chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of PENTACEL was inadvertently administered with no reported adverse event; Initial information received on 12-Mar-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 1 years old male patient who had inadvertently administered expired dose of diphtheria/tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine [pentacel (vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A); Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr); Varicella Zoster Vaccine (Varicella Vaccine); And Pneumococcal Vaccine for Prophylactic vaccination.  On 26-Feb-2024, the patient received a expired dose 4 with a dose of 0.5 ml (millimeter) dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine Suspension for injection (strength: standard, Frequency: Once, expiry date: 24-Feb-2024, lot UJ843AA via intramuscular route in the right vastus lateralis as Immunization (expired product administered) (latency: same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had it 3 times/ suspected vaccination failure; I had it 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had it 3 times/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had it 3 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 08-Mar-2024 This case was reported by a patient via interactive digital media. Patient had them 3 times and got a shot 4 years ago nothing since. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Herpes zoster, Malaise, Weight decreased
Clinical narrative: shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 13-OCT-2023, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Received Date: 03-MAR-2024 This case was reported by a patient via interactive digital media. Patient got the shingles and talk about someone being very sick and it lasted over a month, lost weight, lost appetite and strength. That was the worst feeling that patient ever had in his/her life and he/she would like to tell everyone to get both the shots of vaccine. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: shingles; blistery rash on my back and knees; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles) and blistery rash (Verbatim: blistery rash on my back and knees). The outcome of the shingles and blistery rash were not reported.   It was unknown if the reporter considered the shingles and blistery rash to be related to Shingles vaccine.     It was unknown if the company considered the shingles and blistery rash to be related to Shingles vaccine.   Additional Information: GSK received date: 06-Mar-2024 This case was reported by a reporter via interactive digital media. Patient may have had the shingles. Patient had a blistery rash on back and knees. Patient had the vaccine for shingles but was due for a booster before the rash occurred. Patient stated that, if you're over 50 and had chickenpox as a kid be sure to get vaccinated for shingles. Whatever patient had wasn't that bad. Perhaps patient still had some immunity. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: vaccinated in late September 2023 with SPIKEVAX - and reports mild COVID; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (vaccinated in late September 2023 with SPIKEVAX - and reports mild COVID) in a 76-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Dec-2023, the patient experienced COVID-19 (vaccinated in late September 2023 with SPIKEVAX - and reports mild COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at a dose of for 5 days. On 01-Jan-2024, COVID-19 (vaccinated in late September 2023 with SPIKEVAX - and reports mild COVID) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Suspect vaccine dosage text was reported as first dose. It was stated that reporter travelled during Christmas (25th of December), lady at the airplane window next to him was coughing. Patient was at location for 2 days and then came back home. Patient had usual upper respiratory infection symptoms (stuffy nose, cold, mild fatigue) but also noticed a change in taste. Symptoms lasted approximately a week.   This case was linked to US-MODERNATX, INC.-MOD-2024-763091 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763091:Husband Case
Age: 16.0
Sex: M
Vaccine: MEN
Symptoms: Incorrect dose administered
Clinical narrative: menquadfi at a low temperature of 30.9F for up to 35 minutes out of range with no reported adverse event; one dose of MENQUADFI administered post excursion with no reported adverse event; Initial information received on 11-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16-year-old male patient and reported that Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] which was kept at a low temperature of 30.9f for up to 35 minutes out of range and one dose of menquadfi administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Mar-2024, the patient received Meningococcal A-C-Y-W135 (T CONJ) Vaccine  which was kept at a low temperature of 30.9f for up to 35 minutes out of range with no reported adverse event (product storage error) (latency: Unknown) (lot U7938AA) (expiry date: 28-Feb-2026) via intramuscular route in the right arm for Immunization.  On 11-Mar-2024  one dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] administered to post excursion with no reported adverse event (poor quality product administered) (latenctcy: unknown)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: 2 days after vaccine, right side of face swollen and red with intense itch. After antibiotics and antihistamines, subsided in 7 days. On 12/20, same side reaction, less intense. One month later, approximately 1/24, same reaction. In early February, some redness and swelling, lasted approx 4 days less intense each time.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 24 hrs after vaccines; small area redness upper right arm, 48 hrs. after vaccines are of redness and warm measure 2" x "3 upper (L) arm, not tender.
Age: 1.92
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Lethargy, Skin warm, Vomiting
Clinical narrative: Mom stated her child felt warm, though he did not have an elevated temperature. He vomited during the evening of 3.14.24, which he does when he has a fever. No sick siblings, no other illnesses in the home. He is also lethargic. No rashes at injection sites. Recommended mom call pediatrician Dr. at clinic for further advice.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Redness on her chest and arms. She did not report a difficulty breathing at that time
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Presyncope, Syncope
Clinical narrative: Patient received Tdap vaccine in her left deltoid at the clinic and tolerated the procedure well with no adverse reaction. She left the clinic and had vasovagal reaction causing her to faint (hallway)  for few second outside Clinic . Attended to the scene and activated EMS . Patient's VSS 103/69, HR 71 , O2 sat at 100 % RA. Patient was breathing and had a pulse. She was not aware that she fell and fainted for few seconds. The paramedics arrived, assessed patient for for head trauma  and did not take the patient to the ER for evaluation. The mother of the patient was at the scene as well. Patient got up after being evaluated by the medics and went home. Patient denied of SOB , chest pains or having any other problems. She had Tdap in the past with no problems.
Age: 36.0
Sex: M
Vaccine: TYP
Symptoms: Arthralgia, Joint range of motion decreased, Ultrasound scan, X-ray limb
Clinical narrative: Left shoulder pain with reduced ROM
Age: 4.0
Sex: F
Vaccine: DTPPVHBHPB, HEP, HEPA, MMRV, PNC15
Symptoms: Extra dose administered
Clinical narrative: None, Patient received mistakenly additional Hep B ( Engerix-B and vaxelis)
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, CSF protein increased, CSF white blood cell count negative, Dysphagia, Guillain-Barre syndrome
Clinical narrative: Development of bilateral leg weakness in 4 days, unable to swallow talk Gullaine Barre Syndrome
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness
Clinical narrative: Development of bilateral leg weakness in 4 days, unable to swallow talk Gullaine Barre Syndrome
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Client reports  at 6 AM 3/15/2024 she woke with bilateral erythema of hands with one clear fluid filled blister on palmar side of left hand.  At time of phone call the client reported the blister was still there yet the swelling had dissipated some.  Client denies in conversation any hives, facial swelling, shortness of breath, dizziness, or weakness. Client advised to contact her primary care provider to report symptoms and await further instructions.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I received the covid vaccine Comirnaty on February 27th, 2024 and yesterday, March 14, 2024, I had some hives come up on the back of my hand, today I have hives on the back of my hand. This has happened the first time I received the covid vaccine. They will last off and on each day. I don't think this is a coincidence and I will not be getting any more covid vaccines. Unless they can figure out why some people get hives from this vaccine too. By now I know it's not a coincidence from 5 consecutive vaccines I get hives and I have never gotten hives before.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Urticaria, Vaccination site pain, Vaccination site reaction, Vaccination site warmth
Clinical narrative: RED, WHELPED UP, PAIN IN ARM, AND HOT TO TOUCH AT VACCINE SITE.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Extreme ringing in the ears
Sex: F
Vaccine: TD
Symptoms: Blood test, Condition aggravated, Feeling abnormal, Fibromyalgia, Headache
Clinical narrative: I received the vaccination and within by the time I left there, I was feeling not quite right. I had a small headache and a little bit of nausea feeling (half and hour after receiving the vaccine), which I try to ignore. I came home and had some tea, I went to sleep and woke up with in a few hours and the headache got worst. Terrible terrible headache. Like ice picks stabbing my temples. I have had migraines before, but nothing like this. All of my fibromyalgia symptoms were off the chart. All of them, like never ever like this. All over pain with Muscle and joints with fatigue. Just extreme pain everywhere. Plus a new pain with is the stabbing of the ice pick in my head. My eyes were so sensitive to light, I had to hold my hand over my eyes. I had ringing in my ears, my teeth hurt. I couldnt sleep, the pain was so great, so I took my fibromyalgia medicine and it didnt help whats so ever. My neck was so stiff and painful and the vein in the left side of my neck was pounding. This ice pick headache would move from the top of my head to the left side, then to the right side, then to my temples. It always hurt. The ice pick rather pain moved, all of my body hurt, but that part hurt the most. I could tell you, I couldnt see enough to read, I had all kind of lathargic, with fatiuge and the nausea would come and go. There was a wooshing sound in my ears. If I was to put my head down lower than my heart, it would feel like it would explode. I couldnt pick up anything with my head going down, and I had to sleep with my head straight up. All around my head was like an horrible explosion of pain. I call it a brain pain. I was back in the doctors office within  hours of receiving that vaccination. My pulse was 100 and blood pressure was 189/98
Sex: F
Vaccine: TD
Symptoms: Lethargy, Muscle fatigue, Musculoskeletal stiffness, Nausea, Neck pain
Clinical narrative: I received the vaccination and within by the time I left there, I was feeling not quite right. I had a small headache and a little bit of nausea feeling (half and hour after receiving the vaccine), which I try to ignore. I came home and had some tea, I went to sleep and woke up with in a few hours and the headache got worst. Terrible terrible headache. Like ice picks stabbing my temples. I have had migraines before, but nothing like this. All of my fibromyalgia symptoms were off the chart. All of them, like never ever like this. All over pain with Muscle and joints with fatigue. Just extreme pain everywhere. Plus a new pain with is the stabbing of the ice pick in my head. My eyes were so sensitive to light, I had to hold my hand over my eyes. I had ringing in my ears, my teeth hurt. I couldnt sleep, the pain was so great, so I took my fibromyalgia medicine and it didnt help whats so ever. My neck was so stiff and painful and the vein in the left side of my neck was pounding. This ice pick headache would move from the top of my head to the left side, then to the right side, then to my temples. It always hurt. The ice pick rather pain moved, all of my body hurt, but that part hurt the most. I could tell you, I couldnt see enough to read, I had all kind of lathargic, with fatiuge and the nausea would come and go. There was a wooshing sound in my ears. If I was to put my head down lower than my heart, it would feel like it would explode. I couldnt pick up anything with my head going down, and I had to sleep with my head straight up. All around my head was like an horrible explosion of pain. I call it a brain pain. I was back in the doctors office within  hours of receiving that vaccination. My pulse was 100 and blood pressure was 189/98
Sex: F
Vaccine: TD
Symptoms: Pain, Photophobia, Primary stabbing headache, Pulse abnormal, Sleep disorder
Clinical narrative: I received the vaccination and within by the time I left there, I was feeling not quite right. I had a small headache and a little bit of nausea feeling (half and hour after receiving the vaccine), which I try to ignore. I came home and had some tea, I went to sleep and woke up with in a few hours and the headache got worst. Terrible terrible headache. Like ice picks stabbing my temples. I have had migraines before, but nothing like this. All of my fibromyalgia symptoms were off the chart. All of them, like never ever like this. All over pain with Muscle and joints with fatigue. Just extreme pain everywhere. Plus a new pain with is the stabbing of the ice pick in my head. My eyes were so sensitive to light, I had to hold my hand over my eyes. I had ringing in my ears, my teeth hurt. I couldnt sleep, the pain was so great, so I took my fibromyalgia medicine and it didnt help whats so ever. My neck was so stiff and painful and the vein in the left side of my neck was pounding. This ice pick headache would move from the top of my head to the left side, then to the right side, then to my temples. It always hurt. The ice pick rather pain moved, all of my body hurt, but that part hurt the most. I could tell you, I couldnt see enough to read, I had all kind of lathargic, with fatiuge and the nausea would come and go. There was a wooshing sound in my ears. If I was to put my head down lower than my heart, it would feel like it would explode. I couldnt pick up anything with my head going down, and I had to sleep with my head straight up. All around my head was like an horrible explosion of pain. I call it a brain pain. I was back in the doctors office within  hours of receiving that vaccination. My pulse was 100 and blood pressure was 189/98
Sex: F
Vaccine: TD
Symptoms: Tinnitus, Toothache
Clinical narrative: I received the vaccination and within by the time I left there, I was feeling not quite right. I had a small headache and a little bit of nausea feeling (half and hour after receiving the vaccine), which I try to ignore. I came home and had some tea, I went to sleep and woke up with in a few hours and the headache got worst. Terrible terrible headache. Like ice picks stabbing my temples. I have had migraines before, but nothing like this. All of my fibromyalgia symptoms were off the chart. All of them, like never ever like this. All over pain with Muscle and joints with fatigue. Just extreme pain everywhere. Plus a new pain with is the stabbing of the ice pick in my head. My eyes were so sensitive to light, I had to hold my hand over my eyes. I had ringing in my ears, my teeth hurt. I couldnt sleep, the pain was so great, so I took my fibromyalgia medicine and it didnt help whats so ever. My neck was so stiff and painful and the vein in the left side of my neck was pounding. This ice pick headache would move from the top of my head to the left side, then to the right side, then to my temples. It always hurt. The ice pick rather pain moved, all of my body hurt, but that part hurt the most. I could tell you, I couldnt see enough to read, I had all kind of lathargic, with fatiuge and the nausea would come and go. There was a wooshing sound in my ears. If I was to put my head down lower than my heart, it would feel like it would explode. I couldnt pick up anything with my head going down, and I had to sleep with my head straight up. All around my head was like an horrible explosion of pain. I call it a brain pain. I was back in the doctors office within  hours of receiving that vaccination. My pulse was 100 and blood pressure was 189/98
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Lymphadenopathy, Rash
Clinical narrative: Confirmed full blown shingles case with rash, headache, swollen glands in neck and arm pit. Diagnosed on 3/10. Treated with Famciclovir and Methylprednisolone.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: The patient was given an expired vaccine. It expired on 3-3-2024 and was given on 3-14-2024
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site muscle weakness, Pain
Clinical narrative: Patient has been experiencing soreness/weakness in the right arm near the site of the injection. She complains of excruciating pain when trying to reach across body or behind her body.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient reveiced the wrong vaccine. pt has no outcomes sxs
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired vaccine. No symptoms at the time and later on leaving the office.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Asthenia, Fall, Hepatic enzyme increased, Oedema
Clinical narrative: Hospitalized 10/13/22-10/21/22 Fall, BLE edema, weakness, elevated troponin, UTI, AKI, elevated liver enzymes,
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased, Urinary tract infection
Clinical narrative: Hospitalized 10/13/22-10/21/22 Fall, BLE edema, weakness, elevated troponin, UTI, AKI, elevated liver enzymes,
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Chronic kidney disease, Culture urine positive, Delirium, Dementia
Clinical narrative: Admit date: 3/6/2024  Discharge date: 03/13/2024  Admitting Physician:   Discharge Physician:  Reason for Admission: acute metabolic encephalopathy   Discharge Problem List     * (Principal) RESOLVED: Urinary tract infection   Falls   RESOLVED: Acute metabolic encephalopathy  Procedures: n/a  Consultations: none   Hospital Course:  89 YO female with PMHx of CVA, cervical spine fracture, CKD, HTN, admitted for acute encephalopathy following a ground level fall.  Found to have urinary tract infection and AKI.  Urine culture growing Pseudomonas.  Patient was given total 5 days of IV cefepime.  Kidney function improved with IVF. Mental status is back to baseline. PT OT recommended IPR, accepted. Pt is discharged under stable condition today.    Acute encephalopathy secondary to UTI, mild sepsis (now improved, sepsis resolved) Suspect a component of dementia/sundowning vs UTI - UA consistent with UTI from pseudomonas - treated with IV cefepime 1 g x 5 days (last day is 3/12/24)  Large right hip hematoma s/p GLF  History of frequent falls  Blood loss anemia - Hgb now stable - Plavix resumed.  - PT/OT recommending IPR  - Fall precautions  - Pain control: tylenol - Aggressive bowel regimen with Miralax, senna, milk of mag scheduled.    AKI (resolved) on CKD - encourage po intake  - Strict I/O & daily weights Allergies:  Bactrim [sulfamethoxazole-trimethoprim], Cardizem [diltiazem hcl], Lovenox [enoxaparin], Norvasc [amlodipine], Sulfa (sulfonamide antibiotics), and Vasotec [enalapril maleate]  Wt Readings from Last 1 Encounters: 03/13/24 76.5 kg (168 lb 9.6 oz) FOLLOWUPS  Unresulted Labs: n/a  Outstanding Issues:  high fall risks   Outpatient Diagnostic Tests and Procedures:  repeat BMP   Homecare Arrangements: n/a  Discharge disposition: Rehab Facility / Unit
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fall, Haematoma, Mental status changes, Metabolic encephalopathy, Pseudomonas infection
Clinical narrative: Admit date: 3/6/2024  Discharge date: 03/13/2024  Admitting Physician:   Discharge Physician:  Reason for Admission: acute metabolic encephalopathy   Discharge Problem List     * (Principal) RESOLVED: Urinary tract infection   Falls   RESOLVED: Acute metabolic encephalopathy  Procedures: n/a  Consultations: none   Hospital Course:  89 YO female with PMHx of CVA, cervical spine fracture, CKD, HTN, admitted for acute encephalopathy following a ground level fall.  Found to have urinary tract infection and AKI.  Urine culture growing Pseudomonas.  Patient was given total 5 days of IV cefepime.  Kidney function improved with IVF. Mental status is back to baseline. PT OT recommended IPR, accepted. Pt is discharged under stable condition today.    Acute encephalopathy secondary to UTI, mild sepsis (now improved, sepsis resolved) Suspect a component of dementia/sundowning vs UTI - UA consistent with UTI from pseudomonas - treated with IV cefepime 1 g x 5 days (last day is 3/12/24)  Large right hip hematoma s/p GLF  History of frequent falls  Blood loss anemia - Hgb now stable - Plavix resumed.  - PT/OT recommending IPR  - Fall precautions  - Pain control: tylenol - Aggressive bowel regimen with Miralax, senna, milk of mag scheduled.    AKI (resolved) on CKD - encourage po intake  - Strict I/O & daily weights Allergies:  Bactrim [sulfamethoxazole-trimethoprim], Cardizem [diltiazem hcl], Lovenox [enoxaparin], Norvasc [amlodipine], Sulfa (sulfonamide antibiotics), and Vasotec [enalapril maleate]  Wt Readings from Last 1 Encounters: 03/13/24 76.5 kg (168 lb 9.6 oz) FOLLOWUPS  Unresulted Labs: n/a  Outstanding Issues:  high fall risks   Outpatient Diagnostic Tests and Procedures:  repeat BMP   Homecare Arrangements: n/a  Discharge disposition: Rehab Facility / Unit
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sepsis, Urinary tract infection
Clinical narrative: Admit date: 3/6/2024  Discharge date: 03/13/2024  Admitting Physician:   Discharge Physician:  Reason for Admission: acute metabolic encephalopathy   Discharge Problem List     * (Principal) RESOLVED: Urinary tract infection   Falls   RESOLVED: Acute metabolic encephalopathy  Procedures: n/a  Consultations: none   Hospital Course:  89 YO female with PMHx of CVA, cervical spine fracture, CKD, HTN, admitted for acute encephalopathy following a ground level fall.  Found to have urinary tract infection and AKI.  Urine culture growing Pseudomonas.  Patient was given total 5 days of IV cefepime.  Kidney function improved with IVF. Mental status is back to baseline. PT OT recommended IPR, accepted. Pt is discharged under stable condition today.    Acute encephalopathy secondary to UTI, mild sepsis (now improved, sepsis resolved) Suspect a component of dementia/sundowning vs UTI - UA consistent with UTI from pseudomonas - treated with IV cefepime 1 g x 5 days (last day is 3/12/24)  Large right hip hematoma s/p GLF  History of frequent falls  Blood loss anemia - Hgb now stable - Plavix resumed.  - PT/OT recommending IPR  - Fall precautions  - Pain control: tylenol - Aggressive bowel regimen with Miralax, senna, milk of mag scheduled.    AKI (resolved) on CKD - encourage po intake  - Strict I/O & daily weights Allergies:  Bactrim [sulfamethoxazole-trimethoprim], Cardizem [diltiazem hcl], Lovenox [enoxaparin], Norvasc [amlodipine], Sulfa (sulfonamide antibiotics), and Vasotec [enalapril maleate]  Wt Readings from Last 1 Encounters: 03/13/24 76.5 kg (168 lb 9.6 oz) FOLLOWUPS  Unresulted Labs: n/a  Outstanding Issues:  high fall risks   Outpatient Diagnostic Tests and Procedures:  repeat BMP   Homecare Arrangements: n/a  Discharge disposition: Rehab Facility / Unit
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: ADMINISTRATION ERROR- NO KNOWN ADVERSE EVENT. The patient likely received the entire contents of the single dose vial which contains two times more than the prescribed dose of 0.25mL.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Dizziness, Epistaxis, Nasal cavity packing, Nausea
Clinical narrative: 3-26-21 onset of Afib.  Required an emergency room visit at hospital. This caused severe dizziness and lightheadedness and occasional nausea.  This is a new development that I have never experienced before in my life. Because of the AFIB i was put on Eloquis 5 mg dose twice daily which I will be on for the rest of my life.  On 2-15-24 I had a health scare because of a massive nose bleed.  That required insertion of a dual sided occlusion balloon catheter. I was put again into the ER.  It was not taken out for 11 days due to it's continued bleeding. I have had additional nose bleeds since, one of which was severe.  It does and still requires treatment.  I believe this is a direct result of the adverse event. It will require  some kind of procedure to stop the bleeding.  A procedure like this would require hospitalization, pre treatment because of the effects I get from the iodine contrast media.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dehydration, Diarrhoea, Hyperglycaemia, Hypokalaemia
Clinical narrative: Observation 10/14/22-10/17/22 back pain, dehydration, diarrhea, malaise, hypokalemia, hyperglycemia,
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Observation 10/14/22-10/17/22 back pain, dehydration, diarrhea, malaise, hypokalemia, hyperglycemia,
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: ADMINISTRATION ERROR- NO KNOWN ADVERSE EVENT. The patient likely received the entire contents of the single dose vial which contains two times more than the prescribed dose of 0.25mL.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Constipation, Decreased appetite, Dizziness, Hypoxia
Clinical narrative: Observation 10/16/22-10/19/22 weakness, dizziness, fever, decreased appetite, constipation, hypoxia,
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Observation 10/16/22-10/19/22 weakness, dizziness, fever, decreased appetite, constipation, hypoxia,
Age: 1.75
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: ADMINISTRATION ERROR-NO KNOWN ADVERSE EVENT OR REPORT OF ADVERSE EVENT. This patient likely received the entire contents of the single dose vial which contains two times the prescribed dose of 0.25mL.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: she tested positive for Covid 10/2023.    Date of death 01/25/2024.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: PATIENT WAS GIVEN RSV BY ERROR INSTEAD OF SHINGRIX. MY SUPERVISOR IS CALLING PFIZER TO CHECK ON POSSIBLE ADVERSE RECATIONS.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: ADMINISTRATION ERROR-NO KNOWN OR REPORTED ADVERSE EVENT. The patient likely received the entire contents of the single dose vial containing two times the prescribed dose of 0.25ml.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea, Pain, Sepsis
Clinical narrative: Hospitalized 10/16/22-10/27/22 cough, weakness, body aches, SOB, tachypnea, sepsis, dyspnea, debility,
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Tachypnoea
Clinical narrative: Hospitalized 10/16/22-10/27/22 cough, weakness, body aches, SOB, tachypnea, sepsis, dyspnea, debility,
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: She did not have any kind of adverse event
Age: 55.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: patient reports swollen red arm
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Medical Assistant did not prepare vaccine according to directions, wrong diluent was used to mix resulting in an invalid dose of vaccine.
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: POTENTIAL DOSE ADMINISTRATION ERROR- NO KNOWN ADVERSE EVENT WITNESSED OR REPORTED. This patient likely received the entire contents of the single dose vial which contains twice the the prescribed dose of 0.25mL. The date and time of the second Moderna Injection ages 6mos-11yrs was on 11/26/2022 as listed above.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Double dose of RSV given to pt.  Original dose received 10/02/2023.  Pt came on 12/20/23 asking for RSV without realizing he already got one.  DUR flagged minor "late refill" but was missed by Pharmacist.
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Incorrect route of product administration, Local reaction, Skin warm, Wrong product administered
Clinical narrative: Patient was given TD instead of TB in forearm subcutaneously, instead of IM.  Patient had a localized reaction, approximately baseball size, red and warm to touch. Patient was given Benadryl in the ER, no treatment given in our office.  Reaction went to down to quarter size last time visualized by staff.  Patient refused to let Doctor examine arm.
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered
Clinical narrative: Beyfortus RSV Ig was administered 2x 100 mg in error, should of only gotten 1 dose
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient reports experiencing no significant symptoms. Reported taking two Tylenol tablets. Will follow up with primary care provider.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient has large erythema of the site, warmth to touch. We are treating with Keflex PO x 7 days. Treatment just started today
Age: 55.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: VACCINE WAS GIVEN TO UNDER 60 YEARS OLD PATIENT.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vision blurred
Clinical narrative: blurry vision, dizziness, loss of balance
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: AT THE TIME OF RECEIVING THE SECOND DOSE OF THE VACCINE THE PATIENT REPORS PAIN ON HIS RIGHT  KNEE . SHE WAS IN PAIN  FOR TWO WEEKS WITHOUT BEING ABLE TO BEND HER COMPLETLY. SHE DO NOT REFER TO DOING ANYTHING DIFFERENT IN DIET OR ACTIVITY.
Age: 71.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Pt reported fever and swollen glands the day after vaccine administration.
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC20
Symptoms: Erythema, Hypersensitivity, Injection site urticaria, Urticaria, Vomiting
Clinical narrative: I administered the vaccines around 2:10pm and within a few minutes patient had thrown up. Parents thought patient vomited d/t being worked up about getting vaccines. Parents checked out at 2:17pm and left the office. at 2:40pm I was alerted by our front office manager that parents had returned with patient stating patient was having an allergic reaction. I brought patient back to exam room. Her face, and entire torso were red and covered in hives, there were also a few hives on her legs and arms but just scattered. Patient's PCP and attending physician came directly to the room and ordered IM Benadryl 10mg to be administered to the patient. Medication was administered. Patient was not in any respiratory distress and had no signs of anaphylaxis. Patient and parents were monitored in the exam room until 3:15pm. Patient redness and hives were diminished significally when patient left the office. ED precautions given to parents prior to leaving.
Age: 1.42
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: high fever
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Dry mouth, Heart rate increased, Immediate post-injection reaction, Pharyngeal swelling
Clinical narrative: Pt received vaccine and immediately complained of rapid heart rate. Denied SOB/ Itching/ Swelling of throat. Then reported dry mouth and some swelling of throat. Emergency services was called and pt was taken for further evaluation and management.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Superficial vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Superficial venous thrombus of Left LE diagnosed a few weeks after Moderna vaccine
Age: 50.0
Sex: F
Vaccine: FLU4, HEP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain, swelling, bruising, and limited range of motion of left upper arm and shoulder that began the same day vaccines were administered.  Continues to have pain with certain movements and moderately decreased range of motion in left shoulder as of 3/15/24. Has had some improvement with rest and home physical therapy.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site paraesthesia, Muscular weakness, Musculoskeletal stiffness, Pruritus
Clinical narrative: There was no problem with the injection itself; it was administered correctly. I did experience soreness around the injection site; however weeks later  a stiffness  and slight weakness noted was noted in that area and sometimes in  the entire left arm below the area i received in the injection. The stiffness is still here as I fill out this report and a weakness when I left weights or do push ups.  I experience itching in the crease of my elbow periodically with mild tingling around the bicep but nothing visible.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: gave adult dose to a fully vaccinated child
Age: 18.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult doses given to child
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Decreased appetite, Electric shock sensation
Clinical narrative: Pt reported an electric like shock up her arm immediately after injection.  She was awake all night, flu like symptoms, low grade fever, pain at site of injection until about 1pm this afternoon, back pain, no appetite, shivers, cold, wiped out.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Immediate post-injection reaction, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: Pt reported an electric like shock up her arm immediately after injection.  She was awake all night, flu like symptoms, low grade fever, pain at site of injection until about 1pm this afternoon, back pain, no appetite, shivers, cold, wiped out.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Pt reported an electric like shock up her arm immediately after injection.  She was awake all night, flu like symptoms, low grade fever, pain at site of injection until about 1pm this afternoon, back pain, no appetite, shivers, cold, wiped out.
Age: 70.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Dizziness postural
Clinical narrative: Within two hours of vaccination patient felt dizzy from sitting to standing, checked blood pressure it was 75/50 pulse 93. Symptoms lasted 30 to 45 minutes.
Age: 69.0
Sex: F
Vaccine: FLUA4, PNC20, TDAP
Symptoms: Blister rupture, Pruritus
Clinical narrative: Pt developed a blister to her right arm approximately 3x3 inches. It then popped. Area is itchy.
Age: 72.0
Sex: U
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: 72 year old; This spontaneous report was received from a nurse via company representative referring to 72-year-old patient with unknown gender. Information about patient's historical condition included spleen removal. The patient's concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On an unknown date, the reporter was asking assistance to locate a haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for the patient with spleen removal (product prescribing issue).
Age: 4.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a 4 year old received a PROQUAD dose today (11-MAR-2024),  that expired 18-FEB-2024.; This spontaneous report was received from Other registered medical assistance (RMA) and refers to a 4-year-old patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 11-MAR-2024, received a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #W026316, expiration date: 18-FEB-2024, (strength, and route of administration were not provided) for prophylaxis (expired product administered); and  sterile diluent, solution for injection/infusion, lot #W009643, expiration date: 14-NOV-2024 (strength, route of administration, and indication were not provided). No additional adverse event (AE) (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes zoster, Vaccination failure
Clinical narrative: had once on my back / Suspected vaccination failure; Bells palsy; had once on my back; This serious case was reported by a nurse via interactive digital media and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had once on my back / Suspected vaccination failure) (serious criteria GSK medically significant), bell's palsy (Verbatim: Bells palsy) (serious criteria GSK medically significant) and shingles (Verbatim: had once on my back). The outcome of the vaccination failure was unknown and the outcome of the bell's palsy and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, bell's palsy and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, bell's palsy and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 05-Mar-2024 This case was reported by a patient via interactive digital media. The patient was a nurse, and her husband was a doctor. It was reported by patient as awful, had once on her back and at 87 on her face with, Bell's palsy. She had the shots a few years before the second time.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Oral herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles/almost lost my left eye; got shingles in my mouth; still got shingles on one side of my face, in one side of my nose/on the top of my head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included nerve pain (had nerve pain still, that happened in 2017).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: got shingles/almost lost my left eye) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: got shingles in my mouth) and shingles (Verbatim: still got shingles on one side of my face, in one side of my nose/on the top of my head). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, oral herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, oral herpes zoster and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, oral herpes zoster and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 08-Mar-2024 This case was reported by a patient via interactive digital media. Patient got the shot and still got shingles, on one side of face, in one side of nose, almost lost left eye, in mouth and on the top of head.  The physician said if patient would not have gotten the shot, it would have been worse.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had shingles for 5 weeks now / Suspected vaccination failure; had shingles for 5 weeks now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shingles for 5 weeks now / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles for 5 weeks now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 08-MAR-2024 This case was reported by a patient via interactive digital media. The patient was vaccinated when the vaccine first became available. The patient had shingles for 5 weeks now. Something patient had found to provide relief to the affected area was a heating pad on high setting. Primary care physician (PCP) said vaccination would not a guarantee that the patient would not get shingles, but if they get it, it would be less severe. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case had been linked with US2024AMR032468, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR032468:Same reporter