Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Weight, Weight decreased
Clinical narrative: Arm paralysis; Weight loss: 127 down to 113; Had an eight centimeters cyst; Shoulder abscess; Neck surgeries with a spur removed; Plaque psoriasis breakout doubling up; Pulmonary embolism; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and MONOPLEGIA (Arm paralysis) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis and Osteoarthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 03-Sep-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant). On an unknown date, the patient experienced MONOPLEGIA (Arm paralysis) (seriousness criterion medically significant), WEIGHT DECREASED (Weight loss: 127 down to 113), CYST (Had an eight centimeters cyst), ABSCESS (Shoulder abscess), EXOSTOSIS (Neck surgeries with a spur removed) and PSORIASIS (Plaque psoriasis breakout doubling up). In 2021, PULMONARY EMBOLISM (Pulmonary embolism) had resolved. At the time of the report, MONOPLEGIA (Arm paralysis) and CYST (Had an eight centimeters cyst) outcome was unknown, WEIGHT DECREASED (Weight loss: 127 down to 113) had not resolved, ABSCESS (Shoulder abscess) and PSORIASIS (Plaque psoriasis breakout doubling up) was resolving and EXOSTOSIS (Neck surgeries with a spur removed) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: Weight loss: 127 down to 113.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 12-Apr-2022, Patient took Concomitant medication PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) for indication COVID-19 VACCINATION as Dose 2 via intramuscular route.  The patient had shoulder abscessed and had to remove an eight centimeters cyst. Her physician accidentally sliced through her esophagus causing food consumed to leak into neck cavity and lead to infection. She was on feeding tube, peripherally inserted central catheter line, and being given daily antibiotics as the result of the esophageal accident. In 2021, the patient had discectomy which lead to more infection. In Sep-2021, she had knee surgery, discectomy which lead to more infection and she had abscess from surgery peripherally inserted central catheter line. On 03-Sep-2021, she had a pulmonary embolism for which she was prescribed blood thinners and methicillin-resistant staphylococcus aureus infection was discovered which was drained. She was prescribed antibiotics. She had plaque psoriasis breakout doubling up on medication. Reporter did not have the lot number information, because the packaging was discarded. The reporter's causality with Humira for the events Exostosis, Pulmonary embolism, Weight loss, Catheter site abscess, Abscess, Postoperative infection was no reasonable possibility and for events Methicillin-resistant Staphylococcus aureus infection and Psoriasis flare-up was reasonable possibility. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 45-year-old female patient with relevant history of multiple surgeries, who experienced the unexpected, serious  (medically significant) adverse event of special interest Pulmonary embolism, and event of Monoplegia (Arm paralysis).  The event  Pulmonary embolism occurred on an unknown interval, and the event Monoplegia on an unknown date in the context of receiving  the first dose of mRNA-1273 vaccine. Onset latency could not be determined as the date of vaccination was not reported and the date of onset of event for Monoplegia. Patient was prescribed blood thinners.  Patient subsequently received a non-company brand COVID-19 vaccine Pfizer Biontech (Tozinameran) at an unknown interval.  The relevant history of multiple surgeries remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received included updated medical history. Events Psoriasis flare-up and Catheter site abscess added.; Sender's Comments: This spontaneous case concerns a 45-year-old female patient with relevant history of multiple surgeries, who experienced the unexpected, serious  (medically significant) adverse event of special interest Pulmonary embolism, and event of Monoplegia (Arm paralysis).  The event  Pulmonary embolism occurred on an unknown interval, and the event Monoplegia on an unknown date in the context of receiving  the first dose of mRNA-1273 vaccine. Onset latency could not be determined as the date of vaccination was not reported and the date of onset of event for Monoplegia. Patient was prescribed blood thinners.  Patient subsequently received a non-company brand COVID-19 vaccine Pfizer Biontech (Tozinameran) at an unknown interval.  The relevant history of multiple surgeries remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.