Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 6 | — | LA |
lump; This is a spontaneous report received from a Consumer or other non HCP, Program ID: . A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic; "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "arthritic" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "allergies" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: within first year or year and a half, think was in 2021, or may have been as late as 2022-had twice; "heart issues" (unspecified if ongoing); "anaphylaxis" (unspecified if ongoing), notes: penicillin and sulfa medications. The patient's family history included: "autoimmune disease" (unspecified if ongoing), notes: Son. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; SIMVASTATIN taken for blood cholesterol increased; CETIRIZINE HCL taken for hypersensitivity; FUROSEMIDE taken for fluid retention; OMEPRAZOLE/SODIUM BICARBONATE taken for gastrooesophageal reflux prophylaxis. The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 1; left arm-Lot Number: EP7534), administration date: 13Mar2021, for COVID-19 immunization, reaction(s): "lump"; BNT162b2 (DOSE 2; right arm-Lot Number: EW0151), administration date: 03Apr2021, for COVID-19 immunization, reaction(s): "lump"; BNT162b2 (DOSE 3; Lot Number: FH8020), administration date: 14Oct2021, for COVID-19 immunization, reaction(s): "lump"; BNT162b2 (DOSE 4; Lot Number: FJ4991), administration date: 09Apr2022, for COVID-19 immunization, reaction(s): "lump"; BNT162b2 (DOSE 5; Lot Number: FP7138), administration date: 12Aug2022, for COVID-19 immunization, reaction(s): "lump". The following information was reported: VACCINATION SITE MASS (non-serious), outcome "not recovered", described as "lump". Therapeutic measures were taken as a result of vaccination site mass. Additional information: the very first shot was very painful, thereafter, it really bothered her. It was stated, "there was a hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot." Each time she would get a COVID vaccination, it was stated that the "lump would go back and forth between her two arms." The patient clarified, she experienced lumps in both arms, as she had shots in both arms. The first vaccination was in the left arm. This event happened in the right arm as well and was described as "just terrible." The patient stated when rubbing her arm, she felt lumps and were "still sore but not horrible." The patient felt that this was not anything that would keep her from doing what she needed to do, just made it maybe a little less comfortable. The lumps started in the arm where she initially had the vaccination (in left arm). Then over time the lump seems to have traveled a little bit in the same arm and then again later when she had a shot in her right arm. The patient now had multiple lumps, in both arms. The patient did not know the specific date the lumps started. When she received the first vaccination, within a few days, the lump was still there. The patient was told by the pharmacist that it was a significant lump, and the pharmacist would call the lump an injection injury. When the patient mentioned the event to her doctor, the doctor said they did not know what she was talking about. The patient then clarified, she now had multiple lumps. The patient said, "almost every time she has gotten a shot, she would get a lump and has multiple lumps in both arms." Regarding treatment, when she asked if she should use a hot or cold compress she was told no and that it would work itself out over time and told her to just take acetaminophen (TYLENOL), or acetylsalicylic acid (ASPIRIN). The patient was afraid to massage too much, and she did not really rub it but would check to see if it was still there and if still as big and if it was moving. It did move some, she thinks, from where it was initially. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Allergy; Anaphylaxis (penicillin and sulfa medications); Arthritis; Autoimmune disorder (Son); Autoimmune disorder; Blood pressure high; COVID-19 (within first year or year and a half, think was in 2021, or may have been as late as 2022-had twice); Diabetic; Gastroesophageal reflux; Heart disorder; High cholesterol; Penicillin allergy; Sulfonamide allergy; Water retention
METFORMIN; AMLODIPINE; LOSARTAN; SIMVASTATIN; CETIRIZINE HCL; FUROSEMIDE; OMEPRAZOLE/SODIUM BICARBONATE