chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Spinal cord injury" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Time: 11:00 AM, Anatomical location: Left arm), administration date: 03Feb2021, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, Time: 11:00 AM, Anatomical location: Left arm), administration date: 24Feb2021, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Time: 11:00 AM,, Anatomical location: Left arm), administration date: 03Oct2021, for COVID-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Time: 11:15 AM, Anatomical location: Left arm), administration date: 07Apr2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, 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 with Paxlovid from 21Nov2023 to 25Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE (moderna spike), Vaccine administration time: 13:15, Vaccine lot unknown reason other: Pckg thrown out , Vaccine location: Right arm), administration date: 19Oct2023, when the patient was 72-year-old, for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "not recovered". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The Paxlovid was started on 25Nov2023 and stopped on 30Nov2023 for the treatment of COVID-19. No known allergies.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 43.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "migraines" (unspecified if ongoing); "smoker" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 01Jul2022; PROPRANOLOL, start date: 01Jan2023. 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received COVID-19 anti-viral treatment with Paxlovid from 26Nov2023 to 01Dec2023. The patient had no known allergies.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 22.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 22 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "POTS" (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; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, 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 Paxlovid treatment from 26Nov2023 to 30Nov2023. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Sep2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mitochondrial disease" (unspecified if ongoing); "GERD" (unspecified if ongoing); "skeletal muscular dystrophy" (unspecified if ongoing); "Allergic to CAT scan dye" (unspecified if ongoing); "Allergic to cats the pet" (unspecified if ongoing), notes: Allergic to CAT scan dye and cats the pet. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) positive, notes: After positive for Covid the night before holiday,; (2023) negative, notes: After 5 days I tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient received Paxlovid from 23Nov2023 to 28Nov2023 for treatment of COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 18:00 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: "Hypertension" (unspecified if ongoing); "Allergy to mango" (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 Nov2023, 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: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 26Nov2023 and stop date 01Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 26Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfa drugs" (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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 26Nov2023 to 30Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 01:30 as dose 1, single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: 2 days after negative COVID test. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient received Covid-19 treatment from 26Nov2023 to 30Nov2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 57.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1, Single, Vaccination site: Left arm), administration date: 14May2022, when the patient was 55-year-old, for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient took Paxlovid from 18Nov2023 to 22Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 68.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "mycobacterium avium complex" (unspecified if ongoing); "hashimotos" (unspecified if ongoing); "celiac" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, 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 Paxlovid from 10Nov2023 to 21Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Age: 77.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 77 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 Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 21Nov2023 to 26Nov2023. Clinical course: Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She's had all of the other Pfizer COVID vaccines before and never had any issues before and now she has COVID.; She's had all of the other Pfizer COVID vaccines before and never had any issues before and now she has COVID.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Dec2023 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) all with onset 03Dec2023, outcome "unknown" and all described as "She's had all of the other Pfizer COVID vaccines before and never had any issues before and now she has COVID.". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19. Clinical course: Reporter mentioned that she took the last Pfizer COVID vaccine on Friday and got sick on Sunday. She had all of the other Pfizer COVID vaccines before and never had any issues before and now she had COVID.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300438947 same patient, different dose/event;
Age: 45.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 19May2021 as dose 1, single (Lot number: EW0183), in right arm, on 23Jun2021 as dose 2, single (Lot number: EW0181), in right arm and on 06Jan2022 as dose 3 (booster), 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: "Hashimoto's thyroid" (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 21Nov2023, outcome "recovered" (Dec2023) and all described as "Treatment of COVID-19". 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. Clinical course: The patient took Paxlovid from 22Nov2023 to 27Nov2023. After 10 days of unset of Covid symptoms on 21Nov2023 and starting Paxlovid, the Covid test was negative.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Both my wife and I came down with COVID over holiday this year for the first time; Both my wife and I came down with COVID over holiday this year for the first time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Both my wife and I came down with COVID over holiday this year for the first time". Clinical course: Reporter stated that, on this holiday he would like to express his thanks to science and the fantastic efforts that have been made in the treatment of COVID-19. Both he and his wife came down with COVID over holiday this year for the first time. The advances in both vaccines and treatments turned what two years ago had killed many of generation, into just a bad cold. Reporter stated, many thanks to the scientists and staff at all the pharmaceutical companies involved and also to the agencies who made availability of the treatments to all. As a former employee in the mid '60s, it makes him proud of the association he had with company.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300198454 same reporter and event, different patient;
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 67 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "irregular heart beat" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: Jan2010; ROSUVASTATIN, start date: Jan2010, stop date: 23Nov2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, 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 Paxlovid treatment from 24Nov2023 to 29Nov2023.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Lot number: HG4628) at the age of 65 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LORATADINE, start date: 17Mar2023. Past drug history included: Pfizer / biontech, start date: 07Oct2022, stop date: 07Oct2022, for Covid-19 immunization, notes: DOSE 5 (BOOSTER), SINGLE, Batch/Lot No: GJ6739, Location of injection: Arm Left; Moderna, start date: 27Jul2022, stop date: 27Jul2022, for Covid-19 immunization, notes: DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: 0/6B22A; Pfizer / biontech, start date: 17Oct2021, stop date: 17Oct2021, for Covid-19 immunization, notes: DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: 30155BA; Pfizer / biontech, start date: 19Mar2021, stop date: 19Mar2021, for Covid-19 immunization, notes: DOSE 2, SINGLE, Batch/Lot No: EP7534; Pfizer / biontech, start date: 26Feb2021, stop date: 26Feb2021, for Covid-19 immunization, notes: DOSE 1, SINGLE, Batch/Lot No: EN6202; Amoxicillin, reaction(s): "Known allergies: Amoxicillin". 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". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid (Lot: GK0481), from 04Dec2023 to 04Dec2023, for the treatment of COVID-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ6796) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Duck eggs" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 01Sep2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: Took course of Paxlovid within two days of symptom onset and positive test result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 21Nov2023 to25Nov2023 for treatment of COVID-19.
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCN ALLERGY" (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 Nov2023, outcome "recovered" (Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 25Nov2023 and stop date 30Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 35 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, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, 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 28Nov2023 to 03Dec2023.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 24 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid treatment start date: 27Nov2023, stop date: 01Dec2023) were taken as a result of drug ineffective, covid-19. Clinical course: The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (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 Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid 26Nov2023 to 01Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 12Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm and on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AVAPRO, start date: 17Oct2019, stop date: 06Dec2023; ROSUVASTATIN, start date: 17Oct2019, stop date: 24Nov2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovering" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid treatment from 24Nov2023 to 28Nov2023 for the treatment of COVID-19.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; 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 bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2), on 02Jan2021 at 01:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE, start date: 01Jan2010. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The Paxlovid was started from 25Nov2023 to 29Nov2023 for the treatment of COVID-19.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 at 13:00 as dose 6 (booster), single (Lot number: GL2042) at the age of 69 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Feb2021 at 12:00 as dose 1, single (Lot number: 011M20A), in left arm, on 13Mar2021 at 12:00 as dose 2, single (Lot number: 048A), in right arm, on 26Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 061E21a), in right arm, on 03Sep2022 at 10:00 as dose 5 (booster), single (Lot number: AS7140C), in left arm and on 24Sep2023 at 15:00 as dose 7 (booster), single (Lot number: 3030371), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 20Nov2023, outcome "recovered" (22Nov2023) and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: Body temperature: (20Nov2023) 99.5-100.3, notes: about 12 hours (fever); (29Nov2023) 102-103.5, notes: Fever; (30Nov2023) 102 -104, notes: high fever; (01Dec2023) 102 -104, notes: high fever; (02Dec2023) 102 -104, notes: high fever; (03Dec2023) Unknown results, notes: Fever gone; (04Dec2023) Unknown results, notes: Fever gone; (05Dec2023) Unknown results, notes: Fever gone; (06Dec2023) Unknown results, notes: Fever gone; SARS-CoV-2 test: (20Nov2023) Positive; (22Nov2023) Negative; (23Nov2023) Negative; (24Nov2023) Negative; (25Nov2023) Negative; (26Nov2023) Negative; (27Nov2023) Negative; (29Nov2023) Positive; (06Dec2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 20Nov2023, the patient first tested positive for Covid Symptoms (mild): sore throat, fatigue and had a fever of 99.5-100.3 for about 12 hours. 20Nov - Began Paxlovid 21Nov - Symptoms resolved, felt good 22Nov -Tested negative 23Nov - 27Nov - Continued negative - no symptoms. The patient used Paxlovid from 20Nov2023 to 24Nov2023 for the treatment of Covid-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 at 14:00 as dose 1, single (Lot number: HG4589) at the age of 61 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 5 (BOOSTER), SINGLE, Vaccine lot number: 027E22A, Vaccine location: Right arm), administration date: 01Oct2022, when the patient was 60-year-old, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number: 006M21A, Vaccine location: Right arm), administration date: 15Jul2022, when the patient was 60-year-old, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE, Vaccine location: Right arm), administration date: 20Nov2021, when the patient was 59-year-old, for COVID-19 immunization; moderna (DOSE 2, SINGLE, Vaccine location: Right arm), administration date: 13May2021, when the patient was 59-year-old, for COVID-19 immunization; moderna (DOSE 1, SINGLE, Vaccine location: Right arm), administration date: 14Apr2021, when the patient was 59-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2023 at 14:00, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: treatment of Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received Paxlovid from 03Dec2023 to 03Dec2023 for the treatment of COVID-19. Patient had no known allergies.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cholesterol" (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 Nov2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid treatment from 24Nov2023 to 28Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Device leakage
Clinical narrative: lurer lock of diluent on the  adapter would bend backwards and not lock; The syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine; The lurer lock separated into two pieces; This is a spontaneous report received from contactable reporters (Consumer or other non HCP and Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF5017) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE CONNECTION ISSUE (non-serious), outcome "unknown", described as "lurer lock of diluent on the  adapter would bend backwards and not lock"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "The syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine"; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "The lurer lock separated into two pieces".  Additional information: Reporter had two retailers who reported product defect or malfunctions with the product and looking to see about getting replacement. The lurer lock of diluent on the adapter would bend backwards and not lock. The syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine. The lurer lock separated into two pieces. To her understanding there was issues with the lurer lock syringe where it was instances where it was cracking when put on and attach. Beyond this caller is not sure of further details. They did lose some diluent and the vaccine and had to discard remaining formula. Later confirmed this happened only one time; only one syringe. Reporter indicated she went over with re-instructions and they felt comfortable with the reconstitution method and have not reached out since. They have carton, think got rid of other components because it was broken and lost formula. Complainant does not have the product with them at the time of call.  The reporter considered "lurer lock of diluent on the adapter would bend backwards and not lock", "the syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine" and "the lurer lock separated into two pieces" not related to rsv vaccine prot.subunit pref 2v. Causality for "lurer lock of diluent on the adapter would bend backwards and not lock", "the syringe ended up popping out of the lurer lock ring and subsequently lost diluent and some of vaccine" and "the lurer lock separated into two pieces" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 57.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 21Feb2023, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative Now. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: COVID 19 Treatment with Paxlovid, treatment start date was on 27Nov2023, treatment stop date was on 01Dec2023. No Known allergies, No other medication in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunization. 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 "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Anti-viral COVID-19 Treatment with PAXLOVID. Patient had mild symptoms so far, rebounded.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Dec2023) Negative; (04Dec2023) Negative; (Dec2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The antiviral COVID 19 Treatment with Paxlovid started from 27Nov2023 to 01Dec2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.