Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
flu like symptoms; aches and pains; first dose of shingrix in 2022 and second dose of shingrix on 8 March 2025.; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose received in 2022 with aches and pains and pain at the injection site). Concomitant products included lisinopril, rosuvastatin calcium (Crestor), pantoprazole, prednisone, levothyroxine, ipratropium bromide, salbutamol sulfate (Duoneb), sodium chloride, fluticasone propionate;salmeterol xinafoate and tiotropium bromide monohydrate (Spiriva). On 08-MAR-2025, the patient received the 2nd dose of Shingrix .5 ml. On 08-MAR-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of shingrix in 2022 and second dose of shingrix on 8 March 2025.). On 09-MAR-2025, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms) and pain (Verbatim: aches and pains). Rechallenge with Shingrix was positive. On 10-MAR-2025, the outcome of the influenza-like symptoms and pain were resolved (duration 1 day). The outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the influenza-like symptoms and pain to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms and pain to be related to Shingrix. Linked case(s) involving the same patient: US2025029169 Additional Information: GSK Receipt Date: 10-MAR-2025 I had Shingrix dose in 2022 and again 08-March-2025, the patient did not go back for the second vaccine within the recommended schedule time, which led to lengthening of vaccination schedule. The reporter asked was a third dose recommended due to the time lag in between doses. Recently her physician notified her that to start Nucala she would have to receive the second dose of Shingrix. The patient has not started Nucala yet. The patient had her second dose of Shingrix. After the second dose of Shingrix the patient did have the same flu-like symptoms with aches and pains one day after the resolved the next day. Medications listed in this report were medication that patient was taking in 2025 during second dose of suspect vaccine.; Sender's Comments: US-GSK-US2025029169:
Lisinopril; Crestor; pantoprazole; prednisone; levothyroxine; Duoneb; sodium chloride; Fluticasone propionate/salmeterol xinofoate; Spiriva