Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
bleeding since got the vaccination. She has been having vaginal bleeding for the two years/Bleeding has been too many blood clots; After the first vaccination she had the vaginal bleeding. When got the second shot the bleeding was more intense, was throwing pound of blood clot; enlarged pancreas; cyst on pancreas; Enlarged thyroid; Fibroids; anemia/ low iron; low platelet; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "vaginal bleeding". The following information was reported: VAGINAL HAEMORRHAGE (medically significant), outcome "not recovered", described as "bleeding since got the vaccination. She has been having vaginal bleeding for the two years/Bleeding has been too many blood clots"; CONDITION AGGRAVATED (medically significant), outcome "not recovered", described as "After the first vaccination she had the vaginal bleeding. When got the second shot the bleeding was more intense, was throwing pound of blood clot"; PANCREATIC ENLARGEMENT (non-serious), outcome "not recovered", described as "enlarged pancreas"; PANCREATIC CYST (non-serious), outcome "not recovered", described as "cyst on pancreas"; GOITRE (non-serious), outcome "unknown", described as "Enlarged thyroid"; UTERINE LEIOMYOMA (non-serious), outcome "unknown", described as "Fibroids"; ANAEMIA (non-serious), outcome "unknown", described as "anemia/ low iron"; PLATELET COUNT DECREASED (non-serious), outcome "unknown", described as "low platelet". The events "enlarged pancreas", "cyst on pancreas", "enlarged thyroid", "fibroids", "anemia/ low iron" and "low platelet" required physician office visit. The events "bleeding since got the vaccination. she has been having vaginal bleeding for the two years/bleeding has been too many blood clots" and "after the first vaccination she had the vaginal bleeding. when got the second shot the bleeding was more intense, was throwing pound of blood clot" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood iron: (unspecified date) low; Cyst on Pancreas measured: (2024) had grown a bit more; Platelet count: (unspecified date) low. Therapeutic measures were taken as a result of vaginal haemorrhage, condition aggravated. Clinical course: The reporter was not feeling well, and she was calling to see of can help. The patient received the vaccine 2 years ago. She has an enlarged pancreas, cyst on pancreas, enlarged thyroid, fibroids, and also been bleeding since got the vaccination. She has been having vaginal bleeding for the two years. They were also calling to see if there was any additional information regarding the frequency of this being reported and questions regarding management of symptoms. Agent informed the reporter that she will call her back after speaking with Medical Information with the information she finds out. She will speak with them first and since she is not feeling good will call her back tomorrow. Age of onset reported as like 40 years old. Height: Does not have documentation for accurate estimated, then provided 1.5 (reporter unable to clarify further). It was also reported that she has been seen by several specialist not just one. Already has anemia and low platelet. Event Details: Cyst on Pancreas: Last year they monitored it, measured it. It had grown a bit more. They are going to run analysis and will be sent to surgeon. Enlarged thyroid: Has had many appointments. She lost appointment with specialist. Now she has one for 13Jun. They will run biopsy on her. Referred to their place to get a biopsy. Fibroids: Outcome Unknown and only the Gynecologist can answer if they have improved or not. Vaginal Bleeding: Bleeding has been too many blood clots. She had treatment in the (Withheld), but it did not help. She went to another Gynecologist at the (Withheld) and they gave the same birth control pills that did not help get any better. She had to go to the Emergency Room twice due to bleeding. Now they are sending her to have surgery. She was sent to a blood specialist due to low platelet and iron. Other Conditions: At the time took the vaccination was a very health woman. The patient was not allergic to any previous vaccination, medications, food or other products. Was not taking any medications. The patient did not receive any other vaccines on the same date as the Pfizer vaccine and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Confirms she got the second shot. After the second shot did not get the third one. When got the second shot the bleeding was more intense. Confirms had the bleeding with the first vaccination. After the first vaccination she had the vaginal bleeding, but she was not aware why she was going through it. When she got the second shot was throwing pound of blood clot. The vaccination causing bleeding. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500111636 same patient, different dose/event;
Test Name: iron; Result Unstructured Data: Test Result:low; Test Date: 2024; Test Name: Cyst on Pancreas measured; Result Unstructured Data: Test Result:had grown a bit more; Test Name: platelet; Result Unstructured Data: Test Result:low