Association Between Pfizer COVID-19 Vaccine Adverse Effects and Diabetes Mellitus: A Prospective Multicenter Study.

Introduction The epidemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) triggered the contagion of coronavirus disease 2019 (COVID-19), which killed many individuals globally. The Pfizer BioNTech vaccine was the first messenger ribonucleic acid (mRNA)-based vaccine that boosted immunity against various adverse reactions. The objective of this study was to evaluate the frequency of Pfizer vaccine side effects among participants with and without diabetes mellitus (DM). Methods This multicenter study was cross-sectional and was performed using a non-probability consecutive sampling technique. The study duration was six months, from October 1, 2022, to March 31, 2023. A total of 750 participants who received both doses of the Pfizer vaccine were included in the study. Demographic details such as gender, age, comorbidities, preceding COVID-19 infection, and the occurrence of any local and systemic side effects of the first and second doses of vaccine were recorded. The association between local and general side effects and the presence of DM was assessed using the chi-square test. Results Of the 750 participants included in the study, 289 (77.1%) were males with diabetes mellitus (DM), and 217 (57.9%) were non-diabetic participants; however, 86 (22.9%) females had DM, and 158 (42.1%) were non-diabetic; their mean ages were 48.23 ± 16.22 and 37.56 ± 12.15 years, respectively. The most commonly occurring side effects after receiving the first dose of the Pfizer vaccine were: injection site burning in 251 (66.9%) diabetic and 254 (67.7%) non-diabetic participants. Likewise, the frequency of side effects of the second dose of the Pfizer vaccine showed that the most commonly reported side effects were: muscle pain, found in 240 (64.0%) diabetic patients and 194 (51.7%) non-diabetics, with a statistically significant association (p =0.001). Conclusion This study concluded that participants with DM had local and general adverse effects considerably more frequently than those without DM. The most frequently observed adverse effects in both diabetic and non-diabetic participants were injection site burning, rashes, muscle pain, and fever after receiving both doses of the Pfizer vaccine. Moreover, most of the side effects were minor.

Detecting the most critical clinical variables of COVID-19 breakthrough infection in vaccinated persons using machine learning.

Background: COVID-19 vaccines offer different levels of immune protection but do not provide 100% protection. Vaccinated persons with pre-existing comorbidities may be at an increased risk of SARS-CoV-2 breakthrough infection or reinfection. The aim of this study is to identify the critical variables associated with a higher probability of SARS-CoV-2 breakthrough infection using machine learning. Methods: A dataset comprising symptoms and feedback from 257 persons, of whom 203 were vaccinated and 54 unvaccinated, was used for the investigation. Three machine learning algorithms - Deep Multilayer Perceptron (Deep MLP), XGBoost, and Logistic Regression - were trained with the original (imbalanced) dataset and the balanced dataset created by using the Random Oversampling Technique (ROT), and the Synthetic Minority Oversampling Technique (SMOTE). We compared the performance of the classification algorithms when the features highly correlated with breakthrough infection were used and when all features in the dataset were used. Result: The results show that when highly correlated features were considered as predictors, with Random Oversampling to address data imbalance, the XGBoost classifier has the best performance (F1 = 0.96; accuracy = 0.96; AUC = 0.98; G-Mean = 0.98; MCC = 0.88). The Deep MLP had the second best performance (F1 = 0.94; accuracy = 0.94; AUC = 0.92; G-Mean = 0.70; MCC = 0.42), while Logistic Regression had less accurate performance (F1 = 0.89; accuracy = 0.88; AUC = 0.89; G-Mean = 0.89; MCC = 0.68). We also used Shapley Additive Explanations (SHAP) to investigate the interpretability of the models. We found that body temperature, total cholesterol, glucose level, blood pressure, waist circumference, body weight, body mass index (BMI), haemoglobin level, and physical activity per week are the most critical variables indicating a higher risk of breakthrough infection. Conclusion: These results, evident from our unique data source derived from apparently healthy volunteers with cardiovascular risk factors, follow the expected pattern of positive or negative correlations previously reported in the literature. This information strengthens the body of knowledge currently applied in public health guidelines and may also be used by medical practitioners in the future to reduce the risk of SARS-CoV-2 breakthrough infection.

Post-COVID-19 Vaccination Infection Among Adults in Saudi Arabia: A Cross-Sectional Study.

BACKGROUND: While vaccines were one of the most effective tools to combat the COVID-19 pandemic, breakthrough infections have been reported. AIM OF THE WORK: We aim to evaluate the effectiveness of Pfizer and AstraZeneca vaccines in preventing breakthrough infection, as well as to determine the possible risk factors and outcomes of post-vaccination infection. METHODS: This is a cross-sectional study using self-reported data of adult Saudi residents, including Saudi and non-Saudi people who received at least two doses of either Pfizer or AstraZeneca vaccines. Based on the presence of COVID-19 symptoms that were confirmed by PCR, the participants were classified into three groups: (1) those with evidence of infection before vaccination, (2) those who had infection after vaccination, and (3) those who had infection before and after vaccination. For further evaluation, we compared the severity and outcomes in the participants who were infected before and after vaccination. RESULTS: The study included 694 participants: 69.1% received three doses of the vaccine, and 71.1% of them were vaccinated with the Pfizer vaccine. COVID-19 infection was reported in 48.3% of the total subjects, with a higher infection rate (17.8%) after vaccination compared to 12.5% before vaccination. Additionally, 18.32% of participants experienced infection both before and after vaccination. Out of the total 694 participants, 137 (19.7%) had breakthrough infections. Pfizer vaccine was more prevalent among the non-infected group (74.25% vs. 65.5%), while AstraZeneca vaccine was more prevalent among the infected group (6.4% vs. 5.9% (p<0.039). Diabetes was significantly higher among the infected group (16.9% vs. 8.1%, p=0.001, OR=2.29, 95% CI=1.42-3.68). Among those who were infected before and after vaccination, 71.9% reported less severe symptoms after vaccination. CONCLUSION: Breakthrough infections may occur after vaccination; however, vaccines are overall effective in preventing severe symptoms. Pfizer vaccine appeared to be more effective in preventing COVID-19 infection. The presence of comorbidities, including diabetes, may increase the risk of infection.

The Effect of Third Dose of Pfizer/BioNTech and Moderna COVID-19 mRNA Vaccines on IgG Antibody Titers.

With the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants, the Centers for Disease Control and Prevention (CDC) authorized the third dose of the Pfizer-BioNTech (BNT162b2) vaccine with the rationale for prolonged elevation of anti-SARS-CoV-2 antibody titers and protection against the SARS-CoV-2 virus. To better understand how administration of the third dose of the Pfizer/BioNTech coronavirus disease 2019 (COVID-19) vaccine affects the incidence and severity of SARS-CoV-2 infections, we administered the third dose of the Pfizer-BioNTech (BNT162b2) to 189 participants. Blood samples were collected from participants during each of their scheduled visits (baseline, week two, week 12, and week 24) and tested for semi-quantitative anti-SARS-CoV-2 immunoglobulin G (IgG) titers. Our results showed that administration of the third dose of the Pfizer-BioNTech (BNT162b2) vaccine elicited elevated anti-SARS-CoV-2 IgG antibodies for the 24-week duration of the study. IgG antibody titers were greatest in week two, and progressively decreased by week 12 and week 24, with statistically significant differences between the IgG antibody titers for each collection date.

Common Side Effects of Pfizer COVID-19 Vaccine: An Experience From Pakistan.

Introduction The severe acute respiratory syndrome coronavirus 2 (SARS­CoV­2) epidemic spread quickly. Vaccines are now being distributed to stop the infectious spread and halt fatalities. The Pfizer-BioNTech vaccine was the first mRNA-based vaccine introduced to boost immunity against COVID-19; however, it could lead to various adverse reactions. Therefore, the aim of this study was to assess the prevalence of Pfizer vaccine side effects among participants. Methods This was a multicenter cross-sectional study that was performed using a non-probability sampling method. The study period was about six months from March 1, 2022, to August 31, 2022. A total of 1000 participants who received two doses of the Pfizer vaccine met the inclusion criteria. Demographic details of participants, for example, gender, age, comorbidities, Pfizer vaccine with both doses along with booster dose, previous exposure to coronavirus disease 2019 (COVID-19) infection, and the incidence of any local and systemic side effects following the first and second doses of vaccine, were reported.  Results The study findings showed that out of 1000 participants, 644 (64.4%) were males and 356 (35.6%) were females; their mean age was 43.06±14.98 years. Among them, 280 (28.0%) had hypertension and 356 (35.6%) had diabetes. Following the first dose of the Pfizer vaccine, burning at the injection site and fever were the most commonly reported side effects in 704 (70.4%) and 700 (70.0%) participants, respectively. Following the second dose of the Pfizer vaccine, muscle pain was the most commonly reported side effect in 628 (62.8%) participants. Conclusion This study concluded that the most frequent adverse effects of the Pfizer vaccine were burning at the injection site, fever, pain at the injection site, muscle pain, swelling at the injection site, and joint pain. Moreover, the first dose was associated with more side effects than the second dose.

Selection Effects and COVID-19 Mortality Risk after Pfizer vs. Moderna Vaccination: Evidence from Linked Mortality and Vaccination Records.

Prior research generally finds that the Pfizer-BioNTech (BNT162b2) and Moderna (mRNA1273) COVID-19 vaccines provide similar protection against mortality, sometimes with a Moderna advantage due to slower waning. However, most comparisons do not address selection effects for those who are vaccinated and with which vaccine. We report evidence on large selection effects, and use a novel method to control for these effects. Instead of directly studying COVID-19 mortality, we study the COVID-19 excess mortality percentage (CEMP), defined as the COVID-19 deaths divided by non-COVID-19 natural deaths for the same population, converted to a percentage. The CEMP measure uses non-COVID-19 natural deaths to proxy for population health and control for selection effects. We report the relative mortality risk (RMR) for each vaccine relative to the unvaccinated population and to the other vaccine, using linked mortality and vaccination records for all adults in Milwaukee County, Wisconsin, from 1 April 2021 through 30 June 2022. For two-dose vaccinees aged 60+, RMRs for Pfizer vaccinees were consistently over twice those for Moderna, and averaged 248% of Moderna (95% CI = 175%,353%). In the Omicron period, Pfizer RMR was 57% versus 23% for Moderna. Both vaccines demonstrated waning of two-dose effectiveness over time, especially for ages 60+. For booster recipients, the Pfizer-Moderna gap is much smaller and statistically insignificant. A possible explanation for the Moderna advantage for older persons is the higher Moderna dose of 100 µg, versus 30 µg for Pfizer. Younger persons (aged 18-59) were well-protected against death by two doses of either vaccine, and highly protected by three doses (no deaths among over 100,000 vaccinees). These results support the importance of a booster dose for ages 60+, especially for Pfizer recipients. They suggest, but do not prove, that a larger vaccine dose may be appropriate for older persons than for younger persons.

Cellular and Humoral Immune Responses to Vaccination for COVID-19 Are Negatively Impacted by Senescent T Cells: A Case Report.

BACKGROUND: Herein, we aimed to follow up on the cellular and humoral immune responses of a group of individuals who initially received the CoronaVac vaccine, followed by a booster with the Pfizer vaccine. METHODS: Blood samples were collected: before and 30 days after the first CoronaVac dose; 30, 90, and 180 days after the second CoronaVac dose, and also 20 days after the booster with the Pfizer vaccine. RESULTS: Whilst the positivity to gamma interferon-type cellular response increased after the first CoronaVac dose, neutralizing and IgG antibody levels only raised 30 days after the second dose, followed by a drop in these responses after 90 and 180 days. The booster with the Pfizer vaccine elicited a robust cellular and humoral response. A higher number of double-negative and senescent T cells, as well as increased pro-inflammatory cytokines levels were found in the participants with lower humoral immune responses. CONCLUSION: CoronaVac elicited an early cellular response, followed by a humoral response, which dropped 90 days after the second dose. The booster with the Pfizer vaccine significantly enhanced these responses. Furthermore, a pro-inflammatory systemic status was found in volunteers who presented senescent T cells, which could putatively impair the immune response to vaccination.

Unilateral Pleural Effusion after Third Dose of BNT162b2 mRNA Vaccination: Case Report.

Vaccination remains the best strategy against coronavirus disease 2019 (COVID-19) in terms of prevention. The efficacy and safety of COVID-19 vaccines is supported by well-designed clinical trials that recruited many participants. It is well-known that vaccination is associated with local side effects related to the injection site, and mild, systemic side effects. However, there has been an increase in the occurrence of what is known as infrequent adverse effects in the population of vaccinated individuals in real life. We present the case of a 46-year-old woman with no past medical history, who presented with a sharp chest pain with deep inspiration, a few days after receiving the third dose of the Pfizer-BioNTech COVID-19 mRNA vaccine (BNT162b2). There is an association between the BNT16b2 vaccination and myocarditis, pericarditis, and even bilateral pleural effusions. To the best of our knowledge, this is the first report featuring a unilateral pleural effusion in a patient with no known past medical history, who did not develop cardiac involvement nor have any viral infection. The aim of our report is to inform health professionals of the possibility of encountering this rare adverse event in their daily practice, as the population of individuals who are receiving additional vaccine doses is increasing steadily.

Taste Detection Threshold in Relation to Pfizer COVID-19 Vaccine.

Background The first hit of the COVID-19 pandemic was reported in December 2019 in Wuhan, Hubei province, China, and wholesale seafood markets were reported to be the source of infection. The development of effective and safe vaccines against SARS-CoV-2 has been extremely fast. The development of the COVID-19 mRNA vaccine started in early January 2020, after the release of the SARS-CoV-2 genetic sequence by the Chinese Center for Disease Control and Prevention and its global dissemination by the Global Initiative on Sharing All Influenza Data (GISAID). Aim The current study aims to evaluate the taste detection threshold after the second shot of Pfizer COVID-19 vaccination at different intervals and after the booster shot. Materials and methods A multistage sampling technique was used to select all Iraqi healthcare workers (HCWs) to whom the inclusion criteria were applied, from Baghdad Medical City and Al-Yarmouk Teaching Hospital participated in this study. The total number of selected subjects was 85. The ages of HCWs ranged from 24 to 60 years. The first study group (G1) comprised 30 HCWs who received the COVID-19 vaccination from Pfizer in two doses. The subjects were recruited into this group two weeks to three months after being vaccinated and had no history of COVID-19 symptoms. The second group (G2) comprised 30 HCWs who received the COVID-19 vaccination from Pfizer in two doses. They were recruited three to six months after they were vaccinated and had no prior history of the virus' symptoms. The third group (G3) was of 25 HCWs who received a third booster dose of COVID-19 vaccination from Pfizer two weeks after the booster dose. The taste detection threshold was performed for four basic tastes: sweet, sour, salt, and bitter. Results The taste detection threshold for (sweets) showed a significant difference between the first and second groups and the second and third groups. The taste detection threshold of sweets was significantly higher in the second group. Conclusions After three to six months from getting the second dose, the taste detection threshold for sweets was assessed as high. This means that the flavor will be harder to perceive. Pfizer COVID-19 immunization may be assumed to be one of the causes of defected taste sensation to sweet flavor.

A rare presentation of rapidly progressing myopathy in an adolescent.

We present a case of severe juvenile dermatomyositis with limited response to steroids in an adolescent who developed symptoms within hours after receiving Pfizer BNT162b2 coronavirus disease 2019 vaccine. The patient presented with severe weakness of proximal muscles, dyspnoea, and tachycardia. His muscle enzymes were raised, and he was diagnosed with severe juvenile dermatomyositis following magnetic resonance imaging and muscle biopsy. His management was challenging, requiring multidisciplinary input, and difficult decisions with regard to the appropriate immunomodulatory treatments. The patient had to undergo escalating immunosuppressive treatments before he began to recover clinically and biochemically. To our knowledge, this is the first case in an adolescent although a few cases of similar presentations following coronavirus disease 2019 vaccination have been reported in adults. Elucidating the potential relationship of the vaccine with this severe myopathy in an adolescent is important for global vaccination policies, but avoiding the conflation of association with causation is also crucial in the context of the pandemic.

Abnormal Uterine Bleeding Among COVID-19 Vaccinated and Recovered Women: a National Survey.

The objective of this research was to characterize menstrual changes including amount, duration, and frequency among COVID-19 vaccinated and infected women. We conducted an online nationwide questionnaire survey on premenopausal, non-pregnant women over 18 years of age in Israel, querying about any changes in their menstrual patterns after COVID-19 vaccination or infection. In total, 10,319 women responded, of which 7904 met the inclusion criteria. Changes in menstrual patterns following COVID-19 vaccination or infection were reported in 3689/7476 (49.3%) women compared with 202/428 (47.2%) women, respectively, (P = .387). The most commonly described menstrual disturbance was excessive bleeding (heavy, prolonged, or intermenstrual) in both the vaccinated and infected groups, (80.6% versus 81.4%, respectively, P = .720). Among women who experienced abnormal uterine bleeding (AUB), in most cases (61.1%), it occurred between the vaccination and the ensuing menstrual period. Menstrual disturbances were similar in type among the vaccinated and infected women. In conclusion, AUB emerged as a side effect of the BNT162b2 vaccine and a symptom of the COVID-19 infection and was characterized mainly by excessive bleeding. Although the precise incidence could not be determined in this study, the type of bleeding disorder as well as the characterization of risk factors including increasing age and a baseline menstrual pattern of prolonged, frequent, and heavy menses are well defined. The incidence and the long-term consequences of the BNT162b2 vaccine on uterine bleeding warrant further investigation.

A Patient Develops Bullous Rash After Receiving the Second Dose of COVID-19 Vaccine.

Our knowledge about the clinical spectrum of COVID-19 has continued to evolve. The clinical features of the infection and vaccine are continuously updated. We present a case of bullous pemphigoid after receiving a second dose of the COVID-19 vaccine. This case highlights autoimmune skin findings seen in a patient after COVID-19 vaccination. A 70-year-old male presented with the chief complaint of blistering skin rash. He received his second dose of Pfizer COVID-19 vaccine two days before developing a painful pruritic maculopapular rash that started on his hands and extended proximally to his trunk. Physical exam was remarkable for tense bullae with negative Nikolsky sign. Biopsy and direct immunofluorescence lead to the diagnosis of bullous pemphigoid. The lesions improved significantly with steroids. Various cutaneous eruptions have been reported with Moderna and Pfizer COVID-19 vaccines, including the new onset of bullous pemphigoid. Based on our case, we suggest that bullous pemphigoid after COVID-19 vaccination is responsive to steroids and the prognosis is excellent. Understanding the clinical course and prognosis of bullous pemphigoid from the COVID-19 vaccine is of significant importance as we strive to keep our patients and communities safe. More data is needed to better guide recommendations, but so far looking at the example from our case, the benefits of COVID-19 vaccination seem to outweigh the risks. Therefore, patients should be advised to continue with future vaccinations.

IgG4 related pleural disease: Recurrent pleural effusion after COVID-19 vaccination.

IgG4-related disease is characterized by a systemic fibroinflammatory process associated with substantial infiltration by plasma cells with IgG4 in the organs. Our patient presented with pleural effusion, and was diagnosed with IgG4-related lung disease (IgG4-RLD) after he received two doses of the Pfizer COVID-19 vaccine. The patient developed dyspnea and hypoxia 2 weeks after receiving the second dose of the Pfizer COVID-19 vaccine. CT scan revealed left pleural effusion which was drained. However, the effusion recurred requiring thoracoscopic drainage, placement of an indwelling catheter, and decortication with biopsy. IgG4 serum level was 268 mg/dl and pathology revealed pleural fibrosis, lymphoplasmacytic infiltrates, and increased IgG4-positive plasma cells with no malignant cells leading to a diagnosis of IgG4-RLD. Although COVID vaccine-related IgG4-RLD is a novel finding, having a high degree of suspicion following vaccination is always important for early diagnosis and effective treatment.

Side Effects of COVID-19 Vaccines (Pfizer, AstraZeneca) in Saudi Arabia, Eastern Province.

BACKGROUND: The coronavirus disease 2019 (COVID-19) virus has wreaked havoc on the planet, causing death and illness. Effective vaccination to eradicate the virus is the best approach to safeguarding the globe from it. Our study is considered one of the earliest studies conducted to determine the side effects of COVID-19 vaccines. We started data collection from May 2021 till September 2021, which was the beginning period of vaccine distribution in Saudi Arabia. This study aims to look at potential side effects and factors that contribute to their occurrence. METHODS: The optimal study design for achieving our goals was survey-based. Following Institutional Review Board approval, we created an online self-administered questionnaire using the Google survey webpage (Google LLC, Mountain View, California, United States). We disseminated the survey to 2293 individuals from May 2021 till September 2021 in the eastern province of Saudi Arabia, to males and females above the age of 18 who have been vaccinated by either Pfizer or AstraZeneca in one dose or two doses. RESULTS: The most prevalent side effect was pain at the injection site (60.7%), followed by general fatigue (23.8%) and swelling at the injection site (16.7%), with shortness of breath being the least common (0.9%). When the prevalence of COVID-19 vaccine side effects was compared to the socio-demographic characteristics of participants, we discovered that those without associated comorbidity (p=0.025) and non-smoking participants (p=0.009) showed more side effects. On the other hand, those who received Pfizer vaccine (p0.001) and those who exercised regularly (p0.001) had lower rates of COVID-19 vaccine side effects. Also, obesity was shown to be the most commonly related disease in terms of comorbidities (8.5%), followed by allergy (4.9%) and asthma (4.6%). CONCLUSION: We find that vaccination against COVID-19 has only minor adverse effects. Therefore we anticipate that this study will assist in dispelling rumors about dangerous side effects of the COVID-19 vaccine.

Durability of SARS-CoV-2 Specific IgG Antibody Responses Following Two Doses of Match and Mixed COVID-19 Vaccines Regimens in Saudi Population.

Background: SARS-CoV-2 pandemic continues to threaten the human population with millions of infections and deaths worldwide. Vaccination campaigns undertaken by several countries have resulted in a notable decrease in hospitalization and deaths. However, with the emergence of new virus variants, it is critical to determine the longevity and the protection efficiency provided by the current authorized vaccines. Aim: The aims of this study are to provide data about the magnitude of immune responses in individuals fully vaccinated against COVID-19 in Riyadh province of Saudi Arabia. Also, to evaluate the continuity of specific IgG levels and compare the titers in individuals who have been received two doses of the matched and mixed vaccines, including Pfizer and AstraZeneca against SARS-CoV-2 during the period of three to six months. Moreover, we analyze the current state of immune response in terms of antibody responses in thepopulation postvaccination using homogenous or hetrogenous vaccine regimen. Methods: A total of 141 healthy volunteers were recruited to our study; blood (n=63) and the saliva samples (n=78) and were collected from fully vaccinated individuals in Riyadh city. We employed a specific ELISA assay in plasma and saliva of fully vaccinated individuals. Results: IgG levels varied with age groups with the highest concentration in the age group 19-29 years, but the age group (≥50) had the lowest IgG concentration. The IgG levels in both serum and saliva were higher after three months and start to wane after six months. Individuals who received mixed types of vaccines had significantly better response than Pfizer vaccine alone. Conclusion: The current study investigates the status of humoral responses in different age groups, in terms of antibody measurements. These data will help to evaluate the need for further COVID-19 vaccine doses and to what extent a two-dose regimen will protect vaccinated individuals.

EVALUATION OF COVID-19 VACCINES EFFICACY IN IRAQI PEOPLES.

OBJECTIVE: The aim: The present study was carried out on patients recovered from COVID-19, including those patients who have taken vaccine and those who have not. PATIENTS AND METHODS: Materials and methods: The patients were recruited via an online panel and surveyed at different regions of Iraq from June 1, 2021, to August 30, 2021. RESULTS: Results: Our results demonstrated that the highest percentage of people recommended Pfizer vaccine followed by Sinopharm, while AstraZeneca vaccine was least recommended. CONCLUSION: Conclusions: The efficacy of different vaccines differed significantly; the highest effectiveness was observed with Pfizer vaccine followed by AstraZeneca and Sinopharm with effectiveness ranging from 94%, 89%, and 74%, respectively. Further, the highest percentage of re-infected patients was observed with Sinopharm vaccine followed by Astra Zeneca and Pfizer vaccine, respectively. Also, the highest percent of re-infection with masking used was seen in the case of Sinopharm vaccine followed by AstraZeneca and Pfizer vaccine. Although, we observed that post-vaccination symptoms were lowest than pre-vaccination symptoms, the percent of asymptomatic cases post-vaccination was highest than pre-vaccination cases for all vaccines.

VAERS-reported new-onset seizures following use of COVID-19 vaccinations as compared to influenza vaccinations.

The incidence of new-onset seizures, which we defined as de novo seizures occurring within 4 weeks of receiving any of the US Food and Drug Administration-approved COVID-19 vaccinations as reported in patient-reported data compiled in the US Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System Data (CDC VAERS), has not been explored. The VAERS database contains de-identified patient-reported adverse events following vaccination and represents post-marketing surveillance and analysis of vaccine safety. After adjusting for time at risk, this resulted in estimated incidence rates of 3.19 seizures per 100 000 persons per year for the COVID-19 vaccine and 0.090 seizures per 100 000 persons per year for the influenza vaccines. A data-driven, individualized dataset that is comprehensive and coupled with a longitudinal follow-up in larger numbers of vaccinated individuals is needed to expand on our preliminary findings of vaccine-related seizures.

Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) Side Effects: A Systematic Review.

Vaccinations prevented severe clinical complications of COVID-19. It was considered a vital component of living endemically with COVID-19. The Pfizer-BioNTech vaccine is the first mRNA-based vaccination that enhances immunity. Resulting in various adverse effects that may emerge after vaccination. This systematic review was undertaken to assess the Pfizer-BioNTech vaccine side effects by reviewing the previous studies. A total of 107 PubMed and Google Scholar publications were screened for Pfizer-BioNTech COVID-19 vaccine side effects. Fourteen articles met the study inclusion criteria. The included searching terms were a combination of "Pfizer vaccine and Side effects," "BioNTech vaccine and side effects," and "BNT162b2 vaccine and side effects," as well as all synonyms. The total number of participants in the 14 studies was 10,632 participants. Average of the most frequent side effects of 14 studies were injection site pain 77.34%, fatigue 43%, muscle pain 39.67%, local swelling 33.57%, headache 33.27%, joint pain 25.75%, chills 18.34%, fever 18%, itching 9.38%, lymph nodes swelling 7.86%, nausea 7.58%, dyspnea 7.86%,and diarrhea 6.36%. The average side effects after the first dose were 79% compared with 84% after the second dose. The average occurs side effects in females at 69.8% compared with males 30.2%. Our study reveals that side effects after the Pfizer-BioNTech vaccine are common, but they are usually mild and self-limited. Local reactions like pain at the injection site are the most common. Anaphylactic shock or severe reactions are rare. We hope that our results will reassure the public that the benefits of vaccination far exceed the dangers. Also, help reduce vaccine hesitancy among individuals worried about vaccine safety and possible adverse effects.

Generalized Papulovesicular Eruption as a Side Effect of the Pfizer-BioNTech COVID-19 Vaccine.

COVID-19 is inflicted by SARS-CoV-2 and resulted in a global health crisis that necessitated the urgency of vaccine development to prevent its spreading among the public. Pfizer-BioNTech COVID-19 is one of the emergency use authorized (EUA) vaccines. This vaccine is efficacious against the SARS-CoV-2 virus; nonetheless, recipients have frequently reported side effects. Recipients of this vaccine experienced miscellaneous side effects like fatigue and headache. However, cutaneous eruptions of varying degrees of severity and involvements have been manifesting post-vaccination. Dermatological eruptions following vaccination against COVID-19 disease are poorly recognized. Dermatological manifestations triggered post-vaccination differ in the clinical context and patient's demographic features. The only constant factor is various clinical and histopathological relations to establish the diagnosis of cutaneous eruption post-vaccination. Herein, we report a case of an 18-year-old male with T-cell acute lymphocytic lymphoma (ALL) in remission since August 2018 and other comorbidities. After the administration of the first dose of the Pfizer-BioNTech COVID-19 vaccine, the patient developed pruritic eczematous eruption presenting as grouped erythematous-violaceous papulovesicular lesions with fine scales over his upper and lower extremities. These eruptions started two days after the administration of the vaccine. This eruption became generalized 21 days after receiving the second dose of the Pfizer-BioNTech COVID-19 vaccine. Clinical suspicion of the drug-induced vesicular eruption was suspected; thus, a biopsy was obtained and showed erosions and mixed inflammatory cell infiltrate. From a clinical and histopathological correlation, vesicular eruption following vaccination with Pfizer-BioNTech COVID-19 was confirmed. Nevertheless, other diagnoses cannot be ruled out, but from the clinical-histopathological association, the vaccine-inflicted eruption is the likely culprit. Reports are crucial to understanding the nature of such dermatological manifestation after emerging diseases and counteractions like vaccinations. The dermatological manifestations are vaguely recognized; thus, by reporting on the cases similar to the case in this report, more data will be available to understand the nature and underlying cause of such eruptions.