Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM / LA |
Shingles; had left arm pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cancer (cancer survivor) and zoster vaccination live-attenuated (Zoster vaccination live-attenuated several years ago). Concurrent medical conditions included cardiac failure (Heart failure). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). On 03-JUL-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 03-JUL-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: had left arm pain). On 06-JUL-2025, the patient experienced shingles (Verbatim: Shingles). The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. The outcome of the shingles and pain in arm were not resolved. It was unknown if the reporter considered the shingles and pain in arm to be related to Shingrix. It was unknown if the company considered the shingles and pain in arm to be related to Shingrix. Additional Information: GSK receipt date: 09-JUL-2025 The reporter was the patient. She received her first Shingrix dose in Mar or Apr 2025 and had no problems. On 3rd July 2025 she received her second Shingrix dose in her left arm. She has had left arm pain since then. On 4th July she developed body aches that lasted through 5th July. On 6th July she developed shingles on her left lower abdomen and back. On 6th July she developed pain to the left side of her body. On 6th July she developed a cold sore). She had no prior history of shingles or cold sores. On 7th Jul 2025 she saw her doctor and started treatment with Valtrex and gabapentin. Nothing else was reported.
Cardiac failure (Heart failure)
Medical History/Concurrent Conditions: Cancer (cancer survivor); Zoster vaccination live-attenuated (Zoster vaccination live-attenuated several years ago)
SHINGRIX