Study: NCT00133575

Adverse event: Amenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 10 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 10 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 10 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Blood pressure measurement
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood pressure systolic decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 10 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Endodontic procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 10 at risk

Adverse event: Appetite disorder - post dose 2
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the diary card as "Change in appetite"
Frequency: 1 affected / 10 at risk

Adverse event: Chills - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Chills"
Frequency: 1 affected / 10 at risk

Adverse event: Chills - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Chills"
Frequency: 2 affected / 10 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 7 affected / 10 at risk

Adverse event: Injection site erythema - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 8 affected / 10 at risk

Adverse event: Injection site erythema - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 2 affected / 2 at risk

Adverse event: Fatigue - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 3 affected / 10 at risk

Adverse event: Fatigue - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 3 affected / 10 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 1 affected / 10 at risk

Adverse event: Headache - post dose 2
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 4 affected / 10 at risk

Adverse event: Injection site induration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 4 affected / 10 at risk

Adverse event: Injection site induration - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 5 affected / 10 at risk

Adverse event: Injection site induration - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 2 affected / 2 at risk

Adverse event: Injection site pruritus - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 1 affected / 10 at risk

Adverse event: Injection site pruritus - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 2 affected / 2 at risk

Adverse event: Arthralgia - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 1 affected / 2 at risk

Adverse event: Joint range of motion decreased - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Limitation of motion"
Frequency: 2 affected / 10 at risk

Adverse event: Myalgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 3 affected / 10 at risk

Adverse event: Myalgia - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 1 affected / 2 at risk

Adverse event: Nausea - post dose 1
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 1 affected / 10 at risk

Adverse event: Nausea - post dose 2
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Temperature", taken orally and considered fever if \>= 37.7 degrees celsius
Frequency: 1 affected / 10 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 2 affected / 10 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 1 affected / 10 at risk

Adverse event: Injection site pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 2 affected / 2 at risk

Adverse event: Tenderness - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 2 affected / 10 at risk

Adverse event: Tenderness - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 2 affected / 10 at risk

Adverse event: Axillary pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 1 affected / 2 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 10 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Electrocardiogram PR prolongation
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Electrocardiogram abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Appetite disorder - post dose 1
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the diary card as "Change in appetite"
Frequency: 1 affected / 10 at risk

Adverse event: Appetite disorder - post dose 2
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the diary card as "Change in appetite"
Frequency: 1 affected / 10 at risk

Adverse event: Chills - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Chills"
Frequency: 1 affected / 10 at risk

Adverse event: Chills - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Chills"
Frequency: 1 affected / 10 at risk

Adverse event: Chills - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Chills"
Frequency: 1 affected / 5 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 2 affected / 10 at risk

Adverse event: Injection site erythema - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 1 affected / 10 at risk

Adverse event: Injection site erythema - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 5 affected / 5 at risk

Adverse event: Fatigue - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 5 affected / 10 at risk

Adverse event: Fatigue - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 3 affected / 5 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 4 affected / 10 at risk

Adverse event: Headache - post dose 2
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 3 affected / 10 at risk

Adverse event: Headache - post Dryvax
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 3 affected / 5 at risk

Adverse event: Injection site induration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 1 affected / 10 at risk

Adverse event: Injection site induration - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 2 affected / 10 at risk

Adverse event: Injection site induration - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 5 affected / 5 at risk

Adverse event: Injection site pruritus - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 2 affected / 10 at risk

Adverse event: Injection site pruritus - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 4 affected / 5 at risk

Adverse event: Arthralgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 1 affected / 5 at risk

Adverse event: Joint range of motion decreased - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Limitation of motion"
Frequency: 1 affected / 10 at risk

Adverse event: Joint range of motion decreased - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Limitation of motion"
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 5 affected / 10 at risk

Adverse event: Myalgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 5 affected / 10 at risk

Adverse event: Myalgia - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 2 affected / 5 at risk

Adverse event: Nausea - post dose 1
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 4 affected / 10 at risk

Adverse event: Nausea - post dose 2
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 2 affected / 10 at risk

Adverse event: Pyrexia - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Temperature", taken orally and considered fever if \>= 37.7 degrees celsius
Frequency: 1 affected / 10 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 5 affected / 10 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 5 affected / 10 at risk

Adverse event: Injection site pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 3 affected / 5 at risk

Adverse event: Rash - post dose 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Solicited on the diary card as "Rash"
Frequency: 1 affected / 10 at risk

Adverse event: Rash - post dose 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Solicited on the diary card as "Rash"
Frequency: 1 affected / 10 at risk

Adverse event: Tenderness - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 3 affected / 10 at risk

Adverse event: Axillary pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 1 affected / 5 at risk

Adverse event: Swelling - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm swelling"
Frequency: 1 affected / 10 at risk

Adverse event: Swelling - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm swelling"
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Limb mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Smear cervix abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Appetite disorder - post Dryvax
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the diary card as "Change in appetite"
Frequency: 2 affected / 7 at risk

Adverse event: Chills - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Chills"
Frequency: 1 affected / 7 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 4 affected / 10 at risk

Adverse event: Injection site erythema - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 2 affected / 8 at risk

Adverse event: Injection site erythema - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 7 affected / 7 at risk

Adverse event: Fatigue - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 3 affected / 8 at risk

Adverse event: Fatigue - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 4 affected / 7 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 1 affected / 10 at risk

Adverse event: Headache - post dose 2
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 1 affected / 8 at risk

Adverse event: Headache - post Dryvax
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 1 affected / 7 at risk

Adverse event: Injection site induration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 2 affected / 10 at risk

Adverse event: Injection site induration - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 2 affected / 8 at risk

Adverse event: Injection site induration - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 7 affected / 7 at risk

Adverse event: Injection site pruritus - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 1 affected / 10 at risk

Adverse event: Injection site pruritus - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 2 affected / 8 at risk

Adverse event: Injection site pruritus - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 6 affected / 7 at risk

Adverse event: Arthralgia - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 1 affected / 7 at risk

Adverse event: Joint range of motion decreased - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Limitation of motion"
Frequency: 1 affected / 7 at risk

Adverse event: Myalgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 2 affected / 10 at risk

Adverse event: Myalgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 3 affected / 7 at risk

Adverse event: Nausea - post Dryvax
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 2 affected / 7 at risk

Adverse event: Pyrexia - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Temperature", taken orally and considered fever if \>= 37.7 degrees celsius
Frequency: 1 affected / 7 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 6 affected / 10 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 6 affected / 8 at risk

Adverse event: Injection site pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 4 affected / 7 at risk

Adverse event: Rash - post dose 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Solicited on the diary card as "Rash"
Frequency: 1 affected / 10 at risk

Adverse event: Tenderness - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 2 affected / 10 at risk

Adverse event: Tenderness - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 3 affected / 8 at risk

Adverse event: Axillary pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 1 affected / 8 at risk

Adverse event: Axillary pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 3 affected / 7 at risk

Adverse event: Swelling - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm swelling"
Frequency: 1 affected / 7 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 10 at risk

Adverse event: Pilonidal disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 6 affected / 10 at risk

Adverse event: Injection site erythema - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 8 affected / 10 at risk

Adverse event: Injection site erythema - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 6 affected / 6 at risk

Adverse event: Fatigue - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 4 affected / 10 at risk

Adverse event: Fatigue - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 3 affected / 10 at risk

Adverse event: Fatigue - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 1 affected / 6 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 2 affected / 10 at risk

Adverse event: Injection site induration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 8 affected / 10 at risk

Adverse event: Injection site induration - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 8 affected / 10 at risk

Adverse event: Injection site induration - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 6 affected / 6 at risk

Adverse event: Injection site pruritus - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 3 affected / 10 at risk

Adverse event: Injection site pruritus - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 6 affected / 10 at risk

Adverse event: Injection site pruritus - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 3 affected / 6 at risk

Adverse event: Arthralgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 3 affected / 10 at risk

Adverse event: Myalgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 3 affected / 10 at risk

Adverse event: Nausea - post dose 2
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 2 affected / 10 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 8 affected / 10 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 9 affected / 10 at risk

Adverse event: Injection site pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 1 affected / 6 at risk

Adverse event: Tenderness - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 8 affected / 10 at risk

Adverse event: Tenderness - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 4 affected / 10 at risk

Adverse event: Axillary pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 1 affected / 6 at risk

Adverse event: Swelling - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm swelling"
Frequency: 1 affected / 6 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 10 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 10 at risk

Adverse event: Appetite disorder - post Dryvax
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the diary card as "Change in appetite"
Frequency: 1 affected / 9 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 9 affected / 10 at risk

Adverse event: Injection site erythema - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 10 affected / 10 at risk

Adverse event: Injection site erythema - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 7 affected / 9 at risk

Adverse event: Fatigue - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 3 affected / 10 at risk

Adverse event: Fatigue - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 3 affected / 10 at risk

Adverse event: Fatigue - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 1 affected / 9 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 5 affected / 10 at risk

Adverse event: Headache - post dose 2
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 4 affected / 10 at risk

Adverse event: Headache - post Dryvax
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 1 affected / 9 at risk

Adverse event: Injection site induration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 9 affected / 10 at risk

Adverse event: Injection site induration - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 10 affected / 10 at risk

Adverse event: Injection site induration - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 7 affected / 9 at risk

Adverse event: Injection site pruritus - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 6 affected / 10 at risk

Adverse event: Injection site pruritus - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 6 affected / 10 at risk

Adverse event: Injection site pruritus - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 5 affected / 9 at risk

Adverse event: Arthralgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 1 affected / 10 at risk

Adverse event: Joint range of motion decreased - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Limitation of motion"
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 2 affected / 10 at risk

Adverse event: Nausea - post Dryvax
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 1 affected / 9 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 7 affected / 10 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 7 affected / 10 at risk

Adverse event: Injection site pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 2 affected / 9 at risk

Adverse event: Rash - post dose 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Solicited on the diary card as "Rash"
Frequency: 2 affected / 10 at risk

Adverse event: Tenderness - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 5 affected / 10 at risk

Adverse event: Tenderness - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 2 affected / 10 at risk

Adverse event: Axillary pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 1 affected / 10 at risk

Adverse event: Axillary pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 1 affected / 9 at risk

Adverse event: Swelling - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm swelling"
Frequency: 1 affected / 9 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 10 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 10 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Lactose intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Appetite disorder - post dose 1
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the diary card as "Change in appetite"
Frequency: 4 affected / 10 at risk

Adverse event: Appetite disorder - post dose 2
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the diary card as "Change in appetite"
Frequency: 1 affected / 10 at risk

Adverse event: Chills - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Chills"
Frequency: 1 affected / 10 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 3 affected / 10 at risk

Adverse event: Injection site erythema - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 4 affected / 10 at risk

Adverse event: Fatigue - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 5 affected / 10 at risk

Adverse event: Fatigue - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 5 affected / 10 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 3 affected / 10 at risk

Adverse event: Headache - post dose 2
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 3 affected / 10 at risk

Adverse event: Injection site induration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 1 affected / 10 at risk

Adverse event: Injection site induration - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 3 affected / 10 at risk

Adverse event: Injection site pruritus - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 2 affected / 10 at risk

Adverse event: Injection site pruritus - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 1 affected / 10 at risk

Adverse event: Arthralgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 1 affected / 10 at risk

Adverse event: Joint range of motion decreased - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Limitation of motion"
Frequency: 2 affected / 10 at risk

Adverse event: Joint range of motion decreased - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Limitation of motion"
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 5 affected / 10 at risk

Adverse event: Myalgia - post dose 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 4 affected / 10 at risk

Adverse event: Nausea - post dose 1
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 2 affected / 10 at risk

Adverse event: Pyrexia - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Temperature", taken orally and considered fever if \>= 37.7 degrees celsius
Frequency: 1 affected / 10 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 9 affected / 10 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 6 affected / 10 at risk

Adverse event: Axillary pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 1 affected / 10 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Skin erosion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Appetite disorder - post Dryvax
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited on the diary card as "Change in appetite"
Frequency: 2 affected / 7 at risk

Adverse event: Injection site erythema - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Erythema (redness)", measured in millimeters
Frequency: 3 affected / 12 at risk

Adverse event: Injection site erythema - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 7 affected / 7 at risk

Adverse event: Fatigue - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 1 affected / 12 at risk

Adverse event: Fatigue - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Feeling tired"
Frequency: 1 affected / 11 at risk

Adverse event: Headache - post dose 1
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 1 affected / 12 at risk

Adverse event: Headache - post Dryvax
Serious: no
Organ System: Nervous system disorders
Notes: Solicited on the diary card as "Headache"
Frequency: 1 affected / 7 at risk

Adverse event: Injection site induration - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Induration (Bump/Swelling)", measured in millimeters
Frequency: 2 affected / 12 at risk

Adverse event: Injection site induration - post Dryvax
Serious: no
Organ System: General disorders
Notes: Measured in millimeters at follow up visits by clinic staff
Frequency: 7 affected / 7 at risk

Adverse event: Injection site pruritus - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Itchiness at vaccination site"
Frequency: 6 affected / 7 at risk

Adverse event: Arthralgia - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Joint pain"
Frequency: 1 affected / 7 at risk

Adverse event: Myalgia - post dose 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 1 affected / 12 at risk

Adverse event: Myalgia - post Dryvax
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Solicited on the diary card as "Muscle aches"
Frequency: 2 affected / 7 at risk

Adverse event: Nausea - post Dryvax
Serious: no
Organ System: Gastrointestinal disorders
Notes: Solicited on the diary card as "Nausea"
Frequency: 1 affected / 7 at risk

Adverse event: Pyrexia - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Temperature", taken orally and considered fever if \>= 37.7 degrees celsius
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pain - post dose 1
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 1 affected / 12 at risk

Adverse event: Injection site pain - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 1 affected / 11 at risk

Adverse event: Injection site pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Pain at injection site"
Frequency: 4 affected / 7 at risk

Adverse event: Rash - post dose 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Solicited on the diary card as "Rash"
Frequency: 1 affected / 12 at risk

Adverse event: Tenderness - post dose 2
Serious: no
Organ System: General disorders
Notes: Solicited at follow up visits as "Tenderness"
Frequency: 1 affected / 11 at risk

Adverse event: Axillary pain - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm pain"
Frequency: 4 affected / 7 at risk

Adverse event: Swelling - post Dryvax
Serious: no
Organ System: General disorders
Notes: Solicited on the diary card as "Underarm swelling"
Frequency: 4 affected / 7 at risk