Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Neuropathy peripheral, Physical examination, SARS-CoV-2 test
Clinical narrative: has not been able to sleep and she started crying last night; has not been able to sleep and she started crying last night; Caller received the first dose Pfizer Covid Vaccine on 30Jan2021/received the second dose on 10Sep2021; developed a focal neuropathy behind left knee; throbbing, stabbing pain under her left knee; This is a spontaneous report from a contactable pharmacist (patient herself) from a Pfizer sponsored program. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not reported, expiration date: not reported), via an unspecified route of administration, administered in Arm Right on 10Sep2021 14:00 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization. Medical history included diagnosed with Covid-19 on 26Dec2020 and her symptom included an ear ache. On 04Jan2021 her husband was diagnosed with COVID-19 as well. There were no concomitant medications. Caller was not taking anything when received Pfizer Covid Vaccines. The patient had not received any additional vaccines on same date of the Pfizer Suspect considered as suspect. The patient did not receive any prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) received via an unspecified route of administration, administered in Arm Right on 30Jan2021 at 8:00 AM (at the age of 39 years old) for COVID-19 immunization and had lymph node swelling in right lower quadrant. The patient received the second dose of the Pfizer Covid-19 vaccine on 10Sep2021 and 12 hours later she started having complaints of a throbbing, stabbing pain under her left knee and spoke with her HCP who told her to take ASA 81mg PO (per oral). On Monday 13Sep2021, she went to her HCP where she had blood work done, d-dimer was negative, clot was ruled out, and there was no need for a doppler per HCP. HCP states that she was able to exercise and was fine during the day but when she lays down there was a constant throbbing in the middle back of her left knee area. HCP also stated that she had not been able to sleep and she started crying last night 14Sep2021 because of her complaints. HCP states that her HCP prescribed her Tegretol but she refused the medication but did start Gabapentin which makes her have complaints of constipation and drowsiness. It was reported that within 12 hours of receiving second dose, developed a focal neuropathy behind left knee: Caller states this was disabling and the caller could not sleep. Caller has never experienced anything like this. Caller had to seek out medical attention to rule out any cause, a d dimer test was done and resulted -39. Caller took 81mg Aspirin. Caller received the second dose on 10Sep2021. Caller was told not to get second dose, expected around July. Caller's son was in hospital and caller went on a vacation. Caller received second dose Pfizer Covid Vaccine on 10Sep2021. Caller clarifies the focal neuropathy behind left knee was like bells palsy. Caller started Aspirin 81mg immediately on Saturday, 11Sep2021 and on Monday 13Sep2021 caller had a physical exam and blood taken to get a d dimer test to see if caller needed more attention such as an ultra sound or doppler. The tests came back negative the same day, 13Sep2021. Caller is currently prescribed Gabapentin for this particular pain. The patient was calling for information on how to treat the adverse event. Caller is asking if there is any literature or if Pfizer can say the percentage of patients who have experienced a similar even to the patient. HCP enquired if there is information regarding complaints of focal neuropathy localized in one area after the administration of the Pfizer Covid-19 vaccine. HCP is asking how many cases have been reported of localized focal neuropathy after the administration of the Pfizer Covid-19 vaccine. The reporter assessed the event focal neuropathy behind left knee as disabling. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event "Neuropathy" due to temporal relationship. 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