Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site extravasation, Injection site mass
Clinical narrative: injection site has a big red area which is warm to the touch,red ring, "big knot", flare up; It was 4-5 inches in diameter. It was thicker (described as a "big knot" toward the front of the arm) and seemed to "flare up" and look big but now the "red ring" is reducing in size/going down; injection site has a big red area which is warm to the touch; injection site is sore if you touch it; injection site,  it itches; still fluid from the injection in the arm so she rubbed the injection site area; flu-like symptoms; headache; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Influenza vaccine (prior history of influenza vaccinations) and Covid 19 vaccine (prior history of Covid 19 vaccinations including booster shot). Concurrent medical conditions included idiopathic thrombocytopenia.   On 8th April 2022 15:00, the patient received the 1st dose of Shingrix (intramuscular). On 9th April 2022, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms and headache. On 11th April 2022, the patient experienced injection site erythema, injection site lump, injection site warmth, injection site pain, injection site itching and injection site extravasation. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the injection site lump, injection site warmth, injection site pain, injection site itching and injection site extravasation were not recovered/not resolved and the outcome of the influenza-like symptoms and headache were recovered/resolved.   The reporter considered the injection site erythema, injection site lump, injection site warmth, injection site pain, injection site itching, injection site extravasation, influenza-like symptoms and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-APR-2022  The reporter was the patient.  The patient received 1st dose of Shingrix shot intramuscularly in the left arm, around 3:00 pm on Friday. The patient was not sure if it was in the deltoid muscle, it was more toward the back of the arm.  She did provide the pharmacy's name and address where the shot was given, which should have the lot number/expiration date on file.  On the day of vaccination, patient experienced no side effects.   On 9th April 2022, Saturday and Sunday, she experienced headache and flu-like symptoms.  On Monday, patient had local adverse reactions as she looked at the injection site, the injection site currently (at the time of the report) had a big red area which was warm to the touch; it was sore to touch; and it itched every now and then.  It was 4 to 5 inches in diameter.  It was thicker, as a big knot toward the front of the arm and seemed to flare up and look big but now the red ring was reducing in size/going down.  The patient thought that maybe there was still fluid from the injection in the arm so she rubbed the injection site area, to try to get the fluid to absorb into the muscle.  She had not gone to the physician regarding this. The patient was calling from work so she did not have the paperwork in front of her therefore she was not able to provide the lot number/expiration date of the Shingrix which was administered and thus no further questions were asked, such as her physician contact information. The reporter consented to follow up.