Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

General non-specific symptoms include any general non-specific symptoms, drowsiness, fatigue, irritability and malaise. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting European Medical Agency (EMA) Defined Adverse Events of Interest (AEIs) (Any) & Onset Dates of AEIs Using a Card Based-adverse Drug Reaction (ADR) Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

AEIs were presented by categories depending of the nature of the event. -Fever or other febrile illness; - Local reaction; - General reaction (fatigue, myalgia,etc); - All other presentations that were reported following vaccination (e .g., Bell's palsy, Guillain-Barre syndrome). The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis in a (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Local symptoms include local erythema. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Sensitivity/anaphylaxis AEs include any sensitivity/anaphylaxis AEs, anaphylactic reactions, facial oedema and hypersensitivity reactions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Rash AEs include any rash AEs, generalised rash and rash. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Respiratory/Miscellaneous AE include any respiratory/miscellaneous AE, conjunctivitis, coryza, cough, epistaxis, hoarseness, nasal congestion, oropharyngeal pain, rhinorrhoea and wheezing. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Gastrointestinal AEs include any gastrointestinal AEs, decreased appetite, diarrhoea, nausea and vomiting. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .

Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Musculoskeletal AEs include any musculoskeletal AEs, arthropathy and muscle aches/myalgia. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Neurological AEs include any neurological AEs, Bell's palsy, Guillain-Barre syndrome, headache, peripheral tremor and seizure/febrile convulsions. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative)

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016).

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who receive d the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .

Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .

Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR .

Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Sesnsitivity/Anapylaxis) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting European Medical Agency (EMA) Defined AEIs (Any) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

Local symptoms included local erythema. The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous Adverse Events) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Fever/Pyrexia) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Age-strata, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The age strata analysed were 6 months to 5 years; 6 to 12 years; 13 to 18 years; greater than or equal to (≥) 18-65 years and \>65 years. The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined Any AEIs and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Local Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Respiratory/Miscellaneous AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Gastrointestinal AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Sensitivity/Anaphylaxis AEs) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (General Non-specific Symptoms) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by Chief Medical Officer (CMO)-Specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Musculoskeletal) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Rash) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis (Cumulative).

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.

Number of Subjects Reporting EMA Defined AEIs (Neurological) and Onset Dates of AEIs Using a Card Based ADR Reporting System in the Vaccinated_Fluarix Tetra Group by CMO-specified Risk Status, on a Weekly Basis.

时间窗: Within 7 days post vaccination (anticipated to be between 01 September 2016 and 30 November 2016)

The primary analysis included all subjects vaccinated with GSK vaccine instead of the subjects who received the ADR card as the information whether or not subjects received the ADR card was not encoded in EHR.