Det er sett flere tilfeller av perikarditt (betennelse i hjerteposen) og myokarditt (betennelse i hjertemuskelen) hos de som er vaksinert med Comirnaty eller Spikevax i Norge. Personer i alle aldre har vært rammet, men det er flest tilfeller hos menn under 30 år. Europeiske legemiddelmyndigheter (EMA) mener det er sammenheng mellom vaksinasjon og tilfeller av perikarditt og myokarditt
Perikarditt og myokarditt hos vaksinerte
Risikoen for å få myokarditt ser ut til å være høyere etter to doser med Spikevax (Moderna) enn etter to doser med Comirnaty (BioNTec/Pfizer). Det pågår analysearbeid for å få mer kunnskap om denne risikoen, inkludert risikoen for å få perikarditt.
Hos de fleste begynner symptomene på hjertebetennelse 1-2 uker etter vaksinasjonen, men hos noen kan det ta lengre tid. De fleste tilfellene oppstår etter andre dose av vaksinen. Noen tilfeller har oppstått etter første dose. Hos de fleste pasientene har den akutte tilstanden gått over i løpet av kort tid. I sjeldne tilfeller har det oppstått komplikasjoner. Behovet for videre oppfølging etter den akutte episoden blir vurdert av spesialister.
Vanlige symptomer på perikarditt og myokarditt:
- brystsmerter
- tungpustethet
- hurtig eller uregelmessig puls
Mekanismen bak perikarditt og myokarditt etter vaksinasjon er foreløpig ukjent.
Perikarditt er betennelse i hjerteposen. Vanligste årsak er virusinfeksjon. Det anslås at perikarditt er årsak til om lag 5 % av alle akutthenvisninger for brystsmerter. Perikarditt er vanligere hos menn enn hos kvinner. Perikarditt har vanligvis god prognose. Ved behov behandles perikarditt med smertestillende eller betennelsesdempende legemidler.
Myokarditt er betennelse i hjertemuskelen. Vanligste årsak er virusinfeksjon. De fleste tilfellene har et godartet forløp og krever ikke behandling utover smertestillende eller betennelsesdempende legemidler. Det anbefales gjerne å unngå hard fysisk aktivitet en tid etter et tilfelle med myokarditt. I sjeldne tilfeller kan myokarditt ha et alvorlig forløp med nedsatt hjertefunksjon og hjertesvikt. Perikarditt og myokarditt har mange av de samme symptomene: Brystsmerter, tungpustethet og hurtig eller uregelmessig puls.
Det er meldt om 349 tilfeller av Perikarditt og myokarditt i Norge per 9. desember 2021
Spesialist i indremedisin og hjertesykdommer, Nezar Raouf, mener prognosene er gode.
– Akutt går det veldig bra med dem. De får behandling, så drar de hjem. Men langtidseffekt etter hjerte- og muskelbetennelse som følge av vaksinen har vi ikke god nok data om enda, men prognosen er bra.
Hentet fra Norsk Helseinformatikk (NHI): Myokarditt er en betennelse i hjertemuskelen forårsaket av virus, bakterier, toksiner eller immunreaksjoner.
Tilstanden kan gå over uten behandling, men det kan utvikles behandlingstrengende hjertesvikt.
Betennelsen kan skyldes virus eller bakterier, giftstoffer (toksiner) eller autoimmune reaksjoner. Sistnevnte innebærer at kroppen utvikler antistoffer som angriper hjertemuskulaturen. Tilstanden fører til nedsatt funksjon av hjertet.
Hjertemuskelbetennelse er ingen hyppig sykdom, men milde varianter blir ikke alltid oppdaget og er sannsynligvis hyppigere enn tidligere antatt. Nøyaktige opplysninger om forekomsten mangler av den grunn. Hjertemuskelbetennelse er en av de hyppigste årsakene til plutselig død hos unge mennesker uten kjent sykdom.
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 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 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 – Evidence-based information for parents on the risk for children of COVID-19 vs. the risk of the vaccines (pdf)
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 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 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 https://www.nature.com/articles/d41586-021-02423-8» data-track-category=»body text link»>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.”
Sept. 8, 2021 – Myocarditis and Pericarditis
- 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”
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.
August 14, 2021 – A case of reactivation of varicella–zoster virus after BNT162b2 vaccine second dose? “We still know little about rare and long-term side effects related to COVID-19 vaccines and, even though the vaccination is crucial to stop spreading the virus, it is also important to monitor and report any possible adverse effect associated with the administration of the vaccines. Despite the impossibility of establishing the causal relation between our patient rash and the vaccine, it is reasonable to hypothesize that the vaccination-induced immune stress triggered the varicella–zoster virus reactivation, which is also consistent with the clusters of varicella–zoster virus reactivation already described in COVID-19 patients or in immune-compromised individuals.
August 9, 2021 – Infection-enhancing anti-SARS-CoV-2 antibodies recognize both the original Wuhan/D614G strain and Delta variants. A potential risk for mass vaccination? “Thus, ADE may be a concern for people receiving vaccines based on the original Wuhan strain spike sequence (either mRNA or viral vectors). Under these circumstances, second generation vaccines with spike protein formulations lacking structurally-conserved ADE-related epitopes should be considered.”
August 2, 2021 – Three cases of acute venous thromboembolism in females following vaccination for COVID-19 “While the majority of thrombotic complications following COVID-19 vaccines are primarily from the ChAdOx1 nCov-19 or Ad26.COV2.S vaccines, there is one reported case of a popliteal and peroneal DVT after the second dose of the BNT162b2 (Pfizer–BioNTech) vaccine. Of note, this patient was found to be heterozygous for the Factor V Leiden mutation. To date, this series is the first to report VTE after the mRNA-1273 vaccine in patient with no other apparent risk factors.”
July 31, 2021 – Occurrence of acute infarct-like myocarditis following COVID-19 vaccination: just an accidental co-incidence or rather vaccination-associated autoimmune myocarditis? “Beyond casual mild to moderate post-vaccination side effects that normally disappear within a few hours/days, some other rare adverse effects such as cerebral venous sinus thrombosis, acute ST-segment elevation myocardial infarction (STEMI) with large thrombus in coronary arteries as well as (autoimmune) myocarditis have also been reported recently. We would like to present the findings of three different patients that presented to our hospital until mid of June 2021 and showed unusual serious adverse cardiovascular events of infarct-like myocarditis (in the absence of CAD), possibly linked to preceding COVID-19 vaccination. CMR imaging revealed some interesting patterns of myocardial damage suggestive of “autoimmune” myocarditis that show some minor differences to the well-known CMR pattern of “viral” myocarditis.”
July 28,2021 – Association of Facial Pustular Neutrophilic Eruption With Messenger RNA–1273 SARS-CoV-2 Vaccine “A previously healthy man in his 80s presented to our department 5 days after receiving his second dose of the mRNA-1273 vaccine. He had not had a reaction after the first dose. Within 24 hours of receiving his vaccination, the patient noticed swelling, predominantly of the central face and eyelids, with worsening swelling, pain, and erythema over the next several days. He had weakness, malaise, and subjective fevers.”
July 12, 2021 – COVID-19 Vaccination of Minors Without Parental Consent – Respecting Emerging Autonomy and Advancing Public Health “Children and adolescents have the capacity to understand and reason about low-risk and high-benefit health care interventions. State laws should therefore authorize minors to consent to COVID-19 vaccination without parental permission.”
June 25, 2021 – Maternal and Child Symptoms Following COVID-19 Vaccination Among Breastfeeding Mothers “Several maternal postvaccination symptoms (allergic reactions, fever, chills, muscle pain, headache, fatigue, and injection site pain) were more common after the second dose.
June 24, 2021 – The Safety of COVID-19 Vaccinations—We Should Rethink the Policy “The number of cases experiencing adverse reactions has been reported to be 700 per 100,000 vaccinations. Currently, we see 16 serious side effects per 100,000 vaccinations, and the number of fatal side effects is at 4.11/100,000 vaccinations. For three deaths prevented by vaccination we have to accept two inflicted by vaccination. Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy
June 24, 2021 – Likely link’ between rare heart inflammation and Pfizer, Moderna vaccines -CDC advis’ers ‘ “The CDC earlier this month said it was still evaluating the risk from the condition and did not confirm a causal relationship between the vaccines and the heart issue. The agency, however, said a higher-than-expected number of young men have experienced heart inflammation after their second dose of the mRNA COVID-19 shots, with more than half the cases reported in people between the ages of 12 and 24.
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.”
June 22, 2021 – Acute macular neuroretinopathy following COVID-19 vaccination ‘An association between AMN and both COVID-19 infection and vaccination raises the question as to whether a common immune-mediated pathway can trigger this peculiar macular disease.‘
June 17, 2021 – Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons ‘Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported.’
June 11 2021 – Reported Deaths post COVID Vaccine: Total 5,993 All Deaths Reported to VAERS by Year
June 11, 2021 – First manifestation of multiple sclerosis after immunization with the Pfizer-BioNTech COVID-19 vaccine “The vaccination campaign is supported by initial safety data in MS: a very recently published study in approximately 500 MS patients showed that the relapse rate after vaccination with the Pfizer-BioNTech COVID-19 vaccine was similar (approximately 2%) to the relapse rate in a comparative time period without vaccination. Here we report on a vaccinated patient who experienced the initial clinical manifestation of MS on a background of previously unknown, but likely pre-existing subclinical inflammatory CNS disease.”
June 9, 2021 – Delayed Large Local Reactions to mRNA Covid-19 Vaccines in Blacks, Indigenous Persons, and People of Color “Delayed large local reactions may be less commonly recognized or reported in BIPOC vaccine recipients than in White recipients. Such reactions may result in vaccine hesitancy or incomplete vaccination; as such, proactive outreach is needed to increase education regarding these reactions across diverse communities. We hope that this letter encourages additional research and communication regarding cutaneous vaccine reactions, including delayed large local reactions, in BIPOC recipients.”
June 8, 2021 – Thrombocytopenia including immune thrombocytopenia after receipt of mRNA COVID-19 vaccines reported to the Vaccine Adverse Event Reporting System (VAERS) “”Briefly, a Level 1 (confirmed thrombocytopenia) of diagnostic certainty according to the Brighton definition of thrombocytopenia consists of a platelet count of less than 150 × 109/L AND confirmed by blood smear examination OR presence of signs and symptoms of spontaneous bleeding; Level 2 of diagnostic certainty (unconfirmed thrombocytopenia) is defined as a platelet count of less than 150 × 109/L; and Level 3 of diagnostic certainty is not applicable.”
May 25, 2021 – AZD1222 vaccine‐related coagulopathy and thrombocytopenia without thrombosis in a young female “Considering the homology which adenoviral vectors share with the replication‐incompetent simian adenoviral vector ChAdOx1 used in AZD1222, the ChAdOx vector may be implicated in the VITT pathogenesis. Furthermore, the AZD1222 vaccine employs a tissue plasminogen activator leader sequence to enhance immunogenicity. Such a sequence could, theoretically, negatively impact the fibrinolytic system with fibrinolysis, leading to a marked increase in D‐dimers and hypofibrinogenaemia. Further expert discussions, data collection, monitoring and research are required to fully elucidate the relationship between the AZD1222 vaccine and VITT.
May 20, 2021 – Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients (pdf) “We hypothesize that the cellular immune responses triggered by T-cell activation, which would occur days after the vaccination, lead to direct killing of cells presenting spike protein and an additional release of spike into the blood stream . The mechanisms underlying release of free S1 and the subsequent detection of the intact spike protein remain unclear and require further studies.”
May 14, 2021 – Interim considerations: preparing for the potential management of anaphylaxis after COVID-19 vaccination “Clarification on contraindications and precautions. People with a known (diagnosed) allergy to PEG, another mRNA vaccine component, or polysorbate, have a contraindication to vaccination. People with a reaction to a vaccine or injectable therapy that contains multiple components, one of which is PEG, another mRNA vaccine component or polysorbate, but in whom it is unknown which component elicited the immediate allergic reaction have a precaution to vaccination.”
