Age: 55.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anaemia, Blood test, COVID-19, Hypersensitivity
Clinical narrative: Anemia; Allergy; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (Anemia), COVID-19 (Covid-19) and HYPERSENSITIVITY (Allergy) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Prophylaxis.    No known allergies.  Concurrent medical conditions included Crohn's disease (moderate to severe adult Crohn's disease). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In December 2021, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced ANAEMIA (Anemia) and HYPERSENSITIVITY (Allergy). At the time of the report, ANAEMIA (Anemia) was resolving, COVID-19 (Covid-19) had resolved and HYPERSENSITIVITY (Allergy) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: anemia Anemia and results not reported Results not reported.         It was unknown if patient was enrolled in clinical trial.   Indication for HUMIRA reported as Crohn's disease.   Patient took booster dose of Moderna vaccine on 26-Nov-2021.   The causality with respect to Humira for the event Anemia was reported as reasonable possibility and for events allergy and COVID-19 as not reported. The event of "COVID PAIN ALL OVER" was amended to "COVID".  No treatment drug information was provided.  Company comment-This spontaneous case concerns a 56-year-old male patient, with relevant medical history of Crohn's disease reported, who experienced the non-serious unexpected AESI of COVID-19 unspecified days (December2021) after third dose of mRNA-1273 vaccine. The event resolved on an unknown date. He also experienced non-serious events of Anaemia and Hypersensitivity on unknown dates.  No further details on clinical course, lab test results and treatment received were reported.  Patient had received initial schedule of vaccination with mRNA-1273 with time interval of 28 days. Patient also had received a dose TOZINAMERAN on an unknown date (interchange of vaccine products) details not provided. Relevant medical history remains a confounder to the event anemia. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 56-year-old male patient, with relevant medical history of Crohn's disease reported, who experienced the non-serious unexpected AESI of COVID-19 unspecified days (December2021) after third dose of mRNA-1273 vaccine. The event resolved on an unknown date. He also experienced non-serious events of Anemia and Hypersensitivity on unknown dates.  No further details on clinical course, lab test results and treatment received were reported.  Patient had received initial schedule of vaccination with mRNA-1273 with time interval of 28 days. Patient also had received a dose TOZINAMERAN on an unknown date (interchange of vaccine products) details not provided. Relevant medical history remains a confounder to the event anemia. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.