In clinical trials of both licensed and recommended RSV vaccines, GSK and Pfizer, mild, local injection site reactions (redness, swelling), fatigue, muscle aches and headache were noted.
In the clinical trials of both RSVPreF3 (Arexvy) and RSVpreF (Abrysvo) vaccines, a small number of inflammatory neurologic events, including GBS, were reported after RSV vaccination. Whether these events occurred due to chance or whether RSV vaccination might increase the risk for inflammatory neurologic events is not yet known. CDC is actively monitoring the safety of these vaccines through national safety surveillance systems in order to detect any risk too small to be detected in the clinical trials.
In clinical trials, the vast majority of infants had no side effects detected after nirsevimab administration. The most common side effects noted during the clinical trials of nirsevimab were rash occurring within 2 weeks after injection (seen in 0.9% of nirsevimab recipients versus 0.6% of placebo recipients) and injection site reactions (including redness, pain, swelling) occurring within 7 days after injection (0.3% of nirsevimab recipients versus 0% of placebo recipients). See the product package insert for more details: www.accessdata.fda.gov/drugsatfda_docs/label/2023/761328s000lbl.pdf.
Adverse reactions occurring after administration of nirsevimab alone should be reported to MedWatch online (www.fda.gov/medwatch), by fax, by mail, or by contacting FDA at 1-800-FDA-1088.
Adverse reactions occurring after the coadministration of nirsevimab with a vaccine should be reported to the Vaccine Adverse Event Reporting System (VAERS) https://vaers.hhs.gov, and reports should specify that the patient received nirsevimab on the VAERS form.
Yes. V-safe is a vaccine safety monitoring system that lets recipients of certain new vaccines share with CDC how they feel after vaccination by receiving and responding to a series of periodic text messages. This is a voluntary system and individual recipients must register to participate V-safe. V-safe is available to all RSV vaccine recipients but is not being used for nirsevimab preventive antibody. For information, or to register, visit CDC’s V-safe website at: www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/v-safe/index.html.