chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: M
Vaccine: FLU4
Symptoms: Biopsy bone marrow, Computerised tomogram, Decreased appetite, Electroencephalogram, Febrile convulsion
Clinical narrative: Patient had fevers of 102 starting Jan 4th in the morning. Would resolve during day and come back next morning. Jan 6th patient lost appetite and had vomiting. Jan 7th patient was pretty lethargic. Urgent care stated stomach bug and sent home with zofran. Jan 8th mom wokeup to patient having seizure, focal to left side. EMS said febrile. Visited PCP and sent for bloodwork. Patient had another seizure in lab and was admitted to PICU. Diagnosed with Bacterial Meningitis from Strep Pnuemo & Sepsis. Treated with antibiotics.  Patient improved and became sick again with fevers/ seizures on Jan 14th. Diagnosed with HLH and began steroid treatment Jan 19th.  Discharged to rehab on Jan 31. Discharged to home on Feb 8th. Still receiving follow-up care, IVIG treatment, therapies, etc.
Age: 1.58
Sex: M
Vaccine: FLU4
Symptoms: Gastroenteritis viral, Haemophagocytic lymphohistiocytosis, Immunoglobulin therapy, Intensive care, Lethargy
Clinical narrative: Patient had fevers of 102 starting Jan 4th in the morning. Would resolve during day and come back next morning. Jan 6th patient lost appetite and had vomiting. Jan 7th patient was pretty lethargic. Urgent care stated stomach bug and sent home with zofran. Jan 8th mom wokeup to patient having seizure, focal to left side. EMS said febrile. Visited PCP and sent for bloodwork. Patient had another seizure in lab and was admitted to PICU. Diagnosed with Bacterial Meningitis from Strep Pnuemo & Sepsis. Treated with antibiotics.  Patient improved and became sick again with fevers/ seizures on Jan 14th. Diagnosed with HLH and began steroid treatment Jan 19th.  Discharged to rehab on Jan 31. Discharged to home on Feb 8th. Still receiving follow-up care, IVIG treatment, therapies, etc.
Age: 1.58
Sex: M
Vaccine: FLU4
Symptoms: Lumbar puncture, Magnetic resonance imaging, Meningitis bacterial, Partial seizures, Pneumonia pneumococcal
Clinical narrative: Patient had fevers of 102 starting Jan 4th in the morning. Would resolve during day and come back next morning. Jan 6th patient lost appetite and had vomiting. Jan 7th patient was pretty lethargic. Urgent care stated stomach bug and sent home with zofran. Jan 8th mom wokeup to patient having seizure, focal to left side. EMS said febrile. Visited PCP and sent for bloodwork. Patient had another seizure in lab and was admitted to PICU. Diagnosed with Bacterial Meningitis from Strep Pnuemo & Sepsis. Treated with antibiotics.  Patient improved and became sick again with fevers/ seizures on Jan 14th. Diagnosed with HLH and began steroid treatment Jan 19th.  Discharged to rehab on Jan 31. Discharged to home on Feb 8th. Still receiving follow-up care, IVIG treatment, therapies, etc.
Age: 1.58
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Sepsis, Venogram, Vomiting
Clinical narrative: Patient had fevers of 102 starting Jan 4th in the morning. Would resolve during day and come back next morning. Jan 6th patient lost appetite and had vomiting. Jan 7th patient was pretty lethargic. Urgent care stated stomach bug and sent home with zofran. Jan 8th mom wokeup to patient having seizure, focal to left side. EMS said febrile. Visited PCP and sent for bloodwork. Patient had another seizure in lab and was admitted to PICU. Diagnosed with Bacterial Meningitis from Strep Pnuemo & Sepsis. Treated with antibiotics.  Patient improved and became sick again with fevers/ seizures on Jan 14th. Diagnosed with HLH and began steroid treatment Jan 19th.  Discharged to rehab on Jan 31. Discharged to home on Feb 8th. Still receiving follow-up care, IVIG treatment, therapies, etc.
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Patient her for catch up vaccines, MD ordered KINRIX, administered by nurse, Pediarix should have been ordered and administered.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Fall, Head injury, Hyperhidrosis, Loss of consciousness
Clinical narrative: Approximately 5 minutes after receiving the Tetanus shot, the donor stated the need to lay down because he felt lightheaded. Donor then loss consciousness for less than 2 minutes causing him to fall and hit his head.  Donor was assisted to a bed, ice packs were given, and vital signs were obtained; BP 109/70, pulse: 58. Donor was sweating profusely and pale. Once coherent donor was given water to drink and granola bar.  The donor stated that he probably didn't eat enough that day and denied having felt sick recently or any other factors that would be cause for syncopal episode. Vital signs remained stable; donor left facility with wife.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Pallor
Clinical narrative: Approximately 5 minutes after receiving the Tetanus shot, the donor stated the need to lay down because he felt lightheaded. Donor then loss consciousness for less than 2 minutes causing him to fall and hit his head.  Donor was assisted to a bed, ice packs were given, and vital signs were obtained; BP 109/70, pulse: 58. Donor was sweating profusely and pale. Once coherent donor was given water to drink and granola bar.  The donor stated that he probably didn't eat enough that day and denied having felt sick recently or any other factors that would be cause for syncopal episode. Vital signs remained stable; donor left facility with wife.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 10/10/23
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event
Clinical narrative: No adverse event append. I am doing just to be compliant
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Patient was seen for vaccine catch up. Provider ordered KINRIX. Nurse administered. Provider should have ordered DTaP and IPV.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Guillain-Barre syndrome, Laboratory test
Clinical narrative: AFIB 3/21-7/21 treated at Medical Center. Booster 11/21, Guillian Barre Syndrome 8/22
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Beyond use date was 12/31/23
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Acute disseminated encephalomyelitis, Arthralgia, Asthenia, CSF test, Computerised tomogram
Clinical narrative: Became ill with supposed viral infection in September. Continued with intermittent fever and cough until December when she developed severe headache, joint pain, weakness, urinary retention and was diagnosed with ADEM
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Headache, Inflammatory marker test, Magnetic resonance imaging, Malaise
Clinical narrative: Became ill with supposed viral infection in September. Continued with intermittent fever and cough until December when she developed severe headache, joint pain, weakness, urinary retention and was diagnosed with ADEM
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Urinary retention, Viral infection
Clinical narrative: Became ill with supposed viral infection in September. Continued with intermittent fever and cough until December when she developed severe headache, joint pain, weakness, urinary retention and was diagnosed with ADEM
Age: 1.25
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, Urticaria
Clinical narrative: Hives/urticaria lasted 15-24hrs. Treatment:benadryl. This vaccine was NOT to be administered, it was the result of an error by the attending NP! Pt already had all the required doses for this vaccine!
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Blood test, Computerised tomogram head, Electromyogram, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Patient developed left leg lumbar plexopathy (femoral neuropathy); patient required to use walker and cane; continues to this day
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Nerve conduction studies, Neuropathy peripheral, Spinal X-ray, Walking aid user
Clinical narrative: Patient developed left leg lumbar plexopathy (femoral neuropathy); patient required to use walker and cane; continues to this day
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Aphasia, Computerised tomogram, Confusional state, Dysarthria, Neurological symptom
Clinical narrative: Stroke symptoms. Mental confusion. Body tremors. Slurred speech. Inability to form words to speak.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Tremor
Clinical narrative: Stroke symptoms. Mental confusion. Body tremors. Slurred speech. Inability to form words to speak.
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt is 2 months old and was given a vaccine  for 4-7 yr olds
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC15, RV5
Symptoms: Extra dose administered
Clinical narrative: patient had gotten these immunizations on 2/13/2023 and then on 2/27/2023
Age: 60.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Flushing, Gait disturbance, Gait inability, Nausea, Pain in extremity
Clinical narrative: INMATE COMPLAINING OF FEELING FLUSHED, PAIN IN ARMS, UNABLE TO WALK AND HAD DIFFICULTY AMBULATING DOWN STEPS, COMPLAINTS OF NAUSEA
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Beyond use date was 12/31/23
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Injection site scab, Polymerase chain reaction positive, Rash, Rash papular, Varicella post vaccine
Clinical narrative: Developed scabbed lesion at site of vaccine with development of papular/vesicular lesions on thigh, back and abdomen. Confirmed varicella PCR on 2/28/2024 by lesion swab.
Age: 1.25
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: Developed scabbed lesion at site of vaccine with development of papular/vesicular lesions on thigh, back and abdomen. Confirmed varicella PCR on 2/28/2024 by lesion swab.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given a KINRIX Vaccine when she was supposed to get a plain DTaP vaccine.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Acute uticaria within 15  minutes of vaccine administration. Patient given PO Diphendydrame 25mg x 1 at 1217. Uticaria resolved 1248.  Patient discharged with hydrocortisone cream and additional dose of Diphenhydramine 25 mg 1317.
Age: 52.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Condition aggravated, Loss of consciousness, Seizure
Clinical narrative: Patient has a known seizure disorder for which they take medication. After receiving the vaccinations the patient had a seizure that lasted approximately 2 mins and patient regained consciousness. Care was given to the patient and they will follow up with their neurologist. Pharmacy contacted neurologist as well.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently gave Moderna 12 & up, instead of Moderna 6-11yo
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Pain, Vomiting
Clinical narrative: Patient states she went home and became nauseated, vomited x 1 and passed out. Today she can barely move her arm without severe pain.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Product administered to patient of inappropriate age
Clinical narrative: Pt was given DTap-IPV Kinrix indicated for 4-6 years old, not 6 months old. Pt had some increased swelling at injection site.
Age: 66.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reactions noted
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Cardiac disorder, Cardiac monitoring, Cardiac stress test, Computerised tomogram heart
Clinical narrative: AFIB/heart condition
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging
Clinical narrative: AFIB/heart condition
Sex: F
Vaccine: PNC15, RV5, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was not old enough to receive the vaccines.
Age: 0.75
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Menveo 1-vial dose administered when contraindicated and only advised for children >=10 years of age. No adverse reaction reported after administration.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching - Patient told by PCP to take Benadryl.  Symptoms resolved after treatment with Benadryl per patient
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Decreased appetite, Eye movement disorder, Irritability, Pain
Clinical narrative: She had decreased appetite the following day then 3 days after the immunization she developed movement of her eyes back and forth rapidly that would occur after eating or other times as well. She would fuss and cry and seem to be in pain and unable to see until the movements would stop. This would happen for 1-2 minutes at a time and have been increasing in frequency.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Red reflex abnormal
Clinical narrative: She had decreased appetite the following day then 3 days after the immunization she developed movement of her eyes back and forth rapidly that would occur after eating or other times as well. She would fuss and cry and seem to be in pain and unable to see until the movements would stop. This would happen for 1-2 minutes at a time and have been increasing in frequency.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Basophil percentage decreased, Brain fog, Eosinophil percentage decreased, Feeling abnormal, Injection site erythema
Clinical narrative: Arm that was injected was warm and red to touch down to almost bend of arm for 3 days. Day 3 large hives (size of thumb to size of palm) appeared on back, neck, trunk and some on face. Additionally, I felt very weird, kind of fuzzy headed, malaise, etc. No fever or exposure to illness. Butterfly type rash on cheeks and across bridge of nose. Hives continue with increasing on face so I went to urgent care. Was given steroid pack and sent for labs (day 13) CBC completed, elevated WBC (12.1), Lymph 9.2 @ 74%, Neu 2.7 @ 23%, Eos 0%, Baso 0%, variant lymph 2%, platlet 380,000 normally run 250,000 or so.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Lymphocyte count increased, Lymphocyte percentage increased, Malaise, Neutrophil count normal
Clinical narrative: Arm that was injected was warm and red to touch down to almost bend of arm for 3 days. Day 3 large hives (size of thumb to size of palm) appeared on back, neck, trunk and some on face. Additionally, I felt very weird, kind of fuzzy headed, malaise, etc. No fever or exposure to illness. Butterfly type rash on cheeks and across bridge of nose. Hives continue with increasing on face so I went to urgent care. Was given steroid pack and sent for labs (day 13) CBC completed, elevated WBC (12.1), Lymph 9.2 @ 74%, Neu 2.7 @ 23%, Eos 0%, Baso 0%, variant lymph 2%, platlet 380,000 normally run 250,000 or so.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Neutrophil percentage decreased, Platelet count normal, Rash, Urticaria, White blood cell count increased
Clinical narrative: Arm that was injected was warm and red to touch down to almost bend of arm for 3 days. Day 3 large hives (size of thumb to size of palm) appeared on back, neck, trunk and some on face. Additionally, I felt very weird, kind of fuzzy headed, malaise, etc. No fever or exposure to illness. Butterfly type rash on cheeks and across bridge of nose. Hives continue with increasing on face so I went to urgent care. Was given steroid pack and sent for labs (day 13) CBC completed, elevated WBC (12.1), Lymph 9.2 @ 74%, Neu 2.7 @ 23%, Eos 0%, Baso 0%, variant lymph 2%, platlet 380,000 normally run 250,000 or so.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: PATIENT WAS GIVEN WRONG VACCINE TRUMENBA INSTEAD OF MCV4 (MENQUADFI).
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: R arm swelling and pain, reduced range of motion, onset the day after IZ
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, Pyrexia
Clinical narrative: Patient was given varicella vaccine and proquad that contains varicella on the same visit.  There was no adverse reaction.  Patient had fever that was cleared up with in 24 hours of administration.
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: We administered an expired PNEUMOVAX 23 (lot: U034712, expiration: 30Jul2023) to a patient last night.; arm soreness; body soreness; feverish; This spontaneous report was received from Pharmacist and refers to a male patient of unspecified age.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 17-FEB-2024, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), lot # U034712, expiration date: 30-JUL-2023 (Expired product administered), administered for prophylaxis (strength, and route of administration were not provided). The patient would have a doctor's appointment in approximately one month to get titers drawn and see if the administered expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), was effective.  On an unspecified date in February 2024, it was reported that the only side effects noted after the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection were arm soreness (Pain in extremity), body soreness (Pain), and feverish (Pyrexia) described as the usual side effects from vaccines. At the reporting time, the outcome of the events was not provided.  The causal relationship between all the events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Blood glucose increased, Constipation, Dehydration
Clinical narrative: Diabetes Type 1:  autoimmune dysfunction energy level was rapidly decreasing, moods shift erratically, dehydration, frequent urination. headaches, stomach aches, constipation, troubled sleep and had an insatiable appetite; suffered serious autoimmune, autonomic, and neurological dysfunctions; suffered serious autoimmune, autonomic, and neurological dysfunctions; legs were filled with a sharp, intense, stabbing pain; everything hurt; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a  female patient(age not specified). Patient's current conditions, medical history and  concomitant therapy was not reported. On 09-MAR-2020, (at 13 years old), and on 14-SEP-2020, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) administered for prevention cervical cancer. On an unknown date, after the second vaccination, pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her injection; she developed Diabetes Type 1 occurs in 3 phases with each phase marking an escalating failure of the "B" cells in the pancreas to produce insulin. By the mid-February of 2022, pt noticed that her energy level was rapidly decreasing, and her moods began to shift erratically, she also complained of dehydration and frequent urination, began suffering from regular headaches, stomach aches, constipation, troubled sleep and had an insatiable appetite. In late November 2022, pt awoke predawn saying "everything hurt" and that her legs were filled with a sharp, intense, stabbing pain, her glucose levels were dangerously high at 395 (units not provided), therefore she was taken to the emergency room, more tests were administered, and the endocrinologist advised that based on pt's A1C level of 12.6 (units not provided), she was being diagnosed with phase 3 "honeymoon" stage of Diabetes Type 1. As a proximate result of the company's alleged wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering.  At the time of reporting, pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All the events were considered as disabling by reporter.  Upon internal review, the event of Diabetes Type 1was determined to be medically significant.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Glycosylated haemoglobin increased, Headache, Increased appetite, Mood altered, Pain
Clinical narrative: Diabetes Type 1:  autoimmune dysfunction energy level was rapidly decreasing, moods shift erratically, dehydration, frequent urination. headaches, stomach aches, constipation, troubled sleep and had an insatiable appetite; suffered serious autoimmune, autonomic, and neurological dysfunctions; suffered serious autoimmune, autonomic, and neurological dysfunctions; legs were filled with a sharp, intense, stabbing pain; everything hurt; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a  female patient(age not specified). Patient's current conditions, medical history and  concomitant therapy was not reported. On 09-MAR-2020, (at 13 years old), and on 14-SEP-2020, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) administered for prevention cervical cancer. On an unknown date, after the second vaccination, pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her injection; she developed Diabetes Type 1 occurs in 3 phases with each phase marking an escalating failure of the "B" cells in the pancreas to produce insulin. By the mid-February of 2022, pt noticed that her energy level was rapidly decreasing, and her moods began to shift erratically, she also complained of dehydration and frequent urination, began suffering from regular headaches, stomach aches, constipation, troubled sleep and had an insatiable appetite. In late November 2022, pt awoke predawn saying "everything hurt" and that her legs were filled with a sharp, intense, stabbing pain, her glucose levels were dangerously high at 395 (units not provided), therefore she was taken to the emergency room, more tests were administered, and the endocrinologist advised that based on pt's A1C level of 12.6 (units not provided), she was being diagnosed with phase 3 "honeymoon" stage of Diabetes Type 1. As a proximate result of the company's alleged wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering.  At the time of reporting, pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All the events were considered as disabling by reporter.  Upon internal review, the event of Diabetes Type 1was determined to be medically significant.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Pancreatic failure, Pollakiuria, Sleep disorder, Type 1 diabetes mellitus
Clinical narrative: Diabetes Type 1:  autoimmune dysfunction energy level was rapidly decreasing, moods shift erratically, dehydration, frequent urination. headaches, stomach aches, constipation, troubled sleep and had an insatiable appetite; suffered serious autoimmune, autonomic, and neurological dysfunctions; suffered serious autoimmune, autonomic, and neurological dysfunctions; legs were filled with a sharp, intense, stabbing pain; everything hurt; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a  female patient(age not specified). Patient's current conditions, medical history and  concomitant therapy was not reported. On 09-MAR-2020, (at 13 years old), and on 14-SEP-2020, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strengths, doses, lot numbers, expiration dates, routes of administration and anatomical locations were not provided) administered for prevention cervical cancer. On an unknown date, after the second vaccination, pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her injection; she developed Diabetes Type 1 occurs in 3 phases with each phase marking an escalating failure of the "B" cells in the pancreas to produce insulin. By the mid-February of 2022, pt noticed that her energy level was rapidly decreasing, and her moods began to shift erratically, she also complained of dehydration and frequent urination, began suffering from regular headaches, stomach aches, constipation, troubled sleep and had an insatiable appetite. In late November 2022, pt awoke predawn saying "everything hurt" and that her legs were filled with a sharp, intense, stabbing pain, her glucose levels were dangerously high at 395 (units not provided), therefore she was taken to the emergency room, more tests were administered, and the endocrinologist advised that based on pt's A1C level of 12.6 (units not provided), she was being diagnosed with phase 3 "honeymoon" stage of Diabetes Type 1. As a proximate result of the company's alleged wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), the pt suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering.  At the time of reporting, pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).  All the events were considered as disabling by reporter.  Upon internal review, the event of Diabetes Type 1was determined to be medically significant.
Sex: U
Vaccine: FLUN4
Symptoms: Epistaxis, Immediate post-injection reaction
Clinical narrative: TWO PATIENTS EXPERIENCED A NOSE BLEED IMMEDIATELY FOLLOWING THE FLUMIST ADMINISTRATION; A spontaneous report has been received from a health professional. The report concerns a child of unknown gender of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) unknown, via nasal route, on an unknown date.     A Unknown administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced two patients experienced a nose bleed immediately following the flumist administration (preferred term: Epistaxis).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Spinal disorder
Clinical narrative: Hospitalized for GBS; Spinal issue; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Hospitalized for GBS) (serious criteria hospitalization and GSK medically significant) and spinal disorder (Verbatim: Spinal issue). The outcome of the guillain barre syndrome was resolved with sequelae and the outcome of the spinal disorder was not reported.   The reporter considered the guillain barre syndrome to be related to Shingrix. It was unknown if the reporter considered the spinal disorder to be related to Shingrix.     The company considered the guillain barre syndrome to be related to Shingrix. It was unknown if the company considered the spinal disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-FEB-2024 The patient concomitant product included cholesterol and pain medication. The physician reported that when patient was in hospital for Guillain Barre syndrome. The patient shared about a complicating disease as spinal issues. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster
Clinical narrative: Shivers; patient developed shingles; This non-serious case was reported by a other health professional and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 99D73, expiry date 21-NOV-2025) for prophylaxis.   Co-suspect products included prednisone acetate (Prednisone) for product used for unknown indication.   On 25-JAN-2024, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Prednisone. On 06-FEB-2024, 12 days after receiving Shingrix, the patient experienced shivers (Verbatim: Shivers). In FEB-2024, the patient experienced shingles (Verbatim: patient developed shingles). The action taken with Prednisone was unknown. The outcome of the shingles was not reported and the outcome of the shivers was resolving.   It was unknown if the reporter considered the shingles and shivers to be related to Shingrix.     It was unknown if the company considered the shingles and shivers to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-FEB-2024 This report was submitted via the online direct entry reporting system.  The health care professional reported that the patient was given first dose of Shingrix along with prednisone for another condition and about 1 week later patient developed shingles. 12 days after Shingrix and Prednisone, the patient experienced shivers and it was ongoing. The patient reported that symptoms were treated. It was unknown if the reporter considered the shingles and shivers to be related to Prednisone. The consent to follow up was granted via email.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Just got them for the 3rd time; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella zoster vaccine (had the original Shingles shot) and Shingrix (received 2nd shingles shot by shingrix shots).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Just got them for the 3rd time). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 19-FEB-2024 This case was reported the patient via (social media) interactive digital media. The patient just got them for the 3rd time, not complaining though. The vaccine was absolutely no pain or discomfort. The patient had the original Shingles shot and then had the 2 part shingrix shots. The patient strongly recommend everyone got the vaccine once you turn 50 and felt protected in not haven't gotten a horrible case. The patient received 3 doses of shingles vaccine, which led to extra dose administered.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 0.33 years old patient received Kinrix vaccine; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant patient who received DTPa-IPV (Kinrix) (batch number D947X) for prophylaxis.   Concomitant products included HIB vaccine conj (tet tox) (Acthib) and Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13).   On 27-OCT-2023, the patient received Kinrix. On 27-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 0.33 years old patient received Kinrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Feb-2024 The patient's age was reported as 0.33 years. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. This case was 1 of 6 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024AMR023121:Same reporter US-GSK-US2024AMR023122:Same reporter US-GSK-US2024AMR023123:Same reporter US-GSK-US2024AMR023119:Same reporter US-GSK-US2024AMR023120:Same reporter
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 1-year-old patient who received DTPa-IPV (Kinrix) (batch number 34MF9) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Vaqta), Proquad and Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13).   On 14-DEC-2023, the patient received Kinrix. On 14-DEC-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Feb-2024 The patient received Kinirix below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 6 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024AMR023121:Same reporter US-GSK-US2024AMR023123:Same reporter US-GSK-US2024AMR023117:Same reporter US-GSK-US2024AMR023120:Same reporter US-GSK-US2024AMR023122:Same reporter
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 0.17 years old patient received Kinrix vaccine; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant patient who received DTPa-IPV (Kinrix) (batch number D947X) for prophylaxis.   Concomitant products included HIB vaccine conj (tet tox) (Acthib) and Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13).   On 13-DEC-2023, the patient received Kinrix. On 13-DEC-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 0.17 years old patient received Kinrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Feb-2024 The patient's age was reported as 0.17 years. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. This case was 1 of 6 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024AMR023121:SAME REPORTER US-GSK-US2024AMR023122:SAME REPORTER US-GSK-S2024AMR023123:SAME REPORTER US-GSK-US2024AMR023119:SAME REPORTER US-GSK-US2024AMR023117:SAME REPORTER
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 0.42 years old patient received Kinrix vaccine; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant patient who received DTPa-IPV (Kinrix) (batch number D947X) for prophylaxis.   Concomitant products included Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) and HIB vaccine conj (tet tox) (Acthib).   On 31-AUG-2023, the patient received Kinrix. On 31-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 0.42 years old patient received Kinrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Feb-2024 The patient received Kinrix below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 6 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024AMR023120:Same reporter US-GSK-US2024AMR023123:Same reporter US-GSK-US2024AMR023117:Same reporter US-GSK-US2024AMR023122:Same reporter US-GSK-US2024AMR023119:Same reporter
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 0.17 years old patient received Kinrix vaccine; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant patient who received DTPa-IPV (Kinrix) (batch number D947X) for prophylaxis.   Concomitant products included Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) and HIB vaccine conj (tet tox) (Acthib).   On 15-NOV-2023, the patient received Kinrix. On 15-NOV-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 0.17 years old patient received Kinrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Feb-2024 The patient's age was reported as 0.17 years. The patient received Kinirix who was younger than the indicated age which led to inappropriate age at vaccine administration. This case was 1 of 6 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024AMR023121:SAME REPORTER US-GSK-US2024AMR023117:SAME REPORTER US-GSK-US2024AMR023123:SAME REPORTER US-GSK-US2024AMR023120:SAME REPORTER US-GSK-US2024AMR023119:SAME REPORTER
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 0.33 years old patient received Kinrix vaccine; This non-serious case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant patient who received DTPa-IPV (Kinrix) (batch number G9N2M) for prophylaxis.   Concomitant products included HIB vaccine conj (tet tox) (Acthib).   On 15-MAY-2023, the patient received Kinrix. On 15-MAY-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 0.33 years old patient received Kinrix vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Feb-2024 The patient received Kinrix below the recommended age schedule, which led to inappropriate age at vaccine administration. This case was 1 of 6 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024AMR023121:SAME REPORTER US-GSK-US2024AMR023122:SAME REPORTER US-GSK-US2024AMR023117:SAME REPORTER US-GSK-US2024AMR023119:SAME REPORTER US-GSK-US2024AMR023120:SAME REPORTER
Sex: F
Vaccine: TDAP
Symptoms: Product preparation issue
Clinical narrative: not follow the preparation instructions before administration; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate preparation of medication (Verbatim: not follow the preparation instructions before administration). The outcome of the inappropriate preparation of medication was unknown.   Additional Information: GSK Receipt Date: 21-FEB-2024 The reporter was a GSK/ViiV field staff employee. The patient contacted the department of health with the concern that the Boostrix vaccine she was administered at a pharmacy did not follow the preparation instructions before administration, which led to inappropriate preparation of medication. The reporter did not consent to follow up
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to vaccine exposure during pregnancy and to wrong vaccine administered. The follow up would not possible as no contact details were available. This case was 1 of 128 linked cases reported by the same reporter.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Incorrect RSV shot; At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a consumer via other manufacturer and described the occurrence of wrong vaccine administered in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Incorrect RSV shot) and vaccine exposure during pregnancy (Verbatim: At least 128 pregnant women were mistakenly given the alternative vaccine Arexvy instead of Abrysvo). The outcome of the wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-FEB-2024 The centers for disease control and prevention reported that the mistake involving two vaccines used to treat RSV, a serious respiratory virus. The vaccines were approved for distribution in May neither of the vaccines, Pfizer Abrysvo made by Pfizer, and Arexvy made by GlaxoSmithKline, were listed as safe to treat children experiencing the illness and Arexvy had not been approved for pregnant women. Yet as of 17th January 2024, both were administered to 128 pregnant women and 25 babies, according to the centers for disease control and prevention, though the agency noted that these types of errors were uncommon. The centers for disease control was urging healthcare providers to be more careful and issued a report stated that 128 pregnant women and 25 babies received incorrect vaccines. This news was relative to the estimated one million infants protected from the centers for disease control and prevention stated RSV either by nirsevimab, an immunization recommended for infants younger than 8 months born during RSV season, or through the vaccination of pregnant people. The centers for disease control and prevention stated those reported to had received the unapproved vaccines did not have serious side effects. The pregnant patient received Arexvy vaccine instead of alternative Abrysvo vaccine, which led to wrong vaccine administered and vaccine exposure during pregnancy. The consent to follow up requested. This case was 1 of 128 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR020844: