Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I have had 3 vaccinations and everything, and I still got covid; I have had 3 vaccinations and everything, and I still got covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Lot number: EW0187), in left arm, on 02Jul2021 as dose 2, single (Lot number: EW0217), in left arm and on 04Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis; "cancer survivor" (unspecified if ongoing); "I have hysterectomy" (ongoing), notes: I have hysterectomy; "Acid Reflux" (unspecified if ongoing), notes: Concomitant: PROTONIX [OMEPRAZOLE]; "Astigmatism" (ongoing), notes: I have had Astigmatism in my vision for since I was like 50 years. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE] taken for gastrooesophageal reflux disease. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have had 3 vaccinations and everything, and I still got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I have had 3 vaccinations and everything, and I still got covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Consumer stated, "I just wanted to share with you guys the weird thing from taking that Paxlovid thing. So I am, I have been 'in pedal', I have had 3 vaccinations and everything, and I still got covid and when I took your Paxlovid medication I was kind of almost like towards end of like may be it being an option for me because I didn't have temperature at that point and I think I just had the cough and runny nose instead (event captured conservatively). So my doctor prescribed it to me. I was only able to take it for a morning dose and night dose. Because the entire time I was like 2-3 hours into my taking it I could take bile in my throat  like the whole time so I decided that it was not going to, I didn't want to keep taking it at that point. But the really strange thing that occurred to me while I was on it I have had Astigmatism in my vision for since I was like 50 years, you know, and my Astigmatism actually went away when I was on that medication (Paxlovid) and my vision actually cleared up." Consumer was told about the role of Pfizer Drug Safety. Consumer stated, "I wanted you guys to document this thing with my vision because I thought that it was something, maybe I am one in a million that it happened to but may be its something that can be looked into down the road if I mean I was nice to have clear vision." Purchase Details for Paxlovid: First Dose: Consumer stated, "My first dose was on 11Jun2021. LOT# I think it is E, I think it is N, I don't know the hand writing, Oh I think its W, EW0187." Second Dose: Consumer stated, "It is 02Jul2021 and I got it at (withheld), the address I gave you. LOT# EW0217." Third Dose:  Consumer stated, "I got it at (name withheld). They do not write it clearly. It is 04Feb2022.Do you want the LOT#, okay its 33036 and then I don't know what comes after that, I can't tell for numbers or letters or what." Medical History: Consumer stated, "I am a cancer survivor, so and I have arthritis." Regular Medications: Consumer stated, "Yes, I had hysterectomy (Not clarified further, hence not captured) and several years ago so I am still taking hormones I am taking estradiol. And I take acid reflux (further not clarified) medication protonix or pantoprazole (further not clarified if the patient was taking brand protonix or pantoprazole hence not captured in tab) I think its official name of it. And then I also take Tylenol number 3." Lab Work: Consumer stated, "Not when I was taking all these medications, no. And I did stop, my doctor told me to not take the estradiol while I was taking the medication and to reduce my Tylenol #3  while I was on the medication and I did both things (Further clarification unknown, hence estradiol and Tylenol captured conservatively as suspect; Manufacture not clarified, hence tab left unchecked)." LOT# of Tylenol and Estradiol: Consumer stated, "The LOT# of the one that I was taking back when I that one I was when I took the Paxlovid. I don't know. So, because you know they, I might kind of have for Tylenol but I may not have for estradiol because they have put the prescription in other bottle. So the Tylenol, I don't have the LOT# for Tylenol. And estradiol I don't because they portioned it out to me in another bottle, you know, in prescription bottle." Treatment: Consumer stated, "Oh, no I just stop taking it. Well I had to take antidiarrhea pills because they (Paxlovid) gave me diarrhea." Prior Vaccinations: Consumer stated, "I do not have any vaccinations prior to my taking the Paxlovid. No, I did not." Route of administration and Dosage of Paxlovid: Consumer stated, "Yes, it was oral and so the night time dose that I took was 100 milligrams of ritonavir and then I had 2 tablets of the Nirmatrelvir and each of those tablets was of 150 milligrams. And so that was a night time dose. And then the morning dose was the exact same thing as the night time dose. Route of administration and dosage: Consumer stated, "Well, it was a shot in my left arm in the muscle I guess or whatever they were supposed to take it." Height & Weight: Consumer stated, "I am like 5 feet 6 inches and may be like 163 pounds." Follow up to doctor: Consumer stated, "I guess, I mean I can't speak for him (Hence, tab left unchecked)." Reassurance: Consumer stated, "Yeah, I mean I don't know if its safety issue or not, but I just like I was driving and I was like why are these red break light and street lights are so vivid and intense. And when I finally figured out what is what I was like oh my Astigmatism was gone. I mean like I am used to when I look it like seeing like this  like blurry fizzy 'yellow' like effect and everything and it was straight gone. It was gone for like 4 days. I only took 2 doses of medication but Astigmatism was gone for over 4 days until the stuff was out of my system. Description of Product Complaint: Concern: Consumer stated, "I just wanted to share with you guys the weird thing from taking that Paxlovid thing. So I am, I have been 'in pedal', I have had 3 vaccinations and everything, and I still got covid and when I took your Paxlovid medication I was kind of almost like towards end of like may be it being an option for me because I didn't have temperature at that point and I think I just had the cough and runny nose instead (event captured conservatively). So my doctor prescribed it to me. I was only able to take it for a morning dose and night dose. Because the entire time I was like 2-3 hours into my taking it I could take bile in my throat  like the whole time so I decided that it was not going to, I didn't want to keep taking it at that point. But the really strange thing that occurred to me while I was on it I have had Astigmatism in my vision for since I was like 50 years, you know, and my Astigmatism actually went away when I was on that medication (Paxlovid) and my vision actually cleared up. First Dose: Consumer stated, 11Jun2021. LOT# I think it is E, I think it is N, I don't know the hand writing, Oh I think its W, EW0187. Second Dose: 02Jul2021 LOT# EW0217, Third Dose: 04Feb2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.