Sender's Comments: Based on the given information and known safety profile , the possible contributory role of the suspect for the event vaccination failure and covid-19 cannot be completely excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Pfizer.; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  An 80-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lactose" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Doxycycline, reaction(s): "Allergy: Doxycycline". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot number: EL8983, in the left arm), administration date: 22Jan2021, when the patient was 77-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, lot number: EN6201, in the left arm), administration date: 16Feb2021, when the patient was 77-year-old, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE, ), administration date: 30Mar2022, when the patient was 78-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 10Sep2022, when the patient was 78-year-old, for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Moderna/ Dose #4: Pfizer/ Dose #5: Pfizer."; 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 which included 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
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 46-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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2024, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2024) Positive; (11Jan2024) Negative; (14Jan2024) Positive; (16Jan2024) Positive; (17Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin disorder
Clinical narrative: Last time she had the shot she had a little skin thing; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 33026BD) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; Lot number: EN6204), administration date: 18Mar2021, when the patient was 66-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2; Lot number: ER8729), administration date: 15Apr2021, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "Last time she had the shot she had a little skin thing". Additional information: Last time she had the shot she had a little skin thing but nothing too much.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016999 same patient, different vaccine dose/event;US-PFIZER INC-202400017415 same patient, different dose/event;
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Last time she had the shot she had a little skin thing; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Lot number: 33026BD) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1; Lot number: EN6204), administration date: 18Mar2021, when the patient was 66-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2; Lot number: ER8729), administration date: 15Apr2021, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: SKIN DISORDER (non-serious), outcome "unknown", described as "Last time she had the shot she had a little skin thing". Additional information: Last time she had the shot she had a little skin thing but nothing too much.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400016999 same patient, different vaccine dose/event;US-PFIZER INC-202400017415 same patient, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: Blood pressure high; This is a spontaneous report received from a Consumer or other non HCP.  A male patient in his 60's received BNT162b2 (BNT162B2), as dose 3 (booster), 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. Started in 2020 when the patient got the vaccine. He never had a high blood pressure before. Exact date of vaccination was unknown, but it was an April. It was so bad that he had to go to the hospital, his blood pressure was way high.), administration date: 2020, when the patient was 63 years old, for COVID-19 immunization, reaction(s): "Blood pressure high"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Blood pressure high". The following information was reported: HYPERTENSION (non-serious), outcome "not recovered", described as "Blood pressure high". The event "blood pressure high" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension.  Additional information: The patient reported high blood pressure as soon as he took all three COVID-19 Vaccine shots. Ever since, his doctor kept increasing the blood pressure medicine and checked his record. They got him on the blood pressure medicine and tried to keep him under control, but it was really high.   The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300455133 Same patient, different dose and event;US-PFIZER INC-PV202400008082 Same patient, different dose and event;
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Injected contrast dye" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; 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), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (16Jan2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medications in 2 weeks. The patient was treated with Paxlovid from 05Jan2024 to 09Jan2024.   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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685), in left arm and on 11Jan2021 as dose 2, single (Lot number: EK9231) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Thyroidectomy" (not ongoing); "Former smoker" (not ongoing), notes: Quit 20 years ago. Concomitant medication(s) included: SYNTHROID oral taken for hypothyroidism, start date: Apr2012 (ongoing); CALCIUM taken for supplementation therapy. The following information was reported: COVID-19 (medically significant) with onset 17Jan2021, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 17Jan2021, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2021) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200626570 Same patient, same product (DOSE 3, BOOSTER), different events;US-PFIZER INC-202200559797 Same patient, same product (Dose 1,2,3 LOE), different events;
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: had fever; This is a spontaneous report received from a Consumer or other non HCP.  A 43-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "had fever".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: now that they have Covid; now that they have Covid; This is a spontaneous report received from a Consumer or other non 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 (Primary Immunization series completed; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "now that they have Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: the wife also tested positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient is reported to have taken all the Pfizer Vaccines. currently has COVID.; Patient is reported to have taken all the Pfizer Vaccines. currently has COVID.; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient is reported to have taken all the Pfizer Vaccines. currently has COVID.". Therapeutic measures were taken as a result of covid-19 included Paxlovid.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: FLUC3
Symptoms: Influenza, Influenza B virus test positive, Vaccination failure
Clinical narrative: Influenza type B; Lack of efficacy; This spontaneous case was received on 09-Jan-2024 from other healthcare professional (reference number: SEQW24-00102) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.   On 10-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location: left deltoid, route of administration: not reported) for active immunization against influenza disease. The batch number reported was 944444 and expiry date was 22-May-2024.  On 03-Jan-2024, two months and 24 days after receiving Flucelvax Quadrivalent, the patient experienced influenza type B.  On 08-Jan-2024, the patient underwent nasal swab that verified influenza type B (explicitly coded as 'Vaccination failure'). The patient was prescribed prednisone for treatment.  At the time of the initial reporting, the patient had not recovered from the event of 'influenza B virus infection'.  The reporter did not provide causality assessment.  The events of 'influenza B virus infection' and 'vaccination failure' were considered to be medically significant by a Physician within Department.  Company comment: A female patient of unknown age was vaccinated with Flucelvax Quadrivalent. Two months and 24 days following vaccination, patient experienced influenza type B, and 5 days later, diagnose was confirmed with nasal swab (explicitly coded as 'Vaccination failure'). The patient was treated with prednisone. The patient's medical history and concomitant medications were not reported. Causality for both events is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A female patient of unknown age was vaccinated with Flucelvax Quadrivalent. Two months and 24 days following vaccination, patient experienced influenza type B, and 5 days later, diagnose was confirmed with nasal swab (explicitly coded as 'Vaccination failure'). The patient was treated with prednisone. The patient's medical history and concomitant medications were not reported. Causality for both events is assessed as possibly related, due to plausible temporal relationship.
Age: 24.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Influenza
Clinical narrative: Ended up getting the flu; Very large redness upon her shoulder; This spontaneous case was received on 11-Jan-2024 from other non-healthcare professional (reference number SEQW24-00170) and concerned a 24-year-old female patient.  The patient's concurrent conditions included ulcerative colitis and Still's disease. The patient's concomitant medication included anakinra and Mesalamine (reported as 'Misolamine'), both used for unreported indications.  On 20-Nov-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as regular seasonal flu shot. The batch number reported was 944482 and the expiry date was 30-Jun-2024.  On the same date, right after receiving Flucelvax Quadrivalent, the patient experienced very large redness upon her shoulder.  On 23-Nov-2023, the patient recovered from the event of 'localised erythema'.  On 02-Jan-2024, one month and 13 days after receiving Flucelvax Quadrivalent, the patient ended up getting the flu.  On 07-Jan-2024, the patient recovered from the event of flu.  The reporter did not provide a causality assessment.  The event of flu was considered to be medically significant by Physician within Department.  Company comment: A 24-year-old female patient experienced erythema on the same day following vaccination with Flucelvax Quadrivalent. One month and 13 days following vaccination, patient ended up having influenza. Causality for both erythema and influenza is assessed as possibly related, based on plausible temporal relationship.; Sender's Comments: A 24-year-old female patient experienced erythema on the same day following vaccination with Flucelvax Quadrivalent. One month and 13 days following vaccination, patient ended up having influenza. Causality for both erythema and influenza is assessed as possibly related, based on plausible temporal relationship.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Computerised tomogram head normal, Magnetic resonance imaging, Memory impairment, Mental status changes, Speech disorder
Clinical narrative: 11:00 Vaccine was given at Pharmacy. Dad returned home 11:30am to 4:50pm Dad was at home acting normal. Contractors were at the house looking at the roof. Last normal phone conversation with dad was at 4:50pm. At 6:30 Daughter in Law calls dad and dad has forgotten the events of the last few months and is repeating himself.  Daughter in law alerts Mom and we have the Neighbor come help bring dad into town and to the hospital.                                                                                             Dad has forgotten events of the last several months. He is not able to say what the time year or month is. He dose not know who the president is. He dose know who he is and can ID family members.  He is treated for a possible stroke a TIA.  He was admitted to the hospital and kept overnight. in the morning he regained he memory of events up to about 5:00pm on the 18th. From 5:00pm on the 18th until about 1:30am on the 19th he has no memory of events. Stroke and TIA was ruled out by Blood work and Catscan as well as MRI. He was diagnosed with Transient Global Amnesia.