Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, Left ventricular end-diastolic pressure, Muscle spasms, Pain in extremity, Pallor
Clinical narrative: heart murmur; inappropriate schedule of vaccine administered; supraventricular ectopy/premature atrial contraction; back cramps; blood pressure low; right arm pain; bilateral leg pain; fainting; vasovagal episode; seizure; bradycardia to 40; Information has been received from a registered nurse concerning a 11 year old female patient with good general state of health and no pertinent medical history or drug allergies who on 06-APR-2011 was vaccinated subcutaneously with a dose of varicella virus vaccine live (Oka/Merck)(lot#667071/1467Z) in the back of right arm. There was no concomitant medication. It was reported that no rash occurred at the site of injection post-vaccination. The patient did not have exposure to chickenpox or shingles recently. On 06-APR-2011 the patient experienced fainting, seizure and bradycardia to 40. At the time of the report, the patient had recovered.   Follow-up information was received from the initial reporter (the administering nurse) who provided medical records concerning an 11 year old white female (weight 88 pounds, height 47 inches) who had no illnesses at the time of vaccination. Medical history included cough, post nasal drip and surgery for a lazy eye. Concurrent conditions  included abdominal pain, diarrhea, very poor memory, "challenges in school, not doing well" (per step mother) (noted at office visit 06-Apr-2011). The reporting nurse indicated patient had no applicable pre-existing allergies, birth defects or medical conditions. She was taking no concomitant medications. On 06-Apr-2011, during a well child visit, at 2:45 pm, the patient received her first dose of varicella virus vaccine live (Oka/Merck) (lot#667071/1467Zl expiration date 29-Oct-2012) subcutaneously in the back of her right arm. She concomitantly received her first dose of hepatitis A virus vaccine inactivated (HAVRIX) (lot number AHAVB464BA; expiration date 23-Mar-2013) intramuscularly in the right deltoid. At 2:46 pm, the patient stated, "I feel like I am going to faint". She turned gray and slumped into her stepmom's arms and started shaking her hands and arms. Physician was called to the room. Physician entered the room and patient was on the table, pale and awake with her eyes  rolled back and shaking was noted, lasting about 10 seconds. The patient was alert after the episode and complained of right arm pain and bilateral leg pain. Her heart rate was 50 and pulse oximetry was 100%. Her pulse then increased to 100 and she had leg complaints and after five minutes, she fainted again. The nurse indicated that at 2:49 pm, the patient experienced seizure activity lasting 10 seconds and bradycardia to 40. Emergency Medical Services was called to transfer patient to the emergency room. The stepmother indicated that the patient's blood pressure dropped so low in the ambulance that the medics could not get a reading. When the patient arrived at the emergency room, her vitals became stabilized. An EKG, electrolytes and glucose were normal and she was sent home. The stepmother stated that she and the patient's dad "have seen this type of behavior before where she just fades in and out and they are concerned that [the patient] may have a neurological disorder".  The patient recovered. On 27-Apr-2011, the patient was seen by a cardiologist (was referred for evaluation of syncope) who noted that since the patient's isolated episode on 06-Apr-2011, she had not had any other symptoms referable to the cardiac system or episodes of syncope or presyncope. At time of the visit, EKG was normal (aside from a single ectopic beat). Echocardiogram showed usual anatomic arrangements. No structural defects were identified. There was good biventricular systolic function and no chamber enlargement or hypertrophy. There was no mitral or atrial regurgitation. There was trivial tricuspid regurgitation and pulmonary insufficiency. Right ventricular pressure estimate was low. There was trileaflet aortic valve with normally rising right and left coronary arteries probably. Aortic arch was unobstructed. Septum wall thickness was 0.7 cm, left ventricular free wall was 0.7 cm, left ventricular end diastolic pressure was 4.21 cm, left ventricular end systolic  pressure was 2.7 cm and left ventricular shortening fraction was 35%. The physician's overall impression was that the patient's episode was likely a vasovagal and not cardiac in origin. She was encouraged to increase her fluid and salt intake. A heart murmur was heard which the physician believed was functional. A Holter monitor was placed during the visit. Interpretation was rare supraventricular ectopy primarily in the form of rare ectopic atrial beats, very brief nonsustained run of ectopic atrial rhythm and no ventricular ectopy. The patient reported "back cramps" associated with normal sinus rhythm and single premature atrial contraction.  On 22-MAY-2011, the patient was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck) (lot number 667071/1467Z) subcutaneously in the back of her right arm.  Upon internal review, seizure was considered to be an other important medical event.  Additional information has been requested.  Follow up information has been downloaded from regulatory authority (US-1577272925-E2011-03573) on 06-FEB-2023. The agency considered the events of bradycardia, back cramps, blood pressure low, right arm pain, bilateral leg pain, fainting, vasovagal episode, heart murmur, supraventricular ectopy/premature atrial contraction and inappropriate schedule of vaccine administered to be medically significant.; Sender's Comments: , MERCK1106USA00055:Mfr number