Age: 39.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Immunoglobulin therapy, Paraesthesia
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 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 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 second population. The rate of GBS reported following MIV was higher in the second population. This case involves a 39 year old male patient who was vaccinated with dose of MONOVALENT H1N1 VACCINE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's medical history included asthma. Illness/other in four weeks prior to onset of GBS symptoms were reported as viral upper respiratory tract infection (onset one week before vaccination). Concomitant medications were not reported. On an unspecified date, four hours following vaccination, patient experienced Ascending weakness, numbness, paresthesia in limbs. Patient was diagnosed with Guillain-Barre syndrome. Lab data included cerebrospinal fluid which showed positive albumin cytologic dissociation. Complete blood count was normal. Corrective treatments included 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. Documents held by sender: none. Sender's Comments: This case refers to a patient who received MONOVALENT H1N1 VACCINE and after 4 hours later experienced Guillain-Barre syndrome. Time to onset of 4 hours is compatible with the role of vaccine. Patient had past history of asthma and had upper respiratory tract infection one week prior to vaccination. Further information regarding concomitant medications if any, etiology and clinical details of the recent respiratory tract infection are needed for complete assessment of the case.