chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Mycoplasma test negative, Pneumocystis test negative, Pneumonia, Pulmonary mass, Respiratory pathogen panel
Clinical narrative: Initial Report / Final. Event Term: Pneumonia. Subject Currently participating in the Janssen study protocol dosed with study med on 01/26/2023 Presented to the emergency department with worsening shortness of breath on 05/15/2023. A CT chest 3 days prior to hospitalization showed a right upper lobe pulmonary nodule with ground-glass opacities measuring 1.0 x 1.4 cm. On admission 05/15/2023 chest x-ray showed suspected multilobar atypical pneumonia. She was also noted to have an Acute Kidney injury with a creatinine of 1.9 on admission. CT chest in hospital on 5/15/2023 showed multifocal small airway disease with bronchopneumonia in the posterior right upper lobe and coarse broncho vascular and peripheral opacities in both lower lobes with more consolidative opacities in the basilar portions that may represent areas of organizing pneumonia. Pulmonology was consulted for bronchoscopy. Bronchoscopy was performed on 5/16/2023. Blood cultures had no growth , influenza, COVID negative mycoplasma pneumonia negative strep pneumo negative, Legionella urine negative, Blastomyces not detected, Histoplasma urine not detected, Fungitell negative, Aspergillus negative, MRSA negative, Pneumocystis negative, mycobacterial culture negative, respiratory panel negative, cytomegalovirus PCR negative, no cardia negative, pneumocystis smear fungal smear negative, Legionella culture negative, acid-fast for mycobacterium negative. All micro workup so far has been unremarkable. Given concern for possible tuberculosis with patient's recent travel history and location of lung imaging findings patient was placed on airborne precautions. Multiple cultures were negative, IPAC was. contacted. Subject was initially treated with ceftriaxone and azithromycin transitioned to oral cefdinir on discharge 5/19/2023 to finish out total extended 10-day course. Azithromycin was discontinued. Mycophenolate was held per renal transplant recommendation given active pneumonia. Patient will need to follow up with renal transplant outpatient to discuss timing of restarting this medication. Tacrolimus and prednisone were continued. Given cough and delayed mucus clearance, patient was given Mucinex, phenylephrine nasal spray, Flonase, pep therapy with Aerobika, DuoNebs, hypertonic saline and normal saline nebulizers. All which helped improve patient's congestion and shortness of breath. Patient was also initiated on Claritin to help with postnasal drip and allergic rhinitis. Subject was being sent home with nebulizers and instructions to continue the medications. Patient discharged on 05/19/2023 to home for further recover. Subject will have follow up with pulmonology. Admission: 5/15/2023 / Discharge: 5/19/2023 As per staff casualty/relationship is not study related.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinitis allergic, SARS-CoV-2 test negative, Secretion discharge, Small airways disease
Clinical narrative: Initial Report / Final. Event Term: Pneumonia. Subject Currently participating in the Janssen study protocol dosed with study med on 01/26/2023 Presented to the emergency department with worsening shortness of breath on 05/15/2023. A CT chest 3 days prior to hospitalization showed a right upper lobe pulmonary nodule with ground-glass opacities measuring 1.0 x 1.4 cm. On admission 05/15/2023 chest x-ray showed suspected multilobar atypical pneumonia. She was also noted to have an Acute Kidney injury with a creatinine of 1.9 on admission. CT chest in hospital on 5/15/2023 showed multifocal small airway disease with bronchopneumonia in the posterior right upper lobe and coarse broncho vascular and peripheral opacities in both lower lobes with more consolidative opacities in the basilar portions that may represent areas of organizing pneumonia. Pulmonology was consulted for bronchoscopy. Bronchoscopy was performed on 5/16/2023. Blood cultures had no growth , influenza, COVID negative mycoplasma pneumonia negative strep pneumo negative, Legionella urine negative, Blastomyces not detected, Histoplasma urine not detected, Fungitell negative, Aspergillus negative, MRSA negative, Pneumocystis negative, mycobacterial culture negative, respiratory panel negative, cytomegalovirus PCR negative, no cardia negative, pneumocystis smear fungal smear negative, Legionella culture negative, acid-fast for mycobacterium negative. All micro workup so far has been unremarkable. Given concern for possible tuberculosis with patient's recent travel history and location of lung imaging findings patient was placed on airborne precautions. Multiple cultures were negative, IPAC was. contacted. Subject was initially treated with ceftriaxone and azithromycin transitioned to oral cefdinir on discharge 5/19/2023 to finish out total extended 10-day course. Azithromycin was discontinued. Mycophenolate was held per renal transplant recommendation given active pneumonia. Patient will need to follow up with renal transplant outpatient to discuss timing of restarting this medication. Tacrolimus and prednisone were continued. Given cough and delayed mucus clearance, patient was given Mucinex, phenylephrine nasal spray, Flonase, pep therapy with Aerobika, DuoNebs, hypertonic saline and normal saline nebulizers. All which helped improve patient's congestion and shortness of breath. Patient was also initiated on Claritin to help with postnasal drip and allergic rhinitis. Subject was being sent home with nebulizers and instructions to continue the medications. Patient discharged on 05/19/2023 to home for further recover. Subject will have follow up with pulmonology. Admission: 5/15/2023 / Discharge: 5/19/2023 As per staff casualty/relationship is not study related.
Sex: U
Vaccine: COVID19
Symptoms: Smear test, Sputum retention, Staphylococcus test negative, Streptococcus test negative, Upper-airway cough syndrome
Clinical narrative: Initial Report / Final. Event Term: Pneumonia. Subject Currently participating in the Janssen study protocol dosed with study med on 01/26/2023 Presented to the emergency department with worsening shortness of breath on 05/15/2023. A CT chest 3 days prior to hospitalization showed a right upper lobe pulmonary nodule with ground-glass opacities measuring 1.0 x 1.4 cm. On admission 05/15/2023 chest x-ray showed suspected multilobar atypical pneumonia. She was also noted to have an Acute Kidney injury with a creatinine of 1.9 on admission. CT chest in hospital on 5/15/2023 showed multifocal small airway disease with bronchopneumonia in the posterior right upper lobe and coarse broncho vascular and peripheral opacities in both lower lobes with more consolidative opacities in the basilar portions that may represent areas of organizing pneumonia. Pulmonology was consulted for bronchoscopy. Bronchoscopy was performed on 5/16/2023. Blood cultures had no growth , influenza, COVID negative mycoplasma pneumonia negative strep pneumo negative, Legionella urine negative, Blastomyces not detected, Histoplasma urine not detected, Fungitell negative, Aspergillus negative, MRSA negative, Pneumocystis negative, mycobacterial culture negative, respiratory panel negative, cytomegalovirus PCR negative, no cardia negative, pneumocystis smear fungal smear negative, Legionella culture negative, acid-fast for mycobacterium negative. All micro workup so far has been unremarkable. Given concern for possible tuberculosis with patient's recent travel history and location of lung imaging findings patient was placed on airborne precautions. Multiple cultures were negative, IPAC was. contacted. Subject was initially treated with ceftriaxone and azithromycin transitioned to oral cefdinir on discharge 5/19/2023 to finish out total extended 10-day course. Azithromycin was discontinued. Mycophenolate was held per renal transplant recommendation given active pneumonia. Patient will need to follow up with renal transplant outpatient to discuss timing of restarting this medication. Tacrolimus and prednisone were continued. Given cough and delayed mucus clearance, patient was given Mucinex, phenylephrine nasal spray, Flonase, pep therapy with Aerobika, DuoNebs, hypertonic saline and normal saline nebulizers. All which helped improve patient's congestion and shortness of breath. Patient was also initiated on Claritin to help with postnasal drip and allergic rhinitis. Subject was being sent home with nebulizers and instructions to continue the medications. Patient discharged on 05/19/2023 to home for further recover. Subject will have follow up with pulmonology. Admission: 5/15/2023 / Discharge: 5/19/2023 As per staff casualty/relationship is not study related.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: ADMINISTERED ERROR:  Administered after use by date, no reaction
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lip swelling without respiratory problem, open air, vital signs normal, given loratadine 10 mg Stat, then daily PRN
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Anal haemorrhage, Arthralgia, Deafness unilateral, Diarrhoea
Clinical narrative: NAUSEA, VOMITING, EXTREME ABDOMINAL CRAMPS, MUSCLE AND JOINT PAIN, DIARHEA, ANAL BLEEDING, EXTREME FATIGUE, FEVER, HEADACHE FOR 7 DAYS.  TINNUITIS-CHRONIC . LEFT EAR WENT DEAF -2 DAYS, RIGHT EAR PLUGGED -2 DAYS, FATIGUE - CHRONIC
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: NAUSEA, VOMITING, EXTREME ABDOMINAL CRAMPS, MUSCLE AND JOINT PAIN, DIARHEA, ANAL BLEEDING, EXTREME FATIGUE, FEVER, HEADACHE FOR 7 DAYS.  TINNUITIS-CHRONIC . LEFT EAR WENT DEAF -2 DAYS, RIGHT EAR PLUGGED -2 DAYS, FATIGUE - CHRONIC
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus, Vomiting
Clinical narrative: NAUSEA, VOMITING, EXTREME ABDOMINAL CRAMPS, MUSCLE AND JOINT PAIN, DIARHEA, ANAL BLEEDING, EXTREME FATIGUE, FEVER, HEADACHE FOR 7 DAYS.  TINNUITIS-CHRONIC . LEFT EAR WENT DEAF -2 DAYS, RIGHT EAR PLUGGED -2 DAYS, FATIGUE - CHRONIC
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Lymphadenopathy, Mammogram abnormal, Nausea, Oedema peripheral
Clinical narrative: Armpit Large Swelling *** Mammogram and ultrasound performed and shows presence of 2 axillary lymph nodes demonstrating cortical thickening measuring upward of .5 cm  Nauseu, fever, loss of appetite
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Ultrasound scan abnormal
Clinical narrative: Armpit Large Swelling *** Mammogram and ultrasound performed and shows presence of 2 axillary lymph nodes demonstrating cortical thickening measuring upward of .5 cm  Nauseu, fever, loss of appetite
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: SUFFERED A STROKE ON 5-16-21 REQUIRED EMERGENCY CARE AND 18 DAYS HOSPITALIZATION
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Laboratory test, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: I got my first Pfiser Vaccine on 2/9/2021 The second Pfiser shot on 3/2/21 A Pfiser booster 9/28/21  My symptomswas severe sore throat, congestion, and cough. it lasted two or three days and then started to get better, however it took about three weeks to clear completely.  I was tested at the doctors on 01/24/2022
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: ADMINISTERED ERROR:  Administered after use by date, no reaction
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Hysteroscopy, Polypectomy, Post procedural haemorrhage, Postmenopausal haemorrhage
Clinical narrative: After my booster in November 2021, I started spotting shortly after my booster was administered. I am 15 years post menopausal and have had no periods or spotting until after my booster.  My Gynocologist did a biopsy in December. Reslutls were negative for cancer.  Bleeding and spooting continued and She also performed a D&C and Hysterscopy 3/17.  Results for cancer were negative and one polyp was removed.  Post surgery, bleeding has continue for no known reason.  I want to report this as a vaccination side effect and be advised as to what studies are onging.  My research has proved this is not an isolated incident and many women have reported the same - most women would not know where or how to report.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Uterine dilation and curettage, Vaginal haemorrhage
Clinical narrative: After my booster in November 2021, I started spotting shortly after my booster was administered. I am 15 years post menopausal and have had no periods or spotting until after my booster.  My Gynocologist did a biopsy in December. Reslutls were negative for cancer.  Bleeding and spooting continued and She also performed a D&C and Hysterscopy 3/17.  Results for cancer were negative and one polyp was removed.  Post surgery, bleeding has continue for no known reason.  I want to report this as a vaccination side effect and be advised as to what studies are onging.  My research has proved this is not an isolated incident and many women have reported the same - most women would not know where or how to report.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood creatinine, Borrelia test negative, Condition aggravated, Deafness neurosensory
Clinical narrative: Several weeks after receiving the vaccine, I experienced a very sharp pain and a brief, loud noise in my left ear. The pain varied in intensity but was present at times for approximately 10 days. I also heard odd sounds (e.g., chimes) with the left ear. The pain was followed by sudden onset of severe tinnitus and gradual loss in hearing acuity. Sound was muffled and ear felt full. Prior to this episode, I wore a hearing aid in the left ear for a mild hearing loss. My hearing was re-tested and hearing aid technician noted decline in left ear. When hearing worsened, I went to ENT on 12/14/21 and audiologist tested and noted significant hearing loss in left ear. Saw Physician Asst. in same office on same day. prescribed Prednisone 20 MG tablit taken orally starting with beginning with 60 mgs./day and tapering down to 10 mgs over 16 days. Hearing appeared to worsen. Patient experienced episodes of vertigo. By 12/24/21, patient had difficulty hearing any sound with left ear. MRI was performed on 23/37/21 and patient was tested for Lyme Disease. On 12/29/21, audiologist re-tested hearing. Hearing in left ear had worsened since 12/14/21. Patient was referred to ENT same day. Dr. administered 3 intratympanic steroid injections (12/29/21, 1/7/22, and 1/14/22). On 1/31/22, patient consulted Dr., Otorhinolaryngology. Dr's diagnoses were Meniere's disease of left ear (H81.02) and sensorineural hearing loss unilateral (H90.5). Hearing was tested by Dr., Au.D. on 2/14/22. Significant loss of hearing confirmed during audiological testing.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness unilateral, Ear discomfort, Ear pain, Hypoacusis, Magnetic resonance imaging head normal
Clinical narrative: Several weeks after receiving the vaccine, I experienced a very sharp pain and a brief, loud noise in my left ear. The pain varied in intensity but was present at times for approximately 10 days. I also heard odd sounds (e.g., chimes) with the left ear. The pain was followed by sudden onset of severe tinnitus and gradual loss in hearing acuity. Sound was muffled and ear felt full. Prior to this episode, I wore a hearing aid in the left ear for a mild hearing loss. My hearing was re-tested and hearing aid technician noted decline in left ear. When hearing worsened, I went to ENT on 12/14/21 and audiologist tested and noted significant hearing loss in left ear. Saw Physician Asst. in same office on same day. prescribed Prednisone 20 MG tablit taken orally starting with beginning with 60 mgs./day and tapering down to 10 mgs over 16 days. Hearing appeared to worsen. Patient experienced episodes of vertigo. By 12/24/21, patient had difficulty hearing any sound with left ear. MRI was performed on 23/37/21 and patient was tested for Lyme Disease. On 12/29/21, audiologist re-tested hearing. Hearing in left ear had worsened since 12/14/21. Patient was referred to ENT same day. Dr. administered 3 intratympanic steroid injections (12/29/21, 1/7/22, and 1/14/22). On 1/31/22, patient consulted Dr., Otorhinolaryngology. Dr's diagnoses were Meniere's disease of left ear (H81.02) and sensorineural hearing loss unilateral (H90.5). Hearing was tested by Dr., Au.D. on 2/14/22. Significant loss of hearing confirmed during audiological testing.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Meniere's disease, Scan with contrast normal, Tinnitus, Vertigo
Clinical narrative: Several weeks after receiving the vaccine, I experienced a very sharp pain and a brief, loud noise in my left ear. The pain varied in intensity but was present at times for approximately 10 days. I also heard odd sounds (e.g., chimes) with the left ear. The pain was followed by sudden onset of severe tinnitus and gradual loss in hearing acuity. Sound was muffled and ear felt full. Prior to this episode, I wore a hearing aid in the left ear for a mild hearing loss. My hearing was re-tested and hearing aid technician noted decline in left ear. When hearing worsened, I went to ENT on 12/14/21 and audiologist tested and noted significant hearing loss in left ear. Saw Physician Asst. in same office on same day. prescribed Prednisone 20 MG tablit taken orally starting with beginning with 60 mgs./day and tapering down to 10 mgs over 16 days. Hearing appeared to worsen. Patient experienced episodes of vertigo. By 12/24/21, patient had difficulty hearing any sound with left ear. MRI was performed on 23/37/21 and patient was tested for Lyme Disease. On 12/29/21, audiologist re-tested hearing. Hearing in left ear had worsened since 12/14/21. Patient was referred to ENT same day. Dr. administered 3 intratympanic steroid injections (12/29/21, 1/7/22, and 1/14/22). On 1/31/22, patient consulted Dr., Otorhinolaryngology. Dr's diagnoses were Meniere's disease of left ear (H81.02) and sensorineural hearing loss unilateral (H90.5). Hearing was tested by Dr., Au.D. on 2/14/22. Significant loss of hearing confirmed during audiological testing.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Infant irritability, Rash papular, Rash papulosquamous
Clinical narrative: PT DEVELOPED GENERALIZED ERYTHEMATOUS PAPULO SQUAMOUS RASH., FUSSINESS AFTER THIS OCCURED IN 2 HOURS AFTER INJECTIONS. NO MEDICATIONS GIVEN.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling cold, Insurance issue, Tooth fracture, Tooth loss
Clinical narrative: After getting the first two Vaccine shots with in a month I noticed a huge drop in my weight. I have weighed from 220 to 230 lbs for over 10 years. I was lost to why I had lost the weight so fast until I got my booster shot and I lost 15lbs within a week to two weeks after the shots just like it was after the first two shots. So now all together I have lost about 50 lbs. 30 lbs was about two weeks after first two shots then 15 right after third shot and it's still going down. I also within 24 hours of getting shots would get uncontrollably trimmers from feeling so cold and couldn't get warm and after going to sleep this way my teeth chattered so badly it cracked most of my teeth and had 3 fall out so far.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor, Weight decreased
Clinical narrative: After getting the first two Vaccine shots with in a month I noticed a huge drop in my weight. I have weighed from 220 to 230 lbs for over 10 years. I was lost to why I had lost the weight so fast until I got my booster shot and I lost 15lbs within a week to two weeks after the shots just like it was after the first two shots. So now all together I have lost about 50 lbs. 30 lbs was about two weeks after first two shots then 15 right after third shot and it's still going down. I also within 24 hours of getting shots would get uncontrollably trimmers from feeling so cold and couldn't get warm and after going to sleep this way my teeth chattered so badly it cracked most of my teeth and had 3 fall out so far.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: ADMINISTERED ERROR:  Administered after use by date, no reaction
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product administration error
Clinical narrative: ADMINISTERED ERROR:  Administered after use by date, no reaction
Sex: M
Vaccine: BCG
Symptoms: Death, Disseminated Bacillus Calmette-Guerin infection
Clinical narrative: BCG-itis; Literature Report:   Information has been received from the authors of a published literature article, titled as stated above, regarding a male patient of unknown age who was part of the authors' retrospective study aiming to identify the molecular basis of a syndromic form of severe combined immunodeficiency (SCID) and to perform genomic, molecular, biochemical, structural modeling, and in vitro disease modeling studies to analyze deleterious effects of the PAX1 variants identified.  The patient's medical history included allogeneic hematopoietic stem cell transplantation. Concurrent conditions included combined immunodeficiency (SCID), otofaciocervical syndrome type 2, fail to attain T cell reconstitution, PAX1 gene variation, born to consanguineous parents, severe bilateral microtia, postauricular sinuses, and micrognathia. He suffered from chronic diarrhea, recurrent respiratory infections, exfoliative dermatitis, and lymphadenopathy.   Un an unknown date the patient was vaccinated with a dose of BCG vaccine (manufacturer unknown) (route, and dosage information was not provided) for prophylaxis.  On an unknown date, the patient experienced regional dissemination of Bacille Calmette-Guerin (BCG-itis),   The outcome of the adverse event was unknown.  However, the authors reported that the patient died at 1 year of age.    Upon internal review, disseminated Bacillus Calmette-Guerin infection was considered to be a medically significant event.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature article (case no. 2305USA009605). ; Sender's Comments:  US-009507513-2305USA009605:
Sex: F
Vaccine: BCG
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin E, Blood immunoglobulin E increased, Blood immunoglobulin G decreased, Blood immunoglobulin M normal
Clinical narrative: BCG-itis;   Information has been received from the authors of a published literature article, titled as stated above, regarding a female patient of unknown age who was part of the authors' retrospective study aiming to identify the molecular basis of a syndromic form of severe combined immunodeficiency (SCID) and to perform genomic, molecular, biochemical, structural modeling, and in vitro disease modeling studies to analyze deleterious effects of the PAX1 variants identified.  The patient's medical history included allogeneic hematopoietic stem cell transplantation. Concurrent conditions included combined immunodeficiency (SCID), otofaciocervical syndrome type 2, fail to attain T cell reconstitution, PAX1 gene variation, born to consanguineous parents, small, low-set malformed ears, triangular mouth, down-slanting palpebral fissures, a small nose with a depressed nasal bridge, right facial palsy, recurrent respiratory infections, chronic diarrhea, severe exfoliative dermatitis and was diagnosed with Omenn syndrome.   Un an unknown date the patient was vaccinated with a dose of BCG vaccine (manufacturer unknown) (route, and dosage information was not provided) for prophylaxis.  On an unknown date, the patient experienced regional dissemination of Bacille Calmette-Guerin (BCG-itis).  On an unknow date, reported as at presentation, the patient had the following lab data results: Absolute neutrophil count: 3.8 cells x 10^-3/uL, Absolute lymphocyte count: 46.7 cells x 10^-3/uL, Absolute eosinophil count (unknown date): 9.6 cells x 10^-3/uL, Platelets: 780 x 10^-9/liter, CD3+: 43,985 cells/ul, CD4+: 10,762 cells/ul, CD8+: 17,313 cells/ul, CD19+: 936 cells/ul, CD16/56+: 1,404 cells/ul, In vitro proliferation to PHA (unknown date): 2.5 cpm × 10^-3, Blood immunoglobulin G: 170 mg/dl, Blood immunoglobulin M: 117 mg/dl, Blood immunoglobulin A: less than 25 mg/dl and Blood immunoglobulin E: 10,080 kU/l  The outcome of the adverse event was unknown.  However, the authors reported that the patient died at 8 months of age with progressive severe pneumonitis.    Upon internal review, disseminated Bacillus Calmette-Guerin infection was considered to be a medically significant event.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature article (case no. 2305USA008478). ; Sender's Comments:  US-009507513-2305USA008478:
Sex: F
Vaccine: BCG
Symptoms: CD4 lymphocytes, CD8 lymphocytes, Death, Disseminated Bacillus Calmette-Guerin infection, Eosinophil count increased
Clinical narrative: BCG-itis;   Information has been received from the authors of a published literature article, titled as stated above, regarding a female patient of unknown age who was part of the authors' retrospective study aiming to identify the molecular basis of a syndromic form of severe combined immunodeficiency (SCID) and to perform genomic, molecular, biochemical, structural modeling, and in vitro disease modeling studies to analyze deleterious effects of the PAX1 variants identified.  The patient's medical history included allogeneic hematopoietic stem cell transplantation. Concurrent conditions included combined immunodeficiency (SCID), otofaciocervical syndrome type 2, fail to attain T cell reconstitution, PAX1 gene variation, born to consanguineous parents, small, low-set malformed ears, triangular mouth, down-slanting palpebral fissures, a small nose with a depressed nasal bridge, right facial palsy, recurrent respiratory infections, chronic diarrhea, severe exfoliative dermatitis and was diagnosed with Omenn syndrome.   Un an unknown date the patient was vaccinated with a dose of BCG vaccine (manufacturer unknown) (route, and dosage information was not provided) for prophylaxis.  On an unknown date, the patient experienced regional dissemination of Bacille Calmette-Guerin (BCG-itis).  On an unknow date, reported as at presentation, the patient had the following lab data results: Absolute neutrophil count: 3.8 cells x 10^-3/uL, Absolute lymphocyte count: 46.7 cells x 10^-3/uL, Absolute eosinophil count (unknown date): 9.6 cells x 10^-3/uL, Platelets: 780 x 10^-9/liter, CD3+: 43,985 cells/ul, CD4+: 10,762 cells/ul, CD8+: 17,313 cells/ul, CD19+: 936 cells/ul, CD16/56+: 1,404 cells/ul, In vitro proliferation to PHA (unknown date): 2.5 cpm × 10^-3, Blood immunoglobulin G: 170 mg/dl, Blood immunoglobulin M: 117 mg/dl, Blood immunoglobulin A: less than 25 mg/dl and Blood immunoglobulin E: 10,080 kU/l  The outcome of the adverse event was unknown.  However, the authors reported that the patient died at 8 months of age with progressive severe pneumonitis.    Upon internal review, disseminated Bacillus Calmette-Guerin infection was considered to be a medically significant event.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature article (case no. 2305USA008478). ; Sender's Comments:  US-009507513-2305USA008478:
Sex: F
Vaccine: BCG
Symptoms: Laboratory test, Lymphocyte count increased, Natural killer cell count, Neutrophil count, Platelet count increased
Clinical narrative: BCG-itis;   Information has been received from the authors of a published literature article, titled as stated above, regarding a female patient of unknown age who was part of the authors' retrospective study aiming to identify the molecular basis of a syndromic form of severe combined immunodeficiency (SCID) and to perform genomic, molecular, biochemical, structural modeling, and in vitro disease modeling studies to analyze deleterious effects of the PAX1 variants identified.  The patient's medical history included allogeneic hematopoietic stem cell transplantation. Concurrent conditions included combined immunodeficiency (SCID), otofaciocervical syndrome type 2, fail to attain T cell reconstitution, PAX1 gene variation, born to consanguineous parents, small, low-set malformed ears, triangular mouth, down-slanting palpebral fissures, a small nose with a depressed nasal bridge, right facial palsy, recurrent respiratory infections, chronic diarrhea, severe exfoliative dermatitis and was diagnosed with Omenn syndrome.   Un an unknown date the patient was vaccinated with a dose of BCG vaccine (manufacturer unknown) (route, and dosage information was not provided) for prophylaxis.  On an unknown date, the patient experienced regional dissemination of Bacille Calmette-Guerin (BCG-itis).  On an unknow date, reported as at presentation, the patient had the following lab data results: Absolute neutrophil count: 3.8 cells x 10^-3/uL, Absolute lymphocyte count: 46.7 cells x 10^-3/uL, Absolute eosinophil count (unknown date): 9.6 cells x 10^-3/uL, Platelets: 780 x 10^-9/liter, CD3+: 43,985 cells/ul, CD4+: 10,762 cells/ul, CD8+: 17,313 cells/ul, CD19+: 936 cells/ul, CD16/56+: 1,404 cells/ul, In vitro proliferation to PHA (unknown date): 2.5 cpm × 10^-3, Blood immunoglobulin G: 170 mg/dl, Blood immunoglobulin M: 117 mg/dl, Blood immunoglobulin A: less than 25 mg/dl and Blood immunoglobulin E: 10,080 kU/l  The outcome of the adverse event was unknown.  However, the authors reported that the patient died at 8 months of age with progressive severe pneumonitis.    Upon internal review, disseminated Bacillus Calmette-Guerin infection was considered to be a medically significant event.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature article (case no. 2305USA008478). ; Sender's Comments:  US-009507513-2305USA008478:
Sex: F
Vaccine: BCG
Symptoms: Pneumonitis, T-lymphocyte count
Clinical narrative: BCG-itis;   Information has been received from the authors of a published literature article, titled as stated above, regarding a female patient of unknown age who was part of the authors' retrospective study aiming to identify the molecular basis of a syndromic form of severe combined immunodeficiency (SCID) and to perform genomic, molecular, biochemical, structural modeling, and in vitro disease modeling studies to analyze deleterious effects of the PAX1 variants identified.  The patient's medical history included allogeneic hematopoietic stem cell transplantation. Concurrent conditions included combined immunodeficiency (SCID), otofaciocervical syndrome type 2, fail to attain T cell reconstitution, PAX1 gene variation, born to consanguineous parents, small, low-set malformed ears, triangular mouth, down-slanting palpebral fissures, a small nose with a depressed nasal bridge, right facial palsy, recurrent respiratory infections, chronic diarrhea, severe exfoliative dermatitis and was diagnosed with Omenn syndrome.   Un an unknown date the patient was vaccinated with a dose of BCG vaccine (manufacturer unknown) (route, and dosage information was not provided) for prophylaxis.  On an unknown date, the patient experienced regional dissemination of Bacille Calmette-Guerin (BCG-itis).  On an unknow date, reported as at presentation, the patient had the following lab data results: Absolute neutrophil count: 3.8 cells x 10^-3/uL, Absolute lymphocyte count: 46.7 cells x 10^-3/uL, Absolute eosinophil count (unknown date): 9.6 cells x 10^-3/uL, Platelets: 780 x 10^-9/liter, CD3+: 43,985 cells/ul, CD4+: 10,762 cells/ul, CD8+: 17,313 cells/ul, CD19+: 936 cells/ul, CD16/56+: 1,404 cells/ul, In vitro proliferation to PHA (unknown date): 2.5 cpm × 10^-3, Blood immunoglobulin G: 170 mg/dl, Blood immunoglobulin M: 117 mg/dl, Blood immunoglobulin A: less than 25 mg/dl and Blood immunoglobulin E: 10,080 kU/l  The outcome of the adverse event was unknown.  However, the authors reported that the patient died at 8 months of age with progressive severe pneumonitis.    Upon internal review, disseminated Bacillus Calmette-Guerin infection was considered to be a medically significant event.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of two reports from the same literature article (case no. 2305USA008478). ; Sender's Comments:  US-009507513-2305USA008478:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 14-APR-2023, vaccine was administred on 15-MAY-2023; No adverse event; Patient was administered the bivalent vaccine 1 day after the beyond use date. 5/14/23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the bivalent vaccine 1 day after the beyond use date. 5/14/23), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-APR-2023, vaccine was administred on 15-MAY-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 15-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the bivalent vaccine 1 day after the beyond use date. 5/14/23). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-APR-2023, vaccine was administred on 15-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered the bivalent vaccine 1 day after the beyond use date. 5/14/23), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-APR-2023, vaccine was administred on 15-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered the bivalent vaccine 1 day after the beyond use date. 5/14/23) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 14-APR-2023, vaccine was administred on 15-MAY-2023).    Concomitant medication was not provided. Date the vial was initially stored in the refrigerator on 14-APR-2023. The vial did not undergo any temperature excursions. Vial size reported as 2.5ml. The Before use date of vaccine was 14-May-2023. Dosage text reported as unknown. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-725150, US-MODERNATX, INC.-MOD-2023-725170, US-MODERNATX, INC.-MOD-2023-725171 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Follow-up received and added patient initials, suspect start date and updated I-narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725171:Patient 4 out of 4 patients US-MODERNATX, INC.-MOD-2023-725170:Patient 3 out of 4 patients US-MODERNATX, INC.-MOD-2023-725150:Patient 2 out of 4 patients
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 at 13:15 as dose 5 (booster), single (Lot number: GH9694), in left arm and on 22Apr2023 at 08:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300199940 Same patient, different product, different event;
Age: 24.0
Sex: F
Vaccine: COVID19-2, HEP, HPV9, TD, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Vaccination error
Clinical narrative: Post administration of vaccines, HCG lab results showed the patient was indeed pregnant.; No additional AE; This spontaneous report was received from an other health professional and referred to a 24-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  It was initially reported that the patient was not pregnant and was was vaccinated with 5 vaccines on 22-APR-2023, one of with was varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter injection, 0.5 milliliter, lot #W032507, expiration date: 11-OCT-2024, administered for prophylaxis (route of administration was not provided).  Post administration of vaccines, on an unknown date in April 2023, human chorionic gonadotropin (HCG) lab results showed the patient was indeed pregnant. Labs were drawn a second time to confirm pregnancy results. By gestational age calculated by the period of amenorrhea she would be 4 months and 3 days at the date of inoculation of the vaccine (exposure during pregnancy).  The patient's last menstrual period (LMP) was 22-MAR-2023 and estimated due date (EDD) of 27-DEC-2023. The pregnancy outcome was outcome pending. The fetal outcome was unknown.
Age: 24.0
Sex: F
Vaccine: COVID19-2, HEP, HPV9, TD, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: Post administration of vaccines, HCG lab results showed the patient was indeed pregnant.; No additional AE; This spontaneous report was received from an other health professional and referred to a 24-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  It was initially reported that the patient was not pregnant and was was vaccinated with 5 vaccines on 22-APR-2023, one of with was varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter injection, 0.5 milliliter, lot #W032507, expiration date: 11-OCT-2024, administered for prophylaxis (route of administration was not provided).  Post administration of vaccines, on an unknown date in April 2023, human chorionic gonadotropin (HCG) lab results showed the patient was indeed pregnant. Labs were drawn a second time to confirm pregnancy results. By gestational age calculated by the period of amenorrhea she would be 4 months and 3 days at the date of inoculation of the vaccine (exposure during pregnancy).  The patient's last menstrual period (LMP) was 22-MAR-2023 and estimated due date (EDD) of 27-DEC-2023. The pregnancy outcome was outcome pending. The fetal outcome was unknown.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines; he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines; he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Clarifies he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines; Positive; Positive; Positive. Clinical course: He was not saying it was Pfizer's fault, but the hospital told him it was COVID related. He didn't want anyone to go through what he went through. Clarified he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines. Had never been on a medication his whole life. Had the Flu vaccine, but not sure if it was within 4 weeks. No serious issues, no history of clots or heart issues. Nobody in his family was on medications.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198976 Same patient/product, different dose/events (Dose 3);
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines; he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines; he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation as dose number unknown, single. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Clarifies he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines; Positive; Positive; Positive. Clinical course: He was not saying it was Pfizer's fault, but the hospital told him it was COVID related. He didn't want anyone to go through what he went through. Clarified he was positive for COVID-19 4 separate times after receiving the Pfizer COVID-19 Vaccines. Had never been on a medication his whole life. Had the Flu vaccine, but not sure if it was within 4 weeks. No serious issues, no history of clots or heart issues. Nobody in his family was on medications.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198976 Same patient/product, different dose/events (Dose 3);
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: No Additional AE; she inadvertently administered a 2nd dose of PROQUAD today, 05/08/2023 after a first dose of PROQUAD was administered on 03/14/2023; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 14-MAR-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, lot, expiration date and route of administration were not provided). On 08-MAY-2023, the patient was inadvertently administered a 2nd dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W017568, expiration date: 29-NOV-2023, for prophylaxis (strength, and route of administration were not provided (Inappropriate schedule of product administration). No additional information was provided.  No Additional adverse events, no product quality complaints.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event on patient; Storage in clinical practice; This spontaneous report was received from an office manager concerning to a 11-year-old (also reported as "12-year-old", conflicting information) male patient.  His pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not provided.  On 18-OCT-2022, the patient was vaccinated with one improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (dose, route of administration, anatomical location, and vaccination scheme were not provided) (Product storage error).   It was reported that the reported vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger) . There were no issues, nor adverse event on patient.  The vaccines were purchased with public and private funds and were administered at private doctor's office/hospital. The medication error occurred in the point of storage in clinical practice.  This was one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:Original case