Read and report vaccine reactions, harassment and failures.
The Institute of Medicine (IOM) has acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons, but that vaccine providers cannot accurately predict prior to a vaccine’s administration who will suffer complications, injury or death from vaccination. However, a person who has previously had a serious reaction to a vaccination or is acutely or chronically ill should become informed about all potential risks associated with vaccination and discuss any concerns with a trusted health care professional before receiving a meningococcal vaccine or any other vaccine.
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.
According to the CDC, more than 50 percent of meningococcal serogroup B (BEXSERO or TRUMENBA) vaccine recipients experience mild side effects that may include pain, redness, and swelling to the injection site, headache, joint or muscle pain, fever or chills, diarrhea or nausea, and fatigue. The CDC also warns that persons receiving any vaccine may collapse (faint), experience a severe allergic reaction, and even serious injury and death.
Adverse events reported by Novartis Vaccines and Diagnostics (GlaxoSmithKline) in the pre-licensing clinical trials of BEXSERO vaccine included: redness, pain, and swelling at the injection site; muscle and joint pain; fatigue; nausea; headache; fever; nasopharyngitis; upper respiratory infection; anaphylaxis; juvenile arthritis; acute thyroiditis; bacterial meningitis; appendicitis, muscular weakness, generalized and submandibular lymphadenopathy, rhabdomyolysis; septic shock; pneumonia; and generalized Tonic-Clonic seizure. Four deaths were reported during pre-licensing clinical trials, however, study investigators declared them to be unrelated to vaccination. These deaths included suicide, drowning, motor vehicle accident, and the death of a 7-week-old infant from post-natal respiratory complications. The infant’s mother had received her last dose of the vaccine approximately 9-10 months prior to the infant’s birth. Adverse events reported following FDA approval of BEXSERO have included: vasovagal responses to injection; syncope; allergic reaction; rash; eye swelling; extensive swelling of the vaccinated limb; blisters around or at the injection site; and persistent injection site nodule.
In the United Kingdom, where BEXSERO (4CMenB) has been routinely administered in a three-dose series to infants at 8 weeks, 16 weeks, and between 12-13 months since September 2015, researchers have found that fever related hospitalizations within three days of vaccination have increased significantly when the vaccine is administered at 8 and 16 weeks.
Adverse events reported by Wyeth Pharmaceuticals (Pfizer) in the pre-licensing clinical trials of TRUMENBA vaccine included: pain, swelling, and redness at the injection site; headache; fever; vomiting and diarrhea; fatigue; chills; muscle and joint pain; nervous system disorders; ligament strain; oropharyngeal pain; eye disorders; severe vertigo, chills, and headache; severe vomiting with fever; anaphylaxis; hydrocephalus; post-infectious arthritis; deep vein thrombosis; Type 2 diabetes mellitus; contact dermatitis; decreased appetite; migraine; asthma; hypothyroidism; scoliosis; Crohn's disease; exacerbation of psoriasis; celiac disease; exacerbation of celiac disease; autoimmune thyroiditis; acute idiopathic thrombocytopenia purpura (ITP); Sydenham’s chorea; IgA nephropathy; hyperthyroidism; rheumatoid arthritis; Bell’s Palsy; lymphoid tissue hyperplasia; psychiatric disorders; appendicitis; cellulitis; depression; thymic disorder; extremity weakness; appendicitis; nodular fasciitis; epiphysiolysis; bipolar disorder; leg and wrist fracture; abdominal pain; hemorrhoids; and biliary dyskinesia. One death resulting from a motor vehicle accident was reported during pre-licensing clinical trials. Adverse events reported following FDA approval of TRUMENBA vaccine have included: syncope; hypersensitivity reactions; and anaphylactic reactions.
In clinical trials of Pfizer’s PENBRAYA pentavalent meningococcal vaccine, trial participants received either a dose of PENBRAYA meningococcal vaccine (MenABCWY) or meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY) and TRUMEMBA meningococcal Group B (MenB) vaccine (MenB+MenACWY-CRM) at the first vaccination visit. At the second vaccination visit, trial participants received either PENBRAYA or a dose of MenB (TRUMEMBA).
The safety evaluation of PENBRAYA in clinical trials involved three studies of individuals between the ages of 10 and 25 years of age. 2,744 individuals received PENBRAYA and 1,802 received MenACWY-CRM and MenB at the first vaccination visit. and MenB only at the second vaccination visit. A total of 1,792 participants in both groups had previously received a dose of a MenACWY vaccine. None of the trial participants had previously received a dose of MenB. Clinical trials on the use of PENBRAYA given at the same time as other vaccines were not conducted.
Adverse events reported by Pfizer in the pre-licensing clinical trials of PENBRAYA meningococcal vaccine included: injection site pain, redness, and swelling, fatigue, headache, muscle and joint pain, vomiting, diarrhea, fever, and chills. Females (87.2 percent) who received PENBRAYA reported higher rates than males (75.6 percent) of systemic reactions. Headache and fatigue were the most frequently reported systemic adverse reactions reported.
Within 30 days of vaccination, a total of 9.8 percent of participants in the PENBRAYA and 8.8 percent of participants in the MenB+MenACWY-CRM group reported at least one adverse event following any dose of vaccination. The most commonly reported adverse events were categorized as being related to an infection or infestation or to an injury, poisoning or procedural complication. Falls among both groups were the most commonly reported adverse reaction.
After the first dose of vaccination, 3.6 percent of MenABCWY recipients and 4.2 percent of MenB+MenACWY-CRM recipients sought medical attention within 30 days of vaccination. After the second vaccine dose, 3.6 percent of MenABCWY recipients and 2.8 percent of the MenB recipients sought a medical evaluation. Most of the medical evaluations were reported to be related to a diagnosis of COVID-19.
Among clinical trial participants, one participant in the MenB+MenACWY-CRM group reported new diagnosis of a neuroinflammatory disorder (restless leg syndrome) and two participants reported a new autoimmune disorder (alopecia areata, Hashimoto thyroiditis). There were no reports of newly diagnosed chronic medical conditions among individuals who received PENBRAYA.
Three clinical trial participants reported a total of five serious adverse events (SAE) following PENBRAYA vaccination within 30 days of vaccination. These included spinal injury resulting from a motor vehicle accident, an attempted suicide with a subsequent diagnosis of anxiety and depression six days after the first vaccine dose in an individual with a history of auditory hallucinations and ongoing friendship stressors, and a hospitalization for disruptive mood disorder 14 days after the second vaccine dose in a male with a past history of multiple psychiatric disorders (psychosis, ADHD, oppositional defiant disorder, depression, anxiety). There were no SAEs in the MenB+MenACWY-CRM group. No SAEs were considered by Pfizer’s clinical trial investigators or the FDA to be related to vaccination.
From one month after the second vaccination visit to the six-month follow-up visit, four individuals in the PENBRAYA group and four in the MenB group reported an SAE. Two individuals in the PENBRAYA group reported a diagnosis of depression, and there was one tibial fracture and one post-tonsillectomy bleed. Among the MenB group, the reported SAEs included E Coli Urinary Tract infection, appendicitis, migraine, and a drug overdose. Pfizer’s clinical trial investigators and the FDA determined that none of the SAEs reported at the six-month follow-up visit were related to vaccination.
There were no deaths reported during the clinical trial.
As of March 29, 2024, there have been 47,077 reports of meningococcal vaccine reactions, hospitalizations, injuries and deaths following meningococcal vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 268 related deaths, 5,030 hospitalizations, and 610 related disabilities.
However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur develop after meningococcal vaccination.
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 federal health agencies (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 that only between one 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.
As of April 1, 2024, there have been 140 claims filed in the federal Vaccine Injury Compensation Program (VICP) for 3 deaths and 137 injuries that occurred after meningococcal vaccination. Of that number, the U.S. Court of Claims administering the VICP has compensated 71 children and adults, who have filed claims for meningococcal vaccine injury.
In addition to reactions and injuries following meningococcal vaccination, administration errors resulting in adverse events have also been reported. Menactra (MCV4/MenACWY-D) meningococcal conjugate vaccine is approved to be administered intramuscularly (IM) while Menomune meningococcal polysaccharide vaccine is approved to given subcutaneously (SC). Following FDA approval of Menactra vaccine, multiple reports surfaced regarding the incorrect administration of Menactra vaccine by subcutaneous injection. In September of 2006, the CDC issued a report regarding the over 100 reported vaccine errors involving Menactra vaccine misadministration. Twelve reports resulted in adverse events; however, all were considered to be non-serious. The CDC conducted a study examining immune responses from individuals who received the incorrectly administered vaccine and determined vaccine acquired antibodies to be acceptable and did not recommend revaccination. In this report, the CDC reminded vaccine providers to review all vaccine product inserts prior to administering any vaccine.
In February of 2016, the CDC issued a second report detailing meningococcal vaccine administration errors, this time involving the Menveo (MenACWY-CRM) meningococcal conjugate vaccine. Menveo vaccine is supplied in two separate vials and must be combined prior to vaccine administration. However, between March 1, 2010 and September 22, 2015, 407 reports of Menveo vaccine misadministration were submitted to the Vaccine Adverse Events Reporting System (VAERS). Reported errors included vaccine providers administering only the liquid MenCYW-135 component of the vaccine or otherwise administering only the lyophilized MenA component by reconstituting it in liquids such as saline, sterile water, or even with another vaccine. Fifteen percent of vaccine administration errors involving Menveo resulted in adverse events that included redness to the injection, fever and pain. The CDC also admitted that as a passive surveillance system, VAERS likely only captured a fraction of meningococcal vaccine misadministration error and many more additional cases were likely to have occurred. Again, vaccine providers were advised to review and follow the instructions provided in the vaccine product insert and on the vial labels prior to administration.
NVIC “Quick Facts” is not a substitute for becoming fully informed about Meningococcal disease, meningitis and the Meningococcal vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.