Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Lymphadenopathy, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat intermittenly after took the last shot/sore throat got worse; Lost my sense of taste and smell; Lost my sense of taste and smell; Engulfed lymph nodes; Muscle ache; Fever; Chills; Headache; Couldn't swallow; A little bit of abdominal pain; Cough; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat intermittenly after took the last shot/sore throat got worse), DYSPHAGIA (Couldn't swallow), ABDOMINAL PAIN (A little bit of abdominal pain), COUGH (Cough) and AGEUSIA (Lost my sense of taste and smell) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced DYSPHAGIA (Couldn't swallow), ABDOMINAL PAIN (A little bit of abdominal pain), COUGH (Cough), LYMPHADENOPATHY (Engulfed lymph nodes), MYALGIA (Muscle ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 26-Oct-2021, the patient experienced AGEUSIA (Lost my sense of taste and smell) and ANOSMIA (Lost my sense of taste and smell). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat intermittenly after took the last shot/sore throat got worse). The patient was treated with ASCORBIC ACID for Adverse event, at a dose of 1 gram twice a day; VITAMIN D NOS for Adverse event, at a dose of 5000 IU once a day; ZINC for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat intermittenly after took the last shot/sore throat got worse), DYSPHAGIA (Couldn't swallow), ABDOMINAL PAIN (A little bit of abdominal pain), COUGH (Cough), AGEUSIA (Lost my sense of taste and smell), ANOSMIA (Lost my sense of taste and smell), LYMPHADENOPATHY (Engulfed lymph nodes), MYALGIA (Muscle ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative  COVID-19 PCR test and negative (Negative) Negative COVID-19 rapid test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication was not reported.  It was reported that on 24 Oct 2021, patients sore throat got worse.  It was reported that all symptoms started to improve on 28-OCT-2021 but have not resolved.  The company comment was reported as This case concerns a 57 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of anosmia and ageusia. The events occurred approximately 20 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 57 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of anosmia and ageusia. The events occurred approximately 20 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.