Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Discomfort, Fatigue, Feeling cold
Clinical narrative: he was hot; uncomfortable; feel tired; minor stomach discomfort; severe shivers; cold; temperature of 99.9F; nightmares; pain in his arm; he was so cold he had to put clothes on; couldn't sleep; he was very thirsty; This non-serious case was reported by a consumer via call center representative and described the occurrence of stomach discomfort in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (twice diagnosed with shingles). Previously administered products included Shingrix with an associated reaction of fatigue (In August 2024, 1st dose was received and experienced tiredness, for the tolerance of previous dose refer case - US2024AMR139212). Concurrent medical conditions included renal disease.   On 06-NOV-2024, the patient received the 2nd dose of Shingrix. On 06-NOV-2024, less than a day after receiving Shingrix, the patient experienced stomach discomfort (Verbatim: minor stomach discomfort). On 07-NOV-2024, the patient experienced discomfort (Verbatim: uncomfortable), tiredness (Verbatim: feel tired) and feeling hot (Verbatim: he was hot). In NOV-2024, the patient experienced shivers (Verbatim: severe shivers), cold (Verbatim: cold), body temperature (Verbatim: temperature of 99.9F), nightmare (Verbatim: nightmares), thirst (Verbatim: he was very thirsty), pain in arm (Verbatim: pain in his arm), feeling cold (Verbatim: he was so cold he had to put clothes on) and sleeplessness (Verbatim: couldn't sleep). Rechallenge with Shingrix was positive. The outcome of the stomach discomfort, shivers, cold, body temperature, nightmare, discomfort, thirst, feeling hot, pain in arm and sleeplessness were unknown and the outcome of the tiredness was resolving and the outcome of the feeling cold was not reported.   It was unknown if the reporter considered the stomach discomfort, shivers, cold, body temperature, nightmare, discomfort, tiredness, thirst, feeling hot, pain in arm, feeling cold and sleeplessness to be related to Shingrix.     It was unknown if the company considered the stomach discomfort, shivers, cold, body temperature, nightmare, discomfort, tiredness, thirst, feeling hot, pain in arm, feeling cold and sleeplessness to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR139212   Additional Information: GSK Receipt Date: 07-NOV-2024 Patient stated he had his second dose of Shingrix administered. He stated that he had minor stomach discomfort later that evening after the Vaccination. He stated that he went to bed around midnight and had severe shivers and was cold. He stated that he was so cold that he had to put clothes on, including gloves and hat, and extra blankets. He had a temperature of 99 Degree Fahrenheit.  He had nightmares. He reported that he was very thirsty and had to drink water all night long. He stated that he got up earlier than normal the following morning because he was hot and uncomfortable. He reported he did have some pain in his arm but stated that was to be expected. He stated that his reaction to the second dose of Shingrix was unlike anything he had ever experienced before. He stated that when he had his first dose of Shingrix administered the only adverse event he had was that he was tired. He reported that the first dose of Shingrix was administered in August 2024. On 07-NOV-2024 he stated that he does feel tired but felt some better.; Sender's Comments:  US-GSK-US2024AMR139212: