Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Incorrect dose administered, Off label use, Pain, Product use issue, Swelling
Clinical narrative: fast heartrate; dizziness; weakness; fatigued; Walking is very hard; Off label use; Product use for unapproved combination; Inappropriate dose of Vaccine administered; pain; swelling in the left shoulder area; 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 76-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 76 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for asthma. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: Had asthma prior to the Pfizer BioNTech COVID-19 vaccines and boosters. Was diagnosed in the 1990s. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 1, Batch/Lot number: GN6205), administration date: 09Mar2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 2, Batch/Lot number: EN6208), administration date: 30Mar2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 3 (Booster), Batch/Lot number: FE3950), administration date: 01Nov2021, when the patient was 75-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 4 (Booster), Batch/Lot number: FK9893), administration date: 16May2022, when the patient was 75-year-old, for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 13Oct2022, outcome "unknown", described as "Inappropriate dose of Vaccine administered"; OFF LABEL USE (non-serious) with onset 13Oct2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 13Oct2022, outcome "unknown", described as "Product use for unapproved combination"; PAIN (non-serious) with onset 13Oct2022, outcome "recovering"; SWELLING (non-serious) with onset 13Oct2022, outcome "recovering", described as "swelling in the left shoulder area"; GAIT DISTURBANCE (non-serious) with onset 15Oct2022, outcome "not recovered", described as "Walking is very hard"; DIZZINESS (non-serious) with onset 15Oct2022, outcome "not recovered"; HEART RATE INCREASED (non-serious) with onset 15Oct2022, outcome "not recovered", described as "fast heartrate"; FATIGUE (non-serious) with onset 15Oct2022, outcome "not recovered", described as "fatigued"; ASTHENIA (non-serious) with onset 15Oct2022, outcome "not recovered", described as "weakness". Therapeutic measures were not taken as a result of pain, swelling, heart rate increased, dizziness, asthenia, fatigue, gait disturbance.  Additional information: Other Products mentioned as No. Context: Caller stated that she was reading. Had the COVID vaccine the last one that just came out. Had it on Thursday. Had pain and swelling in the area nothing major. Since Saturday has been having very fast heartbeat, dizziness and weakness. Got very dizzy almost collapse. Walking is very hard. Is wondering if it was a reaction to the vaccine. Clarified that she had the Pfizer BioNTech COVID 19 vaccine captured as provided. Was for the third booster. Clarified that she has had the first two doses and then three boosters. Clarified that total this was her fifth dose of the Pfizer BioNTech COVID 19 vaccine. Saw her doctor and everything very good. Reporter details: Email address captured as provided. Physician details: Unknown. There was no doctor. Went to pharmacy to get it done. Event details: Pain and swelling in her left arm shoulder area started right after the injection on Thursday. Still has mild pain. Still has very little swelling. Very fast heartbeat started Saturday morning. Walking is very hard occasionally, at times is a little better. Treatment mentioned as None.  Product details mentioned as Provided the lot number of GN6205 for the first shot Pfizer BioNTech COVID 19 vaccine on 09Mar2021 and EN6208 for the second shot on 30Mar2021. Received the Pfizer BioNTech COVID 19 vaccine first booster on 01Nov2021 with a lot of FE3950 and the second booster on 16May2022 with a lot of FK9893. Other Medical Conditions mentioned as Had asthma prior to the Pfizer BioNTech COVID 19 vaccines and boosters. Was diagnosed in the 1990s.  Follow-up attempts are completed. No further information is expected.