Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray, X-ray with contrast lower gastrointestinal tract abnormal, X-ray with contrast upper gastrointestinal tract abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a elderly male patient who received SHINGRIX for prophylaxis. On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th April 2018, 1 days after receiving SHINGRIX, the patient experienced neuropathy (serious criteria GSK medically significant), general body pain and myalgia. On 19th April 2018, the patient experienced unable to walk. On an unknown date, the patient experienced rectal bleeding (serious criteria GSK medically significant), internal hemorrhoids, skin blotches, skin discoloration, enlargement of lymph nodes, localized itching, skin lesion, cold feet and weight loss. The patient was treated with gabapentin, amoxicillin sodium, AUGMENTIN, duloxetine and prednisone. On 13th April 2018, the outcome of the general body pain was recovered/resolved. On an unknown date, the outcome of the neuropathy, unable to walk, skin blotches, skin discoloration, localized itching and myalgia were not recovered/not resolved and the outcome of the rectal bleeding, internal hemorrhoids, enlargement of lymph nodes and skin lesion were recovering/resolving and the outcome of the cold feet and weight loss were unknown. It was unknown if the reporter considered the neuropathy, rectal bleeding, internal hemorrhoids, general body pain, unable to walk, skin blotches, skin discoloration, enlargement of lymph nodes, localized itching, myalgia, skin lesion, cold feet and weight loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that before he received the vaccine, he was a healthy, very active 70 years old and was jogging every day. At the time of reporting the patient was on blood thinners (concomitant) which was the only medication he was taking at the reporting time. The patient received SHINGRIX in the left deltoid. The patient reported that initially after receiving SHINGRIX he was fine with only some minor aches and pains that began 1 day after the vaccine and lasted for 3 days. Beginning on 19th April 2018, the aches and pains increased to a point where it affected his ability to walk, and he started having neuropathy in both feet. The patient's myalgia worsened, and the patient was almost wheelchair bound, and could barely get to the bathroom because of the myalgia which began at his shoulders, down his biceps, wrists and calves. The patient reported that his legs feel cold to the touch and also he had lesions develop on all of his knuckles, and on his elbows which were healing at the time of reporting. At the time of reporting, the patient's skin was blotchy and purple and he was experiencing itching of both ankles up to 2 by 3 of his calves. The patient had seen 13 physicians, including a rheumatologist and oncologist. The patient had also lost 40 pounds, but denied any diarrhea or vomiting. The patient reported that he had swollen lymph nodes like "he had the mumps" and was placed on oral prednisone. The patient also had rectal bleeding, had an upper and lower GI (gastrointestinal) series done, and was diagnosed with internal hemorrhoids which were banded. The patient was on Gabapentin for the neuropathy, was given AUGMENTIN, and Duloxetine. The patient had given permission to contact his healthcare professional (HCP) along with contact details. The physician would be seen by the patient in August and also up at healthcare. Lab Comments: On an unspecified date, the patient underwent has had Positron emission tomogram (PET) scans, a bone scan, and full skeletal x-rays result were not reported. On an unspecified date, the patient had an upper and lower GI (gastrointestinal) series done, and diagnosed with internal hemorrhoids.