Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nausea, Rash
Clinical narrative: Passed out; SICK; DID NOT FEEL WELL; FELT FATIGUED; REACTION ON LEG/RASH; Nausea; Flu-like symptom; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 56-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 Psoriatic arthritis.    The patient's past medical history included Ovary removal. Concurrent medical conditions included Psoriatic arthritis.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptom), RASH (REACTION ON LEG/RASH) and NAUSEA (Nausea). In June 2021, the patient experienced ILLNESS (SICK), MALAISE (DID NOT FEEL WELL) and FATIGUE (FELT FATIGUED). The last dose administered for ADALIMUMAB (HUMIRA) was on 18-Aug-2021. In June 2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved, INFLUENZA LIKE ILLNESS (Flu-like symptom) had resolved. At the time of the report, ILLNESS (SICK) and RASH (REACTION ON LEG/RASH) was resolving, MALAISE (DID NOT FEEL WELL) and FATIGUE (FELT FATIGUED) outcome was unknown and NAUSEA (Nausea) had resolved.            No relevant concomitant medications were reported.   The reporter's causality for the event of passed out, flu-like symptoms and nausea with humira (adalimumab)was no reasonable possibility. The reporter's causality for the event of sick and reaction on leg/rash with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event of felt fatigued, did not feel well and not had any significant progress with humira was not provided.  RA's opinion is that there is no reasonable possibility that the events of passed out, sick, felt fatigued,did not feel well, flu-like symptoms, nausea and not had any significant progress with humira are related to humira(adalimumab). RA's opinion is that there is a reasonable possibility that the event of reaction on leg/rash is related to humira (adalimumab).  The patient ended up with a reaction on her leg, a rash and not had any significant progress with Humira. She  stated after getting her second covid vaccine she passed out on 15-Jun-2021 and also had flu like symptoms and nausea from her vaccine. She did not felt well. She ended up really sick, felt fatigued.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  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 is a spontaneous case, reported by a consumer, concerning a 56-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Loss of consciousness, which occurred 1 day after receiving the second dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule. The patient noted appearance of rash on her leg, and reported that after getting her second COVID-19 vaccine she passed out and also had flu like symptoms, nausea, not felt well, really sick, and felt fatigued. No further details about the diagnostic procedures and treatments were provided. It was reported that the event Loss of consciousness had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 56-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Loss of consciousness, which occurred 1 day after receiving the second dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule. The patient noted appearance of rash on her leg, and reported that after getting her second COVID-19 vaccine she passed out and also had flu like symptoms, nausea, not felt well, really sick, and felt fatigued. No further details about the diagnostic procedures and treatments were provided. It was reported that the event Loss of consciousness had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.