Sex: U
Vaccine: COVID19, UNK
Symptoms: Antibody test, Cold urticaria, Hypersensitivity, Pruritus, SARS-CoV-2 antibody test negative
Clinical narrative: No antibodies present; Allergies have intensified; Urticaria with itching, on exposed parts and after exposure to cold; Itching on exposed parts and after exposure to cold/ Urticaria with itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (No antibodies present), HYPERSENSITIVITY (Allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (Itching on exposed parts and after exposure to cold/ Urticaria with itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In January 2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 mg once a day. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (No antibodies present), HYPERSENSITIVITY (Allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (Itching on exposed parts and after exposure to cold/ Urticaria with itching). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (No antibodies present), HYPERSENSITIVITY (Allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (Itching on exposed parts and after exposure to cold/ Urticaria with itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) None was present..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was reported. The Batch number for the suspect product is unknown. Action taken with mRNA-1273 in response to the event was not applicable. Patient stated not wanting to take any chances so got the moderna vaccine due being susceptible to flu and pneumonia.  Very limited information regarding these events has been provided at this time.  However, the date of vaccine administration and the date for the reported events are required for further evaluation. The causality for the event COVID-19 antibody test negative is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28 May 2021 included no new information On 15-Jun-2021: Follow up received on 15-Jun-2021 included additional events of Hypersensitivity, Urticaria, Pruritus and Nasopharyngitis, events outcome.; Sender's Comments: Very limited information regarding these events has been provided at this time.  However, the date of vaccine administration and the date for the reported events are required for further evaluation. The causaity for the event COVID-19 antibody test negative is assessed as not applicable.