chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dyskinesia, Ear infection, Eczema, Food allergy, Gastrooesophageal reflux disease
Clinical narrative: Went limp and was staring into space.  Couldn't get his attention.  Later, his limbs kept going stiff and jerking.  He stopped rolling over that day.  He stopped pushing up on his arms that day.  He stopped babbling that day.  He didn't regain any of those skills until he was almost 11 months old.  He started developing severe recurring ear infections within a week.  He developed severe eczema.  His GERD was out of control.  He developed an anaphylactic allergy to eggs that sent him to the ER the first time he tried eggs at 9 months, and we also found out he was allergic to peanuts.  He developed progressive infantile scoliosis and laryngomalacia.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonia, Laryngomalacia, Mobility decreased, Musculoskeletal stiffness, Scoliosis
Clinical narrative: Went limp and was staring into space.  Couldn't get his attention.  Later, his limbs kept going stiff and jerking.  He stopped rolling over that day.  He stopped pushing up on his arms that day.  He stopped babbling that day.  He didn't regain any of those skills until he was almost 11 months old.  He started developing severe recurring ear infections within a week.  He developed severe eczema.  His GERD was out of control.  He developed an anaphylactic allergy to eggs that sent him to the ER the first time he tried eggs at 9 months, and we also found out he was allergic to peanuts.  He developed progressive infantile scoliosis and laryngomalacia.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Staring
Clinical narrative: Went limp and was staring into space.  Couldn't get his attention.  Later, his limbs kept going stiff and jerking.  He stopped rolling over that day.  He stopped pushing up on his arms that day.  He stopped babbling that day.  He didn't regain any of those skills until he was almost 11 months old.  He started developing severe recurring ear infections within a week.  He developed severe eczema.  His GERD was out of control.  He developed an anaphylactic allergy to eggs that sent him to the ER the first time he tried eggs at 9 months, and we also found out he was allergic to peanuts.  He developed progressive infantile scoliosis and laryngomalacia.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Tendonitis
Clinical narrative: Upper arm pain with motion that has lasted 4 weeks.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Inflammation, Joint range of motion decreased, Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: The patient had arm pain, swelling, limited range of motion, pt had received pneumonia shot and flu shot at same site, of right arm on 11/14. The patient had acute severe local reaction to immunization,  no abscess identified, just diffuse inflammatory changes.
Age: 11.0
Sex: F
Vaccine: DTAP, FLU4, TDAP
Symptoms: Blood test, Chest X-ray, Cough, Pulmonary function challenge test
Clinical narrative: Developed cough few days after vaccine, Barky, dry, persistent cough. 4 months later, she still cough. Saw allergy, asthma, and lung specialist. Treated with 3 sets antibiotics, 4 different cough syrups, double doses of steroids, Singulair, asthma inhalers, nothing helped.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient developed a large rash at injection site on the back or her upper right arm which she thought was cellulitis.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody, Arthralgia, Back pain, Borrelia test, C-reactive protein increased
Clinical narrative: Started with general muscle soreness in the evening on 11/27/14. Pain of the top of left hand and right shoulder through the night requiring 2 ibuprofen and ultimately a Tylenol PM to be able to sleep.  Pain and swelling progressed over the next day or two with swelling of hands and feet with muscle and joint pains especially behind the knees with difficulty with motion.  Pain became so severe that I was barely able to walk on 12/3/14.  I presented to the walk-in where they told me to see my own physician the following day.  I presented to my physician's office the following day and had labs done and prescribed naproxen and a 5 day course of steroids.  The steroids did help but the condition returned.  I was told to change my thyroid from 88 to 100.  The condition worsened so I presented to the ER on 12/11/15 who suggested seeing a rheumatologist. My thyroid labs continued to deteriorate.  I returned to my physician again on 12/15/14 with no improvement.  My labs showed an increased C-reactive protein and my thyroid was off.  My thyroid was again increased to 125 and I was given and increase in my vitamin D.  More labs for thyroid antibodies were done but the condition was not improving.  I again went to the walk-in on 12/21/14 as the edema of my feet was still severe.  I was prescribed hydrochlorothiazide.  Eventually the swelling disappeared.  The joint pains lingered but did improve.  I am continuing to have thyroid issues with pain still in back, hips and shoulders.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Full blood count, Gait disturbance, Metabolic function test, Mobility decreased
Clinical narrative: Started with general muscle soreness in the evening on 11/27/14. Pain of the top of left hand and right shoulder through the night requiring 2 ibuprofen and ultimately a Tylenol PM to be able to sleep.  Pain and swelling progressed over the next day or two with swelling of hands and feet with muscle and joint pains especially behind the knees with difficulty with motion.  Pain became so severe that I was barely able to walk on 12/3/14.  I presented to the walk-in where they told me to see my own physician the following day.  I presented to my physician's office the following day and had labs done and prescribed naproxen and a 5 day course of steroids.  The steroids did help but the condition returned.  I was told to change my thyroid from 88 to 100.  The condition worsened so I presented to the ER on 12/11/15 who suggested seeing a rheumatologist. My thyroid labs continued to deteriorate.  I returned to my physician again on 12/15/14 with no improvement.  My labs showed an increased C-reactive protein and my thyroid was off.  My thyroid was again increased to 125 and I was given and increase in my vitamin D.  More labs for thyroid antibodies were done but the condition was not improving.  I again went to the walk-in on 12/21/14 as the edema of my feet was still severe.  I was prescribed hydrochlorothiazide.  Eventually the swelling disappeared.  The joint pains lingered but did improve.  I am continuing to have thyroid issues with pain still in back, hips and shoulders.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: Started with general muscle soreness in the evening on 11/27/14. Pain of the top of left hand and right shoulder through the night requiring 2 ibuprofen and ultimately a Tylenol PM to be able to sleep.  Pain and swelling progressed over the next day or two with swelling of hands and feet with muscle and joint pains especially behind the knees with difficulty with motion.  Pain became so severe that I was barely able to walk on 12/3/14.  I presented to the walk-in where they told me to see my own physician the following day.  I presented to my physician's office the following day and had labs done and prescribed naproxen and a 5 day course of steroids.  The steroids did help but the condition returned.  I was told to change my thyroid from 88 to 100.  The condition worsened so I presented to the ER on 12/11/15 who suggested seeing a rheumatologist. My thyroid labs continued to deteriorate.  I returned to my physician again on 12/15/14 with no improvement.  My labs showed an increased C-reactive protein and my thyroid was off.  My thyroid was again increased to 125 and I was given and increase in my vitamin D.  More labs for thyroid antibodies were done but the condition was not improving.  I again went to the walk-in on 12/21/14 as the edema of my feet was still severe.  I was prescribed hydrochlorothiazide.  Eventually the swelling disappeared.  The joint pains lingered but did improve.  I am continuing to have thyroid issues with pain still in back, hips and shoulders.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Prothrombin time, Thyroid function test abnormal, Troponin, Urine analysis, Vitamin D
Clinical narrative: Started with general muscle soreness in the evening on 11/27/14. Pain of the top of left hand and right shoulder through the night requiring 2 ibuprofen and ultimately a Tylenol PM to be able to sleep.  Pain and swelling progressed over the next day or two with swelling of hands and feet with muscle and joint pains especially behind the knees with difficulty with motion.  Pain became so severe that I was barely able to walk on 12/3/14.  I presented to the walk-in where they told me to see my own physician the following day.  I presented to my physician's office the following day and had labs done and prescribed naproxen and a 5 day course of steroids.  The steroids did help but the condition returned.  I was told to change my thyroid from 88 to 100.  The condition worsened so I presented to the ER on 12/11/15 who suggested seeing a rheumatologist. My thyroid labs continued to deteriorate.  I returned to my physician again on 12/15/14 with no improvement.  My labs showed an increased C-reactive protein and my thyroid was off.  My thyroid was again increased to 125 and I was given and increase in my vitamin D.  More labs for thyroid antibodies were done but the condition was not improving.  I again went to the walk-in on 12/21/14 as the edema of my feet was still severe.  I was prescribed hydrochlorothiazide.  Eventually the swelling disappeared.  The joint pains lingered but did improve.  I am continuing to have thyroid issues with pain still in back, hips and shoulders.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Significant pain, swelling, unable to lift arm in which vaccine was given. Fever to 102 shortly after receiving vaccine.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: DONOR NOTED A LUMP TO INJECTION SITE ON RIGHT DELTOID WHEN SHE RETURNED HOME. AN AREA OF REDNESS FORMED. AREA WARM AND HARD. SHE HAS NOT DONE ANY TREATMENT. SHE IS ADVISED TO SEEK MEDICAL TREATMENT IMMEDIATLEY.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Confusional state, Erythema, Inflammation, White blood cell count increased
Clinical narrative: The patient became confused, had red arm, high WBC and had pneumonia injection day prior.  The patient was determined to have an inflammatory response and possible cellulitis from vaccination.  It was treated with Ancef and then Keflex.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Soft tissue infection
Clinical narrative: Left forearm soft tissue infection at site of previous pneumax IM injection.  Pt tx with doxy with no improvement, admitted to hospital for IV antibiotic therapy with clindamycin (patient with penicillin allergy).
Age: 34.0
Sex: M
Vaccine: DTAP
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test positive
Clinical narrative: Sore Throat, High Fever, Positive Test for Strep Throat.
Sex: U
Vaccine: TDAP
Symptoms: Monoplegia, Paralysis
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of arm paralysis in a patient who received BOOSTRIX. On 1st October 2014, the patient received BOOSTRIX. On 2nd October 2014, 1 days after receiving BOOSTRIX, the patient experienced arm paralysis (serious criteria GSK medically significant) and paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the arm paralysis were not recovered/not resolved. It was not reported if the reporter considered the arm paralysis and paralysis to be related to BOOSTRIX. Additional information was provided: The patient could not move half of their digits in their left arm and it progressed to the entire left arm. This AE has not resolved no medical interventions have been provided to the patient yet the MD will be getting an MRI for the patient. RN refused to report the AE at the time of the call due to uncertain causality and stated they would call back.
Age: 55.0
Sex: F
Vaccine: FLUC3
Symptoms: Erythema, Paraesthesia, Skin warm
Clinical narrative: 3 days after receiving vaccine - both hands -starting become hot and red occurring multiple times a day-and would last up to 5 min. Initially occurred daily the occurring-less after-but after receiving MMR started occurring-and symptoms went to both feet and tingling along with periods when hands would become hot/red.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ, oral (dose, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Decreased appetite, Irritability, Otitis media acute, Pyrexia
Clinical narrative: Fever 3/3, 3/4 (103/5), 3/5 (100.3); given TYLENOL. Seen in office 3/5, temp 101. Dx w/acute otitis media-put on amoxicillin. Pt. very fussy, and not eating well. 3/7 went to ER, still not eating well, less wet diapers, and very fussy-course with eating. Xray completed showed possible ileus. Follow up appt. 3/9-slight improvement in sx.
Age: 0.59
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: Fever 3/3, 3/4 (103/5), 3/5 (100.3); given TYLENOL. Seen in office 3/5, temp 101. Dx w/acute otitis media-put on amoxicillin. Pt. very fussy, and not eating well. 3/7 went to ER, still not eating well, less wet diapers, and very fussy-course with eating. Xray completed showed possible ileus. Follow up appt. 3/9-slight improvement in sx.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Dysstasia, Erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: By noon, soreness and warm to touch. Pt exercised arm throughout day. By 1630, site swollen to size of dime. Took OTC ADVIL, but increased soreness. Could not sleep on arm. Morning after, swelling size of quarter and hot to touch. Drew circle around erythema, increased redness exceeded circle. Swelling and soreness manageable by 9Mar15.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Hypertension, Palpitations, Pyrexia, Vomiting
Clinical narrative: Pt's mom states pt had reaction for flu vaccine; fever 103.1, heart palpitation fast, blood pressure high, also vomiting.
Age: 28.0
Sex: F
Vaccine: MENB
Symptoms: Chest X-ray, Full blood count, Wheezing
Clinical narrative: Wheezing on exam.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Arthralgia, Body temperature increased, Chills, Feeling abnormal, Mobility decreased
Clinical narrative: Received HPV (#2) flu vaccine 1/12/15. Woke up that night shivering, temp 100.5, c/o trouble moving hips/pain in hips, vomited x1 stayed home next day because legs felt wierd. Then full recovery next day.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Vomiting
Clinical narrative: Received HPV (#2) flu vaccine 1/12/15. Woke up that night shivering, temp 100.5, c/o trouble moving hips/pain in hips, vomited x1 stayed home next day because legs felt wierd. Then full recovery next day.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: C-reactive protein increased, Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica symptoms onset within days of receiving vaccination. Resulted in MD visit, elevated C-reactive enzymes and steroid therapy for pain.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Guillain-Barre syndrome, Mobility decreased, Oropharyngeal pain, Vision blurred, Walking aid user
Clinical narrative: Two days after vac. left arm could not lift. Lasted another day then could not move right arm. Has continued to move back and forth between arms, hands, knees, legs, wrists, ankles, sore throat every several days. Right and left fingers. Left eye blurry. Two separate days was not able to walk without assistance. 1-6-15-ongoing.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection was pink, warm and swollen.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Brain natriuretic peptide increased, Cardiac failure congestive, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Patient was given PREVNAR 13 at a morning appt. That evening developed shortness of breath and went to the ED. Subsequent had 2 more ED visits for SOB. The last one was admitted to hospital with mild CHF. Echo showed 45-50% global hypokinesis.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Ventricular hypokinesia
Clinical narrative: Patient was given PREVNAR 13 at a morning appt. That evening developed shortness of breath and went to the ED. Subsequent had 2 more ED visits for SOB. The last one was admitted to hospital with mild CHF. Echo showed 45-50% global hypokinesis.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: Information has been received from a physician via a literature article, concerning a female who on an unknown date was vaccinated with a dose of GARDASIL 0.5 ml, (dose number, lot#, application site and route were not reported). On an unknown date the patient had a premature birth. The Last Menstrual Period and Estimated Date of Delivery were unknown. The outcome of event was unknown. The investigator considered premature birth to be related to GARDASIL. Upon internal review premature birth was considered to be an other important medical event. Follow-up information was received in a published literature on 02-MAR-2015. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: Information has been received from a physician via a field representative referring to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ (strength, dosage and lot# not reported) orally. On an unknown date the patient was diagnosed with rotavirus after receiving ROTATEQ. The patient was hospitalized on an unspecified date. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect DOB given on patient encounter and in EHR and child was given a 0.5 mg dose on 12/3/14. It was later found that child was under 3 years of age on 12/3/14. Administering Nurse was unaware that DOB was incorrect at time of visit. The correct date of birth was found out on 12/30/14 once client returned for a 2nd visit.
Age: 34.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain
Clinical narrative: Given too high on the shoulder and patient has had pain for >10 days.
Age: 0.2
Sex: U
Vaccine: RV1
Symptoms: Wrong technique in drug usage process
Clinical narrative: Dr. ordered ROTARIX, active ingredient not mixed with diluent, diluent only given to patient.
Age: 1.4
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient needed influenza vaccine. I checked the 2014 Recommended Immunization Schedules for Persons Aged 0 through 18 years under to verify that the patient would need 2 vaccines because he had never had one before. I found #8 Influenza Vaccine and dropped down to the section for children aged 6 months to 8 years. Because I was looking for that specific information, I did not read the section that told the minimum age for the live virus. When I got the vaccine out of the box, there was not an age range on it as there is on the FLUZONE boxes. I had never been told the minimum age is 2 years and only discovered this when I received a fax from an insurance company that had the information on it. I reported to the state as soon as I discovered it and they contacted the manufacturer and found out that it is a valid dose event tho they do not recommend it for under age 2 years.
Age: 4.0
Sex: U
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Live vaccine given less than 28 days following other live vaccines.
Age: 56.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: At a community flu shot clinic, patient received high dose vaccine even though they were not yet 65 years old. Contacted patient in 48 hours and patient reported no unusual discomforts or adverse effects from the flu shot. Stated just  like "last year's" flu shot.
Age: 0.6
Sex: U
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Nurse called out for emergency and second nurse gave BOOSTRIX that was handed to her instead of DTaP.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given 0.5ml dose instead of 0.25ml dose.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was in office and mother requested Flu shot for pt. Pt was given vaccine for 3 years plus but pt was 2 years old. Incident was discussed with MD and mother to be informed.
Age: 15.0
Sex: U
Vaccine: FLUN4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client had just received MMR on 10/25/14, then was given FLUMIST 11/5/14. Had not been 30 days in between live immunizations.
Age: 8.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient is 8 years DTap for 6 years and under should have got Tdap instead.
Age: 3.0
Sex: U
Vaccine: MMR, PNC13
Symptoms: Drug dispensed to wrong patient
Clinical narrative: Nurse gave vaccines for sibling to this patient.
Age: 0.3
Sex: U
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: HPV was mistakenly ordered using the EHR template for ordering vaccines, which lists vaccines alphabetically. The medical assistant did not recognize the error, and administered the vaccination, in place of HIB, which was the intended vaccination.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Requested proper dose in writing, filed proper paperwork and that indicated hi dose be given and still administered low dose without advisement or choice prior notice!
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child was given the 3+ vaccine as that is what sibling was receiving. Vaccine that the child should have received was the 6-35 month product. Boxes and syringes similar in appearance just slightly different coloring. It was confusing as well as estimating child's age to be 3.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient is 2 years old. Received a 3 years and older dose.
Age: 13.0
Sex: M
Vaccine: HPV2
Symptoms: Wrong drug administered
Clinical narrative: The patient is a male and CERVARIX was given to him instead of GARDASIL. We called the patient to come in to receive a GARDASIL vaccine.
Age: 12.0
Sex: M
Vaccine: HPV2
Symptoms: Wrong drug administered
Clinical narrative: The male patient was given CERVARIX instead of GARDASIL.
Age: 17.0
Sex: M
Vaccine: HPV2
Symptoms: Wrong drug administered
Clinical narrative: The male patient was given CERVARIX instead of GARDASIL.
Age: 13.0
Sex: M
Vaccine: HPV2
Symptoms: Wrong drug administered
Clinical narrative: The male patient was given CERVARIX instead of GARDASIL.
Age: 67.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Td ordered, ADACEL given.
Age: 12.0
Sex: U
Vaccine: MMR
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered MMR, and staff gave MMR. Patient should have received MCV.
Age: 57.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Wrong drug administered
Clinical narrative: Client given High Dose instead of Regular flu vaccine. Regular flu and High Dose vaccine container bins had been moved/switched.
Age: 57.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Client given High Dose instead of Regular flu vaccine. Regular flu and High Dose vaccine container bins had been moved/switched.
Age: 21.0
Sex: U
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: High Dose Flu given instead of regular dose.
Age: 60.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Wrong drug administered
Clinical narrative: High dose flu given instead of regular flu vaccine, vaccine container bins had been switched/swapped from their original locations.
Age: 60.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: High dose flu given instead of regular flu vaccine, vaccine container bins had been switched/swapped from their original locations.
Age: 8.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Wrong drug administered
Clinical narrative: High dose flu given instead of regular flu vaccine, vaccine container bins had been switched/swapped from their original locations.
Age: 8.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: High dose flu given instead of regular flu vaccine, vaccine container bins had been switched/swapped from their original locations.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 2 1/2 year old received an adult dosage influenza vaccine. Nurse was distracted by sibling who was crying and thought he was getting a shot. Nurse was trying to reassure him it wasn't for him, but for sister. Nurse then grabbed adult vaccine and administered to the toddler. After administering it, nurse realized what happened. Informed mother of toddler what occurred. Nurse immediately notified provider. Provider then went in to talk to mother of possible risks and would follow up with CDC recommendations.
Age: 5.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Provider ordered ADACEL and staff gave ADACEL. Patient should have had DAPTACEL ordered and given.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given 0.25ml of Flu vaccine.
Age: 55.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received flu vaccine on 10/30/2014 and 12/3/2014.
Age: 27.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Pt was given flu vaccine on 12/2/2014 and 12/10/2014.
Age: 15.0
Sex: U
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Pt given 0.25ml of flu vaccine.
Age: 54.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 54 y/o patient given high dose flu.
Age: 1.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.5ml of flu vaccine. Wronf dose-over dosage.
Age: 0.2
Sex: U
Vaccine: DTAPIPV, PNC13, RVX
Symptoms: Incorrect product formulation administered
Clinical narrative: PENTACEL, PREVNAR, Hep B and Rotavirus ordered. Patient received Rotavirus, PREVNAR, received only the DTaP/IPV of PENTACEL, received only the sterile diluent to be used with Hib. Patient did not receive Hep B or Hib.
Age: 37.0
Sex: U
Vaccine: FLUN4
Symptoms: Syringe issue
Clinical narrative: The plunger on the FLUMIST didn't allow for 50/50 distribution in each nostril. FLUMIST sales rep notified and lot number shared.
Age: 6.0
Sex: U
Vaccine: FLUN4
Symptoms: Syringe issue
Clinical narrative: The plunger on the FLUMIST malfunctioned and didn't allow for 50/50 distribution in each nostril. FLUMIST rep notified and lot number shared.
Age: 9.0
Sex: U
Vaccine: FLUN4
Symptoms: Syringe issue
Clinical narrative: The plunger on the FLUMIST malfunctioned and didn't allow for 50/50 distribution in each nostril. The FLUMIST rep was notified and lot # shared.
Age: 18.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was givem to a male patient, while it should be given to the female patient only.
Age: 11.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX wsa given to a male patient, while it should be given to the female patients only.
Age: 11.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient, while it should be given to the female patients only.
Age: 15.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient, while it should be given to the female patients only.
Age: 4.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Medical assistant did not check expiration date of vaccine. Expired vaccine left in refrigerator.
Age: 2.0
Sex: U
Vaccine: DTAPHEPBIP, HEP, IPV
Symptoms: Extra dose administered
Clinical narrative: Health aide was planning to give DTaP, polio, and Hep B. Give polio and Hep B and give the combo PEDIARIX for INFANRIX (DTaP) so child received extra doses of polio and Hep B.
Age: 30.0
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: I wanted to report this possible error which in case of a recall could have been disastrous or an adverse reaction. The lot# on the FLUZONE had an I and 1 next to each other. "I1" which on the bottle can easily by mistaken by nurses and those entering the vaccines into our system.  I was hoping manufacturing companies would know to not confuse people with I versus 1 and just for the future to never confuse person with 0 versus O as well.
Age: 1.8
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Rotavirus given to 21 month old outside of max age limit.
Age: 1.9
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient given Influenza vaccine, Intranasal at 1 year, 11 months.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: MMR and Varicella ordred. PROQUAD and Varicella given.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: MMR and Varicella ordered. PROQUAD and Varicella given.
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: Pt given PPV23 on 10/8/14 and 10/29/14.
Age: 9.0
Sex: U
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Wrong dose-under dosage.
Age: 10.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Wrong dose-under dosage.
Age: 1.0
Sex: U
Vaccine: HBHEPB, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Hib-HepB and MENACTRA incorrectly ordered. Hib and MENACTRA were given. Manufacturer called since patient was too young to received MENACTRA. Pt needs to return for MMR and Varicella.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt given PROQUAD and Varicella.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt given varicell and PROQUAD.
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Wrong dose-under dosage.
Age: 74.0
Sex: U
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt given PREVNAR 13 vaccine on 9/24/14 and 10/15/2014.
Age: 2.9
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: Nurse gave wrong dose and wrong formulation to a two year old.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: High dose flu vaccine was administered to a person 62 years old. Wrong dose-over dosage.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered
Clinical narrative: FLUZONE HIGH DOSE was given to a person 60 years of ago. Wrong dose-over dosage.
Age: 1.6
Sex: U
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site
Clinical narrative: Flu shot was administered in the glut. Wrong administration site (e.g. gluteus maximus rather than the deltoid).
Age: 25.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was administered the MenCYW component of the MENVEO vaccine only.
Age: 1.0
Sex: U
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered FLUMIST to patient under 2 yrs of ago. Wrong age (patient not correct age for vaccine given).
Age: 1.4
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was ro receive 1st dose of Varicella and 1st dose of MMR. Accidentally gave PROQUAD MMRV (which is a new vaccine to our clinic) instead if MMR and Varicella. The PROQUAD MMRV has Varicella in it, so pt received a double dose of Varicella. This was reported to my supervisor, the the pt's PCP and an occurrence report was filed. I informed pt's mother of mistake. She said that the pt is doing fine and was not having any adverse reactions.
Age: 24.0
Sex: U
Vaccine: FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Tendonitis
Clinical narrative: Vaccine was injection into the bursa rather than the deltoid. It caused bursitis and tendinitis. Wrong administration site (e.g, gluteus maximus rather than the deltoid).
Age: 87.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: An 87 yo patient was given two doses of FLUZONE- HIGH DOSE. One on 9/3/14 and one one 12/10/14.
Age: 0.8
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered
Clinical narrative: Wrong dose of vaccine, for patient age given. Nurse aware of different formulation of flu vaccine for specific patient ages.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients who on unspecified dates were vaccinated with doses of PROQUAD (Merck) (route, dose and lot # not reported) which were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a consumer refers on behalf of himself as a 42 year old male patient. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced malaise. Action taken was not applicable. The outcome of malaise was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (Certified Medical Assistant) referring to a patient of unknown age and gender. On 27-JAN-2015 the patient was vaccinated with a dose of GARDASIL which was post non-supported excursion (lot # K005083, expire date, 04-NOV-2016, dose and route were not reported). No adverse effects were noted. This is one of several cases reported by the same reporter. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Pt received PREVNAR-13 vaccine on 2-9-15, then developed gradually worsening rash on upper left arm around injection site. The rash was characterized by itchiness, swelling, redness, pain, and dryness. By 2-17-15 the rash covered most of her upper arm. Pt scheduled appt with PCP.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Pt received PREVNAR-13 vaccine on 2-9-15, then developed gradually worsening rash on upper left arm around injection site. The rash was characterized by itchiness, swelling, redness, pain, and dryness. By 2-17-15 the rash covered most of her upper arm. Pt scheduled appt with PCP.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker professional refers to an unspecified number of patients of unknown age and gender. Since 20-FEB-2015, the patients were vaccinated with ZOSTAVAX which was improperly stored and administered (dose, route of administration and lot # were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB) (dose, route, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, unspecified patients were vaccinated with an improperly stored dose of GARDASIL (dose, route, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 03-Nov-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Area of erythema measuring 7" x 8" (L) deltoid with induration, warm and tender to touch. Associated with temp 102 that broke spontaneously.
Age: 17.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 17 year old female patient. The patient supposed to receive a second dose of M-M-R II, a second dose of VARIVAX and an unspecified meningococcal vaccine on 27-FEB-2015. The patient received M-M-R II, and unspecified meningococcal vaccines but she was inadvertently administered ZOSTAVAX instead of (Oka/Merck) VARIVAX second dose, lot # K020801, expiration date: 31-JAN-2016, (dose and route of administration were not reported). No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine
Clinical narrative: Information has been received from an advanced practice nurse via company representative referring to an adult male patient who was a relative of the nurse's. On an unknown date the patient was vaccinated with a dose of MMR II injection (lot # not reported), 1 dose once subcutaneously. On an unknown date the patient experienced measles. The reporter reported that there was some uncertainly whether this was actually a diagnosed case of measles or not. There was also some uncertainly as to whether the patient had actually received MMR II as a child. At the time of this report, the event outcome was unknown. The causality between the event and the vaccination was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. The registered nurse stated that doses of ROTATEQ oral (dose, lot number and expiry date were not reported), were exposed to a supported temperature excursion and administered to unspecified patients since the excursion occurred on 17-FEB-2015. No adverse experience has been reported. There was no concomitant medication provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: (R) axillary adenopathy 2 days after ADACEL vaccination given in (R) deltoid.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Nausea, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of nausea in a 63-year-old female patient who received TWINRIX adult (batch number HZ9Z9, expiry date 3rd March 2017). Co-suspect products included Hepatitis B vaccine for an unknown indication. The patient's past medical history included needle stick/puncture (occurred at job). Concurrent medical conditions included allergy. Concomitant products included ZOSTAVAX, Pneumonia Shot, Influenza Shot, cholesterol and Anti-Cholesterol Medication, Blood Pressure Med and Hormone Cream (Nos). On 30th November 2014, the patient received the 1st dose of TWINRIX adult 1 ml. On an unknown date, the dose was an unknown dose. On 13th January 2015, the patient received Hepatitis B vaccine. On an unknown date, less than a day after receiving TWINRIX adult and an unknown time after receiving Hepatitis B vaccine, the patient experienced nausea, inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown. The reporter considered the nausea to be almost certainly related to TWINRIX adult. Additional information received: Female patient received TWINRIX vaccine on 11/30/14 followed by Merck's Hep B vaccine on 01/13/15. Also stated that patient experienced nausea following TWINRIX injection. Occurred the day of injection and resolved within one day. Reporter also mentioned unrelated event of a occupational needle stick at the patient's job (placed in past medical history). No further details to provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (dose, route, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a 24 year old female consumer reporting on herself without any pertinent medical history, drug reactions or allergies. On 12-FEB-2015, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not reported). There was no concomitant medications. The consumer reported that she had a positive pregnancy test, after receiving her third dose of GARDASIL. The patient reported that she received the first and second dose of GARDASIL before she was pregnant (dates not reported). It was reported that the patient called the physician on 26-FEB-2015. The patient became pregnant with Last Menstrual Period (LMP) of approximately 15-JAN-2015, estimated date of conception on 29-JAN-2015 and Estimated Date Delivery (EDD) of approximately 22-OCT-2015. The pregnancy outcome was pending. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Information has been received from a nurse referring to a 55 year old female patient without pertinent medical history and drug reactions/allergies. On 19-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # K018172, expiration date 02-DEC-2015, 0.65 ml, subcutaneously as vaccination. There was no concomitant therapy. On that same date, the patient developed an injection site reaction including knot under skin at injection site and reddened/itchy area immediately around injection site. No rash noted and no other areas affected. The patient called office to seek advice. No lab diagnostics studies performed. Improvement noted as patient had been using BENADRYL (dose unspecified) as recommended by a physician over the phone. At reporting time, the outcome of the vents was recovering. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a female patient of unknown age, regarding herself. The patient's medical history and concurrent conditions were not reported. On 26-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX on her right arm (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. On 27-FEB-2015, the patient experienced pain and soreness on her right arm and also on her chest. The outcome of the patient's pain and soreness on her arm and chest was unknown at the time of the report. Additional information is not expected, as there is no contact information to follow up.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from registered nurse refers to unspecified patients of unkonwn age and gender. Medical history and concurrent conditions were not provided. On a unknown date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX23 (dose, route, lot number and expiry date were not reported). The registered nurse stated no adverse effects reported. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 30-SEP-2014 the patient was vaccinated with a dose of M-M-R II (route, strength, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope after GARDASIL was administered.