Sex: U
Vaccine: TDAP
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This case was reported in a literature article and described the occurrence of guillain barre syndrome in a elderly patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.    On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than 2 months after receiving dTpa vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to dTpa vaccine.  Additional details were provided as follows: This case was reported in a literature article and described the occurrence of Guillain-Barré syndrome (GBS) aged between 65 and 73 years of unspecified gender who was vaccinated with unspecified tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) (manufacturer unknown) for prophylaxis.  The patient was the part of the study that aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group. They searched for and analyzed VAERS reports of Tdap among individuals equal or more than 65 years of age submitted from 1st September 2010 through 31st December 2018. They also retrieved Td reports since Td had been traditionally recommended in adults equal or more than 65?years before the advent of Tdap vaccines. [In this study, they classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, reviewed available medical records. VAERS received a total of 12 Tdap reports of GBS during the review period. Individuals had a median age of 71?years (range: 65-73?years); 7 were males and 5 were females]. No information on patient's medical or family history or concurrent condition or concomitant condition was provided. On unspecified date, after 2005, the patient had received unspecified tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. [In this study, Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) were first licensed for use in children and adults in 2005. Since then, the age group for which the use of the vaccine is approved expanded to include adults equal or more than 65?years of age. In 2012, the Regulatory Authority recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons equal or more than 65?years of age but use of either available Tdap was acceptable. VAERS received a total of 12 Tdap reports of GBS during the review period.Five reports described receipt of Tdap alone. Among the remaining reports, concomitant vaccinations included trivalent inactivated influenza vaccine (n?=?3), live zoster vaccine (n?=?2), cell-culture inactivated influenza vaccine (n?=?1), and pneumococcal polysaccharide vaccine (n?=?1)]. On an unspecified date between 1st September 2010 through 31st December 2018, 0-45 days after vaccination, the patient experienced Guillain-Barré syndrome (GBS). However, the patient's medical record was not available to verify the diagnosis. [In this study, VAERS received a total of 12 Tdap reports of GBS during the review period. The interval from vaccination to onset of neurological symptoms ranged from 0-45?days. Eight reports met Brighton level 1 (n?=?2), level 2 (n?=?4), or level 3 (n?=?2) criteria; three reports did not meet Brighton criteria, but were diagnosed as GBS by the attending physician; and one report did not have medical records available to verify the diagnosis]. Treatment was unknown. The outcome of the event was not provided.  The author commented, "GBS is a rare disorder that affects approximately 3000-6000 persons each year (approximately one to two cases per 100,000 person-years. Approximately two-thirds of GBS cases are triggered by a preceding respiratory or gastrointestinal infection, but GBS has also been associated with vaccinations. A study, which assessed GBS risk after two million doses of Tdap vaccine had been administered to persons aged 10-64?years of age, did not find evidence of an increased risk of this condition following vaccination. In our current review of the VAERS database, we did not find disproportional reporting for GBS among those equal or more than 65?years of age, although in this comparison we did include vaccines potentially associated with GBS. In seven of 12 Tdap reports describing GBS, another vaccine was concomitantly administered making it difficult to assess causality with any vaccine. In the five remaining cases, one could not be verified due to lack of medical records, and in another case the patient presented with gastrointestinal symptoms prior to the neurological symptoms, thereby, confounding any potential association between Tdap and GBS." The author concluded "We did not identify any AEs of concern over nearly a decade of Tdap use among adults equal or more than 65?years of age. Our study adds to the previous review of the VAERS database that encompassed an earlier calendar period (2005-2010) of Tdap use among an elderly population. The findings from our current post-marketing review of Tdap are consistent with findings from prior post-marketing observations and pre-licensure studies among individuals aged equal or more than 65?years." This is 1 of the 6 valid cases reported in this literature article.