Age: 28.0
Sex: M
Vaccine: FLU(H1N1), FLUN3, HEPAB, MNQ, TDAP, FLUN3, FLUX(H1N1), HEPAB, MNQ, TDAP
Symptoms: Areflexia, Ataxia, Demyelination, Dysarthria, Electromyogram abnormal
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140516, 2016SA140962, 2016SA140980, 2016SA141005, 2016SA141097, 2016SA141105 (same literature). The following is verbatim from the article: Abstract: Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season has been published. Methods: We compared two populations' adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44 years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines. Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the military than in the civilian population. The reporting rate of serious AE reports following MIV in the first population (1.19 per 100,000) was about half that reported by the second population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among the first population (1.32 per 100,000) was more than twice that of the second population. Although fewer first population AEs following MIV were reported overall, the rate of Guillain-Barre Syndrome (GBS) (4.01 per million) was four times greater than that in the second population. (1.04 per million). Conclusions: Despite higher vaccination coverage in the first population, the rate of serious AEs following MIV was about half that in the second population. The rate of GBS reported following MIV was higher in the first population. This case involves a 28 year old male patient who was vaccinated with dose of Tdap, dose of MENINGOCOCCAL CONJUGATE VACCINE, dose of LIVE ATTENUATED INFLUENZA VACCINE, dose of MONOVALENT H1N1 VACCINE and dose of HEPATITIS A & B VACCINE (batch number, expiration date, dose, route and site of administration was not reported for all vaccines) on an unspecified date. Illness/other in four weeks prior to onset of Guillain-Barre syndrome symptoms was reported as upper respiratory tract infection. Concomitant medications were not reported. On an unspecified date, 46 days following vaccination, patient experienced headache, numbness in legs and face, blurred vision, areflexia and ataxia on exam and dysarthria. Patient was diagnosed with Miller Fisher variant of Guillain-Barre syndrome. Lab data included electromyography which showed positive for mild acute demyelination. Other lab tests included complete blood count and comprehensive metabolic panel (results were not reported). Corrective treatments included IVIG (Intravenous immunoglobulin). Outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event: Miller Fisher variant of GBS. Documents held by sender: none. Sender's Comments: The patient had Miller Fisher variant of GBS (2) following DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, MENINGOCOCCAL VACCINE, LIVE ATTENUATED INFLUENZA VACCINE, MONOVALENT INFLUENZA A (H1N1), and HEPATITIS A VACCINE/HEPATITIS B VACCINE. Time to onset is unknown detail regarding patient medical history, any infectious history, past vaccination history are needed to further assess the case. Patient has history of upper respiratory tract infection which could be triggering factor. As multiple vaccines are administered the role of each vaccine cannot be assessed.