Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Heart rate, Heart rate increased, Hypertension
Clinical narrative: COVID-19 after vaccination/ still covid positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 after vaccination/ still covid positive) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Previously administered products included for Drug use for unknown indication: Demerol, Sudafed and Tramadol; for Product used for unknown indication: Johnson's (Dose number 1, Location at right arm and misplaced or discarded.). Past adverse reactions to the above products included Allergy with Demerol, Sudafed and Tramadol; and No adverse event with Johnson's.  On 13-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19 after vaccination/ still covid positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 after vaccination/ still covid positive) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 23-May-2022, Heart rate: high (High) High. On 29-May-2022, Blood pressure measurement: high (High) High. On 29-May-2022, Heart rate: high (High) High. On 31-May-2022, Blood pressure measurement: high (High) High. On 31-May-2022, Heart rate: high (High) High. On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 05-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided. Patient had experienced nothing before this incident. It was reported as, he too Paxlovid from May 18 to May 22 for COVID-19. On 22-May-2022, he was tested negative for COVID. On 23-May-2022, he noticed heart was racing and high heart rate. He went to the ER and all tests were normal. On 29-May-2022, visited ER by ambulance with high heart rate and high BP. He was tested for the lab test which were normal. On 31-May-2022, again he had heart rate and BP sky rockets at work and was taken to hospital by ambulance. He did not realize a COVID rebound was a thing until it happened. He took a COVID test and was positive. On 05-Jun-2022, he was still COVID positive. Device date was reported as 05-Jun-2022. Treatment drug included Beta blocker to slow down heart and control high.  Company Comment: This is a spontaneous case reported by a patient, concerning a 39-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred about 3 months and 10 days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient previously received the 1 primary dose with Johnson's vaccine with no adverse events reported to Johnson vaccine. Interchange of vaccine products was noted. It was reported that the patient was treated with nirmatrelvir, ritonavir (PAXLOVID) from 18-May-2022 to 22-May-2022 for 5 days for COVID-19 treatment. On 22-May-2022, SARS-CoV-2 test was negative. The ongoing Covid 19 pandemia is a confounder. The event was resolved with sequelae. Patient went back to work on 23 May 2022 and noticed his heart was racing with high heart rate. He visited ER twice in the next 1 week for increased Heart rate and high BP. All tests were normal. He was treated with Beta blocker to slow down heart and control high BP. On 31-May-2022, SARS-CoV-2 test was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This is a spontaneous case reported by a patient, concerning a 39-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred about 3 months and 10 days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient previously received the 1 primary dose with Johnson's vaccine with no adverse events reported to Johnson vaccine. Interchange of vaccine products was noted. It was reported that the patient was treated with nirmatrelvir, ritonavir (PAXLOVID) from 18-May-2022 to 22-May-2022 for 5 days for COVID-19 treatment. On 22-May-2022, SARS-CoV-2 test was negative. The ongoing Covid 19 pandemia is a confounder. The event was resolved with sequelae. Patient went back to work on 23 May 2022 and noticed his heart was racing with high heart rate. He visited ER twice in the next 1 week for increased Heart rate and high BP. All tests were normal. He was treated with Beta blocker to slow down heart and control high BP. On 31-May-2022, SARS-CoV-2 test was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.