Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gallbladder disorder, Inflammatory marker test, Migraine, Musculoskeletal discomfort
Clinical narrative: costochondritis; after second dose everywhere she had previously inflamed joints & ligaments flared up; ligaments flared up; limping around the house at one point; back was flared at times; mild bleeding even though she is past menopause; sore arm both times; only pain she has had that was not previously inflamed is her right hip & that was bad enough to keep her awake at night; optical migraine; gall bladder flare; This spontaneous case was reported by a nurse and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (mild bleeding even though she is past menopause) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (left knee replacement). Concurrent medical conditions included Osteoarthritis, Raynaud's disease and Osteopenia (osteopenia in her back).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced MIGRAINE (optical migraine) and GALLBLADDER DISORDER (gall bladder flare). On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (mild bleeding even though she is past menopause) (seriousness criterion medically significant), COSTOCHONDRITIS (costochondritis), ARTHRITIS (after second dose everywhere she had previously inflamed joints & ligaments flared up), CONDITION AGGRAVATED (ligaments flared up), GAIT DISTURBANCE (limping around the house at one point), MUSCULOSKELETAL DISCOMFORT (back was flared at times), PAIN IN EXTREMITY (sore arm both times) and ARTHRALGIA (only pain she has had that was not previously inflamed is her right hip & that was bad enough to keep her awake at night). The patient was treated with LEVOFLOXACIN HEMIHYDRATE (LUVOX [LEVOFLOXACIN HEMIHYDRATE]) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Inflammation, at a dose of UNK, qd. At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (mild bleeding even though she is past menopause), MIGRAINE (optical migraine), COSTOCHONDRITIS (costochondritis), ARTHRITIS (after second dose everywhere she had previously inflamed joints & ligaments flared up), CONDITION AGGRAVATED (ligaments flared up), GAIT DISTURBANCE (limping around the house at one point), MUSCULOSKELETAL DISCOMFORT (back was flared at times), GALLBLADDER DISORDER (gall bladder flare), PAIN IN EXTREMITY (sore arm both times) and ARTHRALGIA (only pain she has had that was not previously inflamed is her right hip & that was bad enough to keep her awake at night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2021, Fibrin D dimer: 1000 (High) For COVID & blood clots, was 1000. On 08-Nov-2021, Inflammatory marker test: normal (normal) Normal. On 08-Nov-2021, SARS-CoV-2 test: negative (Negative) never tested positive for COVID.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took a steroid dosepak & that helped at one point.  As soon as the tenderness in her arm was gone after the 2nd dose everywhere she had previously inflamed joints & ligaments flared up. On 24-Sep-2021 patient got a flu shot & had the same reaction as the 2nd Moderna dose that lasted 8 to 10 days just like the Moderna dose.   Concomitant medications was not provided by the reported.  Company comment: This case concerns a  67-year-old, female patient with medical history of Osteoarthritis, Raynaud's disease and Osteopenia , who experienced the unexpected serious event of postmenopausal haemorrhage along with other non serious events including arthritis and costochondritis. The event occurred on an unknown date after the second dose of mRNA-1273. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. Patient's medical history of osteoarthritis confounds causality. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-387076 (Patient Link).; Sender's Comments: This case concerns a  67-year-old, female patient with medical history of Osteoarthritis, Raynaud's disease and Osteopenia , who experienced the unexpected serious event of postmenopausal haemorrhage along with other non serious events including arthritis and costochondritis. The event occurred on an unknown date after the second dose of mRNA-1273. The rechallenge was not applicable as events occurred after second dose and no further dosing was reported or planned, based on information provided. Patient's medical history of osteoarthritis confounds causality. The benefit-risk relationship of mRNA-1273 is not affected by this report.