Serious adverse event following immunization and thromboembolic events associated with COVID19 vaccination: An analysis of nationwide causality assessment from India

Background: Vaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following Immunization (AEFIs) reported for COVID-19 vaccines from India. Methods: Secondary data analysis of the causality assessment reports for the 1112 serious AEFIs published by the Ministry of Health & Family Welfare, Government of India, was conducted. For the current analysis, all the reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal association and the thromboembolic events. Results: The majority of the serious AEFIs assessed were either coincidental (578, 52%) or vaccine product related (218, 19.6%). All the serious AEFIs were reported among the Covishield (992, 89.2%) and COVAXIN (120, 10.8%) vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted analysis, females, the younger age group and non-fatal AEFIs showed a statistically significant consistent causal association with COVID-19 vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant association with higher age and case fatality rate. Conclusion: Deaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the COVID-19 vaccines than the recovered hospitalizations in India. No consistent causal association was found between the thromboembolic events and the type of COVID-19 vaccine administered in India

Solitary tubercular renal cyst in a postpartum lady masquerading as an infected giant renal cyst with urosepsis

Renal tuberculosis presenting as renal cyst is rare. Diagnosing renal tuberculosis in pregnancy is usually delayed due to its atypical presentation. We present a 28-year-old postpartum lady who delivered a healthy baby one month back, with history of intermittent fever and chills. She had high spiking fever (102° F), tachycardia (130/min) and computed tomography showed a 16 × 10 cm right renal cyst. Percutaneous drainage was done, 2 litres of thick pus drained and culture was sterile. After three weeks, deroofing and marsupialization of cyst was done. Biopsy revealed granulomatous inflammation composed of epitheliod histiocytes with central incipient necrosis suggestive of tuberculosis. She was treated with anti-tubercular drugs. As the infant was healthy and had no evidence of tuberculosis, no treatment was initiated. The mother is on follow up for 2 years. This case highlights the rare presentation of renal tuberculosis in puerperium.