Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: neuropathy in her hands and feet; Neuropathy flared up and will never go away completely; Sick for about 10 days; Persistent Fever up to 102F; Razor blades in throat; Heaviness in both ears like an infection; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in her hands and feet) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colon cancer (Patient reported chemo was intense d/t colon cancer in which she development neuropathy.) and Chemotherapy. Concurrent medical conditions included Neuropathy (Patient stated neuropathy flares up when it gets cold but on a day to day basis, she doesn't notice it anymore.). Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Razor blades in throat), EAR INFECTION (Heaviness in both ears like an infection) and PYREXIA (Persistent Fever up to 102F). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in her hands and feet) (seriousness criterion medically significant), CONDITION AGGRAVATED (Neuropathy flared up and will never go away completely) and ILLNESS (Sick for about 10 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in her hands and feet) and CONDITION AGGRAVATED (Neuropathy flared up and will never go away completely) was resolving and OROPHARYNGEAL DISCOMFORT (Razor blades in throat), EAR INFECTION (Heaviness in both ears like an infection), ILLNESS (Sick for about 10 days) and PYREXIA (Persistent Fever up to 102F) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported being sick for about 10 days after 1st vaccine, then symptoms resolved. She stated that neuropathy in her hands and feet came back after her 1st vaccine and was steady about a month then started fading. She went to see her HCP and he doesn't know why it flared up. Patient stated the neuropathy will never go away completely. No treatment medications reported.  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.   This case was linked to MOD-2021-265326 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up received, AE and outcome of the events updated. Case upgraded to serious. Medical history updated. Action taken updated to No change.; 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.