Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site arm hurt for a little bit.; If he doesn´t receive an answer he will end up killing himself, he says he doesn´t got much reason to live.; patient experienced ED problems; On November 7, 2023 I got an erection for 30 minutes but had delayed ejaculation; The patient could not have an orgasim; heart palpitations; This spontaneous case was reported by a patient and describes the occurrence of ERECTILE DYSFUNCTION (patient experienced ED problems) in a 67-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TADALAFIL (CIALIS) tablet for Erectile dysfunction.    The patient's past medical history included Heart valve replacement NOS in 2001 and Stent placement in 2001. Concomitant products included WARFARIN and LISINOPRIL for an unknown indication.   In 2019, the patient started TADALAFIL (CIALIS) (unknown route) 5 milligram as required. On 19-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Nov-2023, TADALAFIL (CIALIS) (unknown route) dosage was changed to 10 milligram. On 07-Nov-2023, the patient experienced ERECTILE DYSFUNCTION (patient experienced ED problems) (seriousness criterion medically significant), EJACULATION DELAYED (On November 7, 2023 I got an erection for 30 minutes but had delayed ejaculation) and ANORGASMIA (The patient could not have an orgasim). In November 2023, the patient experienced PALPITATIONS (heart palpitations). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site arm hurt for a little bit.) and SELF-INJURIOUS IDEATION (If he doesn´t receive an answer he will end up killing himself, he says he doesn´t got much reason to live.). At the time of the report, ERECTILE DYSFUNCTION (patient experienced ED problems), EJACULATION DELAYED (On November 7, 2023 I got an erection for 30 minutes but had delayed ejaculation), ANORGASMIA (The patient could not have an orgasim), PALPITATIONS (heart palpitations), VACCINATION SITE PAIN (injection site arm hurt for a little bit.) and SELF-INJURIOUS IDEATION (If he doesn´t receive an answer he will end up killing himself, he says he doesn´t got much reason to live.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered ERECTILE DYSFUNCTION (patient experienced ED problems), EJACULATION DELAYED (On November 7, 2023 I got an erection for 30 minutes but had delayed ejaculation) and ANORGASMIA (The patient could not have an orgasim) to be related. No further causality assessments were provided for PALPITATIONS (heart palpitations), VACCINATION SITE PAIN (injection site arm hurt for a little bit.) and SELF-INJURIOUS IDEATION (If he doesn´t receive an answer he will end up killing himself, he says he doesn´t got much reason to live.).    The patient received the first Moderna Covid-19 vaccine on FEB-2021, second Moderna Covid-19 vaccine about 28 days after the first Moderna Covid-19 vaccine, first Moderna booster dose in Oct-2021. The patient received additional booster doses in 2022. The patient experienced ED (erectile dysfunction) problems while taking Cialis Tadalofil 5mg tablets. On 07-Nov-2023 patient got an erection for 30 minutes but had delayed ejaculation. The patient could not have an orgasm. Before 07-Nov-2023, the patient was fine with Tadalafil 5mg tablets and always worked great. On 18-NOV-2023 the patient's physician increased the Tadalafil to 10mg tablet to achieve an erection. The patient complained that with Tadalafil 10mg that he got heart palpitations. With 10mg of Tadalafil the patient might get an erection but also might have heart issues. Patient stated that he could be doing better if he could figure out how to detox from the Covid vaccine he received in October. He already checked with his primary care and was going to see an urologist. It was also reported that if patient does not receive an answer he would end up killing himself, he stated he does not got much reason to live. He stated as he was set by all this, he was really, really sad.  Company Comment: This is a spontaneous case concerning a 67-year-old male patient with a history of Heart valve replacement and Stent placement, and use of Tadalafil for erectile disfunction since 2019, who experienced the serious (due to medically significant) unexpected, event of erectile dysfunction, together with other non-serious events which occurred approximately 20 days after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. The mentioned medical history remains as a confounder. Tadalafil was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-751281 (Linked Report). This case was linked to MOD-2023-751295 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2023: Live follow up received. Reporter details, narrative and reference id updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-751281:same reporter/different patient