Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Headache, Induration, Loss of consciousness
Clinical narrative: Arm was hot; Barely able to get up; Arm was painful and all burning up; Arm was painful and all burning up; Passed out state for 3 days; Headache; Arm was hard like a steel plate/arm hard/hard rocks in her arm; Arm got hard with bump at injection site/big round bumps; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out state for 3 days), INDURATION (Arm was hard like a steel plate/arm hard/hard rocks in her arm), FEELING HOT (Arm was hot), MOBILITY DECREASED (Barely able to get up) and PAIN IN EXTREMITY (Arm was painful and all burning up) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027M21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient experienced INDURATION (Arm was hard like a steel plate/arm hard/hard rocks in her arm) and VACCINATION SITE MASS (Arm got hard with bump at injection site/big round bumps). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out state for 3 days), FEELING HOT (Arm was hot), MOBILITY DECREASED (Barely able to get up), PAIN IN EXTREMITY (Arm was painful and all burning up), BURNING SENSATION (Arm was painful and all burning up) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. On 02-Dec-2021, VACCINATION SITE MASS (Arm got hard with bump at injection site/big round bumps) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out state for 3 days), INDURATION (Arm was hard like a steel plate/arm hard/hard rocks in her arm), FEELING HOT (Arm was hot), MOBILITY DECREASED (Barely able to get up), PAIN IN EXTREMITY (Arm was painful and all burning up), BURNING SENSATION (Arm was painful and all burning up) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  Patient  called to report after her Moderna COVID-19 booster dose on 26Nov2021 in her left arm, Patient  started experiencing side effects. Within a couple hours, her arm got hard with a bump at the injection site, like a bug bite with a little point above where Patient  got the shot. Within several hours, there were big round bumps, her arm was hard, like hard like a steel plate, surrounded by hard rocks in her arm where she was shot. Her arm was hot, Patient  was in a passed out state for 3 days, she was barely able to get up. Patient  also got a headache, arm was painful and all burning up. By 7 days later, bumps were all gone, Patient  was completely fine.   This case was linked to MOD-2021-407872, MOD-2021-407874 (Patient Link).