Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Losing smell; Losing taste; Headache; Sore arm; Bruise at the injection; This spontaneous case was reported by a patient and describes the occurrence of ANOSMIA (Losing smell), AGEUSIA (Losing taste), VACCINATION SITE BRUISING (Bruise at the injection), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 939905, 011M20A and 004M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Glaucoma and Hypothyroidism (hypothyroid). Concomitant products included LEVOTHYROXINE and LATANOPROST for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 09-Jun-2022 at 3:40 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 09-Jun-2022, the patient experienced PAIN IN EXTREMITY (Sore arm). On 10-Jun-2022, the patient experienced HEADACHE (Headache). In June 2022, the patient experienced VACCINATION SITE BRUISING (Bruise at the injection). On 19-Jun-2022, the patient experienced ANOSMIA (Losing smell) and AGEUSIA (Losing taste). On 09-Jun-2022, PAIN IN EXTREMITY (Sore arm) had resolved. On 10-Jun-2022, HEADACHE (Headache) had resolved. At the time of the report, ANOSMIA (Losing smell) and AGEUSIA (Losing taste) had not resolved and VACCINATION SITE BRUISING (Bruise at the injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2022, SARS-CoV-2 test: negative (Negative) negative. On 20-Jun-2022, SARS-CoV-2 test: negative (Negative) negative.         It was reported that patient experienced sore arm, and headache for about a day. Then he was fine. He also had a bruise at the injection about the size between a quarter and a silver dollar. Yesterday, on 19Jun2022 in the morning he lost his taste and smell. He took a rapid Antigen test, and it was negative. This morning he still have the same symptoms. He repeated the test and it still negative.  He wanted to know have anybody reported having similar side effects. Patient not had COVID + test or diagnosis.  Patient was taking medication for glaucoma and hypothyroid. Patient's HCP was not aware of side effects.  No treatment medications were provided. Company comment: This spontaneous case concerns a 68-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious of Anosmia and Ageusia. The events occurred 10 days after administration of fourth dose of mRNA-1273, the third dose was given approximately 7 months prior while the initial two doses of mRNA-1273 were given 9 months earlier, the interval between the two doses is 28 days. The patient took SARS-CoV-2 test on June 19 and 20, 2022 which revealed a negative result. It has been reported that the patient experienced headache and soreness of extremity immediately after vaccination, 10 days later patient experienced Anosmia and Ageusia and took a rapid antigen test which showed a negative result, the symptoms persisted the next and again took a test which was again negative. Details of concomitant medications, clinical course, treatment and outcome were not provided. The events were still unresolved at the time of reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious of Anosmia and Ageusia. The events occurred 10 days after administration of fourth dose of mRNA-1273, the third dose was given approximately 7 months prior while the initial two doses of mRNA-1273 were given 9 months earlier, the interval between the two doses is 28 days. The patient took SARS-CoV-2 test on June 19 and 20, 2022 which revealed a negative result. It has been reported that the patient experienced headache and soreness of extremity immediately after vaccination, 10 days later patient experienced Anosmia and Ageusia and took a rapid antigen test which showed a negative result, the symptoms persisted the next and again took a test which was again negative. Details of concomitant medications, clinical course, treatment and outcome were not provided. The events were still unresolved at the time of reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.