Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Pericardial haemorrhage, Platelet count normal, Staphylococcus test positive, Viral infection, White blood cell count normal
Clinical narrative: Initial unsolicited report received from nurse via other company (Takeda) (Manufacturer Report Number: 2016TUS016453) through company representative on 06 January 2017. This case involves a 62 years old female patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, route and site of administration was not reported) on unspecified date and was administered a 300mg dose of ENTYVIO (other company) every 8 weeks via intravenous route from 20 July 2016 for Crohn's diseases and administered a dose of fluconazole on an unspecified date. The patient's previous medications reported as azithromycin, penicillin, amoxicillin. The patient's surgical procedures included bowel resection, femur fracture with repair, appendectomy, cholecystectomy and cardiac catheterization. The patient was former smoker. The patient's ongoing medical condition reported as Crohn's disease, anxiety, hypertension and Type 2 diabetes mellitus. The patient had allergy to latex and natural rubber and was also the patient was allergic to azithromycin, penicillin, amoxicillin (had drug hypersensitivity). The concomitant medications included GLUCOPHAGE. On 28 August 2016, few days after post vaccination of FLUZONE, 39 days following the administration of ENTYVIO the patient experienced sudden acute chest pain with mild shortness of breath. On unspecified the patient experienced large pericardial effusion with evidence of possible right ventricular diastolic collapse (revealed from computerized tomography angiogram), pericardial effusion complicated by cardiac tamponade and also experienced post viral cough syndrome. It was also reported that no action was taken with ENTYVIO. On an unspecified date the patient was hospitalized. On 01-Sep-2016, the patient underwent a pericardial fluid cytology which revealed no malignant cells, no acid fast bacilli growth, no fungus and grew pansensitive coagulase staph. On 04 September 2016, the patients creatinine was 0.7, potassium was 4.1, hemoglobin was 12.1, white blood cell count was 9.82, platelets were 294, lymphocytes 58% and neutrophils was 41%. On 12 September 2016, the patient underwent a transthoracic echocardiogram which revealed as left ventricular ejection fraction was 65% and small, circumferential and partially organized pericardial effusion and also on the same day patient underwent pericardial drainage resulted as cell count and differential from the pericardial fluid show a grossly bloody fluid, with 44422 white cells, with 58% lymphocytes and 41% neutrophils. On an unknown date, the patient's blood pressure was 108/68 mm/HG, heart rate was 92, patient's ECG (electrocardiography) which showed sinus rhythm, normal PR with normal ORS duration. On an unspecified date angiogram was performed that showed negative for pulmonary embolus. Corrective treatment was reported as On 31 August 2016, the patient underwent a pericardiocentesis and 500 ml of bloody fluid was removed and the patient had drain till 02 September 2016.On unspecified date, patient received corrective treatment with colchicine for the indication of pericardial effusion. On unspecified date, patient discharged from the hospital. On unspecified date, patient recovered from pericardial effusion complicated by cardiac tamponade and chest pain (reported as the patient did not experience any recurrence of chest pain) .The outcome for the event of post-viral cough syndrome was not reported and the event mild shortness of breath was not recovered (complained of mild shortness of breath with exertion after discharge). This case was also considered as serious due to seriousness criteria: Required Intervention to Prevent Permanent Impairment/Damage. Reporter Comments: The nurse did not provide a causality assessment for the event of pericardial effusion complicated by cardiac tamponade and post-viral cough syndrome with ENTYVIO. Company Comment: Based on the information provided, a causal association between administration of ENTYVIO and the event of fluid and inflammation around heart cannot be confirmed (lack of data). List of documents held by sender: none. Sender's Comments: This case concerns 62 year old female patient who received INFLUENZA QUADRIVAL A-B VACCINE along with vedolizumab and fluconazole and developed Pericardial effusion complicated by cardiac tamponade, cough syndrome, shortness of breath. Reported event are unexpected after vaccination except cough and shortness of breath. Time to onset was not compatible with role of vaccination. Further information regarding etiological work up, concurrent condition at the time of vaccination, reaction to previous vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.