The Side Effects and Adverse Clinical Cases Reported after COVID-19 Immunization

Rabail, Roshina; Ahmed, Waqar; Ilyas, Madiha; Rajoka, Muhammad Shahid Riaz; Hassoun, Abdo; Khalid, Abdur Rauf; Khan, Moazzam Rafiq; Aadil, Rana Muhammad

doi:10.3390/vaccines10040488

Cited by 39 publications

(20 citation statements)

References 75 publications

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“…In particular, for both cohorts, the most frequently reported local solicited ADR following both the first vaccination cycle and the booster dose was injection site pain. As for systemic solicited ADRs, fatigue, headache, malaise, and myalgia were the most commonly reported; such findings are in line with previously published articles [ 26 , 27 , 28 ].…”

Section: Discussionsupporting

confidence: 90%

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Ciccimarra,

Luxi,

Bellitto

et al. 2024

Vaccines

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In all pivotal trials of COVID-19 vaccines, the history of previous SARS-CoV-2 infection was mentioned as one of the main exclusion criteria. In the absence of clinical trials, observational studies are the primary source for evidence generation. This study aims to describe the patient-reported adverse drug reactions (ADRs) following the first COVID-19 vaccination cycle, as well as the administration of booster doses of different vaccine brands, in people with prior SARS-CoV-2 infection, as compared to prior infection-free matched cohorts of vaccinees. A web-based prospective study was conducted collecting vaccinee-reported outcomes through electronic questionnaires from eleven European countries in the period February 2021–February 2023. A baseline questionnaire and up to six follow-up questionnaires collected data on the vaccinee’s characteristics, as well as solicited and unsolicited adverse reactions. Overall, 3886 and 902 vaccinees with prior SARS-CoV-2 infection and having received the first dose or a booster dose, respectively, were included in the analysis. After the first dose or booster dose, vaccinees with prior SARS-CoV-2 infection reported at least one ADR at a higher frequency than those matched without prior infection (3470 [89.6%] vs. 2916 [75.3%], and 614 [68.2%] vs. 546 [60.6%], respectively). On the contrary side, after the second dose, vaccinees with a history of SARS-CoV-2 infection reported at least one ADR at a lower frequency, compared to matched controls (1443 [85.0%] vs. 1543 [90.9%]). The median time to onset and the median time to recovery were similar across all doses and cohorts. The frequency of adverse reactions was higher in individuals with prior SARS-CoV-2 infection who received Vaxzevria as the first dose and Spikevax as the second and booster doses. The frequency of serious ADRs was low for all doses and cohorts. Data from this large-scale prospective study of COVID-19 vaccinees could be used to inform people as to the likelihood of adverse effects based on their history of SARS-CoV-2 infection, age, sex, and the type of vaccine administered. In line with pivotal trials, the safety profile of COVID-19 vaccines was also confirmed in people with prior SARS-CoV-2 infection.

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Section: Discussionsupporting

confidence: 90%

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Ciccimarra,

Luxi,

Bellitto

et al. 2024

Vaccines

View full text Add to dashboard Cite

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“…The rates of all forms of adverse events were considerably higher after receiving the Pfizer-BioNTech vaccine, and, in addition to mild side effects, serious adverse events were also reported, including anaphylaxis, thromboembolic events, and acute hypertension [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

Multisystem Inflammatory Syndrome in Children (MIS-C), Possibly Due to COVID-19 mRNA Vaccination

et al. 2023

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Multisystem inflammatory syndrome in children (MIS-C) is a potentially life-threatening childhood disease caused by SARS-CoV-2 infection, manifested by the persistence of fever and multi-organ dysfunction, elevated inflammatory markers, and the lack of an alternative diagnosis. It is still unknown if vaccination can precipitate or abrogate MIS-C or if a natural infection preceding or occurring at the time of vaccination plays any role. We present one case of MIS-C in a 16-year-old girl who was fully immunized against COVID-19 (Pfizer), with the second dose received three weeks prior to onset of the disease. She had no history of COVID-19 disease or contact with COVID-19 patients. At admission, she was somnolent, pale, and dehydrated, with cyanotic lips and cold extremities; she was hypotensive with tachycardia and poorly palpable pulses. Initial laboratory results revealed elevated levels of inflammatory markers, and high level of SARS-CoV-2 IgG spike antibodies, while testing for SARS-CoV-2 acute infection and other inflammatory etiologies were negative. Vaccine-related MIS-C was suspected in our case due to the development of MIS-C three weeks following the second dose of the COVID-19 mRNA vaccine, the absence of previous infection or exposure to SARS-CoV-2, and a positive result for IgG anti-spike (S) antibodies.

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“…However, some studies suggest the potential of direct SARS‐CoV‐2 invasion of oral keratinocytes, fibroblasts, tongue, and salivary gland epithelial cells as the etiopathogenic mechanism underlying SARS‐CoV‐2 oral adverse effects 66 . Furthermore, there is growing evidence that anti‐SARS‐CoV‐2 vaccines are related to orofacial side effects 67 . It is noteworthy to mention that there are discrepancies in the descriptions of vaccine‐related orofacial adverse events between the countries.…”

Section: The Badmentioning

confidence: 99%

“… 66 Furthermore, there is growing evidence that anti‐SARS‐CoV‐2 vaccines are related to orofacial side effects. 67 It is noteworthy to mention that there are discrepancies in the descriptions of vaccine‐related orofacial adverse events between the countries. There is a possibility that oral adverse reactions have been probably underreported by healthcare workers.…”

Section: The Badmentioning

confidence: 99%

A comprehensive review of oral microenvironment changes and orofacial adverse reactions after COVID‐19 vaccination: The good, the bad, and the ugly

Najary,

Vatankhah,

Khadivi

et al. 2024

Health Science Reports

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Background and AimsAnti‐severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) vaccines have the potential to alter several biological systems concurrently with remolding the immune system, most of which are related to immunization, while some others are known as adverse effects. This review aims to explore the potential effects of vaccination on the oral microenvironment and classifies them as good, bad, or ugly, with a brief review of facial diseases following coronavirus disease 2019 (COVID‐19) vaccination.MethodsThis study was a comprehensive review conducted through searching related articles in Medline, Scopus, and Google Scholar databases.ResultsOn one side, the “Good” impacts of vaccination on the oro‐nasal mucosa are explained as if the mucosal immune responses followed by SARS‐CoV‐2 vaccines are enough to provide immunity. On the other side, the possible “Bad” and “Ugly” effects of the vaccine, which manifest as orofacial adverse events and autoimmune reactivations, respectively, should be noted. Exacerbation of pre‐existing autoimmune conditions such as lichen planus, pemphigus vulgaris, bullous pemphigoid, and Stevens‐Johnson syndrome have been reported.ConclusionCOVID‐19 vaccines could affect different biological systems alongside stimulating the immune system, and some of these effects are referred to as adverse effects. Nonetheless, these adverse effects are treatable, and healthcare professionals should not prevent patients from taking the first available vaccination.

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The Side Effects and Adverse Clinical Cases Reported after COVID-19 Immunization

Cited by 39 publications

References 75 publications

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Multisystem Inflammatory Syndrome in Children (MIS-C), Possibly Due to COVID-19 mRNA Vaccination

A comprehensive review of oral microenvironment changes and orofacial adverse reactions after COVID‐19 vaccination: The good, the bad, and the ugly

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