Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Nasal congestion, Nausea, Neuropathy peripheral
Clinical narrative: itchy; coughing; congestion; sensitive to light/could not open eyes; sever headaches; sore arm/extremely sore/full body aches; nausea; woke up very sick; swelling in arm; could not lift arm; got round circle; painful; severe neuropathy in whole body; Flare up; full third dose received instead of Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (severe neuropathy in whole body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 026B21A and 026D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke, Pain (centralized post store pain.), Complex regional pain syndrome and Depression. Concurrent medical conditions included Raynaud's disease and Scheuermann's disease. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced NEUROPATHY PERIPHERAL (severe neuropathy in whole body) (seriousness criterion medically significant), CONDITION AGGRAVATED (Flare up), PAIN (painful) and ACCIDENTAL OVERDOSE (full third dose received instead of Booster dose). On 22-Oct-2021, the patient experienced ILLNESS (woke up very sick), PERIPHERAL SWELLING (swelling in arm), MOBILITY DECREASED (could not lift arm), VACCINATION COMPLICATION (got round circle), PRURITUS (itchy), COUGH (coughing), NASAL CONGESTION (congestion), PHOTOPHOBIA (sensitive to light/could not open eyes), HEADACHE (sever headaches), MYALGIA (sore arm/extremely sore/full body aches) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Oct-2021, ACCIDENTAL OVERDOSE (full third dose received instead of Booster dose) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (severe neuropathy in whole body), CONDITION AGGRAVATED (Flare up), ILLNESS (woke up very sick), PERIPHERAL SWELLING (swelling in arm), MOBILITY DECREASED (could not lift arm), VACCINATION COMPLICATION (got round circle), PAIN (painful), PRURITUS (itchy), COUGH (coughing), NASAL CONGESTION (congestion), PHOTOPHOBIA (sensitive to light/could not open eyes), HEADACHE (sever headaches), MYALGIA (sore arm/extremely sore/full body aches) and NAUSEA (nausea) outcome was unknown.            Patient reported that she received steroids as a concomitant for other conditions.  Patient reported that she had Sherwin's disease.  Company comment This case concerns a 62 year-old female patient with a history of stroke, Raynaud's phenomenon, "Sherwin's" disease, complex regional pain syndrome, who experienced the unexpected event of accidental (booster) vaccine overdose and the serious event of peripheral neuropathy. The event occurred approximately 1 day after the third dose of mRNA-1273, which was reported as a full dose rather than a Booster dose. The rechallenge was not applicable as no additional dosing will be administered. The medical history of stroke, Raynaud's phenomenon, and complex regional pain syndrome remain confounders for peripheral neuropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 62 year-old female patient with a history of stroke, Raynaud's phenomenon, "Sherwin's" disease, complex regional pain syndrome, who experienced the unexpected event of accidental (booster) vaccine overdose and the serious event of peripheral neuropathy. The event occurred approximately 1 day after the third dose of mRNA-1273, which was reported as a full dose rather than a Booster dose. The rechallenge was not applicable as no additional dosing will be administered. The medical history of stroke, Raynaud's phenomenon, and complex regional pain syndrome remain confounders for peripheral neuropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.