Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Discomfort, Dry mouth, Eye swelling, Fatigue
Clinical narrative: Malisaie; delayed skin reaction; Rash; Dry mouth; Swelling Around Eye; Slight Discomfort in the evening; Fatigue; nausea; Patient noticed bluish hue like a blood clot over her frontal lobe on upper side of her face and coming down until ear; Feeling spasm/ pain over left side of her forehead; Numbness over her left forehead; Depression; Felt miserable; Vaccination site pain; Body ache / muscle ache; Fever; Headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021. The most recent information was received on 09-Apr-2021 and was forwarded to Moderna on 10-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN DISCOLOURATION (Patient noticed bluish hue like a blood clot over her frontal lobe on upper side of her face and coming down until ear), DEPRESSION (Depression), FEELING ABNORMAL (Felt miserable), MUSCLE SPASMS (Feeling spasm/ pain over left side of her forehead) and HYPOAESTHESIA (Numbness over her left forehead) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Raynaud's disease on 01-Jan-2016 and Seasonal allergy since an unknown date. Concomitant products included WOMEN MULTI from 01-Jan-2015 to an unknown date, DESOGESTREL, ETHINYLESTRADIOL (VOLNEA) from 01-Jan-2019 to an unknown date and MONTELUKAST SODIUM (SINGULAIR) from 10-Mar-2021 to an unknown date for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DEPRESSION (Depression), FEELING ABNORMAL (Felt miserable), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body ache / muscle ache) and HEADACHE (Headache). 05-Feb-2021, the patient experienced PYREXIA (Fever). On 21-Feb-2021, the patient experienced SKIN DISCOLOURATION (Patient noticed bluish hue like a blood clot over her frontal lobe on upper side of her face and coming down until ear), MUSCLE SPASMS (Feeling spasm/ pain over left side of her forehead) and HYPOAESTHESIA (Numbness over her left forehead). In March 2021, the patient experienced DISCOMFORT (Slight Discomfort in the evening), FATIGUE (Fatigue) and NAUSEA (nausea). On 29-Mar-2021, the patient experienced DRY MOUTH (Dry mouth) and EYE SWELLING (Swelling Around Eye). On an unknown date, the patient experienced MALAISE (Malisaie), SKIN REACTION (delayed skin reaction) and RASH (Rash). On 15-Feb-2021, VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body ache / muscle ache) and PYREXIA (Fever) had resolved. On 16-Feb-2021, DEPRESSION (Depression) and FEELING ABNORMAL (Felt miserable) had resolved. On 25-Feb-2021, MUSCLE SPASMS (Feeling spasm/ pain over left side of her forehead) had resolved. At the time of the report, SKIN DISCOLOURATION (Patient noticed bluish hue like a blood clot over her frontal lobe on upper side of her face and coming down until ear), HYPOAESTHESIA (Numbness over her left forehead), DRY MOUTH (Dry mouth), EYE SWELLING (Swelling Around Eye) and RASH (Rash) was resolving, MALAISE (Malisaie), SKIN REACTION (delayed skin reaction), DISCOMFORT (Slight Discomfort in the evening), FATIGUE (Fatigue) and NAUSEA (nausea) outcome was unknown and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Events Headache, Fever (98.3-99) were re-occurred. Treatment information includes on 21 Feb2021 Acetaminophen 8 hour each for 3 days.On 5,6,7,15Mar2021 took 3 Acetyl salicylic acid a day From 16th to 25 Mar 2021 took 1 Acetyl salicylic acid a day On 26 Mar 2021 took 2 Acetyl salicylic acid morning and 2 Acetyl salicylic acid in the evening. From 29 Mar 2021 Patient took 2 Ibuprofen every 8 hours and2 Acetyl salicylic acid a day  From 31 Mar 2021 patient stopped taking Ibuprofen and only taking Acetyl salicylic acid only   This case was linked to MOD-2021-042008 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow up information received on 09 APR 2021.Added Height of the patient.Medical history includes Raynaud's and Seasonal allergies.Concomitant product was added Montelukast.New events Slight discomfort, Swelling around the eye, Nausea, fatigue and re-occurred headache, fever were added.; 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.