Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, COVID-19, SARS-CoV-2 test
Clinical narrative: Anaphylactic reaction; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 52-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In May 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication was not provided. The patient still had COVID as of 04-May-2022. it was mild case and she felt tired and had 24 hour fever. She took Tylenol to help. She still dealt with nagging cough as of 12-May-2022. She had self isolated and was working from home. After she tests negative, she would return to work. She did not get dose of COVID vaccine but had an anaphylaxis reaction. So she was not fully vaccinated. It was unknown if patient was enrolled in COVID -19 vaccine trail.  Company Comment: This spontaneous case reported by consumer concerns a 52-year-old female, with medical history of Rheumatoid arthritis for which she is on treatment with Adalimumab, who experienced expected, serious (medically significant) event anaphylactic reaction and unexpected, non-serious AESI Covid19 after vaccination with a first dose of mRNA-1273 on an unknown date.  Clinical course and treatment for anaphylactic reaction was not reported.  The Covid19 was a mild case; she felt tired, had a nagging cough and fever for 24 hours for which she took Paracetamol (Tylenol).  Ongoing treatment with Adalimumab could be a confounding factor for the events.  The ongoing Covid19 pandemic could also be a contributory factor for Covid19.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by consumer concerns a 52-year-old female, with medical history of Rheumatoid arthritis for which she is on treatment with Adalimumab, who experienced expected, serious (medically significant) event anaphylactic reaction and unexpected, non-serious AESI Covid19 after vaccination with a first dose of mRNA-1273 on an unknown date.  Clinical course and treatment for anaphylactic reaction was not reported.  The Covid19 was a mild case; she felt tired, had a nagging cough and fever for 24 hours for which she took Paracetamol (Tylenol).  Ongoing treatment with Adalimumab could be a confounding factor for the events.  The ongoing Covid19 pandemic could also be a contributory factor for Covid19.  The benefit risk relationship of mRNA-1273 is not affected by this report.