chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive, Urinary retention, Urine analysis normal
Clinical narrative: Patient presents to the ED for confusion, cough, congestion Found to have urinary retention Will place foley catheter UA neg Lactic acidosis at 2.2, hx of CHF with mild pulm edema on CXR with borderline oxygen saturations Will c/w monitoring Avoid aggressive fluid administration given COVID positive No orthopnea     The administration of 30 mL/kg of intravenous fluids would be detrimental or harmful for the patient despite having severe sepsis, hypotension, lactic acid ?4 mmol/L, or documentation of septic shock; AND the patient has one of the conditions below.  I am ordering 0  IV fluids (exact amount or mL/kg ordered is required) now and will reevaluate after given.   Condition(s) affecting decision to limit IV fluids: advanced or end stage heart failure with symptoms with minimal exertion or symptoms at rest or with an activity. Pulm edema on CXR   BNP elevated Will give IV lasix   Given confusion with borderline low oxygen sats with sitting up ~90%, likely benefit from diuresis and tx for COVID   HBS consulted
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: VACCINE ADMINISTERED ONE DAY AFTER THE BEYOND EXPIRATION DATE OF 12/13/2023.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered one day after the Beyond Expiration date of 02/13/2013.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer bivalent vaccine administered one day after the Beyond expiration date of 02/13/2023.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient given expired vaccine
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: none, multiple doses administered
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer vaccine administer one day after the Beyond expiration date of 02/13/2023.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Accidental improper storage of vaccine leading to temperature excursion prior to vaccine administration
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Cervical radiculopathy, Computerised tomogram abdomen abnormal, Diarrhoea
Clinical narrative: I was very sick from the 1st shot had to miss work for 2 days. Nauseous, extreme pain all over.  2nd shot I was sick for a whole week and missed work because of it. Nauseous and even more extreme pain than the first shot. Could barely move and couldn't sleep because of the pain. Adverse events started right away but didn't get diagnosed until March 2022 for Hypothyroidism, now on levothyroxine for that. No energy, couldn't focus, no feeling (emotions) at all. Later 2022 was diagnosed with fatty liver disease and cervical radioculapthy. Have changed lifestyle and eating habits to help with fatty liver disease. Chiropractor for musculoskeletal issues. Symptoms for fatty liver chronic diarrhea that was green and watery or very mushy. Chronic abdominal pain, nausea, my skin feels like it's on fire and like glass in my hands. Severe neck pain so I bought a new pillow and try to stretch it out every day. Chiro helps with pain management. The new diet has helped some with the abdominal pain and I've lost 17 lbs. Still have to watch what I eat and I cut out Mt dew and anything with high fructose corn syrup. I also am using stevia instead of sugar for a sweetener. More raw protein like eggs, bacon, steak, and less carbohydrates.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Emotional poverty, Faeces discoloured, Hepatic steatosis, Hypothyroidism
Clinical narrative: I was very sick from the 1st shot had to miss work for 2 days. Nauseous, extreme pain all over.  2nd shot I was sick for a whole week and missed work because of it. Nauseous and even more extreme pain than the first shot. Could barely move and couldn't sleep because of the pain. Adverse events started right away but didn't get diagnosed until March 2022 for Hypothyroidism, now on levothyroxine for that. No energy, couldn't focus, no feeling (emotions) at all. Later 2022 was diagnosed with fatty liver disease and cervical radioculapthy. Have changed lifestyle and eating habits to help with fatty liver disease. Chiropractor for musculoskeletal issues. Symptoms for fatty liver chronic diarrhea that was green and watery or very mushy. Chronic abdominal pain, nausea, my skin feels like it's on fire and like glass in my hands. Severe neck pain so I bought a new pillow and try to stretch it out every day. Chiro helps with pain management. The new diet has helped some with the abdominal pain and I've lost 17 lbs. Still have to watch what I eat and I cut out Mt dew and anything with high fructose corn syrup. I also am using stevia instead of sugar for a sweetener. More raw protein like eggs, bacon, steak, and less carbohydrates.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Insomnia, Laboratory test, Magnetic resonance imaging neck, Malaise
Clinical narrative: I was very sick from the 1st shot had to miss work for 2 days. Nauseous, extreme pain all over.  2nd shot I was sick for a whole week and missed work because of it. Nauseous and even more extreme pain than the first shot. Could barely move and couldn't sleep because of the pain. Adverse events started right away but didn't get diagnosed until March 2022 for Hypothyroidism, now on levothyroxine for that. No energy, couldn't focus, no feeling (emotions) at all. Later 2022 was diagnosed with fatty liver disease and cervical radioculapthy. Have changed lifestyle and eating habits to help with fatty liver disease. Chiropractor for musculoskeletal issues. Symptoms for fatty liver chronic diarrhea that was green and watery or very mushy. Chronic abdominal pain, nausea, my skin feels like it's on fire and like glass in my hands. Severe neck pain so I bought a new pillow and try to stretch it out every day. Chiro helps with pain management. The new diet has helped some with the abdominal pain and I've lost 17 lbs. Still have to watch what I eat and I cut out Mt dew and anything with high fructose corn syrup. I also am using stevia instead of sugar for a sweetener. More raw protein like eggs, bacon, steak, and less carbohydrates.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Medical diet, Mobility decreased, Musculoskeletal disorder, Nausea, Neck pain
Clinical narrative: I was very sick from the 1st shot had to miss work for 2 days. Nauseous, extreme pain all over.  2nd shot I was sick for a whole week and missed work because of it. Nauseous and even more extreme pain than the first shot. Could barely move and couldn't sleep because of the pain. Adverse events started right away but didn't get diagnosed until March 2022 for Hypothyroidism, now on levothyroxine for that. No energy, couldn't focus, no feeling (emotions) at all. Later 2022 was diagnosed with fatty liver disease and cervical radioculapthy. Have changed lifestyle and eating habits to help with fatty liver disease. Chiropractor for musculoskeletal issues. Symptoms for fatty liver chronic diarrhea that was green and watery or very mushy. Chronic abdominal pain, nausea, my skin feels like it's on fire and like glass in my hands. Severe neck pain so I bought a new pillow and try to stretch it out every day. Chiro helps with pain management. The new diet has helped some with the abdominal pain and I've lost 17 lbs. Still have to watch what I eat and I cut out Mt dew and anything with high fructose corn syrup. I also am using stevia instead of sugar for a sweetener. More raw protein like eggs, bacon, steak, and less carbohydrates.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pain of skin, Skin burning sensation, Weight decreased
Clinical narrative: I was very sick from the 1st shot had to miss work for 2 days. Nauseous, extreme pain all over.  2nd shot I was sick for a whole week and missed work because of it. Nauseous and even more extreme pain than the first shot. Could barely move and couldn't sleep because of the pain. Adverse events started right away but didn't get diagnosed until March 2022 for Hypothyroidism, now on levothyroxine for that. No energy, couldn't focus, no feeling (emotions) at all. Later 2022 was diagnosed with fatty liver disease and cervical radioculapthy. Have changed lifestyle and eating habits to help with fatty liver disease. Chiropractor for musculoskeletal issues. Symptoms for fatty liver chronic diarrhea that was green and watery or very mushy. Chronic abdominal pain, nausea, my skin feels like it's on fire and like glass in my hands. Severe neck pain so I bought a new pillow and try to stretch it out every day. Chiro helps with pain management. The new diet has helped some with the abdominal pain and I've lost 17 lbs. Still have to watch what I eat and I cut out Mt dew and anything with high fructose corn syrup. I also am using stevia instead of sugar for a sweetener. More raw protein like eggs, bacon, steak, and less carbohydrates.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4, MMRV, PNC13
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Adverse Event: Mother and Provider were both under the impression that patient was receiving dose #2 in a year of the influenza. Order was placed by Dr.. While RN was entering the vaccines and noticed that patient chart had documented that he had received his 1st dose on 9/19/2022 and 2nd does on 10/31/2022. Patient did receive dose #3 on 02/17/2023. Mother wrote on Vaccine paper work that this was dose #2. Treatment: informed provider, mother and supervisor. Mother was also informed that if patient is to experience abnormal responses to vaccine to call or seek evaluation. Mother stated that "this is miscommunication due to paper work being faxed from previous provider". Mother also stated that "she was under the impression that this was only patients second influenza vaccine" Outcome: When informing Dr. she stated "Patient will be extra protected."
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; patient received a dose of PROQUAD and VARIVAX concomitantly when the patient was supposed to receive MMR-II and VARIVAX instead of PROQUAD; patient received a dose of PROQUAD and VARIVAX concomitantly when the patient was supposed to receive MMR-II and VARIVAX instead of PROQUAD; This spontaneous report as received from a practical nurse refers to a patient of unknown age and gender. On 20-JAN-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, route and lot # not reported) and a dose of virus vaccine live (oka/merck) (VARIVAX) (dose, route and lot # not reported) (overdose/wrong product administered). The nurse reported that the patient was supposed to receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and virus vaccine live (oka/merck) (VARIVAX) instead of varicella (oka-merck) virus vaccine live (PROQUAD).
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from an other health care professional and referred to a 2-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot # U031544 has been verified to be a valid lot number, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (dose, strength were not provided), and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, lot #W012143, expiration date: 09-NOV-2023, administered orally for prophylaxis (dose, strength was not provided).   The administered doses of the vaccines experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175:
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VAQTA administered after a temperature excursion; This spontaneous report was received from a certified medical assistant and refers to a 12-month-old female. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, intramuscular injection, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly in the left thigh for prophylaxis (strength and exact dose were not provided).  The vaccine underwent temperature excursion of 47.9 degrees Fahrenheit for 47 min (incorrect product storage) in clinical Practice on 01-DEC-2022. Digital Data Logger was involved. No additional adverse event (AE) was reported. There was no product quality complaint (PQC).
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temp excursion 47.9 F; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with the 1st dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W023937, expiration date: 06-DEC-2023 (both confirmed to be valid), administered intramuscularly into the left thigh for prophylaxis (strength and dose were not provided). The vaccine was improperly stored for 47 minutes in the temperature of 47.9 degrees Fahrenheit. The temperature excursion occurred as a result of a reading from a Digital Logger. It was not reported if there was a previous temperature excursion. The was no other adverse events reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: No other issues or concerns noted.; Nurse calling to report that a patient received an expired dose of PMEUMOVAX 23.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On 01-FEB-2023, the patient received an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # U026796, expiration date 28-JAN-2023, for prophylaxis (dose and route were not reported) (expired product administered). Nurse did not know if the product had a previous temperature excursion. No other issues or concerns noted.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Pain in extremity, Vaccination site pain
Clinical narrative: he had pain associated with that; redness, streaking from injection site expanded almost into his right arm pit; redness, streaking from  injection site; streaking from injection site expanded almost into his right arm pit, he had pain associated with that; This spontaneous report was received from a medical assistant and refers to a 62-year-old male patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 08-FEB-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe, lot #W019533, expiration date: 30-SEP-2023, intramuscularly (exact dose, and administration site were not provided) administered for prevention of pneumococcal disease.   On 08-FEB-2023, the patient experienced redness, streaking from injection site expanded almost into his right arm pit, he had pain associated with that (vaccination site erythema, vaccination site pain, erythema, pain in extremity). The patient was treated with cephalexin (manufacturer unknown). The action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not applicable. The outcome of the events was not provided.  The relatedness between the suspect therapy and the events was not provided.  This is one of several reports received from the same reporter.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint swelling, Joint warmth
Clinical narrative: swelling around right elbow; redness around right elbow; warmth around right elbow; This spontaneous report has been received from a medical assistant and refers to a 66-year-old female patient. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 06-FEB-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, intramuscularly, lot # W019533 confirmed to be valid with expiration date 30-SEP-2023 (exact dose, dose number and anatomical location were not reported), for prevention of pneumococcal disease (prophylaxis).  On the same date, the patient experienced redness, warmth, and swelling around right elbow, which was present since the administration of the suspect vaccine. On that day, the patient went to urgent care and was treated with loratadine (CLARITIN) and diphenhydramine (BENADRYL). The patient was instructed by a healthcare professional at the reporter's facility to continue loratadine (CLARITIN) in the morning and diphenhydramine (BENADRYL) in the evening. At the reporting time, the patient was recovering from the events.  The causality assessment between the events and the suspect vaccine was not provided.  This is one of 2 reports from the same reporter.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: diagnosed with pneumonia in September 2022 and October 2022; diagnosed with pneumonia in September 2022 and October 2022; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2019, the patient was vaccinated with a dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dose, dosage regimen, formulation, lot #, expiry date, anatomical location and route of administration were not provided) as prophylaxis. On an unspecified date in 2020, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis.  On an unknown date in September 2022, the patient was diagnosed with pneumonia. Later, in October 2022, the patient was diagnosed with pneumonia again. At the time of report, the outcome of the events was unknown. The action taken with the suspect therapies regarding the events was not applicable.   The causal relationship between pneumonia and the suspect therapies was unknown.  Upon internal review, the events pneumonia in were determined to be medically significant.
Sex: M
Vaccine: MMR
Symptoms: Antibody test abnormal, Mumps antibody test positive, Rubella antibody positive
Clinical narrative: Antibody Titer for Mumps of 79.2; Antibody Titer for Rubella of 32; Antibody Titer for Measles of 1.75; This spontaneous report has been received from a physician referring to a 34-year-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status unknown) (M-M-R II) subcutaneous injection (route of administration, dose, lot number and expiration date were not provided) for prophylaxis.  On unknown dates, his suspect vaccine antibody titers was tested with antibody titer for measles of '1.75', antibody titer for rubella of '32' and antibody titer for mumps of '79.2' (all units not provided) (antibody test abnormal, rubella antibody positive, mumps antibody test positive). At time of reporting, the reporter was unable to confirm if the patient was previously administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status unknown) (M-M-R II) and was also unable to confirm if the patient's suspect vaccine dose series was interrupted prior to or at current call time. The outcome of the events, the causality assessment between suspect vaccine and the events were not reported. No additional adverse event (AE) or product quality complaint (PQC) was reported. No further information was provided.  This is one of two reports from the same reporter (link# US-009507513-2302USA004000).; Sender's Comments:  US-009507513-2302USA004000:case number 02334107
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs. no PQCs reported.; LPN calling for stability evaluation of vaccines with multiple TEs dating back to 03FEB2023. Caller reports that vaccines were administered.; This spontaneous report has been received from a nurse, concerning a 52-months-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 07-FEB-2023, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, strength 50 over 1.0 units (U) per millimeter (ml), one ml once (valid lot number W017819 [expiration date 27-DEC-2023]) (vaccination scheme, anatomical location and frequency were not provided) for prophylaxis, after multiple temperature excursions (TEs) dating back to 03-FEB-2023 (product storage error).   No additional adverse events (AE) were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004298: US-009507513-2302USA004552:
Sex: U
Vaccine: HIBV, RV5, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient. Products were administered 2/13/2023.       ?    Names of vaccines involved (including lot/exp) PEDVAX HIB W015926 2/14/2025; ROTATEQ 187; This spontaneous report was received from the Registered Nurse, and refers to a patient of unknown age, and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 13-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1879875, expiration date: 19-NOV-2023, administered orally for prophylaxis (strength was not provided); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W015926, expiration date: 14-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W024335, expiration date: 01-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided); and sterile diluent, solution for injection/infusion (strength, lot #, expiry date, route of administration, and indication were not provided). The aforementioned vaccines experienced temperature excursion over the weekend: haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ): temperature above 9 Celsius degrees (13.25 C), time frame: 2 hours 32 minutes and 0 seconds (no previous temperature excursion); varicella virus vaccine live (oka/merck) (VARIVAX): temperature -10 Celsius degrees up to 8 Celsius degrees (-9.91 C), time frame: 1 hour 40 minutes 0 seconds, (no previous temperature excursion) (product storage error). No additional adverse events were provided.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; product that experienced temperature excursion over the weekend was administered to a patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-FEB-2023, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (dose, anatomical location and route of administration were not provided; lot # W021182, expiration date 27-FEB-2025). The nurse reported that the vaccine had experienced a temperature excursion over the weekend. During 2 hours 32 minutes, the temperature was above 9°C (13..25C). No previous temperature excursion had occurred. No adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; Nurse reports product that experienced temperature excursion over the weekend was administered to a patient. Product was administered 2/13/2023.       ?    Names of vaccines involved (including lot/exp) VAQTA W036135 5/13/2024        ?    Tempera; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.    On 13-FEB-2023, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) Intramuscular Injection as prophylaxis (lot number: W036135, which was determined to be valid, with an expiration date on 13-MAY-2024) (product storage error).   On approximately 10-FEB-2023 (reported as over the weekend), the administered dose underwent a temperature excursion of 13.25 degrees Celsius (C) for 2 hours and 32 minutes. There was not any previous temperature excursion and no adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of VAQTA was administered; the vaccine had been involved in a previous temperature excursion; This spontaneous report has been received from a licensed practical nurse (LPN) referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history, drug reactions or allergies were not provided.      On 14-FEB-2023, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) vial 50 (units not provided) (1 milliliter, lot # U013476 has been verified to be valid, expiration date was reported and established as 06-FEB-2023 upon internal validation) intramuscularly for prophylaxis (expired product administered). It was also reported the vaccine had been involved in a previous temperature excursion (product storage error). The maximum storage temperature of the vaccine was 49.82 degrees Fahrenheit for a total time frame of 1 hour 30 minutes. No other information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: F
Vaccine: HPV9
Symptoms: Micturition disorder, Syncope
Clinical narrative: a patient experienced syncope and urination; a patient experienced syncope and urination; This spontaneous report was received from a physician and referred to a 12-year-old female patient. The patient's pertinent medical history included seizure. The patient's concomitant medications and drug reactions/allergies were not reported.   On an unknown date in February 2023 (reported as last week), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, anatomical location, strength, lot #, and expiry date were not provided) intramuscularly for prophylaxis and the patient was also vaccinated with another unspecified vaccine.  On an unknown date in February 2023 (reported as last week), the patient experienced syncope and urination (micturition disorder) after administration. On an unknown date in February 2023 (reported as the same day of event occurred), the patient recovered from both events. It was unknown whether the patient was given treatment and It was unknown whether the patient had sought medical attention. The causal relationship between both events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.   Upon internal review, the event syncope was determined to be medically significant.
Age: 1.42
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported, no further information provided; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 17 month old patient of unknown gender.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 08-FEB-2023 the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot # W020525 and expiration date 14-DEC-2023, (anatomical location and route of administration were not provided) for prophylaxis (Product storage error). The suspect vaccine was improperly stored in temperature of 30 Fahrenheit degrees (F) for 3 hours 15 minutes. There was no previous temperature excursion. No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The healthcare worker is reporting that a patient received improperly stored vaccine.; This spontaneous repot has been received from a health care professional, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.    On 08-FEB-2023, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection, at a dose of 1 dosage form as prophylaxis (lot number: W020525, which was determined to be valid, with an expiration date on 14-DEC-2023) (strength, scheme, route and anatomical location of administration were not reported).   The administered dose underwent a temperature excursion of 30 degrees Fahrenheit (F) for 3 hours and 15 minutes. There was not any previous temperature excursion. No adverse event was reported. (Improper storage of product in use)
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no adverse event; The healthcare worker is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VAQTA W021491 12/14/2023 Temperature: 30F Time fr; This spontaneous report was received from a other health professional and refers to a 18 month old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 09-FEB-2023, the patient received improperly stored vaccine of hepatitis a vaccine, inactivated (VAQTA) lot # W021491, expiration date 14-DEC-2023 (dose, route, and anatomical location were not reported) for prophylaxis (product storage error).  Temperature exposed: 30F Time frame: 3 hours 15 minutes
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the Vx and still got the Shingles/Suspected vaccination failure; Still got the Shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Feb-2023 Report's comment: The case was received from the patient via interactive digital media. The patient had the shingles vaccine and still got the shingles. Additional supportive information: 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: Shingles in 2018 got the shot to/Suspected vaccination failure; Shingles in 2018/Now the shingles is back in the same spot; Pain is some bad in my legs; This 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. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and leg pain. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the vaccination failure, shingles and leg pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and leg pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and had shingles in 2018 and now the shingles was back in the same spot the pain was some bad in legs. The patient reporter that the only thing that helped was a heat pad. The reporter did not wish the pain on no one.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's; The HCP reports that a patient was administered an expired dose of RECOMBIVAX HB.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 19-JAN-2023, the patient was vaccinated with an expired dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection 0.5 milliliters (lot number T033149 has been verified as a valid lot number, expiry date reported as 18-NOV-2022, but upon internal review determined as 19-NOV-2022) (strength and frequency were not reported) indicated as prophylaxis (expired product administered).  No additional adverse event were reported.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product storage error
Clinical narrative: 27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter/source case
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter/source case
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, 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: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019068:Same reporter. US-GSK-US2023019068:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash erythematous
Clinical narrative: arm pain; red rash on arm; itchiness on arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, red rash and itchy upper limbs. On an unknown date, the outcome of the pain in arm, red rash and itchy upper limbs were unknown.   It was unknown if the reporter considered the pain in arm, red rash and itchy upper limbs to be related to Shingrix.  Linked case(s) involving the same patient:US2023021201   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The case was reported by the patient. The reporter stated that after receiving his Shingrix, he experienced arm pain, a red rash and itchiness on his arm.  The patient did not specify which arm was affected.  The reporter did not consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose of Shingrix, refer case US2023021201.; Sender's Comments:  US-GSK-US2023021201:Same reporter,same patient
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: She was so sick from the shingles vaccine; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent (Dupilumab)) for atopic dermatitis.   The patient's past medical history included anxiety disorder, gastroesophageal reflux disease, headache, insomnia, obstructive sleep apnea syndrome and unspecified nutritional deficiency. Concurrent medical conditions included autoimmune thyroiditis, celiac disease, essential hypertension, hepatic steatosis, fibromyalgia, generalized anxiety disorder, hypothyroidism, irritable bowel syndrome, major depression, migraine, amyloidosis, atopic dermatitis, hyperlipidemia, psoriasis vulgaris, supraventricular tachycardia, ulcerative colitis, drug hypersensitivity and primary hypertension. Concomitant products included amitriptyline, atorvastatin, azithromycin, buspirone, calcium, colecalciferol, diclofenac, linaclotide, lorazepam, levothyroxine, liothyronine, omeprazole, prednisone, topiramate, amitriptyline hydrochloride, calcium carbonate and dicycloverine.   On 22nd May 2020, the patient received the 1st dose of Shingrix and Dupixent (Dupilumab) (subcutaneous) 300 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. The action taken with Dupixent (Dupilumab) was unknown. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: This case involved a patient who was sick from the shingles vaccine while being treated with Dupilumab (Dupixent) via prefilled pen and varicella zoster vaccine. The patient's past medical treatment and family history were not provided. The patient concomitant medication included Vitamin B complex, Linaclotide (Linzess), Liothyronine (NP thyroid), Vitamin D Nos, Colecalciferol (Vitamin D3 ) and Dicycloverine (Dicyclomine). The patient started taking Dupixent (Dupilumab) solution for injection on 300 mg QOV (every other week) subcutaneously via prefilled pen (strength 300 mg/2m), batch number and expiration date were unknown for other atopic dermatitis and Shingrix (varicella zoster vaccine, dosage, frequency, route device , strength, batch number and expiration date were unknown for prophylactic vaccination. The patient was so sick from the shingles vaccine( illness) unknown latency following the first dose of Dupilumab and varicella zoster vaccine. The action taken was unknown with Dupilumab and varicella zoster vaccine. The information on the batch number was requested. It was not reported that if patient received a corrective treatment for the event (she was so sick from the shingles vaccine). It was unknown if reporter considered sickness to be related to Dupixent (Dupilumab). Additional Supportive Information: The follow up would not possible as no contact details were available.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 9/3/21, 2nd on 11/4/22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd September 2021).   On 4th November 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 9-Feb-2023 Reporter's comment:  The reporter stated that he was wondering if someone that had received their two Shingrix vaccines a year apart - do they need to restart series. The patient reported that the 1st dose was administered on 3rd September 2021 and 2nd dose on 4th November 2022. The reporter wanted to know if he needs to get another dose. Additional supportive information: As patient received 2nd dose one year apart rather that 2 to 6 months which led to drug dose administration interval too long.