Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Chest pain, Drug ineffective, Electrocardiogram
Clinical narrative: COVID-19; COVID-19; Chest pain; GENZYME SUPPORT SERVICES CARE COORDINATION  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2021SA010295 (Sanofi).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2022 as dose 1, single (Batch/Lot number: unknown) at the age of 31 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "kidney disease" (unspecified if ongoing); "Fabry disease" (unspecified if ongoing); "former smoker" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; MONTELUKAST; FABRAZYME intravenous taken for fabry's disease, start date: 04Sep2014. The following information was reported: CHEST PAIN (hospitalization) with onset 23Feb2022, outcome "recovered"; DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown", COVID-19 (hospitalization, medically significant), outcome "recovered" and all described as "COVID-19". The events "covid-19", "drug ineffective" and "chest pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: Normal; Electrocardiogram: Normal; SARS-CoV-2 test: Negative, notes: Did not have Covid-19 at time of vaccination.  Clinical course was reported as following: Patient started having chest pain a few hours later after vaccination. The action taken for agalsidase beta was dosage permanently withdrawn. It was unknown whether 0.2 micron inline filter was used during infusion of agalsidase beta and whether patient received infusion in home setting, Latest date of Infusion was not reported. On an unknown date, after an unknown latency, patient experienced Covid (Covid-19). On 28Jan2022 dosage was changed to 90 mg QOW.  It didn't subside so patient went to urgent Care. They sent patient to the emergency room. Patient cleared a good bill of health. Corrective treatment was not reported for both events. The patient did not have a positive test for SARS-CoV2, the patient was not admitted to an intensive care unit and the patient was still not hospitalized. The patient did not display clinical signs at rest indicative of severe systemic illness and the patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The patient did not have any mutli-organ failure. The event did not require the initiation of new medication or other treatment or procedure. The patient did not have COVID-19 at time of vaccination reaction. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination.  The reporter considered "covid-19" and "chest pain" not related to BNT162b2 and Company causality was not reportable for both events  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow up (09May2022): This is a solicited Follow-up report received from a contactable Physician. This Physician reported in response to HCP letter sent that included: Updated information included: New reporter, relevant medical history, lab data, concomitant drug (dose, frequency), event details (seriousness-hospitalized, emergency room details) and clinical course including additional information were added.; Sender's Comments: Based on the current available information, a casual association between the suspect product BNT162B2 and the reported events drug ineffective, covid-19, and chest pain was assessed as unrelated.