chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events or product quality complaint were reported; inadvertent administration of MMR-II after a temperature excursion; This spontaneous report has been received from a nurse referring to a 4-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.    On 28-MAY-2024 (also reported as between 03-JUN-2024 to 10-JUN-2024, conflicting information), the patient was vaccinated with an improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (recombinant Human albumin (rHA)) (lot number W028735 with expiration date 08-SEP-2024, that had been verified to be valid) administered subcutaneously on the left (unspecified site) for prophylaxis (strength, specific dosage, vaccination scheme and anatomical site of application were not provided), with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot number X012267 with expiration date 30-APR-2025, that had been verified to be valid) administered subcutaneously on the right (unspecified site) for prophylaxis (strength, specific dosage, vaccination scheme and anatomical site of application were not provided) and with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) administered intramuscularly on the left (unspecified site) as prophylaxis (lot # 702y4; expiration date: 22-AUG-2025; strength, specific dosage, vaccination scheme, and anatomical site of application were not provided) (product storage error).   On 03-JUN-2024 (conflicting information since the vaccine was administered on 28-MAY-2024), the vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had a temperature of 53.8F, for a time range of 2 hours 51 minutes 0 seconds. No additional adverse events or product quality complaint were reported. A previous temperature excursion was reported as 53.6F for 2 hours 24 minutes 0 seconds  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2406USA003271:
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; TE for MMR II; This spontaneous report has been received from a Physician, referring a 17-year-old female patient.  The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On an unknown date in 2024 (also reported as beginning on 22-APR-2024 through approximately 14-JUN-2024) multiple vaccines were exposed to multiple temperature excursions (TE); and on 22-MAY-2024, the patient was vaccinated with one of these vaccines, it was the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, rHA, administered at left arm (LA) as prophylaxis (strength, dose administered and route of administration were not provided; lot # reported as W035041, which has been determined to be a valid lot # for this vaccine, expiration date provided and validated to be on 24-MAY-2024) (product storage error). The temperature excursion occurred as a result of a reading from a Digital Data Logger. No additional adverse event (AE) (no adverse event).; Sender's Comments:  US-009507513-2406USA005882:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No addtional AE; improper storage product in use; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient.  The patient's pertinent medical history and drug reactions/allergies and concomitant medication were not reported.  On 04-JUN-2024, the patient  was vaccinated with improper storage first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot # W028734, expiration date: 08-SEP-2024, administered in the right thigh for prophylaxis (strength, dose and route of administration were not provided); first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # X018954, expiration date: 13-JUL-2025, administered in the right thigh for prophylaxis (strength, dose and route of administration were not provided); and first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), lot #5AY2J, expiration date: 10-JUN-2024, administered in the left thigh for prophylaxis (strength, dose, formulation, and route of administration were not provided) at the private doctor's office/hospital (Product storage error). The temperature excursion occurred as a result of a reading from a Digital Data Logger. No prior temperature excursions but multiple current temperature excursions. It was reported that 16 different excursions began on 22-APR-2024 but were identified "last week" between 10-JUN-2024 to 14-JUN-2024. No additional adverse event (AE) was reported (No adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2406USA005882:MSD
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; inadvertent administration of expired VARIVAX to a patient; This spontaneous report was received from a reporter and refers to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JUL-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W005206, expiration date: 14-FEB-2024 (dose, route of administration and vaccination site were not provided) administered for prophylaxis.  On 26-JUL-2024, the patient was inadvertently administrated an expired varicella virus vaccine live (oka/merck) (VARIVAX) (expired product administered). The product expired on 14-FEB-2024. Limited patient demographics were provided. No additional adverse event (AE) and no product quality complaint (PQC) were noted (no adverse event).
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pancreatitis acute
Clinical narrative: diagnosed with acute pancreatitis; This serious case was reported by a consumer via other manufacturer and described the occurrence of acute pancreatitis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   Previously administered products included Covid-19 vaccine (received 1st dose of Covide-19 vaccine intramuscularly in March 2021), Covid-19 vaccine (received 2nd dose of Covide-19 vaccine in April 2021), Covid-19 vaccine (received 3rd dose of Covide-19 vaccine in October 2021) and Covid-19 vaccine (received 4th dose of Covide-19 vaccine in October 2022). Concurrent medical conditions included hypertension, hyperlipidemia, barrett's esophagus, hiatal hernia and iodine contrast media allergy. Concomitant products included hydrochlorothiazide;losartan potassium (Hyzaar), simvastatin, phenytoin, colecalciferol (Vit D3) and losartan.   On 17-DEC-2023, the patient received the 1st dose of Shingrix (left arm). On 17-DEC-2023 10:45, the patient received COVID-19 vaccine (right arm). On 21-DEC-2023 07:30, 4 days after receiving Shingrix, the patient experienced acute pancreatitis (Verbatim: diagnosed with acute pancreatitis) (serious criteria hospitalization, GSK medically significant and other: Serious as per reporter). The outcome of the acute pancreatitis was resolving.   It was unknown if the reporter considered the acute pancreatitis to be related to Shingrix.     The company considered the acute pancreatitis to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 24-JUL-2024 The patient self-reported this case for herself. The patient received Pfizer booster on the same day as Shingrix The most recent Covid-19 vaccine was administered. The patient received within 2 weeks of vaccination was hyzaar, simvastatin, phenytoin, vit D3 and multi vitamin. The reporter reported that, 6 days after the vaccine she was diagnosed with acute pancreatitis and was hospitalized for 6 days.  All the usual causes of pancreatitis were ruled out in the hospital and they were still investigating what may had caused this.  The patient received treatment for pain medication, fluid therapy prior to vaccination. The patient was not diagnosed with Covid-19.; Sender's Comments: Pancreatitis acute is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Miliaria, Pruritus, Rash, Wound
Clinical narrative: Rash on mainly the upper extremeties but some on the top of my legs. A lot on my elbows; She felt that it was a heat rash; open sores from itching; for sweating when she thought I had heat rash; severe itching; This non-serious case was reported by a consumer and described the occurrence of pruritus in a 54-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12-MAR-2024, the patient received Shingles vaccine. On 02-JUL-2024, 112 days after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: severe itching). On an unknown date, the patient experienced rash (Verbatim: Rash on mainly the upper extremeties but some on the top of my legs. A lot on my elbows), heat rash (Verbatim: She felt that it was a heat rash), pain (Verbatim: open sores from itching) and sweating (Verbatim: for sweating when she thought I had heat rash). The patient was treated with prednisone, mupirocin and fluocinonide. The outcome of the pruritus was not resolved and the outcome of the rash, heat rash, pain and sweating were not reported.   The reporter considered the pruritus to be unrelated to Shingles vaccine. It was unknown if the reporter considered the rash, heat rash, pain and sweating to be related to Shingles vaccine.     The company considered the pruritus to be unrelated to Shingles vaccine. It was unknown if the company considered the rash, heat rash, pain and sweating to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUL-2024 The reporter just needed to know who to contact with a few questions. Her dermatologist and pharmacist did not believe it was possible that this was from the shingles vaccine. They both said this was not a symptom of that vaccine.(severe itching). The patient had rash on mainly the upper extremities but some on the top of her legs and a lot on her elbows. The patient had severe itching and rash, also felt that it was a heat rash.
Sex: U
Vaccine: RSV
Symptoms: Feeling abnormal
Clinical narrative: feeling bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a 72-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced feeling bad (Verbatim: feeling bad). The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Arexvy.     It was unknown if the company considered the feeling bad to be related to Arexvy.   Additional Information: GSK Receipt date: 22-JUL-2024 This case was reported by patient via interactive digital media. He/she had his/her first shot in (illegible) 2023, with in (illegible) days he/she felt so (illegible), could breath (illegible), he/she had never had anything wrong with him/her.  (illegible) of this year 2024 he/she started feeling bad again, he/she asked his/her doctor about a booster.  He (illegible) there was not one right now, please wish there was one, two years was a long time to wait when you know you felt better after the first on.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: One of the nurse here gave a pediatric Dose, of the hepatitis B, to an adult.; One of the nurse here gave a pediatric Dose, of the hepatitis B, to an adult.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 49-year-old male patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 22-JUL-2024, the patient received Engerix B pediatric. On 22-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: One of the nurse here gave a pediatric Dose, of the hepatitis B, to an adult.) and underdose (Verbatim: One of the nurse here gave a pediatric Dose, of the hepatitis B, to an adult.). The outcome of the adult use of a child product was unknown and the outcome of the underdose 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: 22-JUL-2024 A reporter reported that one of the nurse here gave a pediatric Dose, of the hepatitis B, to an adult which led to underdose and Adult use of child product. So they are wondering what the protocol was. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling of body temperature change, Headache, Hot flush
Clinical narrative: hot and cold flashes; feeling tired; headaches; chills; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling hot and cold in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling hot and cold (Verbatim: hot and cold flashes), tiredness (Verbatim: feeling tired), headache (Verbatim: headaches), chills (Verbatim: chills) and fever (Verbatim: fever). The outcome of the feeling hot and cold, tiredness, headache, chills and fever were unknown.   It was unknown if the reporter considered the feeling hot and cold, tiredness, headache, chills and fever to be related to Shingrix.     It was unknown if the company considered the feeling hot and cold, tiredness, headache, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUL-2024 The patient self-reported this case. The patient had been experiencing fever, chills, hot and cold flashes, headaches, and feeling tired after receiving her first Shingrix vaccine shot. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: hot and cold flashes; feeling tired; headaches; chills; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling hot and cold in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling hot and cold (Verbatim: hot and cold flashes), tiredness (Verbatim: feeling tired), headache (Verbatim: headaches), chills (Verbatim: chills) and fever (Verbatim: fever). The outcome of the feeling hot and cold, tiredness, headache, chills and fever were unknown.   It was unknown if the reporter considered the feeling hot and cold, tiredness, headache, chills and fever to be related to Shingrix.     It was unknown if the company considered the feeling hot and cold, tiredness, headache, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-JUL-2024 The patient self-reported this case. The patient had been experiencing fever, chills, hot and cold flashes, headaches, and feeling tired after receiving her first Shingrix vaccine shot. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient only got one dose of Shingrix and comes back 14 months later, do I need to start over and give 2 doses?"; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient only got one dose of Shingrix and comes back 14 months later, do I need to start over and give 2 doses?"). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-JUL-2024 The patient only got one dose of Shingrix and comes back 14 months later, which led incomplete course of vaccination.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder, Vaccination failure
Clinical narrative: titers were reported as not providing protection/Failure of Hepatitis vaccines; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 60-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced therapy non-responder (Verbatim: titers were reported as not providing protection/Failure of Hepatitis vaccines). The outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-JUL-2024 The reporter requested information about the need to revaccinate a colleague who had previously completed a series of hepatitis B vaccination. The reporter stated after having a test done the titers were not high enough to provide protection.  The case was filed due to the fact that that extra doses aside from the base series were being planned on being given and the titers were reported as not providing protection, which led to therapy non-responder. The vaccine administration facility was the same as primary reporter.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion/received Bexsero doses that were exposed to a temperature excursion above the normal range (unknown maximum temperature) for 56 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ZH7SN, expiry date 31-JAN-2027) for prophylaxis.   On 18-JUL-2024, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Vaccine administered after temperature excursion/received Bexsero doses that were exposed to a temperature excursion above the normal range (unknown maximum temperature) for 56 hours.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-JUL-2024 Medical Assistant explained that patient received Bexsero doses that were exposed to a temperature excursion above the normal range (unknown maximum temperature) for 56 hours, which led to incorrect storage of drug. The case is linked with US2024091884, by same reporter.; Sender's Comments:  US-GSK-US2024091884:Different patient, same reporter
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive test with symptoms on 1/8/24, took Paxlovid  for 5 days, isolated 5 more days (tested negative on  1/15/24). Covid rebound 1/19/24 - testing positive  again.; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of COVID-19 (Positive test with symptoms on 1/8/24, took Paxlovid  for 5 days, isolated 5 more days (tested negative on  1/15/24). Covid rebound 1/19/24 - testing positive  again.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3919B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 5 Batch/Lot No: GJ3274 Location of injection: Arm Left Vaccine Administration Time: 08:30 AM) on 23-Nov-2022. Past adverse reactions to the above products included No adverse effect with Pfizer / BioNTech. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (amoxicillin) and Allergy to NSAIDs (naproxen).    On 03-Nov-2023 at 3:30 AM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Jan-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Positive test with symptoms on 1/8/24, took Paxlovid  for 5 days, isolated 5 more days (tested negative on  1/15/24). Covid rebound 1/19/24 - testing positive  again.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-Jan-2024 to 13-Jan-2024 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive test with symptoms on 1/8/24, took Paxlovid  for 5 days, isolated 5 more days (tested negative on  1/15/24). Covid rebound 1/19/24 - testing positive  again.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2024, SARS-CoV-2 test: Positive. On 15-Jan-2024, SARS-CoV-2 test: Negative. On 19-Jan-2024, SARS-CoV-2 test: Positive.         No Concomitant medications provided by the reporter.  Patient was experienced Covid-19 rebound symptom post treatment medication on 19-Jun-2024 at 14 :00 hours and at present the symptom was present for patient.  Patient was isolated for five days during course of treatment medication.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation reaction
Clinical narrative: States for this current issue, he has not had an official diagnosis so far for covid or RSV and just has the symptoms; he just feels terrible/he was not great right now; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (States for this current issue, he has not had an official diagnosis so far for covid or RSV and just has the symptoms) and FEELING ABNORMAL (he just feels terrible/he was not great right now) in a 69-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Sickness, COVID-19 and Lost weight. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Patient stated the vaccinations he had were Moderna covid vaccines for all his vaccinations.). Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine. Concurrent medical conditions included Asthma (Patient had mild case of asthma that usually did not present itself unless he got sick; and it began probably 5 years ago when he got sick and he did not have any asthma until he had covid.).    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 IMMUNISATION REACTION (States for this current issue, he has not had an official diagnosis so far for covid or RSV and just has the symptoms) and FEELING ABNORMAL (he just feels terrible/he was not great right now). At the time of the report, IMMUNISATION REACTION (States for this current issue, he has not had an official diagnosis so far for covid or RSV and just has the symptoms) and FEELING ABNORMAL (he just feels terrible/he was not great right now) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported. The patient was worried that he may have either RSV or the newest covid vaccine and he had been fully vaccinated up until this new variant. It was stated the vaccinations he had were Moderna covid vaccines for all his vaccinations. It was reported that patient received RSV vaccine and had no date to provide and stated he was not sure the manufacturer of it, and it was either Pfizer or Moderna. No treatment required for the reported events as of yet.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID test; lack of efficacy; positive COVID test; lack of efficacy; This is a spontaneous report received from a Consumer or other non HCP.  A 32-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Dec2023 as dose 1, single (Lot number:) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Patient has no known allergies. Concomitant medication(s) included: ATARAX [HYDROXYZINE]. There were no other vaccine given the same date nor given in four weeks.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Jul2024 at 20:00, outcome "recovering" and all described as "positive COVID test; lack of efficacy". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective which included Paxlovid.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 2nd COVID Infection Jan2023; 2nd COVID Infection Jan2023; This is a spontaneous report received from a Physician.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 2, single (Lot number: EW0177), in arm and on 11Jan2022 as dose 4, single (Lot number: FL3198), at the age of 53-years-old, in arm, all intramuscular for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 3, booster, single (Lot number: GJ6739), in arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Dec2020 as dose 1, single (Lot number: 011J20A) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "long COVID", start date: Jul2022 (ongoing), notes: Developed after 1st COVID infection; "depression anxiety", start date: 1965 (ongoing); "Hashimoto's thyroiditis" (ongoing); "Rheumatoid arthritis", start date: 2023 (ongoing); "Psoriasis", start date: 2022 (ongoing). Concomitant medication(s) included: WELLBUTRIN oral taken for depression (ongoing); EFFEXOR oral taken for depression (ongoing); ROPINIROLE oral taken for depression (ongoing); METHIMAZOLE oral taken for graves' disease, autoimmune thyroiditis (ongoing); SIMPONI intramuscular taken for rheumatoid arthritis (ongoing). The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2023, outcome "unknown" and all described as "2nd COVID Infection Jan2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Comments: Very dump Line as soon as liquid passed the line. Therapeutic measures were taken as a result of covid-19, drug ineffective which included Paxlovid. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications) and a weakened immune system. The first dose was administered at a hospital but not a facility. The second dose was administered at a doctor's office or urgent care but not a facility. The third dose was administered at a pharmacy or drug store. The fourth dose was administered a facility.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective / COVID-19 cannot be ruled out,Linked Report(s) : US-PFIZER INC-PV202400099201 same reporter/patient/vaccine, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Ejection fraction, Electrocardiogram, Global longitudinal strain, Investigation, Magnetic resonance imaging
Clinical narrative: myocarditis; This is a literature report, Program ID for the following literature source(s).  A 17-year-old male 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: Covid-19 vaccine (Dose 1, manufacture unknown), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), 2 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Ejection fraction: 51 %; Electrocardiogram: ST elevation in V5 and V6 leads, notes: ST depression and PR depression in V1 and V2 leads; Global longitudinal strain: 13.9 %; circumferential strain: 13 %; extracellular volume: 0.31; 1123 msec; 26.3 %; Magnetic resonance imaging: showed horizontal long axis, notes: 7.8% of subepicardial LGE in inferior and lateral LV wall from base to apex; near resolution of LGE was noted, notes: improvement in LVEF was also noted; Troponin: 11.1 ng/ml, notes: elevated. Clinical course: In a single-centre retrospective observational study of 38 adolescents receiving COVID-19 vaccination. Patient presented to hospital with acute chest pain after two days of receiving second dose of tozinameran vaccine. Author Comment: Patient developed Vaccine-induced myocarditis.  The reporter considered "myocarditis" related to BNT162b2.; Sender's Comments: As there is limited information in the case provided, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202400098258 same drug and event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: myocarditis; This is a literature report, Program ID for the following literature source(s).  A 17-year-old male 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: Covid-19 vaccine (Dose 1, manufacture unknown), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), 2 days after the suspect product(s) administration, outcome "recovering". The patient underwent the following laboratory tests and procedures: Ejection fraction: 51 %; Electrocardiogram: ST elevation in V5 and V6 leads, notes: ST depression and PR depression in V1 and V2 leads; Global longitudinal strain: 13.9 %; circumferential strain: 13 %; extracellular volume: 0.31; 1123 msec; 26.3 %; Magnetic resonance imaging: showed horizontal long axis, notes: 7.8% of subepicardial LGE in inferior and lateral LV wall from base to apex; near resolution of LGE was noted, notes: improvement in LVEF was also noted; Troponin: 11.1 ng/ml, notes: elevated. Clinical course: In a single-centre retrospective observational study of 38 adolescents receiving COVID-19 vaccination. Patient presented to hospital with acute chest pain after two days of receiving second dose of tozinameran vaccine. Author Comment: Patient developed Vaccine-induced myocarditis.  The reporter considered "myocarditis" related to BNT162b2.; Sender's Comments: As there is limited information in the case provided, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202400098258 same drug and event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin E, Ejection fraction, Investigation, Magnetic resonance imaging, Myocarditis
Clinical narrative: myocarditis; This is a literature report, Program ID for the following literature source(s).  A 16-year-old male 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: Covid-19 vaccine (Dose 1, manufacture unknown), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), 3 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin E: 19.84 %, notes: decreased; Ejection fraction: 58 %; extracellular volume: 0.25; 1077 + 107 msec; 64 msec; Magnetic resonance imaging: showed left ventricular ejection fraction of 58%, notes: and subepicardial to midmyocardial late gadolinium enhancement (LGE) of up to 26% in inferior and inferolateral LV wall from base to apex; Troponin: 4.56 ng/ml, notes: elevated with ST elevation in lateral leads. Clinical course:In a single-centre retrospective observational study of 38 adolescents receiving COVID-19 vaccination. Patient presented to hospital with chest pain after three days of receiving second dose of tozinameran vaccine. Author Comment:Patient developed Vaccine-induced myocarditis. The reporter considered "myocarditis" related to BNT162b2.; Sender's Comments: As there is limited information in the case provided, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202400098255 same drug and event, different patients;
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: myocarditis; This is a literature report, Program ID for the following literature source(s).  A 16-year-old male 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: Covid-19 vaccine (Dose 1, manufacture unknown), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant), 3 days after the suspect product(s) administration, outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin E: 19.84 %, notes: decreased; Ejection fraction: 58 %; extracellular volume: 0.25; 1077 + 107 msec; 64 msec; Magnetic resonance imaging: showed left ventricular ejection fraction of 58%, notes: and subepicardial to midmyocardial late gadolinium enhancement (LGE) of up to 26% in inferior and inferolateral LV wall from base to apex; Troponin: 4.56 ng/ml, notes: elevated with ST elevation in lateral leads. Clinical course:In a single-centre retrospective observational study of 38 adolescents receiving COVID-19 vaccination. Patient presented to hospital with chest pain after three days of receiving second dose of tozinameran vaccine. Author Comment:Patient developed Vaccine-induced myocarditis. The reporter considered "myocarditis" related to BNT162b2.; Sender's Comments: As there is limited information in the case provided, the causal association between the event myocarditis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202400098255 same drug and event, different patients;
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Total lose of taste 9 days after Covid 19 booster vaccine.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: AGEUSIA (non-serious), 9 days after the suspect product(s) administration, outcome "unknown", described as "Total lose of taste 9 days after Covid 19 booster vaccine.".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Urinary tract infection, Urosepsis
Clinical narrative: Serious urosepsis due to severe grade 2 urinary tract infection; Severe grade 2 urinary tract infection; Initial information received on 22-Jul-2024 via physician regarding a solicited valid serious case issued from a literature article:   Aim: To evaluate the safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication (M2SR) vaccine, alone or coadministered with a licensed inactivated influenza vaccine (Fluzone High-Dose Quadrivalent; hereafter referred to as Fluzone HD), in older adults.  This case involves Elderly patient of unknown age and unknown gender who experienced serious urosepsis following severe grade 2 urinary tract infection (latency: 21 days) and severe grade 2 urinary tract infection (latency: unknown) while receiving vaccine Influenza Vaccine [Fluzone high-dose quadrivalent].  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Patient was non-smoker, without known allergies or serious reactions to any vaccine. Patient was negative for recreational drugs and had not received an influenza vaccine in the past 6 months.  On an unknown date, on day 1, the patient received an intranasal placebo (sterile normal saline) (concomitant medication) followed by a dose of suspect Fluzone high-dose (HD) quadrivalent (Influenza Vaccine) lot number not reported via intramuscular route in unknown administration site. Fluzone HD vaccine was the quadrivalent 2021-22 formulation that included the Cam2020 H3N2 component in addition to the H1N1 B/Victoria and B/Yamagata components. Fluzone HD was supplied in single-dose, prefilled syringes and stored at 2-8 degree Celsius (C) until time of use.  On an unknown date, the patient experienced severe treatment-emergent adverse event (TEAE), grade 2 urinary tract infection (Urinary tract infection) escalated to a serious adverse reaction when they were admitted to hospital for urosepsis (Urosepsis) on day 22.  Action taken: Not applicable. Corrective treatment: Not Reported for both the events. Outcome: Unknown for both the events. Seriousness criteria: Medically significant and hospitalization for urosepsis. Non-serious for urinary tract infection. Reporter's causality: Related for both the events. Company causality: Unassessable for both the events.; Sender's Comments: Sanofi company comment dated 26-Jul-2024: This case involves Elderly patient of unknown age and unknown gender who experienced serious urosepsis following severe grade 2 urinary tract infection and severe grade 2 urinary tract infection while receiving vaccine Influenza Vaccine [Fluzone high-dose quadrivalent]. Based on information received the causal role of Vaccine cannot be excluded due to compatible temporal relationship of ADRs to the Vaccine. Further, information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient had an extra dose for IPOL, with no adverse event; Initial information received on 25-Jul-2024 regarding an unsolicited valid non-serious case received via physician.  This case involves a 5-year-old male patient had an extra dose for IPV (VERO) [IPOL], with no adverse event  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (strength, lot number, expiry date: unknown) as immunization and patient had an extra dose for ipol, with no adverse event (extra dose administered) (latency: same day).  Information regarding batch number and expiration date 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 and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: stated that one of their nurses administered ACTHIB to one of their patient but used a different diluent other than the diluent supplied with no reported adverse event; Initial information received on 26-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 18 months old male patient where reporter stated that one of their nurses administered HIB (PRP/T) VACCINE [ACT-HIB] to one of their patient but used a different diluent other than the diluent supplied with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot- UJ995AA and expiration date- 28-FEB-2025) via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (product preparation error) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose of Hiberix to a 6 month old patient.; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received Hib (Hiberix) (batch number PD39X, expiry date 12-JUL-2024) and (batch number 7525P, expiry date 12-JUL-2024) for prophylaxis.   On 15-JUL-2024, the patient received the 3rd dose of Hiberix. On 15-JUL-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: administration of an expired dose of Hiberix to a 6 month old patient.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 22-JUL-2024 A physician called in to request data about the administration of an expired dose of Hiberix to a 6 month old patient.  The Vaccine Administration Facility was the same as Primary Reporter The provided data about the vaccine and event, as well as the patient. Follow-up was accepted.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Biliary dilatation, C-reactive protein increased, Chest X-ray normal, Conjunctivitis
Clinical narrative: Patient developed symptoms of MISC on 7/22/24; fevers began on 7/22/24 with a Tmax of 38.3 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, headache, abdominal pain, vomiting, diarrhea, hand/foot swelling, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, decreased lymphocytes. ECHO showed only left ventricular hyperdynamic systolic function. Chest x-ray was normal. Abdominal US showed common bile duct dilatation and simple free fluid in the lower abdomen. Patient was admitted to the hospital on 7/25/24 and treated with IVIG and infliximab x 2; he was discharged on 7/30/24. He did not require admission to the ICU.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Echocardiogram abnormal, Headache, Hyperdynamic left ventricle, Immunoglobulin therapy
Clinical narrative: Patient developed symptoms of MISC on 7/22/24; fevers began on 7/22/24 with a Tmax of 38.3 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, lymphopenia, headache, abdominal pain, vomiting, diarrhea, hand/foot swelling, rash, mucocutaneous lesions/conjunctivitis, headache. Abnormal labs included elevated CRP, decreased lymphocytes. ECHO showed only left ventricular hyperdynamic systolic function. Chest x-ray was normal. Abdominal US showed common bile duct dilatation and simple free fluid in the lower abdomen. Patient was admitted to the hospital on 7/25/24 and treated with IVIG and infliximab x 2; he was discharged on 7/30/24. He did not require admission to the ICU.