Sex: F
Vaccine: FLUR4, PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Myalgia, Nasopharyngitis
Clinical narrative: Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse through a specialty pharmacy via other company (Intercept Pharmaceuticals) under MFR number: PM2019000068. This case involves a 61 years old female patient who experienced pain, muscle aches, chills, injection site pain and injection site redness, nasal drip, head cold and fever, while she received vaccines FLUBLOK QIV (also reported as Flu Vaccine VII), PREVNAR 13 and OBETICHOLIC ACID [OCALIVA]. The patient's medical history included primary biliary cirrhosis, unspecified lung disorder, and allergies to penicillin, Bactrim (trimethoprim/sulfamethoxazole), and Ursodiol (ursodeoxycholic acid). Concomitant medications included B Complex (calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride), aloe vera oil, Centrum Silver (ascorbic acid, biotin, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc), Hyzaar (hydrochlorothiazide, lorsartan potassium), Synthroid (levothyroxine sodium), calcium magnesium zinc, folic acid, Vitamin C (ascorbic acid), D3 (colecalciferol), Turmeric (curcuma longa), and fish oil. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported. On an unknown date, the patient received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route. On 19-Nov-2018, the patient started taking OCALIVA (OBETICHOLIC ACID) 5 mg QD oral (with an unknown batch number, 10-Nov-2019) for Primary biliary cholangitis. On an unknown date OCALIVA (OBETICHOLIC ACID) dosage was changed to 5 mg 3 times a week. On an unknown date, the patient experienced fever, chills, muscle aches, pain, nasal drip, a head cold, and injection site pain/redness following the doses of FLUBLOK QIV, PREVNAR 13 and OCALIVA. It was noted that these events could have been secondary to the patient's receipt of the PREVNAR 13 and influenza vaccines or her comorbidities which included an unspecified lung disorder. No lab test was reported. Final diagnosis was fever, head cold, nasal drip, injection site pain and injection site redness, chills, muscle aches and pain. It was not reported if the patient received a corrective treatment. The outcomes of the events were unknown. Sender's comment: Company Comment: Per the current reference safety information - USPI, the reported events of chills, muscle aches, pain, injection site pain, nasal drip, head cold, and injection site redness are listed, and the reported event of fever is listed. Based on the information available, the reported events were considered related to the co-administration of the vaccine injections but not with the obeticholic acid therapy. List of documents held by sender: none.