Body System |
Medical Disorder |
Vaccines Reporting Disorder |
Allergic (5) |
Allergic reactions/hypersensitivity* |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Kinrix, Pediarix, Pentacel, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix |
Anaphylactic and anaphylactoid reactions, including shock* |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, RotaTeq, Tenivac, Trumenba, Twinrix, Varivax |
Angioedema* |
ActHIB, Adacel, Boostrix, Daptacel, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, 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] |
ActHIB, Adacel, Afluria, Boostrix, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Recombivax, RotaTeq, Tenivac, Twinrix |
Autoimmune (7) |
Diabetes mellitus* |
MMR-II |
Guillain-Barré syndrome* |
Adacel, Afluria, Engerix-B, Fluarix, Flulaval, FluMist, Fluzone, Havrix, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Recombivax, Tenivac, Vaqta, Varivax |
Kawasaki disease* [blood vessel disease] |
Rotarix, RotaTeq |
Lupus-like syndrome* |
Recombivax |
Multiple sclerosis (or MS exacerbation)* |
Engerix-B, Havrix, Recombivax, Twinrix |
Pancreatitis* |
Gardasil/Gardasil 9, MMR-II |
Systemic lupus erythematosus* |
Recombivax |
Blood/lymphatic system (10) |
Anemia, aplasic or hemolytic |
Gardasil/Gardasil 9, Pneumovax-23, ProQuad, Varivax |
Epistaxis [nosebleed] |
FluMist, ProQuad |
Extravasation [blood vessel leakage] |
ProQuad |
Hematochezia [bloody stools] |
ProQuad, Rotarix, RotaTeq |
Increased erythrocyte sedimentation rate |
Recombivax |
Leukocytosis [increased white blood cells] |
MMR-II, Pneumovax-23 |
Lymphadenitis [swollen lymph nodes] |
Boostrix, Pneumovax-23, ProQuad |
Lymphadenopathy, including regional |
Boostrix, Daptacel, DT, Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Infanrix, IPOL, Kinrix, MMR-II, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, Tenivac |
Thrombocytopenia [low platelets] |
Afluria, Engerix-B, Fluzone, Havrix, Infanrix, Kinrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta, Varivax |
Thrombocytopenic purpura, idiopathic |
Gardasil/Gardasil 9, Rotarix, Twinrix, Varivax |
Cardiac (6) |
Cyanosis* [bluish discoloration, low oxygen] |
Daptacel, Hiberix, Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel |
Hypotension |
Adacel |
Myocarditis [heart muscle inflammation] |
Adacel, Boostrix |
Palpitations |
Engerix-B, Twinrix |
Pericarditis [pericardial inflammation] |
FluMist |
Tachycardia [abnormally high heart rate] |
Engerix-B, Fluarix, Recombivax, Twinrix |
Congenital (1) |
Congenital anomaly |
Havrix |
Death (2) |
Death |
Gardasil/Gardasil 9, MMR-II, Rotarix, RotaTeq |
Sudden Infant Death Syndrome (SIDS) |
Infanrix |
Ear/labyrinth (5) |
Ear pain |
Engerix-B, Infanrix, ProQuad, Twinrix |
Nerve deafness |
MMR-II, ProQuad |
Otitis media |
MMR-II |
Tinnitis |
Engerix-B, Recombivax, Twinrix |
Vertigo |
Engerix-B, Fluarix |
Eye (15) |
Conjunctivitis |
Engerix-B, Fluarix, MMR-II, Recombivax, Twinrix |
Eye irritation |
Fluarix, ProQuad |
Eye pain |
Fluarix, Flulaval |
Eye redness |
Fluarix |
Eye swelling |
Bexero, Fluarix |
Eyelid swelling |
Fluarix, ProQuad |
Keratitis [corneal inflammation] |
Engerix-B |
Ocular hyperemia [eye inflammation] |
Fluzone |
Ocular palsies* [nerve damage] |
MMR-II, ProQuad |
Optic neuritis/neuropathy, papillitis* [inflammation of optic nerve] |
Engerix-B, Fluzone, MMR-II, ProQuad, Recombivax, Twinrix |
Photophobia [light intolerance] |
Flulaval |
Retinitis, necrotizing [inflammation] |
MMR-II, ProQuad, Varivax |
Retrobulbar neuritis [nerve damage] |
MMR-II, ProQuad |
Uveitis [eye inflammation] |
Recombivax |
Visual disturbances |
Engerix-B, Recombivax, Twinrix |
Gastrointestinal (13) |
Abdominal pain, discomfort |
Fluarix, ProQuad |
Candidiasis* |
ProQuad |
Constipation |
Recombivax |
Diarrhea |
Daptacel, FluMist, MMR-II, Pediarix, Pentacel |
Dyspepsia [indigestion] |
Engerix-B, Twinrix |
Dysphagia [swallowing difficulties] |
Flulaval |
Gastroenteritis |
Rotarix, RotaTeq |
Intussusception, including recurrent/fatal |
Rotarix, RotaTeq |
Mouth ulcers |
ProQuad |
Nausea |
Daptacel, DT, Fluarix, FluMist, Gardasil/Gardasil 9, MMR-II, Pneumovax-23, Tdvax |
Pancreatitis* |
Gardasil/Gardasil 9, MMR-II |
Swelling of mouth, throat or tongue |
Fluarix |
Vomiting |
Flulaval, FluMist, Fluzone, Gardasil/Gardasil 9, MMR-II, Pediarix, Pentacel, Pneumovax-23, Tenivac |
General and injection site (20) |
Abnormal gait |
Flulaval |
Apathy |
ProQuad |
Asthenia [fatigue, weakness] |
Fluarix, Flulaval, Fluzone, Gardasil/Gardasil 9, Infanrix, Pediarix, Tenivac |
Body aches |
Fluarix |
Chest pain |
Fluarix, Flulaval, Fluzone |
Chills |
Fluarix, Gardasil/Gardasil 9, Havrix, Twinrix |
Decreased limb mobility |
Pneumovax-23 |
Feeling hot |
Fluarix |
Fever |
MMR-II, Pneumovax-23 |
Injected limb—extensive swelling |
ActHIB, Bexero, Hiberix |
Injection site abscess |
Adacel, Daptacel, Fluarix, Flulaval, PedvaxHIB, Pentacel, Quadracel |
Injection site bruising |
Adacel, Flulaval |
Injection site cellulitis |
Afluria, Daptacel, Fluarix, Flulaval, Pediarix, Quadracel, Tenivac |
Injection site reactions (mass, pain, warmth) |
Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, Havrix, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Tdvax, Tenivac, Twinrix |
Injection site rash |
Daptacel, Flulaval, IPOL, Prevnar-13 |
Listlessness |
Quadracel |
Malaise |
Gardasil/Gardasil 9, MMR-II, Pneumovax-23, Tdvax, Twinrix |
Peripheral edema |
ActHIB, MMR-II, Pneumovax-23, ProQuad, Tdvax, Tenivac, Varivax |
Pyrexia [fever] |
Tdvax |
Swelling |
MMR-II, ProQuad |
Hepatobiliary/liver (3) |
Elevation of liver enzymes |
Recombivax |
|
Hepatitis |
Havrix, Twinrix |
|
Jaundice |
Havrix, Twinrix |
Immune system (5) |
Allergic reactions/hypersensitivity* |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Kinrix, Pediarix, Pentacel, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix |
Anaphylactic and anaphylactoid reactions, including shock* |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, RotaTeq, Tenivac, Trumenba, Twinrix, Varivax |
Angioedema,* angioneurotic edema |
ActHIB, Adacel, Boostrix, Daptacel, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, MMR-II, Pediarix, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, RotaTeq, Tenivac, Twinrix, Varivax |
Edema |
Adacel |
Serum sickness* |
Afluria, Engerix-B, Fluarix, Havrix, Pneumovax-23, Recombivax, Twinrix |
Infections and infestations (29) |
Atypical measles |
MMR-II, ProQuad |
Bronchitis |
Infanrix, ProQuad |
Candidiasis* |
ProQuad |
Cellulitis |
Daptacel, Infanrix, Pneumovax-23, ProQuad, Tdvax, Varivax |
Early-onset Hib disease |
PedvaxHIB |
Herpes simplex |
ProQuad |
Herpes zoster [shingles] |
Engerix-B, ProQuad, Recombivax, Twinrix, Varivax |
Infection |
ProQuad |
Influenza, influenza-like illness |
Afluria, Flulaval, Havrix, ProQuad |
Invasive Hib disease |
Pentacel |
Kawasaki disease* [blood vessel disease] |
Rotarix, RotaTeq |
Laryngitis |
Flulaval |
Measles |
ProQuad |
Measles-like rash |
MMR-II |
Meningitis (aseptic, eosinophilic) |
Engerix-B, FluMist, MMR-II, Pentacel, ProQuad, Twinrix, Varivax |
Pharyngitis |
Fluarix, Varivax |
Pneumonia, pneumonitis |
MMR-II, ProQuad, Varivax |
Pulmonary congestion |
ProQuad |
Respiratory tract infection |
Infanrix, Pediarix, ProQuad |
Rhinitis |
Fluarix, Flulaval, Havrix, MMR-II, Pentacel, ProQuad |
Secondary bacterial infections (skin, tissue) |
Varivax |
Sinusitis |
ProQuad |
Skin infection |
ProQuad |
Sore throat |
MMR-II, ProQuad |
Tonsillitis |
Fluarix |
Transmission of vaccine virus strains |
RotaTeq |
Varicella (vaccine strain) |
ProQuad, Varivax |
Varicella-like rash |
ProQuad |
Viral infection |
Pentacel |
Investigations (2) |
Abnormal liver function tests |
Engerix-B, Twinrix |
Increased serum C-reactive protein |
Pneumovax-23 |
Metabolic (3) |
Decreased appetite |
Pentacel |
Diabetes mellitus* |
MMR-II |
Mitochondrial encephalomyopathy, Leigh syndrom exacerbation [neurometabolic] |
FluMist |
Musculoskeletal/connective tissue (13) |
Arthralgia [joint pain] |
Boostrix, Engerix-B, IPOL, MMR-II, Pneumovax-23, ProQuad, Recombivax, Tdvax, Twinrix |
Arthritis |
Engerix-B, Flulaval, MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix |
Back pain |
Boostrix |
Hypotonia [low muscle tone] |
Daptacel, Hiberix, Infanrix, Pediarix, Prevnar-13, Quadracel |
Lupus-like syndrome* |
Recombivax |
Muscle spasm |
Adacel |
Muscle weakness |
Engerix-B, Flulaval, Recombivax, Twinrix |
Musculoskeletal pain |
ProQuad |
Musculoskeletal stiffness |
Havrix |
Myalgia [muscle pain] |
Boostrix, IPOL, MMR-II, ProQuad, Tdvax, Tenivac |
Myositis [muscle inflammation] |
Adacel |
Pain in extremities |
Fluarix, Fluzone, Pediarix, Recombivax, Tdvax, Tenivac |
Systemic lupus erythematosus* |
Recombivax |
Nervous system (41) |
Acute disseminated encephalomyelitis |
MMR-II, ProQuad |
Ataxia [nervous system dysfunction] |
MMR-II, ProQuad, Varivax |
Bulging fontanelle |
Pediarix |
Cerebellar ataxia |
Vaqta |
Convulsions/seizures |
ActHIB, Adacel, Afluria, Boostrix, Daptacel, DT, Fluarix, Flulaval, Fluzone, Havrix, Hiberix, IPOL, Kinrix, MMR-II, Quadracel, Recombivax, Tdvax, Twinrix, Varivax |
Depressed level of consciousness |
Boostrix, Pediarix, Pentacel |
Dizziness |
Fluarix, Flulaval, Fluzone, Havrix, MMR-II, ProQuad, Tdvax, Tenivac, Varivax |
Encephalitis, vaccine-induced encephalitis [brain inflammation] |
Boostrix, Engerix-B, FluMist, MMR-II, Pediarix, Recombivax, Twinrix, Vaqta, Varivax |
Encephalomyelitis [brain and spinal cord] |
Afluria, Fluarix, Fluzone |
Encephalopathy [brain disease] |
Afluria, Engerix-B, Flulaval, Havrix, Infanrix, MMR-II, ProQuad, Twinrix |
Facial palsy, Bell’s palsy |
Adacel, Boostrix, Engerix-B, Fluarix, FluMist, Fluzone, ProQuad, Recombivax, Twinrix, Varivax |
Facial (or cranial) nerve paralysis |
Flulaval |
Facial paresis [impaired facial movement] |
Fluarix |
Febrile convulsions/seizures |
Afluria, Daptacel, Fluzone, IPOL, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Quadracel, Recombivax |
Guillain-Barré syndrome* |
Adacel, Afluria, Engerix-B, Fluarix, Flulaval, FluMist, Fluzone, Havrix, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Recombivax, Tenivac, Vaqta, Varivax |
Headache |
DT, Infanrix, IPOL, 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 to immunization (HHE) |
Daptacel, Hiberix, Kinrix, Pediarix, Pentacel, Quadracel |
Lethargy |
Pediarix |
Limb paralysis |
Flulaval |
Measles inclusion body encephalitis |
MMR-II, ProQuad |
Migraine |
Engerix-B, Recombivax |
Multiple sclerosis (or MS exacerbation)* |
Engerix-B, Havrix, Recombivax, Twinrix |
Myelitis [spinal cord disease] |
Adacel, Fluarix, Fluzone, Havrix, Recombivax, Twinrix |
Neuralgia [nerve pain] |
Afluria |
Neuritis (including brachial, polyneuritis) |
Adacel, Afluria, Engerix-B, Fluarix, Fluzone, MMR-II, Twinrix |
Neuropathy, polyneuropathy |
Afluria, Engerix-B, Fluarix, Havrix, MMR-II, ProQuad, Recombivax, Twinrix |
Ocular palsies* [nerve damage] |
MMR-II, ProQuad |
Optic neuritis/neuropathy, papillitis* [inflammation of optic nerve] |
Engerix-B, Fluzone, MMR-II, ProQuad, Recombivax, Twinrix |
Paralysis |
Engerix-B, Twinrix |
Paresis [partial paralysis] |
Engerix-B, Twinrix |
Paresthesia [abnormal skin sensations] |
Adacel, Afluria, Boostrix, Engerix-B, Fluarix, Flucelvax, Flulaval, Fluzone, Havrix, IPOL, MMR-II, Pneumovax-23, ProQuad, Tenivac, Varivax |
Partial seizures, seizures |
Daptacel, Engerix-B, ProQuad |
Presyncope [feeling faint] |
Flucelvax |
Radiculopathy [“pinched nerve” in spine] |
Pneumovax-23, Recombivax |
Somnolence |
Daptacel, DT, Flulaval, Havrix, Hiberix, IPOL, Pediarix, Pentacel, Quadracel, Recombivax |
Subacute sclerosing panencephalitis |
MMR-II, ProQuad |
Syncope, vasovagal syncope [fainting] |
Adacel, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, Fluzone, Havrix, Hiberix, Infanrix, Kinrix, MMR-II, Pediarix, ProQuad, Recombivax, Tenivac, Trumenba |
Transverse myelitis |
Afluria, Engerix-B, Fluzone, MMR-II, ProQuad, Recombivax, Twinrix, Varivax |
Tremors |
Flulaval, ProQuad |
Psychiatric (8) |
Agitation |
IPOL, ProQuad, Recombivax |
Crying/unusual crying |
Pediarix |
Hypersomnia |
ProQuad |
Insomnia |
Flulaval, Pediarix |
Irritability |
MMR-II, Recombivax |
Nervousness |
Pediarix, ProQuad |
Restlessness |
Pediarix |
Screaming |
Daptacel, Pediarix, Pentacel, Quadracel |
Respiratory, thoracic and mediastinal (12) |
Apnea |
Engerix-B, Hiberix, Infanrix, Kinrix, Pediarix, Pentacel, Prevnar-13 |
Asthma, asthma-like symptoms |
Engerix-B, Fluarix, Twinrix |
Bronchospasm |
Engerix-B, Fluarix, Flulaval, MMR-II, ProQuad, Recombivax, Tenivac, Twinrix |
Cough |
Fluarix, Fluzone, Infanrix, MMR-II, Pediarix, Pentacel |
Cyanosis* [bluish discoloration, low oxygen] |
Daptacel, Hiberix, Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel |
Dyspnea [shortness of breath] |
Fluarix, Flulaval, Fluzone, Havrix, Pediarix, Quadracel, Twinrix |
Dysphonia [vocal abnormalities] |
Flulaval |
Oropharyngeal pain |
Fluzone |
Respiratory distress |
Fluarix |
Rhinorrhea [runny nose] |
Fluzone |
Stridor [high-pitched wheezing] |
Fluarix |
Throat tightness |
Flulaval, Fluzone |
Wheezing |
Fluzone, ProQuad |
Skin/ subcutaneous tissue (22) |
Acute hemorrhagic edema of infancy |
MMR-II, ProQuad |
Alopecia [hair loss] |
Engerix-B, Recombivax, Twinrix |
Ecchymoses [subcutaneous bleeding] |
Engerix-B, Recombivax, Twinrix |
Eczema |
Engerix-B, Recombivax, Twinrix |
Erythema [skin redness] |
Fluarix, Infanrix, MMR-II, Pediarix, Pentacel, Tdvax |
Erythema multiforme [skin disorder] |
Engerix-B, Fluarix, Havrix, MMR-II, Pneumovax-23, ProQuad, Prevnar-13, Recombivax, Twinrix, Varivax |
Erythema nodosum [nodules or lumps] |
Engerix-B, Recombivax, Twinrix |
Exanthem [widespread rash] |
Boostrix |
Facial swelling/edema |
Daptacel, Fluarix, MMR-II, ProQuad, 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, ProQuad |
Parotitis [salivary gland inflammation] |
MMR-II, ProQuad |
Pruritus [itchy skin] |
ActHIB, Adacel, Afluria, Boostrix, Daptacel, Fluarix, Flucelvax, Flulaval, Fluzone, Infanrix, Kinrix, MMR-II, Prevnar-13, ProQuad, Tdvax, Tenivac |
Purpura [red/purple spots] |
Engerix-B, MMR-II, ProQuad |
Rash |
ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Hiberix, Infanrix, IPOL, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Tdvax, Tenivac |
Skin discoloration |
Pentacel |
Skin induration |
MMR-II, ProQuad |
Stevens-Johnson syndrome [severe skin reaction] |
Engerix-B, Fluarix, Fluzone, MMR-II, ProQuad, Recombivax, Varivax |
Urticaria* [hives] |
ActHIB, Adacel, Afluria, Boostrix, DT, Engerix-B, Fluarix, Flucelvax, Flulaval, FluMist, Fluzone, Hiberix, Infanrix, IPOL, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Recombivax, RotaTeq, Tenivac, Twinrix |
Vesiculation |
MMR-II |
Vascular (8) |
Cerebrovascular accident |
ProQuad, Varivax |
Flushing |
Flulaval, Fluzone |
Henoch-Schönlein purpura [blood vessel inflammation] |
Boostrix, Fluarix, MMR-II, ProQuad, Varivax |
Pallor |
DT, Flulaval, Hiberix, Pediarix, Pentacel, Prevnar-13, Quadracel |
Petechiae [bleeding capillaries] |
Pediarix, Recombivax |
Polyarteritis nodosa [damaged arteries] |
Recombivax |
Renal vasculitis |
Afluria |
Vasculitis |
Afluria, Engerix-B, Fluarix, Fluzone, Havrix, MMR-II, Recombivax, Twinrix |
Urogenital (2) |
Epididymitis [testicular inflammation] |
MMR-II, ProQuad |
|
Orchitis [inflammation of the testes] |
MMR-II, ProQuad |