Age: 17.0
Sex: M
Vaccine: FLU3, MENB, TDAP
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Heart rate normal, Nausea
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A 17-year-old male patient of an unspecified ethnicity received TRUMENBA (lot/batch number M37314, 01Apr2017) intramuscularly on the deltoid on 17Mar2016 at 10:34 at single dose and TDAP (Sanofi Pasteur, lot number V1524b0) at single dose and influenza vaccine (manufacturer unknown, Sanofi Pasteur not lumber V15218b) at an unknown dose both intramuscularly on the right deltoid on 17Mar016. Relevant medical history included coarctation on the aorta, Wolff-Parkinson-White syndrome and coarc surgery in 2012. The patient was followed by cardiology (last apt was 4 months before this report). Concomitant medications were not reported. The patient previously received a dose of TDAP (Sanofi Pasteur) and two doses of influenza vaccine (manufacture unknown, Sanofi Pasteur) both on an unspecified date. The patient had a normal temperature when the physician examined him on 17Mar2016 and then 40 minutes later, his mom came back to the office and the patient was having symptoms, his fever went up to 102.6, his heart rate was okay, he was just kind of shaking, his hands were shaking, he was having hard time breathing like he was having a panic attack, the patient was having difficulty breathing in the car in the parking lot. They took the patient to emergency room for doctor visit. After well child check up, patient's mother returned to office at approximately 12:50 pm. She stated the patient was having difficulty breathing in the car in the parking lot and the physician went to assess the patient in the parking lot with mom. The physician instructed the front office to call EMS prior to leaving the office. The patient was found in front passenger seat trembling all over and breathing rapidly and complaining of feeling weak on unknown date. Mom said they had been standing in line at (Name) when the patient started having these symptoms. so she got him to the car and drove back to the office. He had had chronic diarrhea with eval pending (as of the time of the report), and vomited the day before this report. He was not currently feeling nauseous. Began to help the patient with deep breathing exercise to slow rapid breathing. Began to feel better and trebling improved. The patient was not admitted to the hospital. The patient underwent lab data on 17Mar2016 which included: heart rate was 95, respiratory rate 786.09 and oxygen saturation was 100%. Physical examination on 17Mar2016 showed: Appearance: well-nourished, well developed, alert, in no acute distress, parent child interaction appropriate for child's age. Respiratory Effort: breathing unlabored. Auscultation of Lungs: normal breath sounds. Auscultation of Heart: regular rate, normal rhythm, no murmurs present. Extremities: no edema, no cyanosis, distal radial pulses equal and strong. The outcome of the events was unknown. The physician stated that the patient provided to him/her information regarding the reported events with the use of the products. The physician considered the vaccine PREVNAR 13 had a causal effect to the adverse events. Follow up (12Apr2016): New information reported from a contactable physician includes: details of vaccination, new suspect vaccine (influenza vaccine), medical history, new events, details of the events, physician's causality assessment and confirmation that the patient provided to him/her information regarding the reported events with the use of the products.