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: This case was reported in a literature article and described the occurrence of Guillain Barre syndrome in a 21-year-old male subject who received Tdap vaccine. Co-suspect products included H1N1 vaccine and IPV. On an unknown date, 32 days after receiving Tdap vaccine, the subject developed Guillain Barre syndrome. Serious criteria included GSK medically significant. Additional event(s) included pneumonia with serious criteria of GSK medically significant and weakness of limbs. The subject was treated with immunoglobulin human normal (IVIG), azithromycin and cefdinir capsule. The outcome of Guillain Barre syndrome was unknown. The outcome(s) of the additional event(s) included pneumonia (unknown) and weakness of limbs (unknown). It was unknown if the investigator considered the Guillain Barre syndrome, pneumonia and weakness of limbs to be related to Tdap vaccine. Relevant Tests: On unknown date Laboratory tests included complete blood count, erythrocyte sedimentation rate and blood culture (results not provided for all). Electromyogram was positive for mild acute demyelination. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Blood culture result was not provided unknown. On an unknown date, Chest X-ray result was right basal lobe infiltrate unknown. On an unknown date, Electromyogram result was demyelination unknown. On an unknown date, Full blood count result was not provided unknown. On an unknown date, Red blood cell sedimentation rate 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 21-year-old male who was vaccinated with unspecified Tdap; unspecified IPV; unspecified live attenuated influenza vaccine (LAIV) and monovalent H1N1 vaccine (MIV) (manufacturers unknown for all) and monovalent H1N1 vaccine (MIV) (Novartis). The patient was the part of retrospective review of military and civilian 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. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On unspecified dates between 1 August 2009 and 31 December 2010, the patient received unspecified Tdap, unspecified IPV, unspecified LAIV and MIV (administration route and site unspecified; dosages unknown; batch number not provided for all). (In this study, vaccine was administered in a military clinic and/or was purchased with military funds and included active personnel in the military branches. Military vaccination coverage among active duty personnel was determined using data from the Medical Surveillance System (MSS), an active surveillance system to integrate data from medical treatment facilities, vaccination centres, and military personnel offices worldwide). On an unspecified date, 32 days after vaccination, the patient experienced ascending weakness in all limbs; he also had a 1 week history of pneumonia (right basal lobe infiltrate on chest x-ray). Subsequently, the patient was diagnosed with Brighton criteria 2 confirmed GBS by a CDC medical officer. Laboratory tests included complete blood count, erythrocyte sedimentation rate and blood culture (results not provided for all). Electromyogram was positive for mild acute demyelination. The patient was treated with intravenous immunoglobulins, azithromycin and cefdinir. The outcome of the event was not reported. The authors did not comment on the relationship between GBS and Tdap and IPV. The authors concluded that "We found higher reporting of GBS following MIV among male service personnel compared with civilian men, even though the rate of serious AEs following MIV by military personnel was about half that reported by the civilian population. The reason for the differences in GBS reporting is not clear but it may be related to differences in reporting practices between the military and civilian sectors, 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 vaccine and the seasonal 2009-2010 influenza vaccine. This is 1 of the 5 valid cases of the same literature article.