Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: 3 massive blood clots in her lungs.; blood bacteria infection; Death certificate indicated she died from pneumonia as a result of COVID.; She passed out 3 times; Patient also had big blood blister in her fingers and hand.; My mother became ill not even a week after her second covid vaccine.; Patient's daughter stated after the second dose her mother started to age quickly and was aching.; She was constantly sleeping and had sudden onset breathing issues.; She was hospitalized in mid January 2022 after multiple falls and eventually died on January 25, 2022 as a result of blood bacteria infection and 3 massive blood clots in her lungs; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (3 massive blood clots in her lungs.), BACTERIAL INFECTION (blood bacteria infection), COVID-19 PNEUMONIA (Death certificate indicated she died from pneumonia as a result of COVID.), LOSS OF CONSCIOUSNESS (She passed out 3 times), BLOOD BLISTER (Patient also had big blood blister in her fingers and hand.), ILLNESS (My mother became ill not even a week after her second covid vaccine.), PAIN (Patient's daughter stated after the second dose her mother started to age quickly and was aching.), SOMNOLENCE (She was constantly sleeping and had sudden onset breathing issues.) and FALL (She was hospitalized in mid January 2022 after multiple falls and eventually died on January 25, 2022 as a result of blood bacteria infection and 3 massive blood clots in her lungs) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 037B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD (Patient had COPD and was taking medication).   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-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 experienced PULMONARY THROMBOSIS (3 massive blood clots in her lungs.) (seriousness criteria death, hospitalization and medically significant), BACTERIAL INFECTION (blood bacteria infection) (seriousness criteria death and hospitalization), COVID-19 PNEUMONIA (Death certificate indicated she died from pneumonia as a result of COVID.) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (She passed out 3 times) (seriousness criteria hospitalization and medically significant), BLOOD BLISTER (Patient also had big blood blister in her fingers and hand.) (seriousness criterion hospitalization), ILLNESS (My mother became ill not even a week after her second covid vaccine.) (seriousness criterion hospitalization), PAIN (Patient's daughter stated after the second dose her mother started to age quickly and was aching.) (seriousness criterion hospitalization), SOMNOLENCE (She was constantly sleeping and had sudden onset breathing issues.) (seriousness criterion hospitalization), FALL (She was hospitalized in mid January 2022 after multiple falls and eventually died on January 25, 2022 as a result of blood bacteria infection and 3 massive blood clots in her lungs) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient died on 25-Jan-2022. The reported cause of death was pneumonia as a result of covid, blood bacteria infection and 3 massive blood clots in her lungs.. An autopsy was not performed. At the time of death, LOSS OF CONSCIOUSNESS (She passed out 3 times), BLOOD BLISTER (Patient also had big blood blister in her fingers and hand.), ILLNESS (My mother became ill not even a week after her second covid vaccine.), PAIN (Patient's daughter stated after the second dose her mother started to age quickly and was aching.), SOMNOLENCE (She was constantly sleeping and had sudden onset breathing issues.), FALL (She was hospitalized in mid January 2022 after multiple falls and eventually died on January 25, 2022 as a result of blood bacteria infection and 3 massive blood clots in her lungs) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   The patient became ill not even a week after her second covid vaccine.   She was constantly sleeping and had sudden onset breathing issues. She was hospitalized in mid-Jan-2022 after multiple falls and eventually died on 25-Jan-2022 as a result of blood bacteria infection and 3 massive blood clots in her lungs. She was inpatient at Hospital. Multiple COVID tests were given while she was hospitalized all of which returned negative. Death certificate indicated she died from pneumonia as a result of COVID.   After the second dose the patient started to age quickly and was aching. She passed out 3 times. The EMS took her to the hospital. Patient had 3 very large blood clot. Patient also had big blood blister in her fingers and hand.  Patient's autopsy was refused.  Treatment information was not provided.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 68-year-old female patient, with relevant medical condition of chronic obstructive pulmonary disease, who experienced the fatal events of Pulmonary thrombosis (AESI), Bacterial infection and COVID-19 pneumonia, the unexpected and serious (due to hospitalization and medically significant) event of Loss of consciousness, and the unexpected and serious (due to hospitalization) events of Blood blister, Illness, Pain, Fall and Somnolence, which occurred after the second dose of mRNA-1273 vaccine. As reported, the patient became ill not even a week after vaccination. She was constantly sleeping and had sudden onset breathing issues. She was hospitalized approximately 8 months after vaccination, after multiple falls and eventually 8 months and a half after mRNA-1273, as a result of blood bacteria infection and 3 massive blood clots in her lungs. Multiple COVID tests were given while she was hospitalized all of which returned back negative. Death certificate indicated she died from pneumonia as a result of COVID. Patient's daughter stated after the second dose her mother started to age quickly and was aching. She passed out 3 times. Patient also had big blood blister in her fingers and hand. Autopsy was refused. Underlying chronic obstructive pulmonary disease could be a confounding factor for COVID-19 pneumonia, bacterial infection and somnolence. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2023: Follow-up information received included Narrative updated.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 68-year-old female patient, with relevant medical condition of chronic obstructive pulmonary disease, who experienced the fatal events of Pulmonary thrombosis (AESI), Bacterial infection and COVID-19 pneumonia, the unexpected and serious (due to hospitalization and medically significant) event of Loss of consciousness, and the unexpected and serious (due to hospitalization) events of Blood blister, Illness, Pain, Fall and Somnolence, which occurred after the second dose of mRNA-1273 vaccine. As reported, the patient became ill not even a week after vaccination. She was constantly sleeping and had sudden onset breathing issues. She was hospitalized approximately 8 months after vaccination, after multiple falls and eventually 8 months and a half after mRNA-1273, as a result of blood bacteria infection and 3 massive blood clots in her lungs. Multiple COVID tests were given while she was hospitalized all of which returned back negative. Death certificate indicated she died from pneumonia as a result of COVID. Patient's daughter stated after the second dose her mother started to age quickly and was aching. She passed out 3 times. Patient also had big blood blister in her fingers and hand. Autopsy was refused. Underlying chronic obstructive pulmonary disease could be a confounding factor for COVID-19 pneumonia, bacterial infection and somnolence. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Pneumonia as a result of COVID; blood bacteria infection; 3 massive blood clots in her lungs.