Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Chest discomfort, Chills, Chromaturia
Clinical narrative: urine was darker; pain at the injection site; she began to experience achiness; joint pain; headache; upset stomach; nausea; acid reflux; pressure in the middle of her chest; having chills/ shivering; fever of 102.4 degrees Fahrenheit; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (For tolerance of 1st dose refer case US2024078060). Concurrent medical conditions included esophageal irritation, hiatal hernia and gastritis.   On 17-JUN-2024, the patient received the 2nd dose of Shingrix. In JUN-2024, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), pain (Verbatim: she began to experience achiness), joint pain (Verbatim: joint pain), headache (Verbatim: headache), upset stomach (Verbatim: upset stomach), nausea (Verbatim: nausea), esophageal acid reflux (Verbatim: acid reflux) and chest pressure (Verbatim: pressure in the middle of her chest). On 18-JUN-2024, the patient experienced chills (Verbatim: having chills/ shivering), fever (Verbatim: fever of 102.4 degrees Fahrenheit) and dark urine (Verbatim: urine was darker). Rechallenge with Shingrix was positive. The outcome of the injection site pain, pain, joint pain and headache were unknown and the outcome of the chills and fever were resolved (duration 2 hrs) and the outcome of the upset stomach, nausea, esophageal acid reflux, chest pressure and dark urine were not resolved.   It was unknown if the reporter considered the injection site pain, pain, joint pain, headache, chills, fever, upset stomach, nausea, esophageal acid reflux, chest pressure and dark urine to be related to Shingrix.     It was unknown if the company considered the injection site pain, pain, joint pain, headache, chills, fever, upset stomach, nausea, esophageal acid reflux, chest pressure and dark urine to be related to Shingrix.   Linked case(s) involving the same patient:  US2024078060   Additional Information: GSK Receipt Date: 21-JUN-2024 The patient reported that she received her 2nd dose and experienced the achiness, headache, joint pain, and pain at the injection site. The 2nd day she was having chills, shivering and fever of 102.4 degrees Fahrenheit. This lasted 2 hours. She was also experiencing an upset stomach with nausea, acid reflux and pressure in the middle of her chest which she described as like reflux. The stomach issues were still present, but she did have a history of gastritis, acid reflux and hiatal hernia and she had taken an Advil to bring down her fever, so she admited this could be the cause of the stomach problems. She stated that on the day after her 2nd dose, she noticed her urine was darker than normal and it has persisted till day of reporting. For tolerance of 1st dose refer case US2024078060.; Sender's Comments:  US-GSK-US2024078060:Another 1st dose case