Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Helicobacter infection, Interchange of vaccine products
Clinical narrative: Helicobacter pylori; Interchange of vaccine products; FELT HUMIRA HAD NOT BEEN WORKING AS WELL SINCE HAVING COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HELICOBACTER INFECTION (Helicobacter pylori), COVID-19 (FELT HUMIRA HAD NOT BEEN WORKING AS WELL SINCE HAVING COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. In October 2021, the patient experienced COVID-19 (FELT HUMIRA HAD NOT BEEN WORKING AS WELL SINCE HAVING COVID-19). On an unknown date, the patient experienced HELICOBACTER INFECTION (Helicobacter pylori) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, HELICOBACTER INFECTION (Helicobacter pylori) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown and COVID-19 (FELT HUMIRA HAD NOT BEEN WORKING AS WELL SINCE HAVING COVID-19) had resolved.            It was unknown if the patient was enrolled in COVID-19 Vaccine trails.  No concomitant medication were reported.  The reporters causality for the events of helicobacter pylori and felt humira had not been working as well since having COVID-19  onset in October 2021 with humira(adalimumab) was no reasonable possibility. The reporters causality for the event of felt humira had not been working as well since having COVID-19 unknown onset was not provided.  No treatment medication were 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 20-year-old female patient, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred in the context of receiving 3rd dose of mRNA-1273 vaccine on an unknown date. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. On unknown dates, patient received 1st and 2nd doses of Tozinameran vaccine and Adalimumab for hidradenitis suppurativa which could be confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 20-year-old female patient, with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 occurred in the context of receiving 3rd dose of mRNA-1273 vaccine on an unknown date. Clinical course and treatment details were not reported. The outcome of event was reported as resolved. On unknown dates, patient received 1st and 2nd doses of Tozinameran vaccine and Adalimumab for hidradenitis suppurativa which could be confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.