Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Haematoma, Pollakiuria, Skin haemorrhage, Vaccination site haemorrhage, Wound haemorrhage
Clinical narrative: Blood started pouring out of old scar on knee and got all over/ wet liquid feeling, left leg; Felt a wet spot dime sized blood spot; Felt liquid sensation running down both sides, it was oozing out and it was not slow at all, it would not clot. bled through a little /blood started spilling out of the left shoulder, blood from a micro sized pore/ dot on the top of his shoulder; Updated bleeding above the Inj. Site after 3rd dose/Excessive bleeding on the injection site; Increased urination 3 hours after the shot-urinating 4 times an hour for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Felt liquid sensation running down both sides, it was oozing out and it was not slow at all, it would not clot. bled through a little /blood started spilling out of the left shoulder, blood from a micro sized pore/ dot on the top of his shoulder) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Scar (scar was at least 20 years old), Nonspecific chest pain (Heart attack like event. Stabbing pain in his chest for 10-15min and then it moved to the center left side of the chest.) in May 2021, Pneumonectomy (Only has one lung) and Open heart surgery (Two previous open heart surgeries). Previously administered products included for Product used for unknown indication: Acyclovir. Concurrent medical conditions included HIV positive.   On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced POLLAKIURIA (Increased urination 3 hours after the shot-urinating 4 times an hour for 6 hours). On 17-Sep-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Updated bleeding above the Inj. Site after 3rd dose/Excessive bleeding on the injection site). On 02-Oct-2021 at 8:00 AM, the patient experienced HAEMORRHAGE (Felt liquid sensation running down both sides, it was oozing out and it was not slow at all, it would not clot. bled through a little /blood started spilling out of the left shoulder, blood from a micro sized pore/ dot on the top of his shoulder) (seriousness criterion medically significant) and HAEMATOMA (Felt a wet spot dime sized blood spot). On 05-Oct-2021, the patient experienced WOUND HAEMORRHAGE (Blood started pouring out of old scar on knee and got all over/ wet liquid feeling, left leg). At the time of the report, HAEMORRHAGE (Felt liquid sensation running down both sides, it was oozing out and it was not slow at all, it would not clot. bled through a little /blood started spilling out of the left shoulder, blood from a micro sized pore/ dot on the top of his shoulder), VACCINATION SITE HAEMORRHAGE (Updated bleeding above the Inj. Site after 3rd dose/Excessive bleeding on the injection site), WOUND HAEMORRHAGE (Blood started pouring out of old scar on knee and got all over/ wet liquid feeling, left leg), HAEMATOMA (Felt a wet spot dime sized blood spot) and POLLAKIURIA (Increased urination 3 hours after the shot-urinating 4 times an hour for 6 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Platelet count: high (High) platelet counts were 14.2 which is high. In May 2021, White blood cell count: high (High) High. On 08-Oct-2021, Platelet count: 252 (abnormal) Complete blood count done with a platelet count of 252.. On an unknown date, Blood creatine: normal (normal) Normal.         He saw several doctors including a to cardiologist for his prior relevant historical condition. Products known to have been used by the patient, within two weeks prior to the event, included Added trilogy inhaler The caller stated that he got the Flu vaccine at the same day in the right arm. Experienced bleeding while showering and there was a pool of blood in the shower. The patient stated the he put medical tape on it to help stop the bleeding and did help but still bled through a little. During prior to vaccination he was not on blood thinners. He has been eating and drinking pineapple (For his kidneys), almonds, pomegranate juice, cooked with two big onions every day, a teaspoon of baking soda every day, and had a lot of chocolates weeks before the bleeding which are supposed to be blood thinners.   This case was linked to MOD-2021-073550, MOD-2021-073555 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2021: Follow-up contains added laboratory investigation details. On 10-Oct-2021: Follow-up information included no new information. On 10-Oct-2021: Significant follow-up contains: added lab data and additional information.; Sender's Comments: This case concerns a 61-year-old male patient with no relevant medical history, who experienced the unexpected non serious events of Vaccination site haemorrhage, Skin bleeding and Wound haemorrhage after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The events Vaccination site haemorrhage and Skin haemorrhage occurred approximately 3 days after the third dose of Spikevax and Wound haemorrhage 21 days after the first dose. Platelet count showed normal results. The rechallenge is not applicable, since a further dose is not expected. The benefit-risk relationship of Spikevax vaccine is not affected by this report. The third dose was given in the context of HIV chronic infection. However, limited information regarding CD4T cell counts has been provided to assess patient´s immunity.