BBIBP-CorV

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An event is serious (based on the ICH definition) when the patient outcome is:

• * death

• * life-threatening

• * hospitalisation

• * disability

• * congenital anomaly

• * other medically important event

A 22-year-old man developed adult multisystem inflammatory syndrome (MIS-A) following COVID-19 vaccination with BBIBP-CorV.

The man presented to the emergency department in Abu Dhabi, United Arab Emirates in December 2020. On 26 October 2020, he was diagnosed with mild COVID-19 illness, loss of sense of smell and sore throat as well as positive COVID-19 polymerase chain reaction (PCR). After full recovery by resolution of symptoms and reverting to negative PCR, on 6 November 2020, he received the first dose of inactivated SARS-CoV-2 vaccine BBIBP-CorV [Sinopharm]. Following the first dose, he remained asymptomatic and well. On 6 December 2020, he received the second dose. A few hours afterwards, he started to experience fatigue and headache. The day after, he started to develop abdominal pain, fever and sore throat. The illness progressed over the following 4 days when he presented to the emergency department with myalgia, nausea, high-grade fever, diarrhoea and vomiting, and a faint erythematous non-itchy rash over his torso, which he noticed earlier that day. He reported a dry irritant cough. He had no history of recent travel, no animal exposure, no consumption of raw dairy product and no sick contacts. He reported taking ibuprofen and one dose of an unspecified antibiotic over the prior few days for symptomatic relief. In the emergency department, he was noted to have a temperature of 39°C, systolic BP of 110mm Hg and tachycardia, 140 beats/minute. Physical examination showed dry mucous membranes with congested throat, bilateral conjunctival infection and left conjunctival haemorrhage. There was a generalised erythematous maculopapular rash, mostly over the back and chest. SARS-CoV-2 PCR from nasopharyngeal swab was found to be negative, however SARS-CoV-2 IgG from serum using Liaison XL SARS-CoV-2 S1/S2 IgG reagent was later found to be strongly positive. Urinalysis revealed significant proteinuria. He was admitted to the ICU for hypotension, with diagnosis of probable sepsis versus vaccine-related illness.

The man was treated empirically with levofloxacin and ceftriaxone. In addition to IV fluids for resuscitation, he was also given hydrocortisone. The hydrocortisone was administered for 2 days and subsequently discontinued once he achieved haemodynamic stability. His BP stabilised. Fever initially ameliorated, but remained persistent throughout his ICU stay. He quickly started to develop generalised body oedema and facial puffiness. He remained tachycardic, diarrhoea persisted, watery occasionally with incontinence. As a result of the anasarca and the myalgia, it was difficult for him to mobilise without the support of a walking frame. Further workup showed evidence of renal impairment with remarkable proteinuria. An ECG showed sinus tachycardia with non-specific T-wave abnormalities, troponin-I and pro-BNP were raised. A transthoracic echocardiogram revealed severe tricuspid regurgitation with normal structure of the tricuspid valve. There was pulmonary hypertension. The right ventricle and atrium were moderately dilated with normal systolic function. Left ventricle cavity size was normal with mildly decreased ejection fraction of 45%. There was a thin rim of pericardial effusion. A chest Ct was negative for pulmonary embolism; however it showed evidence of bilateral moderate pleural effusion along with basal atelectasis. As he achieved relative haemodynamic stability, the hydrocortisone was withdrawn, and he was shifted to the medical ward. Gradually, the high-level fever started to recur. By that time all cultures came back negative, and other workup was unrevealing. Towards the end of the first week following admission, it was apparent that the cause of his illness was not because of an infective cause, neither it was because of an acute flare of a rheumatologic disease. Considering the multisystem involvement, renal, haematologic, cardiac, ophthalmologic and dermatologic in addition to raised inflammatory markers, he met the criteria for multisystem inflammatory syndrome in adults. He underwent therapy with IV steroids, dexamethasone. His condition improved significantly following initiation of dexamethasone, his generalised oedema abated over the following few days, conjunctivitis and skin rash resolved, WBC count normalised, and renal function including albuminuria ameliorated. His inflammatory markers normalised. A repeat transthoracic echocardiography revealed trace tricuspid regurgitation, marked amelioration in right ventricular systolic function, with normal size of the right ventricle and atrium. The pulmonary artery systolic pressure normalised. Dexamethasone was continued for 8 days and then changed to prednisolone. He was discharged with a tapering dose of prednisolone over a period of 2 weeks. When seen in the outpatient clinic 2 weeks following discharge, his symptoms resolved although he had some fatigue and general weakness. His repeat echocardiogram was completely normal.