Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nerve compression
Clinical narrative: Bi-Lateral ulnar nerve entrapment; Covid vaccine details: Administration date: 07Jan2021, Administration time: 10.15 AM; This is a spontaneous report received from a contactable other healthcare professional (HCP) (patient) reporting herself. This is the second of two reports. This report concerns events occurred after the second dose of BNT162B2.  A 39-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3248) via intramuscular route of administration in the left arm on 07Jan2021 10:15 (at the age of 39-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was reported as none. No prior history, no prior illness, no prior medication, no prior symptoms. There were no concomitant medications. Patient did not have Covid prior vaccination and patient did not tested Covid post vaccination. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within four weeks and did not receive any other medications in two weeks. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK5730) via intramuscular route of administration in the left arm on 21Dec2021 at 10:30 (at the age of 39-year-old) as dose 1, single for COVID-19 immunisation and experienced following events: patient started having migraine issues (no prior history), intense pain in the head, sensitive to light, blurred vision, and not able to concentrate, numbness, pins and needle sensations from the elbow to fingers, extreme temperature differences in fingers, loss of strength in arms, extreme sharp pain in both elbows on 24Dec2021 15:00. It was reported that patient received covid vaccine details: administration date: 07Jan2021, administration time: 10.15 am. The patient experienced bi-lateral ulnar nerve entrapment on 14Jan2021. The event was reported as serious with seriousness criteria of persistent/significant disability/incapacity. The event required visit to physician office. Patient was currently having ongoing bi lateral ulnar nerve entrapment symptoms. The patient underwent lab tests and procedures which included electromyogram (EMG) on 14Jun2021: normal; MRI-Cervical on 30Jul2021: normal; nerve conduction study (NCS) test on 14Jun2021: normal. No test thus far has shown any damages, all normal. The reporter considered that BNT162B2 had a causal effect to the adverse event. The patient had not recovered from bi-lateral ulnar nerve entrapment, the outcome of the other event was unknown.   Follow-up attempts are completed. No further information is expected.  Follow-up (20Sep2021): New information reported from the same contactable other HCP (patient) included: route of administration of the 1st dose of the vaccine, information about patient medical history, updated information about lab data, route of administration of the suspect vaccine dose, new serious event (bi-Lateral ulnar nerve entrapment), causality.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event (bi-lateral ulnar nerve entrapment) 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 ,Linked Report(s) : US-PFIZER INC-202101102588 Same reporter/SD, Different dose/AE