Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Blood culture negative, C-reactive protein normal, Culture urine negative, Procalcitonin, Pyrexia
Clinical narrative: Pyrexia; Procalcitonin; C-Reactive protein normal; Blood culture negative; Culture urine negative; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 05-FEB-2024 with the following VAERS primary ID 2715578-1. The original narrative from the sender is as follows:   Patient exposed to sibling with viral illness and developed fever 10/5/2023 that resolved on its own. Patient seen for Health Maintenance exam on 11/7/2023 with normal exam. Patient developed fever on the evening of 11/7/2023 and seen in Emergency Department and admitted for observation.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events of Pyrexia, Procalcitonin, C-Reactive protein normal, Blood culture negative, and Culture urine negative.    COMPANY COMMENT: Pyrexia was assessed as serious due to hospitalization, whereas Procalcitonin, C-Reactive protein normal, Blood culture negative, Culture urine negative were assessed as non-serious.   Pyrexia is listed, whereas Procalcitonin, C-Reactive protein normal, Blood culture negative, Culture urine negative are unlisted for Vaxelis as per the Reference Safety Information (CCDS, PI).   Considering the current knowledge on Vaxelis (Pyrexia is listed as per CCDS, PI) and the onset latency (event occurred 1 day after vaccination), and despite the co-suspect vaccines as confounding factors and lack of information in this case (no medical history of adverse events after the first vaccination with Vaxelis), the causal relationship between Vaxelis and the reported event Pyrexia cannot be excluded and is assessed as related. The causal relationship between Vaxelis and the events Procalcitonin, C-Reactive protein normal, Blood culture negative, Culture urine negative is assessed as not applicable, due to the nature of these events.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Pyrexia was assessed as serious due to hospitalization, whereas Procalcitonin, C-Reactive protein normal, Blood culture negative, Culture urine negative were assessed as non-serious.   Pyrexia is listed, whereas Procalcitonin, C-Reactive protein normal, Blood culture negative, Culture urine negative are unlisted for Vaxelis as per the Reference Safety Information (CCDS, PI).   Considering the current knowledge on Vaxelis (Pyrexia is listed as per CCDS, PI) and the onset latency (event occurred 1 day after vaccination), and despite the co-suspect vaccines as confounding factors and lack of information in this case (no medical history of adverse events after the first vaccination with Vaxelis), the causal relationship between Vaxelis and the reported event Pyrexia cannot be excluded and is assessed as related. The causal relationship between Vaxelis and the events Procalcitonin, C-Reactive protein normal, Blood culture negative, Culture urine negative is assessed as not applicable, due to the nature of these events.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.