Age: 64.0
Sex: M
Vaccine: FLU4, VARZOS, FLUX, VARZOS, FLU4, VARZOS
Symptoms: Chills, Demyelination, Electrocardiogram normal, Fatigue, Feeling cold
Clinical narrative: Stiffness in neck; pain in neck; Skull pain; numbness in his thighs / numbness in his forearms/ numbness in his thighs, toes and; difficult for him to walk; making it difficult use his arms; sweating; only slept 1 hour; nerve pain; muscle pain; muscle spasms; demyelination of the central nervous system; fatigue; body aches; sinus pressure; chest pain; pain in left arm; high blood pressure; not mentally sharp; felt like had cold; Felt like had flu; viral infection; pins and needles; fever; chills; shaking; This case was reported by a consumer via call center representative and described the occurrence of mental dullness in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINES for prophylaxis.   On 19th September 2019, the patient received the 2nd dose of Shingrix and INFLUENZA VACCINES. On 11th October 2019, 22 days after receiving Shingrix and INFLUENZA VACCINES, the patient experienced fever, chills, tremor, viral infection, feeling cold and influenza like illness. On 13th October 2019, the patient experienced mental dullness (serious criteria GSK medically significant), fatigue, general body pain, sinus pressure, chest pain, pain in arm and blood pressure high. In October 2019, the patient experienced pins and needles. On 16th October 2019, the patient experienced demyelination (serious criteria GSK medically significant), nerve pain, muscle pain, muscle spasm and sleeplessness. On 24th October 2019, the patient experienced sweating. In November 2019, the patient experienced stiff neck, neck pain, headache, numbness, unable to walk and mobility decreased. The patient was treated with fluticasone propionate, salmeterol xinafoate (Advair). On an unknown date, the outcome of the mental dullness, demyelination, fatigue, general body pain, sinus pressure, chest pain, pain in arm, blood pressure high, nerve pain, muscle pain, muscle spasm, viral infection, pins and needles, sweating, feeling cold, influenza like illness, stiff neck, neck pain, headache, numbness, sleeplessness, unable to walk and mobility decreased were unknown and the outcome of the fever, chills and tremor were recovered/resolved.   The reporter considered the mental dullness, demyelination, fever, chills, tremor, fatigue, general body pain, sinus pressure, chest pain, pain in arm, blood pressure high, nerve pain, muscle pain, muscle spasm, viral infection, pins and needles, sweating, feeling cold, influenza like illness, stiff neck, neck pain, headache, numbness, sleeplessness, unable to walk and mobility decreased to be possibly related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm and flu vaccine season 2019-2020 in the right arm. The flu vaccine season 2019-2020 manufactured by Merck. On 11th October 2019 at 9 pm, the patient experienced fever and chills, with bad shaking. Less than 22 days after vaccination the patient had fever. The patient went to bed under 2-3 blankets and lay there for 3-4 hours shaking. The patient did not feel bad on next day but on 13th October 2019, had fever, chills, fatigue, body aches, sinus pressure, chest pain, pain in left arm and high blood pressure and felt like had cold anf the flu. Less than 24 days after vaccination, the patient had mental dullness, fatigue, general body pain, sinus pressure, chest pain, pain in arm, blood pressure high, feeling cold and influenza like illness. On 16th October 2019, the patient went to urgent care and was tested for a possible heart attack. The patient went to home that evening with a diagnosis of viral infection.  22 days after vaccination, the patient had viral infection. After at home ate super with his wife and 15 minutes later started having extreme nerve pain from shoulder to fingertips, and very painful muscle spasms in both arms. The patient slept 1 hour that night because of the pain and thought that it might be related to the EKG test because where some of the sensors had been placed on his wrist there was burning, stabbing pain. On 17th october 2019, the patient went to emergency room where they did all the heart tests again and everything still came back normal. The patient did have a fever and high blood pressure, 147/110. The patient's blood pressure was always been 120/80. the patient was told again that it was a viral infection and was told his body would fight it on its own. The patient was sent home with pain in his arms and it continued that way for 5 days. On 21st October 2019, the patient started having severe nerve pain from his hips to his toes with extremely painful muscle spasms in both legs. Less than 27 days after vaccination, the patient had nerve pain, muscle pain and muscle spasm. Warm showers gave 5-10 min of relief, so the patient took 5-6 showers that night even though it was hard to dry off because it felt like the muscles in the arm were tearing. The patient continued to have the severe pain in his arms as well.The nerve pain in both arms and legs is like fire going down his limbs or like electricity and did not sleep that night due to the pain, and hadn't slept the past 5 nights. On 22nd October 2019, the patient went to get a cup of coffee around 4 AM. Within 2 min of finishing the coffee, the pain and spasms left his legs. The patient still had pins and needles in his legs and his arms were still very painful, but his legs did not hurt. Less than 2 months after vaccination, the patient had pins and needles. The pain stayed away until around 10 PM that night when when they came back. On 23rd October 2019, drank a cup of coffee and the leg spasms and associated muscle pain went away again in his legs.Coffee seems to resolve the muscle pain and spams in his legs, but not the nerve pain or any pain and spasms in his arms. Following that night he would sleep from 10 PM-1 or 2 AM and wake up sweating with sheets soaked and his muscles spasming painfully. 35 days after vaccination, the patient had sweating. 2 Weeks ago from the date of reporting, the patient started having pain and stiffness in his neck and would get pain shooting up the right side of the back of his neck to the top of his skull. The shooting pains have become more frequent, from 5-6 times a day to 40 times a day and now go up the left side of his neck as well.Over time the nerve pain has become less, but it has been replaced with numbness in forearms with occasional stabbing pains, but had regained mobility in his shoulders.The patient had numbness in his thighs, toes and ankles and the top of his skull.The pain flares up in the evenings, causing him to only get about 3 hours of sleep. The patient would sometime get 1-2 hours of sleep in the afternoon, but has only gotten a total of 5 hours of sleep during the course of the day for the past 3 weeks. For 13 days prior he would only get 1 hour or less of sleep. When the pain flares he becomes very excited and anxious. The patient seen by 2 different neurologists, did more blood tests and a lumbar puncture. The lumbar puncture showed elevated protein in his spinal fluid and blood tests showed high white blood cell counts.The neurologists also think this is a viral infection, but have not given him a specific diagnoses because many illnesses can cause this type of reaction. The patient had  nerve conductivity test scheduled in about 1 week. The reporter believes these symptoms were caused by a reaction to Shingrix, the flu vaccine or both. The pain has been awful and debilitating, making it difficult for him to walk or use his arms. Less than 3 months after vaccination, the patient was unable to walk and mobility decreased. The more he uses his arms during the day, the worse the pain is at night when it flares up. The patient had less pain and more numbness in his skull, but is having more fatigue and does not feel as mentally sharp as usual. The patient thought the lack of sleep might be causing this, now that the pain has lessened some and he does not have as much adrenaline. The patient concerned, though, that the symptoms were progressing and was experiencing demyelination of the central nervous system. 27 days after vaccination, the patient had Demyelination. The reporter did not consent to follow up.      Lab Comments: X ray of lungs and veins up the back of neck was normal. Heart tests on 17th October 2019 were normal.