Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Post procedural infection, Root canal infection, SARS-CoV-2 test
Clinical narrative: Root canal and infection; Foggy feeling in head/Brain fog; COVID-19; Sleeplessness; Cold; Fatigue; Postoperative infection/Mouth infection due to root canal procedure; This spontaneous case was reported by a consumer and describes the occurrence of ROOT CANAL INFECTION (Root canal and infection), FEELING ABNORMAL (Foggy feeling in head/Brain fog), COVID-19 (COVID-19), INSOMNIA (Sleeplessness) and POST PROCEDURAL INFECTION (Postoperative infection/Mouth infection due to root canal procedure) in a 76-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) injection for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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) at an unspecified dose. In December 2021, the patient experienced POST PROCEDURAL INFECTION (Postoperative infection/Mouth infection due to root canal procedure). On an unknown date, the patient experienced ROOT CANAL INFECTION (Root canal and infection), FEELING ABNORMAL (Foggy feeling in head/Brain fog), COVID-19 (COVID-19), INSOMNIA (Sleeplessness), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue). At the time of the report, ROOT CANAL INFECTION (Root canal and infection) and POST PROCEDURAL INFECTION (Postoperative infection/Mouth infection due to root canal procedure) had resolved, FEELING ABNORMAL (Foggy feeling in head/Brain fog), INSOMNIA (Sleeplessness), NASOPHARYNGITIS (Cold) and FATIGUE (Fatigue) had not resolved and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         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. No concomitant medication was provided. No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. It was reported that on DEC-2021 patient had root canal procedure. The reporter's causality for the events of brain fog, fatigued, sleeplessness, mouth infection due to root  canal procedure onset in December 2021 and cold was not provided. The reporter's causality for the events of COVID positive with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of mouth infection due to root canal procedure onset in December 2021 with HUMIRA(ADALIMUMAB) was no reasonable possibility.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Live follow up received on 06-Apr-2022. Suspect product information, new events, lab test, causality were added.