Sex: F
Vaccine: DTAP, IPV, MMR, VARZOS
Symptoms: Acute disseminated encephalomyelitis, Agitation, Autism spectrum disorder, Cognitive disorder, Developmental regression
Clinical narrative: agitation; intermittent fever; altered mental status; difficulty walking; Initial information received on 28-Aug-2023 by health care professional regarding an unsolicited valid serious case issued from a literature article.  This case involves a 4 years old female patient who experienced agitation, intermittent fever (pyrexia), altered mental status (mental status changes) and difficulty walking (gait disturbance) while receiving vaccines VARICELLA ZOSTER VACCINE, MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE, POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  A developmentally normal, ex-35-week, female presented at age 2 years with sudden onset encephalopathy and seizure activity in the absence of clinical triggers. A diagnosis of acute disseminated encephalomyelitis (ADEM) was made. After 5 days of IV (intravenous) methylprednisolone her condition improved, and seizures abated. The patient was back to her neurocognitive baseline after 7 days. After discharge, the patient's parents reported that her neurocognitive development slowed compared to other children. She was diagnosed with autism spectrum disorder (ASD) at age 3 years and family noted that with any acute illness or vaccination, the patient would have regression of her skills for 2-3 weeks before returning to her baseline. Specifically, the patient would become agitated, irritable, lose expressive language, and refuse to eat, walk, or participate in typical activities (e.g., brushing her teeth). These episodic symptoms are not uncommon in presentation of THMD5.   On an unknown date, two weeks after her 4-year vaccinations (DTap, IPV, MMR, and VAR) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site as prophylactic vaccination, the patient began experiencing episodes of agitation, intermittent fever, altered mental status, and difficulty walking.   The patient was mildly encephalopathic and did have a wide-based gait although this improved without intervention over the subsequent 3 days of hospitalization.   Action taken: not applicable for all vaccines Corrective: unknown for all events Outcome: unknown for all events Seriousness criteria: hospitalization for all events Reporter Causality: Related for all events; Sender's Comments: Sanofi company comment dated 04-SEP-2023: This case involves a 4 years old female patient who experienced agitation, intermittent fever, altered mental status and difficulty walking while receiving vaccines POLIOMYELITIS VACCINE (INACTIVATED) and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.. Based on information received the causal role of VACCINE cannot be excluded due to compatible temporal relationship of ADR to the VACCINE. Further information regarding time to onset, concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of vaccine cannot be assessed.