chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: FLU3, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Chest pain
Clinical narrative: Patient entered the country as an adult, childhood vaccine record unknown/unavailable. Patient reports left sided chest pain, onset 2 days post vaccination (11/01/24), lasting for several days. Patient states he has a history of cardiac symtpoms with a previous vaccination, see section 23. Patient did not seek medical care or evaluation for either incident.
Age: 30.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Abrysvo administered at 28 weeks gestation. Outside of CDC recommended gestational age.
Age: 1.08
Sex: F
Vaccine: RV5
Symptoms: Wrong product administered
Clinical narrative: Gave wrong vaccine which was RotaTeq.  Lot number is unknown.
Age: 39.0
Sex: M
Vaccine: COVID19, FLU3, HEPA, IPV, TD
Symptoms: Product storage error
Clinical narrative: Patient received a dose of IPOL from an opened multi-dose vial. The vial had gone through a temperature excursion earlier in the day, which was unknown at the time of administration. Per the manufacturer, the stability of the IPOL outside of recommended storage conditions has not been evaluated. The lowest temp reached during the excursion was 1.81C. The excursion lasted for about 7 minutes. Another RN at the clinic spoke to a representative at Sanofi Pasteur, who reports that the CDC recommends to re-vaccinate the patient as soon as possible. An RN at clinic called the patient to inform him of the situation and the patient declined to repeat the dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency, Influenza like illness, Viral infection
Clinical narrative: Compromised  immunity against respiratory viruses starting in October 2023.   Continuously catching viruses with flu-like symptoms every 2 to 4:weeks, continuous for the 14 months
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Blood culture, Blood lactic acid decreased, COVID-19
Clinical narrative: HPI: Patient is 79 y.o. male whom presented to the ED with generalized weakness. Chronic health conditions include CAD   T2DM   HTN   HLD   OSA uses CPAP   PVD on AC   hx CVA/TIA Patient reports that he woke this morning feeling weak, having chills, and had a fall on the floor without injury but is on a blood thinner. He states that he was so weak this morning that he had to crawl on the floor to get to a chair to pull himself up after falling. Pt reports that he started having cold and flu s/s yesterday. He vomited one time and has had general nausea since. Wife endorses cold and flu s/s with loss of taste over the last week. They had recently attended a concert. Pt denies general pain  CP,  SOB,  bleeding,  melana. Home medications were last taken last night.  While in the ED pt was noted to be hypoxic with 02 levels of 86%. He was placed on 2 L 02 NC and improved. Additionally he had a temp of 39 C (102.2 F).   ED Labs/Imaging or vitals of concern: Lactic 2.5>1.8>1.6   WBC 11.8   Procal 0.20  COVID + Awaiting blood cultures CT cervical spine no acute changes   CTH no acute changes old CVA present  CXR vascular congestion  ED Treatments/Medications: ATBs: ceftriaxone  Symptom management: Ofirmev 02 NC IVF: 2.25 L NS 0.9   Plan/Assessment:  Resp failure with hypoxia 2/2 Covid +  sats 86% on RA at admission 2L 02 improved to 96. Symptoms started yesterday. Fever on admission. Pt is weak.  -Remdesivir, dexamethasone  -Tylenol Tessalon lozenge Zofran nasal spray  -02 duo-nebs  -Morning dimer CBC lactic procal -obtain legionella urine awaiting blood cultures -continuous pulse ox  cough deep breathe  IS  -PT eval and treat Discharged to Home
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chills, Computerised tomogram head abnormal, Computerised tomogram spine normal, Cough
Clinical narrative: HPI: Patient is 79 y.o. male whom presented to the ED with generalized weakness. Chronic health conditions include CAD   T2DM   HTN   HLD   OSA uses CPAP   PVD on AC   hx CVA/TIA Patient reports that he woke this morning feeling weak, having chills, and had a fall on the floor without injury but is on a blood thinner. He states that he was so weak this morning that he had to crawl on the floor to get to a chair to pull himself up after falling. Pt reports that he started having cold and flu s/s yesterday. He vomited one time and has had general nausea since. Wife endorses cold and flu s/s with loss of taste over the last week. They had recently attended a concert. Pt denies general pain  CP,  SOB,  bleeding,  melana. Home medications were last taken last night.  While in the ED pt was noted to be hypoxic with 02 levels of 86%. He was placed on 2 L 02 NC and improved. Additionally he had a temp of 39 C (102.2 F).   ED Labs/Imaging or vitals of concern: Lactic 2.5>1.8>1.6   WBC 11.8   Procal 0.20  COVID + Awaiting blood cultures CT cervical spine no acute changes   CTH no acute changes old CVA present  CXR vascular congestion  ED Treatments/Medications: ATBs: ceftriaxone  Symptom management: Ofirmev 02 NC IVF: 2.25 L NS 0.9   Plan/Assessment:  Resp failure with hypoxia 2/2 Covid +  sats 86% on RA at admission 2L 02 improved to 96. Symptoms started yesterday. Fever on admission. Pt is weak.  -Remdesivir, dexamethasone  -Tylenol Tessalon lozenge Zofran nasal spray  -02 duo-nebs  -Morning dimer CBC lactic procal -obtain legionella urine awaiting blood cultures -continuous pulse ox  cough deep breathe  IS  -PT eval and treat Discharged to Home
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Culture urine, Dysstasia, Fall, Fibrin D dimer, Full blood count
Clinical narrative: HPI: Patient is 79 y.o. male whom presented to the ED with generalized weakness. Chronic health conditions include CAD   T2DM   HTN   HLD   OSA uses CPAP   PVD on AC   hx CVA/TIA Patient reports that he woke this morning feeling weak, having chills, and had a fall on the floor without injury but is on a blood thinner. He states that he was so weak this morning that he had to crawl on the floor to get to a chair to pull himself up after falling. Pt reports that he started having cold and flu s/s yesterday. He vomited one time and has had general nausea since. Wife endorses cold and flu s/s with loss of taste over the last week. They had recently attended a concert. Pt denies general pain  CP,  SOB,  bleeding,  melana. Home medications were last taken last night.  While in the ED pt was noted to be hypoxic with 02 levels of 86%. He was placed on 2 L 02 NC and improved. Additionally he had a temp of 39 C (102.2 F).   ED Labs/Imaging or vitals of concern: Lactic 2.5>1.8>1.6   WBC 11.8   Procal 0.20  COVID + Awaiting blood cultures CT cervical spine no acute changes   CTH no acute changes old CVA present  CXR vascular congestion  ED Treatments/Medications: ATBs: ceftriaxone  Symptom management: Ofirmev 02 NC IVF: 2.25 L NS 0.9   Plan/Assessment:  Resp failure with hypoxia 2/2 Covid +  sats 86% on RA at admission 2L 02 improved to 96. Symptoms started yesterday. Fever on admission. Pt is weak.  -Remdesivir, dexamethasone  -Tylenol Tessalon lozenge Zofran nasal spray  -02 duo-nebs  -Morning dimer CBC lactic procal -obtain legionella urine awaiting blood cultures -continuous pulse ox  cough deep breathe  IS  -PT eval and treat Discharged to Home
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Influenza, Nasopharyngitis, Nausea, Procalcitonin increased
Clinical narrative: HPI: Patient is 79 y.o. male whom presented to the ED with generalized weakness. Chronic health conditions include CAD   T2DM   HTN   HLD   OSA uses CPAP   PVD on AC   hx CVA/TIA Patient reports that he woke this morning feeling weak, having chills, and had a fall on the floor without injury but is on a blood thinner. He states that he was so weak this morning that he had to crawl on the floor to get to a chair to pull himself up after falling. Pt reports that he started having cold and flu s/s yesterday. He vomited one time and has had general nausea since. Wife endorses cold and flu s/s with loss of taste over the last week. They had recently attended a concert. Pt denies general pain  CP,  SOB,  bleeding,  melana. Home medications were last taken last night.  While in the ED pt was noted to be hypoxic with 02 levels of 86%. He was placed on 2 L 02 NC and improved. Additionally he had a temp of 39 C (102.2 F).   ED Labs/Imaging or vitals of concern: Lactic 2.5>1.8>1.6   WBC 11.8   Procal 0.20  COVID + Awaiting blood cultures CT cervical spine no acute changes   CTH no acute changes old CVA present  CXR vascular congestion  ED Treatments/Medications: ATBs: ceftriaxone  Symptom management: Ofirmev 02 NC IVF: 2.25 L NS 0.9   Plan/Assessment:  Resp failure with hypoxia 2/2 Covid +  sats 86% on RA at admission 2L 02 improved to 96. Symptoms started yesterday. Fever on admission. Pt is weak.  -Remdesivir, dexamethasone  -Tylenol Tessalon lozenge Zofran nasal spray  -02 duo-nebs  -Morning dimer CBC lactic procal -obtain legionella urine awaiting blood cultures -continuous pulse ox  cough deep breathe  IS  -PT eval and treat Discharged to Home
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary congestion, Pyrexia, Respiratory failure, SARS-CoV-2 test positive, Vomiting
Clinical narrative: HPI: Patient is 79 y.o. male whom presented to the ED with generalized weakness. Chronic health conditions include CAD   T2DM   HTN   HLD   OSA uses CPAP   PVD on AC   hx CVA/TIA Patient reports that he woke this morning feeling weak, having chills, and had a fall on the floor without injury but is on a blood thinner. He states that he was so weak this morning that he had to crawl on the floor to get to a chair to pull himself up after falling. Pt reports that he started having cold and flu s/s yesterday. He vomited one time and has had general nausea since. Wife endorses cold and flu s/s with loss of taste over the last week. They had recently attended a concert. Pt denies general pain  CP,  SOB,  bleeding,  melana. Home medications were last taken last night.  While in the ED pt was noted to be hypoxic with 02 levels of 86%. He was placed on 2 L 02 NC and improved. Additionally he had a temp of 39 C (102.2 F).   ED Labs/Imaging or vitals of concern: Lactic 2.5>1.8>1.6   WBC 11.8   Procal 0.20  COVID + Awaiting blood cultures CT cervical spine no acute changes   CTH no acute changes old CVA present  CXR vascular congestion  ED Treatments/Medications: ATBs: ceftriaxone  Symptom management: Ofirmev 02 NC IVF: 2.25 L NS 0.9   Plan/Assessment:  Resp failure with hypoxia 2/2 Covid +  sats 86% on RA at admission 2L 02 improved to 96. Symptoms started yesterday. Fever on admission. Pt is weak.  -Remdesivir, dexamethasone  -Tylenol Tessalon lozenge Zofran nasal spray  -02 duo-nebs  -Morning dimer CBC lactic procal -obtain legionella urine awaiting blood cultures -continuous pulse ox  cough deep breathe  IS  -PT eval and treat Discharged to Home
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: HPI: Patient is 79 y.o. male whom presented to the ED with generalized weakness. Chronic health conditions include CAD   T2DM   HTN   HLD   OSA uses CPAP   PVD on AC   hx CVA/TIA Patient reports that he woke this morning feeling weak, having chills, and had a fall on the floor without injury but is on a blood thinner. He states that he was so weak this morning that he had to crawl on the floor to get to a chair to pull himself up after falling. Pt reports that he started having cold and flu s/s yesterday. He vomited one time and has had general nausea since. Wife endorses cold and flu s/s with loss of taste over the last week. They had recently attended a concert. Pt denies general pain  CP,  SOB,  bleeding,  melana. Home medications were last taken last night.  While in the ED pt was noted to be hypoxic with 02 levels of 86%. He was placed on 2 L 02 NC and improved. Additionally he had a temp of 39 C (102.2 F).   ED Labs/Imaging or vitals of concern: Lactic 2.5>1.8>1.6   WBC 11.8   Procal 0.20  COVID + Awaiting blood cultures CT cervical spine no acute changes   CTH no acute changes old CVA present  CXR vascular congestion  ED Treatments/Medications: ATBs: ceftriaxone  Symptom management: Ofirmev 02 NC IVF: 2.25 L NS 0.9   Plan/Assessment:  Resp failure with hypoxia 2/2 Covid +  sats 86% on RA at admission 2L 02 improved to 96. Symptoms started yesterday. Fever on admission. Pt is weak.  -Remdesivir, dexamethasone  -Tylenol Tessalon lozenge Zofran nasal spray  -02 duo-nebs  -Morning dimer CBC lactic procal -obtain legionella urine awaiting blood cultures -continuous pulse ox  cough deep breathe  IS  -PT eval and treat Discharged to Home
Age: 1.08
Sex: F
Vaccine: RV5
Symptoms: Wrong product administered
Clinical narrative: Gave wrong vaccines which was RotaTeq.  Provider was notified.  Unknown lot number.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: the wrong vaccine was given she needs a higher dose.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood creatinine increased, COVID-19, Computerised tomogram abnormal, Escherichia bacteraemia
Clinical narrative: Name: Patient Medical Record #:   Age:  88 y.o. DOB:  10/XX/19XX Admit date: 12/18/2024  Discharge date: 12/21/2024   Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission: hyponatremia and ecoli bacteremia  Brief Summary of Hospital Stay:   Patient is an 88-year-old female history of paroxysmal AFib on beta blocker and calcium channel blocker, complex partial seizures, anxiety who presented to the emergency department 12/18 with nausea vomiting abdominal cramps.  Lab work showed leukocytosis, elevated creatinine, hyponatremia.  She was also found to be COVID positive.  CT showed evidence of mild hydronephrosis, Foley was placed for about 24 hours and removed with sepsis with portal trial.  Her hyponatremia was thought to be due to GI losses with vomiting, Na improved successfully on normal saline.  Her blood cultures did come back positive for E coli.  She was started initially on ceftriaxone 2 g, with transition to orals on discharge.  Patient was deemed stable for discharge 12/21, discharged home with high-dose oral Keflex.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Escherichia test positive, Hydronephrosis, Hyponatraemia, Leukocytosis, Nausea
Clinical narrative: Name: Patient Medical Record #:   Age:  88 y.o. DOB:  10/XX/19XX Admit date: 12/18/2024  Discharge date: 12/21/2024   Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission: hyponatremia and ecoli bacteremia  Brief Summary of Hospital Stay:   Patient is an 88-year-old female history of paroxysmal AFib on beta blocker and calcium channel blocker, complex partial seizures, anxiety who presented to the emergency department 12/18 with nausea vomiting abdominal cramps.  Lab work showed leukocytosis, elevated creatinine, hyponatremia.  She was also found to be COVID positive.  CT showed evidence of mild hydronephrosis, Foley was placed for about 24 hours and removed with sepsis with portal trial.  Her hyponatremia was thought to be due to GI losses with vomiting, Na improved successfully on normal saline.  Her blood cultures did come back positive for E coli.  She was started initially on ceftriaxone 2 g, with transition to orals on discharge.  Patient was deemed stable for discharge 12/21, discharged home with high-dose oral Keflex.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Vomiting
Clinical narrative: Name: Patient Medical Record #:   Age:  88 y.o. DOB:  10/XX/19XX Admit date: 12/18/2024  Discharge date: 12/21/2024   Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission: hyponatremia and ecoli bacteremia  Brief Summary of Hospital Stay:   Patient is an 88-year-old female history of paroxysmal AFib on beta blocker and calcium channel blocker, complex partial seizures, anxiety who presented to the emergency department 12/18 with nausea vomiting abdominal cramps.  Lab work showed leukocytosis, elevated creatinine, hyponatremia.  She was also found to be COVID positive.  CT showed evidence of mild hydronephrosis, Foley was placed for about 24 hours and removed with sepsis with portal trial.  Her hyponatremia was thought to be due to GI losses with vomiting, Na improved successfully on normal saline.  Her blood cultures did come back positive for E coli.  She was started initially on ceftriaxone 2 g, with transition to orals on discharge.  Patient was deemed stable for discharge 12/21, discharged home with high-dose oral Keflex.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Blood creatine phosphokinase increased, COVID-19, Mental status changes
Clinical narrative: Name:  Patient Medical Record #:  Age:  73 y.o. DOB:  10/xx/19xx  Admit date: 12/19/2024  Discharge date: 12/24/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: DO   Reason for Admission: acute metabolic encephalopathy, rhabdomyolysis  Brief Summary of Hospital Stay:   Patient is a 72-year-old female with history of severe dementia, hypertension, GERD who presented to the emergency department 12/19 with new altered mental status and weakness.  She was found to be COVID positive, then with rhabdomyolysis and AKI. She was febrile and tachycardic. Sepsis workup started by ED, she was initially given boluses of fluids as well as rocephin. She was then transitioned to saline drip. Her CK slowly decreased over the next couple days until it rose again. Lasix was added, which appeared to improve her CK. Her values improved significantly and she was deemed stable for discharge home 12/24 with home care
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic encephalopathy, Pyrexia, Rhabdomyolysis, SARS-CoV-2 test positive, Septic screen
Clinical narrative: Name:  Patient Medical Record #:  Age:  73 y.o. DOB:  10/xx/19xx  Admit date: 12/19/2024  Discharge date: 12/24/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: DO   Reason for Admission: acute metabolic encephalopathy, rhabdomyolysis  Brief Summary of Hospital Stay:   Patient is a 72-year-old female with history of severe dementia, hypertension, GERD who presented to the emergency department 12/19 with new altered mental status and weakness.  She was found to be COVID positive, then with rhabdomyolysis and AKI. She was febrile and tachycardic. Sepsis workup started by ED, she was initially given boluses of fluids as well as rocephin. She was then transitioned to saline drip. Her CK slowly decreased over the next couple days until it rose again. Lasix was added, which appeared to improve her CK. Her values improved significantly and she was deemed stable for discharge home 12/24 with home care
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Name:  Patient Medical Record #:  Age:  73 y.o. DOB:  10/xx/19xx  Admit date: 12/19/2024  Discharge date: 12/24/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: MD  Primary Care Physician: DO   Reason for Admission: acute metabolic encephalopathy, rhabdomyolysis  Brief Summary of Hospital Stay:   Patient is a 72-year-old female with history of severe dementia, hypertension, GERD who presented to the emergency department 12/19 with new altered mental status and weakness.  She was found to be COVID positive, then with rhabdomyolysis and AKI. She was febrile and tachycardic. Sepsis workup started by ED, she was initially given boluses of fluids as well as rocephin. She was then transitioned to saline drip. Her CK slowly decreased over the next couple days until it rose again. Lasix was added, which appeared to improve her CK. Her values improved significantly and she was deemed stable for discharge home 12/24 with home care
Age: 20.0
Sex: F
Vaccine: FLU3, RSV, TDAP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: GIVEN AT 27 WEEKS- RECOMMENDED TO BE GIVEN BETWEEN 32 AND 36 WEEKS. ESTIMATED DUE DATE IS 02/8/2025. THIS IS HER FIRST PREGNANCY, BIRTH IS NOT AVAILABLE-SHE IS STILL PREGNANT AT 33 WEEKS AND 6 DAYS TODAY WHEN REPORT IS BEING DOCUMENTED.
Age: 58.0
Sex: M
Vaccine: COVID19, FLU3, HEP, HEPA, IPV, TD
Symptoms: Product storage error
Clinical narrative: Patient received a dose of  IPOL from an opened multi-dose vial. The vial had gone through a temperature excursion earlier in the day, which was unknown at the time of administration. Per the manufacturer, the stability of the IPOL outside of recommended storage conditions has not been evaluated. The lowest temp reached during the excursion was 1.81C. The excursion lasted for about 7 minutes. Another RN at the clinic spoke to a representative at Sanofi Pasteur, who reports that CDC recommends to re-vaccinate the patient as soon as possible. An RN at clinic called the patient to inform patient of the situation and the patient declined to repeat the dose.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry eye, Erythema, Flushing, Periorbital swelling
Clinical narrative: Approximately 2 days after vaccine received, noticed face red/flushed, [psand eyes a bit puffy (as with dry eyes). No fever.  Lasted about 2 days before fading away.
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Respiratory pathogen panel
Clinical narrative: Shortness of breath, cough
Age: 3.0
Sex: M
Vaccine: COVID19, FLU3, IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: COVID-19 Comirnaty 12+ 2024-25 : 0.3 mL (Route: Intramuscular) given by RN on Left Thigh to 3 year old. No adverse events or treatment needed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pt noted pain in area behind deltoid muscle in arm starting about a week after vaccination. Pain radiated down arm and up through neck, and was severe enough to be noticeable while breathing and preventing her from lifting a gallon of milk.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Day after vaccine, pain in rt deltoid area, hurt to raise arm shoulder level and noticed large red area forming around injection site. Then she noticed hardened area to ssite and a small bump come up approx  1 inclh below original injection site, over the course of several weeks, 2 other bumps came up around original injection site. Reported to Employee Health (EOH) 12/20 for 2nd HepB vaccine. She showed me her arm from her TDaP vaccine and the puncure site is grey and scabbed over with hard lump about the size of quarter underneath there are 3 smaller areas around the site, 2 open with pink tiussue that she says are very itchy and uncomforatble.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site rash, Injection site scab, Injection site swelling, Pain
Clinical narrative: Day after vaccine, pain in rt deltoid area, hurt to raise arm shoulder level and noticed large red area forming around injection site. Then she noticed hardened area to ssite and a small bump come up approx  1 inclh below original injection site, over the course of several weeks, 2 other bumps came up around original injection site. Reported to Employee Health (EOH) 12/20 for 2nd HepB vaccine. She showed me her arm from her TDaP vaccine and the puncure site is grey and scabbed over with hard lump about the size of quarter underneath there are 3 smaller areas around the site, 2 open with pink tiussue that she says are very itchy and uncomforatble.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Puncture site discolouration
Clinical narrative: Day after vaccine, pain in rt deltoid area, hurt to raise arm shoulder level and noticed large red area forming around injection site. Then she noticed hardened area to ssite and a small bump come up approx  1 inclh below original injection site, over the course of several weeks, 2 other bumps came up around original injection site. Reported to Employee Health (EOH) 12/20 for 2nd HepB vaccine. She showed me her arm from her TDaP vaccine and the puncure site is grey and scabbed over with hard lump about the size of quarter underneath there are 3 smaller areas around the site, 2 open with pink tiussue that she says are very itchy and uncomforatble.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Nausea
Clinical narrative: chills, headache, nausea, injection site soreness
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Malaise, Posture abnormal, Snoring, Unresponsive to stimuli
Clinical narrative: Patient was visibly anxious about vaccination. After vaccination was administered, patient stated that she was not feeling well and moved to a different chair. She started to say that she didn't feel well then slumped over in her chair. She started snoring and was breathing but not responding to questions. After a minute or two, she became responsive and was confused and stated that she thought she was sleeping. Patient was provided a wet, cool paper towel and ice packs. She laid in the floor for about 10-15 minutes. Her sister gave her some orange juice and she started walking around. Patient stated that this has never happened before.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: COVID-19 Comirnaty 12+ VFC 2024-25: 0.3 ml (Dose No:1) (Route: Intramuscular) given by LVN on Right Deltoid to 10 year old.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt received dose of Abrysvo 12/23. However, pt already received Arexvy 10/20/2023. No adverse reactions noted. However, vaccine was not indicated.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Skin papilloma
Clinical narrative: Two warts started to show up. One on the inside right big toe and one on left middle toe outside. It was noticed around one month after receiving the vaccine.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient was given a pediatric dose of Covid. No adverse reactions.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Catarrh, Influenza virus test negative, Oxygen saturation decreased, Respiratory syncytial virus test negative, Respiratory tract congestion
Clinical narrative: 12/15: Runny Nose. 12/16: Runny nose cont. Congestion begins as well as heavy mucus build up through the night. 12/17: Oxygen dropping into 80s over night, taken to ER this day, admitted due to low oxygen and heavy mucus build up. Was put on oxygen, given albuterol every 4 hours, had nasal deep suctioning to clear mucus every 8-12 hours. Started steroids on 17th. 12/17 - 12/19: this continued until oxygen improved on 19th. Discharged this day on steroids and albuterol. Heart rate dropped also with steroids and continuous need for albuterol. Improved once off them 12/22
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: 12/15: Runny Nose. 12/16: Runny nose cont. Congestion begins as well as heavy mucus build up through the night. 12/17: Oxygen dropping into 80s over night, taken to ER this day, admitted due to low oxygen and heavy mucus build up. Was put on oxygen, given albuterol every 4 hours, had nasal deep suctioning to clear mucus every 8-12 hours. Started steroids on 17th. 12/17 - 12/19: this continued until oxygen improved on 19th. Discharged this day on steroids and albuterol. Heart rate dropped also with steroids and continuous need for albuterol. Improved once off them 12/22
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid infection requiring hospitalization after vaccination
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Aphasia, Eyelid function disorder, Hypertension, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: about 4 days after getting RSV vax, pt says she was sitting in her chair and went to sleep. When she woke she could hear what was going on and knew what go but she could not open hers eyes or could not speak. She said she had never been so scared in her life. Her cat got her husbands attention to let him know something was wrong. She couldn't do anything but moan to let him know that she couldn't speak or open her eyes. She couldn't squeeze his hand or raise her arm. He called 911. EMT thought she had maybe had a stroke. She was taken to Medical Center ER. She had an MRI, US, and labwork. Everything was negative. She was told she had a TIA.  She was admitted for treatment in the stroke ward. She was given magnesium, treated for HBP, and saline solution. No permanent damage was found but was discharded to follow up with PCP, Neurologist, and to do PT.
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Moaning, Mobility decreased, Transient ischaemic attack, Ultrasound scan normal
Clinical narrative: about 4 days after getting RSV vax, pt says she was sitting in her chair and went to sleep. When she woke she could hear what was going on and knew what go but she could not open hers eyes or could not speak. She said she had never been so scared in her life. Her cat got her husbands attention to let him know something was wrong. She couldn't do anything but moan to let him know that she couldn't speak or open her eyes. She couldn't squeeze his hand or raise her arm. He called 911. EMT thought she had maybe had a stroke. She was taken to Medical Center ER. She had an MRI, US, and labwork. Everything was negative. She was told she had a TIA.  She was admitted for treatment in the stroke ward. She was given magnesium, treated for HBP, and saline solution. No permanent damage was found but was discharded to follow up with PCP, Neurologist, and to do PT.
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Dysarthria, Muscular weakness, Neurological symptom
Clinical narrative: about 4 days after getting RSV vax, pt says she was sitting in her chair and went to sleep. When she woke she could hear what was going on and knew what go but she could not open hers eyes or could not speak. She said she had never been so scared in her life. Her cat got her husbands attention to let him know something was wrong. She couldn't do anything but moan to let him know that she couldn't speak or open her eyes. She couldn't squeeze his hand or raise her arm. He called 911. EMT thought she had maybe had a stroke. She was taken to Medical Center ER. She had an MRI, US, and labwork. Everything was negative. She was told she had a TIA.  She was admitted for treatment in the stroke ward. She was given magnesium, treated for HBP, and saline solution. No permanent damage was found but was discharded to follow up with PCP, Neurologist, and to do PT.
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Aphasia, Eyelid function disorder, Hypertension, Laboratory test normal, Magnetic resonance imaging normal
Clinical narrative: Stroke like symptoms, difficulty speaking, weakness of limbs
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Moaning, Mobility decreased, Transient ischaemic attack, Ultrasound scan normal
Clinical narrative: Stroke like symptoms, difficulty speaking, weakness of limbs
Age: 82.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Dysarthria, Muscular weakness, Neurological symptom
Clinical narrative: Stroke like symptoms, difficulty speaking, weakness of limbs
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: Pt states that her left arm is still tender from administration.  She says she can't lift her arm above her head and it hurts to lay on her side. She said she thought it was a little high at time of injection.  She has not been assessed by a doctor and advised to do so.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid infection requiring hospitalization after vaccination
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid infection requiring hospitalization after vaccination
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid infection requiring hospitalization after vaccination
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Patient rang to report that her left arm was swollen, red and sore the morning after the covid vaccine was given. She also reports diahorrea and a headache which both resolved on Saturday 21st December. Patient to date reports that her left arm has improved but still red and swelling is resolving. Patient did not seek medical advise at the time but has spoken to her husbands doctor today. Advised to follow up with her own Primary Care Provider ASAP.
Age: 4.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Blood glucose, Crying, Fear, Immediate post-injection reaction, Syncope
Clinical narrative: Fainted briefly immediately after the 2 injections were completed, then appeared well but was fearful and crying. Normal physical exam and appeared well. Then observed brother's blood being drawn and fainted again with immediate arousal. Normal glucose, VS, oxygen and discussing fear. Mom noted he had been crying and afraid to get the vaccines and brother's blood draw prior to the occurences.
Age: 9.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Feeling abnormal, Gait disturbance, Loss of consciousness
Clinical narrative: Vaccines were administered per protocol. Client got up and left the room, but started to stumble when he reached the front desk and said he felt strange. Mom and this RN helped him to a chair in the lobby. He passed out for a few seconds. then revived.  He lay down for about 5 minutes, then sat up and drank some water. Said he felt better and sat for about 10 more minutes before leaving with his mom.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered 18 days after "beyond use date".  No adverse reactions reported. Mother notified need to re-vaccinate per CDC guidelines for this situation.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Pharyngeal swelling, Vomiting
Clinical narrative: Anaphylaxis - Throat  swelling, vomiting  - treated in clinic and  emergency room with EpiPen, steroids
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: RN gave PT extra dose of DTaP at visit (Pentacel, Rota, and PCV 20 was due) instead of PCV 20. RN had accidently pulled DTaP instead of PCV 20 and did not scan out before administering like she thought, so she did not catch it until already administered. RN went back and realized her mistake and that she pulled from the wrong bin and grabbed a DTaP instead of a PCV20. When RN was adding vaccine orders in CPRS, she was distracted and while she did order all the correct vaccines, she did not scan all 3 like she thought. She only scanned out Pentacel and Rota so she did not catch that the DTaP was pulled instead of PCV 20. When RN realized her mistake she immediately notified her supervisor and called the Pt's mom to inform of mistake.
Age: 1.58
Sex: M
Vaccine: FLU3
Symptoms: Cough, Injection site rash, Rash, Rhinorrhoea
Clinical narrative: Adverse events: Mom messaged in and sent pictures of the reaction. Mom said the rash started 12/25/2024. Rash spread from injection site to the body. Mom said that he also ended up developing a runny nose and cough. No itchiness of rash per mom.   Treatment:  Dr. advised mom to give 2 mL of Benadryl and see if that improves the rash.  Outcome: Called to follow-up with mom on 12/27/2024 to see how rash was doing. Mom did not do Benadryl  on 12/26/2024, however she did give some on 12/27/2024. No update as of yet on the progress the Benadryl has made.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional dose of Arexvy outside of CDC guidelines.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Non-Hodgkin's lymphoma
Clinical narrative: Non Hodgkin's Lymphoma
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Activated PI3 kinase delta syndrome, COVID-19, Cancer surgery, Chills, Colon cancer stage III
Clinical narrative: First 48 hours: severe fatigue; unable to leave my bed; muscle cramping and pain; skin burning sensation; shakes, chills, aching, malaise.  October 2021 - covid infection with severe coughing. October 2022 breast cancer. March 2024 colon cancer.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen abnormal, Cough, Fatigue, Invasive ductal breast carcinoma, Malaise
Clinical narrative: First 48 hours: severe fatigue; unable to leave my bed; muscle cramping and pain; skin burning sensation; shakes, chills, aching, malaise.  October 2021 - covid infection with severe coughing. October 2022 breast cancer. March 2024 colon cancer.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram abnormal, Mobility decreased, Muscle spasms, Myalgia, Pain
Clinical narrative: First 48 hours: severe fatigue; unable to leave my bed; muscle cramping and pain; skin burning sensation; shakes, chills, aching, malaise.  October 2021 - covid infection with severe coughing. October 2022 breast cancer. March 2024 colon cancer.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pathology test, Skin burning sensation, Tremor
Clinical narrative: First 48 hours: severe fatigue; unable to leave my bed; muscle cramping and pain; skin burning sensation; shakes, chills, aching, malaise.  October 2021 - covid infection with severe coughing. October 2022 breast cancer. March 2024 colon cancer.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient reported to the pharmacy on 12/27/2024 stating his right arm (pointing to bicep area) was sore/hurting. He states that it started about 1 & 1/2 weeks ago (~12/17/2024).
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Pain at the elbow, below the injection site, that travels down to the hand since the injection, increased pain when adding weight to that arm or hand. The pain is like bursitis.  I have not sought any treatment.
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already had the RSV vaccine 12/21/2023.  Patient got it a second time on 12/26/2024.  No adverse effects were reported.  Patient did not realize he had already had the vaccine.  The vaccine did not automatically upload to system on 12/21/2023.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, Pain, Pain in extremity
Clinical narrative: Patient received two high dose flu vaccines, both in the left arm, given 54 days apart. She called on 12/27, 58 days after the second injection, and reported that her arm was still hurting when she lifted it.
Age: 5.0
Sex: M
Vaccine: DTPPVHBHPB, MMRV, PNC20
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child was given a Vaxelis at age 5 years and 3 months. Vaxelis is approved for use in children from 6 weeks through 4 years of age. Child received an additional dose of Hib due to this, other vaccines in Vaxelis were valid.   No adverse reactions were reported. Error was realized on 12/27/2024 when child was in clinic for more vaccines. Mother notified of error and voiced understanding.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient had already received this vaccine on 12/21/2023 and got a second dose on 12/26/2024.  The vaccine from 12/21/2023 was did not automatically submit to system.  Patient though she had not had the vaccine before.  No adverse effects reported.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Culture stool negative, Diarrhoea, Haematochezia, Mucous stools, Parasite stool test negative
Clinical narrative: Toddler has had several doses of Pfizer COVID vaccine in previous years.  This was his first dose of Moderna version; was his yearly booster.  No issues at all with Pfizer dosages.  Loose stool with mucous starting day after Moderna vaccine.  Blood with stool started 3 days after vaccine.  Symptoms persisted for 20 days.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Chest discomfort, Dyspnoea, Hypoaesthesia
Clinical narrative: Patient told me they experienced pain in the left deltoid where the vaccination was done. Patient said they have been experiencing constant pain in their left shoulder that is sharp and shoots down the arm. The patient has been experiencing restricted range of motion in the left arm/shoulder. Patient said the pain has started going through the upper back and right arm now as well. The patient says that since yesterday 12/26/2024 her left arm is getting numb and she feels a tightness in her chest that starts from her left arm side and travels across the left side of her chest. The patient says she is also having a little trouble breathing.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient told me they experienced pain in the left deltoid where the vaccination was done. Patient said they have been experiencing constant pain in their left shoulder that is sharp and shoots down the arm. The patient has been experiencing restricted range of motion in the left arm/shoulder. Patient said the pain has started going through the upper back and right arm now as well. The patient says that since yesterday 12/26/2024 her left arm is getting numb and she feels a tightness in her chest that starts from her left arm side and travels across the left side of her chest. The patient says she is also having a little trouble breathing.
Age: 76.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash appeared all over back and side, rash stop at waist band, but no rash appeared on stomach. It lasted for a few weeks.  It disappeared for 1 week and came back.  (patient use cortisone cream and benadryl spray to alleviate the rash. pt said the products stings when he applied it on.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Pain
Clinical narrative: I don?t know which RSV they gave me. But as soon as the needle went in my arm, I wanted to scream throughout the store. Normally, I do not feel an immunization shot. I had to ice my arm that day and the next day and the next day. It was in extreme pain. Then my arm started itching. The pain has subsided, but now goes down to my fingers. When I called the pharmacist, she said this was a reaction to the vaccine and not a problem with  how it was administered. So I am filling out this report because the new pharmacist told me this is what I needed to do. I am filling out this report seven days after my immunization of RSV.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Chronic migraines  3-4 times monthly for several hours at a time. Beginning shortly after receiving COVID 19 vaccine in 2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Fatigue, Hemiparesis, Nausea
Clinical narrative: Severe dizziness, nausea, fever, fatigue for 3 days
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Parkinson's disease, Pyrexia, SARS-CoV-2 antibody test positive
Clinical narrative: Severe dizziness, nausea, fever, fatigue for 3 days
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, Wrong patient received product
Clinical narrative: Patient was in office for a new patient appointment. There was a miscommunication about if she had already had her flu shot or not. I let her know that she was not due and the other 3 children were due. There was a confusion with the children, and she was given a flu shot and she was not due for this in fact she just had this done on 10/24/2024. I let the mother know and I let the Provider know about this vaccine error and mom understood and did not have any questions. I let her know that she had gotten 2 flu shots within a 2 month period. The correct vaccine was given to the right patient.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Rash
Clinical narrative: patient got this shot at a store (12/18/24) and broke out in a rash from neck to the bottom of legs. picked up steroid today at our store to treat.
Age: 27.0
Sex: F
Vaccine: PNC20
Symptoms: Discomfort, Pain, Product administered at inappropriate site
Clinical narrative: Vaccine and medication were administered in the wrong area (right route) Patient experienced pain/discomfort but no other notable symptoms
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Irritability, Ultrasound abdomen abnormal
Clinical narrative: Vomiting, increased fussiness on 12/26/24. Bloody stool in the afternoon. Imaging consistent with intussusception, required barium enema. Fully reduced with enema. Hospitalized overnight for monitoring, fully resolved by discharge on 12/27/24
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Urinary system X-ray, Vomiting
Clinical narrative: Vomiting, increased fussiness on 12/26/24. Bloody stool in the afternoon. Imaging consistent with intussusception, required barium enema. Fully reduced with enema. Hospitalized overnight for monitoring, fully resolved by discharge on 12/27/24
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Blood pressure measurement, Cough, Heart rate
Clinical narrative: high BP; high HR; palm rash; cough; jaw pain; then lock jaw; blood shot eyes; joint aches; blisters; The initial case was missing the following minimum criteria: No Specified AE. Upon receipt of follow-up information on 20Dec2024, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Feb2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2013 (unspecified if ongoing). There were no concomitant medications. The following information was reported: HYPERTENSION (hospitalization, medically significant), outcome "recovered", described as "high BP"; HEART RATE INCREASED (hospitalization, medically significant), outcome "recovered", described as "high HR"; RASH (hospitalization, medically significant), outcome "recovered", described as "palm rash"; COUGH (hospitalization, medically significant), outcome "recovered"; PAIN IN JAW (hospitalization, medically significant), outcome "recovered", described as "jaw pain"; TRISMUS (hospitalization, medically significant), outcome "recovered", described as "then lock jaw"; OCULAR HYPERAEMIA (hospitalization, medically significant), outcome "recovered", described as "blood shot eyes"; ARTHRALGIA (hospitalization, medically significant), outcome "recovered", described as "joint aches"; BLISTER (hospitalization, medically significant), outcome "recovered", described as "blisters". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; Heart rate: High. Therapeutic measures were taken as a result of hypertension, heart rate increased, rash, cough, pain in jaw, trismus, ocular hyperaemia, arthralgia, blister. Clinical course: The patient reported that she received a dose of the Comirnaty (2023-2024) vaccine on Feb2024 and she developed symptoms that required hospitalization due to the severe reaction to the vaccine. The patient experienced adverse event after taking a Pfizer product. The patient taking was not taking any other medications within 2 weeks prior to the event onset.  Batch/lot number is not provided, and it cannot be obtained.