Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Headache, Hot flush, Inappropriate schedule of product administration, Initial insomnia, Insomnia
Clinical narrative: have not felt right; messed up nervous system; brain fog; Hot face; Red face/ face flushing; Feverish; Face flushing; Dry mouth; Ears had a rushing sound in them / effected hearing; Disconnected feeling; Difficulty concentrating; Headache; Confusion; Panicking feeling; First dose on 1/23/20 / second dose on 10/21/20; Chills / Shivering; Backache; Trouble sleeping; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 13th September 2022) for prophylaxis.   Co-suspect products included influenza virus vaccine inactivated (Fluzone Hd) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on 23rd January 2020 and expereinced chills and backache, refer case US2020221335).   On 21st October 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th September 2020, the patient started Fluzone Hd at an unknown dose and frequency. On 21st October 2020, 5 hrs after receiving Shingrix, the patient experienced shivering, back pain, difficulty sleeping and drug dose administration interval too long. On 22nd October 2020, the patient experienced feeling of warmth facial, red face, fever, facial flushing, dry mouth, ear noises, feeling detached, mental concentration difficult, headache, confusion and panic reaction. On an unknown date, the patient experienced malaise, nervous system disorder and foggy feeling in head. The patient was treated with ibuprofen and prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shivering, back pain, feeling of warmth facial, red face, fever, facial flushing, dry mouth, feeling detached and headache were recovered/resolved and the outcome of the difficulty sleeping, ear noises, mental concentration difficult, confusion and panic reaction were not recovered/not resolved and the outcome of the malaise, nervous system disorder, foggy feeling in head and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shivering, back pain, difficulty sleeping, feeling of warmth facial, red face, fever, facial flushing, dry mouth, ear noises, feeling detached, mental concentration difficult, headache, confusion, panic reaction, malaise, nervous system disorder and foggy feeling in head to be related to Shingrix.  Additional information was provided as follows: On 29th September 2020, the patient received Fluzone HD flu shot. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The patient reported 5 hours after receiving the second dose of Shingrix, she had chills, backache, shivering, and trouble sleeping. The patient reported she took Ibuprofen for the backache. The morning after receiving the second dose the patient reported a hot and red face, was feverish, face flushing, dry mouth, ears had a rushing sound in them, disconnected feeling, difficulty concentrating, headache, confusion, and panicking feeling. Patient reported she went to an urgent care doctor and was given Prednisone 20 mg twice a day for 5 days. Patient reported these events lasted about a week and then resolved with the exception of the rushing noise in the ears, confusion, difficulty concentrating, not sleeping well and panicking feeling which were still ongoing till the time of reporting. The patient did not felt right, effected hearing, messed up central nervous system and brain fog. It was unknown if the reporter considered the shivering, back pain, difficulty sleeping, feeling of warmth facial, red face, fever, facial flushing, dry mouth, ear noises, feeling detached, mental concentration difficult, headache, confusion, panic reaction, malaise, nervous system disorder and foggy feeling in head to be related to Fluzone HD. The reporter consented to follow up This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221342:same reporter US-GLAXOSMITHKLINE-US2020AMR221923:same reporter US-GLAXOSMITHKLINE-US2020221335:Same patient 1st dose