Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nausea, Urticaria
Clinical narrative: Full anaphylactic shock; Hives; Low blood pressure; Dizziness; Stuffy nose; Bad headache; Nausea; A spontaneous report was received from a healthcare facility staff member who was a 36-year-old, female patient who received Moderna's COVID-19 Vaccine, and who developed full anaphylactic shock, nausea, hives, low blood pressure, dizziness, bad headache, and stuffy nose.  The patient's medical history included a latex allergy and pregnancy.  Concomitant product use was not provided by the reporter.   On 06-Jan-2021, approximately 30 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (LOT 01122019) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient received her Moderna vaccine on 06 Jan 2021 at noon.  She reported that approximately 30 minutes after receiving the vaccine, she went into full anaphylactic shock.  She stated that the reaction began with nausea.  She then developed hives, got low blood pressure, and was dizzy.  She was taken to the hospital.  There, she received two rounds of epinephrine along with diphenhydramine and famotidine.  She was released that same day from the hospital once she stabilized.   On 07-Jan-2021, a full 24 hours after receiving her vaccine, she experienced another anaphylactic reaction.  She stated that the reaction happened exactly like it did on 06 Jan 2021 and presented with all the same symptoms.  Patient injected herself with the epinephrine pen that she had at home as soon as the symptoms started.     In addition to the anaphylactic reactions she experienced, patient reported that she had a bad headache since receiving the vaccine as well as a stuffy nose that comes and goes and coincides with hives.  As of 10 Jan 2021, she stated that the flare ups had finally subsided, however, she continued taking diphenhydramine and famotidine as prophylaxis for anaphylactic reaction.   Treatment for the event included epinephrine, diphenhydramine, and famotidine.  Action taken with mRNA-1273 in response to the events, full anaphylactic shock, nausea, hives, low blood pressure, dizziness, bad headache, and stuffy nose, was not provided.   The events, full anaphylactic shock and low blood pressure were considered resolved on 07 Jan 2021. The events, nausea, hives, and dizziness were considered recovered/resolved on 10 Jan 2021.  The outcome of the events, bad headache and stuffy nose, were not reported.; Reporter's Comments: This case concerns a 36-year-old female patient with medical history of latex allergy, who received their first of two planned doses of mRNA-1273 (Lot 01122019), and who experienced the serious unlisted event of Anaphylactic shock, the non-serious listed events of Headache and Nausea, and the non-serious unlisted events of Urticaria, Hypotension, Dizziness, and Nasal congestion.  Based on the current available information and temporal associon between the use of the product and the onset of events starting on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.