Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | UNK | — |
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Arms are sore; a1c elevated (glycosylated haemoglobin increased); This non-serious case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis, Influenza vaccine inact sAg 3v (Fluad) for prophylaxis, Pneumococcal vaccine polysacch 23v (Pneumovax 23) for prophylaxis and sarilumab (Kevzara) for illness. Concomitant products included methotrexate sodium (Methotrexate), tamsulosin hydrochloride, varenicline tartrate, prednisone acetate (Prednisone), colecalciferol and Multivitamins. The patient received the 1st dose of Shingrix .5 ml, COVID-19 vaccine, Fluad .5 ml, Pneumovax 23 .5 ml and Kevzara .5 ml. The patient experienced pain in arm (Verbatim: Arms are sore) and glycosylated hemoglobin increased (Verbatim: a1c elevated (glycosylated haemoglobin increased)). The action taken with Kevzara was unknown. The outcome of the pain in arm and glycosylated hemoglobin increased were unknown. It was unknown if the reporter considered the pain in arm and glycosylated hemoglobin increased to be related to Shingrix. The reporter considered the pain in arm and glycosylated hemoglobin increased to be not reported if related to COVID-19 vaccine, Fluad, Pneumovax 23 and Kevzara. It was unknown if the company considered the pain in arm and glycosylated hemoglobin increased to be related to Shingrix. The company considered the pain in arm and glycosylated hemoglobin increased to be not reported if related to COVID-19 vaccine, Fluad, Pneumovax 23 and Kevzara. Additional Information: GSK Receipt Date: 10-DEC-2025 The batch number was not provided and a request for this information has been made.
METHOTREXATE; TAMSULOSIN HYDROCHLORIDE; VARENICLINE TARTRATE; PREDNISONE; COLECALCIFEROL; MULTIVITAMINS; Kevzara
Test Name: Glycosylated haemoglobin; Result Unstructured Data: (Test Result:Elevated,Unit:unknown,Normal Low:,Normal High:)