Sex: F
Vaccine: COVID19-2, UNK
Symptoms: COVID-19, COVID-19 immunisation, Cardiac disorder, Cytokine storm, Hepatic haemorrhage
Clinical narrative: One of them is dying in pieces; Patient went in to Multi-Organ failure upon 2 days on the Paxlovid/It trashed the patient's organs, emphasizing that it "completely" trashed her organs, it is bad, she had Lacerations; Cytokine storm; She is bleeding from her liver and her spleen; She is bleeding from her liver and her spleen; Her kidneys are failing; She started having problems with her heart; Now every tissue in her body is riddled with spike proteins, her toes are turning black.; She was in so much pain that she couldn't function; Now every tissue in her body is riddled with spike proteins; She got covid after she had the vaccines; interchange of vaccine products; revaccination with different covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of NEAR DEATH EXPERIENCE (One of them is dying in pieces), MULTIPLE ORGAN DYSFUNCTION SYNDROME (Patient went in to Multi-Organ failure upon 2 days on the Paxlovid/It trashed the patient's organs, emphasizing that it "completely" trashed her organs, it is bad, she had Lacerations), CYTOKINE STORM (Cytokine storm), HEPATIC HAEMORRHAGE (She is bleeding from her liver and her spleen), SPLENIC HAEMORRHAGE (She is bleeding from her liver and her spleen) and RENAL FAILURE (Her kidneys are failing) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse effect with Pfizer and Pfizer. Concurrent medical conditions included Diabetes and High cholesterol.   On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (One of them is dying in pieces) (seriousness criterion medically significant), MULTIPLE ORGAN DYSFUNCTION SYNDROME (Patient went in to Multi-Organ failure upon 2 days on the Paxlovid/It trashed the patient's organs, emphasizing that it "completely" trashed her organs, it is bad, she had Lacerations) (seriousness criterion medically significant), CYTOKINE STORM (Cytokine storm) (seriousness criterion medically significant), HEPATIC HAEMORRHAGE (She is bleeding from her liver and her spleen) (seriousness criterion medically significant), SPLENIC HAEMORRHAGE (She is bleeding from her liver and her spleen) (seriousness criterion medically significant), RENAL FAILURE (Her kidneys are failing) (seriousness criterion medically significant), CARDIAC DISORDER (She started having problems with her heart), SKIN DISCOLOURATION (Now every tissue in her body is riddled with spike proteins, her toes are turning black.), PAIN (She was in so much pain that she couldn't function), IMMUNISATION REACTION (Now every tissue in her body is riddled with spike proteins), COVID-19 (She got covid after she had the vaccines), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid-19 vaccine). At the time of the report, NEAR DEATH EXPERIENCE (One of them is dying in pieces), MULTIPLE ORGAN DYSFUNCTION SYNDROME (Patient went in to Multi-Organ failure upon 2 days on the Paxlovid/It trashed the patient's organs, emphasizing that it "completely" trashed her organs, it is bad, she had Lacerations), CYTOKINE STORM (Cytokine storm), HEPATIC HAEMORRHAGE (She is bleeding from her liver and her spleen), SPLENIC HAEMORRHAGE (She is bleeding from her liver and her spleen), RENAL FAILURE (Her kidneys are failing), CARDIAC DISORDER (She started having problems with her heart), SKIN DISCOLOURATION (Now every tissue in her body is riddled with spike proteins, her toes are turning black.), PAIN (She was in so much pain that she couldn't function), IMMUNISATION REACTION (Now every tissue in her body is riddled with spike proteins), COVID-19 (She got covid after she had the vaccines), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) in ER, (Negative) in ER and Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient was started with paxlovid on 28th and on 30th she started having severe pain. By Monday night, she was in so much pain that she couldn't function anymore. She ended up being hospitalized on Day 5 of the paxlovid. Treatment information was not reported. Company comment: This spontaneous case concerns a female patient of an unknown age, with no medical history of diabetes, who experienced the unexpected and serious (disability and medically significant) events of NEAR-DEATH EXPERIENCE, MULTIPLE ORGAN DYSFUNCTION SYNDROME, CYTOKINE STORM (AESI), HEPATIC HAEMORRHAGE, SPLENIC HAEMORRHAGE and RENAL FAILURE (AESI), among other non-serious events. The vaccination date with mRNA-1273.222 vaccine, considered as the third dose of the vaccine schedule, was not reported; hence latency could not be properly assessed. Previously she received two doses of Pfizer vaccine as the first and the second dose of the vaccine schedule (Interchange of vaccine products & Revaccination with different COVID-19 vaccine). On an unknown date she had a positive COVID-19 test, received Paxlovid and her organ problems began 2 days after receiving the medication, the co-suspect drug remains as a confounder. No further clinical information was available for medical review. Patient´s medical history of diabetes could be a confounder for renal failure. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   Reporter did not allow further contact