Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Renal infarct, Renal vein thrombosis, SARS-CoV-2 antibody test
Clinical narrative: renal infarct; a blood clot that killed the upper left quadrant of left kidney; anaphylaxis; This spontaneous case was reported by an other health care professional and describes the occurrence of RENAL INFARCT (renal infarct), RENAL VEIN THROMBOSIS (a blood clot that killed the upper left quadrant of left kidney) and ANAPHYLACTIC REACTION (anaphylaxis) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (patient had bad COVID, Recoverd), Anaphylaxis, Hypersensitivity reaction, Urticaria and Hay fever. Previously administered products included for Product used for unknown indication: Flu vaccine (3 days of flu symptoms) in 2012. Past adverse reactions to the above products included Flu symptoms with Flu vaccine. Concurrent medical conditions included Adhesive tape allergy (Adhesive from bandaids allergy -patient had Eczema and red postules), Latex allergy (Patient had rash, red postules), Drug allergy (Patient had migraine, light sensitivity, stomach aches, severe diarrhea), Environmental allergy (Patient had Congestion, sinus infection, sneezing, bronchitis) since 1975, Hypothyroidism since 1993 and Hypercholesteremia since 1998. Concomitant products included MONTELUKAST SODIUM and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Allergy, ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 28-Jan-2021 at 5:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021 at 5:00 PM, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant). On an unknown date, the patient experienced RENAL INFARCT (renal infarct) (seriousness criteria hospitalization and medically significant) and RENAL VEIN THROMBOSIS (a blood clot that killed the upper left quadrant of left kidney) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in September 2021 due to RENAL INFARCT. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 28-Jan-2021 at an unspecified dose and frequency. At the time of the report, RENAL INFARCT (renal infarct) and RENAL VEIN THROMBOSIS (a blood clot that killed the upper left quadrant of left kidney) outcome was unknown and ANAPHYLACTIC REACTION (anaphylaxis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RENAL INFARCT (renal infarct), RENAL VEIN THROMBOSIS (a blood clot that killed the upper left quadrant of left kidney) and ANAPHYLACTIC REACTION (anaphylaxis) to be possibly related.    This case concerns a 52 year old female patient, with medical history of hypersensitivity to Flu vaccine, drug, latex and environmental allergies, COVID-19 disease and hypercholesterolemia, who experienced serious unexpected events of renal infarct and renal vein thrombosis and also experienced expected event of anaphylactic reaction after the first dose of mRNA-1273. The event anaphylactic reaction occurred the same day after vaccination and renal infarct and renal vein thrombosis occurred 8 months after first dose of mRNA-1273. The rechallange is unknown. Patient´s history of allergies could be considered contributing factor for the event anaphylactic reaction. Patient´s medical history of COVID-19 disease remains a confounder for the event renal vein thrombosis.  Anaphylactic reaction is consistent with the current understanding of the mechanism of action of the vaccine. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Added additional serious events anaphylaxis,renal infarct, Renal vein thrombosis. On 23-Sep-2021: Vaccine facility, vaccine information, patient demographics, medical history, concomitant and treatment medications added, new event( urticaria, feeling hot) added, hospitalisation added for event renal infarct, event start date and outcome updated for anaphylaxis, pruritus and urticaria.; Sender's Comments: This case concers a 52 year old female patient, with medical history of hypersensitivity to Flu vaccine, drug, latex and environmental allergies, COVID-19 disease and hypercholesterolemia, who experienced serious unexpected events of renal infarct and renal vein thrombosis and also experienced expected event of anaphylactic reaction after the first dose of mRNA-1273. The event anaphylactic reaction occurred the same day after vaccination and renal infarct and renal vein thrombosis occurred 8 months after first dose of mRNA-1273. The rechallange is unknown. Patient´s history of allergies could be considered contributing factor for the event anaphylactic reaction. Patient´s medical history of COVID-19 disease remains a confounder for the event renal vein thrombosis.  Anaphylactic reaction is consistent with the current understanding of the mechanism of action of the vaccine. The events were considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.