Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | IM / LA |
Chills; Fever; Fatigue/slept all day; body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date). Concurrent medical conditions included atrial fibrillation. Concomitant products included methotrexate, prednisone and evolocumab (Repatha). On 25-FEB-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 25-FEB-2025, less than a day after receiving Shingrix, the patient experienced chills (Verbatim: Chills), fever (Verbatim: Fever), fatigue (Verbatim: Fatigue/slept all day) and general body pain (Verbatim: body aches). The patient was treated with paracetamol (Tylenol). The outcome of the chills, fever, fatigue and general body pain were not resolved. It was unknown if the reporter considered the chills, fever, fatigue and general body pain to be related to Shingrix. It was unknown if the company considered the chills, fever, fatigue and general body pain to be related to Shingrix. Additional Information: GSK Receipt Date: 27-FEB-2025 The patient received the 2nd dose of Shingrix shot at a local pharmacy. The patient states that he was given a list to check of what medications he was taking, Methotrexate (3 tablets a week and ,physician increased to 6 a week (strength not provided) and Prednisone, and they were in the list. He states, still gave the 2nd shot. The patient reports that he was not taking Methotrexate when he received the 1st dose. The patient reports that he has atrial fibrillation and takes medications for the heart. He also reports taking Repatha 140 mcg every morning. The patient did not recall the date of Shingrix 1st dose, but states that he did not experience any side effects with the 1st dose. The patient reports that the side effects of the 2nd dose started that same evening. He reported having chills that last about an hour, and fever of 100.6 when the fever started. The patient reports he was still hot on 26-February-2025. The patient reports had fatigue and states he slept all day. The patient reported body aches as well. The patient took Tylenol every 4 hours. The patient reports about Shingrix 2nd shot, felt like crap and still not feeling better.
Atrial fibrillation
Methotrexate; Prednisone; Repatha
Test Date: 20250225; Test Name: Body temperature; Result Unstructured Data: (Test Result:100.6,Unit:degree C,Normal Low:,Normal High:)