Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Swelling face, Vaccination site pain, Vomiting
Clinical narrative: Left arm still hurts between elbow and shoulder; Had a hard time looking to the left, due to the pain; Had swelling around whole chest and back; Felt like couldn't breathe; Broke glasses when fell; Fell to the left onto the floor; Felt dizzy while cooking breakfast/terrible dizziness; Could not get up - had to keep lying down; Whole left side was affected; Had a bump on the left side of my head; Sat down at the counter, then passed out/ could not get up - had to keep lying down; Broke ribs when fell/didn't feel good with the ribs until around 6 weeks later; Felt a little chilly, had chills; Nausea/tried to get up felt nauseated; Vomiting/  threw up; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Sat down at the counter, then passed out/ could not get up - had to keep lying down) and CHEST INJURY (Broke ribs when fell/didn't feel good with the ribs until around 6 weeks later) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Sat down at the counter, then passed out/ could not get up - had to keep lying down) (seriousness criterion medically significant), MALAISE (Could not get up - had to keep lying down), FALL (Broke glasses when fell) and FALL (Fell to the left onto the floor). 29-Mar-2021, the patient experienced CHEST INJURY (Broke ribs when fell/didn't feel good with the ribs until around 6 weeks later) (seriousness criterion medically significant) and SWELLING (Had swelling around whole chest and back). 29-Mar-2021, the patient experienced DIZZINESS (Felt dizzy while cooking breakfast/terrible dizziness). 29-Mar-2021, the patient experienced DISCOMFORT (Whole left side was affected), SWELLING FACE (Had a bump on the left side of my head), DYSPNOEA (Felt like couldn't breathe), CHILLS (Felt a little chilly, had chills), NAUSEA (Nausea/tried to get up felt nauseated) and VOMITING (Vomiting/  threw up). On 27-Oct-2021, the patient experienced PAIN IN EXTREMITY (Left arm still hurts between elbow and shoulder) and MUSCULOSKELETAL STIFFNESS (Had a hard time looking to the left, due to the pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 29-Mar-2021, LOSS OF CONSCIOUSNESS (Sat down at the counter, then passed out/ could not get up - had to keep lying down), FALL (Broke glasses when fell) and FALL (Fell to the left onto the floor) had resolved. In May 2021, CHEST INJURY (Broke ribs when fell/didn't feel good with the ribs until around 6 weeks later) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm still hurts between elbow and shoulder) had not resolved and DIZZINESS (Felt dizzy while cooking breakfast/terrible dizziness), MALAISE (Could not get up - had to keep lying down), DISCOMFORT (Whole left side was affected), SWELLING FACE (Had a bump on the left side of my head), MUSCULOSKELETAL STIFFNESS (Had a hard time looking to the left, due to the pain), SWELLING (Had swelling around whole chest and back), DYSPNOEA (Felt like couldn't breathe), VACCINATION SITE PAIN (Sore arm at the injection site), CHILLS (Felt a little chilly, had chills), NAUSEA (Nausea/tried to get up felt nauseated) and VOMITING (Vomiting/  threw up) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 28-Mar-2021, the patient experienced sore arm at the injection site. On 29-Mar-2021, the patient felt dizzy, a little chilly, sat down at the counter and then passed out. The patient had a fall to the left onto the floor, whole left side was affected. The patient was out for a couple of minutes. When woke up had chills, terrible dizziness, nausea on vomiting. The patient could not get up, had to keep lying down. Every time when patient tried to get up felt nauseated and threw up, also had a bump on the left side of head. The patient broke glasses when had fall. The patient brooked ribs when had fall and was on the floor about 3 hrs. The patient felt like couldn't breathe. On 27-Oct-2021, the patient had a hard time looking to the left, due to the pain. The patient had swelling around whole chest and back. The patient did not feel good with the ribs until around 6 weeks later. On 27-Oct-2021, the patient's left arm was hurting between elbow and shoulder at the time of report.  Company Comment : This case concerns a 73-year-old female patient, with  no reported medical history who experienced unexpected events of loss of consciousness and chest injury.  The events occurred approximately 1 day after thesecond  dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is not applicable since the event was reported exclusively after the second dose.  Causality for the reported event was not provided by the reporter. The benefit-risk relation of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-366294 (Patient Link).; Sender's Comments: This case concerns a 73-year-old female patient, with  no reported medical history who experienced unexpected events of loss of consciousness and chest injury.  The events occurred approximately 1 day after thesecond  dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is not applicable since the event was reported exclusively after the second dose.  Causality for the reported event was not provided by the reporter. The benefit-risk relation of Moderna COVID-19 Vaccine is not affected by this report.