Sex: U
Vaccine: ADEN, FLUX, HEPA, MNQ, OPV, TDAP, TDAP
Symptoms: Anaphylactic reaction, Contraindication to vaccination
Clinical narrative: Anaphylaxis; a missed contraindication for Tdap; Anaphylaxis; This case was reported in a literature article and described the occurrence of anaphylaxis in a patient who received Hepatitis A vaccine for prophylaxis.  Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis, Flu unspecified (Flu vaccine) for prophylaxis, Men ACWY-CRM NVS (Meningococcal ACWY Vaccine (potential Menveo)) for prophylaxis, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis, ADENOVIRUS VACCINE for prophylaxis and POLIOMYELITIS VACCINE (IPV VACCINE) for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine at an unknown dose, Tdap Vaccine at an unknown dose, Flu vaccine at an unknown dose, Meningococcal ACWY Vaccine (potential Menveo) at an unknown dose, Tdap Vaccine at an unknown dose, ADENOVIRUS VACCINE at an unknown dose and IPV VACCINE at an unknown dose. On an unknown date, unknown after receiving Hepatitis A vaccine and Tdap Vaccine and not applicable after receiving Flu vaccine, Meningococcal ACWY Vaccine (potential Menveo) and Tdap Vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant), anaphylaxis (serious criteria hospitalization and GSK medically significant) and contraindicated drug administered. On an unknown date, the outcome of the anaphylaxis, anaphylaxis and contraindicated drug administered were unknown.   It was unknown if the reporter considered the anaphylaxis to be related to Hepatitis A vaccine and Tdap Vaccine. The reporter considered the anaphylaxis to be possibly related to Flu vaccine, Meningococcal ACWY Vaccine (potential Menveo) and Tdap Vaccine.  Additional details were reported as follows: This case was reported in a literature article and described the occurrence of anaphylaxis in a patient of unspecified age and gender who was vaccinated with unspecified inactivated poliovirus (IPV), unspecified inactivated influenza (IIV), unspecified meningococcal conjugate (MCV4) and unspecified tetanus, diphtheria & acellular pertussis vaccine (Tdap) vaccines and unspecified adenovirus (manufacturer unknown for all vaccines) for prophylaxis.  The patient was the part of the observational study that aimed to investigate adverse event (AE) reports following the adenovirus vaccine submitted to the Vaccine Adverse Event Reporting System (VAERS). They searched the VAERS database for reports among persons who received adenovirus vaccine during 1st October 2011 through 31st July 2018 including participants in a military observational study. [In this study, they identified those reports filled from 24th October 2011 to 5th October 2012, an FDA-mandated, post marketing military observational study was conducted using the database. This study compared 100,000 recruits exposed to the adenovirus vaccine with a historical unexposed cohort and identified statistical signals for psoriasis, anaphylaxis and other hypersensitivity reactions as emergent AEs possibly related to vaccination. During the study period, VAERS received a total of 100 reports following adenovirus vaccine; among all reports, the earliest vaccination date with the adenovirus vaccine the study identified was November 9, 2011]. The patient was from the military observational study. The patient had a past history of anaphylaxis following Tdap and hepatitis A vaccines (i.e., a missed contraindication for Tdap). No information on patient's family history or concomitant condition was provided. On unspecified date, the patient had received unspecified inactivated poliovirus (IPV), unspecified inactivated influenza (IIV), unspecified meningococcal conjugate (MCV4) and unspecified tetanus, diphtheria & acellular pertussis vaccine (Tdap) vaccines and unspecified adenovirus (administration route and site unspecified, dosage unknown; batch number not provided for all). The age of vaccination was not provided.  On an unspecified date between 1st October 2011 through 31st July 2018, unknown period after vaccination, the patient presented to the hospital with the episode of anaphylaxis. [In this study, The main diagnosis for each report was categorized into a MedDRA System Organ Class (SOC) grouping. Reports suggestive of anaphylaxis or GBS were further classified using the Brighton Collaboration criteria or a physician's diagnosis. Reports are classified as serious based on the Code of Regulations if one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, or congenital anomaly]. This case has been considered as serious due to the hospitalization. Treatment was unknown. [In this study, each of the patients was treated with epinephrine, antihistamine and corticosteroid therapy]. The outcome of event was not reported.  The author commented, "We identified eight reports of anaphylaxis following adenovirus vaccine classified as serious and on review of medical records all were identified as participants in the military observational study. In two patients the anaphylaxis was considered as possibly related to vaccines. In addition, 95 percent of the adenovirus vaccine reports documented co-administration of other vaccines and 50 percent reported co-administration of penicillin G (or other antibiotic if allergic to penicillin) according to standard protocol in this military population. The investigators of the earlier military observational study also commented that concurrent vaccine exposures in the recruit population was an important limiting factor for attributing the statistical signaling outcomes including psoriasis, anaphylaxis and other hypersensitivity reactions as possibly related to the vaccine". The author concluded "The reporting rate for serious AEs was higher than with other vaccines administered in the comparison military recruit population (39 percent vs 18 percent however, we identified no unexpected or concerning pattern of adenovirus vaccine AEs. Co-administration of vaccines and IM Pen G was commonly reported in this military population. These exposures may have contributed to the GBS and anaphylaxis outcomes observed with the adenovirus vaccine. Future adenovirus vaccine safety studies in a population without these co-administrations would be helpful in clarifying the vaccine's safety profile". This is 1 of the 19 valid cases reported in this literature article.