Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Gastrointestinal infection/virus; Sore itchy throat; Hand pain; Painful knees; patient received two doses of Janssen COVID-19 vaccine & booster dose of the Moderna COVID-19 vaccine; she had second Covid was about two weeks after the Moderna Covid-19 booster with Sore itchy throat, headache, very bad dry cough; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL VIRAL INFECTION (Gastrointestinal infection/virus) in a 55-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 products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included COVID-19 ('In Dec 2020, patient had first COVID-19, she had headache, cough, fever, sore throat, fatigue.') in December 2020. Concurrent medical conditions included Rheumatoid arthritis.   On 01-May-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. In 2021, received second dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, 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) UNK, Citrate Free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate Free. On 04-Dec-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received two doses of Janssen COVID-19 vaccine & booster dose of the Moderna COVID-19 vaccine). On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GASTROINTESTINAL VIRAL INFECTION (Gastrointestinal infection/virus) (seriousness criterion hospitalization). In December 2021, the patient experienced COVID-19 (she had second Covid was about two weeks after the Moderna Covid-19 booster with Sore itchy throat, headache, very bad dry cough). On an unknown date, the patient experienced THROAT IRRITATION (Sore itchy throat), PAIN IN EXTREMITY (Hand pain) and ARTHRALGIA (Painful knees). The patient was hospitalized on 10-Dec-2021 due to GASTROINTESTINAL VIRAL INFECTION. At the time of the report, GASTROINTESTINAL VIRAL INFECTION (Gastrointestinal infection/virus), COVID-19 (she had second Covid was about two weeks after the Moderna Covid-19 booster with Sore itchy throat, headache, very bad dry cough) and INTERCHANGE OF VACCINE PRODUCTS (patient received two doses of Janssen COVID-19 vaccine & booster dose of the Moderna COVID-19 vaccine) had resolved, THROAT IRRITATION (Sore itchy throat) and PAIN IN EXTREMITY (Hand pain) outcome was unknown and ARTHRALGIA (Painful knees) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Company Comment : This spontaneous case concerns a 55-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis and co-suspect administration of two doses of the Janssen COVID-19 vaccine, who experienced the unexpected, serious (hospitalization) event of gastrointestinal viral infection, the unexpected, non-serious AESI of COVID-19, and other unexpected and expected, non-serious events. The event gastrointestinal viral infection occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the Janssen COVID-19 vaccine. Of note, the administration date of Humira was not provided and the administration date of the second dose of the Janssen COVID-19 vaccine was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The event gastrointestinal viral infection occurred 6 days after receiving the booster dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (interchange of vaccine products). The event COVID-19 occurred unknown number of days after receiving Humira, unknown number of days after receiving the second dose of the Janssen COVID-19 vaccine, and unknown number of days after receiving the booster dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in Dec2021, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. It was reported that the patient was hospitalized for 5 days with gastrointestinal viral infection. No further clinical information (including details about symptoms, hospitalization, laboartory test/s and treatment) was available for medical review. However, it was reported that while in the hospital, the patient missed doses of Humira. About 2 weeks after receiving the booster dose of the mRNA-1273 vaccine, the patient experienced COVID-19. She had sore and itchy throat, headache, and 'very bad' dry cough. Treatment information was not provided. However, the event had resolved the time of the report. On unknwon dates, the patient also experienced painful knees (arthralgia) and hand pain (pain in extremity). The history of co-suspect administration of two doses of the Janssen COVID-19 vaccine remains a confounder for the event COVID-19. The co-suspect product Humira, a tumor necrosis factor-alpha blocker that can lower the ability of the immune system to fight infections, remains a confounder for the events gastrointestinal viral infection and COVID-19. Since the patient missed doses of Humira while hospitalized, this can also be confounder for the events arthralgia and pain in extremity. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   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.  No concomitant medication was reported.  In Dec-2020, patient had first COVID-19, she had headache, cough, fever, sore throat, fatigue.  On 10-Dec-2022, patient was hospitalized with gastrointestinal infection virus and stayed five days. She missed doses of Humira while in hospital and during Covid. In Dec-2021, she had second Covid was about two weeks after the Moderna Covid-19 booster with sore itchy throat, headache, very bad dry cough.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the events of gastrointestinal infection/virus, itchy throat, painful knees, COVID onset in December 2020, hand pain and COVID onset in December 2021 was not provided. The company's opinion is that there is a reasonable possibility that the event of gastrointestinal infection/virus is related to Humira(adalimumab). The company's opinion is that there is no reasonable possibility that the events of itchy throat, painful knees, COVID onset in December 2020, hand pain and COVID onset in December 2021 are related to Humira (adalimumab).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2022: Significant follow up appended. Updates to patient demographics, event information. The event of itchy throat was added. The event of gastrointestinal infection was amended to gastrointestinal infection/virus. The event of gastrointestinal infection/virus is now considered serious. The event of hospitalization was amended to COVID. remove PT COVID-19 with Onset Date: ??-DEC-2020 and captured in patient history. Current condition added. Remove the Lab Data. Action taken changed for Suspect product. Event "was experiencing side effects from the Moderna vaccine" was removed from event tab. New event added.; Sender's Comments: This spontaneous case concerns a 55-year-old, female patient with history of co-suspect administration of Humira (adalimumab) for Moderate-to-severe Rheumatoid Arthritis and co-suspect administration of two doses of the Janssen COVID-19 vaccine, who experienced the unexpected, serious (hospitalization) event of gastrointestinal viral infection, the unexpected, non-serious AESI of COVID-19, and other unexpected and expected, non-serious events. The event gastrointestinal viral infection occurred unknown number of days after receiving Humira and unknown number of days after receiving the second dose of the Janssen COVID-19 vaccine. Of note, the administration date of Humira was not provided and the administration date of the second dose of the Janssen COVID-19 vaccine was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The event gastrointestinal viral infection occurred 6 days after receiving the booster dose (third dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine (interchange of vaccine products). The event COVID-19 occurred unknown number of days after receiving Humira, unknown number of days after receiving the second dose of the Janssen COVID-19 vaccine, and unknown number of days after receiving the booster dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in Dec2021, hence, the onset latency could not be assessed. The start dates of the other events were not provided, hence, the onset latency also could not be assessed. It was reported that the patient was hospitalized for 5 days with gastrointestinal viral infection. No further clinical information (including details about symptoms, hospitalization, laboartory test/s and treatment) was available for medical review. However, it was reported that while in the hospital, the patient missed doses of Humira. About 2 weeks after receiving the booster dose of the mRNA-1273 vaccine, the patient experienced COVID-19. She had sore and itchy throat, headache, and 'very bad' dry cough. Treatment information was not provided. However, the event had resolved the time of the report. On unknwon dates, the patient also experienced painful knees (arthralgia) and hand pain (pain in extremity). The history of co-suspect administration of two doses of the Janssen COVID-19 vaccine remains a confounder for the event COVID-19. The co-suspect product Humira, a tumor necrosis factor-alpha blocker that can lower the ability of the immune system to fight infections, remains a confounder for the events gastrointestinal viral infection and COVID-19. Since the patient missed doses of Humira while hospitalized, this can also be confounder for the events arthralgia and pain in extremity. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.