Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Headache, Intra-abdominal haemorrhage, Magnetic resonance imaging, Paraesthesia
Clinical narrative: major blood clots; thought she was going to faint; severe abdominal pain/ her stomach blue up again out of the blue; uterine cysts/has some kind of bumps in her uterus; abdominal bleeding; bleeding; intermittent swelling and bloating of the abdomen accompanied by severe abdominal pain/abdomen swells up; headache; tingling over her body from her head to her toes; loss of appetite/no appetite; This is a spontaneous report from a contactable consumer (patient's spouse). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3180 and expiry: unknown), via an unspecified route of administration, administered in arm left on 23Aug2021 unknown time but thinks it was the middle of the afternoon (as reported) as dose 2, single (at the age of 45 years old) for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. Family medical history relevant to adverse event (AEs) was none. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 02Aug2021 (Lot FA7485) as first dose (at the age of 45 years old) for COVID-19 immunization. There were no additional vaccines administered on same date of the Pfizer suspect. Patient's weight was 61.69 kg and height was 165 cm. Stated that the patient's bleeding began on 24Aug2021 right after the 2nd dose of the Pfizer COVID Vaccine and it got really worse and was pretty bad and they had gone to dinner and came back and she ended up in the hospital with major blood clots that came out and thought she was going to faint and took her into the hospital; stated he wanted to know what to do and they wanted her to go back into the hospital and when she was in the hospital initially was when the whole thing started and she had a lot of bleeding and they went in there and looked in her uterus and thought it was a cyst and scraped it down; stated they thought the cysts may be the cause of her pain and did not correct the problem at that time and it was still there. Reported that the patient was admitted to the hospital on 26Aug2021 with severe abdominal pain and bleeding. It was stated that she had to have emergency surgery to stop the bleeding, and the doctors found two uterine cysts they believe could possibly be related. Further stated that she was no longer experiencing bleeding, but rather intermittent swelling and bloating of the abdomen accompanied by severe abdominal pain and headache. It was also reported that patient experienced tingling from head to toe and loss of appetite. She was referred to an OBGYN who did not know what the cause could be. Stated that the patient's spouse was worried about potential blood clots and stroke and was wondering if any of what his wife experienced could be related to the Pfizer BioNTech Covid-19 Vaccine. Stated that she went into the hospital on 26Aug2021 with abdominal bleeding and said she has some kind of bumps in her uterus and the hospital told them they needed to follow up with a GYN and the GYN did not know what was causing the bleeding; stated the patient was still having bleeding and her abdomen swells up like a basketball in her belly and then bleeds and the bleeding comes and goes. The spouse was blaming it on the vaccine and wanted to know what they could do about that. Stated that for the bleeding it was the first day and had been completed but the patient was back to the hospital again a couple of days ago and her stomach blue up again out of the blue; stated they did not know what it was and gave the patient morphine, TYLENOL and VICODIN and reduced the swelling and in 3-4 hours the swelling came back and she was now repeatedly swelling up and down every two hours and clarified the patient was now having no bleeding but has severe abdominal pain and swelling and tingling over her body from her head to her toes, has severe major headache and has no appetite whatsoever. It was mentioned that no HCP information to provide at that time. Stated that the patient has no bleeding at the time of the report but has major abdominal pain off and on all day and a lot of bloating and blows up like a balloon and an hour later it goes back down; stated that the spouse was concerned for the patient's life with the tingling sensation and sees blood rushing to her stomach and she was scratching over her entire body and it goes away; stated the bloating would appear and then drop and she has severe headache over and over; stated she was in good health and the spouse would like to know if any of her severe symptoms were associated with the COVID vaccine. The patient was discharged the next day on 27Aug2021 and the second time she was admitted to the hospital on 23Sep2021 and discharged a couple of hours later on the same day. There were no dosages, lots, expiry dates or NDC numbers for the morphine, VICODIN or TYLENOL to provide as those were administered to the patient in the hospital and did emergency surgery and gave these medications to the patient the following morning; stated they said they found two little cysts and removed them because they were causing a lot of pressure and thought that was causing the pain and they scraped the two little cysts out of the patient's uterus and discharged her a couple of hours later and she had the abdominal swelling at the time of discharge and told her this should be better in a day or two and that everything would be fine and then Thursday she went into the hospital. The doctor gave her morphine again and VICODIN again and said she would be ok and to follow up with a GYN doctor. The patient underwent lab tests and procedures which included CT, MRI, sonogram and a lot of blood work: stated they have no specific results of testing to provide but everything was normal. AE(s) require a visit to emergency room, did not require visit physician office (as reported). The patient was hospitalized, with 1 day hospital stay. No prior vaccinations (within 4 weeks). Therapeutic measures were taken as a result of abdominal bleeding, bleeding, has some kind of bumps in her uterus, major blood clots, severe abdominal pain/ her stomach blue up again out of the blue, intermittent swelling and bloating of the abdomen accompanied by severe abdominal pain. The outcome of the event bleeding was recovered on unspecified date, the outcome of the other events was unknown.  Follow-up attempts are completed. No further information is expected.