Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Echocardiogram, Limb discomfort, Magnetic resonance imaging
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (MRI showed blood clots on the one area that controls the leg/blood clotting in her blood) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058h21a, 037a21b and 040a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Shingrix (1 month prior to Moderna COVID-19 vaccine before 1st dose and had 2nd dose of Shingrix 16 days before.) on 24-Feb-2021. Past adverse reactions to the above products included No adverse event with Shingrix. Concomitant products included ALENDRONATE SODIUM (FOSAMAX), CALCIUM, VITAMIN D [VITAMIN D NOS] and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (Ten days after the Moderna booster lost control of right leg, when out of the blue, a warning that the leg has something wrong, lost control of her leg from the knee down for 20 seconds). On 13-Feb-2022, the patient experienced MUSCULAR WEAKNESS (Two months later had muscle weakness in right leg/she feel muscle weakness in the lower leg). In February 2022, the patient experienced THROMBOSIS (MRI showed blood clots on the one area that controls the leg/blood clotting in her blood) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 80 milligram. At the time of the report, THROMBOSIS (MRI showed blood clots on the one area that controls the leg/blood clotting in her blood), LIMB DISCOMFORT (Ten days after the Moderna booster lost control of right leg, when out of the blue, a warning that the leg has something wrong, lost control of her leg from the kneed down for 20 seconds) and MUSCULAR WEAKNESS (Two months later had muscle weakness in right leg/she feel muscle weakness in the lower leg) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, Blood test: normal (normal) Didn't find nothing. On 29-Nov-2021, Computerised tomogram: normal (normal) Didn't find nothing, no stroke. In February 2022, Echocardiogram: normal (normal) There was no heart issue, and coronary arteries were not blocked. In February 2022, Magnetic resonance imaging: blood clots (abnormal) M.R.I showed blood clots on the one area that controls the leg. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered THROMBOSIS (MRI showed blood clots on the one area that controls the leg/blood clotting in her blood) to be related. No further causality assessments were provided for LIMB DISCOMFORT (Ten days after the Moderna booster lost control of right leg, when out of the blue, a warning that the leg has something wrong, lost control of her leg from the knee down for 20 seconds) and MUSCULAR WEAKNESS (Two months later had muscle weakness in right leg/she feel muscle weakness in the lower leg). The patient had no allergies. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine before the first dose, patient had the second dose of Shingrix 16 days before. Patient had called to report an issue that had with the booster shot. The patient had experienced acute and chronic illnesses at the time of vaccination. patient stated that ten days after the Moderna booster she experienced lost control of right leg, when out of the blue, went to E.R, and they did blood work and a CAT scan and two months later had muscle weakness in right leg, with a warning that the leg has something wrong, lost control of her leg from the knee down for 20 seconds, had called doctor and ordered a MRI and Eco on the heart. She also stated that the weakness in the leg lasted for days from the 13-Feb-2022 to the 15-Feb-2022. She also stated that the blood clotting in her blood was because of the vaccine and that she wanted to know if this was going to continue happening, if she was going to stop having the ability to stop forming blood clots, and that she was a healthy person and this had come out of nowhere. The Adverse event had caused patient to seek medical care, ER for three hours and her leg was fine the whole time she was there, her doctor wanted her to be evaluated for stroke. The patient had not experienced a similar event in the past. The adverse event outcome was ongoing, and rare scary because she didn't have guarantees that was not going to happened again. Since patient had went on the aspirin improved and still had muscle weakness. She had episode where the warning was coming and she had sit and it goes away, she felt muscle weakness in the lower leg. The patient had no COVID-19 test or diagnosis ever. Company comment: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Seriousness criterion Medically Significant) event of Thrombosis 10 days after the third dose of mRNA-1273. Patient lost control of the right leg, went to the ER, blood work and CAT scan didn't find anything. 2 months later patient had muscle weakness in the right leg, MRI showed blood clots in the area that controls the leg, Echocardiogram was normal. Outcome of the event was Not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected, serious (Seriousness criterion Medically Significant) event of Thrombosis 10 days after the third dose of mRNA-1273. Patient lost control of the right leg, went to the ER, blood work and CAT scan didn't find anything. 2 months later patient had muscle weakness in the right leg, MRI showed blood clots in the area that controls the leg, Echocardiogram was normal. Outcome of the event was Not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.