Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Mass at injection site (deltoid muscle), solid and paiful to touch; Rash on neck involved swelling/ass felt very solid and painful to touch and seemed to be located in or near the deltoid muscle; Itchy rash, itching, sevre reaction/rash began to itch; Fever of 100-101; Blurred vision; Rash felt akin to being burned; Rash at the injection site, red and splotchy; Rash are still red/rash was red; Hives; Rash spread all over body, one big red mass/Rash are still sore; Rash are still warm to touch; rash was red and splotchy; having to miss two days of work; Discomfort at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site mass in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAR-2023, the patient received the 1st dose of Shingrix (right arm). In MAR-2023, less than a week after receiving Shingrix, the patient experienced injection site mass (Verbatim: Mass at injection site (deltoid muscle), solid and paiful to touch), injection site discomfort (Verbatim: Discomfort at the injection site), swelling (Verbatim: Rash on neck involved swelling/ass felt very solid and painful to touch and seemed to be located in or near the deltoid muscle) and activities of daily living impaired (Verbatim: having to miss two days of work). On 16-MAR-2023, the patient experienced injection site rash (Verbatim: Rash at the injection site, red and splotchy), red rash (Verbatim: Rash are still red/rash was red), hives (Verbatim: Hives), painful rash (Verbatim: Rash spread all over body, one big red mass/Rash are still sore), burning sensation (Verbatim: Rash felt akin to being burned), skin warm (Verbatim: Rash are still warm to touch) and red spotty rash (Verbatim: rash was red and splotchy). On 19-MAR-2023, the patient experienced fever (Verbatim: Fever of 100-101) and blurred vision (Verbatim: Blurred vision). On 20-MAR-2023, the patient experienced itchy rash (Verbatim: Itchy rash, itching, sevre reaction/rash began to itch). The patient was treated with benadryl (nos) (Benadryl). In MAR-2023, the outcome of the injection site mass and swelling were recovered/resolved. The outcome of the injection site rash, injection site discomfort, red rash, painful rash, itchy rash, skin warm and red spotty rash were not recovered/not resolved and the outcome of the hives and fever were recovered/resolved and the outcome of the burning sensation was not reported and the outcome of the blurred vision was recovering/resolving and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the injection site mass, injection site rash, injection site discomfort, red rash, hives, painful rash, swelling, burning sensation, fever, blurred vision, itchy rash, skin warm, red spotty rash and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the injection site mass, injection site rash, injection site discomfort, red rash, hives, painful rash, swelling, burning sensation, fever, blurred vision, itchy rash, skin warm, red spotty rash and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt date: 21-Mar-2023. Caller is the patient. Patient reported immediately developing a rash at the injection site. Patient reported rash was red and splotchy and contained hives.  Patient reported a mass developed at the injection site late on Thursday night or on Friday.  Patient reported mass felt very solid and painful to touch and seemed to be located in or near the deltoid muscle.  Patient had reported rash began to spread on Sunday.Rash spread from their right arm, across their chest, and soon encompassed the entirety of the patient's body down to their ankles.  Patient had reported that rash was one big, red mass once it had covered the entirety of their body.  Patient reported rash also spread up their neck and onto their scalp.  Patient reported rash on the neck involved swelling. Patient stated that rash felt akin to being burned.  Patient reported experiencing complete blurred vison on Sunday. Patient reported rash began to itch on Monday. Patient stated that rash was no longer covering their entire body, but still remains in patches throughout the body.  Patient reported the patches of rash are still itchy. Patient reported the areas on their neck and chest affected by the rash are still sore.  Patient reported having to miss two days of work due to having to take Benadryl for the itch.  Patient reported HCP has advised they do not receive second dose of Shingrix. The reporter consent to follow up.