Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia, SARS-CoV-2 test
Clinical narrative: paralysis of arm/cannot move arm; It was like I was dead; Can not move my limbs; Lost 70 percent of my hair; I did not get my hair back to all; This is a spontaneous report received from a Nurse.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 2, single (Lot number: FJ1611) at the age of 69 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: It was high blood pressure but it is normal now; "Asthma" (ongoing); "thyroid" (ongoing). Concomitant medication(s) included: CAPTOPRIL taken for hypertension; VERAPAMIL taken for hypertension; SYNTHROID; ACCOLATE taken for asthma (ongoing). The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot/batch number: 32030BD, Patient Route of Administration: Intramuscular, Anatomical Location: Arm Right), administration date: 29Oct2021, when the patient was 69-year-old, for Covid-19 immunisation, reaction(s): "It was like I had a stroke", "I could not move my arm, my right arm; no strength in the arm at all; I dropped things; cannot raise my arm", "I could not move my arm, my right arm; no strength in the arm at all; I dropped things; cannot raise my arm". The following information was reported: ALOPECIA (non-serious) with onset Nov2021, outcome "unknown", described as "Lost 70 percent of my hair; I did not get my hair back to all"; MONOPLEGIA (medically significant), outcome "unknown", described as "paralysis of arm/cannot move arm"; ANXIETY (non-serious), outcome "unknown", described as "It was like I was dead"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Can not move my limbs". The patient underwent the following laboratory tests and procedures: Antibody test: do not have any antibodies; Blood test: do not have lupus; SARS-CoV-2 test: Negative. Clinical course: Patient lost 70 percent of her hair and that was started fallen out three days after she had the shot. Patient had everything done in the right arm. No one ever said that she was going to loose hair or that you are going to get paralysis of your arm, and patient was very concerned. Her brother said it was only temporary, she said (Name withheld) this was serious. Patient said that she could not move her limbs. It was like she was dead. This went on for like 6 months that she cannot move her arm, cannot even lift her arm without using her left arm to lift it, she had no strength. Patient wanted to see if she got any antibodies from this vaccine and came back 4 days later, nurse told her you do not have lupus and do not have any antibodies. Patient reported that she took vaccine end of the 2021 that was almost three years ago. She was 72 now, was 69 then because it was complete fall. Patient was given exercise which she could not do because she could not lift her arm. She was not given any medication. Patient  was just taking blood pressure medicine and thyroid medicine. It was high blood pressure but it was normal now. Patient was on  Verapamil and it is Extended release, ER for years. She left work since and her blood pressure has been fine. Patient' s pressure was really good now. She also had Asthma so she had to take this medication. It was called Accolate, but they have a generic now it was called Zafirlukast tablet (Not clarified if consumer is taking brand or generic, hence not captured), 20 milligrams, twice a day; Sender's Comments: Based on the information available and plausible temporal association, the causal relationship between the reported event Monoplegia  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. ,Linked Report(s) : US-PFIZER INC-202400086701 Same patient/same product, different dose/event;