Age: 68.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Rash, Urticaria
Clinical narrative: getting a rash; I thought I was just getting the hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 68-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 09:30 as dose 1, single (Lot number: HG4680, Expiration Date: 01Dec2023) at the age of 68 years, in arm for covid-19 immunisation; for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), (Batch/Lot number: unknown), in arm. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE oral taken for hypothyroidism. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunisation, reaction(s): "rash", "hives". The following information was reported: URTICARIA (non-serious) with onset 17Oct2023, outcome "unknown", described as "I thought I was just getting the hives"; RASH (non-serious) with onset 17Oct2023, outcome "unknown", described as "getting a rash". The events "getting a rash" and "i thought i was just getting the hives" required physician office visit. Therapeutic measures were not taken as a result of rash, urticaria. Additional information: Transferring stated, "She is calling to report that she is been suffering from chronic hives over the last 3 years and she said she has a flare up of hives after every booster she has received and she confirms that she had Pfizer BioNTech COVID-19 Vaccine doses, her most recent dose was the new Comirnaty 2023-2024 formula for adults in October and right after that she has a giant flare up and she has seen 4 dermatologist and 2 allergist, she had no issues after her primary series doses (Later consumer stated, "It started when I first had the COVID vaccine.") and she had no issues, no flare-ups, no hives after the initial primary series doses however she has flare-ups after each one of the boosters that she has received. She said they had done food allergy test." When paraphrased the concern, consumer stated, "I am okay, however I am having the flare-up of the chronic hives." Age at time of Event: Consumer stated, "Right now I am 68 but it started when I first had the COVID vaccine, may be 66 (As consumer was unsure hence not captured). I do not have my vaccine card in front of me so whatever, so when the first COVID vaccine came out." Date and time of vaccine administration (Comirnaty): Consumer stated, "I had the Pfizer vaccine on 17Oct2023. It was like 9:30 in the morning." Dose: Consumer stated, "I have got this sticker from Pfizer, it just says, my date of birth, the date and then it is LOC number and then the Comirnaty or whatever it is and the dose is 12 years and up dose." Route of administration: Consumer stated, "It was in the arm."Indication: Consumer stated, "Yes, I have taken it many times (Further indication was not clarified appropriately over the call)."Other medication: Consumer stated, "Just a thyroid medication, I take a 100 mg of Levothyroxine, I take the non generic Synthroid, Levothyroxine, 100 mg (Units of dose was not further clarified hence not captured in tab) each morning for hypothyroidism."Dose, Frequency, Route of Administration, formulation: First thing in the morning with water, by mouth, one time a day, tablet.Treatment: Consumer stated, "Other than, I have been to 2 allergist and 3 dermatologist, No." Anatomical location: Consumer stated, "I do not remember, I could not tell you that today."If the vaccination was administered at Military Facility: Consumer stated, "No."Prior vaccination (Within 4 weeks): Consumer stated, "I had a flu shot."Consumer stated, "I have no record of that I just had a flu shot (Hence suspect captured Unspecified flu shot) from the same pharmacist."Date: Consumer stated, "On the same day, that is why I can not remember because they gave one on one arm and one on the other. Two different arms, one with flu and on one they gave me COVID vaccine on the other."Reassurance: Consumer stated, "No, I am all set. I guess I just wanted to confirm that other people might be having a rash or hives or something from the vaccine so I can stop going to an allergist or dermatologist and I just know know that this is what to expect." When probed if previous department has resolved the query, consumer stated, "They did, yes."  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381386 Same product, same event, different dose;