Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Headache, Hyperaesthesia, Intervertebral disc protrusion, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 62-year-old male patient who received SHINGRIX. Concurrent medical conditions included prostate cancer. Concomitant products included testosterone. On 16th April 2018, the patient received the 1st dose of SHINGRIX .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired. On 16th April 2018, the patient experienced nerve pain and unable to walk. The patient was treated with gabapentin and analgesic, nos. On an unknown date, the outcome of the nerve pain, unable to walk, post herpetic neuralgia, touch sensitivity increased and activities of daily living impaired were not recovered/not resolved. The reporter considered the nerve pain, unable to walk and post herpetic neuralgia to be related to SHINGRIX. It was unknown if the reporter considered the touch sensitivity increased and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received first dose of SHINGRIX in morning. At night, the patient awoke with excruciating nerve pain up his leg so that he could not walk. The pharmacist reported that patient was also experiencing post herpetic neuralgia like sensitivity to touch and cannot wear clothing on the area due to sensitivity. The pharmacist reported that patient went to ER that night and received gabapentin and narcotic pain relievers. The pharmacist that events have not resolved and that today patient has gone back to ER seeking additional treatment. The pharmacist that patient received SHINGRIX at another pharmacy location. Upon internal review by the safety physician, following corrections were made: The event post herpetic neuralgia was removed. Follow up information was received by a pharmacist via call center representative on 24th May 2018: This case was upgraded to serious due to the event nerve pain and herniated disc (seriousness criteria hospitalization). The patient's demographics were updated. The VAERS details were updated. The patient's historical conditions include shingles and chickenpox. Less than a year, after receiving SHINGRIX, the patient experienced herniated disc, dermatomal pain, altered sensitivity to touch and prodromal symptoms like headache and photophobia. The patient was hospitalized from 23rd April 2018 to 28th April 2018. Less than a month, after receiving SHINGRIX, the patient experienced post herpetic neuralgia. The post herpetic neuralgia was considered as complications of herpes zoster present or specific organ involvement. The diagnosis of herpes zoster was not confirmed. The location of the specific affected dermatomes was given as left leg or hip. Upon follow up with the patient Magnetic resonance imaging (MRI) revealed that herniated disc which caused resulting nerve pain. At this time we can conclude that adverse events were not related to SHINGRIX, just coincidence that herniated disc occurred when the patient got vaccine. The patient still having nerve pain and had back surgery to correct the herniated disc or bulging disc. It was concluded that not adverse events, bulging disc caused symptoms. It was unknown if the reporter considered the herniated disc, touch sensitivity increased, activities of daily living impaired, post herpetic neuralgia, headache and photophobia to be related to SHINGRIX.