Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood test abnormal, Burning sensation, Dyspepsia, Erythema
Clinical narrative: started having pains on my left side of torso; burning sensation; was not able to eat; rash; redness; liver enzymes were elevated; heartburn; nauseou; I had so many GI side effects for 3 weeks; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of gastrointestinal disturbance in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, immediately after receiving Shingrix, the patient experienced gastrointestinal disturbance (Verbatim: I had so many GI side effects for 3 weeks), heartburn (Verbatim: heartburn) and nausea (Verbatim: nauseou). On an unknown date, the patient experienced upper abdominal pain (Verbatim: started having pains on my left side of torso), burning sensation (Verbatim: burning sensation), unable to eat (Verbatim: was not able to eat), rash (Verbatim: rash), erythema (Verbatim: redness) and elevated liver enzymes (Verbatim: liver enzymes were elevated). The outcome of the gastrointestinal disturbance was resolved (duration 3 weeks) and the outcome of the heartburn, nausea, upper abdominal pain, burning sensation, unable to eat, rash and erythema were not reported and the outcome of the elevated liver enzymes was resolving.   It was unknown if the reporter considered the gastrointestinal disturbance, heartburn, nausea, upper abdominal pain, burning sensation, unable to eat, rash, erythema and elevated liver enzymes to be related to Shingrix.     It was unknown if the company considered the gastrointestinal disturbance, heartburn, nausea, upper abdominal pain, burning sensation, unable to eat, rash, erythema and elevated liver enzymes to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2023 The pharmacist reported that she got her first dose in February and had so many GI side effects for 3 weeks right after taking the dose. It started with heartburn and nauseous. Then she started having pains and a burning sensation on her left side of torso where the stomach was located. She was not able to eat due to how she was feeling. She actually thought she had stomach cancer or something.  After seeing her primary care physician and doing several tests, her liver enzymes were elevated but ultrasound came back normal. Her liver enzymes were fine on her blood work last year and there really was not an explanation on why they were elevated.  She had blood work done again about a month later, and the enzymes had come down but were still a bit high.  The reporter stated that the whole thing was actually miserable and scary.  She knew she was due for her second dose, but she was so scared to take it and have 3 weeks of the same side effects.  The reporter asked if it was seen before with Shingrix. She had the rash and redness which she knew was normal. She was looking of guidance on what should be done. She did not want Shingrix, and she knew the importance of the vaccine as she was a pharmacist herself.  The reporter consented to follow up.