Age: 72.0
Sex: M
Vaccine: COVID19, FLUX, UNK
Symptoms: COVID-19, COVID-19 immunisation, Contusion, Depressed mood, Interchange of vaccine products
Clinical narrative: Skin was very thin; Bumps into things skin bruises; Felt depressed about COVID; COVID-19; Soreness in arm; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; Nausea; Weight gain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), SKIN ATROPHY (Skin was very thin), CONTUSION (Bumps into things skin bruises), DEPRESSED MOOD (Felt depressed about COVID) and COVID-19 (COVID-19) in a 72-year-old male 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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Lupus erythematosus. Concurrent medical conditions included Psoriatic arthritis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate Free. In 2021, the patient experienced WEIGHT INCREASED (Weight gain). On an unknown date, the patient experienced SKIN ATROPHY (Skin was very thin), CONTUSION (Bumps into things skin bruises), DEPRESSED MOOD (Felt depressed about COVID), COVID-19 (COVID-19), PAIN IN EXTREMITY (Soreness in arm), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NAUSEA (Nausea). At the time of the report, WEIGHT INCREASED (Weight gain), SKIN ATROPHY (Skin was very thin), CONTUSION (Bumps into things skin bruises), DEPRESSED MOOD (Felt depressed about COVID), COVID-19 (COVID-19), PAIN IN EXTREMITY (Soreness in arm), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Weight: gained 7 Pounds. On an unknown date, Weight: gained 30 Pounds.         The patients skin was very thin due to lupus. If he bumped into things, his skin bruised. He had flu vaccine and COVID booster at the same time and experienced soreness in his arm and nausea. He gained weight about 30 pounds during COVID. He was feeling depressed about COVID. No treatment information was reported.  The manufacturer causality of events, skin was very thin and bumps into things skin bruises was not assessable and of events weight gain, felt depressed about COVID, soreness in arm, nausea and COVID-19 was reported as no reasonable possibility with Humira.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow-up received included updated co-suspect vaccine and narrative. On 26-Apr-2022: follow up received product information, event information and narrative updated.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 72-year-old male patient with relevant medical history of Lupus erythematosus, who experienced the unexpected serious (medically significant) event Systemic lupus erythematosus, in the context of the 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, prior to Pfizer COVID-19 vaccination (Revaccination with different COVID-19 vaccine and Interchange of vaccine products). It was reported that the patient also experienced increased in weight of 30 and 7 pounds on unknown dates, thinning of the skin, skin bruises, COVID-19 with depressed mood, arm soreness, and nausea. No further details about the clinical course, diagnostic procedures and treatments were provided. Outcome of the events were unknown. The medical history of Lupus erythematosus remains as a confounder for the event Systemic lupus erythematosus. The benefit-risk relationship of mRNA-1273 is not affected by this report.