Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | Unknown | — |
unspecified mass; body does not work the same; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported. On an unspecified date, the patient experienced unspecified mass and body does not work the same. (dose series 1). The doctors found a mass in my body, and know have to get it removed. Patient do not have the money to get it removed because patient was not working . Ever sense patient got the Covid-19 vaccine, body does not work the same. They are not looking for money, just for someone to help with this. The action taken with janssen covid-19 vaccine was not applicable. The outcome of unspecified mass and body does not work the same was not reported. This report was associated with a product quality complaint: Product Complaint 90000351091. This report was serious (other medically important condition).; Sender's Comments: V0: Mass. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.