Sex: F
Vaccine: UNK
Symptoms: Anaphylactic reaction
Clinical narrative: possible anaphylaxis; Initial information received on 07-Jan-2020 regarding an unsolicited valid serious case regarding an unsolicited valid serious literature case.   The following is verbatim from the article: Introduction: The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons _65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group.Methods: We searched for and analyzed VAERS reports of Tdap among individuals _65 years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting.Results: VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were injection site erythema (26%; n = 468), injection site pain (19%; n = 335), injection site swelling (18%; n = 329), and erythema (18%; n = 321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n = 34) and infections and infestations (n = 18.6%; n = 18) were most commonly reported. Data mining did not identify any vaccine- AE combination reported more frequently than expected. Conclusions: We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults _65 years of age. Findings from this post-marketing review are consistent with prior post marketing observations and pre-licensure studies.  This case involves 86 years old female patient who experienced possible anaphylaxis (anaphylactic reaction), while she received vaccine [DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE] DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  The medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious possible anaphylaxis (anaphylactic reaction) (Unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant.  No laboratory data reported.  Final diagnosis was anaphylactic reaction.  It was not reported if the patient received a corrective treatment.  The outcome for the event anaphylactic reaction was unknown.  There will be no information on the batch number.; Sender's Comments: This case concerns an 86 years old female patient who presented with anaphylactic reaction with unknown latency after vaccination with Diphtheria, Tetanus and Acellular Pertussis Vaccine. The time to onset is unknown with the role of vaccine. Based upon the reported information, the role of the vaccine cannot be assessed.