Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Magnetic resonance imaging, SARS-CoV-2 test, Vaccination failure
Clinical narrative: a high level of inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Lot number: 32030DD, Expiration Date: 28Feb2022) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Pulmonary embolism" (unspecified if ongoing); "Blood clots" (unspecified if ongoing); "Cancer" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 01, Batch Number: EN6203, Expiration date: 30Jun2021), administration date: 22Feb2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "a high level of inflammation"; BNT162b2 (Dose Number: 02, Batch Number: EN6207, Expiration date: 31Jul2021), administration date: 15Mar2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "a high level of inflammation". The following information was reported: INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "a high level of inflammation". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Consumer stated, Okay, I am taking, I was diagnosed with COVID, Monday and my symptoms started Sunday so, my doctor gave me Paxlovid, and Tuesday I started the dosage. I have had a pulmonary embolism (Intent: Medical History), I have had several blood clots so, I am on blood thinners. The blood thinners that they labelled on the interaction wasn't the one that I am on Eliquis. So, he put me on it because of my age and all of what you know, the symptoms. So, I am on my last day, and I went into the bathroom, and I started brushing my teeth and I know, with blood thinners and all that if your gum start bleeding then your blood is thin. So, my gum started bleeding so, I was wondering what to do, should I finish the last dosage or call my doctor. Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information department and telephone# was shared as withheld, option 3, 8 AM to 9 PM, Monday to Friday. Consumer was requested to contact healthcare provider for the concern. Further Questions: Consumer stated, can you call back What are they, they are questions about the drug Okay, go ahead and ask the questions. Mailing Address: Consumer stated, "You probably have me in the system (Further clarification unknown if consumer called earlier in Pfizer Drug Safety hence, checked as an initial report) because I had a reaction to the booster (Pfizer COVID-19 Vaccine) and everything. I had reaction with every shot yes, with the vaccine and everything, I had a high level of inflammation from it, from COVID. Product Details of Paxlovid: LOT#, Expiration date, NDC# and UPC#: Consumer stated, "Where is, you mean this number where the bar code is Where is the expiration date on it, I don't see the expiration date. The only thing I see is the bar code saying 300691 that type of stuff. Product Details of Eliquis: LOT#, Expiration date, NDC# and UPC#: Consumer stated, Okay, the LOT# is SN1018 looks like a S, with a S behind it. Sep2024 (Expiration date clarified as Sep2024). Consumer stated, here it is NDC 0069-1085-30, this is for your Paxlovid. For the Eliquis you want? It says SN, is that the number you want. Product Details of Pfizer COVID-19 Vaccine: Lot# and Expiration date: Consumer stated, Okay, the first one was EN6203, 22Feb2021, that's when I had the vaccine, or do you want expiration date of that. Expiration date for that first one was 30Jun2021.Okay, for the second one it was EN6207, expiration date is 31Jul2021, I received that 15Mar2021. The last one was 32030DD, expiration 28Feb2022, those are the three (Pfizer COVID-19 Vaccine) that I have taken. I took that on 01Dec2021). Start date of Paxlovid: Consumer stated, Whatever date Tuesday is, I don't know what the dates are right now. Medical Conditions and Concomitant Medication: Consumer stated, "Only the blood thinners and blood pressure. Laboratory Test: Consumer stated, I haven't had any blood in the last two weeks, I just went for MRI because I had cancer. Treatment: Consumer stated, no, I haven't. Whenever my gum start bleeding usually if I am on blood thinners, I stop the blood thinner for a while (Further clarification unknown hence event captured conservatively). Consumer stated, I also get with the drug (Paxlovid) there is a metallic taste in my mouth. Reassurance: Consumer stated, no, thank you.  Follow up attempts are completed. No further information is expected.