Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 75d3a | IM / RA |
got an itchy rash, size of a dime, near the injection site; got an itchy rash, size of a dime, near the injection site; I've had minor headaches the last few days; bleeding during the injection; I got a sore arm; bruised arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 75d3a, expiry date 31-MAR-2027) for prophylaxis. The patient's past medical history included shingles (Mild case of shingles in the past). Concurrent medical conditions included thyroid disorder. Concomitant products included levothyroxine sodium (Levothyroxine). On 21-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). In MAY-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: I got a sore arm) and bruising of arm (Verbatim: bruised arm). On 21-MAY-2025, the patient experienced injection site hemorrhage (Verbatim: bleeding during the injection). On 27-MAY-2025, the patient experienced injection site rash (Verbatim: got an itchy rash, size of a dime, near the injection site), injection site itching (Verbatim: got an itchy rash, size of a dime, near the injection site) and headache (Verbatim: I've had minor headaches the last few days). The patient was treated with ibuprofen sodium (Ibuprofen). On 28-MAY-2025, the outcome of the headache was resolved (duration 1 day). The outcome of the injection site rash and injection site itching were not resolved and the outcome of the injection site hemorrhage, pain in arm and bruising of arm were unknown. It was unknown if the reporter considered the injection site rash, injection site itching, injection site hemorrhage, pain in arm, bruising of arm and headache to be related to Shingrix. It was unknown if the company considered the injection site rash, injection site itching, injection site hemorrhage, pain in arm, bruising of arm and headache to be related to Shingrix. Additional Information: GSK Receipt Date : 28-MAY-2025 The patient received Shingrix and experienced sore and bruised arm. The day before reporting, she got an itchy rash, size of a dime, near the injection site. She had minor headaches the last few days, treatable with ibuprofen. Then the patient was called and she provided further details. She stated that she took a photo of the rash yesterday when it showed up. She mentioned that it was very itchy. The Shingrix shot number one was administered intramuscularly in the upper right arm and there was bleeding during the injection. She indicated that this was unusual as she normally did not bleed during a vaccination. She was not on aspirin. She indicated that she had a mild headache yesterday and also on the day of reporting. Each headache was treated with ibuprofen and resolved. She stated that headaches were uncommon for her, she said she hardly got headaches.
Thyroid disorder
Medical History/Concurrent Conditions: Shingles (Mild case of shingles in the past)
Levothyroxine