chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Twinrix in February and has not received the second nor third.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 31-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 01-FEB-2024 with batch number H7RF2).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Twinrix in February and has not received the second nor third.). The outcome of the incomplete course of vaccination was not reported.   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: 23-AUG-2024 The pharmacist reported that the patient received the first dose of Twinrix in February and had not received the second nor third dose.  The reporter requested regarding data and about the schedule that should be followed. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/ still is having some shingles outbreaks; still is having some shingles outbreaks; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ still is having some shingles outbreaks) (serious criteria GSK medically significant) and shingles (Verbatim: still is having some shingles outbreaks). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2024 and 29-AUG-2024 The request submitted by sales representative and retrieved by medical information at start of business as the doctor had a patient that received both doses of Shingrix, however still was having some shingles outbreaks. He wondered if the patient would need to be re-vaccinated. They were not sure if the patient received both doses within the 2 to 6 months. No further details were provided. The medical information did not had any other details available. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (Dose 1 and Dose 2).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: LACK OF EFFECT; GOT COVID; This spontaneous report received from a patient via managed social media, concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that they all just got this Johnson and Johnson and it was not legal anymore? Or it was banned? But it was effective and supposed to work like they all were told, but no they were lied too. They got the shot and got Covid (Dose in series 1) they had it right now.  On an unspecified date, the patient experienced lack of effect (Dose in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lack of effect and got covid was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Drug ineffective: Additional information received in this version updates on the PQC results  The event is a special reporting situation and owing to its own nature, it is not possible to attribute this occurrence to the suspect drug. Hence, the causality is considered INCONSISTENT with vaccine administration
Sex: U
Vaccine: COVID19-2, DTAPIPVHIB, PNC15, RV5
Symptoms: Expired product administered, Irritability
Clinical narrative: Fussy that night after vaccines; Vail was initially stored in refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023/Doses were given greater than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of IRRITABILITY (Fussy that night after vaccines) and EXPIRED PRODUCT ADMINISTERED (Vail was initially stored in refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023/Doses were given greater than 12 hours post puncture) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for Prophylactic vaccination.    Co-suspect products included non-company products PENTACEL for Prophylactic vaccination, PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.    Concurrent medical conditions included Cough (Ongoing at the time of event and prior to one month onwards) since 2023, Plagiocephaly (Improving) since 12-Jan-2023 and Teething. Concomitant products included IBUPROFEN for Teething, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 09-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received third dose of PENTACEL (Intramuscular use) 1 dosage form, third dose of PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) (Intramuscular use) 1 dosage form and third dose of ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (unknown route) 1 dosage form. On 09-Jun-2023, the patient experienced IRRITABILITY (Fussy that night after vaccines) and EXPIRED PRODUCT ADMINISTERED (Vail was initially stored in refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023/Doses were given greater than 12 hours post puncture). At the time of the report, IRRITABILITY (Fussy that night after vaccines) and EXPIRED PRODUCT ADMINISTERED (Vail was initially stored in refrigerator on 01-Jun-2023, first punctured on 08-Jun-2023 and was administered on 09-Jun-2023/Doses were given greater than 12 hours post puncture) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: same experience being a-fib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (same experience being a-fib) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (same experience being a-fib) (seriousness criteria hospitalization and medically significant). At the time of the report, ATRIAL FIBRILLATION (same experience being a-fib) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown whether the patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine or not. No concomitant medication was reported. The dosage text was reported as unknown. Reporter causality was not reported.  No treatment medication was reported.  This case contains information for the 3rd patient out of 3 patients.  Company Comment: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported who experienced the unexpected serious (due to hospitalization and medically significant) AESI of atrial fibrillation that occurred unknown days after receiving the a dose of SPIKEVAX COVID-19 VACCINE NOS vaccine. No further details about the clinical course, diagnostic procedures and treatments were provided. The outcome of the events was reported as unknown. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-773040 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-773040:master case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Hepatic steatosis, Illness, Influenza like illness
Clinical narrative: Mild fatty liver; Flu-like symptoms; Got really sick after her last booster; This spontaneous case was reported by a patient and describes the occurrence of HEPATIC STEATOSIS (Mild fatty liver), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (Got really sick after her last booster) in a 63-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 038A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-May-2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEPATIC STEATOSIS (Mild fatty liver), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (Got really sick after her last booster). At the time of the report, HEPATIC STEATOSIS (Mild fatty liver), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and ILLNESS (Got really sick after her last booster) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Mild fatty liver.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The caller stated that she got really sick after receiving her last booster dose in 2022. She was healthy prior to receiving the last dose. Caller further elaborated that she was not on medication, not drinking, and not eating unhealthily. Patient suspected that the fatty liver first occurred after the second dose but was leaning more towards the last booster dose. She also exhibited flu-like symptoms. Patient stated that she was feeling better at the time of report, since the event.  Treatment information was not reported.   This case was linked to MOD-2024-773238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2024: Live follow-up received and updated patient's age, added new event of sickness, updated suspect dosage details, updated outcome of events Fatty liver and Influenza like illness, updated narrative.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in his arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in his arm). At the time of the report, PAIN IN EXTREMITY (soreness in his arm) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  Dosage text was reported as unknown. No treatment information was reported.   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Feeling abnormal, Pyrexia, Tremor
Clinical narrative: chills; shakes; fever; and is feeling like crp; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), TREMOR (shakes), PYREXIA (fever) and FEELING ABNORMAL (and is feeling like crp) in a 60-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Moderna covid-19 vaccine (Dose 1) in January 2021, Moderna covid-19 vaccine (Dose 2) in January 2021, Moderna covid-19 vaccine (Booster) in 2021 and Moderna covid-19 vaccine in 2022. Past adverse reactions to the above products included No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 27-Aug-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In August 2024, the patient experienced CHILLS (chills), TREMOR (shakes), PYREXIA (fever) and FEELING ABNORMAL (and is feeling like crp). At the time of the report, CHILLS (chills), TREMOR (shakes), PYREXIA (fever) and FEELING ABNORMAL (and is feeling like crp) outcome was unknown.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that patient had normal side effects.  Treatment information was not provided.  Reporter causality was not reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: feeling nauseous; tired; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (feeling nauseous) and FATIGUE (tired) in an 85-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA (Flu shot on August 26th). Past adverse reactions to the above products included No adverse effect with INFLUENZA. Concurrent medical conditions included Blood pressure high.    On 28-Aug-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Aug-2024 at 3:00 AM, the patient experienced NAUSEA (feeling nauseous) and FATIGUE (tired). At the time of the report, NAUSEA (feeling nauseous) and FATIGUE (tired) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. She received a COVID vaccine on 28-Aug-2024 and at 3am she woke up feeling nauseous. She did not throw up and she did not have fever. She states that she still felt nauseous and tired. No treatment medication was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: wight loss; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT DECREASED (wight loss) in a 75-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT DECREASED (wight loss). At the time of the report, WEIGHT DECREASED (wight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Loss.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were provided. Dosage text for suspect product was reported as unknown. No treatment medication was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Brain fog, Memory impairment, Somnolence
Clinical narrative: brain fog; forgetfulness; poor equilibrium; extended sleepiness - 12 to 18 hours daily; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Oct2023 as dose 1, single (Lot number: HF9300) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "fibro" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for influenza immunisation, start date: 04Nov2023, stop date: 04Nov2023. The patient also took other concomitant therapy. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Dose number: 1; Lot: GJ2524; in left arm), administration date: 24Sep2022, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "extended sleepiness, 12 to 18 hours daily". The following information was reported: SOMNOLENCE (non-serious) with onset 27Oct2023, outcome "recovered" (Dec2023), described as "extended sleepiness - 12 to 18 hours daily"; BRAIN FOG (non-serious), outcome "not recovered"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "forgetfulness"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "poor equilibrium". Therapeutic measures were not taken as a result of somnolence, brain fog, memory impairment, balance disorder.  Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s). The patient was taking any other medications within 2 weeks of the event starting. In 2023, extended sleepiness -12 to 18 hours daily, recovered after about 3 months but ongoing brain fog, forgetfulness, and poor equilibrium - haven't driven in 10 months.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400245221 Same reporter, patient, product; different dose/events;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: sore throat and some sneezing and runny nose/patient took the Covid test, and it was positive; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Aug2024 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: COVID-19 (non-serious) with onset 28Aug2024, outcome "unknown", described as "sore throat and some sneezing and runny nose/patient took the Covid test, and it was positive". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient called in regard to the question about the Covid vaccine (Clarified as Pfizer COVID-19 Vaccine) that the patient got this morning (28Aug2024) and this afternoon, the patient started getting like sore throat and some sneezing and runny nose. The patient took the Covid test, and it was positive. The patient asked, "Can the injection cause the positive test?".   Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate, Heart rate increased
Clinical narrative: cardiac effects; heart rate went up too high; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid vaccine (Dose 1), administration date: 2021, for COVID-19 immunization, reaction(s): "didn't work well". The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac effects"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heart rate went up too high". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had cardiac effects from Pfizer Covid-19 vaccine. Her heart rate went up too high. She first had Moderna covid vaccine in 2021, it didn't work well, switched to Pfizer, she thinks for her second dose, after that she switched to Novavax which didn't cause her heart rate to go up. She is in her mid to late 40's.   Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: spend this three year kidney transplant anniversary both of us have COVID-19; spend this three year kidney transplant anniversary both of us have COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 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. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "spend this three year kidney transplant anniversary both of us have COVID-19". Clinical course: Reporter was disappointed in the vaccine that was created she and her husband had taken the shots so faithful. Her husband had kidney transplant 31Aug2021 and reporter was doner and because they trusted the shot they got to spend these three years of kidney transplant anniversary and both of them had COVID-19 so all she was asking was to make sure the shots were good because she had updated shot on 10Aug and got really sick which she just found out that she had COVID-19.  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-PV202400113483 Same reporter/product, Different patient;US-PFIZER INC-202400246873 Same patient and product, Different dose and events;
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Individual reported husband died of a blood clot; This is a spontaneous report received from a Consumer or other non HCP from a sales representative.  A 54-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: THROMBOSIS (death, medically significant), outcome "fatal", described as "Individual reported husband died of a blood clot". The patient date of death was unknown. Reported cause of death: "Individual reported husband died of a blood clot". It was not reported if an autopsy was performed.  Clinical Course: It was unknown if patient received any other vaccines on same date or in 4 weeks. Also it was unknown if patient received any other medications in two weeks. It was reported that the reporter's husband died of a blood clot and had received a COVID 19 vaccine but uncertain as to which manufacturer. Also not sure if husband had COVID 19 before or after being vaccinated.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Individual reported husband died of a blood clot
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, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Aug2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "kidney transplant doner", start date: 31Aug2021, stop date: 31Aug2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER)), for COVID-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "not recovered" and all described as "COVID-19". The clinical course was reported as follows: The patient reported that she had taken all 6 COVID-19 vaccines, wore a mask, and did not get around a lot of people. The patient wanted to make sure the Pfizer vaccines were good (as reported) because she received her last dose on 10Aug2024 and got really sick and just found out that she has COVID-19.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 13.0
Sex: U
Vaccine: MEN, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient was supposed to get MENQUADFI, but the doctor administered BEXSERO with no adverse event; Initial information received on 21-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 13 years unknown gender patient who was supposed to get MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI], but the doctor administered bexsero 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 a  dose of suspect BEXSERO not produced by Sanofi Pasteur via unknown route in unknown administration site for immunization (strength, dose, batch number and expiry date unknown) and was supposed to get menquadfi, with no adverse event (wrong product administered) (same day latency). Information on batch number corresponding to the one at time of event occurrence was requested   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: 9.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: inadvertently administered only the liquid DTaP-IPV component of the PENTACEL vaccine, without first mixing it with the lyophilized Hib component with no reported adverse event; Initial information received on 22-Aug-2024 regarding an unsolicited valid non-serious case received from health professional.  This case involves a 9 months old male patient who was inadvertently administered with only the liquid dtap-ipv component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], without first mixing it with the lyophilized hib component, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Aug-2024, the patient was inadvertently received (0.5 ml once, dose 3) of only the liquid dtap-ipv component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, without first mixing it with the lyophilized hib component, with no reported adverse event (Single component of a two-component product administered) (latency: same day) (lot UJ983AA, Expiry date: 12-Dec-2025) via intramuscular route in the left leg for immunization.   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: FLU4
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: accidentally given a patient with a double dose of the FLUZONE HD QIV with no reported Adverse event; Initial information received on 21-Aug-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was accidentally given with a double dose of the Influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Aug-2024, the patient received a dose of suspect Influenza quadrival a-b high dose hv vaccine lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation (extra dose administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  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: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient accidentally received 2 shots of FLUZONE HD with no reported adverse event; Initial information received on 22-Aug-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68-year-old female patient who accidentally received 2 shots of influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Aug-2024, the patient accidentally received 2 shots of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine (0.5 ml dose) Suspension for injection in pre-filled syringe Frequency : twice and strength: high dose of lot UT8419AA and expiry date: 30-Jun-2025 via intramuscular route in the left area for immunization with no reported adverse event (extra dose administered) (latency: on same day).  Reportedly, patient came with her husband to get the Fluzone HD injection, but patient was given two injections of the Fluzone HD by accident. The pharmacist did call the patient back after 5 hours, and the patient told the pharmacist that she was feeling okay. Treatment: Sit in the health room for 15 minutes, but there were no AE that happened and the patient left.   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: M
Vaccine: COVID19
Symptoms: Ventricular enlargement
Clinical narrative: Enlarged heart ventricle; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 72-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol. Concomitant medication(s) included: LIPITOR. The following information was reported: VENTRICULAR ENLARGEMENT (non-serious), outcome "unknown", described as "Enlarged heart ventricle".  Additional information: The reporter's father experienced enlarged ventricle from the Pfizer COVID-19 Vaccine. The reporter was wondering how to treat that and how can they get information from the company to do tests and add the patient's adverse event to the package insert's list of adverse events. The reporter was seeking treatment from the company and wanted the company to pay for the damages as well.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Renal transplant
Clinical narrative: kidney transplant; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), 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: RENAL TRANSPLANT (medically significant) with onset 31Aug2021, outcome "unknown", described as "kidney transplant". Clinical course: Reporter's husband had taken the shots so faithful. Her husband had to have a kidney transplant 31Aug2021, reporter was his doner.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400246874 same reporter/patient, different product/events;US-PFIZER INC-PV202400113483 same reporter, different patient/product/events;
Sex: F
Vaccine: RSV, RSV
Symptoms: Musculoskeletal stiffness
Clinical narrative: she felt stiff all over; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Aug2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "muscle disease" (unspecified if ongoing), notes: underlying muscle disease. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "she felt stiff all over".  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV, RSV
Symptoms: Musculoskeletal stiffness, Myalgia
Clinical narrative: she felt stiff all over; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Aug2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "muscle disease" (unspecified if ongoing), notes: underlying muscle disease. The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "she felt stiff all over".  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: living with pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.   A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "living with pain".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: U
Vaccine: DTAP
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: administered an extra dose of DAPTACEL with no reported Adverse event; Initial information received on 26-Aug-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient of unknown demographics who was administered an extra dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 in 2023, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site as immunization and was reported administered an extra dose of daptacel with no reported adverse event (extra dose administered) ( latency: on same day).  Information regarding batch number corresponding to the one at time of event occurrence is requested.  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: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acne, Dermatitis allergic
Clinical narrative: Sever skin allergy. Pimples all over body
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lethargy, Pyrexia, Rash
Clinical narrative: Sever skin allergy. Pimples all over body
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Rash
Clinical narrative: pt had fever for a few days and then developed rash on arm
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Headache, Neck pain, Sleep disorder
Clinical narrative: Approximately 12 hours after vax, neck and head ache, ear ache on same side as shot, aches in joints enough to keep me awake. These events ceased after 12 hours and I felt fine. I'd never had a reaction to a Moderna Covid vax before.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Injection site reaction:  Swelling (hard to the touch), redness with heat, pain and itchy.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction:  Swelling (hard to the touch), redness with heat, pain and itchy.
Age: 50.0
Sex: M
Vaccine: COVID19, FLUC4, VARZOS
Symptoms: Abdominal pain upper, Chills, Differential white blood cell count, Electrocardiogram, Full blood count
Clinical narrative: Symptoms included chills, fever, muscle/body aches, headaches over the course of 48 hours after vaccination. Treatment included ibuprofen and Sudafed-D. Additional symptom of severe abdominal pain in the right upper-quadrant occured  approximately 60+ hours after vaccinations. Care was sought at the emergency room at emergency room.
Age: 50.0
Sex: M
Vaccine: COVID19, FLUC4, VARZOS
Symptoms: Headache, Hepatic enzyme increased, Hepatic steatosis, Lipase, Metabolic function test
Clinical narrative: Symptoms included chills, fever, muscle/body aches, headaches over the course of 48 hours after vaccination. Treatment included ibuprofen and Sudafed-D. Additional symptom of severe abdominal pain in the right upper-quadrant occured  approximately 60+ hours after vaccinations. Care was sought at the emergency room at emergency room.
Age: 50.0
Sex: M
Vaccine: COVID19, FLUC4, VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Ultrasound abdomen abnormal
Clinical narrative: Symptoms included chills, fever, muscle/body aches, headaches over the course of 48 hours after vaccination. Treatment included ibuprofen and Sudafed-D. Additional symptom of severe abdominal pain in the right upper-quadrant occured  approximately 60+ hours after vaccinations. Care was sought at the emergency room at emergency room.
Age: 59.0
Sex: M
Vaccine: FLU4, PNC20, VARZOS
Symptoms: Dizziness, Ear pain, Vomiting projectile
Clinical narrative: Wife called the next morning reporting  that the patient was very dizzy with projectile vomiting  and severe ear pain. (He did not want to go to urgent care or ER.) I called back to check on him later that day and he was some better.  As of today, 9/2/24, pt is feeling much better.
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: Asthma, Condition aggravated, Cough, Fatigue, Myalgia
Clinical narrative: Muscle aches on 2nd day after vaccines, coughing/asthma increased 24 hours after vaccine. Coughed until vomiting. Pain in stomach muscles from coughing 48 hours after vaccines. Tiredness on day of vaccines, Redness on arm where vaccines given. Localized soreness where vaccine given.
Age: 40.0
Sex: M
Vaccine: COVID19-2, FLUR4
Symptoms: Vaccination site erythema, Vaccination site pain, Vomiting
Clinical narrative: Muscle aches on 2nd day after vaccines, coughing/asthma increased 24 hours after vaccine. Coughed until vomiting. Pain in stomach muscles from coughing 48 hours after vaccines. Tiredness on day of vaccines, Redness on arm where vaccines given. Localized soreness where vaccine given.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Discomfort, Dizziness, Fatigue
Clinical narrative: This was the spikevax 24-25 lot 3042560. About 20 minutes after vaccination, I felt dizzy. About 2 hours after vaccination, I broke out in hives, was very hot, had a racing heart beat, and was generally uncomfortable. I considered going to urgent care as I hadnt experienced this feeling with any other covid vaccine/booster. My breathing became shallow either from reaction or anxiety to the reaction. I took a zyrtec and the acute allergic reaction reduced within an hour. I am still tired 48 hours later but dont have hives.  My hr is stable but my bp is still elevated 56 hours later.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Hypersensitivity, Hypopnoea, Palpitations
Clinical narrative: This was the spikevax 24-25 lot 3042560. About 20 minutes after vaccination, I felt dizzy. About 2 hours after vaccination, I broke out in hives, was very hot, had a racing heart beat, and was generally uncomfortable. I considered going to urgent care as I hadnt experienced this feeling with any other covid vaccine/booster. My breathing became shallow either from reaction or anxiety to the reaction. I took a zyrtec and the acute allergic reaction reduced within an hour. I am still tired 48 hours later but dont have hives.  My hr is stable but my bp is still elevated 56 hours later.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This was the spikevax 24-25 lot 3042560. About 20 minutes after vaccination, I felt dizzy. About 2 hours after vaccination, I broke out in hives, was very hot, had a racing heart beat, and was generally uncomfortable. I considered going to urgent care as I hadnt experienced this feeling with any other covid vaccine/booster. My breathing became shallow either from reaction or anxiety to the reaction. I took a zyrtec and the acute allergic reaction reduced within an hour. I am still tired 48 hours later but dont have hives.  My hr is stable but my bp is still elevated 56 hours later.
Sex: U
Vaccine: PNC20, PNC20
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase normal
Clinical narrative: ALT spiked to 512; AST spiked to 201; liver damage; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Jul2024 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: LIVER INJURY (medically significant) with onset 2024, outcome "unknown", described as "liver damage"; ALANINE AMINOTRANSFERASE INCREASED (medically significant) with onset 19Jul2024, outcome "unknown", described as "ALT spiked to 512"; ASPARTATE AMINOTRANSFERASE INCREASED (medically significant) with onset 19Jul2024, outcome "unknown", described as "AST spiked to 201". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (19Jul2024) 512; Aspartate aminotransferase: (04Jun2024) 19; (19Jul2024) 201. The shot caused liver damage.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20, PNC20
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver injury
Clinical narrative: ALT spiked to 512; AST spiked to 201; liver damage; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Jul2024 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: LIVER INJURY (medically significant) with onset 2024, outcome "unknown", described as "liver damage"; ALANINE AMINOTRANSFERASE INCREASED (medically significant) with onset 19Jul2024, outcome "unknown", described as "ALT spiked to 512"; ASPARTATE AMINOTRANSFERASE INCREASED (medically significant) with onset 19Jul2024, outcome "unknown", described as "AST spiked to 201". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (19Jul2024) 512; Aspartate aminotransferase: (04Jun2024) 19; (19Jul2024) 201. The shot caused liver damage.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.