Minor to Moderate Side Effects of Pfizer-BioNTech COVID-19 Vaccine Among Saudi Residents: A Retrospective Cross-Sectional Study

El-Shitany, Nagla A.; Harakeh, Steve; Badr-Eldin, Shaimaa M.; Bagher, Amina M.; Eid, Basma G.; Almukadi, Haifa; Alghamdi, Badrah S.; Alahmadi, Ahlam A.; Hassan, Nibal A; Sindi, Nariman; Alghamdi, Samar A.; Almohaimeed, Hailah M.; Mohammedsaleh, Zuhair M.; Al-Shaikh, Turki M.; Almuhayawi, Mohammed S.; Ali, Soad Shaker; El‐Hamamsy, Manal

doi:10.2147/ijgm.s310497

Cited by 209 publications

(303 citation statements)

References 8 publications

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“…These findings are in agreement with El-Shitany et al 17 and Polack et al 1 , stating that the vaccine-associated systemic side effects are more common among younger people and after the second dose of the vaccine, but disagree with them in reporting that injection site pain was more frequent among people younger than 55 years compared with older people (in fact, all people vaccinated reported injection site pain).…”

Section: Discussionsupporting

confidence: 89%

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021

et al. 2021

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Objectives On 21 December 2020 the European Commission granted conditional marketing authorisation in the European Union for the anti-COVID-19 mRNA vaccine Bnt162b2 (Comirnaty, Pfizer/BioNTech). The main endpoint of this epidemiological, observational, prospective and monocentric study was to identify the number, types, and severity of adverse events following immunisation that occurred in subjects who had been previously infected with COVID-19, and in those who had not, after vaccination with Comirnaty, and to compare the two groups of subjects looking at events that occurred within a month after the first and the second dose. Methods Data were gathered by a questionnaire. The results included the responses of all healthcare workers (2030) of the IRCCS Sacro Cuore Don Calabria Hospital (Italy) vaccinated between 1st January and 28th February 2021. Adverse effects of the vaccine were reported after the first and the second doses. Results There was a statistically significant increase (p<0.001, χ 2 =35.60) in participants who experienced some side-effects after receiving the first dose of the vaccine and who had previously been infected with the coronavirus, compared with participants who had not previously been infected. 46.76% (136) of the participants who had previously been infected experienced some side-effects after the first dose of vaccine, and 63.23% (184) experienced some sideeffects after the second dose, compared with 29.15% (507) after the first dose and 70.79% (1231) after the second dose in those who had not been previously infected. The number of participants who experienced side-effects after the second dose and had previously been infected was significantly lower compared with participants who had not previously been infected (p=0.0094, χ 2 =6.743). Conclusions Most of the side-effects identified in this trial were also reported by the manufacturer and the US Food and Drug Administration. Active surveillance should always continue to constantly check the vaccine's risk/ benefit ratio over time.

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Section: Discussionsupporting

confidence: 89%

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021

et al. 2021

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“…This study found that tenderness and local pain around the injection site are the most commonly reported side effects, and it occurred on the same day after the injection and lasted for about one day [ 17 ]. Furthermore, in a study conducted on participants receiving Pfizer-BioNTech in Saudi Arabia, it was found that 70% to 80% of the study participants have reported pain at the site of injection [ 18 ]. Unlike other studies, most of the participants in our study reported having tiredness and headache, and this is mainly explained by the younger age of our participants (median is 26 years) compared to others’ findings [ 17 , 18 ].…”

Section: Discussionmentioning

confidence: 99%

“…Furthermore, in a study conducted on participants receiving Pfizer-BioNTech in Saudi Arabia, it was found that 70% to 80% of the study participants have reported pain at the site of injection [ 18 ]. Unlike other studies, most of the participants in our study reported having tiredness and headache, and this is mainly explained by the younger age of our participants (median is 26 years) compared to others’ findings [ 17 , 18 ]. As it’s also evidenced in several studies that younger individuals reported a higher frequency of side effects compared to older individuals [ 9 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

“…However, with the current sample, we found a significant difference between the participants who experienced side effects by the second injection (10% vs. 4%, p 0.012). It has been reported, either from the trial results or the real-world data, that the side effects associated with the COVID-19 vaccine are mild to moderate [ 9 , 10 , 17 , 18 ]. In the current report, we found that only 3% of the participants needed to see a doctor due to the side effects of the vaccines, and 1% admitted to the hospital, a finding that can be reassuring for the concerned public about the safety of the available vaccines.…”

Section: Discussionmentioning

confidence: 99%

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Evaluation of Side Effects Associated with COVID-19 Vaccines in Saudi Arabia

et al. 2021

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Background: Pfizer-BioNTech and Oxford-AstraZeneca are recently introduced vaccines to combat COVID-19 pandemic. During clinical trials, mild to moderate side effects have been associated with these vaccines. Thus, we aimed to evaluate short-term post-vaccination side effects. Methods: Cross-sectional, retrospective study using an online questionnaire was conducted among COVID-19 vaccines recipients in Saudi Arabia. General and demographic data were collected, and vaccine-associated side effects after receiving at least one dose of each vaccine were evaluated. Results: Our final sample consisted of 515 participants with a median age of 26 years. Most of the study participants were female (57%). Nearly 13% of the study subjects have reported previous infections with SARS-CoV-2. Oxford-AstraZeneca and Pfizer-BioNTech vaccines have been received by 75% and 25% of the study participants, respectively. Side effects associated with COVID-19 vaccines have been reported by 60% of the study subjects, and most of them reported fatigue (90%), pain at the site of the injections (85%). Conclusion: Side effects that are reported post Oxford-AstraZeneca and Pfizer-BioNTech vaccines among our study participants are not different from those that were reported in the clinical trials, indicating safe profiles for both vaccines. Further studies are needed to evaluate the effectiveness of the current vaccines in protection against SARS-CoV-2 reinfections.

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“…The trial concluded that the slight excess of Bell’s palsy in this trial and the BNT162b2 vaccine trial raised a concern that it may be more than a chance event, and this possibility bears close monitoring [ 2 ]. A retrospective study with 455 participants found three cases of Bell’s palsy and one with body tingling in individuals who received the first dose of the BNT162b2 vaccine [ 8 ].…”

Section: Discussionmentioning

confidence: 99%