Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 7ZM55 | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
body ache; fever; arm swelling; Adjuvant administered alone; gave just the adjuvant component alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number N77J2, expiry date 23-OCT-2026) and (batch number 7ZM55, expiry date 15-NOV-2026) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On 07-FEB-2025, the patient received the 2nd dose of Shingrix. On 06-DEC-2024, the patient received the 1st dose of Shingrix. On 07-FEB-2025, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant administered alone) and inappropriate dose of vaccine administered (Verbatim: gave just the adjuvant component alone). On an unknown date, the patient experienced general body pain (Verbatim: body ache), fever (Verbatim: fever) and swelling arm (Verbatim: arm swelling). The outcome of the general body pain, fever and swelling arm were resolving and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the general body pain, fever and swelling arm to be related to Shingrix. It was unknown if the company considered the general body pain, fever and swelling arm to be related to Shingrix. Additional Information: GSK Receipt Date : 12-FEB-2025 Registered Nurse mentioned that a patient got a first dose of Shingrix on December 6th 2024 and they came to get a second dose on February 7th 2025 but they accidentally gave just the adjuvant component alone which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. So when they realized of the error, they discussed with the patient and decided to give another dose properly mixed on the other arm that same day. Reporter mentioned that after the first dose the patient experienced body aches, fever and arm swelling, and they recommended patient to took Tylenol or Benadryl if needed after the second dose if they feel symptoms, but mentioned that patient was feeling fine so far.; Sender's Comments: US-GSK-US2025018343:same reporter