Age: 26.0
Sex: M
Vaccine: FLU(H1N1), HEPAB
Symptoms: Dizziness, Guillain-Barre syndrome, Hypoaesthesia, Miller Fisher syndrome, Ophthalmoplegia
Clinical narrative: This case was reported in a literature article and described the occurrence of Miller Fisher syndrome in a 26-year-old male subject who received Hepatitis A and Hepatitis B vaccine. Co-suspect products included H1N1 vaccine. The subject's past medical history included headache and vertigo. Concurrent medical conditions included sinusitis (2 weeks prior to onset of GBS symptoms). On an unknown date, 2 days after received Hepatitis A and Hepatitis B vaccine, the subject developed Miller Fisher syndrome. Serious criteria included GSK medically significant. Additional event(s) included numbness, light headedness, diplopia, areflexia, ataxia and ophthalmoplegia with serious criteria of GSK medically significant. The subject was treated with azithromycin and vitamin B12. The outcome of Miller Fisher syndrome was unknown. The outcome(s) of the additional event(s) included numbness (unknown), light headedness (unknown), diplopia (unknown), areflexia (unknown), ataxia (unknown) and ophthalmoplegia (unknown). It was unknown if the investigator considered the Miller Fisher syndrome, numbness, light headedness, diplopia, areflexia, ataxia and ophthalmoplegia to be related to Hepatitis A and Hepatitis B vaccine. Relevant Tests: on unknown date, Laboratory tests included computed tomography of brain and blood culture (results not provided). Diagnostic tests (unless otherwise stated, normal values were not provided). On an unknown date, Blood culture result was not provided unknown. On an unknown date, Computerised tomogram head result was not provided unknown. Additional information was provided: This case was reported in a literature article and described the occurrence of Guillain Barre syndrome (GBS) in a 26-year-old male who was vaccinated with unspecified Hep A/B vaccine (manufacturer unknown) and MIV (Novartis). The patient concerns to case no. 7 of the table 3 from the literature article. The patient was the part of retrospective review of two populations' vaccine adverse events reporting system (VAERS) reports to investigate possible differences in adverse events reporting rates for both the 2009 pandemic H1N1 and 2009-2010 seasonal influenza vaccines. In this study, all VAERS reports were reviewed by a CDC medical officer who classified the AEs based on information in the text of the report and in medical records (when available) according to one of the following body system categories: hypersensitivity (e.g., anaphylaxis, angioedema, dyspnea, urticaria, wheezing), cardiovascular (e.g., arrhythmia, hypertension, hypotension, myocarditis), ENT (ears, nose, throat), gastrointestinal (e.g., vomiting, diarrhea), local reaction (e.g., pain, tenderness, erythema), musculoskeletal (e.g., arthralgia, arthritis), neurologic (e.g., paresthesia, peripheral neuropathy, Bell's palsy, Guillain-Barre syndrome, convulsion), pregnancy-specific outcomes (e.g., spontaneous abortion, fetal death), psychiatric, respiratory (e.g., influenza-like illness, rhinorrhea, sore throat, cough), other infectious, other non-infectious conditions (e.g., diabetes, thrombocytopenia, multiple symptoms) and death. The patient had a history of headaches and vertigos. No information on patient's family history or concomitant medication was provided. Concurrent medical conditions included sinusitis (2 weeks prior to onset of GBS symptoms). On unspecified dates between 1 August 2009 and 31 December 2010, the patient received unspecified Hep A/B and MIV (administration route and site unspecified; dosages unknown; batch number not provided for all). (In this study, vaccine was administered in a specific clinic and/or was purchased with specific funds. Vaccination coverage among patients was determined using date from an active surveillance system to integrate data from medical treatment facilities, vaccination centres, and patient offices worldwide. On an unspecified date, 2 days after vaccination, the patient was lightheaded, had diplopia, numbness, areflexia on exam, ataxia and ophthalmoparesis. Subsequently, the patient was diagnosed with Brighton criteria 2 confirmed Miller Fisher variant of GBS by a CDC medical officer. Laboratory tests included computed tomography of brain and blood culture (results not provided). The patient was treated with azithromycin and vitamin B12. The outcome of the event was not reported. The authors did not comment on the relationship between GBS and Hep A/B vaccine. The authors concluded that "We found higher reporting of GBS following MIV among male patients in the first population compared with the second population of men, even though the rate of serious AEs following MIV by the first population was about half that reported by the second population. The reason for the differences in GBS reporting is not clear but it may be related to differences in reporting practices between the first population, preceding infections and other potential environmental exposures. Of note, during the 2009-2010 influenza season, the CDC and the Food and Drug Administration actively solicited reports of serious events such as GBS which may have been linked with the H1N1 2009 monovalent vaccine and the seasonal 2009-2010 influenza vaccine. This is 1 of the 5 valid cases of the same literature article.