Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Tricuspid valve incompetence
Clinical narrative: Initial report received on 29 September 2009 from an investigator in a trial. A 77 year old female subject developed chest pain on 25 September 2009, 16 hours after she had received an intramuscular injection of INFLUENZA VIRUS VAC USP TRIVAL A AND B HIGH DOSE, SUBVIRION-U (batch nubmer-UD12307), on left deltoid on 25 September 2009. The subject had a medical history of asthma, hypertension, anxiety and depression (details not provided). Family history included: The subject's father had a history of CVA (cerebrovascular accident) and mother had a history of questionable CVA or MI (myocardial infarction) in her older age to which she died. On 25 September 2009, the subject developed chest pain, shortness of breath and elevated blood pressure for which she went to the emergency room. MI (myocardial infarction) was ruled out and the final diagnosis of chest pain and hypertension was made leading to hospitalization on the same day. Concomitant medications were not reported. Laboratory tests included EKG and cardiac enzymes tests which ruled out MI (details not provided). Treatment details not provided. The event of chest pain resolved on 26 September 2009 and the subject was discharged from the hospital on the same day. The subject is planned to contact PCP (primary care physician) for cardiac stress testing. According to the investigator, the event of chest pain was not related to the study vaccine. The serious adverse event did not lead to the termination of the subject from the study. No documents were held by the sender. Follow up received on 03 October 2009: The subject was vaccinated about noon, was home at approximately 4 p.m. where she developed midsternal heaviness and tightness which lasted for hours and was associated with nausea and diaphoresis. She checked her blood pressure at home and the systolic pressure was found to be over 200 after which she called up 911 as the chest discomfort did not resolve. She was taken to the and given aspirin en route. At ER where she was treated with unspecified IV fluids and Oxygen, her blood pressure was 150/80 mmHg, heart rate of 88/ min, and oxygen saturation 99% on room air. She was hospitalized overnight, EKG and cardiac enzymes were tested which ruled out MI (Myocardial Infarction). The subject reported that she believes that the events may be related to the vaccine she received but is unsure. The chest pain gradually resolved and the subject was discharged on 26 September 2009 the following day. The subject was allergic to Penicillin and Benadryl and she had also received unknown influenza vaccine in October 2008 and pneumococcal vaccine in 2008 (details not provided). Relevant concomitant medications included Benezapril 10 mg once daily and Alprazolam 0.5 mg once daily. Laboratory data included a blood test done on 25 September 2009 for NT-proBNP showed higher value of 823.5 mg/dl. CT scan of chest was done on 25 September 2009 did not show any pulmonary embolism. However, there was a presence of mild increased scattered atelectasis and/or infiltrate involving right lung base. EKG also showed mild mitral regurgitation, trace tricuspid regurgitation, aortic sclerosis and mild aortic regurgitation and no evidence of MI. According to the investigator, the event of chest pain was related to the study vaccine.