Age: 59.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cardiac disorder, Condition aggravated, Death, Product storage error
Clinical narrative: This is a spontaneous case, initially received from other health professional on 07-Mar-2019, concerning a 59-year-old, adult male patient. The patient's current conditions included hypertension, coronary heart disease, chronic obstructive pulmonary disease (COPD) and biventricular congestive heart failure (reported as medical history). The patient's concomitant medications included Albuterol, INCRUSE ELLIPTA, carvedilol, atorvastatin, furosemide, SPIRIVA, lisinopril, clopidogrel and ipratropium bromide. It was reported that on 11-Feb-2019, vaccines reached lowest temperature of 32.4 F (first excursion) and it was out of range for 1 hour. On 02-Mar-2019, temperature of the vaccines again reached 26.2 for 1 1/2 hours. On 05-Mar-2019, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: YF44209 and expiry date: 30-Jun-2019] which underwent temperature excursion for active immunization against influenza. On the same day, the patient was also administered with non-company suspect vaccine PNEUMOVAX [anatomical location: left deltoid, dose, route of administration, batch number and expiry date: not reported] for immunization against pneumococcal disease. It was reported that, on an unspecified date, the patient passed away due to cardiac complications of pre-existing medical conditions. The reporter assessed the case as non-serious. Case re-opened for completion of full data entry: 07-Mar-2019. Follow up received from other health professional on 17-Apr-2019: It was reported that they had no information on the patient, until they were recently informed that the patient passed away due to cardiac complications of pre-existing medical conditions. Hence, the event 'cardiac disorder' with fatal outcome was added in the event tab. Hence, the classification 'special case with no AE' was deleted in general tab. The case was upgraded from non-serious to serious. The case outcome was changed from unknown to fatal. The narrative and case comment were amended accordingly. Reporter's Comments: A 59-year-old male patient with concurrent conditions hypertension, coronary heart disease, chronic obstructive pulmonary disease (COPD) and biventricular congestive heart failure was administered AFLURIA QUADRIVALENT vaccine which underwent temperature excursion. The patient died due to cardiac complications, unspecified period post vaccination. Despite the lack of onset latency, the company assessed the causality of the event cardiac disorder as not related, considering the pre-existing heart conditions as the alternative aetiology. The event incorrect product storage assessed as not related to suspect vaccine, considering the incidental nature of the event and the event drug administration error assessed as not related to suspect vaccine, considering the accidental nature of the event. The company assessed the event 'cardiac disorder' as serious (medically significant). Reported Cause(s) of Death: Due to cardiac complications of pre-existing medical condition.