Age: 1.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Otitis media, Polymerase chain reaction positive, Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: This case was reported in a literature article and described the occurrence of arm paralysis in a 1-year-old patient who received Hepatitis A vaccine. Co-suspect products included varicella vaccine. On an unknown date, the patient received Hepatitis A vaccine at an unknown dose and varicella vaccine at an unknown dose. On an unknown date, 10 days after receiving Hepatitis A vaccine, the patient experienced arm paralysis (serious criteria GSK medically significant), fever, bilateral otitis media, weakness of arms, generalized maculopapular rash, vomiting, diarrhea, diminished reflexes, decreased muscle tone and grip strength decreased. The patient was treated with antibiotics NOS. On an unknown date, the outcome of the arm paralysis, diminished reflexes, decreased muscle tone and grip strength decreased were not recovered/not resolved and the outcome of the fever, bilateral otitis media, weakness of arms, generalized maculopapular rash, vomiting and diarrhea were unknown. The reporter considered the arm paralysis, fever, bilateral otitis media, weakness of arms, generalized maculopapular rash, vomiting, diarrhea, diminished reflexes, decreased muscle tone and grip strength decreased to be related to Hepatitis A vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of arm paralysis in a 1-year-old of unspecified gender who was vaccinated with unspecified hepatitis A (manufacturer unknown) and unspecified varicella vaccine (non-GSK manufacturer). The patient presented during a community-wide EV-D68 outbreak associated with flaccid paralysis. The patient was reported to be healthy. No information on patient's medical or family history or concurrent medical conditions was provided. No information on patient's concomitant medications was provided. On an unspecified date, the patient received unspecified hepatitis A and unspecified varicella vaccine (administration route and site unspecified; dosage unknown; batch number not provided for both). On an unspecified date, 8 days after vaccination with unspecified hepatitis A and unspecified varicella vaccines, the patient developed bilateral otitis media, was febrile for which he received an unspecified antibiotic. 2 days later, the patient developed proximal weakness of the left arm, generalized maculopapular rash, vomiting and diarrhea. The patient experienced a decreased left biceps reflex and muscle tone; there was a good movement of the left hand, and a slightly decreased grip. Cerebrospinal fluid (CSF) analysis revealed no organisms, red blood cells of 4188 per mm3, white blood cell at 46 per mm3, protein at 39 mg/dL, and glucose at 57 mg/dL. CSF by Polymerase Chain Reaction (PWCR) revealed wild-type varicella zoster virus (Wt-VZV DNA). Multiplex respiratory PCR panel and CSF were negative for enteroviruses, though serum was positive for high-titer (Immunoglobulin G; IgG) neutralizing antibodies against EV-D68 virus. Diagnostic testing for multiple other pathogens was negative. Varicella zoster virus (VZV) IgG avidity was consistent with a primary VZV antibody response. Magnetic resonance imaging of the brain and spine with contrast were normal. Serial electromyographies were consistent with injury of the motor neurons or ventral roots at C5-7 level. It was reported that the patient remained paralyzed 1.5 years later. Treatment was unknown. The outcomes of the events were not reported. The authors did not comment on the causality relationship between the events of febrile, bilateral otitis media, generalized maculopapular rash, vomiting and diarrhoea and the unspecified hepatitis A and varicella vaccines. However, the authors comment on the causality for the event of paralysis with unspecified hepatitis A and varicella vaccines was the "Molecular  methods aided a complex AEFI causality assessment and excluded vaccination as a cause of paralysis. Wt-VZV, a known neurotropic virus, may have caused or contributed to the child's paralysis."