Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Arthralgia, Chills, Dizziness, Fatigue
Clinical narrative: ADVERSE EVENT; DIZZINESS; PAIN; PAIN IN EXTREMITY; ARTHRALGIA; CHILLS; HEADACHES; PYREXIA; NAUSEA; INJECTION SITE PAIN; MYALGIA; FATIGUE; This solicited report received from a health care professional concerned multiple patients of unspecified age and sex. The patients was enrolled in a non-company sponsored study. This patients was also referenced in literature:  The patients height, and weight were not reported. The patients concurrent conditions included: diabetes mellitus, heart disease, chronic obstructive pulmonary disease, transient ischemic attack, heart failure, hypertension, and cancer. Methods: A retrospective analysis examined vaccine adverse event reporting system (VAERS).reports between 14-DEC-2020 and 08-OCT-2021 and focused on AE reports related to COVID-19 vaccines and AE outcomes [e.g., emergency room (ER) visits after being vaccinated, hospitalization, prolongation of existing hospitalization, life-threatening events, disability, birth defect, and death]. Reporting odds ratios (RORs) and Breslow-Day statistics were used to compare AE reporting between COVID-19 and non-COVID vaccines and between individual COVID-19 vaccines. The patients initiated treatment with covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported), start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced adverse event, dizziness, pain, pain in extremity, arthralgia, chills, headaches, pyrexia, nausea, injection site pain, myalgia, and fatigue, and was hospitalized (date unspecified). On an unspecified date, the patients died from unspecified adverse events (dose series 1). It was not reported if an autopsy was performed. Results: Between 14-DEC-2020 and 08-OCT-2021, a total of 661,614 adverse event reports were submitted to VAERS. Among these reports, 604,157 (91.32%) reports were of COVID-19 vaccines. Among all COVID-19 vaccine-related reports, there were 262,883 (43.51%) reported pertaining to the Pfizer-BioNTech COVID-19 vaccine, 284,765 (47.13%) reported pertaining to the Moderna COVID-19 vaccination, 55,111 (9.12%) reported pertaining to the Janssen COVID-19 vaccine, and 1,308 (0.22%) reported with the missing manufacturer. There were 75,911 (12.56%) patients who visited the emergency room (ER) after being vaccinated and 36,030 (5.96%) patients reported hospitalization with an average length of 3.11 days (in the range of 122 days). In addition, 9,193 (1.52%) individuals reported to be experiencing life-threatening events, 8,890 (1.47%) individuals reported disability, 7,674 (1.27%) individuals were reported as dead, 343 (0.06%) individuals reported birth defect, and 305 (0.05%) individuals had prolongation of existing hospitalization after being vaccinated. The top 10 adverse events reports for all COVID-19 vaccines and individual Janssen COVID-19 vaccines by frequency included headaches, chills, pyrexia, dizziness, nausea, pain in extremity, arthralgia, injection site pain, myalgia, fatigue, and pain. Headache, fatigue, chills, pyrexia, and pain were among the top 5 commonly reported adverse event for all three COVID-19 vaccines, overall and individually. It was reported that 7,674 individuals died after they were administered the COVID-19 vaccines with a mean age of 72.75 (range: 0.42106), accounting for 1.27% of all AE reports of COVID-19 vaccines. Among these death cases, 3,500 (45.61%) received the Pfizer-BioNTech COVID-19 vaccine, 3,329 (43.38%) received the Moderna COVID-19 vaccine, 814 (10.61%) received the Janssen COVID-19 vaccine, and 31 (0.40%) deaths with unidentified vaccine manufacturer. A total of 2,025 (26.39%) death cases indicated previous diagnoses of hypertension, and 1,237 (16.12%) death cases had cancer. Other common comorbidities included diabetes mellitus (DM) (10.65%), heart disease (9.47%), chronic obstructive pulmonary disease (COPD) (5.75%), transient ischemic attack (TIA) (5.72%), and heart failure (5.20%). During 14-DEC 2020 and 08-OCT-2021, reporting odds ratios (RORs) of all seven serious AE outcomes between COVID-19 vaccines and non-COVID vaccines indicated a potentially higher ROR in ER visits (ROR = 1.08, 95% CI = 1.081.09), hospitalization, (ROR = 1.21, 95% CI = 1.141.28), prolongation of existing hospitalization (ROR = 1.41, 95% CI = 1.011.96), and life-threatening events (ROR = 1.20, 95% CI = 1.071.35). The increased ROR in ER visits, hospitalization, and life-threatening events for COVID-19 vaccines was consistent with results from sensitivity analysis, but not for prolongation of existing hospitalization (ROR = 0.56, 95% CI = 0.420.75 in sensitivity analysis) and death (ROR = 1.87, 95% CI = 1.692.07 in sensitivity analysis. For the Janssen COVID-19 vaccine vs. all other vaccines, RORs for the five assessed serious AE outcomes (i.e., ER visits, hospitalization, prolongation of existing hospitalization, life-threatening events, and death) indicated a higher ROR in these serious events for the Janssen COVID-19 vaccine in both main and sensitivity analyses. Conclusion: Most current VAERS reports showed that the most commonly reported Es of COVID-19 vaccines were mild. Cases with a mortality outcome tended to occur in older adults with underneath conditions. Close ongoing surveillance in the safety of COVID-19 vaccines is critical and will inform the use of individual COVID-19 vaccines. Given the known limitations associated with the passive spontaneous reporting system, such as VAERS, our findings need to be further assessed and verified through longitudinal, large healthcare data systems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died from unspecified adverse events (dose series 1) on an unspecified date, and the outcome of headaches, chills, pyrexia, dizziness, nausea, pain in extremity, arthralgia, injection site pain, myalgia, fatigue and pain was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and adverse event, dizziness, pain, pain in extremity, arthralgia, chills, headaches, pyrexia, nausea, injection site pain, myalgia, and fatigue as related. Company causality between covid-19 vaccine ad26.cov2.s, and adverse event was not related.. This report was serious (Death, Hospitalization Caused / Prolonged, Congenital Anomaly/Birth Defect, Other Medically Important Condition, Life Threatening, and Disability Or Permanent Damage).; Sender's Comments: V0:  Adverse event. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.; Reported Cause(s) of Death: ADVERSE EVENT