Age: 1.9
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site pain, Insomnia, Otitis media, Speech disorder
Clinical narrative: This case was reported by a physician, who was also the subjects grandmother, and described the occurrence of injection site redness in a 28 month old male subject who was vaccinated with Pediarix, MMR and Varicella for prophylaxis. The subjects medical history included toxic mold exposure while in utero and C section birth due to breech presentation. The subject received Vitamin K at birth. Concurrent medical conditions included fever and possible ear infection, for which the subject was being treated with amoxicillin. Concurrent medications include Echinacea. On 9/14/06, the father of the subject took him to an office visit where the subject received 1st dose of Pediarix 0.5ml left, 1st dose of MMR left, and 1st dose of Varicella right leg. Prior to 9/14/06, the subject had not received any immunizations due to his mothers wishes. Neither the office visit nor the vaccinations administered on 9/14/06 were authorized by the subjects mother. At the time of reporting the subjects parents were going through a divorce. On 9/14/06 immediately after vaccination with MMR vaccine, Pediarix and Varicella vaccine, at the MMR and Pediarix sites of injection left leg, the subject experienced redness, swelling and soreness. At an unspecified time after the vaccination, there was pus present at the Varicella vaccine site of injection right leg. On the day of the vaccinations, 9/14/06 the subject developed possible speech impairment and seemed to get tongue tied when he was speaking. Also on an unspecified date, since being vaccinated, the subject developed self destructive behavior which was described as the child had been throwing himself to the floor and hitting his head on the floor. He then was beating his head with his fists. A physician was visited as a result of the adverse events. The injection site redness and swelling resolved on an unspecified date. At the time of reporting, the possible speech impairment was unresolved. The outcome of the self destructive behavior, pus at injection site and injection site soreness was unspecified. According to the reporting physician, the subjects regular pediatrician has recommended no further vaccinations. The reporting physician considered the redness and swelling at the injection site and possible speech impairment were probably related to vaccination with Pediarix, MMR and Varicella. This case was assessed as medically serious by manufacturer (OMIC). Follow up regarding this case was received on 10/4/06. According to follow up information, the subjects medical history included ear infections which were considered attributable to the subjects start of day care and exposure to mold at the same time. The subject experienced a possible ear infection on 4/14/06, reoccurring from a Rocephin shot on 3/23/06, The Pediarix, MMR and Varicella were administered on 4/14/06, not 6/14/06, as was initially reported. Although it was initially reported that the subject experienced injection site redness, swelling and soreness immediately after the vaccinations, follow up information indicated the earliest event occurred on 4/16/06, which was two days following vaccination with Pediarix, MMR and Varicella. It was also reported that the events were associated with erroneous administration and the the subjects father did not wish for him to receive vaccinations. The subjects mother had previously declared and was exercising a religious exemption to immunization for herself and the subject. The subjects full medical history was not provided to the clinic staff by the subjects father and the subjects mother was not contacted by the clinic. The mother and father's separation was know by the clinic staff and the fathers sister was on staff at the clinic. A complaint was filed with board against the clinic doctor and nurse. According to follow up on an unspecified date following vaccinations with Pediarix, MMR, and Varicella vaccine, the subjects pediatrician stated that the subject had marked reactions for the next few weeks with increased aggression, increased frequency of temper tantrums, and generally not being himself. It was also reported that the father kept the subject from two days of onset of shots and the subject did not sleep the entire time. the subject was treated with detoxification protocol. As a result of the events, the Pediarix, MMR, and Varicella vaccine immunization series were all discontinued. At the time of reporting, the injection site redness, injection site swelling, speech impairment, pus at injection site, injection site soreness, and self destructive behavior were improved and the reporter considered these events were related to Pediarix, MMR, and Varicella vaccine. The outcome of the unable to sleep, increased aggressiveness, increased frequency of temper tantrums, and generally not being himself were not specified.