chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller has covid and thinks she got it from her husband who is in the hospital; Caller has covid and thinks she got it from her husband who is in the hospital; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller has covid and thinks she got it from her husband who is in the hospital". The events "caller has covid and thinks she got it from her husband who is in the hospital" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid. Clinical course: Caller had covid and thought she got it from her husband who was in the hospital. She went to an urgent care and was given Paxlovid and started it that evening. Because of her covid, no one could visit her.  She stated she got the Pfizer covid vaccine and booster.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 72.0
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 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jul2023 as dose 3 (booster), single (Lot number: GJ3268U) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Aug2022 as dose 1, single (Lot number: FP7138), in left arm and on 21Oct2022 as dose 2, single (Lot number: GH91093), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Nov2023 as dose 4 (booster), single (Lot number: UT8157CA), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Nov2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 14Dec2023, stop date: 18Dec2023) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300455003 same patient, same drug, different event, different dose;
Age: 55.0
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 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "known allergies: Penicillins and Almonds" (unspecified if ongoing); "known allergies: Penicillins and Almonds" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2023) Negative, notes: Negative test at day 2 after Paxlovid; (20Dec2023) Positive, notes: Positive test at day 5 after last dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid from 15Dec2023 to 20Dec2023 for Treatment of COVID-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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.  A 66-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Open heart in 2015", start date: 2015 (not ongoing). Concomitant medication(s) included: CARVEDILOL, start date: 03Aug2022, stop date: 23Dec2023. 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 with paxlovid from 11Dec2023 to 16Dec2023. Clinical course: 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.
Age: 68.0
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 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); 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 which included Paxlovid from 14Dec2023 to 18Dec2023. Clinical course: The patient felt mostly recovered after day 5 of Paxlovid. He did not had known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 45.0
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 45-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), 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 "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: After Paxlovid, I tested negative and was symptom free. Therapeutic measures (Paxlovid treatment start date: 11Dec2023, stop date: 15Dec2023) were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 55.0
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 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 09:30 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: DALFAMPRIDINE, start date: 01Sep2015; OCREVUS, start date: 01Jan2019. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline". Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, anatomical location: Arm Left), administration date: 23Nov2021, when the patient was 53-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, anatomical location: Arm Left), administration date: 27Jul2022, when the patient was 54-year-old, for COVID-19 immunisation; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, anatomical location: Arm Left), administration date: 04Nov2022, when the patient was 54-year-old, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE, anatomical location: Arm Left), administration date: Mar2021, when the patient was 53 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE, anatomical location: Arm Left), administration date: Apr2021, when the patient was 53 years old, for COVID-19 immunisation. 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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included paxlovid from 17Dec2023 to 20Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 09Dec2023 to 14Dec2023. Clinical course: 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 73-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Elevated cholesterol" (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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 11Dec2023 to 16Dec2023. Clinical course: 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.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:00 as dose 1, single (Lot number: HG4628) at the age of 34 years, in left arm for covid-19 immunisation, Device Lot Number: HG4628. The patient's relevant medical history included: "High BMI" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); 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 "recovered" (23Dec2023 at 10:00) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Dec2023) Negative, notes: I was negative at 10 AM on 23Dec2023, (day 8 of isolation). Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 16Dec2023 to 20Dec2023. Clinical course: During the course of Paxlovid, The patient's Covid symptoms improved rapidly. Symptoms had resolved by day 6, and he was attempting to "test out" of isolation by taking rapid antigen Covid tests. He was negative at 10 AM on 23Dec2023, (day 8 of isolation).  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: 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 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Lot number: hg4629) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Promethazine, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose 1; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (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 "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Covid-19 treatment with Paxlovid (Lot: g17325) stared from 13Dec2023 to 17Dec2023.  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, 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 60-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), 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; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (Dec2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 06Dec2023 to 11Dec2023.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 as dose 1, single (Lot number: HG6396) at the age of 69 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; unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2; unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster); unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (booster); unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (booster); unknown Manufacturer), 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 15Dec2023 to 20Dec2023.  No follow-up attempts are possible.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid symptoms started 07Dec2023 Started Paxlovid that night. Became negative 12Dec or 13Dec.; Covid symptoms started 07Dec2023 Started Paxlovid that night. Became negative 12Dec or 13Dec.; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Lot number: 9265), in left arm, on 21Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 10Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 12Jun2022 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Low thyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Allergy: Sulfa" (unspecified if ongoing); "Allergy: Iodine" (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 07Dec2023, outcome "recovered" (Dec2023) and all described as "Covid symptoms started 07Dec2023 Started Paxlovid that night. Became negative 12Dec or 13Dec.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) negative, notes: Became negative 12Dec or 13Dec; (Dec2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Dec2023 to 12Dec2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300455101 Same patient/same product, different dose/event;
Age: 55.0
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 55-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 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: Covid-19 vaccine (Dose 4 (Booster); Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment.Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Dec2023 to 17Dec2023.  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: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 44-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Vaccine location: Left Arm), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Received treatment from Paxlovid from 13Dec2023 to 18Dec2023, Lot#1969072A. 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.
Age: 73.0
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 73-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 14:00 as dose 1, single (Lot number: Hda835) at the age of 73 years, 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Received treatment of Paxlovid from 12Dec2023 to 16Dec2023 for treatment of COVID-19. No known allergies.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: test positive on days 8, 9, & 10; test positive on days 8, 9, & 10; This is a spontaneous report received from a Consumer or other non HCP.  A 67-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN B [VITAMIN B NOS], start date: 01Jan2022. Past drug history included: Erythromycin, reaction(s): "Drug Allergies: erythromycin"; Livalo, reaction(s): "Drug Allergies: livalo". Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "unknown" and all described as "test positive on days 8, 9, & 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Continued to test positive on days 8, 9, & 10; (2023) Positive, notes: Continued to test positive on days 8, 9, & 10; (2023) Positive, notes: Continued to test positive on days 8, 9, & 10. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment with Paxlovid, Treatment start date was on 17Dec2023, Treatment stop date was on 20Dec2023.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound (tested positive again within days after testing negative following my prescribed intake of Paxlovid and recommended isolation); Rebound (tested positive again within days after testing negative following my prescribed intake of Paxlovid and recommended isolation); This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Rebound (tested positive again within days after testing negative following my prescribed intake of Paxlovid and recommended isolation)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound (tested positive again within days after testing negative; Positive, notes: Rebound (tested positive again within days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information included Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 15Dec2023. Treatment stop date: 20Dec2023. Indication: Treatment of COVID-19
Age: 53.0
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 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's 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 Done, Manufacture: Unknown), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course included Anti-Viral Details: [{Product=Covid 19 Treatment, Brand=Paxlovid, Treatment Start Date=15Dec2023, Treatment Stop Date=20Dec2023, Indication=Treatment Of Covid-19}]. Ended Treatment On 20Dec2023. Had No Symptoms. By 23Dec2023 Congestion And Coughing Has Returned.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 80.0
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.  An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 at 12:00 as dose 1, single (Lot number: HD9867) at the age of 80 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (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 with paxlovid from 05Dec2023 to 09Dec2023.   No follow-up attempts are possible.
Age: 67.0
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 67-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Nov2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Location of injection: Arm Right), administration date: 02Apr2021, when the patient was 64-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Location of injection: Arm Left), administration date: 23Apr2021, when the patient was 64-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Location of injection: Arm Right), administration date: 01Dec2021, when the patient was 65-year-old, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Location of injection: Arm Left), administration date: 20Jul2022, when the patient was 66-year-old, for COVID-19 immunisation. 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 which included Paxlovid from 12Dec2023 to 22Dec2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: 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 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), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (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: (Dec2023) Negative, notes: tested negative on three previous days; (26Dec2023) Positive, notes: Tested positive again on day 6 after final dose of Paxlovid, after having tested. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical information: COVID rebound. Tested positive again on day 6 after final dose of Paxlovid, after having tested negative on three previous days. COVID 19 Treatment: Paxlovid. start date: 15Dec2023, stop date: 20Dec2023.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 66.0
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 66-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Known allergies. 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.  Clinical information: vaccine administration time reported as 01:00 PM. The patient received anti-viral treatment of Covid-19 product Paxlovid from 12Dec2023 to 17Dec2023. Covid symptoms returned after about 3 days finishing the full 5-day paxlovid treatment.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 , in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Pencillin" (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 "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID-19 Treatment with Paxlovid, Treatment start date was on14Dec2023, Treatment stop date was on18Dec2023, No other medical history.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  An 81-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Nov2023 at 11:45 as dose 1, single (Lot number: HD9876), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE NUMBER UNKNOWN, SINGLE , Vaccine brand- Other,, Vaccine brand other- Moderna,, Vaccine brand unknown- False,, Vaccine administration date- 28May2022,, Vaccine lot number- 037A22B,, Vaccine lot unknown- False,, Vaccine dose number unknown- True,, Vaccine dose number unknown reason- Unknown,, Vaccine location- Right arm), administration date: 28May2022, for COVID-19 immunization; moderna (DOSE NUMBER UNKNOWN, SINGLE , Vaccine brand- Other,, Vaccine brand other- Moderna,, Vaccine brand unknown- False,, Vaccine administration date- 19Sep2021,, Vaccine lot number- 048F,, Vaccine lot unknown- False,, Vaccine dose number unknown- True,, Vaccine dose number unknown reason- Unknown,, Vaccine location- Right arm), administration date: 19Sep2021, 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID 19 treatment of Paxlovid started from 13Dec2023 and stopped on17Dec2023. No other medication in two weeks.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Oct2023 at 12:00 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: "Colitis ulcerative" (unspecified if ongoing); "strawberries" (unspecified if ongoing), notes: known allergies: strawberries. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 nos (vaccine brand: Pfizer / BioNTech,, vaccine brand unknown: False,, vaccine administration date: 09Sep2022,, vaccine administration time: 11:00 PM,, vaccine dose number: 1, vaccine location: Left arm), administration date: 09Sep2022, when the patient was 61-year-old, 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 4 days after testing negative after covid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: COVID 19 treatment of pfizer paxlovid treatment started on 12Dec2023 and stopped date on 17Dec2023.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 38.0
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 38-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Drug Allergy", notes: known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid for the treatment of COVID-19 from 15Dec2023 to 20Dec2023.  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, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Oct2023, stop date: 26Dec2023; ATORVASTIN, start date: 01Oct2023, stop date: 23Dec2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Dec2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid from 13Dec2023 to 17Dec2023 for the treatment of COVID-19. Patient had no known allergies.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. No further information is expected.
Age: 40.0
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 Nurse.  A 40-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Obese" (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, SINGLE , MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE , MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE , MANUFACTURER UNKNOWN), 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: Positive, notes: positive rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Based on available information a contributory role of BNT162b2 omi xbb.1.5 to the reported event, drug ineffective, covid-19 cannot be totally excluded as efficacy of a drug varies from individual to individual. The case will be reassessed once further information is available
Age: 62.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Condition aggravated, Headache, SARS-CoV-2 test negative
Clinical narrative: I have been experiencing headaches, since ~ January 2022 - this would have been shortly after my 3rd COVID shot (all 3 were Moderna). They seem to be a cough or extertional pressure headache, somewhat mitigated by Topamax.  Since Dec of 2021, I have had 2 boosters of Pfizer, and then most recently a booster of Moderna.  Eight days after this most recent booster, my head really seemed to "fill up", and the headaches got quite severe for a few days, then subsided to a more controlled level, where they remain. I am wondering if you have had this reported by anyone, and if there is any association with the vaccine (inflammatory response?).    Further, in December of 2022, I started developing a cough.  Right around Christmas of 2022, my husband developed COVID-19 (note, my most recent boosters prior to this #4:  4/12/22 and #5:  10/19/22, both Pfizer).  I tested repeatedly for COVID, but never tested positive.  Instead, I had this cough that became worse over time.  It persisted into January and I couldn't get rid of it.  Finally, I went to the doctor and she told me I had asthma.  I was shocked.  I had never had asthma before.  I was on a steroid inhaler (Alvesco) for months, and finally was back to normal in late spring.  So, I am wondering  could the asthma have been cause by an inflammatory response to the vaccine or a response to an exposure to the virus?  I was fine until early August, when I went to a movie theatre where I think I may have been exposed to COVID.  The asthma returned and I was back on an inhaler, but just for a month this time.  Then, I got a booster vaccination in October (Moderna, discussed above), and the very strange thing happened with my head and my headaches.  So, I am wondering: 1) Has anyone else ever reported any issues like this before? 2) Are the headaches and the asthma just a coincidence in timing with the vaccinations? 3) Do I continue to get COVID vaccinations and just try to manage the headaches and the asthma (whether they are related or not)? 4) Do I avoid further COVID vaccination due to potential severe effects (if I weren't managing my headaches with the Topamax, I'm wondering what would have happened to my head due to the pressure  of course, that assumes? the pressure was caused by an immune/inflammatory response to the vaccine)?  As an interesting additional point, to my knowledge, I have never had COVID-19 (no doubt, thanks to my immunizations).  Thank you for your thoughts.
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Gastrointestinal sounds abnormal
Clinical narrative: Borborygmi (ongoing 2 weeks later), diarrhea (few hours after 1st dose, lasted 3 hours)
Age: 3.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: expired vaccine