Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Interchange of vaccine products, Pruritus
Clinical narrative: All previous COVID-19 vaccines were Moderna COVID-19 Vaccines; local itchiness; 3-inch diameter of erythema/redness; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team,   An 80-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 15:00 as dose 3 (booster), 0.3 ml single (Lot number: GH9693, Expiration Date: Jun2023) at the age of 80 years intramuscular, in left deltoid for COVID-19 immunisation. The patient's relevant medical history included: "Drug sensitivities and allergies" (unspecified if ongoing). Concomitant medication(s) included: TRICOR [FENOFIBRATE] (ongoing); VITAMIN D NOS (ongoing). Past drug history included: Rosuvastatin, start date: Sep2022, stop date: 2022, reaction(s): "Itch", notes: Lot: 19222155, Expiry: Apr2024, Strength: 10mg; Ampicillin, start date: 1972, reaction(s): "allergies", notes: 50 years ago; Trimethoprim sulfur, reaction(s): "allergies", notes: few years ago, reaction twice. Vaccination history included: Moderna COVID-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Moderna COVID-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Flu vaccine (many years ago, lymph nodes also), reaction(s): "allergic", "local rash", "local swelling"; Flu vaccine (last year, without an event), administration date: 2021, for Influenza immunization. The following information was reported: PRURITUS (non-serious) with onset 07Oct2022, outcome "not recovered", described as "local itchiness"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 07Oct2022 at 15:00, outcome "unknown", described as "All previous COVID-19 vaccines were Moderna COVID-19 Vaccines"; ERYTHEMA (non-serious) with onset Oct2022, outcome "not recovered", described as "3-inch diameter of erythema/redness".  The reporter considered "all previous covid-19 vaccines were moderna covid-19 vaccines", "local itchiness" and "3-inch diameter of erythema/redness" not related to BNT162b2, BNT162b2 OMI BA.4-5.  Additional information: The patient received the bivalent Pfizer BioNTech COVID-19 vaccine on 07Oct2022 at about 3:00 PM in the afternoon. It was that evening, an hour or 2, later in the evening she was itching. It was within a couple hours of being back home, certainly within 3 to 4 hours. As of last night, she was still having it. The patient has a history of drug sensitivities and allergies and other things. The reporter stated he had seen a couple of situations where it was not a drug allergy but was really related to inert ingredients and not the product. The reporter suspects that this was a local reaction. The reporter looked at the patient's arm and saw what he estimated to be a 3-inch diameter of erythema. He was sure it got worse over 48 hours because of the amount of erythema and large area. The reporter didn't know about when the redness started; it was certainly red the next day. Regarding causality, the reporter thinks the itchiness was due to the preservative. It was an irritating reaction to something or a component, an inner component, not the vaccine itself. At least 10 days ago, the patient was started on generic rosuvastatin. She took one dose and a couple of hours later had itch. That has quit. The reporter stated it was possible she was allergic to statin, but can't find anything in reading about allergy to statin. Many years ago, she had similar type reaction to flu vaccine, he thought it was swelling and rash. She said lymph nodes also. She stopped taking flu vaccine and she thought she was allergic. She took flu vaccine last year without an event, but he was not sure. The reporter stated he knows flu vaccine reaction was many years ago. It was a local reaction. It wasn't anaphylactic or itchy all over body or rash.; Sender's Comments: The causal association between the events of vaccine products, Pruritus and Erythema and the suspect drug BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be totally excluded but also consider possible contributory effects from patient's medical history.