Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Clumsiness, Fatigue, Feeling abnormal, Foot deformity, Malaise
Clinical narrative: Forgetfulness; Surgery; Spinal fusion surgery; Strain; Nightmare; Pinched nerve; Nerve damage; Foot deformity; Clumsiness; Swelling of feet; Pain; Feeling unwell; Tiredness; Feeling abnormal; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), FATIGUE (Tiredness), FEELING ABNORMAL (Feeling abnormal), MEMORY IMPAIRMENT (Forgetfulness), SURGERY (Surgery), SPINAL FUSION SURGERY (Spinal fusion surgery), MUSCLE STRAIN (Strain), NIGHTMARE (Nightmare), NERVE COMPRESSION (Pinched nerve), NERVE INJURY (Nerve damage), FOOT DEFORMITY (Foot deformity), CLUMSINESS (Clumsiness), PERIPHERAL SWELLING (Swelling of feet) and PAIN (Pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced MALAISE (Feeling unwell) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and FEELING ABNORMAL (Feeling abnormal) (seriousness criterion medically significant). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Forgetfulness) (seriousness criterion medically significant), SURGERY (Surgery), SPINAL FUSION SURGERY (Spinal fusion surgery) (seriousness criterion medically significant), MUSCLE STRAIN (Strain) (seriousness criterion medically significant), NIGHTMARE (Nightmare) (seriousness criterion medically significant), NERVE COMPRESSION (Pinched nerve) (seriousness criterion medically significant), NERVE INJURY (Nerve damage) (seriousness criterion medically significant), FOOT DEFORMITY (Foot deformity) (seriousness criterion medically significant), CLUMSINESS (Clumsiness) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling of feet) (seriousness criterion medically significant) and PAIN (Pain) (seriousness criterion medically significant). In 2021, MALAISE (Feeling unwell), FATIGUE (Tiredness) and FEELING ABNORMAL (Feeling abnormal) had resolved. At the time of the report, MEMORY IMPAIRMENT (Forgetfulness) had resolved and SURGERY (Surgery), SPINAL FUSION SURGERY (Spinal fusion surgery), MUSCLE STRAIN (Strain), NIGHTMARE (Nightmare), NERVE COMPRESSION (Pinched nerve), NERVE INJURY (Nerve damage), FOOT DEFORMITY (Foot deformity), CLUMSINESS (Clumsiness), PERIPHERAL SWELLING (Swelling of feet) and PAIN (Pain) outcome was unknown. Not Provided          No concomitant medicine were provided. No treatment medicine were provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Administration date of HUMIRA was unknown and drug was discontinued. Patient paused Humira for procedure and surgery per doctor recommended two weeks after surgery should not administer her Humira. She had forgetfulness and felt she lost her mind, but found it. She was not well after  2nd COVID vaccine, felt near death and tired, and 24 hours later she had negative symptoms. The booster was  not problem. The patient had spinal fusion surgery and it was horrible nightmare. It was like double hockey stick gone through. She experienced L5 nerve was pinched and damaged and pain could not made away and left foot was enormous. She used ambulatory assistance and Titanium over 5L4.Patient gone to hospital visit. As per recommended she was gone back on Humira. After took two doses of Humira she experienced foot was swelling. She felt more clumsy before than now. On 17 Mar 2022 she lifted heavier object than expected strained.  For HUMIRA, the reporter causality for the events of Spinal fusion injury, Nightmare, Clumsy, Foot swelling, Pain was not provided. For the event of Surgery was a reasonable possibility. For the event of Forgetfulness, Not well, Tired, Felt near death, Strained lifting was no reasonable possibility.  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: Company comment: This is a spontaneous case concerning a 53-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events spinal fusion surgery, nerve injury, nerve compression and peripheral swelling, among others. The events occurred on an unknown date on relation to the tree doses of mRNA-1273.  After spinal fusion surgery, patient experienced pain, muscle strain, nerve compression and nerve damage. Diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as MS as per medical. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2022: Significant follow up contains new events: Spinal fusion injury, Strained lifting, Nightmare, Nerve was pinched and damaged, Left foot was enormous, Clumsy, Foot swelling and Pain.; Sender's Comments: Company comment: This is a spontaneous case concerning a 53-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events spinal fusion surgery, nerve injury, nerve compression and peripheral swelling, among others. The events occurred on an unknown date on relation to the tree doses of mRNA-1273.  After spinal fusion surgery, patient experienced pain, muscle strain, nerve compression and nerve damage. Diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events seriousness captured as MS as per medical. The benefit-risk relationship of mRNA-1273 is not affected by this report.