Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Lethargy, Myalgia
Clinical narrative: INCREASED SEIZURE ACTIVITY; LETHARGY; CHILLS; SORENESS AT THE INJECTION SITE; HEADACHE; MUSCLE PAIN; NAUSEA; FEVER; This solicited report received from a health care professional via literature. The aim of this study was to collect information on the experiences of patients with Dravet syndrome (DS) surrounding COVID-19 vaccination, including preventative measures and side effects, to better inform the decision-making process for caregivers and health care providers. The patient's height, and weight were not reported. The patient's concurrent conditions included: dravet syndrome. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on 2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  Survey responses from 156 caregivers represented individuals with DS aged 12 and older; of these, 119 (76 percent) reported having received at least one dose of COVID-19 vaccination. Of the 120 individuals who had received at least one dose of a COVID-19 vaccine, 99 (83 percent) received the PfizerBioNTech vaccine, 16 (13 percent) received Moderna, three (2 percent) received AstraZeneca, two (2 percent) received Janssen. The most commonly reported side effects were lethargy for 23 (19 percent, D1) individuals, and soreness at the injection site for 32 (27 percent, D1) individuals. Fewer than 10 percent reported headache, muscle pain, nausea, or chills after a COVID-19 vaccine dose. Fever was reported for six (5 percent) after Dose 1. After Dose 1, 11 (9 percent) individuals with DS had increased seizure activity. When side effects occurred, they were most likely to appear between 6 and 24 h following COVID-19 vaccination for either dose. Following the COVID-19 vaccine, antipyretics were given to 71 (59 percent) individuals after D1. Patients received an average of 3.2 doses of antipyretics, most commonly in the first 24 h following vaccination. Bridge Anti-seizure medication (ASMs) were used for 10 (8 percent) individuals after D1. Bridge ASMs included clonazepam, clobazam, lorazepam, clorazepate, and diazepam. Overall, the use of antipyretics or bridge ASMs was not linked to increased seizure activity. Increased seizure activity was instead more likely to be reported in individuals using antipyretics following D1 (10/71, 14.1 percent, p = .03) than those who did not use antipyretics. Additionally, increased seizure activity was also more likely to be reported in those who indicated use of a bridge ASM with D1 versus reports of increased seizures in those who did not use bridge ASMs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased seizure activity, lethargy, soreness at the injection site, headache, muscle pain, nausea, chills and fever was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and increased seizure activity, and lethargy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, soreness at the injection site, headache, muscle pain, nausea, and fever was related.  The authors concluded that, this study provides valuable information for families, caregivers, those patients who might have a better cognitive function, and health care providers navigating decisions regarding COVID-19 vaccination for individuals with DS. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231129710- Increased seizure activity. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.