Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Injection site pain began immediately/painful arm; Weakness of her arm; Instructed her to take two puffs from her BREO 100/25 Mcg until the new device arrives; Instructed her to take two puffs from her BREO 100/25 Mcg until the new device arrives; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included fluticasone furoate, vilanterol trifenatate (Breo Ellipta) inhalation powder (batch number KN6J, expiry date 31-MAY-2027) for histoplasmosis and respiratory disorder and salbutamol sulfate (Ventolin Hfa) inhaler for product used for unknown indication. The patient's past medical history included non-insulin-dependent diabetes mellitus, glaucoma, sleep apnea and histoplasmosis. Additional patient notes included Cardiac (unknown issue).. Concomitant products included levothyroxine sodium (Synthroid), diltiazem and ezetimibe. On an unknown date, the patient received RSV vaccine (unknown arm). In APR-2025, the patient started Breo Ellipta (oral) 100/25 mcg 1 puff(s) daily (1 puff(s) daily). On an unknown date, the patient started Ventolin Hfa (oral) 1 puff(s) as needed. On an unknown date, immediately after receiving RSV vaccine and an unknown time after starting Breo Ellipta and Ventolin Hfa, the patient experienced injection site pain (Verbatim: Injection site pain began immediately/painful arm), weakness of arms (Verbatim: Weakness of her arm), off label dosing (Verbatim: Instructed her to take two puffs from her BREO 100/25 Mcg until the new device arrives) and prescribed overdose (Verbatim: Instructed her to take two puffs from her BREO 100/25 Mcg until the new device arrives). The dose of Breo Ellipta was increased. Ventolin Hfa was continued with no change. The outcome of the injection site pain and weakness of arms were not resolved and the outcome of the off label dosing and prescribed overdose were not applicable. It was unknown if the reporter considered the injection site pain and weakness of arms to be related to RSV vaccine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. GSK receipt date: 17-OCT-2025 Product start date for RSV vaccine was 2024. Event start date for Injection site pain and mascular weakness was 2024.Patient Historical condition includes cardiac,The batch number was not provided and a request for this information had been made. There was no official diagnosis, they are investigating. The patient was an 87-year-old female who reported that she had been taking Breo 100 mcg/25 mcg for about six months for a diagnosis of moderate persistent reactive airway disease without complications, with a history of histoplasmosis (off-label use). Because her condition had deteriorated, her doctor had ordered Breo 200/25 mcg and had instructed her to take two puffs from her Breo 100/25 mcg until the new device arrived. She reported that, many hours after using her Breo while sitting quietly, she exhaled a "large, light-colored cloud" that resembled smoke and had no odor or taste. She stated that this had occurred three times in the past six months, with the most recent event ten days earlier. She also used Ventolin intermittently, about once a month. She mentioned that in 2024 she had received an RSV vaccination (manufacturer unknown) and that injection site pain had begun immediately and continued to the present, accompanied by intermittent arm weakness. She reported that she had received physical therapy for this issue and that the therapy continued on an intermittent basis. Upon internal review 18-NOV-2025: Updated TTO for RSV vaccine for Injection site pain, weakness of arms, off label dosing and Prescribed overdose, Standard VAERS details, Anatomical location, Product indication, Product start date for RSV vaccine removed and outcome of event injection site pain and weakness of arms updated to not recovered.
Medical History/Concurrent Conditions: Glaucoma; Histoplasmosis; Non-insulin-dependent diabetes mellitus; Sleep apnea; Comments: Cardiac (unknown issue).
SYNTHROID; DILTIAZEM; EZETIMIBE; Breo Ellipta; Ventolin HFA