Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID 19 after two Modema COVID 19 vaccines and two Moderna COVID 19 vaccine boosters/she was short of breath/couldn't sleep/bad taste in her mouth/bad taste to a bitter taste/uncomfortable with the taste in mouth/got the virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID 19 after two Modema COVID 19 vaccines and two Moderna COVID 19 vaccine boosters/she was short of breath/couldn't sleep/bad taste in her mouth/bad taste to a bitter taste/uncomfortable with the taste in mouth/got the virus) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048121A, 022M20A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack. Concurrent medical conditions included Lupus erythematosus (Autoimmune disease) and Rheumatoid arthritis (Autoimmune disease).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID 19 after two Modema COVID 19 vaccines and two Moderna COVID 19 vaccine boosters/she was short of breath/couldn't sleep/bad taste in her mouth/bad taste to a bitter taste/uncomfortable with the taste in mouth/got the virus). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) ongoing from 25-May-2022 for COVID-19, at a dose of 3 dosage form twice a day. At the time of the report, COVID-19 (Tested positive for COVID 19 after two Modema COVID 19 vaccines and two Moderna COVID 19 vaccine boosters/she was short of breath/couldn't sleep/bad taste in her mouth/bad taste to a bitter taste/uncomfortable with the taste in mouth/got the virus) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking lots of unspecified concomitant medications.  It was reported that the patient diagnosed with COVID-19 and had shortness of breath therefore, the patient went to the emergency room in an ambulance and the doctor gave her Paxlovid to take for 5 days. On 25-May-2022, the patient had Paxlovid and had the bitter taste in her mouth. It was explained that the patient took the Paxlovid at 8:00 AM and about an hour after she could not sleep because of the bad taste.The patient mentioned she ate a little chocolate and drank water, but the bad taste came back. The patient still had the bad taste. However, bad taste was a little less severe. It was mentioned that the patient first time got the virus. The patient reported that she had not stopped taking the Paxlovid, she was reluctant to take it. The patient also asked, if Paxlovid could do something like bad taste and could she stop taking Paxlovid. It was clarified that there was no dose to change, Paxlovid just comes in the box.  NDC number of Paxlovid was provided.  Company Comment This spontaneous case concerns a 63-year-old female patient, with relevant medical history of systemic lupus erythematosus and rheumatoid arthritis, who experienced the unexpected non-serious AESI of COVID-19 that occurred on an unknown date after the 4th dose of mRNA-1273 vaccine. SARS-CoV-2 test was reported positive (date not reported). As reported, patient was diagnosed with COVID-19 three days ago and had shortness of breath, hence rushed to emergency room and prescribed with Paxlovid for 5 days. Patient reported she could not sleep and was having a bitter taste right after Paxlovid intake. At the time of reporting the outcome of event was not resolved. Medical history of systemic lupus erythematosus and rheumatoid arthritis could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events was assessed as non-serious based on medical judgment.; Sender's Comments: This spontaneous case concerns a 63-year-old female patient, with relevant medical history of systemic lupus erythematosus and rheumatoid arthritis, who experienced the unexpected non-serious AESI of COVID-19 that occurred on an unknown date after the 4th dose of mRNA-1273 vaccine. SARS-CoV-2 test was reported positive (date not reported). As reported, patient was diagnosed with COVID-19 three days ago and had shortness of breath, hence rushed to emergency room and prescribed with Paxlovid for 5 days. Patient reported she could not sleep and was having a bitter taste right after Paxlovid intake. At the time of reporting the outcome of event was not resolved. The medical history of systemic lupus erythematosus and rheumatoid arthritis could be considered as risk factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events was assessed as non-serious based on medical judgment.