chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myalgia, Pain, Skin swelling
Clinical narrative: Thursday: PM Sorness, puffy and swollen: Friday: painful joints and stiffness all over, muscle pain, weakness in hands and accompanied with dizziness. Friday PM: muscle pain spread to shoulder places and other areas in the thorax and no longer localized. Saturday: patient began to note improvement, motrin that was started Thursday is continued. redness and swelling are also improved. Saturday night: noticeable pain in left lymph node, still experiencing discomfort and soreness on the left side.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Thursday: PM Sorness, puffy and swollen: Friday: painful joints and stiffness all over, muscle pain, weakness in hands and accompanied with dizziness. Friday PM: muscle pain spread to shoulder places and other areas in the thorax and no longer localized. Saturday: patient began to note improvement, motrin that was started Thursday is continued. redness and swelling are also improved. Saturday night: noticeable pain in left lymph node, still experiencing discomfort and soreness on the left side.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Blood creatine phosphokinase normal, Blood culture, C-reactive protein normal, Carbon dioxide decreased, Crying
Clinical narrative: Patient developed fever up to 102F approximately 24 hours after receiving his vaccines. The fever persisted and he was brought in for evaluation and had a measured rectal temperature in the Emergency Room up to 104.7F (40.4C) on 5/12/24 at 11:46am. He also presented with inconsolable crying that lasted about 12 hours. No vomiting. No diarrhea (normal stool yesterday). No URI symptoms. Had been still drinking and eating ok. Good urine output. No rash. No known ingestions and no access to medications in the home, no other substances in the home.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Haemoglobin decreased, Influenza virus test negative, Irritability, Mean cell volume decreased, Metabolic acidosis
Clinical narrative: Patient developed fever up to 102F approximately 24 hours after receiving his vaccines. The fever persisted and he was brought in for evaluation and had a measured rectal temperature in the Emergency Room up to 104.7F (40.4C) on 5/12/24 at 11:46am. He also presented with inconsolable crying that lasted about 12 hours. No vomiting. No diarrhea (normal stool yesterday). No URI symptoms. Had been still drinking and eating ok. Good urine output. No rash. No known ingestions and no access to medications in the home, no other substances in the home.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Metabolic function test abnormal, Microcytic anaemia, Procalcitonin normal, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Patient developed fever up to 102F approximately 24 hours after receiving his vaccines. The fever persisted and he was brought in for evaluation and had a measured rectal temperature in the Emergency Room up to 104.7F (40.4C) on 5/12/24 at 11:46am. He also presented with inconsolable crying that lasted about 12 hours. No vomiting. No diarrhea (normal stool yesterday). No URI symptoms. Had been still drinking and eating ok. Good urine output. No rash. No known ingestions and no access to medications in the home, no other substances in the home.
Age: 1.25
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative, Stool analysis normal, Ultrasound abdomen normal
Clinical narrative: Patient developed fever up to 102F approximately 24 hours after receiving his vaccines. The fever persisted and he was brought in for evaluation and had a measured rectal temperature in the Emergency Room up to 104.7F (40.4C) on 5/12/24 at 11:46am. He also presented with inconsolable crying that lasted about 12 hours. No vomiting. No diarrhea (normal stool yesterday). No URI symptoms. Had been still drinking and eating ok. Good urine output. No rash. No known ingestions and no access to medications in the home, no other substances in the home.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Started to experience bruising at site of injection (reminiscent of a failed attempt of a blood draw) approx. 15 or so after injection.  The injection itself was un-noteworthy as see did not feel the needle.  The bruising was not communicated to us until 5-10-2024. Experienced typical soreness at site of injection post vaccination.  "bruising" is improving but still visible.  Never experienced swelling or fever
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient called and got a her 2nd shingles shot on 05/10/24.  The first shot she had no problems with at all.  Patient said she had a reaction on the 2nd shop.  She has a red spot that started as a dime, then quarter, then half dollar and now the size of the lid on our large bottles.  I recommended her to use ice, ibuprofen, massage and benadryl on 5/11/24 hoping it would help and it would get smaller, but instead t is still got larger.  I told her to go to urgent care to possibly get a steroid or steroid shot.  She said she has an appointment on 05/13/24 with her primary, so she is going to see how tomorrow goes.  I told her to please check in and/or pharmacist will follow up 05/13/24. I will also fill out a VAERS.
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Abdominal pain upper, Gastrooesophageal reflux disease, Infantile spitting up, Infantile vomiting, Insomnia
Clinical narrative: Excessive vomiting, spitting up, fussiness, stomach pain, reflux, inability to sleep
Age: 0.08
Sex: M
Vaccine: RV1
Symptoms: Irritability
Clinical narrative: Excessive vomiting, spitting up, fussiness, stomach pain, reflux, inability to sleep
Age: 88.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The patient experienced redness in the area encompassing approximately 1/3 of the upper arm starting the evening of the vaccination.  Recently then patient has noticed heat and itching in the area.  There is no decreased mobility and no pain associated with it
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electromyogram, Exercise tolerance decreased, Gait inability, Nerve conduction studies
Clinical narrative: Within 2 weeks I experienced shortness of breath and numbness and tingling in both hands/fingers.  I did not report it because I had researched adverse effects and it stated the effects usually were temporary.  Mine never got better.  Had nerve conduction tests on both arms/hands and it determined that the problem was not coming from my neck.  I am unable to physically exercise or walk as I use to due to the extreme shortness of breath.  I am seeing a pulmonologist but the issue has not been diagnosed and medications (inhalers) do not help at all.  I have been dealing with this for almost 3 years now.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pulmonary function test
Clinical narrative: Within 2 weeks I experienced shortness of breath and numbness and tingling in both hands/fingers.  I did not report it because I had researched adverse effects and it stated the effects usually were temporary.  Mine never got better.  Had nerve conduction tests on both arms/hands and it determined that the problem was not coming from my neck.  I am unable to physically exercise or walk as I use to due to the extreme shortness of breath.  I am seeing a pulmonologist but the issue has not been diagnosed and medications (inhalers) do not help at all.  I have been dealing with this for almost 3 years now.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Neurological impairment, dizziness, brain fog, body aches, nerve pain, muscle spasms, heart palpitations, body tremors.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nervous system disorder, Neuralgia, Pain, Palpitations
Clinical narrative: Neurological impairment, dizziness, brain fog, body aches, nerve pain, muscle spasms, heart palpitations, body tremors.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Neurological impairment, dizziness, brain fog, body aches, nerve pain, muscle spasms, heart palpitations, body tremors.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Nervous system disorder, Syncope
Clinical narrative: Syncope , autonomic nervous disorder, possible Dysautonomia and POTS
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Cardiogenic shock, Cardioversion, Chest pain
Clinical narrative: August 28 2022 went to ER with substernal chest pain, atrial fib , atrial flutter, cardiogenic shock                                                                                                 Cardioversion, Pericardiocentesis.  Diagnosed with pericarditis
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Laboratory test, Pericardial drainage, Pericarditis
Clinical narrative: August 28 2022 went to ER with substernal chest pain, atrial fib , atrial flutter, cardiogenic shock                                                                                                 Cardioversion, Pericardiocentesis.  Diagnosed with pericarditis
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Acute kidney injury, Anaemia, Atypical haemolytic uraemic syndrome, Blood creatinine increased, Blood lactate dehydrogenase increased
Clinical narrative: Hemolytic uremic syndrome; stool also tested positive for E-Coli; This spontaneous report was received from a consumer and referred to a 4-month-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 19-APR-2024, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #Y003996, expiration date: 27-APR-2025, administered orally (dose, strength was not provided); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 7v (crm197) (PREVNAR) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); and  hib vaccine (HIB) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided), all administered for prophylaxis as 4 month vaccinations. ,  On that day (19-APR-2024), the patient experienced hemolytic uremic syndrome with a mild fever. On 20-APR-2024, the patient had some vomiting. On 21-APR-2024, the patient was not eating and was taken to hospital. The patient was admitted on that day. During the hospital, the patient was diagnosis with hemolytic uremic syndrome, the patient was treated for hemolytic uremic syndrome. On an unknown date in 2024, the stool tested positive for E.Coli. The patient also had genetic test (result not reported). On 02-MAY-2024, the patient was discharged from the hospital. It was reported on 04-MAY-2024, the patient recovered from hemolytic uremic syndrome. The outcome of stool tested positive for E.Coli was unknown.   The casual relation between hemolytic uremic syndrome and stool tested positive for E.Coli and all vaccines was not reported. Upon internal review, the event Hemolytic uremic syndrome was determined to be medically significant.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Cytogenetic analysis abnormal, Diarrhoea, Escherichia test positive, Haemolysis, Pyrexia
Clinical narrative: Hemolytic uremic syndrome; stool also tested positive for E-Coli; This spontaneous report was received from a consumer and referred to a 4-month-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 19-APR-2024, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #Y003996, expiration date: 27-APR-2025, administered orally (dose, strength was not provided); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 7v (crm197) (PREVNAR) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); and  hib vaccine (HIB) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided), all administered for prophylaxis as 4 month vaccinations. ,  On that day (19-APR-2024), the patient experienced hemolytic uremic syndrome with a mild fever. On 20-APR-2024, the patient had some vomiting. On 21-APR-2024, the patient was not eating and was taken to hospital. The patient was admitted on that day. During the hospital, the patient was diagnosis with hemolytic uremic syndrome, the patient was treated for hemolytic uremic syndrome. On an unknown date in 2024, the stool tested positive for E.Coli. The patient also had genetic test (result not reported). On 02-MAY-2024, the patient was discharged from the hospital. It was reported on 04-MAY-2024, the patient recovered from hemolytic uremic syndrome. The outcome of stool tested positive for E.Coli was unknown.   The casual relation between hemolytic uremic syndrome and stool tested positive for E.Coli and all vaccines was not reported. Upon internal review, the event Hemolytic uremic syndrome was determined to be medically significant.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Red blood cell schistocytes present, Rotavirus test positive, Thrombocytopenia, Transfusion, Vomiting
Clinical narrative: Hemolytic uremic syndrome; stool also tested positive for E-Coli; This spontaneous report was received from a consumer and referred to a 4-month-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 19-APR-2024, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #Y003996, expiration date: 27-APR-2025, administered orally (dose, strength was not provided); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 7v (crm197) (PREVNAR) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); and  hib vaccine (HIB) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided), all administered for prophylaxis as 4 month vaccinations. ,  On that day (19-APR-2024), the patient experienced hemolytic uremic syndrome with a mild fever. On 20-APR-2024, the patient had some vomiting. On 21-APR-2024, the patient was not eating and was taken to hospital. The patient was admitted on that day. During the hospital, the patient was diagnosis with hemolytic uremic syndrome, the patient was treated for hemolytic uremic syndrome. On an unknown date in 2024, the stool tested positive for E.Coli. The patient also had genetic test (result not reported). On 02-MAY-2024, the patient was discharged from the hospital. It was reported on 04-MAY-2024, the patient recovered from hemolytic uremic syndrome. The outcome of stool tested positive for E.Coli was unknown.   The casual relation between hemolytic uremic syndrome and stool tested positive for E.Coli and all vaccines was not reported. Upon internal review, the event Hemolytic uremic syndrome was determined to be medically significant.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Cytogenetic analysis, Haemolytic uraemic syndrome, Poor feeding infant, Pyrexia, Vomiting
Clinical narrative: Hemolytic uremic syndrome; stool also tested positive for E-Coli; This spontaneous report was received from a consumer and referred to a 4-month-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 19-APR-2024, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #Y003996, expiration date: 27-APR-2025, administered orally (dose, strength was not provided); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 7v (crm197) (PREVNAR) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided); and  hib vaccine (HIB) (strength, formulation, dose, lot #, expiry date, and route of administration were not provided), all administered for prophylaxis as 4 month vaccinations. ,  On that day (19-APR-2024), the patient experienced hemolytic uremic syndrome with a mild fever. On 20-APR-2024, the patient had some vomiting. On 21-APR-2024, the patient was not eating and was taken to hospital. The patient was admitted on that day. During the hospital, the patient was diagnosis with hemolytic uremic syndrome, the patient was treated for hemolytic uremic syndrome. On an unknown date in 2024, the stool tested positive for E.Coli. The patient also had genetic test (result not reported). On 02-MAY-2024, the patient was discharged from the hospital. It was reported on 04-MAY-2024, the patient recovered from hemolytic uremic syndrome. The outcome of stool tested positive for E.Coli was unknown.   The casual relation between hemolytic uremic syndrome and stool tested positive for E.Coli and all vaccines was not reported. Upon internal review, the event Hemolytic uremic syndrome was determined to be medically significant.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs were reported; Nurse reported that a patient received GARDASIL 9 doses shorter than recommended interval.  First dose was given on 3/15/2024 and second dose was given on 3/29/2024.; This spontaneous report has been received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications was not provided.  The patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection doses shorter than recommended interval; the first dose was given on 15-MAR-2024 and second dose was given on 29-MAR-2024. Both vaccines were administered at 1 dose as prophylaxis (routes of administration and anatomical locations were not provided) (inappropriate schedule of product administration). The lot and expiration date was available only for the second dose: lot number 1967338 has been verified to be valid, expiration date 26-JAN-2026. No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: not reported any additional AEs; a dose of MMR II was administered on 04/24/2024 after the product experienced a temperature excursion on the same day, 04/24/2024; This spontaneous report has been received from a registered medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.   On 24-APR-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose: 1 dose, expiration date: 22-AUG-2024, lot number X02332 was not valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and did not match any Company product; route and strength were unknown) for prophylaxis after the product experienced a temperature excursion on the same day (product storage error). The reporter confirmed that patient has not reported any additional adverse events. No further information available currently.  Administered doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced the temperature excursion below 10.3 degree Celsius for 3 hours and 5 minutes. No previous temperature excursions reported.
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Antibody test negative, Clostridium test negative, Corynebacterium test negative, Measles antibody negative, Mumps antibody test negative
Clinical narrative: Vaccine responses to Haemophilus influenza B, measles, mumps, rubella (MMR), and varicella were absent; Information has been received from the authors in the published literature article entitled as stated below, and refers to a 13-year-old male patient. The patient's concurrent conditions included atopic  dermatitis, seasonal allergies, and recurrent upper respiratory tract infections. Additionally, the patient was later diagnosed with common variable immunodeficiency. The patient's medical history and concomitant medications were not reported.  On an unspecified dates, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection (dose, lot #, expiry date, route of administration, and anatomical location were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (dose, lot #, expiry date, route of administration, and anatomical location were not provided); and varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (dose, lot #, expiry date, route of administration, and anatomical location were not provided). All vaccines were administered for prophylaxis.  On an unspecified date, the patient had vaccine titers measurement for Haemophilus influenza B, measles, mumps, rubella, and varicella; however, all results were reported as absent (Therapy non-responder). Additionally, titers for tetanus, diphtheria, and poliovirus were also absent.  At the time of reporting, the action taken with al suspect vaccines regarding the event was not applicable. The outcome of the event therapy non-responder was unknown.  The relatedness between the event with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown), and varicella virus vaccine live (oka/merck) (manufacturer unknown) was considered as related.  A copy of the published article has been requested.
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rubella antibody negative, Therapy non-responder
Clinical narrative: Vaccine responses to Haemophilus influenza B, measles, mumps, rubella (MMR), and varicella were absent; Information has been received from the authors in the published literature article entitled as stated below, and refers to a 13-year-old male patient. The patient's concurrent conditions included atopic  dermatitis, seasonal allergies, and recurrent upper respiratory tract infections. Additionally, the patient was later diagnosed with common variable immunodeficiency. The patient's medical history and concomitant medications were not reported.  On an unspecified dates, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) injection (dose, lot #, expiry date, route of administration, and anatomical location were not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (dose, lot #, expiry date, route of administration, and anatomical location were not provided); and varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (dose, lot #, expiry date, route of administration, and anatomical location were not provided). All vaccines were administered for prophylaxis.  On an unspecified date, the patient had vaccine titers measurement for Haemophilus influenza B, measles, mumps, rubella, and varicella; however, all results were reported as absent (Therapy non-responder). Additionally, titers for tetanus, diphtheria, and poliovirus were also absent.  At the time of reporting, the action taken with al suspect vaccines regarding the event was not applicable. The outcome of the event therapy non-responder was unknown.  The relatedness between the event with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown), and varicella virus vaccine live (oka/merck) (manufacturer unknown) was considered as related.  A copy of the published article has been requested.
Sex: U
Vaccine: PNC15, RV5, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse called to report TE where products have been administered to patients. No Additional AE/PQC.; Nurse called to report TE where products have been administered to patients. No Additional AE/PQC.; This spontaneous report was received from Other Health Professional and refers to a currently 7-month-old patient of unknow gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly store doses of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 mL injection, lot # reported as x019438, expiration date reported as 07-NOV-2025 (dose, anatomical location and route of administration were not provided), rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid at a dose of 2 mL, orally, lot # reported as 2003139, expiration date reported as 30-APR-2025 (strength was not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection (strength, dose, anatomical location, and route of administration were not provided), lot # reported as u7767ba, expiration date reported as 26-MAY-2026; all the vaccines were administered for prophylaxis. The doses were exposed to a temperature excursion of 9.85 Celsius degrees for 30 mins, no previous temperature excursion reported. At the reporting time, the patient had not presented any adverse reaction (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Guillain Barre syndrome; Totally paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria GSK medically significant) and paralysis (Verbatim: Totally paralyzed) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported and the outcome of the paralysis was resolved (duration 3 months).   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome and paralysis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-May-2024 This case was reported by a patient's wife via interactive digital media. The reporter reported that after getting this Shingles vaccine her husband experienced Gillian barre syndrome and was totally paralyzed for 3 months.  The reporter stated that we almost lost him.  The reporter reported that be very careful.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; mild outbreak of shingles on my face; a mild case it was very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In NOV-2023, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: mild outbreak of shingles on my face) and pain (Verbatim: a mild case it was very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2024 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine several years ago, then last November he/she had a mild outbreak of shingles on his/her face. Despite being a mild case it was very painful, luckily for him/her it did not get too close to the eye. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: DTAP
Symptoms: Syringe issue, Underdose
Clinical narrative: Underdose; One syringe leaked at the luer lock hub/tip during administration; Product Complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a patient who received DTPa (Infanrix) (batch number GG39D, expiry date 07-JUN-2025) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced accidental underdose (Verbatim: Underdose), syringe leak (Verbatim: One syringe leaked at the luer lock hub/tip during administration) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental underdose, syringe leak and pharmaceutical product complaint were 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-MAY-2024 The reporter was the HCP (nurse), an experienced vaccinator who reported that one syringe leaked at the luer lock hub/tip during administration related adverse event as underdose which led to  accidental underdose, syringe leak and pharmaceutical product complaint. The syringe and needle were discarded and were not available for return to GlaxoSmithKline. No picture was taken. The reporter stated that during administration the defect was discovered. The mixing/shaking was performed vigorously after reconstitution. The leak was at the luer lock tip. The syringe was not pre-assembled with needle some time before administration. 25G 1 inch Luer lock size gauge needle was used. The carton and luer lock was not damaged. The needle, which was used was not available it was discarded. There was no damage/breakage on the syringe barrel. Patient identifiers were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Mal administration because first dose was given 28-Jan-2022 and 2nd on 11-Feb-2022; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 11-FEB-2022, the patient received the 2nd dose of Shingrix. On 11-FEB-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Mal administration because first dose was given 28-Jan-2022 and 2nd on 11-Feb-2022). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 02-May-2024 The patient received 2nd dose of Shingrix, early than the recommended interval, which led to shortening of vaccinations schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Peripheral swelling
Clinical narrative: some of the blisters looked to be leaking blood or fluids; large swelling in arm the size of a baseball; There were smaller blister like marks around it; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JAN-2024, the patient received the 1st dose of Shingrix (unknown arm). On 11-JAN-2024, 1 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: large swelling in arm the size of a baseball) and blister (Verbatim: There were smaller blister like marks around it). On an unknown date, the patient experienced blister rupture (Verbatim: some of the blisters looked to be leaking blood or fluids). The outcome of the swelling arm and blister were unknown and the outcome of the blister rupture was not reported.   The reporter considered the swelling arm and blister to be related to Shingrix. It was unknown if the reporter considered the blister rupture to be related to Shingrix.     The company considered the swelling arm and blister to be related to Shingrix. It was unknown if the company considered the blister rupture to be related to Shingrix.   Additional Information: GSK receipt date: 02-MAY-2024 The reporter reported that a patient received Shingrix vaccine and experienced large swelling in arm the size of a baseball after receiving Shingrix. There were smaller blister like marks around it, she stated that some of the blisters looked to be leaking blood or fluids.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I feel like dying; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of impending doom in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of no adverse event (received 1st dose of Shingles vaccine on unknown date and had no problems).   On 30-APR-2024, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced impending doom (Verbatim: I feel like dying). The outcome of the impending doom was not reported.   It was unknown if the reporter considered the impending doom to be related to Shingles vaccine.     It was unknown if the company considered the impending doom to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAY-2024 This case was received from the patient via interactive digital media. The patient got the second vaccine yesterday morning and he/she felt like dying.
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Nurse reports 1 year old male patient was administered Kinrix; he should have received Pediarix; Prior to the Kinrix dose, had 2 DTaP doses and 2 IPV doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included DTaP (The patient had received 2 DTaP doses.) and IPV (The patient had received 2 IPV doses.).   On 26-MAR-2024, the patient received Kinrix. On 26-MAR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Nurse reports 1 year old male patient was administered Kinrix ), wrong vaccine administered (Verbatim: he should have received Pediarix) and inappropriate schedule of vaccine administered (Verbatim: Prior to the Kinrix dose, had 2 DTaP doses and 2 IPV doses). The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were 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: 30-APR-2024 The nurse reported that the 1 year old male patient received Kinrix vaccine, when he should have received Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administration. The reported that the patient had fine. The reported that prior to the Kinrix vaccine, the patient had received 2 Dtap doses and 2 IPV doses which led to Inappropriate schedule of vaccine administered. The error was not discovered at the time of reporting. The reporter consented to follow up.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received Menveo one vial presentation expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 10-APR-2024, the patient received Menveo. On 10-APR-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: received Menveo one vial presentation expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-APR-2024 The nurse reported patient received expired dose of one vial presentation of Menveo. The patient received an expired dose of Menveo vaccine, which led to expired vaccine used. This is 1 of 3 linked cases for another patient by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024055470:another patient/ same reporter US-GSK-US2024055471:another patient/ same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site; Itchiness at injection site; Injection Site Warm to Touch; Raised Area at Injection Site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) (batch number X5J23, expiry date 25-JAN-2026) for prophylaxis.   On 23-APR-2024, the patient received the 1st dose of Shingrix (left arm). On 24-APR-2024, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Redness at injection site), injection site itching (Verbatim: Itchiness at injection site), injection site warmth (Verbatim: Injection Site Warm to Touch) and injection site swelling (Verbatim: Raised Area at Injection Site). The outcome of the injection site erythema, injection site itching, injection site warmth and injection site swelling were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site itching, injection site warmth and injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site itching, injection site warmth and injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2024 The reporter reported that the patient received their first dose of Shingrix in the left arm, and the following day the injection site became warm, raised, itchy and red. The adverse event was ongoing. The reporter inadvertently did not collect patient age, gender, date of birth. The healthcare professional gave permission for follow up but he was a student so requests follow up attempts go to the Pharmacist there at the email address provided. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in product usage process
Clinical narrative: inappropriate reconstitution technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong technique in product usage process (Verbatim: inappropriate reconstitution technique). The outcome of the wrong technique in product usage process 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: 30-APR-2024 HCP reported that the needle will not attach to the luer lock syringe for Hiberix, however, it was determined that a luer lock compatible needle was not used as it stated in the package insert which led to wrong technique in product usage process.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: she got both doses they weren't in the recommended timeframe of like 2 to 6 months recommended; a third dose this past Saturday; 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 73-year-old female patient who received Herpes zoster (Shingrix) (batch number L995Y, expiry date 15-MAY-2026) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2020, received first dose).   On 27-APR-2024, the patient received the 3rd dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 27-APR-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: a third dose this past Saturday). On an unknown date, the patient experienced drug dose administration interval too long (Verbatim: she got both doses they weren't in the recommended ahmm timeframe of like 2 to 6 months recommended). The outcome of the drug dose administration interval too long and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 30-APR-2024 Reporter called and reported that the patient came in and she had told us that she only received one of the Shingles dose back in 202, after further phone called and investigation, patient had received both doses and then received a third, which led to extra dose administered. Reporter reported that there was no issue, the first time around when she got both doses they were not in the recommended, they were on like 7 and a half months or 8 months. Patient was told by her doctor to restart the schedule. The reporter consented to follow-up. The patient received the second dose later than the recommended schedule, which led to drug dose administration interval too long.
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a patient received Kinrix who was not at the appropriate age.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number D947X, expiry date 25-JAN-2025) for prophylaxis.   On 14-SEP-2023, the patient received Kinrix. On 14-SEP-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a patient received Kinrix who was not at the appropriate age.). The outcome of the inappropriate age at vaccine administration 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: 30-APR-2024 CMA stated a patient received Kinrix who was not at the appropriate age.  She assumed the patient was supposed to get separate Dtap and Polio vaccines because of the age. The Vaccine Administration Facility was the same as Primary Reporter The reported consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: a 51 years old female patient received only diluent portion of Shingrix.; patient received only diluent portion of Shingrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-APR-2024, the patient received Shingrix. On 30-APR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: a 51 years old female patient received only diluent portion of Shingrix.) and inappropriate dose of vaccine administered (Verbatim: patient received only diluent portion of Shingrix.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-APR-2024 Medical assistant reported that on reporting day the patient received only diluent portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. At the time of call the reporter did not have lot and expiry of the product when asked. The reporter consented to follow-up.
Age: 20.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose on 31st December 2013; 2nd on 25th July 2012; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 20-year-old female patient who received HAB (Twinrix) (batch number AHABB276AC, expiry date 22-JUN-2015) for prophylaxis.   Co-suspect products included HAB (Twinrix) (batch number AHABB231BA, expiry date 24-NOV-2013) for prophylaxis.   Previously administered products included Twinrix (On 22nd June 2010, received first dose at the age of 18 years old).   On 31-DEC-2013, the patient received the 3rd dose of Twinrix. On 25-JUL-2012, the patient received the 2nd dose of Twinrix. On 25-JUL-2012, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd on 25th July 2012). On 31-DEC-2013, the patient experienced drug dose administration interval too long (Verbatim: 3rd dose on 31st December 2013). The outcome of the drug dose administration interval too long and drug dose administration interval too long were 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-MAY-2024 Licensed practical nurse was asked about the Hepatitis B status of a patient who received the complete Twinrix series but separated by a year or two. Reporter also asked about the coverage as the patient received the first dose at the age of 18 year instead of 19 year. The patient received 2nd  and 3rd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule. The reporter consented to follow-up.