Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, SARS-CoV-2 test, Urinary tract infection
Clinical narrative: she didn't feel right; She was already really sick; she felt horrible; she also had a silent UTI that didn't hurt; Patient took a home test and it was positive for COVID; Chronic sinus infections/she always has bad sinuses; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient took a home test and it was positive for COVID), CHRONIC SINUSITIS (Chronic sinus infections/she always has bad sinuses), MALAISE (she didn't feel right), ILLNESS (She was already really sick) and URINARY TRACT INFECTION (she also had a silent UTI that didn't hurt) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiomyopathy (Cardiomyopathy), Heart disease, unspecified (Heart disease), Blood pressure high (High blood pressure), Cancer (Treated cancer) and Seasonal allergy (Seasonal allergy pollen).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced CHRONIC SINUSITIS (Chronic sinus infections/she always has bad sinuses). On 20-May-2022, the patient experienced COVID-19 (Patient took a home test and it was positive for COVID) and URINARY TRACT INFECTION (she also had a silent UTI that didn't hurt). On an unknown date, the patient experienced MALAISE (she didn't feel right), ILLNESS (She was already really sick) and FEELING ABNORMAL (she felt horrible). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency; AMOXICILLIN on 13-May-2022 for Chronic sinusitis, at a dose of 500 milligram twice a day; AMOXICILLIN from 16-May-2022 to 20-May-2022 for Chronic sinusitis, at a dose of 750 milligram twice a day; AZITHROMYCIN (Z-PAK) on 20-May-2022 for Chronic sinusitis, at a dose of she only took 2 tablets of that in the morning and CEFPODOXIME on 20-May-2022 for Urinary tract infection NOS, at a dose of 100 milligram twice a day. At the time of the report, COVID-19 (Patient took a home test and it was positive for COVID), CHRONIC SINUSITIS (Chronic sinus infections/she always has bad sinuses), MALAISE (she didn't feel right), ILLNESS (She was already really sick), URINARY TRACT INFECTION (she also had a silent UTI that didn't hurt) and FEELING ABNORMAL (she felt horrible) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: negative (Negative) Negative (home test). On 15-May-2022, SARS-CoV-2 test: negative (Negative) Negative (home test). On 20-May-2022, Blood test: fine Fine. On 20-May-2022, Chest X-ray: fine Fine. On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive (home test). On 22-May-2022, SARS-CoV-2 test: negative (Negative) Negative.         Patient's height: between 5 feet 2 inches and 5 feet 3 inches. Concomitant Medication: Patient does not want to go into all of these.  Patient reported that she suffered from chronic sinus infections and allergies and in May-2022, the week of 09-May-2022, she did not feel right and by either the 09-May-2022 or 10-May-2022, interrupted herself and said then by 13-May-2022 she was sick. She thought it was sinuses, she got really sick, by Friday (20-May-2022) so then her daughter decided to take her to the emergency room (ER), they did an X-ray it was fine, she was short of breath, her oxygens low, she was in the ER for an hour, it went on, her symptoms. She had a positive home test (but she thought she had covid longer than that). The ER doctor thought she was better safe than sorry and gave a prescription for Paxlovid which she had taken on Saturday 21-May-2022. She does feel better, she was also still taking antibiotics for her sinuses. The PCR test was taken on 20-May-2022 Friday, she stated that there could been false positives or false negatives, it depends on the viral load. Patient wanted to ask about efficacy of the Paxlovid if started about 5 days after having symptoms because agent explained that it was recommended to start Paxlovid within 5 days of symptoms but in this case it was started after but did not get any information. Patient was vaccinated with 4 shots of the Moderna, she was very careful, but there was a lot of people in the neighborhood with breakthrough infection. Patient stated that her symptoms either started the week of the 09-May-2022 or 16-May-2022. Patient clarified that she took an at home test on 12-May-2022, it was negative, then she took an at home test on 15-May-2022 and it was negative, and then on Friday 20-May-2022 since she felt horrible she took the PCR test and it was negative, she then came home on the 20-May-2022 and took a home test and it was positive. This made her think on 15-May-2022, she said might be sinus.  Company Comment: This is a spontaneous case concerning a 68-year-old female patient with relevant medical history of Heart Disease and Cancer, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient suffered from chronic Sinusitis and patient did not feel right, was sick, and self-medicated with antibiotics. She had a positive COVID-19 home test 7 days later and was then brought to the Emergency department and was short of breath, low oxygen levels and with UTI, other diagnostics were normal. She was prescribed with Paxlovid and antibiotics for her UTI. No other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The medical history of Heart Disease and Cancer remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with relevant medical history of Heart Disease and Cancer, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient suffered from chronic Sinusitis and patient did not feel right, was sick, and self-medicated with antibiotics. She had a positive COVID-19 home test 7 days later and was then brought to the Emergency department and was short of breath, low oxygen levels and with UTI, other diagnostics were normal. She was prescribed with Paxlovid and antibiotics for her UTI. No other clinical or treatment details were given. It was reported that the outcome of the event was unknown. The medical history of Heart Disease and Cancer remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.