chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
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 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 3 (booster), single (Lot number: Aj6665) at the age of 54 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) 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 Dec2023, 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 16Dec2023 to 21Dec2023.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 12:00 as dose 1, single (Lot number: HH7595) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension under control" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 15Dec2023 to 19Dec2023. Patient had no known allergies.
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 48-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Stroke" (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 Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 13Dec2023 to 17Dec2023. Clinical course: Patient received Moderna, on an unknown date as dose 3 (booster), single (Batch/Lot number: 027H21B) for covid-19 immunization. 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.; 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: M
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 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "heart failure" (unspecified if ongoing); "Pulmonary edema" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. 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 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 03Dec2023 to 07Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Nurse.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NORTRIPTYLINE (Other medication in 2 weeks product: Nortriptyline. Other medication in 2 weeks stop date: 14Dec2023.). Past drug history included: Bactrim, reaction(s): "Drug allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19. Symptoms started again 4 days after negative result.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event Drug ineffective and COVID 19 cannot be ruled out.
Age: 69.0
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 70-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 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for blood pressure measurement, on 01Jan2018; TELMISARTAN taken for blood pressure measurement, on 01Jan2018; DILTIAZEM taken for blood pressure measurement, on 01Jan2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient Anti viral covid treatment Paxlovid started on 17Dec2023 till 21Dec2023.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 70.0
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 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received treatment with Paxlovid from 18Dec2023 to 23Dec2023 for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 28.0
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 28-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment with Paxlovid from 08Dec2023 to 13Dec2023 for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 47.0
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 Consumer or other non HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient's relevant medical history included: "Raynauds" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Other medication in 2 weeks was reported as no. Paxlovid treatment started from 18Dec2023 to 22Dec2023.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 as dose 1, single (Lot number: HF9275) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Lot number: 6J3208), administration date: 20Apr2023, when the patient was 66-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSETER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 18Dec2023 to 23Dec2023.  No follow-up attempts are possible.
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 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 05:30 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. Past drug history included: Iodine, reaction(s): "Allergies: Iodine"; Neosporin, reaction(s): "Allergies: Neosporin". Other medical history: Multiple. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Paxlovid from 17Dec2023 to 21Dec2023 for treatment of covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Osteonecrosis, SARS-CoV-2 test
Clinical narrative: Bilateral Hip Avascular Necrosis diagnosed in 2022, Bilateral Knee / Right Tib Fib Avascular Necrosis diagnosed 2023; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 2, single (Lot number: FF2587) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Prev dose brand=Pfizer, Prev dose brand unknown=False, Is bivalent=False, Prev dose lot number=FF2587, Prev dose lot unknown=False, Prev dose vaccine location=Right arm), administration date: 09Sep2021, when the patient was 21-year-old, for Covid-19 Immunization. The following information was reported: OSTEONECROSIS (disability, medically significant) with onset Feb2022, outcome "recovered with sequelae", described as "Bilateral Hip Avascular Necrosis diagnosed in 2022, Bilateral Knee / Right Tib Fib Avascular Necrosis diagnosed 2023". The event "bilateral hip avascular necrosis diagnosed in 2022, bilateral knee / right tib fib avascular necrosis diagnosed 2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of osteonecrosis.  Clinical course: Bilateral Hip Avascular Necrosis was diagnosed in 2022, Bilateral Knee/Right Tib Fib Avascular Necrosis was diagnosed  in 2023. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other medications in two weeks.There was no other vaccine in four weeks and no covid prior vaccination. Since the vaccination, the patient had been tested positive for COVID-19. Patient had no known drug allergy. The patient received treatment with Bilateral Hip Replacements for the adverse event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300456625 same patient, different dose/event;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Bilateral Hip Avascular Necrosis diagnosed in 2022, Bilateral Knee / Right Tib Fib Avascular Necrosis diagnosed 2023; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 2, single (Lot number: FF2587) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Prev dose brand=Pfizer, Prev dose brand unknown=False, Is bivalent=False, Prev dose lot number=FF2587, Prev dose lot unknown=False, Prev dose vaccine location=Right arm), administration date: 09Sep2021, when the patient was 21-year-old, for Covid-19 Immunization. The following information was reported: OSTEONECROSIS (disability, medically significant) with onset Feb2022, outcome "recovered with sequelae", described as "Bilateral Hip Avascular Necrosis diagnosed in 2022, Bilateral Knee / Right Tib Fib Avascular Necrosis diagnosed 2023". The event "bilateral hip avascular necrosis diagnosed in 2022, bilateral knee / right tib fib avascular necrosis diagnosed 2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of osteonecrosis.  Clinical course: Bilateral Hip Avascular Necrosis was diagnosed in 2022, Bilateral Knee/Right Tib Fib Avascular Necrosis was diagnosed  in 2023. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no other medications in two weeks.There was no other vaccine in four weeks and no covid prior vaccination. Since the vaccination, the patient had been tested positive for COVID-19. Patient had no known drug allergy. The patient received treatment with Bilateral Hip Replacements for the adverse event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300456625 same patient, different dose/event;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Osteonecrosis, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: FF2587), in right arm and on 30Sep2021 as dose 2, single (Lot number: FF2587) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Nasal Swab.  Clinical course: No covid prior vaccination. Patient tested for covid post vaccination. No Known Drug Allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300456493 same patient, different dose/event;
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 22-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: FF2587), in right arm and on 30Sep2021 as dose 2, single (Lot number: FF2587) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Nasal Swab.  Clinical course: No covid prior vaccination. Patient tested for covid post vaccination. No Known Drug Allergy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300456493 same patient, different dose/event;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years 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), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) negative, notes: After taking paxlovid for 5 days i tested negative; (2023) positive, notes: tested positive again with mild symptoms; (2023) positive, notes: Eight days later I am still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received treatment with Paxlovid from Dec2023 to Dec2023 for COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 37.0
Sex: M
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 38-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacture: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacture: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series done, Manufacture: Unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (27Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received treatment with Paxlovid from 18Dec2023 to 23Dec2023 for COVID-19. Rebound Covid Infection. I Had Tested Negative Two Days In A Row, And Then Developed Symptoms Overnight. I Tested With A Rapid Antigen Test This Morning And Was Positive Again. Symptoms Are Similar To The Initial Infection With Sore Throat And Sinus Congestion, But Without Fever This Time.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 at 08:45 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 at 08:30 as dose 2, single (Lot number: ER8727), in left arm, on 01Oct2021 at 08:30 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 28Mar2022 at 11:45 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years, in left arm for covid-19 immunisation; elasomeran (SPIKEVAX), on 24Sep2023 at 15:30 as dose 5 (booster), single), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2023 at 15:30, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19..  Clinical course: No known allergies. The patient received PAXLOVID as a therapeutic measure from 18Dec2023 to 23Dec2023.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment/Prior COVID infection 20Jul2022; COVID 19 Treatment/Prior COVID infection 20Jul2022; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 01Jun2022 at 12:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 65 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 at 12:00 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 at 12:00 as dose 2, single (Lot number: EN6208), in left arm and on 10Nov2021 at 12:00 as dose 3 (booster), single (Lot number: EW0172), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "RNY Gastric bypass surgery", start date: 2008 (unspecified if ongoing), notes: RNY Gastric bypass surgery (2008); "morbid obesity", start date: 1998, stop date: 2012, notes: Roux-en-Y gastric bypass surgery. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "unknown" and all described as "COVID 19 Treatment/Prior COVID infection 20Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) Positive, notes: Prior covid infection 20Jul2022 and also treated with Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19 (Paxlovid).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300418417 Same patient/drug/event, different dose;
Age: 49.0
Sex: M
Vaccine: COVID19, 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 52-year-old male patient received BNT162b2 (BNT162B2), on 01Jun2021 at 12:00 as dose 2, single (Lot number: EW0182) at the age of 49 years, in left arm for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for COVID-19 immunization. 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), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks and known allergies, other medical history reported no. Patient had Paxlovid for COVID-19 treatment. Treatment start date: 14Dec2023, and stop date: 19Dec2023.
Age: 71.0
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 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer (recovered)" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "cero negative rheumatoid arthritis" (unspecified if ongoing); "known allergies: Some spices" (unspecified if ongoing); "known allergies: bee stings" (unspecified if ongoing); "known allergies: statins" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Imitrex, reaction(s): "known allergies: Imitrex", notes: known_allergies Some spices, bee stings, statins, Imitrex. Vaccination history included: BNT162b2 (DOSE NUMBER UNKNOWN, SINGLE, vaccine brand: Pfizer / BioNTech vaccine brand unknown: False, vaccine administration date: 24Apr2023, vaccine administration time: 02:00 PM, vaccine lot number: I have had all allowed vaccines, vaccine lot unknown: False, vaccine dose number unknown: True, vaccine dose number unknown reason: UNKNOWN, vaccine location: Left arm), administration date: 24Apr2023, when the patient was 70-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, vaccine brand unknown: True, vaccine brand name unknown: COVID19 Vaccine, vaccine lot unknown: True, vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number unknown: True, vaccine dose number unknown reason: UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Reporter stated, Your form was very difficult to use. I have had all available vaccinations and boosters. I developed Covid rebound after taking Paxlovid for five days. I actually feel like I'm getting it again.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 40.0
Sex: M
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 40-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm 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; Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) negative, notes: Tested negative after 6 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid from 19Dec2023 to 23Dec2023 for the treatment of 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: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from an Other HCP.   A 29-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: COVID-19 vaccine (dose 1, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 2, single; manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (dose 3 (booster), single; 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 "Treatment of COVID-19". 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.   Sender's Comments:  The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported events Drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Vomiting; Mild muscle soreness at injection site; low grade fever; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Other Case identifier(s): 2023NVX-US-000001832 (RA).  A 31-year-old female of an unspecified race was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect Covid-19 vaccine unspecified dose (dose 5 or 6 of COVID-19 vaccine) in the right arm on 10-NOV-2023 at 36 weeks of gestation. Co-suspect medications included Abrysvo (RSV vaccine prot. subunit pref 2V) dose 1 in the left arm on 10-NOV-2023. Medical history included Third trimester pregnancy, Factor II mutation, and Rubber sensitivity (skin rash on contact with latex). The individual received an unspecified bivalent COVID-19 booster in the spring of 2022, and had no current illnesses. Concomitant medications included Tylenol (acetaminophen), unspecified prenatal vitamins, and Zyrtec (cetirizine hydrochloride). On 10-NOV-2023, the individual experienced an exposure during pregnancy (PT: Exposure during pregnancy).  On 11-NOV-2023 at 10 am, the individual started vomiting (PT: Vomiting). The same day, the individual also experienced injection site pain (PT: Injection site pain) and pyrexia (PT: Pyrexia). Treatment for the events included Tylenol. On 10-NOV-2023, the event outcome of Exposure during pregnancy was recovered/resolved. On 11-NOV-2023, the event outcomes of Vomiting, Injection site pain, and Pyrexia were recovered/resolved.  Lot number was not provided in the report.  The CDC's adverse event description (narrative) was provided as follows: 36 weeks pregnant. Vomiting started at 10am the day after receiving both vaccinations. Managed symptoms at home. Mild muscle soreness at injection site and low grade fever (controlled with Tylenol). Cannot remember if this is 5th or 6th dose of covid shot. It is the booster after receiving the bivalent booster last spring.  A discrepancy was identified in the source document. The reported date of onset was 11-NOV-2023, but the event start date of Exposure during pregnancy was assessed as 10-NOV-2023 (date of vaccination) due to the nature of the event.  Sender Comment: This 31-year-old female experienced: Exposure during pregnancy, Injection site pain, Pyrexia and Vomiting after vaccination with Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The events Exposure during pregnancy, Injection site pain, Pyrexia and Vomiting were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered possible.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problems; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart problems". Additional information: Patient has been having heart problems for 3 years since he/she took the COVID shot and has not worked since then. When patient tried to work they were calling the ambulance to get him/her. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2023-752716 (MODERNA).  A 55-year-old male patient received BNT162b2 (BNT162B2 NOS), on 11Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive.  Clinical course: The reporter explained that the son went to a party last year in 13Nov2022 and were vaccinated 11Nov2022 and about half of the people there came down with the virus after the party and won't go if isn't up to date. The reporter reported that there was about 30 people at the party and doesn't know if any of them were vaccinated. mentioned that and son had a mild case because they were vaccinated but couldn't remember symptoms because it was a year ago. Reported that son was tested and was positive, didn't, but knew was because was around him and felt awful and rotten. The reporter also says that son did not receive the Moderna Covid-19 vaccine. Son received the Pfizer Covid-19 vaccine.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: still contracted Covid; still contracted Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  An 89-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "still contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient took Pfizer vaccines and boosters and has inquiry as to why patient still contacted Covid. The reporter consider event as caused by suspect product(s) was not known.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Myocardial infarction
Clinical narrative: Heart attack; heart issue; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: MYOCARDIAL INFARCTION (hospitalization, medically significant), outcome "unknown", described as "Heart attack"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart issue". The event "heart attack" required emergency room visit. Therapeutic measures were taken as a result of myocardial infarction, cardiac disorder.  Clinical course: The patient been invested in Pfizer since early Covid hit. It has been a bad investment. The patient also had what appeared to be a heart attack not long after getting the Pfizer vaccine shot. The EMT's said it was probably the vaccine. The patient was their 5th patient in a week, after having the shot. The patient had no previous cardiac issues and continue not to. Besides the myocardial event days in the hospital, the patient spent 6 months being treated as a heart issue patient, including all additional medications, before the medical establishment finally agreed it was only a reaction to the vaccine shot. So, no more interest in Pfizer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Who do I or my physician report an adverse and potentially fatal response to Covid shot?; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (life threatening), outcome "unknown", described as "Who do I or my physician report an adverse and potentially fatal response to Covid shot?".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19, FLUX, PPV, RVX
Symptoms: Dyspnoea, Feeling cold, Loss of personal independence in daily activities
Clinical narrative: cold days after that affected his normal activities; has felt a cold days; shortness of breath daily; Initial information received on 21-Dec-2023 regarding an unsolicited valid serious case received from a patient.  This case involves a 74-year-old male patient who had cold days after that affected his normal activities, has felt a cold days and shortness of breath daily after receiving covid-19 vaccine, RSV vaccine, pneumococcal vaccine and influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Dec-2023, the patient received unknown dose of suspects influenza vaccine produced by unknown manufacturer; RSV vaccine not produced by Sanofi Pasteur; COVID-19 vaccine not produced by Sanofi Pasteur and pneumococcal vaccine produced by unknown manufacturer (strength, formulation, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date in Dec-2023, the patient had cold days after that affected his normal activities (loss of personal independence in daily activities), has felt a cold day (feeling cold) and shortness of breath daily (dyspnoea) (unknown latency) following the administration of influenza vaccine, pneumococcal vaccine, RSV vaccine and covid-19 vaccine.   Reportedly, Caller reports shortness of breath daily. Caller reports receiving 4 non-live vaccinations (COVID19, Flu, RSV, and Pneumococcal) on the same day a week ago and has felt a cold days after that affected his normal activities.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (has felt a cold days, cold days after that affected his normal activities, shortness of breath daily).  At time of reporting, the outcome was Unknown for all the events.   Seriousness criteria: The event cold days after that affected his normal activities (loss of personal independence in daily activities) was leading to disability.; Sender's Comments: Sanofi Company Comment dated 29-Dec-2023: This case involves a 74-year-old male patient who had cold days after that affected his normal activities, has felt a cold days and shortness of breath daily after receiving covid-19 vaccine, RSV vaccine, pneumococcal vaccine and influenza vaccine. Based upon the reported information, the role of the vaccine cannot be assessed. However, lack of information regarding past medical history, treatment(s), family history precludes comprehensive case assessment. US-SA-2023SA403063:SanofiPVPortal20231222000989
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: systemic rash over her body; Initial information received on 15-Dec-2023 from Regulatory Authority regarding an unsolicited valid non-serious courtesy case received from a consumer/ Non-Healthcare Professional.  This case involves a 69-year-old female patient who had systemic rash over her body after receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history included Short of breath. The patient's past medical treatment included Nitroglycerin (took nitroglycerin to keep her blood vessels dilated, but she reported that she's mainly been off nitroglycerin for the past 10 years since she changed her diet). The patient's past vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Ischemia and Angina pectoris (microvascular heart disease (INOCA or ANOCA).  The patient takes an unspecified ACE inhibitor and beta blocker.  On an unknown date in 2020, the patient received unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, formulation, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization). There will be no information available on the batch number for this case.  On an unknown date the patient had systemic rash over her body (rash) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken was not applicable.  The patient received steroids for 10 days as corrective treatment for the event (systemic rash over her body).  At time of reporting, the outcome was Unknown for the event systemic rash over her body.  No further follow-up is anticipated.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise
Clinical narrative: Chills, headache, malaise
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood thyroid stimulating hormone decreased, Brain natriuretic peptide increased, COVID-19, COVID-19 pneumonia
Clinical narrative: DISCHARGE SUMMARY --                                    Account Number: Admitted: 11/28/2023 Discharge Date: 11/29/23    PCP    Recommended Outpatient Testing o Follow up with PCP   Results Pending At Discharge o None       Clinical Summary   Patient is a 73 y.o. male patient of CNP with history of Hypothydroidism, CHF, T2DM, Hyperlipidemia, HTN, presented with chest tightness and sob    Acute respiratory failure w/ hypoxia Covid-19 Virus Pneumonia Multifocal pneumonia Date of onset of symptoms: 11/23 Symptoms present on admission: Chest tightness, SOB, hypoxia, coughing Date of covid positive test: 11/28 Vaccination status: vaccinated Oxygen requirements on admission: 1 L Currently off O2 Cough productive of green sputum since 11/23 Influenza antigen test negative CXR showed patchy L basilar opacities Fever and leukocytosis absent at this time WBC count 6.62 Sputum culture negative MRSA probe, Strep pneumonia and legionella antigen negative Mycoplasma IgM antibody negative Received levaquin in ED due to allergies Procalitonin .7 has significant allergies, started on Levaquin for bacterial coverage  Hospital course remdesivir and steroids, but has been discontinued continue Levofloxacin 750 mg orally x 5days   Elevated Troponin CAD s/p CABG 2009 PAD CHF Reported history of cardiac cath w/ stent placement Hx of triple bypass BNP mildly elevated at 331 Troponin of 31 & Delta of 9 secondary due to hypoxia EKG was unremarkable for ischemic changes     Hypothyroidism On synthroid 125 mcg TSH of 0.97   Normocytic anemia Hgb 12.5; MCV 93.6   Type 2 DM w hyperglycemia Morbid obesity: BMI 37.94 Metformin 1000 mg; tresiba 20 units; jardiance 25 mg Pending A1C Glucosuria on UA   Mixed HLD On crestor 20 mg HTN On lisinopril-hydrochlorothiazide 20-12.5 On metoprolol 25 mg bid