Age: 76.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Aphasia, Blood creatine phosphokinase, C-reactive protein, Culture urine, Differential white blood cell count
Clinical narrative: collapsed to the floor; unable to walk; Dizziness; severe chilling; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 25Jan2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 28Dec2022 at 12:15 as dose 4 (booster), single (Lot number: FJ6796, Expiration Date: 31Jan2024) at the age of 76 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Polymyalgia rheumatica", start date: Jan2017 (ongoing), notes: Polymyalgia rheumatica; "Allergies" (ongoing); "Cholesterol" (ongoing); "Blood clots" (ongoing); "B/P" (ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement (ongoing); WARFARIN taken for thrombosis, start date: Aug2019 (ongoing); ATORVASTATIN taken for blood cholesterol (ongoing); MONTELUKAST [MONTELUKAST SODIUM] taken for hypersensitivity (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Time: 10:57 am, Site and Route of injection: Left Arm, Batch/Lot number: EM9810), administration date: 11Feb2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (Dose: 2nd, Time: 10:44 am, Site and Route of injection: Left Arm, Batch/Lot number: EN6200), administration date: 04Mar2021, when the patient was 74-year-old, for COVID-19 immunization; BNT162b2 (Dose: 3rd, Time: 12 noon, Site and Route of injection: Left Arm, Batch/Lot number: FC3184), administration date: 01Oct2021, when the patient was 75-year-old, for COVID-19 Immunization. The following information was reported: DIZZINESS (hospitalization) with onset 28Dec2022 at 20:15, outcome "recovered"; CHILLS (hospitalization) with onset 28Dec2022 at 20:15, outcome "recovered", described as "severe chilling"; GAIT INABILITY (hospitalization) with onset 29Dec2022, outcome "recovered", described as "unable to walk"; FALL (hospitalization) with onset 29Dec2022 at 02:00, outcome "recovered", described as "collapsed to the floor". The patient was hospitalized for fall, chills, gait inability, dizziness (discharge date: 31Dec2022, hospitalization duration: 3 day(s)). The events "collapsed to the floor", "severe chilling", "unable to walk" and "dizziness" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: (29Dec2022) 56, notes: Unit: u/L; C-reactive protein: (29Dec2022) 65.5 mg/l; Full blood count: (29Dec2022) Unknown results; I had lab work: (unspecified date) Unknown results, notes: Lab Test (Within two weeks): Consumer stated, "Yes, when I was in the hospital yes, I had lab work."; Metabolic function test: (29Dec2022) Unknown results; Protein total: (29Dec2022) 2.2; Red blood cell sedimentation rate: (29Dec2022) 20, notes: unit: mm/He; Urine analysis: (29Dec2022) Unknown results. Therapeutic measures were not taken as a result of fall, chills, gait inability, dizziness.   Clinical course: Vaccine facility type: Pharmacy or Drug store (4rth dose booster), Vaccine facility type: Pharmacy or Drug store (3rd dose booster), Vaccine facility type: Hospital (2nd dose), Vaccine facility type: Hospital (1st dose). I have had a reaction (Further not specified the reaction, hence event captured as per the verbatim) to the two Pfizer booster (Suspect clarified as Pfizer COVID-19 Vaccine), and I did not report the first one which was in Oct2021 but I was hospitalized for three days this time (Further hospitalization details were not available over the call, hence event captured as per the verbatim) after getting the newest booster and I thought somebody needed to know this." Vaccine at 12:15 pm 28Dec2022. Severe chilling and Dizziness at 8:15 pm. Wake up my husband around 2 am, 29Dec2022 standing beside bed, told him and was "going down" and collapse to the floor. I was unable to walk without assistance. My husband took me to the E.R, I was admitted. Dismissed around 8:00 pm on 31Dec2022. Onset time: 8:15 pm, Seriousness Criteria: If hospitalization, duration of stay: 3 day Treatment: No. Reporter information: Other, please specify: Self