Read the fine print, part two – Nearly 400 adverse reactions listed in vaccine package inserts
08/16/2020 // News Editors // Views

Package inserts are available online for all vaccines licensed in the U.S. In addition to containing bits of practical information for the clinicians who administer the vaccines, the inserts provide members of the public with one of their only opportunities to learn about a vaccine’s contraindications, warnings, precautions and—perhaps most importantly—potential adverse reactions.

(Article republished from ChildrensHealthDefense.org)

The inserts communicate the information about adverse reactions in two distinct sections: “Clinical trials experience” (Section 6.1) and “Data from postmarketing experience” from the U.S. or other countries (Section 6.2). In April, 2020, Children’s Health Defense summarized the postmarketing data for over three dozen vaccines given routinely to American infants, children and adolescents. That tally showed that vaccines touted for the prevention of 13 illnesses (Table 1) have been linked to at least 217 adverse medical outcomes reported post-licensure, including serious infections, autoimmune conditions, life-threatening allergies and death.

As noted in April, the postmarketing list is far from exhaustive, because manufacturers have the latitude to decide which outcomes to list in the inserts—using loose criteria determined by severity, frequency of reporting and “strength of evidence for a causal relationship.” In addition, vaccine adverse events are notoriously underreported, not least because medical schools do not teach doctors to recognize vaccine injuries. But what would the picture look like if the adverse reactions observed during clinical trials were also added to the list?

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This combination of clinical trial and postmarketing data presents a dramatic picture, with almost double the total number of undesirable post-vaccination outcomes …

Double trouble

Children’s Health Defense can now answer that question. The revised chart (Table 2) includes the adverse reactions reported in the clinical trial sections of 41 vaccine brands covering diphtheria, Haemophilus influenzae type b, hepatitis A, hepatitis B, human papillomavirus, influenza, meningococcal infection, pertussis, pneumococcal infection, polio, rotavirus, tetanus and varicella. This combination of clinical trial and postmarketing data presents a dramatic picture, with almost double the total number of undesirable post-vaccination outcomes—397 different types of reactions reported pre- and post-licensure.

Although roughly 400 adverse events is a sobering number, again, it is probably an underestimate. This is because most clinical trials follow participants for an absurdly short period of time—three days here, seven days there—and do not capture problems that arise beyond that brief window, even though clinicians recognize (and the scientific literature confirms) that vaccine reactions are not always immediate or acute. Moreover, even for those few days of monitoring, the inserts are often short on details, citing only a smattering of adverse events collected from a predetermined list of “solicited” reactions and only sometimes accepting “unsolicited” feedback. In addition, the fact that vaccine clinical trials typically compare vaccine against vaccine rather than vaccine against inert placebo makes it easy to divert attention from specific adverse reactions by simply citing “similar rates” of adverse reactions in both groups.

… and that vaccines can cause the very illnesses—or adverse consequences of those illnesses—that they are supposed to prevent.

Clinical trial themes

The April discussion of postmarketing adverse events noted several themes, including the facts that all vaccines are capable of producing adverse reactions (though Gardasil and Gardasil 9 are macabre standouts) and that vaccines can cause the very illnesses—or adverse consequences of those illnesses—that they are supposed to prevent. The clinical trial data reinforce these points and also highlight some new themes:

  • The adverse reactions reported following clinical trials do not necessarily match up to the adverse reactions reported post-licensure. This is particularly the case for vaccine-associated deaths; whereas the April postmarketing-only list included just two categories of death associated with six vaccines, the addition of clinical trial data brings the total up to 40 types of death associated with 13 vaccines.
  • Sizeable proportions of participants in vaccine clinical trials experience unpleasant reactions, including fever, chills, pain, nausea, diarrhea, vomiting, headache, rash, loss of appetite and irritability.  For example, in clinical trials for the five-pronged Pentacel vaccine (diphtheria, tetanus, pertussis, Haemophilus influenzae type b and polio)—given as a four-dose series beginning at six weeks of age—almost half of the young children (48%) experienced injection-site “tenderness” after the first dose (defined as “whimpering” or crying when the arm or leg was touched or moved); about the same percentage (46%) experienced “lethargy,” 59% cried “inconsolably” and 77% were “fussy” or “irritable.” In adolescents, the Adacel vaccine given as a booster for tetanus-diphtheria-acellular pertussis (Tdap) produced injection-site pain in almost eight in ten teens (78%), and one in five (20%) study participants experienced pain rated as “moderate to severe.” More than two-fifths (44%) suffered from headaches.
  • Clinical trials also document more serious reactions with the potential to cause longer-term problems. Adverse reactions of particular concern—especially in the young—include asthma, seizures, heart problems, sleep problems and joint and muscle pain. Nine vaccines list anorexia as a clinical trial reaction. Surprisingly, while numerous package inserts mention serious and potentially lifelong conditions like transverse myelitis (11 vaccines) and Guillain-Barré syndrome (20 vaccines) in their postmarketing section, only a few list them as a clinical trial outcome despite hundreds of published studies pointing to post-vaccination onset.
  • Intentional and unintentional injuries are more prominent in the clinical trial data than in the postmarketing reports, particularly in association with Gardasil and certain meningococcal vaccines (abbreviated as MenACWY). These events include alcohol intoxication and drug overdose; suicidal thoughts or attempts; head and limb injuries; and falls resulting in injuries. Noting that syncope (fainting) is a common post-vaccination reaction in adolescents and young adults, the CDC states, “In 2005, the Vaccine Adverse Event Reporting System (VAERS) began detecting a trend of increasing syncope reports that coincided with the licensure of 3 vaccines for adolescents: human papillomavirus (HPV), MenACWY, and Tdap. Of particular concern among adolescents has been the risk for serious secondary injuries, including skull fracture and cerebral hemorrhage.” (One of the robustly healthy volunteers in the current clinical trials for the Moderna Covid-19 vaccine illustrated this very point, narrowly escaping injury when his girlfriend caught him in the midst of a fainting episode.)
  • Illustrating how vaccines can cause what they are supposed to prevent, the clinical trials for the ProQuad measles-mumps-rubella-varicella vaccine—intended to prevent infections associated with rashes—highlighted an astounding array of rashes. The ProQuad insert lists seven different types of rash-related adverse reactions: “rash,” “injection-site rash,” “measles-like rash,” “rubella-like rash,” “varicella-like rash,” “vesicular rash” and “viral exanthema” (an eruptive rash associated with viral infections). Across both the clinical trial and postmarketing data, ProQuad injection also appears to precede numerous infections, including “atypical measles” and measles, varicella (chickenpox), bronchitis, cellulitis and other skin infections, herpes simplex (cold sores), herpes zoster (shingles), influenza or “influenza-like illness,” meningitis, pneumonia, respiratory tract infections, sinusitis, sore throats and other viral infections.

Researchers interested in solutions rather than convenient coronavirus cover stories would do well to review the information contained in vaccine package inserts.

Mysteries explained?

One of the autoimmune conditions encountered during the clinical trials for meningococcal and rotavirus vaccines (and also reported post-licensure) is a condition called Kawasaki disease (KD). Diagnosed solely on the basis of symptoms (high fever plus symptoms such as rash, redness and lymph node swelling), KD came out of nowhere in the 1960s and 1970s when childhood vaccine programs were starting to gear up. The published literature confirms Bexero meningococcal B and rotavirus vaccination as likely triggers for KD and, in addition, points to numerous other vaccines as possible culprits, including those for hepatitis Ahepatitis BinfluenzaPrevnar-13 and multiple vaccines administered in a single health care visit. Canadian researchers have identified KD as a “condition of interest” for pediatric vaccine safety surveillance.

Ordinarily fairly obscure, KD made headlines this year when researchers started speculating that it might be one of the apparently myriad faces of SARS-CoV-2. In the UK—the first country in the world to start administering (in 2015) three doses of Bexero to infants—researchers were also the first to suggest that KD might be Covid-19-related. This week, a different group of researchers raised the same question about another low-profile autoimmune condition, myasthenia gravis, asking whether it, too, could be connected to SARS-CoV-2. Researchers interested in solutions rather than convenient coronavirus cover stories would do well to review the information contained in vaccine package inserts. This information clearly points the way to a different set of questions and answers, pertaining not only to autoimmunity but also to the many other health problems besieging American children.

Table 1. Vaccine package inserts reviewed

Type

of Vaccine

Brand Name

Manufacturer

Vaccines containing

diphtheria, tetanus and pertussis components

Adacel (Tdap) Sanofi Pasteur
Boostrix (Tdap) GlaxoSmithKline

(GSK)

Daptacel (DTaP) Sanofi
Diphtheria

and Tetanus Toxoids Adsorbed (DT)

Sanofi
Infanrix (DTaP) GSK
Kinrix (DTaP-IPV) GSK
Pediarix (DTaP-HepB-IPV) GSK
Pentacel (DTaP-IPV/Hib) Sanofi
Quadracel (DTaP-IPV) Sanofi
Tdvax (Td) MassBiologics
Tenivac (Td) Sanofi
Haemophilus

influenzae type b (Hib)

ActHIB Sanofi
Hiberix GSK
PedvaxHIB Merck
Hepatitis A and/or B Engerix-B (HepB) GSK
Havrix (HepA) GSK
Recombivax HB (HepB) Merck
Twinrix (HepA/HepB) GSK
Vaqta (HepA) Merck
Human papillomavirus (HPV) Gardasil Merck
Gardasil 9 Merck
Influenza Afluria Quadrivalent Sequirus
Fluarix GSK
Flublok

Quadrivalent (age 18 and older)

Protein Sciences

Corporation

Flucelvax Sequirus
Flulaval Quadrivalent GSK
FluMist AstraZeneca
Fluzone Quadrivalent Sanofi
Meningococcal A, C, W and/or Y Menactra Sanofi
Menomune Sanofi
Menveo GSK
Meningococcal B Bexero GSK
Trumenba Pfizer
Measles-mumps-rubella

(MMR) and MMR+varicella (MMRV)

MMR-II Merck
Proquad Merck
Pneumococcal Prevnar-13 Pfizer
Pneumovax-23 Merck
Inactivated polio (IPV) IPOL Sanofi
Rotavirus vaccines Rotarix GSK
RotaTeq Merck
Varicella Varivax Merck

Table 2. Clinical trial and post-marketing adverse events reported in vaccine package inserts, by body system

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



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