Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Burn oral cavity, Fatigue, Feeling hot, Injection site pain
Clinical narrative: for unable to brush their teeth due to the pain; patient spent all day in bed; Burn inside mouth; Fatigue; incredible thirst; Feverish feeling; Pain at injection site; rash several inches below; Pain; blistering; This serious case was reported by a consumer via call center representative and described the occurrence of burned mouth in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-MAY-2023, the patient received the 2nd dose of Shingrix (right arm). In MAY-2023, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site), rash (Verbatim: rash several inches below), thirst (Verbatim: incredible thirst), feeling hot (Verbatim: Feverish feeling), pain (Verbatim: Pain) and blistering of mouth (Verbatim: blistering). On 16-MAY-2023, the patient experienced burned mouth (Verbatim: Burn inside mouth) (serious criteria GSK medically significant), fatigue (Verbatim: Fatigue) and bedridden (Verbatim: patient spent all day in bed). On an unknown date, the patient experienced activities of daily living impaired (Verbatim: for unable to brush their teeth due to the pain). On 18-MAY-2023, the outcome of the fatigue was resolved (duration 2 days). The outcome of the burned mouth and rash were not resolved and the outcome of the injection site pain, thirst and feeling hot were resolved and the outcome of the bedridden and activities of daily living impaired were not reported and the outcome of the pain and blistering of mouth were unknown.   It was unknown if the reporter considered the burned mouth, injection site pain, rash, fatigue, thirst, feeling hot, bedridden, pain, blistering of mouth and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the burned mouth, injection site pain, rash, fatigue, thirst, feeling hot, bedridden, pain, blistering of mouth and activities of daily living impaired to be related to Shingrix.   Additional Information: Additional Information: GSK receipt date: 19-MAY-2023. The reporter was husband of patient.  It was reported patient received second dose of Shingrix, in the right arm and patient experienced pain at the injection site. Patient developed a rash several inches below the injection site, on the right arm.  The patient experienced fatigue which lasted Tuesday through Thursday. And spent all day in bed on Tuesday and Wednesday, due to the fatigue.  The patient reported feeling feverish but did not have a fever.  The patient experienced incredible thirst. And developed what appears to be a burn on the roof of the mouth on Tuesday. It was reported burn on roof of patient's mouth worsened and spread on Wednesday, to the point patient was unable to brush their teeth due to the pain.  The patient stated the burn on the roof of the mouth feels as though it's blistering and likened it to feeling as though they tried to eat something too hot, and it burned the interior of their mouth. The patient stated fatigue, pain at injection site, feverish feeling, and thirst had resolved. And rash on arm was still visible and burn on the roof of the mouth is ongoing. The reporter consented to follow up.