Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Injection site erythema, Injection site pain, Injection site pruritus, SARS-CoV-2 test
Clinical narrative: Positive for COVID; Injection site was sore, red and itchy; Injection site was sore, red and itchy; Injection site was sore, red and itchy; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    Concurrent medical conditions included Panuveitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. In April 2022, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID) (seriousness criterion hospitalization). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site was sore, red and itchy), INJECTION SITE PRURITUS (Injection site was sore, red and itchy) and INJECTION SITE ERYTHEMA (Injection site was sore, red and itchy). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID) outcome was unknown and INJECTION SITE PAIN (Injection site was sore, red and itchy), INJECTION SITE PRURITUS (Injection site was sore, red and itchy) and INJECTION SITE ERYTHEMA (Injection site was sore, red and itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood pressure measurement: elevated Elevated blood pressure.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information mentioned.  On an unknown date, patient experienced increased blood pressure and noted that the injection site was red, hot and itchy. In APR2022, patient got a positive COVID-19 test. The injection site recovered from events later on an unknown date.  Causality for co-suspect Humira was provided as no reasonable possibility for events of COVID and elevated blood pressure, and possibility for injection site red, hot and itchy.  Company comment  This is a spontaneous case concerning a 70 year old female patient, with medical history of Panuveitis, who experienced the unexpected, serious (Hospitalization) event of SARS-CoV-2 test positive (Positive for COVID) unknown days after receiving an unspecified dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events, on an unknown date. In April 2022, SARS-CoV-2 test was positive. Patient had elevated blood pressure on an unknown date. Patient was using Adalimumab (HUMIRA) for Panuveitis. No information was provided regarding the comorbidities, risk factors, symptoms, clinical course, labs, diagnostic procedures, and treatment details. The outcome of the event was unknown. Advanced age of the subject, use of Adalimumab are risk factors. Ongoing Covid 19 pandemia is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70 year old female patient, with medical history of Panuveitis, who experienced the unexpected, serious (Hospitalization) event of SARS-CoV-2 test positive (Positive for COVID) unknown days after receiving an unspecified dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events, on an unknown date. In April 2022, SARS-CoV-2 test was positive. Patient had elevated blood pressure on an unknown date. Patient was using Adalimumab (HUMIRA) for Panuveitis. No information was provided regarding the comorbidities, risk factors, symptoms, clinical course, labs, diagnostic procedures, and treatment details. The outcome of the event was unknown. Advanced age of the subject, use of Adalimumab are risk factors. Ongoing Covid 19 pandemia is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.