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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 cross-sectional study involving 38 patients, 8 patients [including 2 men and 1 woman; aged 16−60s; not all sexes and ages stated] were described, who developed pain at the injection site, fatigue, fever, increase in seizure frequency, aching, sore arm and swelling at the injection site, chills, diarrhoea, tachycardia, worsening of swallowing, generally unwell or drowsiness following AZD-1222 or COVID-19-Vaccine-Pfizer-BioNTech vaccine [dosages, routes and duration of treatments to reactions onsets not stated; not all outcomes stated].
The patient, who had Dravet syndrome, received AZD-1222 vaccine [COVID Oxford/AstraZeneca vaccine]. However, the patient developed pain at the injection site after the second dose of AZD-1222 vaccine.
The patient, who had Dravet syndrome, received AZD-1222 vaccine. However, the patient developed fatigue, pain at the injection site and fever after the second dose of AZD-1222 vaccine.
The patient, who had Dravet syndrome, had been seizure free for 10 years prior to the vaccination. The patient received the first dose of AZD-1222 vaccine. Eleven days following vaccination, the patient experienced increase in seizure frequency. The patient also developed side effects of fatigue, aching and fever. The patient did not experience any side effects after the second dose of AZD-1222 vaccine.
The patient aged 25−34 years, who had Dravet syndrome and had previously been suspected for COVID-19 infection based on clinical symptoms, received the first dose of AZD-1222 vaccine. However, the patient developed side effects of swelling and sore arm at the injection site, aching, fatigue, fever, tachycardia, diarrhoea, chills and worsening of existing problems with swallowing. After 5 days, all the side effects resolved.
The patient aged 16−17 years, who had Dravet syndrome and had previously been suspected for COVID-19 infection based on clinical symptoms, received COVID-19-Vaccine-Pfizer-BioNTech vaccine [Pfizer/BioNTech vaccine]. Following first dose of vaccine, the patient developed side effects of aching, fatigue and sore arm.
The man in his 60s received first dose of the AZD-1222 vaccine in January 2021. In the 48 hours following the vaccination, he developed increase in seizure frequency and fever. He was treated with clobazam and paracetamol. His symptoms resolved within 48 hours. In March 2021, he received his second dose of AZD-1222 vaccine. After the second dose, he did not experience any side effects or change in seizure frequency.
The woman in her 20s received the first dose of COVID-19-Vaccine-Pfizer-BioNTech vaccine in February 2021 with no reported side effects. In April 2021, she received the second dose of COVID-19-Vaccine-Pfizer-BioNTech vaccine. However, she developed mild drowsiness after the second dose.
The man in his 20s received both doses of AZD-1222 vaccine (precise dates unknown). After the first dose, he was generally unwell with an increased seizure frequency which lasted for 5 days. There were no reported side effects after the second dose.
Reference
- Clayton LM, et al. The impact of SARS-CoV-2 vaccination in Dravet syndrome: A UK survey. Epilepsy and Behavior 124: Nov 2021. Available from: URL: http://www.elsevier.com/inca/publications/store/6/2/2/8/2/2/index.htt [DOI] [PMC free article] [PubMed]