Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Feeling cold, Immunisation, Somnolence
Clinical narrative: Sudden body temperature drop.; Uncontrollable shaking; body felt cold; woke up groggy but ok; Dose number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 10:00 (Lot number: FH 8030 or FM) at the age of 78 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pulmonary Fibrosis" (unspecified if ongoing), notes: Pulmonary Fibrosis; "penicillin" (unspecified if ongoing); "Afib" (unspecified if ongoing); "Diabetes Interstitial lung disease" (unspecified if ongoing); "Diabetes Interstitial lung disease" (unspecified if ongoing); "latex" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM [DILTIAZEM HYDROCHLORIDE]; FUROSEMIDE; POTASSIUM; FLU VACCINE VII, administration date Oct2021. Past drug history included: Iodine, reaction(s): "Known Allergy: Iodine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER 8729, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 02May2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 04Apr2021, when the patient was 78 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 10:00, outcome "unknown", described as "Dose number 3"; BODY TEMPERATURE DECREASED (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "Sudden body temperature drop."; TREMOR (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "Uncontrollable shaking"; FEELING COLD (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "body felt cold"; SOMNOLENCE (non-serious) with onset 17Nov2021 16:30, outcome "recovering", described as "woke up groggy but ok". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of body temperature decreased, tremor, somnolence. Therapeutic measures were taken as a result of feeling cold.  Additional information: Sudden body temperature drop. Uncontrollable shaking, body felt cold as tho suddenly in sub zero temp. Inside entire time added more clothing not enough then added heating pad direct to body and fell asleep. Woke up groggy but OK. AE resulted in: None of the above. If covid tested post vaccination: No, Location of injection for vaccine received within 4 weeks PRIOR: Flu shot - Left arm, Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store, List of any other medications the patient received within 2 weeks of vaccination: Diltiazem 240mg, Furosemide 40mg, Potassium 10meq,  Follow-up attempts are completed. No further information is expected.