Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Nerve injury, Noninfective encephalitis, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: This case was reported by a consumer and described the occurrence of brain inflammation in a 61-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date 28th February 2021) for prophylaxis. On 29th August 2018, the patient received SHINGRIX. On 30th August 2018, 1 days after receiving SHINGRIX, the patient experienced fever (serious criteria hospitalization), nausea (serious criteria hospitalization) and shivering (serious criteria hospitalization). On 1st September 2018, the patient experienced tiredness. On 6th September 2018, the patient experienced stomach pain (serious criteria hospitalization), pain in upper extremities (serious criteria hospitalization), general body pain (serious criteria hospitalization), axillary pain and chest pain. On 8th September 2018, the patient experienced feeling unwell. On 9th September 2018, the patient experienced brain inflammation (serious criteria hospitalization and GSK medically significant), osteitis (serious criteria hospitalization), numbness generalized (serious criteria hospitalization), balance difficulty (serious criteria hospitalization), paresthesia (serious criteria hospitalization) and walking difficulty. On 11th September 2018, the patient experienced energy decreased (serious criteria hospitalization). On 12th September 2018, the patient experienced headache (serious criteria hospitalization). In October 2018, the patient experienced peripheral swelling. On 17th October 2018, the patient experienced nerve damage. In December 2018, the patient experienced activities of daily living impaired. On an unknown date, the patient experienced knee deformity, abnormal thinking and impaired work ability. The patient was treated with paracetamol (Acetaminophen), hydrocodone bitartrate + paracetamol (Norco) and ondansetron (Zofran). On 6th September 2018, the outcome of the tiredness was recovered/resolved. On an unknown date, the outcome of the brain inflammation, osteitis, shivering, balance difficulty, feeling unwell, activities of daily living impaired, peripheral swelling, knee deformity, abnormal thinking, walking difficulty, axillary pain, impaired work ability, chest pain and nerve damage were unknown and the outcome of the fever, numbness generalized, energy decreased and headache were not recovered/not resolved and the outcome of the nausea and general body pain were recovered/resolved and the outcome of the stomach pain, pain in upper extremities and paresthesia were recovering/resolving. It was unknown if the reporter considered the brain inflammation, osteitis, fever, nausea, shivering, stomach pain, pain in upper extremities, numbness generalized, balance difficulty, paresthesia, general body pain, energy decreased, headache, feeling unwell, tiredness, activities of daily living impaired, peripheral swelling, knee deformity, abnormal thinking, walking difficulty, axillary pain, impaired work ability, chest pain and nerve damage to be related to SHINGRIX. Additional details were reported as follows: After vaccination the patient experienced inflammation of the brain and spine which required hospitalization. On the same day after vaccination at 2:00 AM, the patient awoke with shivering and feeling nauseous. The body temperature was an approximately 102 and the patient took Acetaminophen, but temperature did not return to normal range and nausea continued. On 31st August 2018, the nausea was subsided, but temperature remained in the 100 plus range. In between 1st September to 6th September 2018, the patient felt tired and body temperature remained in the 99.5 to 101 plus range. On 6th September 2018, the patient began had severe stomach pain in a band around her abdomen and in central abdomen up into her chest. Also, an occasional pain in her left armpit below the muscle where vaccine was injected. On 7th September 2018, the body temperature creeped up in the 101 plus range and nausea returned. On 8th September 2018, the body temperature reached to 103.2 accompanied by nausea. The patient Went to visit primary care physician. The basic blood work was done and a stomach x-ray taken. The physician advised that, to visit an emergency room if the patient was not feeling better in the morning. On 9th September 2018, the fever, nausea, and pain continued. The patient Went to emergency room and had a series of blood tests, one of which might had damaged a nerve in her right hand, along with an abdominal CT scan. Then, the patient was went to home with instructions to visit an emergency room at one of the larger hospitals for a neurological evaluation if the patient did not feel better in the morning and prescribed for Norco and Zofran. The patient's body was beginning to feel numb, tingly, and painful and the patient was having trouble walking and maintaining balance. On 10th September 2018, the patient definitely not feeling well this morning and the body felt numb, tingly and painful to touch from chest to toes. The patient could not walk without assistance and went to emergency room.  The physician seemed quite concerned about the patient's condition as did the hospital physician and so the patient began another round of tests with several blood draws and a brain MRI with and w/without contrast. After these tests, the patient admitted to the general floor of the hospital and then a short time later transferred the neurology floor. On 11th September 2018, the patient's body still numb, tingly, painful and weak. On the same day, the patient had more test like blood draw, Lumbar Puncture and two spinal MRIs. On 12th September 2018, the pain subsided but still numb, tingly and weak.  The patient woke up with headache. On 13th September 2018, the pain almost gone and the numbness and tingling reduced. The patient discharged from hospital. In between 13th September 2018 to 18th September 2018, the patient was resting and recuperating at home. Each day the numbness and tingling were decreased and the patient was regaining strength and energy but not completely recovered. For weeks the patient had continued to experienced numbness and tingling from her waist down. It was difficult to describe but for days, two to five times an hour, the patient experienced what felt like a mild electric shock to a band (like a shock collar) around her abdomen followed by tingling in her legs that felt like was carbonation injected into her legs. On 17th October 2018, the patient visited to the neurologists again and their opinion was simply that the patient had "overdone"  The patient woke up feeling great. The shock sensations were only occurring about once an hour, the patient felt strong and energetic, so she skipped her afternoon nap and ran errands for an hour and a half. Then the patient had to return to work and walked briskly to work, and then suddenly the patient body felt like all of my nerves exploded. For 15 to 30 seconds the patient felt like I had no control over her body and she need help. After resting, the patient was able to get up and walk but felt exhausted. The patient's friend dropped her at home and spent the rest of the evening on the couch. On Monday, the patient felt he best since 29th August 2018. The shock sensations, numbness and tingling had been minimal and felt much more energetic. At the time of reporting, the numbness and tingling continued to decrease. The patient still experienced whole body tingling, especially when she physically active or tired. The patient recreational activity was walking. The patient was not walk for long distance. The shock sensations was still occurred occasionally and still her energy level low and tired easily. At one point, the physician and the patient were concerned that the reaction might leave her paralyzed, worse or dead. The patient felt very sad about this experienced. The patient wanted to know, how this would affect as her age, physically, mentally, emotional well-being, lifespan, lifestyle and financially.