Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test, Lower limb fracture, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; FELT WOOZY; INCONTINENCE; CONFIRMED CLINICAL VACCINATION FAILURE; NO ENERGY; HEADACHE; HIT HER KNEE AND BROKE HER KNEE (IMMOBILIZED); LEFT SHOULDER HURTS; LOST BALANCE; FEELING DEPRESSED; FELL AND FELT TERRIBLE; HORRIBLE COUGH/COUGHING; TEENY BIT OF SNIFFLES; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 73 year old female. Initial information was processed along with the additional information received on 29-JUL-2021. The patient's weight was 58.97 kilograms, and height was 163 centimeters. The patient's past medical history included: covid-19 (had a little bit of symptoms and covid before getting the vaccine) and concurrent conditions included: little bit high cholesterol (did not taking anything, doctor did all kinds of exams and cholesterol was a little high) and other pre-existing medical conditions included: Patient never had asthma and never experienced this adverse events before. She was so sick prior vaccinations within 4 weeks (could not event get of the house). The patient had been very healthy and never had influenza vaccine ever, not prone to colds, did test her at hospital for flu and she was negative. Patient's family history included her brother passed away from a rare disease 2 years ago, a neurological thing. Nothing to do with any of this and never had Covid. Patient is not a drug taker. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) 1 total, dose was not reported, administered on 03-APR-2022 for covid-19 prophylaxis. Age at time of vaccination 73 years old. Concomitant medications included low dose thyroid medication. On 04-APR-2022, patient had horrible cough (had symptoms Iike sniffles and coughing, that lasted one day (dose number in series 1). The patient recovered from horrible cough/coughing, and teeny bit of sniffles on 05-APR-2022. The patient received additional non-company suspect vaccine included: tozinameran (Pfizer biontech covid-19 vaccine) (dose number in series 2) (form of admin, route of admin was not reported, batch number: FJ4989, expiry: unknown) dose was not reported, administered on 06-JUN-2022 at 13:00 to left arm for covid-19 prophylaxis.  On 07-JUN-2022 (the next day), the patient woke up feeling like she did not know what to do, had a horrible cough (coughing so badly), which was the least of her problems (dose number in series 2). The coughing did not go away and she started being incontinent (because of the coughing) that happened because of every time she coughed, had no energy and thought she was dying and that might be she had Covid (dose number in series 2). She did not want to go to doctor. On 11-JUN-2022, she had to go to ER because she thought she was dying. she went to the hospital and she was not admitted to the hospital, it was just to the emergency room (ER), she was coughing so badly, they put her in a separate area and had to wait outside for an hour, she was very uncomfortable. The coughing was not that bad but she felt woozy and had no energy at all, never felt that before in her life, even when she had Covid just felt like she was sick (dose number in series 2). They gave her a Covid - 19 test and influenza test both was negative. Chest X ray did not show anything. Doctor said it could be a viral infection and did not know it was just a coincidence. She was just feeling so bad. Doctor gave her antibiotics in case it was some lung infection or something. She really coughed for like 3 weeks without having bronchitis or anything. Coughing and incontinence (because of the coughing) were better not and never had that before, this was horrible. Still had it a little bit and she was trying to drink a lot of water. Had been using a little pad and never had that before, ever. Doctor told her about over the counter stuff. On an unspecified date in JUN-2022, patient reported left shoulder hurts (dose number in series 2). Two weeks after booster (JUN-2022), she lost her balance, fell and felt terrible, hit her knee and broke her knee, she was still not well form the cough (dose number in series 2). She also had headaches after the booster never had headaches like that before (dose number in series 2). She had been immobilized for 2 weeks (JUN-2022) (dose number in series 2). It might be between immobilizing and eating well, taking it easy, it would make her feel better but had been feeling depressed (dose number in series 2). Just recently (JUL-2022), had all the heart exams and echocardiogram (echo tests) and Treadmill, every heart test, showed nothing. At the time of reporting, she still had the headaches in the morning and some of the other symptoms that had not gone away. She still had a little bit of incontinence but, was not the same. Patient had emergency room and physician office visit for the events of felt woozy and had no energy at all, just felt like she was sick, coughing, incontinent, lost her balance and fell, hit her knee and broke her knee. It was reported that, patient had Covid, did the Covid test. Had a little bit of sniffles and did test at the hospital that was positive, possibly tested positive for Covid after receiving booster dose (confirmed Covid-19 infection, dose number in series 2). She was unable to clarify dates of this positive Covid-19 test and if it was after receiving booster dose. Thus patient had confirmed clinical vaccination failure (dose number in series 1). She had another test and was negative, reported it was a false positive. Never had Covid symptoms anyway. She reported that, her life was over and she had no energy, that headaches were in the morning and was depressed. She had this broken knee and going to see the doctor again on Thursday (28-JUL-2022). She was immobilized at home with huge brace and had to sleep with it. In general, she did not feel well. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from horrible cough/coughing, and teeny bit of sniffles on 05-APR-2022, was recovering from incontinence, had not recovered from hit her knee and broke her knee (immobilized), feeling depressed, confirmed covid-19 infection, no energy, and headache, and the outcome of felt woozy, lost balance, fell and felt terrible, left shoulder hurts and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000244442.; Sender's Comments: V0:20220754469-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive  relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20220754469-Covid-19 vaccine ad26.cov2.s-  hit her knee and broke her knee(immobilized) .The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS. Therefore, this event(s) is considered not related.