Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Face oedema, Lip swelling, Rash, Somnolence, Swelling face
Clinical narrative: Initial unsolicited report received from a nurse on 03-Nov-2017. This case involves a four-year-old male patient who was vaccinated with a 0.5ML single dose of QUADRACEL (batch number: C5248AA) and PROQUAD (batch number, expiry date and site of administration were not reported) via intramuscular route on 02-Nov-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient began to wheeze, cough and started with all over hives, he experienced lip and facial swelling. This is a case of suspected anaphylaxis. The patient previously received PENTACEL 3 times without incident. Laboratory data was not reported. The patient received corrective treatment with Neb Med Tx. Epi pen, Oral BENADRYL and DECADRON SQ while he was improving they called an ambulance and sent him to the emergency room as a precaution. At the time of report the patient was recovering from the events. Case was reported as serious by reporter due to medically significant event. Follow-up report received from a nurse on 04-Dec-2017. The patient was vaccinated with QUADRACEL and PROQUAD on 02-Nov-2017 around 12.00 p.m. Patient's medical history included atopic dermatitis-mild and allergic rhinitis. It was reported that the patient was good prior of the vaccination. On 02-Nov-2017, approximately 5 minutes later at 12.05 p.m., the patient developed coughing, swelling of lips, and increased work of breathing. On same day, the patient required the ER/doctor visit. He was noted to be a febrile, temperature at 97.4 degree F, 95 % on room air. His heart rate was 130 s, blood pressure was measured. Upon auscultation, the patient had coughing with moderate lip swelling and diffuse end expiratory wheezing. The patient was started with albuterol sulfate 2.5 mg nebulizer treatment, BENADRYL 12.5 mg/5 ml at a dose of 5 ml with continuous pulse oximetry. He was recognized to having an anaphylactic reaction to the vaccination, and then developed with facial edema, with diffuse hives from his neck down to his legs. He was able to converse the entire time but seemed increasing somnolent. Due to difficulty swallowing, the patient was unable to BENADRYL, so started with EPIPEN injection at a dose of 0.15 mg via Intramuscular route, and DECADRON at a dose of 10 mg via IM in his right Bicep. Then, the patient was stable on room air, alert although slightly disoriented, and able to tolerate his secretions. Also reported that the patient was presence of dermatological or mucosal symptoms (rash and urticaria) and respiratory symptoms. The patient was recovered from events on 02-Nov-2017. List of documents held by sender: none. Sender's Comments: Follow-up information received on 04-Dec-2017, changes the previous medical assessment as follows: Reported symptoms of cough, wheeze, hives, lip swelling, facial swelling, excessive somnolence, difficulty swallowing and disorientation are consistent with the diagnosis of anaphylactic reaction. Time to onset is compatible with the role of vaccine. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.