Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Oropharyngeal pain, Pharyngeal hypoaesthesia, Vertigo, Vomiting
Clinical narrative: hospitalized/ "almost died"; ramsey hunt syndrome; Suffer shingles, including any all og its sequelae; Shingles; hearing loss; This spontaneous report as received from a nurse refers to a 65 years old male patient with no drug reactions/allergies. The medical history of the patient included cancer. The patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (Lot number reported as H0139009) (Lot number H0139009 is an invalid lot number for zoster vaccine live) subcutaneously on 13-NOV-2012. No concomitant medications were reported.   The nurse called stating the patient received zoster vaccine live (ZOSTAVAX) on 13-NOV-2012 developing Ramsey Hunt Syndrome and was hospitalized. The patient started to experience symptoms on 20-NOV-2012. The patient saw his primary care physician initially. He was also referred to an ENT (Ear, Nose and Throat) specialist on 07-DEC-2012. CT scan, lab work and spinal tab were performed without any results. However his symptoms exacerbated and he was hospitalized on 12-DEC-2012 and spent 3 to 4 days in the hospital. The patient was still experiencing deafness in one ear, trouble swallowing and partial paralysis of his throat. He was still recuperating at home. He was prescribed acyclovir for his condition. The patient had a history of cancer however he was in remission for the past year and had not received any therapy related to cancer in the past year. At the time of reporting, the outcome was reported as recovering.  Followup information has been received: all telephone attempts to obtain follow-up information have been unsuccessful.  Follow up information was received: nurse stated that she had received multiple calls from the safety department at least every week since she provided this report.  She had left voice mails for the safety department .She did not provide a better way to contact her. She stated that the patient still had a loss of hearing to the one side with paralysis and loss of sensation in one side of his throat; he had to be extremely careful when he eats, and his oncologist, informed the patient that if he could keep his weight at 190 pounds, he would not have to receive a feeding tube.  Nurse reported that the patient was under treatment for lymphoma and was in remission for at least a year prior to his receipt of zoster vaccine live (ZOSTAVAX) and the subsequent development of his current difficulty as described above.  The patient was hospitalized.  Follow up information was received from the registered nurse concerning a patient. Demographics such a height and weight were updated. Current conditions of the patient included Penicillin (PCN) allergy, Allopurinol allergy and Uloric allergy post lymphoma-2 years. On 13-NOV-2012, at 15:20, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (lot number and expiry date reported as H013944 and 25-OCT-2013 respectively) in the right arm at public health clinic or hospital. The patient experienced sore throat, processed over next 1-2 weeks then lost 20 pounds in 2 weeks due to vertigo, nausea/vomiting, double vision, loss of hearing in right ear. The patient eventually saw a physician at ENT, 2 weeks later, on 24-NOV-2012 (previously reported as 20-NOV-2012), the patient was diagnosed with Ramsay-Hunt syndrome. The event was considered to be life threatening and resulted in significant disability. Patient was hospitalized for 5 days. Then he saw an oncologist and was sent for admission to the hospital. He was admitted for further work up. At the time of vaccination patient was clear of recurrence of lymphoma. Outcome of the event was unknown (previously reported as recovering) and he was continued to have dysphagia. The patient required a medical intervention. No signed informed consent form was obtained.   Follow up information was received from the registered nurse stating that on an unknown date in December 2012 (reported as "Late December 2012") (previously reported as "13-NOV-2012") the patient was vaccinated with zoster vaccine live (ZOSTAVAX) On an unknown date in 2013 (reported as "Early 2013") the patient experienced hearing loss (medically significant) and also experienced he was hospitalized at an unspecified hospital on an unspecified date after receiving the zoster vaccine live (ZOSTAVAX) and the nurse reported that the patient "almost died" but did not (hospitalization and life threatening). The outcome of hospitalized/ "almost died" and hearing loss was unknown. The relationship between the events and zoster vaccine live (ZOSTAVAX) was not reported.  This F/U report was received on 15-MAR-2021 from a lawyer regarding a case in litigation and refers to a patient male patient of 65-year-old. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In November 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified). As a result of his receipt of zoster vaccine live (ZOSTAVAX), in December 2012, the pt was caused to suffered shingles, including any and all of its sequelae (ill-defined disorder). As a result of his receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, hearing loss was determined to be medically significant and hospitalized/ "almost died" was determined to be life threatening.; Sender's Comments:  US-009507513-1301USA000006: