Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood test, Fatigue, Headache, Illness
Clinical narrative: Post procedural constipation; Anemic; Sinus infection; Sickness; Pain; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of POST PROCEDURAL CONSTIPATION (Post procedural constipation), ANAEMIA (Anemic), SINUSITIS (Sinus infection), ILLNESS (Sickness), PAIN (Pain), FATIGUE (Tiredness) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Esophageal dilation procedure. Concurrent medical conditions included Rheumatoid arthritis.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second 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) Citrate Free. In July 2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced POST PROCEDURAL CONSTIPATION (Post procedural constipation) (seriousness criterion medically significant), ANAEMIA (Anemic) (seriousness criterion medically significant), SINUSITIS (Sinus infection) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant) and PAIN (Pain) (seriousness criterion medically significant). In July 2021, FATIGUE (Tiredness) and HEADACHE (Headache) had resolved. At the time of the report, POST PROCEDURAL CONSTIPATION (Post procedural constipation), ANAEMIA (Anemic), SINUSITIS (Sinus infection), ILLNESS (Sickness) and PAIN (Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Anemic.         No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported. 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  Company comment  This spontaneous case concerns a 51 year old female patient with concurrent condition of rheumatoid arthritis , who experienced the unexpected serious (medically significant) events of Post procedural constipation, Anaemia , Sinusitis, Illness, Pain, Fatigue and Headache, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine on an unknown date. No information on exact dates of events and vaccination schedule, detailed clinical course, reports of relevant investigations and treatment details was available in the report. Co-suspect adalimumab could be a risk factor for the event Sinusitis. History of oesophageal dilation procedure could be contributory to Post procedural constipation. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 51 year old female patient with concurrent condition of rheumatoid arthritis , who experienced the unexpected serious (medically significant) events of Post procedural constipation, Anaemia , Sinusitis, Illness, Pain, Fatigue and Headache, unknown days after receiving the first dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the second dose with the same vaccine on an unknown date. No information on exact dates of events and vaccination schedule, detailed clinical course, reports of relevant investigations and treatment details was available in the report. Co-suspect adalimumab could be a risk factor for the event Sinusitis. History of oesophageal dilation procedure could be contributory to Post procedural constipation. The benefit-risk relationship of mRNA-1273 is not affected by this report.