Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Pulmonary oedema, Pyrexia, Urinary tract infection
Clinical narrative: FLUID IN LUNG; ALLERGIC REACTION TO COVID VACCINE; Fever; UTI; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (FLUID IN LUNG), ALLERGY TO VACCINE (ALLERGIC REACTION TO COVID VACCINE), PYREXIA (Fever) and URINARY TRACT INFECTION (UTI) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced PULMONARY OEDEMA (FLUID IN LUNG) (seriousness criteria hospitalization and medically significant), ALLERGY TO VACCINE (ALLERGIC REACTION TO COVID VACCINE) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and URINARY TRACT INFECTION (UTI) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to ALLERGY TO VACCINE, PULMONARY OEDEMA, PYREXIA and URINARY TRACT INFECTION. At the time of the report, PULMONARY OEDEMA (FLUID IN LUNG), ALLERGY TO VACCINE (ALLERGIC REACTION TO COVID VACCINE), PYREXIA (Fever) and URINARY TRACT INFECTION (UTI) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: elevated. On an unknown date, Blood sodium: Low. On an unknown date, Body temperature: 104. On an unknown date, Heart rate: low. On an unknown date, Platelet count: DECREASED.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient reported she had a allergic reaction to the Moderna Covid vaccine and was in the hospital for five days. She had platelets decreased, fever of 104, Kidney, liver and sodium went too low. She also had fluid in lung and UTI. The reporter's causality for the event(s) of ALLERGIC REACTION TO COVID VACCINE, FLUID IN LUNG, PLATELETS DECREASED, FEVER, LOW SODIUM, UTI, LOW HEART RATE and SUGAR ELEVATED was not provided. There was no reasonable possibility that the event of ALLERGIC REACTION TO COVID VACCINE is related to IMBRUVICA(IBRUTINIB). The events of FLUID IN LUNG, PLATELETS DECREASED, FEVER, LOW SODIUM, UTI, LOW HEART RATE and SUGAR ELEVATED was not assessable. No treatment medication was reported. 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 an adult female patient of unknown age with no medical history reported, who experienced the unexpected, serious (hospitalization) events of pulmonary oedema, pyrexia, and urinary tract infection an unknown time after the first dose of mRNA-1273. The patient was hospitalized for 5 days where blood work results showed elevated blood sugar, platelets decreased, and sodium decreased. Information regarding clinical evaluation, further diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with no medical history reported, who experienced the unexpected, serious (hospitalization) events of pulmonary oedema, pyrexia, and urinary tract infection an unknown time after the first dose of mRNA-1273. The patient was hospitalized for 5 days where blood work results showed elevated blood sugar, platelets decreased, and sodium decreased. Information regarding clinical evaluation, further diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.