Age: 19.0
Sex: M
Vaccine: FLUX(H1N1), HEPAB
Symptoms: Immunoglobulin therapy, Nausea, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Initial unsolicited report received from the literature on 29-Jul-2016. This case is linked to cases 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140516, 2016SA140980, 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 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 19 year old male patient who was vaccinated with a dose of Monovalent H1N1 Vaccine on an unspecified date and a dose of Hepatitis A & B vaccine (manufacturer: other) (batch number, route and site of administration not reported for both vaccines) on an unspecified date one week earlier. The patient's medical history was not documented. Concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced nausea (reported as one week prior to Guillain-Barre syndrome symptoms) and cough, vomiting and diarrhea (reported as one day before Guillain-Barre syndrome symptoms). On an unspecified date, nine days following the MIV vaccination, the patient experienced numbness and paresthesia and was diagnosed with Guillain-Barre syndrome. Relevant laboratory test included cerebra spinal fluid: with normal protein and no white blood cells, electromyography was positive for mild acute demyelination and MRI of brain, cervical and thoracic spine, drug screen and complete blood count (results not reported). Corrective treatment included IV immunoglobulin. The outcome of events were not reported. Upon internal review the case was considered as serious because of important medical event: Guillain-Barre syndrome. Documents held by sender: none. Sender's Comments: Patient had Guillain-Barre syndrome 9 days following MONOVALENT INFLUENZA A (H1N1) 2009 VACCINE and HEPATITIS A VACCINE/HEPATITIS B 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 gastrointestinal infection symptoms like vomiting, diarrhea nausea and respiratory infection symptom like cough 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 is also positive for acute mild demyelination on EMG. Based on the available information the role of vaccine cannot be excluded.