Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
she has been just diagnosed with MAC; This serious case was reported by a pharmacist via call center representative and described the occurrence of mycobacterium avium complex infection in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced mycobacterium avium complex infection (Verbatim: she has been just diagnosed with MAC) (serious criteria GSK medically significant). The patient was treated with rifampin and ethambutol. The outcome of the mycobacterium avium complex infection was unknown. It was unknown if the reporter considered the mycobacterium avium complex infection to be related to Shingrix. It was unknown if the company considered the mycobacterium avium complex infection to be related to Shingrix. Additional Information: GSK Receipt Date: 04-FEB-2025 The reporter had a patient who wanted to take Shingrix but had just been diagnosed with mycobacterium avium complex infection and was on rifampin and ethambutol. They didn't know if it was a good idea since this had just started. This was to be the second dose. She had received the first dose in October 2024. During the chat, the HCP asked if it was possible to administer the second Shingrix dose to the patient. The HCP mentioned that the first dose was in October 2024 but did not specify the date. They set this as 01-Oct-2024 because the system does not allow setting only the month and year.; Sender's Comments: Mycobacterium avium complex infection is an unlisted event which is considered unrelated to GSK vaccine Shingrix.