Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blepharospasm, Colitis ulcerative, Disease recurrence, Dizziness
Clinical narrative: ulcerative colitis; Caller stated she had hives after her vaccine/she also had hives on 10Jul on her right leg and on 15Jul on her right arm; She was diagnosed with shingles on 04Jul2021; she has a history of shingles and has had 2 shingles vaccines in her past.; Intensive back pain, lower back pain; Eye twitching; eye sensitivity; lightheaded/dizzy; feeling hungover; She also reported feeling facial numbness "felt like novocain in my jaw" for a few minutes after the vaccine.; This is a spontaneous report from a contactable (patient) nurse.  A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 12Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included shingles from an unknown date. The patient's concomitant medications were not reported. Historical vaccine information included shingles vaccines for immunisation and ended up with rash. Caller states she has a history of shingles and has had 2 shingles vaccines in her past. They were, actually years ago, years ago. They were not new. They were shingles vaccines. The patient experienced ulcerative colitis on an unspecified date, caller stated she had hives after her vaccine/she also had hives on 10jul on her right leg and on 15jul on her right arm on 10Jul2021, she was diagnosed with shingles on 04jul2021 on 04Jul2021, lightheaded/dizzy, feeling hungover on 14Jun2021, she also reported feeling facial numbness "felt like novocain in my jaw" for a few minutes after the vaccine on 12Jun2021, eye twitching (blepharospasm) (non-serious) on 18Jun2021 with outcome of recovered , eye sensitivity on 16Jun2021, intensive back pain, lower back pain on 19Jun2021. It was reported, Caller was a 48 y/o female.Caller states she has a history of shingles and has had 2 shingles vaccines in her past. She has taken shingles medication which has caused her to develop ulcerative colitis. Caller states she received her first Pfizer Covid vaccine dose on 12Jun2021. She was diagnosed with shingles on 04Jul2021. She states she also had hives on 10Jul on her right leg and on 15Jul on her right arm. She reports that after the first dose she felt lightheaded, dizzy, and hungover. She states she had eye sensitivity on 16Jun2021 and eye twitching on 18Jun2021, which have resolved. She also reported feeling facial numbness "felt like novocain in my jaw' for a few minutes after the vaccine. Caller wants to know if there was a connection between her shingles diagnosis and the vaccine. another fact was patient had 2 shingles vaccine and 2, 2 shingles vaccine and the one was 1 shot and the other one was 3 and she ended up with rash and expect it to be better. Therapeutic measures were taken as a result of she was diagnosed with shingles on 04jul2021. The seriousness for event ulcerative colitis was medically significant. The outcome for event Eye twitching and eye sensitivity was recovered on an unknown date in 2021 while rest were unknown.; Sender's Comments: The event of Ulcerative colitis is assessed as possibly related to the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) based on temporal association, but consider also possible contributory effects from patient's medical history  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.