Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Pain, Weight gain poor
Clinical narrative: UNABLE TO PUT ON WEIGHT; CRAMPS; pain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT GAIN POOR (UNABLE TO PUT ON WEIGHT), MUSCLE SPASMS (CRAMPS) and PAIN (pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Colectomy total in 2003. Concurrent medical conditions included Crohn's ileitis since 2007.   On 15-Apr-2021, the patient started COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 14-Jan-2022, COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced WEIGHT GAIN POOR (UNABLE TO PUT ON WEIGHT) (seriousness criterion medically significant), MUSCLE SPASMS (CRAMPS) (seriousness criterion medically significant) and PAIN (pain) (seriousness criterion medically significant). At the time of the report, WEIGHT GAIN POOR (UNABLE TO PUT ON WEIGHT) and MUSCLE SPASMS (CRAMPS) outcome was unknown and PAIN (pain) had not resolved.            No concomitant medication information was reported.  In 2003, patient's whole large intestine removed. In 2007, crohn's disease appeared in small intestine tried to control with Humira. She had bag. She had to change it more often and had bad cramps at times. Humira had slowed the crohn's in small intestine. She was unable to put on weight.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  Company comment.  This spontaneous case concerns a 46  year  old, female patient with Crohn's disease as concurrent condition (with total colectomy), who received two doses of co  suspect product JNJ 78436735 COVID  19 vaccine, and a booster dose of mRNA-1273 vaccine, and experienced the unexpected, serious medically significant events of weight gain poor, muscle spasms and pain. Events onset date were not reported; hence latency and temporal association cannot be properly assessed. Patient was in treatment with co  suspect product Adalimumab (Humira) for Crohn's disease. On an unspecified date she felt cramps, she had to change her colostomy bag more often, and she was unable to gain weight. No further details were provided for medical review. Crohn's disease with total colectomy remains as risk factors for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 46  year  old, female patient with Crohn's disease as concurrent condition (with total colectomy), who received two doses of co  suspect product JNJ 78436735 COVID  19 vaccine, and a booster dose of mRNA-1273 vaccine, and experienced the unexpected, serious medically significant events of weight gain poor, muscle spasms and pain. Events onset date were not reported; hence latency and temporal association cannot be properly assessed. Patient was in treatment with co  suspect product Adalimumab (Humira) for Crohn's disease. On an unspecified date she felt cramps, she had to change her colostomy bag more often, and she was unable to gain weight. No further details were provided for medical review. Crohn's disease with total colectomy remains as risk factors for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.