Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chest X-ray, Electrocardiogram, Magnetic resonance imaging
Clinical narrative: Irritated skin; Red blood count dropped a bit; White blood count dropped a bit; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Irritated skin), RED BLOOD CELL COUNT DECREASED (Red blood count dropped a bit) and WHITE BLOOD CELL COUNT DECREASED (White blood count dropped a bit) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 014M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Hysterectomy (hysterectomy at age of 40), Knee replacement (at the age of 70) and Hip replacement (at the age of 70). Previously administered products included for Drug use for unknown indication: Prednisone. Past adverse reactions to the above products included No adverse event with Prednisone. Concurrent medical conditions included Hypertension, Bone disorder NOS, Pain, Upper respiratory disorder, Dermatitis, Non-tobacco user, Rheumatoid arthritis and Blood disorder. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Blood disorder, RALOXIFENE for Bone disorder NOS, DOXYCYCLINE and DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]) for Dermatitis, ATORVASTATIN for High cholesterol, AMLODIPINE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOROTHIAZIDE) and HYDROCHLOROTHIAZIDE for Hypertension, PARACETAMOL (TYLENOL) for Pain, DL-ALPHA TOCOPHERYL ACETATE (VITAMIN E [DL-ALPHA TOCOPHERYL ACETATE]) for Upper respiratory disorder.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-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) 40 milligram every two weeks. In May 2021, the patient experienced RED BLOOD CELL COUNT DECREASED (Red blood count dropped a bit) and WHITE BLOOD CELL COUNT DECREASED (White blood count dropped a bit). On 19-May-2021, the patient experienced SKIN IRRITATION (Irritated skin). The patient was treated with IRON at an unspecified dose and frequency and VITAMIN B12 [VITAMIN B12 NOS] at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (Irritated skin) was resolving and RED BLOOD CELL COUNT DECREASED (Red blood count dropped a bit) and WHITE BLOOD CELL COUNT DECREASED (White blood count dropped a bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Blood pressure measurement: Normal. On 07-Mar-2021, Body temperature: Normal. On 07-Mar-2021, Electrocardiogram: Normal. In April 2021, Magnetic resonance imaging: (Negative) Negative. In May 2021, Chest X-ray: Normal. In May 2021, Red blood cell count: Dropped. In May 2021, White blood cell count: Dropped.         It was unknown if the patient was enrolled in COVID-19 vaccine trials. Patient was non-alcoholic.  Patient was taking Humira for more than 10 years. Patient had alternative etiology for the event of irritated skin was reported as adhesive from heart monitor.  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.   This case was linked to MOD-2021-623613 (Patient Link).