chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tongue biting, Urinary incontinence
Clinical narrative: I experienced a Nocturnal seizure from this new Trigger event. Friday March 22, I received my first Shingles vaccine shot. That night I had another seizure. After I awoke, I felt extreme muscle fatigue and weakness from head to toe. Had a bad tongue bite and noticed a little bit of urinating and drooling occurred when asleep. This was my 7 NS in 2 years and the others were triggered by high levels of emotional stress lasting an extended period of time.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: I experienced a Nocturnal seizure from this new Trigger event. Friday March 22, I received my first Shingles vaccine shot. That night I had another seizure. After I awoke, I felt extreme muscle fatigue and weakness from head to toe. Had a bad tongue bite and noticed a little bit of urinating and drooling occurred when asleep. This was my 7 NS in 2 years and the others were triggered by high levels of emotional stress lasting an extended period of time.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Condition aggravated, Drooling, Muscle fatigue, Seizure
Clinical narrative: Seizure later in the evening after vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tongue biting, Urinary incontinence
Clinical narrative: Seizure later in the evening after vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizure later in the evening after vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Deafness neurosensory, Deafness unilateral, Sudden hearing loss, Tinnitus, Vertigo
Clinical narrative: SSNHL Right ear with vertigo and tinnitus on 10/16/2023. Prednisone 60mg initially and weaning, 2 week course started on day 5.  No relief. Trans tympanic inj. prednisone 11/16/23. No relief. Vertigo, deafness and loud tinnitus on going.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Headache, Seizure
Clinical narrative: Parents present to clinic with sibling for separate visit. Father let this RN know that child had a seizure 2 days after receiving vaccines. Father states that patient was complaining of a headache and then began convulsing. Father states they took patient to Hospital where he was discharged after "a few hours" and told to follow up with his PCP. Father states patient has been acting like his usual self with no other complaints or issues. This RN scheduled patient with Health Department Pediatrician in for follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fall, Fatigue, Vomiting
Clinical narrative: Hospitalized 12/2/22-12/8/22 Fall, weakness, fatigue, vomiting, diarrhea,
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Symptoms: Right thigh is swollen, red and hot to touch.  Treatment: Start Cephalexin Suspension 250mg/5mL Orally every 12hrs for 7days
Age: 30.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Injection site joint pain, Pain, Vaccination site movement impairment
Clinical narrative: Shoulder joint pain began on 3/23/2024, the day after the vaccination was administered. The night of 3/24/2024 and the following day (today), joint pain around the injection site became severe. Shoulder movement is limited and very painful.
Age: 30.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Shoulder joint pain began on 3/23/2024, the day after the vaccination was administered. The night of 3/24/2024 and the following day (today), joint pain around the injection site became severe. Shoulder movement is limited and very painful.
Age: 15.0
Sex: F
Vaccine: PNC15
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: Vaccine Error: A medical assistant administered PCV15 instead of HPV vaccination to the patient.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blister, Malaise, Pain, Pain in extremity
Clinical narrative: Started as a rash, then blisters then open sores (ulcers).  Absolutely horrible.   Very painful.  Dr. said at the time he seen an average of 3 -5 people per month but mine was the absolute worse that he had ever seen  He took pictures of my legs and shared with other doctors.  I used 3 creams and different times and had my legs and left foot wrapped in Saran Wrap for months.  The sick has finally healed but still dealing with my left foot on top being very sensitive.  Can't wear regular shoes.  Legs still hurt and sting.  I get infusions for for my legs.  This had made the arthritis worse for me as well.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Ulcer
Clinical narrative: Started as a rash, then blisters then open sores (ulcers).  Absolutely horrible.   Very painful.  Dr. said at the time he seen an average of 3 -5 people per month but mine was the absolute worse that he had ever seen  He took pictures of my legs and shared with other doctors.  I used 3 creams and different times and had my legs and left foot wrapped in Saran Wrap for months.  The sick has finally healed but still dealing with my left foot on top being very sensitive.  Can't wear regular shoes.  Legs still hurt and sting.  I get infusions for for my legs.  This had made the arthritis worse for me as well.
Age: 24.0
Sex: F
Vaccine: HEPAB, HPV9, IPV, MMR
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash
Clinical narrative: While waiting for vaccination record, patient noted itching on her rignt arm where the MMR was administered.  Patient noted redness around the immunization location.  No other injection site had redness noted. Patient denied shortness of breath or itching in the throat.  throat was examine and no swelling noted.  Lung sounds clear in all quadrants.  Patient complained to staff that itching had spread to the whole arm.  Verbal orders for Benadyl given by PA.  Patient was given 2 25mg  (50mg  total) of Benadryl by RN and patient was monitored for 30minutes Patient informed of signs and symptoms watch out for  and were given emergency department precaustions.  Patient's throat evaluated after Benadryl given, no swelling noted, lung sounds clear.  Rash on right arm dissipated.  Patient adviced to call center if they have questions.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event
Clinical narrative: No events reported.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema
Clinical narrative: Blister formation, redness beginning on March 20, 2024. Patient started on valacyclovir and Keflex.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: patient  got bruised around injection site
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Discomfort, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: On 03/22/2024 employee reports that she began to feel nauseous as she was driving home approximately  75 minutes after receiving Hepatitis B vaccine. Developed headache, dizziness and experienced itching at the injection site. She took acetaminophen and Benadryl which helped relieve itching and discomfort.  Employee presented to Occupational Health at approximately 0800 03/25/2024 to show me her left deltoid where she received Hepatitis B vaccine on Friday. 3.5 - 4.0 cm in diameter area of erythema, tenderness. No longer itching. Applied ice packs.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Nausea, Pruritus
Clinical narrative: On 03/22/2024 employee reports that she began to feel nauseous as she was driving home approximately  75 minutes after receiving Hepatitis B vaccine. Developed headache, dizziness and experienced itching at the injection site. She took acetaminophen and Benadryl which helped relieve itching and discomfort.  Employee presented to Occupational Health at approximately 0800 03/25/2024 to show me her left deltoid where she received Hepatitis B vaccine on Friday. 3.5 - 4.0 cm in diameter area of erythema, tenderness. No longer itching. Applied ice packs.
Age: 58.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Blood test, HIV test, Hepatitis A virus test, Hepatitis B virus test, Injury associated with device
Clinical narrative: PHARMACY TECHNICIAN ADMINISTERED BOTH VACCINES TO PT. AFTER ADMINISTERING BOTH VACCINES SHE ACCIDENTLY STUCK HERSELF WITH THE USED NEEDLE. THE PHARMACY TECHNICIAN STUCK HERSELF IN HER PINKY FINGER.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Patient reporting muscle spasms on the same arm and around the site of injection daily since receiving the vaccination. Patient was advised to also report to physician and seek physician advice/examination.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received a second RSV vaccine that was not indicated.  Patient received first RSV vaccine 10/19/2023.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Neck pain, Presyncope, Spinal X-ray normal
Clinical narrative: Patient extremely nervous before injections. Vaccines were administered, patient stayed seated in the exam room for approximately 15 minutes after injections. Upon exiting the clinic, patient had vasovagal episode in waiting room area. Mom was able to hold child up until a clinical staff member grabbed the child from mother and lowered her to the floor. Patient did not hit her head or have any injury from falling. Patient was evaluated and treated by a physician before leaving the clinic. Physician diagnosed as Vasovagal episode. Patient was complaining of neck pain afterwards. Physician did order neck XRay on patient. XRay results were normal.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with COVID-19 infection
Age: 71.0
Sex: F
Vaccine: HEP
Symptoms: Feeling hot, Flushing, Hypotension, Pruritus
Clinical narrative: Pt administered first dose of Hep B vaccine with pt consent. 5 minutes after pt recieved vaccine pt presented with itching, flushing, feeling warm, and hypotension, pt was given a saline bolus/flush, RN administered 50mg of benadryl IVP, symptoms were relieved after benadryl was administered. Vital signs stable and pt left the clinic in stbale condition.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Impaired work ability, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Day (3/18) of vaccine in the evening I felt sickly and tired.  Went to bed and did not wake up until next morning.  Went to work late as I felt groggy.  Arm felt like a weight was in it.  Soreness/Redness at injection site.  Hard to life arm to shoulder.  Injection site hot to touch.  On 3/23 very red, hot, and weird pattern.  That night took first benadryl.  3/24, still sore to touch and red.  took another benadryl that night.  3/25 upper arm area appears to be bruised, hot and sore to touch.  Feel yucky.  Informed clinic and civilian PCP - no return call or followup.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Limb discomfort, Malaise, Mobility decreased, Somnolence
Clinical narrative: Day (3/18) of vaccine in the evening I felt sickly and tired.  Went to bed and did not wake up until next morning.  Went to work late as I felt groggy.  Arm felt like a weight was in it.  Soreness/Redness at injection site.  Hard to life arm to shoulder.  Injection site hot to touch.  On 3/23 very red, hot, and weird pattern.  That night took first benadryl.  3/24, still sore to touch and red.  took another benadryl that night.  3/25 upper arm area appears to be bruised, hot and sore to touch.  Feel yucky.  Informed clinic and civilian PCP - no return call or followup.
Age: 16.0
Sex: F
Vaccine: MNQ, PNC20
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt given Prevnar 20 vaccine instead of Gardical 9. Noticed 10 days after vaccine was given while doing inventory. No adverse effects patients mom called left message for immediate call back.
Age: 16.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: wrong vaccination.
Age: 84.0
Sex: F
Vaccine: PNC20
Symptoms: Expired product administered
Clinical narrative: Patient was given expired dose of Prevnar 20 to right deltoid; Dose expired 01/2024.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: pt got the Spikevax vaccine 3-21-24.  The next day her arm was red and swollen.  She described the swelling as around 12 by 8cm on her arm.  She returned to the pharmacy on 3-24-24 around 3pm and showed the pharmacist on duty the arm and discussed her reaction.  Patient was instructed to go to an urgent care to be safe.  She went to urgent care and was prescribed cephalexin and was instructed to take Benadryl nightly until swelling goes down.  Pt Returned to pharmacy 3-25-24 and said that her swelling has gone down significantly and she feels much better.  Patient and urgent care are unsure if the cause was allergy related or an infection.
Age: 4.0
Sex: F
Vaccine: IPV, MMRV
Symptoms: Mycobacterium tuberculosis complex test, Rash
Clinical narrative: Patient presented to clinic for TB skin test reading. Mother shows this RN a full body rash on the child. Mother states Patient has had this happen after every vaccine she has received. Consulted with APN in clinic and counseled mother signs and symptoms of worsening allergic reaction and to use Benadryl per APN.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Injection site bruising, Injection site haemorrhage
Clinical narrative: Reports mild fatigue, black and blue bruising at injection site, with "pinholes in a few places that bled" for nearly a week. Patient reports no pain at injection site.  Encouraged her to reach out to PCP tomorrow if not improved; also faxed provider about this report and AE's reported with request to follow up with patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Erythema, Eye pruritus, Fatigue, Headache
Clinical narrative: Cold sore on left side of lip at time of injection, then 24 hours after vaccine I developed a low grade fever (99.9), sharp pains on left side of head, and fatigue. Then 48 hours after vaccine I developed more sores over left lip and chin below lip (large, red and painful), sores inside mouth on left side only (roof of mouth, tongue, and inside left cheek), painful teeth on left side, painful cheekbone (left) with small red sore on left cheek. All continued getting worse with each day, then 5 days after vaccine, left eye became red and itchy.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia, Oral herpes, Pain, Toothache
Clinical narrative: Cold sore on left side of lip at time of injection, then 24 hours after vaccine I developed a low grade fever (99.9), sharp pains on left side of head, and fatigue. Then 48 hours after vaccine I developed more sores over left lip and chin below lip (large, red and painful), sores inside mouth on left side only (roof of mouth, tongue, and inside left cheek), painful teeth on left side, painful cheekbone (left) with small red sore on left cheek. All continued getting worse with each day, then 5 days after vaccine, left eye became red and itchy.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site coldness, Injection site hypoaesthesia, X-ray limb normal
Clinical narrative: Left shoulder, numbness, and coldness. Warm compress, acetaminophen, ibuprofen, tapping, movement, did not help.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: patient came to the store because the area surrounding the injection site was slightly red and itchy - I advised her this is not uncommon with this vaccination - she can apply ice or a cold pack intermittently if she wants to. I said it wouldn't surprise me and I wouldn't be concerned if it's still slightly red and somewhat itchy for a few more days.
Age: 74.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: my facility is not the one who provided patient with the vaccine so i do not have all the information. Patient came to us due to the reaction. the patient was given vaccine on the L deltoid on 3/22/2024. on sunday 03/24/2024 granddaughter noticed that the area was a golf ball size  and then this morning 03/25/2024  it has spread to a 3.5 inch x6 inch width that has been marked by granddaughter. it is warm and hot to the touch, red, hard nodule to the area.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging ear, Magnetic resonance imaging normal, Tinnitus
Clinical narrative: Noise in my ears. Started off soft but now its loud and annoying. This started around 2/2/24. I went ot the ER, they said it was tinnitus and referred to ENT. ENT gave me an MRI that showed nothing there. ENT said tinnitus as well.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: no symptoms show during the observation period.
Age: 51.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site erythema, Pain in extremity
Clinical narrative: On March 18th, 2024, the patient received a pneumococcal vaccination in the left deltoid region. Following the vaccine administration, the patient reported experiencing mild soreness in her arm, which is a known and common side effect of such immunizations. However, on March 23rd, the patient observed the development of redness in the injection site area. Consequently, the patient sought guidance from the patient advisory nurse, who recommended that the patient seek medical attention at a nearby convenient care. During the medical evaluation, the attending healthcare provider, documented the patient's symptoms and determined that the patient was likely experiencing an allergic reaction to the vaccine. The healthcare provider initiated a course of treatment with Cephalexin.
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Bundle branch block left, Dyspnoea, Electrocardiogram abnormal, Fatigue, Heart rate decreased
Clinical narrative: EXTREME FATIGUE DEVELOPED IN THE MONTHS AFTER HER FIRST PFIZER BOOSTER (FALL 2023 SERIES) (PREVIOUS VACCINES AND BOOSTER WAS MODERNA), AS WELL AS SHORTNESS OF BREATH, HEART RATE WHICH HAS BEEN REGULARLY MEASURED 4X/WEEK FOR YEARS SUDDENLY WAS CONSISTENTLY 30 BPMS LOWER THAN NORMAL.
Age: 1.0
Sex: M
Vaccine: UNK, UNK, UNK, UNK, UNK
Symptoms: Circumstance or information capable of leading to medication error, Product lot number issue
Clinical narrative: Scanned vaccines to be given to patient, proceeded to patient room, verified patient name/ DOB, injected patient with vaccines, I documented vaccines accidentally clicked Lot # out of Varicella vaccine, proceeded to document site given, accept as incomplete, went to med room and put Vaxieles Lot # into Varicella Lot #.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Culture wound, Vaccination site papule, Vaccination site ulcer
Clinical narrative: Small papule at vaccination site following vaccination. I saw this patient 6 months after the vaccine (3/25/24) and this had developed into an ulcer 2cm x 1cm
Age: 5.0
Sex: F
Vaccine: DTAP, DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Quadracel and Infanrix given on 3/22/24 together.
Age: 1.0
Sex: M
Vaccine: COVID19, FLU4, HEPA, MMRV
Symptoms: Product preparation error
Clinical narrative: Patient was given undiluted Pfizer 6m-4year vaccine.
Age: 1.25
Sex: M
Vaccine: HEPA, PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient presented to the office 2 days after receiving the vaccinations with redness swelling and induration to the outer right thigh just lateral to the injection sites.  The redness and swelling did not encompass the injection sites.  The reaction was local.  There is no obvious pain or itching.  The patient has had no fever no other symptoms acting normal per baseline. I marked the outer borders of the redness with a sharpie marker and sent in a watch and wait antibiotic of Keflex with instructions to initiate the antibiotic over the weekend if the redness spread outside of the marked borders
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Administration error. Administered 12 and older formulation to 10 year old child
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Morbillivirus test positive, Nasopharyngeal swab, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Pt. was reported to our LHJ on 3/14/24 by hospital with a concern for possible measles.  It was reported that pt. had been recently vaccinated and did not have any epidemiologic risk factors or any known exposures to someone with measles.  In talking with pt.'s mother it was reported that pt. had been sick on and off with a respiratory illness and ear infections for the last month.  Pt. developed a fever of 101.4 on 3/08/24.  Parents able to control fever with anti-puretics.  Pt. developed maculopapular rash on face on 3/12/24 which then spread all over his body.  Hospital collected NP and urine for testing.  MeVa PCR testing required due recent vaccination.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Urine analysis
Clinical narrative: Pt. was reported to our LHJ on 3/14/24 by hospital with a concern for possible measles.  It was reported that pt. had been recently vaccinated and did not have any epidemiologic risk factors or any known exposures to someone with measles.  In talking with pt.'s mother it was reported that pt. had been sick on and off with a respiratory illness and ear infections for the last month.  Pt. developed a fever of 101.4 on 3/08/24.  Parents able to control fever with anti-puretics.  Pt. developed maculopapular rash on face on 3/12/24 which then spread all over his body.  Hospital collected NP and urine for testing.  MeVa PCR testing required due recent vaccination.
Age: 52.0
Sex: F
Vaccine: HEPA, VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received Havrix (hep A) and Shingrix (shingles) on 3/18/24. She reported to me on 3/25/24 stating that allergic reaction symptoms started the day before on 3/24/24. I was puzzled as to why it took a week for any side effects to occur. She insisted that she had no issues during the week between administration and yesterday. She had redness, slight swelling, itching, and dull/achy pain of the injection site area. I advised her to continue to use an ice pack, oral benadryl, and oral acetaminophen to help with the symptoms. And I advised her to report to her doctor in a few days if symptoms do not improve.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; inadvertent administration of VARIVAX to multiple patients after a temperature excursion; 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 21-FEB-2024, the patient was inadvertently administered with an improperly storage dose of varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, lot #X021284, expiration date: 20-AUG-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). Temperature was at  (-) 13.1C for 18 minutes. No previous temperature excursion occurred. No additional adverse event was reported.   This is one of several reports from the same reporter.
Age: 4.0
Sex: U
Vaccine: HIBV, PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient was vaccinated with improper storage dose of LIQUID PEDVAXHIB and VAXNEUVANCE; This spontaneous report was received from a nurse practitioner and refers to a 4-year-old patient of unknown gender with no illness at the time of vaccination. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported.  On 04-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion of at total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes.  On 13-DEC-2023, the patient was vaccinated with an improperly storage dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, lot # X003664, expiration date 10-NOV-2025 (also reported as 12-NOV-2025),  and improperly storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), intramuscularly, lot # X019438, expiration date 07-NOV-2025 (also reported as 30-AUG-2025), both vaccines for prophylaxis (product storage error). The temperature excursion occurred because of a reading from Digital Data Logger in the vaccines' storage in clinical practice. There was no adverse event.  This is one of several reports from the same reporter.     ; Sender's Comments:  US-009507513-2403USA004981: US-009507513-2403USA004979: US-009507513-2403USA004978: US-009507513-2403USA004977: US-009507513-2403USA004976: US-009507513-2403USA004975: US-009507513-2403USA004975: US-009507513-2403USA004974: US-009507513-2403USA004980: US-009507513-2403USA004999: US-009507513-2403USA004998: US-009507513-2403USA004997: US-009507513-2403USA004996: US-009507513-2403USA004995: US-009507513-2403USA004994: US-009507513-2403USA004993: US-009507513-2403USA004986: US-009507513-2403USA004992: US-009507513-2403USA004991: US-009507513-2401USA016206: US-009507513-2403USA004989: US-009507513-2403USA005000: US-009507513-2403USA004987: US-009507513-2403USA004990: US-009507513-2403USA005306: US-009507513-2403USA005307: US-009507513-2403USA005308: US-009507513-2403USA005309: US-009507513-2403USA005305: US-009507513-2403USA005311:
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 12-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 08-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 18-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 13-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 12-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 15-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 12-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 08-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 5-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 25-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 6.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 5-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 25-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 5-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 06-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 18-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 10-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 4-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 30-OCT-2023 , the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) 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
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 14-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 25-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 18-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 20-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 12-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 25-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 15.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 15-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 25-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 8.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 8-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 25-OCT-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 6.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 6-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 17-JAN-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 10.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 10-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 13-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperature excursion; This spontaneous report was received from an nurse practitioner and referred to a 11-year-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 15-NOV-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, lot #W031980, expiration date was reported as 24-OCT-2024 but upon internal validation established as 06-OCT-2024, administered subcutaneously for prophylaxis (strength, dose and anatomical site of administration were not provided). The administered vaccine was exposed to the multiple temperature excursions from 19-OCT-2023 to 22-JAN-2024 (product storage error). There were no prescription drug for the experience. No additional adverse event (AE) reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2401USA016206:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer reported that VARIVAX was administered to one consumer following a temperature excursion; This spontaneous report was received from Nurse Practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-FEB-2024, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) Lot#: X023323, expiration date: 20-SEP-2025 (strength, dose, dose number, route, and anatomical location were not provided) administered for prophylaxis.  It was reported that excursion was still ongoing at the time of the call and the product was not back in range. The temperature was 41°F and time frame was 72 hours (at time of administration). There was no previous temperature excursión. No additional adverse event was reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE.; her third dose on 3/12/2024; This spontaneous report was received from a office manager and referred to a female patient with unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  The patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection on 29-AUG-2019 (strength, dose, anatomical location, route of administration, lot and expiration date unknown) for prophylaxis, her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection was on 05-NOV-2019 (strength, dose, anatomical location, route of administration, lot and expiration date unknown).  On 12-MAR-2024, the patient received her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (lot: w014479, expiration date was not provided but upon internal validation established as 16-DEC-2024, strength, dose, anatomical location, route of administration were not provided)  (Inappropriate schedule of product administration). No other adverse event (AE) occurred (No adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; Caller reported AE on behalf of a patient who was administered improperly stored VARIVAX on 2/22/2024.; 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 22-FEB- 2024, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X021281, expiration date: 20-AUG-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 of 10.2 Fahrenheit (F) degrees/ 6 F up to 14 F degrees for 18 minutes. No additional adverse event was reported (no adverse event).