Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus, Tremor, Vertigo, Visual impairment
Clinical narrative: The racing heart has turned into just episodes of heart fluttering; Feels like motor running in gut after 1st dose; Had to grab head to not fall out after 1st dose, Heavy head; Freezing after 1st dose; Shaking after 1st dose; Tinnitus, thumping in my ears; can't work or read a computer screen; ear thumping; lost 22 pounds; Not able to do normal activities including use of phone to scroll, computer without getting dizzy, bending over, cleaning and any exercise that involves exertion, jumping or bending; Arm tightening and releasing after 1st dose; Headache after 1st dose, intermittent pain in the right back of my head; More than 36 days and has not got the second dose/she has not got her second dose yet; Dizzy after 1st dose; Difficulty swallowing; Difficulty breathing; Fizzing in gut after 1st dose; Pain under left ribcage after 1st dose, thought I was dying many times.; neuropathy in my feet with cold and tingling down my legs as well as stumbly feeling feet; Heart racing after 1st dose; Looked up at ceiling and saw black dots; Whole room flipped after 1st dose; Vertigo after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in my feet with cold and tingling down my legs as well as stumbly feeling feet) and CARDIAC FLUTTER (The racing heart has turned into just episodes of heart fluttering) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAFUSION WOMEN'S from 01-Jan-2010 to an unknown date and VITAFUSION FIBER WELL FIT from 01-Jan-2010 to an unknown date for an unknown indication.    On 04-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OCULAR DISCOMFORT (Looked up at ceiling and saw black dots) and DISCOMFORT (Whole room flipped after 1st dose). 04-Mar-2021, the patient experienced VERTIGO (Vertigo after 1st dose). On 08-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in my feet with cold and tingling down my legs as well as stumbly feeling feet) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Fizzing in gut after 1st dose), MUSCULOSKELETAL CHEST PAIN (Pain under left ribcage after 1st dose, thought I was dying many times.), DYSPHAGIA (Difficulty swallowing) and DYSPNOEA (Difficulty breathing). 08-Mar-2021, the patient experienced PALPITATIONS (Heart racing after 1st dose) and DIZZINESS (Dizzy after 1st dose). In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days and has not got the second dose/she has not got her second dose yet). On an unknown date, the patient experienced CARDIAC FLUTTER (The racing heart has turned into just episodes of heart fluttering) (seriousness criterion medically significant), GASTROINTESTINAL PAIN (Feels like motor running in gut after 1st dose), HEAD DISCOMFORT (Had to grab head to not fall out after 1st dose, Heavy head), PERIARTHRITIS (Freezing after 1st dose), TREMOR (Shaking after 1st dose), TINNITUS (Tinnitus, thumping in my ears), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), WEIGHT DECREASED (lost 22 pounds), MALAISE (Not able to do normal activities including use of phone to scroll, computer without getting dizzy, bending over, cleaning and any exercise that involves exertion, jumping or bending), LIMB DISCOMFORT (Arm tightening and releasing after 1st dose) and HEADACHE (Headache after 1st dose, intermittent pain in the right back of my head). The patient was treated with PROBIOTICS NOS for Discomfort abdominal, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in my feet with cold and tingling down my legs as well as stumbly feeling feet), CARDIAC FLUTTER (The racing heart has turned into just episodes of heart fluttering), OCULAR DISCOMFORT (Looked up at ceiling and saw black dots), DISCOMFORT (Whole room flipped after 1st dose), VERTIGO (Vertigo after 1st dose), PALPITATIONS (Heart racing after 1st dose), GASTROINTESTINAL PAIN (Feels like motor running in gut after 1st dose), ABDOMINAL DISCOMFORT (Fizzing in gut after 1st dose), MUSCULOSKELETAL CHEST PAIN (Pain under left ribcage after 1st dose, thought I was dying many times.), HEAD DISCOMFORT (Had to grab head to not fall out after 1st dose, Heavy head), PERIARTHRITIS (Freezing after 1st dose), TREMOR (Shaking after 1st dose), DYSPHAGIA (Difficulty swallowing), DYSPNOEA (Difficulty breathing), TINNITUS (Tinnitus, thumping in my ears), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), WEIGHT DECREASED (lost 22 pounds), MALAISE (Not able to do normal activities including use of phone to scroll, computer without getting dizzy, bending over, cleaning and any exercise that involves exertion, jumping or bending), DIZZINESS (Dizzy after 1st dose), LIMB DISCOMFORT (Arm tightening and releasing after 1st dose) and HEADACHE (Headache after 1st dose, intermittent pain in the right back of my head) had not resolved and PRODUCT DOSE OMISSION ISSUE (More than 36 days and has not got the second dose/she has not got her second dose yet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Differential white blood cell count: inconclusive (Inconclusive) Inconclusive. On 17-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 17-Mar-2021, Full blood count: inconclusive (Inconclusive) Inconclusive. On 17-Mar-2021, Metabolic function test: inconclusive (Inconclusive) Inconclusive. On 22-Mar-2021, Fibrin D dimer: inconclusive (Inconclusive) Inconclusive. On 01-Apr-2021, Magnetic resonance imaging head: inconclusive (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: 158/78 (High) 158/78. On an unknown date, Heart rate: 145 breaths per minute (abnormal) racing heart rate up to 145 BPM at rest.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She had not got her second dose yet.  Company comment: This case concerns a 36-year-old female patient who received the first dose of mRNA-1273 and after 36 days had not received the second dose (product dose omission.  The patient also experienced additional adverse events which show temporal relationship with the administration of the product and hence causal association cannot be excluded. The event of product doe omission is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Additional information added on 29-May-2021, had updated reporter information, patient information, Lab details, concomitant medication, new events,start date of event and outcome of events. On 21-Jul-2021: Follow up received on 21-Jul-2021, new events were added.; Sender's Comments: This case concerns a 36-year-old female patient who received the first dose of mRNA-1273 and after 36 days had not received the second dose (product dose omission.  The patient also experienced additional adverse events which show temporal relationship with the administration of the product and hence causal association cannot be excluded. The event of product doe omission is assessed as not applicable.