chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     It was reported that patient had no allergy or diseases. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 16-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 16-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent vaccine for ages 12 years plus was administered on 16-Mar-2023 after expiry date on 11-Mar-2023.).    No concomitant information was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Upper body pain months after receiving 2nd dose; shoulder pain months after receiving 2nd dose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162B2, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE , Lot number: Unknown, Route of administration: Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Upper body pain months after receiving 2nd dose"; ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain months after receiving 2nd dose". It was unknown if therapeutic measures were taken as a result of pain, arthralgia.  Additional Information: It was Unknown whether patient was diagnosed with COVID prior vaccination. It was Unknown whether patient tested COVID after vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
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 contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GJ5324) at the age of 47 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "c-PTSD" (unspecified if ongoing), notes: c-PTSD; "allergies" (unspecified if ongoing), notes: allergies; "asthma" (unspecified if ongoing); "overweight" (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 Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer 5th dose: 07Oct2022/ Moderna 4th dose: 21May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05May2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "5x cancer" (unspecified if ongoing); "heart failure" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 01Dec2021; ENTRESTO, start date: 01Dec2021; METOPROLOL, start date: 01Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Dec2021, outcome "unknown", described as "Pfizer 5th dose: 07Oct2022/ Moderna 4th dose: 21May2022"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: for 3 consecutive days; (Mar2023) Negative; (Mar2023) Negative; (Mar2023) Positive, notes: beginning 4 days after completing paxlovid, returned to testing positive for, as of today, 5 days; (28Mar2023) Positive, notes: beginning 4 days after completing paxlovid, returned to testing positive for, as of today, 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: After getting negative test results for 3 consecutive days, beginning 4 days after completing Paxlovid, the patient returned to testing positive for, as of today, 5 days, while being asymptomatic the entire time, except for the initial 4 days. The patient had no known allergies.  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.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Sinusitis, Vaccination failure
Clinical narrative: she had high cholesterol after being vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 22Sep2021 as dose 2, single (Lot number: FF8839) at the age of 42 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Diagnosed as a kid; "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Pfizer, Lot number: FC3184, Anatomical Site of injection: Upper right arm, Route of Administration: intramuscular), administration date: 31Aug2021, when the patient was 42-year-old, for Covid-19 immunization. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious) with onset 2022, outcome "recovering", described as "she had high cholesterol after being vaccinated". The event "she had high cholesterol after being vaccinated" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood cholesterol increased. Additional information: 2nd dose, Pfizer, Anatomical Site of injection: upper left arm. First time she had COVID she was prescribed an antimalarial medication. She was on so many other medications also. Didn't really know or differentiate the medications made her sick. Doesn't know about all that. Clarified she was fine on the medications she took for the first time she had COVID. Has asthma and if she would have gotten sick, then she would have gotten sick. Had COVID before the vaccines and refused hospitalization. She healed at home and was out for a long time, 65 days she was down. Lives with her husband and two kids and no one else got sick. Right now she has it and whole family has been tested and no one else is positive. For High cholesterol, start date: It was last year (2022), went to doctor in maybe Jan and her cholesterol was back down. Don't really remember. She didn't have high blood pressure, didn't have diabetes. She had high cholesterol and took a statin for it. Is the only medication she takes. Clarified statin to rosuvastatin at 20mg once daily by mouth at nighttime. Clarified product was in a pharmacy vial. Stopped taking rosuvastatin.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300137749 same patient, different dose/event;
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased
Clinical narrative: she had high cholesterol after being vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 22Sep2021 as dose 2, single (Lot number: FF8839) at the age of 42 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing), notes: Diagnosed as a kid; "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Pfizer, Lot number: FC3184, Anatomical Site of injection: Upper right arm, Route of Administration: intramuscular), administration date: 31Aug2021, when the patient was 42-year-old, for Covid-19 immunization. The following information was reported: BLOOD CHOLESTEROL INCREASED (non-serious) with onset 2022, outcome "recovering", described as "she had high cholesterol after being vaccinated". The event "she had high cholesterol after being vaccinated" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood cholesterol increased. Additional information: 2nd dose, Pfizer, Anatomical Site of injection: upper left arm. First time she had COVID she was prescribed an antimalarial medication. She was on so many other medications also. Didn't really know or differentiate the medications made her sick. Doesn't know about all that. Clarified she was fine on the medications she took for the first time she had COVID. Has asthma and if she would have gotten sick, then she would have gotten sick. Had COVID before the vaccines and refused hospitalization. She healed at home and was out for a long time, 65 days she was down. Lives with her husband and two kids and no one else got sick. Right now she has it and whole family has been tested and no one else is positive. For High cholesterol, start date: It was last year (2022), went to doctor in maybe Jan and her cholesterol was back down. Don't really remember. She didn't have high blood pressure, didn't have diabetes. She had high cholesterol and took a statin for it. Is the only medication she takes. Clarified statin to rosuvastatin at 20mg once daily by mouth at nighttime. Clarified product was in a pharmacy vial. Stopped taking rosuvastatin.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300137749 same patient, different dose/event;
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, Wrong product administered
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine dose number=1, Vaccine lot number=GJ5342 / Bivalent Lot administered as Dose 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). 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 12Sep2022 at 13:00 as dose 1, single (Lot number: GJ5342) at the age of 67 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Known allergies: Dust mites" (unspecified if ongoing), notes: Known allergies: Dust mites. The patient's concomitant medications were not reported. Past drug history included: Atovaquone-proguanil hcl for Known allergies: Atovaquone-Proguanil Hcl, notes: Known allergies: Atovaquone-Proguanil Hcl.  The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Sep2022 at 13:00, outcome "unknown", described as "Vaccine dose number=1, Vaccine lot number=GJ5342 / Bivalent Lot administered as Dose 1"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid given as treatment of covid-19 from 18Mar2023 to 22Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID 19 Treatment.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), in Sep2022 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. Vaccination date of dose 2 was reported as 28Dec2020 (pending clarification). The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hyperuricemia" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2015; ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2015; ALLOPURINOL, start date: Jan2015; VITAMIN D3, start date: Jan2015; ROSUVASTATIN, start date: 01Apr2022; ACETAMINOPHEN. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID-19"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Mar2023) Negative, notes: Negative antigen test 25Mar2023 and resolution of symptoms. Symptoms recurred 28Mar2023 (headache) and antigen test again became positive; (28Mar2023) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events COVID-19, drug ineffective and the suspect  product BNT162b2.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment.; COVID 19 Treatment.; Dose 5: Moderna; Dose 4: Pfizer/Biontech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206), in left arm, on 04Apr2021 as dose 2, single (Lot number: EW0151), in right arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF2589), in right arm and on 25May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Sep2022 as dose 5 (booster), single (Lot number: AS7145B), in left arm for covid-19 immunisation. The patient had no relevant medical history. No allergy. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Sep2022, outcome "unknown", described as "Dose 5: Moderna; Dose 4: Pfizer/Biontech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment.". The patient was tested negative at home after Paxlovid, but hoarseness and runny nose resumed, and tested positive at home five days later, 29Mar2020
Sex: M
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) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. 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: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 12Sep2022 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3249), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL3269), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Mar2023, outcome "unknown" and all described as "Covid". On 17Mar2023 the patient had the beginning of nasal symptoms and tested positive for Covid antigens. She had had the original 2 vaccinations using your product and 3 boosters as listed. Therapeutic measures were taken as a result of event. The patient used Paxlovid starting 17Mar2023 for 5 days.
Age: 49.0
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162B2 NOS has been requested and will be submitted if and when received.
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) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: G55342), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 13Jan2021 as dose 2, single (Lot number: EL1283), in right arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "I used to be obese" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol tartrate, start date: Jan1998; Rosuvastatin, start date: Jan2003; Dyazide, start date: Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
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) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative, notes: Tested negative twice after taking Paxlovid; (Mar2023) Negative, notes: Tested negative twice after taking Paxlovid; (Mar2023) Positive, notes: Positive again COVID rebounded. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 13Mar2023 to 17Mar2023. The known allergies were reported as none and other medical history was reported as none.   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: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events COVID-19, drug ineffective and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). This case will be reassessed should additional information become available.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Hazelnuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included Paxlovid from 28Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
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.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Mar2021 as dose 1, single (Lot number: 044A21A), in left arm, on 15Apr2021 as dose 2, single (Lot number: 042B21A), in left arm and on 13Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Sep2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Mar2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Mar2023) Positive; (27Mar2023) very faint line on a home test; (29Mar2023) test line was very dark again. Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received treatment with Paxlovid from 29Mar2023 to 25Mar2023 (lot number 661321) for COVID-19 treatment. The patient tested positive on 20Mar2023 and began Paxlovid that night. By 27Mar2023, had no symptoms and a very faint line on a home test. On 29Mar2023, cold symptoms returned-headache, runny nose-and test line was very dark again. On 30Mar2023, symptoms remained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: PCR covid test date=18Jul2022, covid test result=Positive; Pfizer Dose 1, 2, 3; PCR covid test date=18Jul2022, covid test result=Positive; Pfizer Dose 1, 2, 3; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL0140), as dose 2, single (Lot number: EL3249) and as dose 3 (booster), single (Lot number: EW0183) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Lot number: 068H21A) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shrimp" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: Vespids" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Sessional rhinitis" (unspecified if ongoing); "Hx concussion" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "unknown" and all described as "PCR covid test date=18Jul2022, covid test result=Positive; Pfizer Dose 1, 2, 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jul2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300135046 same reporter/patient/product, different dose/event;
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Tinnitus
Clinical narrative: ringing in my ear; anatomical location and route of administration, consumer stated, "It was the left shoulder."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Joint pain" (unspecified if ongoing), notes: Joint pain. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, LOT#: ER2613., ), administration date: 16Mar2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "ringing in his ears", "increasingly harder for him to hear"; BNT162b2 (Bivalent BioNTech (Suspect captured as Pfizer BioNTech Covid-19 Vaccine Bivalent) , LOT#: EW0150), administration date: 09Apr2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "anatomical location and route of administration, consumer stated, "It was the left shoulder."", "Joint Pain". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 10Dec2021, outcome "unknown", described as "anatomical location and route of administration, consumer stated, "It was the left shoulder.""; TINNITUS (non-serious), outcome "not recovered", described as "ringing in my ear".  Additional information: The patient informed that he received the Vaccine 2 and guess that was couple of years ago, when it first came out. He got the Booster, got the 2 shots and a Booster, and he had a constant, ringing in his ear, non-stop (conclusion that is Tinnitus).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300139633 same reporter/patient/product, different dose/event in time;US-PFIZER INC-202300133258 same reporter/patient/product, different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 03Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
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 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 06Oct2021 as dose 2, single (Lot number: FE3590), in left arm and on 03May2022 as dose 3 (booster), single (Lot number: FM9992), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient has no known allergies.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis; left leg weakness and left thigh numbness; This is a spontaneous report received from contactable physician.  A 78-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MYELITIS TRANSVERSE (medically significant), 6 days after the suspect product(s) administration, outcome "recovered", described as "Transverse myelitis; left leg weakness and left thigh numbness". The patient with multiple underlying medical problems developed left leg weakness and left thigh numbness 6 days after receiving the listed COVID-19 booster along with an influenza vaccine. She was later diagnosed with transverse myelitis possibly associated with one of the vaccines. Treated successfully with corticosteroids. The event took place after use of product.  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: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug BNT162b2 to the reported event "Transverse myelitis; left leg weakness and left thigh numbness" cannot be completely excluded based on temporal association. Concomitant influenza vaccine may also play a conytributory role. This case will be re-assessed when additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhagic stroke, Nervous system disorder
Clinical narrative: Hemorrhagic stroke; Apparent neurological deficits; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization. The following information was reported: HAEMORRHAGIC STROKE (medically significant), outcome "unknown", described as "Hemorrhagic stroke"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "Apparent neurological deficits". Clinical course: Patient received 2nd monovalent vaccine dose. Within 1-2 hours post dose, patient was not feeling well and layed on floor. Patient was diagnosed with a hemorrhagic stoke and has apparent neurological deficits from the event. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the event Hemorrhagic stroke. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My husband took the test and had COVID; My husband took the test and had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My husband took the test and had COVID". The patient  underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: took the test and had COVID. Clinical course: Caller stated the reporter's husband (patient) and the reporter were coming off of a trip. They were both really sick coming home and really tired. When they got home, they had the test in the blue box and the test in the orange and white box. The reporter's husband took the test and had COVID. They've had all of their shots. Pfizer actually.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Heart rate, SARS-CoV-2 test
Clinical narrative: covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 17Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "idiopathic hypersomnia" (unspecified if ongoing); "inappropriate sinus tachycardia" (unspecified if ongoing); "Allergy-induced asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive 7 days after finishing paxlovid; Heart rate: inappropriate sinus tachycardia. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Positive for Covid; Positive for Covid; first /second/first booster/second booster : Moderna/last booster: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 84 years for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown), on 10Mar2021 as dose 2, single (Batch/Lot number: unknown), on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 27Apr2022 as dose 4 (booster), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2022, outcome "unknown", described as "first /second/first booster/second booster : Moderna/last booster: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Mar2023) Negative; (21Mar2023) Positive; (27Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died because of BNT162B2 vaccine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died because of BNT162B2 vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The reporter also said he knew 3 clients of his who died from the Pfizer vaccine. The reporter was very irate and did not want to provided further details without a medical refund and did not want to be contacted any further if there was no refund evolved.  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-202300112856 same reporter/drug/event, different patient;; Reported Cause(s) of Death: died because of BNT162B2 vaccine
Age: 56.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of tenivac was administered to a patient, with no reported adverse event; Initial information received  on 14-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 56 years old male patient who received expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] was administered to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Mar-2023, the patient received 0.5 ml dose (total) of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids NO Preservative Adult Suspension for injection lot U6922AA and expiry: 22-Jan-2023 via intramuscular route in the right deltoid for immunization.   On 14-Mar-2023, the patient developed a non-serious event expired dose of tenivac was administered to a patient, with no reported adverse event (expired product administered) same day following the administration of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of tenivac was administered to a patient, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired dose of tenivac was administered to a patient, with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: that expired ACTHIB had been administered twice with no reported adverse event; Initial information received on 24-Mar-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 5 months old female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] twice with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On 20-Mar-2023, the patient received 0.5ml dose of suspect HIB (PRP/T) vaccine (frequency- once, strength - standard, lot - UJ649AAA, expiry date  - 03-Mar-2023) via intramuscular route in the thigh nos for prophylactic vaccine.   On 20-Mar-2023 the patient received expired acthib twice with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.