Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Loss of consciousness, Pain in extremity, Peripheral swelling
Clinical narrative: Fever; Had swelling in her hands/hands became quite swollen; pain in the arms and hands/developed pain the leg and the thigh/Thigh felt heavy/thigh felt painful when she walks up and down the stairs; pain in the arms and hands; developed pain the leg and the thigh felt heavy and thigh felt painful when she walks up and down the stairs; developed pain the leg and the thigh felt heavy and thigh felt painful when she walks up and down the stairs; Dizzy; Passed out; Had trouble breathing; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PERIPHERAL SWELLING (Had swelling in her hands/hands became quite swollen), PAIN IN EXTREMITY (pain in the arms and hands/developed pain the leg and the thigh/Thigh felt heavy/thigh felt painful when she walks up and down the stairs), PAIN IN EXTREMITY (pain in the arms and hands), the first episode of PAIN IN EXTREMITY (developed pain the leg and the thigh felt heavy and thigh felt painful when she walks up and down the stairs), the second episode of PAIN IN EXTREMITY (developed pain the leg and the thigh felt heavy and thigh felt painful when she walks up and down the stairs), DIZZINESS (Dizzy), LOSS OF CONSCIOUSNESS (Passed out) and DYSPNOEA (Had trouble breathing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Had swelling in her hands/hands became quite swollen) (seriousness criterion hospitalization), PAIN IN EXTREMITY (pain in the arms and hands/developed pain the leg and the thigh/Thigh felt heavy/thigh felt painful when she walks up and down the stairs) (seriousness criterion hospitalization), PAIN IN EXTREMITY (pain in the arms and hands) (seriousness criterion hospitalization), the first episode of PAIN IN EXTREMITY (developed pain the leg and the thigh felt heavy and thigh felt painful when she walks up and down the stairs) (seriousness criterion hospitalization), the second episode of PAIN IN EXTREMITY (developed pain the leg and the thigh felt heavy and thigh felt painful when she walks up and down the stairs) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Had trouble breathing) (seriousness criterion hospitalization). The patient was hospitalized on 19-Mar-2021 due to DIZZINESS, DYSPNOEA, LOSS OF CONSCIOUSNESS, PAIN IN EXTREMITY, PAIN IN EXTREMITY, PAIN IN EXTREMITY, PERIPHERAL SWELLING and PYREXIA. At the time of the report, PYREXIA (Fever), PERIPHERAL SWELLING (Had swelling in her hands/hands became quite swollen), PAIN IN EXTREMITY (pain in the arms and hands/developed pain the leg and the thigh/Thigh felt heavy/thigh felt painful when she walks up and down the stairs), PAIN IN EXTREMITY (pain in the arms and hands), the last episode of PAIN IN EXTREMITY (developed pain the leg and the thigh felt heavy and thigh felt painful when she walks up and down the stairs), DIZZINESS (Dizzy), LOSS OF CONSCIOUSNESS (Passed out) and DYSPNOEA (Had trouble breathing) had resolved.            Company Comment: This spontaneous case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected, serious events of pyrexia, peripheral swelling, pain in extremity (LLT: pain in arm), pain in extremity (LLT: pain in hand), pain in extremity (LLT: pain in leg), pain in extremity (LLT: pain in thigh), dizziness, loss of consciousness and dyspnoea. The events, which resulted in hospitalization, occurred 1 day after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient was hospitalized 8 days after vaccination (19Mar2021). The doctors did a variety of tests and all results came back normal. The patient was given steroids affording relief of symptoms. The events had resolved at the time of the report. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-419309 (Patient Link).; Sender's Comments: This spontaneous case concerns a 72-year-old, female patient with no relevant medical history, who experienced the unexpected, serious events of pyrexia, peripheral swelling, pain in extremity (LLT: pain in arm), pain in extremity (LLT: pain in hand), pain in extremity (LLT: pain in leg), pain in extremity (LLT: pain in thigh), dizziness, loss of consciousness and dyspnoea. The events, which resulted in hospitalization, occurred 1 day after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient was hospitalized 8 days after vaccination (19Mar2021). The doctors did a variety of tests and all results came back normal. The patient was given steroids affording relief of symptoms. The events had resolved at the time of the report. The rechallenge was not applicable as no additional dosing is expected. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.