Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Dizziness  (After 2nd Vaccine); Labored Breathing  (After 2nd Vaccine); Low Blood Pressure   (After 2nd Vaccine); Multiple Blood Clots Red area under the injection site, Symptoms were returning (After 2nd Vaccine); Spider Veins going  from Arm to Chest   (After 2nd Vaccine); Hot to the touch left Arm  (After 2nd Vaccine); Protruding Red Veins on Left Arm (After 2nd Vaccine); Purple Swollen entire left arm from under the Injection Site to fingers (After 2nd Vaccine); Red band  (3 inches wide and 4-5" long)  Below the Injection Site (After 2nd Vaccine); Swollen 1/2 inch below the Injection Site; Fever (After 2nd Vaccine); Chills (After 2nd Vaccine); Left Arm Hurt (After 2nd Vaccine); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Multiple Blood Clots Red area under the injection site, Symptoms were returning (After 2nd Vaccine)), PERIPHERAL SWELLING (Purple Swollen entire left arm from under the Injection Site to fingers (After 2nd Vaccine)), SPIDER VEIN (Spider Veins going  from Arm to Chest   (After 2nd Vaccine)), DIZZINESS (Dizziness  (After 2nd Vaccine)), DYSPNOEA (Labored Breathing  (After 2nd Vaccine)), HYPOTENSION (Low Blood Pressure   (After 2nd Vaccine)), SKIN WARM (Hot to the touch left Arm  (After 2nd Vaccine)), PAIN IN EXTREMITY (Left Arm Hurt (After 2nd Vaccine)), SUPERFICIAL VEIN PROMINENCE (Protruding Red Veins on Left Arm (After 2nd Vaccine)), VACCINATION SITE ERYTHEMA (Red band  (3 inches wide and 4-5" long)  Below the Injection Site (After 2nd Vaccine)), VACCINATION SITE SWELLING (Swollen 1/2 inch below the Injection Site), PYREXIA (Fever (After 2nd Vaccine)) and CHILLS (Chills (After 2nd Vaccine)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included MESALAZINE (LIALDA), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MULTIVITAMIN [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 25-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left Arm Hurt (After 2nd Vaccine), PYREXIA (Fever (After 2nd Vaccine)),  and CHILLS (Chills (After 2nd Vaccine)) . On 26-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red band  (3 inches wide and 4-5" long)  Below the Injection Site (After 2nd Vaccine), and VACCINATION SITE SWELLING (Swollen 1/2 inch below the Injection Site) .On 27-Apr-2021, the patient experienced PERIPHERAL SWELLING (Purple Swollen entire left arm from under the Injection Site to fingers (After 2nd Vaccine)). On 28-Apr-2021, the patient experienced SPIDER VEIN (Spider Veins going  from Arm to Chest   (After 2nd Vaccine)), SKIN WARM (Hot to the touch left Arm  (After 2nd Vaccine)) and SUPERFICIAL VEIN PROMINENCE (Protruding Red Veins on Left Arm (After 2nd Vaccine)). On 02-May-2021, the patient experienced THROMBOSIS (Multiple Blood Clots Red area under the injection site, Symptoms were returning (After 2nd Vaccine)) (seriousness criteria medically significant), DIZZINESS (Dizziness  (After 2nd Vaccine)) DYSPNOEA (Labored Breathing  (After 2nd Vaccine))  and HYPOTENSION (Low Blood Pressure   (After 2nd Vaccine)). On 02-May-2021, DIZZINESS (Dizziness  (After 2nd Vaccine)) and HYPOTENSION (Low Blood Pressure   (After 2nd Vaccine)) outcome was unknown, DYSPNOEA (Labored Breathing  (After 2nd Vaccine)) had resolved. On 14-May-2021, PYREXIA (Fever (After 2nd Vaccine)) and CHILLS (Chills (After 2nd Vaccine)) had resolved. At the time of the report, THROMBOSIS (Multiple Blood Clots Red area under the injection site, Symptoms were returning (After 2nd Vaccine)), PERIPHERAL SWELLING (Purple Swollen entire left arm from under the Injection Site to fingers (After 2nd Vaccine)), SPIDER VEIN (Spider Veins going  from Arm to Chest   (After 2nd Vaccine)), SKIN WARM (Hot to the touch left Arm  (After 2nd Vaccine)), PAIN IN EXTREMITY (Left Arm Hurt (After 2nd Vaccine)), SUPERFICIAL VEIN PROMINENCE (Protruding Red Veins on Left Arm (After 2nd Vaccine)), VACCINATION SITE ERYTHEMA (Red band  (3 inches wide and 4-5" long)  Below the Injection Site (After 2nd Vaccine)) and VACCINATION SITE SWELLING (Swollen 1/2 inch below the Injection Site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Blood pressure measurement: low (Low) low. On 10-May-2021, Full blood count: wbc very high (High) WBC very high. On an unknown date, Full blood count: normal (normal) normal. On an unknown date, Ultrasound scan: multiple blood clots in the red area (abnormal) Multiple Blood Clots in the Red area under the injection site.         The patient did not have a medical history of blood clots.  On 25APR2021 the patient experienced fever, chills, and her arm hurt. On 26APR2021 her left arm hurt really bad and was swollen 1/2 inch below the injection site (3 inches wide and 4-5" long) and also had a red band  wrapped around the left arm below the injection site. On 27Apr2021 the patient's entire arm from under the Injection site to her fingers became swollen and purple. The patient visited the emergency room (ER) and was told to elevate it and place ice on the area and was prescribed Advil. On 28APR2021 the patients veins were protruding, were red and hot to the touch and she experienced spider veins started going to her chest. On 30Apr2021, she went back to the ER . The doctor gave her a steroid and suggested an ultrasound. 02MAY2021 she started experiencing labored breathing, dizziness, and low blood pressure. She visited the ER  again. The doctor performed an ultrasound, an EKG, a chest x-ray, and a hot scan of the heart. The ultrasound of the left arm showed multiple blood clots in the red area under the injection site. The doctor started her on Eliquis. On 10May2021 the symptoms were returning. A complete blood count (CBC) showed white blood cells (WBC) were very high but a second blood level showed, on an unknown date showed normal WBC. On 14May2021, the swelling on the arm had come down and her arm was still purple but a  lighter color purple with dark protruding veins and spider veins still visible. The patient continued taking Eliquis.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Significant F/U Case & Email ID Add. Conmeds., medical history, Lab data, Product dsetails, iNarrative 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.