Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | AK0928 | — |
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; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Aug2023 as dose 7 (booster), single (Lot number: AK0928) at the age of 60 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: 1st time in 2021 or 2022 after a couple Covid vaccines, Covid again, probably about a year later; "headaches" (ongoing), notes: both times having Covid; "muscle aches" (ongoing), notes: both times having Covid; "allergic to penicillin" (unspecified if ongoing), notes: anaphylaxis; "allergic to sulfa medications" (unspecified if ongoing), notes: anaphylaxis; "heart disease" (unspecified if ongoing); "arthritis" (unspecified if ongoing), notes: heart issues; "terrible seasonal allergies" (unspecified if ongoing), notes: would end up getting exacerbated and go into bronchitis; "bronchitis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High blood cholesterol" (unspecified if ongoing); "water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing), notes: son suffers from autoimmune disease; "long covid" (unspecified if ongoing), notes: felt like it took forever to get over it. Covid that did sort of linger. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; SIMVASTATIN taken for hypercholesterolaemia; CETIRIZINE HCL taken for hypersensitivity; FUROSEMIDE taken for fluid retention; OMEPRAZOLE/SODIUM BICARBONATE taken for abdominal discomfort. Vaccination history included: BNT162b2 (dose 1, batch/lot number EP7534, left arm which was done at a school), administration date: 13Mar2021, when the patient was 57-year-old, for Covid-19 Immunization, reaction(s): "lump"; BNT162b2 (dose 2, batch/lot number EW0151, shot in right arm), administration date: 03Apr2021, when the patient was 57-year-old, for Covid-19 Immunization, reaction(s): "lump"; BNT162b2 (dose 3, batch/lot number FH8020, administered in arm), administration date: 14Oct2021, when the patient was 58-year-old, for Covid-19 Immunization, reaction(s): "lump"; BNT162b2 (dose 4, batch/lot number FJ4991, administered in arm), administration date: 09Apr2022, when the patient was 58-year-old, for Covid-19 Immunization, reaction(s): "lump"; BNT162b2 (dose 5, batch/lot number FP7138, administered in arm), administration date: 12Aug2022, when the patient was 59-year-old, for Covid-19 Immunization, reaction(s): "lump"; Bnt162b2 (dose 6, batch/lot number GHA703 or maybe OHA703 (not sure), administered in arm), 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 "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". The events "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" required physician office visit. 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: The patient had total of 8 Covid vaccines, she was not sure if that was all of them. That was all she has documented, not sure if she had more. The patient informed that the facility where vaccine was administered was in pharmacies. The patient did receive any other vaccines but definitely it would not have been on the same day. She has not had any other vaccines on same day, or within 4 weeks prior to covid vaccines, her own personal habit that she would not have done vaccines at same time because if she were to have bad reaction, she would not know if it was from one thing or the other. The patient informed that 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. The patient clarified that she experienced in lumps in both arms, had shots in both arms. The first one in left arm and happened in right arm as well, was just terrible. She certainly has good days where she felt good. Also has to do with the weather which may make no sense but if there was terrible humidity day she can be in so much discomfort and specifically where she got shots can be very tender. The patient was rubbing arm right now, felt lumps still sore but not horrible. It was not anything that would keep her from doing what she needed to do, just made it maybe a little less comfortable. The patient informed that the lump started in arm where she initially had shot was in left arm. Then over time 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. Now, has multiple lumps, in both arms. She had called pharmacy, wondering if that was normal. She was told by pharmacist that it was a significant lump that the pharmacist would call the lump an injection injury. When she mentioned to her doctor, doctor said did not know what she was talking about. She clarified, she now has multiple lumps. Almost every time she has gotten a shot she would get a lump and has multiple lumps in both arms. The adverse event did not require a visit to the Emergency Room. The patient informed that 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. She 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, she thinks, from where it was initially. She informed that treatment was really not able to take any NSAIDS so she would only rely on Tylenol and because she was diabetic, worried about kidneys so she did not take very much Tylenol. She would do more CBD, which was a derivative of hemp, she would rub that on there and it would sometimes be effective. She has tried another natural thing called Arnica. The results of those seem to be hit or miss. She was big on drinking water like when she was sick with anything in any kind of way she drinks as much good water as possible, that seems to help a bit. Being very purposeful about staying hydrated as best she can and just moving best as she can and stretching. She did not take any kind of prescribed medication for it, or anything like that.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500198984 same patient/events, different dose;US-PFIZER INC-202500196438 same patient/events, different dose;US-PFIZER INC-202500196502 same patient/product, different dose/events;US-PFIZER INC-202500197706 same patient/product, different dose/events;US-PFIZER INC-202500199013 same patient/events, different dose;US-PFIZER INC-202500199014 same patient/events, different dose;US-PFIZER INC-202500199015 same patient/events, different dose;US-PFIZER INC-202500199012 same patient/events, different dose;
Headache (both times having Covid); Muscle ache (both times having Covid)
Medical History/Concurrent Conditions: Arthritis (heart issues); Autoimmune disorder (son suffers from autoimmune disease); Bronchitis; COVID-19 (1st time in 2021 or 2022 after a couple Covid vaccines, Covid again, probably about a year later); Diabetic; Gastric disorder; Heart disease, unspecified; Hypercholesterolaemia; Hypertension; Long COVID (felt like it took forever to get over it. Covid that did sort of linger); Penicillin allergy (anaphylaxis); Seasonal allergy (would end up getting exacerbated and go into bronchitis); Sulfonamide allergy (anaphylaxis); Water retention
METFORMIN; AMLODIPINE; LOSARTAN; SIMVASTATIN; CETIRIZINE HCL; FUROSEMIDE; OMEPRAZOLE/SODIUM BICARBONATE
Test Name: weight; Result Unstructured Data: Test Result:approximately 230