Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Haemorrhage, Headache
Clinical narrative: stomach ache; headache; I experienced bleeding from a previous scratch site on my left leg which had pretty much healed itself with a scab, but the scab was missing.; I experienced bleeding from a previous scratch site on my left leg which had pretty much healed itself with a scab, but the scab was missing.; This spontaneous case was reported by a patient and describes the occurrence of the first episode of HAEMORRHAGE (I experienced bleeding from a previous scratch site on my left leg which had pretty much healed itself with a scab, but the scab was missing.) and the second episode of HAEMORRHAGE (I experienced bleeding from a previous scratch site on my left leg which had pretty much healed itself with a scab, but the scab was missing.) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Concussion (loss of balance due to a concussion, asthma). Concurrent medical conditions included Asthma (loss of balance due to a concussion, asthma).    On 27-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 27-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced the first episode of HAEMORRHAGE (I experienced bleeding from a previous scratch site on my left leg which had pretty much healed itself with a scab, but the scab was missing.) (seriousness criterion medically significant). On 28-Oct-2023, the patient experienced the second episode of HAEMORRHAGE (I experienced bleeding from a previous scratch site on my left leg which had pretty much healed itself with a scab, but the scab was missing.) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache) and HEADACHE (headache). At the time of the report, last episode of HAEMORRHAGE (I experienced bleeding from a previous scratch site on my left leg which had pretty much healed itself with a scab, but the scab was missing.) had resolved and ABDOMINAL PAIN UPPER (stomach ache) and HEADACHE (headache) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Other than the headache and stomachache, that time at about 11:00 p.m.  On the 27 of October, he experienced bleeding from a previous scratch site on his left leg which had pretty much healed itself with a scab, but the scab was missing. He had cleaned and applied a bandage to the area and thought nothing of it. Then at approximately 1:45 a.m. On the 28th of October I noticed the exact same problem with a scabbed over scratch on his right forearm. Again, no pain, just bleeding, but too like the previous situation, the scab was completely missing, and performed the same procedure of clearing and applying a bandage to the bleeding site. He had not performed any activities that could had affected either site because he was unable to perform any activities requiring strength due to his loss of balance condition and physical therapy for that condition today. Patient had loss of balance due to a concussion and asthma. The patient reports he was taking 13 different medications.   Concomitant medications were not reported. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-747810 (E2B Linked Report).  Company comment: This spontaneous case concerns a 74-year-old male patient, with a previous scratch reported, who experienced the unexpected and serious (medically significant) events of HAEMORRHAGE (among other non-serious events), on the same day of the dose of mRNA-1273.815 vaccine, considered as the fifth dose of the vaccine schedule, on his left leg. On the following day of vaccination, he experienced the exact same problem of bleeding with a scratch on his right forearm. As treatment he performed the same procedure of clearing and applying a bandage to the bleeding sites. Previously he received 4 doses of Moderna vaccine, with non-serious events. No further clinical information was available for medical review. Patient´s age could be a risk factor for bleeding. The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2023: Live follow-up received include medical history updated, inarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747810:Same patient (Different vaccine)