Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
COVID/extreme shortness of breath, respiratory stuff going on/so much fluid backed up; COVID / extreme shortness of breath, respiratory stuff going on / so much fluid backed up; COVID / extreme shortness of breath, respiratory stuff going on / so much fluid backed up; congestive heart failure / extremely ill; kidney failure / extremely ill; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2026-794505 (Moderna), MOD-2026-794506 (Moderna). A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Feb2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Advanced COPD" (unspecified if ongoing); "Carotid artery stenosis in right and leff carotid arteries" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing); "Heart block", start date: Aug2018 (unspecified if ongoing); "Aortic valve replacement", start date: Aug2018 (unspecified if ongoing), notes: with a bovine aortic valve (Edward's valve) prior to COVID lockdown; "total heart block", start date: 2021 (unspecified if ongoing); "Medtronics Micro pacemaker", start date: 2021 (unspecified if ongoing), notes: after a total heart block in 2021. The patient's concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE. Lot/Batch Number: 029L20A), administration date: 21Jan2021, for Covid-19 immunization; moderna COVID vaccine (DOSE 2, SINGLE. Lot/Batch Number: 024M20A), administration date: 18Feb2021, for Covid-19 immunization; moderna COVID vaccine (DOSE 3, SINGLE. Lot/Batch Number: 012F21A), administration date: 29Oct2021, for Covid-19 immunization; moderna COVID vaccine (DOSE 5, SINGLE. Lot/Batch Number: 002M21A), administration date: 12May2022, for Covid-19 immunization; moderna COVID-19 vaccine, bivalent (original and omicron ba.4/ba.5) (DOSE 5, SINGLE. Lot/Batch Number: HS714513), administration date: 23Sep2022, for Covid-19 immunization; spikevax 2023-2024 (DOSE 6, SINGLE.), administration date: 31Oct2023, for Covid-19 immunization; Flu vaccine (each year), for Immunization; Rsv vaccine, administration date: 2025, for Immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset Sep2025, outcome "unknown" and all described as "COVID / extreme shortness of breath, respiratory stuff going on / so much fluid backed up"; CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant) with onset Sep2025, outcome "unknown", described as "congestive heart failure / extremely ill"; RENAL FAILURE (hospitalization, medically significant) with onset Sep2025, outcome "not recovered", described as "kidney failure / extremely ill"; FLUID RETENTION (hospitalization, medically significant) with onset 30Sep2025, outcome "unknown", described as "COVID/extreme shortness of breath, respiratory stuff going on/so much fluid backed up". The patient was hospitalized for covid-19 (start date: 30Sep2025); for renal failure (start date: 08Oct2025, discharge date: 11Oct2025, hospitalization duration: 4 day(s)). The event "covid / extreme shortness of breath, respiratory stuff going on / so much fluid backed up" required emergency room visit. The patient underwent the following laboratory tests and procedures: Renal function test: (08Oct2025) still so high; SARS-CoV-2 test: (23Sep2025) Positive. Therapeutic measures were taken as a result of covid-19, renal failure. Clinical Course: Patient had received 6 Moderna COVID vaccines between 2021 and 2023 and received a Pfizer COVID vaccine in February 2025 where their (REDACTED) did not carry the Moderna vaccine at the time. Patient then ended up catching COVID in September of 2025. When that occurred, ended up with congestive heart failure and kidney failure. Patient had been extremely ill, but managed to be working with the heart transition clinic and moving right along. And so far gotten the pneumonia vaccine, waited 4 weeks, and then got the flu vaccine, waited 4 weeks. Now they've okayed them to go ahead and get a COVID shot. Patient had gotten so many comorbidities, going on right now, injured kidneys, so had that kidney failure issue and being seen for all of this, type 2 diabetic and COPD. Also stated that in 2024, got steroid injections in back for lower lumbar stenosis, and cervical stenosis in neck. Because of the injection schedule, they did it separately, neck first and then back several weeks later. Due to the fact that they were giving those high doses of steroids, patient couldn't do. The steroids would have cancelled the vaccination benefit. So that was why patient didn't get it and it was during the season when everybody really try to get it. So as soon as the doors and windows close up, they wanted to be vaccinated because they were in a confined area. So then through the summer kind of just didn't worry about it and then ended up, like (REDACTED). So as soon as they could get it was February and that was after those injections. Confirmed that these health issues happened after 2021. Then added that other chronic diseases that had been going on for years before patient was given any Moderna vaccine and those include advanced COPD, carotid stenosis of the left and right arteries, Medtronic micro pacemaker inserted right inside the heart because of the total heart block, (REDACTED) had suffered in 2021. Previously in August 2018, had aortic valve replaced with a bovine aortic valve (Edward's valve). On 23SEPT2025, they went to the emergency room and were tested positive for COVID and were sent home. Five days later, had extreme shortness of breath, respiratory stuff going on, had to call the ambulance. So they took back on 30Sep2025 and admitted. Patient was hospitalized and according to (REDACTED) starting 30SEPT2025, had so much fluid backed up that they gave tons of Lasix, caused a kidney injury and was already in heart failure from the fluid and it was just a mess. On 05OCT2025, patient was sent home, but re-admitted on 08OCT2025 till 11OCT2025 because kidney values were still so high. Stated that: "the doctors were feeling that that the COVID situation may have ticked everything off, but (REDACTED) so borderline and fragile with all these other systems that, could have just been enough to cause everything to snowball, to get bigger." Lasix administered during hospitalization post COVID infection in September 2025 (not asked if medication is still being administered). Patient received high dose flu vaccine and pneumonia-20 this year (2026). Reporter causality was not reported. 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-202600059538 same reporters/SD, different patient/events;
Medical History/Concurrent Conditions: Aortic valve replacement (with a bovine aortic valve (Edward's valve) prior to COVID lockdown); Artificial cardiac pacemaker wearer (after a total heart block in 2021); Carotid artery stenosis; COPD; Heart block; Heart block complete; Type 2 diabetes mellitus
Test Date: 20251008; Test Name: kidney values; Result Unstructured Data: Test Result:still so high; Test Date: 20250923; Test Name: covid test; Test Result: Positive