Sex: F
Vaccine: DTAPIPVHIB, FLU4, DTAPIPVHIB
Symptoms: Encephalopathy, Fall, Gait inability, Head banging, Lethargy
Clinical narrative: possible encephalopathy; sleep seizures; hitting the head against the wall; being uncomfortable; being Lethargic; loss of balance; falling; unable to run around; speaking progress had reversed; choking; not breathing; Initial information received on 18-Nov-2019 regarding an unsolicited valid serious case received from a consumer/ non health care professional (patient's mother).  This case is linked to case 2019SA326913.  This case involves a 19 months old female patient who experienced encephalopathy (encephalopathy), choking (choking), sleep seizures (seizure), hitting the head against the wall (agitation), uncomfortable (discomfort), lethargic (lethargy), loss of balance (Balance disorder), falling (fall), unable to run around (gait inability), speaking progress had reversed (Speech disorder developmental ) and not breathing (dyspnea), while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no history of encephalitis.  Concomitant vaccination and medication included INFLUENZA VACCINE (INFLUENZA VACCIN) and RANITIDINE (RANITIDINE). Ranitidine was stopped.  On 06-Dec-2018, the patient received a fourth dose of 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot U1952AB (Expiry date unknown) via intramuscular route in the left thigh.  On unknown date, the patient developed a serious encephalopathy (encephalopathy) with sleep seizures (seizure), hitting the head against the wall (agitation), uncomfortable (discomfort), lethargic (lethargy), loss of balance (Balance disorder), falling (fall), unable to run around (gait inability), speaking progress had reversed (Speech disorder developmental ) and (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This events were assessed as medically significant.  On unknown date, the patient developed a serious choking (choking) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  On unknown date, the patient developed a non-serious not breathing (dyspnea), (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Relevant laboratory test results included: Electroencephalogram - in Mar2019:  [results were fine]  Final diagnosis was not breathing, speaking progress had reversed, unable to run around, falling, loss of balance, lethargic, uncomfortable, hitting the head against the wall, sleep seizures, choking and encephalopathy.  The patient was treated with AMOXICILLIN (AMOXICILLIN), PARACETAMOL (TYLENOL) and IBUPROFEN (MOTRIN [IBUPROFEN]).  The event outcome is reported as recovering from all the events (based on statement that the patient is fine now).; Sender's Comments: Based on limited information available on events encephalopathy, choking, seizure developmental disorder role of company vaccine can not be assessed.