Note: This document contains side effect information about sars-cov-2 (covid-19) ad26 vaccine, recombinant. Some dosage forms listed on this page may not apply to the brand name Janssen COVID-19 Vaccine.
Applies to sars-cov-2 (covid-19) ad26 vaccine, recombinant: parenteral suspension for im use.
Special Alerts:
A standardized concentration for this drug has been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. The drug is included in a standard concentration list which may apply to an IV or oral compounded liquid formulation. For additional information, see the ASHP website [Web].
COVID-19 Vaccine, Viral Vector (Janssen)is no longer commercially available in the U.S. See the FDA website ([Web]) for information on drugs that have been discontinued.
National Alert Network (NAN) Alert Regarding Influenza and COVID-19 Vaccine Mix-ups:600 On October 15, 2021, the National Alert Network (NAN) issued an alert to make vaccine providers aware of reports of accidental mix-ups between the influenza (flu) and COVID-19 vaccines. The alert is based on 16 cases reported to the Institute for Safe Medication Practices (ISMP) error reporting programs. Most of the reports ISMP has received involve administration of one of the COVID-19 vaccines instead of an influenza vaccine; in 3 cases, patients received an influenza vaccine instead of a COVID-19 vaccine. Because most of the errors were reported by consumers, details about the contributing factors were not provided in many cases. However, possible contributing factors include increased demand for vaccination services, the ability to administer the flu and COVID-19 vaccines during the same visit, syringes located next to each other, unlabeled syringes, distractions, and staffing shortages. The alert provides recommendations for preventing such vaccine mix-ups. For additional information, consult the NAN alert at [Web].
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that COVID-19 Vaccine (Janssen) is not an approved vaccine for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under an FDA emergency use authorization (EUA) for active immunization to prevent COVID-19. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information contained in the accompanying monograph, and specifically disclaims all such warranties. Readers of this information are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information contained in the monograph in any and all practice settings. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Side effects include:
Primary vaccination: Local adverse effects include injection site pain (48.6%), erythema (7.3%), and swelling (5.3%). Onset usually within first 1–2 days after vaccination with median duration of 2 days. However, local adverse effects reported to last >7 days in some vaccine recipients. Systemic adverse effects include headache (38.9%), fatigue (38.2%), myalgia (33.2%), nausea (14.2%), and fever (9%).
Booster dose: Local adverse effects in individuals 18–55 years of age include injection site pain (59.6%) and erythema (1.1%). Local adverse effects reported in vaccine recipients ≥65 years of age include injection site pain (20.8%). Systemic adverse effects reported in vaccine recipients 18–55 years of age include headache (41.6%), fatigue (51.7%), myalgia (36%), nausea (10.1%), and fever (5.6%). Systemic adverse effects reported in vaccine recipients ≥65 years of age included headache (27.1%), fatigue (33.3%), myalgia (10.4%), and nausea (2.1%).
