Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | LA |
body ache; Headache; broke out with a rash in the mouth; Chills; Sweating; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (Had vaccine 12 years ago). Concurrent medical conditions included diabetes. Additional patient notes included The patient had sensitive system and react bad to all vaccines/medications. She takes medications for diabetes.. On 03-AUG-2024, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills), sweating (Verbatim: Sweating), general body pain (Verbatim: body ache), headache (Verbatim: Headache) and rash mouth (Verbatim: broke out with a rash in the mouth). The outcome of the chills and sweating were resolved (duration 1 week) and the outcome of the general body pain and headache were resolved and the outcome of the rash mouth was not resolved. It was unknown if the reporter considered the chills, sweating, general body pain, headache and rash mouth to be related to Shingrix. It was unknown if the company considered the chills, sweating, general body pain, headache and rash mouth to be related to Shingrix. Additional Information: GSK Receipt Date: 28-JAN-2025 The patient was diabetic and that takes medications for diabetes. She had the Zostavax vaccine 12 years ago. She reported that she got her 1st dose of Shingrix on 03 August 2024. The patient received the vaccine at a local pharmacy, and it was administered in the left arm. The patient reported that she had headache and body aches. She had sweating and chills that lasted for a week. These events have been resolved. The patient concerned about getting the 2nd dose because had a sensitive system and react bad to all vaccines/medications. The patient inquired Shingrix related to Likens planus. She broke out with a rash in the mouth a few days ago. The patient was not sure what it was and was concerned about getting the 2nd dose of Shingrix because she was told that this condition and Shingrix were related. No additional events were reported. Did not given consent to follow up.
Diabetes
Comments: The patient had sensitive system and react bad to all vaccines/medications. She takes medications for diabetes.