chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 49-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Feb2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot: FE35, there may be numbers that got erased on his vaccine card for this lot number. Its laminated.), administration date: 07Oct2021, when the patient was 47-year-old, for Covid-19 Immunization; bnt162b2 (DOSE 2, SINGLE, Lot: 330308D), administration date: 09Dec2021, when the patient was 47-year-old, for Covid-19 Immunization. The following information was reported: HYPERTENSION (hospitalization, life threatening) with onset 2023, outcome "unknown", described as "high blood pressure". The patient was hospitalized for hypertension (start date: 20Nov2023, discharge date: 01Dec2023, hospitalization duration: 12 day(s)). The event "high blood pressure" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (2023) High. Therapeutic measures were not taken as a result of hypertension.  Clinical course: The caller was a consumer that mentioned details of contract they signed when they got the Pfizer covid booster stating they are clear from any diagnosis from one year. He got a pick up order and was picked up by the police and hospitalized for high blood pressure and he mentioned about dying at the hospital and the contract was ignored by the primary care physician. He was calling about a contract that he signed about the covid booster that he was working on with his primary physician. His primary care physician/ primary doctor violated the contract. He was calling to get a copy of this contract from Pfizer to exonerate him for one year after the booster. The patient did not think its high blood pressure, he was a vegetarian, he was fine with his blood pressure and working with his primary care physician as far as losing weight and not drinking caffeine. when he was hospitalized, he was given a bunch of stuff and he knows he was exonerated from any diagnosis for a year and this what he was working on with his physician but then they came and took him in handcuffs to the hospital and told him it was high blood pressure. The patient was not being treated, wanted him to take high blood pressure pills and he will not take them.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "Allergy". Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Batch/Lot: GJ2524 , Location of injection: Arm Left), administration date: 05Oct2022, when the patient was 60-year-old, for COVID-19 immunisation; Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: tested negative for four days. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 29Nov2023 to 04Dec2023. Clinical course: Patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
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) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 30Nov2023 to 06Dec2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Reporter's wife died.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300442815 same drug/reporter, different patient/event;; Reported Cause(s) of Death: died
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 4 unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 5 unknown manufacturer), for COVID-19 immunization.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took treatment from 28Nov2023 to 03Dec2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "joint pain" (unspecified if ongoing), notes: controlled by celecoxib; "muscle pain" (unspecified if ongoing), notes: controlled by celecoxib. 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 "recovered" (Dec2023) and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2023) Negative, notes: she finished paxlovid and tested negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient came down with COVID last week and took Paxlovid (Start date: Dec2023 and stop date: Dec2023. It was unknown that whether the patient had any known allergies.  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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Oct2023 at 12:45 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Bnt162b2, start date: 13Apr2021, stop date: 13Apr2021, for COVID-19 immunization, notes: DOSE 1, SINGLE; Bnt162b2, start date: 22Oct2021, stop date: 22Oct2021, for COVID-19 immunization, notes: DOSE 2, SINGLE; Bnt162b2, start date: 21Jul2022, stop date: 21Jul2022, for COVID-19 immunization, notes: DOSE 3 (BOOSTER), SINGLE, Anatomical location: Arm Right; Bnt162b2, bnt162b2 omi ba.4-5, start date: 17Jan2023, stop date: 17Jan2023, for COVID-19 immunization, notes: DOSE 4 (BOOSTER), SINGLE, Anatomical location: Arm Right. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Nov2023, outcome "recovered" (03Dec2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Nov2023) Positive, notes: After initially testing positive for covid (first ever diagnosis with Covid) with only minor symptoms; (03Dec2023) Negative. Therapeutic measures (Paxlovid treatment start date: 29Nov2023, stop date: 02Dec2023) were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 09Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown"; 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.  Clinical course: No known allergies. The patient received Paxlovid from 21Nov2023 to 25Nov2023 as a treatment for the event.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: 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 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bronchiectasis" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levoquin, reaction(s): "Allergy"; Bactrim, reaction(s): "Allergies". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19, which included treatment with Paxlovid from 30Nov2023 to 04Dec2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Moderna 01Dec2021 / Pfizer / BioNTech 04Dec2022; 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 42-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 12:00 as dose 4 (booster), single (Lot number: GJ6665) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2021 at 12:00 as dose 1, single (Lot number: 032M20A), in left arm, on 16Apr2021 at 12:00 as dose 2, single (Lot number: 027B21A), in left arm and on 01Dec2021 at 12:00 as dose 3 (booster), single (Lot number: O30H21B), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna 01Dec2021 / Pfizer / BioNTech 04Dec2022". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: I had a bloody nose after all vaccines and boosters except for my last one on 9/22/23; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 7 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Oct2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (DOSE 1, SINGLE, Left arm, intramuscular, GL9261, 17:30), administration date: 29Jan2021, for COVID-19 immunisation, reaction(s): "Epistaxis"; comirnaty (DOSE 2 SINGLE, Left arm, intramuscular, WTEM9809), administration date: 18Feb2021, for COVID-19 immunisation, reaction(s): "Epistaxis"; comirnaty (DOSE 3 (BOOSTER), SINGLE, Left arm, FC3181), administration date: 16Aug2021, for COVID-19 immunisation, reaction(s): "Epistaxis"; comirnaty (DOSE 4 (BOOSTER), SINGLE, Left arm, intramuscular, FA8020), administration date: 22Jan2022, for COVID-19 immunisation, reaction(s): "Epistaxis"; comirnaty (DOSE 5 (BOOSTER), SINGLE, FM7553, arm, 15:00), administration date: 04Jun2022, for COVID-19 immunisation, reaction(s): "Epistaxis", "Haemorrhage urinary tract"; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, arm, intramuscular, GH9693), administration date: 19Sep2022, for COVID-19 immunisation, reaction(s): "Epistaxis", "Blood urine present", "Anaemia", "Proteinuria". The following information was reported: EPISTAXIS (non-serious), outcome "recovered", described as "I had a bloody nose after all vaccines and boosters except for my last one on 9/22/23". Therapeutic measures were not taken as a result of epistaxis. Additional information: All bloody noses happened within 24 hours of injection. Patient had bloody nose after all vaccines and boosters except for the last one on 22Sep2023. Patient notified her doctor after the first but was told to wait for 24 hours and just monitor. As of the time of reporting, all stopped within 24 hours. Between 29Jan2021 and 22Sep2023, patient has had 8 vaccines and boosters. She also got COVID on Oct2022.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Hypoaesthesia, Peripheral swelling, Rhinorrhoea
Clinical narrative: swollen arm (later numb arm); swollen arm (later numb arm); cough; runny nose; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received bnt162b2 (BNT162B2), in 2021 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: PERIPHERAL SWELLING (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "swollen arm (later numb arm)"; COUGH (non-serious), outcome "unknown"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; ASTHENIA (non-serious), outcome "unknown", described as "weakness". Additional information: Reporter stated that he received the Pfizer COVID vaccine and then developed an array of symptoms immediately afterward.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: Parkinson, onset date 23Jan; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64-year-old male patient received bnt162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 61 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (ongoing); "Cholesterol" (ongoing); "Diabetes" (ongoing); "Knees replaced", start date: 2010 (unspecified if ongoing), notes: (Include surgical procedures and dates): 2010 and 2014 (knees); "Right hip replaced", start date: 2018 (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); METFORMIN taken for diabetes mellitus (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Time: 09:00 AM, Site and route of injection: Upper left Arm, Route of administration: Intramuscular, Batch/Lot number: Lot ER8733), administration date: 29Mar2021, when the patient was 61-year-old, for Covid-19 Immunization; bnt162b2 (DOSE 2, SINGLE, Time: 10:30, Site and route of injection: Upper left Arm, Route of administration: Intramuscular, Batch/Lot number: Lot# EW0161), administration date: 19Apr2021, when the patient was 61-year-old, for Covid-19 Immunization. The following information was reported: PARKINSON'S DISEASE (medically significant), outcome "not recovered", described as "Parkinson, onset date 23Jan". Therapeutic measures were taken as a result of parkinson's disease.  Clinical information : The patient received Carbidopa-Levodopa for Parkinson twice a day.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: YF-VAX was administered using a different diluent with no adverse event; Initial information received on 04-Dec-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves patient of (unknown age and gender) to whom yellow fever vaccine -  [YF-VAX] was administered using a different diluent with no 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 0.5 ml  once (1x) dose of suspect yellow fever vaccine - Solution for injection (strength,lot number and expiry date not reported) via unknown route in unknown administration site for Immunization using a different diluent with no adverse event (product preparation error)  (latency: on 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.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: inappropriate use due to administration of an expired dose to a patient with no adverse event; Initial information received on 06-Dec-2023 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves an unknown age and gender patient who received an expired dose of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine [Quadracel], 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 an expired dose of suspect Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/Ipv (Mrc5) Vaccine, (suspension for injection), with no reported adverse event (expired product administered) (latency: same day) (strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  No lab data reported.  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: liquid all over her arm after she got the injection with no reported adverse event; liquid all over her arm after she got the injection with no reported adverse event; did not get the full dose of the vaccine with no adverse event; Initial information received on 07-Dec-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 25 years old female patient who experienced liquid all over her arm after she got the influenza quadrival A-B vaccine [Fluzone QIV] and did not get the full dose of the vaccine with no adverse.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Dec-2023, the patient received an unknown dose once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: AU1074A; strength: standard) via unknown route in the left deltoid for Immunization and had liquid all over her arm after she got the injection (accidental exposure to product) (exposure via skin contact) and did not get the full dose of the vaccine (incorrect dose administered) (latency: same day). No adverse event reported.  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.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: adacel exposed to 47.1°F, 46.9°F, 46.9°F, 46.9°F upto 48 hours with no reported adverse event; inappropriate use due to administering a vaccine post excursion with no reported adverse event; Initial information was received on 07-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 28 years old male patient who reported that diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] exposed to 47.1°f, 46.9°f, 46.9°f, 46.9°f up to 48 hours with no reported adverse event and inappropriate use due to administering a vaccine post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Dec-2023, the patient received a dose 1 of 0.5 ml of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot 2CA69C1, Expiry date : 20-Jul-2025, strength was unknown) via intramuscular route in the right deltoid for prophylactic vaccination(Immunization) and adacel exposed to 47.1°f, 46.9°f, 46.9°f, 46.9°f up to 48 hours with no reported adverse event (product storage error) and inappropriate use due to administering a vaccine post excursion with no reported adverse event (poor quality product administered) (latency : same day).  Reportedly "Was it from a human error? Unknown Product/s still suitable for use after the excursion? No Have vaccines been administered post-excursion? Yes This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. This situation is pre-assessed as a medication error/an inappropriate use due to administering a vaccine post excursion. "  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event adacel exposed to 47.1°f, 46.9°f, 46.9°f, 46.9°f upto 48 hours with no reported adverse event and was Unknown for the event inappropriate use due to administering a vaccine post excursion with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Age: 39.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Normal soreness at injection site on 12/7. By 9pm on 12/7, soreness was much more severe and it hurt to use my right arm. By Friday, 12/8 I developed a 103 degree fever, 4x4 inch raised area surrounding  injection site with redness, pain, and warmth. Site was itchy. It hurt to lift up my arm. Continued to spread and get larger that evening. On Saturday, 12/9 at 8am, I went to the Urgent care. They administered IM Celestone Soluspan and prescribed Omnicef 300mg 1 capsule 2 times a day for 1 week. By 1030 am, the pain and redness improved.
Age: 39.0
Sex: F
Vaccine: PNC20
Symptoms: Pain, Pyrexia
Clinical narrative: Normal soreness at injection site on 12/7. By 9pm on 12/7, soreness was much more severe and it hurt to use my right arm. By Friday, 12/8 I developed a 103 degree fever, 4x4 inch raised area surrounding  injection site with redness, pain, and warmth. Site was itchy. It hurt to lift up my arm. Continued to spread and get larger that evening. On Saturday, 12/9 at 8am, I went to the Urgent care. They administered IM Celestone Soluspan and prescribed Omnicef 300mg 1 capsule 2 times a day for 1 week. By 1030 am, the pain and redness improved.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Mammogram abnormal, Swelling, Tenderness, Ultrasound breast abnormal
Clinical narrative: Patient experienced welt in right armpit, same side as vaccine. Approximately the size of half golf ball. Very sore and tender, even without touch. Some relief in swelling after 1-2 weeks but remains swollen and tender now 6 months later.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient experienced welt in right armpit, same side as vaccine. Approximately the size of half golf ball. Very sore and tender, even without touch. Some relief in swelling after 1-2 weeks but remains swollen and tender now 6 months later.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia
Clinical narrative: Rapid heartbeat, insomnia (haven't slept in 2 full days)
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Brain fog, Rash, Rash macular
Clinical narrative: Red splotches / rash on legs and torso so far for 3 days - contacted my primary physician and was prescribed prednisone   Blotches are fading and there are fewer now   I feel  a bit foggy at times but otherwise generally feel fine
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Injection site bruising, Injection site pain, Skin warm, Swelling
Clinical narrative: My arm was very red and swollen and hot for about 10 days. The swelling has subsided but the inject site is still bruised and tender.
Sex: F
Vaccine: RSV
Symptoms: Chest X-ray, Dyspnoea, Dyspnoea exertional, Feeling abnormal
Clinical narrative: Was administered shot for R SV on Friday October 20th at pharmacy. No reaction until October 25 & 26 with severe shortness of breath, I do have COPD and have been getting very severe short of breath since this first incident. At this point any movement produces uncontrolled shortness of breath. I am on oxygen 24/7 went from 2 to e liters since this started. I have been feeling worse each day that passes. I definitely feel that it is a result of the. Shot.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called and reported that a dose of VARIVAX was administered to a patient after a temperature excursion. Caller stated the dose was administered on 11/3/2023 and the product had 4 temperature excursion prior being administered; This spontaneous report was received from a licensed practical nurse (LPN) referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not reported.  It was reported that on unknown dates, a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W031810 has been verified to be valid, expiration date reported as 15-OCT-2024, but upon internal validation established as 05-OCT-2024) underwent 4 temperature excursions before being administered. The previous excursion occurred from 6 degrees Fahrenheit (F) to 14 degrees Fahrenheit (also reported as 6 F) for 25 minutes; from 6 degrees Fahrenheit to 14 degrees Fahrenheit (also reported as 10F) for 1 hour 29 minutes; from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour 15 minutes previously, and 6 F for a time frame of 36 minutes. On 03-NOV-2023, the patient was vaccinated with the improper stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). The reporter stated that the patient had not reported any symptoms (No adverse event). No additional adverse events or product quality complaint (PQC) were reported.; Sender's Comments:  US-009507513-2311USA006715: US-009507513-2311USA006506: US-009507513-2311USA006232:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported GARDASIL9 was administered to one patient during a temperature excursion. See temperature excursion case number 02509934. Date of administration unknown. Patient demographic information not provided. HCP reported patient is asymptomatic.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender whose medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (reported as during a temperature excursion), the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, batch number reported as W077025 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and did not correspond to any Company product, with expiration date reported as 14-DEC-2024, administered for prophylaxis (strength, lot number, vaccination shceme, anatomical injection site, and route of administration were not provided). The healthcare provider (HCP) stated that the patient was asymptomatic.  The dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored in a temperature of 10 degrees Celsius (C) for fifhteen minutes (product storage error). It was reported that there was not previous temperature excursion. No additional adverse events (AE) were reported (no adverse event).  This case was classified as non-valid due to the lack of patient identifiers.  Follow-up information has been received from the nurse on 02-DEC-2023. The patient's identifiers updated. Patient was a 15-year-old male patient. It was confirmed the patient did not experience any symptoms after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (1 dose, after clarification, lot number should be lot# W007025 which was verified as a valid lot number and expired on 04-DEC-2024) on 24-OCT-2023. The nurse stated that she would not be sending over the form since she had no additional information.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; an adult patient being administered a pediatrics dose of VAQTA/underimmunized - pediatric HepA administered instead of adult HepA; Indicate at which point in the process the medication error occurred: prescribing and administration; # of previous doses: 2 - was repeating series due to stem cell transplant/pre-xisting physician diagnosed medical condition: history of allogenic stem cell transplant requiring re-vaccination; This spontaneous report was received from a nurse refers to a 19-year-old male patient. The patient's concurrent condition included ill-defined disorder (reported as: hgb s-s disease) and chronic kidney disease. The patient's medical history included allogenic stem cell transplantation (reported as: history of allogenic stem cell transplantation + requiring re-vaccination), thrombosis and exposure to radiation. The patient's concomitant medication was not reported.  On 11-MAR-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # U031911, expiration date: 11-NOV-2022, 0.5 milliliter in the right deltoid (route of administration was not reported) for prophylaxis.  It was reported that, on 11-MAR-2022, adult patient received a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (incorrect dose administered). It was indicated that the process of the medication error occurred in prescribing and administration (product prescribing error). Number of previous doses was provided as 2. The patient was repeating series due to stem cell transplant (extra dose administered). No additional adverse event reported (no adverse event).
Age: 0.25
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; Product confusion; inadvertent administration of VAQTA to a 3-month-3-day old patient instead of VAXELIS; This spontaneous report was received from a nurse referring to a 3-month-3-day-old patient with unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported.  On 08-DEC-2023, due to product confusion, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), 0.5 milliliter intramuscular injection, 0.5 milliliter/dose inadvertently administered for prophylaxis (lot #, expiry date, anatomical site of administration and route of administration were not provided) instead of  diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) 0.5 milliliter injection, 0.5 milliliter/dose for prophylaxis (vaccination scheme frequency, anatomical location, lot #, expiry date, and route of administration were not provided) (product confusion, wrong product administered). No symptom was reported (no adverse event).  There was obtained consent to contact the reporter.
Sex: M
Vaccine: HPV4
Symptoms: Abdominal mass, Congenital anomaly, Term baby
Clinical narrative: mass in abdomen; mother vaccinated with Gardasil before pregnancy; This spontaneous report has been received from a lawyer from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (# 2310USA011696), concerning a neonate male patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On unknown dates in 2006, the patient's mother was vaccinated with the first and the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact doses, route of administration, anatomical location, lot numbers and expiration dates were not reported). On an unspecified date in 2007, she was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot number and expiration date were not reported), all for prophylaxis (all doses administered before pregnancy) (foetal exposure before pregnancy).  On an unknown date in 2009, the patient was full-term born with a mass in his abdomen. The outcome of the event was not reported. The reporter considered the event to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of mass in abdomen was determined to be congenital anomaly.; Sender's Comments:  US-009507513-2310USA011696:Mother Case US-009507513-2312USA004380: US-009507513-2312USA004394: US-009507513-2312USA004386:
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Cold sweat, Dehydration, Dizziness, Hyperglycaemia, Hypotension
Clinical narrative: After receiving a Tetanus vaccination, the donor stated he was feeling faint. Donor was noted to be pale and clammy. Donor had an approximate 10 second loss of consciousness after which he was answering questions appropriately. Vital signs were obtained and donor was determined to bed hypotensive (69/44). Cold compressed was applied and the donor was given oral fluids. Vital signs were obtained again blood pressure was lower (50/35). The donor's legs were elevated, and donor continued to drink fluids. Vital signs were retaken and improved. Donor stated he only had a banana to eat prior to donating plasma. Donor stated he was feeling better, color returned and vital signs were within norma limits. Donor then stated he was feeling lightheaded again and could only see white light, stated he felt like he would pass out. Donor again had a loss of consciousness for approximately 10-15 seconds. Noted to be pale and clammy, blood pressure could not be read by machine. Decision was made to call EMS at 1241. Vital signs were attempted again and would not read. At 1246, vital signs were retaken and found to be very hypotensive (67/44).  EMS arrived shorty after and assumed care.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Hypothyroidism, Laboratory test abnormal, Loss of consciousness, Pallor
Clinical narrative: After receiving a Tetanus vaccination, the donor stated he was feeling faint. Donor was noted to be pale and clammy. Donor had an approximate 10 second loss of consciousness after which he was answering questions appropriately. Vital signs were obtained and donor was determined to bed hypotensive (69/44). Cold compressed was applied and the donor was given oral fluids. Vital signs were obtained again blood pressure was lower (50/35). The donor's legs were elevated, and donor continued to drink fluids. Vital signs were retaken and improved. Donor stated he only had a banana to eat prior to donating plasma. Donor stated he was feeling better, color returned and vital signs were within norma limits. Donor then stated he was feeling lightheaded again and could only see white light, stated he felt like he would pass out. Donor again had a loss of consciousness for approximately 10-15 seconds. Noted to be pale and clammy, blood pressure could not be read by machine. Decision was made to call EMS at 1241. Vital signs were attempted again and would not read. At 1246, vital signs were retaken and found to be very hypotensive (67/44).  EMS arrived shorty after and assumed care.
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse event. I was instructed to complete this form as patient was not 60 years old at the time of vaccination. However, patient was 59 years and 10 months old, and has severe (uncontrolled) diabetes and who also recently suffered a central stroke with subsequent speech and motor deficits. Patient is non-language speaking and has a history of no-shows to our clinic. In my medical opinion, patient was appropriate for this vaccine, as not only was she very near the age of 60 but she is extremely susceptible to RSV infection that could prove fatal considering her poor health history. Because she does not consistently come to appointments, it felt appropriate to take advantage of her attendance and provide this important mode of protection despite being 2 months younger than the official requirement.
Age: 62.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site pain, Middle insomnia, Muscular weakness, Paraesthesia
Clinical narrative: After receiving the injection there was pain of about a "6" for a week after the injection which then subsided to about a "4" over the following few weeks. The initial pain has since subsided but  I now have a constant dull ache in the area of the injection and below the injection sight to my tight elbow. My right arm is weak and I have tingling in my fingers when I  wake during the night and when I get up in the morning.  I am checking permanent damage below as the side effects are still present and do not appear to be going away.
Age: 0.08
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There were no adverse event that happened with the patient. The wrong vaccine was given to the patient.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood glucose normal, Chest pain, Chills, Confusional state
Clinical narrative: Fever 101, shakes, chills, headache, body aches, joint pain and swelling, chest pain- 36 hrs, confusion, complete exhaustion, lightheadedness,injection site very angry and swollen- still 4 days later
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Full blood count normal, Headache, Injection site swelling
Clinical narrative: Fever 101, shakes, chills, headache, body aches, joint pain and swelling, chest pain- 36 hrs, confusion, complete exhaustion, lightheadedness,injection site very angry and swollen- still 4 days later
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint swelling, Pain, Pyrexia, Tremor
Clinical narrative: Fever 101, shakes, chills, headache, body aches, joint pain and swelling, chest pain- 36 hrs, confusion, complete exhaustion, lightheadedness,injection site very angry and swollen- still 4 days later
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Deep vein thrombosis, Diarrhoea, Mouth swelling, Peripheral swelling
Clinical narrative: Anaphylactic reaction of swelling of mouth, hands and feet. Then vomiting, diarrhea and fever.  Followed by DVTs confirmed by ultrasound.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Ultrasound Doppler abnormal, Vomiting
Clinical narrative: Anaphylactic reaction of swelling of mouth, hands and feet. Then vomiting, diarrhea and fever.  Followed by DVTs confirmed by ultrasound.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid 19 Breakthrough Infection
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Muscular weakness, Tremor
Clinical narrative: Joint pain, dizziness, shaking, chills, muscle weakness, lasted 24 hours, from 8 AM till 8 AM.