Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Affected area faded to a purplish-greenish bruise; Injection site became swollen; Injection site became inflamed; Injection site became painful; Injection site became itchy; This non-serious case was reported by a consumer and described the occurrence of injection site swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number Z3H93, expiry date 07-JUL-2024) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of injection site reaction (received Flu vaccine in 2021). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 17-MAY-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Injection site became swollen), injection site inflammation (Verbatim: Injection site became inflamed), injection site pain (Verbatim: Injection site became painful), injection site itching (Verbatim: Injection site became itchy) and injection site bruising (Verbatim: Affected area faded to a purplish-greenish bruise). The outcome of the injection site swelling, injection site inflammation, injection site pain and injection site itching were resolved (duration 5 days) and the outcome of the injection site bruising was not reported.   It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain, injection site itching and injection site bruising to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site inflammation, injection site pain, injection site itching and injection site bruising to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAY-2023 The patient reported that she was doing detective work to try and discover what it was she reacted to from one of Shingles vaccines. The patient had a shingles vaccine series and had a localized reaction at the injection site only with the second shot.  The patient stated that if possible, she would like to know what the difference was and if any, between the ingredients in the first shot versus the second one.  The patient only reacted to the second Shingle shot and it was the same reaction that she also had to a flu vaccine back in 2021. The manufacturer of flu vaccine was completely different, and she was unable to locate further information on it. The patient stated that was it possible to tell her if there was a difference in ingredients used for the above mentioned GSK vaccines. The reaction she had was a 3 inch diameter circle around the injection site which became swollen, inflamed, painful, and itchy. The effect lasted five days until the affected area faded to a purplish-greenish bruise. The patient stated that she will attach a picture and that mentioned vaccines were for Shingles. The patient stated that the information was very important to her and if she can avoid vaccines that contain whatever ingredient she reacted to going forward, she would very much like that.  The patient stated that it was very bothersome, and she would prefer not to experience it again. The patient stated that if needed any further information, please feel free to contact her.