Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: BODY MUSCLE SWELLING; COULDN'T WALK; NO ENERGY TO WALK; COLD SWEATS ALL OVER THE BODY; COULDN'T SLEEP; Nausea/FEELING NAUSEATED; Vomit; BODY ACHE; Shortness of breath/COULDN'T BREATHE; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SWELLING (BODY MUSCLE SWELLING), GAIT INABILITY (COULDN'T WALK), ASTHENIA (NO ENERGY TO WALK), COLD SWEAT (COLD SWEATS ALL OVER THE BODY) and INSOMNIA (COULDN'T SLEEP) in a 57-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 an unknown indication.    Concurrent medical conditions included Ulcerative colitis, Anxiety, Non-tobacco user and Abstains from alcohol. Concomitant products included SERTRALINE for Anxiety, MESALAMINE and MESALAZINE (LIALDA) for Ulcerative colitis.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness). On 20-Nov-2021, the patient experienced DYSPNEA (Shortness of breath/COULDN'T BREATHE) and MYALGIA (BODY ACHE). On 21-Nov-2021, the patient experienced MUSCLE SWELLING (BODY MUSCLE SWELLING), GAIT INABILITY (COULDN'T WALK), ASTHENIA (NO ENERGY TO WALK), COLD SWEAT (COLD SWEATS ALL OVER THE BODY), INSOMNIA (COULDN'T SLEEP), NAUSEA (Nausea/FEELING NAUSEATED) and VOMITING (Vomit). At the time of the report, MUSCLE SWELLING (BODY MUSCLE SWELLING), GAIT INABILITY (COULDN'T WALK), ASTHENIA (NO ENERGY TO WALK), COLD SWEAT (COLD SWEATS ALL OVER THE BODY), INSOMNIA (COULDN'T SLEEP), DYSPNOEA (Shortness of breath/COULDN'T BREATHE), DIZZINESS (Dizziness), VOMITING (Vomit) and MYALGIA (BODY ACHE) was resolving and NAUSEA (Nausea/FEELING NAUSEATED) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, Heart rate: heart beating was off when have a regular walk. On an unknown date, Blood test: Normal.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Reporter did not have the lot number information, because the packaging was discarded.  On 21-Nov-2021, The patient experienced heart beating was off when have a regular walk and could not  breathe.  On 03-Dec-2021, The patient experienced feeling nauseated.  Unknown date in 2021, The shortness of breath and nausea were resolved.  The reporter's causality for the events of body muscle swelling, heart beating was off when have a regular walk, couldn't walk, no energy to walk, dizziness, cold sweats all over the body, couldn't sleep, couldn't breathe, shortness of breath, feeling nauseated, nausea, vomit and body ache with humira (adalimumab)was a reasonable possibility.  No treatment information was provided.  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