Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cytomegalovirus infection, Hypergammaglobulinaemia benign monoclonal, Immunisation reaction, Lyme disease, Musculoskeletal disorder
Clinical narrative: Cytomegalovirus infection; Bad reaction to COVID vaccine/ankle, arms and general feeling bad; Bad reaction to COVID vaccine/general feeling bad; Lyme's disease; Lung clot; diagnosed with Monoclonal gammopathy of undetermined significance; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Lung clot), LYME DISEASE (Lyme's disease) and CYTOMEGALOVIRUS INFECTION (Cytomegalovirus infection) in a 62-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) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced HYPERGAMMAGLOBULINAEMIA BENIGN MONOCLONAL (diagnosed with Monoclonal gammopathy of undetermined significance). In July 2022, the patient experienced PULMONARY EMBOLISM (Lung clot) (seriousness criterion medically significant). In September 2022, the patient experienced LYME DISEASE (Lyme's disease) (seriousness criterion medically significant). On an unknown date, the patient experienced CYTOMEGALOVIRUS INFECTION (Cytomegalovirus infection) (seriousness criterion medically significant), MUSCULOSKELETAL DISORDER (Bad reaction to COVID vaccine/ankle, arms and general feeling bad) and IMMUNISATION REACTION (Bad reaction to COVID vaccine/general feeling bad). At the time of the report, PULMONARY EMBOLISM (Lung clot), CYTOMEGALOVIRUS INFECTION (Cytomegalovirus infection), HYPERGAMMAGLOBULINAEMIA BENIGN MONOCLONAL (diagnosed with Monoclonal gammopathy of undetermined significance), MUSCULOSKELETAL DISORDER (Bad reaction to COVID vaccine/ankle, arms and general feeling bad) and IMMUNISATION REACTION (Bad reaction to COVID vaccine/general feeling bad) outcome was unknown and LYME DISEASE (Lyme's disease) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. AbbVie's opinion was that the causality for the event(s) of Bad reaction to COVID vaccine/ankle, arms and general feeling bad unknown onset with Adalimumab Solution for Injection was No Reasonable Possibility. AbbVie's Alternative Etiology for Bad reaction to COVID vaccine/ankle, arms and general feeling bad with Adalimumab Solution for Injection: Most likely related to use of a covid 19 vaccine HUMIRA  Musculoskeletal disorder, No Reasonable Possibility No treatment medications were provided.  Company comment: This Spontaneous case concerns a 62 years old female patient, with no medical history, who experienced unexpected serious (medically significant) events of pulmonary embolism, Lyme disease, cytomegalovirus infection, which occurred unspecified days after a dose (Dose number not specified) of mRNA-1273 vaccine. Patient experienced lung clot and patient had nonserious bad reaction to ankle, arms and general feeling bad, Lyme disease. At the time of reporting, outcome of event  pulmonary embolism, cytomegalovirus virus is unknown and Lyme disease is recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 62 years old female patient, with no medical history, who experienced unexpected serious (medically significant) events of pulmonary embolism, Lyme disease, cytomegalovirus infection, which occurred unspecified days after a dose (Dose number not specified) of mRNA-1273 vaccine. Patient experienced lung clot and patient had nonserious bad reaction to ankle, arms and general feeling bad, Lyme disease. At the time of reporting, outcome of event  pulmonary embolism, cytomegalovirus virus is unknown and Lyme disease is recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.