Sex: U
Vaccine: COVID19, COVID19
Symptoms: Eczema, Fibrin D dimer, Full blood count, Heart rate, Metabolic function test
Clinical narrative: Positive for SARS-CoV2/COVID rebound; Long COVID-19; Tingling neuropathy; Tachycardia; Eczema like symptoms; Decreased concentration; Skin pain; Dry/peeling skin; Dry/peeling skin; Tingling neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Tingling neuropathy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Concurrent medical conditions included Congenital pyloric stenosis (onset date: from birth, but stable and no treatment at the time of report.), Premature ventricular contractions (approximately from 2016, occasional and no treatment.), Asthma (occasional, on albuterol and/or steroid inhalers.) and Non-sustained ventricular tachycardia (approximately from 2016, occasional and no treatment.).   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2023, the patient experienced NEUROPATHY PERIPHERAL (Tingling neuropathy) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia), ECZEMA (Eczema like symptoms), DISTURBANCE IN ATTENTION (Decreased concentration), PAIN OF SKIN (Skin pain), SKIN EXFOLIATION (Dry/peeling skin), DRY SKIN (Dry/peeling skin), PARAESTHESIA (Tingling neuropathy) and POST-ACUTE COVID-19 SYNDROME (Long COVID-19). On 05-Sep-2023, the patient experienced COVID-19 (Positive for SARS-CoV2/COVID rebound). The patient was treated with SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) ongoing from 19-Sep-2023 at an unspecified dose and frequency; BECLOMETASONE DIPROPIONATE (QVAR) ongoing from 07-Oct-2023 at a dose of UNK, ongoing; PREDNISONE on 06-Oct-2023 at a dose of 10 milligram; PREDNISONE at a dose of 40 milligram, if 10 mg ineffective and PREDNISONE ongoing since an unknown date at a dose of 20 milligram, tappering dose. At the time of the report, NEUROPATHY PERIPHERAL (Tingling neuropathy), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Decreased concentration), PARAESTHESIA (Tingling neuropathy) and COVID-19 (Positive for SARS-CoV2/COVID rebound) had not resolved, ECZEMA (Eczema like symptoms), PAIN OF SKIN (Skin pain), SKIN EXFOLIATION (Dry/peeling skin) and DRY SKIN (Dry/peeling skin) had resolved and POST-ACUTE COVID-19 SYNDROME (Long COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2023, SARS-CoV-2 test: (Positive) nasal swab and rapid antigen test. On 13-Sep-2023, SARS-CoV-2 test: Positive. On 14-Sep-2023, SARS-CoV-2 test: Negative. On 16-Sep-2023, SARS-CoV-2 test: Negative. On 19-Sep-2023, Heart rate: 120-140 with very light activity and limited activities.. On 19-Sep-2023, SARS-CoV-2 test: Positive. On 25-Sep-2023, Chest X-ray: Negative. On 25-Sep-2023, Fibrin D dimer: Negative. On 26-Sep-2023, SARS-CoV-2 test: Positive. On 04-Oct-2023, Chest X-ray: Negative. On 04-Oct-2023, Fibrin D dimer: (Negative) normal. On 04-Oct-2023, Full blood count: normal. On 04-Oct-2023, Metabolic function test: normal. On 09-Oct-2023, Angiogram: Negative. On 09-Oct-2023, Full blood count: normal. On 09-Oct-2023, Metabolic function test: slightly low potassium, otherwise normal. On 09-Oct-2023, Troponin: normal.         Concomitant medication was not reported.  The patient had not taken any other vaccinations within four weeks prior to the first administration. The fourth booster dose was taken due to high risk of frequent institutional or occupational exposure to coronavirus.  The patient cough which was progressively worsening during and after covid rebound which required systemic steroids (ongoing at the time of report). The dyspnea with ambulation and tachycardia also were progressively worsening during and after covid rebound which limited activities at the time of report. The patient had nausea occasionally and headaches, dizziness, tingling neuropathy, decreased concentration and exhaustion with waxing and waning since the onset of the illness. The patient developed long covid progressively.  During rebound period, the patient had skin pain for 1 day. Few days later had dry/peeling skin for 1 day and transient maculopapular rash for 1 day few days later. Since then patient had waxing and waning eczema like symptoms. It was reported that the initial covid test was negative on day 9, then rebounded on day 14 to 21 and was negative again on day 22.  At the time of report, base line asthma was worse and arrhythmia was symptomatically worse with tachycardia.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Neuropathy peripheral, which occurred related to mRNA-1273 vaccine, administered as a fourth dose within COVID-19 vaccination schedule. Co-suspect product included non-company product Tozinameran. As reported, patient experienced tingling neuropathy that was waxing and waning since onset of COVID-19. SARS-CoV-2 test was performed, with positive result. Chest X-ray and fibrin D dimer were negative. Full blood count and metabolic function test were normal. Patient received treatment with salbutamol sulfate, beclomethasone dipropionate and prednisone. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747625 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747625:Same reporter