chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 months old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 30-NOV-2016, the patient was vaccinated with the second improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 15 months old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 30-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA0044667: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004477:  US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 1.58
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 19 months old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 01-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 7-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 02-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517: US-009507513-1704USA004514:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Polymerase chain reaction, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster in a previously vaccinated patient. Painful unilateral rash and headaches. Given treatment for illness.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt called on call service stating arm was swollen to the size of an apple and warm to touch and very painful to the point he was unable to sleep at all. patient wife also got the same vaccine same lot # M04324. her arm was also swollen and very painful. We have several other people who have reported very painful arms for up to 1 week with this same lot #. Has there been any other reports?
Age: 1.3
Sex: U
Vaccine: DTAP
Symptoms: Abnormal behaviour, Body temperature increased, Expired product administered
Clinical narrative: Medical Assistant brought it to my attention that she gave a expired vaccine to a patient. The above name vaccine was given on 1/27/2017, provider was made aware and I was made aware. Patient's parent stated patient had a mild temp of 99.0 F, and the child was a bit fastidious but is not active. Vaccine had expired 12/03/2016. It was overlooked by both LVN during monthly check and MA prior to be given.
Age: 0.4
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt. was only 5 months and 19 days old when she first got the flu vaccine (too young). Age of patient at time of event: 5 months 19 days.
Age: 1.7
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: I was asked by another nurse where the lot # was for Hepatitis A vaccine because she could not find it in the template format we use at the clinic. The vaccine was taped to a sticky note, asking that information. The vaccine that was taped to the sticky note was an adult dose Hepatitis A (1.0ml). The patient she was administering it to was under 18 years of age; therefore, needing a 0.5ml dose. I was asked to report the error as I am the immunization coordinator for the clinic. The nurse did speak with our supervisor about what to do next, and she was instructed to call our VFC coordinator at the state level. I am unsure if parents were ever called and informed of the vaccine administration error.
Age: 7.0
Sex: U
Vaccine: DTAP, IPV, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient and parents presented with an email from the school nurse with a list of immunizations required for school admission with foreign transfer and foreign vaccine logs. The temp. MA reviewed the list of immunization required by the school nurse which appeared to be appropriate Pre-K vaccines, DTaP, IPV, and Varicella and administered them. When the VFC report was filled the vaccine was inappropriate for the age of the child as she was 7 and the error was discovered. All parties involved were informed and while the dose does not need to be repeated, VFC noted a report should be filed.
Age: 8.0
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. schedule incorrectly to return for 2nd dose of flu. 2nd dose was administered 1.5 week earlier that minimum of 30 days.
Age: 52.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of flu vaccine in the same season.
Age: 7.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient seen for WCC and catch up immunizations. KINRIX ordered and administered but patient was too old for product.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Patient received wrong dose of flu. Instead of 0.25ml patient received 0.5ml.
Age: 39.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received inadvertently a second flu vaccine in the same season.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Yesterday (1/25/17), a medical assistant administered the PENTACEL diluent w/out rec-constituting it w/the powder. Only DTaP/IPV were given, not Hib. The medical assistant noticed the powder vial after the diluent was administered. Age of patient at time of event: 4 months 4 days.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Provider ordered 2nd dose of two dose series for HAVRIX. Medical assistant got confused on age and gave adult dose 1.0 ml instead of 0.5 ml. Medical assistant thought that 15 years of age was adult and did not verify with package insert. Age of patient at time of event: 15 years.
Age: 20.0
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Staff gave an expired vaccine/did not check the vaccine expiration date. Response to question 6: Vaccine was moved to another building/fridge without notifying vaccine coordination (reporting person). I though vaccine had been used when I went to pull it. Age of patient at time of event: 20 years.
Age: 48.0
Sex: U
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: TDaP was drawn up from stock but should have been drawn up from private stock. Vaccine was not used and error did not reach pt.
Age: 29.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received first flu vaccine 11/11/16 then returned to clinic on 01/12/17 and received another flu vaccine. Pt notified by MD on 01/17/17 and stated she feels fine with no adverse reactions noted.
Age: 0.07
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Baby of wrong age given vaccine. Age of patient at time of event: 26 days.
Age: 39.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MMRV was administered to a 39 year old patient erroneously.
Age: 1.3
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Fifteen Month Old female patient received three immunizations - it was not noted that the expiration date on the viral had expired until nurse went to document in patient's chart. The State Department for Immunization was contacted immediate for direction.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Patient and parent informed staff their school required them to show proof of vaccination for MMR and Varicella. We did not have proof. Parent and patient agreed to MMR and VARICELLA vaccine, however staff inadvertently administered PROQUAD.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Patient was to received MMR and instead received MMRV.
Age: 21.0
Sex: U
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: A dose of DTaP was administered intramuscular instead of a dose of TDaP to a 21 year old pregnant women, who was 31 weeks gestation on 1/6/17.
Age: 25.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt. arrived in clinic in need of 4 adult vaccinations. RN requested adult vaccines from in house pharmacy. Adult Hep A was requested and HAVRIX was given to RN. RN did not know that pharmacy stocked ped/adol doses. Ped/adol vaccinations traditionally kept in separate refrigerator for nursing access. HAVRIX given to pt. along with other 4 adult vaccinations. Error was caught after pt. left the clinic while charting. Attempts to contact pt. have been made to return to clinic to get a full adult dose of Hep A. Pt. will be contacted and reports have been written. Age of patient at time of event: 25 years.
Age: 24.0
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Mistakenly gave a patient diluent for MENVEO without adding it to the powdered vaccine. Age of patient at time of event: 24 years. Type of Event: Vaccine/component omission - Diluent given without the vaccine.
Age: 61.0
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Patient received TDaP that was unneeded. Had previous TDaP vaccination on 3/14/11. Patient was not pregnant. Age of patient at time of event: 61 years.
Age: 69.0
Sex: U
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate dose of PREVNAR 13. Had received dose previously on 11/18/15. Age of patient at time of event: 69 years. Type of Event: Extra dose.
Age: 0.2
Sex: U
Vaccine: HIBV, HPV9
Symptoms: Wrong drug administered
Clinical narrative: Vaccine was administered in error, pt was supposed to get HIB but was administered HPV.
Age: 0.2
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: 2 month old given vaccine when thought to be PREVNAR.
Age: 57.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered TD, DTAP was given by the nurse.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was given Hepatitis A vaccine and did not need one was due for a MENACTRA. Age of patient at time of event: 11 years.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: It was brought to me attn. on Friday, 2/17/17, in the afternoon, by my Medical Support supervisor, that I had "...documented a 3+ flu for this 2 yr old child." I was at a different clinic that day so was unable to research this incident until I returned to my normal clinic on 2/20/17. I replied to my MSS on Monday, 2/20/17, stating I had documented the vaccine correctly but had given the patient the incorrect flu vaccination. He instructed me to follow the "Procedure: Immunization Accuracy". I called the CDC on 2/20/17 at 3:45pm, however, they were closed for holiday. I called the CDC again on 2/21/17 at 9:45am and reported the above incident to employer at CDC. Employee stated that the side effect of giving the older child flu shot to this younger patient would have been increased redness or skin reaction around the area the shot was given. The patient should still get the 2nd dose of flu vaccine like normal if they return to the clinic. Employee asked if the parent called us to notify us of any issues with this vaccination, and I told her no. She said it is recommended to call the Health Dept for further recommendations. I called Health Dept. She started I need to s/w their nurse so she transferred me to the nurse on duty. I had to leave a vm for the nurse to call us back. I forwarded this patient case to the patient's PCP to review today.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Patient stated she began to experience the reaction on the morning of 04/09/2017. The reaction included nodule formation, induration, and swelling at the site of injection. Cold compress was suggested for treatment of swelling.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Pain in extremity
Clinical narrative: Pt received Tdap vaccine as recommended in pregnancy. Pt woke the next morning with pain in arm. Pain would wake pt in during the night w/ pain at a 10/10 on pain scale. Pain radiated down into left arm. Pt tried Tylenol and heat/ice with no relief. Pt was put on 6-day course of prednisone. Pt had f/u apt and states symptoms are 70% better.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Dizziness, Headache, Nausea
Clinical narrative: Employee was given a Hepatitis B vaccination to her left deltoid. Employee came to the medical staff at the plasma center to report feeling dizzy, light headed, nausea, upset stomach and a head ache. Employee was able to lay down on a medical bed and s/s mostly resolved with only c/o head ache and light headedness.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received PENTACEL vaccine on left thigh. Entire thigh became red and swollen for 2-4 hours. Onset was several hours after vaccine administration. Symptoms resolved in 24 hours.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: Patient reported pain in shoulder and shoulder joint of arm that injection was given.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Information has been received from a registered nurse, via a company representative, concerning a 71 year old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date in March 2016 (reported as one year ago), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (PNEUMOCOCCAL 13V CONJ VACCINE (CRM197) (dose, strength, frequency, route of administration, anatomical location, lot# and expiration date were not provided), for prophylaxis. On 16-MAR-2017 (also reported as within the last 2 weeks), the patient was vaccinated with PNEUMOVAX23 route of administration was reported as injection (dose, strength and anatomical location were not provided) (lot # N003997 with expiration date 20-OCT-2018), for prevention of pneumococcal disease. On 17-MAR-2017 (reported as within 1 day of receiving the vaccine), the patient experienced arms that were red, painful to touch and feverish. The patient sought medical attention and an unspecified treatment was given for adverse events. It was unknown if any laboratory diagnostics studies were performed. At the time of reporting, the patient's outcome was reported as recovered. The causality assessment between PNEUMOVAX23 and all the adverse events was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 05-APR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # L051102, expiration date 17-JUN-2017 (dose, route and site of administration were not reported) for prophylaxis. The administered dose of PROQUAD was stored in the temperature between 15 and 46 degrees Fahrenheit for 25 hours. Data logger was involved. There were no previous temperature excursions reported. The administered dose of vaccine was reconstituted with a sterile water diluent (manufacturer unknown), which did not undergo a temperature excursion. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 28-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 5 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 31-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 31-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 02-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479:  US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 month old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 02-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004506: US-009507513-1704USA004505: US-009507513-1704USA004495: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 05-DEC-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Fever of 101.3 the day after vaccines administered. Fever responded to Tylenol and decreased throughout the day. Pea-sized pink spot on right thigh at injection site.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Joint swelling, Myalgia, Pain, Pyrexia
Clinical narrative: Developed fever, pain, swelling in R knee that had surgical TKA about 10 yrs ago. Pain lasted about 48 hours. Treated with OTC ibuprofen for muscle aches and fever.
Age: 16.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Dizziness, Face injury, Fall
Clinical narrative: PATIENT HAD DIZZINESS WHILE STILL IN OFFICE, FELL OVER AND HIT FACE ON DOORWAY.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Redness at injection site, swelling, warm. eventually progressed to some blistering at site, noted after band-aids removed.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Erythema, Pain, Pruritus, Swelling
Clinical narrative: SWELLING, ITCHING, BURNING,SORENESS, REDNESS.
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: None.
Age: 1.0
Sex: F
Vaccine: FLUX, MMR, PNC13, VARCEL, FLUX, MMR, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 12 month old female patient. The patient's concurrent conditions and medical history were not provided. On 23-JAN-2017 at 11:20 hours, the patient was vaccinated with a extra dose of VARIVAX Lot # reported as M004662, at the same time, she was vaccinated with influenza virus vaccine inactivated (6-35 months) Lot # M60994 both in the right lateral thigh, besides, she received M-M-R II (lot # reported as M007464) and PCV-13 (lot # M60994); both in the left lateral thigh (strength, dose and expiration date were not reported for any vaccine) the indication for all the vaccines was prophylaxis. The patient did not have any illness at the time of vaccination. The patient's parents were called and made aware that the patient had been received an extra dose VARIVAX. The patient's parents verified that the patient showed no adverse reactions. Additional information is not expected as all relevant information has already been received.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information was received on 04-APR-2017 from a nurse who was reporting on a 12 month old male patient. Concomitant medications and medical history were not reported. On 03-APR-2017, the patient received a dose of VARIVAX (lot M010484, expires 01-MAR-2018) intramuscularly and a dose of PROQUAD (lot M043308, expiration 24-APR-2018) intramuscularly at the same time. No symptoms were reported. No other information was provided. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received on 04-APR-2017 from a registered nurse who reported that a 12-month old male patient was given VARIVAX (Inj), intramuscular (Site of administration, Lot number, and Expiration date were not reported) and PROQUAD (Route, site of administration, Lot number, Expiration date were not reported) vaccinations at same time. (The nurse also reported that the patient received the vaccines "concomitantly".) No dates or times of vaccinations reported) for prophylaxis. No symptoms reported. No product quality complaint (PQC) was reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received on 04-APR-2017 from a pharmacist who reported that  patient of unknown age and gender. The pharmacist reported that on 04-APR-2017, an expired dose of PNEUMOVAX 23 (Route and site of administration were not reported) was inadvertently administered to a patient for prophylaxis. The Lot number was reported as L029406 with expiration date of 26-MAR-2017. A Lot check was requested and it was reported that Lot number L029406 is an invalid Lot number for Pneumococcal Vaccine, Polyvalent (23-valent). No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Hepatitis viral, Ophthalmic herpes zoster, Rash vesicular, Varicella zoster virus infection, Viral infection
Clinical narrative: Literature report: 2016-NOV-01. It was reported in a Letter to the Editor received from the authors, referring to an 18 month old female patient who suffered from recurrent sino-pulmonary and viral infections due to varicella zoster virus (VZV) and Epstein-Barr virus (EBV) due to combined immunodeficiency (CID) with defective T cell proliferation in response to activation by antigens, anti-CD3 or anti-CD3/CD28, with weak or no impact on TCR-mediated cytokine production and homozygous CTPS1 mutations identified by exome sequencing. The patient's medical history included a hematopoietic stem cell transplant (SCT). The patient was currently I excellent health, 10 years post-transplant. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant medications were not reported. Following the administration of varicella virus vaccine live (oka/merck) (manufacturer unknown), the patient developed vesicular lesions on her legs. Then, one month later, she developed generalized varicella with VZV isolated from a typical lesion from blood (varicella zoster virus infection). Although this acute episode improved with acyclovir, as the months ensued, she suffered from recalcitrant vesicular eruptions, including one episode with corneal involvement (ophthalmic herpes zoster) and presumed varicella hepatitis (hepatitis viral). At the time of the report, the outcome of varicella zoster virus infection, ophthalmic herpes zoster and hepatitis viral was unknown. The relatedness of the aforementioned adverse events with varicella virus vaccine live (oka/merck) (manufacturer unknown) was considered as related since the events occurred followed the vaccine administration. Upon internal review, ophthalmic herpes zoster and hepatitis viral were considered to be medically significant adverse events. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 31-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 01-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 01-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.