Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Injection site pain, Limb discomfort, Pyrexia, Swelling
Clinical narrative: Breast cancer female; DISCOMFORT WITH FEET/HAD COUPLE OF WEEKS WITHOUT BEING ABLE TO WALK. DUE TO THE ISSUES WITHE THE BOTTOM OF HER FEET; DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE; DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE; FELT LIGHT HEADED, DIZZY WHEN INJECTED HUMIRA; WITHOUT BEING ABLE TO WALK DUE TO ISSUES WITH THE BOTTOM OF  FEET/had discomfort with her feet; HIGH BLOOD PRESSURE; LOSS OF APPETITE; BURN FEET; SWOLLEN; HIGH BLOOD PRESSURE; Chills; Fever; BURN WHILE GOING IN; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER FEMALE (Breast cancer female) in a 59-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 Rheumatoid arthritis.    The patient's past medical history included Tobacco user. Concurrent medical conditions included Blood pressure high and Rheumatoid arthritis.   On 04-Sep-2020, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to .8 milliliter. On 20-Nov-2020, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to .4 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) .4 milliliter. In 2020, the patient experienced INJECTION SITE PAIN (BURN WHILE GOING IN). On an unknown date, the patient experienced BREAST CANCER FEMALE (Breast cancer female) (seriousness criterion medically significant), GAIT INABILITY (DISCOMFORT WITH FEET/HAD COUPLE OF WEEKS WITHOUT BEING ABLE TO WALK. DUE TO THE ISSUES WITHE THE BOTTOM OF HER FEET), DRY MOUTH (DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE), DRY EYE (DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE), DIZZINESS (FELT LIGHT HEADED, DIZZY WHEN INJECTED HUMIRA), LIMB DISCOMFORT (WITHOUT BEING ABLE TO WALK DUE TO ISSUES WITH THE BOTTOM OF  FEET/had discomfort with her feet), HYPERTENSION (HIGH BLOOD PRESSURE), DECREASED APPETITE (LOSS OF APPETITE), BURNING SENSATION (BURN FEET), SWELLING (SWOLLEN), CONDITION AGGRAVATED (HIGH BLOOD PRESSURE), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, BREAST CANCER FEMALE (Breast cancer female), DECREASED APPETITE (LOSS OF APPETITE), SWELLING (SWOLLEN), CHILLS (Chills) and PYREXIA (Fever) had resolved, GAIT INABILITY (DISCOMFORT WITH FEET/HAD COUPLE OF WEEKS WITHOUT BEING ABLE TO WALK. DUE TO THE ISSUES WITHE THE BOTTOM OF HER FEET), DRY MOUTH (DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE), DRY EYE (DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE), DIZZINESS (FELT LIGHT HEADED, DIZZY WHEN INJECTED HUMIRA), LIMB DISCOMFORT (WITHOUT BEING ABLE TO WALK DUE TO ISSUES WITH THE BOTTOM OF  FEET/had discomfort with her feet), HYPERTENSION (HIGH BLOOD PRESSURE) and CONDITION AGGRAVATED (HIGH BLOOD PRESSURE) had not resolved and BURNING SENSATION (BURN FEET) and INJECTION SITE PAIN (BURN WHILE GOING IN) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant drugs were not reported.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial..The reporters causality for the events due to HUMIRA 40MG/0.8ML(ADALIMUMAB) of BREAST CANCER FEMALE, LOSS OF APPETITE, DISCOMFORT WITH FEET/WITHOUT BEING ABLE TO WALK DUE TO ISSUES WITH THE BOTTOM OF FEET unknown onset, CHILLS, FELT LIGHT HEADED,DIZZY WHEN INJECTED HUMIRA, DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE unknown onset, BURN FEET, DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE unknown onset, SWOLLEN, DISCOMFORT WITH FEET/WITHOUT BEING ABLE TO WALK DUE TO ISSUES WITH THE BOTTOM OF FEET unknown onset, HIGH BLOOD PRESSURE, FEVER and HUMIRA 40 MILLIGRAM 0.8 MILLILITER BURN WHILE GOING IN was not provided.The reporter's causality for the events due to 40MG/0.4ML(ADALIMUMAB) of BREAST CANCER FEMALE, LOSS OF APPETITE, CHILLS, SWOLLEN and FEVER with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of DISCOMFORT WITH FEET/WITHOUT BEING ABLE TO WALK DUE TO ISSUES WITH THE BOTTOM OF FEET unknown onset, FELT LIGHT HEADED, DIZZY WHEN INJECTED HUMIRA, DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE unknown onset, BURN FEET,DRY EYES AND MOUTH AND COULD NOT PRODUCE MOISTURE unknown onset, DISCOMFORT WITH FEET/WITHOUT BEING ABLE TO WALK DUE TO ISSUES WITH THE BOTTOM OF FEET unknown onset, HIGH BLOOD PRESSURE and HUMIRA 40 MILLIGRAM 0.8 MILLILITER BURN WHILE GOING IN was not provided.Treatment medications included injections(unspecified) in the foot as they burn.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 59 year old female patient, with no relevant medical history, who experienced the unexpected serious (medically significant) event of Breast cancer female , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up received contains significant information patient demographics added, suspect drug details were added, event (injection site burning) was added.; Sender's Comments: This spontaneous case concerns a 59 year old female patient, with no relevant medical history, who experienced the unexpected serious (medically significant) event of Breast cancer female , unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. She also reported of decreased appetite. No information on detailed clinical course, relevant investigations and treatment was available in the report. The event resolved. Co-suspect adalimumab could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.