Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC, RAB, VARCEL
Symptoms: No reaction on previous exposure to drug, Overdose, Pyrexia
Clinical narrative: Initial report received on 05 August 2009 from a consumer's parent. A 4-year-old female patient, whose past medical history was not reported, had received on 04 August 2009 two different 2.1 mL intramuscular injections of IMOGAM (lot number D0206-3) in the right and left thigh. This constituted a double dose of IMOGAM. The patient also received the same day, a first dose of IMOVAX (Lot number B0359-2); a dose of IPOL; a dose of DTAP (Trade name and manufacturer name not reported); a dose of MMR (trade name and manufacturer name not reported); a dose of PREVNAR (manufacturer Wyeth); and a dose of VARIVAX (manufacturer Merck). The lot numbers, routes and sites of administration were not reported for the DTaP, IPOL, MMR, PREVNAR and VARIVAX. The route and site was not reported for the IMOVAX vaccine. Indication for the IMOVAX vaccine was not reported. Per the parent, that evening following the vaccinations, the patient developed a fever that persisted thru the night. The patient required a doctor visit; however, it was not reported whether the patient had received any treatment, or if any diagnostic tests or laboratory data were performed. At the time of the report, the recovery status was unknown. Follow-up information received 09 October 2009 from a consumer's parent (who is a health care professional) and two other nurses. The patient had no medical history, no concomitant medications, and no illness at the time of vaccination. She had no adverse event following prior vaccination. On 04 August 2009 at 15:15, the IMOVAX Rabies had been administered in the right deltoid muscle, the IPOL (lot number A1229) had been administered in the left vastus lateralis, the DTAP (GSK, lot number AC14B100AA) had been administered in the left deltoid muscle, the MMR (Merck, lot number 0008Y) 0.5 ml subcutaneously in the left upper arm, the PREVNAR (Wyeth, lot number D48927) 0.5 ml intramuscularly in the right vastus lateralis and the VARIVAX (Merck, lot number 1329X) 0.5 ml subcutaneously in the right upper arm. Later during the evening of vaccination, the patient developed a fever. She was still active and playing, she wasn't lethargic, and no concerns were expressed by the parent. Corrective treatment was not reported. The patient did not require a doctor's visit, as was previously reported. She had no fever the following day. The patient recovered. She received subsequent doses of IMOVAX Rabies (lot number B0359) on the following dates: 07 August 2009 (left vastus lateralis, 11 August 2009 (left vastus lateralis), and 18 August 2009 (right vastus lateralis). Follow-up information received 07 December 2009 from a health care professional. According to the reporter, the patient had been exposed to a bat in the house. The bat was released and testing had not been performed. The patient had no wound. The patient was administered 2.1 mL of IMOGAM in each thigh. The patient's mother was instructed to administer TYLENOL if needed; however, no treatment was given for the fever. The patient' mother did not bring the patient in for an office visit because the patient's activity level was normal. The patient did not experience any reactions after subsequent doses of IMOVAX were received. No further information was provided.