chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: The nurse used the Merck diluent to reconstitute the MENVEO, and the patient was immunized with this product.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Wrong age (patient not correct age for vaccine given).
Age: 0.7
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Female-8 month old was given KINRIX instead of just DTAP per recommendation of an urgent care. Mother dose not immunize but 8 month old was bitten by a rabbit and was advised to get DTAP once at least. No consent was signed before mother left and mother only wished to get DTAP only. KINRIX was given by mistake. MA-C thought they had drawn up DTAP only but was combo IPV and DTAP. MA did not make sure mother signed consent prior to her administering or leaving. Tried contacting mother but BAD # in chart for pt. so letter sent out with information. Risk management and GlaxoSmithKline the manufacturer were also involved.
Age: 0.3
Sex: U
Vaccine: DTAP, DTAPIPV, IPV
Symptoms: Wrong drug administered
Clinical narrative: Four month old child was given KINRIX combo vaccine; instead of the individual doses.
Age: 12.0
Sex: F
Vaccine: DT
Symptoms: Wrong drug administered
Clinical narrative: Patient was a 12 year old girl that received a DT booster for a bilateral foot wound. Based on the patient's age, she should have received the Td vaccine, which has less diphtheria compared to the DT vaccine. No harm or loss of therapeutic effect is believed to have resulted from this event.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Dr had entered a varicella that patient had previously received and when he ordered the other vaccines it was highlighted bold like the ones he orders. And I assumed wrongly that the dr was ordering the varicella as well. I did not look at the date. It was my fault for not looking at the date.
Age: 0.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Doctor ordered PEDIARIX and nurse administered KINRIX, she thought they were interchangeable.
Age: 48.0
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: When doing state inventory, notices count was off, a dose intended for child was found to have been given to an adult. Patient will be contacted, Staff member was informed of error. VFC dose replaced.
Age: 1.3
Sex: U
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Wrong drug administered
Clinical narrative: I was supposed to give pcv13 and I gave PEDIARIX to a 16 mo. boy.
Age: 45.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Employee Immunization Clinic, Employees card was tagged for an MMR and employee had 2 records with one MMR on each record. MMR administered instead of Varicella. We notified the employee and she received on the same day the needed 2nd dose of the Varicella to comply with Employee immunization policy. There were no adverse reactions noted from the MMR vaccine. So Employee received an additional MMR that was not needed, in addition to the varicella that was needed to stay current.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Two siblings came in together for a well child visit with the same provider and they were given each other vaccinations. A 4 year old female was given a dose of hep A pediatric dose when she was suppose to receive the MMR, Varicella and KINRIX. Her brother, a 11 year old male received the MMR, Varicella and the KINRIX when he was supposed to only get the Hep A vaccination. Supervisor was notified as well as CDC and the mother of the two patients regarding the incident.
Age: 49.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient came in to receive vaccinations for Immigration Status Change (ISC). Patient was given several vaccines including an MMR that had expired the day before. The day of expiration was on a Sunday and vaccines had not been removed from inventory. RN that gave vaccines did not check expiration date until after vaccine had been administered and was being charted. Event was reported to supervisor. Dose was repeated with non-expired vaccine and afterwards supervisor found guidance from IAC stating that repeat dose should wait for 28 days to be given. Agency incident report was filled out and system to flag vaccines expiring in next month was devised to prevent these errors in the future. Nurses also instructed to chart vaccines as they are being drawn up so that CIIS drop down menu will not show the lot number if it has expired. This would alert the nurse to recheck the vaccine.
Age: 19.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: LPN accidentally gave an adult Hepatitis B to a 19 yr old woman, and she was supposed to receive and adult Hepatitis A vaccine to complete her series. Patient was notified and correct vaccine (adult Hep A) was given after the event.
Age: 34.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: The provider ordered VARICELLA vaccine to a patient with negative titer. On May 19, 2016, the patient was given Zoster instead of Varicella. On June 1, 2016 the same patient came into the clinic and requested for her IZ records. Med error was discovered. The provider was informed and gave an order for Varicella vaccine. Another staff gave the patient Zoster vaccine. (ZOSTAVAX lot number L039096)
Age: 0.3
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: ROTARIX was given IM instead of orally.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient received KINRIX on Friday, 06/03/2016. Patient was later noted to have received PENTACEL on 10/15/2016. Since he was already years old at the time he received the PENTACEL, further doses of dtap and polio were not needed. Patient's guardian was called today (Monday,06/06/2016) and the error was reviewed. Patient's guardian reports patient had no adverse reactions or effects from the vaccines given that day.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Vaccine was not mixed and the patient was given just the diluent.
Age: 60.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: On 3.23.16 provider order PCV 13 for one patient and Tdap for another. 5.19.16 patient called to confirm vaccine administered because her summary of benefits reflected Tdap not PCV 13. Discussed with staff and provider. Staff states they are adamant they administered correct vaccine, although inadvertently charted in wrong chart. Provider determined best to re-vaccinate. Patient who needs Tdap will return next available and patient who needs PCV 13 will return in one year. Reminder for both set in patients chart.
Age: 59.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Underdose
Clinical narrative: The patient was administered Hep A peds/adol dose instead of Hep A adult dose.
Age: 1.8
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 21 month old given 1 ml Hep A #2 instead of 0.5ml. Physician and parents informed. Child well in follow up the following days.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received a TDAP vaccine at visit today that wasn't needed. He had previously received a TDAP vaccine on 09/17/07. This was missed during chart prep. Patient is a 64 y/o male w/ dx of BPH, schizophrenia, low back pain, HTN, and hip pain.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine was given to Pt. who was under 4 yrs. of age.
Age: 3.0
Sex: U
Vaccine: DTAP, FLU4, HEPA
Symptoms: Extra dose administered
Clinical narrative: Pt's IZ records were not complete in our practice. Later mom brought full IZ records and we found that the vaccines above listed were duplicates.
Age: 1.4
Sex: U
Vaccine: DTAP, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Received an e-mail vaccine error message 6/17/16 from our management company for our EMR for date of service 4/4/16 vaccines. After reviewing patient immunization history in our EMR and Child Profile. All 3 vaccines were administered 31 months ahead of schedule for this patient. Staff member was contacted but currently out of the office until 6/20/16. E-mail was sent to staff member to contact me about this incident when she returns. Incident also reported to practitioner's supervisor, who was involved in the event.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a child that was under 4yrs. of age. Age of patient at time of event: 4 months
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: My son was given GARDASIL instead of varicella.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a child under 4yrs. of age. Age of patient at time of event: 4 months.
Age: 12.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired product administered
Clinical narrative: FLUMIST expired was administered.
Age: 8.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired product administered
Clinical narrative: Expire FLUMIST administered.
Age: 0.4
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a Pt. that was under 4 yrs. of age.
Age: 22.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Vaccine given was expired.
Age: 0.8
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a Pt. that was under 4 yrs. of age.
Age: 20.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: The immunization that was given was expired.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The 10yr old patient received an adult dose of the Hep A vaccine. The person making the error did not realize the error until going to chart the injection later in the day.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a Pt. under 4 yrs. of age.
Age: 0.9
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine administered to an 11-month old patient.
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, Wrong drug administered
Clinical narrative: 2 month old baby boy was given an expired PNEUMOVAX 23 instead of PCV 13. Patients mother informed. Instructed to look out for any reactions. Instructed patients mother to take patient to the nearest hospital if any reactions.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage
Clinical narrative: New Medical Assistant in charge of monitoring vaccine storage unit temperatures. Freezer temperatures out of range for several days before recognized. Freezer malfunctioned. Five patients received nonviable vaccine: three (3) received vaccine on 04/28/16 and two (2) on 04/25/16.
Age: 0.9
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: ROTATEQ was given to an 11 months 5 days.
Age: 1.5
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave KINRIX to 18mo old.
Age: 4.0
Sex: U
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a MCV4P instead of MMR that was due.
Age: 3.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Patient was accidently given a dose of Zoster vaccine instead of varicella vaccine.
Age: 1.7
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Pt. was accidently given ZOSTAVAX for their 12 month vaccines instead of VARIVAX by the medical assistant. Once error was identified, the provider was notified, who then proceeded to call the state health dept. immunization and hospital for assistant on possible adverse events and to discuss future dosing schedule. Attempted to notify the mother, but had to leave a voicemail and wasn't able to explain the situation until the next morning when mother was reached. Mother was very understanding.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Staff member inadvertently administered KINRIX to child instead of PEDIARIX. Staff states they mixed the "rix" vaccine re: age group. Action-staff educated of age group for KINRIX and PEDIARIX. The KINRIX box now has age range written on box.
Age: 38.0
Sex: U
Vaccine: JEV1
Symptoms: Drug administered at inappropriate site
Clinical narrative: Gluteus Maximus administration rather than the deltoid.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: Wrong drug administered
Clinical narrative: The wrong vaccine was given in error.
Age: 4.0
Sex: U
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: When giving the vaccine I had twins and grabbed the other's vaccine and gave the patient 2 polio's the other twin received the correct vaccines.
Age: 0.8
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient came to office for well child check with immunizations. He was 10 months old and due for the 6 months vaccines. He as given unneeded dose of HIB. PEDVAX is a 3 dose series with the 3rd dose being given at minimum of 12 months of age. He should not have gotten this.
Age: 48.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: It was brought to our attention that the third hepatitis B vaccine dose was administered too soon. The patient received his first does on 9/21/15, a second dose on 11/17/2015 and then a third dose on 12/29/2015. It appears that the first dose was not charted in the patients immunizations and the person that administered the third dose did not check CAIR to verify what does he was on. Pt did not report any harmful side effects from the vaccines given. Per CAIR, the third dose was supposed to be given on 2/23/2016. We have since been education staff on the importance of checking the patients chart and CARI records to confirm the vaccine schedule.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Only the liquid portion of PENTACEL was administered to patient. Staff member did not grab both liquid and powder vials. Vaccine was not reconstituted with powder (HIB).
Age: 1.8
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Nurse was helping room patient and gave a vaccine that another staff member recorded that patient needed.
Age: 37.0
Sex: U
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: Went to doctor for hepatitis b vaccine. Was given HPV instead.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient came in for her second dose of pneumococcal vaccine. She know she had received a dose about a year ago and wasn't sure which one. The pharmacist did not verify with MD and gave a dose of PREVNAR. The patient had actually already received a dose of PREVNAR and needed a dose of PNEUMOVAX instead.
Age: 0.9
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 9 mo old for well child visit. Because there was a combo vaccine available the clinician gave a KINRIX instead of individual vaccines. Clinical states that she was unaware of the age requirements since we do not carry this vaccine in our private stock and it is not used often. Of note, nowhere on the vaccine box does it state age requirements.
Age: 0.6
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient given only one component of the combination vaccine.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given to a 2 y/o, indicated for 4-6 y/o. Age of patient at time of event: 2 years.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered
Clinical narrative: A child inadvertently received two doses of ROTATEQ vaccine one week apart.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Wrong drug administered
Clinical narrative: HAVRIX vaccine was administered instead of PEDIARIX.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given to 2 y/o, indicated for 4-6y/o.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given to 2 y/o, indicated for 4-6y/o. Age of patient at time of event: 2 years.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Wrong vaccine given based on age. Age of patient at time of event: 2 years 3 months
Age: 0.2
Sex: M
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: My 2 month old twins were getting their first set of vaccinations at the same time. I split the vaccines in half and two weeks apart since my boys were premature at birth. On 3/14 they received the second half of their vaccines to complete their 2 month set. On 4/25 I received a call from their pediatrician and was told one of my twins was given PPSV23 vaccine instead of PCV13. She had checked the wrong box in the computer and the wrong vaccine was give to one of my twins. She stated they called the CDC for side effects and I was told he will be fine and there are no side effects of the error. Also told I have to start over with this vaccine since the PPSV23 is not effective in children in under 2 years of age. In addition, the medical assistance administering the vaccines did not question why one twin was receiving a different vaccine or ask me if my twins were meant to received different vaccines that day.
Age: 0.7
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given first Rota at 7 months of age. Didn't check that patient hadn't ever received Rota. Wrong age (patient not correct age for vaccine given).
Age: 24.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: Patient presented in clinic to receive vaccines for admission to community college, the program required MMR and Varicella. Pt and the nurse (writer) discussed his HIV status and whether needed to inform the school of positive status. Nurse (writer) administered both live vaccines, and discovered after administering vaccine that pt should not have received live vaccine due to HIV status, RN supervisor and pts Infectious Disease MD was inform of incident. Patient was informed of possible reaction to vaccines and to call another Dr.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: This 18 year, 5 month old patient presented for annual exam. Order was given for Hep A vaccine #1. Nurse gave adult Hep A instead of pediatric dose.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Immunization not marked for age group.
Age: 40.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Hep A vaccine was drawn up by staff and syringe was labeled. Injection was then administered by a different staff member. When that staff member went to document the injection it was discovered the vaccine was expired by 1 week.
Age: 4.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Extra dose administered
Clinical narrative: My daughter went in for her four year checkup was supposed to get a varicella, MMR, DTAP, and polio shot. An hour later the doctor called and said the nurse accidentally gave he the varicella and MMR combo which is PROQUAD and gave her the single dose of varicella and MMR, therefore she has two doses of each in her system. I hope she dose not have any negative effects, and no on else has to go through this. I am trusting the doctor did report this as well as they told me they were.
Age: 10.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: Mother came in to the clinic with her 3 children (ages 10, 12 and 16). This nurse administered FLUMIST to all the children per mother's request. However, it was later discovered that the FLUMIST had expired 7 days prior on 12/30/2015.
Age: 4.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: 0.25 dose given to 4 year old.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient was given expired MCV vaccine on 5/4/16.
Age: 30.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient received MMR intramuscular on left deltoid. This injection was to be administered SC. Age of patient at time of event: 30 years 6 months.
Age: 30.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient received MMR intramuscular Right Deltoid and VARIVAX intramuscular Left Deltoid. They should have been administered SC. Age of patient at time of event: 30 and 6 months.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: PENTACEL was not mixed with diluent. Patient instructed to come back for separate HIB.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given an adult dose of Hep A instead of the adolescent version. There has been reeducation for the staff to triple checking vaccines to keep this from occurring again. Pt will still received the 2nd dose of Hep A in 6 months to finish out series. This pt is 186# and 70". Age of patient at time of event: 15 years 8 months.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Impaired healing, Injection site reaction, Injection site scab, Wound
Clinical narrative: Initial unsolicited report received from a physician on 20 August 2015. A 63-year-old female patient, whose concomitant medications were not reported, had received an intradermal dose of Fluzone ID and an intramuscular dose of Pneumovax (manufacturer Merck) (batch number, dose and site of administration site of administration were not reported for both vaccines) on 9 October 2014. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. On 9 October 2014, same day after vaccination, the patient experienced an injection site reaction and a scab formed at the injection site which fell off and there was a wound. Patient was seen by a MD for wound care. The patient required emergency room or physician visit. Laboratory investigations and corrective treatments were not reported. On an unspecified date the patient was recovered from the vaccination site scab and injection site reaction and wound took 2-3 months to heal. Documents held by sender: none. Follow-up information received from a physician on 09 October 2015. The event coding was updated from injection site reaction to vaccination site reaction. No other information reported.
Age: 0.17
Sex: M
Vaccine: DTAP, FLUX, HIBV, IPV, PPV, RVX
Symptoms: Thrombocytopenic purpura
Clinical narrative: Thrombocytopenic Purpura on bottom of foot.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Headache, Multiple sclerosis, Nuclear magnetic resonance imaging, Ophthalmological examination
Clinical narrative: Blurry vision and headaches approximately two weeks after GARDASIL injection. Now diagnosed with MS.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred
Clinical narrative: Blurry vision and headaches approximately two weeks after GARDASIL injection. Now diagnosed with MS.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Facial pain, Gingival pain, Pain in jaw
Clinical narrative: Initial solicited pregnancy report received from a pharmacist on 05 February 2015. This is a retrospective pregnancy registry case for study.  A 30-year-old female subject had received an injection of Fluzone QIV intramuscularly (batch number: UI188AA, Expire date: 30 June 2015) dose, dose in series and site of administration was not reported on 03 February 2015. Subject had no illness at the time of vaccination. The subject's pre-existing physician diagnosed allergies, birth defects, medical conditions includes pregnancy. On 03 February 2015, two to three hours after vaccination subject had experienced jaw pain which has progressed to her gums, cheeks, and facial structures. The last menstrual period and estimated date of delivery was unknown. At the time of vaccination the subject was pregnant. Laboratory data and corrective treatment was not provided. At the time of this report the subject was not recovered from the events. Relationship to investigational product according to Company: associated. Relationship to investigational product according to Investigator: not reported Documents held by sender: none. Follow up information received on 30 December 2015: On 30 December 2015 at 10:30 am the reporter reported that she was unable to follow-up because they did not have the subject's pregnancy information or the information which was requested. It was additionally reported that the reporter did not have the subject's OB/Gyn or responsible physician's contact. However a follow up with the subject would be done. Sender's Comments: Follow-up information received on 14 January 2016: A 30-year-old female subject had received the study vaccine during her pregnancy on 03 February 2105. (information regarding LMP, date of conception, EDD or USG findings were unknown). She experienced non-serious adverse events of facial pain and gum pain on the same day of vaccination.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient presented to our office 07/14/2016 with a localized 2cm erythema on the upper right arm warm to the touch and painful per patient.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal discomfort, Asthenia, Dehydration, Diarrhoea, Nausea
Clinical narrative: Began with general nausea and upset stomach. Started vomiting around 6:30 progressed to include watery diarrhea. Both continued pretty violently until around 10:30 PM. Terribly dehydrated! She then tapered off back to nausea and upset stomach through the night. This morning she is weak but recovering well.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Began with general nausea and upset stomach. Started vomiting around 6:30 progressed to include watery diarrhea. Both continued pretty violently until around 10:30 PM. Terribly dehydrated! She then tapered off back to nausea and upset stomach through the night. This morning she is weak but recovering well.
Age: 26.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Pruritus, Skin warm, Tenderness
Clinical narrative: Started as a inch red welt day after injection. Over the course of 5 days has become 3 inches in diameter red welt/ induraction circle. Tender. Warm to touch.  Itching.  Treatments used ibuprofen, Tylenol, Benadryl.
Age: 26.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Started as a inch red welt day after injection. Over the course of 5 days has become 3 inches in diameter red welt/ induraction circle. Tender. Warm to touch.  Itching.  Treatments used ibuprofen, Tylenol, Benadryl.
Age: 1.0
Sex: F
Vaccine: HIBV, PPV
Symptoms: Injection site urticaria, Pyrexia, Urticaria
Clinical narrative: She broke on in hives on her face. They started off small and got larger. Some of them disappeared off of her face and then she had then on her arms and legs. Accompanied by a fever of 102.1 being the highest. After the dr told me to give her Benadryl she continued to get them. The following morning her legs were covered with small clusters of hives and her face had larger ones. The Benadryl was administered every 6 hrs 1.5 ml. It did help after an hour or so but they always came back. This last for 5 days. I kept returning to Drs. Office considering her she had a fever for so long and still had rash.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Injection site discolouration, Injection site mass
Clinical narrative: Initial unsolicited report received from a pharmacist on 15 September 2015. This case involves a 73-year-old female patient who was vaccinated with a dose FLUZONE HD [batch number: UI427AA, expiry date: 28 March 2016, dose, dose in series were not reported) via intramuscular route in left deltoid on 15 September 2015. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 15 September 2015, few seconds following the vaccination, the patient had blood after the injection and than feels a lump 2cm at the injection site light blue under the skin. Laboratory data and corrective treatment were not reported. The patient was not recovered from the event. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Swelling face
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 15 September 2015. This case involves 74 years old female patient who was vaccinated with a dose of FLUZONE HD (batch number UI454AA, expiry date-21 April 2016, dose and route of administration were not reported) in left deltoid and first dose of PREVNAR 13 (manufacturer- Merck, batch number, expiry date, dose and route of administration were not reported) in left deltoid on 11 September 2015. Illness at time of vaccination was reported as none. Birth defects and medical conditions were unknown and patient did not have known allergies. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced jaw swelling. It was unsure if it was on the same side as the injections or any other description to the swelling. It was planned to advise the patient to seek medical treatment (required ER visit). The patient required emergency room and physician visit. Laboratory investigation was reported as none. Corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: FLUX, PPV, VARCEL
Symptoms: Allergy to vaccine, Blood glucose normal, Glycosylated haemoglobin increased, Hypersensitivity
Clinical narrative: Initial unsolicited report received from a consumer on 16 September 2015. This case involves a 16-year-old male patient who was vaccinated with a dose Pneumonia Shot, Influenza vaccine and a dose of Chicken pox vaccine [batch number, expiry date, dose, dose in series, route and site of administration were not reported] on an unknown date. The patient was also receiving another vaccine but the consultant cannot recall which other vaccine. The patient had a medical history of allergy to cillin antibiotics and diabetes. Previous medications included Humalog on sliding scale along with a lower dosage (35 units, then later 45 units) of LANTUS. The patient's body was rejecting Humalog i.e with burning of the skin and huge welts at the injection sites which lasted 8 to 10 hours. Concomitant medications included LANTUS at a dose of 85 units q pm. The patient's diabetes was managed with LANTUS but the problem with LANTUS was it "only comes in 100 unit pens" and reporter heard about Toujeo which "comes is 300 unit pens". The current dosage requires 4 to 6 shots to empty the needle which was helping blood sugar to "work itself out". On an unknown date, following the vaccination, the patient seems to be allergic to many things, including, the pneumonia shot, the flu shot, the chicken pox vaccine. Laboratory data included sugar level which was 85 currently and it was 200 in the past. The patient's A1C was decreased from 14 to 10. Corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Condition aggravated, Dizziness, Dysgeusia, Immediate post-injection reaction
Clinical narrative: Initial unsolicited report received from a nurse on 18 September 2015. This case involves a 48-year-old female patient who was vaccinated with a first dose of FLUZONE QIV (batch number: UI187AA, expiration date: 30 June 2015, dose and site of administration were not reported) intramuscularly on 31 October 2014. The patient had a medical history of hypertension, gastroeosophagal reflux disease (GERD) Chronic renal, and allergy to Calcium, eggs, bee stings, latex, shell fish, antibiotics. Illness at time of vaccination was none reported. The patient did not receive any other vaccinations within four weeks of vaccinations. On 31 October 2014, immediately following the vaccination, the patient developed dizziness, bad taste in her mouth, blood pressure of 200/104, and swelling. The patient required ER or doctor visit. Lab data was not reported. The patient received Solumedrol intramuscularly as a corrective treatment. The patient was recovered on an unspecified date. List of documents held by sender: none.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from a nurse on 18 September 2015. This case involves a 48-year-old female patient who was vaccinated with a first dose of FLUZONE QIV (batch number: UI187AA, expiration date: 30 June 2015, dose and site of administration were not reported) intramuscularly on 31 October 2014. The patient had a medical history of hypertension, gastroeosophagal reflux disease (GERD) Chronic renal, and allergy to Calcium, eggs, bee stings, latex, shell fish, antibiotics. Illness at time of vaccination was none reported. The patient did not receive any other vaccinations within four weeks of vaccinations. On 31 October 2014, immediately following the vaccination, the patient developed dizziness, bad taste in her mouth, blood pressure of 200/104, and swelling. The patient required ER or doctor visit. Lab data was not reported. The patient received Solumedrol intramuscularly as a corrective treatment. The patient was recovered on an unspecified date. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Initial unsolicited report received from a non-health care professional (patient's daughter) on 21 September 2015. This case involves a 53 years old female patient who was vaccinated with a dose of FLUZONE QIV (batch number, dose, route and site of administration was not reported) on 18 September 2015. Illness at time of vaccination was not reported. The patient did not have any known allergy, and did not have any medical history. Concomitant medications were not reported. On 18 September 2015, same day at evening following the vaccination, the patient experienced itching, burning, "welt" at injection site and following day's area was enlarged toward her underarm. It was also reported that the patient continued to have swelling or "welt" that was itching, burning, painful area, size of 5 to 6 inches and located toward her underarm. Lab data and corrective treatments were not reported. The patient was recovered from injection site swelling, itching or burning and patient was not recovered from other events. Follow-up information received from a physician on 29 October 2015. The patient had received 0.5 ml of FLUZONE QIV intramuscularly in left deltoid. On an unknown date, following the vaccination, the patient had developed cellulitis at injection site. The patient was seen at physician office on 22 September 2015. The patient was treated with Keflex 500 mg for one week. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a non-health care professional (patient's daughter) on 21 September 2015. This case involves a 53 years old female patient who was vaccinated with a dose of FLUZONE QIV (batch number, dose, route and site of administration was not reported) on 18 September 2015. Illness at time of vaccination was not reported. The patient did not have any known allergy, and did not have any medical history. Concomitant medications were not reported. On 18 September 2015, same day at evening following the vaccination, the patient experienced itching, burning, "welt" at injection site and following day's area was enlarged toward her underarm. It was also reported that the patient continued to have swelling or "welt" that was itching, burning, painful area, size of 5 to 6 inches and located toward her underarm. Lab data and corrective treatments were not reported. The patient was recovered from injection site swelling, itching or burning and patient was not recovered from other events. Follow-up information received from a physician on 29 October 2015. The patient had received 0.5 ml of FLUZONE QIV intramuscularly in left deltoid. On an unknown date, following the vaccination, the patient had developed cellulitis at injection site. The patient was seen at physician office on 22 September 2015. The patient was treated with Keflex 500 mg for one week. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Urinary incontinence
Clinical narrative: Patient passed out and urinated.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture, Cellulitis, Chills, Decreased appetite, Erythema
Clinical narrative: Right arm: redness, sore, swelling, chills and fever up to 102 degrees. Loss of appetite and sleep. Infection/right arm, cellulitis.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Localised infection, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Right arm: redness, sore, swelling, chills and fever up to 102 degrees. Loss of appetite and sleep. Infection/right arm, cellulitis.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Burning sensation, Rash pruritic
Clinical narrative: ITCHY RASH, BURNING ON UPPER ARM. NO FEVER, FELT WEAK.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Malaise, Vomiting
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 22 September 2015. This case involves a 93-year-old female patient who was vaccinated with second dose of FLUZONE HD (batch number: UI427AA, expiry date: 28 March 2016) intramuscularly in left deltoid on 14 September 2015. The patient's illness at time of vaccination reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergies: none known. Medical history reported as intermittent atrial fibrillation, mitral valve prolapse, hypothyroidism, osteoporosis. Concomitant medications were not reported. On 14 September 2015, few hours following the vaccination, the patient had developed vomiting, feeling of "lead in her feet", fatigue, malaise. Laboratory data and corrective treatment were not reported. On an unknown date, the patient was recovered from vomiting. The patient was not recovered from fatigue and malaise. List of documents held by sender: none. Follow up report received from nurse (ARNP- Advanced Registered Nurse Practitioner) on 28 December 2015. The patient previously received first dose of FLUZONE HD on 2014 without any adverse event. The patient did not receive any other vaccine prior to 14 September 2015. The patient did not have any known drug allergy and patient was well at the time of vaccination. The patient did not perform any lab test. The patient was recovered from the events (reported as feeling somewhat better on 28 September). "It was reported that completely resolved to prior state of health no later than 6 October 2015".
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Initial unsolicited report received from a non-healthcare professional  on 22 September 2015. This case involves a 72 years male patient who was vaccinated with an intramuscular second dose (previously received one dose) of FLUZONE HD (batch number UI457AA, expiration date 22 April 2016) in left deltoid on 22 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. Concomitant medications were not reported. On 22 September 2015, same day following the vaccination, the patient experienced pin prick of blood in left deltoid and a dime size diameter of swelling 2-3mm height. Lab data and corrective treatments were not reported. The patient was recovered from the event in three minutes. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Initial unsolicited report received from a Pharmacist on 22 September 2015. This case involves a 66 years old female patient who was vaccinated with a second dose of FLUZONE HD (batch number: UI454AA), (dose was unknown) via intramuscular route in the left deltoid on 20 September 2015. The patient's medical history and concomitant medications were unknown. It was reported that, on 21 September 2015 (1 day after vaccination) the patient had events as red, itchy, warm 3 inches below injection site and wraps around arm and patient also states that she had a similar site reaction last year that lasted for 1 week. Lab data and corrective treatments were unknown. The outcome of the events were unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146045, 2015SA146046, 2015SA146047,2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background: Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods: ESP-VAERS monitors patient's electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results: In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. Conclusions: An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves a patient (age and gender not reported), who was vaccinated with a dose of INFLUENZA VACCINE (IIV) (manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient developed a possible allergic reaction to the vaccine. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Documents held by sender: none. Follow-up information received from physician on 19 October 2015. No additional information was provided.
Sex: U
Vaccine: FLUX
Symptoms: Local reaction
Clinical narrative: Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background. Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results. In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. Conclusions. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves patient (age and gender not reported), who was vaccinated with a dose of INFLUENZA VACCINE (IIV) (Manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced local immunization reaction. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Documents held by sender: none. Follow-up information received from physician on 19 October 2015. No additional information was provided.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Presyncope
Clinical narrative: Pt was given vaccination at 1100 and at 1105 patient experienced a vasovagal episode and lost consciousness for approx. 5 seconds.