Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Illness, Iron deficiency, Malaise, Muscle tightness
Clinical narrative: nerve pain; Generalised aching; Not feel well; Sick; Depression; Fibromyalgia; Legs and feet swelled and felt tight; Legs and feet swelled and felt tight; neck pain/hurting; LEGS FEET SWELLED AND FELT TIGHT/BELLY SWELLING; Iron low; CHEST PAIN and ACID REFLUX; PAIN and ACID REFLUX; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve pain), PAIN (Generalised aching), MALAISE (Not feel well), ILLNESS (Sick) and DEPRESSION (Depression) in an elderly 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 Crohn's disease and Ulcerative colitis.    Previously administered products included for Drug use for unknown indication: cymbalta. Past adverse reactions to the above products included No adverse event with cymbalta. Concurrent medical conditions included Ulcerative colitis and Crohn's disease.   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2022, received third 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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced NEURALGIA (nerve pain), PAIN (Generalised aching), MALAISE (Not feel well), ILLNESS (Sick), DEPRESSION (Depression), FIBROMYALGIA (Fibromyalgia), MUSCLE TIGHTNESS (Legs and feet swelled and felt tight), PERIPHERAL SWELLING (Legs and feet swelled and felt tight), NECK PAIN (neck pain/hurting), ABDOMINAL DISTENSION (LEGS FEET SWELLED AND FELT TIGHT/BELLY SWELLING), IRON DEFICIENCY (Iron low), CHEST PAIN (CHEST PAIN and ACID REFLUX) and GASTROOESOPHAGEAL REFLUX DISEASE (PAIN and ACID REFLUX). At the time of the report, NEURALGIA (nerve pain), PAIN (Generalised aching), MALAISE (Not feel well), CHEST PAIN (CHEST PAIN and ACID REFLUX) and GASTROOESOPHAGEAL REFLUX DISEASE (PAIN and ACID REFLUX) outcome was unknown and ILLNESS (Sick), DEPRESSION (Depression), FIBROMYALGIA (Fibromyalgia), MUSCLE TIGHTNESS (Legs and feet swelled and felt tight), PERIPHERAL SWELLING (Legs and feet swelled and felt tight), NECK PAIN (neck pain/hurting), ABDOMINAL DISTENSION (LEGS FEET SWELLED AND FELT TIGHT/BELLY SWELLING) and IRON DEFICIENCY (Iron low) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: IRON LEVEL: Low..         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of NERVES IN NECK BURNED, SICK, DEPRESSION, FIBROMYALGIA, LEGS AND FEET SWELLED AND FELT TIGHT/BELLY SWELLING unknown onset, LEGS FEET SWELLED AND FELT TIGHT/BELLY SWELLING, LEGS AND FEET SWELLED AND FELT TIGHT/BELLY SWELLING unknown onset, NECK PAIN/HURTING, IRON LOW, CHEST PAIN and ACID REFLUX with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporters causality for the events of NOT FEEL WELL, NERVE PAIN and BODY ACHES was not provided.  Unknown date SLEEP STUDY TEST was done waiting for results.  No treatment medication were reported.  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 is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of Fibromyalgia, on unknown date after receiving the third dose of mRNA-1273 vaccine. The patient was treated with Duloxetine. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-624159 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2022: Significant follow-up received contains lab data added and events added.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of Fibromyalgia, on unknown date after receiving the third dose of mRNA-1273 vaccine. The patient was treated with Duloxetine. The event was resolving at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.