Study: NCT05400746

Adverse event: Nausea / Stomach issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Inc Acid Reflux, Gastrocolic, Gastroesophageal reflux, Stomach cramps
Frequency: 2 affected / 8 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: inc: Dry Cough
Frequency: 3 affected / 8 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 8 at risk

Adverse event: Heavy feeling to arm of vaccination
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Itching to vaccination site (pruritus)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Notes: Inc Itchy Throat
Frequency: 3 affected / 8 at risk

Adverse event: Large Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Epididymitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Inc Runny Nose
Frequency: 4 affected / 8 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: General disorders
Notes: These are the reports that were raised as AEs, as opposed to just being recorded on the participant diaries.
Frequency: 1 affected / 8 at risk

Adverse event: Pangs in hands
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Restlessness/insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Right upper limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Inc: Right Arm Pain, "Right Shoulder, Right Back and Right knee Pain"
Frequency: 2 affected / 8 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sneezing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Inc Somnolence
Frequency: 2 affected / 8 at risk

Adverse event: Throat ulcers
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Tingling in left wrist
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Twisted ankle
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain at injection site - moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 2 affected / 8 at risk

Adverse event: Pain at injection site - mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 7 affected / 8 at risk

Adverse event: Itch at injection site - moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 1 affected / 8 at risk

Adverse event: Itch at injection site - mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 2 affected / 8 at risk

Adverse event: Warmth at injection site - moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 1 affected / 8 at risk

Adverse event: Warmth at injection site - mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 4 affected / 8 at risk

Adverse event: Redness at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: No redness was reported post Day7 after vaccination in participant diaries
Frequency: 7 affected / 8 at risk

Adverse event: Arthralgia - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Arthralgia - Mild
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: From participant diaries
Frequency: 5 affected / 8 at risk

Adverse event: Myalgia - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Myalgia - Mild
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: From participant diaries
Frequency: 5 affected / 8 at risk

Adverse event: Fever - Moderate
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Fever - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 2 affected / 8 at risk

Adverse event: Headache - Moderate
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 4 affected / 8 at risk

Adverse event: Headache - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 6 affected / 8 at risk

Adverse event: Fatigue - Severe
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue - Moderate
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 2 affected / 8 at risk

Adverse event: Fatigue - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 6 affected / 8 at risk

Adverse event: Nausea - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 2 affected / 8 at risk

Adverse event: Malaise - Moderate
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Malaise - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 5 affected / 8 at risk

Adverse event: Nausea / Stomach issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Inc Acid Reflux, Gastrocolic, Gastroesophageal reflux, Stomach cramps
Frequency: 2 affected / 8 at risk

Adverse event: Back and shoulder ache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: inc: Dry Cough
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Impetigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Infected Wisdom Tooth
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Injury to Coccyx
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Insect bites
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Notes: Inc Itchy Throat
Frequency: 1 affected / 8 at risk

Adverse event: Jaw Ache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dysmenorrhea/longer menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Inc: Longer menstrual bleeding, Period Pain
Frequency: 2 affected / 8 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Inc Runny Nose
Frequency: 1 affected / 8 at risk

Adverse event: Pain at injection site
Serious: no
Organ System: General disorders
Notes: These are the reports that were raised as AEs, as opposed to just being recorded on the participant diaries.
Frequency: 1 affected / 8 at risk

Adverse event: Sinus pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain at injection site - moderate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Pain at injection site - mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 6 affected / 8 at risk

Adverse event: Warmth at injection site - mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: From participant diaries
Frequency: 6 affected / 8 at risk

Adverse event: Redness at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: No redness was reported post Day7 after vaccination in participant diaries
Frequency: 5 affected / 8 at risk

Adverse event: Arthralgia - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: From participant diaries
Frequency: 2 affected / 8 at risk

Adverse event: Arthralgia - Mild
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Myalgia - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: From participant diaries
Frequency: 2 affected / 8 at risk

Adverse event: Myalgia - Mild
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: From participant diaries
Frequency: 5 affected / 8 at risk

Adverse event: Fever - Moderate
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 2 affected / 8 at risk

Adverse event: Fever - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Headache - Moderate
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 4 affected / 8 at risk

Adverse event: Headache - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 7 affected / 8 at risk

Adverse event: Fatigue - Moderate
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Fatigue - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 7 affected / 8 at risk

Adverse event: Nausea - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 3 affected / 8 at risk

Adverse event: Malaise - Moderate
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 1 affected / 8 at risk

Adverse event: Malaise - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 6 affected / 8 at risk

Adverse event: Bruising to vaccination site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk

Adverse event: Redness at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: No redness was reported post Day7 after vaccination in participant diaries
Frequency: 1 affected / 1 at risk

Adverse event: Headache - Mild
Serious: no
Organ System: General disorders
Notes: From participant diaries
Frequency: 1 affected / 1 at risk