Received Mar 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | RA |
Car accident; immunocompromised; This serious case was reported by a nurse via sales rep and described the occurrence of automobile accident in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-JUN-2024, the patient received the 2nd dose of Shingrix (right arm). On 04-JUN-2024, less than a day after receiving Shingrix, the patient experienced automobile accident (Verbatim: Car accident) (serious criteria hospitalization and other: Serious as per reporter). On an unknown date, the patient experienced immunocompromised (Verbatim: immunocompromised) (serious criteria GSK medically significant). The outcome of the automobile accident was resolved with sequelae and the outcome of the immunocompromised was not reported. The reporter considered the automobile accident and immunocompromised to be related to Shingrix. The company considered the automobile accident and immunocompromised to be unrelated to Shingrix. Additional Information: GSK receipt date: 25-FEB-2025 The patient had car accident. Patient was subsequently hospitalized and was referred to every specialist. It was determined that by doctors that the 2nd dose of Shingrix caused the patient to become immunocompromised. Patient was on Thyroid medicine at the time of reporting for unknown indication.; Sender's Comments: Road traffic accident and Immunodeficiency are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Test Name: Red blood cells; Result Unstructured Data: (Test Result:very low,Unit:unknown,Normal Low:,Normal High:); Test Name: White blood cells; Result Unstructured Data: (Test Result:very high,Unit:unknown,Normal Low:,Normal High:)