Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Hyperhidrosis, Injection site haemorrhage, Injection site nodule, Muscular weakness, Nasopharyngitis
Clinical narrative: sweating; weakness muscle; psoriasis flare-up; injection site nodule; injection site bleeding; cold; rash; fever; This spontaneous case was reported by a physician and describes the occurrence of HYPERHIDROSIS (sweating), MUSCULAR WEAKNESS (weakness muscle), PSORIASIS (psoriasis flare-up), INJECTION SITE NODULE (injection site nodule), INJECTION SITE HAEMORRHAGE (injection site bleeding), NASOPHARYNGITIS (cold), RASH (rash) and PYREXIA (fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    Concomitant products included TESTOSTERONE for an unknown indication.   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) (unknown route) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion hospitalization prolonged), MUSCULAR WEAKNESS (weakness muscle) (seriousness criterion hospitalization prolonged), PSORIASIS (psoriasis flare-up) (seriousness criterion hospitalization prolonged), INJECTION SITE NODULE (injection site nodule) (seriousness criterion hospitalization prolonged), INJECTION SITE HAEMORRHAGE (injection site bleeding) (seriousness criterion hospitalization prolonged), NASOPHARYNGITIS (cold) (seriousness criterion hospitalization prolonged), RASH (rash) (seriousness criterion hospitalization prolonged) and PYREXIA (fever) (seriousness criterion hospitalization prolonged). At the time of the report, HYPERHIDROSIS (sweating), MUSCULAR WEAKNESS (weakness muscle), PSORIASIS (psoriasis flare-up), INJECTION SITE NODULE (injection site nodule), INJECTION SITE HAEMORRHAGE (injection site bleeding), NASOPHARYNGITIS (cold), RASH (rash) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided.  Company Comment : This case concerns a 64-year-old male hospitalized with a serious unexpected event of hyperhidrosis, muscular weakness, psoriasis, injection site nodule, injection site haemorrhage, nasopharyngitis, rash and pyrexia. Event onset with unknown latency after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 64-year-old male hospitalized with a serious unexpected event of hyperhidrosis, muscular weakness, psoriasis, injection site nodule, injection site haemorrhage, nasopharyngitis, rash and pyrexia. Event onset with unknown latency after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.