Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Asthenia, Dizziness, Dysarthria, Dyspnoea
Clinical narrative: Anaphylactic shock and almost died; Could not breath/shortness of breath/really hard time with her lungs and breathing; slurred words; weak; woozy; worn out; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic shock and almost died) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Immune system disorder (NOS) (patient  had a compromised immune system before she got the vaccine.). Concurrent medical conditions included Hypertension and Seizure (seizure medication at night). Concomitant products included HYDROCODONE for Nerve pain, VERAPAMIL for Tachycardia and Blood pressure.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic shock and almost died) (seriousness criteria hospitalization, medically significant and life threatening), DYSPNOEA (Could not breath/shortness of breath/really hard time with her lungs and breathing), DYSARTHRIA (slurred words), ASTHENIA (weak), DIZZINESS (woozy) and FATIGUE (worn out). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (intravenous) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic shock and almost died), DYSPNOEA (Could not breath/shortness of breath/really hard time with her lungs and breathing), DYSARTHRIA (slurred words), ASTHENIA (weak), DIZZINESS (woozy) and FATIGUE (worn out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use provided was seizure medication at night, muscle relaxer for spine and neck.   Treatment information provided was 2 rounds of steroids.  At the beginning of summer that patient went into Anaphylactic shock and almost died, could not breath, slurred words after receiving the first dose of the Moderna vaccine in the hospital parking lot. There was an ambulance there who gave her IV Benadryl and took her to the hospital where she received two rounds of steroids. She was sent home after a few hours with steroids and injection just in case she went into shock again. Monitored her for the following week. As a result of the shock, patient had been experiencing shortness of breath, feeling worn out, having a really hard time with her lungs and breathing, feeling weak and woozy. Patient was very upset because she could not get the second shot or any other vaccine. Patient had not tested positive for Covid19 in the past.  company comment: This case concerns a 58 year old female patient, with medical history of immune system disorder, who experienced serious expected event of anaphylactic reaction  after first dose of mRNA-1273. The event occurred on the same day of receiving the mRNA-1273 vaccine. The re-challenge is not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 58 year old female patient, with medical history of immune system disorder, who experienced serious expected event of anaphylactic reaction  after first dose of mRNA-1273. The event occurred on the same day of receiving the mRNA-1273 vaccine. The re-challenge is not applicable since only information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.