The Adverse Reactions of Pfizer BioNTech COVID-19 Vaccine Booster Dose are Mild and Similar to the Second Dose Responses: A Retrospective Cross-Sectional Study

Nagla A El-Shitany; Amina M Bagher; Lenah Saeed Binmahfouz; Basma G Eid; Haifa Almukadi; Shaimaa M Badr-Eldin; Manal El-Hamamsy; Zuhair M Mohammedsaleh; Fayez M Saleh; Mohammed S Almuhayawi; Samar A Alghamdi; Rana A Arab; Soad S Ali; Steve Harakeh; Badrah S Alghamdi

doi:10.2147/IJGM.S376316

The Adverse Reactions of Pfizer BioNTech COVID-19 Vaccine Booster Dose are Mild and Similar to the Second Dose Responses: A Retrospective Cross-Sectional Study

Int J Gen Med. 2022 Aug 26:15:6821-6836. doi: 10.2147/IJGM.S376316. eCollection 2022.

Authors

Nagla A El-Shitany¹, Amina M Bagher², Lenah Saeed Binmahfouz², Basma G Eid², Haifa Almukadi², Shaimaa M Badr-Eldin^{3

4}, Manal El-Hamamsy⁵, Zuhair M Mohammedsaleh⁶, Fayez M Saleh⁷, Mohammed S Almuhayawi⁸, Samar A Alghamdi⁹, Rana A Arab¹⁰, Soad S Ali^{11

12}, Steve Harakeh^{12

13}, Badrah S Alghamdi^{14

15}

Affiliations

¹ Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tanta University, Tanta, Egypt.
² Department of Pharmacology and Toxicology, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
³ Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
⁴ Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt.
⁵ Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.
⁶ Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, University of Tabuk, Tabuk, Saudi Arabia.
⁷ Department of Medical Microbiology, Faculty of Medicine, University of Tabuk, Tabuk, Saudi Arabia.
⁸ Department of Medical Microbiology/Parasitology and Molecular Microbiology Laboratory, King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
⁹ Department of Oral Biology, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia.
¹⁰ Medicine Program, Ibn Sina National College for Medical Studies, Jeddah, Saudi Arabia.
¹¹ Department of Histology, Faculty of Medicine, Assiut University, Assiut, Egypt.
¹² Yousef Abdullatif Jameel Scientific Chair of Prophetic Medicine Application, Faculty of Medicine (FM), King Abdulaziz University, Jeddah, Saudi Arabia.
¹³ King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia.
¹⁴ Department of Physiology, Neuroscience Unit, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
¹⁵ Pre-Clinical Research Unit, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia.

Abstract

Background: Like other vaccines, Pfizer BioNTech's COVID-19 vaccine efficacy against SARS-CoV-2 virus infections begins to decline within a few months after the 2^nd dose. On August 12, 2021, the FDA allowed additional Pfizer BioNTch's COVID-19 vaccine dose (3^rd or booster dose) for individuals with weakened immunity. This study aimed to evaluate the short-term adverse reactions (ADRs) of the 2^nd and the 3^rd doses of the Pfizer BioNTech COVID-19 vaccine.

Methods: Information for this study was collected by Google Form questionnaire (online survey). The results included responses from 442 people, the majority from Saudi Arabia.

Results: The most common local ADRs following the 3^rd dose were injection site pain, injection site hypersensitivity, and axillary lymph node swelling. The most common systemic ADRs were fatigue, muscle pain, bone pain, headache, and fever less than 38ºC. Less common systemic ADRs were shivering, fever more than 38ºC, nasal congestion and rhinorrhea, arrhythmia, cough, abdominal pain, chest tightness, nausea, diarrhea, vomiting, and tachypnea. Rare systemic ADRs were constipation, dizziness and vertigo, lack of concentration, sore throat, excessive hair loss, dysmenorrhea and heavy menstruation, and Bell's palsy. Severe allergic reactions were reported by 2.6% of participants after the 2^nd dose, compared with none after the 3^rd dose. Nasal congestion and runny nose are more frequent after the 3^rd dose. The ADRs of the 2^nd and 3^rd doses were significantly more prevalent in females. 12% of participants reported ADRs lasting more than one week after the 3^rd dose compared to 5% after the 2^nd dose. People ≤ 60 years were more affected by the vaccine ADRs.

Conclusion: Most of the ADRs reported after the 3^rd vaccine dose were consistent with the Pfizer vaccine information sheet and similar to the 2^nd dose ADRs.

Keywords: Pfizer-BioNTech COVID-19 vaccine; adverse drug reactions; booster dose; fatigue; injection site pain; online questionnaire; second dose.