Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dizziness, Dyspnoea, Exposure via breast milk, Fear
Clinical narrative: my oxygen count had dropped/ oxygen dropped into the 70's; with a rapid pulse / pulse skyrocketed to 160 / my pulse hovers around 110-120; shortness of breath; pneumonia; she confirmed that she is breast feeding; I fear it could kill me/ I was quite concerned that my life was in danger; body aches; headache; nausea; severe reaction; flu like symptoms; dizzy; Asthma aggravated; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), PNEUMONIA (pneumonia), OXYGEN SATURATION DECREASED (my oxygen count had dropped/ oxygen dropped into the 70's) and HEART RATE INCREASED (with a rapid pulse / pulse skyrocketed to 160 / my pulse hovers around 110-120) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced VACCINATION COMPLICATION (severe reaction), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizzy), ASTHMA (Asthma aggravated), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea). On 20-Jun-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and HEART RATE INCREASED (with a rapid pulse / pulse skyrocketed to 160 / my pulse hovers around 110-120) (seriousness criterion hospitalization). On 04-Jul-2021, the patient experienced OXYGEN SATURATION DECREASED (my oxygen count had dropped/ oxygen dropped into the 70's) (seriousness criterion hospitalization). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (she confirmed that she is breast feeding) and FEAR (I fear it could kill me/ I was quite concerned that my life was in danger). At the time of the report, DYSPNOEA (shortness of breath), PNEUMONIA (pneumonia), OXYGEN SATURATION DECREASED (my oxygen count had dropped/ oxygen dropped into the 70's), HEART RATE INCREASED (with a rapid pulse / pulse skyrocketed to 160 / my pulse hovers around 110-120) and ASTHMA (Asthma aggravated) had not resolved, VACCINATION COMPLICATION (severe reaction) and FEAR (I fear it could kill me/ I was quite concerned that my life was in danger) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizzy), EXPOSURE VIA BREAST MILK (she confirmed that she is breast feeding), MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Patient was due for her second shot coming weekend.  Company comment: This is a case of Maternal Exposure via Breast Milk concerning a 43-year-old female patient with previous relevant medical history of asthma, who experienced the associated unexpected events of Dyspnea, Heart Rate Increased, Oxygen saturation decreased and Pneumonia. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) with outcome of hospitalization. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of asthma remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-261759.   See case MOD-2021-261759 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: significant follow up appended: concomitant drugs and events added; Sender's Comments: This is a case of Maternal Exposure via Breast Milk concerning a 43-year-old female patient with previous relevant medical history of asthma, who experienced the associated unexpected events of Dyspnea, Heart Rate Increased, Oxygen saturation decreased and Pneumonia. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine) with outcome of hospitalization. The rechallenge was not applicable since only information about the first dose was disclosed. The medical history of asthma remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.