Read and report vaccine reactions, harassment and failures.
Can Respiratory Syncytial Virus (RSV) vaccine cause injury & death?
At this time data is limited to clinical trial data in healthy individuals, and may not be representative of real world data that has yet to be gathered due the recent rollout of the vaccine’s use in the general population. To learn more about vaccine effectiveness vs. efficacy visit our RSV vaccine effectiveness web page. To learn more about RSV vaccine injuries and deaths, click the links below.
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.
According to data released March 29, 2024 by the CDC, 4,339 adverse reactions, including 31 deaths and 272 hospitalizations, have been reported to the Vaccine Adverse Events Reporting System (VAERS). Over 68 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.