Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Immunisation reaction, Immunodeficiency
Clinical narrative: First time he had an anaphylactic shock was on April 2021, six months later he had other episode in Nov/ had to go to the hospital/ each time it happens gets worst and worst; Immunocompromised; Patient experienced side effects; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNODEFICIENCY (Immunocompromised) and ANAPHYLACTIC SHOCK (First time he had an anaphylactic shock was on April 2021, six months later he had other episode in Nov/ had to go to the hospital/ each time it happens gets worst and worst) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006a21a and 001a21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ANAPHYLACTIC SHOCK (First time he had an anaphylactic shock was on April 2021, six months later he had other episode in Nov/ had to go to the hospital/ each time it happens gets worst and worst) (seriousness criteria hospitalization and medically significant) and IMMUNISATION REACTION (Patient experienced side effects). On an unknown date, the patient experienced IMMUNODEFICIENCY (Immunocompromised) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and OXYGEN at an unspecified dose and frequency. At the time of the report, IMMUNODEFICIENCY (Immunocompromised) and ANAPHYLACTIC SHOCK (First time he had an anaphylactic shock was on April 2021, six months later he had other episode in Nov/ had to go to the hospital/ each time it happens gets worst and worst) had not resolved and IMMUNISATION REACTION (Patient experienced side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were provided. Patient had no allergies. Patient had no history relating to mentioned adverse event and had no Acute and Chronic illnesses at the time of vaccination. Reporter stated that the patient was not immunocompromised but at the time of report the patient was. Reporter stated that following vaccination a month after the patient got the vaccine on April 2021 patient experienced side effects, four episodes of anaphylactic shock and had to go to the hospital. First time patient had an anaphylactic shock was on April 2021, six months later patient had other episode in November. Reporter stated that the adverse event outcome was ongoing, felt like patient was going to have one more episode. Patient went to the ER four times, spent hours in the ER. The patient did not experienced a similar event in the past. Patient was rushed to the hospital and received steroids.  Company comment:This Spontaneous case concerns a 25-years-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Immunodeficiency and Anaphylactic shock (hospitalization and medically significant) that occurred in the context of second dose of mRNA-1273 vaccination. Latency cannot be assessed since event onset date was not disclosed. It was reported that following vaccination a month after patient experienced side effects, four episodes of anaphylactic shock and had to go to the hospital and six months later patient had another episode. The patient was treated with epinephrine (epipen), oxygen and steroids at hospital. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2022-617595 (Patient Link).; Sender's Comments: This Spontaneous case concerns a 25-years-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) event of Immunodeficiency and Anaphylactic shock (hospitalization and medically significant) that occurred in the context of second dose of mRNA-1273 vaccination. Latency cannot be assessed since event onset date was not disclosed. It was reported that following vaccination a month after patient experienced side effects, four episodes of anaphylactic shock and had to go to the hospital and six months later patient had another episode. The patient was treated with epinephrine (epipen), oxygen and steroids at hospital. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.