Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | CR5XF | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | CR5XF | IM / LA |
she was still experiencing tingling at injection site of her Shingrix vaccine; tingling in left arm and hand and also her left foot and middle of her back/intermittent tingling; erythemotous area about 2 inches below injection site; Rash faded but still present in initial area; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis. On 16-FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 17-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). In FEB-2024, an unknown time after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced rash (Verbatim: Rash faded but still present in initial area). On 19-FEB-2024, the patient experienced injection site erythema (Verbatim: erythemotous area about 2 inches below injection site). On 20-FEB-2024, the patient experienced tingling of extremity (Verbatim: tingling in left arm and hand and also her left foot and middle of her back/intermittent tingling). On 23-OCT-2024, the patient experienced injection site tingling (Verbatim: she was still experiencing tingling at injection site of her Shingrix vaccine). The outcome of the injection site erythema was unknown and the outcome of the injection site tingling, tingling of extremity and rash were not resolved. It was unknown if the reporter considered the injection site erythema, injection site tingling, tingling of extremity and rash to be related to Shingrix and Shingrix. It was unknown if the company considered the injection site erythema, injection site tingling, tingling of extremity and rash to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 The physician reported that the patient received 2 doses of Shingrix and Fluzone and experienced paresthesia after both vaccines. The Fluzone was received on 31st October 2024 in right arm. The patient had erythemotous area about 2 inches below injection site and then on 20th February 2024 patient called complained of tingling in left arm and hand and also her left foot and middle of her back. On 28th February 2024 the patient complained of intermittent tingling throughout her whole body and the rash faded but still present in initial area. She felt site of erythematous area on left arm was more tingly than the rest of her body and that continued on. The physician sent patient to neurologist who didn't think much of anything and stated symptoms faded out on their own and then MD stated patient got the flu shot (Fluzone) and the symptoms started again. When asked for dates of the symptoms fading out, the MD stated she got call from patient on 23rd October 2024 stating she was still experiencing tingling at injection site of her Shingrix vaccine up her shoulders and down the arm and a little bit in her left leg and that it was very intermittent and very random. The reporter stated patient was still experiencing paresthesia as of today (till the time of reporting)