Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Product dose omission issue, Tinnitus, Urine analysis, Vocal cord inflammation
Clinical narrative: Ear sensitivity to all sounds; Immunology; Pain in left calf; Sharp headache; Afraid to take a second shot; Sore throat; Inflamed vocal cords and larynx; Acid reflux; Not being able to drive for first 6 weeks; Hot flashes; Chest tightness; Short breath; Asthma; Allergy; Extreme anxiety; Sleeplessness; Neuropathy; Muscle twitching/Nerve twitching in hand, arms, thighs and left side of stomach; Tinnitus/ severe sudden tinnitus (8 out of 10 loudness), Extreme ear sensitivity to all sounds,buzzing; Head feeling full/ severe brain fog/head felt full of pressure; Severe brain fog; Tingling in the heels/Tingling in forehead, frontal lobe/ buzzing up and down spine; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Mononucleosis in 1979. Concurrent medical conditions included Allergy to antibiotic (Allergy to ciprofloxacin, had side effects six months earlier similar to neuropathy and muscle twitches as occurred now).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PARAESTHESIA (Tingling in the heels/Tingling in forehead, frontal lobe/ buzzing up and down spine). On 23-Mar-2021, the patient experienced TINNITUS (Tinnitus/ severe sudden tinnitus (8 out of 10 loudness), Extreme ear sensitivity to all sounds,buzzing), HEAD DISCOMFORT (Head feeling full/ severe brain fog/head felt full of pressure) and FEELING ABNORMAL (Severe brain fog). On 29-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant) and MUSCLE TWITCHING (Muscle twitching/Nerve twitching in hand, arms, thighs and left side of stomach). On 14-Apr-2021, the patient experienced ASTHMA (Asthma) and HYPERSENSITIVITY (Allergy). In April 2021, the patient experienced ANXIETY (Extreme anxiety) and INSOMNIA (Sleeplessness). On 17-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) and DYSPNOEA (Short breath). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), VOCAL CORD INFLAMMATION (Inflamed vocal cords and larynx), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not being able to drive for first 6 weeks), HOT FLUSH (Hot flashes), HYPERACUSIS (Ear sensitivity to all sounds), IMMUNE SYSTEM DISORDER (Immunology), PAIN IN EXTREMITY (Pain in left calf), HEADACHE (Sharp headache) and PRODUCT DOSE OMISSION ISSUE (Afraid to take a second shot). The patient was treated with ALPRAZOLAM (XANAX) in March 2021 for Adverse event, at an unspecified dose and frequency; PREDNISONE on 24-Mar-2021 for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. On 15-Jul-2021, NEUROPATHY PERIPHERAL (Neuropathy) and MUSCLE TWITCHING (Muscle twitching/Nerve twitching in hand, arms, thighs and left side of stomach) had resolved. At the time of the report, TINNITUS (Tinnitus/ severe sudden tinnitus (8 out of 10 loudness), Extreme ear sensitivity to all sounds,buzzing), HEAD DISCOMFORT (Head feeling full/ severe brain fog/head felt full of pressure), FEELING ABNORMAL (Severe brain fog) and HEADACHE (Sharp headache) had not resolved, PARAESTHESIA (Tingling in the heels/Tingling in forehead, frontal lobe/ buzzing up and down spine), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Short breath), ANXIETY (Extreme anxiety), INSOMNIA (Sleeplessness), OROPHARYNGEAL PAIN (Sore throat), VOCAL CORD INFLAMMATION (Inflamed vocal cords and larynx), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not being able to drive for first 6 weeks), HOT FLUSH (Hot flashes), ASTHMA (Asthma), HYPERSENSITIVITY (Allergy), HYPERACUSIS (Ear sensitivity to all sounds) and IMMUNE SYSTEM DISORDER (Immunology) outcome was unknown and PAIN IN EXTREMITY (Pain in left calf) and PRODUCT DOSE OMISSION ISSUE (Afraid to take a second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: high (High) Rapid heart beat. On 14-Apr-2021, Blood immunoglobulin E: 9 (Low) Low. On 14-Apr-2021, Cytomegalovirus test: 6.10 (High) High. On 14-Apr-2021, Herpes simplex: 43.30 (Inconclusive) 43.30. In April 2021, Full blood count: normal (normal) Normal and. On 15-Apr-2021, Full blood count normal (normal) Hemoglobin 15.7 and Hemotocrit 45.9. On 15-Apr-2021, Metabolic function test: normal (normal) Showed Calcium level of 10.5  and  Albumin 5.3. In April 2021, Urine analysis: abnormal (abnormal) Urine metabolic and vitamin analysis. Mostly good, High arsenic levels.. On an unknown date, Acoustic stimulation tests: normal (normal) Hearing was excellent in both ears. On an unknown date, X-ray: abnormal (abnormal) Found acid reflux.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The diagnostic tests reported also includes: On 12 Apr 2021, Complete Metabolomix which reports Taurine, Manganese, Dihomo-y-linolenic Acid, Sarcosine, Arginine, Serine all showed up as high. On 14 Apr 2021, Immunology test was done. Laboratory test performed and reported as EBV VCA IgG H was 512, EBV anti nuclear AG H greater that 600 and HHV 6 IgG antibodies was 1.99.   None of the doctors believed that any of the events was from the vaccine.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received. Patient demographics updated, new events were added including pain in extremity and headache, lab data was added, treatment information was updated. On 07-Aug-2021: Follow-up information received. Patient's Medical history was added, New events including Neuropathy peripheral, chest discomfort, feeling abnormal, dyspnea, anxiety, insomnia, oropharyngeal pain, vocal cord inflammation, gastroesophageal reflux disease, loss of personal independence in daily activities, hot flush, asthma, allergy and product dose omission issue were added. Laboratory details was added, and treatment information were updated.; 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.