Sex: F
Vaccine: HEP
Symptoms: Ear pain, Erythema, Fatigue, Gait disturbance, Haemorrhagic diathesis
Clinical narrative: Case received via regulatory authority. Regulatory authority received case on 4th December 2018 and subsequently forwarded to GSK on 14th December 2018. This spontaneous report was received from a physician via another company (Amgen, Inc. - USASP2013074499, AbbVie Inc - Abbvie 17P-163-1835558-00) by the license partner Johnson & Johnson and was forwarded to regulatory authority on 09-Nov-2018. This case concerns a 65-year-old female patient. The patient's weight was 70 kilograms, height was not reported. The patient's medical history and concurrent conditions included: allergy, anemia, atrial fibrillation, bronchiectasis, cataract, coronary artery disease, gait disturbance, gastroesophageal reflux disease, hiatal hernia, hypergammaglobulinemia benign monoclonal, hyperlipidemia, hypothyroidism, intraocular lens implant, irritable bowel syndrome, myopathy, neuropathy peripheral (neuropathy peripheral esophageal stenosis), pain, pancreatic cyst, and partial seizures. The patient had previously experienced drug allergy when taking tramadol. On an unspecified date, the patient initiated ZYRTEC tablet, unknown 10 mg once a day, initiated for drug use for unknown indication. Co-suspect drugs included SUDAFED (unspecified, unknown) initiated on an unknown date for drug use for unspecified indication, LASIX for drug use for unspecified indication, methotrexate for drug use for unspecified indication, PLAQUENIL for drug use for unspecified indication, potassium for drug use for unspecified indication, XANAX for drug use for unspecified indication, sulfasalazine for drug use for unspecified indication, TRILEPTAL for drug use for unspecified indication, ENBREL for drug use for unspecified indication, LIALDA for drug use for unspecified indication, BACTRIM for drug use for unspecified indication, ISORDIL for drug use for unspecified indication, ARAVA for drug use for unspecified indication, ampicillin for drug use for unspecified indication, GEODON for drug use for unspecified indication, ANTIVERT for dizziness, ACTEMRA for drug use for unspecified indication, rituximab for drug use for unspecified indication, ciprofloxacin for drug use for unspecified indication, colchicine for drug use for unspecified indication, LYRICA for drug use for unknown indication, ciclosporin for drug use for unspecified indication, erythromycin for drug use for unspecified indication, hepatitis b vaccine for drug use for unspecified indication, ZENPEP for drug use for unspecified indication, etanercept for drug use for unspecified indication, HUMIRA for drug use for unknown indication, COMPAZINE for drug use for unspecified indication, ACTIFED for drug use for unspecified indication, DIAMOX for drug use for unspecified indication, DILAUDID for drug use for unspecified indication, doxycycline for drug use for unspecified indication, dyazide for drug use for unspecified indication, iron for drug use for unspecified indication, and KEFLEX for drug use for unspecified indication. Concomitant medications included ergocalciferol for drug use for unspecified indication, multivitamin for drug use for unspecified indication, mupirocin for drug use for unspecified indication, oseltamivir phosphate for drug use for unspecified indication, montelukast sodium for drug use for unspecified indication, levothyroxine sodium for drug use for unspecified indication, sertraline hydrochloride for drug use for unspecified indication, ciclosporin for drug use for unspecified indication, paracetamol for drug use for unspecified indication, citalopram hydrobromide for drug use for unknown indication, hydrocortisone for drug use for unknown indication, zinc for drug use for unknown indication, ketotifen for drug use for unknown indication, cyanocobalamin for drug use for unknown indication, ranitidine hydrochloride for drug use for unknown indication, dexamethasone for drug use for unknown indication, tacrolimus for drug use for unknown indication, and cyanocobalamin for drug use for unknown indication. 11-JAN-2011, the patient experienced black out, bleed easily, anaphylaxis, interstitial lung disease, rheumatoid arthritis, Sjogren's disease, wrist wound, Enbrel tolerance, allergic to medication, exhibit edema, tenderness, warm skin, dry skin, erythema/redness, generalized, osteoarthritis, chill, sneezing, change in appetite, fatigue/tiredness/tired, dermal problem, ear pain, mouth sore, rhinorrhea, trouble in swallowing, photophobia, chronic pain, itching, visual disturbances, shortness of breath, wheezing, abdominal pain, diarrhea, constipation, myalgia, back pain, joint swelling, arthralgia, gait problem, neck pain, neck stiffness, dizziness, weakness, numbness, headache/frontal headache, bruises, dysphoric mood, nausea, vomiting, unclear thinking, weak, rash, blisters, hallucinations, stomach upset and wrist, infection. Laboratory data was provided as follows: blood pressure 117/78, body temperature 36.4 Celsius, heart rate 74, pulse rate 74. Action taken with cetirizine hydrochloride, pseudoephedrine hydrochloride, ciclosporin, acetazolamide, hydromorphone hydrochloride, doxycycline, dyazide, iron, cefalexin, furosemide, methotrexate, hydroxychloroquine phosphate, potassium, alprazolam, sulfasalazine, oxcarbazepine, etanercept, mesalazine, bactrim, isosorbide dinitrate, leflunomide, ampicillin, ziprasidone hydrochloride, ancovert, tocilizumab, rituximab, ciprofloxacin, colchicine, pregabalin, erythromycin, hepatitis b vaccine, pancrelipase, etanercept, adalimumab, prochlorperazine and ACTIFED was not reported. Outcome of the all events were not reported. This report was serious (medically significant). Reporter causality: unavailable. Additional information: Suspect medications included POTASSIUM. Containing generics POTASSIUM NOS. Concomitant medications included Multivitamin & Mineral. Containing generics Ascorbic ACID, BIOTIN, CALCIUM, CALCIUM PANTOTHENATE, COLECALCIFEROL, CYANOCOBALAMIN, DL-ALPHA TOCOPHERYL ACETATE, ERGOCALCIFEROL, FERROUS FUMARATE, FOLIC ACID, IODINE, IRON, MAGNESIUM, MAGNESIUM OXIDE, MAGNESIUM OXIDE, MANGANESE, MANGANESE SULFATE, NICOTINAMIDE, PANTOTHENIC ACID PHOSPHORUS, POTASSIUM, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, RETINOL ACETATE, RIBOFLAVIN, THIAMINE MONONITRATE, ZINC GLUCONATE. Lab Comments: On unknown date Blood pressure test was performed and result was 117/118. On unknown date Body temperature test was performed and result was 36.4. On unknown date Heart rate test was performed and result was 74. On unknown date Pulse rate test was performed and result was 74. Reporter's Comments: Spontaneous report was received from a physician. An adult female patient with medical history of allergy, anemia, atrial fibrillation, bronchiectasis, cataract, coronary artery disease, gait disturbance, gastroesophageal reflux disease, hiatal hernia, hypergammaglobulinemia benign monoclonal, hyperlipidemia, hypothyroidism, intraocular lens implant, irritable bowel syndrome, myopathy, neuropathy peripheral, pain, pancreatic cyst, and partial seizures developed black out, bleed easily, anaphylax.