Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Heart rate
Clinical narrative: result of anaphylaxis,anaphylaxis due to COVID-19 vaccination; severe respiratory distress; struggled to breathe/labored breathing/feeling as though her airway was becoming blocked,airways obstructed; stridor; poor oxygen saturation; condition continued to decline; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (result of anaphylaxis,anaphylaxis due to COVID-19 vaccination), RESPIRATORY DISTRESS (severe respiratory distress), DYSPNOEA (struggled to breathe/labored breathing/feeling as though her airway was becoming blocked,airways obstructed), STRIDOR (stridor), OXYGEN SATURATION DECREASED (poor oxygen saturation) and CONDITION AGGRAVATED (condition continued to decline) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension, Reactive airways disease and Anaphylactic reaction to drug. Previously administered products included for Wheezing: Albuterol; for Shortness of breath: Albuterol. Past adverse reactions to the above products included Allergic reaction with Albuterol and Albuterol. Concurrent medical conditions included Environmental allergy.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced RESPIRATORY DISTRESS (severe respiratory distress) (seriousness criteria hospitalization and medically significant), DYSPNOEA (struggled to breathe/labored breathing/feeling as though her airway was becoming blocked,airways obstructed) (seriousness criterion hospitalization), STRIDOR (stridor) (seriousness criterion hospitalization), OXYGEN SATURATION DECREASED (poor oxygen saturation) (seriousness criterion hospitalization) and CONDITION AGGRAVATED (condition continued to decline) (seriousness criterion hospitalization). On 24-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (result of anaphylaxis,anaphylaxis due to COVID-19 vaccination) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized from 23-Mar-2021 to 24-Mar-2021 due to ANAPHYLACTIC REACTION, CONDITION AGGRAVATED, DYSPNOEA, OXYGEN SATURATION DECREASED, RESPIRATORY DISTRESS and STRIDOR. The patient died on 24-Mar-2021. The reported cause of death was Anaphylaxis. An autopsy was performed. At the time of death, RESPIRATORY DISTRESS (severe respiratory distress), DYSPNOEA (struggled to breathe/labored breathing/feeling as though her airway was becoming blocked,airways obstructed), STRIDOR (stridor), OXYGEN SATURATION DECREASED (poor oxygen saturation) and CONDITION AGGRAVATED (condition continued to decline) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Heart rate: lost pulses lost pulses.         No concomitant medications were reported No treatment medications were reported  Patient started to have a reaction 15-20 minutes after receiving the vaccine Patient was intubated and was taken to the emergency room, Patient had arrived just before 5:30 pm. Upon arrival to the hospital patient was reintubated for airway tube positioning and lost pulses. CPR was initiated and return of spontaneous circulation was achieved but her condition continued to decline. The family elected not to have her resuscitated at 11:40 a.m. Patient died on March 24, 2021 at 11:55 a.m.  Company Comment: This  spontaneous case concerns a 68 year old female  with relevant medical history of hypertension , reactive airway disease ,anaphylactic reaction to drug albuterol  and environmental allergy , who experienced Serious ( , unexpected event of anaphylactic reaction , dyspnea, stridor , oxygen saturation decreased and condition aggravated which occurred on the same day post vaccination with the 1st dose of mRNA-1273 ( Moderna Covid 19 Vaccine ) .  These events occurred  within 15-20 minutes after administration of the vaccine.  Patient was intubated and was taken to the emergency room. Upon arrival to the hospital patient was reintubated for airway tube positioning and lost pulses. CPR was done and return of spontaneous circulation was achieved but her condition continued to decline. The family decided on Do not resuscitate status .The patient died one day post vaccination with the 1st of the mRNA-1273 vaccine and the reported cause of death was "anaphylaxis due to COVID-19 vaccination" as per report of the autopsy based on the source document. The medical history of reactive airway disease, environmental allergy  and anaphylactic reaction  to medication are confounders for this case ( this patient has a high hypersensitivity and reaction to medications or any outside factors not to exclude vaccines ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Live follow-up received  Past medical historical information was updated.; Sender's Comments: This  spontaneous case concerns a 68 year old female  with relevant medical history of hypertension , reactive airway disease ,anaphylactic reaction to drug albuterol  and environmental allergy , who experienced Serious ( , unexpected event of anaphylactic reaction , dyspnea, stridor , oxygen saturation decreased and condition aggravated which occurred on the same day post vaccination with the 1st dose of mRNA-1273 ( Moderna Covid 19 Vaccine ) .  These events occurred  within 15-20 minutes after administration of the vaccine.  Patient was intubated and was taken to the emergency room. Upon arrival to the hospital patient was reintubated for airway tube positioning and lost pulses. CPR was done and return of spontaneous circulation was achieved but her condition continued to decline. The family decided on Do not resuscitate status .The patient died one day post vaccination with the 1st of the mRNA-1273 vaccine and the reported cause of death was "anaphylaxis due to COVID-19 vaccination" as per report of the autopsy based on the source document. The medical history of reactive airway disease, environmental allergy  and anaphylactic reaction  to medication are confounders for this case ( this patient has a high hypersensitivity and reaction to medications or any outside factors not to exclude vaccines ) . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Anaphylaxis