Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Rash, Raynaud's phenomenon
Clinical narrative: Case number PHEH2017US005531, is an initial spontaneous report received from a health care professional (Office manager) on 21 Feb 2017. This report refers to a 25 years old female patient. Medical history was not reported. Concomitant medication included as spironolactone. The patient was vaccinated with first dose of FLUCELVAX QUADRIVALENT (batch number: 186866) into left deltoid, at a dose of 0.5 ml on 12 Jan 2017 at 17:58 pm, intramuscularly. On 17 Jan 2017, the patient developed prolonged muscle and joint aches and that happened right after she got the shot. On 17 Jan 2017, the patient developed polyarthralgias. Patient developed pain in her hands, feet, knees, ankles and elbows. It was more severe for 02 weeks, now improved. Patient knee pain was worse in cold or after exercise, intermittent. More recently it was more constant. Patient now has myalgias, she had pain from knees down. Patient had tingling, paresthesia, pain in calves and feet on an unknown date. Patient 02 nights could not sleep, myalgias and severe leg pain, no restless legs, last night pain in left leg. Patient had low back pain and injured her back, rash and left ear lower extremities, does not think it was psoriasis, feels itchy. Patient had Raynaud, 5 toes on an unknown date. Patient was worse after sitting for long periods worse at night. Patient received MIRALAX and took PRN ibuprofen 600. Patient ruled out celiac and had endoscopy. Patient had dry eyes and severity up to 8/10. On 11 Feb 2017 at 10:30 AM, the patient had Serum chloride 95 nmol/L (normal range 96 to 106 nmol/L), Calcium serum 10.3 mg/dl (normal range 8.7 to 10.2 mg/dl), Alkaline Phosphatase 37 IU/L (normal range 39 to 117 IU/L), PH 8.0 (normal range 5.0 to 7.5) (Unit unspecified), Total cholesterol 240 mg/dl (normal range 100 to 199 mg/dl), LDL cholesterol calcium 148 mg/dl (normal range 0 to 99 mg/dl), Vitamin D, 25 Hydroxyl 29.1 ng/ml (normal range 30.0 to 100.0 ng/ml), Carbonic Anhydrase VI IgM A 24.0 Eu/ml (normal range, Less than 20 Eu/ml equal to Negative and greater than 20 Eu/ml equal to Positive). Patient received meloxicam 15 mg, 1 tablet daily with food p.r.n. on 23 Feb 2017. Reporter stated that they were not sure even if that was due to the vaccine. It was reported that 2-3 days after vaccine administered patient started feeling achy and reporter did not associate the symptoms with the vaccine. The patient was still having the symptoms and they were worse. The outcome of the events myalgia and arthralgia was reported as condition unchanged and rest of the events were not reported. The seriousness of the events myalgia and arthralgia was reported as serious (disability) and rest of the events was not reported. The causality of the events were not reported. The seriousness assessment of coeliac disease was upgraded serious (medically significant) based on the Novartis Important Medical Event list. Follow up report received from a health care professional (Office manager) on 24 Mar 2017: Added patient demographics (patient ID, height and weight), concomitant medication (spironolactone), suspect drug information (vaccination time and vaccination site), updated events date (myalgia and arthralgia), added events (02 nights could not sleep, injured her back, left ear lower extremities, Raynaud, ruled out celiac, dry eyes and severity up to 8/10, low back pain, pain in her hands and feet, pain in calves and feet, severe leg pain, pain in left leg, tingling and paresthesia, rash and feels itchy), laboratory data, treatment medications (MIRALAX, ibuprofen and meloxicam) and reporter comments.