Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Intense itching; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA319539 (Sanofi).  A 66-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Oct2024 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Sep2024 as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Blood cholesterol increased" (ongoing); "Hypertension" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; ROSUVASTATIN CALCIUM taken for blood cholesterol increased. Vaccination history included: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: URTICARIA (non-serious) with onset 10Oct2024, outcome "recovering", described as "Hives"; PRURITUS (non-serious) with onset 10Oct2024, outcome "not recovered", described as "Intense itching". Therapeutic measures were taken as a result of urticaria, pruritus.  Additional information: Initial information received on 24Oct2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a female patient who had hives and intense itching after receiving vaccines influenza vaccine and covid-19 vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Blood cholesterol increased and Hypertension. Concomitant medications included Lisinopril (Lisinopril) for Hypertension; and ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol increased. On 19Sep2024, the patient received unknown dose of suspect influenza vaccine (unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination. On 07Oct2024, the patient received unknown dose of suspect COVID-19 vaccine (unknown strength, formulation, lot and expiry date) not produced by Sanofi Pasteur via intramuscular route in the arm NOS (Not otherwise specified) for Covid-19. On 10Oct2024 the patient developed hives (urticaria) and intense itching (pruritus) (Latency 3 days) following the administration of COVID-19 vaccine and (Latency 21 days) following the administration of influenza vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, I just recently got the latest Covid vaccine (Later clarified as Pfizer COVID-19 Vaccine) two weeks ago. I have gotten all of the vaccines from Pfizer and this is the only time that, I got it on October the 7th (Later clarified as 7Oct2024) and on Thursday, the 10th (Later clarified as 10 Oct2024), I started to break out in hive and intense itching and that is still going on. I still have hives. I do not know, I went on Prednisone for three days that helped but then it came back. So, I went to my doctor yesterday and I am on antihistamines three times a day and some heavy creams but I must have been, I do not really know. I must been sensitive to perhaps what they are telling me, the preservatives in the vaccine. After that steroid treatment (Unspecified medication) came, then they just came back. So, I went to the doctor yesterday again and as I said I am on heavy antihistamines and cream and hopefully these go away soon. Other medical conditions and other medications: Consumer stated, "I take a Stain, Rosuvastatin I guess it is. It is called rosuvastatin, I think it's called Crestor, 5 milligrams." When probed for which medicinal condition, patient is taking Crestor, consumer stated, "High Cholesterol. Yes, hives are still here and yes." Outcome: Consumer stated, "It is improved sightly but I am taking a lot of antihistamines. consumer stated, "I got the flu shot on September 19th. Action taken was not applicable. The patient was treated with prednisone for Urticaria and antihistamines three times a day and some heavy cream. At time of reporting, the outcome was Recovering / Resolving for the event hives and was Not Recovered / Not Resolved for the event intense itching.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.