Spontaneous adverse event reporting by COVID-19 vaccinated healthcare professionals through an electronic form implemented by the hospital pharmacy

Aim Implementation of a web-form based pharmacovigilance plan for the spontaneous notification of adverse events to the Comirnaty® COVID-19 vaccine during its administration to hospital healthcare professionals. Methods An electronic pharmacovigilance form was developed containing 8 pre-defined event options, an open answer option for the description of other events and/or symptoms, and a question about the overall intensity of symptoms. The adverse events reports were standardised according to physiological and pathological condition. Results A total of 4119 adverse events notifications were obtained with a 45% rate of electronic notification. The most clinically relevant events reported were: tachycardia (n=19), dyspnoea (n=7), chest pain (n=6), facial/labial oedema (n=6), lipothymia (n=5), bronchospasm (n=2), herpetic infection (n=2), vasculitis (n=2), arrhythmia (n=1), difficult to control arterial hypertension (n=1), gastritis (n=1) and spontaneous abortion (n=1). Regarding the intensity of symptoms (n=2928), 70.0% were reported as mild, 25.8% as moderate and 4.27% as severe, with higher intensity in the 2nd dose compared to 1st dose. The highest frequency of severe events were reported in the groups from 40 to 59 years in both vaccination periods. During the vaccination process, no hospitalisations and no deaths were notified and/or recorded. Conclusion In this real world study, comparing with Comirnaty clinical trials program, it was observed a higher frequency of adenomegaly and gastrointestinal disorders. Noteworthy, the notification of a case of miscarriage. The use of hospital pharmacy pharmacovigilance electronic forms, seemed to be relevant to notification adherence and to obtain a greater and faster knowledge of COVID-19 vaccine safety profile.

Hemophagocytic lymphohistiocytosis associated with the use of lamotrigine

ObjectiveTo describe adverse event reports of hemophagocytic lymphohistiocytosis (HLH) reported in association with lamotrigine.MethodsThe Food and Drug Administration Adverse Event Reporting System database of spontaneous adverse event reports and medical literature databases were searched for cases of HLH reported in association with lamotrigine. Cases were included if they met the case definition of suspected or confirmed HLH and if causal association was assessed as robust or supportive.ResultsEight cases met the case definition for HLH and were deemed causally associated with lamotrigine. These 8 cases of HLH had a plausible temporal relationship because they occurred within a 24-day interval from lamotrigine initiation. The doses ranged from 25 mg every other day to 250 mg once daily in the 6 cases that reported this information. Seven patients improved with drug discontinuation and one patient died after drug discontinuation and receiving an unspecified chemotherapy.ConclusionsLamotrigine is associated with immune-related adverse reactions including HLH. HLH is a potentially fatal event; prompt recognition and early therapeutic intervention to mitigate the event is important in improving patient outcomes.