chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient received 4 yr. old vaccines on 07-17-17. Patient came in 07-19-17 because the left thigh had large 10 cm diameter local reaction to the PROQUAD vaccine. It was slightly warm, erythematous and slightly swollen with a small bruise centrally. No pain.
Age: 0.92
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a physician who was reporting on an 11 months old infant (gender not reported). No medical history or concomitant medications were reported. On 11-JUL-2017, the 11 month old patient received a dose of ROTATEQ oral liquid (lot M018957, expires 22-NOV-2017) for prophylaxis. No adverse effects were reported. No further information is available. Additional information is not expected. No further information is available.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On an unknown date, the patient may have received an improperly stored dose of either VARIVAX lot # M005971, expiration date 02-FEB-2018 or ZOSTAVAX lot # M041510, expiration date 27-JUL-2017 for prophylaxis (dose not reported). The administered dose of vaccine were reconstituted with sterile diluent (lot # and expiration date were reported as unknown). The medical assistant was not sure which vaccine the patient may have received. The dose was stored at temperatures in the range of 6 degrees Fahrenheit to 14 degrees Fahrenheit for a total time frame of 8 hours as identified by a digital data logger. It was reported that there were no previous temperature excursions. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received on 30-JUN-2017 from a physician via a company representative regarding an 18-year-old patient (gender not reported). Medical history, concurrent conditions, concurrent medications, and allergies were not reported. The physician had reported to the field representative that the 18-year-old patient was inadvertently administered an adult dose of VAQTA (dose, route of administration, site of administration, Lot number and expiration date were not reported). The indication was not reported. It was not further reported if the patient was to receive the pediatric formulation but was inadvertently administered an adult dose of VAQTA. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a pharmacist who reported that a patient (age and gender not reported) received a dose of ZOSTAVAX subcutaneous (lot# reported as N012092, expiration 31-MAR-2018) reconstituted with sterile diluent (lot# K021919, expiration 30-SEP-2017) on 11-JUL-2017. The pharmacist reported that, after this dose was administered, the patient's wife stated that the patient had already received a dose of ZOSTAVAX (lot#/expiration unspecified) on an unspecified date "4 years ago". No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received on 10-JUL-2017 from a registered nurse regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient received an expired dose of M-M-R II (lot # L024265, expiration date 01-JUL-2017) (dose, route, site of administration not reported), reconstituted with properly store and non-expired sterile water diluent (unknown lot #, unknown expiration). No adverse effects reported. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On multiple unknown dates,  the patients were most likely vaccinated with doses of improperly stored VARIVAX lot # M043582 and expiration date 28-OCT-2017, for prophylaxis (route of administration and anatomical location were not reported), which were stored in the range of 15°Fahrenheit degrees to 46°Fahrenheit degrees for 48 (units not specified). Concomitant therapies included sterile diluent. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved.
Age: 0.05
Sex: U
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: A Nurse at our clinic administered an expired dose of vaccine to a child. The nurse entered the vaccine into the electronic system and into registry but when entering into registry he entered the wrong lot number for the PCV 13 vaccine so the system did not catch his expired vaccine data entry.
Age: 1.0
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Syringe issue
Clinical narrative: Attempt to engage needle safety s/p administration, glass vial of prefilled syringe broke. No harm came to patient or Nurse. Reported to state and manufacturer.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Immunisation, No adverse event
Clinical narrative: Pt is 19 yrs old. He received a pediatric dose of Hep A on 4/12/17instead of adult dose. Pt did not have any reaction.Pt notified and revaccinated with adult dose of Hep A on 4/22/17.
Age: 15.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Dtap administered instead of Tdap.
Age: 0.67
Sex: U
Vaccine: RV1
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given 3rd rota past 8 months, they were 8 months and 8 days.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: I (MA-C) gave a DTap Vaccine after getting verbal orders to give to a patient even outside of age ranges per my provided. I gave the vaccine in the left deltoid and the patient did not have any complications. VIS sheet was given to the parent in office.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose of PEDVAX at 6 months of age. This is an extra unneeded dose.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses of Hep A. The dose of Hep A given on 3/25/2013 was documented as HPV #2. This caused her to receive an extra dose of Hep A. Hep A #1 - 3/19/2012; Hep A #2 - 3/25/2013 (documented incorrectly); Hep A #3 - 4/15/2016.
Age: 1.17
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 14 month old child was behind on vaccines. KINRIX was administered as 3rd polio and 3rd DTaP.
Age: 14.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Two RNs reviewed registry's IZ routing slip for doses due. Both failed to notice that patient had already received a dose of seasonal influenza vaccine for the 2016-17 season and that the due date shown on the routing slip for the next dose of seasonal influenza vaccine was later in 2017 (well after the vaccine administration date). The new Immunization Registry does not visually distinguish between doses currently due and those due in the future, contributing to this error.
Age: 34.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Nurse administered MMRV when order stated MMR.
Age: 1.0
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was seen in the office for his 12 mth well check appt. It was written in our huddles that he was getting MMR, VARIVAX and KINRIX (Dtap and IPV) vs. MMR, VARIVAX and PCV13. KINRIX is given at 4 yrs. well checks but the Medical Assistant followed the huddle and give MMR, VARIVAX and KINRIX. Per CDC Dtap dose counts as his 4th dose but he got 4th dose of IPV before needed and will need another dose at 4 yrs. old. Age of patient at time of event: 1 years.
Age: 0.75
Sex: U
Vaccine: HEP, HIBV, HIBV
Symptoms: Wrong drug administered
Clinical narrative: I took my 9 month old baby to the doctor's office strictly for an immunization nurse visit. She should have received DTaP, Hib and IPV. The nurse walked into the room and stated she confused the Hib with Hep B, mistakenly thinking Hib was part of the DTaP shot and then stated that my daughter would receive 3 shots instead of two. I already knew she should receive 3 shots. I later received a call that the nurse mistakenly administrated Hepatitis B instead of Hib.
Age: 3.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Given to 3 y.o. 10 months.
Age: 56.0
Sex: U
Vaccine: HEPAB
Symptoms: Wrong drug administered
Clinical narrative: Patient was already immune to hepatitis A, based on Hepatitis A Ab test that came back positive in March of 2017. However, the Hepatitis A-Hepatitis B combination vaccine was administered in 4/2017 despite known Hepatitis A immunity.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Chest discomfort, Headache, Injection site pain, Lethargy, Lymph node pain
Clinical narrative: Started on Thursday (two days after vaccination) as a mild headache with soreness around injection site after the pain had gone away. Lethargy and full body aches with low grade fever on Friday with sensitive neck lymph nodes. Same symptoms on Saturday with the addition of hives on the neck and itchy scalp. Sunday morning woke with armpit adjacent to injection site's lymph node tenderness, and nausea that persisted all day with continuous low grade fever. Random "bug bite"-like lesions on arms, legs, back, and abdomen. Tightness in chest, almost similar to heartburn, with no phlegm or cough.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Pain, Pruritus, Pyrexia, Skin lesion
Clinical narrative: Started on Thursday (two days after vaccination) as a mild headache with soreness around injection site after the pain had gone away. Lethargy and full body aches with low grade fever on Friday with sensitive neck lymph nodes. Same symptoms on Saturday with the addition of hives on the neck and itchy scalp. Sunday morning woke with armpit adjacent to injection site's lymph node tenderness, and nausea that persisted all day with continuous low grade fever. Random "bug bite"-like lesions on arms, legs, back, and abdomen. Tightness in chest, almost similar to heartburn, with no phlegm or cough.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Started on Thursday (two days after vaccination) as a mild headache with soreness around injection site after the pain had gone away. Lethargy and full body aches with low grade fever on Friday with sensitive neck lymph nodes. Same symptoms on Saturday with the addition of hives on the neck and itchy scalp. Sunday morning woke with armpit adjacent to injection site's lymph node tenderness, and nausea that persisted all day with continuous low grade fever. Random "bug bite"-like lesions on arms, legs, back, and abdomen. Tightness in chest, almost similar to heartburn, with no phlegm or cough.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of May received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Age: 12.0
Sex: F
Vaccine: HPV9, IPV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: POLIO WAS GIVEN INSTEAD OF MENACTRA NO REACTION.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swollen Rt. Arm, Ibuprofen 600mg, Doxycycline 100mg.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of May received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Age: 2.0
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered Tdap instead of DTaP to a 26 month old child. Age of patient at time of event: 26 months.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 3 year old wwc. I gave pf flu on pt's 3rd birthday and should have given the adult flu. I notified pt's mom and she will bring the patient in to have adult flu given.
Age: 29.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Provider ordered MMR for patient. Patient stated she needed. Medical Assistant gave MMR. However, when entering into electronic health record, it was discovered pt. had complete MMR series and this was a 3rd MMR.
Age: 1.2
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: On 04/04/2017 I accidently administered a TDaP by mistake. I thought I grabbed the DTaP box from the shelf as the two are only a shelf apart (one above the other). I double checked the vial and still thought I had the correct one. As I went to document this vaccine I noticed that the Lot number for the DTaP were not matching the Lot number I had on the patients face sheet. So I went to check the Lot on the DTaP box and sure enough I had the wrong one, so I checked the TDaP box and the lot numbers matched. I then realized I made a vaccine error.
Age: 18.0
Sex: U
Vaccine: HEP, HPV9
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered 1 mL IM left arm of GARDASIL 9 instead of 0.5mL by Medical Assistant 1. She was also administered 1mL of Hep B in the same arm by Medical Assistant 2. Due to misdocumentation in patients chart by Medical Assistant 1.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: CMA received order for PROQUAD, vaccine mixed and administered intramuscular instead of subcutaneous route. Error was not noted till documenting the vaccination when it was noted that the order read subcutaneous and there was no drop down option for intramuscular in the EMR.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Wrong drug administered
Clinical narrative: I was in a rush, and the MMR, Varicella and MMRV are stored next to each other, and I took the wrong vaccine out of the freezer. I made the error of giving the wrong vaccine to the child.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Extra dose administered
Clinical narrative: I administered PEDIARIX to a 4 year old healthy male rather than the INFANRIX. I notified my supervisor. I spoke in length to CDC and GSK (manufacturer). Child also received IPV. I spoke in length to the child's mother. Age of patient at time of event: 4 years 2 months.
Age: 1.67
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation error
Clinical narrative: Vaccine/component omission - Diluent given without the vaccine.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: Hepatitis B pediatric vaccine was ordered and requested for a newborn. Hepatitis A pediatric vaccine was sent from pharmacy and administered to patient. Error was caught by pharmacy after administration of the vaccine. Age of patient at time of event: 2 days.
Age: 0.75
Sex: U
Vaccine: DTAP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: The wrong vaccine was written on the face sheet which should have been Dtap.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Administered hepatitis A vaccine to patient in error. New immunization registry (Immunization Registry, version 2-CARI2) produces a routing slip that does not distinguish between doses due on the day of the visit, as opposed to doses in the future. In spite of my practice of reviewing dates carefully and using a ruler to cross out doses due later, I gave the patient hepatitis A vaccine. I only noticed the error when entering the doses into the registry. Although I have filed a product update notice with the CAIR2 team, the only near-term solution to this problem is to slow down and carefully look at every "due date" and cross out those after the date of visit.
Age: 4.0
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Immunization was given too soon. Age of patient at time of event: 4 years.
Age: 1.67
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine given too soon. Age of patient at time of event: 20 months.
Age: 6.0
Sex: U
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Wrong drug administered
Clinical narrative: The vaccines ordered by provider were MMRV, IPV, DTaP and Hep A. This patient insurance was a commercial insurance and VFC vaccines were used in error.
Age: 11.0
Sex: U
Vaccine: HPV9, MNQ, TDAP
Symptoms: Wrong drug administered
Clinical narrative: The vaccines that were administered to the patient were the correct vaccines the error was that VFC vaccines given to a patient with commercial insurance.
Age: 42.0
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Nausea, Pyrexia, Vomiting, Wrong drug administered
Clinical narrative: Pt. given Pneumo 13 vs Pneumo 23 as ordered. Pt then C/O pain at injection site and a rush of fever the next day with nausea and vomiting.
Age: 0.08
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given KINRIX earlier date. Recommendation of age for vaccine is 4-6 years old. Spoke with manufacturer GlaxoSmithKline Pharmacist stated that this is a valid dose for patient. And does not need to be repeated.
Age: 1.42
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: Administered an expired vaccine.
Age: 1.0
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. was given Dtap too early. Age of patient at time of event: 1 years.
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child 2 years 8 months was given dose for 36 months and up. Age of patient at time of event: 2 years 8 months.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: Gave an expired vaccine to patient.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: A third dose was administered.
Age: 3.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given PEDIARIX before the recommended age. Spoke with manufacturer and they stated that according to the CDC it counts as a valid dose and should not be repeated. Age of patient at time of event: 3 years 6 months.
Age: 25.0
Sex: U
Vaccine: DTAPHEPBIP, HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Pregnant patient (15 weeks) ws given second dose of HPV vaccine instead of Hep B vaccine.
Age: 0.08
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given KINRIX earlier date. Recommendation of age for vaccine is 4-6 years old. Spoke with manufacture GlaxoSmithKline Pharmacist stated that is a valid dose for patient. And does not need to be repeated.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: First dose of HAVRIX for 12 year old patient. Gave 1440 units/1 mL instead of FDA approved 720 units/0.5 mL dose.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: HPV 3 administered on 12/22/16 and documented in EMR but not state registry. Records were not reconciliated and HPV was readministered on 2/20/17.
Age: 1.08
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient needed MMR and Varicella. Staff administered MMRV and Varicella.
Age: 0.02
Sex: U
Vaccine: DTAP, DTAPIPV, IPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX dose was administered to a 4 month old child.
Age: 0.25
Sex: U
Vaccine: MMRV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: After the physician gave the drug orders to the nurse, the nurse accidentally marked the incorrect vaccine to be given on the immunization routing slip in the patient's chart. The vaccine ordered was PREVNAR 13, but it was listed right below the MMRV, which was marked instead. Therefore, a PROQUAD vaccine was administered into the right thigh of a 3 month old baby. The correct vaccine was administered into the left vastus of the patient as prescribed following the medication error.
Age: 17.0
Sex: U
Vaccine: HIBV
Symptoms: Product label confusion, Wrong drug administered
Clinical narrative: The doctor ordered the "Meningo" vaccine for the patient. The medical assistant that was drawing up and administering vaccines that day thought the HIB vaccine was the same as the meningococcal vaccine because the manufacturer labeled the box as "Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate)." The medical assistant was not very familiar with how each vaccine box looked like and was confused by the label. The error was caught when a student volunteer that was entering vaccines into the online record realized that the Lot # of the vaccine administered did not correspond with the correct vaccine. The patient's guardian was notified and the patient returned the next week to receive the correct vaccine. Age of patient at time of event: 17 years 10 months.
Age: 43.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received 3-doses of VAQTA at 0, 7, and 9 months.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: 2 varicella given.
Age: 0.08
Sex: U
Vaccine: HEP, TDAP
Symptoms: Wrong drug administered
Clinical narrative: I (medical assistant) was on the phone and the physician asked me to administer vaccination to patient. I thought she said TDaP. I administered the TDaP. The immunization that was supposed to be given was Hep B. This TDaP was not ordered.
Age: 2.92
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None stated.
Age: 0.83
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Had 10 month old baby. Baby was given KINRIX instead of PEDIARIX.
Age: 0.05
Sex: U
Vaccine: DTAP, HEP, HIBV, PNC13, RVX
Symptoms: Wrong drug administered
Clinical narrative: I had a 7 month old come in for her 6 months vaccine. I was getting the vaccines ready and I grabbed a Hep B instead on a PREVNAR. The patient was also getting a DTaP, Hib and Rota.
Age: 12.0
Sex: U
Vaccine: RV1
Symptoms: Wrong drug administered
Clinical narrative: 2 children needing vaccines at the same time, a baby and older child. The parent took the ROTARIX and gave it to the older child.
Age: 9.0
Sex: U
Vaccine: HEP, HEPA
Symptoms: Intercepted drug administration error
Clinical narrative: Patient had three different Immunization records, one of which indicated patient had not been given Hep A and Hep B vaccine, therefore vaccine was order by provider. Vaccine was prepared and verified by provider but not given to patient. Third immunization record was provided after vaccine was prepared, that indicated vaccine had been given.
Age: 19.0
Sex: U
Vaccine: RAB
Symptoms: Product storage error
Clinical narrative: Patient was given 3 doses RABAVERT vaccine that had been stored improperly in the freezer.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site pruritus
Clinical narrative: The symptoms are reported as being mild. The symptoms occur daily. The location is right arm. He states the symptoms are acute and have worsened. Patient is in today due to an allergic reaction after receiving a shot here at the clinic on right arm. He endorses pruritis around the shot area.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Tenderness
Clinical narrative: Patient woke up day after receiving a vaccine with a red, itchy, localized reaction. It was also painful to the touch and has an approximate size of 3 in x 2 in. She is self treating with diphenhydramine, ibuprofen, and ice.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Arthritis, Pain, X-ray abnormal
Clinical narrative: Right arm has severe to mild severe pain lifting it from the base of the body. Pain does not go away after 21 days and counting. Physician says I am victim of Arthritis which I do not accept as I did not have any arthritis in the right arm prior to this incident of taking the shot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient did not have adverse reaction. Vaccine was EXP.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient called on 7/24/17 to report symptoms of low grade fever, sore throat, difficulty breathing from the night before.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site swelling, Skin warm, Urticaria
Clinical narrative: Patient reports that she had a red welt the afternoon of 7/22/17 and for most of 7/23/17. She had been counseled that an injection site reaction could occur and she was not alarmed. The evening of 7/23/17 her red welt started to blister and feel warm to the touch. She called the pharmacy the morning of 7/24/17 to report the reaction. The patch is raised and about the size of a silver dollar right over the injection site. She reports that she is otherwise feeling well- no fever.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Left arm injection site swelling, severe pain, warmth, fever 99.9F, chills, nausea.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Left arm injection site swelling, severe pain, warmth, fever 99.9F, chills, nausea.
Age: 57.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site haemorrhage, Injection site swelling, Pruritus
Clinical narrative: Gave pt 3 IMZ on 7/18. BOOSTRIX and HAVRIX in left arm and ENGERIX-B in right arm. Right arm is ok however, Left arm has bruising at the top of the shoulder and a raised red streak around the middle of the deltoid muscle. Pt said her left arm itched a little but had no pain. These symptoms occurred the day following IMZ. The BOOSTRIX injection bled at the time of injection but HAVRIX injection was fine. Pt came in on 7/24 to report adverse rx. Pt has been taking BENADRYL and I recommended she put an ice pack on the red raised area and continue the BENADRYL. The bruise was fading when she came in on 7/24. Recommended she see a physician if it got any worse.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product preparation error
Clinical narrative: Possible misadministration of PENTACEL vaccine. Vaccine inventory audit discovered 1 remaining vial of the PENTACEL diluent (DTaP/ Polio solution portion) so it is assumed that an incorrect diluent was used to mix with the Hib powder portion of the vaccine rendering the vaccine not valid. It is unclear which child in the month of May received the invalid dose, so all families are being notified of the possible error and offered re-vaccination.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Heart rate increased, Rash, Tremor, Vomiting
Clinical narrative: Temp between 103-104.6 shaking bumps rapid heart beat vomiting.
Age: 4.0
Sex: U
Vaccine: DTAP, TD
Symptoms: Wrong drug administered
Clinical narrative: Pt. came in today for a Dtap. Pt. was given Td in error. Mom notified. Health Dept. notified. I was given the ok to administer the Dtap today. Mom notified and Dtap was given. Age of patient at time of event: 58 months.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 17 y/o received Adult HAVRIX dose.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash pruritic
Clinical narrative: Given MMR + Varicella and KINRIX: Developed itchy rash - first noted on face and upper extremities - when arrived home 2 hr. later noted also lower extremity itchy rash - truncal area spared (did.
Age: 28.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: 3 inches diameter swelling on (R) arm at injection site with itching. Will use CLARITIN OTC for itching and cool compresses.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Body temperature increased, Decreased appetite, Headache
Clinical narrative: Within 1-2 hrs after injection, Pt C/O joint pain, muscle pain, injection site, red, swollen, painful down to above elbow. Felt weak, lethargic, temp was 101.4 and went up and down for 3 days following injection. No appetite, both feet felt numb between toes and on top/bottom of feet. Had HA and pain in throat on one side only when swallowing. Symptoms slowly resolving. Still not 100% as of 7/24.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Within 1-2 hrs after injection, Pt C/O joint pain, muscle pain, injection site, red, swollen, painful down to above elbow. Felt weak, lethargic, temp was 101.4 and went up and down for 3 days following injection. No appetite, both feet felt numb between toes and on top/bottom of feet. Had HA and pain in throat on one side only when swallowing. Symptoms slowly resolving. Still not 100% as of 7/24.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Odynophagia, Oropharyngeal pain
Clinical narrative: Within 1-2 hrs after injection, Pt C/O joint pain, muscle pain, injection site, red, swollen, painful down to above elbow. Felt weak, lethargic, temp was 101.4 and went up and down for 3 days following injection. No appetite, both feet felt numb between toes and on top/bottom of feet. Had HA and pain in throat on one side only when swallowing. Symptoms slowly resolving. Still not 100% as of 7/24.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt. reported fever 7/19/17 103 degrees F at home. Seen in walk in clinic 7/20/17 Fever 99.4. Pt. had been taking TYLENOL. Advised: fluids, rest, OTC ADVIL/TYLENOL per box instructions. Seen at doctor's office 7-21-17.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient states had a sore arm, hard to lift the day of the vaccine, then returned to pharmacy on 7/23/17 with a red, swollen, sore arm. Pharmacist recommended she take BENADRYL and see her provider if symptoms worsened or did not improve. Called patient 7/24/17, patient states much better today, still not feeling great, but swelling and redness are much better. She had an appointment with her provider on Thursday. Pharmacist sent information on vaccine reaction to her provider.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Injection site warmth, Pyrexia, Rash erythematous, Swelling
Clinical narrative: Red flat rash, with calor, lateral aspect of the R deltoid, bicep, which was associated with low grade fever. The fever resolved in 1 day. Rash remained with generalized swelling and calor, 3 days.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site reaction, Skin reaction
Clinical narrative: Pt. developed erythematous localized skin reaction at injection site. Pruritic in nature. Occurring day following vaccination. Patient ultimately treated with antibiotics as skin reaction, presumed cellulitis resolved.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient reported it happen on 6/2/17 the area on left deltoid became red and itchy.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid redness, swollen, warm and itchy.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, body aches, chills, fever.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema and warmth to touch in 6" x 3" area just below site of MENVEO and TDaP injection 2 days ago on 7/22/17. Seen by MD. ZYRTEC and BENADRYL. Advised for possible allergic reaction to return if Pt becomes febrile.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Nervousness, Seizure, Unresponsive to stimuli
Clinical narrative: Seizure lasting approximately 10 seconds, starting 5 mins after injection. We had her lay down for at least 15-20 mins following seizure. When she sat up, she felt nauseated, but no vomiting. Pt. laid down for another 10 mins, and felt ok sitting up the next time. A few minutes following first HPV vaccination, I responded to a call for help inside exam room. Mom stated that pt. was seizing. Pt had eyes closed, supine with legs hanging off the side of the bed and head next to the wall. Brought legs onto the bed and held her head away from the wall to protect it, and had the MA get the doctor. No visual shaking at this time, but she was non responsive while mom called to her three times. I called her name and touched the front of her shoulder and within a couple seconds she opened her eyes, looking suddenly alert. She looked around to the people in the room and spoke normally. No apparent tiredness or pallor. Mom reports she called for help as soon as she recognized what looked to her like seizure activity. Episode lasted approximately 5-10 seconds, Dr. entered the room just after she became responsive again, and spoke with mom regarding the episode, and the plan going forward. Pt. rested in the exam room for at least an hour and blood pressure was checked twice, supine and sitting, with no change from the initial BP taken today. ER precautions given. She was scheduled for an EEG on 7/26/17. Hx: Mom stated that she had 3-4 seizures when she was younger, non febrile. After first seizure, she was taken to the ER, where doctors witnessed another seizure. She had 1-2 more seizures 1-2 weeks after that. Pt was seen by a Neurologist, and took medication: LAMICTAL for 1 year. No more seizures after that, so she was taken off the medication. Mom reports that she also had a fainting episode when getting blood drawn on 10/26/13. Pt was sitting in her lap and she felt patient slump back into her chair. She was pale, and had no apparent seizure activity that mom recognized. In both cases: today, and for the blood draw in 2013, she was very nervous.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: Patient walked out of room feeling dizzy, then lead to nausea. Medical assistant gave patient water and had him lay down.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right leg is red, swollen, indurated, and warm.
Age: 62.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Muscle loss, nerve issues flu-like symptoms-loss of coordination-instability when walking or standing, pain in entire body at some point.
Age: 62.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Blood test, Computerised tomogram, Coordination abnormal, Dysstasia, Gait disturbance
Clinical narrative: Muscle loss, nerve issues flu-like symptoms-loss of coordination-instability when walking or standing, pain in entire body at some point.
Age: 62.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Influenza like illness, Muscle atrophy, Pain
Clinical narrative: Muscle loss, nerve issues flu-like symptoms-loss of coordination-instability when walking or standing, pain in entire body at some point.
Age: 56.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain
Clinical narrative: Severe and prolonged pain. Patient is has had ongoing physical therapy, pain medications, and steroid injections.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Culture, Erythema, Headache, Musculoskeletal stiffness, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician through a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced bumps where injection was given and sore throat on 14Jul2017 with outcome of unknown. The physician was not sure if the sore throat was viral and related to the TRUMENBA. They felt like it was related to something other than the vaccine.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Pain, Pain in extremity, Pyrexia, Streptococcus test negative
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician through a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced bumps where injection was given and sore throat on 14Jul2017 with outcome of unknown. The physician was not sure if the sore throat was viral and related to the TRUMENBA. They felt like it was related to something other than the vaccine.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Injection site rash, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician through a Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced bumps where injection was given and sore throat on 14Jul2017 with outcome of unknown. The physician was not sure if the sore throat was viral and related to the TRUMENBA. They felt like it was related to something other than the vaccine.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received on 11-JUL-2017 from a 72 year old female patient who reported she was administered ZOSTAVAX one single injection "about 2.5 years ago" for prevention of shingles (date of vaccination, dose, lot#/expiration not reported). Concomitant medication included two unspecified inhalers, SYMBICORT and INCRUSE ELLIPTA. On 20-JUN-2017, patient experienced shingles for an unspecified reason. Treatment provided included PERCOCET and NEURONTIN. Patient reported she had an outpatient visit to a community medical center on an unspecified date. Outcome of shingles was not recovered. No further adverse event information was available. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received on 14-JUL-2017 from a nurse who reported that an unspecified patient received a dose of GARDASIL 9 (lot#/expiration unspecified) on 29-JUN-2017 and a second dose of GARDASIL 9 (lot#/expiration unspecified) on 14-JUL-2017. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA, HPV9, MMR, RV5, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 13-JUL-2017 from a registered nurse regarding an unspecified number of patients (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA, M-M-R II, GARDASIL 9, RECOMBIVAX HB, ROTATEQ and VARIVAX (dose, route, site of administration and lot numbers not reported). It was not known if sterile diluent used to reconstitute M-M-R II and VARIVAX was improperly stored, at the time of the call. No adverse effects were reported. No further information was provided. Temperature: Unknown by reporter at time of call. Time frame: Unknown by reporter at time of call. Previous temperature excursion? Unknown by reporter. Was call because of a data logger? Yes. On the same day the nurse called back to provide lot #s and expiration dates. VAQTA (lot # N012324, exp 05-APR-2018), M-M-R II (lot # M047302, exp 30-NOV-2018; lot # N002337, exp 20-JAN-2019 and lot # M039914, exp 26-SEP-2018), GARDASIL 9 (lot #N003703, exp 29-OCT-2019; lot # L037554, exp 25-DEC-2017), RECOMBIVAX HB (lot #N006321, exp 08-NOV-2019; lot # N009802, exp 19-DEC-2019), ROTATEQ (lot # N009948, exp 21-OCT-2018 and lot # N003396, exp 03-NOV-2018), VARIVAX no lot #'s provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure during pregnancy, Exposure via eye contact, Exposure via skin contact, No adverse event
Clinical narrative: Information was received on 11-JUL-2017 from a pharmacist who is also the patient. No concomitant medications were reported. Patient was reported to be 13 weeks pregnant. On 11-JUL-2017, while the pharmacist was administering a dose of ZOSTAVAX (lot # N013289, expires 04-JUL-2018) (dose, route and site not reported) reconstituted with sterile water diluent (lot L033143, expires 16-APR-2018), "the tip of the plastic syringe and the needle separated while administering [the vaccine] and the ZOSTAVAX splashed into my eyes, mouth and face and I am 13 weeks pregnant." The pharmacist confirms that the full dose was not administered to the intended patient (MARRS # 1707USA009340). No adverse effects reported. No further information was provided. Additional information has been requested. This is one of two reports from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue
Clinical narrative: Information was received on 11-JUL-2017 from a pharmacist who is also the patient. No concomitant medications were reported. Patient was reported to be 13 weeks pregnant. On 11-JUL-2017, while the pharmacist was administering a dose of ZOSTAVAX (lot # N013289, expires 04-JUL-2018) (dose, route and site not reported) reconstituted with sterile water diluent (lot L033143, expires 16-APR-2018), "the tip of the plastic syringe and the needle separated while administering [the vaccine] and the ZOSTAVAX splashed into my eyes, mouth and face and I am 13 weeks pregnant." The pharmacist confirms that the full dose was not administered to the intended patient (MARRS # 1707USA009340). No adverse effects reported. No further information was provided. Additional information has been requested. This is one of two reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age (gender not reported). The patient's current conditions, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored (incorrect product storage) VARIVAX lot # M039317, expiration date: 20-SEP-2018, (strength, dose and route of administration were not reported) for prophylaxis after first temperature excursion but previous to second temperature excursion. Concomitant therapies included sterile diluent(STERILE DILUENT) (lot/batch#M024783, expiration date: 15-JAN-2019). No adverse effects were reported. On an unspecified date, the temperature excursion was 1.7 °C for 7 hours 36 minutes. Previous temperature excursion was reported as -8 °C for 1 hour 39 minutes. No PQC was involved. The outcome of incorrect product storage and no adverse effects was unknown.
Sex: U
Vaccine: HEP, HEPA, HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 10-JUL-2017 from a licensed practical nurse (LPN) and refers to an unspecified patient of unknown age and gender. The nurse reported that an unspecified patient may have received an improperly stored dose of one of the following vaccines, but she is not sure which of the vaccines the unspecified patient received. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The names of the vaccines involved were GARDASIL [Lot number L036301, expiration date reported as 31-DEC-2017 (The expiration date of 10-DEC-2017 is the date that automatically showed in the product screen.) Lot number M034437, expiration date reported as 02/2019.]; RECOMBIVAX HB (Lot number M035487, expiration date 02/2018); VAQTA (Lot number M018644, expiration date 09/2017 (Expiration date shows as 20-SEP-2017 in the product screen); and ROTATEQ (Lot number M044395, 01-MAY-2018 (The expiration date of 31-MAY-2018 is the date that automatically showed in the product screen.) The temperature was reported as -0.5 degrees Celsius (C) for the time frame of 14 hours. There was no previous temperature excursion. The call was because of a "data logger". Product quality complaint was not involved. No adverse effect reported. No additional information was provided. A Lot verification request has been sent for GARDASIL Lot number M034437, expiration date reported as 02/2019. Additional information has been requested.