Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Swelling face, Swollen tongue, Tongue discolouration, Tremor
Clinical narrative: The fever went away and then came back; Thrown for a loop; Felt bad; Not slepping weel; Shaking; Would close her eyes and feel like she would pass out; Her face became swollen; after getting steroids, her tongue began to swell; Black streaks under her chin; Veins looked darker and more pronounced under her tongue; Face became red/her skin was red; She was not feeling well; Dizzy; Her skin was itchy; Lymph nodes started swelling; they were huge and could seem them; high Fever/had a bad fever; Headache/had a terrible headache; Chills; Joint pain; Muscle pain, body ache; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONFUSIONAL STATE (Thrown for a loop), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Not slepping weel), TREMOR (Shaking) and PRESYNCOPE (Would close her eyes and feel like she would pass out) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 08B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced CONFUSIONAL STATE (Thrown for a loop), FEELING ABNORMAL (Felt bad), POOR QUALITY SLEEP (Not slepping weel), TREMOR (Shaking), PRESYNCOPE (Would close her eyes and feel like she would pass out), SWELLING FACE (Her face became swollen), SWOLLEN TONGUE (after getting steroids, her tongue began to swell), SKIN DISCOLOURATION (Black streaks under her chin), TONGUE DISCOLOURATION (Veins looked darker and more pronounced under her tongue), ERYTHEMA (Face became red/her skin was red), MALAISE (She was not feeling well), DIZZINESS (Dizzy), PRURITUS (Her skin was itchy), LYMPHADENOPATHY (Lymph nodes started swelling; they were huge and could seem them), PYREXIA (high Fever/had a bad fever), HEADACHE (Headache/had a terrible headache), CHILLS (Chills), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain, body ache) and NAUSEA (Nausea). On an unknown date, the patient experienced PYREXIA (The fever went away and then came back). The patient was treated with STEROIDS for Adverse event, at an unspecified dose and frequency; ANTIBIOTICS for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 24-Apr-2021, DIZZINESS (Dizzy) and PYREXIA (high Fever/had a bad fever) had resolved. At the time of the report, CONFUSIONAL STATE (Thrown for a loop), POOR QUALITY SLEEP (Not slepping weel), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain, body ache) and NAUSEA (Nausea) had not resolved and FEELING ABNORMAL (Felt bad), TREMOR (Shaking), PRESYNCOPE (Would close her eyes and feel like she would pass out), SWELLING FACE (Her face became swollen), SWOLLEN TONGUE (after getting steroids, her tongue began to swell), SKIN DISCOLOURATION (Black streaks under her chin), TONGUE DISCOLOURATION (Veins looked darker and more pronounced under her tongue), ERYTHEMA (Face became red/her skin was red), MALAISE (She was not feeling well), PRURITUS (Her skin was itchy), LYMPHADENOPATHY (Lymph nodes started swelling; they were huge and could seem them), HEADACHE (Headache/had a terrible headache), CHILLS (Chills) and PYREXIA (The fever went away and then came back) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Concomitant product use was not provided by the reporter. Treatment of the events included, steroid shot, antibiotics, prednisone, diphenhydramine(benadryl).  Patient reported that at 10:30 am the same day post vaccination, she started getting events and thus consulted her HCP and was told that she was having an adverse reaction.   This case was linked to MOD-2021-094660 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient demographics (date of birth, address), new events, treatment information, batch number of first dose updated. On 29-Jun-2021: Follow-up information received on 29-Jun-2021 contains non-significant information. Declined further contact information for follow up.