Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Otosalpingitis, Pain, Pruritus, Rash
Clinical narrative: Gas; Pain; DISCOMFORT WITH DIET; itching on trunk after shingle injection and itching after COVID vaccine.; EUSTACHIAN TUBE INFECTION AFTER COVID VACCINE; SORE TROAT AFTER COVID VACCINE; RASH ON FACE/NECK/BACK OF LEGS; Allergic reaction to antibiotics/Macrobid allergy; Vaccination site pruritus; CROHNS DISEASE SYMPTOMS; BRUISING AT INJECTION SITE ON STOMACH; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHNS DISEASE SYMPTOMS) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INJECTION SITE BRUISING (BRUISING AT INJECTION SITE ON STOMACH). On an unknown date, the patient experienced CROHN'S DISEASE (CROHNS DISEASE SYMPTOMS) (seriousness criterion medically significant), FLATULENCE (Gas), PAIN (Pain), DISCOMFORT (DISCOMFORT WITH DIET), PRURITUS (itching on trunk after shingle injection and itching after COVID vaccine.), OTOSALPINGITIS (EUSTACHIAN TUBE INFECTION AFTER COVID VACCINE), OROPHARYNGEAL PAIN (SORE TROAT AFTER COVID VACCINE), RASH (RASH ON FACE/NECK/BACK OF LEGS), DRUG HYPERSENSITIVITY (Allergic reaction to antibiotics/Macrobid allergy) and VACCINATION SITE PRURITUS (Vaccination site pruritus). At the time of the report, CROHN'S DISEASE (CROHNS DISEASE SYMPTOMS), INJECTION SITE BRUISING (BRUISING AT INJECTION SITE ON STOMACH), FLATULENCE (Gas), PAIN (Pain) and DISCOMFORT (DISCOMFORT WITH DIET) was resolving and PRURITUS (itching on trunk after shingle injection and itching after COVID vaccine.), OTOSALPINGITIS (EUSTACHIAN TUBE INFECTION AFTER COVID VACCINE), OROPHARYNGEAL PAIN (SORE TROAT AFTER COVID VACCINE), RASH (RASH ON FACE/NECK/BACK OF LEGS), DRUG HYPERSENSITIVITY (Allergic reaction to antibiotics/Macrobid allergy) and VACCINATION SITE PRURITUS (Vaccination site pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of BRUISING AT INJECTION SITE ON STOMACH, CROHNS DISEASE SYMPTOMS, GAS, PAIN and DISCOMFORT WITH DIET with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of ITCHING ON TRUNK AFTER SHINGLE INJECTION, RASH ON FACE/NECK/BACK OF LEGS, ITCHING AFTER COVID VACCINE, SORE TROAT AFTER COVID VACCINE, EUSTACHIAN TUBE INFECTION AFTER COVID VACCINE and MACROBID ALLERGY with HUMIRA(ADALIMUMAB) was no reasonable possibility.  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 67 - year - old female patient, in treatment with co - suspect product Adalimumab due to Chron's disease (unknown onset), who received the first dose of mRNA - 1273 vaccine and experienced the serious medically significant unexpected event of Crohn's disease. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented discomfort with diet, pain, and flatulence, which could be related with Chron's disease. No further clinical information was available for medical reviewing. Patient's mentioned medical history remains as confounder since flaring of symptoms is part of the natural course of Crohn's disease (but diagnosis date is not available). The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67 - year - old female patient, in treatment with co - suspect product Adalimumab due to Chron's disease (unknown onset), who received the first dose of mRNA - 1273 vaccine and experienced the serious medically significant unexpected event of Crohn's disease. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. On an unspecified date, the patient presented discomfort with diet, pain, and flatulence, which could be related with Chron's disease. No further clinical information was available for medical reviewing. Patient's mentioned medical history remains as confounder since flaring of symptoms is part of the natural course of Crohn's disease (but diagnosis date is not available). The benefit risk relationship of mRNA-1273 is not affected by this report.