Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | HJ7224 | — |
Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms; Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP from product quality group, Program ID:. A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Dec2023 as dose 1 (toppac), single (Lot number: HJ7224) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: Second time she had covid; "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "arthritic" (unspecified if ongoing); "Allergies: penicillin" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "she seasonal has terrible allergies/allergies" (unspecified if ongoing); "bronchitis" (unspecified if ongoing), notes: would end up getting exacerbated and go into bronchitis and gets that once a year, almost faithfully, in the fall; "afterwards did get Covid, more than once" (unspecified if ongoing), notes: first or second year of the pandemic in 2021 or 2022. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; SIMVASTATIN taken for blood cholesterol increased; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; FUROSEMIDE taken for fluid retention; OMEPRAZOLE/SODIUM BICARBONATE taken for abdominal discomfort. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; LOT: EP7534, in left arm), administration date: 13Mar2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "The terrible muscle aches and you know the soreness, the shot spot you know which I can still feel, I still feel a knot under my skin in several spots of my arms spots", "The terrible muscle aches and you know the soreness, the shot spot you know which I can still feel, I still feel a knot under my skin in several spots of my arms spots", "The terrible muscle aches and you know the soreness, the shot spot you know which I can still feel, I still feel a knot under my skin in several spots of my arms spots", "lump an injection injury"; BNT162b2 (DOSE 2, SINGLE; LOT: EW0151, in right arm), administration date: 03Apr2021, when the patient was 57-year-old, for Covid-19 immunization, reaction(s): "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms", "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; LOT: FH8020, in left arm), administration date: 14Oct2021, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "lump an injection injury", "hard lump that stayed there quite a long time and then the lump traveled a little bit from where first did the shot/would get Covid shots, lump would go back and forth between her two arms"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; LOT: FJ4991, in left arm), administration date: 09Apr2022, when the patient was 58-year-old, for Covid-19 immunization, reaction(s): "Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms", "Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (DOSE 5 (BOOSTER), SINGLE; LOT: FP7138, Arm), administration date: 12Aug2022, when the patient was 59-year-old, for Covid-19 immunization, reaction(s): "Almost every time she got a shot she would get a lump", "Muscle aches", "headaches", "it just took down her overall energy and stamina", "if there is a terrible humid day she can be in so much discomfort", "it just took down her overall energy and stamina", "where she got shots can be very tender"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 7 (BOOSTER), SINGLE; LOT: AK0928, in Arm), administration date: 04Aug2023, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have traveled; same arm and then again later; a shot in her right arm; has multiple lumps, in both arms", "gotten a shot she would get a lump and has multiple lumps in both arms/over time lump seems to have traveled; same arm and then again later; a shot in her right arm; has multiple lumps, in both arms"; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE; in Arm Left), for Covid-19 immunization, reaction(s): "lump". The following information was reported: VACCINATION SITE MASS (non-serious), LIMB MASS (non-serious), outcome "not recovered" and all described as "Each time she would get Covid shots, lump would go back and forth/every time she got a shot she would get a lump and has multiple lumps in both arms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site mass, limb mass. Additional information: Additional information: It was reported that, patient got Covid after being vaccinated, patient thinks, more than once. Thinks patient had the vaccine a couple of times by then. Takes as precaution because patient has autoimmune disease and her son suffers from autoimmune disease. Son had chemo over 10 years, his autoimmunity was dangerously low right now. He goes through these treatments and caller has to be careful as well as she can be on a regular basis. Has had some lingering, guesses they might even call it long Covid. Patient had studied up on it, trying to decipher if its one thing or another. Believes patient only had covid twice, if that second time was in fact Covid, it was very similar. Had been well otherwise, all though patient had diabetes, has heart issues. Is not a sickly person that was always sick with something. Because of her practices in handwashing and wearing masks out, which she still does, thinks was actually with all things she would normally get like she seasonal has terrible allergies, that would end up getting exacerbated and go into bronchitis and gets that once a year, almost faithfully, in the fall. Thankful to Pfizer because, between of her practices and having had the vaccines, has been more well overall as far as colds, flu, bronchitis. Had literally never had bronchitis since getting the first Covid shot. And she has learned to be more careful in public. Muscle aches and headaches: Clarified, she had the muscle aches and headaches both times having Covid. The very first shot was very painful thereafter, it really bothered her. There was 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 Covid shots, lump would go back and forth between her two arms. Clarified, she experienced in lumps in both arms, had shots in both arms. Treatment: Really not able to take any NSAIDS so patient would only rely on Tylenol and because she is diabetic, worries about kidneys so she does not take very much Tylenol. Patient would do more CBD, which was a derivative of hemp, she would rub that on there and it would sometimes be effective. Has tried another natural thing called Arnica. Results of those seem to be hit or miss. Lump started in arm where she initially had shot was in left arm. Then over time lump seems to have travelled a little bit in the same arm and then again later when patient had a shot in her right arm. Now, has multiple lumps, in both arms. Specific date this started, unknown. Was when she got first shot, within a few days after that the lump was still there. Was told by pharmacist that it is a significant lump that the pharmacist would call the lump an injection injury. Clarified, she now has multiple lumps. Almost every time she has gotten a shot, patient would get a lump and has multiple lumps in both arms. Treatment: There was not really treatment because, when she asked if she should use hot or cold compress was told no. Said it would work itself out over time and told her to just take Tylenol, or Aspirin. Was afraid to massage too much and did not really rub it but would check to see if still there and if still as big and if it was moving. It did move some, patient thinks, from where it was initially. Patient thinks that was the lot number Eighth Dose: Pfizer thinks it says 23-24. Administered on16Dec2023 LOT: Can't tell since writing was messed up and states the first character was either a H or # and then J7324 or J7224. Patient cannot tell what it states for lot number due to writing. When clarifying that, caller had total of 8 Covid vaccines, Patient stated, she was not sure if that was all of them. That was all patient has documented, not sure if she had more. patient does not have any further details to provide for any other covid vaccine or any further lot numbers. Patient only had what was on her three vaccine cards as provided above.
Medical History/Concurrent Conditions: Arthritis; Autoimmune disorder; Blood pressure high; Bronchitis; COVID-19 (Second time she had covid); COVID-19 (first or second year of the pandemic in 2021 or 2022); Diabetic; Heart disorder; High cholesterol; Penicillin allergy; Seasonal allergy; Stomach discomfort; Sulfonamide allergy; Water retention
METFORMIN; AMLODIPINE; LOSARTAN; SIMVASTATIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FUROSEMIDE; OMEPRAZOLE/SODIUM BICARBONATE
Test Date: 20250926; Test Name: glucose serum stick; Result Unstructured Data: Test Result:234; Comments: Unit: Not Provided, was high; Test Date: 20250926; Test Name: Hemoglobin A1C; Result Unstructured Data: Test Result:9.8; Comments: Unit: Not Provided, a little high; Test Date: 2021; Test Name: Covid test; Test Result: Positive