Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEP, PNC13, RV5
Symptoms: Abnormal behaviour, Arnold-Chiari malformation, Back pain, Bowel movement irregularity, Cerebral haemorrhage
Clinical narrative: This spontaneous report from a consumer was retrieved from an online article and refers to a 7-month-old female patient. The patient was a healthy baby with normal physical and cognitive development before vaccination. On an unknown date (reported as when the patient was 6-month-old), the patient was vaccinated with first doses of ROTATEQ, oral (lot #, expiration date and dose were not provided), RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not provided), PREVNAR 13 (dose, route of administration, lot # and expiration date were not provided) and Hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided). On an unknown date, after vaccination, the patient became fussy and lethargic. She also suddenly became unresponsive, both mentally and physically and she could not hold her head up right or move her arms and appeared to display symptoms of a stroke. Due to these events, the patient was brought to the emergency room and had computed tomography (CT) scan and magnetic resonance imaging (MRI) performed (results were not provided). On the same day, the patient was sent home and referred to a pediatrician. On an unknown date (reported as by next morning), the patient was unable to sit and appeared paralyzed in several parts of her body. Due to this event, the patient was hospitalized and placed in intensive care unit (ICU) on breathing machine and received unspecified steroids as treatment. The patient was in the ICU for 8 days. On an unknown date, the patient had bleeding in her brain and additionally was diagnosed with transverse myelitis spinal cord disease. On unknown dates, the patient experienced trouble walking, numbness in her feet, headaches and constant back pain. She would have episodes where she appeared stuck for 30 to 45 minutes. In 2015 (reported as last year at the time of the report), the patient was diagnosed with Chiari malformation. In October 2015, the patient was vaccinated with the second round of immunizations with 5 in 1 combo vaccine DTaP-Hep B-IPV and haemophilus influenzae type B vaccine and the patient's health worsened after that. On an unknown date, the patient also experienced severely damaged vision, speech impediments, difficulty communicating, behavioral problems and bowel movement problems (because of which the patient was forced to use diapers). The outcome of lethargy, being unresponsive, having symptoms of stroke, being paralyzed, bleeding in brain, transverse myelitis, spinal cord disease, numbness in feet, constant back pain, Chiari malformation and bowel movement problems was not reported. The outcome of chronic headaches, irritability, severely damaged vision, speech impediments, difficulty communicating and behavioral problems was reported as not recovered. The outcome of being unable to walk was reported as recovered on an unknown date. The relatedness between the events and suspect vaccines was not reported. Upon internal review, the events of having symptoms of a stroke, being paralyzed, bleeding in brain, transverse myelitis spinal cord disease and Chiari malformation were considered to be medically significant.