Effectiveness of the Comirnaty (BNT162b2, BioNTech/Pfizer) vaccine in preventing SARS-CoV-2 infection among healthcare workers, Treviso province, Veneto region, Italy, 27 December 2020 to 24 March 2021.
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ABSTRACT:
SUBMITTER: Fabiani M
PROVIDER: S-EPMC8086247 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background Coronavirus disease-19 (COVID-19) due to acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is the largest emergency that humanity had to be dealing with in the last century. During the last months, different types of vaccines have been designed to contain the ongoing SARS-CoV-2 pandemic, with successful results in many countries. Comirnaty (Pfizer/BioNtech) COVID-19 vaccine is a lipid nanoparticle-formulated, nucleoside mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2. Although vaccines have an undeniable efficacy, they can also present several neurological side effects, including headache. According to ICHD-3 Classification, status migrainosus (SMg) is described as a debilitating migraine attack lasting for more than 72 h. Symptoms of SMg can be very severe, preventing the normal daily activities of the individual. Case presentation In the present report, we describe a case of SMg that lasted 11 days, time correlated with the second dose of COVID-19 vaccine (Pfizer/Comirnaty) in a 37-year-old woman with a history of migraine without aura. Conclusions In patients with a history of migraine, COVID-19 vaccination could lead to a worsening of headache and, in rare cases, to the development of a SMg. This may be related to the inflammatory response that occurs after vaccination. Supplementary Information The online version contains supplementary material available at 10.1007/s10072-021-05741-x.
| S-EPMC8607053 | biostudies-literature
Project description:Introduction Le vaccin Pfizer est un vaccin à ARN messager. De rares cas de réaction d’hypersensibilité immédiate ont été rapportés. Nous rapportons un cas de réaction d’hypersensibilité retardée de type érythème pigmenté fixe (EPF) après vaccin anti-COVID-19 Comirnaty® de Pfizer/BioNTech. Matériel et méthodes Une femme de 54 ans, au seul antécédent de rhinite allergique aux pollens, a développé dans les 24 heures qui ont suivi la vaccination par Comirnaty® au bras droit, une plaque érythémateuse arrondie bien limitée de 3 cm de diamètre, du poignet controlatéral. L’évolution était marquée par une fine desquamation périphérique 15 jours plus tard, et a régressé en 25 jours avec un érythème séquellaire sur une partie de la plaque. À l’interrogatoire, le seul facteur déclenchant trouvé était l’injection du vaccin. Vingt-huit jours plus tard, la deuxième injection a été réalisée provoquant une récidive de la lésion au même endroit. L’étude histologique montrait une dermite vacuolaire et spongiotique avec des nécroses kératinocytaires, compatible avec une toxidermie. Nous avons conclu au diagnostic d’EPF après vaccination avec Comirnaty®. L’EPF a été traité par application de crème de dipropionate de béclométhasone. La plaque a régressé en 21 jours. Cinq semaines après la deuxième dose de vaccin, des patch-tests ont été réalisés sur la lésion, avec le vaccin pur et dilué à 30 % dans de la vaseline. Le patch-test était positif (+) pour le vaccin dilué dans 30 % de vaseline après 48 heures. Le patch-test avec polyéthylène glycol (PEG) dilué dans 30 % de vaseline était positif (+) après 144 heures. Nous contre-indiquons le PEG sous forme injectable ainsi qu’en sachet pour préparation colique du fait de la quantité importante de PEG que cela contient ; en revanche, le macrogol renfermé dans des comprimés n’a pas été contre-indiqué (très faible quantité, aucun cas rapporté avec cette forme). Discussion Seul un autre cas d’EPF après vaccin Comirnaty® a été décrit dans la littérature, chez une femme jeune, avec une érosion centrale secondaire. L’éruption était vésiculo-bulleuse après la deuxième injection. Les tests cutanés n’ont pas été réalisés. Dans la littérature, il existe de rares cas d’EPF après vaccins, contre la grippe (1 cas bulleux du dos et des cuisses, 1 cas au poignet, 1 cas sur la main), contre le papillomavirus (1 cas bulleux du bras), contre la fièvre jaune (1 cas sur le nez). Les délais de survenue variaient entre 2 h et 4 jours après vaccination. Des patch-tests ont été réalisés dans 3 cas, dont 2 avec vaccin anti-grippal et étaient positifs et un avec le papillomavirus, négatif. Les contre-indications avec les vaccins et leurs excipients n’ont pas été discutés. Nous rapportons un cas d’EPF après vaccin Comirnaty® confirmé par un patch-test avec le vaccin et le PEG contenu dans le vaccin. En cas d’EPF après vaccination anti-COVID-19, le rapport bénéfice/risque est en faveur de la poursuite du schéma vaccinal.
| S-EPMC8603746 | biostudies-literature
Project description:SARS-CoV-2 Delta (B.1.617.2) variant of concern (VOC) and other VOCs are spreading in Europe. Micro-neutralisation assays with sera obtained after Comirnaty (BNT162b2, BioNTech/Pfizer) vaccination in 36 healthcare workers (31 female) demonstrated significant fold change reduction in neutralising titres compared with the original virus: Gamma (P.1) 2.3, Beta (B.1.351) 10.4, Delta 2.1 and 2.6. The reduction of the Alpha (B.1.1.7) variant was not significant. Despite being lower, remaining neutralisation capacity conferred by Comirnaty against Delta and other VOCs is probably protective.
| S-EPMC8326656 | biostudies-literature
Project description:The messenger RNA vaccine against SARS-CoV-2 is effective at preventing COVID-19-associated hospitalization, and the Centers for Disease Control and Prevention has recommended vaccination for all eligible individuals. We demonstrate a case involving a patient who developed a life-threatening acute asthma exacerbation after receiving their third dose of the BNT16b2 vaccine. Because eosinophilia was observed after the second inoculation, it was considered likely that the patient had been sensitized to the BNT16b2 vaccine. Theoretically, the SARS-CoV-2 vaccine could trigger the exacerbation of asthma. It should be recognized that repeated SARS-CoV-2 vaccination may be a risk factor for the acute exacerbation of asthma.
| S-EPMC9477784 | biostudies-literature
Project description:Purpose: To understand the single cell landscape of patients treated with the BNT162b2 mRNA vaccine
2021-06-25 | GSE171964 | GEO
Project description:BackgroundCoronavirus disease 2019 (COVID-19) has spread worldwide. Vaccination is now recommended as one of the effective countermeasures to control the pandemic or prevent the worsening of symptoms. However, its adverse effects have been attracting attention. Here, we report an autopsy case of multiple thromboses after receiving the first dose of the BNT162b2 mRNA vaccine (Comirnaty, Pfizer/BioNTech) in an elderly woman.Case presentationA 72-year-old woman with a history of diffuse large B-cell lymphoma in the stomach and hyperthyroidism received the first dose of the BNT162b2 mRNA vaccine and died 2 days later. The autopsy revealed multiple microthrombi in the heart, brain, liver, kidneys, and adrenal glands. The thrombi were CD61 and CD42b positive and were located in the blood vessels primarily in the pericardial aspect of the myocardium and subcapsular region of the adrenal glands; their diameters were approximately 5-40 μm. Macroscopically, a characteristic myocardial haemorrhage was observed, and the histopathology of the characteristic thrombus distribution, which differed from that of haemolytic uraemic syndrome and disseminated intravascular coagulation, suggested that the underlying pathophysiology may have been similar to that of thrombotic microangiopathy (TMA).ConclusionThis is the first report on a post-mortem case of multiple thromboses after the BNT162b2 mRNA vaccine. The component thrombus and characteristic distribution of the thrombi were similar to those of TMA, which differs completely from haemolytic uraemic syndrome or disseminated intravascular coagulation, after vaccination. Although rare, it is important to consider that fatal adverse reactions may occur after vaccination and that it is vital to conduct careful follow-up.
| S-EPMC9540301 | biostudies-literature
Project description:Immune thrombocytopenia is an autoimmune disease that can cause bleeding in severe cases. Although available published data do not associate the BNT162b2 vaccine (Pfizer-BioNTech) with the risk of developing thrombocytopenia, the ChAdOx1 nCov-19 vaccine has raised concerns about its potential link with thrombosis and thrombocytopenia. We would like to clarify whether the BNT162b2 vaccine administration may interfere with pre-existing conditions and whether it may cause a risk of thrombocytopenia. Herein, we report three cases of post-vaccine thrombocytopenia among patients with rheumatoid arthritis (RA); one case in which a causal relationship cannot be ruled out with the BNT162b2 vaccine was officially announced. Furthermore, we reviewed reports of adverse events and death cases with a focus on thrombocytopenia and hemorrhages, following vaccination with BNT162b2 in Japan between February 17, 2021 and July 16, 2021, as reported by the Ministry of Health, Labour, and Welfare within the general population. The three cases in this report share the common features of old age, RA, chronic renal failure or hypertension, and pre-existing mild thrombocytopenia at baseline. A total of 746 death cases were reported during this time period, with death by bleeding accounting for 8.8% of the total deaths, of which 84.8% were cranial and statistically higher in young women than among elderly women. The risk-benefit ratio of the vaccine needs to be reconsidered based on high- and low-risk population types and ethnicity. To do so, the expansion of the pharmacovigilance system for BNT162b2 vaccination is urgently required worldwide.
| S-EPMC8514746 | biostudies-literature
Project description:ObjectiveCoronaVac (Sinovac) Covid-19 vaccine has recently been approved for emergency use by the World Health Organization. However, data on its reactogenicity in real-world settings is scant. This study aimed to compare self-reported post-vaccination adverse reactions between CoronaVac and Comirnaty (Pfizer-BioNTech).MethodsWe adopted a prospective cohort study design using online surveys from the day of first-dose vaccination with intensive follow-up through two weeks after the second dose (11 time points). The primary outcome was adverse reactions (any versus none) and secondary outcomes were the sub-categories of adverse reactions (local, systemic, and severe allergic reactions). Potential effect modification across multimorbidity status, older age, and sex was examined.ResultsIn total, 2,098 participants who were scheduled to complete the 14th-day survey were included, with 46.2% receiving Comirnaty. Retention rate two weeks after the second dose was 81.0% for the CoronaVac group and 83.6% for the Comirnaty group. Throughout the follow-up period, 801 (82.7%) of those receiving Comirnaty and 543 (48.1%) of those receiving CoronaVac reported adverse reactions. Adjusted analysis suggested that compared with Comirnaty, CoronaVac was associated with 83%-reduced odds of any adverse reactions [adjusted odds ratio (AOR) = 0.17, 95% confidence interval (CI) 0.15-0.20], 92%-reduced odds of local adverse reactions (AOR = 0.08, 95% CI 0.06-0.09), and 76%-reduced odds of systemic adverse reactions (AOR = 0.24, 95% CI 0.16-0.28). No significant effect modification was identified.ConclusionThis post-marketing study comparing the reactogenicity of Covid-19 vaccines suggests a lower risk of self-reported adverse reactions following vaccination with CoronaVac compared with Comirnaty.
| S-EPMC8818394 | biostudies-literature
Project description:BackgroundThe Pfizer BioNTech COVID-19 vaccine was the first to receive emergency authorization and approval from the FDA. Therefore, it is preferred by most recipients; however, many people are concerned about the vaccine's side effects. At the time of the study, December 2021, Palestine lacked a national reporting system for monitoring adverse vaccine effects. Therefore, this study investigates the post-vaccine adverse events following the Pfizer/BioNTech COVID-19 Vaccine administration in Palestine and identifies the occurrence, extent, and severity among university staff, employees, and students at Birzeit University.MethodA questionnaire-based retrospective cross-sectional study was conducted using a university website (Ritaj), social media platforms (e.g., Facebook and Telegram), and in-person interviews. The Chi-square, Fisher's exact, and McNemar's tests were used to investigate significant relationships. Data were analyzed using SPSS version 22.ResultsIn total, 1137 participants completed the questionnaire, 33.2% were males, and the mean age was 21.163 years. All participants received at least one dose of the Pfizer-BioNTech COVID-19 vaccine. Approximately one-third of participants reported no adverse effects after receiving the first, second, or third doses (34%, 33.6%, and 32.5%, respectively). The most commonly reported adverse events were fever, chills, headache, fatigue, pain and swelling at the injection site, muscle pain, and joint pain. Allergic reactions were reported by 12.7% of the participants; furthermore, participants with a history of allergy or anaphylaxis before vaccination had a significantly higher tendency for post-vaccination allergic reactions. Eight participants reported rare side effects, including 7 (0.6%) cases of thrombocytopenia and one (0.1%) case of myocarditis. Males aged less than 20 years and smokers were significantly less likely to complain of adverse events. The number of reported side effects was significantly higher after the second vaccine dose than after the first dose. Finally, participants infected with COVID-19 before vaccination was significantly associated with side effects such as fever, chills, shortness of breath, and persistent cough.ConclusionIn this study, the most common post- BNT162b2 Vaccination reported self-limiting side effects similar to those reported by Pfizer/BioNTech Company. However, higher rates of allergic reactions were reported in this sample. Rare side effects, such as thrombocytopenia and myocarditis, were reported by 8 participants. COVID vaccines have been developed at an accelerated pace, and vaccine safety is a top priority; therefore, standard monitoring through a national adverse event reporting system is necessary for safety assurance. Continuous monitoring and long-term studies are required to ensure vaccine safety.
| S-EPMC9814351 | biostudies-literature
Project description:Real-world analysis of the incidence of SARS-CoV-2 infection post vaccination is important in determining the comparative effectiveness of the available vaccines. In this retrospective cohort study using deidentified administrative claims for Medicare Advantage and commercially insured individuals in a research database we examine over 3.5 million fully vaccinated individuals, including 8,848 individuals with SARS-CoV-2 infection, with a follow-up period between 14 and 151 days after their second dose. Our primary outcome was the rate of Covid-19 infection occurring at 30, 60, and 90 days at least 14 days after the second dose of either the mRNA-1273 vaccine or the BNT162b2 vaccine. Sub-analyses included the incidence of hospitalization, ICU admission, and death/hospice transfer. Separate analysis was conducted for individuals above and below age 65 and those without a prior diagnosis of Covid-19. We show that immunization with mRNA-1273, compared to BNT162b2, provides slightly more protection against SARS-CoV-2 infection that reaches statistical significance at 90 days with a number needed to vaccinate of >290. There are no differences in vaccine effectiveness for protection against hospitalization, ICU admission, or death/hospice transfer (aOR 1.23, 95% CI (0.67, 2.25)).
| S-EPMC9061778 | biostudies-literature