Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Her nose is running a little; was positive for Covid 19; had a little bit of a headache; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Her nose is running a little), COVID-19 (was positive for Covid 19) and HEADACHE (had a little bit of a headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 vaccination.    The patient's past medical history included Supraventricular tachycardia (had about a year before high blood pressure). Concurrent medical conditions included Blood pressure high (had for about 14-15 years). Concomitant products included POTASSIUM for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form twice a day. On an unknown date, the patient experienced RHINORRHOEA (Her nose is running a little), COVID-19 (was positive for Covid 19) and HEADACHE (had a little bit of a headache). At the time of the report, RHINORRHOEA (Her nose is running a little), COVID-19 (was positive for Covid 19) and HEADACHE (had a little bit of a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Medical history included coronary ablation she thought in 2007 or 2008.  Concomitant medication included unspecified blood pressure medications.  The patient had a little bit of a headache and nose that had not run like that for the longest time and not slept in 2 days. The patient had not slept because the day before on day of reporting it felt like someone hit in back of head and sides of head, it was killing the patient. On the day of reporting the patient did not feel that way only nose was running a little. Company comment: This spontaneous case concerns a 53-year-old, female patient with medical history of Blood pressure high, who experienced the unexpected, non-serious AESI of COVID-19. Non-serious events of Rhinorrhea and Headache were also reported. The exact date of onset of the event was not specified in respect to the administration of three doses of mRNA-1273, hence latency could not be assessed. The initial two doses of mRNA-1273 were given approximately 8 months prior to the third dose, the interval between the two doses is 28 days. It has been reported that the patient experienced runny nose and headache and thought it was just an allergic reaction, on August 1, 2022, the patient took a SARS-CoV-2 test which yielded a positive result, she began her regimen of Paxlovid immediately. The outcome of the event is unknown at the time of the report. The patient's medical history of High blood pressure could be a confounder to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 53-year-old, female patient with medical history of Blood pressure high, who experienced the unexpected, non-serious AESI of COVID-19. Non-serious events of Rhinorrhea and Headache were also reported. The exact date of onset of the event was not specified in respect to the administration of three doses of mRNA-1273, hence latency could not be assessed. The initial two doses of mRNA-1273 were given approximately 8 months prior to the third dose, the interval between the two doses is 28 days. It has been reported that the patient experienced runny nose and headache and thought it was just an allergic reaction, on August 1, 2022, the patient took a SARS-CoV-2 test which yielded a positive result, she began her regimen of Paxlovid immediately. The outcome of the event is unknown at the time of the report. The patient's medical history of High blood pressure could be a confounder to the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.