Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Faint; Low grade fever; headache; nausea; diarrhea; cold sweat; Lightheadedness; This serious case was reported by a consumer via call center representative and described the occurrence of faint in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (had shingles in left inner thigh in the past, years ago). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced faint (Verbatim: Faint) (serious criteria GSK medically significant), low grade fever (Verbatim: Low grade fever), headache (Verbatim: headache), nausea (Verbatim: nausea), diarrhea (Verbatim: diarrhea), cold sweat (Verbatim: cold sweat) and light headedness (Verbatim: Lightheadedness). The outcome of the faint and light headedness were not reported and the outcome of the low grade fever, headache, nausea, diarrhea and cold sweat were resolved. It was unknown if the reporter considered the faint, low grade fever, headache, nausea, diarrhea, cold sweat and light headedness to be related to Shingrix. The company considered the faint to be unrelated to Shingrix. It was unknown if the company considered the low grade fever, headache, nausea, diarrhea, cold sweat and light headedness to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR014324 Additional Information: GSK Receipt Date: 06-JAN-2025 The patient self-reported this case for herself. The patient stated she was over 70 years old and received Shingrix 5 months ago from the date of reporting in 2024. She stated she was due to take dose 2 on 20-FEB-2025. She was afraid she would have symptoms like with dose 1. She said hours after receiving dose 1, she experienced low grade fever, headache, nausea, diarrhea, cold sweats, faint and lightheaded in 2024. Referred her to HCP (health care professional). CDC (centers for disease control and prevention) phone number provided.; Sender's Comments: Syncope is an unlisted event which, due to the following criteria (insufficient information provided about the clinical description) is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025AMR014324:same patient
Medical History/Concurrent Conditions: Shingles (had shingles in left inner thigh in the past, years ago)