Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate irregular, Off label use, Urinary incontinence, Vaccination site pain
Clinical narrative: Side effects after the booster; Side effects after the booster; Joint pain; Heartbeat that was really moving; She felt like a zombie; Bladder incontinence; Injection site was painful; Had chills; Tiredness; This is a spontaneous report from a contactable Nurse. This contactable 66-year-old female (patient) reported for herself that.  A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3181), (At the age of 66-years) dose 3 via an unspecified route of administration, administered in Arm Right on 17Aug2021 11:30 as dose 3, single for covid-19 immunisation. Medical history included Bladder incontinence from an unknown date (from a few years), Chronic lymphocytic leukaemia from a couple of years, Multiple sclerosis From unknown To 1996, Hip replacement from the last couple of years; mentions she has to take antibiotics before any dental work due to the hip. Concomitant medication included rituximab infusion by IV twice yearly two weeks apart taken for chronic lymphocytic leukaemia from an unspecified start date and ongoing; fesoterodine fumarate (TOVIAZ) 4mg take once daily by mouth taken for urinary incontinence bladder control is a miracle; it made a night and day difference; she went from no control to control over her bladder from an unspecified start date and ongoing; baclofen 10mg take one half twice daily taken for restless legs syndrome from an unspecified start date and ongoing; bupropion 150mg once daily by mouth taken for an unspecified indication from an unspecified start date and ongoing; ascorbic acid (VITAMIN C) 1000 % daily value; take eleven capsules once daily taken for an unspecified indication from an unspecified start date and ongoing; tocopherol (VITAMIN E [TOCOPHEROL]) 1000IU take twice daily by mouth taken for an unspecified indication from an unspecified start date and ongoing; silybum marianum (MILK THISTLE) 300mg take twice daily by mouth taken for liver health; probiotics take once daily by mouth taken for an unspecified indication from an unspecified start date and ongoing: stinging nettles 480mg take one twice daily by mouth taken for kidney health. No Additional Vaccines Administered on Same Date of the product Suspect. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. It was reported that patient brother said he had a reaction to the COVID second shot. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3246) dose 1 via an unspecified route of administration, administered in Upper Left Arm for COVID-19 immunization on 28Jan2021 10:00AM and experienced Sore arm, and Injection site pain. Patient previously took Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6200) dose 2 via an unspecified route of administration, administered in Upper Left Arm for COVID-19 immunization on 18Feb2021 1000AM and experienced chills, Weakness, Wonky feeling, didn't sleep very well, Tiredness, and Her balance was not quite there. It was reported that for bladder incontinence she tried a few meds that she was allergic to; one was trospium chloride, she doesn't have doses; and oxybutynin. Adds sulfa gives her hives; she is also allergic to myrbetriq; and allergic to nickel on the skin or bandages that are not latex, plastic is fine. She doesn't have any product or information for the products and cannot provide NDC, lot or expiration date. The patient had side effects after the booster (extra dose administered and off label use) on 17Aug2021. patient experienced had chills, tiredness, and injection site was painful on Aug2021. patient experienced joint pain, heartbeat that was really, he felt like a zombie, and bladder incontinence on 17Aug2021. Patient calling regarding the Pfizer BionTech COVID 19 vaccine. Adds she is calling about the booster dose. Mentions her computer crapped out on her and doing it on her phone is hard so she decided to call in. Mentions she previously reported after the second dose online. No report reference known to caller. Today she wants to report adverse effects; she had two days of side effects after the booster. first dose 28Jan2021 at 10:00AM in Upper Left Arm; EL3246; administered at withheld Hospital; second dose 18Feb2021 at 10:00AM in the upper left arm; lot EN6200; administered at withheld Hospital; third dose booster 17Aug2021 at 1130AM in the upper Right arm; lot FC3181; administered at #. Caller sees no other writing on the vaccination card, no NDC, expiration date or dose. The first dose she just had a sore arm and injection site pain. The second one she had chills that night; weakness and had to hold on to things; kind of wonky feeling; didn't sleep very well and had tiredness at night. Adds she had to hold on to things as her balance was not quite there. Mentions she got up at 03:00 AM to report, she did the regulatory authority report and the company report. The booster went a little more, she had chills, tiredness; took a super-hot shower before she went to bed as the chills were starting in hands and feet; joint pain; injection site was painful; and then the other thing was a heartbeat that was really moving. Then she felt like a zombie; she was running errands yesterday and trying to stay focused driving. Adds she also noticed bladder incontinence that started after this dose for sure. She already has some bladder incontinence from MS and she takes a medication that helps it; controls it so she doesn't have it. But after the booster, when she gets up, she just lets go; everytime she peed all the way and the a little more in the toilet. She used a lot of pads, men's pads, but it is getting better now; her medication kicked in. She didn't notice it so much on the second dose. Adds staying in bed a long time this time really helped. Caller rates all of her events as not serious. When ask for causality, she states yes, all of these events are related to the vaccine because she didn't have any of this before. Treatment: She has not gone to the emergency room or seen a doctor for any of her side effects and reported no treatment. Communication: Caller mentions she reported to company online after the second dose. No report reference number known. This will be follow up. Caller was provided with this report reference number. Caller mentions her brother had a reaction to the COVID second shot. A clone report is created to document the brother's experience. This is report one of two. No product complaint to report and no medical information request. The outcome of events had chills, heartbeat that was really moving was recovered on 17Aug2021, outcome of event joint pain, and she felt like a zombie was recovered on 19Aug2021, outcome of event. Outcome of events tiredness, and bladder incontinence and injection site painful was recovering  The lot number for the vaccine, [BNT162B2], was not probided and will be requested during follow-up.