Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Globulin, Henoch-Schonlein purpura, Herpes simplex test, Procalcitonin, Red blood cell sedimentation rate
Clinical narrative: IgA vasculitis; This literature-non-study case was reported in a literature article and describes the occurrence of HENOCH-SCHONLEIN PURPURA (IgA vasculitis) in a 38-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HENOCH-SCHONLEIN PURPURA (IgA vasculitis) (seriousness criteria hospitalization and medically significant). The patient was treated with KETOROLAC (intravenous) at a dose of 30 milligram; MAGNESIUM SULFATE (intravenous) at a dose of 2 gram; NORMAL SALINE (iv bolus) at a dose of 1 liter; ACETAMINOPHEN for Fever and Chills, at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, HENOCH-SCHONLEIN PURPURA (IgA vasculitis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: Negative. On an unknown date, Blood creatinine: 0.41 mg/dl. On an unknown date, Blood immunoglobulin A (47-310 mg/dl): 418 mg/dl elevated, upon follow up 3 weeks after vaccination. On an unknown date, C-reactive protein: elevated at 19.7 mg/L and elevated at 23.8 mg/L. On an unknown date, Double stranded DNA antibody: Negative. On an unknown date, Globulin: 3.9 gram per decilitre elevated. On an unknown date, Herpes simplex test: Negative. On an unknown date, Procalcitonin: Negative. On an unknown date, Red blood cell sedimentation rate: 50 mm/hr elevated. On an unknown date, Rheumatoid factor (0-14 international unit per millilitre): 25.4 international unit per millilitre. On an unknown date, Urine analysis: showed 20/high power field (HPF) red blood cells, 20/HPF white blood cells, and negative protein. On an unknown date, Varicella virus test: Negative.     mRNA-1273 (Spikevax) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered HENOCH-SCHONLEIN PURPURA (IgA vasculitis) to be related.    No Concomitant medications were reported.  Patient was in good health who developed a pruritic, purpuric, maculopapular rash associated with fever, chills, headache, diarrhea, abdominal pain, and a burning skin sensation shortly after being vaccinated for COVID-19 with an initial dose of the Moderna mRNA vaccine. Clinical manifestations and laboratory findings were consistent with a diagnosis of immunoglobulin A (IgA) vasculitis.   Patient had no known history of previous vaccination reactions. On day 1 after vaccination, she exhibited flu-like constitutional symptoms known to that of COVID- 19 vaccination. Her symptoms included fever, chills, headache, diarrhea, and abdominal pain. Because of the severity of her illness, she presented to the emergency department that afternoon. After evaluation, the patient was given ketorolac, magnesium sulfate, and 1 liter of normal saline bolus. After this, she improved, her vital signs stabilized, and she was discharged to home. Later that evening, she developed fever and chills, which resolved with over-the-counter acetaminophen.   On the fourth day after vaccination, she developed a diffuse, painful burning sensation throughout her skin that disturbed her sleep. She noticed a rash, which began on areas of pressure, such as the lower abdomen and pubic region along her waistline, that became pruritic and eventually appeared on her extremities. Her symptoms progressively worsened, for which she presented to the ED late on the seventh day after vaccination. The infectious disease service was consulted, and after evaluation, she received diphenhydramine, which helped with her symptoms, but not with the rash appearance. The patient neither had any recent travel history nor any known exposure to dust mites, bed bugs, or other infestations.  Company Comment: This is a literature non-study case concerning a 38-year-old, female patient with no medical history reported, who experienced the unexpected serious event (due to medically significant and hospitalization) Henoch-Schonlein purpura (reported as IgA vasculitis). The event occurred one day after receiving the first dose of mRNA-1273 vaccine (vaccination date and event date were not reported). Patient had no known history of previous vaccination reactions. On day 1 after vaccination, she exhibited flu-like constitutional symptoms known to that of COVID- 19 vaccination. Her symptoms included fever, chills, headache, diarrhea, and abdominal pain. Because of the severity of her illness, she presented to the emergency department that afternoon. After evaluation, the patient was given ketorolac, magnesium sulfate, and 1 liter of normal saline bolus. After this, she improved, her vital signs stabilized, and she was discharged to home. Later that evening, she developed fever and chills, which resolved with over-the-counter acetaminophen. On the fourth day after vaccination, she developed a diffuse, painful burning sensation throughout her skin that disturbed her sleep. She noticed a rash, which began on areas of pressure, such as the lower abdomen and pubic region along her waistline, that became pruritic and eventually appeared on her extremities. Her symptoms progressively worsened, for which she presented to the ED late on the seventh day after vaccination. The infectious disease service was consulted, and after evaluation, she received diphenhydramine, which helped with her symptoms, but not with the rash appearance. The patient neither had any recent travel history nor any known exposure to dust mites, bed bugs, or other infestations. In addition, she did not receive any other medications before developing the rash. Relevant diagnostic tests included Blood creatinine of 0.41 mg/dl (no reference ranges were provided), elevated Blood immunoglobulin A of 418 mg/dl upon follow up 3 weeks after vaccination (reference range 47-310 mg/dl), elevated C-reactive protein of 19.7 mg/L (at hospitalization) and 23.8 mg/L upon follow up 3 weeks after vaccination (no reference ranges were provided), elevated Globulin of 3.9 g/dL (no reference ranges were provided), elevated red blood cell sedimentation rate of 50 mm/hour (no reference ranges were provided) and elevated Rheumatoid factor of 25.4 IU/mL (reference ranges 0-14.0 IU/mL). Urine analysis showed 20/high power field (HPF) red blood cells, 20/HPF white blood cells, and negative protein (no reference ranges were provided). Antinuclear antibody, Double stranded DNA antibody, Herpes simplex virus 1 & 2 tests, Procalcitonin and Varicella Zoster virus test resulted Negative. Patient declined any additional vaccination doses because of the extent of her reaction to the first dose. The patient was treated with ketorolac, magnesium sulfate, normal saline, acetaminophen, diphenhydramine and prednisone. At the time of the report, the event was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2023: Live Follow up received by safety on 26-May-2023 has Email and Article propagated contains significant information: Reporter information, citation details, patients details, lab data, action taken and I narrative added.