Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: got up to use bathroom felt like a quick feeling of fainting; tenderness to the skin; aches and pain; dizziness; fever; chills/chilling; Diagnosed with covid19 in November/December; Dose 1 - 28Jan 2021 & Dose 2 -25Feb 2021, Diagnosed with covid19 in November/December 2021; arm soreness for over a day; acute sinusitis swelling of nostril; bronchitis into the bronchial's.; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (got up to use bathroom felt like a quick feeling of fainting), PAIN OF SKIN (tenderness to the skin), PAIN (aches and pain), ACUTE SINUSITIS (acute sinusitis swelling of nostril) and BRONCHITIS (bronchitis into the bronchial's.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was working at a place where people were coming in and out. Caught COVID- 19 before they new what it was.) in 2020 and Disability (Went on disability as medically frail in early 2021 prior to COVID shots.) in 2021.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (arm soreness for over a day). In November 2021, the patient experienced DRUG INEFFECTIVE (Dose 1 - 28Jan 2021 & Dose 2 -25Feb 2021, Diagnosed with covid19 in November/December 2021) and COVID-19 (Diagnosed with covid19 in November/December). On an unknown date, the patient experienced PRESYNCOPE (got up to use bathroom felt like a quick feeling of fainting), PAIN OF SKIN (tenderness to the skin), PAIN (aches and pain), ACUTE SINUSITIS (acute sinusitis swelling of nostril), BRONCHITIS (bronchitis into the bronchial's.), DIZZINESS (dizziness), PYREXIA (fever) and CHILLS (chills/chilling). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. In February 2021, PAIN IN EXTREMITY (arm soreness for over a day) had resolved. At the time of the report, PRESYNCOPE (got up to use bathroom felt like a quick feeling of fainting), PAIN OF SKIN (tenderness to the skin), PAIN (aches and pain), DRUG INEFFECTIVE (Dose 1 - 28Jan 2021 & Dose 2 -25Feb 2021, Diagnosed with covid19 in November/December 2021), DIZZINESS (dizziness), PYREXIA (fever) and CHILLS (chills/chilling) outcome was unknown and ACUTE SINUSITIS (acute sinusitis swelling of nostril), BRONCHITIS (bronchitis into the bronchial's.) and COVID-19 (Diagnosed with covid19 in November/December) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) Headrush (BP) lowered.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. The patient was diagnosed with COVID-19 in Nov/Dec- 2021 had fatigue, lost taste and smell, felt like dying, so much sinus, acute sinusitis swelling of nostril, and bronchitis into the bronchioles. Took 15 days to come out of all that. Treatment done was two rounds of unspecified antibiotics to clear it up and nose spray. Testing was done by hospital.   Company comment: This is a spontaneous case concerning a 55-year-old male patient with no relevant medical history who experienced unexpected event of COVID-19 (AESI), drug ineffective was considered as an additional event. The events occurred approximately 9 months after the second dose of mRNA-1273 vaccine. Treatment included unspecified antibiotics. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405948 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Reporter details and new event LOE was added.; Sender's Comments: This is a spontaneous case concerning a 55-year-old male patient with no relevant medical history who experienced unexpected event of COVID-19 (AESI), drug ineffective was considered as an additional event. The events occurred approximately 9 months after the second dose of mRNA-1273 vaccine. Treatment included unspecified antibiotics. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.