Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral swelling, Product dose omission issue, Rash, Ultrasound scan
Clinical narrative: Tingling in my legs; Leg pain; Pain in my lower wrist area/every once in a while there was a dull pain; DVT blood clot in her ulnar vein/wrist; Big and swollen arm; Lumps on the inside part of upper arm/ 10 lumps; COVID arm; Itching; Arm being beet red/rash; Hurt like hell /was really sore that night/ painful next day; Bit of hypochondriac and has not received a second dose; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (DVT blood clot in her ulnar vein/wrist) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PAIN (Hurt like hell /was really sore that night/ painful next day) and PRODUCT DOSE OMISSION ISSUE (Bit of hypochondriac and has not received a second dose). On 25-Mar-2021, the patient experienced PERIPHERAL SWELLING (Big and swollen arm), LIMB MASS (Lumps on the inside part of upper arm/ 10 lumps), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Itching) and RASH (Arm being beet red/rash). On 28-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT blood clot in her ulnar vein/wrist) (seriousness criterion medically significant). On an unknown date, the patient experienced PARAESTHESIA (Tingling in my legs), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Pain in my lower wrist area/every once in a while there was a dull pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 2, every 4 hours and APIXABAN (ELIQUIS) for Adverse event, at an unspecified dose and frequency. On 23-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Bit of hypochondriac and has not received a second dose) had resolved. On 31-Mar-2021, VACCINATION SITE PRURITUS (Itching) and RASH (Arm being beet red/rash) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT blood clot in her ulnar vein/wrist), VACCINATION SITE PAIN (Hurt like hell /was really sore that night/ painful next day), PERIPHERAL SWELLING (Big and swollen arm), LIMB MASS (Lumps on the inside part of upper arm/ 10 lumps), VACCINATION SITE REACTION (COVID arm), PARAESTHESIA (Tingling in my legs), PAIN IN EXTREMITY (Leg pain) and ARTHRALGIA (Pain in my lower wrist area/every once in a while there was a dull pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Imaging procedure: normal (normal) lungs did not have a blood clot. On 27-Mar-2021, Ultrasound scan: abnormal (abnormal) found a DVT blood clot in her ulnar vein.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Patient called the CDC due to the adverse events. On 27 Mar 2021, patient felt like something wrong. Some of the lumps had gone, but one lump on the inside of her elbow was larger and more painful than the rest. Patient went to the ER and the doctor told her he doesn't know why there was a lump. Patient was sent to cape coral hospital for imaging of her lungs as she cannot take iodine contrast. Patient has been to the ER for pain and tingling in her legs 2 separate time since then.  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.  Further information has been requested.; 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.  Further information has been requested.