Particularly, as previously described, vaccination with ChAdOx1 nCov-19 may cause the rare development of immune thrombocytopenia mediated by platelet-activating antibodies against PF4, which clinically mimics heparin-induced autoimmune thrombocytopenia. Although we discuss here with two exemplificative cases related to ChAdOx1 nCoV-19 vaccination, we strongly recommend by using this diagram in all cases of AEFI related to COVID-19 vaccination, considering that severe adverse effects could occur with any kind of vaccine. 5. led us to conclude that vaccination with ChAdOx1 nCov-19 may cause the rare development of immune thrombocytopenia mediated by platelet-activating antibodies against platelet element COH000 4 (PF4), which clinically mimics heparin-induced autoimmune thrombocytopenia. Rabbit Polyclonal to EPHB6 We suggest the adoption of the proposed methodology in order to confirm or rule out a causal relationship between vaccination and the event of AEFI. spp., em Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus /em ). Checks for additional viral infections (we.e., cytomegalo disease (CMV); EpsteinCBarr disease (EBV); herpes simplex virus (HSV); varicella-zoster disease (VZV). Detection of the viral vector of the COVID-19 vaccine. 3. Results 3.1. Structure of the AEFI Methods for COVID-19 Vaccination The proposed procedures are based on the same structure of the WHO AEFI recommendations, including eligibility (case ascertainment), checklist, algorithm and final classification (Number 1). Open in a separate window Number 1 Structure of the causality assessment recommendations for AEFI following COVID-19 vaccine administration. 3.2. Eligibility Eligibility represents an important prerequisite that triggers the next step in the assessment of causality. Usually at this stage, the reviewers defined the so-called causality query. Considering the severe adverse effects reported in the literature, in the case of the COVID-19 vaccination, the query is definitely if the COVID-19 vaccine/vaccination caused thrombosis and thrombocytopenia. 3.3. Checklist To explore the possible causal association between the COVID-19 vaccination and severe adverse effects, several questions were included in the checklist (Table 1). The table has been structured into four sections: (1). Order of the evidence; (2). temporal proximity; (3). evidence for other causes; (4). published evidence. The first step is the definition of a temporary relationship between COVID-19 vaccine administration and the onset of adverse effects. The second step is to analyze the temporal proximity to confirm the symptoms occurred within a plausible time windowpane after vaccine administration. According to the literature, three weeks after administration represent an ideal period that should be monitored to evaluate the AEFI after COVID-19 vaccination [8,9]. Table 1 Causality assessment recommendations for AEFI following COVID-19 vaccine administration: checklist. 1.?Order of events Was the COVID-19 vaccine administered before COH000 the observed symptoms occurred? Yes No 2.?Temporal proximity Did the observed symptoms occur within 21 days following vaccination? Yes No Write the time interval between vaccination and event of observed symptoms Place time in days 3.?Evidence for other causes ??For each question, please answer Y (Yes), N (No), UK (Unknown), NA (Not applicable) br / ??Please write the reason behind your choice in the notice column. Category Items Y N UK NA Notice History 3.1 Has the patient ever tested positive for COVID-19 illness? Please, create the COH000 time and the period of COVID-19 illness 3.2 Has the patient ever been vaccinated for COVID-19 illness before? If so, please create the name of vaccine and the vaccination day. 3.3 Has the patient ever experienced any diseases after any type of vaccination? Individuals condition before appearance of symptoms ??Has the patient ever experienced any items below before the manifestation of COVID-19 vaccine severe adverse effects? If so, please indicate the event data.3.4 Upper respiratory infections 3.5 Personal history of other venous thrombosis and embolism (ICD-10- CM Z86 Diagnosis Code) 3.6 Severe cardiomyopathy (ICD-10-CM category I42) 3.7 Other infections (i.e., HBV, HCV, HIV) 3.8 Surgery 3.9 Other pathologies Patient examination ??Was a test among those listed below performed after the manifestation of COVID-19 vaccine severe adverse effects? If so, write the day of the test, test result, and specific other useful info.3.10 Post-mortem investigation (with histological and IHC investigations 3.11 Thrombosis panel test 3.12 Genetic screening for hypercoagulability 3.13 Molecular checks for detection of SARS-CoV-2 using additional lung samples 3.14 Molecular checks for detection of SARS-CoV-2 in atypical samples, using formalin-fixed paraffin-embedded (FFPE) cells specimens 3.15 Panel for respiratory viruses 3.16 Panel for respiratory bacterial pathogens 3.17 Checks for additional viral infections 3.18 Detection of viral vector COVID-19 vaccine Immunization anxiety 3.19 Were the observed symptoms a pressure response to vaccination? (e.g., acute stress response, vasovagal syncope, hyperventilation, panic, etc.) Vaccine quality 3.20 Could the vaccine given to this patient have a quality defect or be substandard or counterfeit? (i.e., checking production lot, storage condition, etc.) Immunization COH000 errors (please, write type of error, if any) 3.21 Did anything unusual occur.
