According to the CDC, individuals receiving meningococcal vaccines targeting meningococcal serogroups A, C, Y, and W-135 (Menactra or Menveo) may experience mild side effects such as pain or redness at the injection site, headache, fatigue, and muscle pain. Additionally, the CDC warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, and even serious injury and death.
Adverse events reported by Sanofi Pasteur in the Menactra vaccine product insert include: injection site redness, pain, and swelling; irritability; diarrhea; drowsiness; anorexia; headache; fatigue; vomiting; abnormal crying; loss of appetite; rash; joint pain; chills; anaphylaxis; wheezing; upper airway swelling; difficulty breathing; hypotension; itching; hives; lymph node swelling; Guillain-Barre syndrome; convulsions; dizziness; facial palsy; vasovagal syncope; paresthesia; transverse myelitis; acute disseminated encephalomyelitis; muscle pain; and extensive swelling of the injected limb and injection site.
Adverse events reported by Novartis Vaccines and Diagnostics (GlaxoSmithKline) in the pre-licensing clinical trials of Menveo vaccine include: injection site tenderness, swelling, and redness; sleepiness; irritability; persistent crying; changes in eating habits; diarrhea; vomiting; fever; rash; headache; joint and muscle pain; malaise; nausea; chills; dehydration; gastroenteritis; Kawasaki’s Disease; acute disseminated
encephalomyelitis; appendicitis; pneumonia; staphylococcal infection; dehydration; tonic and febrile convulsion; limb injury; varicella; road traffic accidents; vitello-intestinal duct remnant; Cushing’s syndrome; viral hepatitis; pelvic inflammatory disease; intentional multiple drug overdose; simple partial seizure; suicidal depression and suicide attempts. Among infants and young children under 2 years of age, two deaths were reported within 28 days of vaccination. Deaths were listed as sepsis and sudden death. Adverse events reported following the licensing of Menveo vaccine have included: anaphylaxis; falls; head injury; vaccination site cellulitis, pain, redness, persistent itching, swelling, and inflammation; extensive swelling of the vaccinated limb; fatigue; malaise; fever; ear pain; hearing impairment; vestibular disorder; vertigo; eyelid ptosis; increased body temperature; increased Alanine aminotransferase; bone and joint pain; skin exfoliation; oropharyngeal pain; balance disorder; facial paresis; dizziness; syncope; tonic convulsions; headache; and Bell’s palsy. In a post marketing safety study, the administration of Menveo vaccine concomitantly with Tdap and HPV vaccine was noted to significantly increase the risk of Bell’s palsy within 84 days of vaccine administration.
A 2017 published study of Menveo vaccine by researchers who examined adverse reaction reports submitted to the Vaccine Adverse Events Reporting System (VAERS) between 2010 and 2015 noted additional medical conditions following vaccination to include Guillain-Barre syndrome, facial nerve palsy, seizures, intracranial hypertension, acute disseminated encephalomyelitis, chronic inflammatory demyelinating polyradiculopathy, migraine, headache, hypotonia/motor delay, polyneuritis, neuromyopathy, anaphylaxis, allergic reactions, drug eruption, vasovagal syncope, myocarditis and pericarditis, appendicitis, viral meningitis, streptococcal pneumonia, Steven Johnson Syndrome, erythema multiforme, fibromyalgia, pyomyositis, muscular weakness, juvenile idiopathic arthritis, psychiatric disorders, gastrointestinal disorders, glioma, osteosarcoma, Kawasaki’s disease, idiopathic thrombocytopenic purpura (ITP), and hyperthyroidism.
Adverse events reported by Sanofi Pasteur in the pre-licensing clinical trials of MenQuadfi vaccine include: injection site pain, swelling, and redness, fever, muscle pain, malaise, headache, dizziness, syncope, nausea, vomiting, nasal congestion, dizziness, dysgeusia (distorted sense of taste), hypoaesthesia (decreased sense of taste), rash, injection site infection, viral pharyngitis, upper respiratory tract infection, sinusitis, urinary tract infection, otitis externa, pharyngitis streptococcal, arthralgia and back pain.
In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality , published in 2012 by the Institute of Medicine (IOM), nine reported vaccine adverse events following meningococcal serogroup A, C, Y, and W-135 vaccination were evaluated by a physician committee. These adverse events included encephalitis, encephalopathy, multiple sclerosis, chronic headache, Guillain-Barre Syndrome, acute disseminated encephalomyelitis, chronic inflammatory disseminated polyneuropathy, anaphylaxis, and transverse myelitis.
In eight of the nine meningococcal vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between meningococcal vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination. The IOM committee, however, concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and meningococcal vaccine.
