Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine

Carli, Giuseppe; Nichele, Ilaria; Ruggeri, Marco; Barra, Salvatore; Tosetto, Alberto

doi:10.1007/s11739-021-02685-0

Cited by 132 publications

(138 citation statements)

References 4 publications

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“…Similarly, the Johnson & Johnson vaccine was also temporarily suspended in April 2021 by the FDA, as several people developed rare blood-related problems of thrombosis with thrombocytopenia syndrome leading to cerebral venous sinus thrombosis (CVST) [ 51 ]. A DVT has also been reported shortly after the second dose of an mRNA-based vaccine as well [ 52 ]. Anaphylaxis as an acute allergic reaction has also been reported as a rare event for some vaccines, such as mRNA COVID-19 vaccines [ 53 ] and adenovector vaccines against COVID-19 [ 54 ].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Zarei²,

et al. 2021

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The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their efficacy, side effects and immunogenicity. All relevant publications were systematically searched and collected from major databases up to 12 March 2021. A total of 25 RCTs (123 datasets), 58,889 cases that received the COVID-19 vaccine and 46,638 controls who received placebo were included in the meta-analysis. In total, mRNA-based and adenovirus-vectored COVID-19 vaccines had 94.6% (95% CI 0.936–0.954) and 80.2% (95% CI 0.96.4–0.92.7) efficacy in phase II/III RCTs, respectively. Efficacy of the adenovirus-vectored vaccine after the first (97.6%; 95% CI 0.939–0.997) and second (98.2%; 95% CI 0.980–0.984) doses was the highest against receptor-binding domain (RBD) antigen after 3 weeks of injections. The mRNA-based vaccines had the highest level of side effects reported except for diarrhea and arthralgia. Aluminum-adjuvanted vaccines had the lowest systemic and local side effects between vaccines’ adjuvant or without adjuvant, except for injection site redness. The adenovirus-vectored and mRNA-based vaccines for COVID-19 showed the highest efficacy after first and second doses, respectively. The mRNA-based vaccines had higher side effects. Remarkably few experienced extreme adverse effects and all stimulated robust immune responses.

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Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Zarei²,

et al. 2021

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“…Also, hypersensitivity-related ADRs were observed in 0.63% of vaccinated people, including few anaphylaxis reactions [ 2 ]. Recently, many cases of VITT have been reported, with incidence apparently between 1 in 125 000 and 1 in 1 million, with most of them attributed to the ChAdOx1 nCoV-19 Vaccine [ 7 ], and only 1 reported case of DVT was linked to the BNT162b2 mRNA COVID-19 vaccine [ 5 ].…”

Section: Discussionmentioning

confidence: 99%

“…EMA reported 222 cases of newly developed thrombosis and thrombocytopenia shortly after vaccination with ChAdOx1 nCoV-19 (AstraZeneca); most of the reported cases were in females under the age of 55 years [ 3 ]. Among 54 million recipients of the Pfizer-BioNTech mRNA vaccine, 35 possible cases of central nervous system thrombosis were reported [ 4 ] and there was only 1 case of deep vein thrombosis (DVT) among 3010 vaccinated health workers in Italy [ 5 ]. Also, there have been a few reports of cerebral venous sinus thrombosis among more than 7 million recipients of the Johnson & Johnson/Janssen vaccine and 5 million recipients of the Moderna mRNA vaccine [ 4 ].…”

Section: Introductionmentioning

confidence: 99%

A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine

et al. 2021

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Patient: Female, 59-year-old Final Diagnosis: Deep vein thrombosis • pulmonary embolism • thrombosis Symptoms: Chest pain • shortness of breath Medication: — Clinical Procedure: — Specialty: Hematology • Infectious Diseases • General and Internal Medicine Objective: Unusual clinical course Background: The COVID-19 pandemic is an ongoing cause of the current global healthcare crisis. Several vaccines were approved for use by emergency vaccination campaigns worldwide. At present, there are very few reports of COVID-19 vaccine-induced immune-thrombotic thrombocytopenia, a variant of heparin-induced thrombocytopenia (HIT), in comparison to the massive number of vaccinated people worldwide. Case Report: A 59-year-old woman presented to the Emergency Department with a 3-day history of sudden-onset left leg pain 7 days after receiving her first dose of BNT162b2 mRNA COVID-19 (Pfizer-BioNTech). She was diagnosed with deep vein thrombosis (DVT) and pulmonary embolism (PE) and found to have a positive HIT screen with optical density (OD) of 0.6 via ELISA test. She was hospitalized for 4 days and discharged home with an oral anticoagulant (rivaroxaban). Conclusions: This case report describes a possible link between BNT162b2 mRNA COVID-19 (Pfizer-BioNTech) vaccination and thromboembolism. However, further data are needed to support such an association.

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“…5 Facial palsy has been also reported in a study of patients undergoing a SARS-CoV-2 vaccination with mRNA-based vaccines. 6 There is also one report about a deep venous thrombosis (DVT) following the second dose of an mRNA vaccine. 7 Since DVT is a potential risk factor for ischaemic stroke in case of a patent foramen ovale (PFO), we should recognize that venous thrombosis as a potential side effect of SARS-CoV-2 vaccines may secondarily concern also the neurologist.…”

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confidence: 99%

SARS‐CoV‐2 vaccines are not free of neurological side effects

Finsterer

Scorza

2021

Acta Neurol Scand

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Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine

Cited by 132 publications

References 4 publications

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine

SARS‐CoV‐2 vaccines are not free of neurological side effects

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