chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abnormal behaviour, Cough, Feeling abnormal, Hyporesponsive to stimuli, Malaise
Clinical narrative: Fever100-102, stuffy nose, sore throat, stomach ache, delirious, nausea and vomiting since Sunday 9/22, worst symptoms Monday 9/23, fever 100-101, stuffy nose, sore throat, stomachache 9/24 as of present- symptoms appear to be less
Age: 6.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nasal congestion, Nausea, Oropharyngeal pain, Sleep disorder, Vision blurred
Clinical narrative: Fever100-102, stuffy nose, sore throat, stomach ache, delirious, nausea and vomiting since Sunday 9/22, worst symptoms Monday 9/23, fever 100-101, stuffy nose, sore throat, stomachache 9/24 as of present- symptoms appear to be less
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pt was given pediatric dose of Pfizer-BioNTech Covid-19 vaccine
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Pt was given pediatric dose of Pfizer-BioNTech Covid-19 Vaccine. Not the one labeled for adult administration.
Age: 61.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Injection site swelling, Urticaria
Clinical narrative: FULL BODY HIVES, SWELLING ON INJECTION SITE. Pt took OTC benadryl q6h.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient was given children's dosage (5-12 years of age), patient is 76 years of age.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR
Symptoms: Vaccination site granuloma, Vaccination site pruritus
Clinical narrative: Itchy granuloma of skin present at vaccine site of MMR on Left upper outer thigh. Mom states that the granuloma has been there "since she got her MMR vaccine".
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Skin lesion
Clinical narrative: Childs mother showed up at HD to report that since child received the Dtap vaccine on 9/19/24 he has developed a lesion on his right buttock and has small lesions towards inner gluteal folds. Mom showed this nurse a picture of the lesion, which appears to look more like excoriation and does not mimic a rash. Referred mom to take child to his PCP office for evaluation.
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given was the HD form rather than the standard dose, even though pt is not 65+
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Lymphoedema
Clinical narrative: Lymphedema left bicep, extreme exhaustion lasting five days
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Venipuncture
Clinical narrative: Mom reports pt ( who 's twin also received vaccine ) developed light pink bumps on face near left eye and for head  while they were in  the lab( same bldg as PCP )  getting blood work drawn after the visit . Mom returned to office for observation . Pt was observed for 30 min and sx did not worsen. homecare advise given . On f/u call today mom reported rash subsided but not totally gone- "very light" and did not spread. Item 20 was answered yes as mom reports rash is nearly gone so recovering would be more appropriate.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain, Acute kidney injury, Aspiration pleural cavity, Blood creatinine increased, Blood lactic acid
Clinical narrative: Pt received vaccine in clinic at approximately 130pm.  At approximately 4pm had sudden onset tremors / chills / left sided abdominal pain. Patient was brought by ambulance to ER and noted hypotensive 87/38. Initially afebrile but spiked to 101.4 F. Sepsis workup completed (see below for lab results). Given IVF w/o effect. Empirically treated with ceftriaxone. Needed IV pressor support - levophed x12 hours. Admitted with pleural effusions - thoracentesis on 9/20 withdrew 700cc fluid. Improved over course of hospitalization (9/18 through 9/22). Origin of hypotension / septic presentation unclear.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Body temperature increased, Chest X-ray abnormal, Chills, Computerised tomogram abdomen, Hypotension
Clinical narrative: Pt received vaccine in clinic at approximately 130pm.  At approximately 4pm had sudden onset tremors / chills / left sided abdominal pain. Patient was brought by ambulance to ER and noted hypotensive 87/38. Initially afebrile but spiked to 101.4 F. Sepsis workup completed (see below for lab results). Given IVF w/o effect. Empirically treated with ceftriaxone. Needed IV pressor support - levophed x12 hours. Admitted with pleural effusions - thoracentesis on 9/20 withdrew 700cc fluid. Improved over course of hospitalization (9/18 through 9/22). Origin of hypotension / septic presentation unclear.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Leukocytosis, Pleural effusion, Renal disorder, Staphylococcus test negative, Tremor
Clinical narrative: Pt received vaccine in clinic at approximately 130pm.  At approximately 4pm had sudden onset tremors / chills / left sided abdominal pain. Patient was brought by ambulance to ER and noted hypotensive 87/38. Initially afebrile but spiked to 101.4 F. Sepsis workup completed (see below for lab results). Given IVF w/o effect. Empirically treated with ceftriaxone. Needed IV pressor support - levophed x12 hours. Admitted with pleural effusions - thoracentesis on 9/20 withdrew 700cc fluid. Improved over course of hospitalization (9/18 through 9/22). Origin of hypotension / septic presentation unclear.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: Pt received vaccine in clinic at approximately 130pm.  At approximately 4pm had sudden onset tremors / chills / left sided abdominal pain. Patient was brought by ambulance to ER and noted hypotensive 87/38. Initially afebrile but spiked to 101.4 F. Sepsis workup completed (see below for lab results). Given IVF w/o effect. Empirically treated with ceftriaxone. Needed IV pressor support - levophed x12 hours. Admitted with pleural effusions - thoracentesis on 9/20 withdrew 700cc fluid. Improved over course of hospitalization (9/18 through 9/22). Origin of hypotension / septic presentation unclear.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Acute kidney injury, Blood culture negative, Blood lactic acid increased, Blood pressure decreased, Chills
Clinical narrative: Pt received vaccine in clinic at approximately 130pm.  At approximately 4pm had sudden onset tremors / chills / left sided abdominal pain. Patient was brought by ambulance to ER and noted hypotensive 87/38. Initially afebrile but spiked to 101.4 F. Sepsis workup completed (see below for lab results). Given IVF w/o effect. Empirically treated with ceftriaxone. Needed IV pressor support - levophed x12 hours. Admitted with pleural effusions - thoracentesis on 9/20 withdrew 700cc fluid. Improved over course of hospitalization (9/18 through 9/22). Origin of hypotension / septic presentation unclear.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram kidney abnormal, Hypotension, Intensive care, Pyrexia, Renal disorder
Clinical narrative: Pt received vaccine in clinic at approximately 130pm.  At approximately 4pm had sudden onset tremors / chills / left sided abdominal pain. Patient was brought by ambulance to ER and noted hypotensive 87/38. Initially afebrile but spiked to 101.4 F. Sepsis workup completed (see below for lab results). Given IVF w/o effect. Empirically treated with ceftriaxone. Needed IV pressor support - levophed x12 hours. Admitted with pleural effusions - thoracentesis on 9/20 withdrew 700cc fluid. Improved over course of hospitalization (9/18 through 9/22). Origin of hypotension / septic presentation unclear.
Age: 88.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Septic shock, Tremor, Urine analysis normal
Clinical narrative: Pt received vaccine in clinic at approximately 130pm.  At approximately 4pm had sudden onset tremors / chills / left sided abdominal pain. Patient was brought by ambulance to ER and noted hypotensive 87/38. Initially afebrile but spiked to 101.4 F. Sepsis workup completed (see below for lab results). Given IVF w/o effect. Empirically treated with ceftriaxone. Needed IV pressor support - levophed x12 hours. Admitted with pleural effusions - thoracentesis on 9/20 withdrew 700cc fluid. Improved over course of hospitalization (9/18 through 9/22). Origin of hypotension / septic presentation unclear.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash at Injection site
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, TDAP, VARZOS, COVID19, FLUA4, TDAP, UNK
Symptoms: Herpes virus infection
Clinical narrative: Patient came in 9/24/24 stating that a couple of days following her Shingrix vaccine, the had an outbreak of herpes (which she had prior to the injection).  She feels that the injection is the factor that lead to the outbreak.  She did not confirm her suspicion with her primary care physician as far as we were able to ascertain.
Age: 76.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: none at this time
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: Patient received arexvy vaccine on 9/5/24. The vaccine was mixed with a syringe of sterile water 0.7mL manufactured by Merck instead of the adjuvant suspension that was provided with the Arexvy.
Age: 32.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Incorrect route of product administration, Injury, Product administered at inappropriate site
Clinical narrative: rph student intern administered flu and covid vaccines in patient right arm on 9/6/2024 as recorded in VAR.  Patient later sought medical treatment and was hospitalized for injury..   Patients doctor called in the pharmacy on 9/20/2024 to inform that the vaccine was administered into patients right rotator cuff and patient was currently in the hospital.   Liability intake was called with reference 23627619
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Type III immune complex mediated reaction, Vaccination site pain, Vaccination site swelling
Clinical narrative: Patient returned Monday 09/23/24 to have the site of the vaccination reviewed for swelling and arm pain in right deltoid.  Patient reports the day the vaccination was given 09/20/24, they could not move their fingers and this was affecting how they got dressed and ate as pain level was very high. Patient also reports having a shooting pain down the arm.  Patient was diagnosed with Arthus reaction and given 5 days of Prednisone 09/23/24.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Gave pt im fluzone rt arm in deltoid. Patient comes back with swelling and arm bump.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Blood test normal, Computerised tomogram head normal, Computerised tomogram neck normal, Computerised tomogram spine normal, Diarrhoea
Clinical narrative: Severe Diarrhea 9/19/24 beginning  27 hours after shot; passed out 3:20 9/20. Ended up in ER
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Electrocardiogram normal, Loss of consciousness
Clinical narrative: Severe Diarrhea 9/19/24 beginning  27 hours after shot; passed out 3:20 9/20. Ended up in ER
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Skin exfoliation
Clinical narrative: patient had received flu and covid on left arm and RSV on right arm. On patient's right arm she had received her RSV in her right deltoid on 9/18/24. She had a reaction on night of 9/20/24. Her right bicep had a layer of skin peel about palm size. She went to hospital today on 9/24/24 to get treated with antibiotic and cream.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC20, RV1
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Developed a blanching maculopapula rash at around noon on 9/18/24.  Start on chest and slowly over the day spread to face/scalp and upper thighs and arms
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope for 30 seconds ... Patient had stated on information forms had history of syncope during vaccinations.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Infection, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Expiration date: 6/30/25   (Also used Diluent : Lot 429P7  Exp.11/25/26   So I had alot of swelling and redness and pain at the injection site And it was HOT for 5 days It bruised me 3" down my arm and 2" wide. All my muscles hurt for days, legs, everything. I knew this Dr. does not like me so was skeptical to get it from her as  I have NEVER  had an allregic reaction to a shot in my life!
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Expiration date: 6/30/25   (Also used Diluent : Lot 429P7  Exp.11/25/26   So I had alot of swelling and redness and pain at the injection site And it was HOT for 5 days It bruised me 3" down my arm and 2" wide. All my muscles hurt for days, legs, everything. I knew this Dr. does not like me so was skeptical to get it from her as  I have NEVER  had an allregic reaction to a shot in my life!
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 1st flushot vaccine on 07/29/2024. Patient received a 2nd flushot on 09/23/2024.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: patient developed an area of redness around the injection site about 6 inches in diameter.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Herpes-like cold sores reported in the mouth a few days after the Comirnaty vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Got a 1" x 2" rash on the left side of my neck 47 hours after the shot. Note: got the flu shot (Fluzone) at the same appointment as the COVID shot.
Age: 4.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: We gave shot that we weren't supposed to. We wanted to give Quadracel. He is having no side effects or reactions as of 9/23/2024.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received 1st flushot on 07/29/2024. Patient then received a 2nd flushot on 09/23/2024
Age: 28.0
Sex: F
Vaccine: UNK
Symptoms: Arrhythmia, C-reactive protein, Chest pain, Pericarditis
Clinical narrative: Chest pains started slowly months after the vaccine, they would come and go for months until I started experiencing  heart Arrhythmias, and the chest pains started to get worse and worse. The outcome is pericarditis
Age: 67.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Patient received Boostrix and Prevnar 20 at the same Left arm on 09/18/2024. Patient has injection site reaction, painful, red & swelling area about 2 inches in diameter. Patient could not sleep and feel irritated at the injection site. The pharmacist advised patient to continue taking Ibuprofen & Tylenol, in addition take 1 Benadryl at night; circle the injection site area, advised patient if the swelling & redness spread, patient is to contact her MD right away.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling, Urticaria
Clinical narrative: Welt - red, warm, raised
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Swollen and Painful at injections site. Red blister on site. Having numbness in left arm all the way from my collar bone down to my fingertips.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Electrocardiogram, Fall, Joint injury, Nausea, Posture abnormal
Clinical narrative: At 1140 am was called over by MA stating patient has fallen. Upon assessment pt was noted to be sitting on bilat buttocks with bilat leg extended in front of him and MA holding his torso up. Pt is alert, oriented and verbal. Per mother patient started to slouch over to the side and fell.  NP was notified. Pt was then assisted into WC by staff and taken back into room to be evaluated by NP. New orders for ECG and new set of vitals. Pt and mother deny patient hitting head when he fell but stated he did hurt bilateral knees when he fell. No bruising or laceration noted to Bilat knees at the moment. Pt stated when he started walking towards clinic lobby to have blood draw he started feeling nauseous. Patient stated he hasn't had anything to eat and he was really nervous about the vaccine and blood draw. Per mother this is the first time this has happened to him. Pt is noted to be able to move BUE, BLE, able to ambulate and sit up with no complications.    ECG and VS completed and provided to NP for review.  VS BP: 99/61 Pulse: 59 02: 99% RA R:20 Pain: 0/10   Pt left clinic at 1243 pm alert & oriented x4 and verbal. Pt was able to walk out of clinic with no c/o pain, discomfort or SOB.    New order per NP for Holter monitor provided to pt/mother with scheduling number and referral coordinators number. Both verbalized understanding and agreed to call to schedule appt.    Incident report completed.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Immunisation reaction
Clinical narrative: AN EXTRA DOSE WAS GIVEN AFTER THE SERIES WAS COMPLETE; PT HAD TYPICAL SIDE EFFECTS OF IMMZ
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test, Antinuclear antibody, Asthenia, Blood creatine phosphokinase, Blood thyroid stimulating hormone
Clinical narrative: Massive insulin resistance (went from 50 units Levemir & 30 units Novolog per day -- that had been my dose for about 20 years --  to 330 units Humilin RU-500, 180 units Humalog per day)  This took about.  Endocrinologist gave the latter as a treatment which is holding my blood sugar relatively steady at the moment. I am now a very brittle diabetic, though.  Given a diagnosis of Fibromyalgia by Dr.  Debilitating chronic pain.  Overwhelming Chronic Fatigue. Very bad brain fog.  PCP switched Lexapro to Duloxatine and Buspirone.  Lisinopril dropped in favor of Losartan HCZ as edema is also now an issue.  Holding steady but the flares of fibromyalgia are becoming more frequent and more debilitating.  I was given a disability placard and a scrip for a powerchair/scooter.  I am now disabled.  The timeline was 1 year from being "normal" to being disabled.  I fought the label for another year because I kept hoping to get better.  I no longer hope that and just have to deal with it.  The rapid slide started within 2 weeks of the 1st shot and by 1 month was already majorly changing how I used insulin.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain fog, C-reactive protein, Complement factor C3, Complement factor C4, Condition aggravated
Clinical narrative: Massive insulin resistance (went from 50 units Levemir & 30 units Novolog per day -- that had been my dose for about 20 years --  to 330 units Humilin RU-500, 180 units Humalog per day)  This took about.  Endocrinologist gave the latter as a treatment which is holding my blood sugar relatively steady at the moment. I am now a very brittle diabetic, though.  Given a diagnosis of Fibromyalgia by Dr.  Debilitating chronic pain.  Overwhelming Chronic Fatigue. Very bad brain fog.  PCP switched Lexapro to Duloxatine and Buspirone.  Lisinopril dropped in favor of Losartan HCZ as edema is also now an issue.  Holding steady but the flares of fibromyalgia are becoming more frequent and more debilitating.  I was given a disability placard and a scrip for a powerchair/scooter.  I am now disabled.  The timeline was 1 year from being "normal" to being disabled.  I fought the label for another year because I kept hoping to get better.  I no longer hope that and just have to deal with it.  The rapid slide started within 2 weeks of the 1st shot and by 1 month was already majorly changing how I used insulin.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diabetes mellitus inadequate control, Double stranded DNA antibody, Electrophoresis protein, Fatigue, Fibromyalgia
Clinical narrative: Massive insulin resistance (went from 50 units Levemir & 30 units Novolog per day -- that had been my dose for about 20 years --  to 330 units Humilin RU-500, 180 units Humalog per day)  This took about.  Endocrinologist gave the latter as a treatment which is holding my blood sugar relatively steady at the moment. I am now a very brittle diabetic, though.  Given a diagnosis of Fibromyalgia by Dr.  Debilitating chronic pain.  Overwhelming Chronic Fatigue. Very bad brain fog.  PCP switched Lexapro to Duloxatine and Buspirone.  Lisinopril dropped in favor of Losartan HCZ as edema is also now an issue.  Holding steady but the flares of fibromyalgia are becoming more frequent and more debilitating.  I was given a disability placard and a scrip for a powerchair/scooter.  I am now disabled.  The timeline was 1 year from being "normal" to being disabled.  I fought the label for another year because I kept hoping to get better.  I no longer hope that and just have to deal with it.  The rapid slide started within 2 weeks of the 1st shot and by 1 month was already majorly changing how I used insulin.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insulin resistance, Light chain analysis, Oedema, Pain, Protein total
Clinical narrative: Massive insulin resistance (went from 50 units Levemir & 30 units Novolog per day -- that had been my dose for about 20 years --  to 330 units Humilin RU-500, 180 units Humalog per day)  This took about.  Endocrinologist gave the latter as a treatment which is holding my blood sugar relatively steady at the moment. I am now a very brittle diabetic, though.  Given a diagnosis of Fibromyalgia by Dr.  Debilitating chronic pain.  Overwhelming Chronic Fatigue. Very bad brain fog.  PCP switched Lexapro to Duloxatine and Buspirone.  Lisinopril dropped in favor of Losartan HCZ as edema is also now an issue.  Holding steady but the flares of fibromyalgia are becoming more frequent and more debilitating.  I was given a disability placard and a scrip for a powerchair/scooter.  I am now disabled.  The timeline was 1 year from being "normal" to being disabled.  I fought the label for another year because I kept hoping to get better.  I no longer hope that and just have to deal with it.  The rapid slide started within 2 weeks of the 1st shot and by 1 month was already majorly changing how I used insulin.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate, Thyroxine free, Urine analysis, Urine electrophoresis
Clinical narrative: Massive insulin resistance (went from 50 units Levemir & 30 units Novolog per day -- that had been my dose for about 20 years --  to 330 units Humilin RU-500, 180 units Humalog per day)  This took about.  Endocrinologist gave the latter as a treatment which is holding my blood sugar relatively steady at the moment. I am now a very brittle diabetic, though.  Given a diagnosis of Fibromyalgia by Dr.  Debilitating chronic pain.  Overwhelming Chronic Fatigue. Very bad brain fog.  PCP switched Lexapro to Duloxatine and Buspirone.  Lisinopril dropped in favor of Losartan HCZ as edema is also now an issue.  Holding steady but the flares of fibromyalgia are becoming more frequent and more debilitating.  I was given a disability placard and a scrip for a powerchair/scooter.  I am now disabled.  The timeline was 1 year from being "normal" to being disabled.  I fought the label for another year because I kept hoping to get better.  I no longer hope that and just have to deal with it.  The rapid slide started within 2 weeks of the 1st shot and by 1 month was already majorly changing how I used insulin.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: PATIENT RECEIVED FIRST DOSE ON 06/25/2024. HIS SECOND DOSE WAS ADMINISTERED TOO SOON (BEFORE 56 DAYS HAD PASSED). HE EXPERIENCED TYPICAL SIDE EFFECTS OF VACCINE.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Symptoms of induration and redness from vaccine insertion point toward the inner axila. 4.5cm wide, 9 cm from injection point. Minor reaction, advised to follow up with PCP if symptoms do not improve. Noted improvement with icing. Decreased erythema and induration as of 5 days from vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Headache, Lumbar puncture normal, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Pt developed meningitis like symptoms with severe headache, neck stiffness, dizziness and fever. Lumbar puncture was negative for meningitis.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: White blood cell count increased
Clinical narrative: Pt developed meningitis like symptoms with severe headache, neck stiffness, dizziness and fever. Lumbar puncture was negative for meningitis.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Computerised tomogram, Dehydration, Differential white blood cell count, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: 5-6 hours after vaccine, when outside in the heat, and slightly dehydrated, pt. had a syncope episode that mom felt like possibly was a seizure. She went to ER and EEG, CT, EKG were normal. Dx with syncope. Very likely related to the heat, but wanted to be thorough and report event. This was her 2nd Bexero vaccine. She had her first dose of bexero previously without any problems. She also has had the flu vaccine every year without any history of problems.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Exposure to extreme temperature, Full blood count, Heat stroke, Metabolic function test, Urine analysis abnormal
Clinical narrative: 5-6 hours after vaccine, when outside in the heat, and slightly dehydrated, pt. had a syncope episode that mom felt like possibly was a seizure. She went to ER and EEG, CT, EKG were normal. Dx with syncope. Very likely related to the heat, but wanted to be thorough and report event. This was her 2nd Bexero vaccine. She had her first dose of bexero previously without any problems. She also has had the flu vaccine every year without any history of problems.
Age: 17.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Urine ketone body present
Clinical narrative: 5-6 hours after vaccine, when outside in the heat, and slightly dehydrated, pt. had a syncope episode that mom felt like possibly was a seizure. She went to ER and EEG, CT, EKG were normal. Dx with syncope. Very likely related to the heat, but wanted to be thorough and report event. This was her 2nd Bexero vaccine. She had her first dose of bexero previously without any problems. She also has had the flu vaccine every year without any history of problems.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Medical assistant gave Tdap on 9/23/24 at 16:00 into the left deltoid. This vaccine was administrated in Error and patient was supposed to received COVID -19 injection. MD and patient notified. Patient to come back to clinic on 9/30/24 to receive her COVID-19 injection
Age: 79.0
Sex: F
Vaccine: COVID19, FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was inappropriately given a 2nd dose of RSV vaccine when they had a dose in 2023. Patient has not reported any issues thus far.
Age: 1.5
Sex: M
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No side effects reported; HCP calling to report a patient was inadvertently given GARDASIL 9 instead of VAQTA.; HCP calling to report a patient was inadvertently given GARDASIL 9 instead of VAQTA.; This spontaneous report was received from a registered nurse and referred to an 18-month-old male. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 09-SEP-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #X022735, expiration date: 12-APR-2026 (strength, dose anatomical site of administration and route of administration were not provided) inadvertently instead of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (strength, dose description, lot #, expiry date, and route of administration were not provided) for prophylaxis (Wrong product administered, Product administered to patient of inappropriate age). It was unknown if medical attention was sought or treatment was given. No side effects reported/No additional information/clarification provided/No additional adverse event (no AE).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; patient received PROQUAD and VARIVAX inadvertently simultaneously approximately two months ago.; This spontaneous report was received from other health professional and refers to an 1-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent.   On an unknown date in July 2024 (reported as 'approximately 2 months ago'), the patient was vaccinated inadvertently simultaneously with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection and  varicella virus vaccine live (oka/merck) (VARIVAX) injection (exact doses, lot #, expiration dates, routes of administration and anatomical locations were not provided) for prophylaxis (Accidental overdose). No side effects reported (No adverse effect).   Lot # is being requested and will be submitted if received.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; that patient received inappropriately stored PROQUAD; This spontaneous report was received from  a medical assistant and refers to a 4-year-old female patient.  The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX).   On 23-MAY-2024, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #Y003143, expiration date: 27-JUL-2025, administered subcutaneously on the left thigh for prophylaxis (exact dose, strength were not provided) following a temperature excursion (Improper storage of product in use). No adverse effects reported. It was stated that a digital data logger was involved.  This is one of 2 cases from the same reporter.; Sender's Comments:  US-009507513-2405USA007454:
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Product preparation error
Clinical narrative: Nurse called to report VARIVAX was reconstituted with normal saline and administered to a patient.  No symptoms reported.  Consent to correspond was granted.  No additional AE/PQC.; No additional adverse event; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X026789, expiration date: 14-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided); and normal saline (NORMAL SALINE), unk (strength, formulation, lot #, expiry date, route of administration, and indication were not provided). The vaccine was reconstituted with normal saline and administered to a patient (Product preparation error). No additional adverse event was reported.
Age: 13.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A patient that was administered an expired dose of MMR-II; This spontaneous report has been received from a nurse regarding a 13-year-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 19-SEP-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (expired product administered), 0.5 milliliter, administered as prophylaxis (lot number reported as W026512, which has been verified as valid, with an expiration date reported and established as 22-AUG-2024) (strength, vaccination scheme, route of administration, and anatomical site of injection were not provided).  No additional adverse events were reported in the patient.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 10-DEC-2020, the patient received the 2nd dose of Shingrix. On 09-OCT-2020, the patient received the 1st dose of Shingrix. On 16-SEP-2024, 1376 days after receiving Shingrix and 1438 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 The patient received 2 doses of Shingrix and was diagnosed with an early stage of a new shingles outbreak. The patient stated that it was a pretty mild case. The patient asked that need to consider a booster or re-vaccination after this episode has cleared. This case was considered as suspected vaccination failure as details regarding 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(1 and 2 dose).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles/I know too many people who have had and suffered from the virus; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/I know too many people who have had and suffered from the virus). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles 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 to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 This case was reported via (social media) interactive digital media. The reporter know too many people (patients) who had the Shingrix vaccine and suffered from the virus and had no regrets. The patient's had suffered from shingles and had no regrets about getting vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, Influenza, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; got the flu; Covid-19; quarantined for two weeks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Influenza vaccine for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Influenza vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine and an unknown time after receiving Influenza vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), quarantine (Verbatim: quarantined for two weeks) (serious criteria clinically significant/intervention required), shingles (Verbatim: shingles), influenza (Verbatim: got the flu) and covid-19 (Verbatim: Covid-19). The outcome of the vaccination failure, shingles, influenza and covid-19 were not reported and the outcome of the quarantine was resolved (duration 2 weeks).   It was unknown if the reporter considered the vaccination failure, quarantine, shingles, influenza and covid-19 to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and quarantine to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, influenza and covid-19 to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2024 This case was reported by a patient's children via interactive digital media. The reporter reported that the patient (reporter's dad) got vaccinated for the shingles twice. The reporter mentioned that the patient was quarantined for two weeks. The patient would get a flu shot every year and still got the flu. The reporter mentioned that the vaccines were for money only, not for health.  The reporter asked that caught covid after the vaccine and booster. It was unknown if the reporter considered the shingles, influenza, quarantine and covid-19 to be related to flu shot. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of 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, details regarding completion of primary vaccination schedule ) is considered unrelated to GSK vaccine Shingles vaccine(1st dose sand 2nd dose). Quarantine  is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine(1st dose sand 2nd dose).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blindness unilateral, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles in my right eye; still got Shingles in my right eye. Now today I'm Blind in that Eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: still got shingles in my right eye) (serious criteria GSK medically significant) and blind right eye (Verbatim: still got Shingles in my right eye. Now today I'm Blind in that Eye) (serious criteria GSK medically significant). The outcome of the vaccination failure and ophthalmic herpes zoster were not reported and the outcome of the blind right eye was not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and blind right eye to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, ophthalmic herpes zoster and blind right eye to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-SEP-2024 This case was reported by a patient via interactive digital media. The patient got both shots and still got Shingles in his/her right eye and now today (on the reporting day) he/she was blind in that eye. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(dose 1 and 2).                              Ophthalmic herpes zoster and Blindness unilateral are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine(dose 1 and 2).
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Mobility decreased, Multiple sclerosis relapse, Social avoidant behaviour
Clinical narrative: severe exacerbation (flare up); almost bedridden; now very shy; This serious case was reported by a consumer via interactive digital media and described the occurrence of multiple sclerosis exacerbation in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple sclerosis. Family history included shingles (patient's grandma had shingles).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced multiple sclerosis exacerbation (Verbatim: severe exacerbation (flare up)) (serious criteria GSK medically significant), bedridden (Verbatim: almost bedridden) and shyness (Verbatim: now very shy). The outcome of the multiple sclerosis exacerbation, bedridden and shyness were not resolved.   It was unknown if the reporter considered the multiple sclerosis exacerbation, bedridden and shyness to be related to Shingrix.     The company considered the multiple sclerosis exacerbation to be unrelated to Shingrix. It was unknown if the company considered the bedridden and shyness to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 and 19-SEP-2024 The case was received from the patient via interactive digital media. The patient reported that he/she have had a fear of getting the shingles since his/her early 20's when he/she took care of his/her grandmother.  The patient spoke with the neurologist about when he/she should get the vaccine in between their medications for multiple sclerosis.  After receiving the first dose, the patient ended up in a severe exacerbation that (flare up) that hit him/her so fast and so hard left them almost bedridden before he/she could take all the thousands of milligrams of steroids to stop it.  The patient reported that although there was a warning in the vaccine advertisement about the guilliane barre syndrome, but there was no warning about multiple sclerosis or any kind of neurological disease and there needs to be.  The patient knew his/her triggers (heat & stress) and he/she did not have either of those before he/she was faced with the active symptoms of the multiple sclerosis.  The patient had take an infusion of medication for multiple sclerosis to slow the progression and to help and keep flare ups at bay.  Needless to say that the patient not get the second dose after this experience and was shy of any other kinds of vaccines. There needs to be a warning that included multiple sclerosis and/or any kind of neurological diseases.; Sender's Comments: Multiple sclerosis exacerbation is an unlisted event which is considered unrelated to GSK  vaccine Shingrix.
Sex: M
Vaccine: DTAP, RVX
Symptoms: Eczema, Erythema, Irritability, Lymphadenopathy, Pyrexia
Clinical narrative: had facial swelling; redness; irritable; had low grade fever; struggling with skin problems; had eczema; flake into wounds; swollen lymph nodes in the back of his head and neck; possible allergy; hives; This non-serious case was reported by a consumer and described the occurrence of hives in a 7-month-old male patient who received DTPa (Infanrix) (batch number TX77L) for prophylaxis.   Co-suspect products included Rotavirus vaccine for prophylaxis.   Concomitant products included mupirocin, triamcinolone, hydroxyzine, ketoconazole and fluocinolone acetonide (Fluocinolone).   On 04-APR-2024, the patient received Infanrix .5 ml and Rotavirus vaccine. On 05-APR-2024, 1 days after receiving Infanrix and Rotavirus vaccine, the patient experienced hives (Verbatim: hives). On an unknown date, the patient experienced facial swelling (Verbatim: had facial swelling), erythema (Verbatim: redness), irritability (Verbatim: irritable), low grade fever (Verbatim: had low grade fever), skin disorder (Verbatim: struggling with skin problems), eczema (Verbatim: had eczema), wound (Verbatim: flake into wounds), swollen lymph nodes (Verbatim: swollen lymph nodes in the back of his head and neck) and allergy (Verbatim: possible allergy). The outcome of the hives, facial swelling, erythema, irritability, low grade fever, skin disorder, eczema, wound, swollen lymph nodes and allergy were not resolved.   It was unknown if the reporter considered the hives, facial swelling, erythema, irritability, low grade fever, skin disorder, eczema, wound, swollen lymph nodes and allergy to be related to Infanrix, Infanrix Pre-Filled Syringe Device and Rotavirus vaccine.     It was unknown if the company considered the hives, facial swelling, erythema, irritability, low grade fever, skin disorder, eczema, wound, swollen lymph nodes and allergy to be related to Infanrix, Infanrix Pre-Filled Syringe Device and Rotavirus vaccine.   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: 14-SEP-2024 The reporter reported that the patient had received Infanrix hexa along with the Rotavirus vaccine. The reporter mentioned that shortly after vaccination, their son had facial swelling and redness became irritable and had low grade fever. They struggled with skin problems since then. His dermatologist thought he had ongoing urticaria, but it was not typical bumps. Eczema developed after the shot, and sometimes it will be flaked into wounds. He also had 4 swollen lymph nodes in the back of his head and neck. They believed there might have been an ongoing immune response or possible allergy, but no consult to allergist had been made by doctors. The reporter mentioned that it all started after these vaccines and had been ongoing 4 months.