Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, SARS-CoV-2 test, Vomiting
Clinical narrative: Cataract; Itchy; Blood pressure high; COVID-19; Sick to stomach; threw up; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataract), PRURITUS (Itchy), HYPERTENSION (Blood pressure high), COVID-19 (COVID-19), ABDOMINAL DISCOMFORT (Sick to stomach) and VOMITING (threw up) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Abstains from alcohol, Non-smoker, Cataract operation (first) and Cataract operation (Second) on 15-Sep-2021. Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant), PRURITUS (Itchy) (seriousness criterion medically significant), HYPERTENSION (Blood pressure high) (seriousness criterion medically significant), COVID-19 (COVID-19) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Sick to stomach) (seriousness criterion medically significant) and VOMITING (threw up) (seriousness criterion medically significant). At the time of the report, CATARACT (Cataract) was resolving, PRURITUS (Itchy), HYPERTENSION (Blood pressure high) and COVID-19 (COVID-19) had resolved and ABDOMINAL DISCOMFORT (Sick to stomach) and VOMITING (threw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Over 200. On an unknown date, SARS-CoV-2 test: (Positive) Positive.         It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  Patient experienced COVID-19 symptoms included fever and chills from her second dose for 2-3 days and sore arm after first dose. Patient felt sick to her stomach, threw-up and feeling itchy everywhere.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer, concerning a 75-year-old female patient with relevant medical condition of moderate to severe chronic Psoriasis treated with Adalimumab, who experienced the unexpected serious (medically significant) events of Cataract, Pruritus, Hypertension, Abdominal discomfort, Vomiting, and unexpected serious (medically significant) adverse event of special interest COVID-19, in the context of 2 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. It was reported that the patient had sore arm after the first vaccination, and suffered from fever and chills after the second vaccination. Patient was infected with COVID-19 and experienced abdominal discomfort, vomiting, and itchiness from the unspecified infusion. Patient also noted increased in blood pressure up to over 200. No further details about the other diagnostic procedures and specified treatments were provided. The medical condition of moderate to severe chronic Psoriasis remains as a confounder for the event Pruritus, and intake of Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-633325 (Patient Link).; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 75-year-old female patient with relevant medical condition of moderate to severe chronic Psoriasis treated with Adalimumab, who experienced the unexpected serious (medically significant) events of Cataract, Pruritus, Hypertension, Abdominal discomfort, Vomiting, and unexpected serious (medically significant) adverse event of special interest COVID-19, in the context of 2 doses of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact vaccination date nor event onset date were provided. It was reported that the patient had sore arm after the first vaccination, and suffered from fever and chills after the second vaccination. Patient was infected with COVID-19 and experienced abdominal discomfort, vomiting, and itchiness from the unspecified infusion. Patient also noted increased in blood pressure up to over 200. No further details about the other diagnostic procedures and specified treatments were provided. The medical condition of moderate to severe chronic Psoriasis remains as a confounder for the event Pruritus, and intake of Adalimumab, which is an immunosuppressant, increases the susceptibility of patient to acquire COVID-19 infection. The benefit-risk relationship of mRNA-1273 is not affected by this report.