Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Poor peripheral circulation, Rash, Weight
Clinical narrative: Depression; General body pain / BODY ACHE; Fatigue / SECOND COVID-19 VACCINE KNOCKED OUT WITH TIRED/FATIGUE; Localized rash / RASHES ON KNEES TO TOES/LEG RASH; Peripheral swelling; EYE ALLERGY; Precancerous lesion of cervix / PRE CANCER CELLS IN CERVIX; Macular degeneration / DRY EYES TO MACULAR DEGENERATION / had issues with dry eyes which after a while turned into macular degeneration or supe; Back disorder / BACK WENT OUT BAD; SWOLLEN ANKLES; Poor peripheral circulation / BAD CIRCULATION IN FEET/TOES/HANDS AND SWOLLEN; This spontaneous case was reported by a consumer and describes the occurrence of CERVICAL DYSPLASIA (Precancerous lesion of cervix / PRE CANCER CELLS IN CERVIX) and MACULAR DEGENERATION (Macular degeneration / DRY EYES TO MACULAR DEGENERATION / had issues with dry eyes which after a while turned into macular degeneration or supe) in a 60-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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second 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. In August 2020, the patient experienced CERVICAL DYSPLASIA (Precancerous lesion of cervix / PRE CANCER CELLS IN CERVIX) (seriousness criterion medically significant), MACULAR DEGENERATION (Macular degeneration / DRY EYES TO MACULAR DEGENERATION / had issues with dry eyes which after a while turned into macular degeneration or supe) (seriousness criterion medically significant), BACK DISORDER (Back disorder / BACK WENT OUT BAD), JOINT SWELLING (SWOLLEN ANKLES), POOR PERIPHERAL CIRCULATION (Poor peripheral circulation / BAD CIRCULATION IN FEET/TOES/HANDS AND SWOLLEN), PERIPHERAL SWELLING (Peripheral swelling), EYE ALLERGY (EYE ALLERGY) and RASH (Localized rash / RASHES ON KNEES TO TOES/LEG RASH). In April 2021, the patient experienced PAIN (General body pain / BODY ACHE) and FATIGUE (Fatigue / SECOND COVID-19 VACCINE KNOCKED OUT WITH TIRED/FATIGUE). On an unknown date, the patient experienced DEPRESSION (Depression). In April 2021, PAIN (General body pain / BODY ACHE) and FATIGUE (Fatigue / SECOND COVID-19 VACCINE KNOCKED OUT WITH TIRED/FATIGUE) had resolved. At the time of the report, CERVICAL DYSPLASIA (Precancerous lesion of cervix / PRE CANCER CELLS IN CERVIX), BACK DISORDER (Back disorder / BACK WENT OUT BAD) and JOINT SWELLING (SWOLLEN ANKLES) outcome was unknown, MACULAR DEGENERATION (Macular degeneration / DRY EYES TO MACULAR DEGENERATION / had issues with dry eyes which after a while turned into macular degeneration or supe), POOR PERIPHERAL CIRCULATION (Poor peripheral circulation / BAD CIRCULATION IN FEET/TOES/HANDS AND SWOLLEN), DEPRESSION (Depression) and PERIPHERAL SWELLING (Peripheral swelling) had not resolved and EYE ALLERGY (EYE ALLERGY) and RASH (Localized rash / RASHES ON KNEES TO TOES/LEG RASH) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Biopsy cervix: found cells. On an unknown date, Weight: Lost 30 pounds.         No concomitant medications were provided by the reporter.  It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. Patient's cervical cells removed in March and May 2022.  Causality for Humira (adalimumab):  The reporter's causality for the event(s) of pre cancer cells in cervix, weight loss, bad circulation in feet/toes/hands and swollen onset in August 2020 and depression was not provided.  The reporter's causality for the event(s) of dry eyes to macular degeneration, rashes on knees to toes/leg rash, eye allergy, back went out bad, swollen ankles, bad circulation in feet/toes/hands and swollen onset in August 2020, second covid-19  vaccine knocked out with tired/fatigue and body ache onset in April 2021 and second covid-19 vaccine knocked  out with tired/fatigue and body ache onset in April 2021 with humira (adalimumab) was no reasonable possibility.   No treatment medications were provided by the reporter.  Company Comment: This spontaneous case concerns a 60-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Cervical dysplasia and Macular degeneration in association with the mRNA-1273 vaccine and co-suspect drug Adalimumab. It was reported that patient received Adalimumab (start date unknown) for moderate to severe rheumatoid arthritis. Patient received 2 doses of mRNA-1273 vaccine at an interval of 28 days. The events occurred approximately 7 months prior to the 1st dose of mRNA-1273 vaccine. Patient reported eye allergy and had issues with dry eyes which after a while turned into macular degeneration. Clinical course was not reported. Cervical biopsy was done and found cells (as reported verbatim). It was reported that patient underwent removal of cervical cells approximately 1 year and 7 months after the events' onset. The outcome of macular degeneration was reported as not resolved, and cervical dysplasia unknown. The co-suspect Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 60-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Cervical dysplasia and Macular degeneration in association with the mRNA-1273 vaccine and co-suspect drug Adalimumab. It was reported that patient received Adalimumab (start date unknown) for moderate to severe rheumatoid arthritis. Patient received 2 doses of mRNA-1273 vaccine at an interval of 28 days. The events occurred approximately 7 months prior to the 1st dose of mRNA-1273 vaccine. Patient reported eye allergy and had issues with dry eyes which after a while turned into macular degeneration. Clinical course was not reported. Cervical biopsy was done and found cells (as reported verbatim). It was reported that patient underwent removal of cervical cells approximately 1 year and 7 months after the events' onset. The outcome of macular degeneration was reported as not resolved, and cervical dysplasia unknown. The co-suspect Adalimumab could be considered as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness was assessed based on medical judgement.