Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Inappropriate schedule of product administration
Clinical narrative: Slightly elevated temperature / Fever; Headache; Muscle pain; Aches; Chills; Tiredness; Fogginess; Late dose; Swelling about 2 &1/2 to 3 inches around the injection site; Soreness about 2 &1/2 to 3 inches around the injection site; Redness about 2 &1/2 to 3 inches around the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma and immune system disorder.   On 6th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 6th July 2020, less than a day after receiving Shingrix and an unknown time after starting Excedrin, the patient experienced headache. On 7th July 2020, the patient experienced fever. In July 2020, the patient experienced injection site swelling, injection site pain, injection site erythema, muscle pain, general body pain, chills, tiredness, foggy feeling in head and drug dose administration interval too long. The patient was treated with paracetamol, aspirin, caffeine (Excedrin), paracetamol (Tylenol) and ibuprofen (Advil). Rechallenge with Shingrix was positive. On 7th July 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, headache, tiredness and foggy feeling in head were not recovered/not resolved and the outcome of the muscle pain, general body pain and chills were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, injection site swelling, injection site pain, injection site erythema, headache, muscle pain, general body pain, chills, tiredness and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had a slightly elevated temperature of up to 99.7 and know this seems close to the normal 98.6, however my temperature usually runs between 96 & 97 degrees.  The patient had been taking Tylenol to knock out the fever but it did not seem to help. There has been an issue with some telephone exchanges in our area and we cannot reach our doctor. The patient had a fever of as high as 100.5 degrees and took Tylenol, Advil, and Excedrin to help relieve this and had resolved.  The patient reported swelling, soreness and redness about 2 &1/2 to 3 inches around the injection site and this has not resolved.  The patient reported a headache after the injection and this was better but has not resolved completely. The patient reported muscle pain, aches, and chills after the injection and these had resolved at this time and reported tiredness and fogginess that began after the injection and both have improved but not completely resolved. The patient did not had lot number or expiration date information to provide for either dose of Shingrix. This case linked with US2020AMR125326 and US2020AMR125327, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR125326:Husband's case 1st dose US-GLAXOSMITHKLINE-US2020AMR125327:Husband's case 2nd dose US-GLAXOSMITHKLINE-US2020AMR125323:same reporter