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A 76-year-old man experienced extravascular haemolysis while being treated with eculizumab for paroxysmal nocturnal haemoglobinuria, a Morel-Lavallee lesion while on apixaban for atrial fibrillation, and a severe local reaction to fluorouracil for pretibial basal cell carcinoma. His medical history included complications such as iron overload, neutropenia, and thrombocytopenia, as well as a diagnosis of metastatic squamous cell carcinoma. Treatment with pegcetacoplan was initiated to address symptomatic anaemia, and despite some complications, his haemoglobin levels improved without the need for red cell transfusions. He also underwent surgery for neurogenic claudication and reported increased energy levels and activity post-treatment. [Extracted from the article]

Six cases of myocarditis, pericarditis, or myopericarditis following vaccination with tozinameran (Pfizer-BioNTech) in adolescents aged 14-17 were reported in a study conducted between March 2022 and May 2023. Symptoms included chest pain, palpitations, and dyspnea, with diagnoses of myocarditis, pericarditis, or myopericarditis. Causality assessment indicated a probable relation between the vaccine and the adverse events. [Extracted from the article]

A 33-year-old woman experienced pain at the injection site, flu-like symptoms, and severe relapsed autoimmune hemolytic anemia (AIHA) after receiving the elasomeran COVID-19 vaccine. Despite treatment with prednisone, she showed lack of efficacy in managing the AIHA. The woman was admitted to the hospital with symptoms of severe anemia, received transfusions, and was discharged after improvement with dexamethasone therapy. The case study highlights the potential toxicities and lack of efficacy associated with elasomeran and prednisone in treating severe relapsed AIHA. [Extracted from the article]

A 54-year-old man developed antisynthetase syndrome (ASyS) after receiving the elasomeran (Moderna-COVID-19 Vaccine) booster. Initially presenting with shortness of breath and stiffness in his hands, further testing revealed interstitial lung disease (ILD) and elevated aldolase and creatinine kinase levels. Treatment with prednisone provided temporary relief, but symptoms returned once steroid therapy was stopped. Subsequent autoimmune testing confirmed the diagnosis of ASyS, and treatment with azathioprine and rituximab led to significant improvement and near-complete remission of symptoms. [Extracted from the article]

Two case reports describe men aged 26 and 27 who developed acute myocarditis after receiving the tozinameran (Comirnaty) vaccine. In the first case, a 26-year-old man with a history of viral myocarditis experienced pain in the left shoulder and neck after receiving the booster dose. Tests revealed myocardial edema and wall motion abnormalities, confirming acute myocarditis. The patient was treated with ACE inhibitors and beta-blockers and had a normal follow-up examination after four weeks. In the second case, a 27-year-old man presented with chest pain and was diagnosed with acute myocarditis based on test results. He also received treatment with ACE inhibitors and beta-blockers and had a normal follow-up examination after four weeks. [Extracted from the article]

A 58-year-old man developed toxic epidermal necrolysis after receiving the AZD-1222 vaccine for COVID-19. He experienced skin lesions that progressed to involve his entire body, as well as difficulty breathing and swallowing. The man was admitted to the ICU and received supportive care, including intubation and immune-globulin treatment. After 4 weeks, his skin and mucosal lesions healed, but he experienced partial vision loss in his left eye as a result of corneal epithelial defects. The Naranjo algorithm suggested a possible association between the vaccine and toxic epidermal necrolysis. [Extracted from the article]

A 24-year-old man developed Henoch-Schonlein purpura (HSP) after receiving the tozinameran (Pfizer-BioNTech COVID-19) vaccine. He experienced a rash, arthralgia, and abdominal pain, along with elevated white blood cell count and proteinuria. A biopsy confirmed leukocytoclastic vasculitis, consistent with HSP. Treatment with tofacitinib temporarily improved symptoms, but they relapsed. Prednisone was then prescribed, leading to resolution of symptoms. The patient's blood tests returned to normal, and he was tapered off prednisone over three months. [Extracted from the article]

A 64-year-old man developed generalised eruptive keratoacanthoma after receiving the tozinameran COVID-19 vaccine. The man had a history of diabetes and hypertension and experienced itchy lesions on his limbs 10 days after vaccination. Physical examination revealed dome-shaped, crateriform lesions on his upper and lower limbs. Histopathological examination confirmed the diagnosis of generalised eruptive keratoacanthoma. The man was treated with off-label IV cemiplimab, which resulted in complete resolution of all lesions. [Extracted from the article]

A retrospective study described 25 patients who developed various skin disorders after receiving the SARS-COV-2 vaccine inactivated Sinovac Biotech or tozinameran. The patients, aged 17-69 years, developed conditions such as urticaria, leukocytoclastic vasculitis, purpuric rash, Sweet's syndrome, lichenoid drug eruption, psoriasis, acneiform eruption, or pigmented purpuric dermatosis. Some patients received both vaccines and experienced urticaria, while others developed different cutaneous conditions. Skin biopsy findings confirmed the diagnoses. Treatment with antihistamines or steroids led to significant clinical improvement, and none of the urticaria patients experienced recurrence. However, three patients experienced exacerbations of their symptoms after receiving booster doses of the SARS-COV-2 vaccine inactivated Sinovac Biotech. [Extracted from the article]

A 45-year-old man with generalised pustular psoriasis (GPP)-like eruption experienced lack of efficacy with clobetasol, calcipotriol, and clindamycin treatments. He also developed GPP-like eruption flare after receiving the COVID-19 vaccine and experienced a rebound effect when discontinuing adalimumab. The man presented with a pustular rash that spread over his body and was diagnosed with psoriatic arthritis. Treatment with clobetasol, calcipotriol, and clindamycin did not yield satisfactory results, but increasing the frequency of adalimumab and adding methotrexate improved his condition. A GPP-like eruption flare occurred after the COVID-19 vaccine and discontinuation of adalimumab, but subsequent COVID-19 infections had minimal impact on his condition. [Extracted from the article]

A case-control study published in Vaccine found that there may be an increased risk of heavy menstrual bleeding (menorrhagia) requiring hospital care for three months after receiving the primary dose of a COVID-19 mRNA vaccine, but not after booster doses. The study used data from four French National Health Data System databases and included nonpregnant women aged 15-50. The risk of hospital care for menorrhagia was significantly higher in those who received their last primary vaccination dose 1-3 months prior, compared to unvaccinated women. However, the risk was not significantly increased after booster vaccination. The study suggests that there may be an increased risk of heavy menstrual bleeding following COVID-19 vaccination with mRNA vaccines during the three-month period after the primary vaccination. [Extracted from the article]

A study published in Vaccine suggests that the combination of post-infection COVID-19 seropositivity and COVID-19 vaccination may be linked to the development of severe heart failure and cardiogenic shock after a heart attack. The study, conducted in Spain, examined patients admitted to the hospital with ST-segment elevation myocardial infarction (STEMI) or non-ST-elevation MI (NSTEMI). Within six months post-heart attack, 9.7% of patients experienced a major adverse cardiac event, with a 6-month mortality rate of 5.3%. Patients with STEMI who had received COVID-19 vaccination and were COVID seropositive had a higher risk of severe heart failure. However, the study design does not allow for a determination of whether vaccinated patients with positive SARS-CoV-2 serology had an increased risk of heart attack. [Extracted from the article]

In a retrospective study of 250 patients, five cases were described where individuals with multiple sclerosis (MS) experienced adverse reactions following administration of the COVID-19 vaccines elasomeran and tozinameran. These reactions included acute left eye ptosis, pseudo relapse of MS, and lack of efficacy. The patients experienced these reactions after receiving either the first or second dose of the vaccines, but in most cases, the symptoms resolved over time. It is important to note that these cases are specific to individuals with MS and may not be representative of the general population. [Extracted from the article]

A study of 550 patients found that women aged 22-76 developed various toxicities, such as spasms, fever, skin rash, peripheral edema, syncope, or itching, after receiving tozinameran or elasomeran for SARS-CoV-2 immunization. One woman experienced a lack of efficacy with paracetamol for fever. The adverse reactions were resolved without medical intervention, and the women received subsequent doses of the vaccines. [Extracted from the article]

A 72-year-old man developed ANCA-associated pauci-immune glomerulonephritis after receiving the tozinameran (Pfizer-BioNTech COVID-19 mRNA vaccine). He experienced symptoms such as paraesthesia, influenza-like symptoms, and acute kidney injury. Tests confirmed the diagnosis, and he received treatment with methylprednisolone and rituximab. After six months, his renal function improved, and he was discharged on maintenance therapy. Although he later tested positive for SARS-CoV-2, he did not experience any complications. [Extracted from the article]

Two case reports were described in a journal article, involving a 52-year-old woman and a 51-year-old man who developed hypersomnia after receiving the AZD-1222 COVID-19 vaccine. The woman had a history of sleep apnea and experienced excessive daytime sleepiness and weakness after receiving the booster dose of the vaccine. The man also developed excessive daytime sleepiness after receiving two doses of the vaccine and was diagnosed with sleep apnea. Both patients were advised to take modafinil, but the woman refused and her symptoms improved spontaneously, while the man experienced drug intolerance. Lifestyle modifications and regular exercise were recommended for the man, but his excessive daytime sleepiness persisted. [Extracted from the article]

A man in his 50s developed glial fibrillary acidic protein astrocytopathy after receiving the NVX-CoV-2373 COVID-19 vaccine. He experienced symptoms such as migrainous headache, anorexia, nausea, night sweats, malaise, cauda equina syndrome, hiccups, encephalopathy, and cranial neuropathies. Neuroimaging revealed brain stem, spinal cord, and cauda equina involvement, and his anti-glial fibrillary acidic protein antibody levels were strongly positive. The man was treated with methylprednisolone, plasmapheresis, and rituximab, leading to significant improvement in his condition. [Extracted from the article]

An elderly man developed myocarditis after receiving the Moderna COVID-19 vaccine, elasomeran. The man had mild hypertension and received his fourth and fifth booster doses of the vaccine. He experienced drops in blood pressure after each vaccination, which became more severe with each dose. The man was eventually diagnosed with myocarditis caused by elasomeran. [Extracted from the article]

A 50-year-old woman with systemic lupus erythematosus (SLE) developed COVID-19 pneumonia while being treated with rituximab. She was hospitalized due to worsening symptoms and tested positive for SARS-CoV-2. The woman received various treatments, including oxygen therapy, remdesivir, piperacillin-tazobactam, enoxaparin, budesonide, dexamethasone, and immune-globulin. After her clinical condition improved, she was discharged and eventually made a full recovery. [Extracted from the article]

An 80-year-old man experienced lack of efficacy and non-ST segment elevation myocardial infarction while undergoing treatment for immune thrombocytopenia. He initially received prednisone and immune-globulin, followed by ciclosporin which led to the myocardial infarction. Subsequent treatments with azathioprine, romiplostim, danazol, vincristine, and fostamatinib were ineffective. He had a mild response to eltrombopag and prednisone, but romiplostim, danazol, and vincristine were discontinued due to lack of efficacy. He experienced a relapse of immune thrombocytopenia after receiving the Pfizer-BioNTech vaccine for COVID-19, indicating lack of efficacy. Despite multiple treatments, he required hospitalizations and ongoing prednisone and immune-globulin therapy. [Extracted from the article]

Two case studies were conducted on women who developed Cronkhite-Canada syndrome after receiving the tozinameran or elasomeran COVID-19 mRNA booster vaccinations. In the first case, a 61-year-old woman experienced chronic watery diarrhea, blood and pus in her stool, and other symptoms after receiving the elasomeran vaccine. She was diagnosed with Cronkhite-Canada syndrome and her symptoms improved with prednisolone treatment. In the second case, a 63-year-old woman had similar symptoms after receiving the tozinameran vaccine and also saw improvement with prednisolone treatment. Follow-up endoscopy was not performed for the second case. [Extracted from the article]

A 56-year-old man developed adult-onset Still's disease (AOSD) after receiving the Ad26.COV2-S and tozinameran vaccines for COVID-19. He initially presented with dyspnea and chest pain, and subsequent tests revealed pleural and pericardial effusion. He was treated with medications such as prednisone and colchicine, and his symptoms improved. However, he experienced a recurrence of symptoms and received anakinra, which led to a decrease in pericardial effusion and improvement in laboratory findings. The diagnosis of AOSD secondary to the vaccines was made based on clinical presentation and ruling out other causes. [Extracted from the article]

A 54-year-old woman developed transient exocrine pancreatic insufficiency (EPI) after receiving the tozinameran (Comirnaty) vaccine. She experienced diarrhea, bloating, abdominal cramping, and other symptoms after the first dose, which partially improved but worsened after the second dose. The woman was diagnosed with EPI and treated with pancrelipase enzyme supplementation, which resulted in symptom resolution. She later discontinued the supplementation and remained symptom-free after six months. [Extracted from the article]

A retrospective analysis conducted at a hospital in Germany described two cases of vaccine failure following immunization with a tick-borne encephalitis (TBE) vaccine. The first case involved a 13-year-old girl who experienced severe symptoms and neurological complications despite receiving two doses of the vaccine. The second case involved a 16-year-old boy who also experienced severe symptoms and neurological complications, despite receiving multiple doses of the vaccine. In both cases, laboratory tests confirmed that the antibodies produced after immunization had a lower capability of neutralizing the TBE viruses the patients were presumably infected with, suggesting vaccine failure. [Extracted from the article]

A 36-year-old woman experienced bilateral inguinal nodes, optic neuritis, and mydriasis after receiving a diphtheria-tetanus vaccine. She presented with reduced visual acuity, blurred vision, and a severe headache. The symptoms appeared 18 days after vaccination. The woman was treated with prednisone and lenses, which resulted in significant improvement in optic neuritis and partial improvement in mydriasis. After 16 months, her visual acuity remained normal. [Extracted from the article]

A 36-year-old woman experienced bilateral inguinal nodes, optic neuritis, and mydriasis after receiving a diphtheria-tetanus vaccine. She presented with reduced visual acuity, blurred vision, and a severe headache. The symptoms appeared 18 days after vaccination. The woman was treated with prednisone and refractive lenses, which resulted in significant improvement in optic neuritis and partial improvement in mydriasis. After 16 months, her visual acuity remained normal. [Extracted from the article]

A 77-year-old man developed subacute myopericarditis after receiving the elasomeran COVID-19 vaccine. He experienced symptoms such as dyspnea and chest pressure three weeks after receiving the booster dose. Medical tests revealed pericardial effusion and other abnormalities, leading to a diagnosis of subacute myopericarditis. The man was treated with pericardiocentesis and colchicine, and after three months of follow-up, the condition resolved. [Extracted from the article]

A 75-year-old woman experienced a lack of efficacy following vaccination with AZD-1222 and tozinameran. She had received two doses of the AstraZeneca vaccine and a Pfizer booster dose. After developing a fever and difficulty breathing, she was diagnosed with severe COVID-19 pneumonia. Despite treatment, her condition worsened, and she ultimately passed away. Genome sequencing revealed the presence of the FL.2 variant of the virus. [Extracted from the article]

An 80-year-old woman experienced vaccine failure and developed erythrodermic sarcoidosis with systemic involvement after receiving the tozinameran COVID-19 vaccine. She also did not respond well to treatment with dupilumab for her erythroderma and pruritus. Despite receiving the vaccine, she contracted COVID-19, indicating its failure. Biopsies revealed a drug-associated T-cell dyscrasia and a diagnosis of erythrodermic sarcoidosis with systemic involvement was made. Treatment with tofacitinib resulted in improvement of her condition. [Extracted from the article]

A 46-year-old woman developed palmoplantar pustulosis after receiving the elasomeran COVID-19 vaccine. She also experienced a lack of efficacy when treated with betamethasone dipropionate for the pustulosis. The woman initially developed a rash on her palms and soles two weeks after the first vaccine dose, which worsened after the second dose. She tried over-the-counter cortisone and petrolatum with minimal improvement before switching to betamethasone dipropionate, which also did not work. After visiting a dermatologist, she was diagnosed with palmoplantar pustulosis secondary to elasomeran and was successfully treated with tacrolimus ointment. [Extracted from the article]

A retrospective study involving 17 patients with systemic lupus erythematosis (SLE) reported a case of a 30-year-old woman who received belimumab for SLE and showed a lack of efficacy after receiving the tozinameran vaccine. The woman had been diagnosed with SLE 10 years ago and was also taking prednisone, hydroxychloroquine, and azathioprine. Despite receiving three doses of the vaccine, she did not exhibit an immunogenic response. The study concluded that immunogenicity was impaired regardless of belimumab treatment, and the woman did not show an immunogenic response to the tozinameran vaccine. [Extracted from the article]

A case series study described 15 patients, including 8 women and 7 men aged 21-47 years, who developed vaccine-induced immune thrombotic thrombocytopenia (VITT) after receiving the Ad26.COV2-S, tozinameran, or AZD-1222 vaccines. Symptoms of VITT appeared 2-16 days after vaccination, and laboratory findings showed low platelet counts and elevated D-dimer levels. Thrombosis was observed in various locations throughout the body. Based on these findings, all patients were diagnosed with VITT. The outcomes of the patients were not fully reported. [Extracted from the article]

This article discusses three cases of women with pemphigus vulgaris (PV) who developed COVID-19 despite being vaccinated against the virus. The first case involved a 36-year-old woman who experienced a flare of PV after receiving rituximab and later tested positive for COVID-19. The second case involved a 41-year-old woman who had a flare of PV after weaning off prednisone and also tested positive for COVID-19 despite being vaccinated. The third case involved a 52-year-old woman who developed COVID-19 after receiving rituximab and being vaccinated. These cases highlight the lack of efficacy of COVID-19 vaccines in individuals with PV and the potential for rebound or worsening of the condition. [Extracted from the article]

Author InformationAn event is serious (based on the ICH definition) when the patient outcome is: Drug interaction• * death * life-threatening * hospitalisation * disability * congenital anomaly * other medically important eventA 20-year-old woman developed leukopenia following concomitant administration of lamotrigine for bipolar disorder and COVID-19 immunisation with COVID-19-vaccine [routes and dosages not stated]. [Extracted from the article]

A 79-year-old woman developed a rare subepidermal blistering disease after receiving COVID-19 vaccinations. She had received two doses of the Sinovac-CoronaVac vaccine and a booster dose of the Pfizer-BioNTech vaccine. The woman experienced pruritic cutaneous blisters one week after the booster dose. Physical examination showed tense and haemorrhagic blisters, and skin biopsies confirmed the diagnosis of subepidermal blistering disease. Treatment with clobetasol led to improvement, but the lesions recurred after discontinuation and were managed with topical corticosteroids. [Extracted from the article]

A case report published in Reactions Weekly describes a woman in her 70s who developed acute cholangitis after receiving the Pfizer BioNTech BNT162b2 SARS-CoV-2 vaccine booster (tozinameran) and aducanumab, a drug used to treat Alzheimer's disease. The woman had a history of polymyalgia rheumatica and was receiving aducanumab infusions. After receiving the vaccinations, she experienced flu-like symptoms, diarrhea, vomiting, and fever. Laboratory tests indicated acute cholangitis, which was managed at home with ibuprofen and oral hydration. The woman later experienced another bout of a specific type of brain abnormality associated with aducanumab, but her symptoms eventually resolved. The acute cholangitis was believed to be a result of the interaction between tozinameran and aducanumab. [Extracted from the article]

Rates of hospital visits in Denmark for 27 AEs were investigated after a fourth dose of mRNA COVID-19 vaccine with bivalent Pfizer-BioNTech or Moderna vaccine in 1 740 417 adults aged 50 years and older who had received three previous monovalent COVID-19 vaccine doses of BNT162b2 or mRNA-1273. A bivalent mRNA COVID-19 vaccine booster dose does not increase the risk of adverse events (AEs) in older adults, according to findings of a nationwide Danish study published in the I BMJ i . [Extracted from the article]