chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Injection site swelling, Petechiae, Swelling, Tenderness
Clinical narrative: 3/28 - Vaccine administered. 3/29 - Mild swelling (left upper arm). 3/30 - Mild swelling, tenderness to palpation, erythema and petechiae -  DURICEF prescribed for 7 days.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site induration
Clinical narrative: Patient has darkened pigmentation on skin where bandage was applied after vaccine administration. The area is hardened.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Immunisation reaction, Injection site erythema, Injection site warmth
Clinical narrative: Pt received BEXSERO on 04/03/17, developed increasing redness and warmth to touch on 04/04/17 at site (left deltoid). Pt seen at Urgent Care on 4/05-Imm Reaction vs. Cellulitis, then seen in PCP office on 4/6/17 for same. Started on Cephalexin course 4/6/17.
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information was received from a pharmacist concerning a 42 year old female patient who on an unknown date, was vaccinated with GARDASIL 9 (lot number, expiration date, dosage, and route of administration not provided). No information was reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. No side effects to report. No further information to report. 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 registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of PROQUAD (dose, route and anatomical location were not reported) (lot # M029595 and expiration date 10-DEC-2017) for prophylaxis.  Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004456: US-009507513-1704USA004454: US-009507513-1704USA004455: US-009507513-1704USA004452: US-009507513-1704USA004453.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date in approximately January 2017 (reported as in or after January 2017), the patient was vaccinated with an improperly stored dose of VARIVAX lot # M006722, expiration date: 08-FEB-2018, as prophylaxis (Strength, dose and route were not reported), which experienced a temperature excursion between 6 to 14 Fahrenheit degrees for 2 months. There were no previous temperature excursions reported. Data logger was not involved. The patient's concomitant therapies included sterile diluent, lot # reported as L019306, expiration date:04-MAR-2018. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL with a Lot # reported as L035105 with an expiration date of 14-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects reported.  It was reported that from 23-DEC-2016 to 31-DEC-2016, the vaccine was exposed to a temperature of 32 to 36 Fahrenheit degrees range (0 to 1 centigrade degrees) for a time frame of 177.5 hours (for 6 cycles); from 03-JAN-2017 to 31-JAN-2017, the vaccine was exposed to the same temperature for a time frame of 464.5 hours (for 21 cycles); from 02-FEB-2017 to 28-FEB-2017, the time frame was 409.5 hours (for 16 cycles) and from 01-MAR-2017 to 15-MAR-2017, the time frame was 61 hours (for 6 cycles). The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004439: US-009507513-1704USA004438: US-009507513-1704USA004440: US-009507513-1703USA010028:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of PROQUAD (dose, route and anatomical location were not reported) (lot # M029595 and expiration date 10-DEC-2017) for prophylaxis.  Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004456: US-009507513-1704USA004454: US-009507513-1704USA004455: US-009507513-1703USA013275: US-009507513-1704USA004453:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of VARIVAX (dose, route and anatomical location were not reported) (lot # M038225 and expiration date 07-SEP-2018) for prophylaxis. Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004456: US-009507513-1704USA004454: US-009507513-1704USA004455: US-009507513-1704USA004452: US-009507513-1703USA013275.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of VARIVAX (dose, route and anatomical location were not reported) (lot # M038225 and expiration date 07-SEP-2018) for prophylaxis.  Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004456: US-009507513-1703USA013275: US-009507513-1704USA004455: US-009507513-1704USA004452: US-009507513-1704USA004453:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of VARIVAX (dose, route and anatomical location were not reported) (lot # reported as M034485 and expiration date 27-JUL-2018) for prophylaxis. Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine.  There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004456: US-009507513-1704USA004454: US-009507513-1703USA013275: US-009507513-1704USA004452: US-009507513-1704USA004453:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. In March 2017, the patient was vaccinated with the improperly stored dose of VARIVAX (dose, route and anatomical location were not reported) (lot # reported as M034485 and expiration date 27-JUL-2018) for prophylaxis. Additionally, a propped stored sterile diluent (manufacturer unknown) (lot # and expiration date were not reported) was used to reconstitute the vaccine. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 480 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013275: US-009507513-1704USA004454: US-009507513-1704USA004455: US-009507513-1704USA004452: US-009507513-1704USA004453.
Age: 1.75
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 1 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 13-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-009507513-1612USA007652: 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-009507513-1704USA004506: 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, concurrent conditions or pertinent medical history reported. On 13-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-009507513-1612USA007652: US-009507513-1704USA004460: 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-009507513-1704USA004506: 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: 27.0
Sex: F
Vaccine: TD
Symptoms: Headache, Oropharyngeal pain, Pain
Clinical narrative: Initial unsolicited report received from a Nurse on 30-MAR-2017. This case involves a 27-year-old female patient who was vaccinated with dose of TENIVAC (batch number: U5251AA, expiry date, dose and dose in series were not reported) intramuscularly in the left deltoid on 28-MAR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also reported as none. On 29-MAR-2017, one day of following the vaccination, the patient had developed sore throat, body ache and mild headache. The patient's emergency room (ER) or doctor visit was not reported. Laboratory investigations were not reported. Patient received salt water gargle, OTC Chloroseptic, hot liquids, Ibuprofen PM, Emergen "c" drink as Corrective treatment. The outcome of event was not reported. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Biopsy, Blood test, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother)  on 30-Mar-2017. This case involves a two-month-old female patient who was vaccinated with first dose of ACTHIB (Batch number: UH768AA; expiry date: 17-Dec-2012; dose and route of administration were not reported) in left thigh on 14-Feb-2013. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The patient did not received any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 14-Feb-2013 on that night, same day following the vaccination, the patient had developed redness, swelling and heat at the injection site, small palpable lump in left thigh that feels like a grain of rice and constantly itches the site. The patient required ER/ doctor visit. It was reported that the patient had been referred to a surgeon and an oncologist looking for possible cancer at the site. Laboratory investigations included ultrasound, biopsy, xray, blood work and other testing to rule out cancers. Corrective treatments were not reported. Patient was not recovered from the events. It was reported that patient was still under evaluation and the lump continues. List of documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Injection site swelling, Injection site warmth, Laboratory test, Ultrasound scan, X-ray
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother)  on 30-Mar-2017. This case involves a two-month-old female patient who was vaccinated with first dose of ACTHIB (Batch number: UH768AA; expiry date: 17-Dec-2012; dose and route of administration were not reported) in left thigh on 14-Feb-2013. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. The patient did not received any other vaccinations within 4 weeks of vaccinations. Concomitant medications were not reported. On 14-Feb-2013 on that night, same day following the vaccination, the patient had developed redness, swelling and heat at the injection site, small palpable lump in left thigh that feels like a grain of rice and constantly itches the site. The patient required ER/ doctor visit. It was reported that the patient had been referred to a surgeon and an oncologist looking for possible cancer at the site. Laboratory investigations included ultrasound, biopsy, xray, blood work and other testing to rule out cancers. Corrective treatments were not reported. Patient was not recovered from the events. It was reported that patient was still under evaluation and the lump continues. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer, Manufacturer report number: 2017118436) on 30-MAR-2017. This case involves a female patient (unknown age) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported), on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed allergy to flu shot. Lab data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Biopsy skin abnormal, Injection site granuloma, Injection site inflammation, Injection site mass, Irritability
Clinical narrative: Initial unsolicited report received from a physician on 30-MAR-2017. This case involves a six months-old male patient (reported as four months old) who was vaccinated with single dose of PENTACEL (batch number C5149AB, expiry date, dose and dose in series were not reported) via intramuscularly in the left thigh on 24-Jan-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as Unknown per reporter and Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On unspecified date, two months following the vaccination, the patient had developed an inflammatory mass of 2x2.9x2.9CM on the left thigh. On 20-Mar-2017, 55 days following the vaccination biopsy of the left thigh muscle showed acute and foreign body cells and granulomas. On unspecified date, following the vaccination the patient experienced Irritability and fever of 103 Fahrenheit. On unspecified date, patient was hospitalized. It was also reported that patient required doctor visit. The patient's Laboratory investigations was reported as MRI. On unspecified date, Acid- Fast Bacilli (AFB) and cultures resulted as negative. The corrective treatment of the patient was not reported. The outcome of inflammatory mass of 2x2.9x2.9 cm and acute and foreign body cells and granuloma's was reported as resolving. The outcome of Irritability and fever was not reported. On unspecified date, patient was discharged (three days duration). Documents held by sender: none. Sender's Comments: This case concerns a 4 months old male patient who received PENTACEL and developed an inflammatory mass, 2 months post vaccination which showed acute and foreign body cells and granuloma's on biopsy. Time to onset is too long to be compatible with the role of vaccine. Further information on medical history including birth history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Mycobacterium test negative, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Initial unsolicited report received from a physician on 30-MAR-2017. This case involves a six months-old male patient (reported as four months old) who was vaccinated with single dose of PENTACEL (batch number C5149AB, expiry date, dose and dose in series were not reported) via intramuscularly in the left thigh on 24-Jan-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as Unknown per reporter and Illness at the time of vaccination was reported as none. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On unspecified date, two months following the vaccination, the patient had developed an inflammatory mass of 2x2.9x2.9CM on the left thigh. On 20-Mar-2017, 55 days following the vaccination biopsy of the left thigh muscle showed acute and foreign body cells and granulomas. On unspecified date, following the vaccination the patient experienced Irritability and fever of 103 Fahrenheit. On unspecified date, patient was hospitalized. It was also reported that patient required doctor visit. The patient's Laboratory investigations was reported as MRI. On unspecified date, Acid- Fast Bacilli (AFB) and cultures resulted as negative. The corrective treatment of the patient was not reported. The outcome of inflammatory mass of 2x2.9x2.9 cm and acute and foreign body cells and granuloma's was reported as resolving. The outcome of Irritability and fever was not reported. On unspecified date, patient was discharged (three days duration). Documents held by sender: none. Sender's Comments: This case concerns a 4 months old male patient who received PENTACEL and developed an inflammatory mass, 2 months post vaccination which showed acute and foreign body cells and granuloma's on biopsy. Time to onset is too long to be compatible with the role of vaccine. Further information on medical history including birth history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: He has arm pain after the immunization. He had redness, swelling and warmth at the injection site starting 4/6/17. The redness extended beyond the injection site from 4/6-4/7/17. By 4/7 the redness was of the upper arm and no further spread.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient had received a flu vaccine previously on 01/13/2017 and another on 04/03/2017. Followed up with parent of patient and no adverse reactions noted.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient indicates she has had pain at the site of the immunization since the date of the immunization. (times are estimated due to length of time since occurance).
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-03-09.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Oth complications following immunization, init on 2017-03-10.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2017-03-17.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-03-29.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2017-04-04.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Blood culture negative, Chest X-ray normal, Culture urine negative, Feeling abnormal, Influenza virus test negative
Clinical narrative: Postvaccination fever on 2017-04-04.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: Pyrexia, Ultrasound scan normal, Unresponsive to stimuli, Urine analysis normal, Viral test negative
Clinical narrative: Postvaccination fever on 2017-04-04.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PPV, RVX
Symptoms: White blood cell count increased
Clinical narrative: Postvaccination fever on 2017-04-04.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Epistaxis, Platelet count decreased
Clinical narrative: Pt presented to the ED due to prolonged nose bleeding. Platelets 12.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Back pain, Blood iron decreased, Decreased appetite, Disturbance in attention, Headache
Clinical narrative: Pt started getting a headache 2 days after receiving hpv9. Headache slowly got worse and on days 18 and 19 after shot.  Had difficulty focusing on those 2 days. Headache then started to improve, but continues to have pain on day 22.  Pt also suffered from general body aches and back and neck pain. Decreased appetite. Treated with OTC pain relievers. Seen by local provider 4-11-17 for headache.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Neck pain, Pain
Clinical narrative: Pt started getting a headache 2 days after receiving hpv9. Headache slowly got worse and on days 18 and 19 after shot.  Had difficulty focusing on those 2 days. Headache then started to improve, but continues to have pain on day 22.  Pt also suffered from general body aches and back and neck pain. Decreased appetite. Treated with OTC pain relievers. Seen by local provider 4-11-17 for headache.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Pain
Clinical narrative: A mass in her right arm relating to a flu shot she received three weeks ago. Large mass on right arm in the deltoid region approximately the size of an egg. Pt denies that it is painful to touch.She states it is painful on certain movements.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female patient. The patient's concurrent conditions included heart disease. The patient did not have any concomitant medications or drug reactions/allergies to be reported. On 06-MAR-2017, the patient was vaccinated with ZOSTAVAX subcutaneously into deltoid at an angle using 5/8 inch needle (dose, strength and frequency were not provided) (lot # M035696 with expiration date 07-NOV-2017), to prevent shingles. On an unknown date in March 2017, the patient had bump at the injection site which was like a tuberculosis test bump. It was unknown if a treatment was given for the adverse event. No laboratory diagnostics studies were performed. The patient's outcome and the causality assessment between ZOSTAVAX and the adverse event were not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a pharmacist concerning a patient of unknown age and gender. In approximately 2015 (reported as "2 years ago"), the patient began the HPV series with dose one of GARDASIL (lot number, expiration date, dosage and route of administration not provided). On 27-MAR-2017, the patient presented for vaccination with GARDASIL 9 (lot number M041213, expiration date 22-JUN-2019) as the second dose in the HPV series. At the time of the call, the patient had not yet received the second dose of GARDASIL 9. No adverse effects reported. No additional information was provided. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical student (a certified medical assistant) referring to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies. On 28-MAR-2017, the patient was vaccinated with ROTATEQ oral (lot # M018958 and expiration date 03-MAR-2018) for an unknown indication (dose and strength were not reported). This vaccine had a temperature excursion of 50 Fahrenheit degrees (°F) (the range was from 47 °F to 77 °F) for 48 hours.  No previous temperature excursions were reported and a data logger was involved. No adverse effects were reported and no further information was provided. The reporter also mentioned that the products were not administered to other patients since the time of the excursion. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 30-MAR-2017 from a medical assistant regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 15-MAR-2017 the patient was vaccinated with a dose of ZOSTAVAX lot # M037013, expiration 22-NOV-2017 subcutaneous for prophylaxis which underwent a temperature excursion. Other suspect therapies included sterile diluent (STERILE DILUENT). The vaccine was stored between 6 degrees F and 14 degrees F for 1 hour and 4 minutes and between 15 degrees F and 46 degrees F (also reported as 40.2 degrees F) for 105 hours and 5 minutes. No previous temperature excursion was reported. The call was made due to a data logger. The patient has not reported an adverse experience. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of PNEUMOVAX23 with a Lot # reported as L029306 with an expiration date of 26-MAR-2017 and with Lot # reported as M0275552 with an expiration date of  04-FEB-2018 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that from 23-DEC-2016 to 31-DEC-2016, the vaccine was exposed to a temperature of 32 to 36 Fahrenheit degrees range (0 to 1 centigrade degrees) for a time frame of 177.5 hours (for 6 cycles); from 03-JAN-2017 to 31-JAN-2017, the vaccine was exposed to the same temperature for a time frame of 464.5 hours (for 21 cycles); from 02-FEB-2017 to 28-FEB-2017, the time frame was 409.5 hours (for 16 cycles) and from 01-MAR-2017 to 15-MAR-2017, the time frame was 61 hours (for 6 cycles). The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004439: US-009507513-1703USA010028: US-009507513-1704USA004440: US-009507513-1704USA004437:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of M-M-R II with a Lot # reported as L030162 with an expiration date of 11-AUG-2017 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that from 23-DEC-2016 to 31-DEC-2016, the vaccine was exposed to a temperature of 32 to 36 Fahrenheit degrees range (0 to 1 centigrade degrees) for a time frame of 177.5 hours (for 6 cycles); from 03-JAN-2017 to 31-JAN-2017, the vaccine was exposed to the same temperature for a time frame of 464.5 hours (for 21 cycles); from 02-FEB-2017 to 28-FEB-2017, the time frame was 409.5 hours (for 16 cycles) and from 01-MAR-2017 to 15-MAR-2017, the time frame was 61 hours (for 6 cycles). The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ with a Lot # reported as L033543 with an expiration date of 30-MAY-2017 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects reported. It was reported that from 23-DEC-2016 to 31-DEC-2016, the vaccine was exposed to a temperature of 32 to 36 Fahrenheit degrees range (0 to 1 Centigrade degrees) for a time frame of 177.5 hours (for 6 cycles); from 03-JAN-2017 to 31-JAN-2017, the vaccine was exposed to the same temperature for a time frame of 464.5 hours (for 21 cycles); from 02-FEB-2017 to 28-FEB-2017, the time frame was 409.5 hours (for 16 cycles) and from 01-MAR-2017 to 15-MAR-2017, the time frame was 61 hours (for 6 cycles). The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004439: US-009507513-1704USA004438: US-009507513-1703USA010028: US-009507513-1704USA004437.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX intramuscularly instead of subcutaneously, which had a lot # of M038350 (expiration date was not provided), for prophylaxis.  No adverse experiences were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Feeling abnormal, Myalgia, Pain, Pyrexia, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation.  Medical history included pneumonia about 4-5 years ago. Concomitant medications were not reported. On an unspecified date, the patient experienced feeling terrible, muscle ache, everything ache, shaking, fever over 102°F. The outcome of fever was recovered and the outcome for the other events was unknown.
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Adverse event following immunisation
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for herself. A 72-year-old female patient received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation.  Medical history included pneumonia about 4-5 years ago. Concomitant medications were not reported. On an unspecified date, the patient experienced feeling terrible, muscle ache, everything ache, shaking, fever over 102°F. The outcome of fever was recovered and the outcome for the other events was unknown.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Local swelling, Pain, Vomiting
Clinical narrative: Per MD's report - Significant redness and swelling localized to upper arm area: C/O feeling achy, vomiting multiple times  (x1 day) 3 day after received vaccine; No treatment.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Urticaria
Clinical narrative: Patient received MENACTRA and BEXSERO at 3 pm on 4-5-17. Woke up on morning of 4-6-17 covered in hives. Went to nurse practitioner on 4-10-17 and was given steroids. Nurse called Health Dept. to report reaction and to seek guidance on whether to advise patient to get second dose of BEXSERO or not.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: Rash and other nonspecific skin eruption (swollen, tender left deltoid area).
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4-3-17 - after shot pt. walking to car felt nauseous, faint, has had severe headache since shot, severe tenderness, very hot around injection, very red and injection area swelled up to a tear drop size measured around 42ml in length. 4-11-17 spoke with pt. sym. resolved after 4 days. "She's fine now."
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site warmth, Nausea
Clinical narrative: 4-3-17 - after shot pt. walking to car felt nauseous, faint, has had severe headache since shot, severe tenderness, very hot around injection, very red and injection area swelled up to a tear drop size measured around 42ml in length. 4-11-17 spoke with pt. sym. resolved after 4 days. "She's fine now."
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: Arm swelled into bump around injection site immediately after injection. Sent pt to walk in clinic. No other RXN (hives, anaphylaxis, pain, itching).
Age: 67.0
Sex: F
Vaccine: JEV, MNQ
Symptoms: Deafness unilateral, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: Japanese Encephalitis vaccine given on 1-16-17. On 2/13-14/2017 had fever 102, headache/nausea - sick x 4 days then cleared up. Did not have JE booster. On arrival at destination 3/1/17 had hearing loss Right ear, no improving on oral steroids. 4/17/17 recovered from fever, nausea and headache. Still recovering from hearing.
Age: 47.0
Sex: M
Vaccine: PPV
Symptoms: Localised oedema, Nausea, Vomiting
Clinical narrative: Localized edema. Nausea, vomiting.
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Peripheral swelling, Respiratory tract congestion
Clinical narrative: Pt not sure when vax was administered either in November 2016 or March 2017. 2 days later after vax, chest congestion began and it still have it. Went to doctor on 3/23/17. Pt prescribed multiple medications but only fill Furosemide 20mg. because legs swollen from knees to ankles and feet. Considering stopping water pills because they are not doing anything. Today feels worse, weaker, tired. Was hospitalized in January doesn't know if related since doesn't remember vax date.
Age: 67.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and urticaria, pruritus. Acyclovir 1200 mg tid, Triamcinolone bid.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Erythema multiforme, Myalgia
Clinical narrative: Myalgia and Erythema. Multiform.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pruritus, Urticaria
Clinical narrative: Myalgia and urticaria, pruritus.
Age: 71.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache
Clinical narrative: Headache.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria. Pruritus.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Local reaction, Pain, Pruritus
Clinical narrative: Pt came to ED stating she received a pneumococcal vaccine that morning at 11am and she noticed swelling of the LUA around 1 pm progressively getting worse. And local edema, erythema and itching and pain.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Left arm pain in shoulder radiating into neck. Has had body aches, stomach feeling sore, fever to 101. Also having headache.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Left arm pain in shoulder radiating into neck. Has had body aches, stomach feeling sore, fever to 101. Also having headache.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Headache, Nausea, Pruritus
Clinical narrative: Light-headedness, nausea, itching, headache.
Age: 63.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Cough, Pulmonary congestion, Respiratory tract congestion
Clinical narrative: Congested cough/lungs filling up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Nodule, Pruritus generalised, Rash erythematous
Clinical narrative: CELLULITIS, BIG KNOT, QUITE A LARGE RED RASH, BUMPY KNOT, ITCHING ALL OVER THE BODY.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: LEFT ARM STARTED TO HURT, AND IT WAS REALLY PAINFUL AND WENT TO THE HOSPITAL 4/3/17. PATIENT WAS GIVEN NORCO FOR A WEEK. THEN PATIENT'S PAIN RETURNED AND WENT TO  HOSPITAL 4/8/2017 2:30 PM.
Age: 0.75
Sex: F
Vaccine: IPV
Symptoms: Mucous stools
Clinical narrative: Possible hematochezia, mucously stool after each IPV vaccine, both in combo (PEDIARIX at 2 mos. PENTACEL at 4 mos) and singly on 12/19/16.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Muscular weakness
Clinical narrative: Pt. was given vaccine (IM) in right upper arm. Got up and moved to a different chair to wait for his prescriptions to be filled. After 10 min he felt his head start pounding then felt severe muscle weakness from his neck, down his arms, his back, to the top of his thighs. Pt. recovered after 20 min. Went home and took ibuprofen. "Felt 99%".
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Forgetting things began Sunday, coughing tightness in chest, spasms in right arm, chills exhaustion, loose bowels. Temp and BP ok.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Memory impairment, Muscle spasms
Clinical narrative: Forgetting things began Sunday, coughing tightness in chest, spasms in right arm, chills exhaustion, loose bowels. Temp and BP ok.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Decreased appetite, Injection site warmth, Pyrexia
Clinical narrative: Mother reports fever of 101 and decreased appetite as well as left leg feeling warmer to touch than right leg. Infant was vaccinated at appx 1610 PM on 4/10/17 and held for 15 min following immunizations. No reaction noted.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, swollen, warm to touch and sore when touched.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Grip strength decreased
Clinical narrative: Pt. C/O total body weakness (dropping things, couldn't grasp wrench to any strength x 24 hrs after receiving inj. on 3/20/17. It resolved after 24 hours.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Leukocytosis, Pain in extremity
Clinical narrative: Patient called stating she is having pain, fever on left arm. Dr. agreed to see her in clinic on that day. She had impressive cellulitis and she also had leukocytosis. Dr. changed antibiotic to doxy and cephalexin to cover staph and strep. The next day she was no better, again he walked her for clinic visit and erythema and induration were worse and fever persisted. Dr. arranged for her to be admitted an personally wheeled her to her room and arranged for STAT dose of Vancomycin. She remained febrile yesterday on vanc and UNASYN. I visited her twice. ID was consulted overnight. They advised that we report the lot number of the vaccine we gave the patient to the HD. Dr. spoke to the lady and she stated nothing unusual and observed the usual antiseptic procedure. The patient will go home today on Linezolid.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Patient called stating she is having pain, fever on left arm. Dr. agreed to see her in clinic on that day. She had impressive cellulitis and she also had leukocytosis. Dr. changed antibiotic to doxy and cephalexin to cover staph and strep. The next day she was no better, again he walked her for clinic visit and erythema and induration were worse and fever persisted. Dr. arranged for her to be admitted an personally wheeled her to her room and arranged for STAT dose of Vancomycin. She remained febrile yesterday on vanc and UNASYN. I visited her twice. ID was consulted overnight. They advised that we report the lot number of the vaccine we gave the patient to the HD. Dr. spoke to the lady and she stated nothing unusual and observed the usual antiseptic procedure. The patient will go home today on Linezolid.