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Adverse events reported during clinical trials of ERVEBO included: injection site pain, swelling, and redness; headache; fever; nausea; fatigue; muscle pain; joint pain, swelling, stiffness, warmth, and redness; abnormal sweating; rash; mouth ulcers; vesicular lesions; arthralgia; arthritis; anaphylaxis; cerebrovascular accident; hemorrhagic stroke; subarachnoid hemorrhage; pulmonary embolism; and death.
White blood cell counts were evaluated in nearly 700 individuals who received ERVEBO. Decreases in neutrophils were noted in at least 43 percent of vaccine recipients and 85 percent experienced a decrease in lymphocytes. Neutrophils, a type of white blood cell, are vital to the immune system as they attack and destroy bacteria that invade the body. Low neutrophil counts can put an individual at a higher risk of serious infection. Leukocytes, another type of white blood cell, are also critical to the immune system and protect the body against infection.
Arthralgia (joint pain) and severe arthralgia occurring between Day 0 and Day 42 were reported at higher rates in persons vaccinated with ERVEBO in comparison to placebo recipients.
There was a higher rate of arthritis occurring between Day 5 and 56 among ERVEBO vaccine recipients. In some cases, vaccinated individuals experienced persistent and recurrent joint pain. In studies, all joint types were noted to be affected. Persons with a past history of arthritis and females were found to be at a higher risk of arthritis post-vaccination.
Women who were inadvertently vaccinated or who became pregnant within 60 days of ERVEBO vaccination were also found to be at a higher risk of miscarriage. Eighty-four women were unintentionally vaccinated in early pregnancy or within two months of vaccination or enrollment in the clinical trial. Forty-five percent (14 of 31) of pregnant women who were immediately vaccinated experienced a miscarriage in comparison to 33 percent (11 of 33) of unvaccinated women.
Using the MedAlerts search engine, from FDA approval in December 2019 through March 29, 2024, there have been 52 reports of Ebola vaccine reactions, hospitalizations, injuries, and deaths following Ebola vaccination made to the federal Vaccine Adverse Events Reporting System (VAERS), including 3 hospitalizations, 3 related disabilities and 1 related deaths.