Body System
|
Medical Disorder
|
Reported in Clinical
Trials
|
Reported Post-marketing
|
Allergic (6) |
Allergic reactions/
hypersensitivity |
Varivax |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, FluMist, Fluzone, Gardasil/Gardasil 9, Hiberix, Infanrix, IPOL, Kinrix, Menveo, Pediarix, Pentacel, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix |
Allergy to vaccine |
Gardasil/Gardasil 9 |
|
Anaphylaxis and
anaphylactoid reactions, including shock |
Bexero, Fluarix, MMR-II |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menveo, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, RotaTeq, Tenivac, Trumenba, Twinrix, Varivax |
Angioedema,
angioneurotic edema |
Menveo, MMR-II, Recombivax |
ActHIB, Adacel, Boostrix, Daptacel, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, Menactra, Menomune, MMR-II, Pediarix, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, RotaTeq, Tenivac, Twinrix, Varivax |
Serum sickness |
|
Afluria, Engerix-B, Fluarix, Havrix, Pneumovax-23, Recombivax, Twinrix |
Urticaria [hives] |
Engerix-B, Havrix,
MMR-II, PedVaxHIB, Prevnar-13, Recombivax, Twinrix, Vaqta, Varivax |
ActHIB, Adacel, Afluria, Boostrix, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Hiberix, Infanrix, IPOL, Kinrix, Menactra, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Recombivax, RotaTeq, Tenivac, Twinrix |
Autoimmune (15) |
Autoimmune diseases |
|
Gardasil/Gardasil 9 |
Autoimmune thyroiditis |
Gardasil/Gardasil 9 |
|
Celiac disease |
Gardasil/Gardasil 9 |
|
Cutaneous lupus
erythematosus |
Gardasil/Gardasil 9 |
|
Diabetes mellitus
(insulin-dependent) |
Boostrix,
Gardasil/Gardasil 9, Pediarix, Pneumovax-23 |
MMR-II |
Graves’/Basedow’s
disease |
Gardasil/Gardasil 9 |
|
Guillain-Barré syndrome
(GBS) |
IPOL, MMR-II, PedVaxHIB |
Adacel, Afluria, Engerix-B, Fluarix, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menomune, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Recombivax, Tenivac, Vaqta, Varivax |
Kawasaki disease |
Menveo, Rotarix,
RotaTeq |
Rotarix, RotaTeq |
Lupus-like syndrome |
|
Recombivax |
Multiple sclerosis (or
exacerbation) |
Gardasil/Gardasil 9 |
Engerix-B, Havrix,
Recombivax, Twinrix |
Pancreatitis |
MMR-II, Pneumovax-23 |
Gardasil/Gardasil 9, MMR-II |
Rheumatoid arthritis/juvenile
rheumatoid arthritis |
Gardasil/Gardasil 9 |
|
Scleroderma |
Gardasil/Gardasil 9 |
|
Systemic lupus
erythematosus |
Gardasil/Gardasil 9 |
Recombivax |
Thrombocytopenia/idiopathic
thrombocytopenic purpura (ITP) [low platelets] |
Daptacel, Gardasil/Gardasil 9, MMR-II, PedVaxHIB |
Afluria, Engerix-B, Fluzone, Gardasil/Gardasil 9, Havrix, Infanrix, Kinrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Rotarix, Twinrix, Vaqta, Varivax |
Blood/lymphatic system
(11) |
Anemia (aplasic or
hemolytic) |
|
Gardasil/Gardasil 9,
Pneumovax-23, ProQuad, Varivax |
Epistaxis [nosebleed] |
|
FluMist, ProQuad |
Extravasation [blood
vessel leakage] |
|
ProQuad |
Hematochezia [bloody
stools] |
RotaTeq |
ProQuad, Rotarix,
RotaTeq |
Hemorrhage |
Gardasil/Gardasil 9 |
|
Increased erythrocyte
sedimentation rate |
|
Recombivax |
Leukocytosis [increased
white blood cells] |
MMR-II |
MMR-II, Pneumovax-23 |
Lymphadenitis/swollen
lymph nodes |
Adacel |
Boostrix, Pneumovax-23,
ProQuad |
Lymphadenopathy,
including regional |
Engerix-B, Havrix, MMR-II, Recombivax, Varivax |
Boostrix, Daptacel, DT, Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Infanrix, IPOL, Kinrix, Menactra, Menveo, MMR-II, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, Tenivac |
Neutropenia, chronic |
Pediarix |
|
Thrombocytopenia/idiopathic
thrombocytopenic purpura (ITP) [low platelets]* |
Daptacel,
Gardasil/Gardasil 9, MMR-II, PedVaxHIB |
Afluria, Engerix-B, Fluzone, Gardasil/Gardasil 9, Havrix, Infanrix, Kinrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Rotarix, Twinrix, Vaqta, Varivax |
Cardiac (10) |
Angina pectoris |
Pneumovax-23, Tenivac |
|
Cyanosis* [bluish,
low oxygen] |
|
Daptacel, Hiberix, Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel |
Heart failure |
Pneumovax-23 |
|
Hypotension |
Engerix-B, Recombivax |
Adacel, Menactra |
Myocardial infarction |
Pneumovax-23 |
|
Myocarditis [heart
muscle inflammation] |
Gardasil/Gardasil 9 |
Adacel, Boostrix |
Palpitations |
|
Engerix-B, Twinrix |
Pericarditis [pericardial
inflammation] |
|
FluMist |
Pleuropericarditis |
Flublok (> age 50) |
|
Tachycardia [abnormally
high heart rate] |
|
Engerix-B, Fluarix,
Recombivax, Twinrix |
Congenital (1) |
Congenital anomaly |
|
Havrix |
Death, by cause (40) |
Unspecified |
Flublok, IPOL,
Prevnar-13, Tenivac |
Gardasil/Gardasil 9 |
Acute lymphocytic
leukemia |
Gardasil/Gardasil 9 |
|
Acute renal failure |
Gardasil/Gardasil 9 |
|
Arrhythmia |
Gardasil/Gardasil 9 |
|
Asphyxia |
Pentacel |
|
Aspiration |
Daptacel |
|
Autoimmune disease |
Gardasil/Gardasil 9 |
|
Breast cancer |
Gardasil/Gardasil 9 |
|
Cardiopulmonary arrest |
Tenivac |
|
Cardiovascular |
Prevnar-13,
Pneumovax-23 |
|
Cerebral hemorrhage |
Gardasil/Gardasil 9 |
|
Cerebrovascular
accident |
Gardasil/Gardasil 9 |
|
Congenital
immunodeficiency and sepsis |
Pediarix |
|
Convulsive disorder |
Pediarix |
|
Drug overdose |
Gardasil/Gardasil 9 |
|
Fetal |
|
MMR-II |
Gunshot wound |
Gardasil/Gardasil 9 |
|
Head trauma |
Pentacel |
|
Homicide |
Gardasil/Gardasil 9 |
|
Hyperthyroidism |
Gardasil/Gardasil 9 |
|
Hypovolemic septic
shock |
Gardasil/Gardasil 9 |
|
Infectious disease |
Gardasil/Gardasil 9 |
|
Intussusception |
RotaTeq |
Rotarix, RotaTeq |
Motor vehicle accident |
Gardasil/Gardasil 9 |
|
Myocardial infarction |
Tenivac |
|
Nasopharyngeal cancer |
Gardasil/Gardasil 9 |
|
Neoplasm |
Gardasil/Gardasil 9,
Prevnar-13 |
|
Neuroblastoma |
Pediarix, Pentacel |
|
Pancreatic cancer |
Gardasil/Gardasil 9 |
|
Peritonitis |
Prevnar-13 |
|
Pneumonia |
Rotarix |
|
Pulmonary embolism |
Gardasil/Gardasil 9 |
|
Pulmonary infection |
Prevnar-13 |
|
Pulmonary tuberculosis |
Gardasil/Gardasil 9 |
|
Sepsis, septic shock |
Gardasil/Gardasil 9,
Menveo, Prevnar-13 |
|
Stomach adenocarcinoma |
Gardasil/Gardasil 9 |
|
Sudden infant death
syndrome (SIDS) |
Menveo, Pediarix,
Pentacel, Prevnar-13, RotaTeq |
Infanrix |
Suicide |
Gardasil/Gardasil 9 |
|
Traumatic brain
injury/cardiac arrest |
Gardasil/Gardasil 9 |
|
Unexplained sudden
death |
Gardasil/Gardasil 9 |
|
Ear/labyrinth (8) |
Earache |
Recombivax |
|
Ear pain |
|
Engerix-B, Infanrix,
Menveo, ProQuad, Twinrix |
Hearing impaired |
|
Menveo |
Nerve deafness |
MMR-II |
MMR-II, ProQuad |
Otitis media/ear
infection |
Afluria, Fluarix,
PedVaxHIB, RotaTeq, Vaqta, Varivax |
MMR-II |
Tinnitis |
|
Engerix-B, Recombivax,
Twinrix |
Vertigo |
Havrix, Recombivax,
Twinrix |
Engerix-B, Fluarix,
Menveo |
Vestibular/balance
disorder |
|
Menveo |
Endocrine (6) |
Cushing’s syndrome |
Menveo |
|
Goiter |
Gardasil/Gardasil 9 |
|
Hyperthyroidism |
Gardasil/Gardasil 9 |
|
Hypothyroidism |
Gardasil/Gardasil 9 |
|
Thyroiditis |
Gardasil/Gardasil 9 |
|
Toxic nodular goiter |
Gardasil/Gardasil 9 |
|
Eye (17) |
Conjunctivitis |
Vaqta |
|
Eye complaints |
Varivax |
|
Eye irritation/itching |
Vaqta |
|
Eye pain |
|
Fluarix, Flulaval |
Eye redness |
|
Fluarix |
Eye swelling |
|
Bexero, Fluarix |
Eyelid ptosis [drooping] |
|
Menveo |
Eyelid swelling |
|
Fluarix, ProQuad |
Keratitis [corneal
inflammation] |
|
Engerix-B |
Ocular hyperemia [eye
inflammation] |
|
Fluzone |
Ocular palsies [nerve
damage] |
MMR-II |
MMR-II, ProQuad |
Optic
neuritis/neuropathy, papillitis [optic nerve inflammation] |
Gardasil/Gardasil 9,
MMR-II |
Engerix-B, Fluzone,
MMR-II, ProQuad, Recombivax, Twinrix |
Photophobia [light
intolerance] |
Havrix |
Flulaval |
Retinitis, necrotizing
[inflammation] |
MMR-II |
MMR-II, ProQuad,
Varivax |
Retrobulbar neuritis [nerve
damage] |
|
MMR-II, ProQuad |
Uveitis [eye
inflammation] |
Gardasil/Gardasil 9 |
Recombivax |
Visual disturbances |
|
Engerix-B, Recombivax,
Twinrix |
Gastrointestinal (21) |
Abdominal pain,
discomfort |
Boostrix, Engerix-B, Fluarix, Flulaval, FluMist, Gardasil/Gardasil 9, Havrix, Menomune, Recombivax, Twinrix, Vaqta, Varivax |
Fluarix, ProQuad |
Candidiasis |
|
ProQuad |
Colonic polyp |
Tenivac |
|
Constipation |
Engerix-B, Infanrix,
Vaqta, Varivax |
Recombivax |
Crohn’s disease |
Gardasil/Gardasil 9 |
|
Diarrhea |
Adacel, Afluria, Boostrix, Engerix-B, Fluarix, Flulaval, Gardasil/Gardasil 9, Havrix, Hiberix, Menactra, Menomune, Menveo, MMR-II, PedVaxHIB, Prevnar-13, ProQuad, Recombivax, Rotarix, RotaTeq, Trumenba, Twinrix, Vaqta, Varivax |
Daptacel, FluMist, Menomune,
MMR-II, Pediarix, Pentacel |
Dysgeusia [altered
sense of taste] |
Havrix |
|
Dyspepsia [indigestion] |
Pneumovax-23,
Recombivax |
Engerix-B, Twinrix |
Dysphagia [swallowing
difficulties] |
|
Flulaval |
Gastroenteritis |
Flulaval, Gardasil/Gardasil 9, Kinrix, Menveo, Pediarix, Pentacel, Prevnar-13, Rotarix, RotaTeq, Vaqta |
Rotarix, RotaTeq |
Gastrointestinal
infection |
FluMist |
|
Inflammatory bowel
disease |
Gardasil/Gardasil 9 |
|
Inguinal hernia |
Menactra |
|
Intussusception,
including recurrent |
Rotarix, RotaTeq |
Rotarix, RotaTeq |
Mouth ulcers |
|
ProQuad |
Nausea |
Adacel, Afluria, Bexero, Boostrix, Engerix-B, Fluarix, Flublok, Flulaval, Gardasil/Gardasil 9, Havrix, Menveo, MMR-II, Recombivax, Twinrix, Vaqta, Varivax |
Daptacel, DT, Fluarix, FluMist, Gardasil/Gardasil 9, Menomune, MMR-II, Pneumovax-23, Tdvax |
Swelling of mouth,
throat or tongue |
|
Fluarix |
Teething |
Afluria, Vaqta, Varivax |
|
Ulcerative colitis |
Gardasil/Gardasil 9,
Pneumovax-23 |
|
Vitello-intestinal duct
remnant |
Menveo |
|
Vomiting |
ActHIB, Adacel, Afluria, Boostrix, Daptacel, Engerix-B, Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, IPOL, Menactra, Menomune, Menveo, MMR-II, PedVaxHIB, Prevnar-13, ProQuad, Recombivax, Rotarix, RotaTeq,
Trumenba, Twinrix, Vaqta, Varivax |
Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Menomune, MMR-II, Pediarix, Pentacel, Pneumovax-23,
Tenivac |
General and injection
site (35) |
Abnormal gait |
|
Flulaval |
Apathy |
|
ProQuad |
Asthenia [fatigue,
weakness] |
Hiberix, Pneumovax-23,
Vaqta |
Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Infanrix, Menomune, Pediarix, Tenivac |
Body aches |
Adacel, Recombivax |
Fluarix |
Chest pain |
Pneumovax-23, Tenivac |
Fluarix, Flulaval, Fluzone |
Chills/shivering |
Adacel, Afluria, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Menactra, , Menveo, Prevnar-13, Recombivax, Trumenba, Vaqta, Varivax |
Fluarix, Gardasil/Gardasil 9, Havrix, Menomune, Twinrix |
Decreased limb mobility |
|
Pneumovax-23 |
Dehydration |
Kinrix, Menveo,
Pentacel, Rotarix, Vaqta |
|
Drowsiness/sleepiness |
ActHIB, Daptacel, Fluarix, Flulaval, Fluzone, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menomune, Menveo, Pediarix, PedvaxHIB |
|
Ecchymosis [bruising] |
Engerix-B, Fluarix, Flucelvax, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta |
Engerix-B, Recombivax,
Twinrix |
Edema |
Vaqta |
Adacel |
Fatigue |
Afluria, Bexero, Boostrix, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, Havrix, Menactra, Menomune, Menveo, MMR-II, Prevnar-13, Recombivax, Trumenba, Twinrix, Varivax |
Gardasil/Gardasil 9, Menomune, Menveo |
Feeling hot |
|
Fluarix |
Fever/pyrexia |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menomune, Menveo, MMR-II, Pediarix, PedVaxHIB, Pentacel, Prevnar-13, ProQuad, Quadracel, Recombivax, Rotarix, RotaTeq, Tenivac, Trumenba, Twinrix, Vaqta, Varivax |
Menomune, Menveo, MMR-II, Pneumovax-23, Tdvax |
Hematoma |
Gardasil/Gardasil 9, Havrix, Varivax |
|
Hypernatremia [excess
sodium] |
Kinrix |
|
Increased arm
circumference |
Adacel, Boostrix, Daptacel, Infanrix, Kinrix, Pentacel, Quadracel |
|
Increased thigh
circumference |
Infanrix |
|
Injected limb—extensive
swelling |
Boostrix, Daptacel, Infanrix, Quadracel |
ActHIB, Bexero, Hiberix, Menactra, Menveo |
Injection-site abscess |
|
Adacel, Daptacel, Fluarix, Flulaval, PedvaxHIB, Pentacel, Quadracel |
Injection-site bruising |
Afluria, Gardasil/Gardasil 9, ProQuad, Vaqta |
Adacel, Flulaval |
Injection-site
cellulitis |
|
Afluria, Daptacel, Fluarix, Flulaval, Menveo, Pediarix, Quadracel, Tenivac |
Injection-site pain and
other reactions (induration, warmth) |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menomune, Menveo, Pediarix, PedvaxHIB, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix, Vaqta, Varivax |
Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, Havrix, Hiberix, Infanrix, IPOL, Kinrix, Menactra, Menomune, Menveo, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Tdvax, Tenivac, Twinrix |
Injection-site rash |
ProQuad, Vaqta, Varivax |
Daptacel, Flulaval,
IPOL, Prevnar-13 |
Interference with normal
activity of arm |
Daptacel, DT,
Prevnar-13 |
|
Itching |
Afluria, Varivax |
|
Lightheadedness |
Recombivax |
|
Listlessness |
|
Quadracel |
Malaise |
Adacel, Afluria, Engerix-B, Fluarix, Flucelvax, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menomune, Menveo, MMR-II, Quadracel, Recombivax, Tenivac, Varivax |
Gardasil/Gardasil 9, Menomune, Menveo, MMR-II, Pneumovax-23, Tdvax, Twinrix |
Medical attention
sought |
Pediarix |
|
Pain in extremity |
Fluarix |
|
Peripheral edema |
|
ActHIB, MMR-II, Pneumovax-23, ProQuad, Tdvax, Tenivac, Varivax |
Severe pain |
Bexero |
|
Swelling |
Afluria, Adacel, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flublok, Flucelvax, Fluzone, Infanrix, IPOL, Kinrix, Menactra, Menomune, Pediarix, PedVaxHIB, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix, Vaqta, Varivax |
Menveo, MMR-II, ProQuad |
Tiredness |
Adacel, FluMist, IPOL |
|
Hepatobiliary/liver (3) |
Elevation of liver
enzymes |
|
Recombivax |
Hepatitis |
Menveo |
Havrix, Twinrix |
Jaundice |
|
Havrix, Twinrix |
Infections and
infestations (51) |
Appendicitis |
Gardasil/Gardasil 9,
Menveo |
|
Atypical measles |
MMR-II |
MMR-II, ProQuad |
Bronchiolitis |
Daptacel, Pediarix,
Pentacel, Prevnar-13, RotaTeq |
|
Bronchitis |
Flulaval |
Infanrix, ProQuad |
Cellulitis |
Daptacel, Infanrix,
Tenivac, Vaqta |
Daptacel, Gardasil/Gardasil 9, Infanrix, Pneumovax-23, ProQuad, Tdvax, Varivax |
Cellulitis-like
reaction |
Afluria |
|
Chlamydia |
Gardasil/Gardasil 9 |
|
Cholecystitis |
Tenivac |
|
Croup |
Afluria, Fluzone, Vaqta |
|
Early-onset Hib disease |
PedVaxHIB |
PedvaxHIB |
Glomerulonephritis |
Gardasil/Gardasil 9 |
|
Herpes simplex/cold
sore |
Varivax |
ProQuad |
Herpes zoster [shingles] |
ProQuad, Menactra |
Engerix-B, ProQuad, Recombivax, Twinrix, Varivax |
Infection |
|
ProQuad |
Influenza,
influenza-like illness |
Engerix-B, Fluarix, Gardasil/Gardasil 9, Recombivax, Twinrix |
Afluria, Flulaval,Havrix, ProQuad |
Invasive Hib disease |
|
Pentacel |
Laryngitis |
Menveo |
Flulaval |
Laryngotracheo-bronchitis |
Vaqta |
|
Localized infection |
Tenivac |
|
Measles |
|
ProQuad |
Measles-like rash |
MMR-II, ProQuad, Vaqta |
MMR-II |
Meningitis (aseptic,
eosinophilic) |
Daptacel |
Engerix-B, FluMist, MMR-II, Pentacel, ProQuad, Twinrix, Varivax |
Nasal congestion |
Afluria, Fluarix,
Gardasil/Gardasil 9, Vaqta |
|
Pelvic inflammatory
disease |
Gardasil/Gardasil 9,
Menveo |
|
Pharyngitis/
nasopharyngitis |
Afluria, Bexero, Fluarix, Flulaval, Gardasil/Gardasil 9, Havrix, Pneumovax-23, ProQuad, Recombivax,
RotaTeq, Vaqta |
Fluarix, Varivax |
Pharyngitis
streptococcal |
Vaqta |
|
Pharyngolaryngeal pain |
Fluarix |
|
Pneumonia, pneumonitis,
lobar pneumonia, bilateral pneumonia |
Daptacel, Gardasil/Gardasil 9, Hiberix, Menomune, Menveo, MMR-II, Pentacel, Prevnar-13, RotaTeq, Varivax |
MMR-II, ProQuad,
Varivax |
Pulmonary congestion |
|
ProQuad |
Pulmonary embolism |
Gardasil/Gardasil 9 |
Gardasil/Gardasil 9 |
Nephritis/pyelonephritis
[kidney infection] |
Gardasil/Gardasil 9 |
|
Pertussis |
Daptacel |
|
Respiratory congestion |
Fluarix, Vaqta |
|
Respiratory tract
infection (upper or lower) |
Afluria, Engerix-B, Fluarix, Flulaval, FluMist, Gardasil/Gardasil 9, Havrix, PedVaxHIB, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta, Varivax |
Infanrix, Pediarix, ProQuad |
Rhinitis |
Fluarix, Flucelvax,
MMR-II, Recombivax, Vaqta |
Fluarix, Flulaval,
Havrix, MMR-II, Pentacel, ProQuad |
Roseola |
Vaqta |
|
Rubella-like rash |
ProQuad, Vaqta |
|
Secondary bacterial
infection (skin, tissue) |
|
Varivax |
Sepsis |
Daptacel, Pediarix |
|
Sinusitis |
FluMist |
ProQuad |
Skin infection |
|
ProQuad |
Sore throat |
FluMist, MMR-II |
MMR-II, ProQuad |
Sneezing |
FluMist |
|
Staph infection |
Menveo |
|
Tonsillitis |
|
Fluarix |
Tracheitis |
PedVaxHIB |
|
Transmission of vaccine
virus strains |
|
RotaTeq |
Varicella |
Flulaval, Menveo |
|
Varicella (vaccine
strain) |
|
ProQuad, Varivax |
Varicella-like rash |
ProQuad, Vaqta, Varivax |
ProQuad |
Viral infection |
ProQuad, Vaqta |
Pentacel |
Injury (intentional
and unintentional) (10) |
Accidental drug ingestion |
Hiberix |
|
Alcohol intoxication |
Pneumovax-23 |
|
Fall |
Menactra |
Menveo |
Falling with injury |
|
Gardasil/Gardasil 9 |
Head injury |
|
Menveo |
Intentional
multiple-drug overdose |
Menveo |
|
Limb injury |
Menveo |
|
Road accident |
Menveo |
|
Suicidal depression |
Menveo |
|
Suicide attempt |
Menveo |
|
Investigations (6) |
Abnormal liver function
tests |
|
Engerix-B, Twinrix |
Alanine
aminotransferase increased |
|
Menveo |
Body temperature
increased |
|
Menveo |
Creatine phosphokinase
increased |
Havrix |
|
Diagnostic studies |
Pediarix |
|
Increased serum
C-reactive protein |
|
Pneumovax-23 |
Metabolic (3) |
Change in eating habits |
Menveo |
|
Loss of appetite,
decreased appetite |
Afluria, DT, Fluarix, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, Menactra, Pediarix, Prevnar-13, Recombivax, Rotarix, Varivax |
Pentacel |
Mitochondrial
encephalomyopathy, Leigh syndrome exacerbation [neurometabolic] |
|
FluMist |
Musculoskeletal and
connective tissue (24) |
Ankylosing spondylitis
[rare arthritis] |
Gardasil/Gardasil 9 |
|
Arm pain |
Engerix-B, Vaqta |
|
Arthralgia [joint
pain] |
Adacel, Bexero, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, Gardasil/Gardasil 9, Havrix, MMR-II, Menactra, Menomune, Menveo, Prevnar-13, Recombivax, Tenivac, Trumenba, Twinrix, Varivax |
Boostrix, Engerix-B, Gardasil/Gardasil 9, IPOL, Menomune, Menveo, MMR-II, Pneumovax-23, ProQuad, Recombivax, Tdvax, Twinrix |
Arthritis |
Gardasil/Gardasil 9,
MMR-II |
Engerix-B, Flulaval,
MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix |
Arthropathy |
Gardasil/Gardasil 9 |
|
Back pain |
Engerix-B, Fluarix, Gardasil/Gardasil 9, Pneumovax-23, Recombivax, Twinrix, Vaqta |
Boostrix |
Bone pain |
|
Menveo |
Cramps |
Engerix-B, Recombivax |
|
Hip and wrist fracture |
Tenivac |
|
Hypotonia [low
muscle tone] |
Pentacel |
Daptacel, Hiberix,
Infanrix, Pediarix, Prevnar-13, Quadracel |
Invertebral disc
protrusion |
Menactra |
|
Muscle spasm |
|
Adacel |
Muscle
weakness/weakness |
Adacel, Engerix-B, Recombivax, Tenivac, Twinrix |
Engerix-B, Flulaval, Recombivax, Twinrix |
Musculoskeletal pain |
Fluarix |
ProQuad |
Musculoskeletal
stiffness |
|
Havrix |
Myalgia [muscle pain] |
Adacel, Afluria, Bexero, Daptacel, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menveo, MMR-II, Pneumovax-23, Quadracel, Recombivax, Trumenba, Twinrix, Vaqta, Varivax |
Boostrix, Gardasil/Gardasil 9, IPOL, Menactra, Menomune, MMR-II, ProQuad, Tdvax, Tenivac |
Myositis [muscle
inflammation] |
|
Adacel |
Neck pain |
Engerix-B, Fluarix,
Pneumovax-23, Recombivax |
|
Pain in extremities |
|
Fluarix, Fluzone,
Pediarix, Recombivax, Tdvax, Tenivac |
Psoriatic arthropathy |
Gardasil/Gardasil 9 |
|
Reactive arthritis |
Gardasil/Gardasil 9 |
|
Shoulder pain |
Engerix-B, Recombivax |
|
Stiff neck |
Recombivax, Varivax |
|
Stiffness |
Pneumovax-23, Vaqta,
Varivax |
|
Nervous system (45) |
Acute disseminated
encephalomyelitis (ADEM) |
Menveo, MMR-II |
Gardasil/Gardasil 9,
Menactra, MMR-II, ProQuad |
Ataxia [nervous
system dysfunction] |
MMR-II |
MMR-II, ProQuad,
Varivax |
Bulging fontanelle |
|
Pediarix |
Cerebellar ataxia |
|
Vaqta |
Convulsions/seizures |
ActHIB, Daptacel, Havrix, Hiberix, Infanrix, Menactra, Menomune, Menveo, Pediarix, PedVaxHIB, Pentacel, Prevnar-13, RotaTeq |
ActHIB, Adacel, Afluria, Boostrix, Daptacel, DT, Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, IPOL, Kinrix, Menactra, MMR-II, Quadracel, Recombivax, Tdvax, Twinrix, Varivax |
Depressed level of
consciousness |
|
Boostrix, Pediarix,
Pentacel |
Dizziness |
Engerix-B,
Gardasil/Gardasil 9, MMR-II, Recombivax, Twinrix |
Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menomune, Menveo, MMR-II, ProQuad, Tdvax, Tenivac, Varivax |
Encephalitis,
vaccine-induced encephalitis [brain inflammation] |
MMR-II |
Boostrix, Engerix-B, FluMist, MMR-II, Pediarix, Recombivax, Twinrix, Vaqta, Varivax |
Encephalomyelitis [brain
and spinal cord] |
|
Afluria, Fluarix,
Fluzone |
Encephalopathy [brain
disease] |
MMR-II, Pentacel |
Afluria, Engerix-B, Flulaval, Havrix, Infanrix, MMR-II, ProQuad, Twinrix |
Facial palsy, Bell’s
palsy |
|
Adacel, Boostrix, Engerix-B, Fluarix, FluMist, Fluzone, Menactra, Menveo, ProQuad, Recombivax, Twinrix, Varivax |
Facial (or cranial)
nerve paralysis |
Adacel |
Flulaval |
Facial paresis [impaired
facial movement] |
|
Fluarix, Menveo |
Febrile
convulsions/seizures |
Afluria, Daptacel, Fluzone, Infanrix, Hiberix, Menveo, MMR-II, Pediarix, Pentacel, Prevnar-13, ProQuad, RotaTeq, Vaqta, Varivax |
Afluria, Daptacel, Fluzone, IPOL, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Quadracel, Recombivax |
Headache |
Adacel, Afluria, Bexero, Boostrix, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, Havrix, Menactra, Menomune, Menveo, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix, Vaqta, Varivax |
DT, Gardasil/Gardasil 9, Infanrix, IPOL, Menomune, Menveo, MMR-II, ProQuad, Tdvax, Twinrix |
Hypoesthesia [decreased
tactile sensitivity] |
|
Adacel, Engerix-B, Fluarix, Flulaval, Havrix, Recombivax, Twinrix |
Hypokinesia [loss of
muscle movement] |
|
Flulaval |
Hypotonic-hyporesponsive
episode (HHE) |
Daptacel, Infanrix, Prevnar-13 |
Daptacel, Hiberix,
Kinrix, Pediarix, Pentacel, Quadracel |
Hypertonia |
Havrix |
|
Infantile spasms |
Daptacel, Pediarix |
|
Lethargy |
ActHIB, Daptacel,
FluMist, Pentacel |
Pediarix |
Limb paralysis |
|
Flulaval |
Measles inclusion body
encephalitis (MIBE) |
MMR-II |
MMR-II, ProQuad |
Migraine |
Adacel, Fluarix,
Twinrix |
Engerix-B, Recombivax |
Motor neuron disease |
|
Gardasil/Gardasil 9 |
Myelitis [spinal
cord disease] |
|
Adacel, Fluarix,
Fluzone, Havrix, Recombivax, Twinrix |
Nerve compression |
Adacel |
|
Neuralgia [nerve
pain] |
|
Afluria |
Neuritis (including
brachial, polyneuritis) |
MMR-II |
Adacel, Afluria, Engerix-B, Fluarix, Fluzone, MMR-II, Twinrix |
Neuropathy,
polyneuropathy |
MMR-II |
Afluria, Engerix-B, Fluarix, Havrix, MMR-II, ProQuad, Recombivax, Twinrix |
Numbness |
Varivax |
|
Paralysis |
|
Engerix-B,
Gardasil/Gardasil 9, Twinrix |
Paresis [partial
paralysis] |
|
Engerix-B, Twinrix |
Paresthesia [abnormal
skin sensations] |
MMR-II, Recombivax,
Twinrix |
Adacel, Afluria, Boostrix, Engerix-B, Fluarix, Flucelvax, Flulaval, Fluzone, Havrix, IPOL, Menactra, Menomune, MMR-II, Pneumovax-23, ProQuad, Tenivac, Varivax |
Partial seizures,
seizures |
Menveo |
Daptacel, Engerix-B,
ProQuad |
Presyncope [feeling
faint] |
|
Flucelvax |
Radiculopathy [“pinched
nerve” in spine] |
Pneumovax-23 |
Pneumovax-23, Recombivax |
Somnolence |
Engerix-B, ProQuad,
Twinrix |
Daptacel, DT, Flulaval,
Havrix, Hiberix, IPOL, Pediarix, Pentacel, Quadracel, Recombivax |
Subacute sclerosing
panencephalitis (SSPE) |
MMR-II |
MMR-II, ProQuad |
Syncope, vasovagal
syncope [fainting] |
Flublok, MMR-II,
Twinrix |
Adacel, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, Fluzone, Gardasil/Gardasil 9, Havrix, Hiberix, Infanrix, Kinrix, Menactra, Menomune,
Menveo, MMR-II, Pediarix, ProQuad, Recombivax, Tenivac, Trumenba |
Tingling |
Engerix-B |
|
Tonic convulsions |
Menveo |
Menveo |
Transverse myelitis |
MMR-II |
Afluria, Engerix-B, Fluzone, Gardasil/Gardasil 9, Menactra, MMR-II, ProQuad, Recombivax, Twinrix, Varivax |
Tremors |
Pneumovax-23 |
Flulaval, ProQuad |
Unresponsiveness |
Daptacel |
|
Psychiatric (15) |
Agitation |
Engerix-B, Twinrix |
IPOL, ProQuad,
Recombivax |
Anorexia |
ActHIB, Daptacel,
Havrix, Engerix-B, IPOL, Menactra, Menomune, Twinrix, Vaqta |
|
Crying (abnormal,
unusual, persistent or inconsolable) |
ActHIB, Daptacel, DT, Flulaval, Fluzone, Hiberix, Infanrix, IPOL, Menactra, Menveo, PedVaxHIB, Pentacel, Prevnar-13, Vaqta |
Pediarix |
Decreased sleep |
Prevnar-13 |
|
Depression |
Pneumovax-23 |
|
Disturbed sleep |
Recombivax, Varivax |
|
Fretfulness |
Daptacel |
|
Fussiness |
ActHIB, Daptacel,
Hiberix, Infanrix, IPOL, Pediarix, Pentacel |
|
Hypersomnia |
|
ProQuad |
Increased sleep |
Prevnar-13 |
|
Insomnia |
Engerix-B, Gardasil/Gardasil 9, Havrix, Recombivax, Twinrix, Vaqta |
Flulaval, Pediarix |
Irritability |
ActHIB, Afluria, , Engerix-B, Fluarix, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, IPOL, Menactra, Menomune, Menveo, Pediarix, PedVaxHIB, Pentacel, Prevnar-13, ProQuad, Recombivax, Rotarix, RotaTeq, Twinrix, Vaqta, Varivax |
MMR-II, Recombivax |
Nervousness |
Varivax |
Pediarix, ProQuad |
Restlessness |
Hiberix |
Pediarix |
Screaming |
|
Daptacel, Pediarix,
Pentacel, Quadracel |
Reproductive (2) |
Dysmenorrhea |
Fluarix |
|
Menstruation disorders |
Vaqta |
|
Respiratory, thoracic
and mediastinal (19) |
Apnea |
ActHIB, Daptacel |
Engerix-B, Hiberix, Infanrix, Kinrix, Pediarix, Pentacel, Prevnar-13 |
Asthma, asthma-like
symptoms |
Daptacel, FluMist, Gardasil/Gardasil 9, Pediarix, Pentacel, Tenivac, Vaqta |
Engerix-B, Fluarix,
Twinrix |
Asthmatic crisis |
Gardasil/Gardasil 9 |
|
Bronchial constriction |
Vaqta |
|
Bronchial
hyperreactivity |
Havrix |
|
Bronchospasm, bronchial
spasm |
Daptacel,
Gardasil/Gardasil 9, MMR-II, Prevnar-13, RotaTeq |
Engerix-B, Fluarix, Flulaval, Gardasil/Gardasil 9, MMR-II, ProQuad, Recombivax, Tenivac, Twinrix |
Cough |
Afluria, Fluarix, Flucelvax, Flulaval, Fluzone, Gardasil/Gardasil 9, FluMist, MMR-II, ProQuad, Recombivax, Rotarix, Vaqta, Varivax |
Fluarix, Fluzone,
Infanrix, MMR-II, Pediarix, Pentacel |
Cyanosis* [bluish
discoloration, low oxygen] |
|
Daptacel, Hiberix,
Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel |
Difficulty breathing |
|
Menactra |
Dyspnea [shortness
of breath] |
Prevnar-13 |
Fluarix, Flulaval, Fluzone, Havrix, Menomune, Pediarix, Quadracel, Twinrix |
Dysphonia [vocal
abnormalities] |
|
Flulaval |
Hypoxia |
Daptacel, FluMist |
|
Oropharyngeal pain |
Afluria, Flucelvax,
Flulaval, Gardasil/Gardasil 9 |
Fluzone, Menveo |
Respiratory distress |
Havrix |
Fluarix |
Rhinorrhea [runny
nose] |
Afluria, Fluarix, Flulaval, FluMist, Fluzone, HepB, MMR-II, ProQuad, Rotarix, Vaqta, Varivax |
Fluzone |
Stridor [high-pitched
wheezing] |
|
Fluarix |
Throat tightness |
|
Flulaval, Fluzone |
Upper airway swelling |
|
Menactra |
Wheezing |
FluMist, Menveo, Vaqta |
Fluzone, Menactra,
ProQuad |
Skin/ subcutaneous
tissue (33) |
Acute hemorrhagic edema
of infancy |
MMR-II |
MMR-II, ProQuad |
Alopecia [hair loss] |
Gardasil/Gardasil 9 |
Engerix-B, Recombivax, Twinrix |
Contact rash |
Varivax |
|
Dermatitis |
Vaqta, Varivax |
|
Diaper rash |
Varivax |
|
Dry skin |
Varivax |
|
Eczema |
Varivax |
Engerix-B, Recombivax,
Twinrix |
Erythema [skin
redness] |
ActHIB, Adacel,Afluria, Bexero, Engerix-B, Flucelvax, Fluzone, IPOL, Menactra, Menveo, PedVaxHIB, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, Twinrix,
Vaqta, Varivax |
Fluarix, Infanrix, Menactra, Menveo, MMR-II, Pediarix, Pentacel, Tdvax |
Erythema multiforme [skin
disorder] |
Flucelvax, MMR-II, Prevnar-13 |
Engerix-B, Fluarix, Havrix, MMR-II, Pneumovax-23, ProQuad, Prevnar-13, Recombivax, Twinrix, Varivax |
Erythema nodosum [nodules
or lumps] |
Gardasil/Gardasil 9 |
Engerix-B, Recombivax,
Twinrix |
Exanthem/viral
exanthema [widespread rash] |
ProQuad, Vaqta |
Boostrix |
Facial swelling/edema |
Prevnar-13 |
Daptacel, Fluarix, MMR-II, ProQuad, Varivax |
Heat rash |
Varivax |
|
Hyperhydrosis [abnormal
sweating] |
|
Flulaval, Havrix, Twinrix |
Impetigo |
|
ProQuad, Varivax |
Lichen planus [inflammatory
skin rash] |
|
Engerix-B, Twinrix |
Panniculitis [disease
of fatty layer of skin] |
MMR-II |
MMR-II, ProQuad |
Parotitis [salivary
gland inflammation] |
MMR-II |
MMR-II, ProQuad |
Pigmentation disorder |
Gardasil/Gardasil 9 |
|
Pruritus [itchy skin] |
Afluria, Engerix-B, Fluarix, Havrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta, Varivax |
ActHIB, Adacel, Afluria, Boostrix, Daptacel, Fluarix, Flucelvax, Flulaval, Fluzone, Infanrix, Kinrix, Menactra, Menomune, Menveo, MMR-II, Prevnar-13, ProQuad, Tdvax, Tenivac |
Psoriasis |
Gardasil/Gardasil 9 |
|
Purpura [red/purple
spots] |
MMR-II |
Engerix-B, MMR-II,
ProQuad |
Pustular psoriasis |
Gardasil/Gardasil 9 |
|
Rash |
Adacel, Afluria, Engerix-B, Flublok, Flulaval, Havrix, Menactra, Menomune, Menveo, MMR-II, PedVaxHIB, Prevnar-13, ProQuad, Recombivax, Twinrix, Vaqta, Varivax |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Menomune, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Tdvax, Tenivac |
Rash morbilliform |
Vaqta |
|
Rash vesicular |
ProQuad, Vaqta |
|
Skin discoloration |
|
Pentacel |
Skin exfoliation |
|
Menveo |
Skin induration |
|
MMR-II, ProQuad |
Stevens-Johnson
syndrome [severe skin reaction] |
Gardasil/Gardasil 9,
MMR-II |
Engerix-B, Fluarix, Fluzone, MMR-II, ProQuad, Recombivax, Varivax |
Sweating |
Engerix-B, Fluarix,
Flucelvax, Pneumovax-23, Recombivax, Twinrix |
|
Vesiculation |
|
MMR-II |
Vitiligo |
Gardasil/Gardasil 9 |
|
Vascular (10) |
Cerebrovascular
accident |
Kinrix, Pneumovax-23,
Tenivac |
ProQuad, Varivax |
Deep venous thrombosis |
|
Gardasil/Gardasil 9 |
Flushing |
Engerix-B, Recombivax,
Twinrix |
Flulaval, Fluzone |
Henoch-Schönlein
purpura [blood vessel inflammation] |
MMR-II |
Boostrix, Fluarix,
MMR-II, ProQuad, Varivax |
Pallor |
|
DT, Flulaval, Hiberix,
Pediarix, Pentacel, Prevnar-13, Quadracel |
Petechiae [bleeding
capillaries] |
Engerix-B, Twinrix |
Pediarix, Recombivax |
Polyarteritis nodosa [damaged
arteries] |
|
Recombivax |
Raynaud’s phenomenon |
Gardasil/Gardasil 9 |
|
Renal vasculitis |
|
Afluria |
Vasculitis |
MMR-II |
Afluria, Engerix-B,
Fluarix, Fluzone, Havrix, MMR-II, Recombivax, Twinrix |
Urogenital (6) |
Dysuria [difficult
urination] |
Recombivax |
|
Epididymitis [testicular
inflammation] |
MMR-II |
MMR-II, ProQuad |
Orchitis [inflammation
of the testes] |
MMR-II |
MMR-II, ProQuad |
Proteinuria |
Gardasil/Gardasil 9 |
|
Urinary retention |
Pneumovax-23 |
|
Urinary tract infection |
Gardasil/Gardasil 9,
RotaTeq |
|