Project description:A growing number of cutaneous adverse reactions have been reported following the administration of a COVID-19 vaccine. We describe a series of twenty patients who developed a variety of cutaneous conditions within two weeks of receiving the Pfizer/ BioNTech BNT162b2 vaccine.
Project description:On May 10, 2021, the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) was expanded to include adolescents (May 10, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use). We describe clinical characteristics of 8 adolescents who presented over the course of 36 days to Nicklaus Children's Hospital with perimyocarditis within 4 days of receiving a dose of BNT162b2 vaccine.
Project description:IntroductionIn February 2021, New Zealand began its largest ever immunisation programme with the BNT162b2 mRNA coronavirus disease 2019 (COVID-19) vaccine.ObjectiveWe aimed to understand the association between 12 adverse events of special interest (AESIs) and a primary dose of BNT162b2 in the New Zealand population aged ≥5 years from 19 February 2021 through 10 February 2022.MethodsUsing national electronic health records, the observed rates of AESIs within a risk period (1-21 days) following vaccination were compared with the expected rates based on background data (2014-2019). Standardised incidence ratios (SIRs) were estimated for each AESI with 95% confidence intervals (CIs) using age group-specific background rates. The risk difference was calculated to estimate the excess or reduced number of events per 100,000 persons vaccinated in the risk period.ResultsAs of 10 February 2022, 4,277,163 first doses and 4,114,364 second doses of BNT162b2 had been administered to the eligible New Zealand population aged ≥5 years. The SIRs for 11 of the 12 selected AESIs were not statistically significantly increased post vaccination. The SIR (95% CI) for myo/pericarditis following the first dose was 2.3 (1.8-2.7), with a risk difference (95% CI) of 1.3 (0.9-1.8), per 100,000 persons vaccinated, and 4.0 (3.4-4.6), with a risk difference of 3.1 (2.5-3.7), per 100,000 persons vaccinated following the second dose. The highest SIR was 25.6 (15.5-37.5) in the 5-19 years age group, following the second dose of the vaccine, with an estimated five additional myo/pericarditis cases per 100,000 persons vaccinated. A statistically significant increased SIR of single organ cutaneous vasculitis (SOCV) was also observed following the first dose of BNT162b2 in the 20-39 years age group only.ConclusionsA statistically significant association between BNT162b2 vaccination and myo/pericarditis was observed. This association has been confirmed internationally. BNT162b2 was not found to be associated with the other AESIs investigated, except for SOCV following the first dose of BNT162b2 in the 20-39 years age group only, providing reassurances around the safety of the vaccine.
Project description:Introduction and importanceMessenger RNA vaccines, commonly known as mRNA vaccines, are the first COVID-19 vaccines that have been authorized and licensed in the United States. Two mRNA vaccines, BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) are available. Mass vaccination remains the most critical way to halt the spread of the COVID pandemic. The most common adverse effects of the COVID vaccines are headache, muscular soreness, weariness, redness, swelling, and tenderness at the injection site. The dermatological adverse effects of mRNA vaccines, on the other hand, are little understood. We present a case of bullous fixed medication eruption following delivery of the second dose of Pfizer's Covid-19 vaccination.Case presentationWe discuss the case of a 78-year-old man who went to the Emergency Department at King Fahad Medical City in Riyadh, Saudi Arabia, with numerous bullae throughout his extremities one day after receiving the second dosage of Pfizer Covid-19 vaccine. The bullae began three days before his presentation, and they were preceded by intense pruritus and urticated plaques. A skin biopsy was performed which revealed IgG (+1), IgM (+1), and C3 (+1) staining of the basement membrane. Another punch skin biopsy taken from an intact bulla was suboptimal compressing of dermal tissue only, revealing modest perivascular lymphocytic infiltrative and scattered eosinophils. This pathological picture with superficial perivascular inflammatory dermatitis, and the presence of eosinophils suggests drug-induced bullous pemphigoid. The patient was treated with topical and systemic corticosteroids, fusidic acid cream, and emollients after a confirmed diagnosis of bullous pemphigoid was obtained. He was hospitalized for 3 weeks as a case of severe sepsis due to a skin infection, and he was started initially on empiric antibiotics with piperacillin-tazobactam plus vancomycin that was later upgraded to meropenem and vancomycin based on the results of the blood and wound cultures. The patient suffered a pulmonary embolism on the second day of hospitalization and was placed on a heparin infusion that could potentially contribute to his death one month after discharge from our hospital.Clinical discussionBullous pemphigoid is the most frequent autoimmune bullous disease. It occurs in the elderly. The cause of this disease is unknown, although it sometimes can be triggered by taking certain medications. Two case reports have also revealed bullous pemphigoid eruption following immunization. One case report reported a 78-year-old lady with diabetes and Alzheimer's disease who developed tense bullae on her face and torso after getting the second dosage of the Pfizer-BioNTech COVID-19 Vaccine. Another case study described a 77-year-old male patient who developed generalized pruritis and bullae on erythematous bases one day after receiving the AstraZeneca COVID-19 vaccination. This new-onset bullous pemphigoid phenomenon has also been observed with other vaccinations such as rabies and swine flu.ConclusionAlthough uncommon, several dermatological side reactions like bullous eruptions have been reported following the mRNA Pfizer Covid-19 vaccination. According to this case report, Bullous pemphigoid might be caused by the mRNA- (Pfizer) Covid-19 Vaccine.
Project description:BackgroundAn association between thrombotic events and SARS-CoV-2 infection and the adenovirus-based COVID-19 vaccines has been established, leading to concern over the risk of thrombosis after BNT162b2 COVID-19 vaccination.ObjectivesTo evaluate the risk of arterial thrombosis, cerebral venous thrombosis (CVT), splanchnic thrombosis, and venous thromboembolism (VTE) following BNT162b2 vaccination in New Zealand.MethodsThis was a self-controlled case series using national hospitalisation and immunisation records to calculate incidence rate ratios (IRR). The study population included individuals aged ≥12 years, unvaccinated, or vaccinated with BNT162b2, who were hospitalised with one of the thrombotic events of interest from 19 February 2021 through 19 February 2022. The risk period was 0-21 days after receiving a primary or booster dose of BNT162b2.Results6039 individuals were hospitalised with one of the thrombotic events examined, including 5127 with VTE, 605 with arterial thrombosis, 272 with splanchnic thrombosis, and 35 with CVT. The proportion of individuals vaccinated with at least one dose of BNT162b2 ranged from 82.7 % to 91.4 %. Compared with the control unexposed period, the IRR (95 % CI) of VTE, arterial thrombosis, splanchnic thrombosis, and CVT were 0.87 (0.76-1.00), 0.73 (0.56-0.95), 0.71 (0.43-1.16), and 0.87 (0.31-2.50) in the 21 days after BNT162b2 vaccination, respectively. There was no statistically significant increased risk of thrombosis following BNT162b2 in different ethnic groups in New Zealand.ConclusionThe BNT162b2 vaccine was not found to be associated with thrombosis in the general population or different ethnic groups in New Zealand, providing reassurance for the safety of the BNT162b2 vaccine.
Project description:As more individuals were coronavirus disease 2019 (COVID-19) vaccinated, unexpected side effects appeared. Herein, we present the case of a 30-year-old man with myopathy in both extremities after the second dose of the Pfizer-BioNTech (BNT162b2) COVID-19 vaccine. Symptoms, swelling and pain, started from the proximal upper and lower extremities and extended to the distal parts. Although he underwent massive hydration, the muscle enzyme level continuously increased. He complained of dysphagia and dysarthria. Microscopically, muscle biopsy showed multifocal or scattered macrophage infiltration and degenerated myofibers. In contrast to general myopathy including inflammatory myositis and rhabdomyolysis, vaccine-induced inflammatory myositis shows a prolonged increase in muscle enzyme levels and multifocal macrophage infiltration with necrosis of the muscle fibers. Symptoms improved with glucocorticoid and immunosuppressive treatment. If vaccinated individuals experience severe and continuous muscle pain and swelling, clinicians should consider vaccine-induced inflammatory myositis, measure the muscle enzyme levels, and perform muscle biopsy for a definite diagnosis.
Project description:Background Coronavirus disease-19 (COVID-19) due to acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is the largest emergency that humanity had to be dealing with in the last century. During the last months, different types of vaccines have been designed to contain the ongoing SARS-CoV-2 pandemic, with successful results in many countries. Comirnaty (Pfizer/BioNtech) COVID-19 vaccine is a lipid nanoparticle-formulated, nucleoside mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2. Although vaccines have an undeniable efficacy, they can also present several neurological side effects, including headache. According to ICHD-3 Classification, status migrainosus (SMg) is described as a debilitating migraine attack lasting for more than 72 h. Symptoms of SMg can be very severe, preventing the normal daily activities of the individual. Case presentation In the present report, we describe a case of SMg that lasted 11 days, time correlated with the second dose of COVID-19 vaccine (Pfizer/Comirnaty) in a 37-year-old woman with a history of migraine without aura. Conclusions In patients with a history of migraine, COVID-19 vaccination could lead to a worsening of headache and, in rare cases, to the development of a SMg. This may be related to the inflammatory response that occurs after vaccination. Supplementary Information The online version contains supplementary material available at 10.1007/s10072-021-05741-x.
Project description:Hypersensitivity reactions can be a side effect to any vaccine, but they are usually rare. The COVID-19 vaccination may cause hypersensitivity, and several cases of delayed hypersensitivity (DH) to hyaluronic acid (HA) dermal filler have been documented. The current report presents a case of a 36-year-old female patient with DH to HA dermal filler after receiving the Pfizer-BioNTech COVID-19 vaccine. Symptoms, including dryness, swelling, and a painless nodule, appeared after the first and second doses of the vaccine. The patient was treated with intralesional hyaluronidase and triamcinolone in the outpatient clinic. Although HA is relatively safe and routinely used in aesthetic medicine, DH reactions must be considered. Therefore, an appropriate patient history should be obtained, and physicians should provide counselling on the potential reactions to avoid these adverse effects.