Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Lip swelling, Myalgia, Ocular hyperaemia
Clinical narrative: paralysis of legs; feeling like tongue, lips, and throat were beginning to swell; feeling like tongue, lips, and throat were beginning to swell; feeling like tongue, lips, and throat were beginning to swell; hot and cold body temperature; burning eyes, eyes on fire as if someone poured acid in them; Red eyes; peppery hot taste in mouth, empty bland taste in her mouth; body aches; lower back pain; itching in upper torso; itching at injection site; fever of 103; throbbing headache; fatigue; body chills; muscle aches / body aches; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of DIPLEGIA (paralysis of legs) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included No adverse drug reaction (No medical history reported.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DIPLEGIA (paralysis of legs) (seriousness criterion medically significant), PHARYNGEAL SWELLING (feeling like tongue, lips, and throat were beginning to swell), LIP SWELLING (feeling like tongue, lips, and throat were beginning to swell), SWOLLEN TONGUE (feeling like tongue, lips, and throat were beginning to swell), FEELING OF BODY TEMPERATURE CHANGE (hot and cold body temperature), EYE IRRITATION (burning eyes, eyes on fire as if someone poured acid in them), OCULAR HYPERAEMIA (Red eyes), TASTE DISORDER (peppery hot taste in mouth, empty bland taste in her mouth), PAIN (body aches), BACK PAIN (lower back pain), PRURITUS (itching in upper torso), VACCINATION SITE PRURITUS (itching at injection site), PYREXIA (fever of 103), HEADACHE (throbbing headache), FATIGUE (fatigue), CHILLS (body chills) and MYALGIA (muscle aches / body aches). On 04-Apr-2021, DIPLEGIA (paralysis of legs), PHARYNGEAL SWELLING (feeling like tongue, lips, and throat were beginning to swell), LIP SWELLING (feeling like tongue, lips, and throat were beginning to swell), SWOLLEN TONGUE (feeling like tongue, lips, and throat were beginning to swell), FEELING OF BODY TEMPERATURE CHANGE (hot and cold body temperature), PAIN (body aches), BACK PAIN (lower back pain), PYREXIA (fever of 103), FATIGUE (fatigue), CHILLS (body chills) and MYALGIA (muscle aches / body aches) had resolved. At the time of the report, EYE IRRITATION (burning eyes, eyes on fire as if someone poured acid in them), TASTE DISORDER (peppery hot taste in mouth, empty bland taste in her mouth), PRURITUS (itching in upper torso), VACCINATION SITE PRURITUS (itching at injection site) and HEADACHE (throbbing headache) had not resolved and OCULAR HYPERAEMIA (Red eyes) had resolved.            Patient had no concomitant medications on file. The patient took acetaminophen as advised by her healthcare provider to help alleviate the symptoms, but the symptoms were not relieved.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. MOD-2021-073883:Dose 1