Dolores Rodríguez1,2,3, Pilar Ordoñez1, Roser Llop1,2, Sebastián Videla1,2,3,4, Aurema Otero3,4, Thiago Carnaval1, Violeta Poltorak5, Miguel Moya-Guerola5, Cristina Masuet-Aumatell5, Soledad Rodriguez6, Pilar Hereu1,2,3. 1. Clinical Pharmacology Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain. 2. Pharmacology Unit, Department of Pathology and Experimental Therapeutics, School of Medicine and Health Sciences, Barcelona University, L'Hospitalet DE Llobregat, Barcelona, Spain. 3. IDIBELL Research Department, L'Hospitalet DE Llobregat, Barcelona, Spain. 4. Clinical Research Support Unit, Clinical Pharmacology Department, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain. 5. Preventive Medicine Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain. 6. Basic Prevention Unit Department, Bellvitge University Hospital, L'Hospitalet DE Llobregat, Barcelona, Spain.
Abstract
AIM: Vaccination against SARS-CoV2 has been proposed as a fundamental element for the control of the pandemic. This study aimed to describe the suspected adverse reactions (ADR) reported by vaccinated hospital workers. METHODS: A descriptive study of suspected ADR was conducted between January and March 2021. The suspected ADR were identified using a specifically designed electronic form and spontaneous reporting. Data were also collected regarding the characteristics of the professionals, vaccine administered, severity, and outcome of ADR. RESULTS: 8169 professionals received 2 doses of SARS-CoV2 vaccine (6672 Comirnaty® and 1497 Spikevax®) and 894 reports of suspected ADR were reported (762 for Comirnaty® and 132 for Spikevax®), resulting in a cumulative ADR incidence of 10.94% (95%CI: 10.27-11.62). The majority of ADR were reported only after the second dose, 497 (56.2%), while 211 (23.6%) were reported only after the first dose and 186 (21%) after both doses. The symptoms were mostly mild, did not require medical assistance, and disappeared within approximately 3 days. One hundred and seventeen professionals had a history of COVID-19 infection. These studies reported, statistically significant, more suspected ADR after the first dose (42.7%) than those with no history of COVID-19 (20.7%). Among professionals, more ADR occurred after the first dose with the Spikevax® vaccine (41.6%) than with the Comirnaty® vaccine (20.5%). CONCLUSION: The majority of suspected ADR reported were described in the summary of product characteristics (SmPC). Professionals with a history of COVID-19 reported more suspected ADR after the first dose than did those without a history.
AIM: Vaccination against SARS-CoV2 has been proposed as a fundamental element for the control of the pandemic. This study aimed to describe the suspected adverse reactions (ADR) reported by vaccinated hospital workers. METHODS: A descriptive study of suspected ADR was conducted between January and March 2021. The suspected ADR were identified using a specifically designed electronic form and spontaneous reporting. Data were also collected regarding the characteristics of the professionals, vaccine administered, severity, and outcome of ADR. RESULTS: 8169 professionals received 2 doses of SARS-CoV2 vaccine (6672 Comirnaty® and 1497 Spikevax®) and 894 reports of suspected ADR were reported (762 for Comirnaty® and 132 for Spikevax®), resulting in a cumulative ADR incidence of 10.94% (95%CI: 10.27-11.62). The majority of ADR were reported only after the second dose, 497 (56.2%), while 211 (23.6%) were reported only after the first dose and 186 (21%) after both doses. The symptoms were mostly mild, did not require medical assistance, and disappeared within approximately 3 days. One hundred and seventeen professionals had a history of COVID-19 infection. These studies reported, statistically significant, more suspected ADR after the first dose (42.7%) than those with no history of COVID-19 (20.7%). Among professionals, more ADR occurred after the first dose with the Spikevax® vaccine (41.6%) than with the Comirnaty® vaccine (20.5%). CONCLUSION: The majority of suspected ADR reported were described in the summary of product characteristics (SmPC). Professionals with a history of COVID-19 reported more suspected ADR after the first dose than did those without a history.
Authors: Barton F Haynes; Lawrence Corey; Prabhavathi Fernandes; Peter B Gilbert; Peter J Hotez; Srinivas Rao; Michael R Santos; Hanneke Schuitemaker; Michael Watson; Ann Arvin Journal: Sci Transl Med Date: 2020-10-19 Impact factor: 17.956
Authors: Fernando P Polack; Stephen J Thomas; Nicholas Kitchin; Judith Absalon; Alejandra Gurtman; Stephen Lockhart; John L Perez; Gonzalo Pérez Marc; Edson D Moreira; Cristiano Zerbini; Ruth Bailey; Kena A Swanson; Satrajit Roychoudhury; Kenneth Koury; Ping Li; Warren V Kalina; David Cooper; Robert W Frenck; Laura L Hammitt; Özlem Türeci; Haylene Nell; Axel Schaefer; Serhat Ünal; Dina B Tresnan; Susan Mather; Philip R Dormitzer; Uğur Şahin; Kathrin U Jansen; William C Gruber Journal: N Engl J Med Date: 2020-12-10 Impact factor: 91.245
Authors: Lindsey R Baden; Hana M El Sahly; Brandon Essink; Karen Kotloff; Sharon Frey; Rick Novak; David Diemert; Stephen A Spector; Nadine Rouphael; C Buddy Creech; John McGettigan; Shishir Khetan; Nathan Segall; Joel Solis; Adam Brosz; Carlos Fierro; Howard Schwartz; Kathleen Neuzil; Larry Corey; Peter Gilbert; Holly Janes; Dean Follmann; Mary Marovich; John Mascola; Laura Polakowski; Julie Ledgerwood; Barney S Graham; Hamilton Bennett; Rolando Pajon; Conor Knightly; Brett Leav; Weiping Deng; Honghong Zhou; Shu Han; Melanie Ivarsson; Jacqueline Miller; Tal Zaks Journal: N Engl J Med Date: 2020-12-30 Impact factor: 91.245