Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time; Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time; 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 number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Water retention" (unspecified if ongoing); "for stomach" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "heart issues" (unspecified if ongoing); "Allergic to penicillin" (unspecified if ongoing), notes: with anaphylaxis; "Allergic to sulfa medications" (unspecified if ongoing), notes: with anaphylaxis; "arthritic" (unspecified if ongoing); "Covid" (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 abdominal discomfort; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity. The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, LOT: EP7534 (left arm)), administration date: 13Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, LOT: EW0151 (Right arm)), administration date: 03Apr2021, for COVID-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT: Probably FH8020), administration date: 14Oct2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time". The patient underwent the following laboratory tests and procedures: Blood glucose: (26Sep2025) 234, notes: was high; Unit: Not Provided; Glycosylated haemoglobin: (26Sep2025) 9.8, notes: a little high; Unit: Not Provided; Weight: (unspecified date) 230, notes: Approximately. Clinical course: Clarified omeprazole (20mg) with sodium bicarbonate (1100mg), it states the sodium bicarbonate allows for absorption. Clarifies this is all in one medication, all in one tablet. Caller states everything she has suffered, in her opinion, has been worse than what the vaccine the vaccine provided her, as in her ability to get Covid, to have it and not die from it like so many. Feels like much of what she suffered from, the vaccine and having Covid, has been relatively low, comparatively. Is still thankful. Was significantly affected, does not know if from the vaccination or from having had Covid. Got Covid after being vaccinated, she thinks, more than once. Thinks she had the vaccine a couple of times by then. Takes as precaution because she has autoimmune disease and her son suffers from autoimmune disease. Has had some lingering, guesses they might even call it long Covid. She has studied up on it, trying to decipher if its one thing or another. Thinks this would have been first shot. Knows she had Covid within first year or year and a half, think was in 2021, or may have been as late as 2022. Second time she had Covid, was not able to test since she saved the test for her son. Clarified, caller got Covid first time, after having a couple Covid vaccines. Was definitely more than once, was in 2021 or 2022. Then had Covid again, probably about a year later, was very similar to first time. Severity of it, was not as horrible but felt like it took forever to get over it. Finally, someone said it is maybe not matter of not being over it because she would probably not get anyone else sick. Is what they call long covid when having lingering effects. Clarified, she thinks she had significant effects first time having Covid that did sort of linger. Looking back on it, definitely had that the second time. Believes she only had covid twice, if that second time was in fact Covid, it was very similar. Had been well otherwise, all though she has diabetes, has heart issues. Is not a sickly person that is 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 normal 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. Has 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. Muscle aches and headaches: Is something that has lingered, still experiencing now. In her mind she does not know what to zero in on for exact cause since she is 62 and is arthritic. 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 where 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 kid 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. 4th Dose Pfizer covid vaccine: 09Apr2022 (LOT: FJ4991). 5th dose: Pfizer covid vaccine: 12Aug2022 (LOT: FP7138). Sixth Dose: Does not know what was written but states it says either RAW or DAW then provides GHA703 or maybe OHA703, but thinks they should have been more clear in the writing on her vaccine card and then states she thinks it is a G but she is not sure. She thinks it was also given at the (withheld). Something over to the left written really tiny and thinks it VOORW or maybe it says VOOM or V00M or V00N and then states maybe the R is a V but she does not know. It is horrible writing and then below that says BLBAWA or who knows what is written there. Unable to clarify further as caller states it is all on the same line and the handwriting is horrible and she does not know about this one. There is nothing else written by sixth dose. Seventh Dose: 04Aug2023. She thinks it says Pfizer and then thinks it says (withheld) LOT: AK0928, she thinks that is the lot number. Eighth Dose: Pfizer thinks it says 23-24. Administered on 16Dec2023. LOT: Can't tell since writing is messed up and states the first character is either a H or # and then J7324 or J7224. She cannot tell or confirm what it states for lot number due to handwriting. When clarifying that caller had total of 8 Covid vaccines, she states she is not sure if that is all of them. That is all she has documented, not sure if she had more. Caller confirms she does not have any further details to provide for any other covid vaccine or any other lot numbers. She only has what is on her three vaccine cards as provided above. Did the patient receive any other vaccines on the same date as the Pfizer vaccine? Would be almost impossible to remember but definitely does know it would not have been on the same day Did see recently that Pfizer is suggesting that which is what prompted her call in the first place that it is being suggested to get Covid shot when getting flu shot and she was unable to do that. Is there reason for that? Is that more beneficial to get covid and flu shot together? Caller advised to refer, advised that, they have product specific information to provide. When clarifying that she has not had any other vaccines on same day, or within 4 weeks prior to covid vaccines, caller states, she does not think so. Is 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. 3. Did the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine? Unknown. Took Covid vaccine afterwards did get Covid, more than once. Believes she only had covid twice, if that second time was in fact Covid, it was very similar. When clarifying that, caller had total of 8 Covid vaccines, she states she is not sure if that is all of them. That is all she has documented, not sure if she had more. Caller confirms she does not have any further details to provide for any other covid vaccine or any further lot numbers. She only has what is on her three vaccine cards as provided above. Patient stated, "I am ma'am. I'm in a high risk category, "I have been now without my shots for almost a year I think It's been over a year actually you know in the very beginning you guys had us come like every 3 to 4 months and then I went out to 6 months and now it's been like I said over a yearI I am seen by a doctor in a local clinic here, and when I got my Flu and Pneumonia shot the other day, he informed me that they don't have any and they won't have any and they cannot provide it for me I'm like at the end of my rope and I feel this growing anxiety because you know the Flu and you know Pneumonia season is upon us everybody's coughing and getting sick and I mean even the tests I had for COVID when the last ones were sent by the (Withheld) service, they were the ones that had expired but they okayed them. You know for the extended time and so I wouldn't even know if I had it I just feel very anxious I just feel like I'm in a desperate situation I'm just as careful as possible but I've had COVID twice Or I think it was twice I know once I definitely had it and second time felt similar and I did not have a test and I just kind of sheltered in place and did all the things for myself I could I'm very anxious about it" After explaining to (Withheld) the enrollment requirements she stated, "I am unemployed I am as I know of in the state of (Withheld) under the poverty level" When asked if had any questions, (Withheld) stated, "I guess not Before when I was vaxed I still wear my mask out because I'm just that careful, because not all, and I wasn't even thinking all that much for me. When asked to confirm that she had COVID before, (Withheld) stated "I got COVID yes, in, I think it was the first or second year of the pandemic and I had had my shots by then. I only think that I had it a second time because it was so similar to the first but it was, it wasn't horribly severe, but it seemed to last for a long time, and I'll be honest I haven't felt like the same since then I feel like a lot of things in my natural life" When asked to confirm that this was all after the vaccine, (Withheld) stated, "Yes but like I said I imagine that when you think about it, what I had was so much less than what it could've been um, so, but even at that you know you feel crappy anyway, but It was like a, maybe like a hard Flu, um, but the worst thing of it was the, was 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, but I'm still grateful because you know that's a small price to pay."
Medical History/Concurrent Conditions: Arthritis; Autoimmune disorder; Blood pressure high; COVID-19; Diabetic; Heart disorder; High cholesterol; Penicillin allergy (with anaphylaxis); Stomach discomfort; Sulfonamide allergy (with anaphylaxis); 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; Comments: was high; Unit: Not Provided; Test Date: 20250926; Test Name: Hemoglobin A1C; Result Unstructured Data: Test Result:9.8; Comments: a little high; Unit: Not Provided; Test Name: Weight; Result Unstructured Data: Test Result:230; Comments: Approximately