Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Speech disorder, Vaccination site erythema, Vaccination site warmth
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2022 at 14:00 as dose 3 (booster), single (Lot number: FK9894) at the age of 63 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: J&J (Dose 1, Lot 1805022, Given in left arm), administration date: 19Mar2021, when the patient was 61-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Lot FF2590, 1st dose of was the Pfizer COVID vaccine, Given in the left arm), administration date: 10Nov2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: SPEECH DISORDER (medically significant) with onset Apr2022, outcome "unknown", described as "She was talking out of her head and did not make sense"; NAUSEA (non-serious) with onset 21Apr2022 at 14:45, outcome "not recovered", described as "Nauseated"; MALAISE (non-serious) with onset 22Apr2022 at 03:00, outcome "not recovered", described as "Just don't feel well"; AMNESIA (non-serious) with onset 22Apr2022 at 03:00, outcome "recovering", described as "She has no memory of 8 hours of her life"; PYREXIA (medically significant) with onset 22Apr2022 at 03:00, outcome "recovering", described as "Temperature, and it was 103.6 degrees Fahrenheit/low grade fever"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Apr2022 at 08:00, outcome "not recovered", described as "Arm where she got injection feels like it has fever in it and is hot and red to touch"; VACCINATION SITE WARMTH (non-serious) with onset 22Apr2022 at 08:00, outcome "not recovered", described as "Arm where she got injection feels like it has fever in it and is hot and red to touch/she was so hot and he never felt her that hot before"; PAIN IN EXTREMITY (non-serious) with onset 22Apr2022 at 08:00, outcome "unknown", described as "Left arm feels like it has a fever in it and hot and red to touch /she noticed it was really red and hurting"; FATIGUE (non-serious), outcome "unknown", described as "Tired". The events "she was talking out of her head and did not make sense" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (22Apr2022) 103.6 F. Therapeutic measures were taken as a result of speech disorder, pyrexia. Clinical course: Caller had 2nd booster on this past Thursday. Got real nauseated, which was understandable because got nauseated before got booster. Caller was really tired and went to bed. Her husband got her up and when he came back he touched her arm or shoulder and said caller was so hot and he never felt her that hot before. Caller sat up in bed looked over at him and fell back on her pillow. Caller had no memory of 8 hours of her life. He put clothes on her and took her into the living room to take temperature and it was 103.6 degrees Fahrenheit. Fever started at 03:00. Caller ran low grade fever on Saturday evening and Sunday and was taking Tylenol and switching it with Motrin. That was they told to take at the hospital. When caller had the fever was talking out of her head and did not make sense. It scared her husband and he called EMS. They took her to the emergency room. Caller had no recollection of it though. They gave IV fluids and were running it really fast to get it through her system. They gave something to reduce fever but caller did not know what it was. Caller was discharged and released under husband care. Given IV fluid quickly and something to bring fever down which caller did not know what medication. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. No follow-up attempts are possible. No further information is expected.