chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Wrong age; administered the wrong vaccine to a patient; Inappropriate schedule of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Previously administered products included Vaxelis (received first dose of Vaxelis on 11-OCT-2023), Vaxelis (received second dose of Vaxelis on 21-NOV-2023) and Vaxelis (received third dose of Vaxelis on 22-JAN-2024).   On 05-MAR-2025, the patient received Kinrix. On 05-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Wrong age), wrong vaccine administered (Verbatim: administered the wrong vaccine to a patient) and inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were not applicable.   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: 05-MAR-2025  The other health professional reported that they administered the wrong vaccine to a patient which led to wrong vaccine administered. Kinrix was given and patient was 19 months old which led to inappropriate age at vaccine administration.  The patient got 3 prior Vaxelis doses which led to inappropriate schedule of vaccine administered.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was the patient's 3rd dose of DTaP and IPV; nurse assistant administered Kinrix to an underage child; administered Kinrix to an underage child instead of separate Dtap and Polio vaccines; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis.   On 05-MAR-2025, the patient received Kinrix. On 05-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Kinrix was the patient's 3rd dose of DTaP and IPV), inappropriate age at vaccine administration (Verbatim: nurse assistant administered Kinrix to an underage child) and wrong vaccine administered (Verbatim: administered Kinrix to an underage child instead of separate Dtap and Polio vaccines). The outcome of the inappropriate schedule of vaccine administered, inappropriate age at vaccine administration and wrong vaccine administered were not applicable.   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: 07-MAR-2025 A nurse assistant administered Kinrix which was the patient's 3rd dose of DTaP and IPV to an underage child instead of separate Dtap and Polio vaccines which led to inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and wrong vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported; extra dose of GARDASIL 9; This spontaneous report was received from a nurse and refers to a 16-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-FEB-2025, the patient received an extra dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), at 0.5 mL for prophylaxis, after previously completing the 3 doses series on 10-MAR-2021 (injection site, route of administration, expiration date, and lot # were not reported), (extra dose administered). No adverse effects were reported.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Fall, Myocardial infarction
Clinical narrative: Online report mid 50's male. Victim was employed as a bus operator since at least 2011 to the day of his death. His employer conducted a purged COVID-19 vaccines non-recipients by 11/01/2021. His son did a fundraiser after the victim's sudden death on 12/08/021. His son stated that around 04:15am the victim suffered a double heart attack and fell down the stairs prior to his shift. He was transported to hospital and died the same day. Based on these facts I suspect this victim was a recipient of a COVID-19 vaccine. Unable to obtain other info, dates, lot#, etc.
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Deafness, Pruritus, Swelling face, Swelling of eyelid
Clinical narrative: Swelling of face, eye lids (can provide picture) noted 6/10/2024 RX Methylprednisolone 4 mg 21 qty.  6/25/24 Prednisone 10 mg (42 tabs) 6 tabs X2 daily, 2 days, 4qdX2D, 3qdx2d, 2 daily x 3 days 1 qd.  9/13/2024 Admin at urgent care for repeat of swelling/itching. Diagnosed with cellulitis Dr The course of prednisone relieved in June 2024 was repeated with Doxycyline Monohydrate 100 x 7 days. December 5, 2024 loss of hearing -> Dec. 9, 2024. disimpactim of both ears at clinic
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; Indicate at which point in the process the medication error occured: preparation for administration; HCP called to report an expired dose of MMRII was administered to a patient; This spontaneous report has been received from a nurse, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 14-FEB-2025, the patient was vaccinated with an expired dose (Expired product administered) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) solution for injection, at a dose of 0.5 milliliters (ml), as prophylaxis, lot number X000177, which has been verified to be valid, expiration date reported and validated as 22-JAN-2025)  plus a sterile diluent (BAXTER STERILE DILUENT).   Follow up received from nurse on 20-FEB-2025. The report regarding 27-year-old female patient. The patient's pertinent medical history included being not immune to mumps. Concomitant medication included Vitamin d (Ergocalciferol), 50 mg Desvenlafaxine, Extended-release tablets (Desvenlafaxine fumarate) and Skyla (Levonorgestrel). It was updated that patient was vaccinated in left arm. It was indicated that medication error occurred at point of preparation for administration (product preparation error).  On 14-FEB-2025, The patient was return to the office after discovering she was not immune to mumps. The person which was administering the vaccine retrieved it from the refrigerator, logged it to the appropriate page, and brought it to the room. She had the patient sign the consent and administered the vaccine. It wasn't until the patient left what she noticed that vaccine was expired. She returned to refrigerator and saw that all the MMR vaccines in the box ere expired and removed them. The patient was informed about the event through a call and was assured that the vaccine would cause no harm and they would not be needed to revaccinate.
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported.  No PQC; Inbound call from medical assistant who is requesting expiration date for VARIVAX. Caller provides lot number and OMC confirmed expiry date. Based on confirmed expiry date this product was administered to a patient one day post expiry. Date of admini; This spontaneous report was received from an other health professional and refers to a(n) 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 14-MAY-2020, the patient was vaccinated with expired dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), Injection, lot #R013566 and expiration date 13-MAY-2020 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (expired vaccine used). No side effects/symptoms reported (no adverse event)
Age: 9.0
Sex: M
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Improper storage of product in use; No adverse event; This spontaneous report was received from a nurse referring to a 9-year-old male patient.  Information regarding the patient's concurrent conditions, medical history was not provided. Concomitant medications included hepatitis a vaccine inact (HAVRIX), influenza vaccine inact sag 4v (FLUCELVAX) hepatitis b vaccine rHBsAg (yeast) (ENGERIX B). .  On 05-Dec-2024, the patient was vaccinated with an improperly storage of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, administered subcutaneously in the left arm (valid lot number Y008284 with an expiration date on 21-OCT-2025) for prophylaxis.  There was no adverse effect reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-02-26 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 07/25/2015 , Central date : 2025-02-20 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Bone pain, Chills, Decreased appetite, Dizziness, Erythema
Clinical narrative: feel ill with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for 2-3 days.; did not eat for 2-3 days.; pain in his upper arm; pain in his upper arm that escalated to include swelling and redness; pain in his upper arm that escalated to include swelling and redness; tossed and turned when trying to sleep and the pain in his arm was so bad it would wake him up; bones ached all through his body; felt so bad; This spontaneous report was received from a 65-year-old male patient referring to himself.   The patient's medical history was not reported. The patient's concurrent conditions included hay fever in spring. Concomitant medications included Trazodone HCL (Trazodone hydrochloride), Ibuprofen (Ibuprofen), 25 mg Losartan (Losartan potassium), Aspirin (Acetylsalicylic acid) and medications reported as Amphetaphine and Vluvoxamine .  On 27-FEB-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) (lot #Y016291 reported as YOU16291, expiration date: 06-Dec-2026) 0.5 mL (0.5mL / once), administered by Intramuscular route as prevention of Pneumonia. The patient began feeling pain in his upper arm the same day the vaccine was administered that escalated to include swelling and redness. Then began to feel "ill" the next day with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for 2-3 days. The patient stated his symptoms included headaches so back "he did not know what to do" that he used Tylenol and Ibuprofen to treat which helped but then the pain would come back when the medication wore off. The patient also stated his bones ached all through his body and he spiked a fever with chills for two days after the vaccine which has resolved. He felt so bad he tossed and turned when trying to sleep and the pain in his arm was so bad it would wake him up. The consumer stated his symptoms began to improve on 03-MAR-2025 and continue to improve today, 04-MAR-2025. The only symptoms that remained at the time of the report were a swollen, painful, red arm where the injection site and runny nose. The consumer did not report the adverse issues and side effects to his healthcare professional nor did he seek medical attention.    The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) was not provided.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Malaise, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: feel ill with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for 2-3 days.; did not eat for 2-3 days.; pain in his upper arm; pain in his upper arm that escalated to include swelling and redness; pain in his upper arm that escalated to include swelling and redness; tossed and turned when trying to sleep and the pain in his arm was so bad it would wake him up; bones ached all through his body; felt so bad; This spontaneous report was received from a 65-year-old male patient referring to himself.   The patient's medical history was not reported. The patient's concurrent conditions included hay fever in spring. Concomitant medications included Trazodone HCL (Trazodone hydrochloride), Ibuprofen (Ibuprofen), 25 mg Losartan (Losartan potassium), Aspirin (Acetylsalicylic acid) and medications reported as Amphetaphine and Vluvoxamine .  On 27-FEB-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) (lot #Y016291 reported as YOU16291, expiration date: 06-Dec-2026) 0.5 mL (0.5mL / once), administered by Intramuscular route as prevention of Pneumonia. The patient began feeling pain in his upper arm the same day the vaccine was administered that escalated to include swelling and redness. Then began to feel "ill" the next day with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for 2-3 days. The patient stated his symptoms included headaches so back "he did not know what to do" that he used Tylenol and Ibuprofen to treat which helped but then the pain would come back when the medication wore off. The patient also stated his bones ached all through his body and he spiked a fever with chills for two days after the vaccine which has resolved. He felt so bad he tossed and turned when trying to sleep and the pain in his arm was so bad it would wake him up. The consumer stated his symptoms began to improve on 03-MAR-2025 and continue to improve today, 04-MAR-2025. The only symptoms that remained at the time of the report were a swollen, painful, red arm where the injection site and runny nose. The consumer did not report the adverse issues and side effects to his healthcare professional nor did he seek medical attention.    The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) was not provided.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Rhinorrhoea, Sleep disorder
Clinical narrative: feel ill with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for 2-3 days.; did not eat for 2-3 days.; pain in his upper arm; pain in his upper arm that escalated to include swelling and redness; pain in his upper arm that escalated to include swelling and redness; tossed and turned when trying to sleep and the pain in his arm was so bad it would wake him up; bones ached all through his body; felt so bad; This spontaneous report was received from a 65-year-old male patient referring to himself.   The patient's medical history was not reported. The patient's concurrent conditions included hay fever in spring. Concomitant medications included Trazodone HCL (Trazodone hydrochloride), Ibuprofen (Ibuprofen), 25 mg Losartan (Losartan potassium), Aspirin (Acetylsalicylic acid) and medications reported as Amphetaphine and Vluvoxamine .  On 27-FEB-2025, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) (lot #Y016291 reported as YOU16291, expiration date: 06-Dec-2026) 0.5 mL (0.5mL / once), administered by Intramuscular route as prevention of Pneumonia. The patient began feeling pain in his upper arm the same day the vaccine was administered that escalated to include swelling and redness. Then began to feel "ill" the next day with a cold symptoms, runny nose, tiredness, dizziness, lightheadedness and did not eat for 2-3 days. The patient stated his symptoms included headaches so back "he did not know what to do" that he used Tylenol and Ibuprofen to treat which helped but then the pain would come back when the medication wore off. The patient also stated his bones ached all through his body and he spiked a fever with chills for two days after the vaccine which has resolved. He felt so bad he tossed and turned when trying to sleep and the pain in his arm was so bad it would wake him up. The consumer stated his symptoms began to improve on 03-MAR-2025 and continue to improve today, 04-MAR-2025. The only symptoms that remained at the time of the report were a swollen, painful, red arm where the injection site and runny nose. The consumer did not report the adverse issues and side effects to his healthcare professional nor did he seek medical attention.    The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) was not provided.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash pruritic
Clinical narrative: color of upper arm became red, itchy raised skin, some lumps--spread the length of the outer upper arm ---skin red and itchy breakouts continuing intermittently to this day, especially on upper arm and wrist.
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus
Clinical narrative: PATIENT HAD LOCALIZED IRRITATION.  THE VACCINE SITE WAS RED AND ITCHY.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Erythema, Fatigue, Headache, Malaise
Clinical narrative: Severe fatigue; More than usual redness, swelling, itching and pain in left arm.  Constant headache across forehead.  Weakness sensation and overall feeling of being unwell with running nose and sneezing.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Pruritus, Rhinorrhoea, Sneezing
Clinical narrative: Severe fatigue; More than usual redness, swelling, itching and pain in left arm.  Constant headache across forehead.  Weakness sensation and overall feeling of being unwell with running nose and sneezing.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Hospice for dx COPD
Age: 67.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Polymyalgia rheumatica
Clinical narrative: POLYMYALGIA RHEUMATICA
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Nerve injury, Product administered at inappropriate site
Clinical narrative: Tdap (please note Tdap of unknown manufacturer,due to being administered @ OB/GYN) to patient 28 weeks pregnant. Adverse event axillary nerve damage due to improper vaccine administration site.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Pyrexia
Clinical narrative: fever, fatigue, not eating solid food, stools a little looser than normal
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute kidney injury, Blood pressure decreased, COVID-19, Computerised tomogram abdomen abnormal
Clinical narrative: Name:   Medical Record #:  Age:  79 y.o. DOB:  2/xx/19xx  Admit date: 3/8/2025  Discharge date:  3/10/2025  Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission:  Abdominal pain with concerns for small-bowel obstruction that was clinically ruled out  Brief Summary of Hospital Stay: Patient is a 79 y.o. female with h/o incarcerated hernia s/p repair in 2019, anxiety disorder, GERD, hypertension, CVA, dysphagia, asthma, anxiety would presented with sore throat for the past 4 days secondary to COVID-19 though did have intermittent bouts of abdominal pain for which CT of the abdomen pelvis was performed which showed findings suspicious for partial small bowel obstruction related to an internal hernia with transition point near the back containing umbilical hernia. General surgery consulted and evaluated patient and assessed that patient did not have small-bowel obstruction clinically and patient was able tolerate general diet without any issues and discharge home on 03/10. Patient with some soft blood pressures around time of discharge with systolics in the 90s to 100s for which patient's losartan 50 and Lasix 40 mg daily were paused though these can be restarted at next PCP visit if blood pressure is stable.  Issues Requiring Follow Up: -follow up to ensure that blood pressures were not restarting home losartan 50 and Lasix 40 daily  Patient Active Problem List   Diagnosis Date Noted ? Abdominal pain 03/09/2025 ? Umbilical hernia 03/08/2025 ? COVID 03/08/2025 ? Chronic HFrEF (heart failure with reduced ejection fraction) (HCC) 06/16/2024 ? Acute diverticulitis 06/16/2024 ? AKI (acute kidney injury) (HCC) 06/16/2024 ? Incarcerated umbilical hernia 08/23/2022 ? Osteopenia 11/20/2019 Discharged to Home
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Heart failure with reduced ejection fraction, Oropharyngeal pain, Umbilical hernia
Clinical narrative: Name:   Medical Record #:  Age:  79 y.o. DOB:  2/xx/19xx  Admit date: 3/8/2025  Discharge date:  3/10/2025  Admitting Physician: MD  Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission:  Abdominal pain with concerns for small-bowel obstruction that was clinically ruled out  Brief Summary of Hospital Stay: Patient is a 79 y.o. female with h/o incarcerated hernia s/p repair in 2019, anxiety disorder, GERD, hypertension, CVA, dysphagia, asthma, anxiety would presented with sore throat for the past 4 days secondary to COVID-19 though did have intermittent bouts of abdominal pain for which CT of the abdomen pelvis was performed which showed findings suspicious for partial small bowel obstruction related to an internal hernia with transition point near the back containing umbilical hernia. General surgery consulted and evaluated patient and assessed that patient did not have small-bowel obstruction clinically and patient was able tolerate general diet without any issues and discharge home on 03/10. Patient with some soft blood pressures around time of discharge with systolics in the 90s to 100s for which patient's losartan 50 and Lasix 40 mg daily were paused though these can be restarted at next PCP visit if blood pressure is stable.  Issues Requiring Follow Up: -follow up to ensure that blood pressures were not restarting home losartan 50 and Lasix 40 daily  Patient Active Problem List   Diagnosis Date Noted ? Abdominal pain 03/09/2025 ? Umbilical hernia 03/08/2025 ? COVID 03/08/2025 ? Chronic HFrEF (heart failure with reduced ejection fraction) (HCC) 06/16/2024 ? Acute diverticulitis 06/16/2024 ? AKI (acute kidney injury) (HCC) 06/16/2024 ? Incarcerated umbilical hernia 08/23/2022 ? Osteopenia 11/20/2019 Discharged to Home
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL, HEPA, MMRV, PNC20, VARCEL
Symptoms: Wrong patient
Clinical narrative: Patient here in office for his 12M HC, triaged patient and placed in clinic room. Health check completed and schedule changed to "Immunizations". Would usually give immunizations but was drawing labs on another patient. Therefore, someone else offered to give immunizations to patient. After clinic had closed both employees came into my office and explained patient had received an MMRV and also a Varicella along with the rest of his 12M shots. I then stated they need to make an incident report and call the OPM.  I personally called the OPM the next morning to report incident.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC20, VARCEL, HEPA, MMRV, PNC20, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient here in office for his 12M HC, triaged patient and placed in clinic room. Health check completed and schedule changed to "Immunizations". Would usually give immunizations but was drawing labs on another patient. Therefore, someone else offered to give immunizations to patient. After clinic had closed both employees came into my office and explained patient had received an MMRV and also a Varicella along with the rest of his 12M shots. I then stated they need to make an incident report and call the OPM.  I personally called the OPM the next morning to report incident.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Headache, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: injection site reaction : redness , warm to touch traveling down arm, slight headache
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: patient got the prevnar 20 2 years ago and got one on 3/16/2025
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Cerebrovascular accident, Peripheral coldness, Seizure
Clinical narrative: stroke, seizure, cold hands and feet
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt did not have an adverse reaction. This nurse gave an expired dose of DTap/IPV.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: High dose administered by mistake.
Age: 1.67
Sex: M
Vaccine: DTAP, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom reported redness on left thigh,  as well as leg swelling on 3/12 at 1021. Mom went to emergency room at Hospital on same day at 1504.  At 2215 that night, mom reported ED wanted them to follow up with us in clinic, they came to a 1530 appointment the next day on 03/13/2025. MD saw patient and explained to mom that it seemed to be a localized reaction that should continue to improve.
Age: 92.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Med error-incorrectly administered flu vaccine again on 3/6/2025. No adverse reactions observed.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Condition aggravated, Pyrexia, Seizure
Clinical narrative: Breakthrough seizure.  She took her medications at 7:30AM as per usual.  Had a breakthrough seizure at 9:00AM.  Waited for seizure to stop.  Clammy hands post seizure and low grade fever.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Rash
Clinical narrative: Fever after vaccines. Rash 5 days after vaccines.
Age: 0.83
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Hyperresponsive to stimuli, Infantile back arching, Lethargy, Pyrexia, Tremor
Clinical narrative: At the time, my 10-month-old was fine until that evening, fever spiked 102.7, he became lethargic, shaking and arching his back. Within the five days after, he became very disconnected. He was Un responding to his name, decline in smiles and engagement with parents and others. He was not the same baby and two weeks later is finally back to himself.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Contusion, Erythema, Local reaction, Nausea
Clinical narrative: Localized reaction, with erythema and bruising, elevated Blood pressure, nausea
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event rxn. Patient received expired dose - MMR II lot expired 10/11/24
Age: 50.0
Sex: M
Vaccine: COVID19, FLU3, PNC20, VARZOS
Symptoms: Myalgia, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Muscle Aches / Body Pain / Congestion / Fever 99.7 f
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Cough, Decreased appetite, Pyrexia, Rash maculo-papular
Clinical narrative: EXATHEMATOUS MACULAPAPULAR RASH ON FACE, SCALP, NECK, CHEST, ARMS, BUTTOCKS AND LOWER LEGS,. PALMS OF HANDS AND TOPS OF FEET SPARED. PT WAS EVALUATED BY PROVIDER, MOTHER TO MONITOR FOR FEVER NOT CONTROLLED BY FEVER REDUCER, COUGH, DECREASED APPETITE, LETHARGY OR CHANGE IN BEHAVIOR AND REACH OUT TO OFFICE WITH ANY OF THESE SYMPTOMS
Age: 23.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Client received Bexsero doses 1 and 2 in 2018 at a different clinic and these doses were invalid due to storage and handling.  This dose (counted as her first) was the third time she received Bexsero.  Today, she noticed non-raised redness in vaccination arm that extended halfway to her elbow.  She denies tenderness (except slight tenderness at injections sites) and itchiness.  She has a wellness visit scheduled and so will discuss reaction with her provider.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Ultrasound scan
Clinical narrative: PAIN AT INJECTION SITE- ONGOING
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Diarrhoea, Rotavirus test positive
Clinical narrative: diarrhea for 3-4 weeks after the vaccine
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: PATIENT WAS INADVERTENTLY GIVEN DTAP INSTEAD OF TDAP AT 11 YEARS OLD.  No Harm or adverse event symptoms to patient.   But at well child visit next year will vaccinate with TDaP.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Pt vaccine record was not printed before administration resulting in an extra dose being given
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Hydrocephalus, Hypertension, Magnetic resonance imaging head abnormal
Clinical narrative: Dizziness High blood pressure can not maintain balance
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: On 3/14/25 at approximately 1pm the patient was given Tdap instead of Dtap.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large area of redness, swelling, itching, and pain to touch around the site of injection (Left deltoid).
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Local reaction, Skin warm
Clinical narrative: Large local reaction, warm to touch and bigger than size of palm.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Epistaxis, Immune thrombocytopenia, Laboratory test, Migraine
Clinical narrative: On 2/13/25 pt started having a nosebleed that lasted until the afternoon on 2/14/25. Also had a migraine headache. Both of those resolved and then pt noticed bruising and petechiae.  Sought medical attention on 2/15/25 and was admitted to the hospital with ITP diagnosis. Platelet count was 5 upon admission. Pt was in hospital for two days and continues to monitor platelet levels which have fluctuated.  Pt received FFP in addition to other treatments.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Petechiae, Platelet count decreased, Transfusion
Clinical narrative: On 2/13/25 pt started having a nosebleed that lasted until the afternoon on 2/14/25. Also had a migraine headache. Both of those resolved and then pt noticed bruising and petechiae.  Sought medical attention on 2/15/25 and was admitted to the hospital with ITP diagnosis. Platelet count was 5 upon admission. Pt was in hospital for two days and continues to monitor platelet levels which have fluctuated.  Pt received FFP in addition to other treatments.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Laboratory test, Pyrexia
Clinical narrative: Cough, shortness of breath, intermittent fevers
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Administered what I thought would beTdap #2 using catch-up schedule, I did not account for the Td administered by the panel physician so the Tdap administered on 1/15/2025 is not valid
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional dose of the shigrix vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lip swelling, Nasal congestion
Clinical narrative: Pt. states she had swelling and redness at injection site on left arm. Pt. states patchy area with itching in left arm that started approximately 1 inch below injection site that measured approximately 5x3 inches around, irregular shaped. Pt. states she also had some nasal stuffiness and lower lip swelling following injection. Pt. states no concerns for breathing issues at time of reaction and so forth.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: significant localized rash, swelling, itching
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: Death
Clinical narrative: Death 1 week after getting shots, unknown if related
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abnormal faeces, Biopsy colon abnormal, Blood test normal, Clostridium test negative
Clinical narrative: Three days after the vaccine, I developed unusual stools. This progressed and worsened over the next weeks turning from loose stool to diarrhea. Upon a seven times per day diarrhea on 12/26/24 I was sent to an urgent care center (no regular Dr appointments during Christmas week). I had blood tests, stool tests, was given a precautionary antibiotic due to abdominal pain and diverticulitis was suspected. A CAT scan disproved this. I was pretty much home bound for 12 weeks due to urgent 'bathroom calls', usually 1 hour after eating. I finally had a colonoscopy on 2/28/25 and biopsies were taken. Pathology returned result of microscopic lymphocytic colitis. The past week, the 13th week has been a mixed bag of semi-normal bowel movements.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis microscopic, Colonoscopy abnormal, Computerised tomogram abdomen normal, Culture stool negative, Diarrhoea
Clinical narrative: Three days after the vaccine, I developed unusual stools. This progressed and worsened over the next weeks turning from loose stool to diarrhea. Upon a seven times per day diarrhea on 12/26/24 I was sent to an urgent care center (no regular Dr appointments during Christmas week). I had blood tests, stool tests, was given a precautionary antibiotic due to abdominal pain and diverticulitis was suspected. A CAT scan disproved this. I was pretty much home bound for 12 weeks due to urgent 'bathroom calls', usually 1 hour after eating. I finally had a colonoscopy on 2/28/25 and biopsies were taken. Pathology returned result of microscopic lymphocytic colitis. The past week, the 13th week has been a mixed bag of semi-normal bowel movements.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Faecal calprotectin increased
Clinical narrative: Three days after the vaccine, I developed unusual stools. This progressed and worsened over the next weeks turning from loose stool to diarrhea. Upon a seven times per day diarrhea on 12/26/24 I was sent to an urgent care center (no regular Dr appointments during Christmas week). I had blood tests, stool tests, was given a precautionary antibiotic due to abdominal pain and diverticulitis was suspected. A CAT scan disproved this. I was pretty much home bound for 12 weeks due to urgent 'bathroom calls', usually 1 hour after eating. I finally had a colonoscopy on 2/28/25 and biopsies were taken. Pathology returned result of microscopic lymphocytic colitis. The past week, the 13th week has been a mixed bag of semi-normal bowel movements.
Age: 45.0
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient presented for 3rd dose of HPV vaccine and was given PCV 15 in error. No symptoms noted at the time if administration of vaccine. Patient has been contacted, and clinic will conduct further follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via unknown route
Clinical narrative: The patient received the shot and the when the pharmacist activated the safety mechanism, the small amount that was left in the needle squirted in the patient's eye.
Age: 0.92
Sex: F
Vaccine: PNC20
Symptoms: Full blood count, Influenza virus test negative, Lymphocyte percentage increased, Metabolic function test normal, Neutrophil percentage decreased
Clinical narrative: Starting ~11 hours following, she had a diffuse macular papular rash across thighs, back of knees that then spread down to her ankles. 20 min following, here soles of her feet swelled and turned bright red. no rash across chest or back.
Age: 0.92
Sex: F
Vaccine: PNC20
Symptoms: Platelet count increased, Rash, Rash macular, Rash maculo-papular, Respiratory syncytial virus test negative
Clinical narrative: Starting ~11 hours following, she had a diffuse macular papular rash across thighs, back of knees that then spread down to her ankles. 20 min following, here soles of her feet swelled and turned bright red. no rash across chest or back.
Age: 0.92
Sex: F
Vaccine: PNC20
Symptoms: SARS-CoV-2 test negative, Urine analysis normal, White blood cell count increased
Clinical narrative: Starting ~11 hours following, she had a diffuse macular papular rash across thighs, back of knees that then spread down to her ankles. 20 min following, here soles of her feet swelled and turned bright red. no rash across chest or back.
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: MMRV given to a 17 year old. no adverse reactions
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product storage error
Clinical narrative: Patient was administered Covid 19 vaccine that was beyond use. Prefilled syringe, syringe tip was attached for more than 4 hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Patient requested prevnar-20, but patient received Shingrix in error by pharmacist.  She experienced severe symptoms with fever, body aches and headache.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, IPV, PNC15, RV5
Symptoms: Circumstance or information capable of leading to medication error, Wrong product administered
Clinical narrative: Pt was given pediarix, and IPOL polio.  Both  the hib bottle and the polio bottle were stored side by side. Both vials were similar in size and color. The polio was drawn up and injected instead of the hib bottle.
Age: 67.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Swelling, tenderness, pain, red
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The child di not have adverse event.  The vaccine was expired
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient developed urticaria and subjective fever 14 hours after receiving immunization. He was evaluated in the ED 2 days in a row. He was seen in our office 72 hours after receiving all 4 vaccines, and still experiencing urticaria on arms, legs, back, chest, and inguinal folds
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Cough, Ear swelling, Erythema, Joint swelling, Pyrexia
Clinical narrative: Patient experienced symptoms approximately 8 hours after vaccine administration, reporting swollen joints, high fever (100.9 F), swollen ears (swollen, red, hot to touch) and coughing.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm
Clinical narrative: Patient experienced symptoms approximately 8 hours after vaccine administration, reporting swollen joints, high fever (100.9 F), swollen ears (swollen, red, hot to touch) and coughing.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Chills, Cyanosis, Livedo reticularis
Clinical narrative: Mottled skin on neck and face on injected side, blue lips, rigors lasting approximately 30 minutes
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC15
Symptoms: Extra dose administered
Clinical narrative: Patient was given a separate Hepatitis B vaccine in addition to a combination vaccine that included DTap, Hep B and IPV.  Patients mother informed and declines any symptoms or adverse side effects. Local health department also notified.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Erythema, Headache, Loss of consciousness, Nausea
Clinical narrative: Redness, swelling, painful-(stabbing pain),swollen with a knot, bruised, headache, nausea, vomited next day and passed out next day--she has been using Ice, Tylenol or Ibuprofen
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Nodule, Pain, Swelling, Vomiting
Clinical narrative: Redness, swelling, painful-(stabbing pain),swollen with a knot, bruised, headache, nausea, vomited next day and passed out next day--she has been using Ice, Tylenol or Ibuprofen
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, HPV9, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Hepatitis A Adult dose given to pediatric client.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash vesicular
Clinical narrative: Patient noticed a vesicular rash on her neck that eventually extended along the dermatome.  It spreaded to her neck, chest, and arm and feels like sunburn
Age: 0.75
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash to trunk
Age: 68.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Burning sensation, Erythema, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports having swollen and painful arm after receiving 2 vaccines Capvaxive and Boostrix.   The patient received both vaccines in the left arm on Thursday 27th. The next day the patient reported her arm became red, swollen, painful, burning, and itching.   On Tuesday 4th her arm continued to become more swollen and red. She reported the incident to her physician was treated with a steroid shot.   The patient visits us today to report the incident to the pharmacy. She said although the redness and burning stopped after 2 weeks she still has lingering arm pain, range of motion issues, pain in her fingers and hand.
Age: 68.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Pruritus
Clinical narrative: Patient reports having swollen and painful arm after receiving 2 vaccines Capvaxive and Boostrix.   The patient received both vaccines in the left arm on Thursday 27th. The next day the patient reported her arm became red, swollen, painful, burning, and itching.   On Tuesday 4th her arm continued to become more swollen and red. She reported the incident to her physician was treated with a steroid shot.   The patient visits us today to report the incident to the pharmacy. She said although the redness and burning stopped after 2 weeks she still has lingering arm pain, range of motion issues, pain in her fingers and hand.
Vaccine: VARZOS
Symptoms: Decreased appetite, Insomnia, Weight decreased
Clinical narrative: Iost a lot of weight; lack of appetite; lack of sleep; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weight loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (recived 1st dose on an unknown date).   On 11-JUN-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced weight loss (Verbatim: Iost a lot of weight), appetite absent (Verbatim: lack of appetite) and sleep loss (Verbatim: lack of sleep). The outcome of the weight loss, appetite absent and sleep loss were not reported.   It was unknown if the reporter considered the weight loss, appetite absent and sleep loss to be related to Shingrix.     It was unknown if the company considered the weight loss, appetite absent and sleep loss to be related to Shingrix.   Additional Information: GSK receipt date: 01-FEB-2024 This case was reported by a patient via interactive digital media. The patient said he/she suffered severe side effects after the second dose of the vaccine that sent them to the emergency room. The patient experienced weight loss, lack of appetite and sleep. The patient reported that he/she had been at least 6times in the emergency department of different hospitals.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient never received second dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient never received second dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 26-FEB-2025 The reporter was the patient who received his first dose of Shingrix over 2 years ago. He never received his second dose which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: raised bump that is red, 4 inches from injection site, size of a thumb; raised bump that is red and hot to touch, 4 inches from injection site, size of a thumb; Swelling of injection site; hardening injection site; Fever; Headache; Fatigue; Chills; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-FEB-2025, the patient received Shingrix (left deltoid) .5 ml. In FEB-2025, less than a week after receiving Shingrix, the patient experienced chills (Verbatim: Chills). On 22-FEB-2025, the patient experienced injection site swelling (Verbatim: Swelling of injection site), injection site induration (Verbatim: hardening injection site), fever (Verbatim: Fever), headache (Verbatim: Headache) and fatigue (Verbatim: Fatigue). On 28-FEB-2025, the patient experienced raised rash (Verbatim: raised bump that is red, 4 inches from injection site, size of a thumb) and feeling hot (Verbatim: raised bump that is red and hot to touch, 4 inches from injection site, size of a thumb). The patient was treated with cetirizine hydrochloride (Zyrtec) and ibuprofen. On 25-FEB-2025, the outcome of the injection site swelling, fever, headache, fatigue and chills were resolved and the outcome of the injection site induration was resolved (duration 3 days). The outcome of the raised rash and feeling hot were not resolved.   The reporter considered the injection site swelling, injection site induration, fever, headache, fatigue, chills, raised rash and feeling hot to be related to Shingrix.     The company considered the injection site swelling, injection site induration, fever, headache, fatigue, chills, raised rash and feeling hot to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAR-2025 Reporter was a pharmacist reporting for herself.