ABSTRACT
Background: To determine the safety profile of Sinopharm COVID-19 vaccine and identify breakthrough infections. Method: The study design was analytical cross sectional. An online questionnaire was filled by 1033 respondents between 16th and 22nd April 2021. Adults who had received both doses of Sinopharm COVID-19 vaccine more th nd than a week ago or only a single dose with serious side effect were included in the study. The frequency and severity of vaccination related side effects were assessed and breakthrough infection identified. Results: The mean age of participants was 36.7 +/- 12.91(18 - 92) years. Ninety one percent of participants (n=946) were health care professionals. One fifth (n=225/1033, 21.8%) had suffered from COVID-19 infection prior to vaccination, confirmed using the nasal RT-PCR test. None of the participants reported serious (grade III) or life threatening (grade IV) adverse reactions after either of the two doses. The most common side effects after the first dose were pain at injection site (20.3%), fatigue (20.3%), headache (13.9%), myalgia (12.5%) and fever (9.3%) whereas after the second dose were fatigue (16.8%), pain at injection site (15.8%), myalgia (14%) and fever (6.7%). The side effects were more common in participants who had previous history of COVID-19 infection. Of 225 previously infected participants, 97(43.1%) (p value=0.020) and 90 (40%) (p value=0.001) participants had side effects after 1st and 2nd dose respectively. 16 participants (1.55%) developed PCR positive COVID-19 infection two weeks after the second dose while 3(0.29%) participants had a re-infection. There was one case of probable severe COVID-19 infection, 2 weeks after the second dose and recovered completely with treatment. Conclusion: Our study shows that Sinopharm COVID-19 vaccine is generally safe with no serious side effects. The side effects were however, more common in inviduals who already had COVID-19 infection. The COVID-19 breakthrough infection and reinfection could occur after the vaccination.
ABSTRACT
Objective: To determine the spectrum of clinical presentation, multisystem involvement and treatment outcome in children with MIS-C. Study Design: A descriptive cohort study Place and Duration of Study: Conducted at The Children's Hospital and Institute of Child Health, Lahore from May 15, 2020 to November 22, 2020. Material and Methods: Children (aged 0-16 years) with features of this new inflammatory syndrome who fulfilled the WHO criteria for MIS-C and required admission to hospital were prospectively identified. Demographic and clinical data were collected from patient records and entered on a predesigned proforma and results were analyzed on SPSS 20. Results: A total of 24 patients were enrolled in the study. Majority were males (17/24, 70%). Mean age of presentation was 7.3 years. Six patients (25%) had a positive PCR for SARS CoV-2 but none of the patients had been symptomatic with classic COVID-19 respiratory symptoms in the 6 weeks prior to admission. Comorbid conditions were present in only 2 patients (8%). SARS-CoV-2 antibodies were positive for 23/24 patients (96%). Despite being clinically unwell, with laboratory evidence of elevated C-reactive protein, ferritin, and D-dimers, no pathological organism was isolated in any of the 24 children. There were two major presentations: one as atypical or typical Kawasaki disease (18 of 24, 75%) and a more severe second one with shock or low cardiac output (6 of 24, 25%). Common presenting features were fever, body aches, and abdominal pain. Four out of 24 (16%) patients had sufficient criteria for typical Kawasaki disease, whereas 18 children (75%) presented more sub acutely with presentation resembling Kawasaki disease;all had at least two features of classic Kawasaki. Myocardial dysfunction seen in 3 patients (12%) and pericardial effusion was observed in 5 patients (20%). Coronary artery dilatation was seen in 12 (50%) patients. All 6 children with shock-like presentation had coronary artery involvement. Twenty children (83%) received intravenous immunoglobulin within the first 2 days of their stay. Thirteen (54%) patients received therapeutic anticoagulation (enoxaparin) on the basis of the high risk of thromboembolism and number of D-dimers. There was one death (4%). Conclusion: The SARS-COV 19 pandemic led to the identification of a new and potentially life-threating childhood disease, referred to as MIS-C. Prompt diagnosis and early treatment with IVIGs has shown a good early outcome. .