Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Dysphagia, Gait disturbance, Lymphadenopathy, Pain in extremity
Clinical narrative: level 9 out of 10 pain in spine making it difficult to walk; 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks; pain in arm; burning in stomach; difficulty swallowing; fever greater than 103,; Swollen lymph node around neck, difficulty swallowing, burning in stomach, fever greater than 103, level 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks and disappeared, pain in; This is a spontaneous report from a contactable other health care professional. A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unknown), via intramuscular, administered in left arm on 03Mar2021 at 10:30 am (at the age of 42-year-old) as single dose for COVID-19 immunization in hospital. The patient medical history includes Post stage 4 breast cancer, autoimmune disease, many surgeries from breast cancer 10 plus years ago, Laminectomy L4-5 >10 years. Allergies to medications, food or other products was reported as yes, but details are not reported. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in right arm on 10Feb2021 10:30 as single dose for COVID-19 immunisation. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 03Mar2021 16:00, the patient experienced Swollen lymph node around neck, difficulty swallowing, burning in stomach, fever greater than 103, level 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks and disappeared, pain in arm less than 48 hours. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given with Tordol shot and medications for severe spams of spine and back. The events assessed as serious. The patient underwent lab tests and procedures which included body temperature (pyrexia): greater than 103 on 03Mar2021. The outcome of all events was resolved.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of Gait disturbance, Spinal pain and Pain in arm cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes 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.