chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Maternal exposure before pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: pregnancy test was positive; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure before pregnancy in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number abxc06aa, expiry date 30-MAR-2023) for prophylaxis.   In DEC-2022, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced vaccine exposure before pregnancy (Verbatim: pregnancy test was positive). The outcome of the vaccine exposure before pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Bexsero): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-May-2023 No additional adverse event information available per health care professional. The reporter declined to follow-up. The patient received a dose of Bexsero and few days later was tested positive for pregnancy, which led to vaccine exposure before pregnancy.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HCP reporting having mixed and administered two of the diluent portions of Shingrix.; HCP reporting having mixed and administered two of the diluent portions of Shingrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: HCP reporting having mixed and administered two of the diluent portions of Shingrix.) and inappropriate preparation of medication (Verbatim: HCP reporting having mixed and administered two of the diluent portions of Shingrix.). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 15-May-2023 The reporter did not have any additional adverse vent information available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The reporter reporting that mixed and administered two of the diluent portions of Shingrix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was accidentally given instead of Pediarix; kinrix given to 4 month old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 15-MAY-2023, the patient received Kinrix. On 15-MAY-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix was accidentally given instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: kinrix given to 4 month old patient). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAY-2023 The reporter was an office manager. The information for the immunogenicity, safety and recommendations was solicited and given.  Information about vaccine, patient and event were collected.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The 4-month old patient received Kinrix accidentally instead of Pediarix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received Infanrix by mistake instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number LS444, expiry date 16-SEP-2023) for prophylaxis.   On 12-MAY-2023, the patient received Infanrix (intramuscular). On 12-MAY-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Received Infanrix by mistake instead of Boostrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-MAY-2023 The reporter reported that the patient received Infanrix vaccine by mistake when Boostrix should have been given. The reporter consented to follow up. The patient received Infanrix who was elder than the indicated age which led to inappropriate age at vaccine administration.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired dose of Pediarix was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number J953N, expiry date 11-MAY-2023) for prophylaxis.   On 15-MAY-2023, the patient received Pediarix. On 15-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired dose of Pediarix was administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-MAY-2023 The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. The patient received an expired dose of Pediarix vaccine, which led to expired vaccine used.
Age: 10.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered outside of approved age range. Administered to a 10 year old patient; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 01-NOV-2021, the patient received Pediarix. On 01-NOV-2021, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administered outside of approved age range. Administered to a 10 year old patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 09-MAY-2023 Pediarix manufacturer was not specified. No information was provided regarding subsequent dose (administered outside of approved age range), additional information about the adverse event, maladministration outside of approved age range. The reporter did not consent to follow-up. The patient received Pediarix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021) and NO ADVERSE EVENT (No adverse event) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B, 026C21A and FR2587) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered with first dose on 16-Apr-2021 and second dose on 02-Aug-2021).    No concomitant medications were provided. The Patient reports no adverse events after the administration.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-724228 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724228:(Bivalent Case)
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Urticaria
Clinical narrative: Having problems with hives a year or two ago after one the shots of Moderna.; He tested positive on Saturday; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Having problems with hives a year or two ago after one the shots of Moderna.) and COVID-19 (He tested positive on Saturday) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2023, the patient experienced COVID-19 (He tested positive on Saturday). On an unknown date, the patient experienced URTICARIA (Having problems with hives a year or two ago after one the shots of Moderna.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in May 2023 at an unspecified dose and frequency. At the time of the report, URTICARIA (Having problems with hives a year or two ago after one the shots of Moderna.) and COVID-19 (He tested positive on Saturday) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. It was reported that patient went through a lot of trouble. He got tablets of Paxlovid and was feeling pretty good with the medication considering he was tested positive on Saturday.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Renal cancer
Clinical narrative: kidney cancer; 1st dose 01-22-21 lot 043l20a and 2nd dose 03-05-21 lot 013a21a; This spontaneous case was reported by a patient and describes the occurrence of RENAL CANCER (kidney cancer) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059m21a, 037f21a, 013a21a and 043l20a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 01-22-21 lot 043l20a and 2nd dose 03-05-21 lot 013a21a). In November 2022, the patient experienced RENAL CANCER (kidney cancer) (seriousness criterion medically significant). The patient was treated with PEMBROLIZUMAB (KEYTRUDA) ongoing since an unknown date for Kidney cancer, at an unspecified dose and frequency. At the time of the report, RENAL CANCER (kidney cancer) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 01-22-21 lot 043l20a and 2nd dose 03-05-21 lot 013a21a) outcome was unknown.            No concomitant information was reported. The patient had kidney cancer and stated that they cut all the cancer out. It was reported that patient was on immunotherapy with the drug KEYTRUDA for kidney cancer and wanted to know if it was okay for him to take another COVID shot. No treatment information was provided. Company comment: This spontaneous case concerns a 70-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of RENAL CANCER, approximately 5 months after the fourth dose of mRNA-1273 vaccine. Patient was treated with pembrolizumab. Inappropriate schedule of vaccine administered was also reported since he received the first and the second dose of mRNA-1273 vaccine 42 days apart. No further information for medical review. Patient´s age could be a risk factor for renal cancer. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient administered the 2nd bivalent dose to a patient 6 weeks after the 1st one instead of 8 weeks; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered the 2nd bivalent dose to a patient 6 weeks after the 1st one instead of 8 weeks) and NO ADVERSE EVENT (No adverse event) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. GJ3274) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-May-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered the 2nd bivalent dose to a patient 6 weeks after the 1st one instead of 8 weeks). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered the 2nd bivalent dose to a patient 6 weeks after the 1st one instead of 8 weeks) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient administered the 2nd bivalent dose to a patient 6 weeks after the 1st one instead of 8 weeks).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-724230 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724230:(Monovalent Case)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Lot number 030g22b expired 5/9/23. vaccine given 5/12/23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Lot number 030g22b expired 5/9/23. vaccine given 5/12/23) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Lot number 030g22b expired 5/9/23. vaccine given 5/12/23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Lot number 030g22b expired 5/9/23. vaccine given 5/12/23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Lot number 030g22b expired 5/9/23. vaccine given 5/12/23).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (patient got both Moderna primary series). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 12-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap).    Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Moderna COVID-19 Vaccine, Bivalent was administered after accidental refreeze.).    No concomitant medication details was reported. No treatment medication details was reported.
Age: 64.0
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; Pfizer, Dose: 1, 2, 3 / Moderna, Dose: 4, 5; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 66-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 07Jan2021 as dose 2, single (Lot number: EL3246), in right arm and on 20Oct2021 as dose 3 (booster), single (Lot number: 30130BA) at the age of 64 years, in right arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 16Sep2022 as dose 5 (booster), single (Lot number: AS7143C), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24May2022 as dose 4 (booster), single (Lot number: 03BA22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Prior asthma" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing); "treated with radiation", start date: May2021 (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Jan2021; FLUOXETINE, start date: 01Jan2020; ELDERBERRY BLACK FLOWERS, start date: 01Jan2021; ZINC, start date: 01Jan2021; VITAMIN D3, start date: 01Jan2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24May2022, outcome "unknown", described as "Pfizer, Dose: 1, 2, 3 / Moderna, Dose: 4, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive home Covid antigen test; negative, notes: repeat antigen test day after completing meds was negative; Positive, notes: Covid antigen test the next day was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: Positive home Covid antigen test. Took the prescribed Paxlovid 3 capsules twice daily for 5 days. Also, symptoms resolved and repeat antigen test day after completing meds was negative. Three days later, mild upper respiratory symptoms returned and repeat Covid antigen test the next day was positive. Respiratory symptoms still present now, yet not as severe as the initial episode of Covid which was treated with Paxlovid. That was first infection during the three years since Covid first appeared. The patient received Paxlovid treatment from 29Apr2023 to 03May2023 for covid-19 with brand Pfizer. Patient had no known allergies. Sender's Comments: Based on the information in the case report, a possible causal relationship between the events vaccination failure, covid-19, interchange of vaccine products and suspect drug BNT162B2 cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am COVID-19 positive right now; I am COVID-19 positive right now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Jan2022 as dose 3 (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "I am COVID-19 positive right now". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive, notes: I am COVID-19 positive right now.  Clinical course: Patient was COVID-19 positive right now, patient was back vaccinated it was Pfizer vaccine the first two vaccines (Clarified as Pfizer COVID-19 Vaccine) then got a booster when they were recommended the Booster shot (Clarified as Pfizer COVID-19 Vaccine Booster) that was Jan2022, and wanted to know how good is this vaccines this is, for how long this going to expire or should got in. Also, wanted to know considered himself fully vaccinated or just other 4 vaccine that need to get it again or there is more vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 10Mar2023 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 at 15:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 10Sep2021 at 15:00 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, 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 from 08May2023 to 12May2023.  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-202300190697 Same patient/vaccine, different dose/event;
Age: 75.0
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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 01May2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received other medication in 2 weeks.Patient received Paxlovid for COVID 19 treatment from 05May2023 to 10May2023. Patient had not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously receive a COVID-19 Vaccine. No known allergies was reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:00 as dose 6 (booster), single (Lot number: 9J3275) at the age of 72 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD disease" (unspecified if ongoing); "Prostatectomy", start date: 2014, stop date: 2014. The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril allergy". 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". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid treatment from 01May2023 to 07May2023.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 at 11:00 as dose 1, single (Lot number: EN6202), in left arm, on 01Apr2021 at 11:00 as dose 2, single (Lot number: EV0151), in left arm, on 11Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 08Apr2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostrate Cancer" (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 Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient was treated with Paxlovid.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Prostatic specific antigen, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: GK3642), in right arm, on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 11Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "had prostate cancer" (unspecified if ongoing), notes: but had prostate removed and am now cancer free with PSA of 0.0; "had prostate removed" (unspecified if ongoing), notes: but had prostate removed and am now cancer free with PSA of 0.0; "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C, start date: 01Jan2022; ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE], start date: 01Jan2022; MONTELUKAST SODIUM, start date: 01Jan2022; AMLODIPINE BESYLATE, start date: 01Jan2022; TRAZODONE, start date: 01Jan2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Prostatic specific antigen: (unspecified date) 0.0; SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive for COVID on day; (02May2023) Negative, notes: then tested negative for 2 days in a row (May 2nd & 3rd); (03May2023) Negative, notes: then tested negative for 2 days in a row (May 2nd & 3rd); (12May2023) Positive; (14May2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GH9701) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 at 14:00 as dose 1, single (Lot number: EL9263), in left arm, on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL9263), in left arm, on 17Aug2021 at 12:00 as dose 3 (booster), single (Lot number: FA7485), in right arm and on 09Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (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 May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 01May2023 to 06May2023.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GJ6759) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Oct2022 as dose 3 (booster), single (Lot number: FE3592) 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 included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iv contrast, reaction(s): "Allergy", notes: IV contrast.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, latency 1 year 7 months 5 days after the suspect product(s) administration, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, the event drug ineffective is considered related to BNT162b2 and BNT162b2 omi ba.4-5.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic migraine" (unspecified if ongoing); "RLS" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "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), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient used Paxlovid (anti-viral) from 06May2023 to 10May2023 for the treatment of 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.
Age: 88.0
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 90-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 88 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 was not reported. The patient took 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. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with Paxlovid.  Additional information: The patient had no known allergies.  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
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 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Paxlovid Treatment start date was 11May2023, Indication was Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received paxlovid treatment from 04May2023 to 08May2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
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) (Pharmacist). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid).; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal association between the reported adverse events drug ineffective, Covid-19 and the suspect  product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19/Sick/Congested; Treatment of COVID-19/Sick/Congested; 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 08Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJU989), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in 2019 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: "Hypothyroidism" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19/Sick/Congested". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccinated and double boosted, patient took their 1st vacation since 2019. Left on 20Apr2023. They woke congested on 30Apr2023, the morning they were flying home. Took home test and both tested positive. Started Paxlovid on 01May. On 12May, she felt like she had a head cold, but no other symptoms. Tested positive 14May. Spouse tested negative on 14May. Though they got sick, she was reporting "country" below because this report was about the rebound.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), 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: "HBP" (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 "COVID 19 Treatment".  Therapeutic measures Paxlovid  (start date: 03May2023, stop date: 08May2023) were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks. Patient do not have any known allergies.