Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: was hospitalized recently for 2 or 3 overnights for blood clots before she got the 4th dose; This spontaneous case was reported by a nurse and describes the occurrence of THROMBOSIS (was hospitalized recently for 2 or 3 overnights for blood clots before she got the 4th dose) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer (She is ex-cancer patient) in 2011.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-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 (was hospitalized recently for 2 or 3 overnights for blood clots before she got the 4th dose) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (was hospitalized recently for 2 or 3 overnights for blood clots before she got the 4th dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient experienced after receiving 4 doses (2nd dose lot # 007M20A on 9Feb2021; 3rd dose lot # 012F21A on 26Oct2021; 4th dose lot # 049L21A on 6May2022) of the Moderna Covid-19 Vaccine. Patient stated that they gave her a full dose as the 3rd dose but was not sure which dosage they gave her for her 4th dose. Patient said that she was an ex-cancer patient & says she had lung cancer in 2011. patient said that she was not on immunosuppressants and did not think patient was immunocompromised. Patient said that she was recently for 2 or 3 overnights for blood clots before she got the 4th dose & was now on blood thinners.  No concomitant information were reported by the reporter.  Treatment includes: Blood thinners  Company comment: This spontaneous case concerns an 88-year-old female patient, with a relevant history of lung cancer, who experienced the unexpected, serious Adverse Event of Special Interest (hospitalization, medically significant) of Thrombosis, that occurred unknown days after the third dose of mRNA-1273 vaccine administration. Patient was hospitalized for 2-3 days due to blood clots prior to receiving the 4th dose of mRNA-1273 vaccine. Underlying history of lung cancer and the patient's age could be the risk factor. Patient is not on any immunosuppressants. She was treated with blood thinners.  Outcome of the event was reported as unknown. Previously patient had received the primary series of mRNA-1273 vaccine as dose 1 and 2 with no adverse event reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-569082.; Sender's Comments: This spontaneous case concerns an 88-year-old female patient, with a relevant history of lung cancer, who experienced the unexpected, serious Adverse Event of Special Interest (hospitalization, medically significant) of Thrombosis, that occurred unknown days after the third dose of mRNA-1273 vaccine administration. Patient was hospitalized for 2-3 days due to blood clots prior to receiving the 4th dose of mRNA-1273 vaccine. Underlying history of lung cancer and the patient's age could be the risk factor. Patient is not on any immunosuppressants. She was treated with blood thinners.  Outcome of the event was reported as unknown. Previously patient had received the primary series of mRNA-1273 vaccine as dose 1 and 2 with no adverse event reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report..