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Nagla A El-Shitany,1 Amina M Bagher,2 Lenah Saeed Binmahfouz,2 Basma G Eid,2 Haifa Almukadi,2 Shaimaa M Badr-Eldin,3,4 Manal El-Hamamsy,5 Zuhair M Mohammedsaleh,6 Fayez M Saleh,7 Mohammed S Almuhayawi,8 Samar A Alghamdi,9 Rana A Arab,10 Soad S Ali,11,12 Steve Harakeh,12,13 Badrah S Alghamdi14,15 1Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tanta University, Tanta, Egypt; 2Department of Pharmacology and Toxicology, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 3Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 4Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt; 5Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt; 6Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, University of Tabuk, Tabuk, Saudi Arabia; 7Department of Medical Microbiology, Faculty of Medicine, University of Tabuk, Tabuk, Saudi Arabia; 8Department of Medical Microbiology/Parasitology and Molecular Microbiology Laboratory, King Abdulaziz University Hospital, Jeddah, Saudi Arabia; 9Department of Oral Biology, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia; 10Medicine Program, Ibn Sina National College for Medical Studies, Jeddah, Saudi Arabia; 11Department of Histology, Faculty of Medicine, Assiut University, Assiut, Egypt; 12Yousef Abdullatif Jameel Scientific Chair of Prophetic Medicine Application, Faculty of Medicine (FM), King Abdulaziz University, Jeddah, Saudi Arabia; 13King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi Arabia; 14Department of Physiology, Neuroscience Unit, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; 15Pre-Clinical Research Unit, King Fahd Medical Research Center, King Abdulaziz University, Jeddah, Saudi ArabiaCorrespondence: Nagla A El-Shitany, Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tanta University, Tanta, Egypt, Email nagla_fouad@yahoo.com; naglaa.fouad@pharm.tanta.edu.egBackground: 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 2nd dose. On August 12, 2021, the FDA allowed additional Pfizer BioNTch’s COVID-19 vaccine dose (3rd or booster dose) for individuals with weakened immunity. This study aimed to evaluate the short-term adverse reactions (ADRs) of the 2nd and the 3rd 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 3rd 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 2nd dose, compared with none after the 3rd dose. Nasal congestion and runny nose are more frequent after the 3rd dose. The ADRs of the 2nd and 3rd doses were significantly more prevalent in females. 12% of participants reported ADRs lasting more than one week after the 3rd dose compared to 5% after the 2nd dose. People ≤ 60 years were more affected by the vaccine ADRs.Conclusion: Most of the ADRs reported after the 3rd vaccine dose were consistent with the Pfizer vaccine information sheet and similar to the 2nd dose ADRs.Keywords: Pfizer-BioNTech COVID-19 vaccine, adverse drug reactions, booster dose, second dose, injection site pain, fatigue, online questionnaire

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-Hamamsy16,17 1Department of Pharmacology and Toxicology, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 2Department of Pharmacology and Toxicology, Faculty of Pharmacy, Tanta University, Tanta, Egypt; 3Special Infectious Agents Unit, King Fahd Medical Research Center, Yousef Abdullatif Jameel Chair of Prophetic Medicine Application, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; 4Department of Pharmaceutics, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 5Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt; 6Department of Physiology, Neuroscience Unit, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia; 7Department of Biological Sciences, Faculty of Science, King Abdulaziz University, Jeddah, Saudi Arabia; 8Department of Biology, Faculty of Science, Taif University, Taif, Saudi Arabia; 9Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia; 10Department of Oral Biology, Faculty of Dentistry, King Abdulaziz University, Jeddah, Saudi Arabia; 11Department of Basic Science, Faculty of Medicine, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia; 12Department of Medical Laboratory Technology, Faculty of Applied Medical Sciences, University of Tabuk, Tabuk, Saudi Arabia; 13Department of Biology, College of Science and Arts at Khulis, University of Jeddah, Jeddah, Saudi Arabia; 14Department of Microbiology and Medical Parasitology, Faculty of Medicine, King Abdulaziz University, Jeddah, 21589, Saudi Arabia; 15Department of Histology, Faculty of Medicine, Assiut University, Assiut, Egypt; 16Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; 17Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, EgyptCorrespondence: Nagla A El-ShitanyDepartment of Pharmacology and Toxicology, Faculty of Pharmacy, King Abdulaziz University, Al-Sheekh Kamal Street, Alsulimaniah, Jeddah, Saudi ArabiaTel +966 545923440Email nagla_fouad@yahoo.comBackground: 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, side effects, injection site pain, hypersensitivity, flu-like symptoms, online survey