Read and report vaccine reactions, harassment and failures.
Can Respiratory Syncytial Virus (RSV) vaccine cause injury & death?
According to the U.S. Centers for Disease Control and Prevention, side effects following RSV vaccine may include redness, pain, and swelling at the injection site, fatigue, headache, muscle & joint pain, diarrhea, nausea and fever.
Guillain-Barre Syndrome (GBS), a rare but serious neurological disorder that causes inflammation of the peripheral nerves with complications that include temporary or chronic paralysis, including full body paralysis, have been reported in association with RSV vaccines.
According to a CDC analysis of data on RSV vaccinations given between May 3, 2023 and April 14, 2024 in persons 60 years of age and older, reports of GBS following RSV vaccination were higher than expected. Rates of GBS following GSK’s AREXVY RSV vaccine were reported at 1.5 cases per million doses, while rates following Pfizer’s ABRYSVO RSV vaccine were reported at 5 cases per million doses. Two GBS-related deaths were noted among 18 reported deaths from “a variety of reasons” post vaccination. Additional causes of deaths were reported as cardiovascular events, RSV infection, sepsis, hepatic encephalopathy, and severe respiratory illness and failure.
Pre-term births and high blood pressure, including pre-eclampsia, have been reported among women who received RSV vaccine during pregnancy.
IMPORTANT NOTE: NVIC encourages you to become fully informed about Respiratory Syncytial Virus (RSV) and the Respiratory Syncytial Virus (RSV) vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
During clinical trials for ABRYSVO, in persons 60 years of age and older, the most commonly reported adverse events included swelling, pain, and redness at the injection site, fatigue, headache, muscle and joint pain, nausea, vomiting diarrhea, and fever.
In the first month following vaccination, more people in the vaccine group reported severe adverse events. These severe adverse events included falls, sepsis, congestive obstructive pulmonary disease, and infections/infestations. Study investigators, however, reported that these adverse events were likely not related to vaccination.
Atrial fibrillation, a serious heart disorder, that may lead to complications such as stroke, heart attack, or heart failure, occurred at a higher rate among vaccine recipients than those who received the placebo. While clinical trial investigators reported that the vaccine was not responsible, the FDA has stated that they are continuing to investigate.
Two cases of Guillain Barre Syndrome (GBS), a rare neurological disorder that causes inflammation of the peripheral nerves with complications that can include temporary or chronic paralysis, including full body paralysis, and may lead to death, also occurred during the clinical trial, at a rate of approximately 1 in 9,000. Additionally, one clinical trial participant who received the experimental RSV vaccine experienced a delayed allergic reaction, with complications that included shortness of breath, chest pain, and loss of consciousness.
Pfizer’s clinical trials used a placebo solution containing ingredients that were similar to the vaccine, minus the RSV antigens, rather than using an inert saline placebo.
In clinical trials of the vaccine for use in pregnant women, individuals who received the vaccine experienced higher rates of injection site and systemic reactions than those who received the placebo. The most commonly reported systemic reactions included fatigue, headache, muscle and joint pain, nausea, vomiting, and diarrhea.
Severe or life-threatening adverse events occurring within one month of vaccination were higher among women who received the RSV vaccine, when compared to those who received the placebo (2.2 percent in the vaccine group versus 1.5 percent in the placebo group). Women who received the RSV vaccine were also more likely to experience a non-serious adverse event within one month of vaccination (11.2 percent versus 10. 8 percent).
Women who received the RSV vaccine were more likely to experience premature delivery of their infants when compared to those who received the placebo (5.6 percent versus 4.7 percent). Higher rates of pre-eclampsia and gestational hypertension were noted among vaccine recipients when compared to those who receive the placebo.
In the recommendation for the use the Pfizer RSV vaccine in pregnant women for the prevention of RSV illness in their newborn infants, the CDC’s Advisory Committee on Immunization Practices noted that:
“For the GRADE assessment of harms, results from the phase 2b and phase 3 trials were pooled¶¶ (9,16). The overall evidence certainty using GRADE criteria was rated as very low, driven by the uncertainty in the critical harm outcome of preterm birth (<37 weeks’ gestation).*** ACIP judged the benefits of maternal RSVpreF vaccination at 32–36 weeks’ gestation to outweigh the potential risks for preterm birth and hypertensive disorders of pregnancy.”
GRADE (Grading of Recommendations Assessment, Development and Evaluation) is an evidence-based framework used by the CDC’s ACIP to assess the type or quality of evidence about a vaccine's expected health impacts and the balance of health benefits and risks, along with the values and preferences of persons affected, and health economic analyses.
According to the GRADE system used by the ACIP for evaluating evidence, very low certainty evidence means that confidence in the evidence is lacking and that The true effect is likely to be substantially different from the estimate of effect.
Pfizer’s clinical trial data also reported that 37.1 percent of infants whose mothers received the RSV vaccine experienced an adverse event within one month of birth, with 15.5 percent reported as serious, 4.5 percent as severe, and 1 percent as life-threatening. One woman who received the RSV vaccine died due to complications from post-partum hemorrhage and hypovolemic shock after delivery. Eighteen intrauterine deaths were also reported in clinical trials, with 10 occurring in the vaccine group and 8 in the vaccine group.
In pre-licensing clinical trials, the most frequently reported side effect was pain at the injection site. Within four days of receipt of the vaccine, the most commonly reported systemic adverse events included fatigue, myalgia, headache, arthralgia, and fever. Severe systemic adverse events occurred in 3.3 percent of individuals who received the vaccine.
One case of Guillain-Barre Syndrome (GBS) was reported among the 15,400 clinical trial participants. There was also a higher rate of vaccine recipients who experienced atrial fibrillation in comparison to those who received the placebo. Additional serious side effects included Bell’s Palsy, gout, pancytopenia, Graves’ Disease, and aggravation of psoriasis.
GSK also reported that in one clinical trial, Study 007, which studied the use of the experimental RSV shot when given at the same time as the quadrivalent influenza vaccine, of the 442 participants, two cases of Acute Disseminating Encephalomyelitis (ADEM) had occurred, with one case resulting in death.
Clinical trials of an experimental RSV vaccine without an adjuvant that contained the same RSVPreF3 antigen as AREXVY conducted in pregnant women found higher rates of pre-term births when compared to those who received a placebo containing sucrose reconstituted with saline (6.81 percent versus 4.95 percent). GSK halted all clinical trials of the vaccine in pregnant women in February 2022 due to an undisclosed safety signal that occurred during the clinical trials.
In pre-licensing clinical trials, the most frequently reported side effect was injection site pain. Within seven days of receipt of MRESVIA, the most commonly reported systemic adverse events included fatigue, headache, nausea/vomiting, muscle & joint pain, and chills. Higher rates of intensely itchy hives (urticaria) were reported among MRESVIA vaccine recipients than those who received the placebo.
One clinical trial participant who received MRESVIA reported facial paralysis within four days of vaccination. Additional adverse events reported among clinical trial participants who received MRESVIA included dehydration, allergic rhinitis, polymyalgia rheumatica, dermatitis, cardiac arrythmias including atrial fibrillation, pericarditis, superficial vein thrombosis, thrombocytopenia, and death. There were 106 deaths reported among clinical trial participants who received the vaccine, and 125 deaths among those who received the placebo. None of the reported deaths were considered to be related to vaccination by clinical trial investigators.
On July 17, 2023, the FDA approved the drug nirsevimab under the trade name Beyfortus, a monoclonal antibody, for the prevention of RSV in infants and children up to 24 months of age. Though the CDC has determined that it can define nirsevimab as a vaccine for their purposes, nirsevimab is not classified as a vaccine by the FDA, American Medical Association or the World Health Organization. To learn about nirsevimab, visit NVIC’s RSV Prevention and Treatment page.
According to data released October 25, 2024 by the CDC, 6,215 adverse reactions, including 50 deaths and 398 hospitalizations, have been reported to the Vaccine Adverse Events Reporting System (VAERS). Nearly 67 percent of adverse events occurred in persons 60 years of age and older.
Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to VAERS, many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence to suggest that only between 1 and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.