chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: a female patient received a 1st Twinrix dose on 04-Nov-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 45-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (a female patient received a 1st Twinrix dose on 04-Nov-2024, batch number 2KR55, expiry date 03 January 2025).   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: a female patient received a 1st Twinrix dose on 04-Nov-2024). The outcome of the incomplete course of vaccination was not applicable.   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 : 06-MAR-2025 On 06th March 2025 pharmacist mentioned that a female patient received a 1st Twinrix dose on 04th November 2024, and now, the patient was late for the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HCP gave 2nd dose on 22-Feb-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received HAB (Twinrix adult) (batch number M4B34, expiry date 28-SEP-2026) for prophylaxis.   Previously administered products included Twinrix adult (got his first shot on 14-JUNE-2024).   On 22-FEB-2025, the patient received the 2nd dose of Twinrix adult. On 22-FEB-2025, an unknown time after receiving Twinrix adult, the patient experienced drug dose administration interval too long (Verbatim: HCP gave 2nd dose on 22-Feb-2025). The outcome of the drug dose administration interval too long was not applicable.   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 : 07-MAR-2025 The patient received 2nd dose of Twinrix adult, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 60.0
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: recived expired dose of Arexvy; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 60-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (expiry date 24-FEB-2025) for prophylaxis.   On 07-MAR-2025, the patient received the 1st dose of Arexvy. On 07-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: recived expired dose of Arexvy). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK receipt date: 10-MAR-2025 The director of a site explained that they administered an expired dose of Arexvy vaccine which led to, expired vaccine used. It was the first dose of a Respiratory Syncytial Virus vaccine for this patient. The reporter did not had lot number for the vaccine. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix late second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 41-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of vaccine on an unknown date).   On 10-MAR-2025, the patient received the 2nd dose of Twinrix. On 10-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix late second dose). The outcome of the drug dose administration interval too long was not applicable.   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 : 10-MAR-2025 The patient self-reported this case for himself/herself A patient reported that she had Twinrix later than she was supposed to because she did not get a notification from her facility at the time that it should be administered, which led to drug dose administration interval too long.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Trigger type 1 diabetes; This spontaneous case was reported by a non-health professional and describes the occurrence of TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) in a 16-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080748) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 50 microgram. On 07-Jan-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) (seriousness criterion medically significant). At the time of the report, TYPE 1 DIABETES MELLITUS (Trigger type 1 diabetes) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: has been experiencing injection site soreness for 7 months; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (has been experiencing injection site soreness for 7 months) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    No Medical History information was reported.   On 18-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 18-Sep-2024, the patient experienced VACCINATION SITE PAIN (has been experiencing injection site soreness for 7 months). At the time of the report, VACCINATION SITE PAIN (has been experiencing injection site soreness for 7 months) had not resolved.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-783153 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-783153:Invalid case multiple patients having similar events
Sex: M
Vaccine: FLUX, PNC20
Symptoms: Myalgia
Clinical narrative: Muscle back pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 63-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single). The patient's relevant medical history included: "Pneumonia" (unspecified if ongoing), notes: 2 or 3 weeks before getting Prevnar 20. The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Muscle back pain". Therapeutic measures were taken as a result of back pain.  Additional information: The caller mentioned he received Prevnar 20 and got the vaccine two or might be three weeks after he had pneumonia. Stated that after two days he had muscle back pain and mentioned he had also received a flu shot. He thought that the influenza vaccine was not related to his symptoms because he had the same vaccine last year without adverse event. The back pain goes up and down has taken advil and Tylenol for 3 weeks. Caller would like to know if this pain was normal. The caller wants to know how long the back pain would last. The speaker would like to know what medications to take to relieve back pain.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID again; COVID again; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 71-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "medical conditions" (ongoing); "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Paxlovid for COVID-19 treatment. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunization; Comirnaty (DOSE 2), for COVID-19 immunization; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID again". The clinical course was reported as follows: An elder patient with medical conditions mentioned, had been getting the Pfizer COVID vaccinations every year since they were released. The patient had COVID previously, despite the vaccine. The patient reported had COVID again and was prescribed nirmatrelvir/ritonavir.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Rash
Clinical narrative: broken out in such a rash on stomach, back and arms; tired; looked like a picture of shingles; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 14Jan2025 as dose number unknown, single at the age of 82 years for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 20Jan2025 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 18Jan2025, outcome "not recovered", described as "broken out in such a rash on stomach, back and arms"; HERPES ZOSTER (non-serious) with onset 2025, outcome "unknown", described as "looked like a picture of shingles"; FATIGUE (non-serious) with onset 2025, outcome "unknown", described as "tired". The events "broken out in such a rash on stomach, back and arms" required physician office visit. Therapeutic measures were taken as a result of rash. Additional information: rash was just getting worse. It had been a long time and couldn't figure out. It was really bad. The patient went to the doctor and was given 2 pills and some triamcinolone acetonide ointment, nothing helped. Couldn't figure out what was different and this was the only thing and someone said maybe it was the shot and he was tired, so tired and he was sleeping. It looked like a picture of shingles but it was all over his body like that and clarified it was his back and his stomach and his arms.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Influenza virus test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: came back positive for COVID/started with the symptoms; Last year (2024) the patient had COVID/came back positive for COVID; Last year (2024) the patient had COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 77-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN (ongoing); FOSAMAX (ongoing). Vaccination history included: Bnt162b2 (PRIMARY IMMUNIZATION SERIES COMPLETED), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, BOOSTER, SINGLE), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 2024, outcome "unknown", described as "Last year (2024) the patient had COVID"; VACCINATION FAILURE (medically significant) with onset 2024, outcome "not recovered", described as "Last year (2024) the patient had COVID/came back positive for COVID"; DISEASE RECURRENCE (medically significant) with onset 10Mar2025, outcome "not recovered", described as "came back positive for COVID/started with the symptoms". The events "last year (2024) the patient had covid/came back positive for covid", "last year (2024) the patient had covid" and "came back positive for covid/started with the symptoms" required physician office visit. The patient underwent the following laboratory tests and procedures: Influenza virus test: Unknown results; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 (last year) with Paxlovid. Clinical course: Last year (2024) the patient had COVID, they prescribed Paxlovid. The patient went to doctor today (11Mar2025) for a pre-op because she has another surgery on the 27th of this month, and patient was not feeling well, the patient took flu test and COVID test, came back positive for COVID. The patient's doctor called the pharmacy immediately and sent the prescription. The patient said this was the second time having been taking Paxlovid (not started yet). The patient started with the symptoms yesterday (10Mar2025). The patient had all vaccines through Pfizer.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: PNC20
Symptoms: Asthma, Drug ineffective, Hypersensitivity, Pneumonia
Clinical narrative: was hospitalized with Pneumonia; was hospitalized with Pneumonia; bad asthma; allergies; 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), in 2020 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Pneumonia", start date: 2020 (unspecified if ongoing); "a virus", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), PNEUMONIA (hospitalization, medically significant) all with onset May2024, outcome "unknown" and all described as "was hospitalized with Pneumonia"; ASTHMA (non-serious), outcome "not recovered", described as "bad asthma"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "allergies". The patient was hospitalized for drug ineffective, pneumonia (start date: May2024). Therapeutic measures were taken as a result of asthma. Clinical course: Patient received Prevnar 20 in 2020 and second part 2021 and was hospitalized with  pneumonia in 2024. Doctor recommended patient to get Capvaxive but it was not covered by medical insurance (withheld). It was confirmed that patient has not yet received Capvaxive and "it's thousands of dollars". Patient has bad asthma and takes Advair, patient has allergies. Patient has a need, they were in the hospital last May2024 with pneumonia.  Patient tried to get the vaccine last year but once you get Prevnar 20, don't get it again.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500054706 same patient and product, different dose and event;
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got COVID/ I had three of your vaccinations, Pfizer's vaccinations; got COVID/ I had three of your vaccinations, Pfizer's vaccinations; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 66-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pain management" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID/ I had three of your vaccinations, Pfizer's vaccinations". The patient had three Pfizer's vaccinations. When they were asked to confirm that they had received Pfizer vaccinations, the patient stated, "Yep, long time ago, when COVID was [inaudible]." After providing their provider information, the caller stated, ". He's my primary doctor, and then I have a pain management doctor; he's the one that prescribed the medication for me."
Sex: M
Vaccine: MEN
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Passed out 3 separate times; 3 separate seizures 2 years ago after receiving meningococcal booster; Initial information received on 09-Mar-2025 regarding an unsolicited valid  serious case received from an unknown reporter.  This case involves Child male patient who passed out 3 separate times and 3 separate seizures 2 years ago after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization).   On an unknown date the patient passed out 3 separate times (loss of consciousness) and 3 separate seizures (seizure) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.   Information on the batch number was requested corresponding to the one at time of event occurrence.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Unknown for both the events.  Seriousness criteria: Both the events were assessed as medically significant.; Sender's Comments: Sanofi company comment dated 12-mar-2025: This case involves Child male patient who passed out 3 separate times and 3 separate seizures 2 years ago after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Further information regarding concurrent condition during 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 the individual suspect vaccine cannot be assessed
Age: 0.5
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administration of the second dose of FLUZONE NP one week earlier than the minimum interval, with no reported advrse event; Initial information received on 11-Mar-2025 regarding an unsolicited valid  non-serious case received from a Other health professional.  This case involves, a 6 months old and unknown gender patient who had administration of the second dose of Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] one week earlier than the minimum interval, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Jan-2025, the patient received (dose 1) and on 31-Jan-2025, (dose 2) of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination was administration of the second dose of fluzone np one week earlier than the minimum interval, with no reported adverse event (inappropriate schedule of product administration) (latency-22 days).  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.   Reportedly, Medical assistant wanted to know if the patient was going to be okay and if they need an additional dose if the second dose was one week too early. They also asked what to do if the patient was not able to receive the second dose of FLUZONE NP four weeks from the invalid dose.They said that they still have patients to attend to and disconnected from the call.  Action taken was not applicable.  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: 1.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired PENTACEL administered, with no reported adverse event; Initial information received on 12-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 year old female patient who had expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis a vaccine for Immunization.  On 11-Mar-2025, the patient received a dose 1 of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) lot UJ973AA , Frequency : Once, Expiry date : 12-Feb-2025 (Expired product administered) via intramuscular route in the right thigh for Immunization with no reported adverse event (latency : same day) (strength was unknown).  Action taken was not applicable.   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.
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Open ipol was administered post excursion with no reported adverse event; Initial information received on 12-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who had open IPV (VERO) [IMOVAX POLIO] was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) ,Concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect IPV (VERO) (suspension for injection) lot W1C751M, Expiry date: 18-Nov-2025, strength was unknown via unknown route in unknown administration site for Immunization of open ipol was administered post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Reportedly "Reason: power outage Max/low temperature reached: max temp of 63.3°F (17.39°C)Duration: 12 hours and 25 mins. Previous Excursion? NONE. Human error? NO.Does extended stability data cover the excursion? The UNOPEN products are supported by the extended stability information post excursion but the punctured IPOL is not. "  Action taken was not applicable.   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: VARZOS
Symptoms: Myelitis transverse
Clinical narrative: Transverse Myelitis; This serious case was reported by a physician via sales rep and described the occurrence of myelitis transverse in a adult male 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 myelitis transverse (Verbatim: Transverse Myelitis) (serious criteria GSK medically significant). The outcome of the myelitis transverse was resolved.   The reporter considered the myelitis transverse to be possibly related to Shingrix.     The company considered the myelitis transverse to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2025 Patient had been vaccinated with Shingrix dose 1. A few days after the vaccination the patient went to the emergency room and had developed Transverse Myelitis. The patient was treated and managed by neurology and with physical therapy the patient recovered. The hospital physicians had no other causes and believed the vaccine might have caused the issue. The patient later refused to get the 2nd dose but has fully recovered.; Sender's Comments: Myelitis transverse is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose after a year; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a 3-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received first dose of Bexsero at 7 months).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: second dose after a year). The outcome of the drug dose administration interval too long was not applicable.   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: 05-MAR-2025 The case was received from the patient via (Bexsero GSK Chatbot) interactive digital media. The reporter had a patient who received first dose of Bexsero at 7 months and the second dose after a year. At the time of reporting the patient had 3 years and 10 months.  The reporter asked was she safe, should she get another dose. The patient received second dose of Bexsero longer than the recommended interval which led to lengthening of vaccination schedule.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/ vaccine did not work; shingles 3 times; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure/ vaccine did not work) (serious criteria GSK medically significant) and shingles (Verbatim: shingles 3 times). The outcome of the vaccination failure and shingles were resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-JAN-2025 The patient had shingles 3 times unfortunately the vaccine did not work. The patient had indescribable pain from shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, 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, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix  .
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: administered only the sterile water for injection component of the Priorix vaccine; administered only the sterile water for injection component of the Priorix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old female patient who received MMR (Priorix) (batch number A2J35, expiry date 01-SEP-2025) for prophylaxis.   On 02-MAR-2025, the patient received Priorix. On 02-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: administered only the sterile water for injection component of the Priorix vaccine) and inappropriate dose of vaccine administered (Verbatim: administered only the sterile water for injection component of the Priorix vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   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 : 03-MAR-2025 Pharmacy manager reported that two patients were administered only the sterile water for injection component of the Priorix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2025026207, reported by same reporter different patient.; Sender's Comments:  US-GSK-US2025026207:Same reporter/Diffrent patient
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 49-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 16th May 2024).   On 04-MAR-2025, the patient received the 2nd dose of Twinrix. On 04-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was not applicable.   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:04-MAR-2025 Pharmacist called to verify when the 3rd dose of Twinrix could be administered. The reporter did not consent to follow-up. No lot number nor expiry date were available. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test
Clinical narrative: No titers; 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 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, 1 year after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced therapy non-responder (Verbatim: No titers). The outcome of the therapy non-responder was not applicable.   Additional Information: GSK Receipt Date: 06-MAR-2025 The Shingrix information for a patient vaccinated with Shingrix, two doses, and showed no titers on a standard lab test 1 year later.  The reporter asked was there a specific lab test to show immunity for Shingrix. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Contracted COVID; contracted COVID; This is a spontaneous report and received from Consumer or other non HCPs, Program ID.  An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "trouble hearing" (unspecified if ongoing); "my ears are all sort of plugged up" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "Contracted COVID"; COVID-19 (medically significant), outcome "not recovered", described as "contracted COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: have COVID, notes: she tested me and discovered I do, in fact, have COVID. The patient just contracted COVID for the first time her life. The patient got all the Pfizer vaccines but had come down with it, shockingly. The patient went to an urgent care office here and the patient was tested and discovered the patient had COVID, and was prescribed then sent the prescription in for the PAXLOVID 5-day regimen.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Mobility decreased
Clinical narrative: patient woke up unable to move in hospital for 5 days and diagnosed with guillan-barre syndrome
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: vaccine was confused for another vaccine , Pt had no symtems to vaccine give.
Age: 80.0
Sex: F
Vaccine: PNC21
Symptoms: Fatigue, Injection site swelling
Clinical narrative: PATIENT SAID HER LEFT ARM WAS SWOLLEN AROUND INJECTION SITE AND PATIENT FELT TIRED/FATIGUE FOR THE NEXT 2 DAYS.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Patient reported redness at the injection site and severe pain, nausea, fever, fatigue.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Pain, Pain in extremity, Pyrexia
Clinical narrative: patient came by today and said she was in hospital for shortness of breath, fever, body aches, arm pain.  says the dr told her not to take the Boostrix vaccine again.  he gave her steroid and cetirizine
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: Localized rash on upper deltoid.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema of eyelid, Eyelids pruritus
Clinical narrative: Patient had itching of eyelids and redness of  upper eyelids yesterday. She is better today.Mother gave her Motrin yesterday. She does not have any systemic symptoms like cough , wheezing, abdominal discomfort or vomiting
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Mobility decreased, Pain in extremity
Clinical narrative: Patient experienced extreme pain in her arm to a point where she could not move it. No redness or streaks on arm. Patient went to the emergency room because she experienced so much pain.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Feverish, severe chills, moderate headache, severe joint pain,  severe muscle and body aches, severe fatigue and tiredness, moderate diarrhea, severe sleepiness.  Approx 7 days.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Somnolence
Clinical narrative: Feverish, severe chills, moderate headache, severe joint pain,  severe muscle and body aches, severe fatigue and tiredness, moderate diarrhea, severe sleepiness.  Approx 7 days.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Discomfort, Eyelid disorder, Facial paralysis
Clinical narrative: bells palsy.  left sided facial paralysis, eye irritation and discomfort due to inability to blink.  md prescribed valtrex, erythromycin opthlamic ointment, and medrol dose pack.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Decreased interest, Hypersomnia
Clinical narrative: Sleeping 18 hrs a day for a month, no interest, week, confused
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Pt got a metallic taste in her mouth. Pt was given a bottle of water. Pt left before resolution of adverse taste
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arm, painful, muscle ache lasting for 2 weeks
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: sore arm, painful, muscle ache lasting for 2 weeks
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Muscular weakness
Clinical narrative: pt presents in march, the 13th, complaining of weakness in his left shoulder.  he cant raise his arm above his head.  he is not ill, does not have redness, swelling, or pain in the shoulder.  about 2-3-5 days after the injection the shoulder started to become weak and is still weak 1 month later.  on physical exam, he has paralysis/weakness of supraspinatus and infraspinatus muscles.  trapezius, deltoid, and subscapularis muscles all seem to be working fine.  he does not remember any "pain" that proceeded this issue.  he did not suffer any injury or accident.  he is not playing any sports or using any ladders, nothing he can think of, other than the vaccine, that could have caused this.
Age: 28.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Erythema, Hyperhidrosis, Palpitations
Clinical narrative: Patient started  experiencing heart palpitations, redness of face, sweating and rash after being given the  flu vaccination. The adverse reaction lasted over 45 minute and had to call emergency service. He later said he always have a reaction when he receives vaccinations.
Age: 28.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Erythema, Hyperhidrosis, Palpitations
Clinical narrative: Patient started  experiencing heart palpitations, redness of face, sweating and rash after being given the  flu vaccination. The adverse reaction lasted over 45 minute and had to call emergency service. He later said he always have a reaction when he receives vaccinations.
Age: 85.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted. Patient received a Prevnar 20 dose in 2022 that was not reported to facility. This is the patient's second dose of Prevnar 20
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received Prevnar 20 on 06/30/2023 so did not need to receive the dose on 03/12/2025.  The state registry did not pick it up because patient had the vaccine given in another state.  The advisor tool PneumoRecs Vax Advisor recommended the vaccine because the patient stated she had never had Prevnar 20.  The patient did not remember receiving vaccine in 2023. She stated today 3/13/2025 that she feels fine and has not had any reactions.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Anxiety, Dizziness, Loss of consciousness, Mydriasis, Pallor
Clinical narrative: Patient left the office in stable and normal state. After the vaccination, he walked out of the office with Mom. Few seconds later, Mom comes back to the front desk, saying, "something happened to my son". MA rushed to the parking lot with Mom. I also followed quickly. We found him in their car, sitting down. Mom said, as soon as he sat down in the car, he just suddenly started with mild convulsive movements for few seconds then passed out. He awoke after few seconds. When I arrived at the scene, he was awake, but slightly closing his eyes, sleepy, but responsive. He was looking pale and diaphoretic. He was responsive to my questions. He looked very anxious. His pulse was low at 55. He said he felt dizzy. I reclined the seat. After 45-60 seconds , we brought the O2 tank out into the car and started him on 3 LPM of 100% O2, because of persistent paleness and sleepiness. Despite the O2, he was still looking pale and complained that his vision was blurry and couldn't see a thing. His pupils were dilated. The car was exposed to the sun and his face was in the sun, so I asked the Mom to move the car closer to the office door. The distance was about 200 feet. O2 was continued for another minute. He was still looking pale and still sleepy, but awake. 911 was dialed by Mom approximately about 4-5 minutes from the time of his syncope. His vision returned and started to look pinkish. By the time EMS arrived , his vision was back and his color and alertness have improved. EMS took over and I left the scene. He was checked and was sent home in their car. He was not brought to ER.  He seemed to have a vaso-vagal syncope and a slightly prolonged post-syncopal state. The triggering factor was vaccination.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Seizure, Somnolence, Unresponsive to stimuli, Vision blurred
Clinical narrative: Patient left the office in stable and normal state. After the vaccination, he walked out of the office with Mom. Few seconds later, Mom comes back to the front desk, saying, "something happened to my son". MA rushed to the parking lot with Mom. I also followed quickly. We found him in their car, sitting down. Mom said, as soon as he sat down in the car, he just suddenly started with mild convulsive movements for few seconds then passed out. He awoke after few seconds. When I arrived at the scene, he was awake, but slightly closing his eyes, sleepy, but responsive. He was looking pale and diaphoretic. He was responsive to my questions. He looked very anxious. His pulse was low at 55. He said he felt dizzy. I reclined the seat. After 45-60 seconds , we brought the O2 tank out into the car and started him on 3 LPM of 100% O2, because of persistent paleness and sleepiness. Despite the O2, he was still looking pale and complained that his vision was blurry and couldn't see a thing. His pupils were dilated. The car was exposed to the sun and his face was in the sun, so I asked the Mom to move the car closer to the office door. The distance was about 200 feet. O2 was continued for another minute. He was still looking pale and still sleepy, but awake. 911 was dialed by Mom approximately about 4-5 minutes from the time of his syncope. His vision returned and started to look pinkish. By the time EMS arrived , his vision was back and his color and alertness have improved. EMS took over and I left the scene. He was checked and was sent home in their car. He was not brought to ER.  He seemed to have a vaso-vagal syncope and a slightly prolonged post-syncopal state. The triggering factor was vaccination.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: Pt reported severe red bumps and blisters around entire neck.
Age: 55.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received an additional Prevnar 20 vaccine - he received the first one on 9/12/24 and second 3/11/25 - patient reports no adverse reactions at this time
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Injection site discolouration, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: On the evening of the vaccine pt developed significant swelling in rt thigh, spoke to doctor at our after hours location who recommended cool compresses and tylenol "if bad", they used compresses but no tylenol given.  10 days later there is still significant induration of 5cm in length by 2 cm at distal end and 2.5 cm at superior part, sl warmth, no fluctuant areas, overlying area of induration looks bruised, family thought it was tender but baby did not seem bothered with my palpation of area. FROM in bilat LE.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy bone marrow, Biopsy skin abnormal, Blood test, Chromosomal analysis, Computerised tomogram
Clinical narrative: Shortly after receiving the vaccine I became very itchy, mostly on my back at first, then all over. I developed a rash between my shoulder blades by the spring of 2022. The rash spread to my whole torso and became red, hot and inflamed. The doctors thought it was an allergic reaction or contact dermatitis. Eventually I got a biopsy in March of 2023. It came back positive for Cutaneous T-Cell Lymphoma. I later had more testing done and I also have blood and bone marrow involvement at low levels. I see a Dermapathologist and an oncologist regularly and have currently failed all non-systemic treatments. I have recently started Methotrexate. It is helping  but hasn?t cleared yet, they are going to up my dose in a few weeks.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cutaneous T-cell lymphoma, Differential white blood cell count, Flow cytometry, Fluorescent in situ hybridisation, Full blood count
Clinical narrative: Shortly after receiving the vaccine I became very itchy, mostly on my back at first, then all over. I developed a rash between my shoulder blades by the spring of 2022. The rash spread to my whole torso and became red, hot and inflamed. The doctors thought it was an allergic reaction or contact dermatitis. Eventually I got a biopsy in March of 2023. It came back positive for Cutaneous T-Cell Lymphoma. I later had more testing done and I also have blood and bone marrow involvement at low levels. I see a Dermapathologist and an oncologist regularly and have currently failed all non-systemic treatments. I have recently started Methotrexate. It is helping  but hasn?t cleared yet, they are going to up my dose in a few weeks.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Laboratory test abnormal, Metabolic function test, Metastatic lymphoma, Pathology test
Clinical narrative: Shortly after receiving the vaccine I became very itchy, mostly on my back at first, then all over. I developed a rash between my shoulder blades by the spring of 2022. The rash spread to my whole torso and became red, hot and inflamed. The doctors thought it was an allergic reaction or contact dermatitis. Eventually I got a biopsy in March of 2023. It came back positive for Cutaneous T-Cell Lymphoma. I later had more testing done and I also have blood and bone marrow involvement at low levels. I see a Dermapathologist and an oncologist regularly and have currently failed all non-systemic treatments. I have recently started Methotrexate. It is helping  but hasn?t cleared yet, they are going to up my dose in a few weeks.