Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (clots in leg/blood clotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 040A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood (Patient had blood clots since she was 18 years old and had two clots in leg where she can feel it) and Surgery (Patient had surgery on the legs to break the veins down (has had a total of 5 surgeries in the past)). Concurrent medical conditions included Alcohol allergy (Allergic to rubbing alcohol), COPD, Sensitive skin, Grass allergy (Same side effects so it makes it hard to distinguish) and Pollen allergy (Same side effects so it makes it hard to distinguish).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (clots in leg/blood clotting) (seriousness criterion medically significant), MUSCLE SPASMS (Cramping/muscle spams), NASAL CONGESTION (stuffy nose), LACRIMATION INCREASED (Runny eyes), AGEUSIA (The shot knocked out taste for food) and VACCINATION SITE PAIN (Normal aching from getting the shot then I have). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (clots in leg/blood clotting), MUSCLE SPASMS (Cramping/muscle spams), NASAL CONGESTION (stuffy nose), LACRIMATION INCREASED (Runny eyes), AGEUSIA (The shot knocked out taste for food) and VACCINATION SITE PAIN (Normal aching from getting the shot then I have) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient at one point stated that she was concerned that they overdosed her. She stated she received the same paperwork as she had before. Company comment: This is a spontaneous case concerning a 58-year-old, female patient with a history of blood clot and Chronic obstructive pulmonary disease, who experienced, according CCDS, the serious (due to medically important condition) unexpected, AESI of Trombosis and the non-serious unexpected AESI of Ageusia. The event occurred after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The medical history of blood clot and concurrent condition of chronic obstructive pulmonary disease remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2021-409813 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow up received with no new information; Sender's Comments: This is a spontaneous case concerning a 58-year-old, female patient with a history of blood clot and Chronic obstructive pulmonary disease, who experienced, according CCDS, the serious (due to medically important condition) unexpected, AESI of Trombosis and the non-serious unexpected AESI of Ageusia. The event occurred after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The medical history of blood clot and concurrent condition of chronic obstructive pulmonary disease remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.