Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, COVID-19, Computerised tomogram, Dyspnoea
Clinical narrative: If laid back on the right side could not breath at all/ If rolled to the left side it could but to the right side could not inhale at all; Inflamed due to the vaccine/ Old injury site was all inflamed; Feeling that was having a pulmonary embolism/ Might have a pulmonary embolism on the right lung; Had pain in the back; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Feeling that was having a pulmonary embolism/ Might have a pulmonary embolism on the right lung), DYSPNOEA (If laid back on the right side could not breath at all/ If rolled to the left side it could but to the right side could not inhale at all) and INFLAMMATION (Inflamed due to the vaccine/ Old injury site was all inflamed) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer, Cancer surgery (Old injury site 2 or 3 years old) and Total knee replacement (7 in the scale of pain). Concurrent medical conditions included Neuropathy (The patient had a total knee replacement and instantly got the neuropathy), Arthritis, COPD and Clotting disorder (Second blood clotting disease called anti tropine 3/ Blood clots in the lungs). Concomitant products included APIXABAN (ELIQUIS) for Clot blood, FOLIC ACID (FOLIC) for Clotting disorder, GABAPENTIN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (If laid back on the right side could not breath at all/ If rolled to the left side it could but to the right side could not inhale at all) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY EMBOLISM (Feeling that was having a pulmonary embolism/ Might have a pulmonary embolism on the right lung) (seriousness criteria hospitalization and medically significant), INFLAMMATION (Inflamed due to the vaccine/ Old injury site was all inflamed) (seriousness criterion hospitalization) and BACK PAIN (Had pain in the back). The patient was treated with MORPHINE for Adverse event, at an unspecified dose and frequency. In April 2021, DYSPNOEA (If laid back on the right side could not breath at all/ If rolled to the left side it could but to the right side could not inhale at all) had resolved. At the time of the report, PULMONARY EMBOLISM (Feeling that was having a pulmonary embolism/ Might have a pulmonary embolism on the right lung), INFLAMMATION (Inflamed due to the vaccine/ Old injury site was all inflamed) and BACK PAIN (Had pain in the back) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, COVID-19: negative (Negative) Negative. On an unknown date, Blood test: normal (normal) Everything come back normal. On an unknown date, Computerised tomogram: normal (normal) CT test with contrast, with dye, but did not see anything on it. On an unknown date, Fibrin D dimer: abnormal (abnormal) Showed activity like clot.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included blood pressure pills, protonic for the stomach, thyroid medicine, Procyon for neuropathy, Folic (Vitamin D, helps reduce the clotting), Fariba and another unknown medicine for COPD. Patient had no history of myocarditis or pericarditis. The patient had feeling of pulmonary embolism. The patient then went to a prompt care clinic and was taken to a hospital. 7 or 8 hours or so they understood that patient might have a pulmonary embolism on the right lung from cancer surgery and that they were inflamed due to the vaccine.  Company Comment: This case concerns a 63-year-old, male patient with medical history of cancer surgery total knee replacement, neuropathy, arthritis, COPD and clotting disorder, who experienced the unexpected events of pulmonary embolism, dyspnoea, inflammation which required hospitalization, and back pain. The events occurred on an unknown date after the second dose of mRNA-1273. On the night of the injection, patient had an issue where if laid back on the right side could not breath at all. If rolled to the left side, it could but to the right side could not inhale at all. The patient had feeling of pulmonary embolism. The patient then went to a prompt care clinic and was taken to a hospital. 7 or 8 hours or so they understood that patient might have a pulmonary embolism on the right lung from cancer surgery and that they were inflamed due to the vaccine. On an unknown date CT test with contrast, with die, was done but with no findings. As treatment, patient was given larger doses of steroids and antibiotics in huge amounts. The patient was released, and it took 6 weeks before all the symptoms were gone. The rechallenge was not applicable for all events but back pain for which it is positive. The above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-383113 (Patient Link).; Sender's Comments: This case concerns a 63-year-old, male patient with medical history of cancer surgery total knee replacement, neuropathy, arthritis, COPD and clotting disorder, who experienced the unexpected events of pulmonary embolism, dyspnoea, inflammation which required hospitalization, and back pain. The events occurred on an unknown date after the second dose of mRNA-1273. On the night of the injection, patient had an issue where if laid back on the right side could not breath at all. If rolled to the left side, it could but to the right side could not inhale at all. The patient had feeling of pulmonary embolism. The patient then went to a prompt care clinic and was taken to a hospital. 7 or 8 hours or so they understood that patient might have a pulmonary embolism on the right lung from cancer surgery and that they were inflamed due to the vaccine. On an unknown date CT test with contrast, with die, was done but with no findings. As treatment, patient was given larger doses of steroids and antibiotics in huge amounts. The patient was released, and it took 6 weeks before all the symptoms were gone. The rechallenge was not applicable for all events but back pain for which it is positive. The above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.