Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Tenderness, Thrombophlebitis superficial, Thrombosis, Vaccination complication
Clinical narrative: Lump in vein; blood clot on hand; Superficial thrombophlebitis; Negative reaction/Most severe reaction/delayed reaction; Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful; Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive; Warm/warmer than surrounding skin; Tender/tender to touch; Could not move hand and wrist/ Unable to use hand/Unable to turn wrist; Panicked; swelling of right hand: from below last thumb joint to past wrist; purplish discoloration/red discoloration; Redness/erythema local/ with red; frightening experience; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Lump in vein) and THROMBOSIS (blood clot on hand) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 005C21AAAAA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Carpal tunnel syndrome (More painful) since 1998. Previously administered products included for Product used for unknown indication: FLU (welts on upper torso) in 1996. Concurrent medical conditions included Vascular disorder NOS (Vascular issue), Vein disorder (Clogged lower vein), Allergic to cats, Hypertension since 2003, Hyperlipidemia since 2003, Type 2 diabetes mellitus since 2004, Neuropathy since 2004, Osteoarthritis since 2006, Left bundle branch block since 2006, Cholesterol, Allergy to antibiotic (Allergic to ampicillin - felt ill, nauseous.), Sulfonamide allergy (Allergic to Sulfa drugs - difficulty breathing), Allergy to nuts (Allergic to almond - swelling of tongue, mild to moderate), Drug allergy (Allergic to other -cillin meds-no antibiotic reaction, caused nausea.), Perfume sensitivity (Allergic to chemical fragrances a used some allergic asmtha,  issue has mostly gone/resolved itself) and Allergic asthma. Concomitant products included LOSARTAN POTASSIUM and LABETALOL HCL for Blood pressure, SIMVASTATIN for Cholesterol, UBIQUINOL for Energy increased, GABAPENTIN for Pain management, IRON for Supplementation therapy, METFORMIN HCL for Type 2 diabetes mellitus, HORSE CHESTNUT EXTRACT for Vein disorder.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced DEEP VEIN THROMBOSIS (Lump in vein) (seriousness criterion medically significant), THROMBOSIS (blood clot on hand) (seriousness criterion medically significant), THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis), VACCINATION COMPLICATION (Negative reaction/Most severe reaction/delayed reaction), PAIN IN EXTREMITY (Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful), PERIPHERAL SWELLING (Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive), FEELING HOT (Warm/warmer than surrounding skin), TENDERNESS (Tender/tender to touch), MOBILITY DECREASED (Could not move hand and wrist/ Unable to use hand/Unable to turn wrist), PANIC REACTION (Panicked), JOINT SWELLING (swelling of right hand: from below last thumb joint to past wrist), SKIN DISCOLOURATION (purplish discoloration/red discoloration), ERYTHEMA (Redness/erythema local/ with red) and FEELING ABNORMAL (frightening experience). The patient was treated with VITIS VINIFERA SEED (GRAPE SEED EXTRACT [VITIS VINIFERA SEED]) for Vascular disorder NOS, at an unspecified dose and frequency. On 12-Jul-2021, THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis), VACCINATION COMPLICATION (Negative reaction/Most severe reaction/delayed reaction), FEELING HOT (Warm/warmer than surrounding skin), TENDERNESS (Tender/tender to touch), MOBILITY DECREASED (Could not move hand and wrist/ Unable to use hand/Unable to turn wrist), PANIC REACTION (Panicked), JOINT SWELLING (swelling of right hand: from below last thumb joint to past wrist), SKIN DISCOLOURATION (purplish discoloration/red discoloration), ERYTHEMA (Redness/erythema local/ with red) and FEELING ABNORMAL (frightening experience) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (Lump in vein), PAIN IN EXTREMITY (Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful) and PERIPHERAL SWELLING (Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive) had resolved and THROMBOSIS (blood clot on hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) mmHg.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After second shot on 10-Jul-2021 patient experienced extreme pain, swelling of right hand: from below last thumb joint to past wrist. Swollen lump on surface vein below thumb, tender to touch, and warmer than surrounding skin, with red, purplish discoloration. On scale of 1 to 10, the pain level was a 10. Unable to turn wrist, swelling was too restrictive and pain was overwhelming.  Unable to use hand. Over course of approximately 2 days the swelling died down and the pain lessened.  The hard lump blood clot on the vein remains. Patient consulted Cardiologist. diagnosed it as Superficial Thrombophlebitis, informed to patient it was blood clot  in the wall of a peripheral/surface vein caused by inflammation. cardiologist recommended for at-home treatment was: warm compresses, raising my arm above my heart as much as possible for at least 1-2 days, & using an anti-inflammatory NSAID like Aleve, etc. Patient indicated that he swelling and associated pain would most likely dissipate within a couple of days.  He also stated the blood clot would take several months to improve/resolve.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-235384 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Significant follow up received and added Patient medical history, concomitants,NewAE ,vaccine details,causality and outcome details, and patient demographics are updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.