chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: DTAP, FLU3, HPV9, MNQ
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A DTAP was given instead of Tdap to a 12 year old.
Age: 32.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Extra dose administered
Clinical narrative: TWO DOSES OF BOOSTRIX WERE GIVEN IN A WEEK. ONE ON 02/21 AND ANOTHER ON 02/27.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED PREVNAR 20 THREE TIMES OVER THE PAST 3 YEARS.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Blood test, Malaise, Urine analysis
Clinical narrative: Two week following the vaccination I became ill with the same Covid symptoms I experienced two years prior. Approximately 35 days into the illness I was diagnosed with AKI (Acute Kidney Injury)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient requested moderna covid-19 vaccine, however, pt was given pfizer-bioNtech covid-19 vaccine
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient requested moderna covid-19 vaccine, however, pt was given pfizer-bioNtech covid-19 vaccine
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Red rash, arm very painful, took 2 Tylenol every 6-8 hours during the day.
Age: 56.0
Sex: M
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Injection site pain, Muscle spasms, Pain, Product administered at inappropriate site, Sleep disorder
Clinical narrative: from 10/20/2024 to 3/18/2025, I have experienced gradual increase and worsening of pain on right shoulder where shingles vaccine was administered high on shoulder.  resulted in lack of sleep, mental hesitation to move freely, pain from annoying to spasmatic.
Age: 56.0
Sex: M
Vaccine: COVID19, FLU3, VARZOS
Symptoms: X-ray limb
Clinical narrative: from 10/20/2024 to 3/18/2025, I have experienced gradual increase and worsening of pain on right shoulder where shingles vaccine was administered high on shoulder.  resulted in lack of sleep, mental hesitation to move freely, pain from annoying to spasmatic.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Pharyngeal paraesthesia, Pharyngeal swelling
Clinical narrative: Pt reports feeling tingling in her throat and swelling in her throat.
Vaccine: BCG
Symptoms: Incorrect route of product administration
Clinical narrative: BCG Intravenous; This spontaneous report was received from a Physician and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with BCG vaccine intravenously for enhance/produce longer and stronger response to the prevention of tuberculosis (lot # and expiration date were not reported) (Incorrect route of product administration).  This is an invalid case due to lack of patient's identifiers. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: DTPPVHBHPB, FLU4, MMRV, PNC20, MMRV
Symptoms: Product storage error
Clinical narrative: No adverse effects reported; received improperly stored PROQUAD; This spontaneous report was received from a nurse referring to a 3-year-old female patient.  Concurrent condition and medical history were not reported. Concomitant vaccines included Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS), Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), and Influenza vaccine inact split 4v (FLUARIX QUADRIVALENT).  On 01-OCT-2024, the facility received a shipment of COIVD vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment.   On 05-FEB-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lyophilisate and solvent for solution for injection, administered subcutaneously in the right thigh for prophylaxis at public health clinic (lot# Y017208 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 13-APR-2026; strength and dose were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, lot#, and expiration date were not reported). It was assumed that the vaccine could be refrigerated and was moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degree Fahrenheit) until administration. The vaccine arrived at the facility on 13-OCT-2025 and was refrigerated until administration (Product storage error). No adverse effects were reported.  This is one of several reports received from the same reporter.
Age: 3.0
Sex: F
Vaccine: DTPPVHBHPB, FLU4, MMRV, PNC20, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; received improperly stored PROQUAD; This spontaneous report was received from a nurse referring to a 3-year-old female patient.  Concurrent condition and medical history were not reported. Concomitant vaccines included Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS), Pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20), and Influenza vaccine inact split 4v (FLUARIX QUADRIVALENT).  On 01-OCT-2024, the facility received a shipment of COIVD vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment.   On 05-FEB-2025, the patient was vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lyophilisate and solvent for solution for injection, administered subcutaneously in the right thigh for prophylaxis at public health clinic (lot# Y017208 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 13-APR-2026; strength and dose were not reported). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, lot#, and expiration date were not reported). It was assumed that the vaccine could be refrigerated and was moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degree Fahrenheit) until administration. The vaccine arrived at the facility on 13-OCT-2025 and was refrigerated until administration (Product storage error). No adverse effects were reported.  This is one of several reports received from the same reporter.
Age: 11.0
Sex: F
Vaccine: FLU3, HPVX
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details reported; Fridge temperature dropped below freezing while office was closed; This spontaneous report was received from the vaccine coordinator and refers to a 11-year-old female patient.   The patient's medical history included asthma and allergies. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 24-OCT-2024, the patient was vaccinated with an improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9)(lot #X025115, expiration date: 19-MAY-2026) administered by Intramuscular route;  and Influenza vaccine  (FLUZONE) (lot #UT8408NA, expiration date: 30-JUN-2025) administered by Intramuscular route (strengths, doses description were not provided) for prophylaxis following a temperature excursion since Fridge temperature dropped below freezing while office was closed. No additional AE details reported.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: HCP states patient has seen a "Significant" improvement in his (non-genital) warts after one dose of GARDASIL 9.  No other informaiton provided.  No additional AEs/PQC reported.; This spontaneous report was received from a nurse and refers to a 9-year-old male patient. The patient's medical history, concomitant therapies, drug reactions or allergies were not reported. The patient's concurrent conditions included (non-genital) warts.   On 15-NOV-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) suspension for injection (valid lot number 2018414, expiration date: 11-DEC-2025) for prevention of human papillomavirus (HPV) (dose, dose number, vaccination scheme, anatomical location, route of administration were not provided).  On 15-NOV-2024, the patient had seen a "significant" improvement in his (non-genital) warts after one dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Therapeutic response unexpected).  No other information provided.  No additional adverse events reported. At the reporting time, the outcome of the event was not provided.   The causal relationship between the event and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) not reported.
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Administration of the adjuvant portion only; Administration of the adjuvant portion only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the adjuvant portion only) and inappropriate dose of vaccine administered (Verbatim: Administration of the adjuvant portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 10-MAR-2025 Reporter stated that the vaccine was not administered in their facility, what happened if only give the liquid component of the Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Malaise, Swelling face
Clinical narrative: Fatigue; cough; Facial swelling; Sickness; Initial information received on 11-Mar-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 23 years old male patient who had fatigue, sickness, cough and facial swelling after receiving influenza vaccine and corticotropin.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Nephrotic syndrome.  Concomitant medications included atorvastatin calcium, furosemide, magnesium oxide; mycophenolate mofetil,  olmesartan medoxomil , potassium chloride, prednisone, spironolactone, tacrolimus, ergocalciferol (vitamin d) and omeprazole, all for Product used for unknown indication.  On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for vaccine (Immunisation) and cortrophin Gel for injection of strength 1 ml 80 iU (International unit) BIW (twice a week) with lot number 307823 and expiry date 30-Jun-2025 subcutaneous for Nephrotic syndrome.  On an unknown date the patient developed a non-serious fatigue, cough and facial swelling (swelling face) (unknown latency)   On 28-Oct-2024 the patient developed a non-serious sickness (illness) (unknown latency).  Information on the batch number was requested corresponding to the one at time of event occurrence  corticotropin (cortrophin) was continued.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for the event fatigue, was Recovered / Resolved on an unknown date for the event cough, was Recovering / Resolving for the event sickness and was Not Recovered / Not Resolved for the event facial swelling.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to only the liquid portion of pentacel was administered to the patient with no reported adverse event; Initial information received on 06-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse and processed together with live-follow up (10-Mar-2025).  This case involves a 5 months old male patient who was administered inappropriately with the liquid portion of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Feb-2025, the patient received 0.5mL of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Suspension for injection (lot number UK194AA expiry date 01-Mar-2026 and strength standard) for immunisation and inappropriately only the liquid portion of pentacel was administered to the patient with no reported adverse event (single component of a two-component product administered)  (latency same day).  Action taken was not applicable.  The age of the patient and dose description of the product was added. Narrative amended accordingly.  Reportedly, nurse would like to know if the patient needs to be revaccinated with Pentacel (Vero) or can they administer the ActHib and the vaccination would be completed.  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 (duplicate entry for pentacel vero #2 deleted) has been amended.
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: accidentally administered 0.1 ml of IPV instead of a PPD skin test to a baby, with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 months old female patient who experienced accidentally administered  IPV (VERO) [IPOL] 0.1 ml of ipv instead of a tuberculin test [Tuberculin Ppd] to a baby,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 Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation; Varicella zoster vaccine  for Immunisation; Hepatitis a vaccine for Immunisation; and Influenza vaccine  for Immunisation.  On 05-Mar-2025, the patient accidentally received 0.1 ml  of suspect IPV (VERO),Suspension for injection, lot Y1A201M, strength: standard,  frequency: once, Expiry date:31-Jan-2027  via unknown route in unknown administration site for Immunization instead of a tuberculin test with no reported adverse event (wrong product administered) (latency: same day).  Reportedly,verified that ipv's brand name is ipo.  Action taken 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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: inappropriate use due to use of alternate diluent 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 an unknown age and unknown gender patient and is reported inappropriate use of  Hib (PRP/T) Vaccine [ACT-HIB] due to use of alternate diluent 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 tHib (PRP/T) Vaccine,Powder and solvent for solution for injection, lot number, strength and expiry date not reported via unknown route in unknown administration site for immunization with use of alternate diluent with no reported adverse event (product preparation error) (latency: same day)  Information on the batch number was requested corresponding to the one at time of event occurrence  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: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: act-hib diluent was mixed with sterile water with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves HIB (PRP/T) vaccine [ACT-HIB] diluent was mixed with sterile water with no reported adverse event.  On an unknown date, HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, lot number and expiry date-unknown) not reported via unknown route in unknown administration site for Immunization and was mixed with sterile water with no reported adverse event (product preparation error).  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: 0.08
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 1-month old patient who was given with PENTACEL by mistake,with no reported adverse event; Initial information received on 17-Mar-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 1 months old female patient who was given with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] 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 (ROTAVIRUS VACCINE) and  PREVNAR 15 for Immunisation.  On 17-Mar-2025, the patient received at dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, Suspension for injection (lot UK174AB and expiry 31-Mar-2026) by mistake, with no reported adverse event (product administered to patient of inappropriate age) (latency same day) via intramuscular route in right leg for immunization.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Cardiomyopathy, Cerebral ischaemia, Ejection fraction decreased
Clinical narrative: I lived a healthy and active lifestyle as a former athlete for much of my life. However, after receiving the two Moderna COVID-19 shots and the booster in May 2021, I began experiencing severe health issues. Approximately six months after my first shot, I was diagnosed with atrial fibrillation (A-Fib), cardiomyopathy, tachycardia, and congestive heart failure, with an ejection fraction of 15%. These conditions have left me in need of a heart transplant. Additionally, I began suffering from neurological disorders due to decreased blood flow to my brain, which has compounded my health challenges. I am currently 52 years old.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Nervous system disorder, Tachycardia
Clinical narrative: I lived a healthy and active lifestyle as a former athlete for much of my life. However, after receiving the two Moderna COVID-19 shots and the booster in May 2021, I began experiencing severe health issues. Approximately six months after my first shot, I was diagnosed with atrial fibrillation (A-Fib), cardiomyopathy, tachycardia, and congestive heart failure, with an ejection fraction of 15%. These conditions have left me in need of a heart transplant. Additionally, I began suffering from neurological disorders due to decreased blood flow to my brain, which has compounded my health challenges. I am currently 52 years old.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Cancer screening, Coagulation test, Computerised tomogram, Deep vein thrombosis, Pulmonary embolism
Clinical narrative: Deep Vein Thrombosis (DVT) in lower left leg; requiring emergency thrombectomy & hospitalization (6 October 2023); Subsequent pulmonary embolism (roughly 3-4 weeks later) requiring life-long course of anticoagulant medication.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast, Thrombectomy, Ultrasound scan, X-ray
Clinical narrative: Deep Vein Thrombosis (DVT) in lower left leg; requiring emergency thrombectomy & hospitalization (6 October 2023); Subsequent pulmonary embolism (roughly 3-4 weeks later) requiring life-long course of anticoagulant medication.
Age: 0.5
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptomatic adverse events; the patient received a third dose of PEDVAXHIB at 6 months of age.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 06-Jan-2025, the patient was vaccinated with a third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) injection (lot #Y003145 has been verified to be a valid lot number, expiration date: 12-Sep-2026; 0.5ml/ series; route and strenght were not provided) for prophylaxis (inappropriate schedule of product administration). No symptomatic adverse events were reported.    This is one of the several reports from the same reporter/facility.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ruxolitinib phosphate (Jakafi) tablet for product used for unknown indication.   On an unknown date, the patient received the 1st dose of Shingrix and Jakafi (oral) 20 mg twice a day (40 mg daily). On 25-FEB-2025, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles) (serious criteria clinically significant/intervention required). The patient was treated with valaciclovir. The action taken with Jakafi was unknown. The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     The company considered the shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 11-MAR-2025 A 66-year-old female patient initiated the use of oral Jakafi (ruxolitinib) 20 mg tablets BID on an unknown date for an unknown indication.  The batch/lot number and expiration date were not reported On 25-FEB-2025, at the time of the report, the patient was diagnosed with shingles and was prescribed with valacyclovir to treat it.  She was in between her first injection of Shingrix and her second injection of Shingrix when she developed signs of shingles.  The outcome of the events was not reported. Concomitant medications were not reported. The Jakafi drug was ongoing. Medical history was not reported. No additional information was provided. Serious spontaneous report Shingles intervention required assessed as listed per the regulatory authority.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13, UNK, UNK, UNK
Symptoms: Adenovirus infection, Adenovirus test positive, Dehydration, Pyrexia
Clinical narrative: adenovirus infection; This 6-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 29-NOV-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 29-NOV-2022, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 29-NOV-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 06-OCT-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 29-NOV-2022, for prophylaxis.   On 05-DEC-2022, 6 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13 and Hiberix and 60 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 adenovirus infection (Verbatim: adenovirus infection). Serious criteria included hospitalization. The subject was treated with ondansetron (Zofran Disintegrating Tablet (Ondansetron)). The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix was no change. The outcome of adenovirus infection was resolved on 21-DEC-2022.   Diagnostic results (reference ranges are provided in parenthesis if available): Adenovirus test-In DEC-2022 Positive.                                                                                                     The investigator considered that there was no reasonable possibility that the adenovirus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix.   The company considered that there was no reasonable possibility that the adenovirus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix.   GSK Receipt date: 16-DEC-2022 and 19-DEC-2022.  patient was admitted to hospital with fever and dehydration on 06DEC2022. Discharged 06DEC2022 positive for adenovirus  Follow-up information received on 24-JAN -2023.  Summary of changes: Vaccination date updated, SAE term updated, TTO updated.  Follow-up information received on 13-Feb-2023  Summary of Changes: Investigator Text and hospitalization details were updated.  Follow-up information received on 13-Jul-2023. Summary of changes: Concomitant drug, event outcome date and outcome of event updated.  Follow-up information received on 15-aug-2023. Summary of changes: Concomitant drug updated to treatment drug.  Follow-up information received on 11-SEP-2023. Summary of changes: Narrative updated.  Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Adenovirus infections, 6 days after receiving the 3rd dose of Bexsero vs Placebo, 3rd dose of DTPa-HBV-IPV, 3rd dose of Prevnar 13, 2nd dose of Rotarix lyophilized formulation , 3rd dose of Hiberix. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Age: 18.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of ipol; max/low temperature reached: 46.7 f (8. 2 c)for 20 minutes, which was administered post excursion with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves temperature excursion of IPV (Vero) [IPOL]; max/low temperature reached: 46.7 f (8. 2 c) for 20 minutes, which was administered to a 18 years old female patient, post excursion 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 Influenza vaccine [Fluzone (Influenza Vaccine)]; and Meningococcal vaccine A/C/Y/W conj (Tet Tox) (Menquadfi) both for Immunisation.  On 11-Mar-2025, caller reported that 0.5ml dose of suspect IPV (VERO) (opened), Suspension for injection (Strength Standard) (Frequency once) lot X1C891M with Expiry date 31-Oct-2026, via intramuscular route in the right arm for Immunization, was exposed to a max/low temperature reached: 46.7 f (8. 2 c) for 20 minutes was administered to patient with no reported adverse event (poor quality product administered) (Latency Same day).  Reportedly, Product/s: fluzone NP, menquadfi and IPOL (Unopened), IPOL (opened); Reason: Power outage; Human error: no; Administered post-excursion: yes; Previous Excursion: none; Does extended stability data cover the excursion: No, for opened IPOL.  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: 0.33
Sex: F
Vaccine: HIBV, MEN, PNC13, UNK, UNK
Symptoms: Abdominal distension, Abdominal mass, Neuroblastoma, Pleural effusion, Tumour biopsy
Clinical narrative: Malignant Neuroblastoma; This 12-month-old female subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 19th August 2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 19th August 2019, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 26th June 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 19th August 2019, for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Prevnar 13 (Non-GSK Comparator) (Prevnar 13) for prophylaxis.   On 18th February 2020, 183 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 237 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 neuroblastoma. Serious criteria included hospitalization and GSK medically significant. Bexsero vs Placebo was discontinued. DTPa-HBV-IPV was discontinued. Hiberix was discontinued. The outcome of neuroblastoma was not recovered/not resolved.   The investigator considered that there was no reasonable possibility that the neuroblastoma may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix.   Relevant Tests: On 18Feb2020 Abdominal ultrasound: 12 x 13 x 5 x 9cm abdominal mass and small pleural effusion on right.   Diagnostic results (unless otherwise stated, normal values were not provided):  On 18th February 2020, Ultrasound abdomen result was see text. On 21st February 2020, Biopsy result was Neuroblastoma (Tumor biopsy).                    Investigator text 18FEB2020 Subject brought to Emergency Room for emesis x2 and abdominal distention. Exam revealed right upper quadrant mass. Chemotherapy to begin 27FEB2020. Spoke with mother 26FEB2020 Subject has discontinued the study and no further information can be obtained.                                                                                   Additional Details: Investigator reported SAE as Malignant Neuroblastoma. Subject withdrawn from study due to this event.  Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of neuroblastoma, 183 days after receiving 3rd doses of Bexsero vs Placebo,  DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe and Hiberix, and 237 days after receiving the 1st dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 12-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Age: 0.33
Sex: F
Vaccine: HIBV, MEN, PNC13, UNK, UNK
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Malignant Neuroblastoma; This 12-month-old female subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 19th August 2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 19th August 2019, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 26th June 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 19th August 2019, for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and Prevnar 13 (Non-GSK Comparator) (Prevnar 13) for prophylaxis.   On 18th February 2020, 183 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 237 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 neuroblastoma. Serious criteria included hospitalization and GSK medically significant. Bexsero vs Placebo was discontinued. DTPa-HBV-IPV was discontinued. Hiberix was discontinued. The outcome of neuroblastoma was not recovered/not resolved.   The investigator considered that there was no reasonable possibility that the neuroblastoma may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix.   Relevant Tests: On 18Feb2020 Abdominal ultrasound: 12 x 13 x 5 x 9cm abdominal mass and small pleural effusion on right.   Diagnostic results (unless otherwise stated, normal values were not provided):  On 18th February 2020, Ultrasound abdomen result was see text. On 21st February 2020, Biopsy result was Neuroblastoma (Tumor biopsy).                    Investigator text 18FEB2020 Subject brought to Emergency Room for emesis x2 and abdominal distention. Exam revealed right upper quadrant mass. Chemotherapy to begin 27FEB2020. Spoke with mother 26FEB2020 Subject has discontinued the study and no further information can be obtained.                                                                                   Additional Details: Investigator reported SAE as Malignant Neuroblastoma. Subject withdrawn from study due to this event.  Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of neuroblastoma, 183 days after receiving 3rd doses of Bexsero vs Placebo,  DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe and Hiberix, and 237 days after receiving the 1st dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 12-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Age: 0.33
Sex: M
Vaccine: HIBV, MEN, MMR, PNC13, UNK, UNK, VARCEL
Symptoms: Computerised tomogram head abnormal, Crying, Decreased activity, Fall, Intensive care
Clinical narrative: Skull Fracture; This 20-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 29th May 2020, for prophylaxis.   On 12th February 2021, 259 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed severe - grade 3 skull fracture. Serious criteria included hospitalization. The subject was treated with paracetamol (Acetaminophen) and midazolam (Versed (Midazolam)). The outcome of skull fracture was recovered/resolved on 18th March 2021.   The investigator considered that there was no reasonable possibility that the skull fracture may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines.   Relevant Tests: On 13Feb2021 CT Head Result showed Calvarium left paracentral occipital acute fracture.   Diagnostic results (unless otherwise stated, normal values were not provided):  On 13th February 2021, Computerised tomogram head result was see text.  Investigator Text On 12Feb2021 subject sustained an occipital skull fracture after falling backwards in his booster chair. The fall was witnessed by the mother. There was no loss of consciousness and he cried right away. He was not as playful and took 2 naps and vomited 4 times before his arrival to the emergency department on 12Feb2021 at 2103. CT head showed Calvarium left paracentral occipital acute fracture. 13Feb2021 at 0127 admitted to Hospital (transferred to pediatric intensive care unit from emergency department) for overnight observation. He was given 2 doses of Midazolam (Versed) via IV route and one dose of IV Acetaminophen. Diet was advanced from clears to regular in the morning and he did not have further episodes of emesis or unusual irritability. After demonstrating an ability to tolerate solid foods and with resolved nausea and vomiting, he was discharged home on 13Feb2021 at 1356 with follow up by pediatric neurosurgery in 2 to 4 weeks. 18Mar2021: Follow up phone consultation with peds neurosurgery reported full recovery.  Follow up information received on 11-Mar-2025 End of study Unblinding completed.  Upon internal review the case was updated on 18-Mar-2025. Study drugs updated.; Sender's Comments: A case of skull fracture, 259 days after receiving 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, in a 20-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (H/O falling backwards in his booster chair).
Age: 0.33
Sex: M
Vaccine: HIBV, MEN, MMR, PNC13, UNK, UNK, VARCEL
Symptoms: Nausea, Skull fracture, Somnolence, Vomiting
Clinical narrative: Skull Fracture; This 20-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 29th May 2020, for prophylaxis.   On 12th February 2021, 259 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed severe - grade 3 skull fracture. Serious criteria included hospitalization. The subject was treated with paracetamol (Acetaminophen) and midazolam (Versed (Midazolam)). The outcome of skull fracture was recovered/resolved on 18th March 2021.   The investigator considered that there was no reasonable possibility that the skull fracture may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines.   Relevant Tests: On 13Feb2021 CT Head Result showed Calvarium left paracentral occipital acute fracture.   Diagnostic results (unless otherwise stated, normal values were not provided):  On 13th February 2021, Computerised tomogram head result was see text.  Investigator Text On 12Feb2021 subject sustained an occipital skull fracture after falling backwards in his booster chair. The fall was witnessed by the mother. There was no loss of consciousness and he cried right away. He was not as playful and took 2 naps and vomited 4 times before his arrival to the emergency department on 12Feb2021 at 2103. CT head showed Calvarium left paracentral occipital acute fracture. 13Feb2021 at 0127 admitted to Hospital (transferred to pediatric intensive care unit from emergency department) for overnight observation. He was given 2 doses of Midazolam (Versed) via IV route and one dose of IV Acetaminophen. Diet was advanced from clears to regular in the morning and he did not have further episodes of emesis or unusual irritability. After demonstrating an ability to tolerate solid foods and with resolved nausea and vomiting, he was discharged home on 13Feb2021 at 1356 with follow up by pediatric neurosurgery in 2 to 4 weeks. 18Mar2021: Follow up phone consultation with peds neurosurgery reported full recovery.  Follow up information received on 11-Mar-2025 End of study Unblinding completed.  Upon internal review the case was updated on 18-Mar-2025. Study drugs updated.; Sender's Comments: A case of skull fracture, 259 days after receiving 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, in a 20-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (H/O falling backwards in his booster chair).
Sex: F
Vaccine: TDAP
Symptoms: Gastrointestinal disorder, Lethargy, Malaise
Clinical narrative: out and sick for like a month; tummy issues; lethargy; This non-serious case was reported by a nurse via call center representative and described the occurrence of lethargy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Covid vaccine (after the second dose). Concurrent medical conditions included autoimmune disorder, ehlers-danlos syndrome, lyme disease, drug allergy (gelatin) and meat allergy.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced lethargy (Verbatim: lethargy), sickness (Verbatim: out and sick for like a month) and abdominal disorder (Verbatim: tummy issues). The outcome of the lethargy was resolved (duration 3 weeks) and the outcome of the sickness and abdominal disorder were unknown.   It was unknown if the reporter considered the lethargy, sickness and abdominal disorder to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the lethargy, sickness and abdominal disorder to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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 retired nurse stated her spouse has a gelatin allergy and last year was given a dose of Tdap vaccine instead of just tetanus and had a bad reaction. This occurred last year, and she was out, and sick for like a month. The brand of Tdap administered was unknown. The patient had immediately had to hit the inhaler way more than she should have, which lasted for two days, use of Benadryl constantly and lethargy for three weeks after, as well as tummy issues, which she declined to provide further details about. The patient had a history of reaction to the Covid vaccine after the second dose, and her provider told her she should not get any booster doses. The patient had a history of untreated Lyme disease, which originated approximately 30 years ago, and resulted in gelatin, meat, and alpha gal allergies as well as EDS (clarified as Ehlers-danlos syndrome) and autoimmune issues. Brand of Tdap was unknown to nurse. It was difficult to keep the nurse on-topic, and specialist was unable to get permission for safety follow up. No further details were provided.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 579F4, expiry date 23-JAN-2025) for prophylaxis.   On 10-MAR-2025, the patient received Arexvy. On 10-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Arexvy). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 10-MAR-2025 Pharmacist reported a patient received an expired dose of AREXVY on 10th March 2025, which led to Expired vaccine used.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: hard red swelling on right upper arm.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Arrhythmia, Atelectasis, Atrial fibrillation, Blood test abnormal
Clinical narrative: Bilateral pulmonary artery, chest pain cardiac silhouette, low oxygen Abnormal heart rhythms, severe sepsis Lupus, Blood test Abnormal Tachypnea, pulmonary infarction cardiac arrest 02/28/21 - Excessive Blood clots 2/24/21 - Tested for the clotting gene, tests were negative 02/25/21 - Atelectasis 03/5/21 - Abnormal heart rhythm cardiomypathy 03/5/21 - ECG - Atrial Fibrillation 03/5/21 - Blood Test Abnormal 04/12/21 - Headaches 4 to 5 days per week Hematemesis - vomiting blood 05/19/21 - Headaches, nausea, blurred vision 03/19/22 - Sinus tachycardia, breathing problems Abnormal ECG 02/7/23 - Myocardial, sinus tachycardia, Blood test Abnormal stress test abnormal, stable Angina, chest pain continuously vomiting, orthopnea, swelling in legs & heart palpitations 05/2/23 - Sinus Tachycardia, myocardial Edema Liver is enlarged, Enlarged cardiac silhouette Having trouble breathing, Respiratory Distress Nonischemic Dilated Cardiomyopathy Chronic combined systolic & Diastolic congestive heart failure 06/16/23 - Chest feels tight, can not breath when waking up 07/31/23 - Night sweats, Lupus, Heart racing, Low Vit. D 10/5/23 - Congestive heart failure, Nonischemic dilated cardiomyopathy 11/1/23 - Right Facial Numbness Numbness radiating down whole right side of body