Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Impaired driving ability, Intellectual disability, Loss of consciousness, Malaise
Clinical narrative: epidemitis; rheumatoid arthritis; massive immune response/immune cells attacking his healthy tissue/ autoimmune reaction to vaccine; near death reaction; fever; chills; difficulty eating; sick mainly due to the reaction from the shot; Could not drive; Bad shape; bad back pain; couldnot bend back; difficulty walking/difficult for him to walk in his kitchen; stiffness/ stiff hands; Joint pain; Shoulder pain; falling; shakes; poor memor; Mind not good; testicle pain; Sjogren's syndrome; dry eyes; dry throat; Lucid; Sleeping a lot; tingling/ every toe was tingling on each feet; numbness/ toes, feet and ankles were numb; nerve damage; peripheral neuropathy; shooting pain/ pain all over the body; itching was consistent with a shingles reaction; unconscious/ passed out; coma; itching on various parts of his body/ was below the surface of skin; delirious; This case was reported by a consumer via call center representative and described the occurrence of epididymitis in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included glaucoma and loss of vision. Concurrent medical conditions included blind left eye.   On 27th February 2018, the patient received the 1st dose of Shingrix (intramuscular). In February 2018, less than a week after receiving Shingrix, the patient experienced general body pain (serious criteria hospitalization and life threatening), generalized pruritus (serious criteria hospitalization and life threatening) and shingles (serious criteria hospitalization and life threatening). In March 2018, the patient experienced peripheral neuropathy (serious criteria hospitalization, GSK medically significant and life threatening), tingling feet/hands (serious criteria hospitalization and life threatening), numbness (serious criteria hospitalization and life threatening), nerve damage (serious criteria hospitalization and life threatening), lucid dreams (serious criteria hospitalization and life threatening) and sleep excessive (serious criteria hospitalization and life threatening). In April 2018, the patient experienced sjogren's syndrome (serious criteria hospitalization, GSK medically significant and life threatening), eye dryness (serious criteria hospitalization and life threatening) and dry throat (serious criteria hospitalization and life threatening). On an unknown date, the patient experienced epididymitis (serious criteria hospitalization, GSK medically significant and life threatening), near death experience (serious criteria hospitalization, GSK medically significant and life threatening), unconscious (serious criteria hospitalization, GSK medically significant and life threatening), coma (serious criteria hospitalization, GSK medically significant and life threatening), fever (serious criteria hospitalization and life threatening), chills (serious criteria hospitalization and life threatening), delirium (serious criteria hospitalization, GSK medically significant and life threatening), eating disorder (serious criteria hospitalization and life threatening), sickness (serious criteria hospitalization and life threatening), impaired driving ability (serious criteria hospitalization and life threatening), posture abnormal (serious criteria hospitalization and life threatening), tremor (serious criteria hospitalization and life threatening), back pain (serious criteria hospitalization and life threatening), movement disorder (serious criteria hospitalization and life threatening), rheumatoid arthritis (serious criteria hospitalization, GSK medically significant and life threatening), walking difficulty (serious criteria hospitalization and life threatening), stiffness (serious criteria hospitalization and life threatening), joint pain (serious criteria hospitalization and life threatening), fall (serious criteria hospitalization and life threatening), autoimmune disorder (serious criteria hospitalization, GSK medically significant and life threatening), memory deficit (serious criteria hospitalization and life threatening), feeble-minded (serious criteria hospitalization, GSK medically significant and life threatening) and testicular pain (serious criteria hospitalization and life threatening). The patient was treated with ibuprofen, acetaminophen, non-drug therapy (Physical Therapy (Nos)) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the epididymitis, numbness, back pain, movement disorder, rheumatoid arthritis, walking difficulty, stiffness, joint pain, autoimmune disorder, sjogren's syndrome, eye dryness, dry throat and testicular pain were not recovered/not resolved and the outcome of the peripheral neuropathy, general body pain, fever, chills, eating disorder, shingles, sickness, impaired driving ability, posture abnormal, nerve damage, tremor, lucid dreams, sleep excessive, fall, memory deficit and feeble-minded were unknown and the outcome of the near death experience, unconscious and coma were resolved with sequelae and the outcome of the delirium, generalized pruritus and tingling feet/hands were recovered/resolved.   It was unknown if the reporter considered the epididymitis, peripheral neuropathy, general body pain, near death experience, unconscious, coma, fever, chills, delirium, eating disorder, generalized pruritus, shingles, sickness, impaired driving ability, posture abnormal, tingling feet/hands, numbness, nerve damage, tremor, lucid dreams, sleep excessive, back pain, movement disorder, rheumatoid arthritis, walking difficulty, stiffness, joint pain, fall, autoimmune disorder, sjogren's syndrome, eye dryness, dry throat, memory deficit, feeble-minded and testicular pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient had a history of glaucoma in left eye and total loss of vision before the vaccination. The patient had a really bad near death reaction 1 and 1/2 hours after the vaccination and was unconscious and in a coma for 5 days and was delirious for another two days after. Less than a week affter getting the vaccine, the patient woke up with shooting pain up the spine that went to his shoulders. Second time he came to consciousness he was awake and experienced fevers and chills.  Then he slept again and woke up with severe pain all over the body and he passed out because of the pain.  He stated that he had difficulty eating for 2 weeks after getting the Shingrix vaccine. Initially less than a month after receiving the shot, he had itching on various parts of his body that was below the surface of the skin. It was went away after a month or two which was consistent with a reaction to the shot and might be shingles. The patient had been really sick and partially from some outside things but mainly due to the reaction from the shot. The patient also reported that, every toe was tingling on each feet and the tingling was matching on both feet for months and then it stopped and his toes, feet and ankles were numb. The numbness was 5 to 6 inches above his ankles and was exactly in the same area on both feet. The patient described it as, when toes went numb he knew it was neurological which occurred 7 days after the vaccination. He had symptoms a half hour after the vaccine but his physician did not believe there was a correlation and denied that it could have happened. That physician had since retired, the patient saw another doctor who said it was impossible even though he was unconscious after getting the shot.  The patient's doctor had told him that, he had peripheral neuropathy in the fall of 2018. His left hand shakes all the time that began in the fall of 2018 and he could not rely on it.  There was nerve damage present on his left and right hand and both hands were shaking, but the left hand was much worse. The patient was lucid and sleeping a lot after 7 days from the reaction with matching tingling toes.  Less than 4 months after the vaccine, the patient could not drive and was in bad shape until early April 2018. The patient also reported bad back pain that was really serious. It was so bad that he could not plant his garlic in the greenhouse without laying on his side because he could not bend his back. This started in late April or early May 2018 but it eased up after physical therapy and he got dry needling which miraculously cured his back pain. He also had stiff hands in the fall of 2018.   In April 2018 less than 3 months after getting the Shingrix, the patient started to experience dry throat and dry eyes. He related these symptoms to an immune response called Sjogren's syndrome. The back pain was located in his lower back and he had another back reaction in late fall and in April, May and June of 2019 also he had another flare up. In May 2019 less than 4 months after the vaccination, in the course of 1 to 2 weeks he had symptoms of rheumatoid arthritis including joints in both feet and made it difficult for him to walk in his kitchen with numbing in his skin and the connective tissue of his feet. The numbness was below the skin in the connective tissue and when he pressed hard he felt the ligaments and bones in the deep parts of the foot. It started to hurt with the arthritis symptoms which had continued till the date of reporting. The patient had a period in 2019 where everything started to get worse including his back pain. The patient was experiencing a massive immune response which he believed was related to the shot. He had an ongoing immune issues like immune cells attacking his healthy tissue and his feet are numb with various health problems. If he had immune response symptoms flare ups, which he had on and off, his back would start hurting again. The symptoms had bilateral symmetry in both feet which still continued.   He also experienced joint pain that was episodic which began months after his autoimmune reaction and had been getting worse since April 2019. He has had difficulty walking and stumbled and fall when turning to do something. He falls at least once a month and has been getting worse since April of 2019. Less than a year of vaccination and a few months later after having an autoimmune reaction to the Shingrix, the patient's testicles hurt bad that he had to go to emergency room and they flared up again. The patient again went to emergency room in early September of 2019 and July of 2019.   This condition he described as Epididymitis as per his urologist. Urologist had suggested him to use ice packs and ibuprofen. On the day before the reporting date, the patient had an episode for 3 to 4 hours and took acetaminophen and ibuprofen which helped.   After couple of weeks of vaccination, the patient's mind had not been good since getting the vaccine. He had been experiencing poor memory weeks after getting the vaccine. The patient consented to follow up and also provided his physician's details.