Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Hypoalbuminaemia, Inappropriate schedule of drug administration, International normalised ratio increased, Iron deficiency anaemia, Lipids normal
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of pulmonary embolism in a 42-year-old female patient who received ENGERIX B adult. The patient's past medical history included road traffic accident (Leg swelling) and female sterilization. Previously administered products included ENGERIX B adult (1st dose received on 20th August 2014) and ENGERIX B adult (2nd dose received on 17th September 2014). Concurrent medical conditions included hypertension and obesity. On 28th January 2015, the patient received the 3rd dos of ENGERIX B adult. On 28th January 2015, an unknown time after receiving ENGERIX B adult, the patient experienced drug dose administration interval too short. In February 2015, the patient experienced pulmonary embolism (serious criteria hospitalization and GSK medically significant) and chest pain. On 16th February 2015, the patient experienced shortness of breath. On an unknown date, the patient experienced iron deficiency anemia and pre-diabetes. The patient was treated with acetaminophen, LOVENOX, ferrous sulfate and Warfarin. On an unknown date, the outcome of the pulmonary embolism was recovered/resolved and the outcome of the shortness of breath, chest pain, iron deficiency anemia, pre-diabetes and drug dose administration interval too short were unknown. The reporter considered the pulmonary embolism to be possibly related to ENGERIX B adult. It was unknown if the reporter considered the shortness of breath, chest pain, iron deficiency anemia and pre-diabetes to be related to ENGERIX B adult. Additional details were received as follows: The blinded study vaccine was confirmed to be the ENGERIX B adult. Patient was 42-year-old, woman, who was enrolled in the other manufacturer's sponsored study. The patient was involved in a car accident prior to the study enrollment. The patient was in a rehabilitation facility, the exact injury that resulted in leg swelling was unknown, but it was confirmed that the time of immobility occurred prior to the onset of the pulmonary embolism. The site stated that no additional information was available. The patient had no previous history of deep vein thrombosis (DVT), smoking, or recent travel. It was unknown if there was a family history of DVT. The patient was not taking any oral or transdermal contraceptives nor hormonal replacement therapy. There were no concomitant medications in relation to pulmonary embolism. On 28th January 2015, the patient received the third dose of blinded study vaccine (ENGERIX B adult), which led to shortening of the vaccination schedule. On 16th February 2015, 20 days after having received the most recent dose (3rd dose) of study vaccine, the patient presented to the hospital with shortness of breath. The patient reported leg swelling and chest pain for the past two weeks. A chest x-ray showed no acute disease and no significant interval changes. A computerized tomography angiogram (CTA) chest showed left upper lobe and probable left lower lobe non-occlusive pulmonary emboli. Clot burden was low, otherwise no evidence acute disease of chest. A venous ultrasound bilateral lower extremity was normal without any evidence of thrombophlebitis. Her international normalized ratio was 1.1, haemoglobin was 11.1, and haematocrit was 35.5. She was found to have pulmonary embolism and was admitted to the hospital for further management. On 17th February 2015, warfarin dosing consultation was obtained as the international normalized ratio levels were sub therapeutic. She was started on LOVENOX and COUMADIN until the International normalized ratio was greater than 2. Further workup included lupus anticoagulant, antiphospholipid antibody, factor V Leiden mutation and prothrombin mutation, which were all reported to be negative (copies of results were unavailable). During the course of the hospitalization the patient had (glycosylated haemoglobin) HbA 1 c of 6.1 percent and was diagnosed with pre-diabetes (a medically attended adverse event) (MAE). She also presented with iron deficiency (MAE) with iron panel showing low iron and percentage saturation, fecal occult blood test negative, hyperglobulinemia and hypoalbuminemia. She was counseled for diet and lifestyle modification and was started on iron supplementation. Thyroid stimulating hormone (TSH) and lipid panel were within normal limits (test values and ranges were not reported). Dietician consultation was obtained to counsel with regards to the diet while on Coumadin. On 20th February 2015, laboratory values included: International normalized ratio 1.2, haemoglobin 11.0 and haemotocrit 31.6. On 21st February 2015, the patient was discharged from the hospital and the event was considered resolved. Her International normalized ratio was 1.3. She received LOVENOX injections and was taught how to self-inject at home. Discharge diagnoses included pulmonary embolism and morbid obesity. Discharge medications were as follows: acetaminophen, LOVENOX injections (twice daily), ferrous sulfate, and warfarin. The patient was scheduled for follow-up with "TriC and Coumadin clinic" in a week and scheduled for further workup of her pre-diabetes as an outpatient. No action was taken with the study vaccine as a result of the event; the patient had received all three doses of the study vaccine prior to the event. The investigator assessed the pulmonary embolism as serious (hospitalization), of severity grade 4, and as possibly related to the study vaccine. An alternative causality was unknown. This case has been linked with cases US2015011102, US2015011104 and US2015011106.