Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site is swollen, red, and painful; injection site is swollen, red, and painful; injection site is swollen, red, and painful; 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 79 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 10:30 (Batch/Lot number: unknown) at the age of 79 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "was a smoker" (unspecified if ongoing), notes: Verbatim: was a smoker. Concomitant medication(s) included: TRELEGY taken for ex-tobacco user (ongoing). Vaccination history included: Bnt162b2 (Vaccine Name: Pfizer Covid vaccine, first dose., Lot Number / Expiry Date: EW0168/unknown, Route, Anatomical Location: left arm below the shoulder, No. of Previous Doses: none, first dose, Date: 10Aug2021), administration date: 10Aug2021, when the patient was 79 years old, for COVID-19 Immunisation, reaction(s): "very minimal pain". The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "not recovered" and all described as "injection site is swollen, red, and painful". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site swelling, vaccination site erythema, vaccination site pain.  Additional information: It was reported that patient had both doses of the vaccine and had no problem with the first, but with the second dose the injection site is swollen, red, and painful. Patient reported that she had nothing other than at the site. Patient further stated she received the first dose on 31Aug at 10AM and it she still had this and it has not gone away. Patient stated with her first injection she didn't even feel it enter her arm and had very minimal pain, no swelling, redness, or pain. Concomitant Products included Trelegy for probably about 6 months because she was a smoker. She was not allergic to it. She took it once a day but sometimes, she forgets. They really haven't diagnosed her with COPD but, she thought she had COPD. She does not smoke now. She had a fabulous experience with the first injection. She couldn't even feel it and had no side effects what so ever. She had the second one 31Aug2021 at 10:30 am and had no side effects as far as nausea and all that stuff. The site where it was injected, is swollen, painful and red. Injection site swollen, painful and red: It all started shortly, probably 12 hours after the injection. It is just a guestimate. She can physically palpate it. It is swollen, red and painful. She had not put any ice or put anything on it. For treatment for she took Aleve. Clarified that it is in her left arm, near the shoulder, right below the shoulder. Patient provided product information from the vaccination card. Second dose lot number: She stated that it is either 30130B19 or 30130819, stated it looks like it could be a B or an 8. Finally decided she better get it because she is 79 years old and the hospitals are full. So, she decided not to push her luck. She had blood work and everything was perfect. That was about 6 months ago. Anatomical location of vaccine was left arm below the shoulder. Adverse events injection site swollen, painful and red started about 12 hours after second injection 31Aug2021. There was no visit reported to Emergency Room and Physician Office. No prior Vaccinations (within 4 weeks). She has never had a flu vaccine in life. No adverse event prior vaccinations, she is a tough little bird. No family medical history relevant to adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.