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Post-marketing study, Chotor study of COMIRNATY vaccenees followed for 11months. Serious adverse events and COVID-19 observed during the follow-up period will be collected, and the long-term safety of this product will be assessed.
The healthcare professionals who are vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) will be followed for 11 months from the day following 28 days after the final vaccination of the initial immunization with this product (end date of observation period in Investigation of Health Status of Recipients Vaccinated First) to 12 months after the final vaccination of the initial immunization with this product, information on serious adverse events and COVID-19 observed during the follow-up period will be collected.
If booster vaccination isn't conducted, the long-term safety after the initial immunization of this product during the follow-up period will be assessed.
If booster vaccination is conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination will be confirmed, and information on serious adverse events and COVID-19 will be continuously obtained after booster vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMIRNATY | COVID-19 mRNA vaccine (nucleoside-modified) |
|
| 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. Individuals 16 years of age and older. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Serious Adverse Events | A serious adverse event was any untoward medical occurrence 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. | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. |
| Proportion of Participants With Severe COVID-19 | By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO. | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. |
| 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. | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects who have been vaccinated with this product and have consented to participate in this study during participation in the Investigation of Health Status of Recipients Vaccinated First at contract sites.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PfizerLocal Country Office | Tokyo | 1518589 | Japan |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | COMIRNATY Intramuscular Injection | The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product. If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed. If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination. This study only collected serious adverse events. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 14570 participants were enrolled in this study. Of the 14570 participants from whom CRFs were collected, 33 participants were excluded from the safety analysis set due to no adverse event information (missing information).
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| ID | Title | Description |
|---|---|---|
| BG000 | COMIRNATY Intramuscular Injection | The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product. If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed. If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination. This study only collected serious adverse events. |
| 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 Serious Adverse Events | A serious adverse event was any untoward medical occurrence 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. | The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded. | Posted | Number | Percentage of Participants | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. |
|
From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COMIRNATY (Tozinameran) (1) If the Booster Vaccination Was Conducted, up to the Day Before Booster. | The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product. If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed. If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination. This study only collected serious adverse events. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2022 | Dec 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 5, 2022 | Dec 14, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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|
| Number of Participants With Serious Adverse Events After Booster Vaccination |
A serious adverse event was any untoward medical occurrence 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. |
| From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) |
| Number of Participants With Severe COVID-19 After Booster Vaccination | By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO. | From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) |
| Number of Participants With Serious Adverse Reactions After Booster Vaccination | A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination 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. | From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) |
| 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 |
|
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product. If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed. If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination. This study only collected serious adverse events. |
|
|
| Primary | Proportion of Participants With Severe COVID-19 | By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO. | The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded. | Posted | Number | Percentage of Participants | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. |
|
|
|
| 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 safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded. | Posted | Number | Percentage of Participants | From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination. |
|
|
|
| Primary | Number of Participants With Serious Adverse Events After Booster Vaccination | A serious adverse event was any untoward medical occurrence 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. | Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines | Posted | Number | Participants | From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) |
|
|
|
| Primary | Number of Participants With Severe COVID-19 After Booster Vaccination | By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO. | Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines | Posted | Number | Participants | From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) |
|
|
|
| Primary | Number of Participants With Serious Adverse Reactions After Booster Vaccination | A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination 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. | Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines | Posted | Number | Participants | From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation) |
|
|
|
| 1 |
| 14,537 |
| 120 |
| 14,537 |
| 0 |
| 0 |
| EG001 | COMIRNATY (Tozinameran) (2) If the Booster Vaccination Was Conducted, After the Booster. | Same as the left. | 0 | 13,695 | 48 | 13,695 | 0 | 0 |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Prinzmetal angina | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cleft lip | Congenital, familial and genetic disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Congenital skin disorder | Congenital, familial and genetic disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Gnathoschisis | Congenital, familial and genetic disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Meniere's disease | Ear and labyrinth disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Bacterial prostatitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Peritonsillar abscess | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Peritonsillitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Airway burns | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Haemangioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Cerebral artery embolism | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Placenta praevia | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Non-systematic Assessment |
|
| Dissociative disorder | Psychiatric disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| IgA nephropathy | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Adenomyosis | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Catamenial pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Respiratory disorder neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Acute abdomen | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Osteochondrodysplasia | Congenital, familial and genetic disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Ovarian cyst torsion | Reproductive system and breast disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Meningitis aseptic | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.1 | 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 |