Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Irritability, Lethargy, Pyrexia, Skin burning sensation, Sneezing
Clinical narrative: lethargic; low urine output; sneezing; tired; weak.; temperature of 102.4 degree F and went up to 103.7 degrees F; would not drink or eat; irritable; face swelled underneath his eyes; crying for hours; skin was a red pink color; skin was a red pink color burning to touch; Initial information was received on 14-May-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 16 month old male patient who experienced lethargic (lethargy), low urine output (urine output decreased), sneezing (sneezing), skin was a red pink color (erythema), skin was a red pink color burning to touch (skin burning sensation), tired (fatigue), weak (asthenia), would not drink or eat (decreased appetite), crying (crying), irritable (irritability), face swelled underneath his eyes (swelling face) and body temperature of 102.4 degree Fahrenheit and went up to 103.7 degrees Fahrenheit (pyrexia) while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was reported that patient typically runs a low grade fever with immunizations.  Concomitant vaccination included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 06-May-2020, the patient received fourth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious body temperature of 102.4 degree Fahrenheit and went up to 103.7 degrees Fahrenheit (pyrexia) within 48 hours following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  On an unknown date, the patient developed a non-serious lethargic (lethargy), low urine output (urine output decreased), sneezing, skin was a red pink color (erythema), skin was a red pink color burning to touch (skin burning sensation), tired (fatigue), weak (asthenia), would not drink or eat (decreased appetite), crying, irritable (irritability) and face swelled underneath his eyes (swelling face) (Unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  On an unknown date, relevant laboratory test results included: Body temperature: 102.4 degree Fahrenheit; on an unknown date: 103.7 degree Fahrenheit; on an unknown date: 101 degree Fahrenheit; Heart rate : 140-150; White blood cell count: 15000; on an unknown date white blood cell count was down to: 10000.  Final diagnosis was lethargy, urine output decreased, sneezing, erythema, skin burning sensation, fatigue, asthenia, decreased appetite, crying, irritability, swelling face and pyrexia.  The patient was treated with CEFTRIAXONE SODIUM (ROCEPHINE) injection and antipyretics and fever came down to 101.  The patient was recovering from fever at the time of report and event outcome was unknown for rest of the events.  The patient had been quarantined for two months prior to this event per report.  There will be no information available on the batch number for this case.