I accidentally gave her Kinrix; a 15 month old baby coming for her shot today; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis. On 15-JAN-2025, the patient received Kinrix. On an unknown date, the patient received Infanrix. On 15-JAN-2025, immediately after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: I accidentally gave her Kinrix) and inappropriate age at vaccine administration (Verbatim: a 15 month old baby coming for her shot today). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-JAN-2025 The nurse called and reported that she had a 15 month old baby coming for her shot on the day of reporting and supposed to did Dtap (Infanrix), and the nurse accidentally gave the patient Kinrix which led to wrong vaccine administered. The vaccine administration facility was the same as primary reporter. During the call, the healthcare professional mentioned that the intended vaccine was Infanrix, instead of Kinrix.

first dose of Shingrix in 2018. He did not know that he needed a second dose at the time; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2018). On 09-JAN-2025, the patient received the 2nd dose of Shingrix. On 09-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in 2018. He did not know that he needed a second dose at the time). The outcome of the drug dose administration interval too long was unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 The reporter was the patient who received his first dose of Shingrix in 2018. The patient did not know that he needed a second dose at the time. The patient received his second dose on the day of reporting which led to lengthening of vaccination schedule.

A 11 years old male patient received an expired dose of Menveo (1 vial) on January 7, 2025.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number BL3ES, expiry date 31-DEC-2024) for prophylaxis. On 07-JAN-2025, the patient received Menveo. On 07-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: A 11 years old male patient received an expired dose of Menveo (1 vial) on January 7, 2025.). The outcome of the expired vaccine used was unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 A medical assistant called to inform that they administered an expired dose Menveo (1 vial) to a 11 years old male patient. The vaccine expired on 31st December 2024. It was administered on 07th January 2025 which led to expired vaccine used. The reporter asked was there any safety information regarding this.

Underage administration of a vaccine dose.; administer Gardasil for HPV but Shingrix was administered in error; 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 25-year-old female patient who received Herpes zoster (Shingrix) (batch number 4878Y, expiry date 13-NOV-2026) for prophylaxis. Co-suspect products included HPV vaccine VLP rL1 4v (yeast) (Gardasil) for prophylaxis. On 08-JAN-2025, the patient received Shingrix. On an unknown date, the patient received Gardasil. On 08-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration of a vaccine dose.) and wrong vaccine administered (Verbatim: administer Gardasil for HPV but Shingrix was administered in error). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional Information: GSK Receipt Date: 09-JAN-2025 The vaccine coordinator or medical assistant called to reporting the underage administration or maladministration of a Shingrix dose to a female patient. The vaccine coordinator or medical assistant asked about any safety concerns or any information they had to be aware. No further information was obtained during this call. The vaccine administration facility was the same as primary reporter. The reporter mentioned that the intention was to administer Gardasil for HPV but Shingrix was administered in error which led to wrong vaccine administered.

received only the adjuvant of Shingrix without reconstituting the vaccine; received only the adjuvant of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a specified number of patients 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 inappropriate preparation of medication (Verbatim: received only the adjuvant of Shingrix without reconstituting the vaccine) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional Information: GSK Receipt Date:17-DEC-2024 Pharmacist called to inform that two patients (gender unknown) received only the adjuvant of Shingrix (without reconstituting the vaccine),which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Also mentioned that a few days later when they realized the error, the patient was called back and was given the vaccine, the adjuvant with the actual vaccine product.

kicked my butt HARD; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of buttock pain 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 buttock pain (Verbatim: kicked my butt HARD). The outcome of the buttock pain was not reported. It was unknown if the reporter considered the buttock pain to be related to Shingles vaccine. It was unknown if the company considered the buttock pain to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-JAN-2024 The patient reported that he/she did not if it was the shingles vaccine, or the one for pneumonia (got them simultaneously) but one of them kicked on buttock hard.

Got the vaccine and shingles again/ suspected vaccination failure; Got the vaccine and shingles again; 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. The patient’s past medical history included shingles. 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: Got the vaccine and shingles again/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the vaccine and shingles again). 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: 08-JAN-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and the shingles again. 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 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.

suspected vaccination failure; had the two shots and still got 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, 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: had the two shots and still got 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-JAN-2025 This case was reported by a patient via interactive digital media. The patient stated that they had the two shots and still got shingles and also stated that doctor said it did not work. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (1st dose)and Shingles (2nd dose)

Broke out with shingles; 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 the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Broke out with shingles). 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: 04-JAN-2025 This case was reported by a patient via interactive digital media. Patient had the shingles shots and two days later after the patient broke out with shingles.

Shingles; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient’s past medical history included giant cell arteritis (other), shingles and ear carcinoma (cancer left ear). Concomitant products included Influenza vaccine (Fluzone), prednisone and hydrocodone. On 12-OCT-2020, the patient received Shingrix. On 15-OCT-2020, 3 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 23-DEC-2024 The patient started therapy with Shingrix and experienced shingles.