Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Nasal discomfort, Pain in extremity, Poor peripheral circulation, Psoriasis
Clinical narrative: NERVE ABLATION; REOCCURRING SINUS ISSUES; SCIATICA NERVE DAMAGE FROM ACCIDENT; RUNNY NOSE/DRAINAGE AND PRESSURE AFTER BEING OUTSIDE; PLAQUE PSORIASIS FLARE UP/PLAQUES ON LOWER LEGS WITH BLISTER; POOR CIRCULATION IN LEGS; RUNNY NOSE/DRAINAGE AND PRESSURE AFTER BEING OUTSIDE; PLAQUE PSORIASIS FLARE UP/PLAQUES ON LOWER LEGS WITH BLISTER; SCIATICA NERVE DAMAGE FROM ACCIDENT; FEET CRAMPING; had aback pain; HAD PAIN DOWN LEGS; ALLERGIES; He also had pain in his knees, elbows and left wrist; SORE ARM AFTER HAD MODERNA VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC NERVE ABLATION (NERVE ABLATION) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. In 2021, the patient experienced PAIN IN EXTREMITY (SORE ARM AFTER HAD MODERNA VACCINE). On an unknown date, the patient experienced THERAPEUTIC NERVE ABLATION (NERVE ABLATION) (seriousness criterion medically significant), SINUS DISORDER (REOCCURRING SINUS ISSUES), ACCIDENT (SCIATICA NERVE DAMAGE FROM ACCIDENT), RHINORRHOEA (RUNNY NOSE/DRAINAGE AND PRESSURE AFTER BEING OUTSIDE), BLISTER (PLAQUE PSORIASIS FLARE UP/PLAQUES ON LOWER LEGS WITH BLISTER), POOR PERIPHERAL CIRCULATION (POOR CIRCULATION IN LEGS), NASAL DISCOMFORT (RUNNY NOSE/DRAINAGE AND PRESSURE AFTER BEING OUTSIDE), PSORIASIS (PLAQUE PSORIASIS FLARE UP/PLAQUES ON LOWER LEGS WITH BLISTER), SCIATICA (SCIATICA NERVE DAMAGE FROM ACCIDENT), MUSCLE SPASMS (FEET CRAMPING), BACK PAIN (had aback pain), PAIN IN EXTREMITY (HAD PAIN DOWN LEGS), HYPERSENSITIVITY (ALLERGIES) and ARTHRALGIA (He also had pain in his knees, elbows and left wrist). At the time of the report, THERAPEUTIC NERVE ABLATION (NERVE ABLATION), SINUS DISORDER (REOCCURRING SINUS ISSUES), ACCIDENT (SCIATICA NERVE DAMAGE FROM ACCIDENT), RHINORRHOEA (RUNNY NOSE/DRAINAGE AND PRESSURE AFTER BEING OUTSIDE), BLISTER (PLAQUE PSORIASIS FLARE UP/PLAQUES ON LOWER LEGS WITH BLISTER), POOR PERIPHERAL CIRCULATION (POOR CIRCULATION IN LEGS), NASAL DISCOMFORT (RUNNY NOSE/DRAINAGE AND PRESSURE AFTER BEING OUTSIDE), PSORIASIS (PLAQUE PSORIASIS FLARE UP/PLAQUES ON LOWER LEGS WITH BLISTER), SCIATICA (SCIATICA NERVE DAMAGE FROM ACCIDENT), MUSCLE SPASMS (FEET CRAMPING) and HYPERSENSITIVITY (ALLERGIES) had not resolved and BACK PAIN (had aback pain), PAIN IN EXTREMITY (HAD PAIN DOWN LEGS), PAIN IN EXTREMITY (SORE ARM AFTER HAD MODERNA VACCINE) and ARTHRALGIA (He also had pain in his knees, elbows and left wrist) outcome was unknown.            No concomitant medication were reported. He did not agree to have physician contacted.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment: This is a spontaneous case reported by a consumer. A 74-year-old male patient completed a two-dose primary series of mRNA-1273 vaccine with an interval of 31 days and experienced medically significant event of nerve ablation and non serious events of reoccurring sinus issues, sciatica nerve damage from accident, runny nose/drainage and pressure after being outside, sore arm, plaque psoriasis flare up, plaques on lower legs with blister, poor circulation in legs, pain down legs, allergies, back pain, arthralgia and feet cramping. Onset date of the events was not provided; hence, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Relevant concurrent medical conditions included Plaque psoriasis which could be a contributory factor for plaques on lower legs with blister, pain down legs and  arthralgia.Psoriasis can flare as part of its natural history. Regarding Adalimumab, reported as co-suspect product, it could be a contributory factor for arthralgia, feet cramping and back pain, also worsening of psoriasis of all subtypes has been reported during postmarketing surveillance. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 74-year-old male patient completed a two-dose primary series of mRNA-1273 vaccine with an interval of 31 days and experienced medically significant event of nerve ablation and non serious events of reoccurring sinus issues, sciatica nerve damage from accident, runny nose/drainage and pressure after being outside, sore arm, plaque psoriasis flare up, plaques on lower legs with blister, poor circulation in legs, pain down legs, allergies, back pain, arthralgia and feet cramping. Onset date of the events was not provided; hence, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Relevant concurrent medical conditions included Plaque psoriasis which could be a contributory factor for plaques on lower legs with blister, pain down legs and  arthralgia.Psoriasis can flare as part of its natural history. Regarding Adalimumab, reported as co-suspect product, it could be a contributory factor for arthralgia, feet cramping and back pain, also worsening of psoriasis of all subtypes has been reported during postmarketing surveillance. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.