Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Submaxillary gland enlargement, Thrombosis
Clinical narrative: left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swollen submandibular gland that got bigger/could feel her mouth getting bigger; ill with something not related to the vaccine; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included stroke on 2007, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) taken for stroke from 2007 to an unspecified stop date; and acetylsalicylic acid (ASPIRIN (E.C.)) taken for stroke from 2007 to an unspecified stop date. The next day on 04Mar2021, the patient had a swollen submandibular gland that got bigger. She could feel her mouth getting bigger. The patient was admitted into the hospital on 07Mar2021 and released on 09Mar2021. She was readmitted to the hospital on 11Mar2021 until 18Mar2021. The patient went back into the hospital on 21Mar2021 and released 20Apr2021. The gland was removed on 13Apr2021. She developed a blood clot. She went to the emergency room and was sent home on Xarelto. The patient mentioned that she received the 1st dose of the vaccine on 03Mar2021 and came down ill with something not related to the vaccine. She was hospitalized for 4 weeks and ended up missing her 2nd dose appointment on 24/Mar/2021. She would like to get her 2nd dose but she is now 5 weeks overdue for it. She mentioned the hospital is recommending that she restart her vaccination. She is looking for guidance from Pfizer. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent had CT and MRI of left arm/wrist which she does not have results to provide. Event relatedness to vaccine was unknown for events, swollen submandibular gland that got bigger, left hand was edematous and cold, left hand pain and blood clot. The outcome of the event blood clot swollen submandibular gland was recovered with sequel on unspecified date, the outcome of ill feeling was unknown and the outcome of the rest of the events was recovering.; Sender's Comments: The 67-year-old female patient had medical history of stroke.  Based on information available, the reported thrombosis and other events were unlikely related to the vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). This case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.