Age: 64.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body height, Hypersensitivity, Lip swelling, Malaise, Off label use
Clinical narrative: my lips were swollen, so I have got like an allergic reaction to vaccine, it has never happened before; my lips were swollen, so I have got like an allergic reaction to vaccine, it has never happened before; I am just feeling very pathetic; I got the Flu shot (Unspecified Flu shot) yesterday too; I got the Flu shot (Unspecified Flu shot) yesterday too; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose 5 (booster), single (Lot number: GM1767) at the age of 64 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 13Dec2022 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 01Mar2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Single), administration date: 22Mar2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (Dose 3 (Booster). Single), administration date: 14Oct2021, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (Dose 4 (Booster), Single), administration date: 08Aug2022, when the patient was 64-year-old, for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 13Dec2022, outcome "unknown" and all described as "I got the Flu shot (Unspecified Flu shot) yesterday too"; HYPERSENSITIVITY (non-serious), outcome "unknown", LIP SWELLING (non-serious), outcome "recovering" and all described as "my lips were swollen, so I have got like an allergic reaction to vaccine, it has never happened before"; MALAISE (non-serious), outcome "unknown", described as "I am just feeling very pathetic". The patient underwent the following laboratory tests and procedures: Body height: like 5 (feet) 3 (inches); Weight: 145 lbs. Therapeutic measures were not taken as a result of hypersensitivity, lip swelling.  Clinical Information: Consumer stated, the patient called cause she actually received a booster of the Pfizer Bivalent (Pfizer COVID-19 Bivalent Vaccine) it says on her card. She received yesterday and last night, around 2 O'clock - 3 O'clock in the morning, this morning, "my lips were swollen, so I have got like an allergic reaction to vaccine, it has never happened before." Consumer stated, 13Dec2022, yesterday Tuesday she got it (13Dec2022). consumer stated, yes, she got people were saying that if there is any reaction to give you guys a call. So her lips swelled up and she just feeling very pathetic on this as well. Her lips swelling went down she didn't go to ER or anything like that but just informing. Consumer stated, Height, I am like 5 (feet) 3 (inches), 145 (pounds), she don't have the exact weight right now. Consumer stated, she don't know what it is, there is a date on it, it only has yesterday's date she don't know the expiration, they didn't write it down. Consumer stated, she don't have that either. She only have what's written on her card, Pfizer bivalent GM1767, yesterday's date and then the clinic name, that's all her card says. Consumer stated, "That's what I am trying to find for you because there is any different location. It is my left, left arm, I believe it was, I got the Flu shot (Unspecified Flu shot) yesterday too, and I can't remember which arm they did one on each arm, I can't remember right now which arm was for which vaccine." Consumer stated, It was a COVID Booster. First and Second Shot of COVID-19 Vaccine: Consumer stated, first one was 01Mar2021 and the 2nd was 22Mar2021. And then she had 2 other boosters in addition and yesterday was her third Booster. Consumer stated, 14Oct2021 and the Second booster was 08Aug2022. Consumer stated, At 2 O'clock in the morning, this morning (14Dec2022). Still experiencing the adverse events. Consumer stated, "I am not, the swelling went down." Consumer stated, "No I didn't, I didn't take anything I just, I was just waiting around to see if it would go down and it went down on its own, but I didn't take anything for it because it was just my lips, it wasn't my face or anything else."