Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Herpes zoster/ shingles; Bad joint pain for while on the therapy/ She Just Had RSV vaccine and states that's causing her profound joint pain; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of shingles in a elderly female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included dupilumab (Dupixent) solution for injection in pre-filled pen (batch number 4F573A, expiry date 31-DEC-2026) for prurigo nodularis. Concurrent medical conditions included joint pain (bad joint pain for while on the therapy), prurigo nodularis and drug allergy (was allergic to Penicillin VK 500 mg tablet, Celebrex 400 mg capsule). Concomitant products included oxygen. On 29-MAY-2025, the patient received RSV vaccine. On an unknown date, the patient started Dupixent (subcutaneous). On an unknown date, an unknown time after receiving RSV vaccine and Dupixent, the patient experienced shingles (Verbatim: Herpes zoster/ shingles) and arthralgia aggravated (Verbatim: Bad joint pain for while on the therapy/ She Just Had RSV vaccine and states that's causing her profound joint pain). The action taken with Dupixent was unknown. The outcome of the shingles was unknown and the outcome of the arthralgia aggravated was resolving. It was unknown if the reporter considered the shingles and arthralgia aggravated to be related to RSV vaccine and Dupixent. It was unknown if the company considered the shingles and arthralgia aggravated to be related to RSV vaccine and Dupixent. Additional Information: GSK Receipt Date: 18-JUL-2025 On an unknown date, the patient started taking Dupilumab solution for injection, strength 300mg/2ml at a dose of 300 mg every other week (QOW) subcutaneously via Dupilumab single dose prefilled pen. The patient received a dose of suspect RSV vaccine via unknown formulation, route and administration site. On an unknown date the patient developed a non-serious event bad joint pain for while on the therapy of Dupilumab or she just had RSV vaccine and stated that was causing her profound joint pain (arthralgia) unknown latency following the first dose intake of Dupilumab and of RSV vaccine. On an unknown date the patient developed a non-serious event shingles (herpes zoster) unknown latency following the first dose intake of Dupilumab and of RSV vaccine. The patient stated that she was just now beginning to recover from it and reported she had shingles. No other details provided. Action taken with Dupilumab (Dupixent) was unknown for arthralgia and no action taken for the event herpes zoster. Action taken with RSV Vaccine was not applicable for arthralgia and unknown for the event herpes zoster. It was not reported if the patient received a corrective treatment for arthralgia and herpes zoster. Additional information was received on 24-Jun-2025 from patient included additional event (herpes zoster) and clinical course.
Drug allergy (was allergic to Penicillin VK 500 mg tablet, Celebrex 400 mg capsule); Joint pain (bad joint pain for while on the therapy); Prurigo nodularis
OXYGEN; DUPIXENT