Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Feeling abnormal, Gait disturbance, Illness, Influenza
Clinical narrative: my veins broke/broken veins; bruises on my forehead on the tip of my eyebrows/got one two weeks ago and it has not faded/bruises inside of my arms and legs/bruises on the ankle part of my legs look like bands/bruised so bad my veins broke/broken veins and bruises is what bothere; heaviness on the left side of my chest/like someone is pushing on it/; Weird stuff/Bad; Chest pain in the middle of my chest; when she takes big steps she feels it still; Sick; Cant get words out; She stood up and went down on the floor; Throwing up sick; Chilly; Nauseated; like vertigo where I felt nauseated/felt wobbly/vertigo; Flu symptoms; Passed right out; Immediately after I stood up I passed right out/when I would go to take a step I get a little dizzy/put my foot down and nothing is there making me feel wobbly/dizzy spells/stood up and went down on the floor/cant get my words out; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Passed right out) and VEIN RUPTURE (my veins broke/broken veins) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu vaccination (she threw up for a week after taking it). Past adverse reactions to the above products included Vomiting with Flu vaccination. Concurrent medical conditions included Lupus syndrome, Drug allergy, Lupus pneumonitis (Her lupus in 20 years hasn't progressed too much but it has now; it has gone to her lungs), Pneumonia, COPD and Nonsmoker. Concomitant products included AMLODIPINE for Blood pressure, BIOTIN for Dry skin, HYDROXYCHLOROQUINE for Lupus syndrome, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach ache, COLECALCIFEROL (VITAMIN D3), METOPROLOL, ESTRADIOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MONTELUKAST SODIUM (SINGULAIR) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced SYNCOPE (Passed right out) (seriousness criterion medically significant) and DIZZINESS (Immediately after I stood up I passed right out/when I would go to take a step I get a little dizzy/put my foot down and nothing is there making me feel wobbly/dizzy spells/stood up and went down on the floor/cant get my words out). On 16-Apr-2021, the patient experienced INFLUENZA (Flu symptoms), VERTIGO (like vertigo where I felt nauseated/felt wobbly/vertigo), CHILLS (Chilly) and NAUSEA (Nauseated). On an unknown date, the patient experienced VEIN RUPTURE (my veins broke/broken veins) (seriousness criterion medically significant), CONTUSION (bruises on my forehead on the tip of my eyebrows/got one two weeks ago and it has not faded/bruises inside of my arms and legs/bruises on the ankle part of my legs look like bands/bruised so bad my veins broke/broken veins and bruises is what bothere), CHEST DISCOMFORT (heaviness on the left side of my chest/like someone is pushing on it/), FEELING ABNORMAL (Weird stuff/Bad), CHEST PAIN (Chest pain in the middle of my chest), GAIT DISTURBANCE (when she takes big steps she feels it still), ILLNESS (Sick), SPEECH DISORDER (Cant get words out), FALL (She stood up and went down on the floor) and VOMITING (Throwing up sick). At the time of the report, SYNCOPE (Passed right out), VEIN RUPTURE (my veins broke/broken veins), DIZZINESS (Immediately after I stood up I passed right out/when I would go to take a step I get a little dizzy/put my foot down and nothing is there making me feel wobbly/dizzy spells/stood up and went down on the floor/cant get my words out), INFLUENZA (Flu symptoms), CONTUSION (bruises on my forehead on the tip of my eyebrows/got one two weeks ago and it has not faded/bruises inside of my arms and legs/bruises on the ankle part of my legs look like bands/bruised so bad my veins broke/broken veins and bruises is what bothere), CHEST DISCOMFORT (heaviness on the left side of my chest/like someone is pushing on it/), FEELING ABNORMAL (Weird stuff/Bad), VERTIGO (like vertigo where I felt nauseated/felt wobbly/vertigo), CHEST PAIN (Chest pain in the middle of my chest), GAIT DISTURBANCE (when she takes big steps she feels it still), ILLNESS (Sick), SPEECH DISORDER (Cant get words out), FALL (She stood up and went down on the floor), VOMITING (Throwing up sick), CHILLS (Chilly) and NAUSEA (Nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) 3-4 times per week as the disease progresses.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  Company Comment: This case concerns a 64-year-old, female subject with a history of Lupus syndrome, who experienced the unexpected event of VEIN RUPTURE. The event occurred on an unknown date after the second dose of Spikevax. The rechallenge was unknown since no information about the third dose was disclosed. The medical history of Lupus syndrome and use of concomitant medication metoprolol and acetylsalicylic acid remains confounders. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-341161 (Patient Link).; Sender's Comments: This case concerns a 64-year-old, female subject with a history of Lupus syndrome, who experienced the unexpected event of VEIN RUPTURE. The event occurred on an unknown date after the second dose of Spikevax. The rechallenge was unknown since no information about the third dose was disclosed. The medical history of Lupus syndrome and use of concomitant medication metoprolol and acetylsalicylic acid remains confounders. The benefit-risk relationship of Spikevax is not affected by this report.