Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Electrocardiogram, Feeling jittery, Magnetic resonance imaging
Clinical narrative: Collapsing; Blood clots; Dehydrated; Tremores; Nausea; Weight loss; Feeling jittery; Leg weakness; Chest pain; Loss of appetite; Dizziness; Head itch; Rash; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from License Party. Other Case identifier: US-BRISTOL-MYERS SQUIBB COMPANY-2022-092477.  A 69-year-old female patient received apixaban (ELIQUIS), since Oct2020 (ongoing) at 5 mg 2x/day, oral for pulmonary embolism, deep vein thrombosis; BNT162b2 (BNT162B2), on 02Sep2021 as dose number unknown, single (Lot number: 919264) for COVID-19 immunisation; spironolactone (SPIRONOLACTONE), from Nov2021 to Oct2022; magnesium sulfate (MAGNESIUM SULFATE), since Apr2022 (ongoing); amiodarone HCl (AMIODARONE HCL), (ongoing); albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), since Oct2020 (ongoing) (Batch/Lot number: unknown) for asthma; allopurinol (ALLOPURINOL), (ongoing) (Batch/Lot number: unknown); aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), since Apr2020 (Batch/Lot number: unknown); atorvastatin (ATORVASTATIN), since Apr2020 (Batch/Lot number: unknown); fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), since Apr2020 (Batch/Lot number: unknown) for asthma; potassium chloride (K-DUR), (Batch/Lot number: unknown); methocarbamol (METHOCARBAMOL), (Batch/Lot number: unknown); midodrine (MIDODRINE), (Batch/Lot number: unknown); meloxicam (MELOXICAM), since 16Sep2021 (ongoing) (Batch/Lot number: unknown); evolocumab (REPATHA SURECLICK), (Batch/Lot number: unknown); hyoscine methobromide (SCOPOLAMINE [HYOSCINE METHOBROMIDE]), (Batch/Lot number: unknown); sertraline (SERTRALINE), (Batch/Lot number: unknown); tramadol (TRAMADOL), (Batch/Lot number: unknown); vitamin d3 (VITAMIN D3), since Apr2020 (Batch/Lot number: unknown); sertraline hydrochloride (ZOLOFT), (Batch/Lot number: unknown). The patient's relevant medical history included: "Fall" (unspecified if ongoing); "Head injury" (unspecified if ongoing); "Back injury" (unspecified if ongoing); "Hospitalization", start date: Apr2022 (unspecified if ongoing); "Tremor" (unspecified if ongoing); "Bruise" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pantoprazole, reaction(s): "Tingling"; Bnt162b2, start date: 03Feb2021, stop date: 03Feb2021, for COVID-19 immunization, notes: dose number unknown, single; lot number: EN4205. The following information was reported: PRURITUS (non-serious) with onset Nov2021, outcome "recovering", described as "Head itch"; RASH (non-serious) with onset Nov2021, outcome "recovering"; DIZZINESS (non-serious) with onset Aug2022, outcome "recovering"; CIRCULATORY COLLAPSE (medically significant), outcome "not recovered", described as "Collapsing"; THROMBOSIS (medically significant), outcome "unknown", described as "Blood clots"; DEHYDRATION (non-serious), outcome "unknown", described as "Dehydrated"; TREMOR (non-serious), outcome "not recovered", described as "Tremores"; NAUSEA (non-serious), outcome "not recovered"; WEIGHT DECREASED (non-serious), outcome "not recovered", described as "Weight loss"; FEELING JITTERY (non-serious), outcome "not recovered"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "Leg weakness"; CHEST PAIN (non-serious), outcome "not recovered"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Loss of appetite". The patient underwent the following laboratory tests and procedures: Chest X-ray: Abnormal; Abnormal; Computerised tomogram: Unknown results; Unknown results; Electrocardiogram: Unknown results; Unknown results; Magnetic resonance imaging: Unknown results; Unknown results; X-ray: Unknown results; Unknown results. The action taken for apixaban, magnesium sulfate, amiodarone HCl, albuterol [salbutamol], allopurinol and meloxicam was dosage not changed; for aspirin [acetylsalicylic acid], atorvastatin, fluticasone furoate, vilanterol trifenatate, potassium chloride, methocarbamol, midodrine, evolocumab, hyoscine methobromide, sertraline, tramadol, vitamin d3 and sertraline hydrochloride was unknown. The action taken for spironolactone was temporarily withdrawn in Oct2022. Therapeutic measures were not taken as a result of circulatory collapse, rash, dizziness, pruritus, tremor, nausea, weight decreased, feeling jittery, muscular weakness, chest pain. Additional information: Rash was mostly on back and shoulders. The patient was sick for several months, she did not know why.  Eliquis is under agreement with Regulatory Authority.  Follow-up (21Sep2022): This is a spontaneous follow-up report received from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-092477. Updated information included: Patient name updated.  Eliquis is under agreement with Regulatory Authority.  Follow-up (03Oct2022): This is a spontaneous follow-up report received from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-092477. Updated information included: Reporter name updated.  Eliquis is under agreement with Regulatory Authority.  Follow-up (20Oct2022): This is a spontaneous follow up report received from contactable reporter consumer from License Party. Other Case identifier: US-BRISTOL-MYERS SQUIBB COMPANY-2022-092477. Updated information includes: lab (added all), suspect drug (added all co-suspects), event (added all except for dehydration), and clinical course.  Eliquis is under agreement with Regulatory Authority.