Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, COVID-19, Fall, Patella fracture, Pneumonia
Clinical narrative: Pneumonia and was hospitalized; Had an accident/fell; Broke her kneecap; Had covid twice; Allergic reaction to Moderna covid vaccine that caused blister on her knuckles/peeling; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Pneumonia and was hospitalized), FALL (Had an accident/fell) and PATELLA FRACTURE (Broke her kneecap) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB for Nasal polyps.    The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Anxiety, Depression and Nasal polyps. Concomitant products included NAPROXEN, EPINEPHRINE (EPIPEN), SUMATRIPTAN SUCCINATE, TRAZODONE, BUSPIRONE, BUPROPION, IBUPROFEN, ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN EXTRA STRENGTH), ACETYLSALICYLIC ACID (ASPIRINE), FLUOXETINE, PARACETAMOL (TYLENOL), ALBUTEROL SULFATE, FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) and MONTELUKAST SODIUM for an unknown indication.   On 20-Nov-2020, the patient started DUPILUMAB (Subcutaneous) 300 milligram. In 2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2021, the patient experienced PNEUMONIA (Pneumonia and was hospitalized) (seriousness criteria hospitalization and medically significant). In August 2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction to Moderna covid vaccine that caused blister on her knuckles/peeling). On 20-Mar-2022, the patient experienced COVID-19 (Had covid twice). On 15-May-2022, the patient experienced FALL (Had an accident/fell) (seriousness criterion medically significant) and PATELLA FRACTURE (Broke her kneecap) (seriousness criterion medically significant). The patient was hospitalized on sometime in September 2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia and was hospitalized), FALL (Had an accident/fell), PATELLA FRACTURE (Broke her kneecap), ALLERGY TO VACCINE (Allergic reaction to Moderna covid vaccine that caused blister on her knuckles/peeling) and COVID-19 (Had covid twice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, SARS-CoV-2 test: (Positive) Patient had COVID. On 20-Mar-2022, SARS-CoV-2 test: (Positive) Patient had COVID.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ALLERGY TO VACCINE (Allergic reaction to Moderna covid vaccine that caused blister on her knuckles/peeling) to be related. No further causality assessments were provided for PNEUMONIA (Pneumonia and was hospitalized), FALL (Had an accident/fell), PATELLA FRACTURE (Broke her kneecap) and COVID-19 (Had covid twice).    Co-suspect drug Dupilumab strength was reported as 150 mg/ml. It was mentioned that the patient had an allergic reaction to the covid vaccine that caused blisters on her knuckles/peeling in Aug-2021 for which patient saw primary care physician and allergy doctor; they felt it was the vaccine and not Dupixent that caused the reaction.    Treatment information was not provided.  Company comment: This spontaneous case concerns a 57-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (hospitalization, medically significant) event of Pneumonia , unexpected serious (medically significant) events of Fall and Patella fracture. The events Fall and Patella fracture occurred 1.5 years after, Pneumonia occurred unknown days after receiving an unspecified dose of mRNA-1273 Vaccine in COVID-19 vaccination series. Additionally, allergy to vaccine (Had allergic reaction to Moderna covid vaccine that caused blister on her knuckles/peeling) was also reported as a non-serious event. Patient had tested positive for COVID-19 (twice). No further information regarding risk factors, additional medical history, clinical course, investigations and treatment received were provided. The outcome of the events was unknown . The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (hospitalization, medically significant) event of Pneumonia , unexpected serious (medically significant) events of Fall and Patella fracture. The events Fall and Patella fracture occurred 1.5 years after, Pneumonia occurred unknown days after receiving an unspecified dose of mRNA-1273 Vaccine in COVID-19 vaccination series. Additionally, allergy to vaccine (Had allergic reaction to Moderna covid vaccine that caused blister on her knuckles/peeling) was also reported as a non-serious event. Patient had tested positive for COVID-19 (twice). No further information regarding risk factors, additional medical history, clinical course, investigations and treatment received were provided. The outcome of the events was unknown . The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report.