Trial Outcomes & Findings for A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People (NCT NCT05621239)

Data of participants who received BNT162b2 messenger ribonucleic acid (mRNA) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) vaccine and reported adverse events (AE) in Indonesia were analysed in this study.

This retrospective observational study used data from Indonesia Vaccine Safety Website as requested by Indonesia Food and Drug Monitoring Agency(BPOM). A total of 72,394,389 participants (48,425,165 \[primary dose\] and 23,969,029 \[booster dose\] received BNT162b2 mRNA SARS-CoV-2 vaccine. Adverse events were reported in 260 participants following administration of the BNT162b2 mRNA vaccine, starting from the time of vaccine availability in Indonesia and data was obtained for these 260 participants.

Race and Ethnicity were not collected from any participant.

An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure.

An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure.

An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure.

An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure.

An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of SAEs reported according to time of onset less than equal to (\<=30) minutes (min) and more than (\>) 30 minutes after administration of BNT162b2 mRNA vaccine primary and booster dose are reported in this outcome measure.

An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The causality of SAEs were classified as coincidence: inconsistent causal association to immunization; vaccine reaction, indeterminate: when adequate information is available but it is not possible to assign it, unclassifiable.

AEs can be categorised into SAEs and non-SAEs. SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs.

An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. Solicited AEs are reported and are part of the uniform collection of information in the registry and unsolicited AEs are volunteered or noted in an unsolicited manner and not as a required data element through a case report form.

An AE was any untoward medical occurrence in a participant who received BNT162b2 mRNA SARS-CoV-2 vaccine; the event need not necessarily have a causal relationship with the treatment. Solicited AEs are reported and are part of the uniform collection of information in the registry. These were classified as local reactions (local pain, local swelling, local erythema) and systemic reactions (fever, nausea/vomitus, headache, malaise/fatigue, arthralgia/myalgia, chill and diarrhea).

An AE was any untoward medical occurrence in a participant who received BNT162b2 mRNA SARS-CoV-2 vaccine; the event need not necessarily have a causal relationship with the treatment. Unsolicited AEs are volunteered or noted in an unsolicited manner and not as a required data element through a case report form. These were classified as local reactions (local sore, local itch and erythema) and systemic reactions (vertigo/dizziness, cough/rhinitis/sore throat, itchy, dyspnea/tachypnea, drowsiness, syncope/loss of consciousness, hypesthesia/paresthesia, chest pain/chest tightness, stomach ache/dyspepsia, seizure, paralysis/paresis, slurred speech, hyperhidrosis and insomnia).