Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Abnormal behaviour, Body temperature increased, Crying, Hypoacusis, Hyporesponsive to stimuli
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 6 month old female patient. It was reported that the patient had none medical history or concomitant medication or drug reaction. On 16-MAY-2016, the patient was vaccinated with ROTATEQ orally (lot number and expiration date were not reported); PENTACEL lot # C5075AA and PREVNAR 13 (lot number and expiration date were not reported). The reporter stated that this last two vaccines were given in separate thighs (lot number, expiration date, dosage and route of administration were not specified for all vaccines). On 27-MAY-2016 (also reported as 27-JUN-2016), the reporter stated that the patient was less responsive to sound (hyporesponsive to stimuli) and also had minor fever of 99.6, furthermore it was reported that the patient was acting strangely, as well as the next morning, it was reported that the patient was not interacting and talking. Nevertheless, the reporter referred on that same day in the afternoon the patient was doing much better. It was also reported that the patient sought medical attention by taking the patient for an exam, though the clinical's exam was normal, the patient was arranged to get a hearing test. However, the mother decided not to take the patient to the hearing specialist, since the baby was only 6 month. At the time of the report, the outcome of less responsive to sound, minor fever and abnormal behaviour was recovered. Additionally, it was reported that no treatment was given for the adverse events, that no laboratory diagnostics were performed, that no intervention to prevent a serious criteria was necessary, that the adverse events were no significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. The relatedness between the adverse events and ROTATEQ was not reported. Follow-up information was received from a licensed practical nurse indicating that the patient had no pre-existing allergies, birth defects, medical conditions or illnesses at the time of vaccination. It was added that the patient had no siblings. On 16-MAY-2016 at 14:45, after a normal well visit, the patient was vaccinated with the third dose of ROTATEQ, lot number L029615, the third dose of PENTACEL intramuscular in the left thigh and the third dose of PREVNAR 13 lot number M35762, intramuscular in the right thigh. In the night of this day, the patient woke every 2 hours crying. On Wednesday morning, 18-MAY-2016 at 09:58 (previously reported as 27-MAY-2016), the patient's mother contacted provider stating that the patient's temperature was 99.6 (units not provided), and seemed less responsive to sounds. In the afternoon, the patient seemed to be acting weird, the mom believed she could not hear and called back later that day to say she believed patient was "coming back around" and that she had sang to her in the car and she seemed to hear her. On the morning of 19-MAY-2016, the mom texted saying that patient was still not talking much or responding when spoken to (speech disorder). The patient remained afebrile with no other complaints. An appointment was made for patient to see covering physician for the next morning. Mother stated later that evening patient was acting more normal and was "Chatty Kathy" that night at dinner. On Friday 20-MAY-2016, the patient was seen by covering physician and had negative exam, was sent to Ear Nose and Throat (ENT) for hearing test which was unable to be performed due to the patient's age. There was no relevant laboratory data and the parents declined further testing, since at that time, patient was acting fine and had remained fine with no further concerns. The patient's status was recovered. The licensed practical nurse did not assess the relationship of the events to ROTATEQ, PENTACEL or PREVNAR 13. Upon medical review deafness was considered to be medically significant. Additional information has been requested. Reporter information, product, event and narrative were updated.