Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Sore throat; Runny nose; at evening saw a faint line, tested again this morning, 05/29, and a strong positive line showed up within 4 minutes; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (at evening saw a faint line, tested again this morning, 05/29, and a strong positive line showed up within 4 minutes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 02720A and 039K20A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL from 01-Jan-2020 to an unknown date and PROGESTERONE from 01-Jan-2020 to an unknown date for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2022, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (at evening saw a faint line, tested again this morning, 05/29, and a strong positive line showed up within 4 minutes). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose) outcome was unknown and COVID-19 (at evening saw a faint line, tested again this morning, 05/29, and a strong positive line showed up within 4 minutes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative. On 28-May-2022, SARS-CoV-2 test: a faint line Tested at evening and saw a faint line. On 29-May-2022, SARS-CoV-2 test: positive (Positive) Tested again at morning and a strong positive line showed up within 4 minutes. Symptoms were increasing.         After Paxlovid treatment, symptoms had disappeared but on 28-May-2022, evening saw a faint line.  The device date was 29-May-2022.  Pfizer have permission to contact about this report and have permission to contact the patient's healthcare provider.  Company comment- This is a spontaneous case concerning a 56-year-old female patient with no relevant medical history, who experienced the unexpected AESI COVID-19 after three doses of mRNA-1273 vaccine were administered After completing Paxlovid treatment, symptoms had disappeared. She tested negative but 2 days later had a runny nose and sore throat. Test performed that evening showed a faint line; she was tested again, and a strong positive line showed up within 4 minutes. Symptoms were increasing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 56-year-old female patient with no relevant medical history, who experienced the unexpected AESI COVID-19 after three doses of mRNA-1273 vaccine were administered After completing Paxlovid treatment, symptoms had disappeared. She tested negative but 2 days later had a runny nose and sore throat. Test performed that evening showed a faint line; she was tested again, and a strong positive line showed up within 4 minutes. Symptoms were increasing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.