Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site pruritus, Injection site swelling, Limb discomfort
Clinical narrative: suddenly started getting what she thought was eye infections, but turned out to be an auto-immune issue after injection; injection site had swollen so much the patient stated it was like a big donut ring around it; Unable to move right arm due to discomfort (arm of injection); itching around injection site; still experiences pain in the general 4 or 5 inch area of the injection site; redness on face and neck; warmth on face and neck; unable to move her right arm due to discomfort; flu-like symptoms; body aches; nausea; itching around injection site and face and neck; This serious case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-FEB-2024, the patient received Shingrix (right arm). On 06-FEB-2024, several hours after receiving Shingrix, the patient experienced autoimmune disorder (Verbatim: suddenly started getting what she thought was eye infections, but turned out to be an auto-immune issue after injection) (serious criteria GSK medically significant), extensive swelling of vaccinated limb (Verbatim: injection site had swollen so much the patient stated it was like a big donut ring around it), injected limb mobility decreased (Verbatim: Unable to move right arm due to discomfort (arm of injection)), injection site itching (Verbatim: itching around injection site), injection site pain (Verbatim: still experiences pain in the general 4 or 5 inch area of the injection site), red face (Verbatim: redness on face and neck), skin warm (Verbatim: warmth on face and neck), discomfort (Verbatim: unable to move her right arm due to discomfort), influenza-like symptoms (Verbatim: flu-like symptoms), general body pain (Verbatim: body aches), nausea (Verbatim: nausea) and pruritus facial (Verbatim: itching around injection site and face and neck). On 15-FEB-2024, the outcome of the autoimmune disorder, extensive swelling of vaccinated limb, injected limb mobility decreased, injection site itching, red face, skin warm, discomfort, influenza-like symptoms, general body pain, nausea and pruritus facial were resolved (duration 9 days). The outcome of the injection site pain was not resolved.   The reporter considered the autoimmune disorder to be possibly related to Shingrix. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injected limb mobility decreased, injection site itching, injection site pain, red face, skin warm, discomfort, influenza-like symptoms, general body pain, nausea and pruritus facial to be related to Shingrix.     The company considered the autoimmune disorder to be possibly related to Shingrix. It was unknown if the company considered the extensive swelling of vaccinated limb, injected limb mobility decreased, injection site itching, injection site pain, red face, skin warm, discomfort, influenza-like symptoms, general body pain, nausea and pruritus facial to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2024 The patient self-reported this case. The patient stated that she received the vaccine on her upper right arm and within a few hours she started experiencing what she thought was normal side effects, but by the next day the symptoms were increasingly worse.  The injection site had swollen so much the patient stated it was like a big donut ring around it, and she also began experiencing redness, and warmth on face and neck, as well as itchiness and the patient was unable to move her right arm due to discomfort.  The patient also began experiencing flu-like symptoms such as body aches and nausea.  The patient's symptoms mostly subsided after around 9 days, but she stated her right arm had never been the same, she still experienced pain in the general 4 or 5 inch area of the injection site.  The patient also started suddenly getting what she believed were eye infections, but turned out to be an auto-immune thing that she believed might had something to do with the vaccine.