Age: 43.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Demyelination, Electromyogram abnormal, Facial paralysis, Full blood count, Guillain-Barre syndrome
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, 2016SA140990, 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 among one population 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. The first population vaccination coverage was provided by the Medical Surveillance System. The second population vaccination coverage was estimated using data from the National 2009 H1N1 Flu Survey and the Behavioral Risk Factor Surveillance System survey. Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the first population than in the second 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 AEs following MIV in the first population 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 43 year old male patient who was vaccinated with a dose of MONOVALENT H1N1 VACCINE (batch number, dose, route and site of administration was not reported) on an unspecified date. The patient had medical history of non-Hodgkin lymphoma (in remission 3.5 year) and allergic rhinitis. 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, 10 days following the vaccination, patient experienced paresthesias, numbness, left side facial droop and weakness in all limbs. Patient was diagnosed with Guillain-Barre syndrome. Lab data included electromyography which was positive for mild acute demyelination. Other lab tests included complete blood count, comprehensive metabolic panel, magnesium, phosphorus, serum IgA, IgG, erythrocyte sedimentation rate and antinuclear antibodies (results not reported). Corrective treatments included prednisolone & acyclovir (for presumed Bell's palsy) and IVIG (Intravenous immunoglobulin). Outcome of events was not reported. Upon internal review the case was considered as serious because of important medical event: Guillain-Barre syndrome. List of documents held by sender: none. Sender's Comments: Patient had Guillain-Barre syndrome 10 days following MONOVALENT INFLUENZA A (H1N1) 2009 VACCINE. Time to onset is compatible with the vaccine, patient had mild acute demyelination on EMG. Guillain-Barre syndrome is usually preceded by upper respiratory tract or gastrointestinal tract infection, influenza infection and vaccination, in this case patient had upper respiratory infection 4 weeks prior which could be triggering factor and also patient was vaccinated with influenza vaccine which is also one of the triggering factors. Patient has medical history of non-Hodgkin lymphoma and allergic rhinitis which could pay a contributory role. Based on the available information the role of vaccine cannot be excluded.