Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Urgent care due to inflammation at injection site; Itchy at injection site; injection pain at site; Hypertensive BP 158/91; Headache; Redness, swelling at injection site - right arm; Redness, swelling at injection site - right arm/ Swelling continued; Temp 101.7 degree F; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site inflammation in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of injection site pruritus (1st dose was received on unknown date and also she had experienced Injection site pain, kindly refer this case - US2023AMR052446). Additional patient notes included no prior history of hypertension.  On 11-FEB-2022, the patient received the 2nd dose of Shingrix (right arm). On 12-FEB-2022, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Temp 101.7 degree F). On 14-FEB-2022, the patient experienced injection site erythema (Verbatim: Redness, swelling at injection site - right arm) and injection site swelling (Verbatim: Redness, swelling at injection site - right arm/ Swelling continued). On 16-FEB-2022, the patient experienced injection site inflammation (Verbatim: Urgent care due to inflammation at injection site), injection site itching (Verbatim: Itchy at injection site), injection site pain (Verbatim: injection pain at site), hypertension (Verbatim: Hypertensive BP 158/91) and headache (Verbatim: Headache). The patient was treated with ambiguous medication nos (Claritin (Nos)). Rechallenge with Shingrix was positive. The outcome of the injection site inflammation, injection site itching, injection site pain and injection site erythema were resolving and the outcome of the injection site swelling was not resolved and the outcome of the hypertension and fever were unknown and the outcome of the headache was not reported.  It was unknown if the reporter considered the injection site inflammation, injection site itching, injection site pain, injection site erythema, injection site swelling, hypertension, headache and fever to be related to Shingrix.  It was unknown if the company considered the injection site inflammation, injection site itching, injection site pain, injection site erythema, injection site swelling, hypertension, headache and fever to be related to Shingrix.  Linked case(s) involving the same patient: US2023052528, US2023AMR052446   Additional Information: GSK Receipt Date: 09-APR-2023 and 11-APR-2023 The reporter stated that, the patient had received the 2nd dose of the Shingrix vaccine in the right arm and had fever 101.7degree F, redness, swelling at injection site - right arm.  She went to urgent care due to inflammation, itchy at injection site (right arm), hypertension BP 158/91.  She took Claritin on 16 February 2022 and had felt better.  She usually tolerate vaccines without any issues. The reporter had consented to follow-up. 3 days after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. 5 days after receiving Shingrix, the patient experienced injection site itching, injection site pain, hypertension and headache.; Sender's Comments:  US-GSK-US2023AMR052446:Same reporter US-GSK-US2023052528:Same reporter - FU1 - deleted.