Sex: F
Vaccine: COVID19
Symptoms: Pallor, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: unable to breathe; went pale; Arm where she received her injection was red; ache in shoulder; felt a little tired; her arm where she got the injection will itch; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (unable to breathe) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Streptococcal infection in October 2020.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ARTHRALGIA (ache in shoulder) and FATIGUE (felt a little tired). On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm where she received her injection was red) and PALLOR (went pale). On 05-Mar-2021, the patient experienced DYSPNOEA (unable to breathe) (seriousness criterion medically significant). In 2021, the patient experienced VACCINATION SITE PRURITUS (her arm where she got the injection will itch). The patient was treated with EPINEPHRINE (intravenous) for Breathing difficult, at an unspecified dose and frequency; PREDNISONE (oral) for Adverse reaction, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse reaction, at an unspecified dose and frequency and FENTANYL for Heart rate increased, Blood pressure low and Pale, at an unspecified dose and frequency. On 04-Mar-2021, PALLOR (went pale) had resolved. On 05-Mar-2021, DYSPNOEA (unable to breathe) had resolved. In 2021, ARTHRALGIA (ache in shoulder), FATIGUE (felt a little tired), VACCINATION SITE ERYTHEMA (Arm where she received her injection was red) and VACCINATION SITE PRURITUS (her arm where she got the injection will itch) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Blood pressure measurement: low (Low) Low. On 04-Mar-2021, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was mentioned by reporter  On 4mar2021 at 11 am, she had outpatient surgery to have her tonsils removed. The procedure was planned prior to vaccination due to persistent strep infections that totaled 6 between oct2020 to end of feb2021. After surgery in the hospital she noticed her right arm where she received her injection it was red. By the time she got home the red spot was beginning to look like a bullseye. The morning following her surgery she was unable to breathe, her husband called 911 and she was given IV epinephrine and prednisone. After one hour her vitals were normal. She was sent home with oral prednisone and Benadryl that she took for 5 days. Her doctor told her that while she was in surgery her blood pressure went really low, her heart rate skyrocketed and she went pale. She was given fentanyl and everything leveled out. She has not had this type of reaction with prior surgeries. Because her arm turned red after the surgery, the doctor was inclined to think there could have been an interaction with the vaccine and anaesthia. She was told to not get the second dose and was denied a booster. She says every couple of months her arm where she got the injection will itch for a minute and stops quickly. This mostly happens at night and she says she thinks it's when she gets warm because it has happened while she was at work stocking shelves and at home when she was leaning on the couch. She consents for safety to contact either via phone or email and has pictures.  This case concerns a female patient of unknown age with reported medical history of recurrent strep infections, who experienced the unexpected serious event of Dyspnoea. The event occurred 9 days after the first dose of mRNA-1273 vaccine. The history of recurrent strep infections was reported to be the indication for pre-scheduled surgery to remove tonsils 8 days after receiving the vaccine and on the day before Dyspnoea occurred. The medications/anesthesia used for the surgery may have contributed to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override was done to add seriousness criteria of Medically significant to event of Dyspnoea based on medical judgement and review of source document description of call to 911 and treatment with IV and oral medications.; Sender's Comments: This case concerns a female patient of unknown age with reported medical history of recurrent strep infections, who experienced the unexpected serious event of Dyspnoea. The event occurred 9 days after the first dose of mRNA-1273 vaccine. The history of recurrent strep infections was reported to be the indication for pre-scheduled surgery to remove tonsils 8 days after receiving the vaccine and on the day before Dyspnoea occurred. The medications/anesthesia used for the surgery may have contributed to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override was done to add seriousness criteria of Medically significant to event of Dyspnoea based on medical judgement and review of source document description of call to 911 and treatment with IV and oral medications.