Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Dysphonia, Dyspnoea, Echocardiogram, Fatigue
Clinical narrative: Bronchospasm; Excessive sputum; Got 2 UTI's; Blood in my urine; Difficulty breathing; Hoarseness; Chest tightness; Numbness; Feeling hot; Flushing; Scar tissue in my R lung; Felt like I was going to die after the second injection; Decreased level of consciousness; tiredness; Low grade fever; Asthma; Inflammation in her lung / there is something in her lungs; So sick; Wheezing that could be heard across the room; cough out of control / could not quit coughing; Shingles; had a reaction to the Moderna shot; blood pressure skyrocketed, it went from normal to 190 or something, elevated blood pressure; Rash in her stomach; Mass in her lungs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY FIBROSIS (Scar tissue in my R lung), NEAR DEATH EXPERIENCE (Felt like I was going to die after the second injection), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), PULMONARY MASS (Mass in her lungs), BRONCHOSPASM (Bronchospasm) and ASTHMA (Asthma) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Pyridium allergy (approximately 20 years ago) throat felt like it was swelling, took Bynadryl OTC.).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced ASTHMA (Asthma) (seriousness criterion medically significant). In 2021, the patient experienced PULMONARY MASS (Mass in her lungs) (seriousness criterion medically significant), PNEUMONITIS (Inflammation in her lung / there is something in her lungs), ILLNESS (So sick), WHEEZING (Wheezing that could be heard across the room), COUGH (cough out of control / could not quit coughing), HERPES ZOSTER (Shingles), VACCINATION COMPLICATION (had a reaction to the Moderna shot), HYPERTENSION (blood pressure skyrocketed, it went from normal to 190 or something, elevated blood pressure) and RASH (Rash in her stomach). On an unknown date, the patient experienced PULMONARY FIBROSIS (Scar tissue in my R lung) (seriousness criterion medically significant), NEAR DEATH EXPERIENCE (Felt like I was going to die after the second injection) (seriousness criterion medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), BRONCHOSPASM (Bronchospasm) (seriousness criterion medically significant), SPUTUM INCREASED (Excessive sputum), URINARY TRACT INFECTION (Got 2 UTI's), BLOOD URINE PRESENT (Blood in my urine), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), CHEST DISCOMFORT (Chest tightness), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot), FLUSHING (Flushing), FATIGUE (tiredness) and PYREXIA (Low grade fever). At the time of the report, PULMONARY FIBROSIS (Scar tissue in my R lung), NEAR DEATH EXPERIENCE (Felt like I was going to die after the second injection), BRONCHOSPASM (Bronchospasm), SPUTUM INCREASED (Excessive sputum), URINARY TRACT INFECTION (Got 2 UTI's), BLOOD URINE PRESENT (Blood in my urine), FATIGUE (tiredness) and PYREXIA (Low grade fever) outcome was unknown and DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), PULMONARY MASS (Mass in her lungs), ASTHMA (Asthma), PNEUMONITIS (Inflammation in her lung / there is something in her lungs), ILLNESS (So sick), WHEEZING (Wheezing that could be heard across the room), COUGH (cough out of control / could not quit coughing), HERPES ZOSTER (Shingles), VACCINATION COMPLICATION (had a reaction to the Moderna shot), HYPERTENSION (blood pressure skyrocketed, it went from normal to 190 or something, elevated blood pressure), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), CHEST DISCOMFORT (Chest tightness), HYPOAESTHESIA (Numbness), FEELING HOT (Feeling hot), FLUSHING (Flushing) and RASH (Rash in her stomach) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: normal (normal) normal. In 2021, Blood pressure measurement: high (High) skyrocketed, it went from normal to 190 or something. In 2021, Blood test: normal (normal) normal. In 2021, Computerised tomogram: normal (normal) normal. In 2021, Culture: negative (Negative) negative. In 2021, Echocardiogram: normal (normal) normal. In 2021, X-ray: abnormal (abnormal) a mass in her lungs and abnormal (abnormal) it's not any better..         Concomitant product use was not provided by the reporter.   Laboratory test included mass in right lung found on x-ray and cat scan, bronchoscopy showed no mass, thought it was infection and did multiple cultures all negative, blood in urine. Treatment included inhaler, blood pressure medicine and other medications, approximately  15 prescriptions by the doctor.  Patient had a reaction to the Moderna shot and it has been going on for six months. She was very healthy.  All within a week of the second dose she went to her doctor and was given an inhaler and sent her home. They gave her blood pressure medicine. At first, they told her it was a mass in her lung, then an infection but the cultures came negative, now they say it was an inflammation. Her condition was not improving. She has been in twelve different medications since then to treat her blood pressure and she has been treated for asthma although she never had asthma and does not think this was asthma. At one point she was even treated for shingles for a rash in her stomach. Before this she was not taking any medications.  Patient was healthy before the second injection and felt like she was going to die after the second injection. Patient then went to three doctors offices. Doctors tried to find other causes, one doctor included diagnosis  as allergic reaction to something she  ate.  Company Comment: This case concerns a 65-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of pulmonary fibrosis, pulmonary mass, bronchospasm and asthma. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was negative since the patient only experienced pyrexia after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.   This case was linked to MOD-2021-275735 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up information was received include additional Contact information. On 10-Sep-2021: Patient's demographics, medical history, lab tests in narrative, vaccine details, vaccine facility name, new events and upgraded case to serious as per IME list, start date for event asthma added; Sender's Comments: This case concerns a 65-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of pulmonary fibrosis, pulmonary mass, bronchospasm and asthma. The events occurred 1 day after the second dose of mRNA-1273. The rechallenge was negative since the patient only experienced pyrexia after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.