Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
sore arm; Swollen arm; red arm; warm arm; Fever; Chills; body ache; Headache; she cannot move her arm well; late dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Received 1st dose of Shingrix vaccine in July of last year). On 14-APR-2025, the patient received the 2nd dose of Shingrix. In APR-2025, less than a week after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm), swelling arm (Verbatim: Swollen arm), erythema of extremities (Verbatim: red arm), skin warm (Verbatim: warm arm), fever (Verbatim: Fever), chills (Verbatim: Chills), general body pain (Verbatim: body ache), headache (Verbatim: Headache), mobility decreased (Verbatim: she cannot move her arm well) and drug dose administration interval too long (Verbatim: late dose). The outcome of the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, headache and mobility decreased were unknown and the outcome of the general body pain was resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, general body pain, headache and mobility decreased to be related to Shingrix. It was unknown if the company considered the pain in arm, swelling arm, erythema of extremities, skin warm, fever, chills, general body pain, headache and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 18-APR-2025 The patient received her second dose of Shingrix on Monday. She stated that after her dose, she experienced a sore, swollen, red, warm arm, fever, chills, body ache and headache. She also states that she cannot move her arm well. She received her first dose of Shingrix in July of last year which led to drug dose administration interval too long. Other Conditions were reported as unknown.