AZD-1222/COVID-19-vaccine/COVID-19-Vaccine-Pfizer-BioNTech

Author Information

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

In a study of 14 patients at a hospital in Saudi Arabia, 5 patients (3 men and 2 women) aged 27−61 years were described, who developed cardiac arrest, seizure, cerebral venous sinus thrombosis (CVST) or pulmonary embolism (PE) following administration of COVID-19-vaccine, AZD-1222 or COVID-19-Vaccine-Pfizer-BioNTech vaccination [dosages and routes not stated; not all times to reaction onsets stated].

Patient 1: A 38-year-old man developed cardiac arrest following administration of COVID-19 vaccine. The man received COVID-19 vaccine (type unknown) in the morning, and was found to be unresponsive at around 8pm on the same day. He received cardiopulmonary resuscitation, and a couple of cycles in the ambulance were done. However, he was announced dead on arrival to the hospital. His history involved a cardiac surgery. WHO-causality assessment result for cardiac arrest and COVID-19 vaccine was noted as (B1), indicating temporal relationship was consistent however, there was insufficient definitive evidence that vaccine caused the event.

Patient 2: A 61-year-old woman developed seizure and PE following administration of COVID-19 vaccine. The woman, who had multiple comorbidities, presented with diarrhoea following immediate onset post COVID-19 vaccine (type unknown). After a few days, she presented to the ER with decrease in level of consciousness. She was admitted due to multiple episodes of seizures and PE. Further, she was noted to be in stable condition, conscious and alert. WHO-causality assessment result for seizure and PE with COVID-19 vaccine was noted as (B2), indicating indeterminate, reviewing factors resulted in conflicting trends of consistency and inconsistency with causal association to immunisation.

Patient 3: A 61-year-old woman developed CVST following administration of AZD-1222 COVID-19 vaccine. The woman, who had multiple comorbidities, presented to the ER with 1-week history of left ear pain, dizziness, headache, tinnitus and nausea, which started 2 weeks after her first AZD-1222 [AstraZeneca] COVID-19 vaccine dose. She was treated with unspecified analgesics and was discharged. After a few days, she presented to the ER due to disorientation, confusion, eye pain and impaired vision. Brain CT scan revealed CVST, a complete thrombosis of the left transverse sinus extending to the left sigmoid sinus and jugular vein. Platelet count was found to be 143 × 10⁹ /L on admission. She was treated with enoxaparin sodium and was discharged after 7 days with a national institutes of health stroke scale (NIHSS) score of 8. WHO-causality assessment result for CVST with AZD-122 vaccine was noted as (B1), indicating indeterminate, temporal relationship was consistent however, there was insufficient definitive evidence that vaccine caused the event. This was stated as a potential signal.

Patient 4: A 40-year-old man developed CVST following administration of AZD-1222 COVID-19 vaccine.

The man received his first AZD-1222 [AstraZeneca] COVID-19 vaccine dose and after 2 weeks, he presented to the ER with severe headache and nausea. He was treated with unspecified analgesics and was discharged. After 2 days, he then presented with worsening headache. Brain CT scan revealed CVST. Platelet on admission was noted to be 128 × 10⁹ /L, and protein S deficiency and functional protein C activity were evident. He was treated with enoxaparin sodium for 3 days, and was discharged in a good condition on apixaban. WHO-causality assessment result for CVST and AZD-1222, showed (A1), indicating consistent causal association to immunisation, vaccine product-related reaction.

Patient 5: A 27-year-old man developed PE following administration of COVID-19-Vaccine-Pfizer-BioNTech vaccine.

The man, who was a heavy smoker, presented to the ER with chest pain. Chest CT revealed pulmonary embolism. He had previously received his second dose of COVID-19-Vaccine-Pfizer-BioNTech [Pfizer] COVID-19 vaccine 2 days prior the presentation. Further, he was treated with enoxaparin sodium and was discharged in a stable condition on apixaban therapy. WHO-causality assessment result for PE and COVID-19-Vaccine-Pfizer-BioNTech vaccine was noted as (B2), indicating indeterminate, reviewing factors resulted in conflicting trends of consistency and inconsistency with causal association to immunisation.