chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown date (s), three doses of improperly stored MMR II (lot#, dose, route and dose number were not provided) might have been administered to patients. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. on 06-JUL-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB injection (lot # J004700, exp 26-NOV-2015, strength, dose and route unspecified). The reporter did not stated if the administered RECOMBIVAX HB was the first dose in the series. No concomitant medication was reported. No adverse symptoms reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Uveitis
Clinical narrative: Information has been received from a physician via a health science consultant referring to unspecified patients of unknown age and gender. There were no medical history and concurrent condition reported. The physician reported that he read in the following medical journals that there had been cases. The cases were reported as the patients were vaccinated with ZOSTAVAX (strength, dose, route, lot# and expiration date not provided) on an unknown date, then developed zoster keratitis and uveitis. No concomitant medication reported. At the time of reporting, the outcome of adverse events was unknown. The causality between adverse events and ZOSTAVAX was not provided. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reprot as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 01-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot number K016313) (dose and route were not provided). There was 87 hours exucrsion. This lot number was received on 08-APR-2015. This is one of several reprots from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to a patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, ten patients were vaccinated with improperly stored PROQUAD (Merck) injection (lot # L005293, expiration date: 17-AUG-2016) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further details were provided. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number patient of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of ROTATEQ via oral. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Red, swollen, inflamed deltoid at the site of injection. Delayed reaction after 48 hrs. No blister no fever.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number patient of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of GARDASIL 9. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Apparent life threatening event, Cyanosis, Dyspnoea, Oxygen therapy
Clinical narrative: Initial information has been received from a physician via Sanofi Pasteur on 06-JUL-2015, referring to a 2 year old female baby patient. Concurrent conditions or pertinent medical history were not reported. On 01-JUL-2015, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot# K012824, expiry date was unknown) intramuscular into deltoid of right upper (dose was not reported) arm. Concomitant therapies were not reported. On 01-JUL-2015, 5 min after vaccination, the patient experienced difficult breathing, cyanosis, purpura on bilateral cheeks and about 1 cm size of purpura behind left ear, scattered bleeding spots on head and neck; this patient's condition was considered as allergy to PNEUMOVAX 23 (allergy to vaccine). The patient was given oxygen in lying position, anti-allergic and symptomatic treatments also were given. It was stated that this symptoms resolved after 10 minutes, therefore, the patient was admitted to superior hospital for further observation. At the time of the report, the patient was recovering from allergy to vaccine. The relatedness between PNEUMOVAX 23 and allergy to vaccine was related, and this adverse event was considered as serious by the physician due to hospitalization, and life threatening by the nurse. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Purpura
Clinical narrative: Initial information has been received from a physician via Sanofi Pasteur on 06-JUL-2015, referring to a 2 year old female baby patient. Concurrent conditions or pertinent medical history were not reported. On 01-JUL-2015, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot# K012824, expiry date was unknown) intramuscular into deltoid of right upper (dose was not reported) arm. Concomitant therapies were not reported. On 01-JUL-2015, 5 min after vaccination, the patient experienced difficult breathing, cyanosis, purpura on bilateral cheeks and about 1 cm size of purpura behind left ear, scattered bleeding spots on head and neck; this patient's condition was considered as allergy to PNEUMOVAX 23 (allergy to vaccine). The patient was given oxygen in lying position, anti-allergic and symptomatic treatments also were given. It was stated that this symptoms resolved after 10 minutes, therefore, the patient was admitted to superior hospital for further observation. At the time of the report, the patient was recovering from allergy to vaccine. The relatedness between PNEUMOVAX 23 and allergy to vaccine was related, and this adverse event was considered as serious by the physician due to hospitalization, and life threatening by the nurse. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Out of PF 6-35 month prefilled FLUZONE. FLUZONE QUADRIVALENT 6 month and older 0.5ml given to 7 month old patient as a second dose of flu vaccine.
Age: 0.7
Sex: U
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Pt came in for five vaccines. One of the injections was given as a PEDIARIX. However, an addition dose of DTaP was given as well. Wrong dose-over dosage. Miscommunication of what vaccines were in combo.
Age: 0.7
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Diluent from Hib vaccine was drawn up but not mixed with powder. Pt was administered diluent only. Vaccine/component omission-Diluent without the vaccine. Diluent and powder not connected with a tie.
Age: 1.6
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: 18 month old child came to doctor for well child check & to catch up on immunizations. Child was due a Dtap; however, child received KINRIX combo instead.
Age: 4.4
Sex: U
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: 4yr old female pt was seen by provider for physical and MA given order for Dtap and other vaccines to be administered to pt what was given Tdap instead. Wrong vaccine. Similar vaccine abbreviations. Products stored near one another.
Age: 12.0
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Busy clinic, late in the day and interpreter needed for adolescent visit for MCV and Tdap vaccines. HPV vaccine series completed previously. Nurse gave HPV vaccine given instead of MCV.
Age: 0.1
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: The patient visit was scheduled for a 2 mos well child check. The immunizations were pre-ordered and the order set was created for a 2 month old patient instead of a 1 mos old patient. Patient received PENTACEL, Rotavirus, and PREVNAR at age 5 weeks instead of receiving the Hep B vaccine. The event was then reported to the physician.
Age: 9.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given PEDIARIX as a catch up vaccine. Pt is over the age of licensure for PEDIARIX.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The mother brought the male child in to the office for a vaccine without seeing the provider, the medical assistant asked the parent which vaccine is she wanting for the child. The mother replied Dtap, the medical assistant was new to this profession and did not question the age and gave the child this vaccine. The child really should have been given a Tdap, the mother was contacted and now I am reporting this vaccine mishap to you. Wrong vaccine. Patient was not seen by provider before vaccine.
Age: 7.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was in for preventative visit. DTAP was ordered and administered. The child was 7 years and 6 months at the time of vaccine administration. Wrong age (patient not correct age for vaccine given).
Age: 0.2
Sex: U
Vaccine: DTAPIPV, DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: PENTACEL was not available so CMA gave DTaP/IPV comno (labeled for 4-6 yrs) and separate Hib vaccines instead to a 2 month old patient.
Age: 1.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: The nurse was to give a Dtap to an 18 month old patient. Nurse accidentally pulled a PEDIARIX out of the fridge to give instead of an INFANRIX. Nurse gave vaccine and found error as putting them in NCIR.
Age: 5.5
Sex: U
Vaccine: IPV, MMR, VARCEL
Symptoms: Wrong patient received medication
Clinical narrative: Patient was registered with incorrect date of birth. The incorrect chart was pulled. Patient was given vaccines that he did not need. Date of birth was not verified at two different intervals of his care.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient needed vaccine for school. She is 23 years old and I gave her a pediatric dose of Hep B when she needed the adult dose.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MMRV was given to a patient over 12 yrs of age.
Age: 1.3
Sex: U
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: 15 month old given 5 doses of PREVNAR instead of 4.
Age: 5.4
Sex: U
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Mom brought two boys to imm clinic-mom requested only wanting to administer only 1-2 shots per visit as she was afraid of vaccines-after administering the 5 yo a HBV and MMR I began screening the two year old-mom then began asking questions about vaccines-I spent 15-20 minutes educating her on the risk of VPD's-then she changed her mind and asked that all shots be given to both boys that were needed-the boys were running around the room-the mom was accompanied by another woman who also was afraid of vaccines-they were conversing-the room was chaotic-I then administered all shots to 2 you-then returned to the 5yo to finish his additional shots that were needed-I left room to get those vaccines-I then administered the remaining shots including a second HBV-good news is that both boys left up to date with immunizations.
Age: 52.0
Sex: U
Vaccine: DT
Symptoms: Wrong drug administered
Clinical narrative: RN administered the wrong Tetanus for a puncture wound for a patient presenting to the clinic.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Hyperhidrosis, Injection site urticaria, Lethargy, Loss of consciousness
Clinical narrative: Patient was given vaccine with no reaction until 10 minutes later at which point patient developed 2 small welts at injection site. Patient then found to be lethargic and diaphoretic and hardly responsive to name. BG 181 mg/dl. BP 160/96 mmHg, HR 92 BPM. Denied SOB, CP, trouble swallowing - airway not compromised. Patient then started to lose consciousness and moan. Oxygen sat 97-100%. Epinephrine 0.3 mgs IM and diphenhydramine 12.5mg PO given. Patient seemed to respond better but unsteady on his feet. Patient then fully alert and answering questions. He was transferred to local ED.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Moaning, Slow response to stimuli
Clinical narrative: Patient was given vaccine with no reaction until 10 minutes later at which point patient developed 2 small welts at injection site. Patient then found to be lethargic and diaphoretic and hardly responsive to name. BG 181 mg/dl. BP 160/96 mmHg, HR 92 BPM. Denied SOB, CP, trouble swallowing - airway not compromised. Patient then started to lose consciousness and moan. Oxygen sat 97-100%. Epinephrine 0.3 mgs IM and diphenhydramine 12.5mg PO given. Patient seemed to respond better but unsteady on his feet. Patient then fully alert and answering questions. He was transferred to local ED.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pruritus
Clinical narrative: Customer went to the store requesting the vaccine PNEUMOVAX 23 which was applied on the left arm deltoid muscle. Pneumonia vaccine as well as the Influenza are only requested by the patient as no prescription is required. PNEUMOVAX with Lot K009876 had an expiration date of 03/19/2016. Prior administration of the vaccine, the patient filled out the VARS and marked off NO on all questions. Customer was administered the vaccine on 04/29/2015. Customer reports pain and itching on 04/30/2015 and she was informed by staff those were secondary common side effects, and if pain persist to visit an ER. Customer reported she applied ice and took RELAFEN. Customer went to Medico Offices across from store and they referred her to the ER. Customer sought medical attention at unknown ER on 05/01/2015. PNEUMOVAX 23 is manufactured by Merck and it is administered to patients ages 59 and above and to those patients whose respiratory system is compromised. A prefilled 0.5 ml injection was administered using a non-retractable needle but tip. Needle is 25 x 1 gauge and it was administered on the left deltoid muscle by staff with certification. Customer was vaccinated against Influenza on February of the current year. Client stated an adverse reaction to the vaccine would have included bronchospasm or anaphylactic shock. Furthermore, client stated the continuous itching of the area is more related to a possible allergic reaction to the liquid of the vaccine. Client provided all related documents such as the VARS and profile. She also stated the VAERS which is filled out online for the CDC when there is a report of an adverse/allergic reaction to the vaccine was completed, but client is unable to provide us with a copy of the form.
Age: 11.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: Male pt was given CERVARIX.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Rash, 7x7cm red mildly red sl warm around site of vaccine.
Age: 0.7
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Patient came in for well child check and was given an expired vaccine.
Age: 0.6
Sex: U
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Provider gave nurse instructions to administer immunizations to patient. Noticed in chart patient was on ROTARIX schedule. Administered ROTARIX along with other vaccines. When inputting data into patients chart RN noticed that that was the third dose of the vaccine and that it only calls for a two dose schedule. Supervisor notified immediately as well as provider.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Four children received an expired dose of PENTACEL on 4/28/15. The vaccines had expired on 4/19/15. The ages of the children were two, 4 months olds and two, 6 month olds.
Age: 0.6
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt received 3rd dose of Hep B 1 month too soon.
Age: 10.0
Sex: F
Vaccine: DTAP, RVX, UNK
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Large swollen hard feverish lump at site of injection. Margins kept getting larger. Gave Benadryl and the swelling began to go down.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Crying, Irritability, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient woke up the morning after receiving the vaccine with a very stiff neck, fussy/crying, complaining of pain in posterior neck.  Somewhat improved when seen in clinic several hours later.  Unclear if related to vaccine.
Age: 0.34
Sex: M
Vaccine: DTAP, HPV4, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse event noted as of 07/09/2015.  HPV vaccine administered in error, was supposed to get PCV13.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Decreased appetite, Ear swelling, Lip swelling, Peripheral swelling, Rash macular
Clinical narrative: Symptoms: red blotches on; face, feet, ears, back, legs, and arms, swelling of; face, lips, hands, ears, and feet, lack of appetite. Treated with 1 tsp. Children's Benadryl.  Following Dr. visit was prescribed Hydroxyzine 10mg.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Swelling face
Clinical narrative: Symptoms: red blotches on; face, feet, ears, back, legs, and arms, swelling of; face, lips, hands, ears, and feet, lack of appetite. Treated with 1 tsp. Children's Benadryl.  Following Dr. visit was prescribed Hydroxyzine 10mg.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site of puncture was sore. Then started to itch badly and became bright pink. Had an appt. with my dermotologist July 7 and showed it to him.  He reported it to Dr. and gave me some cream which stopped the itching.  Today, July 9th it doesn't itch anymore and the color is fading.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria
Clinical narrative: Developed hives around the injection site the next day after receiving Tdap vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Pt describes adverse event began with itching which progressed to redness.  On 07/08/2015 pt came by pharmacy around 10 am and she reported redness, warm to the touch and itching.  I applied an ice pack and she took acetaminophen.  Pt then came to pharmacy on 07/09/2015 in the am and pt is experiencing localized redness and swelling and warm to the touch with an increase diameter in redness from the previous day.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave patient the KINRIX dosage. Which is out of the patients age.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Akinesia, VIIth nerve paralysis
Clinical narrative: Patient reported loss of muscle movement in eye and face.  He want to see doctor and was told suspicion of Bells Palsy related to vaccination.   The doctor is having a CAT scan with patient for follow up tomorrow 07/10/2015.
Age: 5.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: Dtap was ordered and PEDIARIX was administered.
Age: 85.0
Sex: U
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt received this vaccination on 02/06/2015 at her provider's office and then received another one on 05/13/2015 at the pharmacy.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: This vaccine was ordered and given. It was given as the first dose of the series at 16 weeks.
Age: 0.3
Sex: U
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: In preparing the vaccines for this patient I misread the combo vaccine we have supplied and in turn gave the patient an extra dose of the IPV vaccine.
Age: 7.3
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered DTaP to 7y/o
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: A patient age 11 was given a DTaP vaccine, DAPTACEL, instead of Tdap, ADACEL, that was appropriate.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: FLUVIRIN administered instead of FLUZONE HIGH DOSE. Error discovered when reconciling inventory.
Age: 13.0
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt was given wrong vaccine by MA. DTaP given instead of Tdap. Remediation done. State called and recommended right vaccine be given. No interval waiting necessary. Was given same day.
Age: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Client received KINRIX vaccine on 3/30/15 that had expired on 11/23/14.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Client received KINRIX on 4/9/15 that had expired on 11/23/14.
Age: 5.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Client received KINRIX on 4/13/15 that had expired on 11/23/14.
Age: 9.0
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was given Dtap at age 9. He was past due for this vaccine.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Contraindication to vaccination
Clinical narrative: 90 year old male came to pharmacy for refill of prednisone 20mg (3QD). Pharmacist #1 placed ZOSTAVAX recommendation card in his rx bag. Technician talked to patient about ZOSTAVAX and pt was interested in getting vaccine. Pt filled out questionnaire. Rx billing processed and Pharmacist #1 "checked"the RX (Pharmacist #1 did not notice the drug utilization review that was flagged by computer between ZOSTAVAX and prednisone, and he did not look at the patient's answers to vaccine questionnaire at all. Patient was rung up. Pharmacist #2 was then notified that a pt. was waiting for a shingles shot. Pharmacist #2 looked at questionnaire and read part way through it and stopped when noticing pt had checked "I don't know" when asked if he had a shingles shot in the past. Pharmacist #2 then checked online website to see if the vaccine had been administered previously (it had not). Pharmacist #2 forgot to loot at the pt's answers to rest of the questionnaire on the form. Pharmacist #2 did not notice the patient had checked "yes" on the last 2 questions asking if pt was on prednisone or immunosuppressants, and "yes" to if he had received blood transfusions or blood products or immunoglobulins in past year. Pharmacist #2 was also instructing pharmacy intern on how to mix the vaccine, how to administer. During conversation with patient, the patient mentioned he was on prednisone 40 to 60mg daily for 3+ months, but pharmacist #2 did not recall the contraindication between ZOSTAVAX and long-term steroid use. Vaccine was administered. During filing of paperwork, Pharmacist #2 noticed that she had not read the remainder of the questions on the questionnaire, and at the time read about the contraindication between the two products and called the patient, and the patient's physician. Physician prescribed valacyclovir for pr.
Age: 1.6
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient is 18months old and received his first Hepatitis A vaccine on 10/29/14 and came in for his second Hepatitis A vaccine that I gave on 4/21/15. This injection was given 1 week 1 day too soon.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Provider ordered incorrect vaccine and it was administered to child early.
Age: 43.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: A patient came into the clinic for PPD tuberculin skin test. After the provider evaluated the patient and ordered the PPD test, the medical assistant (MA) was instructed to give the test to the patient. After the test was given, the patient was discharged by the MA. Within an hour or so, the lead supervising MA noticed a vial of FLUVIRIN sitting out on a desk. The lead MA asked all the other MAs and providers if anyone ordered the FLUVIRIN vaccine and why it was sitting out instead of in the refrigerator. The provider's MA admitted that she accidentally gave FLUVIRIN instead of tuberculin intradermally in the patient's forearm. Multiple attempts were made to contact the patient without success. The incident was reported to the County Dept of Public Health. 48 hours later, the patient returned to the clinic for PPD read and this was when the incident was disclosed to the patient. The patient had a 3cm area of erythema and mild swelling at the injection site where FLUVIRIN was administered. The patient denied any other problems or history of allergies. The PPD was then correctly given in the other forearm.
Age: 0.3
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccines given to 4 patient's during 1/20-1/22015. An employee working during immunization clinic saw vaccine was expired and I was immediately notified and removed vaccines from refrigerator. The 4 patient's were notified and were later revaccinated. I also contacted our VFC rep and was provided with the necessary information.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Routine check for expired vaccines was conducted 5/5/15. At that time the vaccine was noted to have expired. Review of patient log noted a patient had received the vaccine 2 days after the expiration date.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: MA reconstituted Hib component with MMR diluent and did not mix with DTaP/IPV solution.
Age: 8.0
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Vaccine expiration date was misread. Read as 05/30/15. Actual expiration date was 05/03/15.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Medical Assistant give diluent without actual vaccine.
Age: 13.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A adolescent patient was given an adult dose of HepB immunization.
Age: 29.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: 29 y/o patient received pediatric dose of Hep B.
Age: 31.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Nurse grabbed MMRV PROQUAD from freezer, intending to administer MMR. MMRV was administered to patient. Error was not caught until after patient left, when vaccine was put into EHR.
Age: 1.0
Sex: U
Vaccine: MEA, MMRV
Symptoms: Wrong drug administered
Clinical narrative: MA intended to obtain dose of MMR and Var as separate antigens from freezer. Obtained MMRV instead of Var. Caps are different color but did not note that she had MMRV in hand. Read label while drawing from vial, did not note that she had MMRV rather than Var. Administered to patient. Error found when documentation was being done after the administration.
Age: 51.0
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: I picked up, prepared and then administered a pediatric dose to an adult.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt was given this vaccine early.
Age: 0.54
Sex: F
Vaccine: DTAP, HEP, IPV, PPV
Symptoms: Aphasia, Attention deficit/hyperactivity disorder, Childhood disintegrative disorder, Diarrhoea, Ear infection
Clinical narrative: Child's physical reaction to injection was unlike any previous. She had been saying words and phrases, that stopped completely. She had been crawling, that stopped. She developed chronic diarrhea which lasted for over a year.  She did not speak again for 12 months. She developed chronic ear infections and respiratory illnesses. She also exhibits signs of ADHD.
Age: 0.54
Sex: F
Vaccine: DTAP, HEP, IPV, PPV
Symptoms: Respiratory disorder
Clinical narrative: Child's physical reaction to injection was unlike any previous. She had been saying words and phrases, that stopped completely. She had been crawling, that stopped. She developed chronic diarrhea which lasted for over a year.  She did not speak again for 12 months. She developed chronic ear infections and respiratory illnesses. She also exhibits signs of ADHD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Red area to right upper arm, measures 50mm widex60mm length.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on Leg.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Pyrexia
Clinical narrative: Extreme fussy and fever to 102.4 within 24 hours of 4 mo vaccine-advise split 6 mo vaccines- DTap, polio, Hep B, Prevnar- each given at separate visits. Treatment was supportive care measures for symptoms.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Local swelling
Clinical narrative: Client called to report she developed swelling in her right jaw after taking her third oral typhoid capsule. Exact time of onset not provided by client. This would have been in the past 24-48hrs. No other side effects noted and no treatment reported.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red raised bumps on injected upper arm; less than previous reaction.  Did not seek immediate medical care, but brought to MD's attention at next visit.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site rash
Clinical narrative: RAISED BUMPS ON ARM LOCATION OF VACCINE ADMINISTRATION.  DID NOT ITCH. REFERRED TO MD.
Age: 21.0
Sex: F
Vaccine: HEPA, MEN, SMALL
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral
Clinical narrative: Patient reports redness, streaking edema, numbness to arm, within minutes after vaccination given.  7/9/2015 pt returned to clinic for unrelated reason and reported that all signs and symptoms resolved.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Dizzy, Fever, Arm swollen and red.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Peripheral swelling, Pruritus
Clinical narrative: Patient said arm got swollen and started itching; went to ER and got steroid injection.
Age: 0.51
Sex: M
Vaccine: 6VAX-F, PNC13, RV5
Symptoms: Lethargy, Pyrexia
Clinical narrative: Lethargy and low grade fever 5 hours after shots.
Age: 0.83
Sex: M
Vaccine: DTAP
Symptoms: Abnormal faeces, Asthma, Bronchiolitis, Condition aggravated, Crying
Clinical narrative: Seizures:  Body involuntarily shook, eyes rolled back into his head intermittently for several minutes on and off for about 6 hours.  102 degree fever, inconsolable crying. toxic smelling diapers, refusal to eat, sleeping for 18 hours straight.
Age: 0.83
Sex: M
Vaccine: DTAP
Symptoms: Diet refusal, Dyskinesia, Gaze palsy, Hypersomnia, Pyrexia
Clinical narrative: Seizures:  Body involuntarily shook, eyes rolled back into his head intermittently for several minutes on and off for about 6 hours.  102 degree fever, inconsolable crying. toxic smelling diapers, refusal to eat, sleeping for 18 hours straight.
Age: 0.83
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: Seizures:  Body involuntarily shook, eyes rolled back into his head intermittently for several minutes on and off for about 6 hours.  102 degree fever, inconsolable crying. toxic smelling diapers, refusal to eat, sleeping for 18 hours straight.
Age: 0.83
Sex: M
Vaccine: HEP
Symptoms: Asthma, Crying, Diet refusal, Eye movement disorder, Hypersomnia
Clinical narrative: Seizures:  Body involuntarily shook, eyes rolled back into his head intermittently for several minutes on and off for about 6 hours.  102 degree fever, inconsolable crying. Toxic smelling diapers, refusal to eat, sleeping for 18 hours straight just like the last vaccine when her got DTaP.
Age: 0.83
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Seizure, Tremor, Urine odour abnormal
Clinical narrative: Seizures:  Body involuntarily shook, eyes rolled back into his head intermittently for several minutes on and off for about 6 hours.  102 degree fever, inconsolable crying. Toxic smelling diapers, refusal to eat, sleeping for 18 hours straight just like the last vaccine when her got DTaP.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Injection site erythema, Injection site swelling, Pyrexia, Rhinorrhoea
Clinical narrative: Pt had fever cough runny nose for two weeks and redness and swelling at the site of injection that subsided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Full body aches, fever and red swollen arm that lasted three days.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Crying, Diet refusal, Lethargy
Clinical narrative: Child was inconsolably crying and lethargic all day after receiving the vaccine. Child also refused to eat.
Sex: U
Vaccine: DTAP
Symptoms: Ill-defined disorder, Vaccination complication
Clinical narrative: This case was reported by a consumer and described the occurrence of ill-defined disorder in a child patient who received INFANRIX. On an unknown date, the patient received INFANRIX at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced ill-defined disorder (serious criteria hospitalization). On an unknown date, the outcome of the ill-defined disorder was unknown. It was unknown if the reporter considered the ill-defined disorder to be related to INFANRIX. Additional information was provided: The mother of the child mentioned that the child was hospitalised due to a bad reaction to DTP vaccination. On further questioning, she confirmed that it was INFANRIX that was given, but she did seem sure which variant (Penta or Hexa). When asked about further detail about the reaction, the mother did not want to provide any further information.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. On an unspecified dates, the unspecified patients were vaccinated with doses of ZOSTAVAX (dose, frequency and route were not reported) which had been exposed to temperatures outside of the recommended range. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 07-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, subcutaneous, (lot # K026365 with expiration date: 15-MAR-2015), (strength, frequency and anatomical location were not reported), which was improperly storage. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 07-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. 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 healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of oral, ROTATEQ lot # K010221, K011663, K016313 and lot # reported as K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 regarding the patient of an unknown age and gender who on 02-JUN-2015 was vaccinated with a dose of oral, ROTATEQ (lot number K016313) (dose and route were not provided). There was 87 hours excursion. This lot number was received on 08-APR-2015. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 24-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reprots received from the same source. Additional information has been reuqested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a patient of unknown age and gender. On 15-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (route not provided) which was under 63 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Erythema, warmth, induration, 4 x 6 cm distal to injection site.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Asthma, Condition aggravated, Somnolence
Clinical narrative: Patient developed asthma after the shot (known asthmatic, no recent wheezing) and required 2 albuterol treatments to clear. Patient then took a nap, which he does not normally do.
Age: 1.83
Sex: F
Vaccine: HEPA
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash on arms, legs and back that began about 6-19-15. Mom tried over the counter ointment (steroid). Saw MD on 7-8-15 diagnosed with erythema multiforme and started on prednisone.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: MOC reports child broke out in chicken pox rash 2 days after immunization given.
Age: 54.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, swelling, redness, heat over the entire left arm from the deltoid injection site down to the elbow. Treatment: Cephalexin 500mg twice daily x 10 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Vaccine given 5/6/15, patient seen in clinic 5/8/15 with left arm swelling and redness and tenderness and warmth of arm. Unsure of IZ reaction per provider note. Per mom area remained as above for 20 days following vaccination.
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: None. HIB given instead of Meningococcal vaccine. Pt family notified and will return another day for correct vaccine.
Age: 1.29
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: Wrong technique in drug usage process
Clinical narrative: PENTACEL vaccine was not reconstituted. The patient only received the DTaP-IPV component of the vaccine. Pt will return for vaccine for Hib.
Age: 12.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Asthenia, Blood glucose normal, Dizziness, Headache, Pain in extremity
Clinical narrative: Patient stated that he was feeling lightheaded, weak and had a headache. Patient asked to sit down and blood pressure was taken at approx. 1:55 pm (110/70). Patient given water to drink and two fig bars, which he drank and ate. BP rechecked at approx 2:00 pm (90/60). Patient still stated feeling weak and headache. BP rechecked at 2:04 pm (91/58) and glucose was 156. BP rechecked at approx 2:15pm (101/64). Patient states he is feeling better but still has a headache. Mom instructed to take him to be seen immed. if symptoms persist or get worse but he could be given TYLENOL for headache, fever or pain. Patient's mother called on 6/25/15, patient reports soreness in right arm but no other symptoms.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with a dose of GARDASIL lot # K006960 (route was not provided) which were exposed during 63 hours excursion to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAP, HEP
Symptoms: Crying, Cyanosis, Loss of consciousness, Oxygen saturation decreased, Rash generalised
Clinical narrative: Report 2001028863-2 describes a 4-month-old male who turned blue after receiving an injection of ENGERIX-B. Medical history was not specified. There were no concurrent conditions and no concurrent medications. He had no adverse experiences following receipt of prior immunizations. On 15 November 2001, the vaccinee received his second injections of ENGERIX-B and INFANRIX (GlaxoSmithKline; see report 2001028863-1). Within five minutes post-immunization, the infant began crying, turned blue, experienced a decrease in oxygen saturation to 96%,"appeared to either fall asleep or pass out," and developed a rash on the face and body. The infant was observed in the physician's office for two hours. The rash lasted 1.5 hours. The other events had also resolved, and the infant was sent home. The reporting physician considered the events to be possibly related to INFANRIX and ENGERIX-B administration. The vaccinee received another injection of INFANRIX on 05 February 2002 and he did not experience an adverse event. On 10 July 2015, this case was identified as duplicate of A0355883A. Case A0355883A was voided and all the future correspondence will be added in the present case which stands as case of record for this subject.
Age: 42.0
Sex: M
Vaccine: HEPAB
Symptoms: Balance disorder, Gait disturbance, Sluggishness
Clinical narrative: Sluggish staggering gait no sense of balance.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Red dot rash on both legs and a few red dots on torso. They looked like chickenpox but did not itch and not painful. Sorted over two weeks. Now going away with cortisone.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Headache, Syncope
Clinical narrative: After receiving vaccination patient was alert and talking.  About a minute after the vaccination patient got to his feet and was walking and talking.  About a minute later patient said he felt dizzy and had a syncopal episode which lasted about 15-20 seconds.  Patient was caught before he fainting and sustained no injury.  Patient was able to walk with assistance to an exam table where he was given a icy pop to eat, a cold pack for his head/neck, and his feet were elevated.  Patient was able to leave the office about 15 minutes later, complaining only of a mild headache.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of ROTATEQ lot # K012432, expiration date 20-MAY-2016, through oral route. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 01-JUN-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL (confirmed not GARDASIL 9) (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information is not expected, since there is no consent to contact the physician to follow up.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JUL-2015, the patient was vaccinated with an expired dose of GARDASIL (lot # H020901, expiry date 05-JUL-2015; dose, strength and route of administration were not reported). It was unspecified which dose number in the series this dose was. No adverse experiences were reported. This is one of the several reports received from the same source. Additional information has been requested.