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. 2021 Apr 19:14:1389-1401.
doi: 10.2147/IJGM.S310497. eCollection 2021.

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

Nagla A El-Shitany  1   2 , Steve Harakeh  3 , Shaimaa M Badr-Eldin  4   5 , Amina M Bagher  1 , Basma Eid  1 , Haifa Almukadi  1 , Badrah S Alghamdi  6 , Ahlam A Alahmadi  7 , Nibal A Hassan  8 , Nariman Sindi  9 , Samar A Alghamdi  10 , Hailah M Almohaimeed  11 , Zuhair M Mohammedsaleh  12 , Turki M Al-Shaikh  13 , Mohammed S Almuhayawi  14 , Soad S Ali  15 , Manal El-Hamamsy  16   17
Affiliations

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

Nagla A El-Shitany et al. Int J Gen Med. .

Abstract

Background: The Pfizer-BioNTech COVID-19 vaccine has recently received emergency approval from the US FDA. The mRNA technology was used to manufacture the Pfizer vaccine; however, as a pioneering technology that has never been used in the manufacture of vaccines, many people have concerns about the vaccine's side effects. Thus, the current study aimed to track the short-term side effects of the vaccine.

Methods: The information in this study was gathered by a Google Form-questionnaire (online survey). The results included the responses of 455 individuals, all of whom are Saudi Arabia inhabitants. Adverse effects of the vaccine were reported after the first and the second doses.

Results: The most common symptoms were injection site pain, headaches, flu-like symptoms, fever, and tiredness. Less common side effects were a fast heartbeat, whole body aches, difficulty breathing, joint pain, chills, and drowsiness. Rare side effects include Bell's palsy and lymph nodes swelling and tenderness. Flu-like symptoms were more common among those under 60 years of age, while injection site pain was more frequent among recipients who were 60 years and older. The study revealed a significant increase in the number of females who suffered from the vaccine side effects compared to males. Difficulty of breathing was more reported among recipients who had been previously infected with the coronavirus compared to those who had not been previously infected.

Conclusion: Most of the side effects reported in this study were consistent with Pfizer's fact sheet for recipients and caregivers. Further studies are required to determine the long-term side effects.

Keywords: Pfizer-BioNTech COVID-19 vaccine; flu-like symptoms; hypersensitivity; injection site pain; online survey; side effects.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Flowchart for the COVID-19 vaccine questionnaire participants.
Figure 2
Figure 2
The percentage absence (no symptoms) and presence (yes symptoms) of COVID-19 side effects reported by the study participants following the vaccine’s first, second, and both doses. Results were offered as frequency (percentage (%)).
Figure 3
Figure 3
The reported COVID-19 vaccine side effects after the vaccine’s first, second, and both doses. Results were offered as frequency (percent (%)).
Figure 4
Figure 4
The reported COVID-19 vaccine side effects distribution according to the participants’ ages. Results were offered as frequency (percent (%)).
Figure 5
Figure 5
The correlation between presence and absence of COVID-19 vaccine side effects and the participant’s sex. Results were offered as frequency (percent (%)). Correlation between variables was evaluated using the Chi-square test. ***Significant difference at p ≤ 0.001.
Figure 6
Figure 6
The reported COVID-19 vaccine side effects distribution in participants previously infected with coronavirus versus non-previously infected participants. Results were offered as frequency (percent (%)). Correlation between variables was evaluated using the Chi-square test. ***Significant difference at p ≤ 0.001.
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