thoracic aortic aneurysm; rheumatoid arthritis; diverticulitis recurrent; she was brain dead since heart surgery; chronic diarrhea; This spontaneous report received from a consumer by a business partner (Pfizer Inc.) on 13-Jan-2025 was received by Johnson and Johnson Innovative Medicine on 13-Jan-2025 and concerned a 66 year old female patient. The patient’s height and weight were not reported. Age at time of vaccination was unknown. The patient’s past medical history included: thyroidectomy and radiation, and concurrent conditions included: giant cell arteritis, polymyalgia rheumatica, hiatal hernia, barrett’s esophagus, and diverticulitis. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. Non-company products included: metoprolol succinate (tablet, route of admin not reported, batch number not reported) 100 milligram(s), once daily, administered on Aug-2023 to end date not provided and (tablet, route of admin not reported, batch number not reported) 50 milligram(s), once daily, administered on 2024 to end date not provided, for blood pressure and to beat heart harder. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included: morphine for pain; ketamine for pain., armour thyroid (Started in Summer 2015 after a thyroidectomy and radiation treatment). On an unspecified date, the patient experienced thoracic aortic aneurysm, rheumatoid arthritis, diverticulitis recurrent, she was brain dead since heart surgery, and chronic diarrhea. (dose series 1) She had a thoracic aortic aneurysm and stated that this was the reason for her surgery. Stated that she was diagnosed with thoracic aortic aneurysm after having the Covid vaccine. Stated that it was the Johnson Johnson Covid vaccine and she took it in Nov-2020. She had to get it for her job. Her initial prescribing physician is not aware of this. She saw another physician outside of the prescribing physician after her surgery. The metoprolol tablet was prescribed after the patient’s heart surgery. The chronic diarrhea started gradually after her surgery around the clock. She was on metoprolol for 10-11 months and she has had chronic diarrhea in that time frame. She also had a hernia and a problem with her esophagus. She said that within 12 hours after stopping the metoprolol the diarrhea cleared up. They put her on it for her blood pressure and to make her heart beat harder because she had ascending aorta replacement. Her diarrhea started in the clinic right after surgery and stated that was not diarrhea at that time and was just soft and loose stool. Said that she was astonished that she could goto the bathroom because of the pain meds she was taking were morphine and ketamine. The patient’s hiatal hernia and barrett’s esophagus was prior to use of metoprolol. During the course of the period on the metoprolol , caller also had had diverticulitis 3 times during that period. She only had it once prior to that at age 12 years old. She never had it again until after her heart surgery and that is what made her research it. She said that she was brain dead and said that brain deadness was since having heart surgery. On 15-Aug-2023 was the date of her surgery and by 18-Aug-2023-19-Aug-2023 she was starting to have diarrhea. This was all while on heavy opioids which usually creates the opposite problem. The diarrhea resolved within hours after stopping the metoprolol. Thinks it stopped in Hours of stopping the medciation in Oct-2024 or around the 01-Nov-2024 and was placed back on Amlodipine and HCTZ. Hindsight is 20/20, she did not put all of this together until last yearuntil she went off of the metoprolol on her own. Unsure if diverticulitis occurred prior to surgery. Does not remember the dates of the diverticulitis, but said that 2 occurred in early 2024 and one of them occurred in Fall 2023 after her surgery. She was scheduled to see a Gastroenterologist and when she stopped the metoprolol Succinate ER, the diarrhea stopped and she did not follow up with the gastroenterologist. The action taken with janssen covid-19 vaccine was not applicable and treatment with metoprolol succinate was withdrawn on an unspecified date. The outcome of thoracic aortic aneurysm, rheumatoid arthritis, diverticulitis recurrent and she was brain dead since heart surgery was not reported. The patient recovered from chronic diarrhea on an unspecified date. This report was serious (other medically important condition).; Sender’s Comments: V0; Aortic aneurysm, Diverticulitis, Rheumatoid arthritis, Unevaluable event; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.

suspected leukocytoclastic vasculitis; red spots on legs; This serious case was reported by a consumer via call center representative and described the occurrence of leukocytoclastic vasculitis in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number T74KG) for prophylaxis. On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, 7 days after receiving Fluarix 2024-2025 season, the patient experienced leukocytoclastic vasculitis (Verbatim: suspected leukocytoclastic vasculitis) (serious criteria GSK medically significant) and red spotty rash (Verbatim: red spots on legs). The outcome of the leukocytoclastic vasculitis was not reported and the outcome of the red spotty rash was unknown. It was unknown if the reporter considered the leukocytoclastic vasculitis and red spotty rash to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the leukocytoclastic vasculitis to be unrelated to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the red spotty rash to be related to Fluarix 2024-2025 season and Fluarix 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: GSK Receipt Date: 14-JAN-2025 Reporter was the patient’s father. Patient developed red spots on the legs 7 days after receiving the Fluarix vaccine. Reporter suspected that the patient developed Leukocytoclastic vasculitis (LCV).; Sender’s Comments: Cutaneous vasculitis is an unlisted event which is considered unrelated to GSK vaccine Fluarix 2024-2025 season and Fluarix PRE-FILLED SYRINGE DEVICE.

Suspected Vaccination failure; I got SHINGLES anyways; 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 (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included chemotherapy (User was going through chemotherapy when they contracted shingles.). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got SHINGLES anyways). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 18-JAN-2025 Reporter commented that they got the shingles vaccine but got shingles anyway. Reporter was went through chemotherapy when they contracted shingles. Reporter got a SHINGLES vaccine. It was TWO shots. Reporter got SHINGLES anyways because of the chemo BUT it was mild. No big deal from what he/she heard it was painful. Pharmacist said it was minor because he/she Did had the SHINGLES vaccine. Would had been way worse. So he/she was grateful. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1 and Shingrix dose 2.

Suspected vaccination failure; Got shingles/ very painful and itchy; 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: Got shingles/ very painful and itchy). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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 got the shot and the booster of shingles vaccine. The patient got shingles and had it for 10 days so far. The patient reported it to be very painful and itchy. 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. The follow-up could not be possible as no contact details were available; Sender’s Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine 1 and Shingles vaccine 2.

Suspected vaccination failure; I have the 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. 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: I have the shingles). The patient was treated with lidocaine. 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 and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 15-JAN-2025 and 21-JAN-2025 This case was reported by a patient via interactive digital media. The patient had the shingles, the patient had received shots of shingles vaccine. Thankful mild case but the pain was horrible, the reporter could not take pain medication. The patient was using lidocaine cream. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.

Guillain Barre syndrome; This serious case was reported by a consumer via sales rep and described the occurrence of guillain barre syndrome in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number X4EA5, expiry date 16-OCT-2025) for prophylaxis. On 19-DEC-2024, the patient received the 1st dose of Arexvy. On 30-DEC-2024, 11 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins. The outcome of the guillain barre syndrome was not resolved. The reporter considered the guillain barre syndrome to be related to Arexvy. The company considered the guillain barre syndrome to be unrelated to Arexvy. Additional Information: GSK Receipt Date: 13-JAN-2025 The patient was in hospital for Guillain Barre syndrome and Guillain Barre syndrome was reported as worsened. Patient was vaccinated with Arexvy and went to emergency room on 31st December 2024. The patient had completed 5 treatments of IVIG and still in hospital. Patient was unable to walk and had no feeling/reflexes in legs, unable to move right arm/hand and could not feed herself and on thickened liquids due to swallowing issues.; Sender’s Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.

no side effects or symptoms have been reported; HCP called to report a dose of VARIVAX was administered to a 2-month-old patient. no side effects or symptoms have been reported. No Additional information provided. No AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 2-month-old female patient. No information on patient’s medical history, current conditions and concomitant medications was provided. On 08-NOV-2024 the 2-month-old patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # Y011712 and expiration date 02-JUL-2026, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (product administered to patient of inappropriate age). No side effects or symptoms have been reported (o adverse event).

No additional AE; HBP calling on behalf of Physician with a report of an adverse event regarding an expired dose of PROQUAD that was inadvertently administered to a patient. HBP stated that the PROQUAD had a labeled expiration date of 1/5/2025 and was administered o; This spontaneous report was received from a Health business professional and refers to a patient of unknown age and gender. The patient’s pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported. On 17-JAN-2025, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA[recombinant human albumin]) (PROQUAD) injection, 0.5 milliliter, administered as prophylaxis (Lot No. X018584 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported and upon internal validation established as 05-JAN-2025) (strength, dose number, route of administration, anatomical location of administration and vaccination scheme frequency were not provided)(expired product administered). No additional adverse event was reported (no adverse event)

No adverse side effects were reported; HCP called to report that a patient had been administered MMR II after the expiration date. Administered 1/21/2025, expired 1/19/2025.; This spontaneous report has been received from a nurse regarding a 5-year-old female patient. The patient’s medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On 21-JAN-2025 (also reported as 24-JAN-2025), the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered for prophylaxis, (lot number reported as X002058, expiration date reported and validated as 19-JAN-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not provided) (Expired product administered). No adverse side effects were reported.

No additional adverse event was reported; HCP called to report a patient received a fourth dose of GARDASIL 9 after completing a 3-dose-series in 2022 ( exact date unknown). No side effects or symptoms reported. No additional information reported. No additional AE/ No PQC.; This spontaneous report was received from physician assistant and refers to a 26-year-old female. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On 23-JAN-2025, the patient was vaccinated withfourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, lot #Y012864, expiration date: 29-MAY-2026, administered for prophylaxis (strength, and route of administration were not provided) after completing third dose series in unknown date in 2022 (Extra dose administered). No additional adverse event was provided.