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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
In a study involving 11 patients (9 women and 2 men) aged 32−62 years were described, who developed vaccine-induced immune thrombotic thrombocytopenia (VITT), headache, ischaemic stroke, ecchymoses, haematuria or nose bleeding following COVID-19 vaccination with AZD-1222 [dosages and routes not stated].
Case 1 (from table 1 of the article): A 60-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. One week post-vaccination, she developed VITT. After 12 days of vaccination, the sample was collected for testing. Subsequently, ELISA and HIMEA tests for anti-PF4 antibodies showed positive results. Her platelet count was 5000 /µL. Eventually, she died.
Case 2 (from table 1 of the article): A 32-year-old man had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After 7 days of vaccination, he developed VITT. After 40 days of vaccination, the sample was collected for testing. Subsequently, the ELISA and HIMEA tests for anti-PF4 antibodies showed positive results.
Case 3 (from table 1 of the article): A 58-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After 1−2 weeks post-vaccination, she developed large ecchymoses. On post-vaccination days 30, the sample was collected for testing. Subsequently, the ELISA test for anti-PF4 antibodies showed a negative result. Her platelet count was 280,000 /µL. Later, her large ecchymoses was suspected secondary to AZD-1222.
Case 4 (from table 1 of the article): A 52-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After 1−2 weeks post-vaccination, she developed large ecchymoses. On post-vaccination days 39, the sample was collected for testing. Subsequently, the ELISA and HIMEA tests for anti-PF4 antibodies showed a negative results. Her platelet count was 55,000 /µL. Later, her large ecchymoses was suspected secondary to AZD-1222.
Case 5 (from table 1 of the article): A 59-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After 1−2 weeks post-vaccination, she developed ecchymoses. On post-vaccination days 34, the sample was collected for testing. Subsequently, the ELISA test for anti-PF4 antibodies showed a negative result. Her platelet count was 219,000 /µL. Later, her ecchymoses was suspected secondary to AZD-1222.
Case 6 (from table 1 of the article): A 62-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After 26 days post-vaccination, she developed ischaemic stroke. On post-vaccination days 28, the sample was collected for testing. Subsequently, the ELISA and HIMEA tests for anti-PF4 antibodies showed a negative results. Her platelet count was 257,000 /µL. Later, her ischaemic stroke was suspected secondary to AZD-1222.
Case 7 (from table 1 of the article): A 55-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After vaccination approximately up to 4 weeks, she developed headache and ecchymoses. On post-vaccination days 35, the sample was collected for testing. Subsequently, the ELISA and HIMEA tests for anti-PF4 antibodies showed a negative results. Her platelet count was 369,000 /µL. Later, her headache and ecchymoses were suspected secondary to AZD-1222.
Case 8 (from table 1 of the article): A 53-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After vaccination approximately up to 6 weeks, she developed nose bleeding and ecchymoses. On post-vaccination days 42, the sample was collected for testing. Subsequently, the ELISA and HIMEA tests for anti-PF4 antibodies showed a negative results. Her platelet count was 201,000 /µL. Later, her nose bleeding and ecchymoses were suspected secondary to AZD-1222.
Case 9 (from table 1 of the article): A 50-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After 1−2 weeks post vaccination, she developed ecchymoses. On post-vaccination days 56, the sample was collected for testing. Subsequently, the ELISA and HIMEA tests for anti-PF4 antibodies showed a negative results. Her platelet count was 297,000 /µL. Later, her ecchymoses was suspected secondary to AZD-1222.
Case 10 (from table 1 of the article): A 60-year-old man had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After 2 weeks post-vaccination, she developed headache. On post-vaccination days 47, the sample was collected for testing. Subsequently, ELISA and HIMEA tests for anti-PF4 antibodies showed a negative results. His platelet count was 209,000 /µL. Later, her headache was suspected secondary to AZD-1222.
Case 11 (from table 1 of the article): A 57-year-old woman had received AZD-1222 [ChAdOx1 nCOV-19 vaccine, manufactured by AstraZeneca]. After 1−2 weeks post-vaccination, she developed haematuria, nose bleeding and ecchymoses. After 1−2 weeks post vaccination, the sample was collected for testing. Subsequently, the ELISA test for anti-PF4 antibodies showed a negative result. Her platelet count was 150,000 /µL. Later, her haematuria, nose bleeding and ecchymoses were suspected secondary to AZD-1222.
Reference
- Kristensen SR, et al. Covid-19 vaccination, adverse events, and detection of antibodies. Thrombosis Research 207: 131-133, Nov 2021. Available from: URL: 10.1016/j.thromres.2021.09.020 [DOI] [PMC free article] [PubMed]