Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate/frequency and urgency of these episodes; It significantly disrupts my sleep, the need to urinate wakes me repeatedly throughout the night; After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate/frequency and urgency of these episodes; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Mar2025 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Jan2024; HYDROCHLOROTHIAZIDE LOSARTAN, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: Feb2021, for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 6 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 7 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate". The following information was reported: MICTURITION URGENCY (non-serious), POLLAKIURIA (non-serious) all with onset Mar2025, outcome "unknown" and all described as "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate/frequency and urgency of these episodes"; SLEEP DISORDER (non-serious) with onset Mar2025, outcome "unknown", described as "It significantly disrupts my sleep, the need to urinate wakes me repeatedly throughout the night". Additional information: Patient did not receive any other vaccines on the same date as the Comirnaty vaccine. Patient did not receive any other vaccines within 4 weeks PRIOR to the Comirnaty vaccine. Patient with hypertension, which manage effectively with medication. Since receiving the initial COVID-19 vaccination in Feb2021, patient had seven booster shots. After each Pfizer vaccination, patient experience an intense and unusual side effect starting about 68 hours post-injection. patient develop an overwhelming urge to urinate, to the point where patient must rush to the restroom to avoid an accident. Each time, patient bladder was completely full, and the urine was expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts patient sleep, as the need to urinate wakes me repeatedly throughout the night. Despite trying to rest, patient find it impossible due to the frequency and urgency of these episodes. Notably, after patient first injection, this cycle lasted between 1214 hours. These symptoms only occur following the vaccine. patient question was has anyone else experienced this Should patient continue using the Pfizer version of the vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) 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: Hypersensitivity; Hypertension
ATENOLOL; HYDROCHLOROTHIAZIDE LOSARTAN; ATORVASTATIN