Sex: F
Vaccine: COVID19
Symptoms: Skeletal injury, Skin mass, Wound complication, Wound haemorrhage
Clinical narrative: Fell on steps and scrapped shin bone that had not healed; Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes; Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes; Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes; Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes; Fell on steps and scrapped shin bone that had not healed; Fell on steps and scrapped shin bone that had not healed; Fell on steps and scrapped shin bone that had not healed; Second moderna shot did not make feel well; This spontaneous case was reported by a consumer and describes the occurrence of LIMB CRUSHING INJURY (Fell on steps and scrapped shin bone that had not healed) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Crohn's disease.    Concurrent medical conditions included Rheumatoid arthritis and Crohn's disease.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced LIMB CRUSHING INJURY (Fell on steps and scrapped shin bone that had not healed) (seriousness criterion medically significant), WOUND COMPLICATION (Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes), SKIN MASS (Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes), SCRATCH (Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes), WOUND HAEMORRHAGE (Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes), FALL (Fell on steps and scrapped shin bone that had not healed), SKELETAL INJURY (Fell on steps and scrapped shin bone that had not healed), IMPAIRED HEALING (Fell on steps and scrapped shin bone that had not healed) and MALAISE (Second moderna shot did not make feel well). The patient was treated with MAGNESIUM SULFATE (EPSOM SALT) at an unspecified dose and frequency. At the time of the report, LIMB CRUSHING INJURY (Fell on steps and scrapped shin bone that had not healed), WOUND COMPLICATION (Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes), SKIN MASS (Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes), SCRATCH (Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes), WOUND HAEMORRHAGE (Bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes), FALL (Fell on steps and scrapped shin bone that had not healed), SKELETAL INJURY (Fell on steps and scrapped shin bone that had not healed), IMPAIRED HEALING (Fell on steps and scrapped shin bone that had not healed) and MALAISE (Second moderna shot did not make feel well) outcome was unknown.            No relevant concomitant medications were reported. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the events of bumps on legs/elbows/arms/butt that scratched/bled and would turn onto holes unknown onset, fell on steps and scrapped shin bone that had not healed unknown onset, second moderna shot did not make feel well with adalimumab solution for injection was not provided. No treatment information was provided.  Company comment: This is a spontaneous case concerning a unspecified age female patient, with no relevant medical history reported, who experienced unexpected serious (medically significant) event of limb crushing injury (reported as Fell on steps and scrapped shin bone that had not healed), which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serious event wound complication, skin mass, scratch, wound hemorrhage, fall, skeletal injury, impaired healing is also reported. No further information on risk factors, concurrent illness, clinical course, investigations, treatment given was available in the report At the time of reporting outcome of the event is unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a unspecified age female patient, with no relevant medical history reported, who experienced unexpected serious (medically significant) event of limb crushing injury (reported as Fell on steps and scrapped shin bone that had not healed), which occurred unspecified days after first dose of mRNA-1273 vaccine. Additionally non serious event wound complication, skin mass, scratch, wound hemorrhage, fall, skeletal injury, impaired healing is also reported. No further information on risk factors, concurrent illness, clinical course, investigations, treatment given was available in the report At the time of reporting outcome of the event is unknown. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.