Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Skin discolouration, Ultrasound scan
Clinical narrative: she had a huge blood clot that went from the top of her feet to the knee, and from the top of the knee to the thigh and groin area; She started experiencing fatigue; she started experiencing chills; felt very cold; she felt tenderness in her arm; bones in her chest are hurting; certain parts of her belly are hurting; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (she had a huge blood clot that went from the top of her feet to the knee, and from the top of the knee to the thigh and groin area) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 058F21A, 025A21A and 031M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Hydrocodone (throw up)) and Allergy to antibiotic. Concomitant products included ATORVASTATIN, METFORMIN, METOPROLOL, SERTRALINE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (she felt tenderness in her arm). On 29-May-2022, the patient experienced FEELING COLD (felt very cold) and CHILLS (she started experiencing chills). On 30-May-2022, the patient experienced FATIGUE (She started experiencing fatigue). On 03-Jun-2022, the patient experienced THROMBOSIS (she had a huge blood clot that went from the top of her feet to the knee, and from the top of the knee to the thigh and groin area) (seriousness criteria hospitalization and medically significant). In 2022, the patient experienced BONE PAIN (bones in her chest are hurting) and ABDOMINAL PAIN UPPER (certain parts of her belly are hurting). The patient was hospitalized from 03-Jun-2022 to 04-Jun-2022 due to THROMBOSIS. The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) on 28-May-2022 for Vaccination site tenderness, Pain in hip, Groin pain and Pain in extremity, at an unspecified dose and frequency and APIXABAN (ELIQUIS) in June 2022 for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (she had a huge blood clot that went from the top of her feet to the knee, and from the top of the knee to the thigh and groin area), CHILLS (she started experiencing chills) and FATIGUE (She started experiencing fatigue) was resolving and FEELING COLD (felt very cold), BONE PAIN (bones in her chest are hurting), ABDOMINAL PAIN UPPER (certain parts of her belly are hurting) and VACCINATION SITE PAIN (she felt tenderness in her arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2022, Ultrasound scan: blood clot Test Result: The results of the ultrasound showed that she had a huge blood clot that went from the top of her feet to the knee, and from the top of the knee to the thigh and groin area..         The patient had every bone in her knee, feet, thighs, back were aching, legs had become huge, aches again on her hips, groin area, thighs, legs, extremely painful for her to walk, she started experiencing really bad Charlie horse symptoms which were considered as co-manifestations of Thrombosis. The patient had received her 2nd booster dose of the Moderna COVID-19 vaccine on 27-May-2022. The following day, on 28-May-2022, when she woke up she felt tenderness in her arm which she thought was regular muscle and joint pain due to getting the vaccine, similar to what she experienced after the 1st booster dose. She had received the dose on a Friday. When she started experiencing the pain on Saturday, 28-May-2022, she took Tylenol Arthritis and slept well that night. On Sunday morning, 29-May-2022, she started experiencing aches again on her hips, thighs, groin area, and legs. She took Tylenol again that night but this time it did not work in relieving her pain. She still had the pain, and then she started experiencing chills. She did not think she had a fever or felt warm, but she definitely felt very cold. On Monday morning, 30-May-2022, it was a holiday so she thought she would have some extra time to heal from the shot. However, her symptoms kept getting worse. She started experiencing fatigue and the pain in her groin, upper thigh, and lower legs started getting worse. She also had the chills still ongoing. She could not believe she felt so cold as it was summertime. It kept getting worse. On the Thursday of that week, 02-Jun-2022, she was driving home from work when she started experiencing really bad Charlie horse symptoms. She started having really bad cramps on her driving foot. She had to pull over and go into a parking lot. She was parked there for over an hour because the cramps just kept coming back. The toes on her right foot felt really bad. She finally came home an hour later, ate dinner with her husband and then started getting cramps.  Company comment: This spontaneous case concerns a 56 year old female patient with no relevant medical history who experienced the unexpected, serious (hospitalization, medically significant) adverse event of special interest Thrombosis (LLT: Thrombosis Leg) which occurred 7 days after receiving the fourth dose of mRNA1273. The patient started experiencing aches on her hips, thighs, groin area, and legs 2 days after receiving the second booster dose of mRNA1273. She self medicated with Tylenol but it did not relieve her pain. 3 days post vaccination the patient noticed her symptoms getting worse now accompanied by fatigue and chills. 6 days post vaccination the patient experienced Charley horse symptoms while driving. 7 days post vaccination the patient felt extreme pain when walking which led to her being unable to walk. She also noticed that her legs are swelling. The patient was admitted to the hospital and ultrasound of the legs was done which revealed a huge blood clot that went from the top of her feet to the knee, and from the top of the knee to the thigh and groin area. Patient was referred to an interventional radiologist and hematologist for further evaluation and management. The patient was eventually given Eliquis prior to discharge 8 days post vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-595081 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56 year old female patient with no relevant medical history who experienced the unexpected, serious (hospitalization, medically significant) adverse event of special interest Thrombosis (LLT: Thrombosis Leg) which occurred 7 days after receiving the fourth dose of mRNA1273. The patient started experiencing aches on her hips, thighs, groin area, and legs 2 days after receiving the second booster dose of mRNA1273. She self medicated with Tylenol but it did not relieve her pain. 3 days post vaccination the patient noticed her symptoms getting worse now accompanied by fatigue and chills. 6 days post vaccination the patient experienced Charley horse symptoms while driving. 7 days post vaccination the patient felt extreme pain when walking which led to her being unable to walk. She also noticed that her legs are swelling. The patient was admitted to the hospital and ultrasound of the legs was done which revealed a huge blood clot that went from the top of her feet to the knee, and from the top of the knee to the thigh and groin area. Patient was referred to an interventional radiologist and hematologist for further evaluation and management. The patient was eventually given Eliquis prior to discharge 8 days post vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.