Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Fatigue, Joint swelling, Peripheral swelling
Clinical narrative: She started having kidney related symptoms after her Pfizer dose in May/They did blood tests before her procedure and her kidney tests came back 'almost at three'/They have shut down twice in her life; Her leg swelled up really weird/just the ankles did, all the way up to the thighs and calf; This time, the foot didn't swell up, just the ankles did, all the way up to the thighs and calf.; Her urine turned almost like a green color.; She had back pain,fatigue and then eventually came back to normal; She had back pain,fatigue and then eventually came back to normal; She ended up getting COVID before her dose in September; She ended up getting COVID before her dose in September; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774935 (Moderna).  A female patient in her 60's received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in May2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease/heart disorder" (unspecified if ongoing); "Kidney problems" (unspecified if ongoing); "entire life allergies: more than 259 allergies last time she was tested" (unspecified if ongoing); "lupus" (unspecified if ongoing); "COVID-19", start date: 2019 (unspecified if ongoing), notes: before any vaccine, she had the COVID. The patient's concomitant medications were not reported. Past drug history included: Antibiotics, reaction(s): "Shutdown renal", notes: She says she has very sensitive kidneys, they have shut down from antibiotics. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "never had any issues"; Moderna (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "never had any issues"; Moderna (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "never had any issues"; Moderna (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "never had any issues"; Moderna (DOSE 5 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "never had any issues"; Flu (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN, Name of Drug as Reported Flu shot the a), for immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset May2024, outcome "not recovered", described as "Her leg swelled up really weird/just the ankles did, all the way up to the thighs and calf"; CHROMATURIA (non-serious) with onset May2024, outcome "not recovered", described as "Her urine turned almost like a green color."; BACK PAIN (non-serious), FATIGUE (non-serious) all with onset May2024, outcome "recovered" (2024) and all described as "She had back pain,fatigue and then eventually came back to normal"; ACUTE KIDNEY INJURY (medically significant) with onset May2024, outcome "not recovered", described as "She started having kidney related symptoms after her Pfizer dose in May/They did blood tests before her procedure and her kidney tests came back 'almost at three'/They have shut down twice in her life"; JOINT SWELLING (non-serious) with onset May2024, outcome "not recovered", described as "This time, the foot didn't swell up, just the ankles did, all the way up to the thighs and calf."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "not recovered" and all described as "She ended up getting COVID before her dose in September". The patient underwent the following laboratory tests and procedures: Blood test: (2024) almost at three. Clinical course: Patient wanted the Moderna vaccine because Pfizer almost shut down her kidneys twice. She said that she had COVID 3 times this year because she has not been able to get the Moderna vaccine. She said that every one of these corporate pharmacies only had Pfizer. She had a dose in May (Pfizer). She had gotten that Pfizer dose in May because she had COVID and the doctors treated her and told her to wait a couple of months and then go get it. All her previous doses, before those two Pfizer doses have been with Moderna. She stated that she never had any issues with Moderna products. She got the first 5 Moderna vaccines at the (withheld) Cardiac department. She stated that there were nurses there and they made sure that she did not get a reaction. She did get COVID in 2019 that lasted 7 days, she had a fever, her fatigue was ridiculous and had mucus build up in her left ear. The right side did not have anything, it was all the sinuses on her left ear. She said that she was also cold and that every place she went to she was freezing. She said that before any vaccine, she had the COVID and had SARS and survived them all, she stated 'its like having a cold'. She started having kidney related symptoms after her Pfizer dose in May. Her leg swelled up really weird. She said normally if she has a lot of salt, her foot will swell up. This time, the foot didn't swell up, just the ankles did, all the way up to the thighs and calf. Her urine turned 'almost like a green color'. She had back pain, fatigue and then eventually came back to normal. She let it go and did not bother contacting the doctors about it. She was doing pre-op testing (agent asked what the procedure was and consumer did not want to disclose it - its private, she said) and decided to go get another Pfizer vaccine before her procedure. They did blood tests before her procedure and her kidney tests came back 'almost at three'. They did the tests because they will be giving her general anesthesia for the procedure so they wanted to make sure everything was functioning right. She stated that her procedure was next week. She ended up getting COVID before her dose in Sep. She stated that maybe her body hasn't filed out the first one (vaccine) and then she added another dose and it made it worse. She said, she has very sensitive kidneys, they have shut down from antibiotics. They have shut down twice in her life and she does not want to go through it again because its months and months of being ill. She thought that when she had COVID (before her Sep vaccine) she thought it was a sinus infection but it was COVID.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400133256 same patient/product, different dose/event;