Age: 55.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Swollen tongue, Urticaria
Clinical narrative: Hives; Lip swelling; Tongue swelling; wanted to vomit; almost passed out; right arm burns; Torso and Stomach  Numbness; formed red band around arm; right arm burns, and itches; vaccine site hurt, sore; arm started to feel very hot/ Hot feet, hands; eyes were red; arm got swollen; area was full of fluid; deep penetrating itching at injection site; large scab at injection site; COVID; Bruising; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   Concurrent medical conditions included latex allergy.   On 16th September 2022, the patient received the 1st dose of Shingrix (intramuscular) and Flu vaccine. In September 2022, less than 2 weeks after receiving Shingrix and Flu vaccine, the patient experienced contusion. On 19th September 2022, the patient experienced covid-19. On 23rd September 2022, the patient experienced injection site itching and injection site scab. On 9th October 2022, the patient experienced injection site pain, feeling hot, eye red, swelling arm, fluid retention and itchy upper limbs. On 10th October 2022, the patient experienced erythema of extremities. On an unknown date, the patient experienced hives, lip swelling, swollen tongue, nausea, presyncope, burning sensation and body numbness. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site itching, injection site scab, injection site pain, covid-19, contusion, feeling hot, eye red, swelling arm, fluid retention, hives, lip swelling, swollen tongue, nausea, presyncope, erythema of extremities and body numbness were unknown and the outcome of the burning sensation and itchy upper limbs were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site scab, injection site pain, covid-19, contusion, feeling hot, eye red, swelling arm, fluid retention, hives, lip swelling, swollen tongue, nausea, presyncope, burning sensation, itchy upper limbs, erythema of extremities and body numbness to be related to Shingrix and Flu vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comments: The reporter was a female patient.  The reporter stated that on 16th September 2022, she received her 1st dose of Shingrix vaccine. Patient had the vaccine in her right arm. The patient reported that she had a Flu vaccine in the left arm on the same day.  She reported that on 19th September she and her spouse were diagnosed with Covid. The patient reported she was allergic to Latex.  A week and half later she started a deep penetrating itching and believed bruised. The patient reported that the itching was only at the injection site and it started around 23rd September 2022.  The itching continued and it form a large scab at injection site.  On 9th October 2022, the patient ate a banana and she was not allergic to banana.  This was when the deep itching started. Patient reported that about 15 minutes after she ate the banana, she put a bag hanging from the right arm and it started to feel very hot the bag touched the vaccine site and it hurt and was sore, her eyes were red ,the arm got swollen and the area was full of fluid Patient states she had hives from head to toe lip swelling and tongue swelling. She wanted to vomit, and she almost passed out.  The patient was taking 3 to 4 Benadryl during the day. Her right arm burns, and itches still and she noticed on 10th October 2022, that it formed like a red band around the right arm  The reporter was consented to follow up.