Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fall, Head injury, Hyperhidrosis, Hypoaesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blackout in a 54-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure and blood sugar abnormal. Concomitant products included Vitamin B12 and Aspirin. On 5th June 2018, the patient received SHINGRIX. On 6th June 2018, 1 days after receiving SHINGRIX, the patient experienced neck pain and back pain. In June 2018, the patient experienced fainting. On an unknown date, the patient experienced blackout (serious criteria GSK medically significant), fall, head injury, neck injury, numbness, fever and sweating. On an unknown date, the outcome of the blackout, fall, head injury, neck injury, neck pain and back pain were unknown and the outcome of the fainting, fever and sweating were recovered/resolved and the outcome of the numbness was not recovered/not resolved. It was unknown if the reporter considered the blackout, fall, head injury, neck injury, neck pain and back pain to be related to SHINGRIX. The reporter considered the fainting, numbness, fever and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient received OTC MTV as concomitant drug. The patient received the first dose of the series a day before reporting date between 12:30 and 1 PM. The patient felt fine for 12 hours after receiving the vaccination. The patient awoke early in the morning about 1 AM or 2 AM and went to the restroom to urinate. He fainted in the restroom. The patient described that before he fainted it felt like something was rushing in his brain like a numbness for about half of a minute or less and then he blacked out for a second. After the fainting episode ended, he went back to bed and felt that he had a high fever and was sweating. The patient went back to sleep and then about 4 AM he awoke and again went to the restroom to urinate and fainted again a second time, passing out and falling and hitting his head or back of his neck on the side of the tub. The patient wife heard the loud noise which was made with his fall and discovered him in the bathroom. After the second fainting episode he called the nurse phone line with his insurance and was told he might have fallen because of his blood pressure or blood sugar and that he should call his health care professional. The patient already contacted his health care professional office, and a nurse there told him to monitor his vitals and to contact GSK to see if there have been any reports of fainting with SHINGRIX. The patient had not spoken yet with the responsible physician. The patient was referred to contact his health care professional on the day of reporting during this call. The patient was now having light neck pain and quite a lot of back pain. The patient could not provide exact dosing details and described that the vaccine was administered on his left shoulder close to the top. The patient had never fainted before in his life until after having had this SHINGRIX vaccination. The patient give permission to contact physician. The patient could not provide pharmacy address or phone during the call.