Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Dysphagia, Mass, Swelling face, Tooth abscess
Clinical narrative: Mass; Swallowing disorder; Swelling of face; Tooth Abscess; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Swallowing disorder), SWELLING FACE (Swelling of face), TOOTH ABSCESS (Tooth Abscess) and MASS (Mass) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 032M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis aggravated.    The patient's past medical history included Smoker (Stopped 1981) and Alcohol use (OCCASIONALLY). Concurrent medical conditions included Hives (VICODIN ALLERGY MANIFESTED BY BREAK OUT IN HIVES), Rheumatoid arthritis aggravated, High cholesterol, Blood pressure high and Fibromyalgia. Concomitant products included VALSARTAN for Blood pressure high, DULOXETINE for Fibromyalgia, FOLIC ACID for Folic acid supplementation, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, METHOTREXATE for Rheumatoid arthritis.   In 2004, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free (40 mg,1 in 2 wk). On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DYSPHAGIA (Swallowing disorder) (seriousness criterion hospitalization), SWELLING FACE (Swelling of face) (seriousness criterion hospitalization) and TOOTH ABSCESS (Tooth Abscess) (seriousness criterion hospitalization). On 05-May-2021, the patient experienced MASS (Mass) (seriousness criterion hospitalization). On 12-May-2021, DYSPHAGIA (Swallowing disorder), SWELLING FACE (Swelling of face) and TOOTH ABSCESS (Tooth Abscess) had resolved. At the time of the report, MASS (Mass) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: "Non cancerous mass at the tip of the tongue, Bunch of lumps at the beginning of the tongue".         No Treatment Medication was provided by reporter.   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, concerning a 60-year-old female patient with concomitant medication of Valsartan, who was hospitalized due to the unexpected serious events of Dysphagia, Swelling face, Tooth abscess, and Mass, which occurred 81 to 82 days after receiving the first dose of mRNA-1273 vaccine, and 53 to 54 days after receiving the second dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule. It was reported that the patient was hospitalized for 5 days and was given unknown antibiotics for the abscess found in her tooth. Tooth was extracted after the abscess were gone. Patient stated that during the hospitalization that was the time where the mass on her tongue was found. Patient underwent mass biopsy on an unknown date, which revealed non cancerous mass at the tip of the tongue and bunch of lumps at the beginning of the tongue. It was reported that the event Mass was not resolved, while the other events have resolved. The concomitant intake of Valsartan may cause angioedema of the face, lips and throat, which could be a confounding factor for the events Dysphagia and Swelling face. Tooth abscess could also a confounding factor for the events Dysphagia and Swelling face. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 60-year-old female patient with concomitant medication of Valsartan, who was hospitalized due to the unexpected serious events of Dysphagia, Swelling face, Tooth abscess, and Mass, which occurred 81 to 82 days after receiving the first dose of mRNA-1273 vaccine, and 53 to 54 days after receiving the second dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule. It was reported that the patient was hospitalized for 5 days and was given unknown antibiotics for the abscess found in her tooth. Tooth was extracted after the abscess were gone. Patient stated that during the hospitalization that was the time where the mass on her tongue was found. Patient underwent mass biopsy on an unknown date, which revealed non cancerous mass at the tip of the tongue and bunch of lumps at the beginning of the tongue. It was reported that the event Mass was not resolved, while the other events have resolved. The concomitant intake of Valsartan may cause angioedema of the face, lips and throat, which could be a confounding factor for the events Dysphagia and Swelling face. Tooth abscess could also a confounding factor for the events Dysphagia and Swelling face. The benefit-risk relationship of mRNA-1273 is not affected by this report.