Development and evaluation of a standardized questionnaire for identifying adverse events in vaccine clinical trials

Pharmacoepidemiology and Drug Safety

Volumn 9, Issue 6, 2000, Pages 457-471

  Coplan, P ^a,b   Chiacchierini, L ^a   Nikas, A ^a   Shea, J ^b   Baumritter, A ^b   Beutner, K ^c   Cassidy, W ^d   Sawyer, M ^e   Watson, B ^a   Heyse, J ^a   Guess, H ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c Health Science Center ^*

^d LOUISIANA STATE UNIVERSITY   (United States)

^e EINSTEIN MEDICAL CENTER   (United States)

Author keywords

Adverse events; Clinical trials; Measurement; Questionnaire evaluation; Vaccine

Indexed keywords

CHICKENPOX VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; DIPHTHERIA TETANUS VACCINE; HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HEPATITIS A VACCINE; HEPATITIS B VACCINE; INFLUENZA VACCINE; JAPANESE ENCEPHALITIS VACCINE; MEASLES MUMPS RUBELLA VACCINE; PNEUMOCOCCUS VACCINE; POLIOMYELITIS VACCINE; TYPHIM; TYPHOID VACCINE; VACCINE; YELLOW FEVER VACCINE;

ADOLESCENT; ADULT; ADVERSE DRUG REACTION; AGED; ARTICLE; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA BASE; DEVELOPMENT; DRUG TOLERABILITY; ERYTHEMA; EVALUATION; FATIGUE; FEMALE; FLU LIKE SYNDROME; HEADACHE; HUMAN; INFANT; INFORMATION PROCESSING; INJECTION PAIN; INJECTION SITE; INTERVIEW; IRRITABILITY; MAJOR CLINICAL STUDY; MALE; MEDICAL EXPERT; NAUSEA; NURSE; OTALGIA; PRIORITY JOURNAL; QUESTIONNAIRE; SELF REPORT; SIDE EFFECT; SKIN EDEMA; SOMNOLENCE; STANDARDIZATION; TELEPHONE; VACCINATION;

EID: 0034518195     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/1099-1557(200011)9:6<457::AID-PDS529>3.0.CO;2-R     Document Type: Article

References (12)

1. Assessment of acute pediatric pain: Do child self-report, parent ratings, and nurse ratings measure the same phenomenon?
2. Extensive swelling after booster doses of acellular pertussis-tetanus-diphtheria vaccines
3. MMR2 immunization at 4 to 5 years and 10 to 12 years of age: A comparison of adverse clinical events after immunization in the Vaccine Safety Datalink project
4. Effect of gender, race and parental education on immunogenicity and reported reactogenicity of acellular and whole-cell pertussis vaccines
5. Gender differences in local and systemic reactions to inactivated influenza vaccine, established by a meta-analysis of fourteen independent studies
6. Relating spontaneous adverse experience reports to scores on a questionnaire querying tolerability
7. Adverse reactions associated with simultaneous administration of multiple vaccines to travelers
8. Reactions following administration of influenza vaccine alone or with pneumococcal vaccine to the elderly
9. Screening for a raised rectal temperature in Africa
10. Defining the key parameters for comparing reactions among acellular and whole-cell pertussis vaccines