Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Extra dose administered, Haemorrhage, Off label use
Clinical narrative: epistaxis; Third (Booster) Dose of the Pfizer Covid 19 Vaccine: Given on 19 Aug 2021; Third (Booster) Dose of the Pfizer Covid 19 Vaccine: Given on 19 Aug 2021; Had very severe bleeds 3-5 days after each vaccine; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FC3180 and expiration date was not reported), via intramuscular route of administration in Arm left on 19Aug2021 (Age at vaccination was 71 years) as dose 3, single for covid-19 immunization. Medical history included ongoing hereditary haemorrhagic telangiectasia , thyroid from an unknown date and unknown if ongoing. Concomitant medication(s) included tamoxifen (TAMOXIFEN) taken for epistaxis from 2018 and ongoing, patient has been on this medication for about 4 years; levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for thyroid disorder from an unspecified start date and ongoing. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL8982 and expiration date was not reported), via intramuscular route of administration, in Arm Left on 15Jan2021 as dose 1, single for COVID-19 immunization, epistaxis, sore arm, headache, Blood pressure was 60/32 and severe nosebleed. Patient also received (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number EL9269 and expiration date was not reported), via intramuscular route of administration, Arm Left on 05Feb2021 as dose 2, single for COVID-19 immunization, epistaxis and severe nosebleed.  On 22Aug2021 the patient experienced epistaxis, On 19Aug2021 third (booster) dose of the pfizer covid 19 vaccine: given on 19Aug2021, third (booster) dose of the pfizer COVID 19 vaccine: given on 19 aug 2021. The Sunday after her booster dose of the vaccine, she previously had the other two doses of the vaccine. Patient mentioned she had side effects after all three doses. Transferring agent states that when she was reading safety information to the caller and got to the part about blood thinners the caller stopped her and asked about that part. Patient states that she had a rare blood vessel disease called Hereditary Hemorrhagic Telangiectasia (HHT). Patient states that HHT causes nose bleed because the blood vessels in the nose are deformed so they break and bleed. Patient states that after each vaccine she had nosebleeds. Since she gets them all the time she did not think anything of it. Side effects from HHT is severe nosebleed. Had very severe bleeds 3-5 days after each vaccine. First one I could not stop and was hospitalized. Tamoxifen helps make the nosebleed less severe, but it seems not to work after the vaccines for a few days. The patient did not perform relevant test. Therapeutic measures were taken as a result of epistaxis. The patient was recovered from epistaxis on unspecified date in Aug 2021 and Had very severe bleeds 3-5 days after each vaccine was not recovered and outcome of rest of all events was unknown.    Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.    Follow-up (13Sep2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to Non-HCP follow up letter sent which included that: Patient medical history, past drug events, concomitants, suspect and historical vaccine route and anatomical locations and new event updated.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100936 Same patient, different vaccine dose, similar events