Age: 64.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Influenza like illness, Injection site warmth, Inner ear inflammation, Magnetic resonance imaging brain normal, Pyrexia
Clinical narrative: trouble hearing/ hearing impaired; inflammed inner ear; head felt inflamed; flu-like symptoms; fever; shakes; shivers; headache; Increased heart rate; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included prednisone for inner ear inflammation.   The patient had a Family History of brain neoplasm (father died 6 months ago). Previously administered products included Shingrix with an associated reaction of injection site warmth (for tolerance, refer case US2019175376).   On 1st September 2019, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, the patient started prednisone at an unknown dose and frequency. On 1st September 2019, 7 hrs after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria clinically significant/intervention required), fever (serious criteria clinically significant/intervention required), tremor (serious criteria clinically significant/intervention required), shivers (serious criteria clinically significant/intervention required) and headache (serious criteria clinically significant/intervention required). On 5th September 2019, the patient experienced hearing loss (serious criteria GSK medically significant and clinically significant/intervention required), inner ear inflammation (serious criteria clinically significant/intervention required) and feeling abnormal (serious criteria clinically significant/intervention required). In September 2019, the patient experienced heart rate increased (serious criteria clinically significant/intervention required). The patient was treated with vitamins nos (Multivitamin). On 5th September 2019, the outcome of the influenza-like symptoms, fever, tremor, shivers and headache were recovered/resolved. On an unknown date, the outcome of the hearing loss and inner ear inflammation were not recovered/not resolved and the outcome of the feeling abnormal and heart rate increased were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, tremor, shivers, headache, hearing loss, inner ear inflammation, feeling abnormal and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The case US2019175386 was found to be duplicate of case US2019175381. Hence case US2019175386 would be deleted and all the information of this case will be added in case US2019175381 which is the case of record for this patient. The patient received vaccine on left arm. The patient received Shingrix and within 7-8 hours experienced flu-like symptoms. The patient also had fever, shakes, shivers, and headache that started on same day. On 5th Sepptember 2019, the patient had trouble hearing and her head felt inflamed. The patient went to the physician and received a prescription for prednisone and a head MRI. In September 2019, the patient had head MRI (Nuclear magnetic resonance imaging brain) and result was within normal limits and her physician only ordered it because her father died of a brain tumor 6 months ago. The patient only took the prednisone for 2 days and physician discontinued the medication because she had an increased heart rate. The patient had 30-40 percent hearing loss that persisted due to an inflamed inner ear. It was unknown if the reporter considered the influenza-like symptoms, fever, tremor, shivers, headache, hearing loss, inner ear inflammation, feeling abnormal and heart rate increased to be related to Prednisone. The reporter did not consent to follow up.