Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Complication associated with device, Dental caries, Gingival injury, Mastication disorder
Clinical narrative: Tooth extraction; Post procedural pain; Memory impairment; Dental prosthesis complication; Abrasion gingival; Sinus headache; Upset stomach; Sores mouth; Blistering of mouth; Chewing difficulty; Tooth decay; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH EXTRACTION (Tooth extraction), PROCEDURAL PAIN (Post procedural pain), MEMORY IMPAIRMENT (Memory impairment), DENTAL CARIES (Tooth decay) and ABDOMINAL DISCOMFORT (Upset stomach) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis and Psoriasis.    QUETIAPINE FUMARATE allergy manifested by heart beating very fast, could not stand up without holding into something, dizzy, headache, swollen and shaky extremities.  The patient's past medical history included Ex-smoker (Half A Pack Of Cigarettes A Day) from 1962 to 1980, Alcohol use (wine, variety, occasionally) from 1966 to June 2021, Memory impairment in 2020, Colon operation in September 2000, Appendectomy in September 2000 and Oophorectomy in September 2000. Previously administered products included for Drug use for unknown indication: METHYLPRED, FOSAMAX, ASPIRIN, BUDESONIDE, CLINDAMYCIN, PRAVASTATIN, SPIRONOLACTONE, LOPERAMIDE and QUETIAPINE FUMARATE. Past adverse reactions to the above products included Allergy with ASPIRIN, BUDESONIDE, CLINDAMYCIN, FOSAMAX, LOPERAMIDE, METHYLPRED, PRAVASTATIN, QUETIAPINE FUMARATE and SPIRONOLACTONE. Concurrent medical conditions included Colon cancer since September 2000, Allergy to antibiotic (Penicillin allergy), Sulfonamide allergy (allergy manifested by vomiting), Drug allergy (allergy manifested by sore everywhere), Drug allergy (allergy manifested by sore everywhere), Allergy to antibiotic (CLINDAMYCIN  allergy), Drug allergy (METHYLPRED  allergy manifested by really bad sweat and crying for no reason), Drug allergy (BUDESONIDE allergy manifested by low blood pressure, dizziness, crying,), Drug allergy, Drug allergy (PRAVASTATIN allergy manifested by severe pain in stomach and side of ribs), Drug allergy (SPIRONOLACTONE allergy manifested by headache), Drug allergy (LOPERAMIDE allergy manifested by diarrhea), Panuveitis (Non-infectious intermediate, posterior and panuveitis), Psoriasis (Moderate to severe chronic plaque psoriasis), Bursitis, Fibromyalgia, Thyroid disorder, Arthritis, Indigestion, Potassium deficiency, Hip discomfort, Ear discomfort and Pain. Concomitant products included GABAPENTIN for Arthritis, PARACETAMOL (TYLENOL) for Bursitis, MOMETASONE for Ear discomfort, BUSPIRONE and DULOXETINE for Fibromyalgia, DICLOFENAC SODIUM for Hip discomfort, OMEPRAZOLE for Indigestion, ACETAMINOPHEN;HYDROCODONE for Pain, POTASSIUM CHLORIDE for Potassium deficiency, TRIAMCINOLONE for Psoriasis, LEVOTHYROXINE for Thyroid disorder, MOMETASONE FUROATE (ELOCON) for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. In February 2021, the patient experienced DENTAL CARIES (Tooth decay). On 29-Mar-2021, the patient experienced MASTICATION DISORDER (Chewing difficulty). In April 2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), STOMATITIS (Sores mouth) and ORAL MUCOSAL BLISTERING (Blistering of mouth). In July 2021, the patient experienced SINUS HEADACHE (Sinus headache). On 04-Aug-2021, the patient experienced COMPLICATION ASSOCIATED WITH DEVICE (Dental prosthesis complication) and GINGIVAL INJURY (Abrasion gingival). On an unknown date, the patient experienced TOOTH EXTRACTION (Tooth extraction), PROCEDURAL PAIN (Post procedural pain) and MEMORY IMPAIRMENT (Memory impairment). The patient was treated with IPRATROPIUM BROMIDE at an unspecified dose and frequency and FLUTICASONE PROPIONATE at an unspecified dose and frequency. In April 2021, ABDOMINAL DISCOMFORT (Upset stomach) had resolved. In June 2021, STOMATITIS (Sores mouth) and ORAL MUCOSAL BLISTERING (Blistering of mouth) had resolved. In July 2021, SINUS HEADACHE (Sinus headache) had resolved. On 16-Jul-2021, DENTAL CARIES (Tooth decay) had resolved. On 04-Aug-2021, MASTICATION DISORDER (Chewing difficulty) had resolved. At the time of the report, TOOTH EXTRACTION (Tooth extraction), PROCEDURAL PAIN (Post procedural pain) and MEMORY IMPAIRMENT (Memory impairment) outcome was unknown and COMPLICATION ASSOCIATED WITH DEVICE (Dental prosthesis complication) and GINGIVAL INJURY (Abrasion gingival) had resolved.            On an unknown date, the patient had dental work to pulled out from bottom jaw and had so much pain, tooth issues or teeth was rotten and upset stomach and dental work to pulled out from bottom jaw and had so much pain, could not chew or eat solid food or eat right, does not remember a lot of things, patient had two injection but was not good because that was left out and got too hot, sores on mouth, blister on mouth, bottom plate and dentures in place still cause eruption of teeth and rubbed against gum, worsened memory, did not remember a lot of things or worsened memory and recurrent sinus headache with Humira. The patient had pain medication that caused patient's teeth to be rotten sometime in Feb 2021. On 29 Mar 2021, patient had four hour surgery due to bottom teeth was rotten in which teeth were pulled out and dentist had open up cut again to put pins and magnets and metal plate placed. patient took unspecified antibiotics to avoid infection after the surgery. Patient stopped Humira since March 2021. In first week of Apr 2021, patient had upset stomach for one bad day. On 04 Aug 2021, patient had dentures. On 08 Aug 2021, patient did dumb things. Patient had to be on a liquid diet because patient had issues chewing. Patient had sinus headaches got resolved within the same day. Patient had sores and blisters in mouth when patient was put on temporary teeth. Patient stated patient had dental work done and bottom jaw pulled out and had to be off Humira and was so much in pain. Patient does not remember a lot of things had two injections and not good it was left out and not knowing and got too hot. Patients bottom plate and dentures was in place caused eruption of teeth and rubbing against her gum. Patient took Penicillin as Past drug. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.