Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site mass, Injection site swelling, Loss of personal independence in daily activities, Malaise, Migraine
Clinical narrative: Rash recurs every 2 weeks/non-itchy non-blistered rash on his trunk and back/Pain; sunburn-like rash; Sometimes bruises; increased blood pressure; Non-stop nausea; Non-stop migraine; Prevent normal everyday activities; Product Complaint; Softball-size lump at the injection site; injection site swelling; Didn't feel right; This case was reported by a consumer via call center representative and described the occurrence of injection site lump in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number P7K5P, expiry date 10th September 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included prednisone for blood pressure.   The patient's past medical history included optic nerve infarction, unilateral blindness, spinal cord compression and back surgery.   On 28th July 2022, the patient received the 1st dose of Shingrix (intramuscular). On 30th July 2022, the patient started prednisone at an unknown dose and frequency. On 28th July 2022, less than a day after receiving Shingrix, the patient experienced injection site lump, injection site swelling, feeling unwell, nausea, migraine, activities of daily living impaired and product complaint. On 30th July 2022, the patient experienced painful rash, burning sensation, contusion and increased blood pressure. On an unknown date, the outcome of the injection site lump, injection site swelling, feeling unwell and increased blood pressure were recovered/resolved and the outcome of the painful rash, burning sensation, contusion, nausea, migraine and activities of daily living impaired were not recovered/not resolved and the outcome of the product complaint was unknown.   It was unknown if the reporter considered the injection site lump, injection site swelling, feeling unwell, painful rash, burning sensation, contusion, increased blood pressure, nausea, migraine and activities of daily living impaired to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: This case was self reported by the patient.  Neither the patient nor anyone else had previously reported this complaint to our company.  The patient received first Shingrix.  The patient reported that something was wrong with this particular Shingrix batch. The patient did not feel right after the injection and developed a softball size lump at the injection site. Two days later, the patient experienced a painful, sunburn like, non-itchy, non-blistered rash on his trunk and back. The patient went to the emergency room and was treated with prednisone, and blood pressure increased. The patient reported the prednisone increased his blood pressure. The patient developed rash recurs every two weeks and sometimes includes bruises. Since receiving the vaccine, the patient had non-stop nausea and migraine. The nausea and migraine prevent normal everyday activities.  Nothing, including Botox, controls migraine. femer Nothing relieves his nausea.  The patient saw a neurologist and had a brain scan and blood work, which were negative.  The patient was then referred to an allergist who requested a vaccine sample.  Related adverse event and product quality complaint reports filed under the same case.  The reporter consented to follow up. After 2 days, the patient experienced painful rash, burning sensation, contusion and increased blood pressure. The causality of prednisone was unknown with increased blood pressure. Additional supportive information: This case had been linked with US2022AMR146719, reported by same patient.; Sender's Comments:  US-GSK-US2022AMR146719:same patient