Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lip swelling, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: lips were swollen; fluid filled blisters on my right pinky finger, my left thumb / upper chest./ broke out in a Blister on a finger and thumb / cluster of Blisters on her chest and stomach / chest is still broken out; They itch tremendously / blisters itch; fluid filled blisters on my right pinky finger, my left thumb / upper chest./ broke out in a Blister on a finger and thumb / cluster of Blisters on her chest and stomach / chest is still broken out; they are incredibly uncomfortable; blisters burn; chills; fever; Sore left arm; headache; very swollen / injection site; painful injection site; This case was reported by a consumer and described the occurrence of chills in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number BA5GK, expiry date 4th November 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date, reference case US2021AMR013003). Concurrent medical conditions included cold sores lip (had prior to vaccination).   On 12th January 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 12th January 2021, less than a day after receiving Shingrix, the patient experienced chills, fever, pain in arm and headache. On 14th January 2021, the patient experienced blister, pruritus, blistery rash, discomfort and burning sensation skin. In January 2021, the patient experienced injection site swelling and injection site pain. On 17th January 2021, the patient experienced lip swelling. The patient was treated with benadryl (nos) (Benadryl), prednisone and medication unknown (Cream (Medication Unknown)). Rechallenge with Shingrix was positive. On 13th January 2021, the outcome of the chills, fever, pain in arm and headache were recovered/resolved. On an unknown date, the outcome of the blister and blistery rash were not recovered/not resolved and the outcome of the pruritus, discomfort, burning sensation skin, lip swelling, injection site swelling and injection site pain were unknown.   The reporter considered the chills, fever, pain in arm, headache, blister, pruritus, blistery rash and burning sensation skin to be related to Shingrix. It was unknown if the reporter considered the discomfort, lip swelling, injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received Shingrix vaccine on left arm. The patient experienced very swollen and painful injection site less than a week after vaccination. The patient had a sore left arm, fever, chills and a headache and it was resolved the next day. The patient broke out in a blister on a right pinky finger and thumb with a cluster of blisters on her upper chest and stomach 2 days after vaccination. The patient stated the blisters itch tremendously and burn 2 days after vaccination. The patient took benadryl and used anti-itch cream, but they were incredibly uncomfortable. The patient's lips were swollen 5 days after vaccination and on 18 January 2021, she went to an urgent care and was prescribed prednisone.  As of January 20, patient stated that the blisters on her finger and thumb have dried out, but her chest was still broken out. The reporter asked if you ever heard of this reaction to the Shingrix vaccine before. The reporter did not consent to follow-up.; Sender's Comments:  US-GSKCCFUS-Case-00950897_AE-56409:FU1 US-GLAXOSMITHKLINE-US2021AMR013003:SAME reporter