Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
I am positive; I am positive; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: I have a history of asthma; "I am a cancer survivor" (unspecified if ongoing), notes: I told you that I had cancer, well then I have some conditions. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Sep2025, outcome "unknown" and all described as "I am positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Sep2025) positive, notes: my husband had a little box of the test, and it turns out, I am positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Brief Description of event: COVID After Paxlovid. Event description (include event onset and end dates and event outcomes, whenever possible):During an inbound call for financial assistance, the patient, (name), stated, "she had COVID, she got the COVID vaccine on the 15th, which she was due to get. she got it in (name). She had been traveling here for a few days, and that was on the 15th. On Monday night, she started to feel a little bad, and on Tuesday, she woke up terribly, and she took the test on Wednesday. She thought it might've been something else on Wednesday, which it was last night, her husband had a little box of the test, and it turns out, she was positive. She was 78 years old she had a history of asthma. She had always gotten the Moderna that vaccine, but well, Pfizer was very good too, and here they didn't have Moderna, and she said no, give her Pfizer, since it was very good too, so she received her vaccine. Well, then Wednesday, last night, her husband gave her the test, and indeed, she had COVID. She was a cancer survivor; in addition, she had asthma, so she was the age, the asthma, and the cancer. So, she was very afraid because she don't even have her family there, and her doctor called (name), which was where she received the vaccine, and he told her you hurry and take the Paxlovid pills. So, he sent the order, and she went out because she was feeling terrible, she went out to look for i. She called her insurance and they told her, look, understand, the only thing they can do for her was give her this person who has a program to see if they can help her, because she was running a huge risk like this she was not at home, she don't have her family, and with all the risk that she had" When being offered the enrolment options, (name) stated, "she was 78 years old, she feel like a dog but look how she was now, she don't feel up to go in-what she had is an (name), with this discomfort that she had, she was having too many difficulties to breathe. She'd rather talk to a human, not with the computer, that's all it's going to stress her and she was going to put her worse.She don't have the money to pay (dollar) for a pill. She'll tell them, 8 more or less or 9 months ago, her granddaughter got the A-Flu, and she, without knowing it was so contagious, she got close to her, she kissed her, rubbed and everything that was 8 or 9 months ago. When her son gets from work, he says 'Mom, what he was doing? they can get sick. What were they thinking? Go hurry call to (name).' Who was her primary doctor? She called him and he sent me Paxlovid, and it cost her (name), that was 8 months ago. She was terribly afraid that she'll drown and die here like an idiot" When asked if this was the address where she resides, (name) stated, "Well, look, she was here because her husband was working here, but it's not permanent. When confirming that was her address, she asked for a moment, and (name) can be heard in the background stating, "she was really sick, she think she had COVID. She feel really sick, she was kind of drowning, and she don't want to infect them. She don't want them to come in and get sick" Then (name) and states, "She can't receive anyone, nor open the door, nor infect them with this disease" When asked to confirm if she has a prescription for the medication, (name) stated, "Yes, yes, everything, and today was the last day that the doctor wants her to take it because then afterwards she can't." When being explained about the program income requirement, (name) stated, "she was retired. she's an old lady. She was a decorator. She was left without of job, so like she told them that she had cancer, well then she had some conditions because she had 36 radiotherapies on the rectum and then they burned her rectum guts, they burned her bladder, they know, those were damages that appear later on, so she can't be working a lot either. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Asthma (I have a history of asthma); Cancer (I told you that I had cancer, well then I have some conditions)
Test Date: 20250903; Test Name: COVID Test; Test Result: Positive ; Comments: my husband had a little box of the test, and it turns out, I am positive.