Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Scab, Swollen tongue
Clinical narrative: Vision loss; Hearing loss; little relief from pain medications; tongue and lips swelling, and shortness of breath with gabapentin; tongue and lips swelling, and shortness of breath with gabapentin; tongue and lips swelling, and shortness of breath with gabapentin; he developed "big" unspecified blisters "everywhere" on his body and was diagnosed with shingles, "white pimples and sores"; ankle swelling; scabs on unspecified areas of his body; Information has been received from a 65 years old male patient concerning himself. The patient was allergic to morphine and had no medical history. In July 2015 the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (lot#, route, dose, frequency were not reported) to prevent shingles. There was no concomitant medication. The consumer reported that he developed "big" unspecified blisters "everywhere" on his body (unspecified date in July 2015) after receiving zoster vaccine live (ZOSTAVAX). The consumer stated that he was seen in Emergency Room on 27-JUL-2015 and was diagnosed with shingles. The consumer stated that he was not admitted to the hospital but was prescribed an unspecified narcotic, unspecified antiviral and gabapentin (manufacturer AuroLife Pharma LLC). The consumer reported that he stopped taking the gabapentin "within 5 days" because he developed ankle swelling and tongue swelling. The consumer stated that the scabs on unspecified areas of his body that he developed an unspecified time after receiving zoster vaccine live (ZOSTAVAX) were "coming off" and were "very sensitive". The patient also reported that he was getting worse. The patient had made a second trip to the emergency for terrible blisters and experienced horrible pain at the time of the report. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered.  Causality was not reported.       Information has been received from a lawyer on 24-AUG-2015, regarding a case in litigation concerning a male who was vaccinated with a dose of zoster vaccine live (ZOSTAVAX). The patient alleged to have developed shingles after receiving a dose of zoster vaccine live (ZOSTAVAX).  Additional information has been received on 24-AUG-2015 from a 65 year old male consumer who on 17-JUL-2015 was vaccinated with a dose of zoster vaccine live (ZOSTAVAX). The patient reported that seven days later he had to go to the emergency room for treatment of "full blown shingles." The patient stated he had "blisters from the top of his head to his chest, on the right side." The pain was reported as a 5 on 1 to 10 scale. Treatment included "hydrocode" pain medication and antiviral medication. The pain medication helped a little at that time. The patient reported a low grade fever and the pain scabs and rash were getting worse. The patient returned to the physician and was placed on gabapentin. The patient reported he had a major allergic reaction to gabapentin and "my throat and tongue swelled up and I could not breath." The physician discontinued the gabapentin and prescribed more narcotics. The patient reported that he refused hospitalization at this time. Approximately three and half weeks after the dose of zoster vaccine live (ZOSTAVAX), the patient returned to the emergency room for pain, and he reported the shingles had entered his throat and right ear. Treatment included amitriptyline hydrochloride and pain medication. The patient reported the pain was the most horrible he had ever experienced and getting worse every day.  Additional information had been received on 18-SEP-2015 from a lawyer and a 65 year old male consumer who on 15-JUL-2015 (previously reported as 17-JUL-2015) was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), Lot # K015312, expiration 17-DEC-2015. The patient reported on 24-JUL-2015, he experienced painful "white pimples and sores (chicken pox) then burning red rash." On 27-JUL-2015, the patient presented to the emergency room, was diagnosed with shingles and received acetaminophen and hydrocodone (VICODIN) and "antiviral." The patient was seen by his primary physician and was prescribed gabapentin and acetaminophen and hydrocodone (VICODIN). On 14-AUG-2015, the patient reported no change in his symptoms, and he returned to the emergency room and diagnostic impression was "post zoster neuropathy pain" and treated with oxycodone and amitriptyline. The patient stated when he took gabapentin his "tongue and lips swelled up and had shortness of breath." The physician was notified, and medication discontinued. On that date, the patient said the blisters and rash were slowing down and the pain medications did very little to relieve the pain and itching. The patient stated he had "seen four physicians who have all said he has post zoster nerve pain from the vaccine." At the time of this report, stated he was still experiencing itching and constant pain.  Follow up (F/U) information was received from a lawyer and a male patient (Pt) regarding a case in litigation on 14-JAN-2020. In or around 15-JUL-2015, Pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the Pt suffered shingles, vision loss and hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), Pt's symptoms had resulted in physical limitations not present prior to vaccination. Pt sustained severe, progressive, permanent and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of shingles, vision loss and hearing loss was considered as not recovered. The reporter considered the events of shingles, vision loss and hearing loss to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered shingles, vision loss and hearing loss as disabling events. Upon internal review, the events of vision loss and hearing loss were determined to be medically significant.