Received Apr 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | 046B21A | IM / RA |
permanent damage to reproductive system/no sperm cell seen; heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of AZOOSPERMIA (permanent damage to reproductive system/no sperm cell seen) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A, 014C21A and 060H21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PALPITATIONS (heart palpitation). On an unknown date, the patient experienced AZOOSPERMIA (permanent damage to reproductive system/no sperm cell seen) (seriousness criterion disability). In 2023, PALPITATIONS (heart palpitation) had resolved. At the time of the report, AZOOSPERMIA (permanent damage to reproductive system/no sperm cell seen) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2015, Semen analysis: semen and count - normal results and good motility (14x10^6). On 29-Jun-2021, Semen analysis: semen and count - normal results and good motility (12x10^6). In 2022, Microscopy: seen gradual decrease of moving sperm cell numbers, and moving cells seen not on every try. On 10-Feb-2023, Semen analysis: no sperm cells seen. On 17-Feb-2023, Semen analysis: no sperm cells seen. On 20-Oct-2023, Semen analysis: no sperm cells seen. On an unknown date, Echocardiogram: have not shown any specific issues in the heart. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AZOOSPERMIA (permanent damage to reproductive system/no sperm cell seen) and PALPITATIONS (heart palpitation) to be related. Patient never had an adverse event following any previous vaccine. Concomitant medication was not reported. It was reported that, before vaccination, semen tests (done in 2015 and June 2021) had shown normal amount of motile sperm cells, sometime between June of 2021, and early 2022, Moderna vaccination resulted in permanent damage to his reproductive system. Tests done in 2022 and 2023 had shown that there were no sperm cells seen in the samples. Patient had permanent damage to reproductive systems and also began noticing heart palpitations since Aug-2021, heart palpitations. He never had any problems with heart before. He had followed with cardiologist. After about two years, palpitations were gone. However, reproductive system was damaged permanently. as confirmed by periodic tests done in 2024 and 2025. There were no other events or problems (no health problems, no injuries) that would explain that sperm cells stopped generating in reproductive system, pointing to vaccination as the reason of the problem. It was given that, who received same vaccinations had damaging impacts, one could conclude that it was possible that these specific batches of vaccines were in particular damaging and damaged by vaccine because they came from a very similar ethnic group. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790564 (E2B Linked Report).; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790564:Master case (Wife case)
Test Name: Ultrasound scan of heart; Result Unstructured Data: have not shown any specific issues in the heart; Test Date: 2022; Test Name: self-tests with microscope; Result Unstructured Data: seen gradual decrease of moving sperm cell numbers, and moving cells seen not on every try; Test Date: 201501; Test Name: test of semen/Lab test of semen and count; Result Unstructured Data: semen and count - normal results and good motility (14x10^6); Test Date: 20210629; Test Name: test of semen/Lab test of semen and count; Result Unstructured Data: semen and count - normal results and good motility (12x10^6); Test Date: 20230210; Test Name: test of semen/Lab test of semen and count; Result Unstructured Data: no sperm cells seen; Test Date: 20230217; Test Name: test of semen/Lab test of semen and count; Result Unstructured Data: no sperm cells seen; Test Date: 20231020; Test Name: test of semen/Lab test of semen and count; Result Unstructured Data: no sperm cells seen