Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Antibody test positive, Deafness, Dehydration, Ear pain, Facial paralysis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 53-year-old male patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 2nd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 9th October 2017, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced sinus pain (serious criteria hospitalization) and ear pain (serious criteria hospitalization). In October 2017, the patient experienced dehydration (serious criteria hospitalization), hearing loss (serious criteria hospitalization and GSK medically significant), nausea (serious criteria hospitalization) and vomiting (serious criteria hospitalization). On 17th October 2017, the patient experienced Ramsay-Hunt syndrome (serious criteria GSK medically significant). On 19th October 2017, the patient experienced shingles (serious criteria hospitalization) and facial paralysis (serious criteria hospitalization and GSK medically significant). The patient was treated with Acyclovir and Steroids. On an unknown date, the outcome of the shingles, Ramsay-Hunt syndrome, hearing loss and facial paralysis were not recovered/not resolved and the outcome of the sinus pain and ear pain were unknown and the outcome of the dehydration, nausea and vomiting were recovered/resolved. The reporter considered the shingles, sinus pain, Ramsay-Hunt syndrome, dehydration, hearing loss, nausea, vomiting, ear pain and facial paralysis to be unrelated to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was reported to the physician. The concomitant medication included hypertension medication. The patient received FLUARIX QUADRIVALENT in the right deltoid. On 9th October 2017, the patient started to have ear and sinus pain. On 12th October 2017, the patient went on antibiotics. On 15th October 2017, the patient went to the emergency room and the physician increased his antibiotics and steroids. On 17th October 2017, 15 days after receiving FLUARIX QUADRIVALENT, the patient was diagnosed with Ramsay Hunt Syndrome. The patient received intravenous steroids at that time and Acyclovir. From 19th October 2017, 15 days after receiving FLUARIX QUADRIVALENT, the patient was admitted to the emergency room (ER) with facial paralysis and was diagnosed with shingles in his ear and it ran across the nerve across his face which caused facial paralysis and the patient experienced hearing loss as well. In October 2017, less than a month after receiving FLUARIX QUADRIVALENT the patient experienced nausea, vomiting and dehydration at that time which caused him to be admitted. On 23rd October 2017, the patient was discharged. The patient reported that he had the Varicella Titer test and the results were 574. The physician said that the symptoms were unrelated to the flu shot. The patient lost two days of work and was still experiencing 58 percent hearing loss with facial paralysis on the left side of his face. The reporter indicated that the patient had a job and marital stress, which might have contributed to his condition.