{"id":"https://openalex.org/W4415533341","doi":"https://doi.org/10.18203/2319-2003.ijbcp20253382","title":"Analysis of adverse event reporting patterns following COVID-19 vaccination: findings from VigiAccess, FAERS and EudraVigilance databases with comparative assessment of data representation and categorization across three databases","display_name":"Analysis of adverse event reporting patterns following COVID-19 vaccination: findings from VigiAccess, FAERS and EudraVigilance databases with comparative assessment of data representation and categorization across three databases","publication_year":2025,"publication_date":"2025-10-24","ids":{"openalex":"https://openalex.org/W4415533341","doi":"https://doi.org/10.18203/2319-2003.ijbcp20253382"},"language":"en","primary_location":{"id":"doi:10.18203/2319-2003.ijbcp20253382","doi":"https://doi.org/10.18203/2319-2003.ijbcp20253382","is_oa":true,"landing_page_url":"https://doi.org/10.18203/2319-2003.ijbcp20253382","pdf_url":"https://www.ijbcp.com/index.php/ijbcp/article/download/6009/3939","source":{"id":"https://openalex.org/S2764844374","display_name":"International Journal of Basic & Clinical Pharmacology","issn_l":"2279-0780","issn":["2279-0780","2319-2003"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4322697004","host_organization_name":"Medip Academy","host_organization_lineage":["https://openalex.org/P4322697004"],"host_organization_lineage_names":["Medip Academy"],"type":"journal"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Basic & Clinical Pharmacology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://www.ijbcp.com/index.php/ijbcp/article/download/6009/3939","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5120129981","display_name":"Ram N. Mahurkar","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2802985673","display_name":"Cooper Hospital","ror":"https://ror.org/02ry07h90","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I2802985673"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Ram N. Mahurkar","raw_affiliation_strings":["Department of Pharmacology, HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai, Maharashtra, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacology, HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai, Maharashtra, India","institution_ids":["https://openalex.org/I2802985673"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5039709987","display_name":"Kiran A. Bhave","orcid":"https://orcid.org/0009-0006-1145-4341","observed_orcids":["https://orcid.org/0009-0006-1145-4341"]},"institutions":[{"id":"https://openalex.org/I2802985673","display_name":"Cooper Hospital","ror":"https://ror.org/02ry07h90","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I2802985673"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Kiran A. Bhave","raw_affiliation_strings":["Department of Pharmacology, HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai, Maharashtra, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacology, HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai, Maharashtra, India","institution_ids":["https://openalex.org/I2802985673"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5091594827","display_name":"Prasad R. Pandit","orcid":"https://orcid.org/0009-0005-0901-135X","observed_orcids":["https://orcid.org/0009-0005-0901-135X"]},"institutions":[{"id":"https://openalex.org/I2802985673","display_name":"Cooper Hospital","ror":"https://ror.org/02ry07h90","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I2802985673"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Prasad R. Pandit","raw_affiliation_strings":["Department of Pharmacology, HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai, Maharashtra, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacology, HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai, Maharashtra, India","institution_ids":["https://openalex.org/I2802985673"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5082880203","display_name":"Tejal C. Patel","orcid":"https://orcid.org/0000-0002-7356-7054","observed_orcids":["https://orcid.org/0000-0002-7356-7054"]},"institutions":[{"id":"https://openalex.org/I2802985673","display_name":"Cooper Hospital","ror":"https://ror.org/02ry07h90","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I2802985673"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Tejal C. Patel","raw_affiliation_strings":["Department of Pharmacology, HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai, Maharashtra, India"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacology, HBT Medical College and Dr. R. N. Cooper Hospital, Mumbai, Maharashtra, India","institution_ids":["https://openalex.org/I2802985673"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I2802985673"],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"14","issue":"6","first_page":"1045","last_page":"1053"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9961000084877014,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.9961000084877014,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10118","display_name":"SARS-CoV-2 and COVID-19 Research","score":0.0034000000450760126,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11819","display_name":"Data-Driven Disease Surveillance","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2713","display_name":"Epidemiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/covid-19-vaccination","display_name":"COVID-19 vaccination","score":0.921999990940094},{"id":"https://openalex.org/keywords/vaccine-adverse-events","display_name":"vaccine adverse events","score":0.9760000109672546},{"id":"https://openalex.org/keywords/vaccine-safety","display_name":"vaccine safety","score":0.7580000162124634},{"id":"https://openalex.org/keywords/pharmacovigilance-databases","display_name":"pharmacovigilance databases","score":0.9739999771118164},{"id":"https://openalex.org/keywords/fda-adverse-event-reporting-system","display_name":"FDA Adverse Event Reporting System","score":0.9919999837875366},{"id":"https://openalex.org/keywords/eudravigilance","display_name":"EudraVigilance","score":1.0},{"id":"https://openalex.org/keywords/individual-case-safety-reports","display_name":"individual case safety reports","score":0.8560000061988831},{"id":"https://openalex.org/keywords/headache","display_name":"headache","score":0.6639999747276306},{"id":"https://openalex.org/keywords/fatigue","display_name":"fatigue","score":0.9010000228881836}],"concepts":[{"id":"https://openalex.org/C2777105317","wikidata":"https://www.wikidata.org/wiki/Q4686710","display_name":"Adverse Event Reporting System","level":3,"score":0.8206999897956848},{"id":"https://openalex.org/C57658597","wikidata":"https://www.wikidata.org/wiki/Q1550789","display_name":"Pharmacovigilance","level":3,"score":0.798799991607666},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6888999938964844},{"id":"https://openalex.org/C77088390","wikidata":"https://www.wikidata.org/wiki/Q8513","display_name":"Database","level":1,"score":0.6819000244140625},{"id":"https://openalex.org/C199475168","wikidata":"https://www.wikidata.org/wiki/Q1539689","display_name":"MedDRA","level":4,"score":0.6593000292778015},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.6049000024795532},{"id":"https://openalex.org/C94124525","wikidata":"https://www.wikidata.org/wiki/Q912550","display_name":"Categorization","level":2,"score":0.5703999996185303},{"id":"https://openalex.org/C22070199","wikidata":"https://www.wikidata.org/wiki/Q192995","display_name":"Vaccination","level":2,"score":0.48069998621940613},{"id":"https://openalex.org/C23131810","wikidata":"https://www.wikidata.org/wiki/Q818574","display_name":"Observational study","level":2,"score":0.44429999589920044},{"id":"https://openalex.org/C3019706980","wikidata":"https://www.wikidata.org/wiki/Q445335","display_name":"Vaccine safety","level":4,"score":0.4327000081539154},{"id":"https://openalex.org/C195910791","wikidata":"https://www.wikidata.org/wiki/Q1324077","display_name":"Medical record","level":2,"score":0.42329999804496765},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.3840999901294708},{"id":"https://openalex.org/C23276603","wikidata":"https://www.wikidata.org/wiki/Q158230","display_name":"Pharmacoepidemiology","level":3,"score":0.3422999978065491},{"id":"https://openalex.org/C2780801004","wikidata":"https://www.wikidata.org/wiki/Q1415366","display_name":"Immunization","level":3,"score":0.3314000070095062},{"id":"https://openalex.org/C2993432071","wikidata":"https://www.wikidata.org/wiki/Q45959","display_name":"Drug reaction","level":3,"score":0.29580000042915344},{"id":"https://openalex.org/C167135981","wikidata":"https://www.wikidata.org/wiki/Q2146302","display_name":"Retrospective cohort study","level":2,"score":0.2653999924659729},{"id":"https://openalex.org/C2780542314","wikidata":"https://www.wikidata.org/wiki/Q45959","display_name":"Adverse drug reaction","level":3,"score":0.2502000033855438}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.18203/2319-2003.ijbcp20253382","doi":"https://doi.org/10.18203/2319-2003.ijbcp20253382","is_oa":true,"landing_page_url":"https://doi.org/10.18203/2319-2003.ijbcp20253382","pdf_url":"https://www.ijbcp.com/index.php/ijbcp/article/download/6009/3939","source":{"id":"https://openalex.org/S2764844374","display_name":"International Journal of Basic & Clinical Pharmacology","issn_l":"2279-0780","issn":["2279-0780","2319-2003"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4322697004","host_organization_name":"Medip Academy","host_organization_lineage":["https://openalex.org/P4322697004"],"host_organization_lineage_names":["Medip Academy"],"type":"journal"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Basic & Clinical Pharmacology","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.18203/2319-2003.ijbcp20253382","doi":"https://doi.org/10.18203/2319-2003.ijbcp20253382","is_oa":true,"landing_page_url":"https://doi.org/10.18203/2319-2003.ijbcp20253382","pdf_url":"https://www.ijbcp.com/index.php/ijbcp/article/download/6009/3939","source":{"id":"https://openalex.org/S2764844374","display_name":"International Journal of Basic & Clinical Pharmacology","issn_l":"2279-0780","issn":["2279-0780","2319-2003"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4322697004","host_organization_name":"Medip Academy","host_organization_lineage":["https://openalex.org/P4322697004"],"host_organization_lineage_names":["Medip Academy"],"type":"journal"},"license":"other-oa","license_id":"https://openalex.org/licenses/other-oa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Basic & Clinical Pharmacology","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.9763000011444092,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Observational Study","id":"https://openalex.org/study-designs/observational-study"}],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4415533341.pdf","grobid_xml":"https://content.openalex.org/works/W4415533341.grobid-xml"},"referenced_works_count":12,"referenced_works":["https://openalex.org/W979396035","https://openalex.org/W1505489204","https://openalex.org/W2972855606","https://openalex.org/W2979536690","https://openalex.org/W3017728099","https://openalex.org/W3029864745","https://openalex.org/W3033158347","https://openalex.org/W4225293614","https://openalex.org/W4283395367","https://openalex.org/W4295969579","https://openalex.org/W4312126307","https://openalex.org/W4366992460"],"related_works":["https://openalex.org/W4295969579","https://openalex.org/W7170144205","https://openalex.org/W4200411200","https://openalex.org/W3207775422","https://openalex.org/W2897154393","https://openalex.org/W4400610214","https://openalex.org/W4407757115","https://openalex.org/W3193909907","https://openalex.org/W4401959112","https://openalex.org/W4232362004"],"abstract_inverted_index":{"The":[0,95,116,138],"clinical":[1],"presentation":[2],"of":[3,23,38,98],"COVID-19":[4,39,61,103,163],"varied":[5],"from":[6],"mild":[7],"to":[8,53,68],"severe":[9,24],"or":[10],"fatal":[11],"illness,":[12],"and":[13,67,75,92,112,128,173,195,229],"vaccination":[14,40,62],"played":[15],"a":[16],"pivotal":[17],"role":[18],"in":[19,83,107,110,114,121,143,156,224],"preventing":[20],"the":[21,36,42,152,166,198,202,207,216,231],"spread":[22],"acute":[25],"respiratory":[26],"syndrome":[27],"coronavirus":[28],"2":[29],"(SARS\u2011CoV\u20112).":[30],"Despite":[31],"cumulative":[32],"evidence":[33],"suggesting":[34],"that":[35,206],"benefits":[37],"outweighed":[41],"risks,":[43],"evaluating":[44],"its":[45],"safety":[46,188],"profile":[47],"remained":[48],"imperative.":[49],"This":[50],"study":[51,80],"aimed":[52],"analyse":[54],"adverse":[55,176,211],"events":[56,177],"following":[57],"immunization":[58],"(AEFI)":[59],"after":[60],"using":[63,86],"three":[64,123,183,217],"pharmacovigilance":[65],"databases":[66,124,184,227],"assess":[69],"how":[70,225],"these":[71,226],"data":[72],"were":[73,105,213],"categorized":[74,175,185,197,230],"represented.":[76],"A":[77],"cross-sectional":[78],"observational":[79],"was":[81,125,145,151],"conducted":[82],"January":[84],"2024":[85],"VigiAccess":[87,144,158],"(WHO),":[88],"FAERS":[89,134,172,194],"(U.S.":[90],"FDA),":[91],"EudraVigilance":[93,136,174,196],"(EMA).":[94],"total":[96],"number":[97],"reported":[99,141,210],"AEFI":[100,199],"cases":[101],"for":[102,161],"vaccines":[104,164],"55,49,876":[106],"VigiAccess,":[108],"11,640":[109],"FAERS,":[111],"23,16,918":[113],"EudraVigilance.":[115],"most":[117,139,153,208],"common":[118,154],"reaction":[119,142,155],"group":[120],"all":[122],"general":[126,167],"disorders":[127],"administration":[129],"site":[130],"conditions":[131],"(VigiAccess":[132],"59.07%,":[133],"62.57%,":[135],"62.67%).":[137],"frequently":[140],"headache":[146],"(22.73%),":[147],"while":[148,219],"fatigue":[149],"(19.79%)":[150],"FAERS.":[157],"grouped":[159],"AEFIs":[160],"different":[162],"under":[165],"term":[168],"\u201cCOVID-19":[169],"vaccine,\u201d":[170],"whereas":[171],"by":[178],"specific":[179],"vaccine":[180],"types.":[181],"All":[182],"individual":[186],"case":[187],"reports":[189],"(ICSRs)":[190],"data,":[191],"but":[192],"only":[193],"data.":[200,232],"Overall,":[201],"comparative":[203],"analysis":[204],"revealed":[205],"commonly":[209],"reactions":[212],"consistent":[214],"across":[215],"databases,":[218],"also":[220],"highlighting":[221],"significant":[222],"differences":[223],"represented":[228]},"counts_by_year":[],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2025-10-25T00:00:00"}