Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Post-acute COVID-19 syndrome, Product dose omission issue, Vertigo, Vision blurred
Clinical narrative: then developed pneumonia; has high pressure behind one of her eyes; blurry vision; vertigo; once she gov Covid, she had GI side effects; tightness & electrical shock where bronchial tubes are; leg edema from her knees down her legs & into her ankles; has long Covid, almost passed out on the way to the urgent care; 1st dose20Nov2021; has not gotten the 2nd dose; cardiac enzyme test came back at 0.04, which can indicate heart damage, has an enlarged heart; got Covid-19 on 3 Dec2021; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (then developed pneumonia), CARDIAC DISORDER (cardiac enzyme test came back at 0.04, which can indicate heart damage, has an enlarged heart), COVID-19 (got Covid-19 on 3 Dec2021) and POST-ACUTE COVID-19 SYNDROME (has long Covid, almost passed out on the way to the urgent care) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures (She had anaphylaxis to Infed (iron dextran infusion) which led to seizures and respiratory failure) and Respiratory failure (She had anaphylaxis to Infed (iron dextran infusion) which led to seizures and respiratory failure). Concurrent medical conditions included Crohn's disease (she was obese and disabled due to Crohn's disease which she has since 1995.) since 1995, Obesity (she was obese and disabled due to Crohn's disease which she has since 1995.) and Anaphylactic reaction to drug (She had anaphylaxis to Infed (iron dextran infusion) which led to seizures and respiratory failure.).    On 20-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced COVID-19 (got Covid-19 on 3 Dec2021) (seriousness criterion medically significant). On 18-Feb-2022, the patient experienced CARDIAC DISORDER (cardiac enzyme test came back at 0.04, which can indicate heart damage, has an enlarged heart) (seriousness criterion medically significant). On an unknown date, the patient experienced PNEUMONIA (then developed pneumonia) (seriousness criterion medically significant), OCULAR DISCOMFORT (has high pressure behind one of her eyes), VISION BLURRED (blurry vision), VERTIGO (vertigo), GASTROINTESTINAL DISORDER (once she gov Covid, she had GI side effects), CHEST DISCOMFORT (tightness & electrical shock where bronchial tubes are), OEDEMA PERIPHERAL (leg edema from her knees down her legs & into her ankles), POST-ACUTE COVID-19 SYNDROME (has long Covid, almost passed out on the way to the urgent care) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (1st dose20Nov2021; has not gotten the 2nd dose). The patient was treated with VITAMIN D [VITAMIN D NOS] for Pneumonia, at an unspecified dose and frequency and VITAMIN B12 [VITAMIN B12 NOS] for Pneumonia, at an unspecified dose and frequency. At the time of the report, PNEUMONIA (then developed pneumonia), OCULAR DISCOMFORT (has high pressure behind one of her eyes), VISION BLURRED (blurry vision), VERTIGO (vertigo), GASTROINTESTINAL DISORDER (once she gov Covid, she had GI side effects), CHEST DISCOMFORT (tightness & electrical shock where bronchial tubes are), OEDEMA PERIPHERAL (leg edema from her knees down her legs & into her ankles), CARDIAC DISORDER (cardiac enzyme test came back at 0.04, which can indicate heart damage, has an enlarged heart), COVID-19 (got Covid-19 on 3 Dec2021), POST-ACUTE COVID-19 SYNDROME (has long Covid, almost passed out on the way to the urgent care) and PRODUCT DOSE OMISSION ISSUE (1st dose20Nov2021; has not gotten the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Brain natriuretic peptide: bnp was less than 10 BNP was less than 10. On 18-Feb-2022, Chest X-ray: enlarged heart enlarged heart. On 18-Feb-2022, Echocardiogram: enlarged heart enlarged heart. On 18-Feb-2022, Myocardial necrosis marker: test came back at 0.04, indicate heart damage test came back at 0.04, which can indicate heart damage.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Patient got Covid-19 on 03-Dec-2021, then developed pneumonia for which she had 2 or 3 antibiotics, steroids, vitamin D and vitamin B12. She had a lot of shortness of breath and dark green sputum with the pneumonia. She now has long Covid and has an enlarged heart. She went to an urgent care for the treatment of the pneumonia because her doctor did not have appointments available for 6 months. She almost passed out on the way to the urgent care. She received monoclonal antibodies to treat her Covid. Her post-Covid symptoms include a lot of pain on the left side of her chest, sharp stabbing pains on the left or right side of sternum every now and again, sharp or throbbing pain under her left breast near where ribcage ends, sharp pain sometimes by or behind or under her left shoulder blade, and tightness and electrical shock where bronchial tubes were. She was seeing her gastroenterologist in early February of 2022 and told them about the leg edema from her knees down her legs and into her ankles. The gastroenterologist then did blood tests which showed her BNP was less than 10 and sent her for an x-ray that showed that she has an enlarged heart. On 18-Feb-2022 she had a bunch of tests: chest x-ray, d-dimers test, EKG, echocardiogram and wore a heart monitor.  Company Comment- This spontaneous case concerns a 51-year-old, female patient with relevant history of obesity and Crohn's disease, who experienced the unexpected, serious (Medically significant) events of COVID-19 and Pneumonia, Post-acute COVID-19 syndrome and heart disorder. The patient received only the one dose of mRNA-1273 and the event COVID-19 occurred 13 days after the first dose. The event Cardiac disorder occurred 90 days after administration of mRNA-1273 and onset date for other events was not specified. Patient reported that she received monoclonal antibodies for COVID-19 and 3 antibiotic and steroids for pneumonia (type of microorganism, which caused pneumonia wasn't specified). Patient also reported that she is suffering from long COVID-19 and cardiac disorder with enlarged heart.  Her post-acute COVID-19 syndrome included different type of pains and gastrointestinal problems.  Additional diagnosis included cardiac disorder with enlarged heart (diagnosed based on X-rays) and leg oedema. Blurry vision, vertigo, intraocular pressure increase was also reported as non-serious adverse events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51-year-old, female patient with relevant history of obesity and Crohn's disease, who experienced the unexpected, serious (Medically significant) events of COVID-19 and Pneumonia, Post-acute COVID-19 syndrome and heart disorder. The patient received only the one dose of mRNA-1273 and the event COVID-19 occurred 13 days after the first dose. The event Cardiac disorder occurred 90 days after administration of mRNA-1273 and onset date for other events was not specified. Patient reported that she received monoclonal antibodies for COVID-19 and 3 antibiotic and steroids for pneumonia (type of microorganism, which caused pneumonia wasn't specified). Patient also reported that she is suffering from long COVID-19 and cardiac disorder with enlarged heart.  Her post-acute COVID-19 syndrome included different type of pains and gastrointestinal problems.  Additional diagnosis included cardiac disorder with enlarged heart (diagnosed based on X-rays) and leg oedema. Blurry vision, vertigo, intraocular pressure increase was also reported as non-serious adverse events. The benefit-risk relationship of mRNA-1273 is not affected by this report.