Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Foot fracture, Inappropriate schedule of product administration, Loss of consciousness, Pain, SARS-CoV-2 test
Clinical narrative: passed out; broke 5 metatarsals and broke 1 pinky toe/ cannot walk on her foot/ toe needs to be screwed on again; hurt; first shot on 06-Sept-2021 and second shot on 21-Dec-2021; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) and FOOT FRACTURE (broke 5 metatarsals and broke 1 pinky toe/ cannot walk on her foot/ toe needs to be screwed on again) in a 34-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.     No Medical History information was reported.   On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), FOOT FRACTURE (broke 5 metatarsals and broke 1 pinky toe/ cannot walk on her foot/ toe needs to be screwed on again) (seriousness criterion medically significant), PAIN (hurt) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot on 06-Sept-2021 and second shot on 21-Dec-2021). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), FOOT FRACTURE (broke 5 metatarsals and broke 1 pinky toe/ cannot walk on her foot/ toe needs to be screwed on again) and PAIN (hurt) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot on 06-Sept-2021 and second shot on 21-Dec-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, SARS-CoV-2 test: results not provided Results not Provided. On 01-Oct-2021, SARS-CoV-2 test: results not provided Results not Provided.         On 21-Dec-2021, Patient complained that she visited the orthopedic surgeon who did not properly take care of her. The weight of patient was reported as 165 (no unit).  No Concomitant and treatment medication was provided by reporter.  Company Comment: This spontaneous case concerns a 34-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Loss of consciousness and Foot fracture which occurred on the same day after receiving the second dose of mRNA-1273 vaccine. It was reported after the second dose patient passed out and broke 5 metatarsals and 1 pinky toe due to which she could not walk. She visited orthopedic surgeon and treatment was given, despite of that she needs further procedure. Additionally Inappropriate schedule of product administration is noted as patient received the second dose 3 months and 15 days after the first dose, which is not in accordance with the recommended vaccine interval. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-587035 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2022: Live Follow-up received and Significant information updated with event has been added.; Sender's Comments: This spontaneous case concerns a 34-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Loss of consciousness and Foot fracture which occurred on the same day after receiving the second dose of mRNA-1273 vaccine. It was reported after the second dose patient passed out and broke 5 metatarsals and 1 pinky toe due to which she could not walk. She visited orthopedic surgeon and treatment was given, despite of that she needs further procedure. Additionally Inappropriate schedule of product administration is noted as patient received the second dose 3 months and 15 days after the first dose, which is not in accordance with the recommended vaccine interval. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.