chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Leriche syndrome, Leukocytosis, Pelvic inflammatory disease, Peripheral arterial occlusive disease, Phlebolith
Clinical narrative: Constant diarrhrea, between 10-90x a day, fall risk from diarrhrea - fall and broke ankle & wrist, developed Diverticulitis of small with perforation, Diverticulitis of large intestine with perforation and abscess without bleeding,, sepsis, developed IBD, IBS, periconolic stranding, Endocrine System Disease, Essential Thrombocythemia, Leukocytosis, Urolithiasis, Pelvic Inflammatory Disease, Aorta & Vascularity: Mild aortoiliac atherosclerosis (AIOD) a manifestation of peripheral arterial disease (PAD), (slowing down blood flow plaque from fatty) without aneurysm, 5 mm phlebolith anterior to psoas at level of L4, Heart: Mild Emphysematous, Liver: Mild Hepatic Steatosis  fatty liver, Crohn's Disease, Abnormal findin
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sepsis, Small intestinal perforation, Wrist fracture
Clinical narrative: Constant diarrhrea, between 10-90x a day, fall risk from diarrhrea - fall and broke ankle & wrist, developed Diverticulitis of small with perforation, Diverticulitis of large intestine with perforation and abscess without bleeding,, sepsis, developed IBD, IBS, periconolic stranding, Endocrine System Disease, Essential Thrombocythemia, Leukocytosis, Urolithiasis, Pelvic Inflammatory Disease, Aorta & Vascularity: Mild aortoiliac atherosclerosis (AIOD) a manifestation of peripheral arterial disease (PAD), (slowing down blood flow plaque from fatty) without aneurysm, 5 mm phlebolith anterior to psoas at level of L4, Heart: Mild Emphysematous, Liver: Mild Hepatic Steatosis  fatty liver, Crohn's Disease, Abnormal findin
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Physician spoke with patient's mother, per mother patient is not experiencing any adverse reaction.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure during pregnancy, Foetal growth restriction, Foetal vascular malperfusion, Pathology test
Clinical narrative: Quick drop in fetal growth within 3 months of receiving vaccines. From 66%ile to 10%ile from Sep to Dec. Subsequently found bloodclot in placenta after birth.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash, Urticaria
Clinical narrative: Patient reports injection site soreness and described hive-like bumps that appeared over her whole body 2 days after the injection. She reports taking no OTC medications to treat her condition and states the bumps disappeared on their own a few days after they appeared. Patient states she did not have this reaction to the first dose in the series.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product administration error, Product preparation error
Clinical narrative: Zoster vaccine was reconstituted with the wrong diluent instead of diluent provided by manufacturer.  Unsuccessful in efforts to contact patient of vaccine administration error and was advised to return to clinic to receive the correct dosage.  Several voice messages were left to reach back out to clinic.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Endotracheal intubation, Intensive care, Mechanical ventilation
Clinical narrative: On 7/15/24 resident became unresponsive without VS, CPR initiated and sent to Emergency Dept via ambulance where resident was intubated and placed on ventilator, admitted to ICU and was taken off life support on 7/16/24 and expired on 7/16/24. He tested positive for Covid-19 on 7/15/24 at medical facility.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Resuscitation, SARS-CoV-2 test positive, Unresponsive to stimuli, Withdrawal of life support
Clinical narrative: On 7/15/24 resident became unresponsive without VS, CPR initiated and sent to Emergency Dept via ambulance where resident was intubated and placed on ventilator, admitted to ICU and was taken off life support on 7/16/24 and expired on 7/16/24. He tested positive for Covid-19 on 7/15/24 at medical facility.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Atypical pneumonia, Blood test, Chest X-ray, Chills
Clinical narrative: She got her vaccine about 2 months ago, her hand was swollen for days after that.  She could not believe what was happening, was hurting for about a week.  Her arm was hard and painful as well.  About a week ago she got sick and she went to the ER.  They did testing, they did blood work, chest x-ray, gave her IV's because she told them that she was tired, had a heavy heavy headache that did not go away and was also getting chills and wanted to know what was going on.  She was told that she had walking pneumonia, which she thought she took the vaccine for and does not make any sense to her how she has it in the summertime.  She is a healthy person, and eats healthy, and wonders if she is going to keep getting it or is she going to be left like that.  She is still having pain in her head, is taking antibiotics now, tiredness, has no energy and has pain.  She gets pain and tiredness and when she coughs her head hurts.  She has no history of any health issues ever, she works out and walks daily for 2 hours, she swims, she does water work outs and weights.  She is on Amoxicillin which she was sent home from the ER and was told to come back if she had any worsening or anything.  She is not feeling much better, but has to finish her medications and hopes she is feeling better.  Her concern is what is going to happen in 6 months from now or will she have to keep getting pneumonia.  Does not know why is is recommended and has to go through the pain that she is going through.  She would not recommend this vaccine or any vaccines to anybody.  She got a shingles vaccine the month before this vaccine she believes.    She went to get her medicine and the pharmacy told her that she had to get the vaccine, and feels that we should not be pressured to get a vaccine that we did not ask for and to decide how we should live our lives.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Fatigue, Headache, Induration, Laboratory test
Clinical narrative: She got her vaccine about 2 months ago, her hand was swollen for days after that.  She could not believe what was happening, was hurting for about a week.  Her arm was hard and painful as well.  About a week ago she got sick and she went to the ER.  They did testing, they did blood work, chest x-ray, gave her IV's because she told them that she was tired, had a heavy heavy headache that did not go away and was also getting chills and wanted to know what was going on.  She was told that she had walking pneumonia, which she thought she took the vaccine for and does not make any sense to her how she has it in the summertime.  She is a healthy person, and eats healthy, and wonders if she is going to keep getting it or is she going to be left like that.  She is still having pain in her head, is taking antibiotics now, tiredness, has no energy and has pain.  She gets pain and tiredness and when she coughs her head hurts.  She has no history of any health issues ever, she works out and walks daily for 2 hours, she swims, she does water work outs and weights.  She is on Amoxicillin which she was sent home from the ER and was told to come back if she had any worsening or anything.  She is not feeling much better, but has to finish her medications and hopes she is feeling better.  Her concern is what is going to happen in 6 months from now or will she have to keep getting pneumonia.  Does not know why is is recommended and has to go through the pain that she is going through.  She would not recommend this vaccine or any vaccines to anybody.  She got a shingles vaccine the month before this vaccine she believes.    She went to get her medicine and the pharmacy told her that she had to get the vaccine, and feels that we should not be pressured to get a vaccine that we did not ask for and to decide how we should live our lives.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Malaise, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: She got her vaccine about 2 months ago, her hand was swollen for days after that.  She could not believe what was happening, was hurting for about a week.  Her arm was hard and painful as well.  About a week ago she got sick and she went to the ER.  They did testing, they did blood work, chest x-ray, gave her IV's because she told them that she was tired, had a heavy heavy headache that did not go away and was also getting chills and wanted to know what was going on.  She was told that she had walking pneumonia, which she thought she took the vaccine for and does not make any sense to her how she has it in the summertime.  She is a healthy person, and eats healthy, and wonders if she is going to keep getting it or is she going to be left like that.  She is still having pain in her head, is taking antibiotics now, tiredness, has no energy and has pain.  She gets pain and tiredness and when she coughs her head hurts.  She has no history of any health issues ever, she works out and walks daily for 2 hours, she swims, she does water work outs and weights.  She is on Amoxicillin which she was sent home from the ER and was told to come back if she had any worsening or anything.  She is not feeling much better, but has to finish her medications and hopes she is feeling better.  Her concern is what is going to happen in 6 months from now or will she have to keep getting pneumonia.  Does not know why is is recommended and has to go through the pain that she is going through.  She would not recommend this vaccine or any vaccines to anybody.  She got a shingles vaccine the month before this vaccine she believes.    She went to get her medicine and the pharmacy told her that she had to get the vaccine, and feels that we should not be pressured to get a vaccine that we did not ask for and to decide how we should live our lives.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak on Left Forearm same side of injection after shot given, prescribed Valtrex.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Zoster vaccine was reconstituted with incorrect diluent instead of diluent provided by manufacturer. Patient was notified of vaccine administration error and was advised to return to clinic to receive the correct dosage. Patient scheduled for 7/8/2024 to be administered correct dosage.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation test normal, Fibrin D dimer increased, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Extensive unprovoked blood clot in leg
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Swelling
Clinical narrative: 2 days after injection patient experienced swelling and severe soreness. In which we had patient return to our clinic where we administered Kenalog 40mg. Then we monitored him for 15-20 minutes.
Age: 13.0
Sex: M
Vaccine: HEP, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient just left. no reactions have be reported
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: not appropriate age for vaccine
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient reports a rash on right hip and right lower leg about 1 week post Shingles vaccine.  FNP accessed patient's rash.  Prescribed famciclovir (FAMVIR) 500 mg tablet 7/17/24
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product administration error, Product preparation error, Wrong technique in product usage process
Clinical narrative: Zoster Vaccine was administered incorrectly. Vaccine was reconstituted with the wrong diluent instead of the diluent provided by the manufacturer. Unsuccessful in efforts to contact patient of vaccine administration error and to advise patient to return to clinic to receive correct dosage. Several voice messages were left to reach back out to clinic.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Zoster vaccine was administered incorrectly. Zoster vaccine was reconstituted with the wrong diluent instead of diluent provided by manufacturer. Patient was notified of vaccine administration error and was advised to return to clinic to receive the correct dosage. Patient stated that she will schedule the appointment for zoster administration when she is ready. Patient has yet to schedule an appointment.
Age: 19.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: ITCHING, RASH AND RED BUMPS ON LOWER EXTREMITIES.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: Redness, itching and mild irritation at injection site.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Injection site swelling, Ocular hyperaemia, Pyrexia, Rash, Respiratory tract congestion
Clinical narrative: fever, full body rash, swelling at injections site, congestion, red eyes
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Erythema and swelling of left upper arm, surrounding injection site. Hot to touch, and mild tenderness.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Muscular weakness, Pallor, Posture abnormal
Clinical narrative: 1413: pt loses facial color, slumps head forward, and loses consciousness. Shakes for 5-7 seconds, body is still flexible and is moved from chair to floor. Request for EMS to be called per protocol. Pt comes back to consciousness approximately after 15-20 seconds. No signs/symptoms of seizure. Mom in room. Pt continues to lay on floor. 1415: EMS called to confirm safety of child. Pt receives fanning and cool compress on head to relax. 1422: v/s taken BP: 118/68, pulse 73, SPO2 98% on RA.1420: EMS arrives to assess pt. No concerns from EMS after description of incident and assessment. Pt is moved from floor to chair. Does feel lightheaded in process. 1426: EMS leaves. Pt continues to sit in chair in office with mother and this nurse. 1431. Pt stands up. States feels well but legs "feel like jello." I request that he sits back down and continues to wait. 1436: pt stands again and states that "legs feel less like jello." Pt provided with peanut butter crackers and a green lollipop. 1443: Pt stands again. Feeling well with steady gait. Allowing mother to transport child home and rest. ER precautions provided. Mother and son are watched to vehicle and seen off. 1445: Pt leaves facility in vehicle with mother driving.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tremor
Clinical narrative: 1413: pt loses facial color, slumps head forward, and loses consciousness. Shakes for 5-7 seconds, body is still flexible and is moved from chair to floor. Request for EMS to be called per protocol. Pt comes back to consciousness approximately after 15-20 seconds. No signs/symptoms of seizure. Mom in room. Pt continues to lay on floor. 1415: EMS called to confirm safety of child. Pt receives fanning and cool compress on head to relax. 1422: v/s taken BP: 118/68, pulse 73, SPO2 98% on RA.1420: EMS arrives to assess pt. No concerns from EMS after description of incident and assessment. Pt is moved from floor to chair. Does feel lightheaded in process. 1426: EMS leaves. Pt continues to sit in chair in office with mother and this nurse. 1431. Pt stands up. States feels well but legs "feel like jello." I request that he sits back down and continues to wait. 1436: pt stands again and states that "legs feel less like jello." Pt provided with peanut butter crackers and a green lollipop. 1443: Pt stands again. Feeling well with steady gait. Allowing mother to transport child home and rest. ER precautions provided. Mother and son are watched to vehicle and seen off. 1445: Pt leaves facility in vehicle with mother driving.
Age: 18.0
Sex: F
Vaccine: COVID19, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: !8 yr oold pt presented to clinic for vaccination. Immunization consent form was checked under insurance as VFA=vaccine for adult. Pt was given Adult dose of STATE OUTBREAK HEP A, and Adult dose of HEP B. Pt should have received VFC vaccine for children pediatric dose.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: A red rash developed at the injection site and spread to entire upper arm. The rash was red, slightly raised and warm to the touch. The rash was painful and sore but not itchy. Today is the 6th day since the injection and she states that it is beginning to improve
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE; some of the product may have gotten on the healthcare worker but most of it landed on the table; some of the product may have gotten on the healthcare worker but most of it landed on the table; While injecting the diluent into the vial, there seemed to be an increase in pressure; mulfunction of vial/syringe; This spontaneous report has been received from a medical assistant, referring to a 32-year-old female healthcare worker. The information regarding her concurrent conditions, concomitant therapies or medical history was not provided.  On 17-JUN-2024, the healthcare worker was exposed to measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II), lot# X019102, expiry date 16-JUL-2025, and to sterile diluent (BAXTER STERILE DILUENT), lot# 1950614, expiry date 10-DEC-2025.   During the vaccine preparation an error occurred. The healthcare worker inserted the needle of the prefilled syringe of sterile diluent (BAXTER STERILE DILUENT) into the vial of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II). While injecting the diluent into the vial, there seemed to be an increase in pressure and the product sprayed back out of the vial (Product preparation error). The needle was still inserted in the vial when the product sprayed out around it. Some of the product might have gotten on the healthcare worker but most of it landed on the table (Occupational exposure to product, Accidental exposure to product). It was impossible to specify if the issue was with the vial of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) or the pre-filled sterile diluent (BAXTER STERILE DILUENT); the malfunction of vial/syringe was reported (Device malfunction). This dose was wasted. and the healthcare worker then used another pre-filled syringe of sterile diluent (BAXTER STERILE DILUENT) and another vial of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and had no issues reconstituting the product. Therefore, no patients missed a dose of the vaccine. No additional adverse event reported (no adverse event).
Age: 5.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; her 5 year old daughter was given a GARDASIL 9 vaccine yesterday 7/1/24; This spontaneous report was received from a Consumer and referred to a 5-year-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 01-JUL-2024 (at the age of 5 years old), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional AE.  Lot # is being requested and will be submitted if received.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Device connection issue, Poor quality device used, Syringe issue
Clinical narrative: No additional AE; product began leaking from between the syringe hub and the needle; product began leaking from between the syringe hub and the needle; Between the syringe hub/Luer lock and syringe needle; This spontaneous report was received from an Other Health Professional and referred to a 35-year-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 03-JUL-2024 10:15:00, the was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, lot #X027348, expiration date: 24-JAN-2026, administered at Right Deltoid for prophylaxis (strength, dose and route of administration were not provided).  While the needle was inserted into the patient's right arm, the product began leaking from between the syringe hub and the needle (Syringe issue, Device connection issue, Poor quality device used) (also reported as "twist part of the syringe"). The needle was removed from the patient's arm. The reporter checked and reported that the needle was intact and tightly secured to the syringe. The Other Health Professional administered another dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) to the patient and had no issues with that administration. No additional AE.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; TE with VAQTA.  Administered after being improperly stored.; This spontaneous report was received from an Other Health Professional and referred to a 2-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-JUN-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #X025342, expiration date: 12-MAY-2025, administered for prophylaxis (strength, and route of administration were not provided). The hepatitis a vaccine, inactivated (VAQTA) was administered after being improperly stored (Product storage error). No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2407USA003295:
Sex: M
Vaccine: MMR
Symptoms: Biopsy skin, Erythema, Induration, Papule, Rubivirus test positive
Clinical narrative: Pseudolymphoma With Granulomatous Features; Information marketed has been received from the authors in a published literature article titled as stated below, concerning an 81-year-old male with history of mantle cell lymphoma, treated with hematopoietic stem cell transplant, who presented with a localized collection of firm, red papules and plaques on the left upper arm. Punch biopsies were taken from a papule and plaque and revealed a lymphocytic infiltrate with a histiocytic and subtle granulomatous component. Immunohistochemistry revealed a CD3+/CD8+/ partial T-cell receptor delta+ lymphocytic infiltrate, initially raising concern for lymphoma. The CD8 immunophenotype in conjunction with the granulomatous component and localization to the deltoid arm prompted investigation for evidence of rubella virus. Rubella positive macrophages were detected in multiple granulomas by double immunofluorescent staining. Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) vaccination at the site of the infiltrate (left upper arm) was confirmed by the patient for Prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). This case brings awareness of a rarely reported cause of pseudolymphomatous and granulomatous reaction to MMR vaccine and offers clues to the diagnosis. At the time of reporting, the outcome was not known.    A copy of the published article is attached as further documentation of the patient's experience.    Literature Report:  Lot# is being requested and will be submitted if received.
Sex: M
Vaccine: MMR
Symptoms: Skin plaque
Clinical narrative: Pseudolymphoma With Granulomatous Features; Information marketed has been received from the authors in a published literature article titled as stated below, concerning an 81-year-old male with history of mantle cell lymphoma, treated with hematopoietic stem cell transplant, who presented with a localized collection of firm, red papules and plaques on the left upper arm. Punch biopsies were taken from a papule and plaque and revealed a lymphocytic infiltrate with a histiocytic and subtle granulomatous component. Immunohistochemistry revealed a CD3+/CD8+/ partial T-cell receptor delta+ lymphocytic infiltrate, initially raising concern for lymphoma. The CD8 immunophenotype in conjunction with the granulomatous component and localization to the deltoid arm prompted investigation for evidence of rubella virus. Rubella positive macrophages were detected in multiple granulomas by double immunofluorescent staining. Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR) vaccination at the site of the infiltrate (left upper arm) was confirmed by the patient for Prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). This case brings awareness of a rarely reported cause of pseudolymphomatous and granulomatous reaction to MMR vaccine and offers clues to the diagnosis. At the time of reporting, the outcome was not known.    A copy of the published article is attached as further documentation of the patient's experience.    Literature Report:  Lot# is being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report TE for VARIVAX that occurred on 06/12/24. HCP informed the VARIVAX was inadvertently administered to patient on 07/05/24 at 5:00pm, following the TE. No further details provided. Permission was given to contact HCP. See additiona; This spontaneous report was received from a customer (also reported as ''other'') refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 05-JUL-2024, the patient was inadvertently vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), formulation: injection, lot # X026326, expiration date: 07-NOV-2025 (exact dose, route of administration and anatomical location were not provided) for prophylaxis.    Administered dose of vaccine was exposed to the temperature excursion of 30 degrees Fahrenheit for 1 hour and 45 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: no AE; products that experienced temperature excursion were administered to a patient; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 09-JUL-2024, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (lot #X022980 was valid, expiration date: 18-MAY-2026) and  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (formulation pre-filled syringe, lot #X022479, expiration date: 23-JAN-2026) (exact doses, routes of administration and anatomical location were not provided) for prophylaxis (Product storage error). It was reported that temperature excursion (TE) occurred on unknown days in July 2024 (reported as 'last week'). TE of 2 degrees Celsius (C) (0.3C) for 42 hours was reported. No additional adverse event (AE) or product quality complaint (PQC) was reported (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: that a couple of years ago, a female consumer fainted while receiving the GARDASIL-9 vaccine; This spontaneous report was received from consumer and refers to a female.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date (also reported as a couple of years ago), the patient fainted while receiving the GARDASIL-9 vaccine. It was reported that the patient received 5 vaccines at the one appointment. The  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the third one administrated. At the time of reporting, the outcome of the event was not known.   The causal relationship between adverse event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown. Upon internal review, the event of syncope was determined to be medically significant.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no ae; improperly stored administered ROTATEQ; This spontaneous report was received from a consumer and referred to an 8-week-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 15-JUL-2024,  rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #2003170, expiration date: 19-SEP-2025, strength was not reported) experienced Temperature excursion (TE) with 10.79 degree Celsius (C) for 2 Hours 0 Minutes 0 Seconds; -0.09 C for 0 Hours 15 Minutes 0 Seconds (no cycles). There was no prior excursion. On 16-JUL-2024, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2ml/oral dose, lot #2003170, expiration date: 19-SEP-2025, administered orally for prophylaxis (strength was not provided) (Product storage error). No symptoms reported. Additional AE details unknown (no adverse event).
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: extra dose; Booster dose administerd on 20-APR-2001 (patient was 5 months and 28 days); Second dose administered on 21-FEB-2001 (2 months and 1 day); Vaccine administered on 20-DEC-2000 (1 month and 27 days old); This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (# 2107USA008868), concerning an 58-days-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 20-DEC-2000 (at 58 days of age), the patient was vaccinated with first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (product administered to patient of inappropriate age). Subsequently, on 21-FEB-2001 (at 2 months and 1 day of age), she received a second dose (inappropriate schedule of product administration). Moreover, on 20-APR-2001 (at 5 months and 28 days of age), she received a third dose of the vaccine (inappropriate schedule of product administration). Lastly, on 23-JAN-2002, she received a fourth dose of the vaccine (extra dose administered). All doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations and routes of administration were not provided).; Sender's Comments:  US-009507513-2107USA008868:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Third dose administered on 23-JUL-2001 (at 9-months of age); This spontaneous report has been received from a physician, via a medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (# 2107USA008868), concerning an 9 months-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-NOV-2000 (at 16 days of age), the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection. Subsequently, on 20-DEC-2000 (at 1 month and 27 days of age) and 23-JUL-2001 (at 9-months of age) (inappropriate schedule of product administration) she received the second and third doses of the vaccine respectively. All doses were administered as prophylaxis (strengths, doses, lot #s, expiry dates, anatomical locations, and routes of administration were not provided).; Sender's Comments:  US-009507513-2107USA008868:
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Foetal renal impairment, No adverse event
Clinical narrative: Baby Was Found To Have Pyelectasis at 20 Weeks Gestation; Initial report received on 02-May-2024.  A physician initially reported to the Registry that a fetus was found to have pyelectasis.  The mother (MCN 2024000155) is a 36-year-old pregnant female (race and ethnicity not provided) who received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 12 weeks pregnant.  The mother's medical history, allergies, and concomitant medications of the mother at the time of vaccination were not reported.   The mother's last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On 16-Feb-2024, the patient received dose 1 of a hepatitis b vaccine [HEPLISAV-B (Lot number 943192, expiration date 08 Mar-2026, and NDC number unknown)] intramuscularly in the right deltoid when she was 12 weeks pregnant.    On an unreported date, at week 20 of gestation, the fetus was found to have pyelectasis.  Per the reporter, this can be something that will correct during growth. The mother has a follow up growth scan scheduled in Jul-2024 at 32 weeks gestation.   On 01-May-2024, 76 days after having been vaccinated with the first dose of a hepatitis B vaccine, HEPLISAV-B, the patient received the second dose of a hepatitis B vaccine [ENGERIX-B (no details provided)] and is scheduled for the third dose in August (date not yet determined).  At the time of reporting, on 02-May-2024, week 23 of gestation no adverse effects from the injection were reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious. Pyelocaliectasis is listed as an important medical event in RA, however the company considers the event as non-serious. Pyelectasis is a variation of fetal development, occurs in about 1% of pregnancies and in over 90% of cases, it resolves on its own. With fetal pyelectasis, blockage is mild and results in a slight enlargement in the central area of the kidney. Additional monitoring during pregnancy and after birth is needed.; Sender's Comments: The company assessed the event as non-serious. Pyelocaliectasis is listed as an important medical event in RA, however the company considers the event as non-serious. Pyelectasis is a variation of fetal development, occurs in about 1% of pregnancies and in over 90% of cases, it resolves on its own. With fetal pyelectasis, blockage is mild and results in a slight enlargement in the central area of the kidney. Additional monitoring during pregnancy and after birth is needed.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (she had chickenpox as a child), back surgery (patient had back surgery (dates not specified) at L4-L5 and L5-S1) and shingles (patient stated that the 3 times she has developed Shingles developed along the same nerve root). Previously administered products included Flu vaccine with an associated reaction of bursitis (The patient developed bursitis because the Flu Vaccine was given too high in the right arm and manufacturer of the Flu vaccine was not specified.). Concurrent medical conditions included psoriasis (she has psoriasis).   On an unknown date, the patient received the 2nd dose of Shingrix (left arm) and the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2024 The reporter stated that the patient she has psoriasis and was wondering if this could be the reason, she was getting shingles after Shingrix. The reporter also stated that the patient had chickenpox as a child. The patient stated that she had never had Shingles prior to receiving the Shingrix Vaccine. Both doses of the Shingrix vaccine were administered in the left arm. The patient received both doses of Shingrix at the same pharmacy. The patient developed bursitis in the right arm after receiving a Flu Vaccine. The manufacturer of the Flu vaccine was not specified. The patient developed bursitis because the Flu Vaccine was given too high in the right arm. The patient had back surgery (dates not specified) at L4-L5 and L5-S1. The patient stated that the 3 times she has developed Shingles developed along the same nerve root.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Herpes zoster, Sjogren's syndrome
Clinical narrative: an autoimmune disease called Sjogren's; Shingles; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of sjogren's in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2018, the patient received the 1st dose of Shingrix. In MAY-2024, more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). On an unknown date, the patient experienced sjogren's (Verbatim: an autoimmune disease called Sjogren's) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the sjogren's, shingles and shingles were not reported.   It was unknown if the reporter considered the sjogren's, shingles and shingles to be related to Shingrix.     The company considered the sjogren's to be unrelated to Shingrix. It was unknown if the company considered the shingles and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2024 The patient had receive the 1st dose of Shingrix in July 2018. The patient never returned for the 2nd dose due to unrelated medical issues. The patient have had two cases of shingles since 2018, the most recent in May 2024. The reporter was now anxious to get the second vaccine to prevent any future breakouts. The patient asked question that whether the patient needed to get only the 2nd dose or did the reporter need to repeat the 1st dose as well since the first dose was administered over 6 years ago.  the female patient who has been diagnosed with an autoimmune disease called Sjogren's.; Sender's Comments: Sjogren's syndrome is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; had the shingles vaccine all three shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix, the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: had the shingles vaccine all three shots). The outcome of the vaccination failure and extra dose administered were 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 Shingrix, Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix, Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2024 This case was reported by a consumer via interactive digital media. The reporter reported that the patient got shingles and the patient had the shingles vaccine all three shots, Shingles and Shingrix shots. The vaccine did not work on her. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked to the case US2024AMR088517 reported by the same reporter (brother's case).; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix. US-GSK-US2024AMR088517:same reporter
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; the shingles vaccine all three shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix, the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and extra dose administered (Verbatim: the shingles vaccine all three shots). The outcome of the vaccination failure and extra dose administered were 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 Shingrix, Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix, Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2024 This case was reported by a Consumer via interactive digital media. The reporter reported that the patient got shingles and the patient had the shingles vaccine all three shots, Shingles and shingrix shots. The vaccine did not work on him. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked to the case US2024AMR088514 reported by the same reporter (sister's case).; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix. US-GSK-US2024AMR088514:same reporter different patient
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination site discomfort
Clinical narrative: discomfort in the area where I was vaccinated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 04-JUL-2024, the patient received Shingles vaccine (unknown arm). In JUL-2024, less than a week after receiving Shingles vaccine, the patient experienced injection site discomfort (Verbatim: discomfort in the area where I was vaccinated). The outcome of the injection site discomfort was not reported.   It was unknown if the reporter considered the injection site discomfort to be related to Shingles vaccine.     It was unknown if the company considered the injection site discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:06-JUL-2024 The patient self-reported this case. The patient got vaccinated two days ago and the only thing he/she had was discomfort in the area where he/she was vaccinated, which was his/her arm. His/her sister got the disease and regretted not having been vaccinated sooner.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache,; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: headache,). The outcome of the headache was not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     It was unknown if the company considered the headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUL-2024 This case was reported by a patient via interactive digital media. The patient stated that she got the vaccine last year. First dose gave me a headache, 2nd dose was worse. The patient would rather have those side effects than shingles. The follow-up could not be possible as no contact details were available.