Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Injection site pain, Pain, Rash, Screaming, Urticaria
Clinical narrative: blood curling screams that night; pain, know in his leg; hives all over his body; rash on his extremities and face near his eye; Initial information received on 15-Jun-2019 and 17-Jun-2019, regarding an unsolicited valid serious case received from a nurse.  This case involves a four months old male patient who experienced pain, hives all over his body, rash on his extremities and face near his eye and blood curling screams that night, while he received vaccines PNEUMOCOCCAL VACCINE, ROTAVIRUS VACCINE and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past vaccination(s) included PENTACEL (first dose) with no adverse event.  The patient's past medical history, medical treatment(s), concomitant therapy and family history were not provided.  On 13-Jun-2019, the patient received a 0.5 mL second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ101AAA via intramuscular route in unknown administration site (administration site reported as LVL), a dose of suspect PNEUMOCOCCAL VACCINE lot number not reported via unknown route in unknown administration site and a dose of suspect ROTAVIRUS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious hives all over his body (urticaria) within 24 hour following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE.  On an unknown date, the patient developed a serious rash on his extremities and face near his eye (rash), pain, know in his leg (pain in extremity) and blood curling screams that night (screaming) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE.   All events were assessed as medically significant.  It was reported that, the patient broke with rash all over his body minus his back and belly and developed blood curling screams that night, pain, know in his leg and rash on his extremities and face near his eye but not his trunk. Patient's grand mother stated that they gave him Benadryl and brought him in to the hospital and gave him steroids and it started going away but as soon as the steroids wore off his rash came back. On an unknown date, the patient had blood curling scream that night and again taken to hospital and he received another dose of steroids.  Other relevant tests were not reported.  Final diagnosis was blood curling screams that night, rash on his extremities and face near his eye, hives all over his body and pain.  The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and unspecified steroids.  The patient outcome was considered recovering for rash and Unknown for all other events.  List of documents held by sender: none.; Sender's Comments: This case concerns a four months old male patient who experienced pain in leg, hives all over his body, rash on his extremities and face near his eye and blood curling screams post vaccination with PENTACEL, PNEUMOCOCCAL a and ROTAVIRUS. The time to onset is compatible for urticarial and unknown for other events. Patient did not have any reaction post previous dose of PENTACEL. Moreover, patient's medical condition at time of vaccination, past medical history and lab test ruling out alternate etiologies were not reported. Based upon the reported information and involvement of multiple vaccines, the role of the suspect products cannot be individually assessed.