Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Cough, Crying, Febrile convulsion, Grand mal convulsion, High-pitched crying
Clinical narrative: From initial information received on 2/20/04 from a health care professional regarding an adverse event, it was reported that a 15 month old male pt received a fourth dose of Daptacel, Prevnar, and Comvax on 2/10/04. An unspecified amount of time later, the pt had a seizure. The pt's recovery status is unknown. No other info was available at the time of this report and the reporter stated that more information will be available at follow-up. It is not known if the pt required medical intervention; however, for technical purposes the section "required emergency room/ doctor visit" is checked in box 8 of the VAERS report. From additional info received on 2/27/04 from manufacturer, it was reported that the pt also experienced a temp of 101.4 deg F. The onset of the events began on 2/15/04. Both the seizure and temperature were considered to be medically important events (OMIC). The pt has recovered from these events. No other info was provided. From additional info received on 3/15/04 from another manufacturer (WAES0402USA01608), it was reported that the pt was not hospitalized. The responsible physician's name was provided and the telephone number of the reporting nurse was corrected. From additional info received on 3/29/04, from information provided by another manufacturer, the pt's address and middle initial were provided. The pt received the vaccinations at 10:20 am on 2/10/04. No further info is anticipated, this case is considered closed. Seriousness criteria: other medically significant (OMIC).  From additional information received on 07JUN2004 from a physician, the patient's full name, address and telephone number were provided. From hospital records provided, the patient was seen in the urgent care unit on 15Feb2004 due to cold symptoms and was diagnosed with early right otitis media. His temperature at that time was noted to be 97.7 degrees Fahrenheit (axillary). He was started on Augmentin ES and discharged home. On the way home, the child experienced a seizure, which lasted approximately four minutes. Per the patient's mother, the patient's eyes rolled back and he experienced convulsive movements of his legs, arms, and total body. Reportedly, the patient's arms were crossed over the chest veery tight and his hands were spastic. The child was postictal for about 20 minutes. Emergency services responded and he was noted to have a fever of 101.4 degrees Fahrenheit by the paramedics. He was transported to the emergency room and laboratory testing and reportedly normal. He was given Tylenol and his fever decreaed to 100.5 degrees Fahrenheit. The emergency room physician felt that the event was a febrile seizure. A routine MRI of the head was performed on 08MAR2004 and revealed prominent retro-cerebellar CSF, likely small arachnoid cysts not likely of clinical significance. It was otherwise negative. The adverse events codes for "seizure" and "fever" were updated to "febrile seizure". No further information is anticipated, this case is considered closed.