Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 6 | — | — |
overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident; Each time, her 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; 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 6 (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, when the patient was 66 years old, for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (Dose 2, single), for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 nos (Dose 3 (booster), single), for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; Bnt162b2 (Dose 3 (booster), single), for Covid-19 immunisation, reaction(s): "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 nos (Dose 4 (booster), single), for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; Bnt162b2 (Dose 4 (booster), single), for Covid-19 immunisation, reaction(s): "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 nos (Dose 5 (booster), single), for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; Bnt162b2 (Dose 5 (booster), single), for Covid-19 immunisation, reaction(s): "Each time, her bladder is completely full, and the urine is expelled rapidly. 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 "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident"; POLLAKIURIA (non-serious), outcome "recovered", described as "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; NOCTURIA (non-serious), outcome "recovered", described as "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night". Therapeutic measures were not taken as a result of micturition urgency, pollakiuria, nocturia. Additional information: the patient didn't receive any other vaccines on the same date or within 4 weeks PRIOR to the reported vaccine. The patient had no known allergy. Since receiving the initial COVID-19 vaccination in Feb2021, patient has had seven booster shots. After each Pfizer vaccination, she experienced an intense and unusual side effect starting about 6-8 hours post-injection. She develop an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, her 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, she found it impossible due to the frequency and urgency of these episodes. Notably, after her 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