Sex: F
Vaccine: COVID19, UNK
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction to vaccine/ Anaphylaxis with all Moderna shots; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine/ Anaphylaxis with all Moderna shots) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    There was no reported medical history.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Discontinued. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine/ Anaphylaxis with all Moderna shots) (seriousness criterion medically significant). The patient was treated with UPADACITINIB (RINVOQ) on 19-Apr-2022 at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine/ Anaphylaxis with all Moderna shots) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       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.  It was unknown if patient was enrolled in COVID-19 vaccine trail.  The reporter causality for the Co-suspect Humira for the Events of Anaphylaxis with all Moderna shots, Allergic to Humira and Red pancake sized spot on thigh was not provided.  No concomitant medication reported.  Company Comment:  This spontaneous case concerns an adult female patient with no relevant medical history, who experienced the expected, serious  (medically significant) event of Anaphylactic reaction (Anaphylactic reaction to vaccine/ Anaphylaxis with all Moderna shots) on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of onset of event were not provided. No treatment was reported. Patient subsequently received the 2nd dose and booster dose of mRNA-1273 on unknown dates and intervals, and  reportedly experienced anaphylactic reaction on both doses as well.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-628634 (Patient Link).; Sender's Comments: This spontaneous case concerns an adult female patient with no relevant medical history, who experienced the expected, serious  (medically significant) event of Anaphylactic reaction (Anaphylactic reaction to vaccine/ Anaphylaxis with all Moderna shots) on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency could not be determined as date of vaccination and date of onset of event were not provided. No treatment was reported. Patient subsequently received the 2nd dose and booster dose of mRNA-1273 on unknown dates and intervals, and  reportedly experienced anaphylactic reaction on both doses as well.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.