Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Blackout; Amnesia; BRAIN FEVER; ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,; Clostridium difficile infection; Clostridium difficile infection; DIFFICULTY HEARING; ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,; Anemia; Dehydration; Hand deformity; Broken ankle; RECURRENT FLARE UPS OF PAIN IN ENTIRE BODY; Fever; Fever; ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blackout), AMNESIA (Amnesia), MENINGITIS (BRAIN FEVER), PERIPHERAL SWELLING (ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,), the first episode of CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection) and the second episode of CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection) in a 76-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 UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis. The patient's past medical history included Ankle fracture. Concurrent medical conditions included Abstains from alcohol, Non-tobacco user and Rheumatoid arthritis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. In February 2021, the patient experienced AMNESIA (Amnesia) (seriousness criterion hospitalization) and the first episode of CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection) (seriousness criterion medically significant). On 15-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blackout) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced MENINGITIS (BRAIN FEVER) (seriousness criteria hospitalization and medically significant), PERIPHERAL SWELLING (ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,) (seriousness criterion hospitalization), the second episode of CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection) (seriousness criterion medically significant), HYPOACUSIS (DIFFICULTY HEARING), JOINT RANGE OF MOTION DECREASED (ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,), ANAEMIA (Anemia), DEHYDRATION (Dehydration), HAND DEFORMITY (Hand deformity), ANKLE FRACTURE (Broken ankle), PAIN (RECURRENT FLARE UPS OF PAIN IN ENTIRE BODY), the first episode of PYREXIA (Fever), the second episode of PYREXIA (Fever) and PAIN IN EXTREMITY (ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,). The patient was hospitalized on 15-Jan-2021 due to AMNESIA, MENINGITIS and PERIPHERAL SWELLING, and then on 15-Jun-2021 due to LOSS OF CONSCIOUSNESS. In March 2021, AMNESIA (Amnesia) had resolved. On 15-Apr-2021, MENINGITIS (BRAIN FEVER) had resolved. In 2021, last episode of CLOSTRIDIUM DIFFICILE INFECTION (Clostridium difficile infection) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Blackout) outcome was unknown, PERIPHERAL SWELLING (ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,), HYPOACUSIS (DIFFICULTY HEARING), JOINT RANGE OF MOTION DECREASED (ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,), ANAEMIA (Anemia), DEHYDRATION (Dehydration), ANKLE FRACTURE (Broken ankle) and PAIN IN EXTREMITY (ARM SORE/ARM SWELLED ALL THE WAY FINGER /STUCK STRAIGHT COULD NOT BEND,) had not resolved, HAND DEFORMITY (Hand deformity) and PAIN (RECURRENT FLARE UPS OF PAIN IN ENTIRE BODY) was resolving and last episode of PYREXIA (Fever) had resolved.            No concomitant information provided. No treatment information 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 spontaneous case concerns a 76-years-old female patient, with concurrent medical condition of Rheumatoid arthritis treated with UPADACITINIB (RINVOQ), who experienced the unexpected serious(hospitalization and medically significant) events of Loss of consciousness , Meningitis and unexpected serious (hospitalization) Amnesia, Peripheral swelling and unexpected serious (medically significant) event of Clostridium difficile infection that occurred in context to  second  dose with mRNA-1273 vaccine. No further information on risk factors, co morbidities and treatment was available in the report. The events outcome was unknown. Non-company product UPADACITINIB (RINVOQ), for Rheumatoid arthritis could be the confounder the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant follow-up appended(event updated); Sender's Comments: This spontaneous case concerns a 76-years-old female patient, with concurrent medical condition of Rheumatoid arthritis treated with UPADACITINIB (RINVOQ), who experienced the unexpected serious(hospitalization and medically significant) events of Loss of consciousness , Meningitis and unexpected serious (hospitalization) Amnesia, Peripheral swelling and unexpected serious (medically significant) event of Clostridium difficile infection that occurred in context to  second  dose with mRNA-1273 vaccine. No further information on risk factors, co morbidities and treatment was available in the report. The events outcome was unknown. Non-company product UPADACITINIB (RINVOQ), for Rheumatoid arthritis could be the confounder the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed as per medical judgement and available information.