Age: 1.1
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Body temperature increased, Herpangina, Nasal congestion, Oral pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old male with no allergies or medical history who on 02-JUN-2006 was vaccinated SC in the right leg with a second dose of Varivax (lot # 649998/0909R) that was exposed to elevated temperatures on two occasions. Suspect vaccinations on the same day included an IM second dose in the left upper thigh of DTaP (lot # AC14009BA), an IM second dose in the left lower thigh of Prevnar (lot # B08658A), a SC second dose in the left leg of MMR II (lot # 649811/0491R), and an IM second dose in the right lower leg of ACTHIB (lot # UE785AA). There was no other concomitant medication. Illness at the time of vaccination included anemia (hemoglobin 11.6). The patient had no adverse events following prior vaccinations. A product quality complaint was not involved. Additional information has been received from the nurse who reported that on 03-JUN-2006, at 06:55 AM, the patient had an elevated temperature and had an emergency room (ER) visit. On 04-JUN-2006, at 09:43 AM, he had an elevated temperature and mouth pain. He recovered on 04-JUN-2006. Medical records from the patient's ER visit were received which indicated that he was seen in the ER on 03-JUN-2006 at 03:50 AM with a chief complaint of fever. His parents reported that he had a fever to 102 times one day. He had his one year immunizations in the AM of 02-JUN-2006 and the temperature started on that afternoon. It had not improved with acetaminophen (TYLENOL0 (0.8 mL plus a little more times three at 05:30, "6:60-7," and 9:00 PM) and medication from another country. They denied significant upper respiratory infection symptoms, but he did have slight nasal congestion on 03-JUN-2006. He had no previous history of fever with vaccines but had some local irritation in the past. He had no other problems, lived with his parents, had no sick contacts, and had no recent travel. He was given acetaminophen (TYLENOL) and ibuprofen (MOTRIN) times one which decreased his fever. The summary note indicated that the event was likely related to vaccines. No additional source of infection was identified. They doubted septicemia. He was well hydrated and non-toxic. He was also with inappropriate dosing of acetaminophen (TYLENOL). Too frequent dosing was noted, however it was less than therapeutic dose for weight. It was doubted that there was significant amount for toxicity. The diagnosis was fever, status/post immunizations. The plan included discussing the proper dose and frequency of acetaminophen (TYLENOL), ibuprofen (MOTRIN), supportive care, and return precautions. An attending physician's note indicated that the patient presented with fever, as high as 102 at home, beginning about 12 hours after vaccines were given. There was no note of redness, warmth, or swelling at the injection site. There was perhaps a hint of nasal congestion, but he was drinking normally and had good urine output. On exam he was initially sleeping and then awakened and consolable by the mother. His nose had a hint of congestion but patent and lungs were clear. Overall, his history and physical exam were consistent with a diagnosis of immunization febrile reaction versus early viral illness, not yet defined. There were certainly no signs of toxicity or serious bacterial infection and he was well hydrated. He should be monitored for any other symptom development and he given appropriate doses of acetaminophen (TYLENOL) and/or ibuprofen (MOTRIN) for discomfort and fever control as needed. His discharge condition was satisfactory. Medical records indicated that he was again seen in the ER on 04-JUN-2006 at 08:05 AM with fever and mouth pain times one day. He was positive for rhinorrea which the mother stated was from crying. He had a fever of 103, poor PO intake, was tolerating fluids, and had one wet diaper that AM and one wet diaper on exam. His immunizations were up to date. On exam, his temperature was 99.1. He was healthy, alert, and in no apparent distress. There was clear nasal discharge. He had four teeth coming in well. The diagnosis was herpangina. The plan was to give him (BENADRYL) diphenhydramine hydrochloride/bismuth subsalicylate (KAOPECTATE) 1:1 (1 tsp) PO prior to meals and supportive care. He was well at the time of discharge. No further information is expected.