Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Anaphylactic reaction
Clinical narrative: Possible anaphylaxis; Initial information received on 07-Jan-2020 regarding an unsolicited valid serious case from other healthcare professional, issued from a literature article.    This case is linked to cases 2020SA005922, 2020SA005905, 2020SA005926 and 2020SA005350 (same reporter).  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 a 71 years old male patient who experienced possible anaphylaxis (anaphylactic reaction), while he received 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 an 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.  Laboratory details were not provided.  Final diagnosis was anaphylactic reaction.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of anaphylactic reaction.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a 71 years old male patient who presented with anaphylactic reaction with unknown latency after vaccination with DIPHTHERIA, TETANUS and ACELLULAR PERTUSSIS vaccine produced by unknown manufacturer. The time of onset was unknown with the role of vaccine. Further information including patient's medical condition at the time of vaccination, allergy history, previous vaccination and tolerance, allergy testing and laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.