Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Head injury, Injection site erythema, Injection site swelling, Rash erythematous, Rash generalised
Clinical narrative: Initial case received from a consumer's grandmother on 04 October 2010. A 6 month old male infant, with a history of pyloric surgery and previous rash, hives and nausea to PENTACEL (dose 1), received on 26 August 2010 an injection (dose 2) of PENTACEL, lot number invalid C354AA and a second Hepatitis B vaccine. The patient had no illness at the time of vaccination, took no medications and had no known allergies (NKA). The patient on an unknown date (Monday) developed a rash, hives and persistent crying lasting 4 hours. The outcome was not reported. Follow-up information was received from a physician on 08 October 2010. The patient received the following vaccinations on 16 April 2010: a left thigh intramuscular (IM) injection (dose 1) of PENTACEL, lot number C3542AA and an oral dose 1 of Rotavirus, lot number 1440Y. The patient received his first dose of Hepatitis B vaccine on 20 February 2010. The patient received dose 2 of PENTACEL on 26 August 2010, lot number not reported. The patient's medical history was significant for pyloric stenosis, hives from time to time that were independent of vaccines, oral feedings of 8-16 ounces at a time and deficiencies in immunizations. On the 26 August 2010 office visit, the problem of overfeeding was addressed by advising the caregivers to give 36 ounces a day total and divide them into 5 or 6 feedings. The grandmother shook her head "No" when advised that 16 ounces was too much at one time. The second problem of deficient immunizations was also addressed. The grandmother refused all vaccines offered except PENTACEL. The patient had recent episodes of urticaria - had intermittent episodes of urticaria (from description) most recently yesterday. The grandmother was advised to give dye free BENADRYL 2.5 ml every 6 hours as needed for hives. On 08 September 2010, the mother of the patient called the office to report that the patient had a rash which consisted of raised red bumps on face, back of head, legs and back and has had these intermittently since birth. The bumps have clusters of small bumps and are different sizes from nickel size to half dollar size. The rash had been worse for the last 2 weeks. The area on the back of the head was itchy. On the 04 September 2010, the patient started with a raspy cough, but was afebrile and having wet diapers. The infant fell off a bed on 06 September 2010 and hit his head. The patient has a small bump of front of head after the fall but has no cuts or lacerations. On 08 September 2010, the patient started vomiting and had 3 episodes. The patient does not always make eye contact, does not always follow movement with eyes and seems to crawl slowly. The patient has been crawling without a problem. The caregiver was advised over the phone to be evaluated at the Emergency Department and to follow-up in AM with the doctor's office. Follow-up information was received from a physician on 29 October 2010 reported that the patient only received on 26 August 2010 at approximately 12 noon a PENTACEL vaccine, lot number confirmed as 3542AA and that the patient did not receive a Hepatitis B vaccine. During the office visit on 26 August 2010 at 11:00 AM, the patient's mother indicated that the patient had hives intermittently and inquired at this time about using BENADRYL because of a past history of urticaria. On 26 August 2010 at 1:15 PM the patient's grandmother called the doctor's office to request the name of the vaccine which was given and the lot number of the vaccine. She did not report any adverse reaction at that time. The patient's mother called at 4:40 PM stating that the patient was screaming and crying and covered in rash from head to toe and that his thigh was swollen and red. She was advised to give the patient ibuprofen but the mother stated that she never gives him medication because the patient was allergic to a lot of medication. The mother was advised to give diphenhydramine ? teaspoon (tsp) 4-6 hours. She stated that the patient was "gasping and crying". She was advised to call 911 and take him to the emergency room (ER). There was no record of an ER visit on that date. On the 08 September 2010 they were advised at that time to be seen in the ER immediately and there were no record of an emergency department visit on that date at two medical centers. The pediatrician contacted the County Department of Social Services regarding his impression that there was neglect on the part of the family in neglecting to see that the patient had had routine care and was deficient on immunizations. No follow through by the Department of Social Services was done as it apparently did not meet their criteria for neglect in spite of being advised by the health department to report children of families who were negligent with regard to immunizations. No further information can be provided since the patient has never returned for any follow-up visits and no report has been received from any local emergency departments (ED) regarding any subsequent visits to the ED. Follow-up information was received from a physician on 05 November 2010 confirmed that the initial reporter was the patient's grandmother. It was confirmed that the patient did not receive a Hepatitis B vaccine on 26 August 2010. The only vaccine given on that date was PENTACEL, lot number 3542AA, which was given in the left thigh intramuscularly. No further information was available because the patient has neither followed up nor followed the recommendation of a follow-up in the office nor the triage nurse's recommendation that he be seen in the emergency department. There were no records that he was seen in the emergency department and he has not been back to the doctor's office since that date. It was not expected that they would return to the doctor's office as the grandmother was not happy with the doctor's policy of following the CDC immunization schedule and the doctor's recommendation to her that the vaccines be given according to schedule. A compromise was reached and the PENTACEL vaccine was given on 26 August 2010 and the patient's grandmother and mother did consent to that vaccine at that time. The outcome was reported as unknown. The patient had a reaction to the first dose of PENTACEL on 16 April 2010 at 2 months of age and developed rash and hives which is captured in case 2010-05721. Documents held by sender: Medical records.