patient received only the liquid adjuvant portion of Shingrix; patient received only the liquid adjuvant portion of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number GA99K) for prophylaxis. On 15-JAN-2025, the patient received Shingrix. On 15-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date: 21-JAN-2025 The nurse reported that a patient received only the liquid adjuvant portion of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered At the time of reporting a repeat dose had not yet been administered.

incomplete course of vaccination; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in 2022). 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: incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 28-DEC-2024 Reporter stated that patient received Shingrix vaccine one dose only in 2022 and asked if patient require 1 or 2 doses now. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.

solution squirted on face; Vial leak; Pharmaceutical product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received Herpes zoster (Shingrix) (batch number K72R2, expiry date 24-JAN-2026) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure via skin contact with product (Verbatim: solution squirted on face), product leakage (Verbatim: Vial leak) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the occupational exposure via skin contact with product, product leakage and pharmaceutical product complaint were unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The nurse stated she attempted to insert needle into adjuvant component of Shingrix and the needle bounced off the rubber stopper and the solution squirted onto the health care professional face, which led occupational exposure via skin contact with product.. The reporter something was wrong with the stopper on that vial as she used another adjuvant and was able to successfully withdraw the medication. The patient did receive the dose of Shingrix using another adjuvant vial. The nurse refused to send a picture stating she does not have time to do so. The information received from QA department on 22-JAN-2025 GlaxoSmithKline had completed its investigation for the quality defect that was reported. The investigation included a review of the defect trends and testing of the retained samples and a review of the related production records, all of which demonstrated that the reported batch was produced in compliance with the applicable procedures and met all required specifications. Nothing atypical was identified while the product was under GlaxoSmithKline control which would explain the reported quality defect. The GlaxoSmithKline considered the complaint that was the object of this report as unsubstantiated.

couldnt move my arm; also felt sick for; wiped me out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: couldnt move my arm), feeling unwell (Verbatim: also felt sick for) and fatigue (Verbatim: wiped me out). The outcome of the mobility decreased was resolved and the outcome of the feeling unwell and fatigue were not reported. It was unknown if the reporter considered the mobility decreased, feeling unwell and fatigue to be related to Shingles vaccine. It was unknown if the company considered the mobility decreased, feeling unwell and fatigue to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JAN-2025 This case was reported by a patient via interactive digital media. The- patient received shingles vaccine and it was wiped out, could not move my arm for days also felt sick for that same period of time. The patient said it was a piece of cake compared to getting shingles, get vaccinated.; Sender’s Comments: US-GSK-US2025AMR009137:same reporter

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 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, more than a year after receiving Shingles vaccine and 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 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: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient just finished shots about a year ago and like a month ago came down with shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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 completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).

put me out for a full day; This non-serious case was reported by a consumer and described the occurrence of feeling abnormal in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: put me out for a full day). The outcome of the feeling abnormal was resolved (duration 1 day). It was unknown if the reporter considered the feeling abnormal to be related to Shingrix. It was unknown if the company considered the feeling abnormal to be related to Shingrix. Additional Information: GSK Receipt Date: 26-DEC-2024 The patient self-reported this case for himself. The patient said that he just got his first Shingles vaccine and that put him out for a full day. He did not want to get the full real shingles. He got to get the second vaccine too, and further said everyone else should too.

intermittent muscle pains /leg muscle pain; weakness in legs; difficult to climb stairs/rise from sitting position; No longer have muscle pains in arms and body; This non-serious case was reported by a consumer and described the occurrence of myalgia of lower extremities in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Concurrent medical conditions included hypertension (Treated with Ramipril and Carvedilol), transient ischemic attack (Patient had Transient ischaemic attack in 1999), blood cholesterol increased (Treated with Crestor) and cardiovascular risk (Treated with Jardiance). Concomitant products included carvedilol, ramipril, clopidogrel bisulfate (Plavix), rosuvastatin calcium (Crestor) and empagliflozin (Jardiance). On 23-OCT-2024, the patient received Arexvy. On 28-OCT-2024, 5 days after receiving Arexvy, the patient experienced myalgia of lower extremities (Verbatim: intermittent muscle pains /leg muscle pain), lower extremities weakness of (Verbatim: weakness in legs), activities of daily living impaired (Verbatim: difficult to climb stairs/rise from sitting position) and generalized muscle aches (Verbatim: No longer have muscle pains in arms and body). The outcome of the myalgia of lower extremities, lower extremities weakness of and activities of daily living impaired were not resolved and the outcome of the generalized muscle aches was resolved. It was unknown if the reporter considered the myalgia of lower extremities, lower extremities weakness of, activities of daily living impaired and generalized muscle aches to be related to Arexvy. It was unknown if the company considered the myalgia of lower extremities, lower extremities weakness of, activities of daily living impaired and generalized muscle aches to be related to Arexvy. Additional Information: GSK Receipt Date: 27-DEC-2024 A 87 year female patient received Arexvy vaccine and experienced intermittent muscle pain and weakness in leg. The patient no longer had muscle pains in arms and body but leg pains still persist which was severe at time, worse at night. Leg weakness still persists making it difficult to climb stairs and rise from sitting position. The patient reported that the symptoms was not treated. The patient current condition includes hypertension, Transient ischaemic attack, High cholesterol and Cardiovascular risk

No additional adverse event; HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te; This spontaneous report was received from Other Health Professional and refers to a. The patient’s medical history was not reported. The patient’s concurrent conditions included medication dilution. Concomitant medications included sterile diluent (MERCK STERILE DILUENT) (manufacturer unknown). On 06-DEC-2024, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #Y006522, expiration date: 25-MAR-2026, administered for prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient experienced No additional adverse event. On 06-DEC-2024, the patient experienced HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te. At the time of reporting, the outcome of the event HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te was not known, the outcome of the event No additional adverse event was not known. The action taken with VARIVAX regarding HCP called to report a Temperature Excursion on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that VARIVAX was inadvertently administered after suffering from a Te was reported as Not Applicable. The action taken with VARIVAX regarding No additional adverse event was reported as Not Applicable.

No adverse effects reported; HCP calling to report that patient inadvertently received expired dose of GARDASIL 9 on 1/20/2025 that expired on 1/8/2025. Per post expiry sheet, product is supported. No adverse effects reported. No additional AE. No PQC.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 20-JAN-2025 the patient was inadvertently vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # W029724, expiration date 08-JAN-2025, Single Dose; strength, route were not reported) for prophylaxis (expired product administered). No adverse event was reported.

No adverse event; HCP called to report inadvertent administration of an expired dose of VAQTA to an adult patient.; Dose .5ML; This spontaneous report was received from a nurse regarding a 36-year-old male patient. The patient’s medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported. On 20-JAN-2025, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, 0.5 milliliter, administered for prophylaxis (lot number X020849 has been verified to be a valid number for hepatitis a vaccine, inactivated [VAQTA], expiration date 26-DEC-2024) (anatomical site of injection and route of administration were not provided) (Expired product administered, Incorrect dose administered). No additional adverse event was reported for the patient.