chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Varicella
Clinical narrative: doctor told her that she most likely has chicken pox/suspected chickenpox; bumps/spots, she indicated they look like mosquito bites and continued to grow and; This non-serious case was reported by a consumer via call center representative and described the occurrence of chickenpox in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included magnesium hydroxide (Magnesium), colecalciferol (Vitamin D), oenothera biennis, vitamin e nos (Evening Primrose Oil) and colecalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, vitamin b1 nos (Multivitamin).   On 12-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular use, left deltoid). In MAY-2025, between 1 and 2 months after receiving Shingrix, the patient experienced itchy rash (Verbatim: bumps/spots, she indicated they look like mosquito bites and continued to grow and). On an unknown date, the patient experienced chickenpox (Verbatim: doctor told her that she most likely has chicken pox/suspected chickenpox). The outcome of the chickenpox was not reported, and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the chickenpox and itchy rash to be related to Shingrix.     It was unknown if the company considered the chickenpox and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-JUN-2025 Patient had some questions about side effects/bumps and asked if she should get the 2nd vaccine. She provided further information, she got Shingrix shot 1 on May 12th.  Around May 20th she developed the bumps/spots, she indicated they look like mosquito bites and continued to grow and itch. They asked the patient/reporter where on her body the bumps are and she said they are everywhere from legs, in butt crack, on back, on breasts, from shins to head. As of Saturday May 31st, they stopped growing but every bump was still itching.  She indicated that her doctor did not know what was causing the bumps and prescribed an unspecified topical steroid cream which did not work.  Her son's doctor told her that she most likely has chicken pox. This case is linked with case US2025068863, reported by the same reporter.; Sender's Comments:  US-GSK-US2025068863:SAME REPORTER
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was administered with the Hib part that was diluted with sterile water with no reported adverse event; Initial information received on 05-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 month old male patient was administered with Diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] whose HIB part that was diluted with sterile water 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 Pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation; and Hepatitis B vaccine (ENGERIX-B [Hepatitis B vaccine]) for Immunisation.  On 04-Jun-2025, the patient received a dose 0.5ml of suspect Diphtheria/Tetanus/5 hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UK194AA and expiry date-31-Mar-2026) (strength-unknown) via intramuscular route in lateral side of the thigh for Immunization the whose HIB part that was diluted with sterile water with no reported adverse event (single component of a two-component product administered) (latency- 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.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Opened ipol exposed to 8.07 °C to 9.76 °C upto 14 minutes also it has been exposed to several temperature excursions. After excursions this was administered to three patients with no reported adverse event; Initial information received on 06-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 3 patient and is reported opened IPV (VERO) [IPOL] exposed to 8.07 °c to 9.76 °c upto 14 minutes also it has been exposed to several temperature excursions after excursions this was administered to three patients 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, IPOL exposed to 8.07 °c to 9.76 °c upto 14 minutes also it has been exposed to several temperature excursions, after excursions this was administered to three patients Suspension for injection of lot W1C831M and expiry date: 21-Nov-2025 (strength and dose: not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (poor quality product administered) (latency: on same day).  Reportedly, Previous Excursion Dec-2024 - 3.2 C to 8.67 C for 15 minutes, with IPOL (opened) Aug-2024 - 4.97 C to 8.27 C for 15 minutes, with IPOL (opened) May-2024 - 4.97 C to 8.27 C for 15 minutes, without IPOL (opened) Jan-2024 - 4.16 C to 9.02 C for 15 minutes, without IPOL (opened)Human error: No.  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
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to administration of ACTHIB prepared with sterile water with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered with inappropriate use due to administration of HIB (PRP/T) vaccine [ACT-HIB] prepared with sterile water 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 Diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation.  On 04-Jun-2025, the patient received a 0.5ml dose 2 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength, frequency-once (lot UK111AA and expiry date-31-Aug-2025) via intramuscular route in the left thigh for Immunization which was prepared with sterile water with no reported adverse event (product preparation error) (latency-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: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Day2 Low grade fever, chills, headache, injection site sore; Day 4+ injection site red, hard, hot, itchy
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Day2 Low grade fever, chills, headache, injection site sore; Day 4+ injection site red, hard, hot, itchy
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: possible administration of an expired product with no reported Adverse events; Initial information received on 05-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves possible administration of expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] to a unknown age and unknown gender patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2017, the patient received an dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (once), Suspension for injection, (unknown strength and expiry date) lot U5213BA via unknown route in unknown administration site for immunization which might have been expired with no reported adverse event (expired product administered) (latency 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: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Immunisation reaction, Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: 06-03-2025 per mother - golf ball size lump @ injection site (L) upper thigh = painful, itchy, red, swollen, warm to touch Dx cellulitis L03.119 Vaccine reaction T50.Z95A
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 06-03-2025 per mother - golf ball size lump @ injection site (L) upper thigh = painful, itchy, red, swollen, warm to touch Dx cellulitis L03.119 Vaccine reaction T50.Z95A
Sex: F
Vaccine: PNC21
Symptoms: Influenza like illness
Clinical narrative: FBE reported AE on behalf of HCP who reported on behalf of themselves that they experienced flu-like symptoms within 48 hours of being administered CAPVAXIVE. Additional patient demographics unknown. No additional AE details reported. FBE was made aw; This spontaneous report was received from an Other health professional 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 an unknown date, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), (dose, lot # and expiration date were not reported).  On an unknown date, the patient experienced flu-like symptoms within 48 hours of being administered CAPVAXIVE.   At the reporting time, the outcome of the event was unknown.   The action taken with Pneumococcal 21-valent Conjugate Vaccine was reported as not applicable.   The causal relationship between the event of and Pneumococcal 21-valent Conjugate Vaccine was unknown/not reported/not provided.
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Suspected counterfeit product
Clinical narrative: Email received on 29MAY2025 at 12:22 PM ET from Merck Employee titled: "Gardasil [Human Papillomavirus Quadrivalent Vaccine, Types 6, 11, 16, and 18, Recombinant] - HCP Request" containing a forwarded email from; No symptoms reported; This spontaneous report was received from a nurse practitioner and refers to a(n) 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 an unknown date, the patient started therapy with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), lot #X014950, expiration date: 19-Dec-2025 (exact dose, route of administration and anatomical location were not provided) for an unknown indication.  On an unknown date, the patient contacting to verify the authenticity of a Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) vaccine dose she received in another country. The vaccine was administered in a local clinic, but she did not see the outer packaging. She would like to confirm whether this batch (X014950) was officially distributed to country and whether it is part of a recognized public health or supported program. She would appreciate our confirmation and any additional information you could provide (suspected counterfeit product). No symptoms reported (no adverse event).
Sex: F
Vaccine: PNC21
Symptoms: Hypersensitivity, Immediate post-injection reaction, Oral herpes, Vaccination site swelling
Clinical narrative: Fever blister; a suspected allergic reaction; vaccination site redness; vaccination site swelling; fever; This spontaneous report was received from a nurse referring to a 64-year-old female patient.   The patient's concurrent conditions included type 2 diabetes mellitus (T2DM), and Asthma. Concomitant medications included Valtrex (Valaciclovir hydrochloride), Aspirin (Acetylsalicylic acid; Ascorbic acid), Advair (Fluticasone propionate; Salmeterol xinafoate), and Albuterol (Salbutamol sulfate). Drug Reactions/Allergies included Opioids (Opioids), Dilantin (Phenytoin), and Meperidine (Pethidine).  On 30-May-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL administered by Intramuscular route in Left Deltoid for prevention of pneumococcal infection (lot # and expiration date were not reported)  On 30-May-2025, the patient experienced vaccination site redness and vaccination site swelling. Vaccine was given in the left deltoid and redness and swelling was noted immediately after administration but wasn't warm or painful. The patient reported a subjective fever but never took her temperature (pyrexia).  On 03-Jun-2025, the patient experienced a suspected allergic reaction (Hypersensitivity). On that day, the patient presented to the clinic with a suspected allergic reaction. The patient's temperature was taken at the appointment, and it was reported that the patient to be afebrile. It was also reported that the patient had fever blisters around her mouth and was given Valtrex as treatment (Oral herpes). At the reporting time, the patient was recovering the reported events.  The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown.  Lot # is being requested and will be submitted if received.
Vaccine: DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB, DTPPVHBHPB, HPV9, HPV9, HPV9, HPV9, MMR, MMR, MMR, MMR, RV5, RV5, RV5, RV5
Symptoms: Product storage error
Clinical narrative: HCP called to report TE were multiple excursions occurred starting in November 2024 (exact date unknown). Unknown how many patients received products after improperly stored. No Additional information provided. No Additional AE/ No PQC.    VAXELIS: U; No adverse event; This spontaneous report was received from an other health care professional and refers to an unspecified number of patients of unknown age and gender.    The patients' medical history was not reported. The patients' concurrent conditions were not reported. Concomitant therapies were not reported.  It was reported that the following vaccines experienced multiple temperature excursions: Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) lot# Y010656, expiration date: 29-Nov-2026) 0.5 mL; Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y007615, expiration date: 11-Apr-2026) 0.5 mL; sterile diluent (MERCK STERILE DILUENT), (lot #1973278, expiration date: 06-May-2026) 0.5 mL; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS), (lot #U7970BA, expiration date: 30-Nov-2026) 0.5 mL; Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #2088619, expiration date: 09-Mar-2026) 2 mL. The temperature excursions occurred as follows: on 16-DEC-2024, the lowest temperature of 34 F for 23 Hours and the highest of 41 F for 23 Hours; on 20-DEC-2024, the lowest temperature of 35 F for 16 Hours and the highest of 36 F for 16 Hours; on 23-DEC-2024, the lowest temperature of 34 F for 4 Hours and the highest of 37 F also for 4 Hours; on 30-DEC-2024, the lowest temperature of 37 F for 1 Hour and the highest of 64 F for 1 Hour. The vaccines were administered on 16, 20, 23, and 30-DEC-2024. It was unknown how many patients received products after being improperly stored (Product storage error).  No additional information was provided. There was no additional AE (No adverse event).  This is an invalid report due to multiple patients involved and lack of patients' identifiers.  Follow-up information was received on 09-JUN-2025. The patient was currently 59 years old (product administered to patient of inappropriate age). Details regarding the vaccinations were not provided. It was reported that there were no adverse reactions to any of the administered vaccines.  The case was no longer considered to be invalid.; Reporter's Comments: Keywords : ; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-06-09 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : US-009507513-2292822 , Central date : 2025-06-09 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : US-009507513-2292822
Age: 1.33
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; 16 month old was administered PROQUAD inadvertently with VARIVAX; This spontaneous report was received from a nurse and refers to a 16-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 06-Jun-2025, the patient was inadvertently vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) solution for injection, 0.5 mL and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, 0.5 mL (dose number, route of administration, anatomical location, lot # and expiration date were not reported for both), for prophylaxis (Accidental overdose). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection, 0.5 ml (lot# and expiry date were not reported). The reporter stated that was the only information she received in the email and did not have any additional information to provide. No additional adverse event was reported.  Additional information is not expected.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who was inadvertently administered an expired dose of adult VAQTA on 06/10/2025 (w/ no TEs)-- SUPPORTED via post-expiry memo. No symptoms reported. No additional AE details reported. Obtained consent to conta; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 10-JUN-2025, the patient was inadvertently vaccinated with expired Hepatitis A Vaccine, Inactivated Suspension for injection (VAQTA) (adult), 1 ml (1ml/dose), lot #X026485, expiration date: 11-MAY-2025, administered for prophylaxis (strength, anatomical location and route of administration were not provided) (Expired product administered). No additional adverse events. The outcome of the events was not known. The action taken with the suspect vaccine was not reported, but established as not applicable.
Vaccine: HPV9
Symptoms: Syringe issue, Underdose
Clinical narrative: second dose of GADASIL 9 received was "insufficient" due to "a lot of leakage during vaccination".; second dose of GADASIL 9 received was "insufficient" due to "a lot of leakage during vaccination".; second dose of GADASIL 9 received was "insufficient" due to "a lot of leakage during vaccination".; This spontaneous report was received from a Nurse and refers to a patient of not reported 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 03-JUN-2025, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Z002903, expiration date reported as 03-DEC-2026 but upon internal validation was stated as 15-DEC-2026) (strength, dose description, route of administration not reported) for prophylaxis. It was reported that during vaccination the patient dose received was "insufficient" due to "a lot of leakage during vaccination. Nurse stated that the second dose was administered by a separate HCP and it was not reported that any leakage occurred at the time of vaccination and was unable to confirm if leakage occurred or if patient received less than recommended dose (vaccine underdose, device leakage, poor quality device used).
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 03-JUN-2025 This report was submitted via the online direct entry reporting system. The reporter was a pharmacist. The pharmacist reported a that according to the a patient received a dose of the Zoster Vaccine in 2018. The patient did not recall ever having the vaccine and did not think she ever had Shingrix and had not yet had the second dose. The pharmacist stated that the vaccine administered according to the online records reads Zoster. The pharmacist believed the patient received Shingrix in 2018, but the online record indicated Zoster vaccine. Shingrix or Zostavax could not be confirmed by the reporter at the time of the call.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: 2 quarter sized, red, welts on the left side of lower neck where it meets shoulder/ felt the second one; This non-serious case was reported by a consumer via call center representative and described the occurrence of welts in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-JUN-2025, the patient received the 2nd dose of Shingrix (left arm). On 03-JUN-2025, 1 days after receiving Shingrix, the patient experienced welts (Verbatim: 2 quarter sized, red, welts on the left side of lower neck where it meets shoulder/ felt the second one). The outcome of the welts was not resolved.   It was unknown if the reporter considered the welts to be related to Shingrix.     It was unknown if the company considered the welts to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-JUN-2025 A female patient reported she received second dose of Shingrix vaccine in the left arm and 24 hours later she noticed the first welt and this morning (48 hours after vaccine) felt the second one.  The reporter is experiencing 2 quarter sized, red, welts on the left side of lower neck where it meets shoulder.  She consulted with her pharmacist as her HCP is on vacation.  The medical advice disclaimer was provided and spoke per PI, offered PI and Shingrix website and the reporter was referred to Health Care Professional.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Skin discolouration
Clinical narrative: reddish-gray areas of skin discoloration remain; rash started on her torso; she developed a dry, itchy rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Shingles), stroke (Has had two strokes. The first one was about two years ago and the second in Mar 2025.), heart attack (Heart attack about two years ago) and rash (frequent rashes). Concurrent medical conditions included drug allergy (Allergic to neomycin and other unspecified antibiotics).   On 15-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 22-APR-2025, 7 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: she developed a dry, itchy rash). On an unknown date, the patient experienced skin discolouration (Verbatim: reddish-gray areas of skin discoloration remain) and rash (Verbatim: rash started on her torso). The patient was treated with prednisone acetate (Prednisone) and clobetasol propionate (Clobetasol). The outcome of the itchy rash and rash were resolving and the outcome of the skin discolouration was not resolved.   It was unknown if the reporter considered the itchy rash, skin discolouration and rash to be related to Shingrix.     It was unknown if the company considered the itchy rash, skin discolouration and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-JUN-2025 The case was self reported by patient, she was also a retired health care professional(nurse).  On 15 Apr 2025 she received her first Shingrix dose and on 22 Apr 2025 she developed a dry, itchy rash.  The rash started on her torso.  Over the next two weeks, the rash spread to both arms (not near the injection site), and her back.  She saw an health care professional for the rash and was given oral prednisone for ten days.  About two weeks after seeing an health care professional, she saw her dermatologist and was treated with clobetasol cream 0.025 percent twice daily.  A biopsy of the rash showed hypersensitivity to an arthropod or a medication.   The rash was resolving, but reddish gray areas of skin discoloration remain where the rash has healed.  She was on numerous medications but declined to provide the list during this call.  Nothing else was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: she began breaking out with cold sores on her mouth/lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included arthritis and hypertension.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 months after receiving Shingrix, the patient experienced cold sores (Verbatim: she began breaking out with cold sores on her mouth/lips). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the cold sores was not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.     It was unknown if the company considered the cold sores to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-JUN-2025 The reporter reported that a patient received both doses of Shingrix vaccine and approximately 3 months later she began breaking out with cold sores on her mouth/lips.   The consumer states she has had approximately 2 or 3 outbreaks per year for the last few years.   Consumer states she is being treated for the outbreaks and was prescribed Valtrex to be taken at onset of cold sore.  No further information was obtained/provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure abnormal
Clinical narrative: Patient stated having blood pressure.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of blood pressure abnormal in a female 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 blood pressure abnormal (Verbatim: Patient stated having blood pressure.). The outcome of the blood pressure abnormal was not reported.   It was unknown if the reporter considered the blood pressure abnormal to be related to Shingrix.     It was unknown if the company considered the blood pressure abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2025 The healthcare professional (HCP) stated that he/she knew that patient (over 50 years) had blood pressure, but the reporter was unaware what she was circling for (referring to Pharmacy Patients questionnaire). The patient did not have the data about high or low blood pressure. The reporter reported that the patient marked Yes on Pharmacy's questionnaire field long term diseases without specifications. Patient stated having blood pressure.
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My daughter six months ago vaccinated with bexsero (first dose)/She is 5 years old.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 5-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: My daughter six months ago vaccinated with bexsero (first dose)/She is 5 years old.). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 04-JUN-2025 This case was reported by interactive digital media The reporter reported that daughter six months ago vaccinated with his/her Bexsero (first dose) and now they were going for the second dose. The reporter reported did she need a third dose. 5 year old patient received Bexsero which led to, Inappropriate age at vaccine administration.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: diagnosed with shingles/shockingly painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: diagnosed with shingles/shockingly painful). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-JUN-2025 Reporter stated that in extremely rare cases, if a person has lowered immunity and gets the vaccine, they can get shingles.   Patient got the vaccine a week and a half ago and was diagnosed with shingles three days later and it was shockingly painful.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have them and its been weeks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 86-year-old 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: have them and its been weeks). 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: 05-JUN-2025 This case was reported by a patient via interactive digital media. A patient reported that he/she has them (shingles) and its been weeks. The patient thought he/she had got shots but going to check to make sure. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about  primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles ) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose /first shot of Twinrix in November 2024 and today the second dose was given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis.   Previously administered products included Twinrix (received first dose in November 2024.).   On 02-JUN-2025, the patient received the 2nd dose of Twinrix. On 02-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose /first shot of Twinrix in November 2024 and today the second dose was given ). The outcome of the drug dose administration interval too long was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2025 The pharmacist called regarding a patient who had received the first shot of Twinrix in November 2024 and today the second dose was given which led to drug dose administration interval too long. The pharmacist asked information about the recommended interval between the delayed second dose and the third dose.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Use of a Non-approved diluent; Use of a Non-approved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis.   On 28-MAY-2025, the patient received Menveo. On 28-MAY-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Use of a Non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: Use of a Non-approved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 03-JUN-2025 A Medical assistant called and reported that the Menveo vaccine was administered, and he/she used a different sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked if the patient needs to retake the vaccine. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: FLU3, VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient.; Repeated dose of Shingrix was administered in less time than recommended.; Incorrect storage of drug; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On 08-OCT-2021, the patient received the 3rd dose of Shingrix. On 21-SEP-2021, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received FluLaval 2024-2025 season. On an unknown date, not applicable after receiving Shingrix and FluLaval 2024-2025 season and an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient.), extra dose administered (Verbatim: Repeated dose of Shingrix was administered in less time than recommended.) and incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug, extra dose administered and incorrect storage of drug were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-JUN-2025 and 05-JUN-2025 Registered Nurse called to report that she just have a general question. When a vaccine goes out of range. When a vaccine was stored and it was out of range in the refrigerator and if patient had to revaccinate the patient, how soon can we re-vaccinate them? What should be the time interval if it should be immediately or if patient have wait a certain period of time? The reporter asked these questions specifically for the Flu vaccine and the Shingrix. The reporter consented to follow up. The HCP did not specify the conditions of the temperature excursion since she said it happened a couple of years ago. The repeated dose of Shingrix vaccine was administered in less than 28 days.  She did not know which number of dose was administered. Less than 20 patients were affected but she stated that they made the report. Patient stated that the flu vaccine was Flulaval however she stated that she did not have the information in front of her. The reporter mentioned that a patient received the second dose of Shingrix, however this dose was involved in a temperature excursion, which led to incorrect storage of drug. Therefore, they revaccinate the patient, which led to extra dose administered. The reporter wanted to confirm if the dose given on 08-OCT-2021 was considered valid since the the CDC recommended a 28-day interval from the invalid dose to reduce the risk for interference from interferon on the subsequent doses.
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient got a possible dose of Menveo on 2020; 69 years old female patient vaccinated with two doses of Bexsero; 69 years old female patient vaccinated with two doses of Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 69-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   The patient's past medical history included splenectomy.   On 09-NOV-2020, the patient received the 2nd dose of Bexsero. On 20-JUL-2020, the patient received the 1st dose of Bexsero. On an unknown date, the patient received Menveo. On 20-JUL-2020, an unknown time after receiving Bexsero, Bexsero and Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: 69 years old female patient vaccinated with two doses of Bexsero). On 09-NOV-2020, the patient experienced inappropriate age at vaccine administration (Verbatim: 69 years old female patient vaccinated with two doses of Bexsero). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: patient got a possible dose of Menveo on 2020). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-JUN-2025 Reporter called to ask about a 69 years old female patient who had a splenectomy surgery and the patient was vaccinated on 2020 with two doses of Bexsero and now the patient was coming to receive a dose of Menveo, because she got recommended to get a Men B vaccine every 5 years, which led to inappropriate age at vaccine administration. HCP mentioned that the patient got a possible dose of Menveo on 2020 but they were not really sure because the patient got it in another office and they do not have the record.
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, 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: 05-JUN-2025 The pharmacist reported that a patient was mistakenly administered an expired Twinrix vaccine, which led to expired vaccine used. So wanted to know the lot number of that and see if there is any recommendations.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix second dose never administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15-APR-2019 with batch number 4X733 and expiry date 08 March 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix second dose never administered). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 05-JUN-2025  The Vaccine Administration Facility was the same as Primary Reporter On 5 June 2025, a pharmacist called on behalf of a patient for asking how to proceed on a Shingrix second dose never administered. The patient asked his doctor about getting the complete doses again and wanted it to be confirmed by the manufacturer.   Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Possible administration only of the adjuvant portion; Possible administration only of the adjuvant portion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Possible administration only of the adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: Possible administration only of the adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 05-JUN-2025 It was asked if its possible to use the Arexvy vaccine with another diluent, different that the one in the vaccine box. They reported that they cannot find the adjuvant portion for the Arexvy vaccine. They are not sure if they missed the diluent, if they drop the vial, if a patient received only the diluent, etc During the call, they mentioned that they did not administer the powder portion plus another diluent to any patient, however, we will report this as a possible AE in case that a patient received only the adjuvant portion. As they did not know what happened with the Arexvy diluent, HCP did not provide any patient nor vaccine details. They mentioned that they did not administer the powder portion plus another diluent to any patient, however, we will report this as a possible AE in case that a patient received only the adjuvant portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperlipidaemia, Inflammation, Weight, Weight increased
Clinical narrative: Hyperlipidemia, continues to increase and not lower; Body inflammation; Weight gain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERLIPIDAEMIA (Hyperlipidemia, continues to increase and not lower), INFLAMMATION (Body inflammation) and WEIGHT INCREASED (Weight gain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-May-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 25-Jun-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced HYPERLIPIDAEMIA (Hyperlipidemia, continues to increase and not lower), INFLAMMATION (Body inflammation) and WEIGHT INCREASED (Weight gain). The patient was treated with Fluvastatin sodium (oral use) at a dose of 20 milligram once a day. At the time of the report, HYPERLIPIDAEMIA (Hyperlipidemia, continues to increase and not lower), INFLAMMATION (Body inflammation) and WEIGHT INCREASED (Weight gain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2022, Weight: Weight gain.         Concomitant medication use information was not provided by reporter.