Age: 0.25
Sex: M
Vaccine: HIBV, PNC13, HIBV, PNC13
Symptoms: Abnormal behaviour, Decreased eye contact, Developmental regression, Electroencephalogram normal, Speech disorder
Clinical narrative: eye avoidance/ regress in social skill milestones that he had met/wasn't smiling, making eye contact or making cooing noises,/can't vocalize as much as before/complete impairment of speech and behavioral changes/adverse reaction symptoms; This spontaneous report was received from a consumer regarding her son, a male patient of 3 months old. The patient had no medical history, drug reactions or allergies (reported as none).  On 10-JAN-2020, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) administered Intramuscularly as a single dose (lot number and expiration date were reported as unknown; strength, dose, were not provided) as mandated by his pediatrician. The vaccine was concomitantly administrated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (strength, dose, frequency, route of administration, lot #, expiration date and indication were not provided)  On an unspecified date in January 2020 (reported as within 48 hours), the patient began to display eye avoidance, which was when the reporter became concerned. She reported that after getting the Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13), her son started to "regress" in all the "social skill milestones that he had met" (developmental regression) prior to these vaccinations; hence, her son post-vaccination was not smiling, making eye contact or making cooing noises, which were all basic social skills he was developing and exhibiting fine prior to getting these vaccinations. The mother said her son also "could not vocalize" as much as before receiving the vaccinations.   Medical attention was sought, since she initially contacted a neurologist on 15-JAN-2020 because she thought some of his symptoms could be neurologically based and then subsequently, she contacted his pediatrician on 17-JAN-2020. No treatment was given for the events, but a head ultrasound was performed on 18-JAN-2020, and an Electroencephalogram (EEG) scan on 22-JAN-2020, but neither test results showed anything negative. It was reported that the patient has had 3 emergency room (ER) visits and in the last one, her son was admitted at a hospital on 22-JAN-2020, at around 02:00 (reported as 2 o'clock am, also reported as in the morning) and released late night on the same date. She stated that the physicians her son had seen, do not know what could be causing her son's condition  She felt that based on her observation of her son post-vaccination, he had a "complete impairment of speech and behavioral changes" and she was very concerned because it had been "about 2 and half weeks" since her son was vaccinated, he had not recovered and she had seen at best only a "10 percent improvement" in his adverse reaction symptoms, so the patient's mother was very worried that his symptoms could be permanent.  The causality assessment between the event and both vaccines was considered as related.