Age: 4.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site urticaria, Local reaction, Urticaria
Clinical narrative: This case was reported in a literature article and described the occurrence of urticaria in a 4-year-old male subject who was vaccinated with DTAP vaccine (manufacturer unspecified), Hepatitis A vaccine and poliomyelitis vaccine inactivated (non-gsk). Family history revealed that the subject's sister had experienced very similar reactions of following vaccines, including intermittent painful eruptions at the site of initial large local reactions. Previous and/or concurrent vaccination included MMR vaccine (non-gsk); non-GSK manufacturer; unknown; right arm given on an unspecified date. On an unspecified date, the subject received 5th dose of DTAP vaccine (route unknown, left arm, batch number not provided and 1st dose of Hepatitis A vaccine (route unknown, right arm). Within six hours of vaccination with DTAP vaccine and Hepatitis A vaccine, the subject experienced a very large injection site reaction in the left upper arm. Left arm cellulitis was diagnosed. He also had swelling injection site during approximately 5 days and thereafter, he began experiencing intermittent painful wheal and flare eruptions in the same area of the left arm. At the next scheduled vaccine visit, on an unspecified date, the subject received 2nd dose of hepatitis A vaccine (route unknown, right arm, batch number not provided) and an unspecified dose of Poliomyelitis vaccine inactivated (Non-GSK) (unknown, right arm). Within 6 hours after vaccination with hepatitis A vaccine and Poliomyelitis vaccine inactivated (Non-GSK), the subject developed a large local reaction in the same area of the left arm, despite having not received any vaccines there. This reaction was larger and more painful than the initial one and lasted 1 to 2 days. Afterwards he continued to have wheal and flare up eruptions in the left arm 1 to 2 times per month, usually when he was overheated or exposed to the sun. Recall urticaria was diagnosed. This case was assessed as medically serious by GSK. The subject was treated with cefprozil for the cellulitis but after reevaluation, the treatment was discontinued. At the time of reporting,. urticarial wheal and flare were unresolved. At the time of the CCCR consult, the patient was 12 years of age and had received varicella vaccine without incident, but his parent were hesitant to agree to the tetanus, diphtheria, and acellular pertussis (Tdap) booster and the meningococcal conjugate vaccine. This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that he CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.