Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ERECTILE DYSFUNCTION (Erectile Dysfunction) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 032F21A, 026A21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Essential hypertension since 30-Sep-2016, Hyperlipidemia since 30-Sep-2016, BPH since 30-Sep-2016 and Asthma since 25-Nov-2016. Concomitant products included ALBUTEROL [SALBUTAMOL] from 07-Mar-2022 to an unknown date for Asthma, ASPIRIN [ACETYLSALICYLIC ACID] from 18-Jun-2021 to an unknown date for Cardiovascular disorder NOS, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE/BENAZEPRIL) from 07-Mar-2022 to an unknown date for Hypertension, CYCLOBENZAPRINE from 21-Jun-2022 to an unknown date for Muscle relaxant, INFLUENZA VACCINE (INFLUENZA) for an unknown indication. On 13-Feb-2021 at 11:24 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Mar-2021 at 11:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 20-Nov-2021 at 10:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022 at 11:55 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 21-Jun-2022, the patient experienced ERECTILE DYSFUNCTION (Erectile Dysfunction) (seriousness criterion medically significant), EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered / received a booster dose of Moderna COVID vaccine on 6/21/22; vaccine had reached working expiration on 6/18/22.) and PRODUCT STORAGE ERROR (received a booster dose of Moderna COVID vaccine on 6/21/22; vaccine had reached working expiration on 6/18/22.). The patient was treated with SILDENAFIL (oral) ongoing from 21-Jun-2022 for Erectile dysfunction, at a dose of 100 milligram, 100mg daily PRN. At the time of the report, ERECTILE DYSFUNCTION (Erectile Dysfunction) had not resolved and EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered / received a booster dose of Moderna COVID vaccine on 6/21/22; vaccine had reached working expiration on 6/18/22) and PRODUCT STORAGE ERROR (received a booster dose of Moderna COVID vaccine on 6/21/22; vaccine had reached working expiration on 6/18/22) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The caller was a nurse who stated that they gave vaccines to 5 patients from a vial that was expired as doses were administered after the 30 days use by date. Consent provided to safety for follow up via email and phone. Dose administered after 30-day Use by Date or after manufacturer date of expiry was 18-Jun-2022 but Manufacturer Expiration was 13-Aug-2022. The 5 doses were administered to 5 different patients. The doses were all booster doses per HCP. the Date of vial was initially stored in the refrigerator on 19May2022. The vaccine administered on 21-Jun-2022. The vial had not undergone any temperature excursions. The HCP requested information in written. The manufacturer for the influenza vaccine is given as Seqirus. Company Comment: This spontaneous case concerns a 74-year-old male patient with concurrent Benign prostatic hyperplasia (BPH), Essential hypertension, and Hyperlipidemia, who experienced the unexpected serious (medically significant) event of Erectile Dysfunction on the same day after receiving 4th dose of mRNA-1273 vaccine.  Patient was treated with oral Sildenafil.  Additionally, Expired product administered, and Product storage error were also noted. Patient previously received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 28 days apart, and a third dose of 0.25ml  as first booster dose given approximately 7 months prior to current mRNA-1273 vaccine.  Concurrent benign prostatic hyperplasia remains a confounder, while the advanced age, essential hypertension, and hyperlipidemia could be considered as predisposing risk factors. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. This case was linked to MOD22-016811 (E2B Linked Report). Sender's Comments: This spontaneous case concerns a 74-year-old male patient with concurrent Benign prostatic hyperplasia (BPH), Essential hypertension, and Hyperlipidemia, who experienced the unexpected serious (medically significant) event of Erectile Dysfunction on the same day after receiving 4th dose of mRNA-1273 vaccine.  Patient was treated with oral Sildenafil. Additionally, Expired product administered, and Product storage error were also noted. Patient previously received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 28 days apart, and a third dose of 0.25ml as first booster dose given approximately 7 months prior to current mRNA-1273 vaccine. Concurrent benign prostatic hyperplasia remains a confounder, while the advanced age, essential hypertension, and hyperlipidemia could be considered as predisposing risk factors. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. MOD22-016811: crosslinked ID.