Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Painful; Red/ arm is pretty red today, extending out from the bruised area; Feeling hot; Sore Arm/ left arm is sore; Bruised; arm hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (patient had not a bad case of shingles years ago when she was about 30 years old (pre-existing Shingrix).). Previously administered products included shingles vaccine (she had the one injection shingles vaccine years ago). Concurrent medical conditions included anemia (The patient states that her arm could be sore due to being weak because of anemia and having had a blood transfusion at the hospital (pre-existing Shingrix)). On 21-OCT-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 21-OCT-2025, less than a day after receiving Shingrix, the patient experienced injection site bruising (Verbatim: Bruised), pain (Verbatim: arm hurt), feeling hot (Verbatim: Feeling hot) and pain in arm (Verbatim: Sore Arm/ left arm is sore). On 22-OCT-2025, the patient experienced injection site erythema (Verbatim: Red/ arm is pretty red today, extending out from the bruised area). On an unknown date, the patient experienced pain (Verbatim: Painful). The outcome of the injection site bruising, pain, injection site erythema, feeling hot, pain in arm and pain were not resolved. It was unknown if the reporter considered the injection site bruising, pain, injection site erythema, feeling hot, pain in arm and pain to be related to Shingrix. It was unknown if the company considered the injection site bruising, pain, injection site erythema, feeling hot, pain in arm and pain to be related to Shingrix. Additional Information: GSK Receipt Date: 22-OCT-2025 It was reported that patient was a female that received her first dose of Shingrix yesterday, 21-OCT-2025 in her left arm, and stated that her arm hurt yesterday and it was a really painful injection. The patient stated that her left arm bruised at the injection site yesterday and was still bruised. The patient stated that her left arm was "real hot" and that started immediately after receiving the vaccine. The patient stated she had no fever. The patient stated that her left arm was sore, and it woke her up during the night, and was still sore. The patient stated that her arm could be sore due to being weak because of anemia and having had a blood transfusion at the hospital (pre-existing Shingrix). The patient stated that she had not a bad case of shingles years ago when she was about 30 years old (pre-existing Shingrix). The patient stated that she had the one injection shingles vaccine years ago (no further information provided, unknown product information). The patient had no paperwork to provide the lot/expiry to verify the product but stated that this was the 2-dose vaccine she received. The patient stated she "takes 28 pills" but did not want to provide those in the call. The patient stated she had "a lot of health problems" (no further information provided) and interrupted when asked for medical history. The batch number was not provided and a request for this information has been made.
Anemia (The patient states that her arm could be sore due to being weak because of anemia and having had a blood transfusion at the hospital (pre-existing Shingrix))
Medical History/Concurrent Conditions: Shingles (patient had not a bad case of shingles years ago when she was about 30 years old (pre-existing Shingrix).)