Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with COVID 19 on 22Jun2022 with was a runny nose; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with COVID 19 on 22Jun2022 with was a runny nose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Hip replacement (physical therapy since she had the surgery.) on 22-Mar-2022.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2022, the patient experienced COVID-19 (Diagnosed with COVID 19 on 22Jun2022 with was a runny nose). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 23-Jun-2022 for COVID-19, at a dose of 3 dosage form twice a day. At the time of the report, COVID-19 (Diagnosed with COVID 19 on 22Jun2022 with was a runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not provided by the reporter  Patient did not had lot numbers and expiry dates for her Moderna vaccines.  Patient had bitter taste after two hours of taking Paxlovid, that lasted about 8 hours after first dose , later she took the another dose and couple of hours later the bitter taste started again and was very bitter. The only number patient reported with Paxlovid was PAA183761. The paxlovid was in the form of caplets.  There were two tablets for paxlovid, 150mg Nirmatrelvir (took two of those) and then had 100mg of Ritonavir and took three tablets at the same time, three in the morning and three in the evening.  Patient went to the urgent case for her symptoms and was suggested to go to the company doctor and was later diagnosed with COVID.  The only symptom patient had when she was diagnosed with covid19 was a runny nose. Patient stated that she had no testing in the last two weeks.  Company comment: This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving the 4th dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. The patient took Paxlovid (Nirmatrelvir+Ritonavir). The outcome was reported as unknown. Details of clinical course, further investigations and follow-up were not provided. The patient has taken three doses of mRNA-1273 vaccine prior to the fourth dose (dates unspecified). The current pandemic situation remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Non-significant follow up was received. Quality reference number was updated.; Sender's Comments: This spontaneous case concerns a 75-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving the 4th dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. The patient took Paxlovid (Nirmatrelvir+Ritonavir). The outcome was reported as unknown. Details of clinical course, further investigations and follow-up were not provided. The patient has taken three doses of mRNA-1273 vaccine prior to the fourth dose (dates unspecified). The current pandemic situation remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.