Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Malaise, Migraine, Muscle spasms
Clinical narrative: left neck spasm; felt uneasy; slight pain under sternum; fatigue; pain in her left knee; trembling in her upper body; face became a bright red; heat in her body; weakness in arms and hands; bed bound; pain in her lower back over kidney area; her body would be drenched in sweat mostly around heart and sternum area, she could splash; injection site started having pain; her injection site started having pain, it swelled up; Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic; vomiting; racing heart; facial numbness and tingling; nausea; hard time breathing; shortness of breath; hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape; cough; burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation; Disoriented; began to feel very very thirsty; drinking 1 liter of water; felt pins and needles down her arms; numbness like pins and needles on injection site and neck; and while laying in bed, she felt like she was driving a race card; could not sleep; was going to pass out; high blood pressure; "She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"; twitches in her abdomen, where her abdomen would cramp up; fallen down a short flight of stairs; felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed; dizzy; vertigo; migraine, lightheadedness, ringing ears, cloudy vision and headache; felt like as if someone was sitting on her chest; had a crawling sensation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRESYNCOPE (was going to pass out), CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic), PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed) and DYSPNOEA (hard time breathing; shortness of breath) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bradycardia and Hives (Patient recalls 20 years ago; she had hives.) in 2001. Concurrent medical conditions included Migraine. Concomitant products included RIZATRIPTAN for Migraine.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed) (seriousness criterion disability), DIZZINESS (dizzy), VERTIGO (vertigo), MIGRAINE (migraine, lightheadedness, ringing ears, cloudy vision and headache) and CHEST DISCOMFORT (felt like as if someone was sitting on her chest; had a crawling sensation). On 01-Mar-2021, the patient experienced ABDOMINAL PAIN (twitches in her abdomen, where her abdomen would cramp up) and FALL (fallen down a short flight of stairs). On 02-Mar-2021, the patient experienced PRESYNCOPE (was going to pass out) (seriousness criterion medically significant), RASH MACULAR ("She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"), HYPERTENSION (high blood pressure), INSOMNIA (could not sleep), PARAESTHESIA (felt pins and needles down her arms; numbness like pins and needles on injection site and neck) and RESTLESSNESS (and while laying in bed, she felt like she was driving a race card). On 03-Mar-2021, the patient experienced DISORIENTATION (Disoriented) and THIRST (began to feel very very thirsty; drinking 1 liter of water). On 04-Mar-2021, the patient experienced ORAL DISCOMFORT (burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation). On 05-Mar-2021, the patient experienced DYSPNOEA (hard time breathing; shortness of breath) (seriousness criterion medically significant), URTICARIA (hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape), COUGH (cough), HYPOAESTHESIA (facial numbness and tingling) and NAUSEA (nausea). On 07-Mar-2021, the patient experienced PALPITATIONS (racing heart). On 10-Mar-2021, the patient experienced VOMITING (vomiting). On 11-Mar-2021, the patient experienced CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic) (seriousness criterion medically significant). On 12-Mar-2021, the patient experienced HYPERHIDROSIS (her body would be drenched in sweat mostly around heart and sternum area, she could splash), VACCINATION SITE PAIN (injection site started having pain) and VACCINATION SITE SWELLING (her injection site started having pain, it swelled up). On 13-Mar-2021, the patient experienced BACK PAIN (pain in her lower back over kidney area) and BEDRIDDEN (bed bound). On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in arms and hands). On 17-Mar-2021, the patient experienced PYREXIA (heat in her body). On 21-Mar-2021, the patient experienced ERYTHEMA (face became a bright red) and TREMOR (trembling in her upper body). On 30-Mar-2021, the patient experienced FATIGUE (fatigue) and ARTHRALGIA (pain in her left knee). On 01-Apr-2021, the patient experienced CHEST PAIN (slight pain under sternum). On 02-Apr-2021, the patient experienced MUSCLE SPASMS (left neck spasm) and MALAISE (felt uneasy). At the time of the report, PRESYNCOPE (was going to pass out), CELLULITIS (Had skin eruptions like a boil on her right uper buttock; the boil was thought to be cellulitis and she was given a topical antibiotic), PERIPHERAL PARALYSIS (felt like she could not move her limbs (elbow to fingers, knees to toes),limbs felt like they were frozen and paralyzed), DYSPNOEA (hard time breathing; shortness of breath), RASH MACULAR ("She had a spot appear on her right leg and a ultrasound of her leg was performed to verify if a blood clot had developed (clot was not diagnosed)"), DIZZINESS (dizzy), VERTIGO (vertigo), MIGRAINE (migraine, lightheadedness, ringing ears, cloudy vision and headache), CHEST DISCOMFORT (felt like as if someone was sitting on her chest; had a crawling sensation), ABDOMINAL PAIN (twitches in her abdomen, where her abdomen would cramp up), FALL (fallen down a short flight of stairs), HYPERTENSION (high blood pressure), DISORIENTATION (Disoriented), ORAL DISCOMFORT (burning sensation in her mouth; mouth was dry, tongue was thick and full, no salivation), URTICARIA (hives were on her upper back and under hips; she was covered in hives from, they covered her chest in a "Vshape), COUGH (cough), HYPERHIDROSIS (her body would be drenched in sweat mostly around heart and sternum area, she could splash), BACK PAIN (pain in her lower back over kidney area), MUSCULAR WEAKNESS (weakness in arms and hands), ERYTHEMA (face became a bright red), MUSCLE SPASMS (left neck spasm), INSOMNIA (could not sleep), BEDRIDDEN (bed bound), PARAESTHESIA (felt pins and needles down her arms; numbness like pins and needles on injection site and neck), RESTLESSNESS (and while laying in bed, she felt like she was driving a race card), THIRST (began to feel very very thirsty; drinking 1 liter of water), PALPITATIONS (racing heart), TREMOR (trembling in her upper body), CHEST PAIN (slight pain under sternum), MALAISE (felt uneasy), VACCINATION SITE PAIN (injection site started having pain), VACCINATION SITE SWELLING (her injection site started having pain, it swelled up), FATIGUE (fatigue), VOMITING (vomiting), PYREXIA (heat in her body), ARTHRALGIA (pain in her left knee) and NAUSEA (nausea) outcome was unknown and HYPOAESTHESIA (facial numbness and tingling) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Blood pressure measurement: increased (High) increased. On 02-Mar-2021, Electrocardiogram: unknown (Inconclusive) unknown. On 02-Mar-2021, Heart rate: increased (High) increased. On 02-Mar-2021, Ultrasound Doppler: unknown (Inconclusive) result unknown. On 06-Mar-2021, Blood pressure measurement: increased (High) increased. On 06-Mar-2021, Electrocardiogram: normal (normal) Tests came back fine. On 06-Mar-2021, Heart rate: 110 (High) increased. On 06-Mar-2021, Oxygen saturation: 90 (Low) decreased. On 06-Mar-2021, Ultrasound scan: normal (normal) The tests came back fine. On 07-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. On 18-Mar-2021, Blood pressure measurement: normal (normal) normal. On 18-Mar-2021, Electrocardiogram: unknown (Inconclusive) unknown. On 18-Mar-2021, Heart rate: 85 (High) Pulse was a bit higher than her normal.. On 01-Apr-2021, Fibrin D dimer: unknown (Inconclusive) result unknown. On 01-Apr-2021, Ultrasound Doppler: unknown (Inconclusive) result unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Per report, the patient had a skin eruption which was thought to be cellulitis at the clinic.  Treatment included intravenous infusion with epinephrine, naltrexone, diphenhydramine, rizatriptan, naproxen sodium, TEA, a nerve supplement, and topical antibiotics. She was discharged home with EpiPen, prednisone, and famotidine.  On 01 April 2021, the patient felt like she had a blood clot and received an EKG, D-dimer test, and ultrasound of the heart and lower limbs. On 07 April 2021, the patient reported feeling energetic.  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.; 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.