Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Injection site swelling, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 76-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 17th July 2018 without any issues). Concurrent medical conditions included esophageal acid reflux. On 17th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced localized erythema, pruritus, skin peeling and skin disorder. On 17th January 2019, the patient experienced chills, tremor, cold extremities, sweating, fever, pain in arm and chest pain. On 19th January 2019, the patient experienced rash. On an unknown date, the patient experienced skin warm. The patient was treated with Salve (NOS), METHYLPRED and sulfamethoxazole + trimethoprim (Smz/Tmp Ds). On an unknown date, the outcome of the chills, tremor, cold extremities, sweating, fever, pain in arm, skin peeling, skin warm, chest pain, rash and skin disorder were recovered/resolved and the outcome of the localized erythema and pruritus were recovering/resolving. It was unknown if the reporter considered the chills, tremor, cold extremities, sweating, fever, pain in arm, localized erythema, pruritus, skin peeling, skin warm, chest pain, rash and skin disorder to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The patient stated that night after receiving SHINGRIX vaccine she awoke with chills and shaking. The patient hands and feet were very cold, she put on socks and went back to bed. The patient awakened later in a sweat and had a fever of 101.3 degree F. The patient stated she also had pain her arm and into the left side of her chest, which concerned her to the point where she went to the local Emergency room. The patient had blood work, a stress test and an Echo, which was all negative. The patient stated she was there from 6:30 AM to 7 PM on Friday. The patient stated a rash started on Saturday but was full blown on Sunday. The patient experienced bright redness on her chest up under her chin and over to her right ear, but not on her ear. The patient stated it looked like raw meat. The patient noted up under her chin it was weeping and would crystallize on her skin and on her dresser as it fell. The patient called her doctor on Monday for an appointment, and saw him on Tuesday. The patient had been putting an organic salve on the area, which was helping with the itching. The physician also prescribed her METHYLPRED dose pack and SMZ/TMP DS 800mg/160mg and she had completed both. The patient noted most issues had resolved except slight itching in the morning that resolved throughout the day. The patient noted her doctor did believe this was a reaction to the vaccination. The patient noted she had a 50 cent piece size red area on the left side of her chest, but was not as solid like the right side was. The patient also noted the top of her left hand was bright red, sore and leaking when she went to her physician, he advised she keep it covered with gauze because it was shiny and leaking. The patient also described at the bend on the inside of her right arm it was red and had a linear appearance with a smaller area below it. It was noted she had an IV on her left hand and at the bend of her right arm while in the Emergency room, but she said she didn't receive any medications in the IV's. The patient denied any allergy to latex. The patient also noted a warmth feeling under her skin in the areas of redness. The patient right breast appeared slight pink with red lines. The patient also noted a small red nickel size area red spot on her abdomen that didn't weep. The reporter consented to follow up.