chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Poor quality sleep, Seizure
Clinical narrative: I get very sick 8 hours every time I get a COVID shot.  I feel like I have the flu.  This time, I got the shot in the afternoon so I would get sick while asleep.  I slept poorly and had seizures at 7AM & 8AM for the first time in 11 years.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dysphonia, Nasal congestion, Secretion discharge
Clinical narrative: Persistent stuffy nose and mucous and change of voice for 6 weeks.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: 3 cm erythematous whelt
Age: 88.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Arm was red, swollen, warm to the touch, and itchy patient stated starting 2 or 3 days after the vaccine. We contacted her primary about the reaction. It did not happen at the site of injection (deltoid) but much lower (almost at the elbow and off to the side). Possible it was not from the vaccine based on the potential reaction site.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Imovax was administered by the LVN and documented site of administration as LUOQ. The recommended site of administration for Imovax is at the deltoid only. The patient did not report any adverse effects but complained that it was administered at the wrong site which decreases the effectiveness of the treatment. The patient did receive the remaining 3 doses on her deltoid on 12/6/23, 12/10/23 and 12/17/23. No adverse side effects were reported.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Fatigue, Malaise, Somnolence
Clinical narrative: PATIENT SATTES THAT SHE FELT VERY TIRED AND SLEPT FOR THE MAJORITYOF THE DAY FOR 3 DAYS AFTER RECEIVING THE VACCINATION. IT ALSO MADE HER FEEL VERY UNWELL AND LED TO EXACERBATION OF HER COPD
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Erythema, Induration, Musculoskeletal stiffness, Nodule
Clinical narrative: My arm was sore, hot, and red several days after the vaccination. It seemed to be getting better after about 8-10 days. Then around day 12 it became like a hard knot under my skin. My skin again appeared red. On day 15 I woke up and my left shoulder felt sore and stiff. There is increased redness and the knot under my skin has gotten larger.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Skin warm
Clinical narrative: My arm was sore, hot, and red several days after the vaccination. It seemed to be getting better after about 8-10 days. Then around day 12 it became like a hard knot under my skin. My skin again appeared red. On day 15 I woke up and my left shoulder felt sore and stiff. There is increased redness and the knot under my skin has gotten larger.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: erythema, edema on  left upper arm that began about 24 hours after vaccination. No change with Benadryl. Increasing in size at time of report 1/25/24 at 8pm
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site reaction, Joint range of motion decreased, Myalgia
Clinical narrative: Significant myalgia over right deltoid with some reduction in range in motion of upper right arm.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Nurse called to report temperature excursion for the following vaccines:  VAQTA, PEDVAXHIB, ROTATEQ, and GARDASIL 9.  Upon reviewing excursion questions, Nurse stated unsure if vaccines had been administered as the vaccines had several prior excursio; This spontaneous report as received from a nurse refers to a 2-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 28-DEC-2023, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # 1947634, expiration date: 05-MAY-2024, oral (exact dose and anatomical location were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X008998, expiration date: 14-NOV-2025, intramuscular in the left thigh (exact dose was not provided); diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (GSK), lot # reported as: 39KS9, expiration date reported as: 07-SEP-2028, intramuscular in the left thigh (formulation and exact dose were not provided); pneumococcal vaccine conj 7v (crm197)(PREVNAR)(Pfizer), lot # reported as GW7964, expiration date reported as: 31-DEC-2024, intramuscular in the right thigh (formulation and exact dose were not provided) for prophylaxis.   It was reported that the vaccines storage unit temperature excursion was identified after vaccines administered on 28-DEC-2023. Administered doses of vaccines were exposed to the current temperature excursion on 04-JAN-2024 of 1.9 (units not provided) for 34 minutes. The previous temperature excursion had occurred and was reported as follow: on 20-DEC-2023 of 1.6 (units not provided); on 21-DEC-2023 of 1.1 C for 3 hours and 41 minutes; on 22-DEC-2023 of 1.0 (units not provided) for 5 hours and 24 minutes; on 23-DEC-2023 of 1.4 (units not provided) for 4 hours and 25 minutes; on 24-DEC-2023 of 1.4 C for 4 hours and 47 minutes; on 25-DEC-2023 of 1.0 (units not provided) for 5 hours and 36 minutes; on 27-DEC-2023 of 0.3 (units not provided) for 4 hours and 37 minutes; on 28-DEC-2023 of 2.4 (units not provided) for 4 hours and 8 minutes; on 29-DEC-2023 of 1.7 (units not provided) for 1 hour and 44 minutes; on 30-DEC-2023 of 1.8 (units not provided) for 3 hours and 21 minutes; on 31-DEC-2023 of 1.8 (units not provided) for 3 hours and 19 minutes; on 01-JAN-2024 of 1.8 (units not provided) for 3 hours and 11 minutes; on 02-JAN-2024 of 1.6 (units not provided) for 3 hours and 3 minutes and on 03-JAN-2024 of 1.5 (units not provided) for 2 hours and 57 minutes (product storage error). No additional adverse event reported (no adverse event).
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse called to report temperature excursion for the following vaccines:  VAQTA, PEDVAXHIB, ROTATEQ, and GARDASIL 9.  Upon reviewing excursion questions, Nurse stated unsure if vaccines had been administered as the vaccines had several prior excursio; This spontaneous report as received from a nurse refers to a 2-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 28-DEC-2023, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # 1947634, expiration date: 05-MAY-2024, oral (exact dose and anatomical location were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X008998, expiration date: 14-NOV-2025, intramuscular in the left thigh (exact dose was not provided); diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (GSK), lot # reported as: 39KS9, expiration date reported as: 07-SEP-2028, intramuscular in the left thigh (formulation and exact dose were not provided); pneumococcal vaccine conj 7v (crm197)(PREVNAR)(Pfizer), lot # reported as GW7964, expiration date reported as: 31-DEC-2024, intramuscular in the right thigh (formulation and exact dose were not provided) for prophylaxis.   It was reported that the vaccines storage unit temperature excursion was identified after vaccines administered on 28-DEC-2023. Administered doses of vaccines were exposed to the current temperature excursion on 04-JAN-2024 of 1.9 (units not provided) for 34 minutes. The previous temperature excursion had occurred and was reported as follow: on 20-DEC-2023 of 1.6 (units not provided); on 21-DEC-2023 of 1.1 C for 3 hours and 41 minutes; on 22-DEC-2023 of 1.0 (units not provided) for 5 hours and 24 minutes; on 23-DEC-2023 of 1.4 (units not provided) for 4 hours and 25 minutes; on 24-DEC-2023 of 1.4 C for 4 hours and 47 minutes; on 25-DEC-2023 of 1.0 (units not provided) for 5 hours and 36 minutes; on 27-DEC-2023 of 0.3 (units not provided) for 4 hours and 37 minutes; on 28-DEC-2023 of 2.4 (units not provided) for 4 hours and 8 minutes; on 29-DEC-2023 of 1.7 (units not provided) for 1 hour and 44 minutes; on 30-DEC-2023 of 1.8 (units not provided) for 3 hours and 21 minutes; on 31-DEC-2023 of 1.8 (units not provided) for 3 hours and 19 minutes; on 01-JAN-2024 of 1.8 (units not provided) for 3 hours and 11 minutes; on 02-JAN-2024 of 1.6 (units not provided) for 3 hours and 3 minutes and on 03-JAN-2024 of 1.5 (units not provided) for 2 hours and 57 minutes (product storage error). No additional adverse event reported (no adverse event).
Age: 69.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Anxiety, Fatigue, Heart rate irregular, Palpitations
Clinical narrative: At approximately 9:30 pm, patient began to experience palpitations. He used his home Kardia device, which noted that his heart rate was in 150s to 160s. He subsequently presented to the Emergency Room at Clinic where he was found to be in aflutter. with rapid ventricular rate. He was started on a diltiazem drip and admitted to the Cardiology service. He converted to sinus rhythm and was discharged on his home medications.
Age: 69.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Atrial flutter, Atrioventricular block, Blood potassium normal, Cardioversion, Condition aggravated
Clinical narrative: At approximately 9:30 pm, patient began to experience palpitations. He used his home Kardia device, which noted that his heart rate was in 150s to 160s. He subsequently presented to the Emergency Room at Clinic where he was found to be in aflutter. with rapid ventricular rate. He was started on a diltiazem drip and admitted to the Cardiology service. He converted to sinus rhythm and was discharged on his home medications.
Age: 69.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Electrocardiogram abnormal, Heart rate increased, Laboratory test normal, Palpitations, Sinus rhythm
Clinical narrative: At approximately 9:30 pm, patient began to experience palpitations. He used his home Kardia device, which noted that his heart rate was in 150s to 160s. He subsequently presented to the Emergency Room at Clinic where he was found to be in aflutter. with rapid ventricular rate. He was started on a diltiazem drip and admitted to the Cardiology service. He converted to sinus rhythm and was discharged on his home medications.
Age: 69.0
Sex: M
Vaccine: RSV, RSV
Symptoms: White blood cell count increased
Clinical narrative: At approximately 9:30 pm, patient began to experience palpitations. He used his home Kardia device, which noted that his heart rate was in 150s to 160s. He subsequently presented to the Emergency Room at Clinic where he was found to be in aflutter. with rapid ventricular rate. He was started on a diltiazem drip and admitted to the Cardiology service. He converted to sinus rhythm and was discharged on his home medications.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Tinnitus
Clinical narrative: I woke the next morning with a loud ringing in my ears which hasn't gone away since.; Date of start of drug:29Nov2023/Batch/lot number: FF2590; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2023 at 16:00 as dose 1, single (Lot number: FF2590) at the age of 48 years for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), on 29Nov2023 as dose 1, single (Lot number: U8203CA) for immunisation. The patient didn't receive BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 29Nov2023 at 16:00, outcome "unknown", described as "Date of start of drug:29Nov2023/Batch/lot number: FF2590"; TINNITUS (non-serious) with onset 30Nov2023 at 06:00, outcome "not recovered", described as "I woke the next morning with a loud ringing in my ears which hasn't gone away since.". The event "i woke the next morning with a loud ringing in my ears which hasn't gone away since." required physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Fluzone quad 2023-2024 administered on 29Nov2023. No other vaccine in four weeks. No other medication in two weeks. Patient woke the next morning with a loud ringing in her ears which hasn't gone away since. Ae resulted in: Doctor or other healthcare professional office/clinic visit, disability or permanent damage. AE treatment: she had wax removed from her ears to see if it helped. No prior vaccination and not tested post vaccination. No known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Tinnitus, Wrong product administered
Clinical narrative: I woke the next morning with a loud ringing in my ears which hasn't gone away since.; Date of start of drug:29Nov2023/Batch/lot number: FF2590; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2023 at 16:00 as dose 1, single (Lot number: FF2590) at the age of 48 years for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), on 29Nov2023 as dose 1, single (Lot number: U8203CA) for immunisation. The patient didn't receive BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)). The patient had no relevant medical history. There were no concomitant medications. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 29Nov2023 at 16:00, outcome "unknown", described as "Date of start of drug:29Nov2023/Batch/lot number: FF2590"; TINNITUS (non-serious) with onset 30Nov2023 at 06:00, outcome "not recovered", described as "I woke the next morning with a loud ringing in my ears which hasn't gone away since.". The event "i woke the next morning with a loud ringing in my ears which hasn't gone away since." required physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Fluzone quad 2023-2024 administered on 29Nov2023. No other vaccine in four weeks. No other medication in two weeks. Patient woke the next morning with a loud ringing in her ears which hasn't gone away since. Ae resulted in: Doctor or other healthcare professional office/clinic visit, disability or permanent damage. AE treatment: she had wax removed from her ears to see if it helped. No prior vaccination and not tested post vaccination. No known allergies.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Demyelination, Dyskinesia, Hypoaesthesia, Magnetic resonance imaging spinal abnormal
Clinical narrative: patient started to experience tooth pain on 11/30/23. pain increased progressively. Hospitalized on 12/6/23 and diagnosed with trigeminal neuralgia, was given IV steroid, carbamazepine, then switched to oxcarbazepine. . MRI done on 12/28/23, lesion on cervical spine. Hospitalized again on 12/21/23 and 1/17/23. MRI redone on 1/17/23. Patient being followed by Neurologist. patient is currently on gabapentin and neuro will trial duloxetine
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Neuralgia, Pain in extremity, Trigeminal neuralgia
Clinical narrative: patient started to experience tooth pain on 11/30/23. pain increased progressively. Hospitalized on 12/6/23 and diagnosed with trigeminal neuralgia, was given IV steroid, carbamazepine, then switched to oxcarbazepine. . MRI done on 12/28/23, lesion on cervical spine. Hospitalized again on 12/21/23 and 1/17/23. MRI redone on 1/17/23. Patient being followed by Neurologist. patient is currently on gabapentin and neuro will trial duloxetine
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Spinal disorder, Toothache, Trigeminal neuralgia
Clinical narrative: patient started to experience tooth pain on 11/30/23. pain increased progressively. Hospitalized on 12/6/23 and diagnosed with trigeminal neuralgia, was given IV steroid, carbamazepine, then switched to oxcarbazepine. . MRI done on 12/28/23, lesion on cervical spine. Hospitalized again on 12/21/23 and 1/17/23. MRI redone on 1/17/23. Patient being followed by Neurologist. patient is currently on gabapentin and neuro will trial duloxetine
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumococcal bacteraemia, Streptococcus test positive
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from regulatory authority and refers to a female patient (age group 05-09 years old). The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (lot #, expiration date, strength, route of administration, anatomical location not provided) and with the first, second and third dose of pneumococcal vaccine conj 7v (crm197)(PREVENAR) (strength, route of administration, anatomical location not provided) as prophylaxis.   On an unspecified date in 2011, the patient experienced bacteraemia with a Streptococcus pneumoniae serotyping reported as not available (Pneumococcal bacteraemia). At the reporting time, the outcome of the event was unknown.    Causality assessment between Pneumococcal bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of Pneumococcal bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from regulatory authority and refers to a female patient (age group 50-54 years old). The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (lot #, expiration date, strength, route of administration, anatomical location not provided) as prophylaxis.   On an unspecified date in 2011, the patient experienced pneumonia with a Streptococcus pneumoniae serotyping reported as not available (Pneumonia pneumococcal). At the reporting time, the outcome of the event was unknown.    Causality assessment between Pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of Pneumonia pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PNC15, PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS), concerning a child male patient of unknown exact age (age group reported as "02-04 years"). No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown), or with pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) pre-filled syringe (dose, route of administration, anatomical location, lot number, expiration date, and indication were not reported). Additionally, on unknown dates, the patient was vaccinated with 2 doses of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (dose, route of administration, anatomical location, lot number, expiration date, and indication were not reported).  On an unknown date in 2022, the patient experienced pneumococcal infection, and Streptococcus pneumoniae serotyping was not available. The outcome of this adverse event was not reported.  The relatedness between pneumococcal infection and the suspect vaccines was not provided.   Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from Regulatory Authority, concerning an adult female patient of unknown exact age (age group reported as "45-49 years"). No information regarding the patient's medical history, concurrent conditions, and concomitant medications was provided.  On unknown dates, the patient was vaccinated with two doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (doses, routes of administration, anatomical locations, lot numbers, and expiration dates were not reported), administered for prophylaxis.    On an unknown date in 2011, the patient experienced pneumococcal bacteraemia (reported as bacteraemia), and Streptococcus pneumoniae serotyping was not available. The outcome of this adverse event was not reported.  The relatedness between pneumococcal bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.   Upon internal review, the event of pneumococcal bacteraemia was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Meningitis pneumococcal, Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: meningitis; pneumonia; This spontaneous report has been downloaded from Regulatory Authority, concerning an adult female patient around 55 to 59 years old. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).   On an unknown date in 2014, the patient experienced pneumonia (Pneumonia pneumococcal), Meningitis (Streptococcus pneumoniae meningitis) and streptococcus pneumoniae serotyping was not available. At the time of the report, outcome of the event was not reported.   Causal relationship between suspect vaccine and the event was not reported. Upon internal review, the event pneumonia pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Surveillance System, concerning an elderly male patient between 80-84 years old. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).   On an unknown date in 2014, the patient experienced pneumonia (Pneumonia pneumococcal) and streptococcus pneumoniae serotyping was not available. At the time of the report, outcome of the event was not reported.   Causal relationship between suspect vaccine and the event was not reported. Upon internal review, the event pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS), concerning an adult female patient between 55-59 years old. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with the first and second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).   On an unknown date in 2014, the patient experienced pneumonia (Pneumonia pneumococcal) and streptococcus pneumoniae serotyping was not available. At the time of the report, outcome of the event was not reported.   Causal relationship between suspect vaccine and the event was not reported. Upon internal review, the event pneumonia pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS), concerning an adult male patient between 60-64 years old. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with the first and second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported).   On an unknown date in 2014, the patient experienced pneumonia (Pneumonia pneumococcal) and streptococcus pneumoniae serotyping was not available. At the time of the report, outcome of the event was not reported.   Causal relationship between suspect vaccine and the event was not reported. Upon internal review, the event pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PNC, PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) referring to an child (age: 05-09 years old) female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On an unknown date, the patient was vaccinated with 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided). On unknown date, the patient was vaccinated with pneumococcal vaccine CONJ 7V (CRM197) (PREVENAR), 3 times, for prophylaxis (formulation, strength, dose, route of administration, lot#, and expiration date were not reported).   On an unknown date in 2014, the patient experienced bacteraemia (pneumococcal bacteraemia). On an unknown date in 2014, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.   The causal relationship between the event and suspect vaccines was unknown.   Upon internal review, the event pneumococcal bacteraemia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; This spontaneous report has been downloaded from Regulatory Authority referring to an adult (age: 35-39 years old) male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On an unknown date, the patient was vaccinated with 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).   On an unknown date in 2014, the patient experienced pneumonia (pneumonia pneumococcal). The streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.   The causal relationship between the event and suspect vaccine was unknown.   Upon internal review, the event pneumonia pneumococcal was determined to be medically significant.
Sex: F
Vaccine: PNC, PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: Meningitis; This spontaneous report has been downloaded from Regulatory Authority referring to a child (age: 05-09 years old) female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On an unknown date, the patient was vaccinated with 1 dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided). On unknown date, the patient was vaccinated with pneumococcal vaccine CONJ 7V (CRM197) (PREVENAR), 2 times, for prophylaxis (formulation, strength, dose, route of administration, lot#, and expiration date were not reported).   On an unknown date in 2014, the patient experienced meningitis (meningitis pneumococcal). The streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.   The causal relationship between the event and suspect vaccines was unknown.   Upon internal review, the event meningitis pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Meningitis pneumococcal, Streptococcus test
Clinical narrative: Meningitis; This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) referring to an elderly (age group: 70-74 year-old) male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs, and concomitant therapies was not provided.  On unknown dates, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (exact dose, route of administration, anatomical location, lot #, and expiry date were not provided).  On an unknown date in 2021, the patient experienced meningitis (Meningitis pneumococcal). On an unknown date in 2021, streptococcus pneumoniae serotyping was performed, but results were not available. At the time of reporting, the outcome of the event was unknown.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, meningitis was determined to be medically significant.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Disturbance in attention, Fatigue, Pain in extremity
Clinical narrative: Arm pain debilitating from Jan. 10 to Jan. 25 and still painful.  Fatigue and loss of mental clarity continuing  into second week.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient has not experienced any symptoms/no additional AE; HCP calling to report inadvertently administering PROQUAD to patient over the age of 12; This spontaneous report was received from a pharmacist and refers to an identifiable patient of unknown age ("over the age of 12") and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 16-JAN-2024, the patient over the age of 12 was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Huma albumin)(PROQUAD) lot # reported and confirmed as: X004369, expiration date reported and confirmed as: 07-AUG-2024 (exact dose, dose number, site and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). The patient did not experience any symptoms and there was no additional adverse event reported.
Sex: F
Vaccine: VARCEL
Symptoms: Product container issue, Skin laceration
Clinical narrative: HBP called regarding PQC case #: 02533984, and notes upon opening package, caller sustained small cut from broken glass of package which she describes "small and similar to paper cut" to her right thumb which she states has healed.  Caller noted she; HBP called regarding PQC case #: 02533984, and notes upon opening package, caller sustained small cut from broken glass of package which she describes "small and similar to paper cut" to her right thumb which she states has healed.  Caller noted she; This spontaneous report was received from an office manager and refers to a 30-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 09-JAN-2024 the patient was opening boxes with broken glass of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X021284 and expiration date 20-AUG-2025 (product container issue).  On 09-JAN-2024, the patient experienced small cut to her right thumb (skin laceration) from broken glass. Caller noted she did not seek HCP as the cut healed per caller after applying a band-aid. The outcome of skin laceration was unknown. Action taken with varicella virus vaccine live (oka/merck) (VARIVAX) regarding the event was not applicable.  Th causality between varicella virus vaccine live (oka/merck) (VARIVAX) and the event was not provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE details available.; HCP called to report that a single dose of PEDVAX HIB that was in a not supported TE was administered to a patient. HCP gives permission to contact. No further AE details available. No PQC.       ?    Names of vaccines involved (including lot/exp); This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 03-JAN-2024 the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # X003656 and expiration date 06-NOV-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). The temperature excursion lasted for 6 minutes and 44 seconds in temperature of -13.21 celsius degrees (C) (product storage error and no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant reported a patient received an expired VAQTA.; No additional AEs were reported; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JAN-2024, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) (lot number W028824 has been verified to be a valid lot number, expiration date reported and validated as 07-JAN-2024) (expired product administered). There were no additional adverse events reported.
Sex: F
Vaccine: RSV
Symptoms: Cough, Mobility decreased, Pneumonia, Respiratory syncytial virus infection
Clinical narrative: Pneumonia; RSV; cough; in bed for 3 days; This serious case was reported by a consumer and described the occurrence of pneumonia in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 1045MG3) for prophylaxis.   On 28-DEC-2023, the patient received Arexvy (left arm). On 28-DEC-2023, 4 hrs after receiving Arexvy, the patient experienced pneumonia (Verbatim: Pneumonia) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and cough (Verbatim: cough). On 02-JAN-2024, the patient experienced bedridden (Verbatim: in bed for 3 days). The outcome of the pneumonia, respiratory syncytial virus infection and cough were not resolved and the outcome of the bedridden was resolved (duration 3 days).   It was unknown if the reporter considered the pneumonia, respiratory syncytial virus infection, cough and bedridden to be related to Arexvy.     It was unknown if the company considered the pneumonia, respiratory syncytial virus infection, cough and bedridden to be related to Arexvy.   Additional Information: GSK Receipt Date: 20-JAN-2024 This report was submitted via the online direct entry reporting system. The patient self-reported this case. Reporter seriousness for 4 hrs. After shot intervention was required. 4 hours after shot started with cough. On 2nd January the patient was in bed for 3 days and January 8th after visit at urgent care, the patient was sent to emergency room and diagnosed with Respiratory syncytial virus infection (RSV) and pneumonia. The patient was still not well enough to leave the house and enjoy life.  The reporter asked if it was all possible that the vaccine gave the patient Respiratory syncytial virus infection (RSV).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nasopharyngitis, Vaccination failure
Clinical narrative: common cold; Developed Shingles/suspected vaccination failure; Developed Shingles although I received 2 immunizations; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, hyperlipidemia, male pattern baldness and drug allergy. Concomitant products included atorvastatine, cetirizine, olmesartan, amlodipine and finasteride.   On an unknown date, the patient received the 2nd dose of Shingrix (left arm) and the 1st dose of Shingrix (left arm). On 22-DEC-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Developed Shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Developed Shingles although I received 2 immunizations). On an unknown date, the patient experienced common cold (Verbatim: common cold). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved and the outcome of the common cold was not reported.   The reporter considered the vaccination failure, shingles and common cold to be unrelated to Shingrix and Shingrix.   The company considered the vaccination failure, shingles and common cold to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 22-DEC-2023 A patient was self-reported. He received two Shingrix immunization two years ago and developed shingles and patient had a cold the week prior to developing shingles and it not the flu or covid, it's had a common cold. The shingles was recovered on 07 January 2024. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting. The reporter requesting to consent to follow up.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PEDIARIX and IPOL were administered on the same day; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of overdose in a 3-year-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Polio vaccine inact 3v (Vero) (Ipol) (batch number WIC751M) for prophylaxis.   Concomitant products included MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), HEPATITIS A VACCINE, PNEUMOCOCCAL VACCINE, HEPATITIS B VACCINE and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap).   On 08-DEC-2023, the patient received Pediarix and Ipol (intramuscular) .5 ml. On 08-DEC-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: PEDIARIX and IPOL were administered on the same day). The outcome of the overdose 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: 16-JAN-2024 The reporter reported that received IPV (VERO) (IPOL) in the thigh (vastus lateralis) and Pediarix were administered on the same day (with no reported adverse event), which led to overdose of IPV. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vaccine positive rechallenge
Clinical narrative: achy body and pain after getting both doses of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date, refer case US2024007068).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: achy body and pain after getting both doses of Shingrix). Rechallenge with Shingrix was positive. The outcome of the general body pain was resolved (duration 24 hrs).   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024007068   Additional Information: GSK Receipt Date: 16-JAN-2024 The reporter reported this case for his wife. The patient received Shingrix years ago and patient had achy body and pain after getting both doses of Shingrix that lasted for 12 to 24 hours. The reporter refused to provide demographics and did not provide the time of the events. The reporter did not recall enough regarding the events. The reporter denied consent to follow up. This case was 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024007068:1 st dose case for same patient US-GSK-US2024AMR007443:Same reporter (Husband case, Dose 2) US-GSK-US2024007067:Same reporter (Husband case, Dose 1)
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Pain
Clinical narrative: joint pain; pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included pneumonia.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: joint pain) and pain (Verbatim: pain). The outcome of the joint pain and pain were not reported.   It was unknown if the reporter considered the joint pain and pain to be related to Arexvy.     It was unknown if the company considered the joint pain and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-JAN-2024 This case was reported via (Open field AE monitoring) interactive digital media. The patient was enquiring if he/she could take a pain reliever, (Tylenol) for the pain / joint pain side effects. The follow-up was not possible as contact details were not provided. This case had been linked with US2024AMR009619, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR009619:Same reporter
Sex: U
Vaccine: RSV
Symptoms: Cough
Clinical narrative: Persistent cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of persistent cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced persistent cough (Verbatim: Persistent cough). The outcome of the persistent cough was not reported.   It was unknown if the reporter considered the persistent cough to be related to Arexvy.     It was unknown if the company considered the persistent cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-JAN-2024 This case was reported via (Open field AE monitoring) interactive digital media. The patient was very concerned about persistent cough. The follow was not possible as contact details were not provided. This case had been linked with US2024AMR009618, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR009618:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: injection site pain). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JAN-2024 The reporter stated his friend had several days of injection site pain after the first shot of shingrix vaccine. The rest information was unknown. The reporter did not consented to follow up. This case was linked with US2024AMR011704, same patient different does.; Sender's Comments:  US-GSK-US2024AMR011704:
Sex: F
Vaccine: RSV
Symptoms: Contusion, Erythema, Oedema
Clinical narrative: sent a picture of a female who has redness; edema; bruising on her right arm; This non-serious case was reported by a other health professional via call center representative and described the occurrence of erythema in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 11-JAN-2024, the patient received Arexvy. In JAN-2024, less than a week after receiving Arexvy, the patient experienced erythema (Verbatim: sent a picture of a female who has redness), edema (Verbatim: edema) and contusion (Verbatim: bruising on her right arm). The outcome of the erythema, edema and contusion were unknown.   It was unknown if the reporter considered the erythema, edema and contusion to be related to Arexvy.     It was unknown if the company considered the erythema, edema and contusion to be related to Arexvy.   Additional Information: GSK receipt date:16-JAN-2024 The field representative reports that a health care professional sent her a picture via text of an adverse reaction from an Arexvy vaccine administration.   States that she no longer works with health care professional on a professional level and did not have any information about the  health care professional other than her name.  Health care professional sent a picture of a female who had redness, edema and bruising on her right arm.   HCP reports that all symptoms occurred after an Arexvy administration last Thursday.   No further information was available at that time.   Case number was given to Field representative for her reference.   Field representative states she has sent case number to HCP via text and has requested that call GlaxoSmithKline to follow up with further details. The reporter did not consent to follow up.