chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional referring to 10 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL (dose, route and lot number not provided). They were exposed to 34 F for a total of 237 hours. No adverse effects were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker professional refers to an unspecified number of patients of unknown age and gender. Since 20-FEB-2015, the patients were vaccinated with VARIVAX (Merck) which was improperly stored and administered (dose, route of administration and lot # were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: Information has been received from a 49 year old male patient who enrolled in a market research program referring himself. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, route and frequency were not reported, lot# was unknown). The patient reported he got sicker than when before he got the vaccine. The outcome of got sicker was unknown. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a 65 year old male patient. On 20-FEB-2015 the patient was vaccinated with an expired PNEUMOVAX 23 (lot number J009689, expiry date 29-JAN-2015) 0.5 ml, intramuscularly in the right deltoid. No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX 23 was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. No product quality complaint was reported. This is one of the 2 reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Pt received the ADACEL (Tdap) first on (L) deltoid while sitting down and had no problem. Pt stood up and got GARDASIL (R) deltoid. He had a syncopal episode immediately after the vaccine was given.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphagia, Lip oedema, Malaise, Pruritus
Clinical narrative: Pt. rec'd VARIVAX vaccine at well check-up. Left office and returned shortly after. Eating breakfast c/o feeling ill, itching and difficulty swallowing. Pulse 88 B/P 102/66, O2 sat 94%. Given BENADRYL 50mg po at 9:47am. Cont'd difficulty swallowing, lip edema. 9:52am EPI PEN 0.3mg IM administered. 9:55 reported improvement. Left by squad and transported to local ER for further evaluation.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Onset of redness, swelling and tenderness 8x9cm at injection site without fever, dyspnea of fluctuance. TX with ice, Abx and f/u and NSAID.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist and a healthcare student refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The reporters stated that on 06-MAR-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23 25 (units not provided), lot J011714, expiration date 20-FEB-2015, intramuscularly (dose not reported). There were no known adverse effects. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient while the vaccine should be given to female patients only.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 27-OCT-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given a male patient, while it should be given to the female patients, only.
Age: 5.0
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 5 year old given Hib after max dose age of 4.
Age: 12.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: DTaP given to a 12yr old.
Age: 11.0
Sex: U
Vaccine: HBHEPB
Symptoms: Wrong drug administered
Clinical narrative: Vaccine that was to be provided was Meningococcal Conjugate, available as MENACTRA at clinic. Vaccine actually provided was Hib-HepB.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 04-NOV-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. On unknown dates, the patients were vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and expiration date were not reported). Concomitant therapies were not reported. On an unknown date, after the vaccination, the patients developed shingles. The outcome of shingles was unknown. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to unspecified patients who on unspecified dates were vaccinate with doses of VARIVAX (Merck) (route, dose and lot # not reported) which were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HPV4
Symptoms: Asthenia, Myalgia, Pain, Pyrexia
Clinical narrative: I received the third GARDASIL vaccination at approximately 9:30 am on Friday February 20th. Around 7:30 om I began to feel minor weakness and muscle aches. At 1:30 am on Saturday, February 21st I woke up with a low-grade fever (99 degrees) around 3:30/4 am I woke up with a fever of 102.3 as well as all over muscle aches. The fever and aches continued for approximately 24 hours, until early on Sunday, February 22nd. I had no symptoms other than a fever and aches, and no other flu or cold-like symptoms, such as cough, runny/stuffy nose, congestion, or sneezing. 1glass of wine was consumed approximately 8 hours after the shot was administered.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration
Clinical narrative: Busy immunization clinic. ZOSTAVAX given IM route via deltoid muscle.
Age: 23.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Red spot on arm at vaccine site. Growing from dime size to quarter size over 72 hr period imm after vaccine. Arm is sore pain up into shoulder, down to elbow.
Age: 25.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patoent while this vaccine should be given to female patients only.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 29-OCT-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient, while it should be given to the female patients only.
Age: 16.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient, while it should be given to the female patients only.
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Me and my wife went to the local pharmacy to have immunization for Chicken Pox to clear our medical in May this year. We were given vaccination for ZOSTAVAX. We came to note that the immunization claim was rejected by our Medical insurance stating that it is covered only for 60+. We went straight to Pharmacy and told them about the situation and $473 was refunded. Moreover the Doc who cleared our medical also did not note that.
Age: 0.5
Sex: U
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was given several vaccines at 6m WCC, including hepatitis A. Pt should not have received Hep A vaccine.
Age: 8.0
Sex: U
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt presented for catch up schedule on DTaP and was given DTaP #5 at age 8, not recommended age.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult Hepatitis A dose given to a 17 year old young man.
Age: 11.0
Sex: U
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Patient was to received MENACTRA and received PEDVAXHIB instead.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Provider orderer MMR-V (PROQUAD instead do MMR and VZV separatley (did not know PROQUAD is only approved up to age 12).
Age: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: Male, 18 months old, was given a fourth dose of IPV. Third dose was given in February 2014. Physician stated that error occurred due to new Electronic Medical Record being implemented and the proper vaccine information was not in the EMR. In addition, the nurse failed to check the paper chart to ensure that the child was receiving the correct vaccinations. Contributing factor may have been that the child recently moved to the state and his vaccinations were not all given by this practice.
Age: 1.5
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Male, 18 months old, was given a fifth dose of PREVNAR 13. Fourth dose was given in June 2014. Physician stated that error occurred due to new Electronic Medical Record being implemented and the proper vaccine information was not in the EMR. In addition, the nurse failed to check the paper chart to ensure that the child was receiving the correct vaccinations. Contributing factor may have been that the child recently moved to the state and his vaccinations were not all given by this practice.
Age: 58.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: I gave a pediatric/adolescent dose of Hep B rather than the adult ENGERIX Hep B.
Age: 0.6
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Extra dose administered
Clinical narrative: Patient was given PEDIARIX and PENTACEL at same time. I called the nurse at public health about side effects and then spoke to patient mother and notify her.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Pt was to receive PEDIARIX, given KINRIX by mistake. Medical assistant was confused re: combination vaccines.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 30-OCT-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given a the male patient, while it should be given to the female patients, only.
Age: 17.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given a male patient, while it should be given to the female patients, only.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 26-JAN-2015 the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given a the male patient, while it should be given to the female patients, only.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from  76 year old female patient without drug reactions/allergies. The patient's medical history included recurring shingles. In approximately December 2014 (reported as "at least 2 or 3 months ago"), the patient was vaccinated with a dose of ZOSTAVAX, injection, one shot, (lot #, expiration dated and strength were not reported). Concomitant medications included unspecified blood pressure medicine and cholesterol medicine. The patient reported that she had recurring shingles prior to being prescribed and receiving ZOSTAVAX. She stated that she was told that ZOSTAVAX would keep her shingles from coming back anymore. She received ZOSTAVAX after one of her shingles cases had cleared up. she stated that, "about 4 or 5 weeks after" receiving ZOSTAVAX in approximately January 2015, she developed the shingles again. The patient sought medical attention by seeing her doctor. No lab diagnostics studies were performed. The physician prescribed unspecified "pills". The unspecified pills (manufacturer unspecified) cleared up the case of ZOSTAVAX on an unspecified date which was "3 weeks to a month after" this shingles outbreak began in 2015. The patient recovered from the events. Additional information has been requested.
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Product packaging confusion
Clinical narrative: This spontaneous report has been received from a registered nurse via Company Representative reporting that the color of the packaging for PROQUAD (Merck) and M-M-R II product were very similar and could not be confused. No instances where there had been product confusion were reported. No adverse effect was reported. No patient involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to a 63 year old female patient. On 20-FEB-2015 the patient was vaccinated with an expired PNEUMOVAX23 (lot number J009689, expiry date 29-JAN-2015) 0.5 ml, intramuscularly in the right deltoid (Expired product administered). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with PNEUMOVAX23 was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX23 was unknown. No product quality complaint was reported. This is one of the 2 reports from the same source. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: PNEUMOVAX 23 ordered, PREVNAR 13 given.
Age: 18.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient needed to have DTaP/IPV for school. School refused to allow patient to continue school without appropriate vaccine. Discussed issue with both the school nurse, parent and patient. Patient understood the need for the vaccine for school and agreed to having vaccine.
Age: 7.0
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: At mass back to school vaccination clinic, 7 year old child was administered a DTaP vaccine when Td/Tdap should have been administered. No adverse event noted. Parent notified of incident and facility risk management forms completed. Immunization Branch informed of incident, no further vaccination needed until booster.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Clinic was having refrigeration issues and vaccines were stored at a separate location. It was later discovered that immunization may not have been transported correctly. It was not kept at the proper temperature. Vaccine had already been given.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: Clinic was having refrigeration issues and vaccines were stored at a separate location. It was later discovered that immunization may not have been transported correctly. It was not kept at the proper temperature. Vaccine had already been given.
Age: 6.0
Sex: U
Vaccine: DTAPHEPBIP, IPV
Symptoms: Wrong drug administered
Clinical narrative: Given IPOL instead of VARIVAX. Patient also received a dose of PEDIARIX at same time.
Age: 0.8
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX administered to 10 month old.
Age: 12.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Ran routing slip for pt...the form specifies just DTP as an option. DTaP was given to a 12yo rather than the Tdap that should have been given. In future provider clearly documents what should be given DTaP, Tdap, or Td so no confusion potential exists.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given before pulled from refrigerator.
Age: 1.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong technique in drug usage process
Clinical narrative: PENTACEL was reconstituted with regular diluent (sterile water). The nurse did not grab the correct diluent from the PENTACEL box.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: The patient was given a dose of HepB instead of the ordered dose of HepA.
Age: 0.8
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: My almost 10 month old son received Hepatitis A vaccine. Before the vaccine I asked the nurse which vaccine she recommends that the baby receive this visit to catch him up to his vaccine schedule. She also recommended that I receive PCV 13. The nurse told me that she spoke to the triage nurse and that the triage nurse recommends getting Hepatitis A due to our travel international later this month. This morning the triage nurse said that she reviewed the charts and noticed that our baby received the hepatitis vaccine prematurely. She apologized and said that the nurse was not in that day and has yet to speak to her. The triage nurse told me that the error was given 8 weeks prematurely and should not be given to children under 1 year old.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient need for ZOSTAVAX. Inadvertently administered varicella vaccine.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Accidental exposure to product, Needle issue
Clinical narrative: This spontaneous report was received from a 25 year old female register nurse referring to herself. Concurrent conditions, medical history and allergies were not reported. The patient's historical drug included a measles virus vaccine live (manufacturer unknown) vaccination on an unknown date in 1994. The reporter stated that on 17-FEB-2015, while she was drawing up a M-M-R II (strength, lot number and expiration date were not reported), vaccine to administered to a patient "I drew up the diluent and was pushing the diluent into the powder part of the vaccine and I think there was some pressure (inside the vial with the powder) and I heard a pop and the needle came apart from the hub of the syringe and either just the diluent and some of the vaccine splashed out onto my scrubs". The reporter indicated that it did not get on her skin and did not splash into her face, eyes or mucous membranes. It was unknown if there was any laboratory data. No concomitant therapies were reported. Additional information is not expected, because the reporter did not consent further follow up.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a 58 year old female patient. On 03-MAR-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose and lot # not reported). The physician reported that on 03-MAR-2015, about 5 hours after vaccination, the patient experienced severe pain around injection site. The physician reported there was no swelling or redness around injection site but just plain was reported by patient. It was unknown if PNEUMOVAX 23 dose was the patient's first dose or if patient had any previous dose of PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient. Concurrent condition included high blood pressure and no drug reactions/allergies. Concomitant medication included amlodipine and hydrochlorothiazide (manufacturer unknown). On 15-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (route subcutaneous, dose, lot number and expiration date were not reported). In an approximately October 2014 (reported as one and a half week after receipt of ZOSTAVAX), the patient developed a red, blotchy rash all over his body. On an unknown date, the patient sought for medical attention and was seen by a dermatologist who could not diagnose the rash. The patient was prescribed with prednisone (manufacturer unknown), hydroxyzine, triamcinolone cream. The patient's outcome was not recovered/not resolved (reported as the rash still continues). The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. The registered nurse stated that doses of M-M-R II (dose, route, lot number and expiry date were not reported), were exposed to a supported temperature excursion and administered to unspecified patients since the excursion occurred on 17-FEB-2015. No adverse experience has been reported. There was no concomitant medication provided. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 1.46
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via field representative refers to a 17 month old male patient. The patient's medical history was not reported. On 20-MAY-2014, the patient was vaccinated with the first dose of VAQTA (lot #, dose, route and site of administration were not reported). On 04-NOV-2014, the patient was vaccinated with the second dose of pediatric VAQTA (lot #, dose, route and site of administration were not reported) and experienced inappropriate schedule of vaccine administered. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, route, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Hypotonia, Muscle rigidity, Vomiting
Clinical narrative: 1/14/15 - received HIB and PCV13 vaccines 1015 AM. Approximately 4PM, patient developed vomiting, went rigid and then limp requiring medical transport -> ER. Prior simple episode reported 10/23/14 with exposure to same vaccines.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 04-NOV-2014, the patient was vaccinated with M-M-R II (route, dose and lot # were not reported) which underwent a temperature excursion (on an unspecified date). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.57
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Patient has never had love disease. Patient was given acyclovir 200mg/5ml 1 1/2 tsp. for 5 days. Dx'd with shingles on 6 March 2015.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a 22 year old female patient reporting on behalf of herself as part of a market research program. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the patient got diseases after being vaccinated (details unspecified) (adverse event). The action taken with the therapy with PNEUMOVAX 23 was reported as unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with PNEUMOVAX 23 was unknown. Additional information is not expected as there was no consent.
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report as received from Pfizer (Manufacturer Control N. 2015073572) refers to a female adult patient. On an unspecified date in 2007, the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot #, dose and route not reported). Subsequently, her arm swelled up with PNEUMOVAX 23 (onset date unspecified). At the time of the report, the patient's outcome was unknown. The original reporting source was a pharmacist. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with a dose of M-M-R II (route, strength, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 29-SEP-2014 the patient was vaccinated with a dose of M-M-R II (route, strength, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt given DTaP, IPV, MMR, and Varicella given on 9/18/13 and 7/21/14.
Age: 11.0
Sex: U
Vaccine: TTOX
Symptoms: Wrong drug administered
Clinical narrative: Tdap ordered, tetanus vaccine given.
Age: 2.0
Sex: U
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Hib ordered, Hep B given.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient only received PENTACEL vial. Staff didn't combine with Hib diluent.
Age: 1.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient.
Age: 0.5
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Hep B and Hib ordered. 2 doses of Hep B given.
Age: 22.0
Sex: U
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Hep B ordered, Hib given.
Age: 15.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient while this vaccine should be given to female patients only.
Age: 12.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient while this vaccine should be given to female patients only.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: PEDIARIX ordered, PENTACEL given.
Age: 18.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient while this vaccine should be given to female patients only.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: PENTACEL and Hep B ordered, staff gave PENTACEL and hib. Staff not aware that PENTACEL contained Hib and not Hep B. Pt returned for Hep B.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Varicella ordered, MMR drawn up in error but not given. Both vaccines stored in freezer.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong technique in drug usage process
Clinical narrative: PENTACEL ordered, staff was interrupted while preparing vaccine. Staff mixed PENTACEL powder with sterile water and not mixed with DTAP/IPV. During the double check with another staff member, error was caught before reaching the patient.
Age: 30.0
Sex: U
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: MMR ordered, MENACTRA given.
Sex: U
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: PREVNAR 13 ordered from pharmacy, PNEUMOVAX 23 received. Staff reviewed order and vial, PNEUMOVAX 23 returned to pharmacy. PREVNAR 13 then received and administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: Zoster vacccine was found sitting on counter in med prep room at room temp. Zoster vaccine was received on 06/23 and was found one day later.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: Childs mother refused varicella ad staff gave PROQUAD.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: The pharmacist and pharmacy technician failed to check the vaccine for the expiration date. There were three containers of vaccine in the fridge - one expired MDV, two expired SDV, and one box of in-date SDV. The expired vials were in no way separated from the in-date vials. Upon filling out the form with lot number and expiration date, the pharmacist discovered the error. The expiration date was a little confusing at first, the pharmacist's lack of familiarity with the particular brand of vaccine was a factor.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient received expired dose.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Body temperature increased, Laboratory test, Rash generalised, Rash maculo-papular
Clinical narrative: This spontaneous report was received from a healthcare student refers to a 2 year old female patient without pertinent medical history and with hypersensitivity to amoxicillin. On 09-FEB-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, (strength, dose, frequency and anatomical location were not reported), subcutaneous, (lot number reported as K007781; expiration date: 28-MAY-2016). Other suspect therapies included a dose of M-M-R II, (strength, dose, frequency and anatomical location were not reported), subcutaneous injection, (lot number reported as J013316; expiration date: 22-OCT-2015) and INFANRIX (GlaxoSmithKline), (strength, dose, frequency, route, anatomical location and indication were not reported). There were no concomitant therapies. On 15-FEB-2015, the patient experienced rash maculo-papular on an unspecified area of her body which was continuing to evolve and was currently on her face, trunk, diaper area and legs. On 16-FEB-2015, the patient experienced body temperature increased with a maximum of temperature of 39.7 degrees C (103.5 degrees Fahrenheit) on 18-FEB-2015. Patient continued to have an elevate temperature. On 19-FEB-2015, the patient sought medical attention through office visit and an unspecified lab studies were prescribed but the results were not available. It was reported that no treatment was given for the adverse events. The outcome of body temperature increased and rash maculo-papular was reported as not recovered/not resolved. The relatedness between body temperature increase and rash maculo-papular and therapy with (Oka/Merck) VARIVAX, M-M-R II and INFANRIX (GlaxoSmithKline) was not reported. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This patient was seen for her 15 month WCC. The provider was given the patient's WIR report prior to ordering the vaccines. This was to be the patient's 4th dose of DTaP (INFANRIX). The provider ordered me to give this vaccine. As I looked over the patient's WIR, I did not see this listed as a recommended immunization on the patient's WIR, so I asked the advice of my pod supervisor. She said that she does not go by what is recommended on the WIR, and she told me that since it had been more than 4 weeks from the last dose that she agreed with my provider and told me that it was safe/fine to give the vaccine. It was not until the next day that this showed as invalid on WIR, and I brought it to another provider's attention, who informed me that it was invalid, because the patient had not gotten her vaccines on schedule and that it needed to be 6 months between the 3rd and 4th dose according to the CDC catch up schedule.
Age: 8.0
Sex: U
Vaccine: HIBV
Symptoms: Intercepted drug dispensing error, Product label confusion
Clinical narrative: Near miss: we had a pharmacist almost dispense this as a Tetanuse Toxoid vaccine. Labeling confusion on this box as tetanus toxoid i just a conjugate.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: A 12 mo was marked as being given Hep A when it was actually a 12 year old.
Age: 65.0
Sex: U
Vaccine: HEPA, PPV
Symptoms: Product packaging confusion, Wrong drug administered
Clinical narrative: One of the nurses asked me to look at a bag that contained one vial of VAQTA and PNEUMOVAX 23 to make a point that they look very similar. With the TWINRIX shortage we are using more VAQTA and recently went to single dose PNEUMOVAX 23 the vials are very similar in shape and color.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MMRV was given to a 13 year old adolescent.
Age: 58.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Pt arrived at the clinic requesting a PPCV 23. The pt received a PCV13.
Age: 72.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Pt presented to the clinic requesting a PPSV23. The pt received a PCV13.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Wrong drug administered
Clinical narrative: The wrong vaccine was pulled from the refrigerator. There is one basket with two compartments, a front and a back compartment. There are two labels in the front of the basket to indicate two different vaccines, but the vaccine was pulled from the front compartment, rather than the back.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 4 month old child received KINRIX.
Age: 60.0
Sex: U
Vaccine: MMR, VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: Patient requested MMR, dose#2 and ZOSTAVAX. Vaccine orders were proposed by MA. ZOSTAVAX signed by MD and MMR given verbal approval. Patient received vaccines. After patient left clinic, it was noted in chart that she had reported receiving immunosuppressant drug RITUXAN (contraindication for live vaccine administration while receiving this medication). After further investigation, it was determined that patient had not received this medication for the pat 12 months. However, she is currently on oral immunosuppressive therapy, taking 20mg of methotrexate weekly. PCP (office where vaccine was administered) consulted with rheumatologist. Decided to recommend patient hold methotrexate x4 weeks. At this time, no adverse reaction has been reported.
Age: 16.0
Sex: U
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: PEDVAXHIB was given instead of the MENACTRA.
Age: 16.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given to a male patient while this vaccine should be given to female patients only.
Age: 1.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: PENTACEL ordered, DAPTACEL given.
Age: 1.53
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash maculo-papular, Rash pruritic, Viral rash
Clinical narrative: Macular-papular rash develops on 3/5/15 continuously on abdomen, neck, back and both arms. The rashes are erythematous and itchy. Negative for pain, cough, fever, diarrhea, joint swelling, vomiting, lymphadenopathy and wheezing.
Age: 17.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given the male patient. while it should be given to the female patients, only.
Age: 85.0
Sex: U
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt received PREVNAR 13 on 10/15/14 and 12/9/14.
Age: 13.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given the male patient, while it should be given to the female patients, only.
Age: 17.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given the male patient, while it should be given to the female patients, only.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: PENTACEL ordered, PEDIARIX given. Patient has not received Hib doses.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: PREVNAR 13 ordered, PNEUMOVAX 23 given. Pt received PNEUMOVAX in 2011.
Age: 16.0
Sex: M
Vaccine: HPV2
Symptoms: Product use issue
Clinical narrative: CERVARIX was given a male patient, while it should be given to the female patients, only.
Age: 1.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX was given to a child below 4 years.
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX was given to a child younger than 4 years.
Age: 0.9
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX was given to a child younger than 4 years.
Age: 1.04
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX was given to a child younger than 4 years.
Age: 1.04
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX was given to a child youngrt than 4.
Age: 0.2
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Vaccine was mixed with sterile water instead of the diluent provided.
Age: 50.0
Sex: U
Vaccine: MNQ
Symptoms: Wrong technique in drug usage process
Clinical narrative: Drew up diluent, did not mix with powder. Error caught while drawing up other vaccines. Diluent mixed with powder after realizing error.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received DAPTACEL early. He had DAPTACEL on 11/28/2014 and again on 12/11/2014.
Age: 1.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: LVN meant to give DTaP but gave KINRIX instead. Therefore, patient received DTaP but received an additional dose of IPV.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Back pain, Flank pain, Rash vesicular
Clinical narrative: This spontaneous report was received from a physician refers to a 13 year old male patient. The patient had no pertinent medical history and no known drug reactions or allergies. On 21-MAR-2002, the patient was vaccinated with the first dose of VARIVAX (Merck), 0.5 ml, subcutaneous, lot # reported as 1552L (which is not valid for VARIVAX), expiration date August 2004 or lot # 1249L, expiration date March 2003. On 04-MAY-2009, the patient was vaccinated with the second dose of VARIVAX (Merck), 0.5 ml, subcutaneous, lot # 0097Y, expiration date 16-JAN-2011. There was no concomitant medication. On 28-FEB-2015, the patient experienced rash vesicular which started as left flank and back pain and then the rash actually developed on 03-MAR-2015 according to the patient. On 05-MAR-2015, the patient was seen in the physician office due to developing a shingles like rash on the left hip and thigh laterally. Acyclovir was given as treatment. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical history, drug allergy and concurrent condition was specified. Approximately 4 weeks ago in January 2015, the patient was vaccinated with ZOSTAVAX (dose, unit, frequency, lot number were not specified) for an unknown indication. On an unknown date in February 2015 the patient had been prescribed a medrol dose pack for an unknown diagnosis. No product quality complaint involved (PQC). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Body temperature increased, Headache, Injection site erythema, Injection site rash
Clinical narrative: Red rash with swelling at site, warm to touch, headache, temp to 104, joint pain beginning morning after vaccination. Returned to MD, 48 hrs after shot. Erythematous, speckled rash continues on left upper arm - swollen bicep and tricep. MOTRIN and TYLENOL - 3 doses of prednisone.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Red rash with swelling at site, warm to touch, headache, temp to 104, joint pain beginning morning after vaccination. Returned to MD, 48 hrs after shot. Erythematous, speckled rash continues on left upper arm - swollen bicep and tricep. MOTRIN and TYLENOL - 3 doses of prednisone.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Rash that radiated from injection site to elbow. Red, not raised, hot.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Mom called stating pt. had local reaction at injection site 10 days after vaccine was administered SC/LT. (See 13-A for lot #).
Age: 0.7
Sex: F
Vaccine: HIBV, IPV, PNC13, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Medical assistant inadvertently administered Tdap instead of DTaP to pt for 3rd dose of vaccine. Protocol dictates for pt to receive DTaP and that the administered Tdap will not count toward the pt's required vaccinations since it was only the 3rd dose and not the 4th or 5th.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Cough, Ear pain, Injection site swelling, Joint crepitation
Clinical narrative: Injection given at 5:00 P.M. on 1/16/15. Also given injection of ROCEPHIN and Rx - AUGMENTIN. About 11:00 pm I was awakened by urge to vomit. experienced projectile vomiting. On 1/17/15 awoke with 3" band of swelling at injection site. Violent coughing episode. Swelling continues to date. Joint ache, mostly in neck. Popping noise with movement of spine, knees. Earache in right ear. Several episodes of coughing.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Neck pain, Vomiting projectile
Clinical narrative: Injection given at 5:00 P.M. on 1/16/15. Also given injection of ROCEPHIN and Rx - AUGMENTIN. About 11:00 pm I was awakened by urge to vomit. experienced projectile vomiting. On 1/17/15 awoke with 3" band of swelling at injection site. Violent coughing episode. Swelling continues to date. Joint ache, mostly in neck. Popping noise with movement of spine, knees. Earache in right ear. Several episodes of coughing.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Pt received DTaP immunization 23Feb15 seen at urgent care 3/1/15 for dx cellulitis (R) upper arm trx with KEFLEX.
Age: 17.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician refers to a 17 year old female patient. The patient supposed to receive a second dose of M-M-R II, a second dose of (Oka/Merck) VARIVAX and an unspecified meningococcal vaccine on 27-FEB-2015. The patient received M-M-R II, and unspecified meningococcal vaccines but she was inadvertently administered ZOSTAVAX instead of (Oka/Merck) VARIVAX second dose, lot # K020801, expiration date: 31-JAN-2016, (dose and route of administration were not reported). No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to an over 60 year old female patient. On an unknown date a dose of VARIVAX was inadvertently administered on the patient who was indicated for a dose of ZOSTAVAX. No adverse effects reported. It was unspecified if the patient sought for medical attention. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Cellulitis, Induration, Pyrexia, Tenderness
Clinical narrative: Fever Tmax 104 F, mild induration of anterolateral thighs bilaterally, mild cellulitis appearance, tender to palpation.