Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | LA |
they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they had COVID; they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they had COVID; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they had COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Transferring agent stated, "I have a patient on my backline, and they said that they had taken the Pfizer vaccine (Later clarified as Pfizer COVID-19 Vaccine) previously when they had COVID and then, they have been prescribed the medication (Clarified as Paxlovid) due to them having COVID again. Well, the patient said that they had COVID and that they took the Pfizer vaccine for them for it." Consumer stated, "I have got the COVID again, but my best friend had it three times. We did take our Pfizer shots. We would not take the Moderna, we waited for the Pfizer and got it and I took two vaccines and I got the COVID about a year or later, but I am immune suppressed in 70s and stuff like that and I could understand that, but it was really wild, I did not know I was in the world when I have got it now and it is nothing like the first time I got it." Consumer stated, "I am 73 now as of a couple of weeks ago. I would have been 71. I almost died the first time. I was sick for like 10 days really sick. I just ran a really high fever and threw up constantly. I did not know I was in the world for three days, honestly, yes. The first time, that was bad." Consumer stated, "I can get it for you. We got our booster there too because we had to wait for Pfizer shot to come because everybody ran and got the Moderna and blah, get in line, go through the thing, it was wild. Other medical conditions and concomitant medications: Consumer stated, "I am, I have NPH now. It's called Normal pressure hydrocephalus which is fluid on my brain. I cannot walk, I am immobilized." When clarified if NPH occurred after taking Pfizer COVID-19 Vaccine, consumer stated, "After taking the disease, they say it is a side effect of long COVID." Treatment of NPH: Consumer stated, "There is no treatment, but surgery and they put a shot in your brain and being 73 years old, I do not want to have brain surgery." Lab work: Consumer stated, "Yes, I did. I got lab work. I do not know if it was two weeks. They did not draw blood this past time. They drew blood on the 16th. It is not in the last two weeks. I had blood work done the 16th and I had an extended panel done on the 16Jul2025." If took Paxlovid before or the first time: Consumer stated, "Yes, I took the Paxlovid before and I believe that saved my damn life, I was so sick. Yes so, my doctors called and wanted me to come to the hospital." Start date, stop date, dose, route of administration, formulation and frequency of Paxlovid: consumer stated, "300 and 100, whatever that is." the first Paxlovid in 2023.Date and time of vaccination, anatomical location, route of administration and site of administration: Consumer stated, "We got our vaccines always in the left arm and (Withheld) (patient name could not be phonetically clarified) still has problems with her left arm hurting and I have another friend that has it in her 'leg' (further clarification UNKNOWN. Hence, split not made)." If any other vaccination on the same day or 4 weeks prior: Consumer stated, "No, we are both good and my arm never even swelled up that hard and theirs did. I did not even have a local reaction." During an inbound call for financial assistance, the patient, (Name Withheld), stated, "I have Covid "Later, (Name Withheld) advised, "I can barely hear you. I got you turned up all the way, but I still can't hear you very well. You gotta remember. I'm old. I'm old, and my ears are stopped up anyway. My best friend poured a jug of water in them a few weeks ago, and I still haven't gotten it all out yet. I'm using my caretaker's phone. She's got the damn COVID, too. We both got sick. I can't get out. Because I got the NPH, the Normal pressure hydrocephalus. (Name Withheld) got my disease back in May, I got mine in Mar a year ago, from the vaccine and the disease, long covid, and it makes fluid accumulate in your brain, so when that happens, you can't walk and you have bladder incontinence. But I cannot walk But I'm immunosuppressed and elderly, so you know what I'm saying...It's been a headache for me. I was not like this forever. It's hard to deal with it." Later, after going online to check her eligibility, (Name Withheld) stated, " I'm glad I took the damn Pfizer Shot, whether I got the COVID or not, right?" (Name Withheld) also stated, "I think I might start back sneezing. Oh Lord, I can feel it coming At least this COVID is better than the first one. It was a son of a bitch. I'm telling you. I didn't know where I was for three days. I just sat up in the bed with a high fever, threw up everywhere, and laid back down in it like a nasty person. I never knew I was even alive. It was bad that first one. I'm glad this strain isn't as bad. " While confirming the card details, (Name Withheld) stated, ". I'm choking to death. " Toward the end of the call, (Name Withheld) advised, ". And I've never done without the medication. I took the Paxlovid very, very quickly when I had the other, because I was so definitely ill. They just knew I wasn't gonna make it. My age and all that immune system crap. Of course, I didn't know I was in the world for three days, but whatever. I still survived it." (Name Withheld) also stated, "If I wasn't so hoarse. I can go get my meds, I can go get my meds. And be sure to tell this company. I do appreciate it. I did take their vaccine voluntarily. I was not forced. Both of us. So we both got repercussions. Because, I guess it was such a strong thing and that is a lottery thing. vaccines are just like the lottery. When you take it, it's not 100% guarantee on anything, and we're just glad to have the opportunity that we lived through it. " When asked to confirm if she had taken the Pfizer vaccine previously, (Name Withheld) stated, "I did." Note to DSU: This call was warm transferred to DSU agent (Name Withheld) , reference number (Withheld) ; however, the reportable safety information provided to (Name Withheld) was incomplete. Sending this source document to include: (Name Withheld) stated in Mar a year ago that she took the Pfizer Vaccine. Stated from the Pfizer Vaccine, she got Long COVID, NPH, Normal pressure hydrocephalus, and it makes fluid accumulate in the brain. She went on to explain that when that happens, you can't walk, and you have bladder incontinence, and she cannot walk. The patient also stated that she took Paxlovid during that previous bout of COVID. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Medical History/Concurrent Conditions: Immunosuppression