Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Oxygen saturation, Pain, Pain in extremity, Paraesthesia
Clinical narrative: DVT; Greater then 35 days between Moderna Covid-19 injections.; Could feel a very strong pulse in my right hand.; Pain under my right collarbone; Chest pain right sternum; Two blood clots in my right arm,fully occluded blood clot in my right subclavian vein,partial blood clot in my right axillary vein; Headache; Right arm turned red; Right arm was actively swelling; Right arm discolored; Skin became tight; pain down right arm; Pain in right arm pit; Tingling in right arm and in armpit; Generalized pain in my neck and in my right shoulder; Back pain; pain at the left arm injection site; This spontaneous case was reported by a physician and describes the occurrence of THROMBOSIS (Two blood clots in my right arm,fully occluded blood clot in my right subclavian vein,partial blood clot in my right axillary vein) and DEEP VEIN THROMBOSIS (DVT) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020, Irregular periods and Anxiety. Concomitant products included FLUOXETINE for Anxiety, APIXABAN (ELIQUIS) for an unknown indication.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced VACCINATION SITE PAIN (pain at the left arm injection site). On 15-Jul-2021, the patient experienced PERIPHERAL SWELLING (Right arm was actively swelling), SKIN DISCOLOURATION (Right arm discolored), SKIN TIGHTNESS (Skin became tight), PAIN IN EXTREMITY (pain down right arm), AXILLARY PAIN (Pain in right arm pit), PARAESTHESIA (Tingling in right arm and in armpit), PAIN (Generalized pain in my neck and in my right shoulder), BACK PAIN (Back pain), ERYTHEMA (Right arm turned red) and HEADACHE (Headache). On 02-Aug-2021, the patient experienced THROMBOSIS (Two blood clots in my right arm,fully occluded blood clot in my right subclavian vein,partial blood clot in my right axillary vein) (seriousness criterion medically significant), RADIAL PULSE (Could feel a very strong pulse in my right hand.), BONE PAIN (Pain under my right collarbone) and CHEST PAIN (Chest pain right sternum). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Moderna Covid-19 injections.). At the time of the report, THROMBOSIS (Two blood clots in my right arm,fully occluded blood clot in my right subclavian vein,partial blood clot in my right axillary vein), DEEP VEIN THROMBOSIS (DVT), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Moderna Covid-19 injections.), PERIPHERAL SWELLING (Right arm was actively swelling), SKIN DISCOLOURATION (Right arm discolored), SKIN TIGHTNESS (Skin became tight), PAIN IN EXTREMITY (pain down right arm), AXILLARY PAIN (Pain in right arm pit), PARAESTHESIA (Tingling in right arm and in armpit), PAIN (Generalized pain in my neck and in my right shoulder), BACK PAIN (Back pain), RADIAL PULSE (Could feel a very strong pulse in my right hand.), BONE PAIN (Pain under my right collarbone), ERYTHEMA (Right arm turned red), CHEST PAIN (Chest pain right sternum), HEADACHE (Headache) and VACCINATION SITE PAIN (pain at the left arm injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive. On 02-Aug-2021, Ultrasound scan: abnormal (abnormal) Two blood clots right arm were found on Ultrasound, One was a fully occluded blood clot right subclavian vein. partial blood clot in my right axillary vein. occlusive deep vein thrombosis involving the subclavian vein. Non-occlusive thrombus in the right axillary vein. On an unknown date, Blood pressure measurement: 110/67 mmHg (normal) normal. On an unknown date, Body temperature: 98.2 (Inconclusive) F. On an unknown date, Heart rate: 64 (Inconclusive) Inconclusive. On an unknown date, Oxygen saturation: 98 (Inconclusive) Inconclusive. On an unknown date, Respiratory rate: 17 (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   After the ultrasound patient reported, having severe aching pain under the right collarbone. Patient was prescribed Eliquis 10mg twice daily times 7 days, then took Eliquis 5mg twice daily and patient continued to take Eliquis for 3months. After 15JUL2021 the patient experienced back pain and headache. The patient went to see a chiropractor and had multiple visits with the Chiropractor Treatment information was not provided.  Action taken was not applicable.  Company Comment  This case concerns 36-year-old female patient who experienced the events of deep vein thrombosis and thrombosis. The events occurred approximately 54 days after the first dose of mRNA-1273 and 19 days subsequent after the second dose of mRNA-1273. The rechallenge was not applicable for the events. The event was considered related to the study drug per the reporter's assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-311474.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: follow up received on 13-sep-2021 is Significant follow up Appended - New event (Deep Vein Thrombosis) Was updated; Sender's Comments: This case concerns 36-year-old female patient who experienced the events of deep vein thrombosis and thrombosis. The events occurred approximately 54 days after the first dose of mRNA-1273 and 19 days subsequent after the second dose of mRNA-1273. The rechallenge was not applicable for the events. The event was considered related to the study drug per the reporter's assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.