Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: Unknown. The reporter is the patient. A 71-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 2, single (Lot number: EW015), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 71 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: Note: GERD; "Hemithyroidectomy", start date: 2011 (unspecified if ongoing), notes: Note: Hemithyroidectomy. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroidectomy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She already have first and second dose of the Covid-19 Vaccine as well as the booster dose, so tested positive". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Negative; Body height: (unspecified date) 5.25; Endoscopy: (unspecified date) Unknown results, notes: I am going to have a endoscopy something I want to find out, its going on for 3 years now; SARS-CoV-2 test: (unspecified date) Unknown results, notes: I have used 3 of them now because I had different test it didn't work; (unspecified date) Unknown results, notes: I have used 3 of them now because I had different test it didn't work; (unspecified date) Unknown results, notes: I have used 3 of them now because I had different test it didn't work; (unspecified date) Positive; (Apr2022) Negative; (Apr2022) Negative; Weight: (unspecified date) 118; (unspecified date) 115. Additional Context: "I have caller on hold she is a consumer, she mentioned that she already have first and second dose of the Covid-19 Vaccine as well as the booster dose. So tested positive and also had some adverse events just tingling of feet and she tested positive so, she wants to know the expiration date for the whole test kit that she has and where to get another box for whole test kit." Consumer stated, "Hold on just for a sec I need to turned it down a little bit hold on. I got till you were giving me list of called and above could you just says those again slowly. Right so I have a thing called Clinitest rapid Covid-19 antigen self-test there were five its from (Withheld) and there are five test and I have used 3 of them now because I had different test it didn't work. I knew I was getting sick after two an half years I am very careful, I went to an art exhibit and most of the people they were not wearing mask and I two couple days later 2-3 days later I started felling unusual things and I figured that I had Covid and had some tested and handed it out free here in my community and they showed I was negative. But then I have ordered before I got those test because I didn't know they were available I sent way to government and find some government test and afterwards I had got this mail and when I got Covid I had both types of test and the one I had alterably found out I had Covid from Clinitest rapid and even I did the everything on the same day the other one said I was negative this was only the one worked so I wanted to get some more of this because I have a friend who got Covid twice and even after she have two initial vaccines and booster (Further information was not available over the call hence, split was not made). So I have those and I am 76 so I wanted to make sure if I feel sick again and I have some symptoms I don't know if they are from the virus or from the vaccination. I have been read on upon from the side effects from the vaccination and I was deprived to see that some of the other things I have been experiencing on that list so, I just didn't even think they could be associated with the vaccine itself the shot. "Consumer stated, "You have no way to track this remaining two test still good you don't know how to do that or you don't have capability of doing that. Date of birth: "I am 76 years old that's what I tell you I don't give out my date of birth because people can track you in fraudulently. Start Date of adverse event: Consumer stated, "It was in April I think because I wrote it down hold on I think I now where I got it. I didn't experienced I had it treated afterwards. So I went to art exhibit April 6th and most of the people attending the exhibit didn't have mask on and masking was take it way in prior month February. The day I started experiencing symptoms were Saturday the month of April and than I took a test Sunday that was first day when I took this and it was negative and I had other test that I am trying to get more of and that was the test it that was rapid Covid-19 antigen self test I tested positive than I on the 10".  Height and weight, consumer stated, "I lost some height I am 5.25 (Further clarification unknown hence, captured as event) now and I weight about my weight varies my weight about let see I don't know let say 118, 115." (Further the height and weight is not clarified hence, not captured in tab). Facility name, consumer stated, "Where I got it I told you I got at art exhibit the (Withheld) of art I went to see exhibit lot of people there probably." Facility name, consumer stated, "(Hospital Name Withheld)." LOT# for 2nd dose, consumer stated, "2nd one I got in April and lot# EW0151 and its was 01Apr2021 same location (Withheld)." LOT# for booster 1st dose, consumer stated, "The LOT# FH8020 and the date was 20Oct2021 and I got it at (Withheld) and that's it I didn't get the second booster yet whatever question I was hoping to answered today. You were the person that was going to answer but I was miss lead by prior person I thought I was going to reconnect to someone and ask some question". Informed about Pfizer Medical Information: Consumer stated, "Say that again. This is the right department or the wrong department? Okay so I can ask you question. Okay so you can't help me with expiration date. So that's what I really need to know but I wanted to know since I got Covid and you have the dates of my vaccination and my age. I wanted to know, my understanding is you have 5 months between first vaccination and second one where you can get the second one but since I have had Covid in between I am just wondering I am still should be getting the second booster. Now as I think I am eligible now in May but I was told that we were probably going to have another search in the fall so I was thinking that it might be better for me to wait and because I don't know if there is going to be third booster may be wait until just before the fall. Whenever they think the search is starting to happen. Whether I should wait to get my second booster until then. Can you answer that question?" Consumer was informed about the role of Pfizer Drug Safety, consumer stated, "For what question can you answer. I don't want to waste your time. What sort of question as a Pharmacist are you able to answer. Side effects? Are you able to answer side effects question. Yes or No. You just file a report. Okay since you can't answer my question and why don't you ask me any of the other question that you need to know and the I can try to get the hold of them although they are not going to be available until probably Monday till Tomorrow. Do you have any other questions that you need to know from me. Okay let's wrap it up Because I have been on Phone long time now and nobody has helped me here so. Okay go ahead what else you need to know." LOT# Confirmation, consumer stated," Okay so I can't verify them, it's like get it them all again. Why don't you just assume that you got it all right." Anatomical site, consumer stated, "The first one was in my left. They were both, the first two were in my left because I was in my Car so they were in my first. And the second one I am not sure I did it at (Pharmacy Withheld) So I was sitting in chair. I don't remember." Other medication and Other Medical condition, consumer stated, "Am I suffering from any other medical condition ad what was the second part? Am I taking any medication? Any of my own medication separate from the virus medication Is that what you are asking? Okay I take Levothyroxine (25microgram, once a day, a tablet), And the reason I take it is Hemithyroidectomy in 2011." Treatment, consumer stated, "For the side-effects that I have from the virus I have experienced and that was the reason I wanted to look up my dates. I have been having some problems I don't think that they were associated with vaccine but I was doing some reading today and saw that all my symptoms were on the list and there were many symptoms and my symptoms could be from something else but I had tingling in my feet, for a long time I didn't know what it was and I had swelling with the first test , when I first noticed I had tingling my legs swelled up below my Knee my whole from my ankle to my knee I had swelling, numbness and tingling in my feet I still have it. The swelling I went to the Emergency hospital and they told me that I am negative for lot of thing but I needed to be sure that I slept in prone position because I had just moved and falling from feet on the chair a lot of time and I needed to put some constrictive stocking and elevate my feet to get the flowing to go down. So I went out and bought some stocking and then wore it for maybe for 3 or 4 weeks and the swelling did finally go down. And I tried to elevate my leg as much as I could but I was moving and not getting around. And the I had raspiness in my throat which got worsen since I got Covid this raspiness gotten down into my chest since I have kind of cough, a deep cough that sounds like the kind of cough when you have cold, kind of like and I have had little bit of. So it effects my voice and I am singer and my speaking voice it feels like sand paper when I talk like right now. So I am doing some test to find out if something is going on in my esophagus I use to have GERD. You know what GERD is right. So I took some medication for few years after my Hemithyroidectomy, I had some Raspiness as then and then they took the medication off the market that I was taking called Ranitidine I stopped taking for a while and then because raspiness is a kind of gone away and it came back and I got new prescription the drug may be few weeks after that was taken off the market so I stopped taking it. Medication for my GERD so it has come back something is happening in my esophagus and I am having some test at the end of months variant so I am going to have a endoscopy something I want to find out, its going on for 3 years now. I did have so you wanna things I lot a had Covid now still happening is that what you wanna know is that you want to know both. I have been taking I just went to a doctor about two weeks ago a new doctor and she gave me this is after months and months these things going on this is new doctor two doctor now. He gave me two prescriptions one I have been taking and other one called Protonix its a 40 milligram tablets I take one a day doctor gave me for weeks doses of a day that's for my throat, probably of GERD or whatever is causing something in my coming up my stomach acid, I am not sure and they gave me another for my feet but I have not start taking it yet because when I read the contraindication it said that if people are trying to suicide or start have thought of suicide. (Further clarification unknown) when I take it should take it or should stop taking it and it sound it pretty well so my doctor is on vacation he is coming back tomorrow and I have appointment with him to find out I careful about what I take because of my age. I don't want to start taking something have some wired side effect you know what I mean so I am going to talk to him before start taking it or may not take it what he says. So these only the two things I had for my symptoms and my symptoms may or may not be related to the virus or vaccination I don't think about these vaccines but when I started reading I started taking the dates of my symptoms and it was after I moved here and that was right after those two first vaccination thinking about nobody is able to say what going on with me I wonder if I have side effects with vaccination. I will say the list I saw was not from Pfizer list it was from (Brand name withheld) list but there was list thing kind of common side that people I don't know what is causing my symptoms I had lot of blood test I thought may be diabetic something my in family had symptoms on feet but all tested negative so that was the interesting thing that may be thinking caused by vaccinated that is the reason I called you guys." Is there a product complaint to report? Yes. Description of Product Complaint: Call was transferred from Pfizer Support by (Name Withheld) (CEP ID: Unknown). Employee stated, "I have caller on hold she is a consumer, she mentioned that she already have first and second dose of the Covid-19 Vaccine as well as the booster dose. So tested positive and also had some adverse events just tingling of feet and she tested positive so, she wants to know the expiration date for the whole test kit that she has and where to get another box for whole test kit." When paraphrased above concern, C stated, " Right so I have a thing called Clinitest rapid Covid-19 antigen self test there were five its from (Withheld) and there are five test and I have used 3 of them now because I had different test it didn't work. I knew I was getting sick after two an half years I am very careful, I went to an art exhibit and most of the people they were not wearing mask and I two couple days later 2-3 days later I started felling unusual things and I figured that I had Covid and had some tested and handed it out free here in my community and they showed I was negative. But then I have ordered before I got those test because I didn't know they were available I sent way to government and find some government test and afterwards I had got this mail and when I got Covid I had both types of test and the one I had alterably found out I had Covid from Clinitest rapid and even I did the everything on the same day the other one said I was negative this was only the one worked so I wanted to get some more of this because I have a friend who got Covid twice and even after she have two initial vaccines and booster. So I have those and I am 76 so I wanted to make sure if I feel sick again and I have some symptoms I don't know if they are from the virus or from the vaccination." LOT# for 2nd dose, consumer stated, "2nd one I got in April and lot# EW015." LOT# for booster 1st dose, consumer stated, "The LOT# FH8020." This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in system. Refer to the below table for details: AE Ref No. (CC): # PR ID (CR):. Product- Description (CR): Compound BNT162B2 Covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1. Lot-# (CR): EN6199. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6199 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6199, fill lot EN5331, and the formulated drug product lot EN5320. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: #. PR Link (Previously Investigated CR):. AE Ref No. (CC): # PR ID (CR):. Product- Description (CR): Compound BNT162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial X 1. Lot-# (CR): EW0151. Conclusion of Previously Completed Investigation (FCI/SI/OffCI)*: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0151 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0151, fill lot EP8691, and the formulated drug product lot EP8588. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: #. PR Link (Previously Investigated CR): #. AE Ref No. (CC): # PR ID (CR): #. Product- Description (CR): Compound BNT162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial X 1. Lot-# (CR): EL3247. Conclusion of Previously Completed Investigation (FCI/SI/OffCI)*. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: #. PR Link (Previously Investigated CR): #. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. No follow-up attempts are needed. No further information is expected.