Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral coldness, Platelet count, Platelet count decreased
Clinical narrative: Lowplatelets; Chills; Cold hands and feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Cold hands and feet), PLATELET COUNT DECREASED (Lowplatelets) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PERIPHERAL COLDNESS (Cold hands and feet) and CHILLS (Chills). On an unknown date, the patient experienced PLATELET COUNT DECREASED (Lowplatelets). At the time of the report, PERIPHERAL COLDNESS (Cold hands and feet), PLATELET COUNT DECREASED (Lowplatelets) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low.         Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  On an unknown date, the patient experienced low platelets. In 2021, the patient experienced chills with cold hands and feet. Patient relayed that the day following her covid-19 vaccine, she had chills. States that she had continued to have chills as well cold hands and feet. She thought it was due to Covid-19 vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  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. A 54-year-old female patient, in treatment with RISANKIZUMAB for Plaque psoriasis, completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of platelet count decreased (AESI). Onset date of the event was not provided, latency cannot be assessed. In addition, patient stated that the day following her Covid-19 vaccine, she had chills and that she continued to have chills as well as cold hands and feet. She thought it was due to Covid-19 vaccine, discussion with physician stated this could also be a side effect of RISANKIZUMAB. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 54-year-old female patient, in treatment with RISANKIZUMAB for Plaque psoriasis, completed a two-dose primary series of mRNA-1273 vaccine and experienced non serious event of platelet count decreased (AESI). Onset date of the event was not provided, latency cannot be assessed. In addition, patient stated that the day following her Covid-19 vaccine, she had chills and that she continued to have chills as well as cold hands and feet. She thought it was due to Covid-19 vaccine, discussion with physician stated this could also be a side effect of RISANKIZUMAB. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.