Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Small rash on leg above ankle/rash erythematous/rash is red; Allergy to vaccine; Contusion; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of red rash in a 72-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis and Dupilumab for nasal polyp. Concurrent medical conditions included nasal polyp. On an unknown date, the patient received RSV vaccine and COVID-19 VACCINE. In JUN-2024, the patient received Dupilumab (subcutaneous). On an unknown date, less than 9 months after receiving RSV vaccine and COVID-19 VACCINE and between 3 and 4 months after receiving Dupilumab, the patient experienced red rash (Verbatim: Small rash on leg above ankle/rash erythematous/rash is red), allergy to vaccine (Verbatim: Allergy to vaccine) and contusion (Verbatim: Contusion). The outcome of the red rash, allergy to vaccine and contusion were unknown. The reporter considered the red rash and contusion to be possibly related to RSV vaccine. It was unknown if the reporter considered the red rash, allergy to vaccine and contusion to be related to COVID-19 VACCINE. It was unknown if the reporter considered the red rash and contusion to be related to Dupilumab. The company considered the red rash and contusion to be possibly related to RSV vaccine. It was unknown if the company considered the red rash, allergy to vaccine and contusion to be related to COVID-19 VACCINE. It was unknown if the company considered the red rash and contusion to be related to Dupilumab. Additional Information: GSK receipt date: 27-JUN-2025 In 2024 the patient developed a non-serious events 'a reaction that started 5-6 months ago, could be due to RSV vaccine broke out in rash broken blood vessels now appear darker and spreading, small red patch on her leg spread larger to her ankle and knee' (contusion) (rash erythematous) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab,Covid-19 vaccine and RSV vaccine. In 2024 the patient developed a non-serious event 'small rash on leg above ankle' (rash) and 'a new allergy to covid vaccine' (allergy to vaccine) (unknown latency) following the first dose intake (unknown batch number and expiry date) of Dupilumab and Covid-19 vaccine. The patient stated that the rash was red but no itching. The patient saw her doctor when the patch was small but has not followed up since. Corrective treatment was not reported for all events. No additional information was provided.
Nasal polyp
Dupilumab