Age: 84.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Thrombosis
Clinical narrative: Pneumonia attack after 2nd shot; Diagnosed with multiple blood clots in legs, lungs, and brain after 2nd shot/ Thrombosis after 2nd shot; Collapsed at home after 2nd shot; O2 level fell into 70's at home after 2nd shot; Terrible reaction to Eliquis; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Collapsed at home after 2nd shot), HYPOXIA (O2 level fell into 70's at home after 2nd shot), PNEUMONIA (Pneumonia attack after 2nd shot) and THROMBOSIS (Diagnosed with multiple blood clots in legs, lungs, and brain after 2nd shot/ Thrombosis after 2nd shot) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product APIXABAN (ELIQUIS) for Clot blood.    No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, FENOFIBRATE, LABETALOL, LEVOTHYROXINE, LISINOPRIL, METFORMIN, TORSEMIDE, TRAMADOL, WITHANIA SOMNIFERA (ASHVAGANDAH), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), DOCUSATE SODIUM (COLACE), CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE + CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]), MULTIVITAMIN [VITAMINS NOS], ZEAXANTHIN (LUTEIN [ZEAXANTHIN]), FISH OIL (OMEGA 3 FISH OIL [FISH OIL]), VITAMIN D [VITAMIN D NOS] and VITAMIN A [RETINOL] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started APIXABAN (ELIQUIS) (unknown route) 1 dosage form. In February 2021, the patient experienced FALL (Collapsed at home after 2nd shot) (seriousness criteria hospitalization and medically significant), HYPOXIA (O2 level fell into 70's at home after 2nd shot) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (Diagnosed with multiple blood clots in legs, lungs, and brain after 2nd shot/ Thrombosis after 2nd shot) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PNEUMONIA (Pneumonia attack after 2nd shot) (seriousness criteria hospitalization and medically significant) and ADVERSE DRUG REACTION (Terrible reaction to Eliquis). The patient was hospitalized from sometime in February 2021 to sometime in May 2021 due to HYPOXIA and THROMBOSIS, and then on sometime in February 2021 due to FALL. In May 2021, ADVERSE DRUG REACTION (Terrible reaction to Eliquis) had resolved. At the time of the report, FALL (Collapsed at home after 2nd shot), HYPOXIA (O2 level fell into 70's at home after 2nd shot), PNEUMONIA (Pneumonia attack after 2nd shot) and THROMBOSIS (Diagnosed with multiple blood clots in legs, lungs, and brain after 2nd shot/ Thrombosis after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Oxygen saturation: low (Low) O2 level fell into 70s.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug include probiotics.  Post second vaccine, in late February, while doing physical therapy at home, patient's oxygen level fell into 70s and patient collapsed. In the hospital, patient was diagnosed with multiple blood clots in legs, lungs, and brain. Diagnosis was thrombosis and the physician prescribed Eliquis which eventually took care of the blood clots. The patient was discharged and while getting ready to go home, in the elevator the patient had a pneumonia attack and was re-admitted to the hospital.  Two days later, the patient went home.  Currently patient was at home now and asymptomatic. The patient had a terrible reaction to Eliquis. But patient's husband had the Eliquis discontinued without doctors orders. After discontinuing the Eliquis, patient was able to go to the bathroom without the help of the home aid nurse, and was responsive and answers questions and talks.  Company Comment: This case concerns an 84 year-old female patient with no reported medical history, who experienced the unexpected serious events of Fall, Hypoxia, Thrombosis (AESI), and Pneumonia. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Although the medical history is not reported, the patient reports multiple concomitant medications commonly used to treat chronic comorbidities that may have contributed to the events and the seriousness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-368989 (Patient Link).; Sender's Comments: This case concerns an 84 year-old female patient with no reported medical history, who experienced the unexpected serious events of Fall, Hypoxia, Thrombosis (AESI), and Pneumonia. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Although the medical history is not reported, the patient reports multiple concomitant medications commonly used to treat chronic comorbidities that may have contributed to the events and the seriousness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.