Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Antiphospholipid antibodies, Bladder mass, Dizziness, Expired product administered, Feeling abnormal
Clinical narrative: blood clots/The patient had 6 blood clots removed from her lungs late at night on January 15; feel the second bivalent booster dose vaccine in her body/feels like there is water crashing on rocks in her body/was very foggy/unstable; almost died after these blood clots; dizzy; nauseous; She also was found that the patient had a growth on her bladder. The patient had a surgical procedure to find that the growth was benign; The patient received her second Moderna bivalent booster dose on December 22, 2022 lot number 057M21A expiration date August 13, 2022 patient received in her left arm; flu like symptoms; injection site was warm to the touch; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (blood clots/The patient had 6 blood clots removed from her lungs late at night on January 15), NEAR DEATH EXPERIENCE (almost died after these blood clots) and FEELING ABNORMAL (feel the second bivalent booster dose vaccine in her body/feels like there is water crashing on rocks in her body/was very foggy/unstable) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No medical history information were reported by the reporter.  Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.    On 22-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE WARMTH (injection site was warm to the touch). On 22-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received her second Moderna bivalent booster dose on December 22, 2022 lot number 057M21A expiration date August 13, 2022 patient received in her left arm). In 2023, the patient experienced NEAR DEATH EXPERIENCE (almost died after these blood clots) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PULMONARY EMBOLISM (blood clots/The patient had 6 blood clots removed from her lungs late at night on January 15) (seriousness criteria hospitalization and medically significant), FEELING ABNORMAL (feel the second bivalent booster dose vaccine in her body/feels like there is water crashing on rocks in her body/was very foggy/unstable) (seriousness criterion hospitalization), DIZZINESS (dizzy), NAUSEA (nauseous) and BLADDER MASS (She also was found that the patient had a growth on her bladder. The patient had a surgical procedure to find that the growth was benign). The patient was treated with MECLIZINE HCL at a dose of 25mg in the Morning, and 25mg dose 8 hours later and HEPARIN at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clots/The patient had 6 blood clots removed from her lungs late at night on January 15), DIZZINESS (dizzy) and NAUSEA (nauseous) had not resolved, NEAR DEATH EXPERIENCE (almost died after these blood clots), FEELING ABNORMAL (feel the second bivalent booster dose vaccine in her body/feels like there is water crashing on rocks in her body/was very foggy/unstable), EXPIRED PRODUCT ADMINISTERED (The patient received her second Moderna bivalent booster dose on December 22, 2022 lot number 057M21A expiration date August 13, 2022 patient received in her left arm) and BLADDER MASS (She also was found that the patient had a growth on her bladder. The patient had a surgical procedure to find that the growth was benign) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE WARMTH (injection site was warm to the touch) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antiphospholipid antibodies: tests were false positive. On an unknown date, Laboratory test: found that the patient had a growth on her bladder.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient called an ambulance and was taken to the emergency room. The ambulance immediately put the patient on oxygen and the oxygen was continued in the hospital. The patient had 6 blood clots removed from patient lungs late at night on 15-JAN-2023 or early morning of 16-JAN-2023. The patient said that she almost died after these blood clots. The patient was rushed from the ED to the Operating room. Since 15-JAN-2023, the patient had several lab tests. She also was found that the patient had a growth on her bladder. The patient had a surgical procedure to find that the growth was benign. The patient was worked up for antiphospholipid syndrome or Hughes syndrome the first two tests were positive. Because the patient takes Eliquis her Doctor ordered a separate test in addition to the 3rd antiphospholipid test and found out that the ingredients in Eliquis had caused false positives for antiphospholipid syndrome. The first two antiphospholipid tests were false positives. Metaphorically like a war going on in patient body between the technology and patient antibodies. This started once came home from the hospital. Patient was on a Heparin drip in the hospital and then when patient was discharged from the hospital the vibration was there. The patient used an oxygenator device to measure the amount of oxygen in her body. Patient can visualize a war going on in patient's body between the new technology and patient antibodies. This whole thing had been a nightmare for patient.  Company Comment: This is a spontaneous case concerning a 74-year-old female patient with a history of use of Eliquis for unknown indication, who experienced the serious (due to medically significant and hospitalization) unexpected, events of pulmonary embolism (AESI) and near-death experience, and the serious (due to hospitalization) event of feeling abnormal, which occurred approximately 1 month after a dose of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5), received as the fourth dose of COVID-19 vaccination schedule. It was reported that the patient had 6 blood clots removed from lungs. The patient said that she almost died after these blood clots. Patient was on a Heparin drip in the hospital and then when patient was discharged from the hospital. Concomitant use of Eliquis could suggest a risk factor for event Pulmonary embolism. The benefit-risk relationship of Bivalent .222 (original and omicron BA.4/BA.5) is not affected by this report.   This case was linked to MOD-2023-731715 (Patient Link).; Sender's Comments: Company Comment: This is a spontaneous case concerning a 74-year-old female patient with a history of use of Eliquis for unknown indication, who experienced the serious (due to medically significant and hospitalization) unexpected, events of pulmonary embolism (AESI) and near-death experience, and the serious (due to hospitalization) event of feeling abnormal, which occurred approximately 1 month after a dose of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5), received as the fourth dose of COVID-19 vaccination schedule. It was reported that the patient had 6 blood clots removed from lungs. The patient said that she almost died after these blood clots. Patient was on a Heparin drip in the hospital and then when patient was discharged from the hospital. Concomitant use of Eliquis could suggest a risk factor for event Pulmonary embolism. The benefit-risk relationship of Bivalent .222 (original and omicron BA.4/BA.5) is not affected by this report.