The risk of miscarriage after COVID-19 vaccination before and during pregnancy.

PURPOSE: Pregnant women are at higher risk of severe illness and adverse pregnancy outcomes due to a SARS-CoV-2 infection, which can be prevented by vaccination. Observational studies are needed to ascertain the safety of COVID-19 vaccination during pregnancy. We aimed to determine whether COVID-19 vaccination before and during pregnancy is associated with the risk of miscarriage. METHODS: In this cohort study, we included 4640 pregnant women (mean age: 32.8 ± 3.7 years) from the Dutch Pregnancy Drug Register between February 2021 and August 2022. Information on COVID-19 vaccinations, miscarriage, and confounders was self-reported, using web-based questionnaires. The hazard ratio (HR) of miscarriage (in gestational weeks 6-20) after a COVID-19 vaccination, was estimated using the survival analyses. A COVID-19 vaccination during pregnancy (≥1 COVID-19 vaccination between week 2 and 20 of pregnancy) was included as a time-dependent exposure and vaccination prior to pregnancy was included as a binary exposure. RESULTS: A total of 3202 pregnant women (69%) received ≥1 COVID-19 vaccine in gestational week 2-20. We observed no association of vaccination during pregnancy with the risk of miscarriage (adjusted HR = 1.29, 95% CI = 0.93-1.74). Vaccination prior to pregnancy, however, was associated with a decreased risk of miscarriage (adjusted HR = 0.69, 95% CI = 0.48-0.99). CONCLUSIONS: We demonstrated that COVID-19 vaccination during pregnancy is not associated with an increased risk of miscarriage in gestational weeks 6-20. This study adds to the growing body of evidence demonstrating the safety of COVID-19 vaccination during pregnancy.

Maternal first trimester COVID-19 vaccination and risk of major non-genetic congenital anomalies.

BACKGROUND: Information regarding the risk of early pregnancy COVID-19 vaccination on the development of major congenital anomalies in the offspring is still limited. Here, we study the association between any COVID-19 vaccination during the 1st trimester and at least one major non-genetic congenital anomaly in the offspring. METHODS: We used data from the Dutch Pregnancy Drug Register, an ongoing cohort study. We selected participants with a pregnancy that ended after at least 20 weeks gestation. Pregnant participants self-reported their COVID-19 vaccination status and the presence of congenital anomalies in the offspring. We used logistic regression analyses to study the association between 1st trimester COVID-19 vaccination (gestational week 2 + 0 to 12 + 6) and the risk of at least one major non-genetic congenital anomaly in the offspring. Clustering of anomalies on the ICD10 level by 1st trimester COVID-19 vaccination status was explored using Fisher exact tests. RESULTS: We included 3721 participants of whom 795 (21.4%) were COVID-19 vaccinated during the 1st trimester. The percentage of participants who gave birth to a child with at least one major non-genetic congenital anomaly was comparable between participants who were 1st trimester vaccinated (1.1%) and participants who were not (1.2%) (adjusted odd ratio 0.78 [95% confidence interval 0.35-1.71]). We found no clustering of major non-genetic congenital anomalies by 1st trimester COVID-19 vaccination status (p > .05). CONCLUSIONS: There were no indications of an increased risk of major non-genetic congenital anomalies in the offspring after maternal 1st trimester COVID-19 vaccination. Our findings suggest COVID-19 vaccines are safe during early pregnancy.

[Thrombosis and embolism during Diane-35 use: analysis of reports made to the Netherlands Pharmacovigilance Centre Lareb]. / Trombose en embolie bij gebruik van Diane-35: analyse van meldingen bij Lareb.

After media attention on the possible risks of thromboembolic complications associated with the use of cyproterone/ethinylestradiol (Diane-35 and generics), the Netherlands Pharmacovigilance Centre Lareb received a large number of reports over a short period of time. We describe in detail the reports of serious undesirable effects, also taking into account the indication, time to onset and risk factors, identification of the complication, treatment and course. The reports Lareb received give an insight into the nature and impact of the occurrence of these adverse drug reactions in daily practice. It was mentioned that cyproterone/ethinylestradiol was often used as a contraceptive drug. Some reports mentioned the fact that thrombosis and embolism were not always recognised at an early stage by users.

[Reported adverse events following influenza vaccination]. / Gemelde bijwerkingen na influenzavaccinatie.

OBJECTIVE: Review of case reports of possible adverse events following immunization (AEFI) after vaccination with an influenza vaccine in the past three years. DESIGN: Descriptive, retrospective. METHOD: Lareb (Netherlands Pharmacovigilance Centre) investigated and reviewed reports of possible AEFI after vaccination with an influenza vaccine over seasons 2010-2011, 2011-2012 and 2012-2013. RESULTS: Over the three seasons we received a total of 531 reports after administration of seasonal influenza vaccination. Each year the number of reports increased, especially the reports directly from vaccinees. In 32 cases (6%) the report was considered 'serious', in most cases it was associated with hospitalization. Two reports mentioned that the patient died but a causal relationship with the vaccination was considered unlikely. There were three reports of acute severe reactions, with anaphylaxis, angio-oedema and cardiac arrest. A total of 961 possible AEFI were reported. In 256 (over 25%) AEFI inflammatory symptoms occurred at the injection site. Besides the injection site reactions, headache (101), myalgia (90) and pyrexia (86) were the most reported AEFI. Notably, there were 26 reports of extensive limb swelling, in which injection site inflammation extends beyond shoulder or elbow or around the upper arm. The clinical picture resembles cellulitis or an allergic reaction and usually disappears with symptomatic treatment. Its aetiology is unknown. CONCLUSION: Apart from extensive swelling of the limb, we did not find signs of unknown side effects of influenza vaccination. Based on the reported AEFI, influenza vaccines seem to be safe.