Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Post procedural haemorrhage, Product dose omission issue, Urticaria
Clinical narrative: He did not get the 2nd dose; His doctor's said he was allergic to the shot; bled profusely through the donor site; broke out in hives from head to feethives lasted 6 weeks; This spontaneous case was reported by a consumer and describes the occurrence of POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Burn (Spent 3 weeks at a burn center for burns to both hands & his donor site was on his leg.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) (seriousness criterion medically significant), URTICARIA (broke out in hives from head to feethives lasted 6 weeks), ALLERGY TO VACCINE (His doctor's said he was allergic to the shot) and PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose). At the time of the report, POST PROCEDURAL HAEMORRHAGE (bled profusely through the donor site) and ALLERGY TO VACCINE (His doctor's said he was allergic to the shot) outcome was unknown and URTICARIA (broke out in hives from head to feethives lasted 6 weeks) and PRODUCT DOSE OMISSION ISSUE (He did not get the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was provided. No treatment medication details was provided. Prior to getting the dose patient spent 3 weeks at a burn center for burns to both hands & his donor site was on his leg. About 10 days later patient received his 1st dose & broke out in hives from head to feet & bled profusely through the donor site.  Company Comment: This case concerns a 76-year-old, male patient with relevant medical history included burns to both hands,  who experienced, serious unlisted event of post procedural haemorrhage, among other non-serious events. The event occurred after an unspecified duration from 1st dose of Moderna COVID-19 Vaccine.  The rechallenge was unknown as the date just for first dose was provided. However, it is reported that subject never received 2nd dose of vaccine. The medical history of burns to both hands remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 76-year-old, male patient with relevant medical history included burns to both hands,  who experienced, serious unlisted event of post procedural haemorrhage, among other non-serious events. The event occurred after an unspecified duration from 1st dose of Moderna COVID-19 Vaccine.  The rechallenge was unknown as the date just for first dose was provided. However, it is reported that subject never received 2nd dose of vaccine. The medical history of burns to both hands remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.