chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokalaemia, Influenza, Influenza A virus test positive, SARS-CoV-2 test positive, Supraventricular tachycardia
Clinical narrative: Name:  Age:  78 y.o.  Admit date: 1/30/2025   Discharge date: Feb 3, 2025   Attending Physician at the Time of Discharge: MD  Reason for Admission: Patient presenting with shortness of breath and cough for 2 weeks. HR at clinic was in the 170s so he was sent to the ER.   ER lab workup notable for stable CKD, initial troponin elevated at 31 (delta of negative 4). RVP positive for both Flu A and COVID. Initial EKG noted SVT with wide QRS tachycardia, RBBB and LAFB (bifascicular block) and T wave abnormality (possible inferior ischemia). CXR unremarkable.   Patient given adenosine and initially converted to NSR. Patient then went back into SVT, amiodarone bolus given with conversion to NSR. Patient again flipped into SVT, cardiology consulted and recommended amiodarone drip and admission.    Brief Summary of Hospital Stay:  Principal Problem:   Paroxysmal SVT (supraventricular tachycardia) / flutter with RVR. Likely due to viral infections with COVID and Flu. Did not have much resolution with IV amio and currently on low dose bblocker. Cards had given Dig push x2 and HR has settled and is now NSR> Conitnue lopressor. On eliquis.  CXR neg. F/u Cardiologist Dr.    Influenza A - on Tamiflu. Mucinex. Encourage IS, flutter.    COVID infection - no hypoxia and chest clear. No need for steroids/remdesevir unless hypoxia.    Hypokalemia - replaced.  Active Problems:   Chronic renal insufficiency -CKD 3a - stable.    Benign paroxysmal positional vertigo   Dyslipidemia associated with type 2 diabetes mellitus - on statin.    Essential hypertension - monitor BP.    Hypothyroid - TSH ok. On synthroid.    Malignant neoplasm of prostate - stable. On flomax.    Diabetes mellitus - BS stable.  Resume home meds.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Name:  Age:  78 y.o.  Admit date: 1/30/2025   Discharge date: Feb 3, 2025   Attending Physician at the Time of Discharge: MD  Reason for Admission: Patient presenting with shortness of breath and cough for 2 weeks. HR at clinic was in the 170s so he was sent to the ER.   ER lab workup notable for stable CKD, initial troponin elevated at 31 (delta of negative 4). RVP positive for both Flu A and COVID. Initial EKG noted SVT with wide QRS tachycardia, RBBB and LAFB (bifascicular block) and T wave abnormality (possible inferior ischemia). CXR unremarkable.   Patient given adenosine and initially converted to NSR. Patient then went back into SVT, amiodarone bolus given with conversion to NSR. Patient again flipped into SVT, cardiology consulted and recommended amiodarone drip and admission.    Brief Summary of Hospital Stay:  Principal Problem:   Paroxysmal SVT (supraventricular tachycardia) / flutter with RVR. Likely due to viral infections with COVID and Flu. Did not have much resolution with IV amio and currently on low dose bblocker. Cards had given Dig push x2 and HR has settled and is now NSR> Conitnue lopressor. On eliquis.  CXR neg. F/u Cardiologist Dr.    Influenza A - on Tamiflu. Mucinex. Encourage IS, flutter.    COVID infection - no hypoxia and chest clear. No need for steroids/remdesevir unless hypoxia.    Hypokalemia - replaced.  Active Problems:   Chronic renal insufficiency -CKD 3a - stable.    Benign paroxysmal positional vertigo   Dyslipidemia associated with type 2 diabetes mellitus - on statin.    Essential hypertension - monitor BP.    Hypothyroid - TSH ok. On synthroid.    Malignant neoplasm of prostate - stable. On flomax.    Diabetes mellitus - BS stable.  Resume home meds.   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Dyspnoea, Intensive care, Pulse absent
Clinical narrative: Admit to hospital 2/6/2025 with COVID. Symptoms shortness of breath.. Increased oxygen needs. Patient stopoped breathing and no pulse. Transfer to ICU. Expired 2/7 2:25
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory arrest
Clinical narrative: Admit to hospital 2/6/2025 with COVID. Symptoms shortness of breath.. Increased oxygen needs. Patient stopoped breathing and no pulse. Transfer to ICU. Expired 2/7 2:25
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac hypertrophy, Cardiac stress test, Cardiomyopathy, Dizziness
Clinical narrative: after taking my second dose i started feeling light headed off and on but didnot think it was covid vaccine.    I was always healthy.   I had to get booster and it was even worse.   I ended up passing out .     I went to drs in january 2023 and she recomended me see a cardiologist.   After getting EKg, heart ultrasound and MRI i found out i had Cadiomyopathy hypertrophic. irregular heart beat and thickening in left valve.   Never had issues before
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Heart rate irregular, Left ventricular hypertrophy, Loss of consciousness
Clinical narrative: after taking my second dose i started feeling light headed off and on but didnot think it was covid vaccine.    I was always healthy.   I had to get booster and it was even worse.   I ended up passing out .     I went to drs in january 2023 and she recomended me see a cardiologist.   After getting EKg, heart ultrasound and MRI i found out i had Cadiomyopathy hypertrophic. irregular heart beat and thickening in left valve.   Never had issues before
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart
Clinical narrative: after taking my second dose i started feeling light headed off and on but didnot think it was covid vaccine.    I was always healthy.   I had to get booster and it was even worse.   I ended up passing out .     I went to drs in january 2023 and she recomended me see a cardiologist.   After getting EKg, heart ultrasound and MRI i found out i had Cadiomyopathy hypertrophic. irregular heart beat and thickening in left valve.   Never had issues before
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: PT WAS TERRIFIED OF NEEDLES. SAID SHE WOULD THROW UP, GAGGED BUT DIDN'T THROW UP. SAID SHE WOULD PASS OUT. AFTER 20 MINUTES OF TRYING TO CALM HER, THE VACCINE WAS ADMINISTERED.  ABOUT A MINUTE LATER SHE PASSED OUT IN MOM'S ARMS. I LAID HER ON THE FLOOR AND ELEVATED HER FEET. CHECK HER BREATHING WHICH WAS FINE. WAS GETTING THE SMELLING SALTS WHEN SHE WOKE UP AND ASKED WHY SHE WAS ON THE FLOOR. SHE ASKED FOR A DRINK, GAVE HER A BOTTLE OF WATER. AFTER A COUPLE MINUTES I ALLLOWED TO SIT UP ON THE FLOOR. SHE WAS A LITTLE DIZZY SO SHE STAYED THERE FOR SEVERAL MINUTES THEN MOVED TO A CHAIR. I GAVE HER SOME CHOCOLATE CANDY. AFTER ABOUT 15 MINUTES SHE WAS FEELING WELL ENOUGH TO WALK AND LEAVE.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Dysstasia, Injection site nodule
Clinical narrative: leg has a knot at the injection site, infant will not stand on the left leg
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram head abnormal, Headache, Ischaemic stroke, Malaise
Clinical narrative: 11/18 started feeling sick, lost balance, severe headache, nausea , 11/19went to urgent care -sent to ED . In ED on 11/19 was diagnosed with stoke
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 11/18 started feeling sick, lost balance, severe headache, nausea , 11/19went to urgent care -sent to ED . In ED on 11/19 was diagnosed with stoke
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Limb injury, Product administered at inappropriate site, X-ray limb
Clinical narrative: 1. Injury of right shoulder  Received influenza vaccine on November 16, 2024 at clinic. Since then, pt developed chronic right shoulder pain. Denied any skin changes. Otherwise, denies any previous shoulder injury/procedures. Exam today otherwise, unremarkable. No TTP around injection site. No skin changes. Pt does recall an unusual higher injection site.  - will obtain right shoulder plain film to r/o any bony abnormality  - referral sent to physical therapy for evaluation  - clinical presentation suggestive of SIRVA (shoulder injury related to vaccine administration), which is not a contraindication for receiving flu vaccine, rather the medical staff may have given the vaccine at the subdeltoid bursa  - f/u with me in February 2025 for re-assessment  - return precautions provided Ordered: Referral Request 2.0 -
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Pt received un-needed vaccines due to getting confused with another pt. Mother was notified of event, and spoke with provider after receiving vaccines.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Culture wound negative, Herpes simplex test negative, Rash, Rash vesicular, Varicella virus test positive
Clinical narrative: On 2/4 started with vesicular rash on left arm which spread down the left arm to left hand
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Rash pruritic
Clinical narrative: The only reaction I have had as of today is a small and some what itchy rash on parts of my right and left leg, under my left breast, as well as my left side of my abdomen.  Also small amount on my lower back.  I felt fine after I received Prevnar 20 vaccine and I feel fine now.  The rash is bothersome but not painful.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site rash, Injection site warmth, Rash, Rash erythematous
Clinical narrative: rt upper arm noted with red rash above injection site and warm to touch. cheeks also red with raised rash. ice pack applied to arm.  15 minute recheck by provider revealed arm rash almost gone and no longer warm to touch but cheeks still red. No difficulty breathing. mom states after rash started that she thinks she remembers that child had the same reaction to Hep A vaccine when he received the 1st dose. Provider instructed mom to give a zyrtec before bed.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: mother states pt has little red spots at injection sites- has fever of 105 (over)
Age: 29.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Erythema, Injection site induration, Pruritus, Skin disorder, Swelling
Clinical narrative: Patient reports "red bulls' eye (similar to Lyme disease), bubbling up under the skin, swelling, itchiness, that lasted about a week hen went away. Now, there is a hard feeling under the skin that is the size of a pea that can be felt,  on the left side of the arm at the injection site." Patient believes this is from the HPV vaccine, however, the TDAP vaccine was recorded as being given on this site.   Patient declines any fevers, chills. Used Hydrocortisone cream on the area. Declined ED/EC visit.
Age: 37.0
Sex: M
Vaccine: FLU3, HEPA, IPV, TDAP, VARCEL
Symptoms: Blood test normal, Chest X-ray normal, Dyspnoea, Peripheral swelling, Pyrexia
Clinical narrative: Pt stated he had intermittent fever for 2 days 1/24/2025 to 1/25/2025, mild shortness of breath only one day on 1/24/2025, and some swelling on his left arm from 1/24/2025 to 1/27/2025. Pt stated he had one episode of fainting on 1/26/2025 in the morning. Pt stated at the ER, he had lab drawn, chest xray, and was told by the doctor all the results were normal.  Pt stated he was told by the ER doctor that he had reaction due to receiving multiple vaccinations and he was not told of any allergic reaction.
Age: 37.0
Sex: M
Vaccine: FLU3, HEPA, IPV, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: Pt stated he had intermittent fever for 2 days 1/24/2025 to 1/25/2025, mild shortness of breath only one day on 1/24/2025, and some swelling on his left arm from 1/24/2025 to 1/27/2025. Pt stated he had one episode of fainting on 1/26/2025 in the morning. Pt stated at the ER, he had lab drawn, chest xray, and was told by the doctor all the results were normal.  Pt stated he was told by the ER doctor that he had reaction due to receiving multiple vaccinations and he was not told of any allergic reaction.
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: third dose of Covid-19 vaccine administered one month too early. This dose, therefore, dose not count towards the primary series. Discussed and informed parents of administration error on 2/7/2025.
Age: 57.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Chills, Pain in extremity, Restlessness
Clinical narrative: Pain in arm, shivering all night, super restless, I took Tylenol last night and this morning more manageable but still there
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient given the incorrect vaccine
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Incorrect vaccine given
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site discharge, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed a small bump on left deltoid, mom popped it and it drained clear water. Since then area has been tender, hard to palpated with distinct localized area. Area warm and hard to touch, induration. Per patient, was painful until this morning. Denies pain when provider touch.                                                                                                                                                                                                                      Start mupirocin 2 % topical ointment 1 application 2 times a day for 15 days Start clindamycin HCL 300 mg capsule 150 mg 3 times a day as directed for 5 days
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in injection area; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in injection area). The outcome of the injection site pain was resolving.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JAN-2025 Patient was the reporter. Patient received her 1st Shingrix vaccine in October 2023 in the right arm and has had intense pain since receiving the vaccine.  Patient stated she received the 2nd vaccine in January 2024 in the left arm and had not had any pain.  Patient had reached out to her health professional and the pain was ongoing.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Arthralgia, Injection site bruising, Injection site discolouration, Malaise
Clinical narrative: Client reports pain and swelling at injection site along with some malaise starting after vaccination on 12/18/24. Developed bruising to injection area. Client used analgesics and ice to area. Client stopped in to office today to show left arm to staff. Left upper arm has old bruising- yellow/purple in color. No warmth or redness known. Area of swelling closer to inner area just above elbow is noted by this author but he states that is not a new issue since vaccination. Reports no further discomfort but was concerned as bruising, although appears to be dissipating, remains after >45 days. Advised to continue to monitor and utilize heat/ice if necessary. See healthcare provider if concerns persist or symptoms worsen. Will discuss further COVID vaccinations with his healthcare provider and this agency. Patient verbalizes understanding, agrees with plan of care and intends to comply.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, RSV, COVID19, FLU3, RSV
Symptoms: Bursitis, Joint fluid drainage, Joint swelling
Clinical narrative: Don?t know that elbow bursitis is a reaction.  Swelling of elbow.  It was drained today and Medrol was prescribed.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, RSV, COVID19, FLU3, RSV
Symptoms: Bursitis, Joint swelling
Clinical narrative: Don?t know that elbow bursitis is a reaction.  Swelling of elbow.  It was drained today and Medrol was prescribed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use. This did not include MMR and Variceela
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: It was discovered after the fact that this patient had already received a dose if the Arexvy vaccine on 10/05/2023. Patient has not had any adverse reactions and is aware that she received two doses and does not ever need another dose.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Patient was given vaccine post temperature excursion prior to vaccine being properly cleared by vaccine coordinator with manufactures. Vaccines have successfully been cleared with manufacture and were cleared for patient use.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered. Vaccine was expired by 3 days.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, RV5
Symptoms: C-reactive protein increased, Carbon dioxide decreased, Computerised tomogram head normal, Full blood count, Intensive care
Clinical narrative: Less than 24h after receiving vaccines, infant began having seizure like activity. He was admitted to ICU.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, RV5
Symptoms: Laboratory test normal, Leukocytosis, Respiratory viral panel, Seizure like phenomena, White blood cell count increased
Clinical narrative: Less than 24h after receiving vaccines, infant began having seizure like activity. He was admitted to ICU.
Age: 85.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None, nurse was supposed to give a Tdap and instead gave a Dtap
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event
Clinical narrative: n/a nothing reported from patient or her daughter when called
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC20, RV5
Symptoms: Agitation, Infant irritability, Product administered to patient of inappropriate age
Clinical narrative: Patient received 1 dose of DTAP-IVP Kinrix which is designated for ages 4-6 and he is 4 months old. The error was not known until 01/24/25 when I spoke with the physician when it did not appear on patient's medical record, (technical issues on the facilitie's part). I contacted GSK, obtained the following information: Inadvertent use of Kinrix in children younger then 4 years, immunogenicity & safety. I then phoned mother of child, informed her of the error and common side effects, agitation and irritabiity. She reported the patient had experienced these. I notified her that the doses were valid and would not need to be repeated and to call for further concerns. Today, she reports the patient is fine, doing well and had no further adverse side effects.
Age: 1.33
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Peripheral swelling, Rash
Clinical narrative: localized erythema on Left thigh, followed by erythema and swelling extending to Left foot and then to Right foot and then diffuse rash to trunk/ body
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC21, RV5
Symptoms: Wrong product administered
Clinical narrative: PCV 21 given instead of PCV 15
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Pallor
Clinical narrative: Patient had a Meningococcal vaccine and a T-dap vaccine today.  After those vaccines, patient became light headed and pale.  He did not LOC at all.  He laid down for about 15 min and then started feeling better.  His mother stated that he works him self up before vaccines and this is probably the issue.   Dr. evaluated the patient and felt like he was doing much better after the 15 min and assessment was done by MD. Tried to call the patient's mother to check up on him.  No answer, but I left a message to call us back for an update .RN
Age: 82.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received Prevnar 20 and had already received this shot 12/28/2022 and 8/1/2023 but shots did not show on immprint.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin lesion, Skin warm
Clinical narrative: Patient is a 13 m.o. male brought by mother presenting with a red, hard area to the leg.  He got shots  (12 mos) about 11 days ago and mom not sure if it was in the exact same area but he had a smaller lesion up until 4 days ago, then it worsened and got red, warm.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Limb discomfort, Pain, Tenderness
Clinical narrative: Heaviness and pain in deltoid at site of vaccination.  Raising arm hurts, touching arm hurts, and even just sitting still it aches.  Hot water bottle did not help.  She's had it against all night,  It didn't help.  She also took 2 Tylenol last night cause it was so painful but it didn't help.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Shoulder injury related to vaccine administration, X-ray limb
Clinical narrative: shoulder injury related to vaccine administration (SIRVA) S49.80xA, pain in the left deltoid starting about 48 hours after vaccination and persisting, no other apparent cause.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: only been administered with the saline solution; only been administered with the saline solution; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Hib (Hiberix) (batch number 4777F, expiry date 17-MAR-2026) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: only been administered with the saline solution) and inappropriate dose of vaccine administered (Verbatim: only been administered with the saline solution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2025 Reporter stated that six different patients received a Hiberix vaccine and two of them had only been administered with the saline solution.  Reporter did not know which were the two patients that received the full dose.  Vaccination date was asked, nevertheless the reporter mentioned it occurred between September and December of last year (twenty-twenty four).  They asked about any concerning information regarding safety, or if they have to readminister those two doses.  No patient demographics were provided and no further information was provided. The patients received only saline solution of Hiberix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 2.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: No adverse events known to date
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction noted, discovered that the vaccine expired 02/02/2025
Age: 1.0
Sex: M
Vaccine: COVID19, FLU3, MMR, PNC20, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no known adverse events
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on Neck
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Electrocardiogram, Headache, Injection site pain
Clinical narrative: Minor:  soreness at injection site.  Day after injection, I had chills and a headache.  Second day, I woke up during the night experiencing a high heart rate.  This continued and concerned me enough to contact my primary physician.  My resting heart rate was at times over 100 bpm, which is rare for me.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired on 2/5/2025.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This nurse administered patient a first dose of Rota Teq vaccine when patient was 23 weeks of age. This vaccine's first dose should not be administered after patient is over 15 weeks of age. Patient has had no signs/symptoms as a result.
Age: 12.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: APPROXIMATELY 5 MINUTES AFTER VACCINES WERE ADMINISTERED, PATIENT BECAME NON-RESPONSIVE AND COLOR BECAME PALE. EPISODE LASTED 1-2, THEN PATIENT WAS ORIENTED  TO PERSON PLACE AND TIME
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: During a routine inventory, I noticed there was a vial without a syringe of sterile diluent next to it. I left early the day prior and noticed that was when the vaccine was given. I traced vaccine administration back to previous day to patient and Medical Assistant that scanned the vaccine into the chart.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bladder calculus removal, Calculus bladder, Erectile dysfunction, Laboratory test abnormal, Nephrolithiasis
Clinical narrative: BPH  (Enlarged prostate), Kidney stone, bladder stone, ED. I  did not suspect anything until December of 2024 after seeing a video on social media that my injury was related to the vaccine. The video Dr. drops a bombshell, claiming that the mRNA COVID "vaccines" were deliberately engineered to harm, disable, and kill, with the ultimate goal of reducing human fertility... made me dig a little deeper. I had to have a surgery to remove the kidney stone, a surgery to remove bladder stones, and in July of 2024 I had to have my prostate removed. Prior to this I had never need or been to a urologist for any reason and I have no family history of kidney stones or prostate issues. I had no reason to suspect these issues were from the vaccine shot until I saw that video. The timeline of all these events make it 100% clear to me that having an enlarged prostate, which caused the kidney stone and bladder stones were caused by the vaccine. I would be glad to go into more detail if needed.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prostatectomy, Prostatomegaly, Renal stone removal
Clinical narrative: BPH  (Enlarged prostate), Kidney stone, bladder stone, ED. I  did not suspect anything until December of 2024 after seeing a video on social media that my injury was related to the vaccine. The video Dr. drops a bombshell, claiming that the mRNA COVID "vaccines" were deliberately engineered to harm, disable, and kill, with the ultimate goal of reducing human fertility... made me dig a little deeper. I had to have a surgery to remove the kidney stone, a surgery to remove bladder stones, and in July of 2024 I had to have my prostate removed. Prior to this I had never need or been to a urologist for any reason and I have no family history of kidney stones or prostate issues. I had no reason to suspect these issues were from the vaccine shot until I saw that video. The timeline of all these events make it 100% clear to me that having an enlarged prostate, which caused the kidney stone and bladder stones were caused by the vaccine. I would be glad to go into more detail if needed.
Age: 4.0
Sex: M
Vaccine: COVID19, DTAPIPV, FLUN3, MMRV
Symptoms: Unevaluable event
Clinical narrative: No known adverse events
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no known adverse events reported
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no known adverse event
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: No adverse event noted.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash, topical aquaphor and hydrocortisone cream
Age: 27.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine given in error to a 27 year old female. No reported adverse reaction as of time of this report.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray normal, Chills, Decreased appetite, Dizziness, Erythema
Clinical narrative: Severe Local Reaction - (Swelling, Redness, Pain, Heat, Nodule) doubling in size daily until started on Allegra/Prednisone. Systemic Reaction - Low grade fever, aches, chills, extreme fatigue/malaise, dizziness, loss of appetite, raise in bpm. Low Fever, Fatigue, Malaise, Dizziness, Loss of appetite and nasal congestion persist (currently at day 12).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Feeling hot, Fibrin D dimer normal, Full blood count normal, Heart rate increased
Clinical narrative: Severe Local Reaction - (Swelling, Redness, Pain, Heat, Nodule) doubling in size daily until started on Allegra/Prednisone. Systemic Reaction - Low grade fever, aches, chills, extreme fatigue/malaise, dizziness, loss of appetite, raise in bpm. Low Fever, Fatigue, Malaise, Dizziness, Loss of appetite and nasal congestion persist (currently at day 12).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Human chorionic gonadotropin normal, Influenza virus test negative, Malaise, Metabolic function test normal, Nasal congestion
Clinical narrative: Severe Local Reaction - (Swelling, Redness, Pain, Heat, Nodule) doubling in size daily until started on Allegra/Prednisone. Systemic Reaction - Low grade fever, aches, chills, extreme fatigue/malaise, dizziness, loss of appetite, raise in bpm. Low Fever, Fatigue, Malaise, Dizziness, Loss of appetite and nasal congestion persist (currently at day 12).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule, Pain, Pyrexia, SARS-CoV-2 test negative, Serum sickness-like reaction
Clinical narrative: Severe Local Reaction - (Swelling, Redness, Pain, Heat, Nodule) doubling in size daily until started on Allegra/Prednisone. Systemic Reaction - Low grade fever, aches, chills, extreme fatigue/malaise, dizziness, loss of appetite, raise in bpm. Low Fever, Fatigue, Malaise, Dizziness, Loss of appetite and nasal congestion persist (currently at day 12).
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, Urine analysis normal
Clinical narrative: Severe Local Reaction - (Swelling, Redness, Pain, Heat, Nodule) doubling in size daily until started on Allegra/Prednisone. Systemic Reaction - Low grade fever, aches, chills, extreme fatigue/malaise, dizziness, loss of appetite, raise in bpm. Low Fever, Fatigue, Malaise, Dizziness, Loss of appetite and nasal congestion persist (currently at day 12).
Age: 89.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, Skin warm
Clinical narrative: Patient stated that the agency has her birthday wrong and as a result her insurance has the wrong birthday. They have DOB listed it should be different. When we checked our State database for vaccines we used the correct DOB not realizing she had the wrong birthday on her profile.  It said she was due for this dose, and when asked the patient stated she had never gotten this vaccine before. She got a dose on 01/18/2024.  So she was given a second dose of this vaccine due all of those factors being combined.                                                                                               She has stated her arm was a little warm on the day of the vaccine but as of now she is not experiencing any physical side effects/symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Genital herpes zoster, Herpes zoster, Magnetic resonance imaging spinal abnormal
Clinical narrative: shingles was seen on the patient's lower back, right light knee, and right shin; shingles in addition to her groin and pelvis; stopped being able to void her bladder; unable to defecate; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included intervertebral disc protrusion (mentioned nerve dissection at L5 and herniated disk at L3, L4, and L5). Concomitant products included methylprednisolone sodium succinate (Methylprednisolone), pregabalin, methocarbamol, ibuprofen and valaciclovir hydrochloride (Valacyclovir).   On 26-DEC-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles was seen on the patient's lower back, right light knee, and right shin), genital herpes zoster (Verbatim: shingles in addition to her groin and pelvis), urine output decreased (Verbatim: stopped being able to void her bladder) and decreased stool volume (Verbatim: unable to defecate). The outcome of the shingles and decreased stool volume were unknown and the outcome of the genital herpes zoster was not reported and the outcome of the urine output decreased was resolved.   It was unknown if the reporter considered the shingles, genital herpes zoster, urine output decreased and decreased stool volume to be related to Shingrix.     It was unknown if the company considered the shingles, genital herpes zoster, urine output decreased and decreased stool volume to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JAN-2025 The reporter was the patient who reported receiving her first dose of Shingrix vaccine on 26th December 2024.  On 2nd January 2024 she went to a neurosurgeon for back pain and got an Magnetic resonance imaging which showed a herniated disk at L3, L4, and L5.  She also mentioned nerve dissection at L5.  It was on this day that disseminated shingles was seen on the patient's lower back, right light knee and right shin it crossed multiple dermatomes.  She also experienced pain in the areas of the shingles in addition to her groin and pelvis.  She started valacyclovir on 4th January 2024.  Recently she stopped being able to void her bladder and unable to defecate.  She stopped taking all her medications except for valacyclovir and she was able to urinate and defecate.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Rash, Vaccination failure
Clinical narrative: Suspectd vaccination failure; Recurrent shingles episodes; Flu like symptoms; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspectd vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Recurrent shingles episodes) and influenza-like symptoms (Verbatim: Flu like symptoms). The patient was treated with valaciclovir. The outcome of the vaccination failure was not reported and the outcome of the shingles and influenza-like symptoms were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and influenza-like symptoms to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JAN-2025 The member of the public called and mentioning that the patient got a Shingrix shot four years ago and since the patient got it, the patient had recurrent rash for several times on body and flu like symptoms as well. The patient had been experiencing recurrent shingles. The patient doctor told that the patient could receive another shot six months after not been experiencing any shingles episode. And also has been giving the patient valaciclovir. The reporter asked could you give any advise, did the patient need to see an infectious disease specialist. The patient demographics were obtained in this call. No specific vaccination date nor vaccine details were provided from the member of the Public end. No other information was obtained in this call. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix .
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles; patient that received a third dose of Shingrix on 30-SEP-2024; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number N2954, expiry date 30-APR-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 49Y35, expiry date 31-OCT-2020) for prophylaxis and Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 31-OCT-2020) for prophylaxis.   On 30-SEP-2024, the patient received the 3rd dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, right arm). On 30-SEP-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix and Shingrix, the patient experienced extra dose administered (Verbatim: patient that received a third dose of Shingrix on 30-SEP-2024). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles and extra dose administered were unknown.   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 unrelated 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: 31-JAN-2025 The pharmacist reported that the female patient that received a third dose of Shingrix which led to extra dose administered.  The pharmacist also states that the patient mentioned that she recently (no specific date was provided) had shingles. No further information was available about the case of shingles.  The pharmacist reported all that was provided about this adverse event. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix dose 1, Shingrix dose 2 and Shingrix dose 3.
Sex: U
Vaccine: COVID19
Symptoms: Disability, Multiple allergies, Tinnitus
Clinical narrative: disabled; chronic ear ringing attacks; food and med allergies; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up.  No concomitant medications were reported.  On an unspecified date, the patient experienced disabled, chronic ear ringing attacks, and food and med allergies. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable.  The outcome of disabled, chronic ear ringing attacks and food and med allergies was not reported.  This report was serious (other medically important condition).; Sender's Comments: V0;Disability; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got the vaccine in December and now has COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got the vaccine in December and now has COVID) in a 74-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043822) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J and j covid-19 Vaccine (Dose 1) in October 2021; for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 2) in April 2022, Moderna covid-19 vaccine (Dose 3) in April 2023, Moderna covid-19 vaccine (Dose 4) in October 2023 and Moderna covid-19 vaccine (Dose 5) in April 2024. Past adverse reactions to the above products included COVID-19 with J and j covid-19 Vaccine; and No adverse effect with Moderna covid-19 vaccine, Moderna covid-19 vaccine, Moderna covid-19 vaccine and Moderna covid-19 vaccine.    On 05-Dec-2024, the patient received sixth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 01-Feb-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced COVID-19 (got the vaccine in December and now has COVID). At the time of the report, COVID-19 (got the vaccine in December and now has COVID) had not resolved.            Concomitant product use was not provided by the reporter.  Patient had no other vaccine on the same day as receiving Spikevax.  Treatment information was not provided.  Reporter causality was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2025: Live non-significant follow-up received: reference number added.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial paralysis, Small fibre neuropathy
Clinical narrative: left facial nerve palsy; small fiber peripheral neuropathy; This spontaneous case was reported by a patient and describes the occurrence of FACIAL PARALYSIS (left facial nerve palsy) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Unspecified hypothyroidism, Hyperlipidemia, Constipation chronic and Cancer (cancer survivor (2001)) since 2021.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. In November 2022, the patient experienced SMALL FIBRE NEUROPATHY (small fiber peripheral neuropathy). In 2023, the patient experienced FACIAL PARALYSIS (left facial nerve palsy) (seriousness criterion medically significant). The patient was treated with Pregabalin at an unspecified dose and frequency. At the time of the report, FACIAL PARALYSIS (left facial nerve palsy) and SMALL FIBRE NEUROPATHY (small fiber peripheral neuropathy) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as booster.  She received the Moderna booster on 27-Oct-2022 and two weeks later between November 15th-20th she developed numbness of the right fifth toe and foot outer border, discomfort of the right lower back area (butt), sciatica like symptoms which kept progressing. It progressed and then developed like burning, numbness, tingling, pain of hands, feet, facial (around the lips/mouth) and all extremities and face. In 2023 reporter was then diagnosed with small fiber peripheral neuropathy. On Mar-2023, neurologist placed reporter on steroids, responded very well to the steroids, got better but after the steroids wore off, it all came back. Now has developed left facial nerve palsy and taking pregabalin (start date Jun or July 2023), did not control symptoms very well, could not tolerate high doses and still symptomatic.  Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Somnolence
Clinical narrative: stomach ach; drowsiness; fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ach), SOMNOLENCE (drowsiness) and FATIGUE (fatigue) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ach), SOMNOLENCE (drowsiness) and FATIGUE (fatigue). At the time of the report, ABDOMINAL PAIN UPPER (stomach ach), SOMNOLENCE (drowsiness) and FATIGUE (fatigue) had resolved with sequelae.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.