Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 82-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies to Penicillin" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Indication: Allergies. Concomitant medication(s) included: OLMESARTAN (ongoing); BYSTOLIC (ongoing); ZOCOR; CETIRIZINE taken for hypersensitivity (ongoing); FLUTICASONE nasal (ongoing); IPRATROPIUM BROMIDE (ongoing); OMEPRAZOLE (ongoing); LORAZEPAM (ongoing); DILTIAZEM (ongoing). Past drug history included: Clonidine, reaction(s): "Allergies to Clonidine.", notes: Allergies to Clonidine. The following information was reported: PRURITUS (non-serious) with onset Feb2021, outcome "not recovered", described as "itchy". The event "itchy" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus. Description of Product Complaint: Consumer stated, "Well, I have taken 2 vaccines (Unspecified vaccines) and 2 boosters and I had COVID lets see when I had it on, anyway it was 31Jul, I had the COVID and I was over it 02Aug of this year. I was given by my doctor, it is called Paxlovid. Anyway, between the vaccine and the medication (Paxlovid), I have had these itchy things all over me since Feb2021 and my doctor did give me an antibiotic (Unspecified medication) but it didn't work. I am calling to see what you recommend that I use to get rid of this itching. It is like having hives or something." On paraphrasing the concern, Consumer stated, "Yes, and not just in one place, it is all over my body, my legs, my arms." Product details, Pharmacy details and other details could not be probed as consumer hung up abruptly. Hence further probing could not be done. Limited information available over the call. Consumer was informed about the role of Pfizer Drug Safety. Consumer was informed about the Pfizer department and telephone# was shared as (number withheld), option 3, 8 AM to 9 PM, Monday to Friday, as per EST. Product details, Pharmacy details and other details could not be probed as consumer hung up abruptly. Hence further probing could not be done. Limited information available over the call. QR Comment: Reporter type could not be probed hence captured by default as Consumer or other non-health professional in tab. Warm transfer, GRACE: INT-00732936 with a consumer who is the patient on the line reporting adverse events with Pfizer BioNTech Covid-19 Vaccine. She had the 2 Pfizer BioNTech Covid-19 Vaccine doses and then 2 booster doses. Then she got COVID. She was prescribed Paxlovid. However she reported that since the first series of the vaccine she has had this. itchy rash all over her legs, arms and body that's like getting hives. She reported her doctor gave her antibiotic but it wouldn't go away. She called for recommendations on what to do. cannot give her any recommendations. Caller clarified that she has had 4 doses of Pfizer BioNTech Covid-19 Vaccine including 2 standard doses and 2 booster doses. She clarified that she has had COVID twice since getting Pfizer Covid-19 Vaccine; the first was before her second booster dose; and the second was after her second booster dose. She has lasting effect from second bout of COVID of dry cough which she never had before. She reported onset of the itchy rash all over her legs, arms and body that's like getting hives was about a week or so after her first bout of COVID. She verified other information provided. Doctor gave her the antibiotic in Dec2021 when she had COVID thinking it was hives and it didn't work. She does not know the name of the antibiotic, she only had it for a week or so in Dec2021. The itchy rash gets worse when you get COVID. She still has the itching, she does not know if it is hives or what it is but it's very annoying. The itchy rash got worse every time she had a vaccine and then when she had Paxlovid it really made the hives itch. Completed prescribed therapy as far as they've advised so far. Regarding treatment and medical interventions they gave her the infusion for COVID on 09Dec2021. She started Paxlovid 02Aug2022. Then she tested negative for COVID on 05Aug2022 so she stopped the Paxlovid 05Aug2022, that was the date she took the last Paxlovid. Caller was unable to locate Lot/Expiry on the product packaging, box. She provided from the blister pack itself: Lot: She reported this is hard to read on blister pack, she can't understand it, there's letters in there she can't make out. She got another blister pack and thinks the Lot is GC9419 and Expiry is Mar2023.Patient has had 4 doses of Pfizer BioNTech Covid-19 Vaccine including 2 standard doses and 2 booster doses. Patient had COVID twice since getting Pfizer Covid-19 Vaccine; first before second booster dose; second after second booster dose.EN6201, FE3590, PJ4989. All expiries unknown, caller did not have products with them and this is not on CDC vaccine record card.