Incidence and Characteristics of Delayed Injection Site Reaction to the mRNA-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine (Moderna) in a Cohort of Hospital Employees

• Published in: Clinical infectious diseases 2022-03, Vol.74 (4), p.591-596
• Main Authors: Jacobson, Mark A, Zakaria, Adam, Maung, Zaw, Hart, Colin, McCalmont, Timothy H, Fassett, Marlys, Amerson, Erin
• Format: Article
• Language: English
• Subjects: 2019-nCoV Vaccine mRNA-1273 - adverse effects; Adult; Cohort Studies; COVID-19 - epidemiology; COVID-19 - prevention & control; COVID-19 Vaccines - adverse effects; Female; Hospitals; Humans; Incidence; Injection Site Reaction - epidemiology; Major and Commentaries; Male; Middle Aged; SARS-CoV-2; United States - epidemiology
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1093/cid/ciab518

Abstract Background mRNA SARS-CoV-2 vaccines are administered to 2 million individuals per day in the United States under US Food and Drug Administration emergency use authorization. Methods Observational cohort study of hospital employees who received their first SARS-CoV-2 mRNA vaccination between 14 December 2020 and 8 January 2021, including employees who reported onset of an injection site reaction ≥48 hours after administration of their first or second dose to an employee hotline. Results Thirteen female employees who received the mRNA-1273 vaccine (Moderna) during the first 3 weeks of the SARS-CoV-2 vaccine rollout at San Francisco General Hospital reported a pruritic rash at the injection site appearing 3 -9 days after receipt of their initial dose. Five had milder or similar reactions with earlier onset after the second dose. One additional female employee reported this delayed reaction only after the second dose. None reported serious adverse events or had symptoms severe enough to seek medical attention. These cases represented 1.1% of the 1275 female employees who received their first mRNA-1273 dose and 2.0% of the 557 who were aged 31 -45 years during this initial vaccine rollout. None of 675 males who initiated mRNA-1273 or 3612 employees of any sex who initiated BNT162b (Pfizer) vaccination during this period reported delayed-onset reactions. Conclusions These results suggest that delayed-onset, injection site pruritic rashes after mRNA-1273 SARS-CoV-2 vaccine administration, lasting up to 1 week, occur commonly in females, do not lead to serious sequela, and should not deter receipt of the second vaccine dose. 1.1% of 1275 female employees and 2.0% of those aged 31–45 years receiving the mRNA-1273 SARS-CoV-2 vaccine developed a benign, delayed-onset, pruritic injection site rash not reported by any males or any BNT162b vaccine recipients during hospital vaccine rollout.