Age: 68.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Red blood cells urine positive, Respiratory syncytial virus test negative, Thrombocytopenia, Ulcer haemorrhage, Urine analysis abnormal
Clinical narrative: This is a literature case initially received on 20-May-2019 concerning a 68-year-old, elderly male patient. It was reported that for the past 3 years, the patient received influenza vaccine and had an episode of epistaxis every time he was vaccinated. The patient's historical conditions included Hepatitis C (diagnosed 4 years prior) which was treated with ledispavir/sofosbuvir (2 months prior to vaccination) and an episode of chest pain (treated with aspirin 2 days prior). The patient's surgical history included cholecystectomy and tonsillectomy. The patient was smoker as well as occasional marijuana user with no use of alcohol or other drugs. The patient's current conditions included pre-diabetes, hypertriglyceridaemia, chronic back pain, and anxiety (since unspecified date). The concomitant medications included tamsulosin, fenofibrate and fluticasone. The patient denied any epistaxis throughout other times in the year. On an unspecified date, the patient was administered with suspect vaccine INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for influenza vaccination. The patient was also administered co-suspect vaccine Pneumococcal conjugate vaccine (pneumococcal vaccine conj; dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication.  On an unspecified date, 2 days after vaccination, the patient presented to the urgent care with epistaxis lasting 1-day, gross haematuria, and bleeding gums. The epistaxis had resolved with some external pressure prior to arrival to the emergency department and the patient was no longer bleeding. When they saw his bloody urine, urgent care personnel referred the patient to the emergency department. The patient reported that unlike the previous episodes of epistaxis, the current episode of epistaxis lasted for couple of hours and then resolved spontaneously. The patient also developed gross haematuria as well as bleeding oral ulcers. The patient was hospitalised subsequently. Upon the examination of systems, the patient had no fever, night sweats, recent infections, diarrhoea. Physical exam was significant for non-tender sores over the buccal mucosa, blood in the oropharynx and blood clots in bilateral nares with no active bleeding. The nasal mucosa was otherwise unremarkable. The patient also had a petechial rash scattered over bilateral lower extremities and his trunk. On an unspecified date, lab investigations were performed and complete blood count showed thrombocytes as 0 per micro litres which was compared with 210 000267 000 cells/micro litres in the past; leucocytes 11.1×10E9/L; haemoglobin 132 g/L were within normal limits. Peripheral blood smear confirmed severe thrombocytopaenia with no thrombocyte clumping. Rare small, lightly granulated thrombocytes were present. There were no other significant abnormalities. Serum chemistry had a creatinine of 0.99 mg/dL, glucose 104 mg/ dL, with other lab values normal. Urine microscopy showed erythrocytes (reference 03) less than 100, with 05 leucocytes and no squamous cells or bacteria. Prothrombin time was 10.1 seconds, activated partial thromboplastin time: 23.5 seconds, fibrinogen was 378 mg/dL  and D-dimer was 2.09 mg/L. Nasopharyngeal influenza A, influenza B and respiratory syncytial virus PCR, HIV antigen/antibody, Hepatitis C quantitative viral load, flow cytometry tests results were negative. Patient received a platelet transfusion. He was initiated on both intravenous immunoglobulin (IVIG) therapy and dexamethasone 40 mg daily for 3 days. Then the therapy was switched to oral prednisone 60 mg daily. The patient also received four transfusions of platelets during the admission given his platelet count of 0 per microliter (as reported) and bleeding from both the nose and the urinary tract (platelet transfusion recommended with platelet counts of less than 10 000 per micro litre. The day after initial treatment, his platelet count improved to 39 000 and on the fourth day, it improved to 101 000. By the 10th day, the platelet count was normal at 342 000 per micro litre. The patient was discharged on 60 mg of prednisone as well as a proton pump inhibitor and advised not to receive any further influenza vaccinations. The outcome of the events was recovered. The reporter assessed the case as serious due to hospitalization. The reporter considered that the severe thrombocytopaenia in the patient was due to the influenza vaccination due to the temporal association of the vaccination with the thrombocytopaenia, ruling out of other diagnoses (hepatitis C RNA count was zero and there was no evidence of an infection or lymphoproliferative disorder). Therefore, the reporter assessed the events as related to the suspect vaccine.; Reporter's Comments: A 68-year-old, male patient with historical conditions (Hepatitis C treated with ledispavir/sofosbuvir and chest pain treated with aspirin) experienced epistaxis, gross haematuria, and bleeding gums considered to be immune thrombocytopenic purpura, 2 days after administration of INN Flu Vaccine. Considering the plausible temporal relationship between vaccination and reported events, lack of any underlying conditions or alternative more plausible causes and prior history of epistaxis post influenza vaccine, the company conservatively assessed the events as possibly related to suspect vaccine. However, co-administered Pneumococcal vaccine was considered as non company suspect in this case. The events of physical examination abnormal and investigations (platelet count decreased, urine analysis abnormal, blood smear test abnormal, fibrin d dimer increased) were assessed as not related to suspect vaccine, as these were considered as physical examination findings/investigations supporting diagnosis and/or other reported events.