Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency, Tooth infection, Wheezing
Clinical narrative: Immunity is down by then; teeth infections requiring surgical procedures to remove all his teeth; His lungs were also diagnosed with wheezing; This spontaneous case was reported by a patient and describes the occurrence of IMMUNODEFICIENCY (Immunity is down by then) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 022M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RANITIDINE for GERD.    The patient's past medical history included Brain tumor, Tooth infection, Brain tumor operation and Tooth extraction (Erupted Tooth Surgery). Concurrent medical conditions included GERD since 06-Apr-2020 and Short-term memory impairment (Small memory).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started RANITIDINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunity is down by then) (seriousness criterion medically significant), TOOTH INFECTION (teeth infections requiring surgical procedures to remove all his teeth) and WHEEZING (His lungs were also diagnosed with wheezing). At the time of the report, IMMUNODEFICIENCY (Immunity is down by then), TOOTH INFECTION (teeth infections requiring surgical procedures to remove all his teeth) and WHEEZING (His lungs were also diagnosed with wheezing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered WHEEZING (His lungs were also diagnosed with wheezing) to be related. No further causality assessments were provided for IMMUNODEFICIENCY (Immunity is down by then) and TOOTH INFECTION (teeth infections requiring surgical procedures to remove all his teeth).    Concomitant medications were not reported.  Patient was issued the medication ranitidine when he was diagnosed with GERD in 2019. It was reported that his teeth dentures were gradually removed, they were all infected, teeth were black. Patient also had an emergency wherein he received a shot in his mouth, his gums were cut, and all teeth were surgically removed. Patient's lungs were also diagnosed with wheezing. It was confirmed by the caller that the bad medication patient was talking about was ranitidine. Caller reported that it was not confirmed that if Moderna COVID-19 Vaccine was related to his GERD it needs to be looked.  Patient also mentioned that he thought his immunity was down by then.  It was reported that Call was received from patient to report an adverse event from a non-Moderna product (Ranitidine). Caller initially reported the adverse event on 22Jul2023.  Caller also mentioned that possible overdose from too much medications were received including the Moderna COVID-19 Vaccine. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 69-year-old male patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Immunodeficiency, which occurred on an unknown date related to primary vaccination with mRNA-1273 vaccine. Co-suspect product included non-company product Ranitidine for GERD. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2023: Follow up received is significant. Dose details were added, Event was added and narrative was updated.