Age: 38.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Coxsackie virus test, Cytomegalovirus test positive, Differential white blood cell count normal, Dyspnoea exertional, Dyspnoea paroxysmal nocturnal
Clinical narrative: Case number PHHY2014US142497, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 543274) website on 28 Oct 2014, with the follow-up information received from Quality Assurance Department (reference number: 336137) on 08 Dec 2014. This report refers to a 38-year-old male patient. Concurrent conditions included poorly controlled hypertension, presumed viral illness (URI) with 2-3 day history of a dry cough and rhinorrhea (with clear discharge). Concomitant medications were none. He was vaccinated with FLUCELVAX (batch number: 007021A) into the right arm on 16 Jun 2014. The patient denied fever, chills, sore throat, earache, diarrhea, nausea or vomiting. He also denied an increase in symptoms (dry cough and rhinorrhea) or local redness, swelling or pain at the injection site after the vaccination. He did not miss any work due to his symptoms nor did it interfere with his sleep pattern, activities of daily living or exercise regimen (daily treadmill and weight lifting). The patient cough and runny nose had completely resolved by 01 Jul 2014. The patient remained asymptomatic until 26 Jul 2014. On 26 Jul 2014, the patient uncharacteristically became dyspneic after a light swim and walking a few blocks. On the same day in the night he had three pillows orthopnea. He denied chest pain, chest pressure, palpitations or lightheadedness. On 29 Jul 2014, after a third night of orthopnea the patient reported to the clinic. At that time his weight was up about 20-25 pounds. The patient noted that his ankles were edematous. The patient was transported by ambulance to hospital with new onset heart failure. The patient was diuresed by LASIX over 1-2 days with significant improvement of his symptoms. The patient was transferred to another facility for further evaluation. The patient was recently diagnosed with myocarditis and nonischemic cardiomyopathy. The patient was wearing a Zoll life vest; the patient denies any discharges. On 25 Jun 2014, chest x-ray revealed mild cardiomegaly; no airspace. On 25 Jul 2014, complete blood count (CBC) was normal with exception of neutrophils 35.10% L and eosinophils 11.3% H, comprehensive metabolic panel (CMP) was normal with exception of chloride 108 H, creatinine 1.08 H and glucose 100 H. On 29 Jul 2014, brain natriuretic peptide: 677 H, creatine kinase MB (CKMB): 1.62, Troponin I 0.060 H and creatine kinase: 395 H. On 30 Jul 2014, Low-density lipoprotein (LDL): 147 H, High-density lipoprotein (HDL): 27 L, Triglycerides: 182 H and cholesterol: 210 H, basic metabolic panel (BMP) was normal with exception of glucose 108 H, potassium 3.2 L; CBC with differential count was normal with exception of WBC 11.2. H, eosinophils 9.6% H, basophils 1.8% H; creatinine 1.38, Troponin I: 0.068 H, creatine kinase: 328 H; Thyroid stimulating hormone: 2.69; Magnesium 2.3. On 02 Aug 2014, magnesium: 2.5 H, phosphorus: 4.0; BMP was normal with exception of glucose 145 H, urea nitrogen: 28 H, creatinine: 1.4 H and, Chloride: 97 L. On 26 Aug 2014, herpes simplex virus (HSV) antibody 1 plus 2 IgM: negative, Human herpesvirus 6 (HHSV-6) antibody: IgM less than 1:20; IgG 1:80 H, Cytomegalovirus antibody: IgM negative; IgG positive, Parvovirus B19: IgM 0.1; 1gG 4.8 H, Influenza A antibody: 1:16 H, Influenza B antibody: 1:8 H and Coxsackie B1-6 antibody: 1:16 H. The patient had an echocardiogram, cardiac catheterization, cardiac MRI (results not reported) and was currently being followed by the cardiology clinic. He walked approximately two miles per day at a leisurely pace without symptoms. The patient occasionally complained of paroxysmal nocturnal dyspnea. The patient denied chest pain/discomfort, dyspnea, palpitations, or syncope/presyncope. The patient treatment included ASA, COREG, LIPITOR, MICARDIS, Spironolactone, LASIX and Potassium Chloride. The final outcome of heart failure was condition improving and outcome of other events was unknown. Seriousness was reported as hospitalization. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUCELVAX vaccine (batch number: 007021A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 336137) on 11 Nov 2014: Updated reference number only. Follow-up information received from the Quality Assurance Department (reference number: 336137) on 08 Dec 2014; Updated FLUCELVAX batch review report.