Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | Unknown | — |
Mast Cell Activation Syndrome (MCAS); became disabled; Allergic reactions to covid-19 vaccine; Postural Orthostatic Tachycardia Syndrome (POTS); This spontaneous report received from a health care professional concerned a female patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. The patient's concurrent conditions included: flu, ivf, and recurring ruptured ovarian cysts. The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose and frequency not reported, administered on 2021, 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 2021, the patient experienced mast cell activation syndrome (mcas), became disabled, allergic reactions to covid-19 vaccine, and postural orthostatic tachycardia syndrome (pots). (dose series 1). It was reported that patient experienced: The patient had an allergic reaction to the vaccine, after the allergic reaction to the COVID vaccine the patient developed Mast Cell Activation Syndrome (MCAS), Postural Orthostatic Tachycardia Syndrome (POTS), food allergies, food sensitivities, allergic to makeup, allergic to hair dye, and became disabled. The action taken with janssen covid-19 vaccine was not applicable. The patient had not recovered from mast cell activation syndrome (mcas), became disabled, allergic reactions to covid-19 vaccine and postural orthostatic tachycardia syndrome (pots). This report was serious (other medically important condition).; Sender's Comments: V0- Mast cell activation syndrome , disability, Drug hypersensitivity, : Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Medical History/Concurrent Conditions: Flu; In vitro fertilization; Ovarian cyst ruptured