Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Heart rate increased, Hypoventilation, No reaction on previous exposure to drug, Pallor, Presyncope
Clinical narrative: Information has been received from an insurance company representative via medical records concerning a 63 (also reported as 67) year old patient with no pre-existing physician-diagnosed allergies, birth defects or medical conditions who on 19-JAN-2010, at 14:10, was administered a first dose of ZOSTAVAX (Merck) (Lot # 665293/1175Y, expiration date 14-FEB-2011) subcutaneously in the right tricep. There was no illness at time of vaccination. There were no other vaccinations within 4 weeks prior to 19-JAN-2010. Concomitant therapies included metoprolol tartrate and tramadol. It was reported that the patient passed the screening process and stated that she had not exhibited a reaction to any previous vaccinations. After vaccination she was advised that she needed to stay in the pharmacy for 15 minutes following the vaccination for observation. At approximately 14:20 (also reported as about 15 minutes later), the patient complained of dizziness/light head and weak. She was advised to sit in a chair. Over the next 5 minutes, her condition became worse. Initial assessment indicated marked anxiety, shallow/rapid respiration, and confusion without loss of consciousness, rapid/weak pulse, weakness, confusion and apprehension. Patient was placed in the shock position with legs elevated. Emergency medical services (EMS) was contacted and assistance was requested from the medical staff of the health services. In house emergency equipment was brought to the scene. Initial vitals revealed blood pressure 130/75, pulse rapid and shallow at the radial artery, carotid pulse in excess of 100 and respiratory rate of 64. At approximately 14:27, the registered nurse and others arrived on scene with an EPI PEN, adult 0.3 mg and oxygen. Oxygen was applied with mask at 4 liters per minute. Patient increased in apprehension, pulse remained rapid, and blood pressure was 109/55, respirations were rapid and shallow. The events were assumed as anaphylaxis/apparent adverse reaction to ZOSTAVAX immunization. The assessments provided by the pharmacy nurse were vasovagal not ruling out anaphylactic shock. EPI PEN was administered in anterior lateral thigh, 0.3 ml of 1:1000. Patient's symptoms improved within 4 minutes. At approximately 14:35, EMS arrived. Patient respiration was slowing, confusion and apprehension were decreasing, blood pressure was 185/95, respiratory rate was 25 and pulse was not taken. Patient was passed off to EMS. Patient was transported via ambulance to the hospital emergency room held for observation and released after 19:00 on 19-JAN-2010. Patient's practitioner was consulted and told of patient's sister's report. That had several episodes of dizziness and ashen skin pallor while shopping. The practitioner recommended that the patient make an appointment to be seen as soon as possible after release. Upon internal review, vasovagal and anaphylactic shock treated with EPI PEN were determined to be other important medical events. No further information is available. All available medical records will be provided upon request.