Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate irregular, Off label use, Urinary incontinence, Vaccination site pain
Clinical narrative: joint pain; heartbeat that was really moving; she felt like a zombie; bladder incontinence; she had two days of side effects after the booster.; she had two days of side effects after the booster.; injection site was painful; chills; tiredness; This is a spontaneous report from a contactable other hcp (patient reported for herself). A 67-year-old female patient received third dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: FC3181), via intramuscular route of administration, administered in upper arm right on 17Aug2021 at 11:30 (at the age of 67-year-old) as dose 3, single for COVID-19 immunization. Medical history included CLL (from a couple of years), MS from 1996 to an unknown date, bladder incontinence (from a few years), hip replacement (from the last couple of years; mentions she has to take antibiotics before any dental work due to the hip), allergy to sulfa (adds sulfa gives her hives), allergic to nickel. Family medical history relevant to AE: brother said he had a reaction to the COVID second shot. The patient did not receive any other vaccines prior vaccinations within 4 weeks. The patient concomitant medications included rituximab infusion by IV twice yearly two weeks apart via intravenous route taken for CLL; fesoterodine fumarate (TOVIAZ) at a dose of 4 mg once daily via oral route taken for bladder incontinence; baclofen 5 mg at a dose of 10 mg one half twice daily taken for restless legs; bupropion 150 mg at a dose of 150 mg once daily via oral route taken for an unspecified indication (not giving a rat); vitamin c (ASCORBIC ACID) capsule 1000% daily value; take eleven capsules once daily taken for an unspecified indication (should take it); tocopherol (VITAMIN E) at a dose of 1000IU twice daily via oral route taken for helps with memory; silybum marianum (MILK THISTLE) 300 mg at a dose of 300 mg twice daily via oral route taken for liver health; urtica dioica (HILDE HEMMES HERBALS STINGING NETTLE) 480 mg at a dose of 480 mg twice daily via oral route taken for kidney health; probiotics once daily via oral route taken for an unspecified indication (good for colon), all drugs from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: EL3246), via intramuscular route of administration, administered in upper arm left on 28Jan2021 at 10:00 AM (at the age of 66-year-old) as dose 1, single for COVID-19 immunization and experienced sore arm, injection site pain. Patient took second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Solution for Injection, Batch/Lot Number: EN6200), via intramuscular route of administration, administered in upper arm left on 18Feb2021 at 10:00 AM (at the age of 66-year-old) as dose 2, single for COVID-19 immunization and experienced chills, weakness, wonky feeling, tiredness. The patient past drugs included trospium chloride, oxybutynin, both drugs for bladder incontinence and experienced drug allergy; myrbetriq and experienced drug allergy. On an unspecified date in Aug2021, the patient experienced chills, tiredness, injection site was painful. On 17Aug2021, the patient experienced joint pain, heartbeat that was really moving, she felt like a zombie, bladder incontinence, she had two days of side effects after the booster. Licensed practical nurse calling regarding the Pfizer BionTech COVID 19 vaccine. Adds patient is calling about the booster dose. Mentioned patient previously reported after the second dose online. No report reference known to reporter. Today patient wants to report adverse effects; she had two days of side effects after the booster. Patient is the reporter; mentioned she is down to 159, she has lost on purpose. Reporter is licensed practical nurse reporting on herself. Primary/Prescriber: mentioned this is her old PCP, patient doesn't have the name of the new one. Product: Pfizer COVID 19 vaccine; treatment first dose 28Jan2021 at 10:00 in upper left arm; EL3246; administered at (withheld). Hospital; second dose 18Feb2021 at 10:00 in the upper left arm; lot EN6200; administered at (withheld); third dose booster 17Aug2021 at 11:30 in the upper Right arm; lot FC3181; administered at (withheld). Patient sees no other writing on the vaccination card, no NDC, expiration date or dose. Events: 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. Mentioned patient got up at 03:00 to report, she did the VAERS report and the Pfizer 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; every time 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. Reporter 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. Concomitant Products: Mentioned the Toviaz she takes for bladder control is a miracle; it made a night and day difference; she went from no control to control over her bladder. History: Mentioned 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; patient is also allergic to myrbetriq; and allergic to nickel on the skin or bandages that are not latex, plastic is fine. Patient doesn't have any product or information for the products and cannot provide NDC, lot or expiration date. The patient underwent lab tests and procedures which included heartbeat was really moving on 17Aug2021. The patient did not receive treatment for the events. Outcome of the events tiredness was not recovered; she had two days of side effects after the booster was unknown; injection site was painful, bladder incontinence was recovering; chills was recovered on an unspecified date in Aug2021, heartbeat that was really moving was recovered on 17Aug2021; joint pain, she felt like a zombie was recovered on 19Aug2021.  Causality: sore arm injection site pain, chills, weakness, tiredness, wonky feeling, joint pain, fast heartbeat, didn't sleep very well, felt like a zombie, bladder incontinence: Yes (Related). Causality of all these events is related to the vaccine.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.