Active surveillance of adverse events following COVID-19 vaccines in a tertiary care hospital.

Background: Vaccination is a safe and effective way to prevent disease and save lives, but it may also produce some undesirable adverse events (AEs)which may affect healthy individuals. Therefore, the monitoring of AE following immunization (AEFIs) is necessary. The objective of this study was to assess the AEs following COVID-19 vaccinations in a tertiary care hospital. Methodology: The study was conducted as active vaccine safety surveillance for a period of 6 months among the COVID-19 vaccine beneficiaries of the study site. Active surveillance was conducted via initiating two telephone contacts. The first surveillance was conducted in 8 days and the second surveillance after 28 days of post-vaccination. All identified AEs following immunizations (AEFIs) were reported and analysed by the AEFI investigation team at the study site. The causality assessment of each identified AEFI was performed using the World Health Organization's causality assessment algorithm. Results: A total of 2927 enrolled study population completed the study with a response rate of 80.85%. The study identified 902 AEFIs from 614 study populations with an incidence rate of 20.97%. Of which 794 and 79 AEFIs were associated with COVISHIELD™ and COVAXIN®, respectively. The majority of the events were reported among the age group of 18-29 years. Overall, only three events were serious and no deaths were reported among the study population. A total of 75.59% of events had a consistent causal association with vaccination and were categorized as vaccine product-related reactions. The study identified various factors such as gender (p = 0.019), age (p < 0.05), co-morbid status (p = 0.032) and dose number (p = 0.001) as potential predictors for development of AEFI. Conclusion: The study identified only 0.33% of events as serious, and 99.67% of the study population recovered from the AEFIs, which reveals that COVISHIELD™ and COVAXIN® have a generally favourable safety profile. However, close monitoring is required to identify the potential signals, as the safety data from the clinical trials are limited.

Clinico-epidemiological profile and outcome of infected health care workers during the three consecutive waves of COVID-19 pandemic: a longitudinal cohort study.

Background: Health care workers are considered as high-risk population, who deal with many unknown, undiagnosed, and subclinical infectious diseases in their daily life. Currently, the COVID-19 pandemic posed as an add-on burden for these frontline workers in all aspects. Although, many adverse physical and mental effects of pandemic among health care workers (HCWs) were discussed worldwide, a long-term study for delayed complications needed to be explored. Aim: The study evaluates and compares three waves of the pandemic in various aspects such as the incidence, prevalence, severity, risk factors, and variations in the pattern of COVID-19 infection, impact of vaccination, and post-infection complications among the HCWs. Methodology: A longitudinal observational study was carried out over a period of 2 years and another 6 months for follow-up. The study included all HCWs who tested positive in any one wave of COVID-19 pandemic with any one of the confirmed COVID-19 test. Each COVID-19-affected HCW was followed up through telephone calls and direct interviews conducted at the study site. Admission details and other background details of the study population were collected from the hospital records. Results: A total of 968 HCWs were COVID-19 positive in any of the three waves, and highest incidence (53.00%) was caused by the Omicron variant. High severity and hospitalization was observed in the first wave (no vaccination) and fully immunized personnel were found to be out of danger of being hospitalized during all succeeding waves (chi-square value: 87.04, p < 0.05). Predictors such as female gender, occupational exposure, and comorbid status were identified as possible risk factors for infection. A total of 70 HCWs reported with 104 complications, of which chronic diseases such as new onset of diabetes (n = 3), cardiovascular events (n = 8), worsening of preexisting comorbidities (n = 8), etc. were found out. Conclusions: This study proves the benefit of being immunized rather than the risk of being infected. This study documents that immunization impacted complication and hospitalization rates of COVID-19 infection. This evidence may help in tackling vaccine hesitancy across the nations.

COVID-19 vaccine triggered autoimmune hepatitis: case report.

Autoimmune hepatitis (AIH) is a non-contagious, chronic, inflammatory autoimmune disease in which one's own immune system attacks healthy, normal hepatic cells. The exact cause of AIH is unknown; however, the combination of genetic, environmental (eg, drugs and natural infection) and immunological factors may lead to AIH. AIH may also be potentiated with the use of vaccines: this case reports one such event following immunisation, along with 1 year of follow-up. A female patient in her late 20s presented to the hospital with yellowish discolouration of eyes, urine and stools. Her medical history revealed that she had been vaccinated with the first dose of a COVID-19 vaccine 10 days earlier. She had a history of asymptomatic COVID-19 infection 3 months ago and a history of chronic analgesic consumption for migraine. She was diagnosed as having AIH through extensive clinical and laboratory workup. This case may be an immediate enhancement of a hidden autoimmune disorder triggered by the vaccination. This adverse event following immunisation has an adequate temporal relationship with her COVID-19 vaccine. The causality can be categorised as 'indeterminate' and may be considered as a potential signal following COVID-19 vaccination.

Leukocytoclastic Vasculitis Following COVID-19 Vaccination: A Case Report.

Background: Hypersensitivity or Leukocytoclastic vasculitis (LCV) following the COVID-19 vaccination has been reported rarely all over the world. LCV can be induced by certain factors such as infections, autoimmune disorders, malignancy, or some classes of drugs. Case presentation: A 32-year-old man, who was a known case of seizure disorder from his childhood presented to the department of dermatology with itchy red lesions on extremities and abdomen for the past 1 month. He explains a history of COVID-19 vaccination 1-month back and experienced itching on his lower limbs on the same day at night. A gradual worsening of the condition was observed day by day. He was hospitalized and diagnosed as LCV through clinical and laboratory findings. Conclusion: This case highlights a temporal association with the event of vaccination. The causality assessment showed an indeterminate causal association to LCV with COVID-19 Vaccination.

Efficacy of Ultrasound-Guided Particulate Versus Nonparticulate Steroid Injection in Carpal Tunnel Syndrome: An Open-Label Randomized Control Trial.

Introduction Perineural corticosteroid injection is an extensively used and accepted treatment for carpal tunnel syndrome (CTS). However, to this date, there is no guideline as to which corticosteroid has to be used as the standard treatment for CTS. Triamcinolone acetonide is a commonly used particulate steroid that can cause permanent nerve injury if it is accidentally injected into the nerve. Conversely, dexamethasone sodium phosphate is a nonparticulate steroid that would not cause permanent nerve damage following accidental injection. Methods Mild to moderate cases of CTS, confirmed by nerve conduction studies (NCS), with symptoms greater than three months were recruited. The participants received one session of ultrasound-guided perineural injection by the in-plane axial ulnar-sided approach with 4 mL of either dexamethasone (dexamethasone sodium phosphate 8 mg (2 mL) + 2 mL 0.5% bupivacaine) or triamcinolone (triamcinolone acetonide 40 mg/mL (1 mL) + 2 mL 0.5% bupivacaine + 1 mL normal saline) solution. The parameters assessed were Phalen's test time (in seconds), visual analog scale (VAS), and Boston carpal tunnel questionnaire (BCTQ) scores at baseline and two and four months, and NCS changes in sensory nerve conduction velocity (SNCV) and distal motor latency (DML) of the median nerve at baseline and four months. Statistical analysis was conducted using the software SPSS version 26.0 (IBM Corporation, Armonk, NY, USA). Independent samples t-test was used for comparison between groups and the paired t-test for improvement within each group. P values < 0.05 were considered statistically significant. Results The mean age was 42.64 ± 10.99 in the dexamethasone and 45.22 ± 10.602 in the triamcinolone group cases (P = 0.324).There were 58 females (84.06%) and 11 males (15.94%). Each of Phalen's test time, VAS, and BCTQ scores significantly improved within both dexamethasone and triamcinolone groups at the second and fourth months after injection (P < 0.05). The NCS parameters (SNCV and DML) also significantly improved in both groups at the fourth month after the injection (P < 0.05). However, there were no significant differences in the improvement of Phalen's test time between the two groups (P = 0.745), VAS score (P = 0.319), BCTQ score (P = 0.137), SNCV (P = 0.511), or DML (P = 0.753). Postprocedural pain lasted significantly longer in the triamcinolone group (P < 0.05). No major complications were noted in either of the two groups. Conclusion Dexamethasone is as effective as triamcinolone in improving the symptoms of CTS and can be used as a safer and more effective alternative in the treatment of mild to moderate CTS cases.

Assessment of Physical Disability After Three Months in Patients Recovered From COVID-19: A Cross-Sectional Study.

PURPOSE: This study was done to assess the extent of disability in coronavirus disease 2019 (COVID-19) survivors using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). MATERIAL AND METHODS: This was a cross-sectional study with convenient sampling. Institutional ethical clearance was taken. Informed consent was taken from all patients. Disability assessment was done using WHODAS 2.0. All patients were initial reverse transcriptase-polymerase chain reaction (RT-PCR) positive for COVID-19. Patients with neuromuscular deficits or who were taking medication for psychiatric illness before getting infected with COVID-19 were excluded from the study. RESULTS: Fatigue followed by dyspnea was the most common reported symptom after three months of COVID-19 infection. COVID-19 survivors with fatigue or dyspnea had a more significant disability as compared to other patients. Females had a more significant disability when compared to males. We did not find any significant disability in COVID-19 survivors after three months of disease based on body mass index, hospitalization, diabetes, and oxygen requirements. CONCLUSION: COVID-19 survivors suffered from significant disability after three months of disease especially females and survivors with fatigue or dyspnea. Recognizing post-COVID-19 sequelae and the availability of rehabilitation services will be critical in preventing another public health crisis after acute COVID-19 infection.