Age: 44.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Paraesthesia, Thyroid function test, Upper respiratory tract infection
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case was linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140494, 2016SA140516, 2016SA140962, 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 among a certain population during the pandemic season has been published. Methods: We compared two population 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. One population's vaccination coverage was provided by the Medical Surveillance System. The second population's 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 44-year-old male patient who was vaccinated with a dose of H1N1 Vaccine (manufacturer: unknown, batch number, expiry date, route and site of administration: not reported) on an unspecified date. The patient's medical history included depression. Concomitant medications were not reported. On an unspecified date, one week days post vaccination, patient experienced URTI (Upper respiratory tract infection). On an unspecified date, 31 days post vaccination, patient experienced Ascending paresthesias, numbness and weakness in all limbs. Patient was diagnosed with Guillain-Barre syndrome (neurologist's Diagnosis). Lab data included: cerebrospinal fluid which showed positive albumin cytologic dissociation. Other test included complete blood count, comprehensive metabolic panel, c-reactive protein, thyroid function tests, chest X-ray, MRI lumbar Spine was performed. Patient received IVIG as corrective treatment. Outcome of events was not reported. Upon internal review, the company decided to consider the event as serious because of important medical events: Guillain-Barre syndrome and URTI. Documents held by sender: none. Sender's Comments: Patient had Guillain-Barre syndrome 31 days following MONOVALENT INFLUENZA A (H1N1) 2009 VACCINE. Time to onset is compatible with the vaccine, but too long, Guillain-Barre syndrome is usually preceded by upper respiratory tract or gastrointestinal tract infection, viral infection and vaccination, in this case patient has history upper respiratory infection 7 days after vaccination and also patient was vaccinated with influenza vaccine which is also of the triggering factors, patient is also Positive for albumin cytologic dissociation in CSF. Patient has history of depression, detail medication history are needed to further assess the case. Based on the available information the role of vaccine cannot be excluded.