Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Fatigue, Headache, Leukoplakia oral
Clinical narrative: Parotid glands became very swollen like mumps; Not feeling well; General fatigue; Headache; Fever; Chills; Perileukoplakia (coating on her tongue); This spontaneous case was reported by an other health care professional and describes the occurrence of LEUKOPLAKIA ORAL (Perileukoplakia (coating on her tongue)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-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 experienced LEUKOPLAKIA ORAL (Perileukoplakia (coating on her tongue)) (seriousness criterion medically significant), PAROTID GLAND ENLARGEMENT (Parotid glands became very swollen like mumps), MALAISE (Not feeling well), FATIGUE (General fatigue), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, LEUKOPLAKIA ORAL (Perileukoplakia (coating on her tongue)) and PAROTID GLAND ENLARGEMENT (Parotid glands became very swollen like mumps) outcome was unknown, MALAISE (Not feeling well), FATIGUE (General fatigue) and HEADACHE (Headache) had not resolved and PYREXIA (Fever) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: greater than 600 (Inconclusive) IgG antibody test done and the level was greater than 600.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that approximately five to six months after getting the vaccine, the patient experienced perileukoplakia. Her parotid glands reportedly became tender, like mumps. The patient was not sure if the symptoms were related to the vaccine and her doctors cannot put it together. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment:  This case concerns a 65-year-old female patient with no reported relevant medical history, who experienced the unexpected events of leukoplakia, parotid glands became very swollen like mumps, malaise, fatigue, headache, chills and pyrexia. The event occurred following an unknown length of time after the administration of the second dose of Spikevax. Causality assessment for the event was not provided by the reporter. The rechallenge was unknown since there's no information about the first dose. The events of fatigue, headache, chills and pyrexia although consistent with the current understanding of the mechanism of action of the vaccine may not be associated with vaccine administration in this case.  The condition appears to be more consistent with an ongoing infection. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 65-year-old female patient with no reported relevant medical history, who experienced the unexpected events of leukoplakia, parotid glands became very swollen like mumps, malaise, fatigue, headache, chills and pyrexia. The event occurred following an unknown length of time after the administration of the second dose of Spikevax. Causality assessment for the event was not provided by the reporter. The rechallenge was unknown since there's no information about the first dose. The events of fatigue, headache, chills and pyrexia although consistent with the current understanding of the mechanism of action of the vaccine may not be associated with vaccine administration in this case.  The condition appears to be more consistent with an ongoing infection. The benefit-risk relationship of Spikevax in not affected by this report.