Age: 39.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Electromyogram normal, Guillain-Barre syndrome, Muscle spasms, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case is linked to LINKED CASES 2016SA140381, 2016SA140455, 2016SA140480, 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 during the pandemic season has been published. Methods: We compared different 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 one population versus the other 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 among the first population 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 39 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 type 1 diabetes mellitus. Illness/ other in four weeks prior to onset of GBS symptoms included: Clostridium Difficile infection (detected as inpatient). Concomitant medications were reported as insulin pump. On an unspecified date, two days following vaccination, patient had Paresthesias (whole body) and cramps in legs, and patient was diagnosed with "Sensory GBS (Guillain-Barre syndrome)" (4) vs. small fiber neuropathy (neurologist's diagnosis). Lab data included electromyography: normal exam, brain scan MRI of cervical spine was also performed (results not reported). Patient received supportive treatment. Outcome of events was not reported. Upon internal review, the company decided to consider the event as serious because of important medical event: Guillain-Barre syndrome and small fiber neuropathy. Documents held by sender: none. Sender's Comments: This is a case of a patient who received MONOVALENT INFLUENZA A/H1N1 PRESERVATIVE VACCINE and experienced Guillain-Barre syndrome and suspected small fiber neuropathy. Patient is a known case of diabetes mellitus. Additional information regarding relevant medical history, clinical details surrounding the events, investigation results confirming the diagnosis, concomitant medications, if any and concurrent conditions, if any are needed for complete assessment of the case.