Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Upper respiratory tract infection
Clinical narrative: LOWER STOMACH PAIN; RECURRING, INCOMPLETE BOWEL MOVEMENT; FORGETFULNESS/COULD TELL WHEN MISSED A RINVOQ PILL; DIGESTIVE ISSUES/WENT TO BATHROOM TO URINATE AND ALSO HAD FECES/NEVER EMPTIED; TINGLING SENSATION IN THE HANDS; EXHAUSTED AFTER SECOND COVID-19 VACCINE; Nausea; Upper respiratory tract infection; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (LOWER STOMACH PAIN), GASTROINTESTINAL MOTILITY DISORDER (RECURRING, INCOMPLETE BOWEL MOVEMENT), MEMORY IMPAIRMENT (FORGETFULNESS/COULD TELL WHEN MISSED A RINVOQ PILL), DYSPEPSIA (DIGESTIVE ISSUES/WENT TO BATHROOM TO URINATE AND ALSO HAD FECES/NEVER EMPTIED) and PARAESTHESIA (TINGLING SENSATION IN THE HANDS) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Bowel movement irregularity, Nausea, Tingling feet/hands, Lower abdominal pain, Fibromyalgia, Alcohol use, Hair loss, Swelling arm, Swelling of hands, Swelling of fingers and Swelling of legs. Previously administered products included for Drug allergy: CODEINE (CODEINE ALLERGY), METHOTREXATE (METHOTREXATE ALLERGY) and HYDROXYCHLOROQUINE (HYDROCHLOROQUINE ALLERGY). Past adverse reactions to the above products included Product used for unknown indication with CODEINE, HYDROXYCHLOROQUINE and METHOTREXATE. Concurrent medical conditions included Smoker since 1975. Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for Anticoagulant therapy, ESCITALOPRAM for Depression, ROSUVASTATIN CALCIUM for High cholesterol, EZETIMIBE for High cholesterol and Depression, ATENOLOL for an unknown indication.   In July 2020, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-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 UPADACITINIB (RINVOQ) (Oral) 15 milligram. In July 2020, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection). In 2021, the patient experienced NAUSEA (Nausea). On 27-Aug-2021, the patient experienced FATIGUE (EXHAUSTED AFTER SECOND COVID-19 VACCINE). On an unknown date, the patient experienced ABDOMINAL PAIN LOWER (LOWER STOMACH PAIN), GASTROINTESTINAL MOTILITY DISORDER (RECURRING, INCOMPLETE BOWEL MOVEMENT), MEMORY IMPAIRMENT (FORGETFULNESS/COULD TELL WHEN MISSED A RINVOQ PILL), DYSPEPSIA (DIGESTIVE ISSUES/WENT TO BATHROOM TO URINATE AND ALSO HAD FECES/NEVER EMPTIED) and PARAESTHESIA (TINGLING SENSATION IN THE HANDS). The patient was treated with PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) at an unspecified dose and frequency. In July 2020, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection) had resolved. On 30-Aug-2021, FATIGUE (EXHAUSTED AFTER SECOND COVID-19 VACCINE) had resolved. At the time of the report, ABDOMINAL PAIN LOWER (LOWER STOMACH PAIN), GASTROINTESTINAL MOTILITY DISORDER (RECURRING, INCOMPLETE BOWEL MOVEMENT), MEMORY IMPAIRMENT (FORGETFULNESS/COULD TELL WHEN MISSED A RINVOQ PILL), DYSPEPSIA (DIGESTIVE ISSUES/WENT TO BATHROOM TO URINATE AND ALSO HAD FECES/NEVER EMPTIED), PARAESTHESIA (TINGLING SENSATION IN THE HANDS) and NAUSEA (Nausea) had not resolved.            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 06-Dec-2021: Significant follow-up. event verbatim updated