Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test
Clinical narrative: However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough; However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough; However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough; However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough; she had a sore arm that lasted for a week each time she received a dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough), NASOPHARYNGITIS (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough), COUGH (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough), ANOSMIA (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough) and PAIN IN EXTREMITY (she had a sore arm that lasted for a week each time she received a dose of the Moderna COVID-19 vaccine.) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067F22A) for COVID-19 prophylaxis.     The patent had no allergies. There was no previous COVID-19 diagnosis.  The patient's past medical history included Tinnitus. Concurrent medical conditions included Thyroid disorder.    On 28-Oct-2022, 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. In December 2022, the patient experienced AGEUSIA (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough), NASOPHARYNGITIS (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough), COUGH (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough) and ANOSMIA (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough). On an unknown date, the patient experienced PAIN IN EXTREMITY (she had a sore arm that lasted for a week each time she received a dose of the Moderna COVID-19 vaccine.). At the time of the report, AGEUSIA (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough), NASOPHARYNGITIS (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough), COUGH (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough) and ANOSMIA (However, in DEC2022, she had a really bad cold as well as loss of taste and smell for a few days, and a cough) outcome was unknown and PAIN IN EXTREMITY (she had a sore arm that lasted for a week each time she received a dose of the Moderna COVID-19 vaccine.) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received 5 of the Moderna COVID-19 vaccines since 2021. The patient received 2 doses of her primary series and 3 booster shots. The patient was 64 years old and was having a hard time getting any information on further vaccination recommendation from the doctors. The patient was concerned for getting another shot was because the patient had reactions to the Moderna COVID-19 vaccine with every shot received. The patient had a sore arm that lasted for a week each time the patient received a dose of the Moderna COVID-19 vaccine. The patient had no history of COVID-19 in the past. However, in DEC 2022, the patient had a really bad cold as well as loss of taste and smell for a few days, and a cough. The patient tested 6 times for COVID during that time, but each test came back negative. The patient thinks despite the negative tests, might still have had COVID. The patient wants to know what Moderna's recommendation for the patient, whether the patient should receive additional shots or not.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-733908 (E2B Linked Report).  Company Comment: This spontaneous case concerns a 64  year  old female patient, with no relevant medical history reported, who experienced the unexpected, non  serious AESI ageusia and anosmia. The events occurred approximately 2 months after a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine, reported as fifth dose of her COVID  19 immunization schedule; the patient previously received 2 doses and 2 booster doses with mRNA  1273 vaccines. Latency cannot be properly assessed since exact onset date was not provided. The report stated that she had a cold, cough, as well as loss of taste and smell for a few days. Patient tested 6 times for COVID during that time, but each test came back negative. The patient thinks despite the negative tests, might still have had COVID. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64  year  old female patient, with no relevant medical history reported, who experienced the unexpected, non  serious AESI ageusia and anosmia. The events occurred approximately 2 months after a dose of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine, reported as fifth dose of her COVID  19 immunization schedule; the patient previously received 2 doses and 2 booster doses with mRNA  1273 vaccines. Latency cannot be properly assessed since exact onset date was not provided. The report stated that she had a cold, cough, as well as loss of taste and smell for a few days. Patient tested 6 times for COVID during that time, but each test came back negative. The patient thinks despite the negative tests, might still have had COVID. No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-733908:Master case(monovalent case)