Age: 21.0
Sex: M
Vaccine: FLUX, FLUX(H1N1), IPV, TDAP, FLU(H1N1), FLUN3, IPV, TDAP
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lung infiltration, Muscular weakness, Pneumonia
Clinical narrative: Initial unsolicited report received from the literature on 29 July 2016. This case is linked to 2016SA140361, 2016SA140381, 2016SA140455, 2016SA140480, 2016SA140494, 2016SA140516, 2016SA140962, 2016SA140980, 2016SA140990, 2016SA141005, 2016SA141097 (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 a 21 year old male patient who was vaccinated with a dose of TDAP, a dose of IPV, a dose of Live Attenuated Influenza Vaccine (manufacturer: unknown for all three vaccines) and a dose of Monovalent H1N1 Vaccine (manufacturer: Novartis) (batch number, dose, route and site of administration was not reported for all vaccines) on an unspecified date. The patient's medical history was not documented and concomitant medications were not reported. On an unspecified date, post vaccination, patient developed pneumonia (reported as one week prior to Guillain-Barre syndrome symptoms) and on an unspecified date, 32 days post vaccination patient experienced ascending weakness in all limbs. Patient was diagnosed with Guillain-Barre syndrome (neurologist's Diagnosis). Lab data included chest X-ray, which showed right basal lobe infiltrate, electromyography that was positive for mild acute demyelination. Other test included complete blood count (CBC), erythrocyte sedimentation rate (ESR) and blood culture (Cx) (results not reported). Patient received corrective treatment with IVIG, azithromycin and cefdinir. Outcome of events was not reported. Upon internal review, the company decided to consider the event as serious because of important medical event: Guillain in-Barre syndrome and pneumonia. Documents held by sender: none. Sender's Comments: This case refers to a patient who simultaneously received 4 vaccines, DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, POLIOMYELITIS VACCINE (INACTIVATED), LIVE ATTENUATED INFLUENZA VACCINE and INFLUENZA VIRUS VACCINE MONOVALENT (other manufacturer) and 32 days later experienced Guillain-Barre syndrome. One week prior to Guillain-Barre syndrome, patient also experienced pneumonia. Respiratory tract infections could be the underlying cause of Guillain-Barre syndrome. Additional information regarding relevant medical history, clinical details surrounding the events, underlying cause of pneumonia, investigation results confirming the diagnosis are needed for complete assessment of the case. Moreover, the patient received 4 vaccines concomitantly, making it difficult to assess the role of one vaccine in particular.