Early dose/received it twice, 26 days apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old patient who received Men B NVS (Bexsero) (batch number 4L274, expiry date 30-SEP-2024) for prophylaxis. Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero). On 08-FEB-2024, the patient received the 2nd dose of Bexsero. On 08-FEB-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Early dose/received it twice, 26 days apart). The outcome of the drug dose administration interval too short was 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: 13-JAN-2025 The other health professional had a question about somebody who received the Bexsero vaccine. The other health professional reported that it was a meningitis b Bexsero vaccine, and then there was a question about, he/she know that it was recently updated, the guidance was recently updated for the first and second dose being 6 months but last in January and February of 2024 a patient received it twice, 26 days apart. The other health professional just wanted to know does the patient need to be revaccinated or what was recommended. The patient received second dose of Bexsero shorter than the recommended interval which led to shortening of vaccination schedule.

administration of Infanrix instead of Boostrix to an adult patient; the administration of Infanrix instead of Boostrix to an adult patient; the administration of Infanrix instead of Boostrix to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 45-year-old male patient who received DTPa (Infanrix) (batch number Y7JC3, expiry date 07-SEP-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 13-JAN-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 13-JAN-2025, immediately after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: administration of Infanrix instead of Boostrix to an adult patient), adult use of a child product (Verbatim: the administration of Infanrix instead of Boostrix to an adult patient) and underdose (Verbatim: the administration of Infanrix instead of Boostrix to an adult patient). The outcome of the wrong vaccine administered, adult use of a child product and underdose 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: 13-JAN-2025 The medical assistance reported that the administration of Infanrix instead of Boostrix to an adult patient which led to wrong vaccine administered, adult use of a child product and underdose.

fainted; feeling dizzy; Shortness of breath; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in OCT-2024). On 03-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 05-JAN-2025, 2 days after receiving Shingrix, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant and other: serious as per reporter), dizziness (Verbatim: feeling dizzy) (serious criteria other: serious as per reporter) and shortness of breath (Verbatim: Shortness of breath) (serious criteria other: serious as per reporter). On 07-JAN-2025, the outcome of the fainting and dizziness were resolved (duration 2 days). The outcome of the shortness of breath was not resolved. It was unknown if the reporter considered the fainting, dizziness and shortness of breath to be related to Shingrix. The company considered the fainting, dizziness and shortness of breath to be related to Shingrix. Additional Information: GSK Receipt Date: 07-JAN-2025 The patient spouse reported that a patient receiving his 2nd Shingrix vaccine, had no symptoms after the 1st vaccine, however, he did have symptoms after the 2nd vaccine. 48 hours receiving the 2nd vaccine the patient started feeling dizzy, short of breath and fainted. The ambulance was called, and the patient stayed for 12 hours at the hospital, then he was discharged home. The patient continues to have some shortness of breath, but the dizziness and the fainting has subsided. ER (emergency room) visit required.; Sender’s Comments: Syncope, Dizziness and Dyspnoea are unlisted events which, due to the following criteria (strong temporal association) are considered related to GSK vaccine Shingrix.

Upset stomach; Nauseousness; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient’s past medical history included shingles (The most recent was 4 months ago, and still has a little bit of pain from the Shingles.). In JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced upset stomach (Verbatim: Upset stomach) and nausea (Verbatim: Nauseousness). The outcome of the upset stomach and nausea were not resolved. It was unknown if the reporter considered the upset stomach and nausea to be related to Shingrix. It was unknown if the company considered the upset stomach and nausea to be related to Shingrix. Additional Information: GSK Receipt Date: 07-JAN-2025 The reporter was the patient. About 3 days ago, the patient received the first dose of Shingrix. Ever since, the patient had been experiencing nauseousness and an upset stomach. The patient had developed Shingles 3 times in the past. The most recent was 4 months ago, and still had a little bit of pain from the Shingles

Expired Dose Administered/6 days over the exp date; Extra dose administered; 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 24-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis. Previously administered products included Menveo (received first dose of Menveo on an unknown date). On 06-JAN-2025, the patient received the 2nd dose of Menveo. On 06-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered/6 days over the exp date) and extra dose administered (Verbatim: Extra dose administered). The outcome of the expired vaccine used and extra dose administered were unknown. Additional Information: GSK Receipt Date: 06-JAN-2025 The other health professional reported that an expired dose of Menveo was administered to a patient on the morning of the reporting day. The lyophilized component was 6 days over the expiration date which led to expired vaccine used, the liquid conjugate was still within the expiration date. The other health professional stated there were no adverse reactions after the administration. The patient received 2nd dose of Menveo which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter.

she accidently removed flip cap from shingrix antigen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process 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 wrong technique in drug usage process (Verbatim: she accidently removed flip cap from shingrix antigen). The outcome of the wrong technique in drug usage process was unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 The healthcare professional was the reporter. The reporter stated that she accidently removed flip cap from Shingrix antigen and was unsure when the antigen vial will be used. No further information was known. The adverse event filed after call disconnected. Minimal information obtained to file adverse event.

never got the second dose; 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 the Shingrix vaccine back on 10th March 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: never got the second dose). The outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 27-DEC-2024 Pharmacy Manager reported that the patient never got the second dose of it. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination..

They hurt like hell.; 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 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: They hurt like hell.). The patient was treated with diethylamine salicylate, methyl nicotinate (Aspercreme). The outcome of the shingles was not resolved. 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: 11-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient had 1st dose was going to get the 2nd and it hit god people get the vaccine, it hurt like hell. Patient have it right at time of reporting. Almost finish, patient physician recommended asper cream 5 percent, it numbs the pain for a while.

induration erythema; swelling; warmth; This serious case was reported by a other health professional via sales rep and described the occurrence of induration erythema in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On 07-JAN-2025, an unknown time after receiving Shingrix, the patient experienced induration erythema (Verbatim: induration erythema) (serious criteria GSK medically significant), swelling (Verbatim: swelling) and feeling of warmth (Verbatim: warmth). The outcome of the induration erythema, swelling and feeling of warmth were resolved. The reporter considered the induration erythema, swelling and feeling of warmth to be related to Shingrix. The company considered the induration erythema to be unrelated to Shingrix. The company considered the swelling and feeling of warmth to be related to Shingrix. Additional Information: GSK Receipt Date: 09-JAN-2025 The reporter reported that the patient received a first dose of Shingrix and had induration erythema, swelling, and warmth.; Sender’s Comments: Erythema induratum is an unlisted event which is considered unrelated to GSK vaccine Shingrix.

Autoimmune disorder; Case reference number US-BN-2025-000136 is a spontaneous case initially received from consumer via Communication (reference number: USBAV25-0136) on 17-Jan-2025 and concerns a male patient of unspecified age. The patient’s medical history and concomitant medication details were not provided. On an unspecified date in Sep-2022, the patient received the first dose of Jynneos vaccine (batch number: unknown), at unknown dose, route or site of administration for unknown indication. On an unspecified date in Oct-2022, for unknown of time from the first dose, the patient received the second dose of Jynneos vaccine (batch number: unknown), at unknown dose, route or site of administration. On an unspecified date, unknown of time after vaccination with Jynneos, reported as in the last 24 hours, the patient got diagnosed with autoimmune disorder. At the time of initial report, it was unknown if the patient recovered from the event of autoimmune disorder. The reporter assessed the event of autoimmune disorder as serious due to criteria of disability and medical significance and possible related to Jynneos. No further information was provided.; Reporter’s Comments: A male patient received two doses of the Jynneos vaccine in Sep and Oct 2022. Recently, he was diagnosed with an autoimmune disorder. Recovery status is unknown. The patient’s medical history and concomitant medication details were not provided. The reported event autoimmune disorder is considered unlisted as per RA v7.0 and RA. The causality is assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. The case is serious due to disability and medical significance.; Sender’s Comments: A male patient received two doses of the Jynneos vaccine in Sep and Oct 2022. Recently, he was diagnosed with an autoimmune disorder. Recovery status is unknown. The patient’s medical history and concomitant medication details were not provided. The reported event autoimmune disorder is considered unlisted as per RA v7.0 and RA. The causality was assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product and a plausible mechanism of action cannot be excluded. The case is serious due to disability and medical significance.