Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
NCT ID:
NCT04816669
Description:
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Frequency Threshold:
0
Time Frame:
AEs and SAEs- For Part 1 and Part 2: Day 1 of Dose 1 up to 1 Month after Dose 2 (approximately2 months); Dose 3: From Dose 3 to 1 Month after Dose 3 (up to 1 month); Local reactions/systemic events (systematic collection): Within 7 days after each dose
Study:
NCT04816669
Study Brief:
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BNT162b2 Frozen-Liquid With Ready-to-use (RTU) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with RTU as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. | 0 | None | 0 | 35 | 31 | 35 | View |
| BNT162b2 Lyophilized SDV: Part 1 | Participants were randomized to receive 30 mcg intramuscular dose of lyophilized BNT162b2 in SDV as 2-dose schedule separated by 19 to 23 days. Participants were followed up for safety for 1 month after second dose of vaccine Participants who consented to receive frozen formulation of BNT162b2, received 30 mcg intramuscular single dose of frozen liquid BNT162b2 in MDV at least 90 days post Vaccination 2. Participants were followed up for safety for 1 month after dose 3. | 0 | None | 0 | 279 | 262 | 279 | View |
| BNT162b2 Frozen-Liquid MDV: Part 1 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 in MDV as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. | 0 | None | 0 | 280 | 274 | 280 | View |
| BNT162b2 Frozen-Liquid With Lipid Nanoparticle (LNP) Size: Part 2 | Participants were randomized to receive 30 mcg intramuscular dose of frozen liquid BNT162b2 with LNP as 2-dose schedule separated by 21 days. Participants were followed up for safety for 1 month after second dose of vaccine. | 0 | None | 0 | 35 | 33 | 35 | View |
| BNT162b2 Frozen-Liquid MDV: Dose 3 | Participants who originally received 2 doses of lyophilized SDV formulation of BNT162b2 30 mcg in Part 1 of the study were administered with an additional dose of frozen liquid MDV of BNT162b2 30 mcg at least 3 months after Dose 2. Participants were followed up for safety for 1 month after third dose of vaccine. | 0 | None | 0 | 114 | 87 | 114 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Tinnitus | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v25.0 | View |
| Conjunctivitis allergic | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v25.0 | View |
| Eye pain | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v25.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Injection site erythema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Injection site pruritus | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Seasonal allergy | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA v25.0 | View |
| Acute sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Herpes simplex | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Onychomycosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Suspected COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.0 | View |
| Scratch | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.0 | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v25.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Fibromyalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |
| Attention deficit hyperactivity disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v25.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v25.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Influenza like illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Injection site pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Sinusitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Procedural pain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v25.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Bacterial vulvovaginitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v25.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v25.0 | View |
| Nasal septum deviation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | View |
| Tonsillar inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | View |
| Diarrhoea (DIARRHEA) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Vomiting (VOMITING) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v25.0 | View |
| Chills (CHILLS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Fatigue (FATIGUE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Injection site erythema (REDNESS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Injection site pain (PAIN) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Injection site swelling (SWELLING) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Pyrexia (FEVER) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v25.0 | View |
| Arthralgia (JOINT PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Myalgia (MUSCLE PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | View |
| Headache (HEADACHE) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v25.0 | View |