chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL3302), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 23Aug2021 as dose 3 (booster), single (Lot number: FC3103) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fighting Stage 4 Anal Cancer" (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 Oct2023, 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 which included Paxlovid from 30Oct2023 to 04Nov2023. clinical course: Patient no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366099 Same Patient, different drug/AE;
Age: 48.0
Sex: M
Vaccine: COVID19, 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 49-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: A Week Have Completing The Taking Of Paxlovid. Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 23Oct2023 to 27Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300365985 same patient, different drug/event;
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 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)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid Treatment start date: 09Nov2023. Known allergies: No.  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-202300366010 same reporter/patient, different drug/event;
Sex: F
Vaccine: COVID19, 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Oct2023 (also reported as 12Oct2022) as dose 1, single (Lot number: HG4659), 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), as dose 3, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient has no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Dose 4; Pfizer, Dose 5: Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Apr2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2023 as dose 5 (booster), single (Lot number: 80777010293), 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: "COPD" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 01Jan2023, stop date: 30Oct2023; METOPROLOL, start date: 01Jan2023; FAMOTIDINE, start date: 01Jan2023. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2023, outcome "unknown", described as "Dose 4; Pfizer, Dose 5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid start date on 30Oct2023 and stop date on 03Nov2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300366019 Same reporter/patient, different drug/event;
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine Brand Other=Novavax, Vaccine Brand=Pfizer / Biontech, Vaccine Brand Other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 17Mar2021 at 13:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 07Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 18Oct2023 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Dec2021, outcome "recovered", described as "Vaccine Brand Other=Novavax, Vaccine Brand=Pfizer / Biontech, Vaccine Brand Other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Oct2023, outcome "recovered" (2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid start date on 28Oct2023 and stop date as 01Nov2023. Clinical course: He tested positive for the first time on 28Oct2023 (8 days after his novavax vaccine), then started taking paxlovid that day.   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: Linked Report(s) : US-PFIZER INC-202300366013 Same patient/reporter, different product/event;
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) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Dec2020 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 02Nov2023 to 06Nov2023.  The information on the batch/lot number for 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 drug to the reported drug ineffective cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300367333 Same reporter/patient, different drug, different event.;
Sex: F
Vaccine: COVID19
Symptoms: Body height, Diplegia, Weight, Weight decreased
Clinical narrative: Have been shrinking; Legs were paralyzed from feet to knees, could not lift legs, kind of worried about it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 89-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Handicap" (ongoing), notes: I am also a handicap (Intent: History). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; VITAMIN D3. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: DIPLEGIA (medically significant) with onset 2022, outcome "recovered" (2022), described as "Legs were paralyzed from feet to knees, could not lift legs, kind of worried about it"; WEIGHT DECREASED (non-serious), outcome "not recovered", described as "Have been shrinking". The patient underwent the following laboratory tests and procedures: Body height: Maybe 5'3; Weight: It's like 135, notes: Have been shrinking. Therapeutic measures were not taken as a result of diplegia. Clinical course: This report was not related to a study or programme. There were no investigations. Patient stated, well, she just had a question about the vaccine that she received last year, with the Pfizer and her problem with that one was, that her legs were paralyzed from her feet to her knees, and she could not lift her legs. She was wondering should she get another shot this year, she was kind of worried about it and don not know, if she should get another one or what she should do. Patient reported had 3 shots and then she thought, she had the Booster (later clarified as Pfizer Covid Booster Vaccine) and that was her last shot that she had a problem with. In regard to the vaccination card patient stated it was not handy. She was handicap (Intent: History) here so, it would take her a few minutes to get it. She was not seeing it handy. Regarding treatment patient reported: No, she did not took, it lasted only two days and she just sleep in her recliner because she could not get into bed so, she slept in her recliner for a couple of days and on the third day, her legs were ok. Patient did not ever have any Flu vaccine.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 37.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-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 37 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naproxen, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 31Oct2023 to 04Nov2023.  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-202300367591 Same patient, different drug, different event;
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; 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 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 02Nov2023 to 06Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367599 Same patient, different product, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Breakthrough COVID case even though he was vaccinated/got COVID yesterday; Breakthrough COVID case even though he was vaccinated/got COVID yesterday; This is a spontaneous report received from non-contactable reporter(s) (Nurse).  A male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Breakthrough COVID case even though he was vaccinated/got COVID yesterday". Clinical course: Reporter stated that she wanted to informed that, her husband who had his vaccination got COVID yesterday, last night she calling to report that he had a breakthrough COVID case even though he was vaccinated. The last one he had was the COVID Pfizer Bivalent in Sep. Reporter felt like it was her husband's best decision so she could gave his contact information but that was as far as she wanted to go and he could talk when he was not ill."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are  related to bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5)  cannot be excluded.  This case will be reassessed should additional information become available.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 2 (initial pfizer dose), single (Lot number: GH9702) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14May2022 as dose 1, single (Lot number: 043B21A), in left arm and on 27Oct2023 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Inflammation caused muscle pain" (unspecified if ongoing); "Inflammation caused muscle pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Oct2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, 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 drug ineffective, covid-19. Clinical course: Patient took Paxlovid for treatment of COVID-19 from 31Oct2023 to 06Nov2023. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367608 Same patient, different product/events;
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.  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Batch/Lot number: unknown), in right 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; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (05Nov2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Positive, notes: Treatment of COVID-19; (05Nov2023) Negative. Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 31Oct2023 to 04Nov2023.  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-202300367612 Same patient, different drug/event;
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 25Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) 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 with paxlovid from 09Nov2023 to 09 nov2023.  The information on the batch/lot number for 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 to the reported event Drug ineffective and COVID 19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300367621 Same patient, different drug, different event;
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 contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 16:00 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 and concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Augmentin: Allergy"; Septra, reaction(s): "Septra: Allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 30Oct2023 to 03Nov2023.  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 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 / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300366003 Same patient, different product/event;
Age: 38.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (08Nov2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: Treatment of COVID-19; (08Nov2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Paxlovid given from 01Nov2023 to 05Nov2023. Tested negative on 08Nov2023. There were no symptoms  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367335 same patient, different drug, different event;
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 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: 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: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid treatment from 04Nov2023 to 09Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367338 same patient, different drug, different event;
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Therapeutic response unexpected
Clinical narrative: within 24 hours her smoker's cough of sixty years lessened. Her sinuses also cleared up completely.  She has a cat and she's not allergic, but she does have a sensitivity and her sinuses get activated; 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 71-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 31Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for immunisation; for immunisation. The patient's relevant medical history included: "smallpox" (unspecified if ongoing); "yellow fever" (unspecified if ongoing); "smoker's cough" (unspecified if ongoing), notes: had it for 60 years. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in Oct2023 as dose number unknown, single, in Oct2023 as dose number unknown, single; PNEUMOCOCCAL VACCINE taken for immunisation, in Oct2023 as dose number unknown, single; SHINGRIX taken for immunisation, in Oct2023 as dose 2, single. Vaccination history included: Bnt162b2 (History of all previous immunization with the Pfizer vaccine considered as suspect: 1st dose), for COVID-19 immunization; Shingrix (1st shot was shingles in Sep2023), administration date: Sep2023. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2023, outcome "unknown", described as "within 24 hours her smoker's cough of sixty years lessened. Her sinuses also cleared up completely.  She has a cat and she's not allergic, but she does have a sensitivity and her sinuses get activated". Additional information: Caller, aged 71, received the Abrysvo vaccine on 31Oct2023 at withheld, and within 24 hours her smoker's cough of sixty years lessened. Her sinuses also cleared up completely. She has a cat and she's not allergic, but she does have a sensitivity and her sinuses get activated. That went away after taking the Abrysvo. History of all previous immunization with the Pfizer vaccine considered as suspect was 1st dose. Additional Vaccines Administered on Same Date of the Pfizer Suspect was annual flu shot. Prior Vaccinations (within 4 weeks) included going through series of shingle shot and Covid update and 2 flu and today got pneumonia shot.1st shot was shingles in Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Got shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "Got shingles". Additional information: The reporter stated "why are people having strokes after getting vaccine?. 5 months after vaccine I regret, I had stroke and my friend got shingles".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Stent placement
Clinical narrative: Stents installed. One was in May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: ER8735) at the age of 56 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE; Batch/Lot number: ER8735; Time: In the morning, between 8-10am), administration date: 31Mar2021, for COVID-19 Immunization. The following information was reported: STENT PLACEMENT (medically significant) with onset May2021, outcome "unknown", described as "Stents installed. One was in May2021".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367690 Same patient/vaccine, different dose/events (dose 3);
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 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, MANUFACTURE UNKNOWN), for COVId-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURE UNKNOWN), for COVId-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURE UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURE UNKNOWN), for COVId-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), MANUFACTURE 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". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid treatment from 05Nov2023 to 09Nov2023.  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-202300367514 same patient, different drug/event (Paxlovid case);
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Covid-19; Covid-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), on 06Jun2022 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Feb2021 as dose 1, single (Lot number: 013M2A), in left arm, on 10Mar2021 as dose 2, single (Lot number: 026A21A), in left arm and on 23Oct2021 as dose 3 (booster), single (Lot number: 017F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Jun2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 04Nov2023 to 09Nov2023. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300369161 same patient, different drug/event;
Age: 62.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 17:00 as dose 5 (booster), single (Lot number: Gh9694) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 12Dec2021 as dose 3 (booster), single (Lot number: 33130BA), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: Fk9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Wound bandage adhesive" (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 Oct2023, outcome "unknown" and all described as "Covid 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 21Oct2023 to 25Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300369278 same patient, different drug/event;
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 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: "Ulcerative colitis" (unspecified if ongoing); "SVT" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: 10Sep2014; CRESTOR, start date: 14Feb2018, stop date: 01Nov2023; DILTIAZEM, start date: 04Feb2020, stop date: 01Nov2023. 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 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 01Nov2023 to 06Nov2023. Clinical course: 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.; 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 vaccination failure / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-202300370066 Same patient, different product, different dose/event;
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, 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. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid, start date as 31Oct2023 and stop date as 05Nov2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370153 Same reporter/patient, different product/event;
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Overdose, Pain in extremity
Clinical narrative: dizziness; arm soreness; fatigue; feeling like "the walls are caving in"; My son is 10 and was given the 12+ vaccine; My son is 10 and was given the 12+ vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Nov2023 as dose 1, single (Lot number: HF9298) at the age of 10 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: unknown past drug. Concomitant medication(s) included: CLARITIN [LORATADINE]. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 13Nov2023, outcome "unknown" and all described as "My son is 10 and was given the 12+ vaccine"; PAIN IN EXTREMITY (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering", described as "arm soreness"; DIZZINESS (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering"; FATIGUE (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering", described as "feeling like "the walls are caving in"". Therapeutic measures were not taken as a result of product administered to patient of inappropriate age, overdose. Therapeutic measures were taken as a result of dizziness, pain in extremity, fatigue, feeling abnormal. Additional information: He was given acetaminophen last night before bed.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: dizziness; arm soreness; fatigue; feeling like "the walls are caving in"; My son is 10 and was given the 12+ vaccine; My son is 10 and was given the 12+ vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Nov2023 as dose 1, single (Lot number: HF9298) at the age of 10 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing), notes: unknown past drug. Concomitant medication(s) included: CLARITIN [LORATADINE]. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 13Nov2023, outcome "unknown" and all described as "My son is 10 and was given the 12+ vaccine"; PAIN IN EXTREMITY (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering", described as "arm soreness"; DIZZINESS (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering"; FATIGUE (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering"; FEELING ABNORMAL (non-serious) with onset 13Nov2023 at 06:30, outcome "recovering", described as "feeling like "the walls are caving in"". Therapeutic measures were not taken as a result of product administered to patient of inappropriate age, overdose. Therapeutic measures were taken as a result of dizziness, pain in extremity, fatigue, feeling abnormal. Additional information: He was given acetaminophen last night before bed.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Vomiting
Clinical narrative: every time she takes the COVID shot, she gets definitely sick for two days; Vomiting; Diarrhea; cannot even make it to the bathroom in time and messes up the sheet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 63-year-old female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "every time she takes the COVID shot, she gets definitely sick for two days"; VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea; cannot even make it to the bathroom in time and messes up the sheet". The events "every time she takes the covid shot, she gets definitely sick for two days", "vomiting" and "diarrhea; cannot even make it to the bathroom in time and messes up the sheet" required physician office visit.  Additional information: Every time patient took the COVID shot, she gets definitely sick for two days. Patient had vomiting and diarrhea that she cannot even make it to the bathroom in time and messes up the sheet, it is just a night mare and I was wondering is there anything she could do like after she got the shot may be get some kind of pills from a doctor to wear this off or what.  Patient have the doctor's appointment at 10:30.  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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: menstruating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 3, single, Time: 03:00 pm, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Lot FF2587), administration date: 26Sep2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Time: 11:00 am, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Lot# EL3247), administration date: 15Mar2021, when the patient was 50-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, single, Time: 2pm, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot Number: Lot# EL3247), administration date: 22Feb2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset Apr2022, outcome "unknown", described as "menstruating". The patient was in peri-menopause and she had not had period in almost a year and it came within 2 days of vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306567 same patient/vaccine, different dose and same event;