Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Fatigue, Inappropriate schedule of product administration, Intracranial aneurysm, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 08Sep2021 (Lot number: B4A30130) at the age of 72 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Head" (unspecified if ongoing); "cataract surgery" (unspecified if ongoing); "High cholesterol" (ongoing); "High Blood Pressure" (ongoing); "Cataracts", start date: 2018 (ongoing), notes: Patient had the cataracts before the vaccine, in 2018.; "Macular Edema", start date: Jul2019 (unspecified if ongoing); "Hemorrhage", start date: 2020 (unspecified if ongoing), notes: the hemorrhage in 2020 when she felt uncomfortableness in the left eye; "Benign Tumor on Colon", start date: 2017 (ongoing), notes: Patient was hospitalized for one night for pain on her colon.; "eye injections" (unspecified if ongoing), notes: Had eye injections between 2020 and 2021, began before she had the 1st Pfizer Covid vaccine. Concomitant medication(s) included: TOPAMAX taken for headache (ongoing). Vaccination history included: Bnt162b2 (First Dose: 06Mar2021 Lot: IN6199), administration date: 06Mar2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "pain on her colon where she was not able to move correctly or well", "vision is impaired". The following information was reported: INTRACRANIAL ANEURYSM (medically significant) with onset 20Jan2022, outcome "unknown", described as "actual cerebral atrophy Berry aneurism"; RETINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "bleeding on her retina"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 08Sep2021, outcome "unknown", described as "Second dose 08Sep2021"; ACCIDENT (non-serious) with onset 20Jan2022, outcome "recovering", described as "having been in an accident"; FATIGUE (non-serious) with onset 20Jan2022, outcome "unknown", described as "very tired"; NASOPHARYNGITIS (non-serious) with onset 20Jan2022, outcome "unknown", described as "she was very cold"; CHILLS (non-serious) with onset 20Jan2022, outcome "unknown", described as "shivering"; SOMNOLENCE (non-serious) with onset 20Jan2022, outcome "unknown", described as "she slept and woke up the next day"; VISUAL IMPAIRMENT (non-serious) with onset 20Jan2022, outcome "recovering", described as "she felt like she couldn't see, her whole line of vision was dark, bad, low vision, and she was more blind"; BOWEL MOVEMENT IRREGULARITY (non-serious) with onset 20Jan2022, outcome "unknown", described as "effected her bowel movements"; EATING DISORDER (non-serious) with onset 20Jan2022, outcome "unknown", described as "only eats once a day"; DIZZINESS (non-serious) with onset 20Jan2022, outcome "unknown", described as "dizzy"; MEMORY IMPAIRMENT (non-serious) with onset 20Jan2022, outcome "unknown", described as "she can't remember what to eat". The patient underwent the following laboratory tests and procedures: colonoscopy: (2017) benign tumor, notes: benign tumor was diagnosed in 2017 during a colonoscopy; magnetic resonance imaging: (20Jan2022) actual cerebral atrophy berry aneurism, notes: I got an MRI and result was actual cerebral atrophy Berry aneurism it used to be 3 mm. Therapeutic measures were taken as a result of intracranial aneurysm, accident, bowel movement irregularity. Clinical course: Patient stated she had two Pfizer COVID-19 vaccine, vaccines last one in Sep of last year, since they said 6 months later, she can get the booster. As of now, she had not taken it yet. she was supposed to get it in Mar2022. She was asking should she get it. She was supposed to have surgery where she had an accident. The accident was 20Jan on her head. She got an MRI and result was actual cerebral atrophy Berry aneurism it used to be 3 mm. not sure how big it was now. She was due for angiography of her brain. The last COVID 19 vaccine she had was in September of last year. She asked was that okay to get the booster after the accident before the cataract surgery. She was worried after the accident about what the effect of the booster shot would be and how safe it would be. Previous to that she already had several eye injections between 2020 and 2021, in between that she also had those Pfizer COVID vaccines. But the injections began before the first COVID-19 vaccine. Transferring agent stated her 1st dose of the Pfizer COVID vaccine was on 06Mar2021 and she was not sure of the lot number because stated her vision was impaired and the lot was IN6199 and said she was not sure of that because her vision was impaired, caller stated for her 2nd dose of the Pfizer COVID vaccine, the lot was either B or the number 4 or the letter A and then 30130 and was administered on 08Sep2021. Dates for second dose was greater than 4 weeks after her first dose. Patient stated she also had an issue with a benign tumor on her colon. She was hospitalized for one night for pain on her colon where she was not able to move correctly or well. She stated that why she postponed the second one. She was told after the second one that she had to wait 6 months later, until Mar for the Booster. The benign tumor was diagnosed in 2017 during a colonoscopy. Before she was working in a store, but then she couldn't go back to work and she went to the doctor and told them she had the pain and they recommended her to see a gastroenterologist. The pain started on 07Mar2021 and she was hospitalized from 07Mar2021 to 08Mar2021 and she recovered on 09Mar2021. Patient stated in the meantime they recommended she wait until later for the Booster dose because of her cataract surgery. She will have to have surgery on a cataract for macular edema on her eye and they also recommended removing the cataract. She was delayed in taking the second vaccine because she was having injections in her eye and she had hemorrhage in her left eye. Clarified that it started before the vaccine in Jul2019, and the hemorrhage in 2020 when she felt uncomfortableness in the left eye. Said she should have injections. She had bleeding on her retina in Oct2020 until late Oct2021. She had the cataracts before the vaccine, they started in 2018 but they refused to remove them then, said doesn't think could remove it yet. Then when she had the accident and had bleeding in the eye, one of the doctors said she had cataracts and they needed removed. Accident, cerebral atrophy AE Details: Patient stated she was confused and in a hurry after getting groceries and she got very tired in her bedroom and there was a chair in front of her but she didn't know if she was looking at the chair and she hit her head and felt like she was going to be unconscious and she couldn't get up for 4 hours. There was a knock on the door and it was the RN so she opened the door and let her in and she got her back in the recliner. That occurred on 20Jan2022. She was very cold and wrapped her head in a heating pad because she was shivering and she slept and woke up the next day and she felt like she couldn't see, her whole line of vision was dark, bad, low vision, and she was more blind. Stated with the help of her RN she was improving but it was still ongoing. It had affected her bowel movements and taking in water and she sleeps all the time, and only eats once a day and she was dizzy all of the time. She can't remember what to eat.