Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Influenza like illness, Muscle twitching, Paraesthesia oral, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms for 4-5 days), PERIPHERAL SWELLING (felt her legs pulsing, a swelling up feeling, leg pulsing), VERTIGO (woke up and the whole world was spinning, has a terrible vertigo, spinning), FALL (fell over, crashed on floor) and GAIT INABILITY (couldn't walk) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anaphylactic shock (to medications). Concurrent medical conditions included Drug allergy (allergic to a lot of medications), Celiac disease since 14-Feb-1961, Migraine (Chronic migraine), Depression, Anxiety, Sleep disorder NOS and Vaginitis. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) from 01-Jan-1990 to an unknown date for Depression and Anxiety, ZOLPIDEM TARTRATE (AMBIEN) from 01-Jan-1996 to an unknown date for Sleep disorder NOS, DIAZEPAM (VALIUM) from 01-Jan-2011 to an unknown date for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced PARAESTHESIA ORAL (lip tingled), DISORIENTATION (disorientation), FEELING ABNORMAL (brain foggy), VACCINATION SITE REACTION (injection site crusty and oozy) and MUSCLE TWITCHING (leg pulsing, pulsing veins continue, pulsing in leg and arm). On 31-May-2021, the patient experienced HYPOAESTHESIA (numbness in leg). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms for 4-5 days), PERIPHERAL SWELLING (felt her legs pulsing, a swelling up feeling, leg pulsing), VERTIGO (woke up and the whole world was spinning, has a terrible vertigo, spinning), FALL (fell over, crashed on floor), GAIT INABILITY (couldn't walk), IMPAIRED WORK ABILITY (can't function very well, if she moves too quick everything starts going all over the place), DIZZINESS (dizziness, felt dizzy), VOMITING (threw up), PYREXIA (run a fever, temp broke out, in bed with temperature), HEADACHE (slight headache), DIPLOPIA (vision double, vision getting worse), FATIGUE (tired to get put) and BED REST (was in bed for two days). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms for 4-5 days) had resolved, PERIPHERAL SWELLING (felt her legs pulsing, a swelling up feeling, leg pulsing), VERTIGO (woke up and the whole world was spinning, has a terrible vertigo, spinning), FALL (fell over, crashed on floor), GAIT INABILITY (couldn't walk), IMPAIRED WORK ABILITY (can't function very well, if she moves too quick everything starts going all over the place), DIZZINESS (dizziness, felt dizzy), VOMITING (threw up), PYREXIA (run a fever, temp broke out, in bed with temperature), PARAESTHESIA ORAL (lip tingled), DIPLOPIA (vision double, vision getting worse), DISORIENTATION (disorientation), FEELING ABNORMAL (brain foggy), VACCINATION SITE REACTION (injection site crusty and oozy), HYPOAESTHESIA (numbness in leg), MUSCLE TWITCHING (leg pulsing, pulsing veins continue, pulsing in leg and arm), FATIGUE (tired to get put) and BED REST (was in bed for two days) outcome was unknown and HEADACHE (slight headache) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included suppository for vaginitis. Patient stated that she was in bed because of vertigo. She couldn't function very well, as if she was moving too quick everything started going all over the place. No treatment details was provided. This case was linked to MOD-2021-250503 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: follow up received on 19-JUL-2021 patient demographics, other relevant history, facility information were added and concomitant details and event outcome was updated.