Age: 18.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Albumin CSF increased, Areflexia, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 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 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 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 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 an 18 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 migraine, depression and penicillin (PCN) allergy. Concomitant medications were not reported. On an unspecified date, 97 days post vaccination, patient experienced paresthesia and numbness in upper and lower limbs, areflexia and photophobia. Patient was diagnosed with Guillain-Barre syndrome (neurologist's Diagnosis). Lab data included: cerebrospinal fluid which showed positive albumin cytologic dissociation. Patient received corrective treatment with Plasmapheresis IVIG. 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. Documents held by sender: none. Sender's Comments: This case refers to a patient who received H1N1 VACCINE and 97 days later experienced Guillain-Barre syndrome. The product manufacturer is unknown. Very limited information is provided in this case, however, considering the time to onset of 97 days, the role of the vaccine seems to be unlikely.