Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Pain, redness, and swelling at the injection site; Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering; Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering; Muscle pain; 29-JUL-2025 00:00Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering; Headache; Shivering; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Concomitant products included tirzepatide (Mounjaro). On 29-JUL-2025, the patient received Shingles vaccine. On 29-JUL-2025, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Pain, redness, and swelling at the injection site), injection site erythema (Verbatim: Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering), injection site swelling (Verbatim: Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering), muscle pain (Verbatim: Muscle pain), tiredness (Verbatim: 29-JUL-2025 00:00Pain, redness, and swelling at the injection site Muscle pain Tiredness Headache Shivering), headache (Verbatim: Headache) and shivering (Verbatim: Shivering). The outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering were not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering to be related to Shingles vaccine. It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache and shivering to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 30-JUL-2025 The patient had pain, redness, and swelling at the injection site, muscle pain, tiredness, headache and shivering from 29 Jul 2025.
MOUNJARO