Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Epistaxis
Clinical narrative: Nose bleeds; Nose bleeds was reported as worsened; This is a spontaneous report from a contactable nurse, the patient. A 79-years-old female patient received bnt162b2 (Pfizer Covid Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 04May2021 (age at vaccination: 79-years-old) (Batch/Lot Number: EWO162) as DOSE 1, SINGLE for COVID-19 immunization. Vaccine was not administered at Facility. Medical history included ongoing thyroid disorder and ongoing high blood pressure. Concomitant medications included levothyroxine sodium (SYNTHROID) at 50mg once a day, taken for thyroid disorder (Additional Information for Concomitant Products Synthroid: patient stated she used to be on Armor but it didn't seem to be working. NDC, Lot, Expiration: Unknown) from an unspecified start date and ongoing; olmesartan medoxomil (BENICAR) 5 mg, PRN (as needed) taken for high blood pressure from an unspecified start date and ongoing. Prior Vaccinations (within 4 weeks) was reported as none. AE following prior vaccinations were none (stated she had not had any vaccines as an adult, she might have as a child. Stated she never got sick or the flu). Patient had no family medical history relevant to AE. History of all previous immunization with the Pfizer vaccine and additional vaccines administered on same date of the Pfizer suspect both were reported was none. The patient used to take Armor for her Thyroid, but her thyroid levels fell so low, she had to change brands. The patient received the first vaccine on 04May2021 in her right arm because she was left-handed and she did not want to get a sore arm and a week later, she got a nosebleed (12May2021) so bad that she could not stop it, so she went to the hospital and they charged her and gave Afrin nose spray and she had to see an ENT and have her nose cauterized. Caller states she never had nose bleeds before in her life and nose bleeds was reported as worsened. Caller stated it was about 1/8 a cup of blood. The patient stated she never had a nosebleed in her life, and it scared her to death. Caller states she came home and the first thing she did was bend over and she got another one and again the next day, and Caller states last week she was trying to freeze corn and she would forget and reached down, and she had 3 nose bleeds, because she cannot bend over. Caller stated the hospital told her not to bend over. Caller stated she thought she should report it and then she never went back to get the second one because a RN advised her not to go back for it. Caller stated she cannot get into the ENT until the 29Aug2021. Caller stated she went to one doctor in (place name) and they are not familiar with the area and hate to go there and they could not find it, so they had to make another appt. Caller stated she wanted to make sure to get her haemoglobin checked after this. The patient received treatment with plastic thing that she clips on her nose and Afrin Spray, stated she must sit there and wait 15 minutes after she uses it for it to work. Reporter seriousness for Nose bleeds was medically significant. The events resulted in emergency room and physician office visit. The outcome of the events was not recovered.  Information on the lot/ batch number is available. Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Nose bleeds and Condition worsened. 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.