Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
out of range hemoglobin; out of range Hematocrit; out of range MCH/MCHC; heavy bleeding/blood loss; menstrual cycle started a few days later but did not stop; paleness; weakness; high blood pressure; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Apr2025 as dose 1, 0.1 ug/ml single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 15Apr2025, outcome "not recovered", described as "heavy bleeding/blood loss"; HYPERTENSION (non-serious) with onset 15Apr2025, outcome "not recovered", described as "high blood pressure"; MENSTRUATION ABNORMAL (medically significant) with onset 15Apr2025, outcome "not recovered", described as "menstrual cycle started a few days later but did not stop"; PALLOR (non-serious) with onset 15Apr2025, outcome "not recovered", described as "paleness"; ASTHENIA (non-serious) with onset 15Apr2025, outcome "not recovered", described as "weakness"; HAEMATOCRIT ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range Hematocrit"; MEAN CELL HAEMOGLOBIN CONCENTRATION ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range MCH/MCHC"; HAEMOGLOBIN ABNORMAL (non-serious) with onset 29Apr2025, outcome "not recovered", described as "out of range hemoglobin". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (29Apr2025) High; Haematocrit: (29Apr2025) out of range; Haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin: (29Apr2025) out of range; Mean cell haemoglobin concentration: (29Apr2025) out of range. Therapeutic measures were taken as a result of heavy menstrual bleeding/menstrual cycle started a few days later but did not stop. Clinical course: The shot was given on 12Apr2025. The menstrual cycle started a few days later but did not stop. On 28Apr and 30Apr patient went to urgent care and doctor. The doctor gave her progesterone birth control to stop the bleeding. Patient has been taking one a day, but period has not ended. As of 18May2025, period has continued and is heavy bleeding. Patient has many expected symptoms from blood loss paleness, weakness, high blood pressure, out of range hemoglobin, hematoctit, MCH and MCHC on 29Apr. A new test will take place soon. Event treatment included Progesterone birth control pills. Patient had no known allergies. The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: other medical history: No
Test Date: 20250429; Test Name: blood pressure; Result Unstructured Data: Test Result:High; Test Date: 20250429; Test Name: Hematocrit; Result Unstructured Data: Test Result:out of range; Test Date: 20250429; Test Name: hemoglobin; Result Unstructured Data: Test Result:out of range; Test Date: 20250429; Test Name: MCH; Result Unstructured Data: Test Result:out of range; Test Date: 20250429; Test Name: MCHC; Result Unstructured Data: Test Result:out of range