Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia, Sitting disability, Weight bearing difficulty
Clinical narrative: FINGER AND FEET PAIN; PAIN WHILE DRIVING and sitting down; FLARE UP OF ARTHRITIS/ pain in the elbow/ INFLAMMATION IN LEFT ELBOW; could NOT ROLL ON TO BED/ COULD NOT PUT A WEIGHT ON LEFT ELBOW; BACK STIFFNESS; BACK PAIN; LETHARGY; nausea; feverish; This case was reported by a consumer via other manufacturer and described the occurrence of arthritis in a 31-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, ADALIMUMAB (HUMIRA) for psoriatic arthritis and etanercept (Enbrel) for product used for unknown indication.   The patient's past medical history included chronic myeloid leukemia, bone marrow transplant (due to chronic myeloid leukaemia bone marrow transplant done), alcohol use (12 beer canes a week), hypothyroidism, skin scarring, back pain, pain in fingers, joint pain, foot pain, hives, diarrhea, distended stomach, gastric disorder, graft versus host disease, nail pitting, nail pitting and neurological disorder nos. Previously administered products included MODERNA COVID-19 VACCINE (1st dose received on 28th December 2020) and MODERNA COVID-19 VACCINE (2nd dose received on 25th January 2021). Concurrent medical conditions included nonsmoker and shellfish allergy. Concomitant products included levothyroxine (Levothyroxin).   On an unknown date, the patient received FluLaval Tetra and Flulaval Tetra Pre-Filled Syringe Device. In June 2021, the patient received HUMIRA (subcutaneous) 40 mg. On an unknown date, the patient started Enbrel at an unknown dose and frequency. On 7th October 2021, unknown after receiving FluLaval Tetra and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced lethargy, nausea and fever. On 10th October 2021, the patient experienced stiff back and back pain. On 11th October 2021, the patient experienced arthritis and mobility decreased. On an unknown date, the patient experienced pain in fingers and pain. On 8th October 2021, the outcome of the lethargy, nausea and fever were recovered/resolved. On an unknown date, the outcome of the arthritis, pain in fingers, pain and mobility decreased were unknown and the outcome of the stiff back and back pain were not recovered/not resolved.   It was unknown if the reporter considered the arthritis, pain in fingers, pain, lethargy, nausea, fever, stiff back, back pain and mobility decreased to be related to FluLaval Tetra and Flulaval Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided are as follows: The age at vaccination was not reported. The patient had medical history of chronic myeloid leukemia, alcohol use (12 beer canes a week), bone marrow transplant, hypothyroidism, donor lymphocyte infusion, pitted nails, graft verus host disease, scars in skin, back pain, relapsed chronic myeloid leukemia, pain in fingers, joint and feet, non smoker, shellfish allergy, diarrhea, few hives, manifested by stomach distension, all gastro regian allergy manifested by neurological issue with arms. The patient received Flulaval tetra on an unknown date and had experienced arthritis, pain in fingers, pain, lethargy, nausea, fever, stiff back, back pain and mobility decreased. lethargy, could not roll on to bed, could not put a weight on left elbow, back stiffness, inflammation in left elebow, back pain, nausea, feverish, pain in the left elbow, finger and feet, pain while driving and sitting down and flare up of arthritis. The reporter reported that Humira and Enbrel stopped working. The patient received Levothyroxine for hypothyroidism. It was unknown if the reporter considered the arthritis, pain in fingers, pain, lethargy, nausea, fever, stiff back, back pain and mobility decreased to be related to Humira and Enbrel. The follow-up could not be possible as no contact details were available.