Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Death, Respiratory failure, Tryptase increased
Clinical narrative: Initial literature full article received on 08-Apr-2019 regarding an unsolicited valid serious case. This case was linked to 2019SA111409, 2019SA111422, 2019SA106595, 2019SA111434, 2019SA111441, 2019SA111446  (same literature). Literature abstract: Background: Anaphylaxis, a rare and potentially life-threatening hypersensitivity reaction, can occur after vaccination. Objective: We sought to describe reports of anaphylaxis after vaccination made to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. Methods: We identified domestic reports of anaphylaxis within VAERS using a combination of Medical Dictionary for Regulatory Activity queries and Preferred Terms. We performed a descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given. We reviewed all serious reports and all nonserious reports with available medical records to determine if they met the Brighton Collaboration case definition for anaphylaxis or received a physician's diagnosis. Results: During the analytic period, VAERS received 467,960 total reports; 828 met the Brighton Collaboration case definition or received a physician's diagnosis of anaphylaxis: 654 (79%) were classified as serious, and 669 (81%) had medical records available. Of 478 reports in children aged less than 19 years, 65% were male; childhood vaccines were most commonly reported. Of 350 reports in persons aged 19 years or greater, 80% were female, and influenza vaccines were most frequently reported. Overall, 41% of reports described persons with no history of hypersensitivity. We identified 8 deaths, 4 among persons with no history of hypersensitivity. This case involves a 42 years old female patient who experienced Anaphylactic reaction, respiratory failure and increased serum tryptase level while she received vaccines INFLUENZA VACCINE (TRIVALENT). The patient's past medical history included Asthma; Hereditary onycho-osteodysplasia; allergies to penicillin, quinolones, and naproxen; hepatitis C infection. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant therapy included ceftriaxone via intramuscular route. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (TRIVALENT) produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient developed a serious Anaphylactic reaction, respiratory failure and increased serum tryptase level, 2 minutes following the administration of INFLUENZA VACCINE, (TRIVALENT). These events were leading to death. Other lab test not reported. Final diagnosis was (fatal) Anaphylactic reaction, respiratory failure and increased serum tryptase level. It was not reported if the patient received a corrective treatment. It was not reported if an autopsy was performed. However, the cause of death was reported as Anaphylactic reaction.; Sender's Comments: This case is from a literature article concerning a 02-year-old male patient who died due to anaphylactic reaction followed by cardiopulmonary arrest and increased tryptase 20 minutes after vaccination with INFLUENZA VACCINE (Inactivated influenza), MEASLES-MUMPS-RUBELLA VIRUS VACCINE and VARICELLA VACCINE. Past medical history included Hypoplastic left heart syndrome with subsequent cavopulmonary shunt procedure performed and periodic Cyanosis. Patient was born premature at 33 weeks gestation. Patient's medical condition at time of vaccination and clinical course of the events are not reported. The cause of death was due to anaphylactic reaction and Postmortem lab tests revealed increased serum tryptase level. Rapid onset of symptoms after vaccination suggests vaccine played a role in this episode of anaphylaxis. Although, based upon the available information and nature of the event with multiple suspects, the role of individual vaccine cannot be assessed.; Reported Cause(s) of Death: Anaphylactic reaction.