Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Gout, Immune system disorder, Malaise, Pain, Vaccination site pain
Clinical narrative: She also has gout in ankle; Her immune system went nuts; last night she felt horrible; pain is at the injection site; Then, 12 hours later, woke up with intense pain in entire body; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Oct2023 at 09:30 as dose 1, single (Lot number: HG9498) at the age of 76 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Gout" (unspecified if ongoing); "surgery" (unspecified if ongoing), notes: where she she  had surgery and inflammation earlier where it was not bothering her before; "inflammation" (unspecified if ongoing), notes: where she she  had surgery and inflammation earlier where it was not bothering her before; "Broken arm" (unspecified if ongoing), notes: Sheh ad pain in her left arm which was broken several months ago and still healing. Concomitant medication(s) included: PROBENECID oral taken for gout (ongoing); EZETIMIBE oral taken for blood cholesterol (ongoing). Vaccination history included: bnt162b2 (DOSE NUMBER: 01, Anatomical Site of injection: Left arm, think so, but not written down on card. Usually in left arm. , Route of Administration: Not provided , Batch/Lot number: EL3302), administration date: 25Jan2021, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2 (DOSE NUMBER : 02, Anatomical Site of injection: Probably left arm , Route of Administration: , Batch/Lot number: EN6201), administration date: 15Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; bnt162b2 (DOSE NUMBER : 03 (BOOSTER), Anatomical Site of injection: Probably left arm, Route of Administration: , Batch/Lot number: FE5390), administration date: 12Oct2021, when the patient was 74-year-old, for COVID-19 Immunization; bnt162b2 (DOSE NUMBER : 04 (BOOSTER), Reporter received a 4th dose of the Pfizer Vaccine, Covid Bivalent , Date: 19Oct2022, Lot: GH9703), administration date: 19Oct2022, when the patient was 75-year-old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 24Oct2023 at 21:30, outcome "not recovered", described as "Then, 12 hours later, woke up with intense pain in entire body"; VACCINATION SITE PAIN (non-serious) with onset 24Oct2023 at 21:30, outcome "not recovered", described as "pain is at the injection site"; GOUT (non-serious), outcome "unknown", described as "She also has gout in ankle"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Her immune system went nuts"; MALAISE (non-serious), outcome "unknown", described as "last night she felt horrible". Additional information: She had reactions to a lot of medications, but never previously with vaccines or prior covid vaccines received. She clarified the unusual side effect as she had the shot yesterday morning. At the time she had no pain at injection site. Then, 12 hours later, woke up with intense pain in entire body. She explained her immune system was triggered and was attacking artificial joints. She had 3 of them. She had pain in her left arm which was broken several months ago and still healing, left side of face where she she had surgery and inflammation earlier where it was not bothering her before. She also had gout in ankle. Had pain in hip, two knees, arm, and feet. The pain was so intense she could not get out of bed. She could not call for help or do anything. This severe pain started all same time. Her immune system went nuts. It hit ever area that had a foreign body or injury in the last year. This pain kept him awake all night and after six hours started to decrease. Now at the moment the only pain was at the injection site. All other pain has gone away. This pain started at 10:00 PM, it woke her up. It was that intense it was like body was inflamed.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.