Received Feb 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
rash on left shoulder/rash on her chest/Rash trunk; bicep tendon tore/popeye arm; rash is almost papular; feeling down on Sunday; Fever; Fatigue/feeling down; almost little white heads, very prominent over chest; Arm and chect ithcy; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure, arrhythmia, difficulty breathing and heartburn. Concomitant products included hydrochlorothiazide;triamterene (Maxzide), flecainide, famotidine (Pepcid), atorvastatin and montelukast sodium (Singulair). On 24-JAN-2026, the patient received the 1st dose of Shingrix (left arm). In JAN-2026, less than a week after receiving Shingrix, the patient experienced whiteheads (Verbatim: almost little white heads, very prominent over chest) and pruritus (Verbatim: Arm and chect ithcy). On 24-JAN-2026, the patient experienced fever (Verbatim: Fever) and fatigue (Verbatim: Fatigue/feeling down). On 25-JAN-2026, the patient experienced papular rash on arms (Verbatim: rash is almost papular) and feeling down (Verbatim: feeling down on Sunday). On 25-JAN-2026 20:00, the patient experienced biceps tendon rupture (Verbatim: bicep tendon tore/popeye arm). On 29-JAN-2026, the patient experienced rash (Verbatim: rash on left shoulder/rash on her chest/Rash trunk). The patient was treated with paracetamol (Tylenol). On 26-JAN-2026, the outcome of the fever was resolved. The outcome of the biceps tendon rupture, papular rash on arms, rash and fatigue were not resolved and the outcome of the whiteheads, pruritus and feeling down were not reported. The reporter considered the fever, biceps tendon rupture, papular rash on arms, rash and fatigue to be unrelated to Shingrix. It was unknown if the reporter considered the whiteheads, pruritus and feeling down to be related to Shingrix. The company considered the fever, biceps tendon rupture, papular rash on arms, rash and fatigue to be unrelated to Shingrix. It was unknown if the company considered the whiteheads, pruritus and feeling down to be related to Shingrix. Additional Information: GSK receipt date 29-JAN-2026 The patient after 1st Shingrix vaccination developed a fever of 101, took Tylenol and was feeling down on Sunday, slept all afternoon, went to sleep for the evening at 8pm and had bicep tendon tore. The patient on Monday morning had rash on left shoulder, popeye arm, chest was itchy, had rash on her chest. The patient reported no new dermatologic products and used what appeared to be acetaphyl for washing. The rash was almost papular, almost little white heads, very prominent over chest. The patient called to report these symptoms and asked whether they should receive the second dose." The batch number was not provided and a request for this information has been made.
Arrhythmia; Blood pressure; Difficulty breathing; Heartburn
MAXZIDE; FLECAINIDE; Pepcid; ATORVASTATIN; SINGULAIR
Test Date: 20260124; Test Name: Body temperature; Result Unstructured Data: (Test Result:101,Unit:unknown,Normal Low:,Normal High:)