Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Post-marketing study, Cohort study of COMIRNATY vaccines. To collect information on adverse events and COVID-19 observed after vaccination with COMIRNATY and to assess safety in patients with underlying disease considered to be at high risk of aggravation of COVID-19 who have received vaccination with this product under actual use conditions.
This is a multicenter cohort study to be conducted in individuals with underlying diseases considered to be at high risk of aggravation of COVID-19 who are vaccinated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through preliminary examination sheet or medical interview, etc. and records such as medical records. A health observation diary will be distributed to the subjects participating in this study and they will be requested to record information on local reactions and systemic reactions after vaccination with this product.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMIRNATY | COVID-19 mRNA vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 | Biological | COMIRNATY is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Adverse Reactions | An adverse reaction was any untoward medical occurrence attributed to COMIRNATY in a participant who was vaccinated with COMIRNATY. Relatedness to COMIRNATY was assessed by the physician. The proportion of adverse reactions was presented for the overall observation period, the observation period from the date of the first dose of Comirnaty up to 28 days after the second dose, and the observation period from the date of Dose 1 up to 28 days after Dose 2. | From the date of the first dose to 28 days after the second dose, up to approximately 49 days. |
| Proportion of Participants With Serious Adverse Reactions | A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. The proportion of serious adverse reactions was presented for the overall observation period, the observation period from the first to the second vaccination, and the observation period from the date of Dose 1 up to 28 days after Dose 2. | From the date of the first dose to 28 days after the second dose, up to approximately 49 days. |
| Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination) | Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the first vaccination was collected from 1035 participants of the 1038 safety analysis set participants. | Within 8 days after the date of the first dose. |
| Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination) |
Not provided
Not provided
Inclusion Criteria:
-Subjects who are able to understand the content of this study and to record their symptoms in the health observation diary, and who have provided written consent to participate in this survey by themselves (or parents or legal guardians in the case of minors)
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with underlying disease considered to be at high risk of aggravation of COVID-19 (Underlying diseases considered to be at high risk of aggravation of COVID-19 are based on the range of patients with underlying diseases indicated by the Ministry of Health, Labour and Welfare for priority vaccination.)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Local County | Tokyo | 1518589 | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | COMIRNATY Intramuscular Injection (Tozinameran) | Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 1075 participants were enrolled in this study. Of the 1075 participants from whom CRFs were collected, 37 participants were excluded from the safety analysis set due to the following reasons: No vaccination information (1 participant), No adverse event information (missing information) (1 participant), Disease not covered in this study (35 participants).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | COMIRNATY Intramuscular Injection (Tozinameran) | Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Adverse Reactions | An adverse reaction was any untoward medical occurrence attributed to COMIRNATY in a participant who was vaccinated with COMIRNATY. Relatedness to COMIRNATY was assessed by the physician. The proportion of adverse reactions was presented for the overall observation period, the observation period from the date of the first dose of Comirnaty up to 28 days after the second dose, and the observation period from the date of Dose 1 up to 28 days after Dose 2. | The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. | Posted | Count of Participants | Participants | From the date of the first dose to 28 days after the second dose, up to approximately 49 days. |
|
From the date of the first dose to 28 days after the second dose, up to approximately 49 days.
The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COMIRNATY Intramuscular Injection (Tozinameran) | Participants with underlying disease considered to be at high risk of aggravation of COVID-19, who were vaccinated with Comirnaty as indicated in the approved local product document were observed from the date of Dose 1 to 28 days after Dose 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 27, 2021 | Jan 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2022 | Jan 10, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the second vaccination was collected from 1026 participants of the 1032 participants who received the second vaccination with Comirnaty. |
| Within 8 days after the date of the second dose. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Proportion of Participants With Serious Adverse Reactions | A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician. The proportion of serious adverse reactions was presented for the overall observation period, the observation period from the first to the second vaccination, and the observation period from the date of Dose 1 up to 28 days after Dose 2. | The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. | Posted | Count of Participants | Participants | From the date of the first dose to 28 days after the second dose, up to approximately 49 days. |
|
|
|
| Primary | Proportion of Participants With Local Reactions and Systemic Reactions (The First Vaccination) | Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the first vaccination was collected from 1035 participants of the 1038 safety analysis set participants. | The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. | Posted | Count of Participants | Participants | Within 8 days after the date of the first dose. |
|
|
|
| Primary | Proportion of Participants With Local Reactions and Systemic Reactions (The Second Vaccination) | Local and systemic reactions were treated as specific adverse events of interest in this study, and were reported using the health observation diary filled out by the participants. Severity was rated and recorded as grade 1, 2, or 3 according to the FDA Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Health observation diary for the second vaccination was collected from 1026 participants of the 1032 participants who received the second vaccination with Comirnaty. | The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. | Posted | Count of Participants | Participants | Within 8 days after the date of the second dose. |
|
|
|
| 1 |
| 1,038 |
| 11 |
| 1,038 |
| 114 |
| 1,038 |
| Cardiac failure acute | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Axillary pain | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Injection site paraesthesia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Vaccination site pruritus | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Vaccination site rash | General disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.1 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Brain natriuretic peptide increased | Investigations | MedDRA 24.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Taste disorder | Nervous system disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Chronic eosinophilic rhinosinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Chronic spontaneous urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 24.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
|
| Observation from 2nd vaccination to 28 days |
|
|