Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness, Urticaria
Clinical narrative: feeling nauseous; Headache; had unspecified gastrointestinal symptoms; rash where vaccine was administered; Redness at Injection Site; Muscle Ache in Arm; Heaviness in Arm; Tightness in Arm; Stiffness in Arm; Swelling in Arm; bump on her buttock and more bumps on her legs; fever with no specific onset or duration; chills which is on an off; developing an itchy rash on her back/welps; an itchy rash on her back which turned into hives described as welps; Rash on back on the top left and almost to the center of back/for breaking out on her right foot in between her toes; Eye Swelling; Blood pressure decreased; Itchy Legs; Tender Legs / sore legs; This case was reported by a consumer via call center representative and described the occurrence of hives in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number T2472, expiry date 23rd January 2022) for prophylaxis.   Concurrent medical conditions included esophageal acid reflux, systemic lupus erythematosus, hypothyroidism, migraine, latex allergy, iodine allergy, milk allergy and allergy (allergy to sulfur).   On 10th December 2019, the patient received the 1st dose of Shingrix (unknown). On 10th December 2019, immediately after receiving Shingrix and an unknown time after starting Clobetasol, the patient experienced hives, itchy rash and rash. On 11th December 2019, the patient experienced fever and chills. On 12th December 2019, the patient experienced local swelling. In December 2019, the patient experienced itchy legs, leg pain, eye swelling and blood pressure decreased. On 16th December 2019, the patient experienced injection site rash, injection site erythema, myalgia upper extremities, heaviness in arm, muscle tightness, limbs stiffness and swelling arm. On 22nd December 2019, the patient experienced gastrointestinal symptom nos. On 23rd December 2019, the patient experienced nausea and headache. The patient was treated with benadryl (nos) (Benadryl), dermatologicals nos (Anti Itch Lotion (Nos)), clobetasol propionate (Clobetasol), dermatologicals nos (Calamine Lotion), dermatologicals nos (Oatmeal Baths (Nos)) and steroids nos (Steroids). On an unknown date, the outcome of the hives, itchy rash, rash, fever, local swelling, injection site rash, injection site erythema, myalgia upper extremities, heaviness in arm, muscle tightness, limbs stiffness, swelling arm, itchy legs, leg pain, gastrointestinal symptom nos, eye swelling, headache and blood pressure decreased were unknown and the outcome of the chills and nausea were not recovered/not resolved.   It was unknown if the reporter considered the hives, itchy rash, rash, fever, chills, local swelling, injection site rash, injection site erythema, myalgia upper extremities, heaviness in arm, muscle tightness, limbs stiffness, swelling arm, itchy legs, leg pain, gastrointestinal symptom nos, eye swelling, nausea, headache and blood pressure decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left arm and immediately developing an itchy rash on her back which turned into hives described as welps. The patient tried Benadryl, anti-itch cream, Clobetasol, medicated powder, calamine lotion, oatmeal bath soap, unscented Dove soap, and baby wash with little relief. Her doctor gave a steroid shot and other medication.  The caller still continuously suffering with rash on back. Rash on back described as being on the top left almost to the center of back.  The next day after vaccination caller reported chills which is on an off.  The consumer also reported a fever with no specific onset or duration. Two days later caller reported a bump on her buttock and then more bumps on her legs. Six days following Shingrix vaccination,caller reports rash and redness where vaccine was administered, muscle ache in arm as well as heaviness, stiffness, tightness and swelling in the arm. At an unspecified time frame consumer reported breaking out on her right foot in between her toes. Breakout described as feeling like bed bug bites or scabies.  The caller reported her legs itched and they were tender and sore and had unspecified gastrointestinal symptoms other than flaring up of acid reflux that has been controlled and not bothersome while on maintenance medicine. This morning caller reports having a headache and feeling nauseous and taking medication that she had for migraine. She also reported swelling around eyes and a blood pressure which was lower than usual. Currently, consumer states the thermostat in her house is set to 85 F but she is cold with her insulated onesie pajamas and 3 blankets.