ABSTRACT
INTRODUCTION: The rapid roll-out of novel COVID-19 vaccines made near real-time post-marketing safety surveillance essential to identify rare and long-term adverse events following immunization (AEFIs). In light of the ongoing booster vaccination campaigns, it is key to monitor changes in observed safety patterns post-vaccination. The effect of sequential COVID-19 vaccinations, as well as heterologous vaccination sequences, on the observed post-vaccination safety pattern, remains largely unknown. METHODS: The primary objective of this study was to describe the profile of spontaneously reported AEFIs following COVID-19 vaccination in the Netherlands, including the primary and booster series. Reports from consumers and healthcare professionals were collected via a COVID-19 vaccine-tailored online reporting form by the National Pharmacovigilance Centre Lareb (Lareb) between 6 January 2021 and 31 August 2022. The data were used to describe the most frequently reported AEFIs per vaccination moment, the consumer experienced burden per AEFI, and differences in AEFIs reported for homologous and heterologous vaccination sequences. RESULTS: Lareb received 227,884 spontaneous reports over a period of twenty months. Overall, a high degree of similarity in local and systemic AEFIs per vaccination moment was observed, with no apparent change in the number of reports of serious adverse events after multiple COVID-19 vaccinations. No differences in the pattern of reported AEFIs per vaccination sequence was observed. CONCLUSION: Spontaneous reported AEFIs demonstrated a similar reporting pattern for homologous and heterologous primary and booster series of COVID-19 vaccination in the Netherlands.
Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , COVID-19 Vaccines/adverse effects , Adverse Drug Reaction Reporting Systems , Netherlands/epidemiology , Immunization, Secondary/adverse effects , COVID-19/prevention & control , Vaccination/adverse effectsABSTRACT
During spring 2021, AZD1222 and BNT162b2 were used as prime and BNT162b2 as booster COVID-19 vaccines in Denmark. We obtained self-reported information on systemic reactogenicity day-by-day during two weeks for 2862 healthcare workers vaccinated with heterologous AZD1222+BNT162b2 or homologous BNT162b2+BNT162b2 regimens and compared prevalences of symptoms with unvaccinated healthcare workers. We found comparable systemic reactogenicity during the first week in the two vaccine regimens and no reactogenicity during the second week. Most of the symptoms returned to a level equal to the control population four days after booster vaccination.
ABSTRACT
During spring 2021, AZD1222 and BNT162b2 were used as prime and BNT162b2 as booster COVID-19 vaccines in Denmark. We obtained self-reported information on systemic reactogenicity day-by-day during two weeks for 2862 healthcare workers vaccinated with heterologous AZD1222 + BNT162b2 or homologous BNT162b2 + BNT162b2 regimens and compared prevalences of symptoms with unvaccinated healthcare workers. We found comparable systemic reactogenicity during the first week in the two vaccine regimens and no reactogenicity during the second week. Most of the symptoms returned to a level equal to the control population four days after booster vaccination.
ABSTRACT
Background: Patients with paraganglioma/pheochromocytoma (PPGL) or hereditary predisposition to PPGL often need screening with biochemical labs, imaging and physical exam. Given the rarity of PPGL and hereditary PPGL, care is often provided through specialty centers. Subsequently, patients may have experienced restrictions on travel and delayed scheduling of non-elective procedures due to COVID-19. This study aimed to analyze the impact of COVID-19 on seeking PPGL management. Methods: Patients with a personal history of PPGL or hereditary PPGL risk from the University of Michigan, Brigham Women's Hospital, and Huntsman Cancer Institute were sent a survey in 2021. The survey included questions regarding tumor history (Y/N), gene status, demographics, and experience with COVID. The survey assessed whether they missed any exams related to PPGL diagnosis or screening. Comparative analyses utilized regression and chi-square tests. Patient factors measured in analyses evaluated COVID surveillance (labs, imaging, doctor visit) as the primary outcome and age, institution, gene status, sex, and PPGL history as predicting variables. Results: In total, 241 respondents across three institutions completed the survey. The cohort was primarily female (n = 158, 65.6%). A majority of the cohort identified as White (n = 222, 92%) and non-Hispanic (n = 226, 93.8%). PPGL history was reported in 158 patients (65.6%), 43 of which were pheochromocytoma and 113 were paraganglioma, primarily in the head and neck (n = 78). At time of survey completion, 209 (87%) respondents answered COVID-related questions. Thirty-nine respondents (19.2%) reported missing doctor visits, while 31 (15.3%) report missing HPPGL imaging and 33 (16.3%) report missing lab tests. There were no differences by institution (p > 0.05) on patient reported missed visits. Logistic regression analysis showed no difference in missing visits based on having a hereditary PPGL predisposition gene or sex of respondent (all p-values > 0.05). There was no difference based on PPGL history, though it is unknown if patients missed PGL follow-up or screening. Individuals who missed imaging (Y/N) were more likely to report missing their lab tests (OR = 1.8, p < 0.01) and doctor visit (OR = 1.25, p < 0.01). Age was a significant predictor for missing doctor visits (p = 0.02) with an odds ratio of 1.002 per 1 year increase in age. Conclusions: Though institutions had different COVID-19 restrictions and guidelines by state, there was no difference on missing surveillance or screening. Over 15% of respondents reported missing at least one aspect of PPGL care, indicating a need to re-engage those with PPGL and hereditary PPGL to return to typical screening and surveillance. Patients who miss one aspect of surveillance are likely to have missed other aspects of surveillance and will require evaluation of all aspects of screening to return up to date on needed visits and procedures.