Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ovarian cyst, SARS-CoV-2 test, Thyroid mass, Vaccination site inflammation, Vaccination site swelling
Clinical narrative: Pfizer Booster Vaccine: Ovarian cysts that are complex; Pfizer Booster Vaccine: Nodule on Thyroid; Pfizer Booster Vaccine: White blood cell count has been high; Pfizer Booster Vaccine: Had a lot of swelling in injection arm; Had inflammation because was really hot/Vaccination site warmth; Had inflammation because was really hot/Vaccination site inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 10Jun2022 as dose number unknown (booster), single (Lot number: FK9893) at the age of 41 years, in right arm for covid-19 immunisation; covid-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Batch/lot number: 30135BA; Route of administration: Right arm), administration date: 10Nov2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE; Batch/lot number: FC3183; Route of administration: Right arm), administration date: 01Dec2021, for COVID-19 immunisation. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious) with onset 10Jun2022, outcome "not recovered", described as "Had inflammation because was really hot/Vaccination site inflammation"; VACCINATION SITE WARMTH (non-serious) with onset 10Jun2022, outcome "not recovered", described as "Had inflammation because was really hot/Vaccination site warmth"; VACCINATION SITE SWELLING (non-serious) with onset 10Jun2022, outcome "not recovered", described as "Pfizer Booster Vaccine: Had a lot of swelling in injection arm"; OVARIAN CYST (medically significant), outcome "unknown", described as "Pfizer Booster Vaccine: Ovarian cysts that are complex"; THYROID MASS (medically significant), outcome "unknown", described as "Pfizer Booster Vaccine: Nodule on Thyroid"; WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "Pfizer Booster Vaccine: White blood cell count has been high". The events "pfizer booster vaccine: ovarian cysts that are complex", "pfizer booster vaccine: nodule on thyroid", "pfizer booster vaccine: had a lot of swelling in injection arm", "had inflammation because was really hot/vaccination site warmth", "had inflammation because was really hot/vaccination site inflammation" and "pfizer booster vaccine: white blood cell count has been high" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; White blood cell count: High; Went back up. Therapeutic measures were taken as a result of vaccination site swelling, vaccination site warmth, vaccination site inflammation, white blood cell count increased.  Additional information: Other Products: No. Wanted to report side effect caller had after received Booster shot from Pfizer last year. Reason had to report was because received an expired vaccination from Novavax. Because adverse reaction to Pfizer Booster Vaccine last year, and situation hanging with Vaccine received from Novavax that was expired wanted to file report. HCP: Declines. Saw a primary care physician regarding side effects but was not caller's doctor anymore and did not want to provide any HCP details. Received expired vaccination from Novavax: Clarified vaccine name as Novavax Monovalent Booster. Pfizer Booster Vaccine: Had a lot of swelling in injection arm. Had inflammation because was really hot. Received Pfizer Booster Vaccine on 10Jun2022 and went to the doctor on 28Jun2022 and was given something for inflammation. No further information provided on what was given for inflammation. When received Pfizer Booster Vaccine on 10Jun2022, swelling started right away on 10Jun2022. Did not had glasses on when providing lot, clarified was reading vaccine card in someone else's handwriting. Nobody told caller to switch arms when getting vaccines so won't have a reaction. Event was resolved, gave inflammation. Caller stated felt like some effects have occurred recently. Since issue of having a lot of swelling in injection arm, had some issues that have come up recently. In Nov2022 and Dec2022 all the way up until now in personal opinion. Ovarian cysts that are complex and nodule on Thyroid:  After had Pfizer Booster Vaccine and got over it and everything went to OBGYN because was going through symptoms as a female and not showing anything. Found out had ovarian cysts that are complex. Clarified found had complex cyst and a nodule on thyroid. All of this all of a sudden. Was going to go for surgery to get complex cyst and nodule on thyroid removed and could not get removed, caller's white blood cell count had been high. Had been seeing multiple doctors and none of them were able to pinpoint what issue was. The last doctor went to was a different OBGYN and was told that because caller was given different antibiotics, clarified was given Prednisone and stuff like that and Prednisone was not working, couldn't had been bacterial, could had been viral. Tests: Had been tested and done at home test to see if has Covid and the caller had never had Covid. All tests had been coming out negative that are taken at home. Prednisone: NDC/lot/expiration: Unknown, does not have on hand to provide the information. Dose: First time took 250mg one tablet for 5 days and the second time taken, caller's white blood cell count had gone back up and caller took Prednisone 250mg twice a day. Clarified both times Prednisone was taken, Prednisone did not work. was there a product complaint to report? Yes Description of Product Complaint: Description of complaint: Prednisone was not working. Product strength and count size dispensed: 250mg, took one tablet for 5 days the first time taken, white blood cell count went back up and took again a second time, dose of 250mg twice a day. Clarifies both times Prednisone was taken, Prednisone did not work. Additional lot numbers: Unknown, did not have on hand to provide. Is a sample of the product available to be returned, if requested (Y/N): No, all Prednisone was administered by patient.