Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Hypotonic-hyporesponsive episode, Lethargy, Respiratory rate decreased, Unresponsive to stimuli
Clinical narrative: hypotonic-hyporesponsive reaction; decreased respiration; unresponsiveness; lethargy; Initial information received on 23-Aug-2021 regarding an unsolicited valid serious case received from a physician under medical information  Inquiry Number: 00736023.  This case involves a two-month old male patient who experienced hypotonic-hyporesponsive reaction (Hypotonic-hyporesponsive episode), unresponsiveness (unresponsive to stimuli), lethargy and decreased respiration (Respiration abnormal) after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  On 14-Feb-2011, concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination.   On 14-Feb-2011, the patient received a first 0.5 ml one dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, lot number and expiry date not reported, via unknown route in unknown administration site for prophylactic vaccination respectively.   On an unknown date the patient developed a serious hypotonic-hyporesponsive reaction (hypotonic-hyporesponsive episode), decreased respiration (Respiration abnormal), unresponsiveness (unresponsive to stimuli) and lethargy, 19 days following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. These events were assessed as medically significant.  05-MAR-2011, The patient was hospitalized for these events.  The physician stated that he called on friday and he was calling back returning a call. He would like to know if PENTACEL and ADACEL had the same ingredients and if the ingredients listed in the package inserts were a complete list. He would like to know about PENTACEL. Physician was asking about the safety of ADACEL in an 11-year-old. He was asking if ADACEL can be given to a patient who reported a hypotonic-hyporesponsive reaction following PENTACEL. He was also asking if a hypotonic-hyporesponsive reaction to PENTACEL would appear 19 days after receiving the PENTACEL. He stated that the patient did not have a hypersensitivity or anaphylactic reaction and did not have any seizures after receiving PENTACEL. It sounded like a hypotonic-hyporesponsive reaction to him to the pertussis component of the DTaP (in the PENTACEL). But he thought that a reaction like that would occur within seven days of receiving the vaccine (PENTACEL) and not after nineteen days. He doubt if this was true. It seems like there were a lot of holes in the mother's story. The mother wanted vaccine exemption.   The child also received PENTACEL vaccine on unknown dates, at his 4-month appointment and at his 6-month appointment, and two more doses after that.  The mother said that the child was hospitalized twice for lethargy and unresponsiveness following PENTACEL. There was no mention about the vaccine (PENTACEL) in the hospitalization records. The patients former pediatrician sent him record of one hospitalization. According to the child's vaccination card, it looked like the child was probably under the care of another pediatrician before the previous one. He is going to call the mother back to ask additional questions and see if there are records from a second hospitalization.  No lab data provided.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, on an unknown date the patient was Recovered for the events.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case involves a two months old male patient who experienced hypotonic-hyporesponsive reaction 19 days following the administration of PENTACEL. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (other manufacturer). However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.