Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | — | — |
intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate; This cycle occurs approximately every 20 minutes and lasts for about 8 hours; It significantly disrupts sleep, the need to urinate wakes patient repeatedly throughout the night; This is a spontaneous report received from a Consumer or other non HCP. A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: manage effectively with medication. Concomitant medication(s) included: ATENOLOL, start date: Jan2024; HYDROCHLOROTHIAZIDE;LOSARTAN, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, for covid-19 immunisation, reaction(s): "overwhelming urge to urinate", "disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunisation, reaction(s): "urge to urinate", "disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "This cycle occurs approximately every 20 minutes and lasts for about 8 hours".The following information was reported: MICTURITION URGENCY (non-serious), outcome "recovered", described as "intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; POLLAKIURIA (non-serious), outcome "recovered", described as "This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; NOCTURIA (non-serious), outcome "recovered", described as "It significantly disrupts sleep, the need to urinate wakes patient repeatedly throughout the night". Therapeutic measures were not taken as a result of micturition urgency, pollakiuria, nocturia. Additiona information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s) for which you are reporting. Patient had non allergy. Since receiving the initial COVID-19 vaccination in Feb2021, patient have had seven booster shots. After each Pfizer vaccination, patient experience an intense and unusual side effect starting about 6-8 hours post-injection. Patient develop an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night. Despite trying to rest, patient find it impossible due to the frequency and urgency of these episodes. Notably, after my first injection, this cycle lasted between 12-14 hours. These symptoms only occur following the vaccine. 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-202500067929 same patient/event, different dose;
Medical History/Concurrent Conditions: Hypertension (manage effectively with medication)
ATENOLOL; HYDROCHLOROTHIAZIDE;LOSARTAN; ATORVASTATIN