VigiBase Data search for Adverse Event Reports

Myocarditis Causes

• Viruses. Many viruses are commonly associated with myocarditis, including the viruses that cause the common cold (adenovirus); COVID-19; hepatitis B and C; parvovirus, which causes a mild rash, usually in children (fifth disease); and herpes simplex virus.Gastrointestinal infections (echoviruses), mononucleosis (Epstein-Barr virus) and German measles (rubella) also can cause myocarditis. It’s also common in people with HIV, the virus that causes AIDS.
• Bacteria. Bacteria that can cause myocarditis include staphylococcus, streptococcus, the bacterium that causes diphtheria and the tick-borne bacterium responsible for Lyme disease.
• Parasites. Among these are such parasites as Trypanosoma cruzi and toxoplasma, including some that are transmitted by insects and can cause a condition called Chagas disease. Chagas disease is much more common in Central and South America than in the United States, but it can occur in travelers and in immigrants from that part of the world.
• Fungi. Yeast infections, such as candida; molds, such as aspergillus; and other fungi, such as histoplasma, often found in bird droppings, can sometimes cause myocarditis, particularly in people with weakened immune systems.

5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021

September 22, 2022 – Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults “The Pfizer trial exhibited a 36 % higher risk of serious adverse events in vaccinated participants in comparison to placebo recipients: 67.5 per 10,000 versus 49.5 per 10,000; risk difference 18.0 per 10,000 vaccinated participants (95 % compatibility1 interval 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of SAEs in vaccinated individuals compared to those receiving placebo

September 22, 2022 – No significant increase in Guillain-Barré syndrome after COVID-19 vaccination in adults: A vaccine adverse event reporting system study  In our study, several lines of evidence suggest that in some cases, the association between GBS and COVID-19 vaccination is not entirely coincidental. Firstly, the increased reporting rate of GBS within the first 6 weeks after vaccination. 64 % of cases were reported after 6 weeks of COVID-19 vaccination. Self-controlled and case centered analyses confirmed a greater relative risk of GBS within the risk period compared to control period. Similar results were observed in several studies that suspected or established an association between some cases of GBS and vaccination.

October 12, 2022 – The connection between COVID-19 vaccine abundance, vaccination coverage, and public trust in government across the globe “This study finds a fine balance between the number of vaccine doses secured at the procurement point and the rate of uptake at the recipient end, combined with the public’s level of confidence in the national government. The results indicate that although securing sufficient resource matters, ordering more doses does not necessarily mean better vaccination coverage and efforts should be made to increase the public’s confidence in government and in particular, their belief in immunisation programmes in general.

October 4, 2022 – Fewer than half of US adults plan to get flu vaccine despite warnings of a severe season “According to Walensky, during the last influenza season, 51% of the U.S. population aged 6 months and older received a vaccine, which is similar coverage to what has been observed in previous seasons and prior to the pandemic. However, she added, there was a drop in coverage among certain groups including pregnant women and children who are at higher risk of serious complications. Additionally, vaccine coverage for children aged 6 months to 17 years was 58%, a nearly 6 percentage point decrease from the 2019-2020 flu season and the lowest vaccination coverage observed in children in the last eight seasons.”

October 1, 2022 – A Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after BNT162b2 mRNA Vaccination against COVID-19 “Although there was no history of COVID-19 for this patient, immunohistochemistry for SARS-CoV-2 antigens (spike and nucleocapsid proteins) was performed. Surprisingly, only spike protein but no nucleocapsid protein could be detected within the foci of inflammation in both the brain and the heart, particularly in the endothelial cells of small blood vessels. Since no nucleocapsid protein could be detected, the presence of spike protein must be ascribed to vaccination rather than to viral infection. The findings corroborate previous reports of encephalitis and myocarditis caused by gene-based COVID-19 vaccines.”

September 28, 2022 – New-Onset and Relapsed Membranous Nephropathy post SARS-CoV-2 and COVID-19 Vaccination (pdf) “Common adverse reactions after COVID-19 vaccination included fever, headache, fatigue, myalgia, etc. Nevertheless, since massive vaccination, growing numbers of clinical cases concerning glomerular diseases such as membranous nephropathy (MN), IgA nephropathy  and minimal change disease, etc., have been widely reported.

September 26, 2022 – Revisiting Excess Diagnoses of Illnesses and Conditions in Children Whose Parents ProvidedInformed Permission to Vaccinate Them “Relative Risk and Odds Ratios sustain and augment the original report. Additional office visits, beyond scheduled HCVs, are quantified, controlling for variation in kept HCVs and age/days of care. Estimates of Health Care Incidence (HCI) show that visits above regular HCVs increase due to vaccination by 2.56 to 4.98 additional office visits for vaccine-related health issues per unit increase in vaccination per year“.

July 30, 2022 – Myocarditis and/or pericarditis risk after mRNA COVID-19 vaccination: A Canadian head to head comparison of BNT162b2 and mRNA-1273 vaccines “In 18–29 year-old males who received a second dose of mRNA COVID-19 vaccine, attributable risk of myocarditis and/or pericarditis was found to be 5.69 (95% CI: 4.07 – 7.95; p < 0.001) times higher among mRNA-1273 recipients (n = 106) as compared to BNT162b2 recipients (n = 33). In the same group, Poisson regression modelling estimated that the risk of myocarditis and/or pericarditis was 4.72 (p-value = <0.001) times higher after mRNA-1723 compared to BNT162b2 vaccination.”

July 30, 2022 – Safety of COVID-19 vaccination and acute neurological events: A self-controlled case series in England using the OpenSAFELY platform “We observed a short-term increased rate of Guillain-Barré syndrome and Bell’s palsy after first dose of ChAdOx1 vaccine. The absolute risk, assuming a causal effect attributable to vaccination, was low.”

July 30, 2022 – Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study “A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients.”

June 30, 2022 – Association between Covid-19 Vaccination and Influenza Vaccination Rates “The polarizing nature of vaccination against coronavirus disease 2019 (Covid-19) within the United States threatens public health and has contributed to variable statewide vaccine uptake that ranged from 50 to 80% as of January 2022.Given the divided national landscape and anecdotal evidence from our own patients, we hypothesized that low Covid-19 vaccination rates would be associated with decreases in influenza vaccination rates. Although inferences about specific policies and messaging promoting Covid-19 vaccination are beyond the scope of this ecologic study, our findings suggest that after the widespread availability of Covid-19 vaccines, factors associated with Covid-19 vaccination rates (e.g., safety concerns and mistrust of Covid-19 vaccines or government) may have spilled over to affect influenza vaccination rates.”

July 30, 2022 – Artificial intelligence and clinical data suggest the T cell-mediated SARS-CoV-2 nonstructural protein intranasal vaccines for global COVID-19 immunity ‘Additionally, CD4 + and CD8+ T cell responses were more significant in severe COVID-19 patients which could be related to the differentiation. However, as stated before the differentiation and malfunction of the T cells cannot be considered a major trait but more due to other background pathologies.In summary, based on the given evidence from several clinical and in silico studies, intranasal nonstructural SARS-CoV-2 protein mRNA vaccines have potential to provide global immunity against COVID-19.

July 30, 2022 – Impact of vaccination during pregnancy on infants’ immune responses to vaccinations- definitions and statistical approaches  “Tdap vaccination during pregnancy is also associated with higher anti-polyribosyl ribitol phosphate (PRP) and anti-tetanus toxoid (TT) antibody titers in offspring of vaccinated compared to unvaccinated women. The latter modification of the infants’ immune response is not accurately described by the use of the term “blunting.”

July 30, 2022 – COVID-19 vaccine safety monitoring in low and middle income countries – Time for a bold new approach “Deficiencies in the infrastructure to monitor vaccine safety in many low and middle income countries is a well-recognized challenge. The scarce resources available for public health are generally preferentially allocated for vaccine purchase and delivery rather than for pharmacovigilance. Recently, the WHO has proposed a threshold of at least 10 adverse events following immunization (AEFI) per 100,000 surviving infants as a basic indicator for a functional vaccine pharmacovigilance reporting system.‘

July 30, 2022 – Clinical characteristics and outcome of hospitalized elderly patients with COVID- 19 after vaccine failure ‘We described clinical characteristics and outcome of 160 patients over 65 years (01 September to 31 August 2021) who had a first positive SARS-CoV-2 PCR- test more than 14 days after full vaccination and were hospitalized with COVID-19. Median age of included patients was 84 years, 61.2% were over 80 years; 50.6% were male and most (82.5%) has at least one comorbidity. Up to 84% received specific treatment against COVID-19, including 76.9% low-flow oxygen therapy. We found that overall mortality was 25.6% and 30.6% in those older than 80 years. A higher mortality was significantly associated with older age and treatment with tocilizumab.

July 18, 2022 – In survey, COVID-19 vaccine recipients report changes in menstrual bleeding  – “Menstruating and formerly menstruating people began sharing that they experienced unexpected bleeding after being administered a COVID-19 vaccine in early 2021,” the scientists who led the study wrote. Because vaccine trials typically do not ask about menstrual cycles or bleeding, this side effect was largely ignored or dismissed.

July 13, 2022 – Safety of heterologous primary and booster schedules with ChAdOx1-S and BNT162b2 or mRNA-1273 vaccines: nationwide cohort study “The incidence of hospital contacts for a range of adverse cardiovascular and haemostatic events within 28 days after the second or third vaccine dose, comparing heterologous versus homologous vaccine schedules. Secondary outcomes included additional prioritised adverse events of special interest. Poisson regression was used to estimate incidence rate ratios with adjustment for selected covariates.”

July 7, 2022 – SARS-CoV-2 Infection in Patients with a History of VITT – “Our observations provide in vivo evidence that corroborate our previous in vitro findings that the immune responses against the SARS-CoV-2 spike protein (induced by Covid-19 or any of the Covid-19 vaccines) and against PF4 (induced in association with VITT) are independent. Our finding that Covid-19 does not restimulate anti–PF4 antibodies in patients with a history of VITT provides further insights into the pathogenesis of this disorder and may be helpful in counseling patients regarding further Covid-19 vaccination with an mRNA vaccine.

July 1, 2022 – Post-Vaccinal Encephalitis with Early Relapse after BNT162b2 (COMIRNATY) COVID-19 Vaccine: A Case Report “We support our probable AE diagnosis due to having criteria reported in a previous consensus. In conclusion, we report the case of a patient with a clinical picture of encephalopathy of probable autoimmune etiology after vaccination with BNT162b2 (COMIRNATY) who presented an early clinical relapse after the second dose.”

July 2022 – University-Associated SARS-CoV-2 Omicron BA.2 Infections, Maricopa County, Arizona, USA, 2022 “In conclusion, >50% of 44 case-patients in our cohort experienced symptomatic BA.2 infection, but <25% sought medical care, suggesting BA.2 infection in a young population might be mild. In addition, nearly 75% of case-patients completed a primary vaccination series which, in addition to their age, might have contributed to their mild illness. However, data were insufficient to compare if vaccination status affected whether case-patients experienced symptoms or sought medical care. Among persons who completed a primary vaccine series, only 25% received booster vaccines.”

July 2022 – Multisystem Inflammatory Syndrome after Breakthrough SARS-CoV-2 Infection in 2 Immunized Adolescents, United States “In the first case, headache and myalgia developed in a healthy 14-year-old boy (day 1 of illness); by day 7, fever, abdominal pain, diarrhea, emesis, bloodshot eyes, red cracked lips, and rash had also developed. On day 10, he was brought for treatment to the emergency department and admitted to a quaternary-care pediatric hospital.Three months earlier, he completed the Pfizer-BioNTech 2-dose COVID-19 vaccine series (Figure). One month later, he experienced 3 days of coughing and congestion and tested positive by PCR for SARS-CoV-2 infection, from which he recovered.”

July 2022 – Mental Health Conditions and Severe COVID-19 Outcomes after Hospitalization, United States “Of our study sample of 664,956 hospitalized patients, 77.1% of patients were >50 years of age. Male patients outnumbered female patients in having no MHC diagnoses (55.0%) or schizophrenia (53.8%); female patients outnumbered male patients in having anxiety (61.0%), depression (61.7%), or bipolar disorder (58.8%). We stratified COVID-19 outcomes among hospitalized patients by MHC diagnosis. ”

July 2022 – Self-Reported and Physiologic Reactions to Third BNT162b2 mRNA COVID-19 (Booster) Vaccine Dose “We observed similar trends when analyzing objective and continuous physiologic measurements collected by the smartwatch. Specifically, we identified a considerable increase in heart rate (Figure 3, panels A‒C) and the HRV-based stress indicators (Figure 3, panels D‒F) during the first 48 hours after administration of the third dose.

June 14, 2022 – High-Profile COVID Reinfections; U.K.’s Monkeypox Surge; More Summer Flu? “— A daily roundup of news on COVID-19 and the rest of medicine”

May 26, 2022 – COVID-19 and seasonal influenza: The potential 2021–22 “Twindemic” “Based on the annual findings, the World Health Organization (WHO) convenes a meeting every February and September with experts to recommend which strains of flu should be targeted by the forthcoming vaccines for the northern and southern hemispheres respectively (last ones were from 13 to 23 September on seasonal influenza and from 28 to 30 September on influenza of pandemic potential). Experts met in February 2021 and formulated recommendations on the selection of four viruses for 2021 vaccine in the northern hemisphere. … Despite the COVID-19 vaccination pace in several countries in northern hemisphere, the so-called “twindemic”, simultaneous outbreaks of covid-19 and flu, might indeed overwhelm health systems. On the other hand, employee absences due to mild sickness can cause significant disruption to the functioning of society, for example the recent cancellation of flights over Christmas.”

May 18. 2022 – Severe disease exacerbation after mRNA COVID-19 vaccination unmasks suspected multiple sclerosis as neuromyelitis optica spectrum disorder: a case report “Since the beginning of vaccination against severe acute respiratory syndrome coronavirus (SARS-CoV-2) in the global COVID-19 pandemic, few cases of adverse events associated with occurrence or deterioration of demyelinating CNS diseases such as multiple sclerosis (MS) have been published.

May 15, 2022 – Flare-up of generalized pustular psoriasis combined with systemic capillary leak syndrome after coronavirus disease 2019 mRNA vaccination “There are few reports on CVT after mRNA-based COVID-19 vaccination. These studies suggested that CVT occurrences related to mRNA-based COVID-19 vaccines may be due to endothelial dysfunction caused by spike glycoprotein interactions with endothelial cells resulting in immunothrombosis. If the spike glycoprotein of mRNA-based COVID-19 vaccines binds to the angiotensin-converting enzyme 2 receptor, several inflammatory and thrombogenic molecules, such as leukocyte chemotactic factors, cell adhesion molecules (vascular cell adhesion molecule 1 and intercellular adhesion molecule 1), and procoagulant cytokines, can be activated. This mechanism may cause endothelial dysfunction, particularly in brain endothelial cells, which could contribute to a significant disruption of brain endothelial barrier integrity, ultimately promoting thrombus formation.”

May 13, 2022 – Neutralizing Antibodies Against the SARS-CoV-2 Omicron Variant (BA.1) 1 to 18 Weeks After the Second and Third Doses of the BNT162b2 mRNA Vaccine “Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of BNT162b2. A limitation of our study is that its cross-sectional design precludes evaluation of antibody decrease rates on an individual level. Nevertheless, the observed decrease in population neutralizing antibody titers corresponds to the decrease in vaccine efficacy against polymerase chain reaction–confirmed Omicron infection in Denmark and symptomatic Omicron infection in the United Kingdom.Taken together, vaccine-induced protective antibody responses following a second and third dose of BNT162b2 are transient and additional booster doses may be necessary, particularly in older people; however, conserved T-cell immunity and nonneutralizing antibodies may still provide protection against hospitalization and death.”

May 3, 2022 – Transmissible and Transferable Vaccines  “Many of these diseases have the potential to spread to humans, or have already done so. SARS-CoV-2, the virus that causes COVID-19, is only one of the recent diseases caused by zoonotic spillover. Infectious disease experts are aware of many animal populations – such as bats – that can act as reservoirs for zoonotic viruses. Vaccination of individual animals is only one of the many strategies employed to slow the spread of these pathogens.’

April 21, 2022 – A Rare Case of COVID-19 Vaccine-Induced Thrombotic Thrombocytopenia in a Young Patient “In our case, the young female with no history of previous thrombosis or family history of thrombophilia, presented with a new-onset of worsening headache, dizziness, and vomiting, and signs of increased intracranial pressure 18 days post ChAdOx1 nCov‐19 vaccination. Due to the significant mortality and morbidity associated with VITT, a variety of guidelines have been rapidly developed aiming at assisting physicians in diagnosing and managing this rare complication. Successful treatment requires a multidisciplinary approach, as in this case, which involved intensive care, hematology, neurology, and neurosurgery.”

March 31, 2022 – WHO: Pfizer vaccine potentially linked to hearing loss ‘The most reported COVID-19 vaccines in these cases were Pfizer/BioNTech,’ the WHO newsletter stated. The World Health Organization has published a report citing extremely rare instances of hearing loss and other auditory issues following injection of the COVID-19 vaccine.”

March 27, 2022 – Ischemic Optic Neuropathy After Administration of a SARS-CoV-2 Vaccine: A Report of 2 Cases full text) “This was explained as immune-mediated coagulopathy that can also cause arterial thrombosis, which often affects multiple arterial territories, although small-artery stroke is less common. VITT has been described more frequently with the adenovirus vector vaccine. For the moment, there is only 1 report, by Sangli and colleagues, who describe a catastrophic thrombosis after a second dose of the Moderna SARS-CoV-2 messenger RNA (mRNA) vaccine. However, antibodies against PF4 were not determined in our cases; hence this pathogenic mechanism cannot be completely ruled out.”

March 25, 2022 – Persistent Cardiac Magnetic Resonance Imaging Findings in a Cohort of Adolescents with Post-Coronavirus Disease 2019 mRNA Vaccine Myopericarditis – “This was explained as immune-mediated coagulopathy that can also cause arterial thrombosis, which often affects multiple arterial territories, although small-artery stroke is less common. VITT has been described more frequently with the adenovirus vector vaccine. For the moment, there is only 1 report, by Sangli and colleagues, who describe a catastrophic thrombosis after a second dose of the Moderna SARS-CoV-2 messenger RNA (mRNA) vaccine. However, antibodies against PF4 were not determined in our cases; hence this pathogenic mechanism cannot be completely ruled out.”

March 23, 2022 – COVID-19 mRNA vaccine-related interstitial lung disease: Two case reports and literature review (full text) “Drug-related pneumonitis due to the COVID-19 mRNA vaccine was diagnosed. One case was diagnosed with lymphocytic alveolitis by bronchoalveolar lavage fluid and transbronchial lung cryobiopsy. Both patients were successfully treated with corticosteroids, and they attended outpatient clinics thereafter. Although the safety and efficacy of COVID-19 vaccines have been established, further studies are needed to estimate long-term data and reports of rare adverse reactions.”

March 17, 2022 – An Interesting Case of Fatal Myasthenic Crisis Probably Induced by the COVID-19 Vaccine “It is hypothesized that aggravation of such conditions may be attributed to the cross-reactivity of antibodies generated in response to viral surface epitopes with the proteins present at the NMJ. Indeed, studies have shown that patients with pre-existing MG who contract the COVID-19 infection, may present with respiratory distress syndrome, functional disability even in absence of physical activity, cerebrovascular and cardiovascular diseases, and immune-mediated neuropathy.”

March 15, 2022 – Inflammatory demyelinating polyneuropathy after the ChAdOx1 nCoV-19 vaccine may follow a chronic course “Awareness of this complication and distinction from Guillain-Barré syndrome enables the timely institution of maintenance immunomodulatory treatment. Our report also highlights the likely relationship between vaccination and the subsequent development of CIDP, but definitive demonstration of a causal link needs larger studies.”

March 7, 2022 – Hypersensitivity Reactions to COVID-19 Vaccines—Identify High-Risk Children and Vaccinate the Rest “In patients with a history of anaphylaxis unrelated to a COVID-19 vaccine or its excipients (PEG or PS), prolonged observation time is not necessary. Referral to an allergist is recommended for children with a history of PEG and/or PS-80 allergy or a history of an immediate severe reaction (≤4 hours) after the administration of a COVID-19 vaccine. It is important to note that most patients who react to the first COVID-19 vaccine dose will be able to tolerate the second dose. Because COVID-19 vaccines are safe and effective and severe allergic reactions are rare, it is important to encourage patients to get vaccinated against COVID-19 and avoid booster delays and to refer high-risk children to an allergist.”

March 5, 2022 – Autoimmune mucocutaneous blistering diseases after SARS-Cov-2 vaccination: A Case report of Pemphigus Vulgaris and a literature review (full text) “Notably, almost the 62.5% of the AIBDs cases developed after Pfizer vaccine administration. This figure may possibly be explained in terms of the more frequent use of the Pfizer vaccine compared to the others, as it has been administered to 28% of the population compared to the Moderna vaccine (18%) and the AstraZeneca (12%).

March 2022 – Bullous pemphigoid after second dose of mRNA- (Pfizer-BioNTech) Covid-19 vaccine: A case report (pdf) “Bullous pemphigoid is a rare autoimmune dermatological disorder that primarily affects the elderly beyond the age of 60. The cause of this disease is unknown, although it sometimes can be triggered by taking certain medications. Itching is frequently the first symptom, followed by urticarial lesions and, finally, blisters. Numerous cutaneous abnormalities, most typically local site injection responses, have been described with mRNA COVID-19 vaccinations.

February 27, 2022 – Ischemic stroke shortly after vaccination against SARS-CoV-2: A case-control study “Conclusions: Ischemic strokes occurring shortly after COVID-19 vaccination at our center were similar to those of non-vaccinated patients. Therefore, the relatively high percentage of such patients probably relates to the very high fraction of elderly people vaccinated against SARS-CoV-2 in the Cremona area, rather than to a consequence of vaccination.”

February 14, 2022 – Autopsy Histopathologic Cardiac Findings in Two Adolescents Following the Second COVID-19 Vaccine Dose “We report the autopsy results including microscopic myocardial findings of two teenage boys who died within the first week after receiving the second Pfizer-BioNTech COVID-19 dose. The microscopic findings are not the alterations seen with typical myocarditis. This suggest a role for cytokine storm which may occur with an excessive inflammatory response, as there also is a feedback loop between catecholamines and cytokines

February 12, 2022 – Acute Pericarditis Post mRNA-1273 COVID Vaccine Booster “In addition, an increased risk of myocarditis and pericarditis has been reported following mRNA vaccinations, particularly in adolescent males. A September 2021 systematic review of the literature analyzed 69 available case reports and case series of cardiac complications following mRNA vaccinations and found that out of 243 patients, 227 were diagnosed with myocarditis/myopericarditis, and seven were diagnosed with pericarditis. The majority (92%) were males, and the mean age was 21 years (range, 12-70 years). Three-quarters of the patients who were diagnosed with myocarditis or pericarditis had received the BNT162b2 vaccine (Pfizer-BioNTech), and most (88%) were diagnosed after the second vaccine dose, with a median time from immunization to symptom onset of three days (range: 1.5 hours to 73 days)”

January 25, 2022 – A Pediatric Case of Sensory Predominant Guillain-Barré Syndrome Following COVID-19 Vaccination “With data provided through the Vaccine Adverse Events Reporting System (VAERS), the Centers for Disease Control and Prevention (CDC) and United States Department of Health and Human Services have reported three main adverse events in association with COVID-19 vaccines. Thrombosis with thrombocytopenia syndrome (TTS)4 – a rare syndrome involving venous or arterial thrombosis and thrombocytopenia – and Guillain-Barre syndrome (GBS) have been reported in connection to the Janssen vaccine. Myocarditis has been reported in connection with the Pfizer and Moderna COVID-19 vaccines.

January 19, 2022 – Four cases of acquired hemophilia A following immunization with mRNA BNT162b2 SARS-CoV-2 vaccine. ‘On May 29, 2021, a 73 year-old woman with a remote diagnosis of rheumatoid arthritis and Sjogren syndrome was admitted to our Hospital for spontaneous tongue, jaw and right knee hematomas. She had been injected with BNT162b2 on May 3 (2nd dose). She noticed a first haematoma on the tongue 14 days after the first dose and knee and jaw hematomas few days after the second dose.”

January 18, 2022 – Frequency of Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials A Systematic Review and Meta-analysis “In this systematic review and meta-analysis, approximately one-third of placebo recipients in COVID-19 vaccine randomized clinical trials reported at least 1 systemic AE after both the first and the second dose, with headache and fatigue being the most common. This nocebo response accounted for 76.0% of systemic AEs after the first dose of COVID-19 vaccine, and for 51.8% after the second dose. Public vaccination programs should consider these high nocebo responses.”

January 17, 2022 – Shoulder injury related to SARS-CoV-2 vaccine administration “The National Vaccine Injury Compensation Program in the United States defines shoulder injury related to vaccine administration (SIRVA) as an “adverse event following vaccination thought to be related to the technique of intramuscular percutaneous injection into an arm resulting in trauma from the needle and/or the unintentional injection of a vaccine into tissues and structures lying underneath the deltoid muscle of the shoulder.” We present 2 cases of SIRVA after administration of a SARS-CoV-2 vaccine, a patient with subdeltoid bursitis and another with an intramuscular hematoma. Although intramuscular hematoma is a less common manifestation of SIRVA than bursitis, it may result from the needle injuring an intramuscular vessel at the time of vaccination.

January 17, 2022 – Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications ” Canada

January 11, 2022 – Effect of Anticoagulant Therapy for 6 Weeks vs 3 Months on Recurrence and Bleeding Events in Patients Younger Than 21 Years of Age With Provoked Venous ThromboembolismThe Kids-DOTT Randomized Clinical Trial “Conclusions and Relevance  Among patients younger than 21 years of age with provoked venous thromboembolism, anticoagulant therapy for 6 weeks compared with 3 months met noninferiority criteria based on the trade-off between recurrent venous thromboembolism risk and bleeding risk.“

January 2022 – Three cases of acute venous thromboembolism in females after vaccination for coronavirus disease 2019 “To the best of our knowledge, we are the first to report venous thrombotic complications within days of administration of the mRNA-1273 (Moderna) vaccine. We present a series of three women who developed venous thromboembolism after RNA-1273 vaccination at a single healthcare system.”

December 17, 2021 – Amyloidogenesis of SARS-CoV-2 Spike Protein ” Our data propose a molecular mechanism for amyloidogenesis of SARS-CoV-2 S-protein in humans facilitated by endoproteolysis. The potential implications of S-protein amyloidogenesis in COVID-19 disease associated pathogenesis and consequences following S-protein based vaccines should be addressed in understanding the disease, long COVID-19, and vaccine side effects.

December 21, 2021 – How Does Severe Acute Respiratory Syndrome-Coronavirus-2 Affect the Brain and Its Implications for the Vaccines Currently in Use “Compelling evidence has been published to indicate that the spike protein, which is derived from SARS-CoV-2 and generated from the vaccines currently being employed, is not only able to cross the blood–brain barrier but may cause inflammation and/or blood clots in the brain. Consequently, should vaccine induced expression of spike proteins not be limited to the site of injection and draining lymph nodes there is the potential of long-term implications following inoculation that may be identical to that of patients exhibiting neurological complications after being infected with SARS-CoV-2. However, further studies are needed before definitive conclusions can be made.” . . . “Until such definitive studies are carried out and results substantiated, it lends consideration for caution when deciding whether to administer the COVID-19 vaccines to the younger age groups.”

December 13, 2020 to September 4, 2021 – Table 1. Characteristics of myocarditis/pericarditis reports following COVID-19 mRNA vaccines: Ontario. (pdf) p.4

December 2, 2021 – The COVID-19 pandemic and the menstrual cycle: research gaps and opportunities “Unfortunately, questions about menstruation have been excluded from most large-scale COVID-19 studies (including vaccine trials), so it is currently unclear how many women have experienced menstrual cycle changes, how long these changes persisted, whether menstrual changes reflect common and expected fluctuation in menstrual features over time or the impact of an exposure (e.g. pandemic restrictions, infection/illness, treatment, vaccine) and what exactly this exposure is. Given this complexity, the impact of any menstrual changes since the start of the pandemic is also unclear.”

December 2, 2021 – Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel “Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46).”

November 30, 2021 – Post‐COVID‐19 vaccination IgA vasculitis in an adult “IgA vasculitis (IgAV) may be idiopathic or associated with infection (bacterial or viral including SARS‐CoV‐2), medications, malignancy, or vaccination. Post‐COVID‐19 vaccination reactions include new‐onset leukocytoclastic vasculitis or exacerbation of pre‐existing vasculitis. In children, IgAV is the most common immunization‐related vasculitis, with influenza vaccine being the most commonly associated vaccine with all types of vasculitic events.

November 28, 2021 – Genital necrosis with cutaneous thrombosis after COVID-19 mRNA vaccination “To the best of our knowledge, this is the first case of extensive skin necrosis after COVID-19 vaccination that developed outside the injection site. Although the mechanism of platelet thrombi formation in genital skin is unclear, the short time interval between the vaccination and the onset of symptoms may indicate a causal relationship”

November 24, 2021 – Severity of SARS-CoV-2 Reinfections as Compared with Primary Infections “There were no cases of critical disease at reinfection and 28 cases at primary infection (Table S3), for an odds ratio of 0.00 (95% CI, 0.00 to 0.64). There were no cases of death from Covid-19 at reinfection and 7 cases at primary infection, resulting in an odds ratio of 0.00 (95% CI, 0.00 to 2.57). The odds of the composite outcome of severe, critical, or fatal disease at reinfection were 0.10 times (95% CI, 0.03 to 0.25) that at primary infection. Sensitivity analyses were consistent with these results S2).

November 17, 2021 – Retinal Vascular Events after mRNA and Adenoviral-Vectored COVID-19 Vaccines-A Case Series “The short time span between received vaccination and occurrence of the observed retinal vascular events raises the question of a direct correlation. Our case series adds to further reports of possible side effects with potential serious post-immunization complications of COVID-19 vaccinations.” 

November 11, 2021 – EMA flags Johnson & Johnson COVID vaccine for rare disorder, passes mRNA shots for one side effect but probes another “Rare cases of transverse myelitis have been reported following vaccination with the Johnson & Johnson COVID-19 vaccine,” the company said in a statement. “While the chances of experiencing these conditions are very low, the product information of COVID-19 vaccine Janssen will be updated to include important information about the signs and symptoms of transverse myelitis. The company will continue to work with the European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) and health authorities.”

November 11, 2021 – COVID-19 tracker: J&J, US team up to provide vaccines to conflict zones “In an effort to increase access to vaccines, Johnson & Johnson entered into an agreement with the U.S. government to provide its single-shot vaccine through the COVAX Humanitarian Buffer to vulnerable populations throughout the world. Deliveries to the COVAX Humanitarian Buffer are expected in the coming days.”

November 10, 2021 – Plantar herpes zoster following heterologous recombinant adenovirus-based COVID-19 vaccine “There are some reports of cutaneous reactions after SARS-CoV-2 vaccines with different clinical patterns including pityriasis rosea and chilblain-like lesions. Some cases of herpes zoster have also been reported following the injection of different types of COVID-19 vaccines. Most of them occurred following mRNA-based vaccine, but there are also limited reports of herpes zoster associated with adenovirus vector-based vaccines.”

November 8, 2021 – Abstract 10712: Mrna COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning “At the time of this report, these changes persist for at least 2.5 months post second dose of vac. We conclude that the mRNA vacs dramatically increase inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination.”

November 2021 – Fatal Systemic Capillary Leak Syndrome after SARS-CoV-2 Vaccination in Patient with Multiple Myeloma “A young man with smoldering multiple myeloma died of hypotensive shock 2.5 days after severe acute respiratory syndrome coronavirus 2 vaccination. Clinical findings suggested systemic capillary leak syndrome (SCLS); the patient had experienced a previous suspected flare episode. History of SCLS may indicate higher risk for SCLS after receiving this vaccine.”

October 28, 2021 – Lobar bleeding with ventricular rupture shortly after first dosage of an mRNA-based SARS-CoV-2 vaccine “We report a 67yo female who developed visual impairment, dysarthria, confusion, and fatigue a few hours after a first dosage with an mRNA-based SARS-CoV-2 vaccine (Pfizer). Her previous history listed diabetes, arterial hypertension, arterial occlusive disease, a single renal cyst on the left side, smoking, and ischemic stroke 20y earlier. Stroke was complicated by normal pressure hydrocephalus requiring placement of a ventriculo-atrial (VA)-shunt. Cerebral imaging revealed a right-sided intracerebral bleeding with ventricular rupture and correct placement of the VA-shunt. Neurosurgeons decided against surgical treatment. The further course was dominated by prolonged confusion, visual impairment, and disorientation but ultimately only minor deficits.

October 27, 2021 – Reaction to dermal filler following COVID-19 vaccination “This reaction is thought to represent a delayed-type hypersensitivity reaction to an immunologic trigger following COVID-19 vaccination.”

October 18, 2021 – Canceling the Spike Protein Striking Visual Evidence “Critically ill COVID ICU patients demonstrated elevated D-dimer levels roughly 60% of the time (Iba et al., 2020). An elevated D-dimer test result is almost an absolute confirmation of abnormal blood clotting taking place somewhere in the body. Such clots can be microscopic, at the capillary level, or much larger, even involving the thrombosis of large blood vessels. Higher D-dimer levels that persist in COVID patients appear to directly correlate with significantly increased morbidity and mortality. (Naymagon et al., 2020; Paliogiannis et al., 2020; Rostami and Mansouritorghabeh, 2020).”

October 2021 – Diffuse Thromboses in a 2-year-old With Sepsis and Respiratory Failure “Other respiratory viruses including influenza B, parainfluenza and respiratory syncytial virus have been shown to similarly activate the extrinsic coagulation system via tissue factor. Although this patient’s case, which occurred in March 2019, preceded the global pandemic, certainly SARS-CoV-2 and Multisystem Inflammatory Syndrome in Children would now be at top of the differential diagnosis. Macro and microvascular thrombotic complications are associated with severe presentations of COVID-19 in adult patients, including pulmonary embolisms, deep venous thromboses and diffuse microvascular angiopathic complications detected on autopsies. Similar to the pathogenesis of influenza-associated thrombosis, SARS-CoV-2 is thought to activate the coagulation pathway indirectly by producing endothelial injury. SARS-CoV-2 enters endothelial cells through the ACE2 receptors which through complex pathways stimulates aggressive cytokine release and subsequent activation of the extrinsic clotting cascade via tissue factor. ”

September 30, 2021 – Case Report: ANCA-Associated Vasculitis Presenting With Rhabdomyolysis and Pauci-Immune Crescentic Glomerulonephritis After Pfizer-BioNTech COVID-19 mRNA Vaccination “Interestingly, four cases of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) presenting with pauci-immune crescentic glomerulonephritis (GN) after COVID-19 mRNA vaccination have already been reported.”

September 16, 2021 – Menstrual changes after covid-19 vaccination “Changes to periods and unexpected vaginal bleeding are not listed, but primary care clinicians and those working in reproductive health are increasingly approached by people who have experienced these events shortly after vaccination. More than 30 000 reports of these events had been made to MHRA’s yellow card surveillance scheme for adverse drug reactions by 2 September 2021, across all covid-19 vaccines currently offered.”

September 14, 2021 – Takotsubo syndrome after receiving the COVID-19 vaccine “Upon full review, it is possible that a combination of significant risk factors such as female gender, postmenopausal status, anxiety about receiving the vaccine, prior MINOCA diagnosis, and the effects of the COVID-19 vaccination itself all contributed to the development of TTS.”

September 10, 2021 – How COVID is derailing the fight against HIV, TB and malaria – The pandemic’s effects on efforts to thwart other infectious diseases could exceed the direct impact of COVID-19. “As countries went into lockdown and resources were diverted to combat the pandemic, prevention, testing and treatment services for all three dropped precipitously, although the impacts vary for each. In some countries, says Sands, “the knock-on effects on HIV, TB and malaria could exceed the direct impact of COVID-19”.

September 10, 2021 – COVID in kids and fossil-fuel limits — the week in infographics “Research is beginning to reveal that the reason children have fared well against COVID-19 could lie in the innate immune response — the body’s crude but swift reaction to pathogens.” see pdf

September 9, 2021 – Doctors Work to Treat, Understand Post-Vaccine Shoulder Injury — SIRVA is mainly in the medicolegal realm, but physicians acknowledge its rare possibility “Within a few hours of getting her first COVID-19 shot, Leah Jackson had severe pain in her left shoulder.” … The Trump administration recently tried to cut SIRVA from the $4 billion VICP — which was initially authorized by the National Childhood Vaccine Injury Act of 1986, in response to a rush of lawsuits against vaccine manufacturers — arguing that it was due to improper administration of vaccines, rather than the vaccine itself. But the Biden administration killed the rule in April. Nonetheless, it would not have applied to COVID vaccines, which fall under a different compensation program.”

September 8, 2021 – Booster-dose SARS-CoV-2 vaccination in patients with autoimmune disease “The SARS-CoV-2 vaccination schedule may require further refinement in immunosuppressed populations,” the authors noted, adding that “further studies are needed to address safety and efficacy of booster vaccination, as well as optimal adjustment in peri-vaccination timing of immunosuppressive therapies; this should be investigated further in a clinical trial setting.”

September 8, 2021 – Myocarditis and Pericarditis Following mRNA COVID-19 Vaccination“Since April 2021, there have been more than a thousand reports to the Vaccine Adverse Event Reporting System (VAERS) of cases of inflammation of the heart—called myocarditis and pericarditis—happening after mRNA COVID-19 vaccination (i.e., Pfizer-BioNTech, Moderna) in the United States.”

• Cases of myocarditis reported to the Vaccine Adverse Event Reporting System (VAERS)external icon have occurred:
  • After mRNA COVID-19 vaccination (Pfizer-BioNTech or Moderna), especially in male adolescents and young adults,
  • More often after the second dose
  • Usually within several days after vaccination

September 7, 2021 – Humoral and cellular responses to mRNA vaccines against SARS-CoV-2 in patients with a history of CD20 B-cell-depleting therapy (RituxiVac): an investigator-initiated, single-centre, open-label study “To conclude, the present study shows that patients with a history of B-cell-depleting anti-CD20 therapies, including rituximab and ocrelizumab, have a severely impaired humoral and cellular response to SARS-CoV-2 mRNA-based vaccines. Our analyses provide, to our knowledge, the first estimates of ideal peripheral CD19⁺ and CD4⁺ cell counts and time since last dose of anti-CD20 therapy that would allow a positive humoral response to SARS-CoV-2 vaccines. Following validation in independent cohorts in a prospective setting, these results could provide guidance for coordinating both the administration of SARS-CoV-2 vaccines and B-cell-depleting agents in this population.” Comment: They will go through any lengths to vaccinate the world”

September 2021 – Ramsay Hunt Syndrome: Viral Infection Coexisting with COVID-19 “Various neuropathies both central and peripheral have been reported with SARS-CoV-2-related infection in recent studies. The mechanisms by which it causes cranial neuropathies have recently been hypothesized including neuroinvasion, neurovirulence, neurotropism, or autoimmune mechanisms. However, the exact pathogenesis is yet to be discovered. Isolated unilateral facial nerve palsy in SARS-CoV-2-positive patients has so far been described in many studies. Toscano et al described bilateral facial palsy in the context of Guillain–Barre Syndrome with COVID-19. Adding to the plethora, many SARS-CoV-2 patients have been reported to present with sudden sensorineural hearing loss. Studies have believed that SARS-CoV-2 binds to the angiotensin-converting enzyme-2 receptor expressed in epithelial cells of the middle ear, stria vascularis, and spiral ganglion in mice. This causes an inflammatory response and increase in cytokines such as tumor necrosis factor-α, interleukin-1, and interleukin-6. The mechanisms by which SARS-CoV-2 is believed to cause sensorineural hearing loss are attributed to both direct entry of virus into the cochlea and inflammation leading to cell stress. Mustafa compared the amplitude of transient-evoked otoacoustic emissions and latencies of vestibular evoked myogenic potential between asymptomatic COVID-19 real-time polymerase chain reaction (RT-PCR)-positive patients and normal subjects and found that COVID-19 infection have deleterious effects on cochlear hair cell functions.

August 29, 2021 – Hepatitis C Virus Reactivation Following COVID-19 Vaccination – A Case Report (full text) “After day 10 of follow-up manifest jaundice again increased, accompanied by severe pain in the upper right abdomen, irradiating to the upper left abdomen, followed by loss of consciousness, coma and death on day 23. Hepatitis C was confirmed by the blood test.”

August 27, 2021 – Found 9,652 cases where Vaccine is COVID19 and Symptom is Herpes zoster

August 17, 2021 – Buyer beware: The risks of donor-derived vaccine-induced thrombosis and thrombocytopenia “In March 2021, Vaccine-Induced Thrombosis and Thrombocytopenia (VITT) and central venous sinus thrombosis was recognized, first in Europe with the Astra-Zeneca ChAdOx01 nCoV-19 vaccine, and then in the United States with the Janssen Covid-19 Ad.26.COV2.S vaccine. Not only did this represent a new risk to describe to our patients and colleagues, but because of the life-threatening nature of this complication, we began receiving offers from donors who had died from VITT.