Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Weight, Weight decreased
Clinical narrative: I started to throw in blood; My arm still feels a little bit swelling from the vaccine; it is still swollen; Fever; Then my liver, it started giving more problems; my muscular fascia, growing more bones in my muscular fascia /I have over grown bones in my mouth and I am 'feeling' them; The time I got the shot, I was 180 lbs. now I am 145 lbs; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 2, single (Lot number: EK9231, Expiration Date: Apr2021) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "I had diabetes, like a 700 last year and they put me on multiple medications" (not ongoing); "I already had a fatty liver" (unspecified if ongoing). Concomitant medication(s) included: CARVEDILOL taken for hypertension; LEVOTHYROXINE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EH9899, Anatomical Location: Arm Left), administration date: 21Dec2020, for COVID-19 Immunization, reaction(s): "felt like she had a stroke", "left leg not functioning normally", "fell down", "Pain in leg", "I started to throw in blood", "itchiness in her head", "My arm still feels a little bit swelling from the vaccine; it is still swollen", "fever", "my liver, it started giving more problems", "my muscular fascia, growing more bones in my muscular fascia /I have over grown bones in my mouth and I am 'feeling' them", "The time I got the shot, I was 180 lbs. now I am 145 lbs"; Flu vaccine (I had the flu vaccine, Flu vaccine before the pandemic), for influenza immunization. The following information was reported: HEMATEMESIS (medically significant), outcome "unknown", described as "I started to throw in blood"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "My arm still feels a little bit swelling from the vaccine; it is still swollen"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; LIVER DISORDER (non-serious), outcome "recovered", described as "Then my liver, it started giving more problems"; BONE DISORDER (non-serious), outcome "unknown", described as "my muscular fascia, growing more bones in my muscular fascia /I have over grown bones in my mouth and I am 'feeling' them"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "The time I got the shot, I was 180 lbs. now I am 145 lbs". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2020) Negative; Weight: (unspecified date) 180 lbs, notes: The time I got the shot, I was 180 lbs; (unspecified date) 145 lbs, notes: now I am 145 lbs. Therapeutic measures were taken as a result of hematemesis. Clinical course: Patient reported that after she had the Covid vaccine her health has been really 'crazy', up and down and she did not know if they were putting any nanobots in there because they did not know what is inside, but it was mandatory for her to have those vaccine in order for her to provide healthcare to other patients and her health has declined a lot since she had those. She stated he had the flu vaccine, she did not want to get all at once (Further clarification unknown, hence not captured as event). She did not know what they have injected in that syringe because they do not really give them an explanation what they are injecting to us and if she told them frankly her arm still feels a little bit swelling from the vaccine. It was still swollen and flu vaccine before the pandemic, from 2020, She had been declining a lot. She had been providing care for patients at their home, to the Covid patients. She did not want to put the vaccines because she does not know but she feels like they put some kind of nanobots in there. She stated that was ridiculous. They did not tell them what they are getting when they give them the vaccine. She had swollen arms, fever and all that but it subsided in kind of 3 days and she went back to work. But then she started to throw in blood, up and down, throwing blood from, like she was almost dying. She had to get blood transfusion and they do not know where it came from. So, and then her liver, it started giving more problems because she already had a fatty liver and then that ended up, it functioned well again, good and then they told her that she had diabetes, like a 700 last year and they put her on multiple medications. She did not feel any side effects. Then all of a sudden, her diabetes subsided and she did not have it anymore. So, she did not know what was going on and now it was messing up, which might be her muscular fascia, growing more bones in her muscular fascia (Event captured conservatively). Patient also received BNT162b2 (BNT162B2), on 14Nov2021 as dose 3 (Booster), single (Lot number: FF8841) for covid-19 immunisation.; Sender's Comments: Based on the information provided, there is no information to suggest a causal relationship between BNT162b2 vaccine and the reported event of Hematemesis. Event onset date and onset latency information was not provided at this time. Case will be reassessed upon receipt of additional information. 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-2020510713 Same patient/product, different dose/events.