Received Dec 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TTOX | TETANUS TOXOID (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Drainage/ sneezing; Drainage/ sneezing; fatigue; Chills; Drug dose administration interval to long; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Tetanus vaccine toxoid (Tetanus vaccine) for prophylaxis. The patient's past medical history included shingles (She developed shingles in her eye) and blister (She had occasional small blisters from time to time). Previously administered products included Shingles Vaccine (had received a dose of shingles vaccine (manufacturer unknown, but she believed it had been SHINGRIX) several years earlier) and valacyclovir (she takes Valacyclovir when she starts to break out). On 20-NOV-2025, the patient received Shingrix and Tetanus vaccine. On 20-NOV-2025, an unknown time after receiving Shingrix and not applicable after receiving Tetanus vaccine, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval to long). On 22-NOV-2025, the patient experienced chills (Verbatim: Chills). On 23-NOV-2025, the patient experienced fatigue (Verbatim: fatigue). On 25-NOV-2025, the patient experienced nasal discharge (Verbatim: Drainage/ sneezing) and sneezing (Verbatim: Drainage/ sneezing). The outcome of the chills, fatigue, nasal discharge and sneezing were unknown and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the chills, fatigue, nasal discharge and sneezing to be related to Shingrix and Tetanus vaccine. It was unknown if the company considered the chills, fatigue, nasal discharge and sneezing to be related to Shingrix and Tetanus vaccine. Linked case(s) involving the same patient: US2025152571 Additional Information: GSK receipt date: 25-NOV-2025 The patient received Shingrixon Thursday, 20-NOV-2025 (adverse event: inappropriate schedule of vaccine). She also received a tetanus vaccine (manufacturer not provided) the same day in the other arm. On Saturday, 22-NOV-2025, she began to experience chills. On Sunday, 23-NOV-2025, she felt fatigued. By Tuesday, 25-NOV-2025, she was experiencing drainage and reported that she had been sneezing for the past three days. The batch number was not provided and a request for this information has been made.; Sender's Comments: US-GSK-US2025152571:Same Patient
Medical History/Concurrent Conditions: Blister (She had occasional small blisters from time to time); Shingles (She developed shingles in her eye)