Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cardiac function test normal, Crying, Electrocardiogram normal, Mobility decreased, Pallor
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 5 months old male patient. The patient did not have any pertinent medical history and drug reactions/allergies. Patient's past therapy includes hepatitis B virus vaccine (unspecified). Patient's concurrent condition included Viral upper respiratory infection (URI). Patient's concomitant therapy included vitamin D. The patient had no birth defects or medical conditions. On 19-APR-2018 at the child's second month visit, the patient was vaccinated with ROTATEQ (lot number N032564, expiration date: 30-APR-2019) (dose and anatomical location was not specified) for prophylaxis. Other suspect therapies Included PREVNAR 13 (lot #T62564, in right thigh, first dose) and PENTACEL (received on left thigh, lot# C5368AA, first dose) received on 19-APR-2018, whose dose and route were not reported for prophylaxis. Illness at time of vaccination was reported to be Viral upper respiratory infection (URI). On 19-APR-2018 around 07:PM in the evening after receiving ROTATEQ, the mother placed the patient in an infant swing and noticed that the patient was not breathing and was pale and not moving. Attempted to stimulate him without success. The patient's mother decided to give rescue breaths to the patient. The patient sought medical attention went to an unspecified emergency room (ER). The events were reported to be life threatening hence the child's mother who is an emergency room nurse performed cardiopulmonary resuscitation (CPR) and got the child breathing again. Patient started crying after rescue breaths given and color returned over the next 15-20 minutes. It was reported that no prescription drug treatment was given for the adverse events. The patient was observed on "TCH" for 5 hours. It was reported that child was not admitted and released later that evening. As per patient's mother lab tests were not performed and denied the occurrence of fever, diarrhea or changes in behavior. It was reported that on 23-APR-2018, the patient had Electrocardiography (EKG) and cardiology work up which were reported to be fine. The office had decided to split up the vaccines for further visits. On 20-JUN-2018, the patient was given his 2nd dose of PENTACEL (lot #C5440AA) in the left thigh for prophylaxis (dose and route were not reported) alone at that visit and had no reaction. On 06-JUL-2018, the patient was given his 2nd dose of ROTATEQ (lot #: N029670, expiration date: 03-SEP-2019) and second dose of PREVNAR 13 (lot #T94527) in left thigh for prophylaxis together at the same visit whose dose and route were not reported. Later that evening (on 06-JUL-2018), the patient again stopped breathing which was reported to be life threatening and patient's mother performed CPR and the paramedics were called but he was not taken to the hospital as he seemed fine once he was breathing gain. It was reported that no prescription drug treatment was given for the adverse events. The patient was being scheduled for a neurology evaluation later this month. The outcome of respiratory arrest, unresponsive to stimuli and pallor were reported as recovered/resolved. The reporter did not assess the causality of the events with suspect therapies. There was no product quality complaint (PQC) involved in the report. The patient was reported to be vaccinated at private doctor's office or hospital with private funds. It was reported that temperature excursion occurred as a result of reading from a data logger.