Benign Fasciculation Syndrome and Migraine Aura without Headache: Possible Rare Side Effects of the BNT162b2 mRNA Vaccine? A Case Report and a Potential Hypothesis

The BNT162b2 (Pfizer BioNTech) mRNA vaccine is an effective vaccine against COVID-19 infection. Here, we report an adverse event following immunization (AEFI) in a 48-year-old female patient who presented with fasciculations, migraine auras without headaches and in an increased discomfort of previously present palpitations, as well as excitation and insomnia. Her fasciculations were intermittently present until the time this paper was written, starting from the 6th day post-vaccination; they changed localization and frequency, but most commonly they were generalized, affecting almost all muscle groups. The patient also suffered from two incidents of migraine auras with visual kaleidoscope-like phenomena without headaches a few months after the vaccination. These symptoms were considered to be AEFI and no causal relation with the vaccine could be proven.

A Randomized, Single Centered, Parallel and Open labelled Interventional Study on Effectiveness of Clinical Pharmacists on Adverse Event Following Immunization (AEFI) in Pediatric Population

Background: Adverse events are a major threat to any immunization programs, which in turn have proven to be a boon for developing nations like India. Hindering factors, such as inadequate knowledge, inappropriate attitude, incorrect practices, etc., of the guardian affect the vaccination rate. Aim: This study aims to assess the effectiveness of clinical pharmacist intervention on an adverse event following immunization in the pediatric population receiving immunization. Materials and Methods: Pediatric subjects <5 yrs of both genders receiving immunization in a tertiary care hospital during the period of 8 months were considered. Subjects were randomized into control and interventional groups. Pharmaceutical intervention was done in interventional group in the form of patient counselling, and a patient information leaflet. Adverse event following immunization was recorded and analysed for both groups along with Knowledge, Attitude, and Practice scores of guardians’ pre and post intervention through customized data collection forms. Microsoft excel and statistical software SPSS IBM version 22 was used to analyse the data. Results: The study was conducted on a total of 88 subjects (n) in which 79 were <2 years, 1 and 8 were between 2-4 years and 4-5 years respectively. Forty-ninesubjects (55.69%) were female, while 39 were male (44.31%) with a response and completion rate of 91.66%. 97.7% subjects received Bacillus Calmette-Guerin vaccination (majority), while 8.88% received pneumococcal special vaccine (minority). Adverse event following immunization was recorded in 31(35.22%) cases. Knowledge, Attitude and Practice scores increased by 42.17%, 52% and 12.67%, respectively in guardians after clinical pharmacist intervention. Conclusion: This studydemonstrates that educational inputs, awareness programs, and proper medical professional intervention can act as a helping factor to fight against AEFI and towards the success of an immunization program.

Contextualizing adverse event following immunization data of coronavirus disease 2019 (COVID-19) vaccines in VigiAccess: An approach for reducing COVID-19 vaccine hesitancy

IntroductionVaccination features high among the public health interventions that have contributed significantly to global health. Following the March 2020 declaration by the World Health Organization that coronavirus 2019 (COVID-19) is a global pandemic, several vaccines have been developed and administered to curb the spread of COVID-19. One of the threats to attaining adequate vaccination uptake for these relatively new vaccines are concerns people have about the adverse event following immunization (AEFI) information. This study sought to assess AEFIs reported on COVID-19 vaccines approved for use so far in VigiAccess and to make a case for why AEFIs data in the database must be interpreted with caution.MethodsThe study followed a cross-sectional quantitative study design. VigiAccess was searched on November 10, 2021 for AEFIs reported so far for all the 12 approved COVID-19 vaccines. Data were captured among age groups, sex and continents of the world. Descriptive data were summarized using tables. Frequencies and percentages were used to categorize descriptive variables. No ethical approval was obtained before the commencement of the study as this was essentially a secondary data analysis of AEFI reports which cannot be linked to any individual. Consequently, there was no need for the informed consent process.ResultsOverall, 2,457,386 AEFIs had been reported in VigiAccess. AEFIs were found to be highest among the 18-44 age group (39.7%) and lowest in vaccine recipients below 12 years (0.1%). AEFIs were more common in females than male vaccine recipients with over two-thirds of the vaccine recipients being females. Among the continents of the world, AEFI reports were highest for Europe (50%) and lowest for Africa (3%). The top 10 commonly reported AEFI types were as follows: general disorders and vaccine administrative site conditions (1,481,549, 60.1%), nervous system disorders (1,046,928, 42.6%), musculoskeletal and connective tissue disorders (704,657, 28.6%), gastrointestinal disorders (495,997, 20.2%), investigations with undesirable outcomes (341,677, 13.9%), skin and subcutaneous tissue disorders (335,932, 13.6%), respiratory, thoracic and mediastinal disorders (262,158, 10.6%), infections and infestations (180,873, 7.3%), vascular disorders (132,533, 5.3%) and injury, poisoning and procedural complications (122,519, 5%).ConclusionThe study showed that over 2 million COVID-19 AEFIs were spontaneously reported in VigiAccess, however, no causal relationships could be established between the vaccines and the AEFIs. The public accessing VigiAccess data should be made aware of this lack of association so that they may make well informed health decisions.

Vaccinations and Autoimmune Diseases

Vaccines represent one of the most effective measures of public health medicine, saving countless lives and preventing lifelong disabilities. Vaccines are extremely safe, however, no vaccine is completely free from risks and adverse events can occur following vaccination. An adverse event following immunization (AEFI) may be a true adverse reaction caused by the vaccine or an event that temporally occurred after immunization but is not caused by it. Among the adverse reactions to vaccines, one of the most feared is the triggering of autoimmune diseases, which are a heterogeneous group of disorders characterized by dysregulation of the immune system. Currently, no mechanisms have been demonstrated that could explain the correlation between vaccination and the development of autoimmune diseases. Furthermore, epidemiological studies do not support the hypothesis that vaccines cause systemic autoimmune diseases. The only confirmed associations, although very rare, are those between the flu vaccine and Guillain-Barré syndrome, especially with old vaccine preparations, and measles-mumps-rubella (MMR) vaccine and thrombocytopenia. Due to the SARS-CoV2 pandemic, new types of vaccines have been developed and are now available. Close vaccine safety-surveillance is currently underway for these new vaccines.

Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments

This post hoc analysis of an Italian active pharmacovigilance study describes pharmacological differences of ADEs leading to emergency department (ED) visits and hospitalization in women and men. During the study period (January 2007–December 2018), 61,855 reports of ADEs leading to ED visits were collected. Overall, 30.6% of ADEs resulted in hospitalization (30% in women and 31% in men). Multivariate logistic regression showed that, among women, drug classes significantly associated with an increased risk of hospitalization were heparins (ROR 1.41, CI 1.13–176), antidepressants (ROR 1.12, CI 1.03–1.23) and antidiabetics (ROR 1.13, CI 1.02–1.24). Among men, only vitamin K antagonists (ROR 1.28, CI 1.09–1.50), opioids (ROR 1.30, CI 1.06–1.60) and digitalis glycosides (ROR 1.32, CI 1.09–1.59) were associated with a higher risk of hospitalization. Overall, older age, multiple suspected drugs and the presence of comorbidities were significantly associated with a higher risk of hospitalization. A significantly reduced risk of hospitalization was observed in both women and men experiencing an adverse event following immunization (ROR 0.36, CI 0.27–0.48 and 0.83, 0.42–0.74, respectively) compared to drugs. Results obtained from this real-world analysis highlight important aspects of drug safety between sexes.

Assessment of adverse event following immunization and its co-relates among COVID-19 vaccine recipient in Bundelkhand region of Uttar Pradesh: A cross-sectional study

Background: The COVID-19 pandemic is a global emergency. AEFIs reporting and assessment should be done with high priority as they could change the benefit-risk profile of the vaccine. Objective: To assess adverse effects after COVID-19 vaccination. Methods: This cross-sectional study conducted among 605 heath functionaries taken part from January 2021 to March 2021. Results: The most common AEFI reported was pain at injection site (51.9%). Gender, previous COVID status and perception before vaccination were significantly associated with AEFI. Conclusion: There was no serious adverse event after vaccination. COVID vaccine has a good safety profile.

Suspected immune mediated response to COVID-19 vaccine: two individual case reports

SARS-CoV-2, the virus that causes coronavirus disease 19 (COVID-19), has spread rapidly around the world. Researchers have been working round the clock to develop effective vaccines, which people started receiving in December 2020. Therefore, careful follow-up and surveillance studies for continued vaccine safety monitoring will be needed to ascertain the potential risks of such adverse events or disease. Here, we present two individual cases of pancreatitis and typhilitis following COVID 19 vaccination. In the first case of a 38 years old male patient developed pancreatitis after 4 days of COVID 19 vaccination and in second case, of a 60 years old female patient developing typhilitis after just one day after vaccination. All possible causes of this occurrence were ruled out. Two main factors suggest a possible link to the vaccine, the chronology of the events and the incongruent immune response to the vaccine component. It is not possible to establish a direct causal relation between vaccination and adverse event following immunization; however, this report can be used to alert practitioners to this possibility of adverse event following immunization after COVID-19 vaccine.

Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post-Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments

This post-hoc analysis of an Italian active pharmacovigilance study describes pharmacological differences of ADEs leading to emergency department (ED) visit and hospitalization in women and men. During the study period (January 2007 &ndash; December 2018), 61,855 reports of ADE leading to ED visit were collected. Overall, 30.6% of ADEs resulted in hospitalization (30% in women and 31% in men). Multivariate logistic regression showed that, among women, drug classes significantly associated with an increased risk of hospitalization were heparins (ROR 1.41, CI 1.13-176), antidepressants (ROR 1.12, CI 1.03-1.23) and antidiabetics (ROR 1.13, CI 1.02-1.24). Among men only vitamin K antagonists (ROR 1.28, CI 1.09-1.50), opioids (ROR 1.30, CI 1.06-1.60) and digitalis glycosides (ROR 1.32, CI 1.09-1.59) were associated with a higher risk of hospitalization. Overall, older age, multiple suspected drugs and the presence of comorbidi-ties were significantly associated with a higher risk of hospitalization. A significantly reduced risk of hospitalization was observed in both women and men experiencing and adverse event following immunization (ROR 0.36, CI 0.27-0.48 and 0.83, 0.42-0.74, respectively) compared to drugs. Results obtained from this real-world analysis highlight important aspects of drug safety between sexes.