Adverse Events From Vaccine Package Inserts: Post-Marketing Experience


The following is a list of vaccine adverse events reported post-marketing, compiled from the vaccine package inserts.  It is focused for the most part on the childhood vaccines, although the influenza vaccines are also included. The list of adverse events is grouped for the most part by body “system,” as is done in the inserts. Following the list of adverse events are links to to actual package inserts.

Vaccine Package Inserts: Post-Marketing Experience

 

Blood and lymphatic system disorders

  • Anemia, aplasic or hemolytic (Pneumovax-23, ProQuad, Varivax)
  • Autoimmune hemolytic anemia (Gardasil/Gardasil 9)
  • Epistaxis [nosebleed] (ProQuad)
  • Extravasation blood (ProQuad)
  • Hematochezia [bloody stools] (ProQuad, Rotarix, RotaTeq)
  • Increased erythrocyte sedimentation rate (Recombivax)
  • Leukocytosis (MMR-II, Pneumovax-23)
  • Lymphadenitis (Boostrix, Pneumovax-23, ProQuad)
  • Lymphadenopathy, including regional [enlarged lymph nodes] (Boostrix, Daptacel, DT, Fluad, Fluarix, Flulaval, FluzoneQ and FluzoneHD, Gardasil/Gardasil 9, Infanrix, IPV, Kinrix, MMR-II, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, Tenivac)
  • Thrombocytopenia, including severe [low platelets] (Afluria, Engerix-B, Fluad, FluzoneQ and FluzoneHD, Havrix, Infanrix, Kinrix, MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix, Vaqta, Varivax)
  • Thrombocytopenic purpura, idiopathic (ITP) (Gardasil/Gardasil 9, Rotarix, Twinrix, Varivax)

Cardiac disorders

  • Cyanosis [bluish discoloration] (Daptacel, Hiberix, Infanrix, Pediarix, Pentacel, Prevnar-13, Quadracel)
  • Myocarditis [inflammation of heart muscle] (Adacel, Boostrix)
  • Palpitations (Engerix-B, Twinrix)
  • Pericarditis [inflammation of pericardium] (FluMist)
  • Tachycardia [abnormally high heart rate] (Engerix-B, Fluarix, Recombivax, Twinrix)

Congenital

  • Congenital anomaly (Havrix)

Death

  • Death (Gardasil/Gardasil 9, MMR-II, Rotarix, RotaTeq)
  • SIDS (Infanrix)

Ear and labyrinth disorders

  • 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 disorders

  • 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 [cornea inflammation] (Engerix-B)
  • Ocular hyperemia [eye inflammation] (FluzoneQ and FluzoneHD)
  • Ocular palsies (MMR-II, ProQuad)
  • Optic neuritis/neuropathy, papillitis (Engerix-B, FluzoneQ and FluzoneHD, MMR-II, ProQuad, Recombivax, Twinrix)
  • Photophobia (Flulaval)
  • Retinitis, necrotizing retinitis (MMR-II, ProQuad, Varivax)
  • Retrobulbar neuritis (MMR-II, ProQuad)
  • Uveitis [eye inflammation] (Recombivax)
  • Visual disturbances (Engerix-B, Recombivax, Twinrix)

Gastrointestinal disorders

  • Abdominal pain or discomfort (Fluarix, ProQuad)
  • Candidiasis (ProQuad)
  • Constipation (Recombivax)
  • Diarrhea (Daptacel, FluMist, FluzoneHD, MMR-II, Pediarix, Pentacel)
  • Dyspepsia (Engerix-B, Twinrix)
  • Dysphagia [swallowing difficulties] (Flulaval)
  • Gastroenteritis (Rotarix, RotaTeq)
  • Intussusception and recurrent intussusception (including fatal) (Rotarix, RotaTeq)
  • Mouth ulcers (ProQuad)
  • Nausea (Daptacel, DT, Fluarix, FluMist, FluzoneHD, Gardasil/Gardasil 9, MMR-II, Pneumovax-23, TDVAX)
  • Pancreatitis (Gardasil/Gardasil 9, MMR-II)
  • Swelling of the mouth, throat, and/or tongue (Fluarix)
  • Vomiting (Flulaval, FluMist, FluzoneQ and FluzoneHD, Gardasil/Gardasil 9, MMR-II, Pediarix, Pentacel, Pneumovax-23, Tenivac)

General disorders and administration site conditions

  • Abnormal gait (Flulaval)
  • Apathy (ProQuad)
  • Asthenia [fatigue, weakness] (Fluarix, Flulaval, FluzoneQ and FluzoneHD, Gardasil/Gardasil 9, Infanrix, Pediarix, Tenivac)
  • Body aches (Fluarix)
  • Chest pain (Fluarix, Flulaval, FluzoneQ and FluzoneHD)
  • Chills (Fluarix, FluzoneHD, Gardasil/Gardasil 9)
  • 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, Fluad, Fluarix, Flulaval, Pediarix, Quadracel, Tenivac)
  • Injection site reactions: mass, pain, warmth (Adacel, Afluria, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluad, Fluarix, Flucelvax, Flulaval, Havrix, Hiberix, Infanrix, IPV, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, TDVAX, Tenivac, Twinrix)
  • Injection site rash (Daptacel, Flulaval, IPV, 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 (TDVAX)
  • Swelling (MMR-II, ProQuad)

Hepatobiliary and liver disorders

  • Elevation of liver enzymes (Recombivax)
  • Hepatitis (Havrix, Twinrix)
  • Jaundice (Havrix, Twinrix)

Immune system disorders

  • Allergic reactions/hypersensitivity (ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluarix, Flublok, FluMist, FluzoneQ and FluzoneHD, Hiberix, Infanrix, IPV, Kinrix, Pediarix, Pentacel, Quadracel, Recombivax, Tenivac, Trumenba, Twinrix)
  • Anaphylactic and anaphylactoid reactions, including shock (ActHIB, Adacel, Afluria, Bexero, Boostrix, Daptacel, Engerix-B, Fluad, Fluarix, Flublok, Flucelvax, Flulaval, FluMist, FluzoneQ and FluzoneHD, Havrix, Hiberix, Infanrix, IPV, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, ProQuad, Quadracel, Recombivax, RotaTeq, Tenivac, Trumenba, Twinrix, Varivax)
  • Angioedema, angioneurotic edema [swelling beneath skin] (ActHIB, Adacel, Boostrix, Daptacel, Engerix-B, Fluad, Fluarix, Flucelvax, Flulaval, FluMist, FluzoneQ and FluzoneHD, Havrix, Hiberix, Infanrix, Kinrix, MMR-II, Pediarix, PedvaxHIB, Pneumovax-23, Prevnar-13, ProQuad, RotaTeq, Tenivac, Twinrix, Varivax)
  • Edema (Adacel)
  • Hypotension (Adacel)
  • Serum sickness (Afluria, Engerix-B, Fluarix, Havrix, Pneumovax-23, Recombivax, Twinrix)

Infections and infestations

  • Atypical measles (MMR-II, ProQuad)
  • Bronchitis (Infanrix, ProQuad)
  • Cellulitis (Daptacel, Infanrix, Pneumovax-23, ProQuad, TDVAX, Varivax)
  • Chills (Havrix, Twinrix)
  • Early-onset Hib disease (PedvaxHIB)
  • Herpes simplex (ProQuad)
  • Herpes zoster (Engerix-B, ProQuad, Recombivax, Twinrix, Varivax)
  • Infection (ProQuad)
  • Influenza, influenza-like illness (Afluria, Flulaval, Havrix, ProQuad)
  • Invasive Hib disease (Pentacel)
  • Kawasaki disease (Rotarix, RotaTeq)
  • Laryngitis (Flulaval)
  • Measles (ProQuad)
  • Measles-like rash (MMR-II)
  • Meningitis, aseptic meningitis, eosinophilic meningitis  (Engerix-B, FluMist, MMR-II, Pentacel, ProQuad, Twinrix, Varivax)
  • Pharyngitis (Fluarix, FluzoneHD, Varivax)
  • Pneumonia, pneumonitis (MMR-II, ProQuad, Varivax)
  • Pulmonary congestion (ProQuad)
  • Respiratory tract infection (Infanrix, Pediarix, ProQuad)
  • Rhinitis (Fluarix, Flulaval, FluzoneHD, Havrix, MMR-II, Pentacel, ProQuad)
  • Secondary bacterial infections of skin and soft tissue (Varivax)
  • Sinusitis (ProQuad)
  • Skin infection (ProQuad)
  • Sore throat (MMR-II, ProQuad)
  • Tonsillitis (Fluarix)
  • Transmission of vaccine virus strains to non-vaccinated (RotaTeq)
  • Varicella (vaccine strain) (ProQuad, Varivax)
  • Varicella-like rash (ProQuad)
  • Viral infection (Pentacel)

Investigations

  • Abnormal liver function tests (Engerix-B, Twinrix)
  • Increased serum C-reactive protein (Pneumovax-23)

Metabolic disorders

  • Decreased appetite (Pentacel)
  • Diabetes mellitus (MMR-II)
  • Mitochondrial encephalomyopathy/Leigh syndrome exacerbation [neurometabolic disorder] (FluMist)

Musculoskeletal and connective tissue disorders

  • Arthralgia (Boostrix, Engerix-B, FluzoneHD, IPV, MMR-II, Pneumovax-23, ProQuad, Recombivax, TDVAX, Twinrix)
  • Arthritis (Engerix-B, Flulaval, MMR-II, Pneumovax-23, ProQuad, Recombivax, Twinrix)
  • Back pain (Boostrix)
  • Hypotonia (Prevnar-13)
  • Lupus-like syndrome (Recombivax)
  • Muscle spasm (Adacel)
  • Muscle weakness (Engerix-B, Fluad, Flulaval, Recombivax, Twinrix)
  • Musculoskeletal pain (ProQuad)
  • Musculoskeletal stiffness (Havrix)
  • Myalgia (Boostrix, IPV, MMR-II, ProQuad, TDVAX, Tenivac)
  • Myositis (Adacel)
  • Pain in extremities (Fluarix, FluzoneQ and FluzoneHD, Pediarix, Recombivax, TDVAX, Tenivac)
  • Systemic lupus erythematosus (SLE) (Recombivax)

Nervous system disorders

  • Acute disseminated encephalomyelitis (ADEM) (MMR-II, ProQuad)
  • Ataxia (MMR-II, ProQuad, Varivax)
  • Bulging fontanelle (Pediarix)
  • Cerebellar ataxia (Vaqta)
  • Convulsions/seizures (ActHIB, Adacel, Afluria, Boostrix, Daptacel, DT, Fluad, Fluarix, Flulaval, FluzoneQ and FluzoneHD, Havrix, Hiberix, IPV, Kinrix, MMR-II, Quadracel, Recombivax, TDVAX, Twinrix, Varivax)
  • Depressed level of consciousness (Boostrix, Pediarix, Pentacel)
  • Dizziness (Fluarix, Flulaval, FluzoneQ and FluzoneHD, 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 [inflammation of brain and spinal cord] (Afluria, Fluad, Fluarix, FluzoneQ and FluzoneHD)
  • Encephalopathy [brain disease] (Afluria, Engerix-B, Flulaval, Havrix, Infanrix, MMR-II, ProQuad, Twinrix)
  • Facial palsy, Bell’s palsy (Adacel, Boostrix, Engerix-B, Fluarix, FluMist, FluzoneQ and FluzoneHD, ProQuad, Recombivax, Twinrix, Varivax)
  • Facial (or cranial) nerve paralysis (Flulaval)
  • Facial paresis [impaired movement] (Fluarix)
  • Febrile convulsions/seizures (Afluria, Daptacel, FluzoneQ and FluzoneHD, IPV, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Quadracel, Recombivax)
  • Guillain-Barré syndrome (Adacel, Afluria, Engerix-B, Fluad, Fluarix, Flulaval, FluMist, FluzoneQ and FluzoneHD, Havrix, MMR-II, PedvaxHIB, Pneumovax-23, ProQuad, Recombivax, Tenivac, Vaqta, Varivax)
  • Headache (DT, Infanrix, IPV, MMR-II, ProQuad, TDVAX, Twinrix)
  • Hypoesthesia [decreased tactile sensitivity] (Adacel, Engerix-B, Fluarix, Flulaval, Havrix, Recombivax, Twinrix)
  • Hypokinesia [loss of muscle movement] (Flulaval)
  • Hypotonia [low muscle tone] (Daptacel, Hiberix, Infanrix, Pediarix, Quadracel)
  • Hypotonic-hyporesponsive episode to immunization (HHE) (Daptacel, Hiberix, Kinrix, Pediarix, Pentacel, Quadracel)
  • Lethargy (Pediarix)
  • Limb paralysis (Flulaval)
  • Measles inclusion body encephalitis (MIBE) (MMR-II, ProQuad)
  • Migraine (Engerix-B, Recombivax)
  • Multiple sclerosis (or MS exacerbation) (Engerix-B, Havrix, Recombivax, Twinrix)
  • Myelitis [spinal cord disease] (Adacel, Fluarix, FluzoneQ and FluzoneHD, Havrix, Recombivax, Twinrix)
  • Neuralgia [nerve pain] (Afluria, Fluad)
  • Neuritis, including brachial, polyneuritis [nerve inflammation] (Adacel, Afluria, Engerix-B, Fluad, Fluarix, FluzoneQ and FluzoneHD, MMR-II, Twinrix)
  • Neuropathy, polyneuropathy [nerve damage] (Afluria, Engerix-B, Fluarix, Havrix, MMR-II, ProQuad, Recombivax, Twinrix)
  • Paralysis (Engerix-B, Twinrix)
  • Paresis (Engerix-B, Twinrix)
  • Paresthesia [abnormal skin sensations] (Adacel, Afluria, Boostrix, Engerix-B, Fluad, Fluarix, Flucelvax, Flulaval, FluzoneQ and FluzoneHD, Havrix, IPV, MMR-II, Pneumovax-23, ProQuad, Tenivac, Varivax)
  • Partial seizures, seizures (Daptacel, Engerix-B, ProQuad)
  • Presyncope [feeling faint] (Fluad, Flucelvax)
  • Radiculopathy [“pinched nerve” in spine] (Pneumovax-23, Recombivax)
  • Somnolence (Daptacel, DT, Flulaval, Havrix, Hiberix, IPV, Pediarix, Pentacel, Quadracel, Recombivax)
  • Subacute sclerosing panencephalitis (SSPE) (MMR-II, ProQuad)
  • Syncope, vasovagal syncope [fainting] (Adacel, Bexero, Boostrix, Daptacel, DT, Engerix-B, Fluad, Fluarix, Flucelvax, Flulaval, FluzoneQ and FluzoneHD, Havrix, Hiberix, Infanrix, Kinrix, MMR-II, Pediarix, ProQuad, Recombivax, Tenivac, Trumenba)
  • Transverse myelitis [spinal cord demyelination] (Afluria, Engerix-B, FluzoneQ and FluzoneHD, MMR-II, ProQuad, Recombivax, Twinrix, Varivax)
  • Tremors (Flulaval, ProQuad)

Psychiatric disorders

  • Agitation (IPV, 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 disorders

  • 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, FluzoneQ and FluzoneHD, Infanrix, MMR-II, Pediarix, Pentacel)
  • Dyspnea [shortness of breath] (Fluarix, Flulaval, FluzoneQ and FluzoneHD, Havrix, Pediarix, Quadracel, Twinrix)
  • Dysphonia [vocal abnormalities] (Flulaval)
  • Epistaxis [nosebleed] (FluMist)
  • Oropharyngeal pain (FluzoneQ)
  • Respiratory distress (Fluarix)
  • Rhinorrhea [runny nose] (FluzoneQ)
  • Stridor [high-pitched wheezing] (Fluarix)
  • Throat tightness (Flulaval, FluzoneQ and FluzoneHD)
  • Wheezing (FluzoneQ and FluzoneHD, ProQuad)

Skin and subcutaneous tissue disorders

  • 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 (Engerix-B, Fluad, Fluarix, Havrix, MMR-II, Pneumovax-23, ProQuad, Prevnar-13, Recombivax, Twinrix, Varivax)
  • Erythema nodosum (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 [inflammation of salivary glands] (MMR-II, ProQuad)
  • Pruritus [itchy skin] (ActHIB, Adacel, Afluria, Boostrix, Daptacel, Fluad, Fluarix, Flucelvax, Flulaval, FluzoneQ and FluzoneHD, 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, Fluad, Fluarix, Flucelvax, Flulaval, FluMist, FluzoneQ, Hiberix, Infanrix, IPV, 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, FluzoneQ and FluzoneHD, MMR-II, ProQuad, Recombivax, Varivax)
  • Urticaria [hives] (ActHIB, Adacel, Afluria, Boostrix, DT, Engerix-B, Fluad, Fluarix, Flucelvax, Flulaval, FluMist, FluzoneQ and FluzoneHD, Hiberix, Infanrix, IPV, Kinrix, MMR-II, Pediarix, Pentacel, Pneumovax-23, Prevnar-13, Quadracel, Recombivax, RotaTeq, Tenivac, Twinrix)
  • Vesiculation (MMR-II)

Vascular disorders

  • Cerebrovascular accident (ProQuad, Varivax)
  • Flushing (Flulaval, FluzoneQ and FluzoneHD)
  • 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 [inflamed/damaged arteries] (Recombivax)
  • Renal vasculitis (Afluria, Fluad)
  • Vasculitis [blood vessel inflammation] (Afluria, Engerix-B, Fluad, Fluarix, FluzoneQ and FluzoneHD, Havrix, MMR-II, Recombivax, Twinrix)

Urogenital disorders

  • Epididymitis [testicular inflammation] (MMR-II, ProQuad)
  • Orchitis [inflammation of the testes] (MMR-II, ProQuad)

 

Vaccine Package Inserts

 

Diphtheria, tetanus and pertussis vaccines and combination vaccines:

Adacel Tdap (Sanofi): https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert—Adacel.pdf

Boostrix Tdap (GSK):

https://www.fda.gov/media/76633/download

Daptacel DTaP (Sanofi): https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert—DAPTACEL.pdf

DT (Sanofi):

https://www.fda.gov/media/75962/download

Infanrix DTaP (GSK): https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert—INFANRIX.pdf

Kinrix DTaP-IPV (GSK):

https://www.fda.gov/media/80128/download

Pediarix DTaP-HepB-IPV (GSK):

https://www.fda.gov/media/79830/download

Pentacel DTaP-IPV/Hib (Sanofi):

https://www.fda.gov/media/74385/download

Quadracel DTaP-IPV (Sanofi):

https://www.fda.gov/media/91640/download

TDVAX (MassBiologics):

https://www.fda.gov/media/76430/download

Tenivac Td (Sanofi):

https://www.fda.gov/media/76610/download

 

Haemophilus influenzae type b (Hib) vaccines:

ActHIB (Sanofi):

https://www.fda.gov/media/74395/download

Hiberix (GSK):

https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert—HIBERIX.pdf

PedvaxHIB (Merck):

https://www.fda.gov/media/80438/download

 

Hepatitis vaccines:

Engerix-B HepB (GSK):

https://www.fda.gov/media/79341/download

Havrix HepA (GSK):

https://www.fda.gov/media/119388/download

Heplisav-B (Dynavax Technologies) (clinical trials only):

https://www.fda.gov/vaccines-blood-biologics/vaccines/heplisav-b

Recombivax HepB (Merck):

https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/package-insert-recombivax-hb.pdf

Twinrix HepA/HepB (GSK):

https://www.fda.gov/media/119351/download

Vaqta HepA (Merck):

https://www.merck.com/product/usa/pi_circulars/v/vaqta/vaqta_pi.pdf

 

Human papillomavirus (HPV) vaccine:

Gardasil and Gardasil 9 (Merck):

https://www.fda.gov/media/90064/download

 

Influenza vaccines:

Afluria (Seqirus):

https://www.fda.gov/media/117022/download

Fluad (Seqirus):

https://www.fda.gov/media/94583/download

Fluarix (GSK):

https://www.fda.gov/media/84804/download

Flublok (Protein Sciences Corporation):

https://www.fda.gov/media/123144/download

Flucelvax (Seqirus):

https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Package-Insert—Flucelvax.pdf

Flulaval (GSK):

https://www.fda.gov/media/115785/download

FluMist (AstraZeneca):

https://www.fda.gov/media/83072/download

Fluzone Quadrivalent (Sanofi):

https://www.fda.gov/media/119856/download

Fluzone High-Dose (Sanofi):

https://www.fda.gov/media/119870/download

 

Meningococcal vaccines:

Bexero (GSK):

https://www.fda.gov/media/90996/download

Trumenba (Pfizer):

https://www.fda.gov/media/89936/download

 

 

MMR vaccines:

MMR-II (Merck):

https://www.fda.gov/media/75191/download

Proquad MMRV (Merck):

https://www.fda.gov/media/75203/download

 

Pneumococcal vaccines:

Prevnar-13 (Pfizer):

https://www.fda.gov/media/107657/download

Pneumovax-23 (Merck):

https://www.fda.gov/media/80547/download

 

Polio vaccine:

Inactivated polio vaccine (Sanofi Pasteur):

https://www.fda.gov/media/75695/download

Rotavirus vaccines:

Rotarix (GSK):

https://www.fda.gov/media/75726/download

RotaTeq (Merck):

https://www.fda.gov/media/75695/download

Varicella vaccine:

Varivax (Merck):

https://www.fda.gov/media/119865/download

 

 

The post Adverse Events From Vaccine Package Inserts: Post-Marketing Experience appeared first on Children's Health Defense.

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