Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway.

aimThis study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID-19 during the COVID-19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship between the AE and the suspected COVID-19 vaccine, with a particular focus on the type of unstructured information provided by each group.

methodsVerified duplicate pairs of AE reports following COVID-19 vaccination were extracted from the Norwegian Adverse Drug Reaction Registry. Free-text case narratives were analysed using thematic analysis to categorize types of unstructured information. A scoring system quantified completeness of causality-relevant information, with final scores categorized into levels of completeness. Time intervals from AE onset to reporting were also calculated.

resultsNineteen categories of unstructured information were identified. HCPs more often provided vaccine dose details, clinical observations, test results and causality reflections, while consumers more often described dietary supplements, life consequences and subjective AE explanations (p < .05). In 85% of 127 duplicate pairs, HCPs and consumers provided at least 50% complementary information in free-text narratives. Both groups provided similar levels of causality-relevant information (p = .774). HCPs reported earlier than consumers (p < .05).

conclusionHCPs and consumers provided highly complementary unstructured information and comparable completeness for causality assessment. Collaboration between these groups should be encouraged, particularly in public health and clinical emergencies like epidemics and in situations of high uncertainty.