Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Insomnia, SARS-CoV-2 test
Clinical narrative: Difficulty sleeping/ TROUBLE SLEEPING; Constipation/ CONSTIPATED; Gastric sounds abnormal/ STOMACH GROWL/MAKES GURGLING SOUNDS; Painful joints/ JOINT PAIN IN HIPS AND BACK; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 virus test positive), INSOMNIA (Difficulty sleeping/ TROUBLE SLEEPING), CONSTIPATION (Constipation/ CONSTIPATED), GASTROINTESTINAL SOUNDS ABNORMAL (Gastric sounds abnormal/ STOMACH GROWL/MAKES GURGLING SOUNDS) and ARTHRALGIA (Painful joints/ JOINT PAIN IN HIPS AND BACK) in a 64-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) injection for Crohn's disease.    The patient's past medical history included Fusion lumbar spine. Concurrent medical conditions included Crohn's disease.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  In 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a week.  On 30-Jun-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form once a week. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. On 20-Dec-2021, the patient experienced COVID-19 (COVID-19 virus test positive). On an unknown date, the patient experienced INSOMNIA (Difficulty sleeping/ TROUBLE SLEEPING), CONSTIPATION (Constipation/ CONSTIPATED), GASTROINTESTINAL SOUNDS ABNORMAL (Gastric sounds abnormal/ STOMACH GROWL/MAKES GURGLING SOUNDS) and ARTHRALGIA (Painful joints/ JOINT PAIN IN HIPS AND BACK). At the time of the report, COVID-19 (COVID-19 virus test positive), INSOMNIA (Difficulty sleeping/ TROUBLE SLEEPING) and ARTHRALGIA (Painful joints/ JOINT PAIN IN HIPS AND BACK) had not resolved and CONSTIPATION (Constipation/ CONSTIPATED) and GASTROINTESTINAL SOUNDS ABNORMAL (Gastric sounds abnormal/ STOMACH GROWL/MAKES GURGLING SOUNDS) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, SARS-CoV-2 test: (Positive) COVID 19 HOME TEST POSITIVE. On 21-Dec-2021, Body temperature: 102.12.   On an unknown date of December 2021 (approximately 9 months after the second dose of vaccine administration) the patient experienced congested (feeling abnormal) (outcome unknown) and chills/fever of temperature of 102.12 (Fever chills) (outcome: improved).   It was also reported that on unknown dates the patient felt tiredness/ TIRED/LACK OF ENERGY (outcome not recovered).   Concomitant medication was not provided.  No information regarding treatment medication was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Significant live follow up (medical history, event information, reporter opinion of causality, suspect drug information and narrative description updated) On 17-Feb-2022: Significant live follow up - Updated narrative with medical history