Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Product administration error, Vaccination site mass, Vaccination site pain, Vaccination site reaction
Clinical narrative: it was not given in her muscle, but rather in the soft tissue of the arm; 2 inch big red spot where the injection was; 2 inch big red spot where the injection was; she has a lump and it was very sore; she has a lump and it was very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 at 15:30 as dose 4(booster), single (Lot number: FJ4981) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN oral taken for blood cholesterol, start date: 2022; FOSAMAX oral taken for osteoporosis, start date: 2022. Vaccination history included: BNT162b2 (3rd Booster Dose, single, Location: Left Arm, Time:3:30PM), administration date: 28Oct2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (2nd Dose, single, Location: Left Arm, Time:10:45AM,  lot ER2613.), administration date: 29Mar2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (1st Dose, single, Location: Left Arm, Time:10:30Am, lot EN6202), administration date: 08Mar2021, when the patient was 62-year-old, for Covid-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious) with onset 10May2022 at 15:30, outcome "unknown", described as "it was not given in her muscle, but rather in the soft tissue of the arm"; VACCINATION SITE REACTION (non-serious), ERYTHEMA (non-serious) all with onset May2022, outcome "recovering" and all described as "2 inch big red spot where the injection was"; VACCINATION SITE MASS (non-serious) with onset May2022, outcome "recovered" (May2022), VACCINATION SITE PAIN (non-serious) with onset May2022, outcome "recovering" and all described as "she has a lump and it was very sore".  Additional information : "Caller states that she received the Pfizer-BioNTech COVID-19 Vaccine second booster but it was not given in her muscle, but rather in the soft tissue of the arm. She's worried if this is going to protect her since it was not administered correctly". Caller stated that, she needs some advice, she had her husband both received their 2nd booster on 10May2022 at the withheld . States she had already had 3 previous Pfizer vaccines and she knew it was supposed to get in the muscle in the upper arm. States she pulled the arm of her shirt down over her shoulder so she could inject and the lady told her to pull it further and injected it into the soft tissue part of her arm, not in the muscle. States it was close on the side of her arm where the soft tissue is. Caller stated before she knew it wasn't right it was already over. Stated that since then she has had a 2 inch big red spot where the injection was, she has a lump and it was very sore. Stated she never had a sore arm before that with the other 3, no symptoms whatsoever. Stated that the soreness was pretty much gone and the red spot is still there. Stated the soreness was gone and the redness just about faded. She wants to make sure it is valid and will protect them.  Caller clarified that, the lump was gone and there was slight soreness with rubbing. Stated it was nothing severe enough for her to be that concerned about. States she has to get back to work shortly. Report is not related to a study or programme.  No follow-up attempts are Possible. No further information is expected.