Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G increased, Vaccination site bruising, Vaccination site discolouration
Clinical narrative: Post vaccination, she had developed a black spot; bruising were the injection was administered.; Caller had an IGg antibody test done on May 12, 2021 and got the result as 328.0 mL, and normal range is indicated as 0-14.; This is a spontaneous report received from a contactable consumer(patient). A 58-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown; Expiration Date: unknown), dose 2 via an unspecified route of administration on 17Apr2021 (at the age of 58-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included multiple sclerosis since about 2014. Concomitant medication was Copaxone injection for her multiple sclerosis. Post vaccination, Patient developed a black spot and bruising were the injection was administered. on 12May2021 , an IGg antibody test done and got the result as 328.0 mL, and normal range was indicated as 0-14. Patient wanted to know what the result meant and was it normal. Patient wanted to check if there were any known or reported cases of the appearance of the black spot and/or bruising. Caller may also not be certain as to which Injection product (Copaxone or Pfizer COVID19 vaccine) will the bruising be attributed to. She also would like to know if there were any concomitant interaction between this products following the bruising. No prescribing information was gathered. Copaxone as to general pharmacy knowledge may consider this as a drug that is used as immunosuppressant therapy for multiple sclerosis patients, CONS-use in immunosuppressed patients. Caller mentioned that she read on the internet that Pfizer was currently studying a vaccine/drug therapy specific for Multiple Sclerosis and would like to confirm and gain more information about this. Patient asked that why did she get a negative antibody test after being fully vaccinated. Antibody tests currently authorized are not authorized for the assessment of immune response in vaccinated people. Consumer Inquiry Management (Off-Label or No Info) stated that there was no information about a possible interaction between the two drug products and also used to state that there was no specific information found on PI regarding bruising as side effect, other than injection site redness, swelling and pain. Patient clarified that she meant she gave herself copaxone injection after receiving the vaccine and developed a black spot where the copaxone was given. Patient reported to the black spot as what sounded like hematoma. Caller clarified that she did not have COVID19 per her previous statement that she got COVID19. Caller was referring to vaccine. Caller was referring to vaccine. Caller stated regarding side effects, she did not know about side effects, but after she got the injection in her stomach, she did it every day - she did the copaxone - in the same place, and she got a black spot like. Caller added she was not sure if this was a side effect after the vaccine or some injection. Caller wanted to know if Pfizer knows.Reporter could not specify seriousness of events.The outcome of the events was reported as unknown for all the events.  Follow up attempts are completed. No further information is expected.