Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Tenderness in arm; Redness in arm; swelling in arm; Fever; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On 06-MAY-2025 08:15, the patient received the 2nd dose of Shingrix. On 06-MAY-2025, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: Tenderness in arm), erythema of extremities (Verbatim: Redness in arm), swelling arm (Verbatim: swelling in arm) and fever (Verbatim: Fever). The patient was treated with paracetamol (Tylenol). On 11-MAY-2025, the outcome of the pain in arm, erythema of extremities, swelling arm and fever were resolved (duration 5 days). The reporter considered the pain in arm, erythema of extremities, swelling arm and fever to be related to Shingrix. The company considered the pain in arm, erythema of extremities, swelling arm and fever to be related to Shingrix. Additional Information: GSK Receipt Date: 13-MAY-2025 The nurse reported that the patient received the second dose of Shingrix and shortly after receiving this second dose, she experienced tenderness in arm and started to run a fever. She took a few Tylenol and the fever resolved and the redness, swelling and tenderness of arm continued for 4 to 5 days then resolved. She shared that she applied an ice pack to her arm which helped and had previously reported an adverse event with her first dose of Shingrix which had discouraged her from receiving the second dose until now. The reaction with this second dose not as strong at the first one.