Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash pruritic, Spinal pain, Vaccination site swelling
Clinical narrative: felt like spine was being crushed; severe lymphatic swelling in axilla, chest, back and left breast; fever > 102F with tylenol for over 48 h then remained > 100F for 3 days; debilitating extreme pain in every cell for 24 hours; migraine; sores in mouth; lethargy; lt arm swollen hot, red itchy for a week and a half; lt arm swollen hot, red itchy for a week and a half; This is a spontaneous report received from a contactable other health care professional. A 50-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6206) via intramuscularly in left arm on 19May2021 07:45 (age at vaccination 50year old) as single dose for covid-19 immunization. Medical history included hypertension, Hypothyroid, High blood sugar TB test from an un-known date and unknown if ongoing.  Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included hctz (HCTZ), metformin (METFORMIN); levothyroxine sodium (SYNTHROID); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); olmesartan medoxomil (BENICAR). For all these concomitant products start and stop date and indication were not reported. The patient previously received first dose of BNT162B2 (Lot: EN6199) on 28Apr2021 09:00 AM (age at vaccination 50year old), via intramuscularly, in left arm for covid-19 immunisation. Historical vaccination include flu shot, and patient had history of receiving seldane for unspecified indication. Patient doent had covid prior vaccination and had not tested positive to covid post vaccination. The patient experienced felt like spine was being crushed, severe lymphatic swelling in axilla, chest, back and left breast, fever > 102f with tylenol for over 48 h then remained > 100f for 3 days, debilitating extreme pain in every cell for 24 hours, migraine, sores in mouth, lethargy, lt arm swollen hot, red itchy for a week and a half on 19May2021 19:15. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included body temperature resulted as 102 on 19May2021. The clinical outcome of the events recovered with sequelae on unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded   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.