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.

Development of High-Grade Sarcoma After Second Dose of Moderna Vaccine.

Coronavirus disease 2019 (COVID-19) is a disease characterized by predominantly respiratory symptoms, which can progress to respiratory failure. Due to the novelty of the vaccines, it is difficult to assess if there are any associated long-term side effects. Here, we present a case of an elderly female who received the Moderna COVID-19 vaccine and developed a high-grade sarcoma at the site of the injection. A 73-year-old female with a past medical history of hypertension, hyperlipidemia, and renal angiomyolipoma status post resection in 2019 presented with worsening right upper arm swelling for the past two weeks. She noticed the swelling two to four days after receiving her second dose of the Moderna vaccine within 1 cm from the prior injection site. Physical examination was remarkable for a 6 cm, circular, mobile, soft mass present in the right upper arm. MRI with and without contrast revealed a 5.2 cm soft tissue mass overlying the triceps region with irregular features concerning for malignancy. Fine needle aspiration revealed pathologic characteristics indicative of high-grade sarcoma. The patient ultimately had resection of the mass four months after the initial visit and was diagnosed as having grade 3, stage IIIA undifferentiated, pleomorphic high-grade sarcoma. Herein, we present a case demonstrating the development of high-grade sarcoma at the injection site in an elderly female patient within days of receiving the second dose of the Moderna COVID-19 vaccine. Currently, it is unclear whether there is a true association between the vaccines and malignancy or inflammatory response exacerbating underlying malignancy. This case highlights the necessity to investigate and be aware of such rare, adverse complications that may be associated with the novel COVID-19 vaccinations to guide physicians in their differential diagnosis.

Supraventricular tachycardia and deep vein thrombosis following Moderna vaccination: A case series.

There have been reports of deep vein thrombosis and supraventricular tachycardia following the Moderna vaccination. The timing of SVT and DVT just after vaccination in our case series could suggest possible temporal relationships to the vaccination. But further studies are needed to establish such evidence.

Numerical Simulation for a Hybrid Variable-Order Multi-Vaccination COVID-19 Mathematical Model

In this paper, a hybrid variable-order mathematical model for multi-vaccination COVID-19 is analyzed. The hybrid variable-order derivative is defined as a linear combination of the variable-order integral of Riemann–Liouville and the variable-order Caputo derivative. A symmetry parameter σ is presented in order to be consistent with the physical model problem. The existence, uniqueness, boundedness and positivity of the proposed model are given. Moreover, the stability of the proposed model is discussed. The theta finite difference method with the discretization of the hybrid variable-order operator is developed for solving numerically the model problem. This method can be explicit or fully implicit with a large stability region depending on values of the factor Θ. The convergence and stability analysis of the proposed method are proved. Moreover, the fourth order generalized Runge–Kutta method is also used to study the proposed model. Comparative studies and numerical examples are presented. We found that the proposed model is also more general than the model in the previous study;the results obtained by the proposed method are more stable than previous research in this area.

Fatal Post COVID mRNA-Vaccine Associated Cerebral Ischemia.

Background: Venous thromboses have been linked to several COVID-19 vaccines, but there is limited information on the Moderna vaccine's effect on the risk of arterial thrombosis. Here we describe a case of post-Moderna COVID-19 vaccination arterial infarct with vaccine-associated diffuse cortical edema that was complicated by refractory intracranial hypertension. Case Summary: 24 hrs after receiving her first dose of the Moderna COVID-19 vaccine, a 30-year-old female developed severe headache. Three weeks later she was admitted with subacute headache and confusion. Imaging initially showed scattered cortical thrombosis with an elevated opening pressure on lumbar puncture. An external ventricular drain was placed, but she continued to have elevated intracranial pressure. Ultimately, she required a hemicraniectomy, but intractable cerebral edema resulted in her death. Pathology was consistent with thrombosis and associated inflammatory response. Conclusion: Though correlational, her medical team surmised that the mRNA vaccine may have contributed to this presentation. The side effects of COVID-19 infection and vaccination are still incompletely understood. Though complications are rare, clinicians should be aware of presentations like this one.

Adverse events following immunization with COVID-19 vaccines

Objective: The purpose of this study was to identify Post-Vaccination Adverse Events (PVAE) with Moderna vaccine, locally systemically, and other reactions. Methods: A quantitative descriptive research method with a retrospective approach was used in this study. The study was carried out at RSUD Cicalengka Bandung with a population of employees who had received the Moderna vaccine after two complete doses of Sinovac from August to September 2021. Purposive sampling was used, with a total of 162 respondents calculated using the Yamane formula. Result: The results of this study showed that all respondents (100 %) had experienced PVAE after Moderna vaccination. The PVAEs were classified as systemic (95.1 %), local (92.6 %), and other (53.1 %). Fever (75.9 %) in systemic PVAEs, pain (92 %) in local PVAEs, and lymphadenopathy (25.9 %) in other PVAEs had the highest percentage of reactions. A significant proportion of respondents (27.5 %) reported being unable to work following the Moderna vaccination. Conclusions: PVAE can occur following Moderna vaccination and result in the inability to work, potentially causing service problems. Employees must be scheduled for planned vaccinations and monitored for PVAE to reduce the possibility of adverse effects. © 2023 Academia Nacional de Medicina. All rights reserved.

Moderna COVID-19 Vaccine: A New Player in Vaccine-Induced Thrombosis Without Thrombocytopenia.

This is a case of a 31-year-old male with no past medical history who developed extensive pulmonary embolism (PE) and deep venous thrombosis (DVT) three days after receiving the second dose of the Moderna vaccine. The patient presented with left calf swelling and mild shortness of breath, with no fever or hemodynamic instability. Doppler ultrasound of the left lower extremity showed thrombus in the common femoral, superior, mid-, and distal femoral, popliteal, and posterior tibial veins. Chest CT angiography (CTA) visualized extensive pulmonary emboli in the bilateral main pulmonary, lobar, and segmental arteries. Comprehensive hypercoagulable workup was unrevealing. The leading diagnosis was postulated as vaccine-induced thrombosis (VIT). Due to the diagnosis of bilateral sub-massive PE, the patient was initiated on enoxaparin and continued on direct-acting oral anticoagulation for at least one year. Our report showcases a plausible link between the Moderna vaccine and thrombosis due to the extensive and unprovoked nature of DVT/PE in this patient with a negative hypercoagulable workup. Although the mechanisms behind the messenger ribonucleic acid (mRNA) and double-stranded deoxyribonucleic acid (dsDNA) vaccines vary, the possibility of vaccine-induced thrombosis (VIT) after the Moderna vaccine is highly probable. Vaccine-induced thrombosis should be considered in a patient presenting with unprovoked thrombosis after the Moderna COVID-19 vaccine, and further research needs to be conducted to ascertain the correlation. However, these findings should not dissuade the use of the Moderna vaccine given its proven benefits.

Impact of chemotherapy and/or immunotherapy on neutralizing antibody response to SARS-CoV-2 mRNA-1237 vaccine in patients with solid tumors.

Patients with solid tumors have been a risk group since the beginning of the SARS-CoV-2 pandemic due to more significant complications, hospitalizations or deaths. The immunosuppressive state of cancer treatments or the tumor itself could influence the development of post-vaccination antibodies. This study prospectively analyzed 89 patients under chemotherapy and/or immunotherapy, who received two doses of the mRNA-1237 vaccine, and were compared with a group of 26 non-cancer individuals. Information on adverse events and neutralizing antibodies against the ancestral strain of SARS-CoV-2 (WH1) have been analyzed. Local reactions accounted for 65%, while systemic reactions accounted for 46% of oncologic individuals/cancer patients. Regarding the response to vaccination, 6.7% of cancer patients developed low neutralizing antibody levels. Lower levels of neutralizing antibodies between cancer and non-cancer groups were significant in individuals without previous SARS-CoV-2 infection, but not in previously infected individuals. We also observed that patients receiving chemotherapy or chemoimmunotherapy have significantly lower levels of neutralizing antibodies than non-cancer individuals. In conclusion, our study confirms the importance of prioritizing cancer patients receiving anticancer treatment in SARS-CoV-2 vaccination programs.

Vertigo/dizziness following COVID-19 vaccination.

PURPOSE: This study assessed the vertigo/dizziness in patients following COVID-19 vaccination. PATIENTS AND METHODS: From July 2021 to June 2022, totaling 50 patients with dizzy spells following COVID-19 vaccination by AZ (AstraZeneca-Oxford University, AZD1222), BNT (Pfizer-BioNTech, BNT162b2) or Moderna (Moderna, mRNA-1273) vaccine were enrolled in this study. The interval from vaccination to the onset of vertigo/dizziness was compared with inter-episodic interval of vertigo/dizziness in the same patients, but without vaccination, during past one year (2020). RESULTS: The incidences of severe systemic complication per 106 shots were 0.86 for Moderna vaccine, 1.22 for AZ vaccine, and 1.23 for BNT vaccine. Conversely, rate of post-vaccination vertigo/dizziness was noted in the Moderna group (66 %), followed by the AZ group (20 %) and the BNT (14 %) group, meaning that type of COVID-19 vaccine may affect various organ systems. The median time to the onset of vertigo/dizziness following vaccination is 10d, which is consistent with the onset of IgG production, and significantly less than inter-episodic interval (84d) in the same patients without vaccination. CONCLUSION: Post-vaccination vertigo/dizziness can manifest as exacerbation of previous neurotological disorder. The median time to the onset of vertigo/dizziness following COVID-19 vaccination is 10d. Since the outcome is fair after supportive treatment, the immunomodulatory effect of the vaccines does not undermine the necessity of the COVID-19 vaccination.

Case report: A rare case of Rosai-Dorfman-Destombes disease after the COVID-19 infection.

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is known to cause immune dysregulation and, therefore, has varied and often rare presentations. Rosai-Dorfman-Destombes disease (RDD) is an unusual non-Langerhans cell (non-LC) histiocytosis presenting with massive lymphadenopathy and various systemic symptoms. A 55-year-old Asian-American woman with no significant medical history or recent use of new drugs initially presented with cervical lymphadenopathy and urticarial rash 1 week after receiving the COVID-19 messenger RNA (mRNA) vaccine (Moderna, mRNA-1273) against SARS-CoV-2. The biopsy of the skin rash was consistent with a drug reaction. Approximately 2 months later, she developed mild flu-like symptoms and was diagnosed with a COVID-19 infection. Her symptoms were mild and self-resolving. Approximately 3 months later, she developed a generalized patchy erythematous rash on the face and the body that gradually worsened; diffuse lymphadenopathy involving the bilateral cervical, axillary, and inguinal areas; and constitutional symptoms. Laboratory results were consistent with lymphopenia, anemia, and an elevated sedimentation rate. Supraclavicular lymph node biopsy showed Rosai-Dorfman disease with a marked polyclonal plasmacytosis. She was started on a tapering dose of corticosteroids and showed clinical improvements over the next few weeks. Herein, we present a rare case of a histiocytic disorder that developed after contracting the SARS-COV2 infection in the event of receiving a recent mRNA COVID vaccination.

Exploration of Correlations between COVID-19 Vaccination Choice and Public Mental Health Using Google Trend Search.

Since the global COVID-19 pandemic has great impact on human health and life style, the vaccination is the most effective method for disease control and prevention. However, not all people are willing to be vaccinated because some critical factors affect vaccination aspiration and vaccine choice of the public population. Among these factors, public mental health belongs to a political issue. In this study, Google Trend Search was used to explore the correlation between COVID-19 vaccination choice and public mental health during the period from August/2020 to December/2021. The results suggested that the main public concerns of COVID-19-related mental illnesses are positively correlated with the new cases amount but are negatively correlated with total cases and vaccinated cases amount. Moreover, the results support that the public population took more interest in the Pfizer/BNT COVID vaccine and Moderna COVID vaccine than the AstraZeneca COVID vaccine. Our study shows that investigations of the public mental health should be set up and conducted widely. A complete vaccination program combined with a policy for the improvement of public mental health are very effective for the control and prevention of COVID-19.

Neuro-Ophthalmologic Symptoms Associated With the Moderna mRNA COVID-19 Vaccine: A Case Report.

Multiple neuro-ophthalmological symptoms, such as visual field defects, optic neuritis, and eye movement abnormalities, have been reported with coronavirus disease 2019 (COVID-19) infection. It is unknown whether the COVID-19 vaccine can result in similar neuro-ophthalmological symptoms post-vaccination. Here, we describe a case of optic neuritis after the administration of the mRNA COVID-19 Moderna vaccine. A 47-year-old female presented eight days after receiving the first dose of the Moderna COVID-19 vaccine with impaired vision in the left eye and symptoms consistent with optic neuritis. The patient underwent a workup for infectious etiology, autoimmune diseases, and allergies, which was negative. The patient was treated with a high dose of steroids resulting in the complete resolution of her symptoms. The patient was recommended against the second dose of the mRNA COVID-19 vaccine. Early detection and treatment of optic neuritis are important to prevent the long-term sequelae of neuritis with impaired vision.

Acute Macular Neuroretinopathy Following COVID-19 mRNA Vaccination.

A 21-year-old female developed bilateral acute-onset paracentral scotomas three days after receiving the second dose of her Moderna COVID-19 vaccination. A clinical diagnosis of acute macular neuroretinopathy (AMN) was confirmed after classic findings were demonstrated on near-infrared reflectance imaging, spectral-domain optical coherence tomography, and colored fundus photography. The patient presented with visual acuity of 20/100-1 OD and 20/20 OS. After treatment with brimonidine and difluprednate, at a two-week follow-up, her visual acuity was 20/100-2 OD and 20/25-2 OS. There have been reported cases of AMN following flu-like illnesses as well as after receiving vaccines. However, this is the first report of AMN following vaccination with a Moderna COVID-19 vaccine.

COVID-19 Vaccine-Induced Cerebral Sinus Thrombosis: Coincidence vs. Cause?

Patients who were vaccinated against COVID-19 have experienced thrombosis-thrombocytopenia syndrome and cerebral venous sinus thrombosis (CVST). It is important to be aware of this potential side effect of the vaccine and to be able to recognize early clinical symptoms and signs of CVST. In this paper, we present two cases of COVID-19 vaccination-related CVST. The patients who suffered headaches and seizures were found to have CVST, which was treated with anticoagulation.

Acute Disseminated Encephalomyelitis (ADEM) After Consecutive Exposures to Mycoplasma and COVID Vaccine: A Case Report.

Acute disseminated encephalomyelitis (ADEM) is an autoimmune demyelinating disease of the central nervous system, commonly triggered by viral infections or after immunization. ADEM occurrences in adults are rare. Full spectrum of complications is unknown for novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines. A previously healthy 44-year-old female presented to the emergency room (ER) with acute onset of tingling, numbness, and weakness of both lower extremities, urinary retention, blurred vision in right eye, and midline lower back pain. Physical examination revealed bilateral lower extremity weakness 1/5, absent deep tendon reflexes, and decreased sensation. She received the first dose of SARS-CoV-2 vaccine six days prior to presentation to ER. Imaging of her lumbar spine and head were consistent with an active demyelinating plaque consistent with demyelinating disease either multiple sclerosis (MS) or ADEM. The patient was started on SoluMedrol 500 mg IV twice daily for five days. Serological workup and CSF analysis were nonsignificant except for Mycoplasma pneumonia IgM, elevated myelin basic protein, and positive IgG, IgA, and IgM. Patient gradually improved and was transferred to rehabilitation. Repeat MRI brain and spine showed improvement in previous lesions. However, she had worsening left eye symptoms that prompted her transfer to another facility for plasmapheresis. Plasma exchange was done for five treatments for ADEM. Patient started noticing improvement in vision and was discharged on steroid taper. We report a case of a possible association between ADEM and SARS-CoV-2 mRNA vaccine. It should be considered in the differential diagnosis in any case suggestive of acute demyelination after COVID-19 vaccination.

Unusual arm vein thrombosis after the Moderna (mRNA-1273) COVID-19 vaccination-a case report.

BACKGROUND: Since 2019, all over the world is still suffering from managing never-experienced pandemic era of coronavirus-2019 (COVID-19). Prompt development and administration of vaccines contributed lowering severity of the disease, but adverse events related to vaccination were also reported. Exact association between each adverse conditions and vaccination or COVID-19 infection are being investigated. CASE DESCRIPTION: A 44-year-old Asian male developed right upper arm diffuse swelling 4 days after receiving the third dose of messenger ribonucleic acid (mRNA)-1273 COVID-19 vaccine in his left deltoid muscle. He was previously healthy, but has history of COVID-19 infection 4 months before the third dose vaccination. Venous duplex ultrasound revealed acute thrombosis in the right cephalic arch, axillary vein, and subclavian vein. There were no abnormal laboratory test results. After 3 months of anticoagulation therapy, arm vein thrombosis was completely resolved upon follow-up duplex ultrasonography. CONCLUSIONS: Although, positive COVID-19 polymerase chain reaction (PCR) history might be associated with potential cause of this unusual arm vein thrombosis, we postulate that a possible cause may be secondary to his third dose of mRNA-1273 vaccine given the onset and no prior medical comorbidities. Since the previous studies was mostly done based on mRNA vaccines of other manufacturers rather than Moderna, exact thrombosis mechanism of this case was not established yet. Contralateral arm vein thrombosis is unique to report, and future comprehensive studies are needed.

Impact of Obesity on Vaccination to SARS-CoV-2.

To combat the immense toll on global public health induced by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), new vaccines were developed. While these vaccines have protected the populations who received them from severe SARS-CoV-2 infection, the effectiveness and durability of these vaccines in individuals with obesity are not fully understood. Our uncertainty of the ability of these novel vaccines to induce protective immunity in humans with obesity stems from historical data that revealed obesity-associated immune defects to influenza vaccines. This review analyzes the efficacy of SARS-CoV-2 vaccines in humans with obesity. According to the vaccine safety and efficacy information for the Pfizer, Moderna, and Johnson & Johnson formulations, these vaccines showed a similar efficacy in both individuals with and without obesity. However, clinical trials that assess BMI and central obesity showed that induced antibody titers are lower in individuals with obesity when compared to healthy weight subjects, highlighting a potential early waning of vaccine-induced antibodies linked to obesity rates. Thus, the desired protective effects of SARS-CoV-2 vaccination were potentially diminished in humans with obesity when compared to the healthy weight population, but further studies outlining functional implications of the link between obesity and lower antibody titers need to be conducted to understand the full impact of this immune phenomenon. Further, additional research must be completed to truly understand the immune responses mounted against SARS-CoV-2 in patients with obesity, and whether these responses differ from those elicited by previously studied influenza viruses.