Typhoid shot side effect3/25/2023 ![]() ![]() The most common vaccines given in excess among these serious reports were pneumococcal polysaccharide (13), influenza (10), hepatitis B (9), human papillomavirus (6) and herpes zoster (5). The SOCs most commonly reported among these excess dose serious reports were general disorders and administration site conditions (17), nervous system disorders (7), and immune system disorders (4). Other false positives included MedDRA PTs for multiple drug overdose where a drug but not a vaccine was administered in excess. Some of the false positives included reports with MedDRA PTs for incorrect dose administered, but not an excess dose when reviewed. Ĭlinical review of all available records for the 158 serious reports identified through the initial automated search strategy determined that 64 were cases involving an excess vaccine dose. Vaccine manufacturers are responsible for following up on serious reports or unexpected AEs submitted to them. For serious reports, medical records are routinely requested and made available to VAERS personnel. Reports are classified as serious or non-serious based on the Code of Federal Regulations (21-CFR) if one or more of the following are reported: death, life-threatening illness, hospitalization or prolongation of existing hospitalization, permanent disability, or a congenital anomaly/birth defect. System Organ Class (SOC) is the highest level of the MedDRA hierarchy that provides the broadest classification for AEs (e.g., nervous system disorders). A PT is a distinct descriptor for a symptom, sign, disease, diagnosis, therapeutic indication, investigation, medical error, surgical, or medical procedure, or medical, social, or family history characteristic, but PTs are not necessarily medically confirmed diagnoses. A VAERS report may be assigned one or more MedDRA preferred terms (PTs). Signs and symptoms of AEs are coded by trained personnel using the Medical Dictionary for Regulatory Activities (MedDRA), a clinically validated, internationally standardized terminology. The VAERS report form collects information on age, sex, vaccines administered, dose and lot number, the AE experienced, and health history. VAERS accepts reports from vaccine manufacturers, healthcare providers, vaccine recipients and others. It receives reports of AEs following vaccination but may also receive reports of vaccination errors not describing an AE. VAERS is a US national passive vaccine safety surveillance system created in 1990 and co-administered by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). ![]() The objective of this study is to describe the characteristics of AEs associated with reports in VAERS where an excess dose of vaccine was administered. For most other vaccines in the immunization schedule, there is little if any information on AEs resulting from their excessive administration. In such cases, the benefits and risks of administering the combination vaccine with an unneeded antigen should be carefully considered and discussed with the patient or parent. In some circumstances, the provider might prefer to use a combination vaccine to reduce the required number of injections. The ACIP recommendations state that an excess dose of many live-virus vaccines and Haemophilus influenzae or hepatitis B vaccine has not been found to be harmful, but the risk for an AE might increase when excess doses are administered at an earlier time than the recommended interval for certain vaccines. However, this may be justified if the excess antigen is not contraindicated, if the potential benefits to the patient outweigh the potential risk for adverse events (AEs) associated with the excess antigens, if the products that contain only the needed antigens are not readily available, and if there is better overall economic value if the direct and indirect costs of excess injections are taken into consideration. The Advisory Committee on Immunization Practices (ACIP) has specific recommendations regarding the administration of excess doses of vaccine indicating that administration of excess antigens contained in a combination vaccine should be avoided in most situations. Administration of an excess dose of a vaccine can occur under several scenarios: (1) administration of an excess dose of the same antigen due to a vaccination error (e.g., healthcare provider, documentation, or patient recall errors) (2) in the context of combination vaccines, such as when there is need to provide one of the antigens not readily available as a single antigen (3) when there is a need to provide immunizations to individuals with uncertain vaccination histories, as in the case of special populations (e.g, refugees with missing records and unknown immune status). ![]()
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