Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Loss of consciousness, Myalgia, Nausea
Clinical narrative: Joint pain; Nausea; Fever; has had to use the breathing treatments 4 or 5 times a day due to difficulty breathing; swelling that went up to her collar bone; Swelling of her face & throat; Weakness; swelling of her face & throat that went up from the injection site in her left arm up to her collar bone & the side of her face; Dizziness; Swelling of her face & throat that went up from the injection site in her left arm up to her collar bone & the side of her face; Fatigue big time; Headache; Muscle pain; Was passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was passed out) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Asthmatic (She is asthmatic & uses Albuterol via a nebulizer for breathing treatments.). Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for Asthma.   On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONSCIOUSNESS (Was passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (has had to use the breathing treatments 4 or 5 times a day due to difficulty breathing), BONE SWELLING (swelling that went up to her collar bone), PHARYNGEAL SWELLING (Swelling of her face & throat), ASTHENIA (Weakness), SWELLING FACE (swelling of her face & throat that went up from the injection site in her left arm up to her collar bone & the side of her face), DIZZINESS (Dizziness), VACCINATION SITE SWELLING (Swelling of her face & throat that went up from the injection site in her left arm up to her collar bone & the side of her face), FATIGUE (Fatigue big time), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Was passed out), DYSPNOEA (has had to use the breathing treatments 4 or 5 times a day due to difficulty breathing), BONE SWELLING (swelling that went up to her collar bone), PHARYNGEAL SWELLING (Swelling of her face & throat), ASTHENIA (Weakness), SWELLING FACE (swelling of her face & throat that went up from the injection site in her left arm up to her collar bone & the side of her face), DIZZINESS (Dizziness), VACCINATION SITE SWELLING (Swelling of her face & throat that went up from the injection site in her left arm up to her collar bone & the side of her face), FATIGUE (Fatigue big time), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.            Caregiver was reporting their wife's experiences after receiving Pfizer as her primary series & a booster dose (lot # 069H21A on 29Dec2021) of the Moderna Covid-19 Vaccine. She was asthmatic & uses Albuterol via a nebulizer for breathing treatments. After receiving her booster dose she had to use the breathing treatments 4 or 5 times a day due to difficulty breathing. She had experienced swelling of her face & throat that went up from the injection site in her left arm up to her collar bone & the side of her face. She also had dizziness, weakness, & fatigue big time. She's also had headache, muscle pain, joint pain, nausea, & fever. On Thursday evening when she got home from work she was passed out. The breathing treatments helped then. He was supposed to go get some prednisone tablets that her doctor prescribed for her.  This is a regulatory case concerning a 61-year-old, female patient with relevant medical history of Asthma, who experienced the serious (medically significant) event of a loss of consciousness. The event started one day after the booster dose of mRNA-1273 vaccine. On an unknown date, the patient experienced dyspnea, bone swelling, pharyngeal swelling, asthenia, swelling face, dizziness, vaccination site swelling, fatigue, headache, myalgia, arthralgia, nausea and pyrexia. The patient was treated with PREDNISONE at an unspecified dose and frequency. The rechallenge was not applicable since the first two doses are from another pharmaceutical company (Pfizer). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a regulatory case concerning a 61-year-old, female patient with relevant medical history of Asthma, who experienced the serious (medically significant) event of a loss of consciousness. The event started one day after the booster dose of mRNA-1273 vaccine. On an unknown date, the patient experienced dyspnea, bone swelling, pharyngeal swelling, asthenia, swelling face, dizziness, vaccination site swelling, fatigue, headache, myalgia, arthralgia, nausea and pyrexia. The patient was treated with PREDNISONE at an unspecified dose and frequency. The rechallenge was not applicable since the first two doses are from another pharmaceutical company (Pfizer). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.