chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Tubulointerstitial nephritis, Urine protein/creatinine ratio
Clinical narrative: AKI; AIN; This is a literature report.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; pembrolizumab (PEMBROLIZUMAB), (Batch/Lot number: unknown) for bladder cancer. The patient's relevant medical history included: "Bladder cancer" (ongoing), notes: was on Pembrolizumab. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ACUTE KIDNEY INJURY (medically significant), outcome "recovering", described as "AKI"; TUBULOINTERSTITIAL NEPHRITIS (medically significant), outcome "recovering", described as "AIN". The patient underwent the following laboratory tests and procedures: Blood creatinine: 2.18 mg/dl, notes: (b/1 0.8 mg/dL); C-reactive protein: 40 mg/dl; less than 3, notes: prior; Renal function test: Returned to baseline; SARS-CoV-2 test: Negative; Urine protein/creatinine ratio: 3797, notes: Units: mcg/g Cr (Normal less than 190) Elevated. The action taken for pembrolizumab was dosage permanently withdrawn.  Clinical course: The patient with h/o bladder cancer on pembrolizumab developed AKI. 3 weeks prior she got a booster dose of Pfizer SARS-CoV-2 vaccine. ICPi was discontinued. The patient declined kidney biopsy. Kidney function returned to baseline in 6 weeks without steroids. The cause of AKI was presumed to be AIN based on the elevated uRBP/Cr ratio.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, the causal association between the events Acute kidney injury, Tubulointerstitial nephritis and suspect drug BNT162b2 cannot be cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201326258 Same article/drug/event different patient;US-PFIZER INC-PV202200110499 Same article/drug/event different patient;
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney, Blood creatinine, SARS-CoV-2 test, Tubulointerstitial nephritis
Clinical narrative: 10 days after her first dose of Pfizer SARS-CoV-2 vaccine she developed AKI; AIN; This is a literature report.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; ipilimumab (IPILIMUMAB), (Batch/Lot number: unknown) for metastatic malignant melanoma. The patient's relevant medical history included: "Metastatic melanoma" (ongoing), notes: was on Ipilimumab for Metastatic melanoma. The patient's concomitant medications were not reported. The following information was reported: ACUTE KIDNEY INJURY (medically significant), 10 days after the suspect product(s) administration, outcome "unknown", described as "10 days after her first dose of Pfizer SARS-CoV-2 vaccine she developed AKI"; TUBULOINTERSTITIAL NEPHRITIS (medically significant), outcome "unknown", described as "AIN". The patient underwent the following laboratory tests and procedures: Biopsy kidney: showed AIN; Blood creatinine: 3.4 mg/dl, notes: (b/1 1.3 mg/dL); 1.6 mg/dl, notes: At 5 months; SARS-CoV-2 test: Negative. The action taken for ipilimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of acute kidney injury, tubulointerstitial nephritis. The following death information was reported, despite no fatal outcome. The patient date of death was unknown. Reported cause of death: "Sepsis", "Multiorgan failure". It was not reported if an autopsy was performed.  Clinical Course: A 68 year old female was on ipilimumab for metastatic melanoma. 10 days after her first dose of Pfizer SARS-CoV-2 vaccine, she developed AKI, SCr 3.4 mg/dL (b/1 1.3 mg/dL). COVID-19 PCR was negative. Kidney biopsy showed AIN. ICPi was stopped and oral prednisone (1mg/kg) was started. At 5 months her SCr was 1.6 mg/dL on prednisone 5 mg qd, however she died from sepsis and multiorgan failure.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201326257 Same article/drug/event different patient;US-PFIZER INC-PV202200110499 Same article/drug/event different patient;; Reported Cause(s) of Death: Sepsis; Multiorgan failure
Sex: F
Vaccine: COVID19-2
Symptoms: Migraine, Nasopharyngitis
Clinical narrative: felt like I was getting a cold; migraines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "felt like I was getting a cold"; MIGRAINE (non-serious), outcome "unknown", described as "migraines".  Additional information: On Saturday or Friday we went to get vaccinated in (Place name withheld), we got vaccinated and the night of the vaccine, we got vaccinated at about 7. Of the 4 that we got vaccinated, because we got all vaccinated, the patient also felt like she was getting a cold. The patient read a little bit and saw that could be a side effect. Aside from the sore throat, he had very strong migraines and she did too, but the patient know that headaches are associated with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Laryngoscopy, Vocal cord paralysis
Clinical narrative: This time, she was found to have bilateral VFP with incomplete closure; This is a literature report.  A 45-year-old female with DM, HTN and End Stage Kidney Disease 2/2 Focal Segmental Glomerulosclerosis s/p kidney transplant that failed after 16 years (on low dose tacrolimus) requiring to start hemodialysis presented to the ED with complaints of voice hoarseness with dysarthria and throat itching that started ~30- 45 minutes after having received the first dose of Pfizer-BioNTech COVID-19 vaccine. She underwent Fiberoptic Indirect Laryngoscopy that showed widely patent airway with mobile vocal cords bilaterally. Symptoms were thought to be secondary to a reaction to the vaccine vs mild GERD. She received steroids and was discharged home within 24 hours after symptomatic improvement on steroid therapy. Her voice normalized within a week. Six months later, she received the second dose of Pfizer-BioNTech vaccine, ~30 minutes after which again developed dysphonia and dysarthria. This time, she was found to have bilateral VFP with incomplete closure. Steroid therapy was reinitiated and is slowly being tapered. Her dysarthria has improved; however, she continues to have hoarseness of voice even after 9 months of having received 2nd dose of vaccine. She has not received the booster dose of vaccine.; Sender's Comments: Based on the known the information available the Causal relation between the event Vocal cord paralysis  and suspect drug cannot be excluded completely The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Protein urine present
Clinical narrative: CV-19 vaccine: protein in urine has increased dramatically and seems to be getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; finerenone (KERENDIA), (Batch/Lot number: unknown) at 10 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer.), for covid-19 immunization. The following information was reported: PROTEIN URINE PRESENT (non-serious), outcome "unknown", described as "CV-19 vaccine: protein in urine has increased dramatically and seems to be getting worse". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for finerenone was unknown.  Additional information: Caller is calling about CV-19 vaccine, confirmed manufacturer is Pfizer. CV-19 vaccine: protein in urine has increased dramatically and seems to be getting worse: Had last shot a year ago in Aug, which was caller's 3rd shot. On Pfizer website lists a condition that the vaccine could cause kidney damage, kidney doctor noticed that protein in urine has increased dramatically and seems to be getting worse now. Doctor prescribed caller a special drug called Kerendia, which is very expensive. Caller is wondering if Pfizer will take care of the copayment of Kerendia because copay is very high. No report related to a study or programme.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19-2
Symptoms: Vascular pain
Clinical narrative: pain in the veins that is different; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer.), for COVID-19 immunization. The following information was reported: VASCULAR PAIN (non-serious) with onset 17Nov2022, outcome "unknown", described as "pain in the veins that is different". Additional Information: Patient said he got the Pfizer bivalent vaccine on 16Nov2022 and then after two days, got pain in the veins that was different. He was querying if this was normal, or something was wrong.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Illness
Clinical narrative: got really sick; got some joint problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got really sick"; ARTHROPATHY (non-serious), outcome "unknown", described as "got some joint problems". Therapeutic measures were taken as a result of arthropathy.  Additional information: During report caller mentioned that his sister got really sick off he believed either the Pfizer Covid or Moderna Covid vaccine. She got some joint problems and took steroids. Did not want to report. He would contact his sister and have her report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: its swelling up and that it was getting worse; its swelling up and that it was getting worse; it got harder and more painful and now its itchy; it got harder and more painful and now its itchy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Nov2022 as dose number unknown, single (Lot number: FJ2602) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 2022, outcome "unknown" and all described as "it got harder and more painful and now its itchy"; VACCINATION SITE SWELLING (non-serious) with onset 2022, outcome "not recovered", CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "unknown" and all described as "its swelling up and that it was getting worse".  Additional information: Reporter stated that a patient received her vaccine, the Prevnar 20 vaccine on 21Nov2022 (Monday). She called in the morning of an unknown date and reported that it swelled up and that it was getting worse and she said that was about a centimeter to an inch below where the injection site was and over the last week it got harder and more painful and later it was itchy. She reported that it was like getting worse. Reporter stated that she wanted to report it and then she asked what she should do and they were not 100 percent sure on what to direct her.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: Fatigue; Myalgias; Chills; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 22Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCREVUS. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 24Mar2021, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 23Aug2021, outcome "recovered"; FATIGUE (non-serious) with onset 23Aug2021, outcome "recovered"; MYALGIA (non-serious) with onset 23Aug2021, outcome "recovered", described as "Myalgias".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, CSF test, Magnetic resonance imaging, Paraesthesia, Urinary retention
Clinical narrative: urinary retention; arm paresthesia; leg weakness; This is a literature report.  A 31-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: URINARY RETENTION (medically significant), 1 week after the suspect product(s) administration, outcome "unknown"; PARAESTHESIA (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "arm paresthesia"; ASTHENIA (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "leg weakness". The patient underwent the following laboratory tests and procedures: CSF test: compatible with neuroinflammation; Magnetic resonance imaging: demonstrated T2 hyperintensity, notes: at T5 and T8- T9 with enhancement. Therapeutic measures were taken as a result of urinary retention, paraesthesia, asthenia.  Clinical course: Patient developed arm paresthesias, leg weakness and urinary retention one week following her first dose. She received five days methylprednisolone and IVIG. She remains wheelchair bound with urinary retention. . Other causes of transverse myelitis including neuromyelitis optica and myelin oligodendrocyte associated disease were ruled out. This case raised concern that mRNA vaccinations may be associated with neurologic complications due to heightened immune reactivity.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201325883 Same Article/drug/event and different patient;US-PFIZER INC-202201325886 Same Article/drug/event and different patient;US-PFIZER INC-202201325885 Same Article/drug and different patient and event;US-PFIZER INC-202201325886 Same Article/drug/event and different patient;
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney, Blood creatinine, SARS-CoV-2 test, Tubulointerstitial nephritis
Clinical narrative: Came with AKI after he received first dose; AIN; This is a literature report.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; pembrolizumab (PEMBROLIZUMAB), (Batch/Lot number: unknown) for lung adenocarcinoma. The patient's relevant medical history included: "Lung adenocarcinoma" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ACUTE KIDNEY INJURY (medically significant), outcome "recovered", described as "Came with AKI after he received first dose"; TUBULOINTERSTITIAL NEPHRITIS (medically significant), outcome "recovered", described as "AIN". The patient underwent the following laboratory tests and procedures: Biopsy kidney: Showed AIN, notes: Acute interstitial nephritis (AIN); Blood creatinine: 1.1 mg/dl, notes: b/1; 7.65 mg/dl; declined sharply; 1.7 mg/dl, notes: imrproved; SARS-CoV-2 test: Negative. The action taken for pembrolizumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of acute kidney injury, tubulointerstitial nephritis.  Clinical information. ICPi was stopped and oral prednisone (1 mg/kg) was started. Rechallenge with ICPi was defered.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201326258 Same article/drug/event different patient;US-PFIZER INC-202201326257 Same article/drug/event different patient;US-PFIZER INC-202201326257 Same article/drug/event different patient;US-PFIZER INC-202201326258 Same article/drug/event different patient;
Sex: F
Vaccine: COVID19
Symptoms: Laryngoscopy, Vocal cord paralysis
Clinical narrative: Vocal Fold Paralysis; This is a literature report.  A 45-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "End Stage Kidney Disease" (unspecified if ongoing); "Focal Segmental Glomerulosclerosis" (unspecified if ongoing), notes: 2/2; "kidney transplant" (unspecified if ongoing), notes: failed after 16 years, (on low dose tacrolimus) requiring to start, hemodialysis; "hemodialysis" (unspecified if ongoing). Concomitant medication(s) included: TACROLIMUS taken for renal transplant.  The following information was reported: VOCAL CORD PARALYSIS (hospitalization, medically significant), outcome "recovered", described as "Vocal Fold Paralysis". The event "vocal fold paralysis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Laryngoscopy: widely patent airway with mobile vocal cords, notes: showed widely patent airway with mobile vocal cords bilaterally. Therapeutic measures were taken as a result of vocal cord paralysis.  Clinical Course: Patient had kidney transplant that failed after 16 years (on low dose tacrolimus) requiring to start hemodialysis presented to the ED with complaints of voice hoarseness with dysarthria and throat itching that started 30-45 minutes after patient had the first dose of Pfizer-BioNTech COVID-19 vaccine. She underwent Fiberoptic Indirect Laryngoscopy that showed widely patent airway with mobile vocal cords bilaterally (Vocal Fold Paralysis). Symptoms were thought to be secondary to a reaction to the vaccine vs mild GERD. She received steroids and was discharged home within 24 hours after symptomatic improvement on steroid therapy. Her voice normalized within a week. ; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-Vocal  cord paralysis The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Biopsy kidney, Cardiac tamponade, Computerised tomogram thorax
Clinical narrative: ANCA-Associated Vasculitis Associated With Cardiac Tamponade; ANCA-Associated Vasculitis Associated With Cardiac Tamponade; This is a literature report.  A 74-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Diabetes" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (medically significant, life threatening), CARDIAC TAMPONADE (medically significant, life threatening), outcome "unknown" and all described as "ANCA-Associated Vasculitis Associated With Cardiac Tamponade". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: titer of 1:160; Positive, notes: MPO-ANCA antibody with a titer of 1:160; Biopsy kidney: showed MPO-ANCA mediated crescentic focal, notes: necrotizing and focal sclerosing glomerulonephritis; Computerised tomogram thorax: showed moderate to large pericardial effusion; Echocardiogram: moderate to large pericardial effusion, notes: which was subsequently confirmed on Echocardiogram; Protein urine: nephrotic range proteinuria; Urine protein/creatinine ratio: 4, notes: Unite: g/g. Therapeutic measures were taken as a result of cardiac tamponade.  74- year-old woman with history of Hypertension, Diabetes presented with generalized fatigue and occasional cough after getting Pfizer-BioNTech covid vaccine in June 2021. She had nephrotic range proteinuria with UPCR of 4 g/g, serum positive for MPO-ANCA antibody with a titer of 1:160. CT chest showed moderate to large pericardial effusion which was subsequently confirmed on Echocardiogram. Kidney biopsy was done and showed MPO-ANCA mediated crescentic focal necrotizing and focal sclerosing glomerulonephritis. The patient later developed transient episode of SVT which required higher level of care and a pericardiocentesis was done for cardiac tamponade and impending cardiac collapse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS, CARDIAC TAMPONADE and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Protein urine, Urine protein/creatinine ratio
Clinical narrative: ANCA-Associated Vasculitis Associated With Cardiac Tamponade; ANCA-Associated Vasculitis Associated With Cardiac Tamponade; This is a literature report.  A 74-year-old female patient received BNT162b2 (BNT162B2), in Jun2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing); "Diabetes" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (medically significant, life threatening), CARDIAC TAMPONADE (medically significant, life threatening), outcome "unknown" and all described as "ANCA-Associated Vasculitis Associated With Cardiac Tamponade". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: titer of 1:160; Positive, notes: MPO-ANCA antibody with a titer of 1:160; Biopsy kidney: showed MPO-ANCA mediated crescentic focal, notes: necrotizing and focal sclerosing glomerulonephritis; Computerised tomogram thorax: showed moderate to large pericardial effusion; Echocardiogram: moderate to large pericardial effusion, notes: which was subsequently confirmed on Echocardiogram; Protein urine: nephrotic range proteinuria; Urine protein/creatinine ratio: 4, notes: Unite: g/g. Therapeutic measures were taken as a result of cardiac tamponade.  74- year-old woman with history of Hypertension, Diabetes presented with generalized fatigue and occasional cough after getting Pfizer-BioNTech covid vaccine in June 2021. She had nephrotic range proteinuria with UPCR of 4 g/g, serum positive for MPO-ANCA antibody with a titer of 1:160. CT chest showed moderate to large pericardial effusion which was subsequently confirmed on Echocardiogram. Kidney biopsy was done and showed MPO-ANCA mediated crescentic focal necrotizing and focal sclerosing glomerulonephritis. The patient later developed transient episode of SVT which required higher level of care and a pericardiocentesis was done for cardiac tamponade and impending cardiac collapse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS, CARDIAC TAMPONADE and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing). Concomitant medication(s) included: OCRELIZUMAB. The following information was reported: PYREXIA (non-serious) with onset 05Sep2021, outcome "recovered", described as "Low grade fever".  Additional information: patient age was reported as 36 (no units provided).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Anti-glomerular basement membrane antibody, Anti-glomerular basement membrane disease, Biopsy kidney, Blood creatinine
Clinical narrative: stage 3 acute kidney injury; Anti-GBM Disease; This is a literature report.  IgA nephropathy was the most reported glomerulonephritis post-COVID vaccination. Other reported cases include atypical anti-GBM nephritis, among others. Treatment consists of immunosuppressants and plasmapheresis with renal replacement therapy. Renal outcomes have varied. A case was presented of isolated anti-GBM nephritis in a patient whose renal injury occurred weeks after receiving a booster dose of COVID vaccine. A 59-year-old male with recent history of ureteral stones with stent placement, travel history in the last 6 months and use of doxycycline for suspected Lyme's disease in the last 3 months presented to the emergency department for decreased urine output, fevers, and arthralgias. He also received a Pfizer COVID vaccine booster 6 weeks ago. His symptoms had worsened in the last 2 weeks. On initial evaluation, he was noted to have stage 3 acute kidney injury (AKI) with creatinine 5.3 mg/dL. Although he had findings of nephrolithiasis, no ureteral obstruction or hydronephrosis were noted on imaging. He received extensive infectious work up which was all negative. Hemodialysis was initiated on day 7 for metabolic derangements and volume overload. After infectious work up was negative, renal biopsy was performed revealing linear IgG deposits. Serum anti-GBM antibodies were positive. Despite receiving plasmapheresis, cyclophosphamide and prednisone, the patient continued to require dialysis and was discharged on home hemodialysis. The development of AKI with systemic symptoms occurred about 6 weeks following his COVID vaccine, longer than previously reported cases. The patient also has a history of nephrolithiasis. At this time, direct association of this patient's anti-GBM disease with the COVID vaccine was unclear however remains a clinical consideration. The presentation of anti-GBM disease as unique as disease was limited to renal involvement.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events-Acute Kidney Injury and Anti-GBM disease The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Imaging procedure, Investigation
Clinical narrative: stage 3 acute kidney injury; Anti-GBM Disease; This is a literature report.  IgA nephropathy was the most reported glomerulonephritis post-COVID vaccination. Other reported cases include atypical anti-GBM nephritis, among others. Treatment consists of immunosuppressants and plasmapheresis with renal replacement therapy. Renal outcomes have varied. A case was presented of isolated anti-GBM nephritis in a patient whose renal injury occurred weeks after receiving a booster dose of COVID vaccine. A 59-year-old male with recent history of ureteral stones with stent placement, travel history in the last 6 months and use of doxycycline for suspected Lyme's disease in the last 3 months presented to the emergency department for decreased urine output, fevers, and arthralgias. He also received a Pfizer COVID vaccine booster 6 weeks ago. His symptoms had worsened in the last 2 weeks. On initial evaluation, he was noted to have stage 3 acute kidney injury (AKI) with creatinine 5.3 mg/dL. Although he had findings of nephrolithiasis, no ureteral obstruction or hydronephrosis were noted on imaging. He received extensive infectious work up which was all negative. Hemodialysis was initiated on day 7 for metabolic derangements and volume overload. After infectious work up was negative, renal biopsy was performed revealing linear IgG deposits. Serum anti-GBM antibodies were positive. Despite receiving plasmapheresis, cyclophosphamide and prednisone, the patient continued to require dialysis and was discharged on home hemodialysis. The development of AKI with systemic symptoms occurred about 6 weeks following his COVID vaccine, longer than previously reported cases. The patient also has a history of nephrolithiasis. At this time, direct association of this patient's anti-GBM disease with the COVID vaccine was unclear however remains a clinical consideration. The presentation of anti-GBM disease as unique as disease was limited to renal involvement.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported events-Acute Kidney Injury and Anti-GBM disease The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Oral lichen planus, Stomatitis
Clinical narrative: Oral lichen planus; lichenoid mucositis; This is a literature report.  A 56-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; hydroxychloroquine (HYDROXYCHLOROQUINE), (Batch/Lot number: unknown) for covid-19. The patient's relevant medical history included: "COVID-19", start date: Mar2021 (unspecified if ongoing), notes: diagnosed in March 2021. The patient's concomitant medications were not reported. The following information was reported: ORAL LICHEN PLANUS (medically significant) with onset Apr2021, outcome "unknown"; STOMATITIS (non-serious) with onset Apr2021, outcome "unknown", described as "lichenoid mucositis". The action taken for hydroxychloroquine was unknown. Therapeutic measures were taken as a result of oral lichen planus, stomatitis.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event oral lichen planus and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201330243 Same article/ drug/event and different patient:;US-PFIZER INC-202201330242 Same article/ drug/event and different patient:;US-PFIZER INC-202201330241 Same article/ drug/event and different patient:;
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Biopsy skin, C-reactive protein, Complement factor C3, Complement factor C4
Clinical narrative: systemic lupus erythematosus after COVID-19 vaccination/ Pfizer-BioNTech (BNT162b2); This is a literature report.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "systemic lupus erythematosus after COVID-19 vaccination/ Pfizer-BioNTech (BNT162b2)". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: positive, notes: (1:2560); positive; positive; Biopsy skin: revealed a superficial and deep perivascular, notes: and periadnexal infiltrate comprised of lymphocytes, with occasional neutrophils and neutrophilic debris. These features were consistent with a neutrophilic urticarial dermatosis, which can often be associated with SLE, and thus, pointed to a diagnosis of SLE given the dermatologic and laboratory findings.The scalp lesions were unable to be biopsied due to patient refusal; Complement factor C3: 62.3 mg/dl, notes: low complement levels; Complement factor C4: 11.8 mg/dl, notes: low complement levels; C-reactive protein: 5.1 mg/l, notes: elevated; Examination: ill-defined, erythematous, tender plaques, notes: and nodules on the face, arms, frontal scalp, legs, and chest. The patient also developed scarring alopecia with scalp lesions clinically consistent with discoid lupus erythematosus; Laboratory workup: revealed leukopenia; Protein urine: 54.2 mg/dl, notes: elevated; Urine protein/creatinine ratio: 237 mg/g, notes: units: mg/gm elevated; White blood cell count: 2520 /mm3, notes: units: /UL leukopenia. Therapeutic measures were taken as a result of systemic lupus erythematosus.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-SYSTEMIC LUPUS ERYTHEMATOSUS  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Laboratory test, Protein urine, Systemic lupus erythematosus, Urine protein/creatinine ratio
Clinical narrative: systemic lupus erythematosus after COVID-19 vaccination/ Pfizer-BioNTech (BNT162b2); This is a literature report.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "systemic lupus erythematosus after COVID-19 vaccination/ Pfizer-BioNTech (BNT162b2)". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: positive, notes: (1:2560); positive; positive; Biopsy skin: revealed a superficial and deep perivascular, notes: and periadnexal infiltrate comprised of lymphocytes, with occasional neutrophils and neutrophilic debris. These features were consistent with a neutrophilic urticarial dermatosis, which can often be associated with SLE, and thus, pointed to a diagnosis of SLE given the dermatologic and laboratory findings.The scalp lesions were unable to be biopsied due to patient refusal; Complement factor C3: 62.3 mg/dl, notes: low complement levels; Complement factor C4: 11.8 mg/dl, notes: low complement levels; C-reactive protein: 5.1 mg/l, notes: elevated; Examination: ill-defined, erythematous, tender plaques, notes: and nodules on the face, arms, frontal scalp, legs, and chest. The patient also developed scarring alopecia with scalp lesions clinically consistent with discoid lupus erythematosus; Laboratory workup: revealed leukopenia; Protein urine: 54.2 mg/dl, notes: elevated; Urine protein/creatinine ratio: 237 mg/g, notes: units: mg/gm elevated; White blood cell count: 2520 /mm3, notes: units: /UL leukopenia. Therapeutic measures were taken as a result of systemic lupus erythematosus.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-SYSTEMIC LUPUS ERYTHEMATOSUS  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: systemic lupus erythematosus after COVID-19 vaccination/ Pfizer-BioNTech (BNT162b2); This is a literature report.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), 1 week after the suspect product(s) administration, outcome "recovering", described as "systemic lupus erythematosus after COVID-19 vaccination/ Pfizer-BioNTech (BNT162b2)". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: positive, notes: (1:2560); positive; positive; Biopsy skin: revealed a superficial and deep perivascular, notes: and periadnexal infiltrate comprised of lymphocytes, with occasional neutrophils and neutrophilic debris. These features were consistent with a neutrophilic urticarial dermatosis, which can often be associated with SLE, and thus, pointed to a diagnosis of SLE given the dermatologic and laboratory findings.The scalp lesions were unable to be biopsied due to patient refusal; Complement factor C3: 62.3 mg/dl, notes: low complement levels; Complement factor C4: 11.8 mg/dl, notes: low complement levels; C-reactive protein: 5.1 mg/l, notes: elevated; Examination: ill-defined, erythematous, tender plaques, notes: and nodules on the face, arms, frontal scalp, legs, and chest. The patient also developed scarring alopecia with scalp lesions clinically consistent with discoid lupus erythematosus; Laboratory workup: revealed leukopenia; Protein urine: 54.2 mg/dl, notes: elevated; Urine protein/creatinine ratio: 237 mg/g, notes: units: mg/gm elevated; White blood cell count: 2520 /mm3, notes: units: /UL leukopenia. Therapeutic measures were taken as a result of systemic lupus erythematosus.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-SYSTEMIC LUPUS ERYTHEMATOSUS  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Got it, and now have the flu; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves patient of unknown demographics who got Influenza vaccine, and then had the flu.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for Flu(Influenza). Information regarding batch number details has been requested.  On an unknown date the patient developed a non-serious event got it, and now have the flu (influenza)(unknown latency) following the administration of INFLUENZA VACCINE.  Action taken: not applicable.  Corrective treatment: Not reported.  At time of reporting, the outcome was Unknown for the event got it, and now have the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Only time I ever got the flu was the year I got the shot; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves a patient of an unknown age and gender who reported only time i ever got the flu was the year i got the shot after receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, administration site, lot number and expiry date) for immunisation.  On an unknown date, the patient experienced only time he ever got the flu was the year he got the shot (influenza) (latency: unknown) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.