Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Heart rate, Hypersensitivity, Mobility decreased, Nausea
Clinical narrative: She had an allergic reaction, and possibly an anaphylactic shock to the vaccine; Could barely nod her head; She was unable to speak; She had an allergic reaction; felt a tiny bit of nausea; Started feeling very strange/ felt not enough oxygen was going to the brain/felt she was not going to make it/didn´t know if she was going to live or die; She wasn´t getting enough air; She was wheezing; She had a significant rash on both legs from knees up; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (She had an allergic reaction, and possibly an anaphylactic shock to the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine in January 2021 and Pfizer vaccine in February 2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced RASH (She had a significant rash on both legs from knees up). In December 2021, the patient experienced FEELING ABNORMAL (Started feeling very strange/ felt not enough oxygen was going to the brain/felt she was not going to make it/didn´t know if she was going to live or die), DYSPNOEA (She wasn´t getting enough air), WHEEZING (She was wheezing) and NAUSEA (felt a tiny bit of nausea). On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (She had an allergic reaction, and possibly an anaphylactic shock to the vaccine) (seriousness criterion medically significant), MOBILITY DECREASED (Could barely nod her head), SPEECH DISORDER (She was unable to speak) and HYPERSENSITIVITY (She had an allergic reaction). The patient was treated with CORTISONE for Rash both legs, at an unspecified dose and frequency and OXYGEN for Adverse event, at an unspecified dose and frequency. In December 2021, RASH (She had a significant rash on both legs from knees up) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (She had an allergic reaction, and possibly an anaphylactic shock to the vaccine), FEELING ABNORMAL (Started feeling very strange/ felt not enough oxygen was going to the brain/felt she was not going to make it/didn´t know if she was going to live or die), DYSPNOEA (She wasn´t getting enough air), WHEEZING (She was wheezing), MOBILITY DECREASED (Could barely nod her head), SPEECH DISORDER (She was unable to speak), HYPERSENSITIVITY (She had an allergic reaction) and NAUSEA (felt a tiny bit of nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: results not reported Results not reported. On an unknown date, Chest X-ray: results not reported Results not reported. On an unknown date, Computerised tomogram: results not reported Results not reported. On an unknown date, Heart rate: low (Low) Pulse went down.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had received oxygen and an IV but was not sure what treatment was given.  The patient had received Pfizer vaccine as primary series on Jan 2021 and Feb 2021.  The patient was administered with booster dose on 22 NOV 2021, patient reported that the next day, after showering, she had a significant rash on both legs from the knees up. It had went away with some cortisone cream. Then two weeks later, after taking a shower, she didn't get a rash but started feeling very strange. She wasn't getting enough air, was wheezing, felt not enough oxygen was going to the brain and felt a tiny bit of nausea. She thought she needed to go to the doctor, didn't know what was going on and she felt she was not going to make it. She could felt something was wrong, went to the clinic and was seen by 5 doctors and nurses. She didn't really know what they did to her, but all kind of tests were performed, Blood tests, Cat scan, Chest RX. She was in the E.R Room for 6 hours. The doctor's thought she might had a blood clot, but she didn't, everything looked normal.  This case concerns a 74-year-old female patient with medical history of Asthma, who experienced the expected serious event of Anaphylactic Shock and non-serious event of Wheezing, Dyspnea and Rash. The event of Anaphylactic Shock was medically significant. The event occurred on an unknown interval after receiving the first dose of mRNA-1273 Vaccine. As reported, patient was treated with Cortisone for the Rash, and Oxygen for the adverse event, no other clinical or treatment details were given. It was reported that the outcome of the events was unknown. The medical history of Asthma remains a confounder for the events Wheezing and Dyspnea. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 74-year-old female patient with medical history of Asthma, who experienced the expected serious event of Anaphylactic Shock and non-serious event of Wheezing, Dyspnea and Rash. The event of Anaphylactic Shock was medically significant. The event occurred on an unknown interval after receiving the first dose of mRNA-1273 Vaccine. As reported, patient was treated with Cortisone for the Rash, and Oxygen for the adverse event, no other clinical or treatment details were given. It was reported that the outcome of the events was unknown. The medical history of Asthma remains a confounder for the events Wheezing and Dyspnea. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.