Age: 75.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19
Symptoms: Erythema, Off label use, Product use issue, Pruritus, Rash macular
Clinical narrative: Erythema- weals and red blotches face, front and back torso, arms legs , itching; Erythema- weals and red blotches face; Erythema- wheals and red blotches face, front and back torso, arms legs , itching; Patient started having hives/Hives was red; Off label use; Co-administration of Bivalent Pfizer BioNTech COVID-19 Vaccine and Flu Vaccine/ Product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 10:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 75 years, in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 21Oct2022 as dose 1, single (Lot number: UJ901AA) intramuscular, in right arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Known allergies: eggplant" (unspecified if ongoing); "Known allergies: bananas" (unspecified if ongoing), notes: Known allergies included bananas- itchy inner ears to food listed; "PVC" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: PREVACID; MAXIDE; LIPITOR; ATENOLOL; ZOLOFT. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". Vaccination history included: Covid-19 vaccine (Dose 1, Single, Lot number- UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Lot number- UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Single, Lot number- UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, Single, Lot number- UNKNOWN), for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 21Oct2022, outcome "unknown", described as "Co-administration of Bivalent Pfizer BioNTech COVID-19 Vaccine and Flu Vaccine/ Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 21Oct2022, outcome "unknown"; URTICARIA (non-serious) with onset 23Oct2022, outcome "recovering", described as "Patient started having hives/Hives was red"; RASH MACULAR (non-serious) with onset 23Oct2022 at 12:00, outcome "recovering", described as "Erythema- weals and red blotches face"; PRURITUS (non-serious) with onset 23Oct2022 at 12:00, outcome "recovering", described as "Erythema- weals and red blotches face, front and back torso, arms legs , itching"; ERYTHEMA (non-serious) with onset 23Oct2022 at 12:00, outcome "recovering", described as "Erythema- wheals and red blotches face, front and back torso, arms legs , itching". The events "erythema- weals and red blotches face, front and back torso, arms legs , itching", "patient started having hives/hives was red", "erythema- weals and red blotches face" and "erythema- wheals and red blotches face, front and back torso, arms legs , itching" required physician office visit. Therapeutic measures were taken as a result of pruritus, urticaria, rash macular, erythema. Additional information- Patient was not pregnant at the time of vaccination. Patient was 75-years-old at the time of vaccination. Patient did not receive any other vaccine in four weeks. Other medications in two weeks included Prevacid, Maxide, Lipitor, Atenolol, Zoloft, Vitamin. Patient experienced Erythema- weals and red blotches face, front and back torso, arms legs, itching. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse event which included Benadryl and Singular. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Patient had known allergies to Penicillin, Codeine, eggplant, bananas as itchy inner ears to food listed. Other medical history included High blood pressure, GERD. Patient started having hives. Patient had medical history of HTN, PVC, GERD, anxiety and depression, hyperlipidemia, seasonal allergies. Patient was allergic to Codeine, Penicillin. Patient started having hives on Sunday. Hives are present all over her body, face, arms, torso, back, legs. Hives are red, itching, spots and blotches. The adverse events did not prolong hospitalization. Facility where the most recent COVID-19 vaccine was administered was reported as Doctor office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was prescribed with antihistamines from dermatology. It was unknown if patient was diagnosed with COVID-19, prior to vaccination. It was unknown if patient was tested for COVID-19 since having the vaccination. Device Date was reported as 28Oct2022.