Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Chills, Headache, Illness, Neuropathy peripheral
Clinical narrative: Peripheral neuropathy pain "exploded" in his feet; Feet started "crazy hurting"/ongoing foot pain; Very sick; Fever; Chills; Pounding headache; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy pain "exploded" in his feet) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (Couple of years ago). Concurrent medical conditions included Peripheral neuropathy (Diagnosed 5 years ago), CLL since July 2020, Drug allergy (Allergic to the medication lisinopril.) and Immunocompromised.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy pain "exploded" in his feet) (seriousness criterion medically significant), PAIN IN EXTREMITY (Feet started "crazy hurting"/ongoing foot pain), ILLNESS (Very sick), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Pounding headache). The patient was treated with GABAPENTIN for Adverse event, at a dose of 1800 mg once a day. On 21-Sep-2021, ILLNESS (Very sick), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Pounding headache) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy pain "exploded" in his feet) and PAIN IN EXTREMITY (Feet started "crazy hurting"/ongoing foot pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Antibody test: zero (normal) Antibody test after the 2nd dose and had zero antibodies. In September 2021, Antibody test: zero (normal) Antibody test after the 3rd dose and had zero antibodies.   Patients concomitant medication included Gabapentin, Chronic Lymphocytic Leukemia medications NOS and heart medications NOS. Patient was treated with increased dose of gabapentin.  The patient reported pain was ongoing in feet.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  This case concerns a 71 year old male patient, with medical history of chronic lymphocytic leukemia and peripheral neuropathy diagnosed 5 years ago, who experienced non serious unexpected event of neuropathy peripheral after third dose of mRNA-1273. The event occurred the same day after vaccination. The re-challenge is not applicable.  Patient´s medical history of neuropathy peripheral could be considered a contributing factor. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event [neuropathy peripheral ] was automatically upgraded as serious as per IME list. However, based on information available and as per medical judgement was assessed as non-serious.; Sender's Comments: This case concerns a 71 year old male patient, with medical history of chronic lymphocytic leukemia and peripheral neuropathy diagnosed 5 years ago, who experienced non serious unexpected event of neuropathy peripheral after third dose of mRNA-1273. The event occurred the same day after vaccination. The re-challenge is not applicable.  Patient´s medical history of neuropathy peripheral could be considered a contributing factor. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event [neuropathy peripheral ] was automatically upgraded as serious as per IME list. However, based on information available and as per medical judgement was assessed as non-serious.