chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect immunization type given to 12-month-old patient. The patient should have received Varicella and MMR as separate vaccines. No adverse side effects to incorrect vaccine.
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Rash, Rash erythematous, Rash pruritic
Clinical narrative: RED AND ITCHY RASH ON LEFT ARM AND LEFT SIDE OF TRUNK AND BACK. SEVERE PAIN IN LEFT ARM.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal X-ray, Angiogram cerebral normal, Arteriogram carotid normal, Ataxia, Back pain
Clinical narrative: 11/27/23 Severe back pain;(11/29/23 X-rays thoracic spine and abdomen);12/2/23 abnormal smile on one side of mouth, unsteady walking, numbness in feet and hands (CTA scan head and neck no stroke & blood vessels normal);12/3/23 eyelid drooping both sides, bilateral eyelids unable to fully close, flattening of L naso labial fold, ataxia, numbness in feet and hands, back pain, slurred speech, facial muscle weakness (MRI brain and neck age related small vessel changes, C3-C7 arthritis, bloodwork CBC high WBC count, CMP low sodium, slightly low chloride, SIADH);12/4/23 Lumbar Puncture (elevated protein, elevated glucose, no infection.  GBS diagnosis given. Bloodwork magnesium normal, thyroid slightly high,urine test normal, MRI thoracic spine normal) 12/3 -12/9/23 Hospitalization (IVIg's 12,4,12/5,12/6,12/7); 12/27/23 bloodwork multiple tests' 1/8/24 EMG testing (abnormal results consistent with GBS;1/10/24 MRI brain and spine thoracic; 1/11/24 to present IVIg's ongoing; 3/4/24 EMG testing (abnormal results).
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Blood chloride decreased, Blood magnesium normal, Blood sodium decreased, CSF glucose increased, CSF protein increased
Clinical narrative: 11/27/23 Severe back pain;(11/29/23 X-rays thoracic spine and abdomen);12/2/23 abnormal smile on one side of mouth, unsteady walking, numbness in feet and hands (CTA scan head and neck no stroke & blood vessels normal);12/3/23 eyelid drooping both sides, bilateral eyelids unable to fully close, flattening of L naso labial fold, ataxia, numbness in feet and hands, back pain, slurred speech, facial muscle weakness (MRI brain and neck age related small vessel changes, C3-C7 arthritis, bloodwork CBC high WBC count, CMP low sodium, slightly low chloride, SIADH);12/4/23 Lumbar Puncture (elevated protein, elevated glucose, no infection.  GBS diagnosis given. Bloodwork magnesium normal, thyroid slightly high,urine test normal, MRI thoracic spine normal) 12/3 -12/9/23 Hospitalization (IVIg's 12,4,12/5,12/6,12/7); 12/27/23 bloodwork multiple tests' 1/8/24 EMG testing (abnormal results consistent with GBS;1/10/24 MRI brain and spine thoracic; 1/11/24 to present IVIg's ongoing; 3/4/24 EMG testing (abnormal results).
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Cerebral small vessel ischaemic disease, Decreased nasolabial fold, Dysarthria, Dyskinesia, Electromyogram abnormal
Clinical narrative: 11/27/23 Severe back pain;(11/29/23 X-rays thoracic spine and abdomen);12/2/23 abnormal smile on one side of mouth, unsteady walking, numbness in feet and hands (CTA scan head and neck no stroke & blood vessels normal);12/3/23 eyelid drooping both sides, bilateral eyelids unable to fully close, flattening of L naso labial fold, ataxia, numbness in feet and hands, back pain, slurred speech, facial muscle weakness (MRI brain and neck age related small vessel changes, C3-C7 arthritis, bloodwork CBC high WBC count, CMP low sodium, slightly low chloride, SIADH);12/4/23 Lumbar Puncture (elevated protein, elevated glucose, no infection.  GBS diagnosis given. Bloodwork magnesium normal, thyroid slightly high,urine test normal, MRI thoracic spine normal) 12/3 -12/9/23 Hospitalization (IVIg's 12,4,12/5,12/6,12/7); 12/27/23 bloodwork multiple tests' 1/8/24 EMG testing (abnormal results consistent with GBS;1/10/24 MRI brain and spine thoracic; 1/11/24 to present IVIg's ongoing; 3/4/24 EMG testing (abnormal results).
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Eyelid function disorder, Eyelid ptosis, Facial paresis, Full blood count abnormal, Gait disturbance
Clinical narrative: 11/27/23 Severe back pain;(11/29/23 X-rays thoracic spine and abdomen);12/2/23 abnormal smile on one side of mouth, unsteady walking, numbness in feet and hands (CTA scan head and neck no stroke & blood vessels normal);12/3/23 eyelid drooping both sides, bilateral eyelids unable to fully close, flattening of L naso labial fold, ataxia, numbness in feet and hands, back pain, slurred speech, facial muscle weakness (MRI brain and neck age related small vessel changes, C3-C7 arthritis, bloodwork CBC high WBC count, CMP low sodium, slightly low chloride, SIADH);12/4/23 Lumbar Puncture (elevated protein, elevated glucose, no infection.  GBS diagnosis given. Bloodwork magnesium normal, thyroid slightly high,urine test normal, MRI thoracic spine normal) 12/3 -12/9/23 Hospitalization (IVIg's 12,4,12/5,12/6,12/7); 12/27/23 bloodwork multiple tests' 1/8/24 EMG testing (abnormal results consistent with GBS;1/10/24 MRI brain and spine thoracic; 1/11/24 to present IVIg's ongoing; 3/4/24 EMG testing (abnormal results).
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome, Hyperthyroidism, Hypoaesthesia, Immunoglobulin therapy, Inappropriate antidiuretic hormone secretion
Clinical narrative: 11/27/23 Severe back pain;(11/29/23 X-rays thoracic spine and abdomen);12/2/23 abnormal smile on one side of mouth, unsteady walking, numbness in feet and hands (CTA scan head and neck no stroke & blood vessels normal);12/3/23 eyelid drooping both sides, bilateral eyelids unable to fully close, flattening of L naso labial fold, ataxia, numbness in feet and hands, back pain, slurred speech, facial muscle weakness (MRI brain and neck age related small vessel changes, C3-C7 arthritis, bloodwork CBC high WBC count, CMP low sodium, slightly low chloride, SIADH);12/4/23 Lumbar Puncture (elevated protein, elevated glucose, no infection.  GBS diagnosis given. Bloodwork magnesium normal, thyroid slightly high,urine test normal, MRI thoracic spine normal) 12/3 -12/9/23 Hospitalization (IVIg's 12,4,12/5,12/6,12/7); 12/27/23 bloodwork multiple tests' 1/8/24 EMG testing (abnormal results consistent with GBS;1/10/24 MRI brain and spine thoracic; 1/11/24 to present IVIg's ongoing; 3/4/24 EMG testing (abnormal results).
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck abnormal, Magnetic resonance imaging spinal normal, Spinal X-ray, Spondylitis
Clinical narrative: 11/27/23 Severe back pain;(11/29/23 X-rays thoracic spine and abdomen);12/2/23 abnormal smile on one side of mouth, unsteady walking, numbness in feet and hands (CTA scan head and neck no stroke & blood vessels normal);12/3/23 eyelid drooping both sides, bilateral eyelids unable to fully close, flattening of L naso labial fold, ataxia, numbness in feet and hands, back pain, slurred speech, facial muscle weakness (MRI brain and neck age related small vessel changes, C3-C7 arthritis, bloodwork CBC high WBC count, CMP low sodium, slightly low chloride, SIADH);12/4/23 Lumbar Puncture (elevated protein, elevated glucose, no infection.  GBS diagnosis given. Bloodwork magnesium normal, thyroid slightly high,urine test normal, MRI thoracic spine normal) 12/3 -12/9/23 Hospitalization (IVIg's 12,4,12/5,12/6,12/7); 12/27/23 bloodwork multiple tests' 1/8/24 EMG testing (abnormal results consistent with GBS;1/10/24 MRI brain and spine thoracic; 1/11/24 to present IVIg's ongoing; 3/4/24 EMG testing (abnormal results).
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Urine analysis normal, White blood cell count increased
Clinical narrative: 11/27/23 Severe back pain;(11/29/23 X-rays thoracic spine and abdomen);12/2/23 abnormal smile on one side of mouth, unsteady walking, numbness in feet and hands (CTA scan head and neck no stroke & blood vessels normal);12/3/23 eyelid drooping both sides, bilateral eyelids unable to fully close, flattening of L naso labial fold, ataxia, numbness in feet and hands, back pain, slurred speech, facial muscle weakness (MRI brain and neck age related small vessel changes, C3-C7 arthritis, bloodwork CBC high WBC count, CMP low sodium, slightly low chloride, SIADH);12/4/23 Lumbar Puncture (elevated protein, elevated glucose, no infection.  GBS diagnosis given. Bloodwork magnesium normal, thyroid slightly high,urine test normal, MRI thoracic spine normal) 12/3 -12/9/23 Hospitalization (IVIg's 12,4,12/5,12/6,12/7); 12/27/23 bloodwork multiple tests' 1/8/24 EMG testing (abnormal results consistent with GBS;1/10/24 MRI brain and spine thoracic; 1/11/24 to present IVIg's ongoing; 3/4/24 EMG testing (abnormal results).
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Erythema, Peripheral swelling
Clinical narrative: Patient called the pharmacy and reported that after receiving 1st dose of Shingrix and Spikevax on the same day, her blood pressure spiked by about 30 points over normal. She also reported a red swollen arm. The elevated BP cannot be explained by the swollen arm because the patient reported similar BP readings in both arms and her R arm was not swollen.
Age: 5.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is 5 years old was giving twinrix per guidelines it is only 18 YO and older
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Dizziness and associated headache and nausea
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site rash, Pyrexia, Sleep disorder
Clinical narrative: Fever and disrupted sleep first 24 hours following vaccination, extreme tenderness first 4 days following vaccination, rash present at injection site from vaccination to present (at time submitting this form)
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Myalgia, Pyrexia
Clinical narrative: 32 weeks pregnant . Delivery day Oct 3,2024. Mild fever, muscle pain Aug 10
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Ear discomfort, Erythema, Hot flush
Clinical narrative: Symptoms began 1 week after each dose and continue to this day. Each episode involves Tingly scalp, severe abdominal pain, nausea, feeling sick to stomach, red ears, burning ears, ears hot to the touch, full body itching, hot flash
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Paraesthesia, Pruritus, Skin warm
Clinical narrative: Symptoms began 1 week after each dose and continue to this day. Each episode involves Tingly scalp, severe abdominal pain, nausea, feeling sick to stomach, red ears, burning ears, ears hot to the touch, full body itching, hot flash
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, C-reactive protein normal, Cardioversion, Chest X-ray, Chest pain
Clinical narrative: during week of receiving vaccine developed shortness of breath.  Saw cardiologist on 6/25 who diagnosed persistent afib ( had been well controlled prior, though diagnosed many years ago).  Dr. increased atenolol, then increased again a week later.  had cardio version on 7/12.  Sinus rhythym lasted about 2 hours then back to afib.  lasix added.  On 7/16 developed chest pain-- > ER.  Cat scan showed POSSIBLE pneumonia and pericardial effusion.  Admitted and put on antibiotics, colchicine, and diltiazem added.  Cardiac echo done 7/18 showed afib and pericardial effusion.  no tampenade.  Left hospital on oral diltiazem, lasix, colchicine atenolol and zithromax.  Still in chronic afib.  Follow up echo on 8/6 unchanged.  awaiting follow up with cardiologist.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Condition aggravated, Dyspnoea, Echocardiogram abnormal, Ejection fraction normal
Clinical narrative: during week of receiving vaccine developed shortness of breath.  Saw cardiologist on 6/25 who diagnosed persistent afib ( had been well controlled prior, though diagnosed many years ago).  Dr. increased atenolol, then increased again a week later.  had cardio version on 7/12.  Sinus rhythym lasted about 2 hours then back to afib.  lasix added.  On 7/16 developed chest pain-- > ER.  Cat scan showed POSSIBLE pneumonia and pericardial effusion.  Admitted and put on antibiotics, colchicine, and diltiazem added.  Cardiac echo done 7/18 showed afib and pericardial effusion.  no tampenade.  Left hospital on oral diltiazem, lasix, colchicine atenolol and zithromax.  Still in chronic afib.  Follow up echo on 8/6 unchanged.  awaiting follow up with cardiologist.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Pericardial effusion, Therapy change, Troponin
Clinical narrative: during week of receiving vaccine developed shortness of breath.  Saw cardiologist on 6/25 who diagnosed persistent afib ( had been well controlled prior, though diagnosed many years ago).  Dr. increased atenolol, then increased again a week later.  had cardio version on 7/12.  Sinus rhythym lasted about 2 hours then back to afib.  lasix added.  On 7/16 developed chest pain-- > ER.  Cat scan showed POSSIBLE pneumonia and pericardial effusion.  Admitted and put on antibiotics, colchicine, and diltiazem added.  Cardiac echo done 7/18 showed afib and pericardial effusion.  no tampenade.  Left hospital on oral diltiazem, lasix, colchicine atenolol and zithromax.  Still in chronic afib.  Follow up echo on 8/6 unchanged.  awaiting follow up with cardiologist.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swollen tongue, Urticaria
Clinical narrative: PT HAS TO GO TO ER DUE TO HIVES AND SWELLING OF TONGUE
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Lip oedema, Oral discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: PT HAS TO GO TO ER DUE TO HIVES AND SWELLING OF TONGUE
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pharyngeal oedema, Tongue oedema, Urticaria
Clinical narrative: PT HAS TO GO TO ER DUE TO HIVES AND SWELLING OF TONGUE
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Headache
Clinical narrative: At time of vaccincation: 34 weeks 6 days, second pregnancy, hx of pre-eclampsia with first pregnancy, delivered via C-section. Scheduled C-section for 9/9. ADE: headache
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Patient called 8/11 2:20pm to report that around 11pm last night on 8/10/2024. Patient reports she started having chills, body aches all over and joint aches. Around the early hours of the morning she was also running a fever that did not subside until 8/11/2024 around 7am. She is still experiencing joint aches and headache at 2pm 8/11/2024
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Gastrointestinal disorder, Vomiting
Clinical narrative: GI (Vomiting, Stomach pain)
Age: 58.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, burning at the injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, DTAPIPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse events occurred. Patient was double vaccinated
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site swelling, Injection site warmth
Clinical narrative: 8.10.24 patient complaining of redness, swelling, warmth in the area of the Shingrix dose #1.  started day after vaccine (08/09/24) and is larger. RPH on duty counseled patient to take antihistamine, cool compresses, hydrocortisone 1% topical and seek MD if worsens. 08/11/24: daughter reported patient went to ER on 08/10/24 due to increased swelling, redness and warmth on the vaccination site (no itchiness or irritation) despite use of ibuprofen and hydrocortisone cream. RPh advised patient on 08/10/24 to mark the affected area with a marker and monitor - it was getting bigger so patient went to ER. ER staff determined the reaction was not an allergic reaction to the vaccine, but an infection instead and gave her doxycycline hyclate 100mg antibiotic treatment, asked patient if ER checked her lymph nodes and that was a negative. spoke with patient today and she stated that she is feeling well, and the injection site reaction is not getting worse/bigger after she initiated the antibiotic treatment - counseled patient on the possibility of getting her 2nd dose and needing a clearance from her doctor. ***another patient (related to the affected patient) received the same vaccine from the same lot prepared & given at the same time and HE HAD NO REACTIONS aside from soreness the next day***
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Allergy test negative, Anaphylactic reaction, Ear swelling, Rash, Swelling face
Clinical narrative: Anaphylactic reaction, hives, rash.  Emergency room visit, received epinephrine and intramuscular Benadryl.  Onset of symptoms was July 6.  Swelling of face and ears, hives head to ankles.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Anaphylactic reaction, hives, rash.  Emergency room visit, received epinephrine and intramuscular Benadryl.  Onset of symptoms was July 6.  Swelling of face and ears, hives head to ankles.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Hemiparesis, Magnetic resonance imaging
Clinical narrative: Began having weakness on my left side and it got progressively worse until I ended up in the ER with stroke affecting my right side.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra dose of the Moderna Vaccine. He was last vaccinated on 11/26, 2023.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site induration, Irritability, Pain
Clinical narrative: Localized reaction with induration without redness at vaccines site, fussiness and mild pain
Age: 0.33
Sex: F
Vaccine: PNC15, PNC15
Symptoms: No adverse event, Poor quality device used, Syringe issue, Underdose
Clinical narrative: Administered Vaxneuvance, noted fluid squirting from side of hub upon administration.  No adverse reaction to patient during and after administration.
Age: 0.33
Sex: F
Vaccine: PNC15, PNC15
Symptoms: No adverse event, Syringe issue
Clinical narrative: Administered Vaxneuvance, noted fluid squirting from side of hub upon administration.  No adverse reaction to patient during and after administration.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; TE for MMR II; This spontaneous report was received from a medical assistant referring to a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 01-MAY-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection administered for prophylaxis (Batch/lot# W03504, is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported as 24-MAY-2024; strength, dose, and route of administration were not provided) and the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection administered for prophylaxis (lot #X010531, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 11-APR-2025; strength, dose, and route of administration were not provided); with sterile diluent (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were not reported); on that day, she was also vaccinated with the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) administered for prophylaxis (Batch/lot# 5AYZJ, expiration date reported as 10-JUN-2024; strength, formulation, dose, and route of administration were not provided).   It was reported that the vaccines measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) underwent 16 different current temperature excursions (TE) beginning from (22-APR-2024) through approximately 14-JUN-2024. No prior TE occurred. The details of each excursion were unknown at the time. The patient did not report any adverse issues or side effects from the administration. There was no additional adverse event (AE) or product quality complaint (PQC).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE for MMR II; This spontaneous report was received from a medical assistant referring to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-MAY-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection administered for prophylaxis (Batch/lot# W035041, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 24-MAY-2024; strength, dose, and route of administration were not provided) and the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection administered for prophylaxis (lot #X010531, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 11-APR-2025; strength, dose, and route of administration were not provided); with sterile diluent (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were not reported) (reported as concomitant therapy); on that day, she was also vaccinated with the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) administered for prophylaxis (Batch/lot# 5AY2J, expiration date reported as 10-JUN-2024; strength, formulation, dose, and route of administration were not provided).   It was reported that the vaccines measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) underwent 16 different current temperature excursions (TE) beginning from (22-APR-2024) through approximately 14-JUN-2024 (product storage error). No prior TE occurred. The details of each excursion were unknown at the time. The patient did not report any adverse issues or side effects from the administration. There was no additional adverse event (AE) or product quality complaint (PQC).
Age: 1.0
Sex: M
Vaccine: MMR, PNC20, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE for MMR II; This spontaneous report was received from a medical assistant referring to a 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 11-APR-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection administered via right thigh for prophylaxis (Batch/lot# W028734, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 08-SEP-2024; strength, dose, and route of administration were not provided) and the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection administered via right thigh for prophylaxis (lot # X018954, has been verified to be a valid lot number, expiration date reported and upon internal validation both confirmed as 13-JUL-2025; strength, dose, and route of administration were not provided); with sterile diluent (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were not reported) (reported as concomitant therapy); on that day, he was also vaccinated with the third dose of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20) administered via left thigh for prophylaxis (Batch/lot# HL3889, expiration date reported as 31-MAY-2025; strength, formulation, dose, and route of administration were not provided).   It was reported that the vaccines measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) underwent 16 different current temperature excursions (TE) beginning from (22-APR-2024) through approximately 14-JUN-2024 (product storage error). No prior TE occurred. The details of each excursion were unknown at the time. The patient did not report any adverse issues or side effects from the administration. There was no additional adverse event (AE) or product quality complaint (PQC).; Sender's Comments:  US-009507513-2406USA005882:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events; improper storage of product in use; This spontaneous report has been received from a medical assistant and refers to a 6-month-old patient of unknown gender. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 30-APR-2024, a temperature excursion occurred for 3 days and 23 hours at 74.4 Fahrenheit (F) (minimum temperature 39.02 F and maximum temperature 74.84 F); and on 22-MAY-2024, the patient was vaccinated with one improper stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid as prophylaxis (dose and route of administration were not reported; lot number X015245 has been verified to be valid, expiration date 22-NOV-2024) (product storage error). No previous temperature excursion was reported; and data logger was involved. Additionally, no symptomatic adverse events were reported (no adverse event).
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Device connection issue, No adverse event, Syringe issue, Underdose
Clinical narrative: No injures reported; While the medical assisitant was administering squirted out during time of patient administration; While the medical assisitant was administering squirted out during time of patient administration; This spontaneous report was received from a registered nurse and refers to a 12-year-old male patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On 30-JUL-2024, while the medical assistant was going to be injected needle to administer dose 2 of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9),  lot # X024560,  expiration date 31-MAY-2026, for prophylaxis to the patient (quantity dose and route were not reported), squirted all out of the side of the Luer lock attachment (poor quality device used and needle issue). No crack or broken parts were noticed or seen. Also, medical assistant reported the syringe looked fine, no cracks or breakage was not leaking prior to attempted administration. The patient did not miss any doses. No injuries reported (no adverse event). No additional adverse event or product quality complain were reported. On 05-AUG-2024, the product was returned to the company.
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; patient was administered third dose of GARDASIL 9 ten weeks and one day after second dose of GARDASIL 9.; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 13-NOV-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided). On 15-MAY-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #W010661, expiration date: 19-OCT-2024, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided). On 25-JUL-2024, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1965079, expiration date: 01-FEB-2026, administered for prophylaxis (strength, dose, anatomical site of administration and route of administration were not provided) (9 ten weeks and one day after second dose) (inappropriate schedule of product administration). Nurse stated patient had not reported any adverse events (AE). No further information provided. No additional AE reported (no AE).
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Child received first dose of PROQUAD at 5 years of ager on 05Jul2024. This same child received a second dose of PROQUAD on 02Aug2024.; This spontaneous report was received from a registered nurse and refers to a child patient (exact age and gender not provided).  The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On 05-JUL-2024, at the age of 5 years old,  the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), then, on 02-UG-2024, the patient received the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered). No additional adverse event was reported.  Lot# will be provided uon request.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE; third dose unitl 8/5/2024; second dose 7/7/2023; This spontaneous report was received from a pharmacist and referring 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 21-JUN-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, route, lot#, and expiration date were not reported). On 07-JUL-2023, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration). Patient did not come back for a third dose until 05-AUG-2024 (Inappropriate schedule of product administration). The reporter was requesting information on interrupted series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No additional adverse event (AE) was reported (No adverse event).
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Engerix B last September and did not receive the follow up doses; This non-serious case was reported by a pharmacist via patient support programs and described the occurrence of incomplete course of vaccination in a 32-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 25 September 2023 expiry date 4th April 2025, lot number 79S54).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Engerix B last September and did not receive the follow up doses). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2024 Patient was given the Engerix B last September and did not receive the follow up doses. Till the time of reporting, the patient did not receive 2nd dose of Engerix B, which led to incomplete course of vaccination.
Age: 44.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 44 yea old patient received a dose of Shingrix,; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 44-year-old 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 inappropriate age at vaccine administration (Verbatim: 44 yea old patient received a dose of Shingrix,). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 30-JUL-2024 Healthcare professional, left an email where they stated that a 44 year old patient received a dose of Shingrix, which led inappropriate age at vaccine administration.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric version of the vaccine instead of adult dose; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 54-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   On 30-JUL-2024, the patient received Engerix B pediatric. On 30-JUL-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric version of the vaccine instead of adult dose) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK Receipt Date: 30-JUL-2024 The adult patient got single dose of Engerix-B pediatric version of the vaccine instead of adult dose, which led adult use of a child product and underdose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Incomplete course of vaccination, Paraesthesia
Clinical narrative: Pimples; left arm was tingling; has not received the second dose of Shingrix yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of pimples in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery (Rotator Cuff Surgery) and shingles (outbreak of shingles ). Previously administered products included Acyclovir.   On an unknown date, the patient received the 1st dose of Shingrix (right arm) and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pimples (Verbatim: Pimples), tingling of extremity (Verbatim: left arm was tingling) and incomplete course of vaccination (Verbatim: has not received the second dose of Shingrix yet). The outcome of the pimples was not resolved and the outcome of the tingling of extremity was resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pimples and tingling of extremity to be related to Shingrix.     It was unknown if the company considered the pimples and tingling of extremity to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2024 The reporter was a 69 year old, male patient that states that he received the first dose of Shingrix in either January or February 2024 (no specific date provided). If the first dose of Shingrix was in January 2024, because he has not received the second dose of Shingrix yet, he would be past the 6 month dosing schedule. The patient also reported that in the last few days (no specific date provided), his left arm was tingling, and a few little pimples have shown up on his left arm (AE Filed). The patient reported that the tingling had gone away, and the pimples have not progressed. The patient reported that he did have a possible outbreak of shingles on his left shoulder, 4 to 5 months before receiving the first dose of Shingrix (pre existing Shingrix), and was given Acyclovir 200MG, 1 pill five times a day for seven days as treatment. The patient also reported having had rotator cuff surgery on his left arm in 2018 (pre existing Shingrix). Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose of Shingrix vaccine 3 years after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 9RC7A, expiry date 21-NOV-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ag0).   On 01-APR-2024, the patient received the 2nd dose of Shingrix. On 01-APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received second dose of Shingrix vaccine 3 years after the first dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 01-AUG-2024 Pharmacist reported that 63 year old female patient received second dose of Shingrix vaccine 3 years after the first dose. Pharmacist unsure of exact date of first dose, but the second dose was given on 01 April 2024  The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. This case is linked with US2024096363, same reporter.; Sender's Comments:  US-GSK-US2024096363:Same reporter/Different patient
Age: 29.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the second Twinrix dose 6 months apart from the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 29-year-old male patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose 6 months apart).   On 27-JUL-2024, the patient received the 2nd dose of Twinrix. On 27-JUL-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the second Twinrix dose 6 months apart from the first dose). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2024 Pharmacist reported that a patient received the second Twinrix dose 6 months apart from the first dose. The Healthcare professional asked for recommendations on this issue. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: RAB
Symptoms: Hypersensitivity, Injection site pain, Paraesthesia
Clinical narrative: tingling; allergic reaction; soreness in the arms where the doses were injected; Initial information received on 02-Aug-2024 regarding an unsolicited valid non-serious case received from a patient.  This case involves an unknown age female patient who had tingling, allergic reaction and soreness in the arms where the doses were injected after receiving rabies (HDC) vaccine [Imovax Rabies].  The patient's past medical history included Animal bite. The patient's past medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 24-Jul-2024, the patient received an unknown dose of suspect RABIES (HDC) vaccine, Powder and solvent for suspension for injection (strength: unknown) (lot: W1D211M, expiry date: 30-Nov-2025) via unknown route in unknown administration site as Immunization.   On 27-Jul-2024 she also received an unknown dose of same vaccine with (strength, batch number, expiry date: unknown) via unknown route in unknown administration site as Immunization.  On an unknown date the patient had tingling (paraesthesia), allergic reaction (hypersensitivity) and soreness in the arms where the doses were injected (vaccination site pain) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Reportedly, She received Imovax Rabies 3 years ago and did not have a reaction. She is concerned about why she is having a reaction this time and did not have one last time. She is concerned that this might mean something is wrong with the vaccine  It was unknown if any lab data/test results were available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: Recovering / Resolving for the event.
Age: 15.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patients received his MenQuadfi vaccine today as 2nd dose however he was two months early with no reported adverse event; Initial information received on 02-Aug-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 15-year-old male patient received his meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] vaccine today as 2nd dose however he was two months early with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 24-Aug-2020 the patient received a 0.5 ml total dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength, batch number, expiry date: unknown) via intramuscular route in unknown administration site as Prophylactic Vaccination (immunization).   On 02-Aug-2024, the patient received a 0.5 ml total dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection (strength, batch number, expiry date: unknown) lot U8124AA via intramuscular route in unknown administration site as Prophylactic Vaccination (immunization) and patient received his menquadfi vaccine today as 2nd dose however he was two months early with no reported adverse event (inappropriate schedule of product administration) (latency: 3 years 11 months 9 days).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Module of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: COVID-19, Crying, Diarrhoea, Faeces discoloured, Infant irritability
Clinical narrative: Infant developed fevers, fussiness, inconsolability hours after immunizations. He continued to have 4 days of fevers as high as 102's. He wasn't sleeping and cried for hours, lasted 5-6 days. He had multiple episodes of bright green diarrhea. He then developed a full-body rash.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Pyrexia, Rash, SARS-CoV-2 test positive
Clinical narrative: Infant developed fevers, fussiness, inconsolability hours after immunizations. He continued to have 4 days of fevers as high as 102's. He wasn't sleeping and cried for hours, lasted 5-6 days. He had multiple episodes of bright green diarrhea. He then developed a full-body rash.
Sex: F
Vaccine: MENB
Symptoms: Encephalitis
Clinical narrative: encephalitis; This serious case was reported by a consumer via interactive digital media and described the occurrence of encephalitis in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced encephalitis (Verbatim: encephalitis) (serious criteria GSK medically significant). The outcome of the encephalitis was not resolved.   The reporter considered the encephalitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the encephalitis to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 04-AUG-2024 The case was received from the patient via (social media) interactive digital media. The reporter reported that the patient developed encephalitis from the vaccine.; Sender's Comments: Encephalitis is an unlisted event which is considered unrelated to GSK vaccine Bexsero and Bexsero Pre-Filled Syringe Device.
Age: 67.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering an expired dose of tenivac to patients with no reported adverse event; Initial information received on 08-Aug-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  The case is linked to 2024SA237643,2024SA237418,2024SA237702 and 2024SA237436.  This case involves a 67 years old male patient who was administering an expired dose of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 22-Nov-2023, the patient received a  dose of 0.5 ml of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) (lot U7183AA, Expiry date 24-sep-2023:, strength was unknown) via intramuscular route in the left deltoid for Immunization and administering an expired dose of tenivac to patients with no reported adverse event (expired product administered) (latency: same day).  Reportedly "This situation is pre-assessed as a medication error/an inappropriate use due to administering an expired dose of TENIVAC to patients. Nurse said that uses the expiration date is month-day-year and not date-month-year, so unfortunately, their clinic thought the vaccines will expire in September 2024. Eight patients received the expired vaccine and nurse was able to provide further information."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2024SA237643: US-SA-2024SA237418:02169825 US-SA-2024SA237702:02173254 US-SA-2024SA237436:02173262
Age: 16.0
Sex: M
Vaccine: HPV9, IPV, MNQ
Symptoms: Depressed level of consciousness, Fall, Tremor
Clinical narrative: In the process of giving vaccine (HPV) the patient start to fall over and shake, like he was going to pass out. He recovered quickly. Did not totally lose consciousness. Recovery time frame 5-10 minutes. Assessed vitals gave water, crackers, cold towel. Vitals WNL. Monitored 15 more minutes.