chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure, Visual impairment
Clinical narrative: Suspected vaccination failure; Shingles in eye; Shingles in face; This serious case was reported by a consumer via interactive digital media 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. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Shingles in face). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix.   Additional Information: GSK receipt date: 07-JAN-2025 Patient stated that he/she got the vaccine 4 years ago. And, diagnosed with shingles in the left side of face and eye in early December. At the time of reporting rash was gone, but pain, itch, and impaired vision still very present. Also reported that out of work at least through the end of January when he/she meet with the eye specialist next. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding herpes zoster were unknown at the time of reporting. This case was reported by a patient via interactive digital media.  The follow-up could not be possible as no contact details were available.; 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. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Fluarix was given to a 68 year old, instead of Fluad; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 68-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 37NR4, expiry date 30-JUN-2025) for prophylaxis.   Co-suspect products included Influenza vaccine inact sAg 3v (Fluad) for prophylaxis.   On 09-DEC-2024, the patient received the 1st dose of Fluarix 2024-2025 season. On an unknown date, the patient did not receive Fluad. On 09-DEC-2024, immediately after receiving Fluarix 2024-2025 season, the patient experienced wrong vaccine administered (Verbatim: Fluarix was given to a 68 year old, instead of Fluad). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-DEC-2024  The other health professional reported that one of their members administered a Flu, the normal Fluarix, to a 68 year old male patient, just wanted to see what was GlaxoSmithKline's recommendations on that. The other health professional reported that Fluarix was given to a 68 year old patient, instead of Fluad which led to wrong vaccine administered. Consented The Vaccine Administration Facility was the same as Primary Reporter. This was 1 of 7 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024092435:same reporter US-GSK-US2024043628:same reporter US-GSK-US2024043626:same reporter US-GSK-US2024043624:same reporter US-GSK-US2024043623:same reporter US-GSK-US2024043622:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Shingrix - Route of administration.; Shingrix - Sore arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H79Y, expiry date 13-NOV-2026) for prophylaxis.   On 17-DEC-2024, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Shingrix - Sore arm). On 17-DEC-2024, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix - Route of administration.). The outcome of the pain in arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-DEC-2024 A pharmacist mentioned they administered a Shingrix vaccine to a patient in the upper arm but they are not sure if the vaccine was administered intramuscular in the deltoid.  The pharmacist said that the vaccine was administered in the shoulder for sure. The patient had sore arm. The reporter was ask if this dose valid or patient should be revaccinated. The patient received vaccine other than intramuscular, which led to intramuscular formulation administered by other route.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she had her first dose approximately 4 years ago and did not return for a second dose until today; 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 57-year-old female patient who received Herpes zoster (Shingrix) (batch number B4942, expiry date 06-APR-2026) for prophylaxis.   Previously administered products included Shingrix (first dose received approximately 4 years ago).   On 02-JAN-2025, the patient received the 2nd dose of Shingrix. On 02-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: she had her first dose approximately 4 years ago and did not return for a second dose until today). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-JAN-2025 The reporter stated patient came in to pharmacy on the day of reporting for her second Shingrix dose. The patient reported she had her first dose approximately 4 years ago and did not return for a second dose until today.  The first dose was not at the same pharmacy, so the reporter did not knew exact date of first dose. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up but did not provide email or fax, so use postal. The patient received second dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 25.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: 35 weeks pregnant patient, was given the Arexvy; Unapproved Age; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A4P5G, expiry date 12-OCT-2025) for prophylaxis.   On 08-JAN-2025, the patient received the 1st dose of Arexvy. On 08-JAN-2025, an unknown time after receiving Arexvy, the patient experienced drug use in unapproved population (Verbatim: Unapproved Age). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 35 weeks pregnant patient, was given the Arexvy). The outcome of the vaccine exposure during pregnancy and drug use in unapproved population were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 35 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 09-JAN-2025 The nurse reported that patient at their facility was a 35 weeks pregnant patient, was given the Arexvy immunization by mistake and he/she wonder what kind of information GlaxoSmithKline had regarding that.  The patient was 25 years old and nurse mentioned that she was born which led to drug use in unapproved population.
Age: 68.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidentally administered Infanrix to a 68 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 68-year-old patient who received DTPa (Infanrix) for prophylaxis.   On 09-JAN-2025, the patient received Infanrix. On 09-JAN-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidentally administered Infanrix to a 68 year old patient). The outcome of the inappropriate age at vaccine administration 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: 09-JAN-2025 The pharmacist reported that they accidentally administered Infanrix to patient of an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Chills, Decreased appetite, Dehydration, Dizziness
Clinical narrative: Fainting; Dizziness; Low BP; loss of appetite; Headache; Shivering; Fever; Muscle pain; Dehydrated; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 08-JAN-2025, 2 days after receiving Shingrix, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant), dizziness (Verbatim: Dizziness), blood pressure decreased (Verbatim: Low BP), appetite lost (Verbatim: loss of appetite), headache (Verbatim: Headache), shivering (Verbatim: Shivering), fever (Verbatim: Fever), muscle pain (Verbatim: Muscle pain) and dehydration (Verbatim: Dehydrated). The outcome of the fainting, dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration were not resolved.   It was unknown if the reporter considered the fainting, dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration to be related to Shingrix.     The company considered the fainting to be unrelated to Shingrix. It was unknown if the company considered the dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JAN-2025 The patient self reported the case. Patient called on the day of reporting with the following complaints, dehydration, muscle pain, shivering, headache, fever, loss of appetite, dizziness, blood pressure low, and fainting.  All of these complaints were ongoing.  Patient was actually at a urgent care to receive IV fluids for her dehydration. The reporter consented to follow up.; Sender's Comments: Syncope  is an unlisted event which is considered unrelated to GSK vaccine  Shingrix.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia, Syncope
Clinical narrative: Fainting; Dizziness; Low BP; loss of appetite; Headache; Shivering; Fever; Muscle pain; Dehydrated; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 08-JAN-2025, 2 days after receiving Shingrix, the patient experienced fainting (Verbatim: Fainting) (serious criteria GSK medically significant), dizziness (Verbatim: Dizziness), blood pressure decreased (Verbatim: Low BP), appetite lost (Verbatim: loss of appetite), headache (Verbatim: Headache), shivering (Verbatim: Shivering), fever (Verbatim: Fever), muscle pain (Verbatim: Muscle pain) and dehydration (Verbatim: Dehydrated). The outcome of the fainting, dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration were not resolved.   It was unknown if the reporter considered the fainting, dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration to be related to Shingrix.     The company considered the fainting to be unrelated to Shingrix. It was unknown if the company considered the dizziness, blood pressure decreased, appetite lost, headache, shivering, fever, muscle pain and dehydration to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JAN-2025 The patient self reported the case. Patient called on the day of reporting with the following complaints, dehydration, muscle pain, shivering, headache, fever, loss of appetite, dizziness, blood pressure low, and fainting.  All of these complaints were ongoing.  Patient was actually at a urgent care to receive IV fluids for her dehydration. The reporter consented to follow up.; Sender's Comments: Syncope  is an unlisted event which is considered unrelated to GSK vaccine  Shingrix.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Labyrinthitis, Loss of consciousness, Vertigo, Vestibular neuronitis
Clinical narrative: vetibular neuritis; throw up until pass out; labyrinthitis; the room would spin; sweaty; throw up until pass out; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant), 4 weeks after the suspect product(s) administration, outcome "recovered", described as "vetibular neuritis"; LOSS OF CONSCIOUSNESS (medically significant), VOMITING (non-serious), outcome "unknown" and all described as "throw up until pass out"; LABYRINTHITIS (non-serious), 4 weeks after the suspect product(s) administration, outcome "recovered"; VERTIGO (non-serious), outcome "unknown", described as "the room would spin"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweaty". Clinical details: the patient asked if there have been reports of labyrinthitis/vetibular neuritis after a Pfizer covid booster. He developed this 4 weeks after the vax, took nearly a year to resolve. He mentions that he wound up in a situation where the room would spin, he'd get very sweaty and he'll throw up until he pass out. Caller adds that he was on steroids for almost a year and he found one article linking this but there was a very small number of cases.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vetibular neuritis; throw up until pass out; labyrinthitis; the room would spin; sweaty; throw up until pass out; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant), 4 weeks after the suspect product(s) administration, outcome "recovered", described as "vetibular neuritis"; LOSS OF CONSCIOUSNESS (medically significant), VOMITING (non-serious), outcome "unknown" and all described as "throw up until pass out"; LABYRINTHITIS (non-serious), 4 weeks after the suspect product(s) administration, outcome "recovered"; VERTIGO (non-serious), outcome "unknown", described as "the room would spin"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweaty". Clinical details: the patient asked if there have been reports of labyrinthitis/vetibular neuritis after a Pfizer covid booster. He developed this 4 weeks after the vax, took nearly a year to resolve. He mentions that he wound up in a situation where the room would spin, he'd get very sweaty and he'll throw up until he pass out. Caller adds that he was on steroids for almost a year and he found one article linking this but there was a very small number of cases.  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: RSV
Symptoms: Foetal exposure during pregnancy, Premature baby
Clinical narrative: Preterm birth. Due date 13Feb2025.; This is a spontaneous report received from a Physician from a sales representative.  A neonate patient born to a 33-year-old mother who, while pregnant received RSV Vaccine Prot. Subunit Pref 2v (ABRYSVO) on 04Jan2025 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. A neonate patient was exposed to rsv vaccine prot.subunit pref 2v (ABRYSVO), administration details for the mother: not provided, on 04Jan2025 as dose 1, single (Batch/Lot number: unknown) for maternal immunisation. The mother of the patient was 33 years old at the time of vaccination. The mother is expected to deliver a baby(s) on 13Feb2025. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE BABY (non-serious) with  outcome "unknown", described as "Preterm birth. Due date 13Feb2025. Delivery date ". The baby was delivered premature. Therapeutic measures were not taken as a result of premature baby.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: heart arrhythmia; This is a spontaneous report received from a Consumer or other non HCP from License Party.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "not recovered", described as "heart arrhythmia".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.  BNT162b2  is under agreement with BIONTECH SE.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Dizziness postural, Heart rate increased, Postural orthostatic tachycardia syndrome
Clinical narrative: Heart rate increased; Postural orthostatic tachycardia syndrome; Condition aggravated; Dizziness postural; Initial information received on 13-Jan-2025 regarding an unsolicited valid serious courtesy case received from a consumer.  This case involves a 43 years old female patient who experienced heart rate increased, postural orthostatic tachycardia syndrome, condition aggravated and dizziness postural after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and Covid-19 Vaccine Prot. Subunit (Nvx Cov 2373) (Novavax Covid-19 Vaccine).  The patient's past medical history included Ehlers-Danlos syndrome, Complex regional pain syndrome, Postural orthostatic tachycardia syndrome, Mast cell activation syndrome and Migraine. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Erenumab aooe (Aimovig); Buprenorphine (Butrans); Metoclopramide (Reglan); Duloxetine hydrochloride (Cymbalta); Mirtazapine; Doxepin (Doxepin); and Gabapentin.  On 11-Nov-2024, the patient received a unknown dose of suspect Novavax Covid-19 Vaccine not produced by Sanofi Pasteur injection (strength: 0.5 ml, expiry date and lot number not reported for both suspects) via intramuscular route in unknown administration site as COVID-19 immunization; On the same day, the patient received a unknown dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved Suspension for injection via intramuscular route in unknown administration site as prophylactic vaccination (immunization). There will be no information available on the batch number and expiration date corresponding to the one at time of event occurrence.  On 12-Nov-2024 the patient developed heart rate increased, postural orthostatic tachycardia syndrome, condition aggravated and dizziness postural (latency: 1 day). These events were leading to disability.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all events.; Sender's Comments: Sanofi company comment dated on 16-Jan-2025: This case involves a 43 years old female patient who experienced heart rate increased, postural orthostatic tachycardia syndrome, condition aggravated and dizziness postural after receiving Influenza Quadrival A-B Multidose Vaccine Preserved [Fluzone] and Covid-19 Vaccine Prot. Subunit (Nvx Cov 2373) (Novavax Covid-19 Vaccine). Further information regarding tolerance medical history or family history, concurrent condition and concomitant medication laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Sex: U
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: This situation is pre-assessed as a medication error/an inappropriate use due to administration of ADACEL post-excursion. with no reported adverse event; Initial information received on 13-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an this situation is pre-assessed as a medication error/an inappropriate use due to administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 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 Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine  (Suspension for injection) lot 2CA94C1, Expiry date: 31-AUG-2025, strength was unknown via unknown route in unknown administration site for prophylactic vaccination (Immunization) and this situation is pre-assessed as a medication error/an inappropriate use due to administration of adacel post-excursion with no reported adverse event (poor quality product administered) (latency; same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Multiple use of single-use product, Wrong technique in product usage process
Clinical narrative: the physician is initially  giving half doses of HD Fluzone and having the patient return a week later for the second half with no reported AE; storing the opened product for a week before re-administration with no reported AE; Initial and live follow-up information received on 19-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an elderly unknown gender patient who received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and it was reported that the physician is initially giving half doses of hd fluzone and having the patient return a week later for the second half with no reported ae (adverse event) and storing the opened product for a week before re-administration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE, injection (dose, strength, route: unknown) lot number not reported in unknown administration site as Immunization .  On an unknown date the physician is initially giving half doses of hd fluzone and having the patient return a week later for the second half with no reported ae (incorrect dose administered) and storing the opened product for a week before re-administration with no reported ae (product storage error) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The reporter stated the nurse would like to know what dose should the patients received for the second FLUZONE HD injection. Should the patients receive another half dose, a whole dose or what dose should they receive. She statesdthat she has found multiple practices in which HCPs were administering half-doses of FLUZONE HIGH-DOSE QUADRIVELENT. Reasons provided were either that the patient had an egg allergy (in which case she advises FLUBLOK), or that the practitioner felt that the high-dose is just too much so they wanted to break it into 2 doses. (In which case she advises not using the high-dose). She stated that when she has informed practitioners of underdose information, some of them have declined to change their practice.  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.  Based on data previously received, the following information [age group was captured as Elderly along with case classification as valid] has been amended.
Age: 16.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 16 year-old boy was administered flublok in error with no reported adverse event; Initial information received on 13-Jan-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 16 years old male patient who was administered with influenza trivalent recombinant vaccine [Flublok TIV] in error with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in January 2025, the patient received an unknown dose of influenza trivalent recombinant vaccine Solution for injection (strength- unknown, expiry date 31-MAY-2025 and lot TFAA2406) via unknown route in unknown administration site as Immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency).  Reportedly, pharmacist stated that they had checked on him by telephone every day for 5 days and there had been no adverse reactions reported. Patient did not receive any other vaccines concomitantly.   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: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: a patient, who completed his Pentacel series in nov 2024, was given an extra dose of Pentacel yesterday by mistake with no reported adverse event; Initial information received on 15-Jan-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves, a 16 months old male patient who completed his Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] series in Nov-2024, was given an extra dose of pentacel yesterday by mistake 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 Rotavirus Vaccine and PCV-20 for Immunisation.  On 14-Jan-2025, the patient who completed his Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (once) (lot UK109AA) (unknown strength, expiry date) via intramuscular route in the right thigh for prophylactic vaccination series in Nov-2024, was given an extra dose of Pentacel yesterday by mistake with no reported adverse event (extra dose administered) (latency-same day).   Reportedly, The error happened when the medical assistant (MA) became confused because the patient and his brother had the same date of birth except for the year. The affected patient actually only needed an MMRV vaccine yesterday. However, yesterday the MA was looking at the ''m-track'' record for the patient's brother without realizing it was not the correct patient. The patient's brother, born in 2024, did need Pentacel, PCV- 20, and rotavirus. The patient, born in 2023, only needed MMRV. Therefore, it was the Pentacel, PCV-20, and rotavirus vaccines that were administered in error yesterday as extra doses to patient.  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: F
Vaccine: UNK
Symptoms: Influenza
Clinical narrative: Infected with influenza virus; This spontaneous case, initially received on 06-Jan-2025, was reported by a non-health professional and concerns an adult female patient.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for active immunization, (FLUCELVAX is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine) Dose regimen: 0.5 ml, Route of administration: not reported, Anatomical location: not reported, Lot number: No batch number available and would be requested with follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Infected with influenza virus (Medically Significant, outcome: Unknown).  Patient got infected with influenza virus following seasonal influenza vaccination  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter assessed the event as non-serious and did not provide the causality assessment.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. The case lacks information regarding the strain of influenza with which the patient was diagnosed, clinical presentation, time frame between vaccination and diagnosis of influenza, detailed investigations (swab and blood culture, immunological tests), hence assessed as related.
Age: 1.58
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse reaction; MMR II and Varicella vaccine administered on the same day; This spontaneous report was received from Licensed practical nurse and refers to a 19-month-old female.  The patient has no pre-existing allergies, birth defects of medical conditions nor illness at the time of vaccination. No adverse events following a prior vaccination.Concomitant medications included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20).   On 08-AUG-2024, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #Y005922, expiration date: 13-MAR-2026, administered subcutaneously in the right arm; and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #X019100, expiration date: 16-JUL-2025, administered subcutaneously in the left arm (Inappropriate schedule of vaccine administration). Both vaccines for prophylaxis. It was reported that during the day of the vaccine administration, there was a power loss for approximately 2 hours; however, the vaccines were moved to another refrigerator and freeze before they reached the excursion point. All safety guidelines were followed, and the vaccines were safe and kept the temperature range.  The patient had not adverse reaction.  This is one of several reports from the same source.; Sender's Comments:  US-009507513-2501USA004794:
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 58-year-old 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: "several surgeries" (unspecified if ongoing), notes: I'm 58 years old had several surgeries. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pyrexia
Clinical narrative: Fever of 102.2 on 1/18, fever of 104 on 1/19, nosebleed on 1/20
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Discomfort, Rash, Rash erythematous
Clinical narrative: Pt received a Capvaxive vaccine on 11/21. She did not have any issues until 11/27, when she started to develop small, red rash-like bumps on both arms. They slowly got worse and covered both arms, from hands to upper arm, and within a couple days started to resolve on their own. She did not have any other reaction. She did not report to dr or hospital, and did not take any OTC medicine to make rash go away. It was "uncomfortable", but was gone within a couple days.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: 8 am of 1/20/25 (approximately two and a half days after injection) , splotchy redness in the upper left arm in the area of the injection site. Hotter than surrounding area.  Has stayed that way through the day. Called the pharmacist to discuss. Pharmacist suggested filling out this form.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea
Clinical narrative: Sore arm at the injection site started the day of the vaccine.  Pain gone within 24 hours.  Headache, nausea, and chills the day after the vaccine from 8am - 3pm.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient had no issues with the second shot.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Fatigue, Migraine, Nausea
Clinical narrative: Sever migraine, nausea,  heart palpitations, weak, fatigue, vertigo
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Vertigo
Clinical narrative: Sever migraine, nausea,  heart palpitations, weak, fatigue, vertigo
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a second dose of Arexvy on advice of the dr. patient had NO adverse effects at the time of vaccination
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received a second dose of Arexvy on advice of the dr. patient had NO adverse effects at the time of vaccination
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Type III immune complex mediated reaction
Clinical narrative: Developed substantial redness, induration, and swelling at injection site, measuring 9.5cm x 8.5cm.   Parents sent several photos over the weekend.  Seen in office 1/20, at which point there was central clearing.  No fevers.  Walking and playing normally, felt to represent Arthus reaction.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on arm that received the vaccine on 3rd day after vaccine.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Balance disorder, Diet refusal, Dizziness, Erythema multiforme, Fatigue
Clinical narrative: Two days after his vaccine he started developing a full body rash diagnosed as  erythema multiform at urgent care. It progressed for a week. Days 5, 6 and 7 after had the worst symptoms. His eyes were almost swelled shut, 103 fever, rash on the bottoms of his feet made it difficult to walk, exhaustion, wouldn?t eat or drink, and he was unsteady/dizzy. We were told to him motrin as needed to keel him comfortable and give Zyrtecs for swelling and itchiness
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Gait disturbance, Pruritus, Pyrexia, Rash, Swelling of eyelid
Clinical narrative: Two days after his vaccine he started developing a full body rash diagnosed as  erythema multiform at urgent care. It progressed for a week. Days 5, 6 and 7 after had the worst symptoms. His eyes were almost swelled shut, 103 fever, rash on the bottoms of his feet made it difficult to walk, exhaustion, wouldn?t eat or drink, and he was unsteady/dizzy. We were told to him motrin as needed to keel him comfortable and give Zyrtecs for swelling and itchiness
Age: 0.75
Sex: F
Vaccine: FLU3, HEP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: none
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Reaction to previous exposure to any vaccine
Clinical narrative: none
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: none
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Axillary pain, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Weakness-Severe, Additional Details: unable to straighten elbow and lift arm
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Mobility decreased, Nervous system disorder
Clinical narrative: Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Weakness-Severe, Additional Details: unable to straighten elbow and lift arm
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is asymptomatic / No additional AE; HCP reported a dose of PNEUMOVAX23 was inadvertently administered to a 2 month old patient on 11/12/2024; This spontaneous report was received from a medical assistant, concerning a 2-month-old patient of unknown age.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 12-NOV-2024, the patient was inadvertently vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 0.5 milliliter (mL) (lot number X027348 was verified to be valid, expiration date was reported and confirmed as 24-JAN-2026), administered as prophylaxis by a Health Professional (route of administration and anatomical location were not provided) (Product administered to patient of inappropriate age). The patient was asymptomatic.  No additional details nor adverse event (AE) were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical Assistant stated ROTATEQ was administered on 1/16/2025 during a temperature excursion; This spontaneous report was received from a medical assistant, concerning to a female patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) suffered a temperature excursion (TE) at 1.0 Celsius degrees for 5 hours.   On 16-JAN-2025, the patient stwas vaccinated with the vaccine involved in the TE: rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (strength, dose, and route of administration were not provided;  lot #2073367 has been verified to be valid for this vaccine, expiration date reported and confirmed  as 26-NOV-2025). (Product storage error). No additional adverse event reported (No adverse event).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years, in arm for covid-19 immunisation. The patient did not receive any other vaccine on the same date and within four weeks of vaccination. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergies. Other medical history reported as "several". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (hospitalization, disability, medically significant), outcome "recovered with sequelae" (01Jan2025), described as "Bells Palsy". The patient was hospitalized for bell's palsy (hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of bell's palsy (steroids).  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AEs; VARIVAX and PROQUAD administered at the same visit; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 14-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) subcutaneous injection (0.5 ml, lot #Y012343, expiration date: 11-JAN-2026) subcutaneously for prophylaxis (strength was not provided) and  varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 ml, lot #Y013349, expiration date: 02-AUG-2026) subcutaneously for prophylaxis (strength, and route of administration were not provided), both diluted with sterile diluent (BAXTER STERILE DILUENT), at the same visit (overdose). No additional adverse event (no adverse event) was reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Post herpetic neuralgia; Suspected vaccination failure; Diagnosed with shingles/the blister and scabbing finally cleared up /the rash and blistering clears up and goes away; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 24-AUG-2024, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Diagnosed with shingles/the blister and scabbing finally cleared up /the rash and blistering clears up and goes away). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The patient was treated with gabapentin, ibuprofen (Advil Liqui Gels) and paracetamol (Tylenol). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.     The company considered the vaccination failure, shingles and post herpetic neuralgia to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-JAN-2025 and 09-JAN-2025  This case was reported by a patient via interactive digital media. The patient got the second dose Shingrix vaccine in 2019 and was diagnosed with shingles on 24 August 2024. The blisters and scabbing finally cleared up in about 2 and a half to 3 weeks and had the post herpetic neuralgia.  The patient went to primary care physician and he prescribed gabapentin for the nerve pain.  It helps some but not for very long at a time. The patient was currently living on Advil liquigels and Tylenol rapid release.  Hopefully yours and the patient's would finally went away.  The patient had been told that the nerve pain could last for months even years after the rash/blistering clears up and goes away.  The commercials the patient had seen said that the vaccine was only effective in about 90 percent of people who get the vaccine, so he/she guess that he/she was in that 10 percent out of 100 percent who it did not help, since he/she got the 2 doses of Shingrix vaccine. This case was considered as suspected vaccination failure as details regarding time 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster and Post herpetic neuralgia are unlisted events which are considered unrelated to GSK vaccine Shingrix.