chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient presented to immunization clinic for COVID vaccine booster. Clinic staff member grabbed COVID vaccine single dose vial from refrigerator. COVID Vaccine was removed from box, verified expiration date on vial. Expiration date on vial printed as 2025/01. After completing COVID vaccine screening, vaccine was administered into patient?s left deltoid. Patient departed clinic after vaccine was administered. COVID vaccine box was inspected as it was difficult to scan vial into EMR. Beyond Use Date sticker was then identified to be labeled as 07MAR2024. Upon realizing expired COVID vaccine was administered, clinic staff member contacted patient via telephone. Clinic staff member explained situation and offered patient to return for revaccination with COVID vaccine that was not expired. Patient declined and stated that it would be fine for this year.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Pyrexia
Clinical narrative: Large area of erythema, edema and firmness of skin at injection site of MMR vaccine two days after administration. Fever started 4 days later
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Altered state of consciousness, Cold sweat
Clinical narrative: pt states felt like blacking out, cold sweats, improved after 1-2 minutes of elevating legs and water. Vitals normal
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Food intolerance, Gastrointestinal disorder, Headache, Injection site erythema, Nausea
Clinical narrative: Pt. received TDAP vaccine on 03/15/24- spouse contacted clinic on 3/18/24 to report that on 3/16/24 pt. woke with hives all over and an achy left arm. Pt. reported later that his tongue started to swell and he noticed that his throat felt tight s/p TDAP vaccine. Pt. had been taking Benadryl 2 tabs q4-6h since that time. Pt. originally advised to go to ER but declined stating sx. had been ongoing x3 days. Discussed w/clinic provider who agreed to see pt. in office. Per provider note, TDAP caused hives and throat swelling but no anaphylaxis. Aside from some minor redness at the upper left arm where vaccine was administered, a headache and sore throat, exam was normal at time of office visit . Of note, pt. was having stomach problems and nausea from sockeye salmon (well cooked) which is thought to also be a potential allergy. Pt. did additionally have a TDAP last year, administered on  02/28/2023. Pt. not thought to be at a major risk for anaphylaxis but advised to keep a kit with Benadryl on him and consider an Epi-pen for traveling.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Oropharyngeal pain, Pain in extremity, Pharyngeal swelling, Swollen tongue, Throat tightness
Clinical narrative: Pt. received TDAP vaccine on 03/15/24- spouse contacted clinic on 3/18/24 to report that on 3/16/24 pt. woke with hives all over and an achy left arm. Pt. reported later that his tongue started to swell and he noticed that his throat felt tight s/p TDAP vaccine. Pt. had been taking Benadryl 2 tabs q4-6h since that time. Pt. originally advised to go to ER but declined stating sx. had been ongoing x3 days. Discussed w/clinic provider who agreed to see pt. in office. Per provider note, TDAP caused hives and throat swelling but no anaphylaxis. Aside from some minor redness at the upper left arm where vaccine was administered, a headache and sore throat, exam was normal at time of office visit . Of note, pt. was having stomach problems and nausea from sockeye salmon (well cooked) which is thought to also be a potential allergy. Pt. did additionally have a TDAP last year, administered on  02/28/2023. Pt. not thought to be at a major risk for anaphylaxis but advised to keep a kit with Benadryl on him and consider an Epi-pen for traveling.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Pt. received TDAP vaccine on 03/15/24- spouse contacted clinic on 3/18/24 to report that on 3/16/24 pt. woke with hives all over and an achy left arm. Pt. reported later that his tongue started to swell and he noticed that his throat felt tight s/p TDAP vaccine. Pt. had been taking Benadryl 2 tabs q4-6h since that time. Pt. originally advised to go to ER but declined stating sx. had been ongoing x3 days. Discussed w/clinic provider who agreed to see pt. in office. Per provider note, TDAP caused hives and throat swelling but no anaphylaxis. Aside from some minor redness at the upper left arm where vaccine was administered, a headache and sore throat, exam was normal at time of office visit . Of note, pt. was having stomach problems and nausea from sockeye salmon (well cooked) which is thought to also be a potential allergy. Pt. did additionally have a TDAP last year, administered on  02/28/2023. Pt. not thought to be at a major risk for anaphylaxis but advised to keep a kit with Benadryl on him and consider an Epi-pen for traveling.
Age: 39.0
Sex: F
Vaccine: FLUC4, HEP, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: -patient given extra influenza vaccine accidentally, no adverse events experienced by client.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Pneumonia, Respiratory failure, Sepsis, Wheezing
Clinical narrative: Hospitalized 11/8/22-11/13/22 Respiratory failure, hypoxia, PNA, sepsis, wheezing,
Age: 25.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient requested the last dose of HPV Gardasil. Was mistakenly give Heplisav B dose.  Didn't need Hepatitis vaccination.  Patient notified that they were given the wrong vaccine. then given the correct vaccine that they requested, the HPV Gardasil dose 3.   Documented both vaccines in patient's record.
Age: 10.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Incorrect dose administered
Clinical narrative: Entire contents, approximately 0.5mls of single dose vial of Covid vaccine was administered IM, and not 0.25mls. Nurse called client's parent to f/u and inform them of incident (1640 on 03/18/2024). Mom reports "he is fine. I will give him Tylenol if he has a fever". Mom was instructed to continue to monitor for side effects, and contact HCP prn. Mom will also refer to VIS forms that were provided earlier today, and call PH with any questions or concerns.  Phone call utilized w/Interpreter services.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Anaemia, Asthenia, Haematuria, Leukocytosis
Clinical narrative: Hospitalized 11/8/22-11/13/22 hematuria, anemia, AKI, leukocytosis, debility, pseudoaneurysm in iliac artery,
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vascular pseudoaneurysm
Clinical narrative: Hospitalized 11/8/22-11/13/22 hematuria, anemia, AKI, leukocytosis, debility, pseudoaneurysm in iliac artery,
Age: 7.0
Sex: F
Vaccine: COVID19, FLU4, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Entire contents, approximately 0.5mls of single dose vial of Covid vaccine was administered IM, and not 0.25mls. Nurse called client's parent to f/u and inform them of incident (1655 on 03/18/2024). Mom denies any side effects at the moment, as "she is active and playing outside". Mom was instructed to continue to monitor for side effects, and contact HCP prn. Mom will also refer to VIS forms that were provided earlier today, and call PH with any questions or concerns.  Phone call utilized w/interpreter services.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4, HPV9, MNQ, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Entire contents, approximately 0.5mls  of single dose vial of Covid vaccine was administered IM, and not 0.25mls. Nurse called client's parent to f/u  and inform them of incident (1645 on 03/18/2024). Mom denies any side effects at the moment, as "he is doing good". "If he begins to have pain or develops a fever I will give him Tylenol".  Mom was instructed to continue to monitor for side effects, and contact HCP prn. Mom will also refer to VIS forms that were provided earlier today, and call PH with any questions or concerns.  Phone call utilized w/Interpreter services.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fistula, Haemorrhage, Hyperkalaemia
Clinical narrative: Hospitalized 11/16/22-11/17/22 Bleeding from fistula, hyperkalemia,
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Pneumonia, Productive cough, Pyrexia
Clinical narrative: Hospitalized 11/25/22-11/28/22 Fever, productive cough, dyspnea, PNA, respiratory failure, hypoxia,
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure
Clinical narrative: Hospitalized 11/25/22-11/28/22 Fever, productive cough, dyspnea, PNA, respiratory failure, hypoxia,
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haematuria, Inflammatory marker increased, Malaise, Myocardial necrosis marker increased
Clinical narrative: Hospitalized 11/27/22-12/3/22 dyspnea, productive cough, malaise, pancytopenia, elevated cardiac enzymes, elevated procalcitonin and inflammatory markers, hematuria,
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Pancytopenia, Procalcitonin increased, Productive cough
Clinical narrative: Hospitalized 11/27/22-12/3/22 dyspnea, productive cough, malaise, pancytopenia, elevated cardiac enzymes, elevated procalcitonin and inflammatory markers, hematuria,
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site irritation
Clinical narrative: The injection was extremely painful (and I've had many vaccines and blood draws in my lifetime so this was highly unusual. It felt my skin was burning within in seconds. By the time I got home 30 minutes later, it was already very sore and I could see red spot developing about the size of a quarter. The next day, (20th) it was size of a pickleball and the red irritation spot kept getting bigger. I also experience chills and body aches (Advil helped) the evening of the 19th and 20th. I had headaches (Excedrin helped) and was extremely fatigued. I could barely wake up on the 20th. On the 21st, when the red skin irritation at the injection site was the size of baseball I saw my primary physician. He prescribed Cephalexin (500 mg) for the next 7 days. I took 3 doses on the 21st. Today, the 22nd the irritated skin is about the size of a large grapefruit. It's not as swollen, but still very sore to touch. I'm still concerned because the red irritated skin is still getting bigger in size and very sore to the touch after 3 days. It's not getting any better.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: The injection was extremely painful (and I've had many vaccines and blood draws in my lifetime so this was highly unusual. It felt my skin was burning within in seconds. By the time I got home 30 minutes later, it was already very sore and I could see red spot developing about the size of a quarter. The next day, (20th) it was size of a pickleball and the red irritation spot kept getting bigger. I also experience chills and body aches (Advil helped) the evening of the 19th and 20th. I had headaches (Excedrin helped) and was extremely fatigued. I could barely wake up on the 20th. On the 21st, when the red skin irritation at the injection site was the size of baseball I saw my primary physician. He prescribed Cephalexin (500 mg) for the next 7 days. I took 3 doses on the 21st. Today, the 22nd the irritated skin is about the size of a large grapefruit. It's not as swollen, but still very sore to touch. I'm still concerned because the red irritated skin is still getting bigger in size and very sore to the touch after 3 days. It's not getting any better.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: On 03/21/2024, the above patient was given a Tdap vaccine instead of the ordered Td vaccine by medical assistant. I had instructed medical assistant that the patient needed a tetanus vaccine but that I would like to see the patient's state vaccine record prior to administration of any vaccine. A Td was tentatively ordered pending review of the vaccine records.  I did not see the state of shot record prior to her administering the vaccine. Attempted to call the patient on 03/20/2024 ? unable to leave voicemail. Attempted to call the patient again on 03/21/2024 and left a voicemail for her to call the office back.
Age: 11.0
Sex: M
Vaccine: MMRV, TDAP
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Pt was due for MMR, gave MMRV instead. Talked to provider, they stated i gave the dose too early and it just wont be effective and the pt will need another shot.
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Bronchitis, Chest X-ray abnormal, Dyspnoea, Pneumonia, Respiratory tract congestion
Clinical narrative: Extreme difficulty in breathing,congestion.   Diagnosed with pneumonia after xrays.Treated with 2 antibiotics and inhaler. In March I was diagnosed with acute bronchitis and given pearls, different inhaler, and steroids
Age: 18.0
Sex: U
Vaccine: COVID19-2, FLUA4
Symptoms: Abdominal pain upper, Arthralgia, Chest discomfort, Headache, Injection site erythema
Clinical narrative: The patient presents at Clinic to report symptoms related to Covid vaccine administered at her doctor's office. Manufacturers not known. Symptoms after getting Covid booster and influenza vaccine 2 days ago in right deltoid. Having severe shoulder pain, redness, heat, and firmness at site; muscle aches, severe headache, light sensitivity, fever, chest tightness, and stomach pain.  Symptoms are slowly improving. Has history of severe reactions in the past to Covid vaccines. Denies anaphylaxis.
Age: 18.0
Sex: U
Vaccine: COVID19-2, FLUA4
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Myalgia, Photophobia
Clinical narrative: The patient presents at Clinic to report symptoms related to Covid vaccine administered at her doctor's office. Manufacturers not known. Symptoms after getting Covid booster and influenza vaccine 2 days ago in right deltoid. Having severe shoulder pain, redness, heat, and firmness at site; muscle aches, severe headache, light sensitivity, fever, chest tightness, and stomach pain.  Symptoms are slowly improving. Has history of severe reactions in the past to Covid vaccines. Denies anaphylaxis.
Age: 18.0
Sex: U
Vaccine: COVID19-2, FLUA4
Symptoms: Pyrexia
Clinical narrative: The patient presents at Clinic to report symptoms related to Covid vaccine administered at her doctor's office. Manufacturers not known. Symptoms after getting Covid booster and influenza vaccine 2 days ago in right deltoid. Having severe shoulder pain, redness, heat, and firmness at site; muscle aches, severe headache, light sensitivity, fever, chest tightness, and stomach pain.  Symptoms are slowly improving. Has history of severe reactions in the past to Covid vaccines. Denies anaphylaxis.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Back pain, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Lower Back Pain Leg Pain/Swelling/Weakness Unable to use legs at Times No Bladder Control Loss of Hand Strength/Numbness Neck/Gland Swelling Chest tightening/Trouble breathing Dizziness Severe Headaches Severe Leg Muscle Cramps Eye Floaters High Pitched Sound in Ears Short Term Memory Loss
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Lymphadenopathy, Muscle spasms, Muscular weakness
Clinical narrative: Lower Back Pain Leg Pain/Swelling/Weakness Unable to use legs at Times No Bladder Control Loss of Hand Strength/Numbness Neck/Gland Swelling Chest tightening/Trouble breathing Dizziness Severe Headaches Severe Leg Muscle Cramps Eye Floaters High Pitched Sound in Ears Short Term Memory Loss
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain in extremity, Peripheral swelling, Swelling, Tinnitus
Clinical narrative: Lower Back Pain Leg Pain/Swelling/Weakness Unable to use legs at Times No Bladder Control Loss of Hand Strength/Numbness Neck/Gland Swelling Chest tightening/Trouble breathing Dizziness Severe Headaches Severe Leg Muscle Cramps Eye Floaters High Pitched Sound in Ears Short Term Memory Loss
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence, Vitreous floaters
Clinical narrative: Lower Back Pain Leg Pain/Swelling/Weakness Unable to use legs at Times No Bladder Control Loss of Hand Strength/Numbness Neck/Gland Swelling Chest tightening/Trouble breathing Dizziness Severe Headaches Severe Leg Muscle Cramps Eye Floaters High Pitched Sound in Ears Short Term Memory Loss
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Vaccine was not reconstituted with the adjuvant. Only the adjuvant was given to patient. At the time of this submission patient has had no reactions or adverse events. Patient will decide if he wants to return in 4 weeks to start the series again.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Dry skin, Eyelid rash, Lymphadenitis viral, Lymphadenopathy
Clinical narrative: child broke out into a rash yesterday 3-21-24 on  his trunk, back and eyelids. He received Varicella, MMR and Hep A on 3-12-24 and  DTap,HIB and P15 on 3-19-24.   She states it is a red rash without fluid filled  vesicles.  Child ran fever Tuesday and Wednesday with highest being 101.4.  She  states he also has a lymph node enlarged on his neck.  Mother took child to  doctor this morning and was told that the lymph node was something  viral and would clear up on it's own and that the rash was just dry skin. Mom  states the child is not eating as he normally does.  Asked mother if Doctor  thought it was related to MMR or Varicella vaccine and she said no.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: child broke out into a rash yesterday 3-21-24 on  his trunk, back and eyelids. He received Varicella, MMR and Hep A on 3-12-24 and  DTap,HIB and P15 on 3-19-24.   She states it is a red rash without fluid filled  vesicles.  Child ran fever Tuesday and Wednesday with highest being 101.4.  She  states he also has a lymph node enlarged on his neck.  Mother took child to  doctor this morning and was told that the lymph node was something  viral and would clear up on it's own and that the rash was just dry skin. Mom  states the child is not eating as he normally does.  Asked mother if Doctor  thought it was related to MMR or Varicella vaccine and she said no.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Patient reports heart palpitations since receiving his vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC15
Symptoms: Decreased appetite, Dry skin, Eyelid rash, Lymphadenitis viral, Lymphadenopathy
Clinical narrative: child broke out into a rash yesterday 3-21-24 on  his trunk, back and eyelids. He received Varicella, MMR and Hep A on 3-12-24 and  DTap,HIB and P15 on 3-19-24.   She states it is a red rash without fluid filled  vesicles.  Child ran fever Tuesday and Wednesday with highest being 101.4.  She  states he also has a lymph node enlarged on his neck.  Mother took child to  doctor this morning and was told that the lymph node was something  viral and would clear up on it's own and that the rash was just dry skin. Mom  states the child is not eating as he normally does.  Asked mother if Doctor  thought it was related to MMR or Varicella vaccine and she said no
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC15
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: child broke out into a rash yesterday 3-21-24 on  his trunk, back and eyelids. He received Varicella, MMR and Hep A on 3-12-24 and  DTap,HIB and P15 on 3-19-24.   She states it is a red rash without fluid filled  vesicles.  Child ran fever Tuesday and Wednesday with highest being 101.4.  She  states he also has a lymph node enlarged on his neck.  Mother took child to  doctor this morning and was told that the lymph node was something  viral and would clear up on it's own and that the rash was just dry skin. Mom  states the child is not eating as he normally does.  Asked mother if Doctor  thought it was related to MMR or Varicella vaccine and she said no
Sex: U
Vaccine: HIBV, HIBV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No additional AEs were reported.; Nurse reported that a patient received ACTHIB first on 10/12/2023 then received PEDVAX HIB as the second dose on 12/18/2023 in a series.  No additional AEs were reported. No further information provided.  No PQC.; Nurse reported that a patient received ACTHIB first on 10/12/2023 then received PEDVAX HIB as the second dose on 12/18/2023 in a series.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-OCT-2023, the patient was vaccinated with the first dose of hib vaccine conj (tet tox) (ACTHIB), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided). On 18-DEC-2023, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 dosage form, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), administered as the second dose in a series.  No additional adverse events were reported.
Age: 0.17
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event; Medical Assistant calling to report inadvertently administering GARDASIL 9 vaccine to a 2-month-old patient. Caller stated no adverse events has occurred. Permission to contact HCP was granted. No additional information provided. No additional AE/PQC; This spontaneous report as received from a medical assistant refers to a 2-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 11-MAR-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), formulation: injection, lot # 1957407, expiration date: 23-JAN-2026 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event).
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to a 8-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 03-JAN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 03-JAN-2024]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to an 11-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 13-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 13-DEC-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to a 4-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 08-JAN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 08-JAN-2024]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to a 5-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 01-NOV-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant Human albumin), injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 01-NOV-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to an 11-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 06-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD), injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 06-DEC-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to a 6-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 13-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 13-DEC-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to an 11-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 10-JAN-2024, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 10-JAN-2024]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to an 11-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 18-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 18-DEC-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to a 8-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 18-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 18-DEC-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 9.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from other health professional (nurse practitioner) and refers to a 9-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 18-DEC-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) injection, lot #X009734, expiration date: 30-SEP-2024, administered for prophylaxis (exact dose, anatomical location, and route of administration were not provided).  Administered dose of vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error [onset date: 18-DEC-2023]). There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 15.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Vaccine administerd after multiple temperature excursion; This spontaneous report was received from a nurse practitioner referring to a 15-year-old patient (gender unknown).  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 19-OCT-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) were exposed to the temperature excursion at a total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 04-DEC-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #X012267, expiration date: 30-APR-2025, administered subcutaneously for prophylaxis (strength was not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (rHA), lot #W031980, expiration date: 06-OCT-2024, administered intramuscularly (strength, and indication were not provided) that underwent in a temperature excursion. The temperature excursion occurred because of a reading from the Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event. It was noted that the vaccines were reported as right to use.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2401USA016206: US-009507513-2403USA005243:MSD US-009507513-2403USA005252:MSD US-009507513-2403USA005253:MSD US-009507513-2403USA005255:MSD US-009507513-2403USA005256:MSD US-009507513-2403USA005257:MSD US-009507513-2403USA005258:MSD US-009507513-2403USA005259:MSD US-009507513-2403USA005260:MSD US-009507513-2403USA005261:MSD US-009507513-2403USA005262:MSD US-009507513-2403USA005263:MSD US-009507513-2403USA005264:MSD US-009507513-2403USA005265:MSD US-009507513-2403USA005266:MSD US-009507513-2403USA005267:MSD US-009507513-2403USA005268:MSD US-009507513-2403USA005269:MSD US-009507513-2403USA005270:MSD
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; No PQC/additional AE reported.; This spontaneous report was received from Nurse Practitioner and refers to a 10-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-JAN-2024, the patient was vaccinated with public funds in public health clinic/hospital with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot #X020149, expiration date: 01-AUG-2025 (strength, dose, dose number and anatomical location were not provided) administered for prophylaxis   This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; No PQC/additional AE reported.; This spontaneous report was received from Nurse Practitioner and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JAN-2024, the patient was vaccinated with public funds in public health clinic/hospital with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot # X020149, expiration date: 01-AUG-2025, administered for prophylaxis (strength, dose, dose number and anatomical location were not provided).  This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported. This is one of several reports received from the same reporter.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No PQC/additional AE reported.; HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; This spontaneous report was received from Nurse Practitioner and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-JAN-2024, the patient was vaccinated with public funds in public health clinic/hospital with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot # X020149, expiration date: 01-AUG-2025, administered for prophylaxis (strength, dose, dose number and anatomical location were not provided)   This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:MSD
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; No PQC/additional AE reported.; This spontaneous report was received from Nurse Practitioner and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JAN-2024, the patient was vaccinated with public funds in public health clinic/hospital with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot # X020149, expiration date: 01-AUG-2025, administered for prophylaxis (strength, dose, dose number and anatomical location were not provided).  This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 14.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No PQC/additional AE reported.; HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; This spontaneous report was received from Nurse Practitioner and refers to a 14-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2024, the patient was vaccinated with public funds in public health clinic/hospital with a doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot # X020149, expiration date: 01-AUG-2025; and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous, lot # W031980 , expiration date: 06-OCT-2024 and Albumin status: rHA. Both administered for prophylaxis (strength, dose, dose number and anatomical location were not provided).   This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 19.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No PQC/additional AE reported.; HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; This spontaneous report was received from Nurse Practitioner and refers to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2024 , the patient was vaccinated with public funds in public health clinic/hospital with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot # X020149, expiration date: 01-AUG-2025, administered for prophylaxis (strength, dose, dose number and anatomical location were not provided).  This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No PQC/additional AE reported.; HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; This spontaneous report was received from Nurse Practitioner and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2024, the patient was vaccinated with public funds in public health clinic/hospital with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot # X020149, expiration date: 01-AUG-2025, administered for prophylaxis (strength, dose, dose number and anatomical location were not provided).   This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:MSD
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No PQC/additional AE reported.; HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; This spontaneous report was received from Nurse Practitioner and refers to a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2024, the patient was vaccinated with public funds in public health clinic/hospital with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot # X020149, expiration date: 01-AUG-2025, administered for prophylaxis (strength, dose, dose number and anatomical location were not provided)   This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP confirmed that some products experienced multiple TEs and that some products were administered after experiencing TEs.; No PQC/additional AE reported.; This spontaneous report was received from Nurse Practitioner and refers to a 14-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JAN-2024, the patient was vaccinated with public funds in public health clinic/hospital with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous, lot # X020149, expiration date: 01-AUG-2025, administered for prophylaxis (strength, dose, dose number and anatomical location were not provided)   This vaccine underwent multiple temperature excursion (Product storage error). No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Product was administered to a patient following a temperature excursion.; No additional AE/PQC.; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 11-JAN-2024, the patient was vaccinated with a dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot# U7905AA [lot # U7905AA is an invalid lot# for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)], expiration date: 03-OCT-2025,(strength, exact dose, dose#, route of administration, and anatomical site of vaccination were not provided) for prophylaxis (product storage error). The suspect vaccine underwent a temperature excursion, but exact temperature was not provided (reported as insufficient data). It was reported that there was no previous temperature excursion. No additional adverse event was reported (n adverse event).
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product prescribing error
Clinical narrative: Information related to Immunization prescribed in error for 5 year old child.; No additional AE; This spontaneous report was received from a medical assistant through portal via a company representative and refers to a 5-year-old patient (gender was not provided).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was prescribed in error with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, (strength, exact dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis (Product prescribing error ). No further information or details were provided. No additional adverse event /no  product quality complaints.