Age: 69.0
Sex: F
Vaccine: COVID19-2, UNK, UNK
Symptoms: Dizziness, Fatigue, Pain in extremity, Saliva discolouration
Clinical narrative: Saliva is yellow but thinks it may be from the spray due to rhinoplasty last week; Tired/fatigue; Woozy; A little right arm pain; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Woozy), FATIGUE (Tired/fatigue) and SALIVA DISCOLOURATION (Saliva is yellow but thinks it may be from the spray due to rhinoplasty last week) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products APIXABAN (ELIQUIS) for an unknown indication and SODIUM CHLORIDE (SALINE NASAL SPRAY) for an unknown indication.    The patient's past medical history included Nose bleed (Patient takes Eliquis and it made the skin inside her nose thin, so had nose bleed a couple of months ago) and Rhinoplasty (The doctor did Keratinization inside the nose. It was not done good so she went to another doctor on 15-Mar-2023 and re-did the nose procedure).   On 09-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started APIXABAN (ELIQUIS) (unknown route) at an unspecified dose and SODIUM CHLORIDE (SALINE NASAL SPRAY) (unknown route) at an unspecified dose. On 09-May-2023, the patient experienced DIZZINESS (Woozy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (A little right arm pain). On 10-May-2023, the patient experienced FATIGUE (Tired/fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced SALIVA DISCOLOURATION (Saliva is yellow but thinks it may be from the spray due to rhinoplasty last week) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Woozy), FATIGUE (Tired/fatigue) and PAIN IN EXTREMITY (A little right arm pain) had not resolved and SALIVA DISCOLOURATION (Saliva is yellow but thinks it may be from the spray due to rhinoplasty last week) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered SALIVA DISCOLOURATION (Saliva is yellow but thinks it may be from the spray due to rhinoplasty last week) to be not related. No further causality assessments were provided for DIZZINESS (Woozy), FATIGUE (Tired/fatigue) and PAIN IN EXTREMITY (A little right arm pain).    No concomitant medications were provided. The day after bivalent booster Patient started serious side effects. No PQC detected. It was reported that after procedure the doctor gave Saline nose spray to moisturize the nose. Patient thinks the yellow saliva may be due to the Saline nasal spray.  No treatment medication was provided. Company Comment: This is a spontaneous case concerning a 69-year-old female patient with a history of treatment with Apixaban, who experienced the serious (due to medically significant) unexpected, events of dizziness, fatigue, and saliva discolouration. Events dizziness, fatigue occurred on the following after a dose of mRNA-1273 BIVALENT .222 (Original and Omicron BA.4/BA.5), received as the fifth dose of COVID-19 vaccination schedule. Event saliva discolouration occurred on an unknown date. It was reported that the day after bivalent booster patient started serious side effects. After procedure of rhinoplasty (due to nose bleed a couple of months ago, probably consequence of Apixaban) the doctor gave Saline nose spray to moisturize the nose. Patient thinks the yellow saliva may be due to the Saline nasal spray. Event saliva discolouration was assessed as not related due to alternative explanation. The benefit-risk relationship of mRNA-1273 BIVALENT .222 (Original and Omicron BA.4/BA.5) is not affected by this report.   This case was linked to MOD-2023-724186 (Patient Link).