chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19 included nirmatrelvir, ritonavir (PAXLOVID) from 09Feb2024 to 14Feb2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Suprax, reaction(s): "Known allergies: Suprax"; Prednisone, reaction(s): "Known allergies: Prednisone"; Zithromax, reaction(s): "Known allergies: Zithromax". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Feb2024) Positive, notes: Positive COVID test 5 days after Paxlovid completion. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid from 06Feb2024 to 11Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from an Other HCP.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 5 (booster), single (Lot number: GJ3274) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 4 (booster), single, vaccine lot number: FK9893, vaccine location: Right arm), administration date: 18Apr2022, when the patient was 50-year-old, for Covid-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster), manufacturer unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 09Feb2024 to 13Feb2024.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from an Other HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures included paxlovid from 28Jan2024 to 02Feb2024 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 04Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (vaccine location: Left arm, dose number unknown), for COVID-19 immunization; Covid-19 vaccine (dose number unknown), for COVID-19 immunization; Covid-19 vaccine (dose number unknown). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 53-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Nov2023 at 12:00 as dose 1, single (Lot number: 70461032203) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune hepatitis" (unspecified if ongoing); "cirrhosis and hyper portal extension" (unspecified if ongoing); "cirrhosis and hyper portal extension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization. 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.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Systemic lupus erythematosus" (unspecified if ongoing); "Immunosuppressant" (unspecified if ongoing). Concomitant medication(s) included: AZATHIOPRINE taken for immunosuppressant drug therapy, start date: 01Oct2010, stop date: 01Feb2024. Past drug history included: Fluconazole, reaction(s): "known allergies: Fluconazole"; Hydroxychloroquine, reaction(s): "known allergies: Hydroxychloroquine"; Azithromycin, reaction(s): "known allergies: Azithromycin". 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 including paxlovid.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 19:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Neutropenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Vaccine brand=Pfizer / biontech, administration time: 5:00 PM, dose number 4, Vaccine location: Left arm,), administration date: 21Sep2022, for COVID-19 immunization; BNT162b2 (Vaccine brand=Pfizer / biontech, administration time: 09:00 AM, dose number: 3, Vaccine location: Left arm,), administration date: 29Dec2022, for COVID-19 immunization; BNT162b2 (Vaccine brand=Pfizer / biontech, administration time: 03:00 AM, dose number: 2, Vaccine location: Left arm), administration date: 14Apr2021, for COVID-19 immunization; BNT162b2 (Vaccine brand=Pfizer / biontech, administration time: 05:00 PM, dose number: 1, Vaccine location: Left arm), administration date: 24Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19, treatment was Paxlovid from 06Feb2024 to 11Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400044522 same patient, different vaccine dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 51-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 8 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE 9 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization. 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 with Paxlovid. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "allergies". 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. Paxlovid as treatment from 03Feb2024 to 08Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: consumer and his wife both have covid after vaccine; consumer and his wife both have covid after vaccine; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "consumer and his wife both have covid after vaccine". It was reported that the patient took the Pfizer COVID-19 Vaccine.  She got first vaccine and then second later on and then when they said that she has to get the Boosters, she got the first booster and then after that she got the following booster, so the patient got four of them. She was great and then a year ago in 2023 she got the covid but just very light and they gave her Paxlovid. 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, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400044595 Same reporter/drug/AE, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 14-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillins" (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 Feb2024, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received PAXLOVID as COVID-19 treatment from 05Feb2024 to 10Feb2024.   The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400044053 Same patient, different drug and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  AA 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 12:15 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "lung surgery" (unspecified if ongoing); "allergies: bacterium" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "allergies"; Blood thinners, reaction(s): "allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "recovered" (07Feb2024) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2024) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19 starting on 13Jan2024 until 05Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: so tired all the time; especially her legs where she can barely walk/ having difficulty lifting her legs; This is a spontaneous report received from a Consumer or other non HCP.  An elderly female patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL8982) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "so tired all the time"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "especially her legs where she can barely walk/ having difficulty lifting her legs". Additional information: The tiredness and having difficulty lifting her legs started early and has been going on for she would say after the 2nd dosage 18Feb2021 and that is when it started but it has gotten to the point where she cannot hardly walk, and it is not just the legs and feet where she can hardly but going up stairs is almost impossible.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphonia, Nausea, Pharyngeal disorder, Rash
Clinical narrative: rash on my skin; irritation in my throat; altered my voice/vocal problems; I have some mucus spitting up; thirsty; nauseous; diarrhea; throat problems; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: RASH (non-serious), outcome "unknown", described as "rash on my skin"; THROAT IRRITATION (non-serious), outcome "unknown", described as "irritation in my throat"; DYSPHONIA (non-serious), outcome "unknown", described as "altered my voice/vocal problems"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "I have some mucus spitting up"; THIRST (non-serious), outcome "unknown", described as "thirsty"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; PHARYNGEAL DISORDER (non-serious), outcome "unknown", described as "throat problems". Additional information: within a couple of weeks after patient got the shot back in Dec or Nov and it also, that's what my throat and my voice and it gave me a rash on my skin, since the Covid vaccines in the Covid-19 has affected the patient in 19 (as reported), the vaccines altered the voice and vocal cords, caused throat irritation, and some mucus spitting up. It made the patient very thirsty and nauseous, and a lot of diarrhea.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Secretion discharge, Thirst, Throat irritation
Clinical narrative: rash on my skin; irritation in my throat; altered my voice/vocal problems; I have some mucus spitting up; thirsty; nauseous; diarrhea; throat problems; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: RASH (non-serious), outcome "unknown", described as "rash on my skin"; THROAT IRRITATION (non-serious), outcome "unknown", described as "irritation in my throat"; DYSPHONIA (non-serious), outcome "unknown", described as "altered my voice/vocal problems"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "I have some mucus spitting up"; THIRST (non-serious), outcome "unknown", described as "thirsty"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; PHARYNGEAL DISORDER (non-serious), outcome "unknown", described as "throat problems". Additional information: within a couple of weeks after patient got the shot back in Dec or Nov and it also, that's what my throat and my voice and it gave me a rash on my skin, since the Covid vaccines in the Covid-19 has affected the patient in 19 (as reported), the vaccines altered the voice and vocal cords, caused throat irritation, and some mucus spitting up. It made the patient very thirsty and nauseous, and a lot of diarrhea.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Pneumonia; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (hospitalization) with onset Dec2023, outcome "unknown". The patient was hospitalized for pneumonia (start date: Dec2023). Additional information: The patient reported being in the hospital a couple of months ago (in Dec2023) because of pneumonia.  The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Influenza
Clinical narrative: COVID; COVID; flu; This is a spontaneous report received from a Consumer or other non HCP.  An 84-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for Covid-19 Immunization; Comirnaty (DOSE 2), for Covid-19 Immunization; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER)), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID"; INFLUENZA (non-serious), outcome "unknown", described as "flu". The clinical course was reported as follows: The patient's sister advised the patient is sick, with COVID and the flu. She also reported that the patient had all the COVID Pfizer vaccine. The patient was given nirmatrelvir, ritonavir (PAXLOVID) as treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: patient was given a dose of ADACEL after it suffered a temperature excursion (with no reported adverse event); patient was given a dose of ADACEL after it suffered a temperature excursion (with no reported adverse event); Initial information received on 12-Feb-2024 regarding an unsolicited valid non-serious case received from an other health professional. This was a courtesy case received from Merck & Co.  This case involves an unknown age and unknown gender patient who experienced patient was given a dose of diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] after it suffered a temperature excursion (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (product storage error) (poor quality product administered) (latency- same day).  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.
Sex: U
Vaccine: FLU3
Symptoms: Illness
Clinical narrative: ill; Initial information was received on 13-Feb-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves patients close to 100 Elderly and unknown gender patient who experienced ill after receiving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination(Immunization). The information on batch number was requested.  On an unknown date the patient developed ill (illness) (unknown latency) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine.  Reportedly "the Staff Educator Resident Services informed me yesterday that Medical Director of the Facility is worried about AE's for patients close to 100. She said several of them had to go back to the hospital within a week of injection due to becoming ill. I confirmed that the were administered Fluzone HD after she informed me of the possible AE's with her patients The contact information is as follows, and I was unable to confirm if she would like to be contacted. "  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (ill).  At time of reporting, the outcome was Unknown for the event ill.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: quadracel was given to a patient and it was already expired for 7 days with no reported adverse event; Initial information received on 12-Feb-2024 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 4 years old female patient who was administered Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine [Quadracel] and it was already expired for 7 days with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine Live (ENDERS-EDMONSTON), Mumps vaccine Live (JERYL LYNN), Rubella vaccine live (WISTAR RA 27/3), Varicella Zoster vaccine Live (OKA/MERCK) (PROQUAD) for Prophylactic vaccination.  On 09-Feb-2024, the patient received 0.5 ml dose (5th dose for DTaP vaccination series, 4th dose for IPV vaccination) (strength: standard) of expired suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) vaccine suspension for injection of lot C5970AA and expiry: 02-Feb-2024 via intramuscular route in the right vastus lateralis for immunization; it was already expired for 7 days with no reported adverse event (expired product administered)(latency: same day).  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 and Regulatory Authority 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.
Age: 17.0
Sex: F
Vaccine: HEP, MENB
Symptoms: Hepatitis B antibody negative, Product administered to patient of inappropriate age
Clinical narrative: Previous Hep B titer showed pt not immune after childhood immunizations. Is in EMT school through dual enrollment and returned for Hep B vaccine to develop immunity. Received Heplisav rather than pediatric Hep B vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Angiogram, Computerised tomogram abdomen, Diabetes mellitus, Lymphadenopathy, Pulmonary embolism
Clinical narrative: pulmonary emboli, new onset diabetes, syncope, lymphadenopathy on left side, elevated WBC
Age: 61.0
Sex: M
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Syncope, White blood cell count increased
Clinical narrative: pulmonary emboli, new onset diabetes, syncope, lymphadenopathy on left side, elevated WBC
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Flank pain, Groin pain, Rash
Clinical narrative: Sensitivity/pain along left waist; eruptions on bank, waist, and lower abdomen; flashes of pain through abdomen down to left groin
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count normal, Sensory loss, Syncope
Clinical narrative: Loss feeling complete right side of body and collapsed onto sidewalk 15-20 mins. Mostly feeling recover. Then walked inside and it took another 15-30 mins to regain all feeling.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Purple oval shaped bruises on body on hips, lower back and lower mid sections both sides.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Injection site indentation, Injection site pustule
Clinical narrative: hole in left arm for the past two months, now has pus. has received augmentin and bactrim in december but no improvement was seen. has now been prescribed bactrim with doxycycline.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Lymphadenopathy
Clinical narrative: swelling of lymph nodes under arms
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects known.  Vaccine was given after beyond use date but before expiration date.  Unable to get ahold of patient.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects known.  Patient received vaccine that was after beyond use date but before expiration date.  Unable to get ahold of patient.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Patient was given the vaccine at the pharmacy on 2/16/24. 2 days ago it became red, inflamed, and hard.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging, Mobility decreased
Clinical narrative: multiple strokes, loss of mobility, ...1st stroke was 2 moths after administration of shot in 2021. second stroke Occured almost one year to date of first stroke in 2022, and third stroke one year after that 2023
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat, slight fever, body ache, chills
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Administration Error.   MA gave IM injection.  Not orally.  This is an oral vaccine.   Instructions were either not with the box or not clear to the staff  member and the device/plunger appeared to this individual to be for Injection.   Discovered when documenting administration. Parents contacted, but did not call back until six days later.  No rash or adverse reactions had been noted by them, which was also consistent with data I had found in literature.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mobility decreased
Clinical narrative: Patient came in today and stated that ever since she had the vaccination she is not able to fully extend her arm back or lift it up. It has improved over the past couple of weeks since the vaccination but is not where it was before. The patient stated she only took Aleve for a few days the beginning and it didn't seem to help. This is the first we at the pharmacy are hearing of her ADR.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue, Incontinence, Oedema
Clinical narrative: Incontinence, Edema, Fatigue, Death
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Muscle swelling, Pruritus
Clinical narrative: Acute erythema and swelling of deltoid, diffuse itching but no obvious urticaria or anaphlaxis
Age: 40.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Bone pain, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Fatigue, muscle aches, bone pain,  dizziness, shortness of breath, headache
Age: 40.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Myalgia
Clinical narrative: Fatigue, muscle aches, bone pain,  dizziness, shortness of breath, headache
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: RED, TENDERNESS TO INJECTION SITE.  RASH DEVELOPED 2 DAYS LATER ON 02/17/24, STARTED SMALL AND GREW TO ABOUT PALM SIZE.  IT'S WARM TO TOUCH BUT IS NOT ITCHY OR PAINFUL.  IT HAS BEEN GETTING BETTER ACCORDING TO PATIENT.  SHE HAS NO OTHER REACTION, NO FEVER REPORTED, AND NO OTHER SYMPTOMS OF DISCOMFORT.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bursitis, Injected limb mobility decreased, Insomnia, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: After the vaccine was given in my left arm I have experienced pain.  I am unable to fully lift my left arm due to pain and weakness.  I am having difficulty sleeping.  The pain started after the injection was given.  I have had a course of prednisone that has shown some improvement.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: After the vaccine was given in my left arm I have experienced pain.  I am unable to fully lift my left arm due to pain and weakness.  I am having difficulty sleeping.  The pain started after the injection was given.  I have had a course of prednisone that has shown some improvement.
Age: 6.0
Sex: U
Vaccine: HPV9, TDAP, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE; HBP calling to report an adverse event for GARDASIL 9.  HBP reports a 6 year old patient was inadvertently  administered the GARDASIL 9 Vaccine on 02/12/2024.  No symptoms reported and no additional details provided.  HBP states this is the first dos; This spontaneous report was received from nurse and refers to a 6-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-FEB-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #W028355, expiration date: 07-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse eeant was reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Patient who is older than the indicated age and was inadvertently administered PROQUAD. No symptoms reported. Obtained consent to contact HCP. No additional AE/PQC.; This spontaneous report was received from a nurse, referring to a 20-years-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JAN-2024, the patient was inadvertently vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, 0.5milliliter, valid lot # X011982, expiration date: 22-OCT-2024, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) (product administered to patient of inappropriate age). No reported symptoms. No adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Shingrix over 4 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix over 4 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix over 4 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-FEB-2024 The registered pharmacist reported a patient did not get the second dose. The pharmacist called to enquired about how to proceed. The patient showed up today (at the day of reporting) to possibly get the second dose. The registered pharmacist was unable to provide the date of first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), 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. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 0.25
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: As of currently there have been no adverse reactions, although I want to report negligence and malpractice. My daughter is on a delayed vaccination schedule to minimize aluminum exposure. She is 3.5 months old and received Prevnar at her 2 month visit. She was scheduled to receive DTAP and HIB today after discussing and confirming with her doctor that they had the ACTHIB brand, which does not contain any aluminum. After getting home and reviewing her aftercare sheet, I see that she was given Hep B instead of HIB. We declined Hep B and birth and at her 2 month appointment and explicitly said we did not want her receiving two vaccines at the same time that both contained aluminum. Their gross negligence may not have adverse affect that can be seen now but I am concerned for my daughters development and the lack of professionalism and care at this facility.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Impaired driving ability, Intervertebral disc protrusion, Loss of proprioception
Clinical narrative: Symptoms involved my nervous system, particularly around the area of my neck, primarily my proprioceptive nerves, which effected my balance (NOT vertigo or lightheadedness, but an unsteady feeling that was made worse while standing, more so than walking. Imagine a tug-of-war between your shoulder blades). I would also have problems driving, particularly while at a stop. And other times while sitting in a chair, I'd get the sensation that I was going to fall out of my chair. Other symptoms included intermittent and fleeting problems with vision, particularly on cold mornings. Additionally, I would have anxiety spells that came and went with no apparent cause or reason. The symptoms were persistent, but worse on some days than others. These symptoms have improved over time, but were particularly worse 6 months to a year after initial vaccine. My suspicion is that the J&J shot damaged my nervous system, which weakened my proprioceptive nerves, thus making me prone to further injury and symptoms. The irony is that a friend of mine has been dealing with the same exact thing, and it started roughly a few months after he received the same vaccine. We are both in our 50s, and have never experienced, or even known of this condition we have been dealing with. Many of our doctors have been stumped as well.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging spinal abnormal, Massage, Nerve injury, Nervous system disorder
Clinical narrative: Symptoms involved my nervous system, particularly around the area of my neck, primarily my proprioceptive nerves, which effected my balance (NOT vertigo or lightheadedness, but an unsteady feeling that was made worse while standing, more so than walking. Imagine a tug-of-war between your shoulder blades). I would also have problems driving, particularly while at a stop. And other times while sitting in a chair, I'd get the sensation that I was going to fall out of my chair. Other symptoms included intermittent and fleeting problems with vision, particularly on cold mornings. Additionally, I would have anxiety spells that came and went with no apparent cause or reason. The symptoms were persistent, but worse on some days than others. These symptoms have improved over time, but were particularly worse 6 months to a year after initial vaccine. My suspicion is that the J&J shot damaged my nervous system, which weakened my proprioceptive nerves, thus making me prone to further injury and symptoms. The irony is that a friend of mine has been dealing with the same exact thing, and it started roughly a few months after he received the same vaccine. We are both in our 50s, and have never experienced, or even known of this condition we have been dealing with. Many of our doctors have been stumped as well.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance, Traction, Visual impairment, X-ray
Clinical narrative: Symptoms involved my nervous system, particularly around the area of my neck, primarily my proprioceptive nerves, which effected my balance (NOT vertigo or lightheadedness, but an unsteady feeling that was made worse while standing, more so than walking. Imagine a tug-of-war between your shoulder blades). I would also have problems driving, particularly while at a stop. And other times while sitting in a chair, I'd get the sensation that I was going to fall out of my chair. Other symptoms included intermittent and fleeting problems with vision, particularly on cold mornings. Additionally, I would have anxiety spells that came and went with no apparent cause or reason. The symptoms were persistent, but worse on some days than others. These symptoms have improved over time, but were particularly worse 6 months to a year after initial vaccine. My suspicion is that the J&J shot damaged my nervous system, which weakened my proprioceptive nerves, thus making me prone to further injury and symptoms. The irony is that a friend of mine has been dealing with the same exact thing, and it started roughly a few months after he received the same vaccine. We are both in our 50s, and have never experienced, or even known of this condition we have been dealing with. Many of our doctors have been stumped as well.
Sex: M
Vaccine: RVX
Symptoms: Blood pressure fluctuation, Condition aggravated, Fatigue
Clinical narrative: residual fatigue; This non-serious case was reported by a physician via other manufacturer and described the occurrence of fatigue in a 80-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included scab, compulsive skin picking and blood pressure fluctuation. Previously administered products included Gabapentin (last Friday on 19th January 2024). Concurrent medical conditions included thyroid cancer (C73 Differentiated thyroid cancer (DTC)). Concomitant products included lenvatinib mesilate (Lenvima).   In JAN-2024, the patient received RSV vaccine. In JAN-2024, an unknown time after receiving RSV vaccine, the patient experienced fatigue (Verbatim: residual fatigue). In JAN-2024, the outcome of the fatigue was resolved (duration 4 days).   It was unknown if the reporter considered the fatigue to be related to RSV vaccine.     It was unknown if the company considered the fatigue to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 13-FEB-2024 The patient's wife reported that patient's blood pressure has continued to fluctuate since starting Lenvima but had been a little lower, reporting todays reading of 125/85 per, also voiced that prior to Lenvima patient had scabs on his head from picking at his skin. So, his healthcare professional prescribed Gabapentin 300mg daily last Friday (CS offered Pharmacist consult) and since then the area had cleared up, also reported residual fatigue for four days after having the previously reported RSV vaccine. The relevant medical history included as patient voiced that he had been taking Lenvima as prescribed 10mg. every other day per healthcare professional instruction to start, reported that his blood pressure had been fluctuating to a highest of 168/88 since starting (onset around 7th January 2024).  The patient also received his RSV vaccine yesterday. The patient had diagnosis of C73 Differentiated thyroid cancer (DTC). The patient delivered on 5th January 2024, 10mg daily every other day (per Rx), started on 7th January 2024.
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Staff contacted GSK via phone on 13/02/2024 inquiring about Havrix and what information is available about the administration of a third dose of Havrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 24-month-old male patient who received HAV (Havrix) (batch number L9R92, expiry date 26-SEP-2025) for prophylaxis.   Previously administered products included Havrix (On an unknown date, received first dose with the batch number 2X2EJ and expiry date 14th October 2024) and Havrix (On 13th February 2023, received second dose with the batch number 2YS34 and expiry date 2nd March 2025).   On 13-FEB-2024, the patient received the 3rd dose of Havrix. On 13-FEB-2024, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: Staff contacted GSK via phone on 13/02/2024 inquiring about Havrix and what information is available about the administration of a third dose of Havrix.). The outcome of the extra dose administered 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: 13-FEB-2024 The reporter contacted GSK via phone and inquired about Havrix and what information was available about the administration of third dose of Havrix. They gave information about event, vaccine and patient. The reporter consented to follow up. The reporter reported that the patient received the third dose of Havrix, which led to extra dose administered.