Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pyrexia, Sleep disorder
Clinical narrative: the area where the injection had been given on the arm ballooned up or swelled up; that arm and also it itched; shoulder was a little sore; he could not sleep; Incomplete course of vaccination; really sore and he could not sleep on that arm; had a fever develop; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (The patient stated that as a child his mother told him that his case of chicken pox was so mild that all he had was one pox on his neck.). Family history included shingles (patient aunt had an outbreak of shingles).   In NOV-2022, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, the patient received the 2nd dose of Shingrix. In NOV-2022, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever (Verbatim: had a fever develop). On an unknown date, the patient experienced injection site swelling (Verbatim: the area where the injection had been given on the arm ballooned up or swelled up), injection site itching (Verbatim: that arm and also it itched), injection site pain (Verbatim: really sore and he could not sleep on that arm), shoulder pain (Verbatim: shoulder was a little sore), difficulty sleeping (Verbatim: he could not sleep) and incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the injection site swelling, injection site itching, shoulder pain and difficulty sleeping were resolved and the outcome of the injection site pain was resolved (duration 2 weeks) and the outcome of the fever was resolved (duration 1 day) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site swelling, injection site itching, injection site pain, fever, shoulder pain and difficulty sleeping to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site itching, injection site pain, fever, shoulder pain and difficulty sleeping to be related to Shingrix.   Additional Information: GSK Receipt Date: 1-JUN-2023. The patient had Shingrix shot 1 around Holiday 2022 (November 2022).  The patient had not had Shingrix shot 2 yet.  The patient was not sure if he had passed the 6-month window or not. He did not had the exact date of shot 1 available. After Shingrix shot 1 patient had a fever develop later the day of the shot but it resolved the next morning.  He said he felt hot so he took his temperature; it was 101 degrees but the fever resolved after patient got up out of bed later the next day after the shot. After Shingrix shot number 1 patient reported that shoulder was a little sore due to the needle stick but it recovered quickly. But then 10 to 14 days afterwards the area where the injection had been given on the arm ballooned up or swelled up about 2 Inches such that it looked like his bicep muscle was on his shoulder. It was really sore for about 2 weeks.  It was a huge area and it was really sore and patient could not sleep on that arm and also it itched. There was no rash. All events had resolved. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.