Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Feeling abnormal, Hyperaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Hypersensitivity to touch, like goose bumps; Injection site redness; Injection site swelling; Injection site pain, usual side effects; She described feeling like she had goose bumps/there are no bumps; Skin hypersensitivity/ my skin is hypersensitive to touch for about 2 weeks; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-FEB-2023, the patient received Shingrix (intramuscular, unknown arm). On 06-FEB-2023, 2 hrs after receiving Shingrix, the patient experienced injection site swelling (Verbatim: Injection site swelling) and injection site pain (Verbatim: Injection site pain, usual side effects). On 07-FEB-2023, the patient experienced injection site erythema (Verbatim: Injection site redness). In FEB-2023, the patient experienced feeling abnormal (Verbatim: She described feeling like she had goose bumps/there are no bumps). On 16-FEB-2023, the patient experienced cutaneous hypersensitivity (Verbatim: Skin hypersensitivity/ my skin is hypersensitive to touch for about 2 weeks) and touch sensitivity increased (Verbatim: Hypersensitivity to touch, like goose bumps). The outcome of the touch sensitivity increased and feeling abnormal were not reported.   The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix. It was not reported if the reporter considered the cutaneous hypersensitivity, touch sensitivity increased and feeling abnormal to be related to Shingrix.     The company considered the injection site erythema, injection site swelling and injection site pain to be related to Shingrix. It was not reported if the company considered the cutaneous hypersensitivity, touch sensitivity increased and feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2023 The patient had called at the day of reporting, to asked if hypersensitivity of skin could be a delayed reaction to the Shingrix vaccine as her skin was hypersensitive to touch for about 2 weeks and she was wondering if this could be a delayed side effect of the injection. She reported that on about 16 or 17 February 2023, she began to feel a hypersensitivity to skin beginning on the arm that was vaccinated, then spreading throughout body, including her head. She had no bumps, no discoloration, and no rash. She had denied of having fever or any illness. Nothing was visible on the skin, but she had felt hypersensitivity to touch, even to air.  She described the feeling as if she had goose bumps, but after looking at her skin, she said that, there were no bumps. She also reported that, she had the expected side effects of injection site pain, swelling and redness immediately following her Shingrix vaccine, which had lasted about ten days. Provided medical disclaimer, spoke from Product Information (PI), referred to Healthcare Professional (HCP), provided Medical Information telephone number and gskmedicalaffairs.com website. The reporter had consented to follow-up. Less than a month after receiving Shingrix, the patient experienced touch sensitivity increased and feeling abnormal. 10 days after receiving Shingrix, the patient experienced cutaneous hypersensitivity. 1 day after receiving Shingrix, the patient experienced injection site erythema.