A Collection of Vaccine Ingredients and Possible Adverse Occurrences

Disclaimer: This list contains a combination of many adverse post-vaccination occurrences, and possible occurrences, that have been published in the manufacturer’s documents. Any use of [brackets] is information added by the author.  This list may not contain all the adverse occurrences; it may contain typographical errors, and obviously does not take the place of reading the most current manufacturer’s document in its entirety.  For more information about the product manufacturer’s vaccine documents visit their website, or www.GenerationRescue.org/vaccine_information.

DTaP Vaccine - DAPTACEL®:    

Diphtheria and Tetanus Toxiods and Acellular Pertussis Vaccine Absorbed

Ingredients*: Aluminum Phosphate, Ammonium Sulfate, Formaldehyde or Formalin, Glutaraldehye, 2-Phoenoxyethanol, Casamino Acid, Dimethyl-betacyclodextrin

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):
 
Fussiness, irritability, crying, persistent crying, inconsolable crying, decreased activity, lethargy, fever, anorexia, drowsiness, vomiting, seizures, bronchiolitis, pneumonia, meningitis, sepsis, pertussis, unresponsiveness, cyanosi, nausea, diarrhea, joint swelling, hypersensitivity, allergic reaction, anaphylactic reaction, adema, swelling face, pruritus, rash, HHE [hypotonic-hyporesponsive episode], hypotonia, somnolence, screaming, fretfulness. injection site nodule, injection site rash, injection site mass, cellulitis, injection site abscess,  injection site tenderness, redness, increase in arm circumference, convulsions, febrile, grand mal and partial seizures.

Other Highlights: From the Manufacturer Prescribing Information***: 

1. "A review by the Institute of Medicine [IOM] found evidence for a causal relationship between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome." (p.2 pp.1)
2. "DAPTACEL®  vaccine has not been evaluated for carcinogenic [cancer causing] or mutanegenic [DNA altering] potential or impairment of fertility." (p.7 pp.14) 
3. Pregnancy: "Animal Studies have not been conducted with DAPTACEL vaccine." (p.7 pp.2)

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DTaP Vaccine, INFANRIX®

Diphtheria and Tetanus Toxiods and Acellular Pertussis Vaccine Adsorbed

Ingredients*: Aluminum Hydroxide, Bovine Extract, Formaldehyde or Formalin, Glutaraldyde, 2-Phenoxyethanol, Polysorbate 80.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Fever, irritability, drowsiness, loss of appetite, vomiting, crying, crying (equal to or >1 hour), fussiness (prolonged crying and refusal to play or persistent crying that could not be comforted), crying equal to or >3 hrs, unusual crying, diarrhea, pain (any, or pain defined as sufficiently discomforting to interfere with daily activities, or pain defined as preventing normal daily activities and needing medical advice), hypotonic-hyporesponsive episodes, poor appetite, local redness, swelling tenderness, swelling of the injected limb involving an increase in limb circumference, extensive limb swelling, afebrile seizure, anaphylactic reaction, arthus-type hypersensitivity reactions, Sudden Infant Death Syndrome, cyanosis, cellulitis, convulsions, encephalopathy, hypotonia, respiratory tract infection, erythema, pruritus, rash, urticaria, ear pain, intussusception, idiopathic thrombocytopenic purpura, thrombocytopenia, encephalopathy.  Hospitalization and reported death rates were similar between INFANRIX and DT vaccine recipients.  A review by the IOM found evidence for a causal relationship between receipt of tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "The parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization.” (p.6-7)
2. "INFANARIX has not been evaluated for carcinogenic [cancer causing] or mutagenic  [DNA altering] potential, or for impairment of fertility.” (p.7 pp.3)
3. "The healthcare provider should inform the parents or guardians about the potential for adverse reactions that have been temporally associated with administration of INFANRIX or other vaccines containing similar components" (p.6 pp.8)

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DTaP Vaccine - TRIPEDIA®

Diphtheria and Tetanus Toxiods and Acellular Pertussis Vaccine Adsorbed

Ingredients*: Thimerosal [a vaccine preservative that is approximately 50% mercury by weight], gelatin, ammonium sulfate, aluminum potassium sulfate, Bovine Extract, sodium phosphate, formaldehyde or formalin, polysorbate 80.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Erythema, swelling, tenderness, fever, irritability, drowsiness, anorexia, vomiting, high-pitched cry, persistent cry, fussiness, hypotonic, hyporesponsive episode [HHE], febrile seizure, afebrile seizure, a nodule may be palpable at the injection site for several weeks, anaphylactic reaction, Arthus-type hypersensitivity reactions, a few cases of peripheral mononeuropathy and of cranial mononeuropathy have been reported, idiopathic thrombocytopenic purpura, Sudden Infant Death (SIDS), cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence, and apnea.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "Tripedia vaccine has not been evaluated for its carcinogenic [cancer causing] or mutagenic [DNA altering] potentials or impairment of fertility." (p.6 pp.9)
2. “A review by the Institute of Medicine (IOM) found evidence for a causal relationship between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.” (p.11 pp.2)

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DTaP/HepB/IPV Combination Vaccine, PEDIARIX®

Diphtheria and Tetanus Toxoids and Acellular Pertusis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined

Ingredients*: Aluminum Hydroxide, Aluminum Phosphate, Bovine Protein, Lactalbumin Hydrolysate, Formaldehyde or Formalin, Glutaraldyde, Monkey Kidney Tissue, Neomycin, 2-Phenoxyethanol, Polymyxin B, Polysorbate 80 Yeast Protein

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Seizures, fever, fever requiring medical attention, diabetes mellitus, chronic neutropenia, asthma, pain, redness, swelling, drowsiness, irritability/fussiness, loss of appetite, anaphylactic reaction, arthus-type hypersensitivity reactions, cyanosis, diarrhea, vomiting, fatigue, injection site cellulitis, Sudden Infant Death Syndrome, anaphylactoid reaction, hypersensitivity, upper respiratory tract infection, abnormal liver function tests, anorexia, bulging fontanelle, convulsions, depressed level of consciousness, febrile convulsion, hypotonia, hypotonic-hyporesponsive episodes, lethargy, somnolence, crying, insomnia, nervousness, restlessness, screaming, unusual crying, apnea, dyspnea, angioedema, erthema, rash, urticaria, pallor, petechiae, idiopathic thrombocytopenic purpura, lymphadenopathy, thrombocytopenia, abdominal pain, intussusception, nausea, asthenia, malaise, jaundice, anaphylactic shock, serum sickness-like disease, arthralgia, myalgia, encephalopathy, headache, alopecia, erthema multiforme pruritus, Stevens-Johnson syndrome.  Injection site reactions.

Other Highlights From the Manufacturer Prescribing Information***:

1. "A review by the IOM (Institute of Medicine) found evidence for a causal relationship between receipt of tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome." (p.15 pp.3) 
2. "The parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization." (p.9 pp.7)
3. "PEDIARIX® has not been evaluated for carcinogenic [cancer causing] or mutagenic [DNA altering] potential, or for impairment of fertility." (p.10 pp.2)
   

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Flu Vaccine FluMist®

Influenza Virus Vaccine Live, Intranasal

Ingredients*: Chick Kidney Cells, Egg Protein, Gentamicin Sulfate, Monosodium Glutamate, Sucrose Phosphate Glutamate Buffer.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Wheezing, significant respiratory symptoms, hypersensitivity, including anaphylactic reaction, hospitalizations ("Most hospitalizations observed were gastrointestinal and respiratory tract infections and occurred more than 6 weeks post-vaccination." p.2 pp.17), runny nose, nasal congestion, decreased appetite, irritability, decreased activity (lethargy), sore throat, headache, muscle aches, chills, fever, sneezing, tiredness/weakness, cough, chills, sinusitis, exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome), nausea, vomiting, diarrhea, anaphylactic reaction, facial edema and urticaria, Guillain-Barré syndrome, Bell's palsy, epistaxis, rash, herpes zoster [shingles].

Other Highlights: From the Manufacturer Prescribing Information***:

1. "Do not administer FluMist to children <24 months of age because of increased risk of hospitalization and wheezing observed in clinical trials. (p.1 pp.6)
2. "FluMist should not be administered to any individuals with asthma or children <5 years of age with recurrent wheezing because of the potential for increased risk of wheezing post-vaccination." (p.1 pp.6)
3. FluMist has not been evaluated for its carcinogenic [cancer causing] or mutagenic [DNA altering] potential or its potential to impair fertility." (p.3 pp.16)

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Flu Vaccine, FLUVIRIN®

(Flu)  Influenza Virus Vaccine

Ingredients*:  Thimerosal [a preservative that is approximately 50% mercury by weight] (single dose and multidose), Beta-Propiolactone, Egg Protein, Neomycin, Polymyxin b, Polyoxyethylene 9-10 nonyl phenol (Triton N-101, Octoxynol 9).

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Soreness, body aches, local pain and swelling, fever, malaise, myalgia, fever, irritability, Guillain-Barré syndrome, insomnia, seizure, erthema.  [NOTE: There were no post-marketing adverse events offered on the prescribing instructions.  However, there ere many safety statements that referred to a CDC/ACIP document with suggested guidelines for use – which is not the same as specific studies about this vaccine.]

Other Highlights: From the Manufacturer Prescribing Information***:

1. “Animal reproduction studies have not been conducted with FLUVIRIN®. It is also not known whether FLUVIRIN® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity." (p.3 pp.13). 
2. "The safety and immunogenicity of FLUVIRIN® have not been established in children <4 years of age." (p.3 pp.14) 
3. “Influenza virus is propagated in eggs for the preparation of influenza virus vaccine, thus, this vaccine should not be administered to anyone with a history of hypersensitivity [allergy] to chicken eggs, chicken, chicken feathers or chicken dander." (p.3 pp.8)

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Flu Vaccine FLUZONE®

Influenza Virus Vaccine

Ingredients*: Thimerosal [a preservative that is approximately 50% mercury by weight], egg protein, formaldehyde or formalin, gelatin, octoxinol-9 (Triton X-100).

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Guillain-Barré Syndrome (GBS), thrombocytopenia, lymphadenopathy, anaphylaxis, urticaria, angioedema, convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope, (shortly after vaccination), dizziness, paresthesia, vasculitis, vasodilatation/flushing, dyspnea, pharyngitis, rhinitis, Stevens-Johnson syndrome, fever, pain, prurtis, asthenia/fatigue, pain in extremities, (related to egg allergy) chest pain, hives, angioedema, allergic asthma, systemic anaphylaxis.  Neurological disorders temporally associated with influenza vaccination such as encephalopathy, optic neuritis/neuropathy, partial facial paralysis, and brachial plexus neuropathy have been reported.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "FLUZONE® vaccine has not been evaluated for carcinogenic [cancer causing] or mutagenic [DNA altering] potential, or for impairment of fertility." (p3. pp27.) 
2. Pediatric use: "The immune response and safety of FLUZONE vaccine was evaluated in 31 children between the ages of 6-26 months." (p.4 pp16.)

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Hep B Vaccine ENGERIX-B®

Hepatitis B Vaccine

Ingredients*: Aluminum Hydroxide, Phosphate Buffers, Thimerosal [a vaccine preservative approximately 50% mercury by weight], Yeast Protein.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information): Headache, dizziness, ecchymosis, sweating, malaise, chills, weakness, flushing, tingling, hypotension, influenza-like symptoms, upper respiratory tract illnesses, nausea, anorexia, abdominal pain/cramps, vomiting, constipation, diarrhea, lymphadenopathy, pain, rash, urticaria, petechiae, pruritus, erythema, somnolence, insomnia, irritability, agitation, arthralgia, myalgia, and back, anaphylaxis, erthema, multiforme including Stevens-Johnson syndrome, angioedema, arthritis, arthralgia/arthritis (usually transient), fever and dermatologic reactions, ecchymosis, erythema nodosum, tachycardia/palpitations, bronchospasm including asthma-like symptoms, abnormal liver function tests, dyspepsia, migraine, syncope, paresis, neuropathy including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell's palsy, transverse myelitis, optic neuritis, multiple sclerosis, seizures, thrombocytopenia, eczema, herpes zoster erthema nodosum, alopecia, conjunctivitis, keratitis, visual disturbances, vertigo, tinnitus, and earache, fatigue, induration, erythema, and swelling.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "ENGERIX-B has not been evaluated for carcinogenic [cancer causing] or mutagenic [DNA altering] potential, or for impairment of fertility." (p.7 pp.9)
2. "Animal reproductive studies have not been conducted with ENGERIX-B." (p.7 pp.10)

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Hep B Vaccine RECOMBIVAX HB®

Hepatitis B Vaccine (Recombinant)

Ingredients*: Aluminum Hydroxide, Aluminum Phosphate, Amino Acids, Dextrose, Formaldehyde or Formalin, Mineral Salts, Potassium Aluminum Sulfate, Soy Peptone, Yeast Protein

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Fever, diarrhea, fatigue/weakness, diminished appetite, rhinitis, injection site reactions, nodule formation, headache, malaise, nausea, pharyngitis, upper respiratory infection, sweating, achiness, sensation to warmth, lightheadedness, chills flushing, vomiting, abdominal pains/cramps, dyspepsia, influenza, cough, vertigo/dizziness, paresthesia, pruritus, rash, angioedema, urticaria, arthralgia including monoarticular myalgia, back pain, neck pain, shoulder pain, neck stiffness, lymphadenopathy, insomnia/disturbed sleep, earache, dysuria, hypotension, anaphylaxis, chest discomfort, bronchial spasm, palpitation, symptoms consistent with a hypotensive episode, hypersensitivity syndrome of delayed onset, elevation of liver enzymes, constipation, Guillain-Barré syndrome, multiple sclerosis (and exacerbation of), myelitis including transverse myelitis, seizure, febrile seizure, peripheral neuropathy including Bell's palsy, radiculopathy, herpes zoster, migraine, muscle weakness, hypesthesia, encephalitis, Stevens-Johnson syndrome, alopecia, petechiae, eczema, arthritis, pain in extremity, increased erythrocyte sedimentation rate, thrombocytopenia, systemic lupus erthematosus (SLE), lupus-like syndrome, vasculitis, polyarteritis nodosa, irritability, agitation, somnolence, optic neuritis, tinnitus, conjunctivitis, visual disturbances, syncope, and tachycardia.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "RECOMBIVAX HB® has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility."  (p.6 pp.12)
2. "Animal studies have not been conducted with the vaccine." (p.6 pp.13)
   

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HIB Vaccine ActHIB®

Haemophilus b Conjugate Vaccine (Tetanus Toxiod Conjugate)

Ingredients*: Ammonium Sulfate, Formaldehyde or Formalin, Sucrose.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Fever, irritability, lethargy, tenderness, erthema, induration, irritability, drowsiness, anorexia, diarrhea, vomiting, persistent crying, hypotonic/hyporesponsive episode (HHE), seizures, renal failure, Guillain-Barré Syndrome (GBS).  Pain, redness, swelling at injection site.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "ActHIB vaccine reconstituted with Sanofi Pasteur Inc. DTP or ActHIB vaccine reconstituted with Tripedia vaccine (TriHIBit vaccine) has not been evaluated for its carcinogenic [cancer causing], mutagenic [DNA altering] potential or impairment of fertility." (p.5 pp.16)
2. "The health-care provider should inform the parent or guardian of the benefits and risks of the vaccine." (p.5 pp.2)

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HIB/HepB Vaccine COMVAX®

Ingredients*: Amino Acids, Aluminum Hydroxyphosphate sulfate, dextrose, Formaldehyde or Formalin, Mineral Salts, Sodium Borate, Soy Peptone, Yeast Protein.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Irritability, somnolence, unusual high pitched crying, crying not otherwise specified, crying prolonged (>4 hrs), anorexia, vomiting, otitis media, fever, diarrhea, upper respiratory infection, rash rhinorrhea, respiratory congestion, cough, diaper rash, oral candidasis [yeast infection]. Seizure, febrile seizures,  anaphylaxis, agioedema, urticaria, erythema multiforme, thrombocytopenia.  Injection site pain/tenderness/soreness, swelling/induration, erythema.  Potential Adverse Effects reported in similar vaccine - RECOMBIVAX HB: lymphadenopathy, sterile injection-site abscess; pain at the injection site, symptoms of hypersensitivity including reports of rash pruritus, edema, arthralgia, dyspnea, hypotension, and ecchymosed, tachycardia, syncope, elevation of liver enzymes, increased erythrocyte sedimentation rate, arthritis, Bell's palsy, Guillain-Barré Syndrome, Stevens-Johnson syndrome; alopecia, conjunctivitis, visual disturbances.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "COMVAX® has not been evaluated for its carcinogenic [cancer causing] or mutagenic [DNA altering] potential, or its potential to impair fertility." (p.8 pp.3)
2. Precautions: "The packaging stopper of this product [as with many vaccines] contains natural rubber latex which may cause allergic reactions" (p.7 pp.10)

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HIB / Meningococcal, Liquid PedvaxHIB®

[Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]

Ingredients*: Aluminum Hydroxyphosphate Sulfate

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Irritability, sleepiness, crying, unusual high-pitched crying, prolonged crying (>4 hrs), diarrhea, vomiting, pain, otitis media, rash, upper respiratory infection, fever, tracheitis, urticaria, thrombocytopenia, early onset HIB disease, Guillain-Barré syndrome, lymphadenopathy, angioedema, febrile seizures, injection site pain/soreness, sterile injection site abscess erythema, local erythema, swelling.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "Liquid PedvaxHIB has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility." (p.6 pp.6)
2. "Animal studies have not been conducted with PedvaxHIB." (p.6 pp.7)

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MMR Vaccine, M-M-R II®

Measles, Mumps and Rubella Virus Vaccine Live

Ingredients*: Amino Acid, Bovine Albumin or Serum, Chick Embryo Fibroblasts, Human Serum Albumin, Gelatin, Glutamate, Neomycin, Phosphate Buffers, Sorbitol, Sucrose, Vitamins.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Panniculitis, atypical measles, fever, syncope, headache, dizziness, malaise, irritability, vasculitis, pancreatitis, diarrhea, vomiting, parotitis, nausea, diabetes melitus, thrombocytopenia, purpura, regional lymphadenopathy, leukocytosis, anaphylaxis and anaphylactoid reactions have been reported as well as related phenomena such as angioneurotic edema (including peripheral or facial edema) and bronchial spasm in individuals with or without an allergic history, arthritis, arthralgia, myalgia, encephalitis, encephalopathy, measles inclusion body encephalitis (MIBE), subacute sclerosing panencephalitis (SSPE), Guillain-Barré Syndrome (GBS), febrile convulsions, afebrile convulsions or seizures, ataxia polyneuritis, polyneuropathy, ocular palsies,  paresthesia, aseptic meningitis, pneumonia, pneumonitis, sore throat, cough, rhinitis, Stevens-Johnson syndrome, erythema multiforme, urticaria, rash, measles-like rash, pruritis, burning/stinging at injection site, wheal and flare, redness (erythema) swelling, induration, tenderness, vesiculation at injection site, nerve deafness, otitis media, retinitis, optic neuritis, papillitis, retrobulbar neuritis, conjunctivitis, epididymitis, orchitis, death.

Other Highlights: From the Manufacturer Prescribing Information***:

1. M-M-R II can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  Therefore, the vaccine should not be administered to pregnant female; furthermore, pregnancy should be avoided for 3 months following vaccination..." (p.6 pp.8)
2. "Anaphylactic or anaphylactoid reactions to neomycin (each dose of reconstituted vaccine contains approximately 25 mcg of neomycin)" (p.4 pp.3)
3. "Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination." (p.5 pp.7)

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Pneumococcal, PREVNAR®

Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Ingredients*: Yeast Extract, Aluminum Phosphate, Amino Acid, Soy Peptone.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Fever, seizure, febrile seizure, erythema, induration, tenderness interfered with limb movement, fever, drowsiness, decreased appetite, irritability, drowsiness, restless sleep, vomiting, diarrhea, fussiness, Sudden Infant Death (SIDS), febrile illness, acute gastroenteritis, urticaria-like rash, hypotonic-hyporesponsive episode (HHE), edema, pain or tenderness, redness, inflammation or skin discoloration, mass, or local hypersensitivity reaction, as with other aluminum-containing vaccines, a nodule may occasionally be palpable at the injection site for several weeks, blood and lymphatic system disorders, hypersensitivity reaction including face edema, dyspnea bronchospasm, anaphylactic, anaphylactiod reaction including shock, crying, angioneurotic edema, erythema multiforme.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "PREVNAR has not been evaluated for carcinogenic (cancer causing) or mutagenic (DNA altering) potential, or impairment of fertility" (p.14 pp.2)

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Poliovirus Vaccine, IPOL®

(IPV) Poliovirus Vaccine Inactivated

Ingredients*: Monkey Kidney Cells, Newborn Calf Serum, Formalin, 2-phenoxyethanol, formaldehyde, Neomycin, Streptomycin, and Polymyxin B.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Erythema, induration, pain, fever, sleepiness, fussiness, crying, persistent crying, swelling, tenderness, irritability, tiredness, anorexia, vomiting, GBS [Guillain-Barré syndrome], and death.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "Deaths have been reported in temporal association with the administration of IPV" (p.3 pp.16) 
2. “Long-term studies in animals to evaluate carcinogenic [cancer causing] potential or impairment of fertility have not been conducted.” (p.4 pp.14) 
3. "The health-care provider should provide the Vaccine Information Statements (VISs) which are required to be given with each immunization." (p.4 pp.11)

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Chicken Pox (Varicella), VARIVAX®

Varicella (Chicken Pox) Virus Vaccine

Ingredients*: Bovine Albumin or Serum, Ethylenediamine-Tetraacetic Acid Sodium (EDTA) [a chelation agent], Gelatin, Monosodium l-glutamate, MRC-5 DNA and Cellular Protein, Neomycin, Potassium Chloride, Potassium Phosphate Monobasic, Sodium Phosphate Monobasic, Sucrose.

Published data** (including side effects, adverse effects, potential adverse effects, reactions, reports, experiences, observations or occurrences after vaccination and post marketing experience from Manufacturer Prescribing Information):

Fever >102, Varicella-like rash, upper respiratory illness, cough, irritability/nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching, pneumonitis, febrile seizures, abdominal pain, loss of appetite, otitis, itching, constipation, cold/canker sore, anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema and peripheral edema, anaphylaxis, thrombocytopenia, encephalitis, transverse myelitis, Guillain-Barré Syndrome, Bell's palsy, ataxis, non-febrile seizures, aseptic meningitis, dizziness, paresthesia, pharyngitis, pneumonia / pneumonitis, Stevens-Johnson syndrome, erythema multiforme, Henoch-Schonlein purpura. Secondary bacterial infections of the skin and soft tissue.

Other Highlights: From the Manufacturer Prescribing Information***:

1. "VARIVAX has not been evaluated for its carcinogenic [cancer causing] or mutagenic [DNA altering] potential or its potential to impair fertility." (p.8 pp.8)"
2. "Animal reproduction studies have not been conducted with VARIVAX.  It is also not known whether VARIVAX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity." (p.8 pp.9) 
3. "As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials." (p.10 pp.1) 
4. Contraindication Example: "A history of anaphylactiod reaction to neomycin [an antibiotic] (each dose of reconstituted vaccine contains trace quantities of neomycin)" (p.6 pp.7)

* Vaccine Excipient & Media Summary, Part 2, Excipients included in U.S. Vaccines, by Vaccine. Downloaded 11/08 from: www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

** This list contains a combination of many adverse post-vaccination occurrences, and possible occurrences, that have been published in the manufacturer’s documents. Any use of [brackets] is information added by the author.  This list may not contain all the adverse occurrences; it may contain typographical errors, and obviously does not take the place of reading the most current manufacturer’s document in its entirety.  For more information about the product manufacturer’s vaccine documents visit their website, or www.GenerationRescue.org/vaccine_information.