Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | FP7138 | — |
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; Almost every time she got a shot she would get a lump; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 59-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2022 as dose 5 (booster), single (Lot number: FP7138) at the age of 59 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "muscle aches" (ongoing), notes: she had the muscle aches and headaches both times having Covid; "headaches" (ongoing), notes: she had the muscle aches and headaches both times having Covid; "did get Covid" (unspecified if ongoing), notes: first or second year of the pandemic in 2021 or 2022; "autoimmune disease" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "seasonal has terrible allergies" (unspecified if ongoing); "bronchitis" (unspecified if ongoing), notes: end up getting exacerbated and go into bronchitis; "arthritic" (unspecified if ongoing); "Has high blood pressure" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing), notes: with anaphylaxis; "sulfa" (unspecified if ongoing), notes: with anaphylaxis; "High cholesterol" (unspecified if ongoing). 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 gastrointestinal disorder; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. 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): "lump an injection injury", "very first shot was very painful", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms"; 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): "lump an injection injury", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (DOSE 3 (BOOSTER); lot: FH8020), administration date: 14Oct2021, when the patient was 58-year-old, for COVID-19 Immunization, reaction(s): "lump an injection injury", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms"; BNT162b2 (DOSE 4; lot: FJ4991), administration date: 09Apr2022, when the patient was 58-year-old, for COVID-19 Immunizatio, reaction(s): "lump an injection injury", "Almost every time she got a shot she would get a lump and has multiple lumps in both arms". The following information was reported: VACCINATION SITE MASS (non-serious) with onset 2022, outcome "not recovered", described as "Almost every time she got a shot she would get a lump"; MYALGIA (non-serious), outcome "not recovered", described as "Muscle aches"; HEADACHE (non-serious), outcome "not recovered", described as "headaches"; ASTHENIA (non-serious), MALAISE (non-serious), outcome "unknown" and all described as "it just took down her overall energy and stamina"; DISCOMFORT (non-serious), outcome "unknown", described as "if there is a terrible humid day she can be in so much discomfort"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "where she got shots can be very tender". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, headache, vaccination site pain. Additional information: 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 the first shot was. Within a few days after that the lump was still there. Had called pharmacy, wondering if that was normal. Was told by pharmacist that it is a significant lump that the pharmacist would call the lump an injection injury. Each time she would get Covid shots, lump would go back and forth between her two arms. 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. Almost every time she got a shot she would get a lump and has multiple lumps in both arms. There is no real 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, she thinks, from where it was initially. With regards to muscle aches and headaches, the patient very specifically knows some of that muscle ache and pain was vaccine related because of how it came on, how it lingered. In general, it just took down her overall energy and stamina. Has not really gotten any better, thinks she just learned to just work through it. In general the muscle aches, are just so natural to her now and she can't really differentiate. She certainly has good days when she feels good. Also has to do with the weather, which may make no sense but if there is terrible humidity, if there is a terrible humid day she can be in so much discomfort. And specifically, where she got shots can be very tender. Rubbing arm right now, feels lumps still sore but not horrible. Is not anything that would keep her from doing what she needs to do, just makes it maybe a little less comfortable. Used to garden veraciously, does not do much anymore. If she even has half an afternoon of weeding the aftermath is pretty bad. Even if not immediate, the next day she literally has a down day, where she can't do very much but it is hard to tell exactly what that is from. Treatment: Really not able to take any NSAIDS so she would only rely on Tylenol and because she is diabetic, worries about kidneys so she does not take very much Tylenol. She would do more CBD, which is 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. She is big on drinking water like when she is 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. Does not take any kind of prescribed medication for it, or anything like that.
Headache (she had the muscle aches and headaches both times having Covid); Muscle ache (she had the muscle aches and headaches both times having Covid)
Medical History/Concurrent Conditions: Arthritic-like pain; Autoimmune disorder; Blood pressure high; Bronchitis (end up getting exacerbated and go into bronchitis); COVID-19 (first or second year of the pandemic in 2021 or 2022); Diabetic; Drug allergy (with anaphylaxis); Gastric disorder; Heart disorder; High cholesterol; Penicillin allergy (with anaphylaxis); Seasonal allergy; Water retention
METFORMIN; AMLODIPINE; LOSARTAN; SIMVASTATIN; CETIRIZINE HCL; FUROSEMIDE; OMEPRAZOLE/SODIUM BICARBONATE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]
Test Date: 20250926; Test Name: glucose serum stick; Result Unstructured Data: Test Result:234, was high; Test Date: 20250926; Test Name: Hemoglobin A1C; Result Unstructured Data: Test Result:9.8, a little high