Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PEGVISOMANT (SOMAVERT) for Acromegaly.    The patient's past medical history included Liver disorder in October 2021, Kidney dysfunction in October 2021, Gallbladder stone in October 2021, Dark urine in October 2021 and Hospitalization (Hospitalized for 5 days in October 2021 for liver and kidney function issues, dark tea colored urine (all now resolved)) in October 2021. Concurrent medical conditions included Joint pain since October 2021.   On 01-Mar-2019, the patient started PEGVISOMANT (SOMAVERT) (Oral) 30 milligram. On 31-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient had stopped co-suspect for a while, during all of October 2021, due to liver and kidney function issues, dark tea colored urine and gall stones stuck in bile duct. All resolved now, was hospitalized for 5 days during this in October 2021. Currently reported joint pain and controlled IgF values since. After taking first dose with Moderna COVID vaccine, had an anaphylactic reaction and was taken to the emergency room. Unsure if was admitted or not.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  CC: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced an expected, medically significant event of Anaphylactic reaction after receiving a 1st dose of mRNA-1273 vaccine. Patient visited the emergency department due to her anaphylactic reaction. Further details on the medical history, hospitalization details, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced an expected, medically significant event of Anaphylactic reaction after receiving a 1st dose of mRNA-1273 vaccine. Patient visited the emergency department due to her anaphylactic reaction. Further details on the medical history, hospitalization details, clinical course, diagnostics, and treatments were not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.