Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Anaphylactic reaction, Hypotension, Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: anaphylaxis; pruritus; tongue swelling; throat sweling; hypotension; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case from other healthcare professional, issued from a literature article.  This case is linked to cases 2020SA005907, 2020SA005926, 2020SA005922 and 2020SA005905 (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 78 years old female patient who experienced anaphylaxis (anaphylactic reaction) and hypotension (hypotension), while she received vaccines VARICELLA ZOSTER VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  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 not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER VACCINE) not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed serious anaphylaxis (anaphylactic reaction) and hypotension (hypotension) (unknown latency) as diagnosis and pruritus (pruritus), throat swelling (pharyngeal swelling) and tongue swelling (swollen tongue) as symptoms few minutes following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and VARICELLA ZOSTER VACCINE. All events was assessed as medically significant.  Laboratory data was not reported.  Final diagnosis was hypotension and anaphylaxis.  Patient was treated in the emergency department.  The patient had recovered from events on an unknown date.  There will be no information available on the batch number for this case.; Sender's Comments: This case involves a 78 years old female patient who experienced anaphylactic reaction and hypotension (unknown latency) after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and VARICELLA ZOSTER VACCINE. Time to onset is compatible with the role of vaccine. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.