Age: 83.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, COVID-19, Hypertension, SARS-CoV-2 test
Clinical narrative: he never had high blood pressure until after he got the vaccine and had 4 of them; tested positive for Covid after 4 Moderna; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (he never had high blood pressure until after he got the vaccine and had 4 of them) and COVID-19 (tested positive for Covid after 4 Moderna) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D66K21A, 014F21A, 029K20A and 039K20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    Concurrent medical conditions included Upset stomach. Concomitant products included VALSARTAN for Blood pressure high, PANTOPRAZOLE for Upset stomach.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 3 dosage form twice a day. On an unknown date, the patient experienced HYPERTENSION (he never had high blood pressure until after he got the vaccine and had 4 of them) and COVID-19 (tested positive for Covid after 4 Moderna). At the time of the report, HYPERTENSION (he never had high blood pressure until after he got the vaccine and had 4 of them) and COVID-19 (tested positive for Covid after 4 Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal. On an unknown date, SARS-CoV-2 test: (Positive) Positive.          It was reprted that the patient took Paxlovid and had taken 2 days worth. The patient  had come down with a sore throat and it might be worse then strep throat. The patient  was not sure if that was a side effect from the Paxlovid. It was  so sore and was even a little more difficult to talk. The patient  went to bad previous night and had no sore throat what so ever. At 6am in the morning, the patient woke up with a horrible sore throat. The patient did not know exactly when it started but, he woke up at 6:00 am in the morning because he had the sore throat. It was deep in his throat and was his whole throat, not just one side. It was across his entire throat. The patient had a cup of hot tea with honey in thinking it might soothe his throat and it did not do a thing.  COMPANY COMMENT: This spontaneous case concerns an 83-year-old male patient, with no relevant medical history reported, who experienced the unexpected non-serious events of Hypertension and COVID-19 (AESI) which occurred unknown number of days after receiving the dose 4 of COVID-19 vaccine mRNA-1273, first booster dose in the COVID-19 vaccine series. Patient previously received the 3 full doses of mRNA-1273 vaccine, dose 1 and dose 2 given with an interval of 28 days, dose 3 given 7 months 16 days after the dose 2, and dose 4 given 5 months 19 days after dose 3.  On an unknown date, COVID-19 test (home kit) was positive. Patient took Paxlovid as treatment and, after 2 days, had sore throat, onset reported as almost four months after dose 4. Of note, sore throat may be related to COVID-19. There is no available information regarding clinical course. Since onset dates of both events were not provided, onset latency could not be assessed. The patient's elderly age remains a predisposition risk factor for both events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an 83-year-old male patient, with no relevant medical history reported, who experienced the unexpected non-serious events of Hypertension and COVID-19 (AESI) which occurred unknown number of days after receiving the dose 4 of COVID-19 vaccine mRNA-1273, first booster dose in the COVID-19 vaccine series. Patient previously received the 3 full doses of mRNA-1273 vaccine, dose 1 and dose 2 given with an interval of 28 days, dose 3 given 7 months 16 days after the dose 2, and dose 4 given 5 months 19 days after dose 3.  On an unknown date, COVID-19 test (home kit) was positive. Patient took Paxlovid as treatment and, after 2 days, had sore throat, onset reported as almost four months after dose 4. Of note, sore throat may be related to COVID-19. There is no available information regarding clinical course. Since onset dates of both events were not provided, onset latency could not be assessed. The patient's elderly age remains a predisposition risk factor for both events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.