chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Sore shoulder, still sore after 11 days, radiating down into bicep
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccines were just given today, no adverse events had happened as of yet
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chemotherapy, Colon cancer stage III, Colon operation, Genetic testing, Imaging procedure
Clinical narrative: I received the Johnson & Johnson COVID-19 vaccine on 10/27/2021. At the time of vaccination, I was healthy with no known genetic or familial predisposition for colon cancer.  On 8/2/2023, I was diagnosed with iron deficiency anemia. Follow-up screenings led to a diagnosis of Stage 3c colon cancer on 8/22/2024. I have since undergone major surgery, chemotherapy, and multiple imaging scans.  Genetic testing has ruled out any hereditary factors. My oncologists have not confirmed a direct link to the vaccine, but also have not ruled it out. This report is filed to document the timeline and establish a potential association between the vaccine and this rare, late-onset diagnosis in an otherwise healthy individual.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Iron deficiency anaemia
Clinical narrative: I received the Johnson & Johnson COVID-19 vaccine on 10/27/2021. At the time of vaccination, I was healthy with no known genetic or familial predisposition for colon cancer.  On 8/2/2023, I was diagnosed with iron deficiency anemia. Follow-up screenings led to a diagnosis of Stage 3c colon cancer on 8/22/2024. I have since undergone major surgery, chemotherapy, and multiple imaging scans.  Genetic testing has ruled out any hereditary factors. My oncologists have not confirmed a direct link to the vaccine, but also have not ruled it out. This report is filed to document the timeline and establish a potential association between the vaccine and this rare, late-onset diagnosis in an otherwise healthy individual.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: gave Shingrix vaccine before they realize that have been expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 3ZX3E, expiry date 02-JUL-2025) for prophylaxis.   On 10-JUL-2025, the patient received the 1st dose of Shingrix. On 10-JUL-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: gave Shingrix vaccine before they realize that have been expired). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 10-JUL-2025 The Vaccine Administration Facility was the same as Primary Reporter A Registered Nurse reported that a dose of the Shingrix vaccine was administered before realizing that the vaccine had expired which led to expire vaccine used.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Malaise, Nausea
Clinical narrative: About 24 hours after injection, pt reported that her arm became painful, red, and swollen.  Urgent Care (within same building) was consulted and recommended ice, Benadryl, NSAID, and watchful waiting vs having pt come in to be seen. Follow up on 7/10 (4 days after injection) pt reported her arm was getting better and improving, however, she reported that the day before (3 days after injection) she had a headache, was nauseous, sick, and tired.  It wasn't as bad today, but still feeling sick.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: About 24 hours after injection, pt reported that her arm became painful, red, and swollen.  Urgent Care (within same building) was consulted and recommended ice, Benadryl, NSAID, and watchful waiting vs having pt come in to be seen. Follow up on 7/10 (4 days after injection) pt reported her arm was getting better and improving, however, she reported that the day before (3 days after injection) she had a headache, was nauseous, sick, and tired.  It wasn't as bad today, but still feeling sick.
Age: 44.0
Sex: F
Vaccine: PNC20
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: Patient stopped by after her lab draw to let us know that she received her PCV 20 vaccine and that after midnight she started feeling soreness at the injection site and headache. She was wondering if that was normal. I reviewed with her the VIS in spanish with her and noted to her that those are know effects after vaccination. To monitor symptoms fro the next 24-48 hours if no improvement to contact us.   Injection site was clear of redness or irritation, mild swelling note, ice pack given to patient and advised to ice intermittently on-off every 10-15 minutes for comfort. Patient accepted and understood.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old female patient who received HAV (Havrix) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis.   On 10-JUL-2025, the patient received Havrix. On 10-JUL-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JUL-2025 On 11th July 2025, a nurse practitioner called to report that a medical assistant had used a dose of Havrix which had expired and had been administered to a patient, which led to Expired vaccine used. According to the reporter, the dose had expired on 15th February 2025 and had been administered on 10th July 2025.
Sex: M
Vaccine: PNC20
Symptoms: Cerebrovascular accident, Impaired work ability
Clinical narrative: life-threatening stroke; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 11Jul2025 as dose number unknown, 0.5ml single (Lot number: LW1951) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (life threatening, medically significant), outcome "recovering", described as "life-threatening stroke".  Clinical course: Due to a life-threatening stroke he had and him currently being in recovering he is unable to work.
Age: 76.0
Sex: F
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: inappropriate use due to administration of an expired vaccine with no reported adverse event; Initial information received on 11-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 76-year-old female patient and is reported inappropriate use due to administration of an expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Jul-2025, the patient received a Booster dose 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult Suspension for injection of lot 2CA81C1 and expiry date: 04-Jul-2025 via intramuscular route in the left deltoid for immunization had inappropriate use due to administration of an expired vaccine with no reported adverse event (expired product administered) (latency: on same day).  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: 37.0
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Muscle mass
Clinical narrative: After the last Bexsero injection ( 6/21/25) 2-3 days later she developed a knot about 3-4 centimers in the deltoid muscle of right arm. This did not happen with last injection. She reported this to Dr's nurse. they recommend she pre- medicate with Benadryl but she said it will make her too sleepy and cant do her work. the other recommendation was to alternate arm next time she does not want a reaction in the same arm again.
Age: 8.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt and her father presented to clinic. They spoke vietnamese, I used the language line solutions 1-866-874-3972 spoke to  vietnamese interpreter to verify pt's age and pt's father stated she was 9 years old and verified  with interpreter. Pt received hpv first dose too soon she is not 9 years old she will be 9 years old on 8/12/2025. This nurse read what father wrote as 8/12/2015 not 8/12/2016. Notified nurse manager at  clinic RN, Notified Vaccine Coordinator/Mgr RN, notified my clinic nurse manager Rn. Notified provider on duty NP at  clinic.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abnormal behaviour, Breath sounds abnormal, Developmental delay, Dyskinesia, Genetic testing
Clinical narrative: Medical and Developmental Concerns Timeline (2017)  I first noticed concerning changes in my son's behavior shortly after his 2-month vaccinations. He began shaking his head frequently, both while awake and asleep. Additionally, I observed a gurgling, wheezing noise that was new and persistent. Around this time, I also noticed that he was not meeting developmental milestones expected for his age.  Despite these signs, I continued with the scheduled vaccinations from August 2017 through December 2017.  Over time, it became increasingly clear that my son was experiencing developmental delays. Based on our concerns and observations, our pediatrician referred us for further evaluation and support.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wheezing
Clinical narrative: Medical and Developmental Concerns Timeline (2017)  I first noticed concerning changes in my son's behavior shortly after his 2-month vaccinations. He began shaking his head frequently, both while awake and asleep. Additionally, I observed a gurgling, wheezing noise that was new and persistent. Around this time, I also noticed that he was not meeting developmental milestones expected for his age.  Despite these signs, I continued with the scheduled vaccinations from August 2017 through December 2017.  Over time, it became increasingly clear that my son was experiencing developmental delays. Based on our concerns and observations, our pediatrician referred us for further evaluation and support.
Age: 41.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: I gave the patient a dose of PCV-20 in error. He had already received a PCV-20 on 6/10/2025.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: New onset eczema, mainly on dorsal aspect of bilateral hands, that has been persistent three days after second dose and still present today. No history of eczema in patient. Prescription hydrocortisone used with minimal effectiveness. Various over the counter moisturizers do not work. Aquafor applied after showers has best results but still does not cure the problem.
Age: 51.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Perioral dermatitis
Clinical narrative: redness, itching, and swelling around injection sites one day later, vesicular rash around mouth resembling herpes zoster 4 days later, reported at office visit on 7/14/25 that reaction on right arm improving (see item 20)
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Chromaturia, Dyspnoea, Fatigue, Malaise
Clinical narrative: malaise, fatigue, myalgias, rigors, SOB, oliguria, dizziness dark urine
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Metabolic function test, Myalgia, Oliguria, Urine analysis
Clinical narrative: malaise, fatigue, myalgias, rigors, SOB, oliguria, dizziness dark urine
Age: 50.0
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles once afterwards and I now have it again;  This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles once afterwards and I now have it again). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUL-2025 The patient self-reported this case for himself/herself. The patient had the Shingrix shots when he/she was 50 years old. The patient had shingles once afterwards and he/she now have it again. The patient wanted to know if he/she could receive the Shingrix shots again. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Malaise, Nasal congestion
Clinical narrative: Headache; Weakness generalized; slight malaise; Nasal congestion; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose on 27-JAN-2025, for tolerance of 1st dose of Shingrix, refer case US2025083753).   On 23-JUN-2025, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), weakness generalized (Verbatim: Weakness generalized), malaise (Verbatim: slight malaise) and nasal congestion (Verbatim: Nasal congestion). Rechallenge with Shingrix was positive. The outcome of the headache, weakness generalized, malaise and nasal congestion were resolved.   It was unknown if the reporter considered the headache, weakness generalized, malaise and nasal congestion to be related to Shingrix.     It was unknown if the company considered the headache, weakness generalized, malaise and nasal congestion to be related to Shingrix.   Linked case(s) involving the same patient:  US2025083753   Additional Information: GSK Receipt Date: 03-JUL-2025 The patient received Shingrix shot and he experienced slight malaise/weakness, headache, and some nasal congestion.  These side effects were very minor compared to first Shingrix shot. These events resolved.; Sender's Comments:  US-GSK-US2025083753:same patient/2nd dose
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Dyspnoea, Immune system disorder
Clinical narrative: chest, breathing and heart problems from a weakened immune system; chest, breathing and heart problems from a weakened immune system; chest, breathing and heart problems from a weakened immune system; my immune system was destroyed two years ago; This is a spontaneous report received from a Consumer or other non HCP.  A patient in their 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autistic" (unspecified if ongoing); "flea bite" (unspecified if ongoing), notes: severely sick from being covered in flea bites; "severely sick" (unspecified if ongoing), notes: severely sick from being covered in flea bites; "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, batch/lot: FP7137, anatomical location: arm), administration date: Dec2022, for COVID-19 immunization, reaction(s): "Allergy", "Feeling sick", "Feeling sick"; Bnt162b2 (dose 2, batch/lot: FR2583, anatomical location: arm), administration date: 2023, for COVID-19 immunization, reaction(s): "Arthritis", "Autoimmune disorder", "Cardiac disorder NOS", "Decreased immune responsiveness", "Dyspnoea", "Fatigue extreme", "Allergic reaction", "Illness", "Activities of daily living impaired", "Muscle stiffness", "Myalgia", "Near death experience", "Cancer", "Ache", "Scar". The following information was reported: IMMUNE SYSTEM DISORDER (non-serious) with onset 2023, outcome "unknown", described as "my immune system was destroyed two years ago"; CHEST DISCOMFORT (non-serious), DYSPNOEA (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "chest, breathing and heart problems from a weakened immune system". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300218909 Same patient, different vaccine dose and different event;US-PFIZER INC-202300218333 Same patient, different vaccine dose and different event;
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hive reaction; This non-serious case was reported by a consumer and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Hive reaction). The outcome of the hives was not reported.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUL-2025 The Shingrix vaccine gave a hive reaction on the first dose, so he/she chose to skip the second dose.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: a 10 year old male patient was receiving his second dose of GARDASIL 9 on unknown date and had syncope and passed out; a 10 year old male patient was receiving his second dose of GARDASIL 9 on unknown date and had syncope and passed out; Bump on the head; This spontaneous report was received from a Nurse referring to a 10-year-old male patient.   The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported.   On an unknown date, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) administered by Health Professional as prophylaxis (dose, route of administration, lot #, and expiration date were not reported).  On an unknown date, the patient had syncope and passed out (syncope, loss of consciousness). He fell and hit his head and went to the emergency department (ER) (head injury). At the reporting time, the outcome of the events was unknown.   The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant  (GARDASIL 9) was unknown.   Upon internal review, the events of syncope and loss of consciousness were determined to be medically significant.   Lot # is being requested and will be submitted if received.
Age: 17.0
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: HCP reporting missed dose for GARDASIL-9. A 32-year-old patient had 2 doses of GARDASIL-9 when they were 17 years old and has not had their final dose. HCP did not provide any other information as they rushed to end the call. No additional AE/No PQC.; This spontaneous report was received from an other health professional and refers to a 32-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unknown dates (reported as when the patient was 17 years old), the patient was vaccinated with 2 doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not reported) as prophylaxis and had not had the final dose (Inappropriate schedule of product administration).  Additional information is not expected.
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Fatigue, Injection site reaction, Pyrexia
Clinical narrative: cellulitis; injection site reaction; This spontaneous report was received from a Physician and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 03-Jul-2025, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (lot #Z004301, expiration date: 07-Sep-2026), dose was not provided for prophylaxis.  On 07-Jul-2025, the patient experienced injection site reaction site with fever and fatigue. Patient was admitted to the hospital with cellulitis.   At the reporting time, the outcome of cellulitis and injection site reaction was unknown.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable.   The causal relationship between the event of cellulitis and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.  The causal relationship between the event of injection site reaction and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Therapeutic response unexpected
Clinical narrative: soreness of injected arm; Sinus infection; flu-like symptoms; Unexpected therapeutic benefit; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness of injected arm), sinus infection (Verbatim: Sinus infection), influenza-like symptoms (Verbatim: flu-like symptoms) and unexpected therapeutic effect (Verbatim: Unexpected therapeutic benefit). The outcome of the injection site pain, sinus infection and influenza-like symptoms were resolved and the outcome of the unexpected therapeutic effect was not applicable.   It was unknown if the reporter considered the injection site pain, sinus infection and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the injection site pain, sinus infection and influenza-like symptoms to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR089300   Additional Information: GSK Receipt Date: 03-JUL-2025 The reporter was the patient. He had an unexpected benefit. He did not want to disclose, at this time, what the specific condition was that he had in his background that the Shingrix had a positive effect on it. He said this condition is a condition that occurs world-wide. Shingrix shot 1 on 27 Jan 2025, he experienced a typical headache, soreness of injected arm, general weakness, flu-like symptoms, light cough, runny nose. These events were more intense than he expected. All of these events resolved/came to an end but then he developed a sinus infection. He had never had a sinus infection before. He was prescribed an antibiotic and it resolved.; Sender's Comments:  US-GSK-US2025AMR089300:2nd dose
Age: 99.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: patient was administered only the adjuvant; patient was administered only the adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 99-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-JUL-2025, the patient received Arexvy. On 08-JUL-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered only the adjuvant) and inappropriate dose of vaccine administered (Verbatim: patient was administered only the adjuvant). On 08-JUL-2025, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 08-JUL-2025 The Health Care Professional (Pharmacist) called to report that a patient was administered only the adjuvant of Arexvy vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; He states that he developed shingles about 2-3 months ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure and blood cholesterol increased. Concomitant products included lisinopril, atorvastatin and rivaroxaban (Xarelto).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 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: He states that he developed shingles about 2-3 months ago). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2025 The patient who received 2 doses of shingrix in 2019 and he developed shingles about 2 to 3 months ago. This case was considered as suspected vaccination failure as details regarding 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 details regarding laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant with the antigen; nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant with the antigen; 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 Herpes zoster (Shingrix) for prophylaxis.   On 09-JUL-2025, the patient received Shingrix. On 09-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant with the antigen) and inappropriate dose of vaccine administered (Verbatim: nurse gave a dose of just the adjuvant portion of the SHINGRIX vaccine/did reconstitute adjuvant with the antigen). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 09-JUL-2025 The pharmacist received a call from an unknown nursing supervisor who stated that a facility nurse gave a dose of just the adjuvant portion of the Shingrix vaccine today. The nurse realized that she did not reconstitute adjuvant with the antigen and then administered another dose of antigen and adjuvant which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication.
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I have shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 92-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had the chicken pox at age 3). Concurrent medical conditions included chickenpox (having chicken pox).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles). The patient was treated with aciclovir (Acyclovir) and lidocaine. The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-JUL-2025 Last year (in 2024) the patient had the 2 vaccinations for shingles.  Now at the age of 92 patient had shingles with the pain itches discomfort and fin for its treatment which consists of a very expensive ointment and an oral tablet. The ointment Acyclovir 5 percent, 500 milligrams, antihistamine levocetir 50 milligrams and lidocaine patch for the pain.  After 89 years and having chicken pox patient would have chanced not get the shingles.  But with all your propaganda on getting vaccinated patient got the pain, the itch, the suffered the high cost.  Patient felt the GlaxoSmithKline company should take some responsibility for this patient took advantage the big push to get the 2 injections only for your product to fail. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Ear pain, Herpes zoster, Pain, Pain in jaw, Stomatitis
Clinical narrative: suspected vaccination Failure; developed Shingles in the last few days on head and 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 JUL-2025, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles in the last few days on head and face). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine last year (2024) and just developed shingles in the last few days from reporting.  The shingles was not severe but on head and face.  The sores were around mouth making it hard to eat and drink, shooting pains in jaw to ear and beyond.  Started medication one day prior to the reporting date (07-July-2025).  The patient stated hoping it clears up quickly and did not get in ear or eye. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix.
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination Failure; developed Shingles in the last few days on head and 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 JUL-2025, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles in the last few days on head and face). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure and shingles to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine last year (2024) and just developed shingles in the last few days from reporting.  The shingles was not severe but on head and face.  The sores were around mouth making it hard to eat and drink, shooting pains in jaw to ear and beyond.  Started medication one day prior to the reporting date (07-July-2025).  The patient stated hoping it clears up quickly and did not get in ear or eye. This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; had the first dose of shots they came out with; they are back on / 2 cases back to back; years later I went back for the two part shots; 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 (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had the first dose of shots they came out with), shingles (Verbatim: they are back on / 2 cases back to back) and drug dose administration interval too long (Verbatim: years later I went back for the two part shots). The outcome of the vaccination failure, shingles and shingles were not reported and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUL-2025 This case was reported by a patient via interactive digital media. The reporter can always tell when mine are coming. They follow that same nerve pain & it is such awful pain. The patient had the first dose of shots they came out with. That didn't work so years later I went back for the two part shots which led to drug dose administration interval too long. They actually did work for 5 years but now they are back on 2 cases back to back. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still get shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still get shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2025 This case was reported by a patient via interactive digital media. The patient said trust her that the Shingles shots did not stop from getting shingles. The patient had both Shingles shots and still get shingles. The vaccines were not what they were cracked up to be and reporter was just stating their experience. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was linked with US2025AMR089380, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). US-GSK-US2025AMR089380:Same reporter, different patient
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2025 This case was reported by a consumer via interactive digital media. The reporter said trust her that the Shingles shots did not stop from getting shingles. Reporter's husband got the shot, and he has a bad case of the shingles. The vaccines were not what they were cracked up to be and reporter was just stating their experience. 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 shingles were unknown at the time of reporting. This case was linked with US2025AMR089374, reported by same reporter.; 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 Shingles vaccine. US-GSK-US2025AMR089374:Same reporter, different patient
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had the vaccine, but still got them twice; 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had the vaccine, but still got them twice). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine, but still got them twice.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 82.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received Twinrix 3rd dose earlier than recommended for the standard dosing schedule.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 82-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix) and Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 08-MAY-2025, the patient received the 3rd dose of Twinrix. On 08-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: patient received Twinrix 3rd dose earlier than recommended for the standard dosing schedule.). The outcome of the drug dose administration interval too short was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-JUL-2025 The pharmacist reported that an adult patient received Twinrix 3rd dose earlier than recommended for the standard dosing schedule. Twinrix first dose was on 07th March 2025, Twinrix second dose was on 12th April 2025 and Twinrix third dose was on 08th May 2025 which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Swelling
Clinical narrative: Shingles outbreak.; Swelling; Arm redness; This non-serious case was reported by a nurse via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-JUN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles outbreak.), swelling (Verbatim: Swelling) and erythema of extremities (Verbatim: Arm redness). The outcome of the shingles, swelling and erythema of extremities were unknown.   It was unknown if the reporter considered the shingles, swelling and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the shingles, swelling and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUL-2025 The nurse practitioner called to inform that a patient with some mild shingles symptoms and wanted to beat the shingles symptoms and got the 1st dose of Shingrix on 30th June 2025. The reporter mentioned that after getting Shingrix, patient had swelling and arm redness and shingles symptoms. No further details provided. This case US2025086143 was reported by same reporter.; Sender's Comments:  US-GSK-US2025086143:Same reporter different patient