low blood pressure and pulse; low blood pressure and pulse; viral gastritis//vomiting; Calf pain; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE DECREASED (low blood pressure and pulse), HYPOTENSION (low blood pressure and pulse) and GASTRITIS VIRAL (viral gastritis//vomiting) in a 79-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: High dose flu vaccine (High dose) on 27-Dec-2024. Past adverse reactions to the above products included No adverse effect with High dose flu vaccine. On 15-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In January 2025, the patient experienced GASTRITIS VIRAL (viral gastritis//vomiting) (seriousness criterion hospitalization). On 16-Jan-2025, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced PAIN IN EXTREMITY (Calf pain). On 18-Jan-2025, the patient experienced HEART RATE DECREASED (low blood pressure and pulse) (seriousness criterion hospitalization) and HYPOTENSION (low blood pressure and pulse) (seriousness criterion hospitalization). The patient was hospitalized on 18-Jan-2025 due to GASTRITIS VIRAL, HEART RATE DECREASED and HYPOTENSION. On 19-Jan-2025, HEART RATE DECREASED (low blood pressure and pulse) and HYPOTENSION (low blood pressure and pulse) was resolving. On 20-Jan-2025, PAIN IN EXTREMITY (Calf pain) had resolved. At the time of the report, GASTRITIS VIRAL (viral gastritis//vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Culture: Negative. On an unknown date, Heart rate: Low. On an unknown date, Laboratory test: normal. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. On 18-Jan-2025, patient started vomiting and admitted to the hospital due to low blood pressure and pulse. Blood clots were ruled out. Vomiting stopped. Patient would be released from hospital on 21-Jan-2025. The final diagnosis was viral gastritis. No treatment medications were reported.; Reporter’s Comments: Company comment: Causality of event gastritis viral was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.

lose all muscle control in arms, legs; loose of control bladder; lots of sleeping most of the day; dizzy; fever; chills; nausea; terrific headache; loss of appetite; redness and lump on my arm are flaming; redness and lump on my arm are flaming; This spontaneous case was reported by a patient and describes the occurrence of MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming) and DECREASED APPETITE (loss of appetite) in a 74-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concomitant products included Levothyroxine sodium, Rosuvastatin calcium (Rosuvastatin) and Ezetimibe for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 23-Nov-2024, the patient experienced LIMB MASS (redness and lump on my arm are flaming) and ERYTHEMA (redness and lump on my arm are flaming). On an unknown date, the patient experienced MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), DECREASED APPETITE (loss of appetite), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache). At the time of the report, MUSCULAR WEAKNESS (lose all muscle control in arms, legs), URINARY INCONTINENCE (loose of control bladder), HYPERSOMNIA (lots of sleeping most of the day), LIMB MASS (redness and lump on my arm are flaming), DECREASED APPETITE (loss of appetite), ERYTHEMA (redness and lump on my arm are flaming), DIZZINESS (dizzy), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (terrific headache) had not resolved. Patient had received Moderna Covid vaccines and their booster doses every year since their availability. Patient had reactions to vaccine which caused patient to be bedridden for a few days. Patient had reactions which included losing all muscle control in arms, legs, and bladder; lots of sleeping most of the day; fever, chills, nausea, dizzy, terrific headache, and loss of appetite. It was like a nightmare for the patient. Since 23-Nov-2024, the patient had redness and lump on the arm. It was reported that patient researched online for side affects, but could not find anything close to what patient continued to experience. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2024: Live non-significant follow up received with no new information. On 17-Dec-2024: Live non-significant follow up received with no new information.; Reporter’s Comments: The benefit-risk relationship of the product is not affected by this report.

respiratory issues; the patient had received two total doses of Arexvy; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of respiratory disorder in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date) and Arexvy (received 1st dose of Arexvy vaccine in 2023). On an unknown date, the patient received the 2nd dose of Shingrix and the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patient experienced respiratory disorder (Verbatim: respiratory issues) and extra dose administered (Verbatim: the patient had received two total doses of Arexvy). The outcome of the respiratory disorder and extra dose administered were unknown. It was unknown if the reporter considered the respiratory disorder to be related to Shingrix and Arexvy. It was unknown if the company considered the respiratory disorder to be related to Shingrix and Arexvy. Additional Information: GSK Receipt Date: 15-JAN-2025 Pharmacist reported that the patient was vaccinated with Shingrix at the same time as receiving her second dose of Arexvy which led to extra dose administered. After vaccination the patient had respiratory issues and was transported to the emergency department by personnel was made aware of the the vaccinations administered to the patient, however, was not informed the patient had received two total doses of Arexvy. No further information was known such as medical history of patient, demographics of patient, dates of administration for both doses of Arexvy and the dose of Shingrix, or the patient was admitted into the hospital or released from the emergency department. This case was linked with case US2025005052, reported by the same reporter for different patient.; Sender’s Comments: US-GSK-US2025005052:Same reporter/Different Patient

The patient states “it is maybe a mild shingles; an acne like break out; they popped when I showered; is creeping to the upper part of the back; bumpy blistery rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included The patient was red haired person. On 08-DEC-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 13-DEC-2024, 5 days after receiving Shingrix, the patient experienced rash (Verbatim: is creeping to the upper part of the back) and blistery rash (Verbatim: bumpy blistery rash). On an unknown date, the patient experienced shingles (Verbatim: The patient states “it is maybe a mild shingles), acne (Verbatim: an acne like break out) and blister (Verbatim: they popped when I showered). The patient was treated with hydrocortisone (Cortaid). The outcome of the shingles was unknown and the outcome of the rash was not resolved and the outcome of the blistery rash and blister were resolved and the outcome of the acne was not reported. It was unknown if the reporter considered the shingles, rash, blistery rash, acne and blister to be related to Shingrix. It was unknown if the company considered the shingles, rash, blistery rash, acne and blister to be related to Shingrix. Additional Information: GSK Receipt Date: 03-JAN-2025 The reporter reported that the patient received Shingrix and had a rash as a bumpy blistery rash on patient back, with very small blisters. The reporter describes it as an acne like break out. The reporter reported about the blisters as they popped when patient showered. The blisters went away but not the rash. The reporter states the rash was creeping to the upper part of the back. It was maybe a mild shingles. The rash first appeared on the right section of the back, and it has moved to the upper left part of the back, near the neck and the shoulder. It has moved from right to left. The patient will see a dermatologist next week but states that the nurse recommended to take an oral antihistamine and to apply Cortaid topical cream. The patient has used this for a week and states it has helped. The reporter wanted to share the fact that she was a red-haired person. The reporter states red-haired people react differently to medications, and it was a real thing, it was crazy. The reporter stated we can overreact to medications, and with anesthesia they give less or more depending on the patient, and the patient always overreact to medications.

reconstituted with sterile water; Inappropriate dose of vaccine administered; 1mL was administered to the patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number EK7DG, expiry date 31-DEC-2025) for prophylaxis. On 02-JAN-2025, the patient received Menveo. On 02-JAN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with sterile water), inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered) and overdose (Verbatim: 1mL was administered to the patient). The outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and overdose were unknown. It was unknown if the reporter considered the overdose to be related to Menveo. It was unknown if the company considered the overdose to be related to Menveo. Additional Information: GSK Receipt Date: 03-JAN-2025 The Healthcare Professional reported that Menveo 1 vial was reconstituted with sterile water from the MMR vaccine and 1ml was administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.

absolute fatigue, it started after I got the RSV shot; I couldn’t even walk my dogs; Couldn’t get out of bed for a week; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a female 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 fatigue (Verbatim: absolute fatigue, it started after I got the RSV shot), activities of daily living impaired (Verbatim: I couldn’t even walk my dogs) and bedridden (Verbatim: Couldn’t get out of bed for a week). The outcome of the fatigue, activities of daily living impaired and bedridden were not resolved. It was unknown if the reporter considered the fatigue, activities of daily living impaired and bedridden to be related to Arexvy. It was unknown if the company considered the fatigue, activities of daily living impaired and bedridden to be related to Arexvy. Additional Information: GSK Receipt Date: 01-JAN-2025 Consumer reported that her problem was a absolute fatigue, it started after she got the RSV shot, at the and she couldn’t get out of bed for a week, except to just you know go to bathroom, and essentials like that. She couldn’t even walk her dogs, and then it has just continued on. Here it was a year and half latter, and she talk to the doctor, she went to rheumatologist, she talk to the pharmacist and it just doesn’t let up. She was wondering is there is anything you know and asked for help.

Right upper quadrant pain; This non-serious case was reported by a physician via call center representative and described the occurrence of upper abdominal pain in a adult male patient who received HAB (Twinrix) (batch number 4KF75) for prophylaxis. On 02-JUL-2024, the patient received the 1st dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced upper abdominal pain (Verbatim: Right upper quadrant pain). The outcome of the upper abdominal pain was resolved. It was unknown if the reporter considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device. It was unknown if the company considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: Follow-up information received on 31-DEC-2024. The reporter contacted Medical Information call Center and provided additional information on case AE-117102 about side effects after Twinrix vaccination. The patient experienced right upper quadrant pain after Twinrix and it ran away. Follow up by Safety Team was accepted to his personal email. Summary of changes: Patient tab, product tab, event tab and narrative was updated.; Sender’s Comments: US-GSK-US2024AMR166318:For dose 2nd

Suspected vaccination failure; Shingles about every two months on torso; 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: Shingles about every two months on torso). 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: 16-JAN-2025 This case was reported by a patient via interactive digital media. The patient have had the vaccine and still get shingles about every two months on torso but well, the patient’s were painful just an annoyance. 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 vaccine Shingles vaccine.

Suspceted vaccination failure; had the vaccine and still got them; 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: Suspceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine and still got them). 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: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine and still got shingles and asked do he/she need another. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, 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 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.

Suspected vaccination failure; Ramsey Hunt Syndrome; paralysis; post herpetic nerve damage; shingles right side of face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult 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), ramsay-hunt syndrome (Verbatim: Ramsey Hunt Syndrome) (serious criteria GSK medically significant), paralysis (Verbatim: paralysis) (serious criteria GSK medically significant), post herpetic neuralgia (Verbatim: post herpetic nerve damage) and facial herpes zoster (Verbatim: shingles right side of face). The outcome of the vaccination failure, ramsay-hunt syndrome and facial herpes zoster were not reported and the outcome of the paralysis and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome, paralysis, post herpetic neuralgia and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, ramsay-hunt syndrome and paralysis to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the post herpetic neuralgia and facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 15-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the shingles shot and booster as soon as turned 50, still developed shingles on the right side of face which developed to Ramsey Hunt Syndrome. Still suffered from post herpetic nerve damage and paralysis. The reporter would still recommend the shots though because who know if it would have been worst. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. Herpes zoster oticus and Paralysis are unlisted events which are considered unrelated to GSK Shingles vaccine.