chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site rash, Rash
Clinical narrative: Small raised bumps on lateral aspect of bilateral thighs covering 2/3 of area. 2 providers consulted and patient walked to allergy clinic where provider was expecting him.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Red, raised, tender and itchy around area of vaccination. Subcutaneous Injection.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pharyngitis streptococcal, Polymerase chain reaction positive, Pyrexia, Scab
Clinical narrative: Two-dose varicella vaccine recipient diagnose with varicella. Reported about 50 lesions all over the body, fever >100 degrees F. Lesions in all stages, including vesicles. Also had strep throat. No antivirals prescribed. Lasted 10 days before scabbing. Appeared in crops. History of asthma. No history of varicella.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella, Varicella virus test positive
Clinical narrative: Two-dose varicella vaccine recipient diagnose with varicella. Reported about 50 lesions all over the body, fever >100 degrees F. Lesions in all stages, including vesicles. Also had strep throat. No antivirals prescribed. Lasted 10 days before scabbing. Appeared in crops. History of asthma. No history of varicella.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Pruritus generalised
Clinical narrative: Patient began itching all over his body. The patient has been taking Benadryl to alleviate symptoms. Patient still reports occasional itching. No other symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health worker referring to a number of unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (dose, strength and route unknown, lot #: L021215, expiry date: 10-JUN-2017 or lot #: L011085, expiry date: 01-APR-2017). There was no concomitant therapy reported. No adverse effects were reported. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was reported. On 21-DEC-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck), lot # L040415, expiry date 13-APR-2017 (dose and route of administration were not specified). The patient did not report an adverse effect. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 53-year-old male patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were received as follows: The patient received a complete schedule of Hepatitis B vaccine, but was unsure of specified brand. The patient's hepatitis B antibody titers were never reached appropriate levels, causing the patient to be a therapy non responder. The reporter stated that, they were unsure if the patient's titers were drawn at the right time but because the patient is also a Health care professional, she was assuming they were drawn at the right time. No further information was reported regarding the event.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JAN-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L019127 and expiry date on 27-MAY-2017, (route, frequency and dose were not reported). No adverse effects were reported and no product quality complaint was involved. Additional information is not expected since the reporter did not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates after 18-NOV-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (exact dose and route were not reported, lot # K006135 with expiration date: 29-APR-2016, lot # K011083 with expiration date: 08-AUG-2016). The administered doses experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. No adverse effects were reported. 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 Licensed Practical Nurse, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. On an unknown date, doses of ROTATEQ by oral route (Lot #: L026740, exp date 16-APR-2017; L022446, exp date: 14-FEB-2017; L010128, exp date: 24-JAN-2017) (dose was not reported) which were exposed to temperatures outside of the recommended range were inadvertently administered to the unspecified number of patients. It was unknown if the patient sought medical attention. No adverse effects have been reported. The reporter refers that there was not product quality complaints involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: DTAP, FLU3, HIBV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: Child was inadvertently given a 0.5 ml dose of FluZone instead of the age appropriate 0.25 ml dose for age.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception, ileocolic and then on 12/26 small bowel intussusception.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, swelling of thigh to double in size, warm to touch and itching.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age. On 11-JAN-2016 the patient was vaccinated with PEDVAXHIB lot # L030865 (expiration date 07-JUN-2018), which was improperly stored at 48.5F for 30 minutes (incorrect product storage). There was no previous temperature excursion. No adverse effects reported. Additional information is not expected as it was not allowed to contact the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients. Age, genders, medical history or concurrent conditions were not reported. On an unknown date, doses of VAQTA (L018499, exp date: 25-FEB-2017: L015460, exp date: 20-JUL-2017; L036300 exp date: 04-NOV-2016) (dose and route were not reported) which were exposed to temperatures outside of the recommended range were administered to the unspecified number of patients. It was unknown if the patient sought medical attention. No adverse refers that there was no product quality complaints involved. This is one of several reports from the same source. Lot number L036300 has been verified to be a valid lot number for Hepatitis A vaccine, Inactivated. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Allergy to animal, Allergy to plants, Anaphylactic reaction, Food allergy, Seasonal allergy
Clinical narrative: Anaphylaxis.
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Skin test positive
Clinical narrative: Anaphylaxis.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic, Rash vesicular, Urticaria
Clinical narrative: Patient reports rash started on left hand, spread to entire body, later follow up notes reports rash started as vesicles, very pruritic, treated with Eucerin and BENADRYL creams, also reports hives on entire body starting day after influenza vaccine. Diphenhydramine apply to affected areas TID.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-APR-1994, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, expiration date, dose and route were not provided). On 06-JUN-1994, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot # and expiration date were not provided). No adverse effect was reported. 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 healthcare professional refers to an unspecified patients of unknown age and gender. No pertinent medical history was reported. On unknown dates in 2015 (reported as "since 17-JUL-2015"), the patients were vaccinated with doses of PROQUAD (Merck) (dose and route were not reported) lot # L002419, expiration date 23-JUL-2016 and lot # L007230 expiration date 03-SEP-2016 which were improperly stored. No adverse experience reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Vaccination site rash
Clinical narrative: This spontaneous was received from a consumer as part of a marketing research program, refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot#, expiry date, dose and route were not reported). On a unknown date, the patient experienced rash type reaction in site area of vaccine, red area and cellulitis a few days after vaccination. On an unknown date (also reported as once every few years) the patients experienced fever and achiness. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as reporter did not wish to contact further.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients were not mentioned by the reporter. On an unknown date the patients were vaccinated with VARIVAX (Merck) of lot # L001334, expiry date: 13-JAN-2017 (strength, dose #, route, site of administration and indication were not reported) which had been improperly stored (incorrect product storage). No adverse effects were reported. Product Quality Complaint was not filed. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hair growth abnormal, Pain, Pyrexia, Toothache
Clinical narrative: Pt woke up the next morning with fever, chills T-99 degrees, and aches that lasted for 5 wks. She also has had her upper teeth ache and complains she now has whiskers growing out of her (R) cheek about silver dollar sized.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Dehydration, Diarrhoea, Heart rate increased, Hypotension, Intensive care
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 29 December 2015. This case involves a 19-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number UI450AD, expiration date 30 June 2016, dose and site of administration was not reported) on 18 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. On an unspecified date, few days following the vaccination, the patient experienced hypotension,  dehydration, elevated heart rate, pneumonia and diarrhea. The patient required emergency room or physician visit. The patient was admitted in ICU for a week. Lab data were not reported. He was treated with IV fluids steroids and antibiotics. The patient was discharged from hospital on 7 October 2015. The outcome of events was reported as unknown. List of documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 29 December 2015. This case involves a 19-year-old male patient who was vaccinated with an intramuscular dose of FLUZONE (batch number UI450AD, expiration date 30 June 2016, dose and site of administration was not reported) on 18 September 2015. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. On an unspecified date, few days following the vaccination, the patient experienced hypotension,  dehydration, elevated heart rate, pneumonia and diarrhea. The patient required emergency room or physician visit. The patient was admitted in ICU for a week. Lab data were not reported. He was treated with IV fluids steroids and antibiotics. The patient was discharged from hospital on 7 October 2015. The outcome of events was reported as unknown. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, heated arm at injection site.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash erythematous
Clinical narrative: Erythematous rash on the lower legs and some on the upper arms. No fever. No local redness or swelling.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Broke out in a rash 12/14/15.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Maculopapular rash to face, scalp, neck and trunk that started 3 days after vaccine (1/9/16). Preceeded by 2 days fever 102 that resolved 24 hr before rash appeared.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a patient of unknown gender and age. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date the patient was vaccinated with a dose of improperly stored ZOSTAVAX vial (strength, unit and route unspecified, lot # L032403 and Exp date 26-NOV-2016). No adverse effects were reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Site reaction with significant swelling, redness and hives. Lasted x 3-4 days with BENADRYL and ice.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker referring to a patients of unknown age and gender. Since 02-NOV-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency and route of administration were not reported, lot# L013824 expiration date: 21-APR-2017; lot# reported as L029472 expiration date: 06-AUG-2017), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker referring to a patients of unknown age and gender. Since 02-NOV-2015, the patients were vaccinated with PROQUAD (Merck) (dose, frequency and route of administration were not reported, lot# L030589 expiration date: 01-FEB-2017; lot# L019997 expiration date: 02-DEC-2016), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an other health professional refers to an unspecified number of patients of unknown age and gender. The concurrent conditions and medical history of the patients were not mentioned by the reporter. On an unknown date the patients were vaccinated with M-M-R II of lot # K018990, expiry date: 15-OCT-2016 (strength, dose #, route, site of administration and indication not reported) which had been improperly stored (incorrect product storage). No adverse effects were reported. Product Quality Complaint was not filed. No further information was provided. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt reports the area he received the anthrax shot has become red, swollen and hard to the touch. He further states that he could not move his arm above shoulder level on 01/11/2016, but the pain is slowly going away and his ROM is improving. Pt does not feel that he should seek emergency care at this time.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, Swelling, Itching, slight Hematoma at injection site, with white spot in the middle of the hematoma.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This literature marketed report was received from the authors of a published literature article, concerning 2476 adult patients (aged 40 +/- 16 years) of unknown gender. No information regarding the patients' medical history or concurrent conditions was provided. The objective of the study was to further elucidate the relationship between Hepatitis B virus (HBV) and diabetes. The authors examined the data derived from the Survey from years 2005-2010. Survey was a program of studies designed to assess the health and nutritional status of adults and children. The authors excluded 13902 subjects who were younger than 20 years of age at the time of screening interview and 851 subjects without body mass index (BMI) information. Then, they excluded 933 patient whom hepatitis B serology was not available and 32 subjects, whose diabetes status could not be determined. From 15316 patients included in the analysis, 4063 patients were vaccinated with doses of hepatitis B vaccine (recombinant) (manufacturer unknown) injection (dose and route of administration were not reported) on unspecified dates. The vaccination was assessed by self-report. There were no concomitant therapies reported. 91.07% of the vaccinated patients received all 3 doses of hepatitis B vaccine (recombinant) (manufacturer unknown) and the remaining patients received less than 3 doses. As the analysis was mainly based on the serological results, the authors did not separate the subjects who received all 3 doses or less than 3 doses. It was reported that the immunization status of the patients was assessed by hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb) and hepatitis B surface antigen (HBsAg) testing. Positive hepatitis B immunization status was based on positive result of HBsAb test and negative results of both HBcAb and HBsAg tests. Any other combination of results was considered as negative hepatitis B immunization status. Out of 4063 patients vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown), there was no serological evidence of immunization for hepatitis B in 2476 cases. Therefore, HBV vaccination was deemed to be unsuccessful in those 2476 patients, who were reported to be vaccinated. The outcome of the events was not reported. The reporters considered the event to be related to the therapy with hepatitis B vaccine (recombinant) (manufacturer unknown). They stated that as the titer of HBV declines with time, the high vaccination failure rate in this sample set could be a time-related issue, however they could not exclude other causes from the limited information available. Additional information has been requested.
Age: 78.0
Sex: U
Vaccine: FLU3
Symptoms: Mobility decreased, Nerve injury, Pain in extremity
Clinical narrative: Patient received vaccine 9-21-15. A first report received today 1-13-16. Patient has had arm soreness and has difficulty raising her arm. She advises she has been seeing physician who believes a nerve was hit.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain
Clinical narrative: Site of injection was sore the next morning and has progressively gotten. Patient has pain when he touches the area or sleeps on his left side.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 09-APR-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # k025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. The patient, who was administered a dose of ZOSSTAVAX (dose, frequency and route not provided) on 17-NOV-2014, was inadvertently administered a dose of ZOSTAVAX (dose, frequency and route not provided) on 07-JAN-2016. No adverse effects were reported. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a clinical medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not provided. The patient was administered a dose of improperly stored GARDASIL 9 (lot L016428, with expiration date of 30-JUL-2017, dose and route not provided) on 16-DEC-2015. No adverse effect reported. 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 registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, patient was vaccinated with a dose of PNEUMOVAX 23 (strength, dosage, dose number and route were not provided) lot #L029113 and expiration date 27-MAR-2017, that was improperly storage. No concomitant medications were reported. No adverse effect was reported. No product quality complain was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9, MEN
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 11 year old male patient. Information about the patient's pertinent medical history and concurrent conditions was not reported. The patient did not have drug reactions/allergies. On an unknown date, the patient was vaccinated with GARDASIL 9, (dose, route of administration, lot # and expiration date were not provided); and with a meningococcal vaccine (unspecified) (manufacturer unknown) in the same arm. Concomitant medication was not reported. The reporter stated that the patient complained of injection site pain that lasted 3 days, then subsided for a period described as "a couple of weeks". Following the couple of weeks interval, the patient experienced that the injection site pain returned for an unspecified length of time. The outcome of injection site pain was reported as not recovered, also described as "the pain was continuing currently". The reporter did not assess the relatedness between injection site pain and GARDASIL 9. Additional information is not expected since no consent was given to reach follow up.
Sex: F
Vaccine: HEP
Symptoms: Apnoea, Blood culture negative, C-reactive protein increased, CSF culture negative, CSF glucose normal
Clinical narrative: Oxygen desaturation with feeds as well as persistent apneas and irritability. Baby was admitted for sepsis work up including spinal tap and head ultrasound on 1/10/16. She required nasal cannula treatment. She was placed on antibiotics and antivirals. Due to the irritability, MRI has been ordered and antibiotics are to be continued for 7 day course.
Sex: F
Vaccine: HEP
Symptoms: CSF protein increased, CSF white blood cell count negative, Herpes simplex serology negative, Irritability, Liver function test normal
Clinical narrative: Oxygen desaturation with feeds as well as persistent apneas and irritability. Baby was admitted for sepsis work up including spinal tap and head ultrasound on 1/10/16. She required nasal cannula treatment. She was placed on antibiotics and antivirals. Due to the irritability, MRI has been ordered and antibiotics are to be continued for 7 day course.
Sex: F
Vaccine: HEP
Symptoms: Neonatal hypoxia, Polymerase chain reaction, Ultrasound scan normal, Ultrasound skull, White blood cell count increased
Clinical narrative: Oxygen desaturation with feeds as well as persistent apneas and irritability. Baby was admitted for sepsis work up including spinal tap and head ultrasound on 1/10/16. She required nasal cannula treatment. She was placed on antibiotics and antivirals. Due to the irritability, MRI has been ordered and antibiotics are to be continued for 7 day course.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Choking, Discomfort, Emotional distress, Faeces pale, Haematochezia
Clinical narrative: Blood in stool, dark red, almost black for 4 days, 5th day stool is white and thick, 7th day and 8th day increased fussiness, screaming for long periods of time (10-15 min) not able to console, wake up screaming, choke and forcefully spit up a lot all at once. Occurs 3-4 times a day, uncomfortable when laying on his back and difficulty falling asleep, squirmy and whiny even when falling asleep in mom's arms.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Incomplete course of vaccination, Infantile spitting up, Initial insomnia, Intussusception, Irritability
Clinical narrative: Blood in stool, dark red, almost black for 4 days, 5th day stool is white and thick, 7th day and 8th day increased fussiness, screaming for long periods of time (10-15 min) not able to console, wake up screaming, choke and forcefully spit up a lot all at once. Occurs 3-4 times a day, uncomfortable when laying on his back and difficulty falling asleep, squirmy and whiny even when falling asleep in mom's arms.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Restlessness, Screaming
Clinical narrative: Blood in stool, dark red, almost black for 4 days, 5th day stool is white and thick, 7th day and 8th day increased fussiness, screaming for long periods of time (10-15 min) not able to console, wake up screaming, choke and forcefully spit up a lot all at once. Occurs 3-4 times a day, uncomfortable when laying on his back and difficulty falling asleep, squirmy and whiny even when falling asleep in mom's arms.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Where the Pneumonia13 was given turned very red and hot.  This continued and spread over the top part of my arm. It measured nine inches up and about the same around my arm  Went to the DR. and she prescribed an antibiotic and Steroids. This is the 10th day and is still spreading.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-JUL-2013, the patient was vaccinated with the first dose of ZOSTAVAX (lot # J001694, expiration date: 08-MAY-2014; dose and route were not provided). On 11-JAN-2016, the patient inadvertently received second dose of ZOSTAVAX (lot # reported as L035286, expiration date: 15-DEC-2016; dose and route were not provided). No adverse effects were reported. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Fatigue, Injection site pain, Mobility decreased
Clinical narrative: Muscle ache at injection spot, fatigue, nausea, high-grade fever (102 degrees), inability to move arm.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: Musculoskeletal disorder, Nausea, Nuclear magnetic resonance imaging, Pyrexia, Soft tissue injury
Clinical narrative: Muscle ache at injection spot, fatigue, nausea, high-grade fever (102 degrees), inability to move arm.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: X-ray
Clinical narrative: Muscle ache at injection spot, fatigue, nausea, high-grade fever (102 degrees), inability to move arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large area of swelling, redness and warmth to (L) leg post KINRIX vaccine. Pt. will start antihistamines and oral steroids.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 78 year old female patient. Patient with no pertinent medical history, only allergic to DILANTIN and codeine. on 15-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot # H014366, expiration date 06-NOV-2013) 0.65 ml in the left arm. There was no concomitant medication. The pharmacist reported that on 30-DEC-2015, the patient went to the pharmacy and she had shingles (developed some time in December 2015) on the left side of her face including her left eye through her hairline. It was also reported that there was no treatment given for the adverse events and no lab diagnostics studies were performed. The outcome of herpes zoster and ophthalmic herpes zoster was reported as not recovered. The causality assessment was not provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Eyelid oedema, Injection site erythema, Injection site pruritus, Lacrimation increased, Malaise
Clinical narrative: Injection site is red, itchy, water/puffy eyes. Spoke with patient at 11:30 on 01/13/2016 she stated she felt better but still not as well as she would like. Pt scheduled app. to be seen.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Erythema, Induration, Local reaction, Nausea
Clinical narrative: 1/12 - localized reaction, red with hard center, then in eve - nausea and fever. By 1/13 area increased and redness to axillary area fever cont., nausea and body aches. Local health department suggests to be evaluated. Has apt to see PCP 1/13/16.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: 1/12 - localized reaction, red with hard center, then in eve - nausea and fever. By 1/13 area increased and redness to axillary area fever cont., nausea and body aches. Local health department suggests to be evaluated. Has apt to see PCP 1/13/16.
Age: 0.63
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, HEPA, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Child's MCIR had Hep B scheduled for 5/23/2015, and Hep A was scheduled for 5/23/2016.  Hep A was given 5 months early.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: DEFECTIVE SYRINGE. CONTACTED COMPANY ABOUT EVENT. SYRINGE DID NOT ADMINISTER DOSE PROPERLY. PLUNGER FULLY DEPRESSED. WHEN NEEDLE REMOVED OVER HALF OF DOSE SPRAYED ACROSS THE VACCINATION BOOTH.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache
Clinical narrative: Patient states headache started the day after she received the vaccine and is still present today (1-13-15).
Age: 30.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL
Symptoms: Pyrexia, Sinus tachycardia
Clinical narrative: Sinus tachycardia/Fever.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abnormal behaviour, Anti-aquaporin-4 antibody, Antinuclear antibody, Asthenia, Band neutrophil percentage
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: CSF myelin basic protein, CSF oligoclonal band, Central nervous system lesion, Complement factor C3 increased, Complement factor C4
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Complement factor normal, Computerised tomogram thorax normal, Culture, Differential white blood cell count, Dysarthria
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Encephalitis, Enterovirus test negative, Epstein-Barr virus antibody, Epstein-Barr virus test negative, Flow cytometry
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, HIV antibody, HIV antigen, Haemoglobin normal, Herpes simplex serology
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Herpes simplex serology negative, Immunophenotyping, Lymphocyte percentage decreased, Mycobacterium test, Mycoplasma test
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Plasmapheresis, Platelet count decreased, Pleocytosis
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Polymerase chain reaction, Seizure, Sensory loss, Tic, Treponema test
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Varicella virus test, West Nile virus test, White blood cell count normal, White matter lesion
Clinical narrative: Optic neuritis bilaterally developed 6-7 weeks after her 2nd vaccine. She then developed weakness, behavioral change, dysarthria, facial tics, sensory losses, and difficult-to-manage seizures, w/ multifocal encephalitis, CSF pleiocytosis. Broad workup of autoimmune, infectious, oncologic etiologies over the past month unrevealing so far. Slight improvement on IV steroids, and no improvement w/ 5 cycles plasmapheresis. She continues to worsen clinically and remains inpatient.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Pt. arm swelled up 1 day after shot administered she had to see a doctor who gave her doxycycline antibiotic.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Immediately after receiving her shot pt arm got localized red, itchy, hot reaction at injection site. We put ice pack on it for 15-20 minutes and it resolved completely. Pt said this happens with her allergy shots also.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came in on 1/4/16 to show Rph her arm where shot given. It was red, swollen and hot at injection site.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Mother phoned approx 24 hours after child received vaccine states evening of vaccine, (R) upper arm was reddened, itchy and painful. At time of call, mother stated arm was reddened, swollen and hard from about elbow and up. No SOB, no fever, no nausea or vomiting. Recommended BENADRYL, TYLENOL or ibuprofen and cold packs. Patient's symptoms got worse the next day but then better, now fully recovered.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Pain with injection, soreness swelling same day after few hours, redness spreading over last 3 days, allergies in arm, BENADRYL in pm, KEFLEX, leaving town today so f/u MD if not improving or worsening.
Age: 18.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Headache, nausea, slight fever, tired.
Age: 1.75
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction.  Flumist vaccine was administered at 21 months instead of 24 months of age.
Age: 1.09
Sex: M
Vaccine: DTAP, IPV
Symptoms: Extra dose administered
Clinical narrative: Got TDAP and Polio shot again after receiving them 7 days ago.
Age: 71.0
Sex: M
Vaccine: TYP
Symptoms: Hypersensitivity, Rash
Clinical narrative: 4 hours after taking first dose patient developed a rash.  Patient took diphenhydramine and called Dr.  Rash has since subsided and pt was advised by doctor to discontinue use.  Patient was advised by pharmacist that he would be high risk for getting IM immunization due to suspected allergic reaction to oral vaccine.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Itching and Hives on left arm (where vaccine was administered).
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes zoster diagnosis in a 2-dose varicella vaccine recipient. Unilateral rash in one dermatome, no pain reported. No history of varicella. Prescribed acyclovir.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus, Rash, Skin irritation
Clinical narrative: Could not get a definitive time it started from patient. Said it was "irritating" and itched. Recc. cold compress and possibly Benadryl cream. If area of rash continues to expand seek medical attention. Plan to call tomorrow to follow up. Was told by caregiver she did put neosporin on it right after vaccine.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hypoaesthesia oral, Nausea, Pharyngeal oedema
Clinical narrative: Patient began feeling dizzy. Vitals were assessed. BP 130/90, pulse 108, temp 98.5. She then began to feel nauseated and had complained of mild swelling to her throat. Upon examination, no swelling was noted. Lung sounds were clear bilaterally. Vitals were assessed again at 3:00 PM. BP 118/60, pulse 110, temp 98.6. She then began to complain of numbness to her tongue and lips. No swelling was noted. Patient was given water to drink and was able to calm down. After she calmed down, she did state she felt better but still felt dizzy.
Age: 65.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Patient experienced severe abdominal cramping shortly after taking first dose.  Patient called Dr and doctor advised to d/c use.  Per spouse, patient has no interest in pursuing vaccination with IM vaccine.
Age: 6.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Skin tightness
Clinical narrative: Mother presents to clinic today on 01/13/2016. States she discovered the patients left arm to be swollen, reddened, taut and warm to touch yesterday on 01/12/2016 at 12pm. He also developed a fever of 99.8. She administered "Nurofen" and his fever resolved. She also applied an ice pack to the left arm for 5 minutes.  Currently, mother denies noticing any symptoms of fever, however he is complaining of mild pain on his left arm. Physical assessment shows let arm to be reddened, swollen, taut and warm to touch. Mother denies bringing him to ER or UC. Advised to bring patient to UC or PMD for evaluation of left arm.
Age: 6.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Skin warm
Clinical narrative: Mother presents to clinic today on 01/13/2016. States she discovered the patients left arm to be swollen, reddened, taut and warm to touch yesterday on 01/12/2016 at 12pm. He also developed a fever of 99.8. She administered "Nurofen" and his fever resolved. She also applied an ice pack to the left arm for 5 minutes.  Currently, mother denies noticing any symptoms of fever, however he is complaining of mild pain on his left arm. Physical assessment shows let arm to be reddened, swollen, taut and warm to touch. Mother denies bringing him to ER or UC. Advised to bring patient to UC or PMD for evaluation of left arm.
Age: 0.74
Sex: F
Vaccine: FLU4
Symptoms: Autopsy, Death
Clinical narrative: Patient received flu vaccine on 12-16-15 at a well child 9 month check. Patient had no preexisting conditions, no adverse reaction. Patient died on 12-18-15 from unknown causes pending autopsy/coroner report. No adverse reaction occurred prior to death.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT HAVING SEVERE ARM ACHES/PAIN LEADING TO TROUBLE LIFTING ARM UP (CONTINUED ISSUES FOR 2 MONTHS CURRENTLY. TOOK 2 ROUNDS OF STEROID DOSE PACKS TO HELP RESOLVE SOME PAIN).
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: Local skin reaction at injection site, redness and swelling, few hives. Irritated area measures 2.5 inches long by 2 inches wide. Patient claims it hurts and at touch it is warm and hard. Flushed face and increased tiredness.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site urticaria, Injection site warmth, Skin reaction
Clinical narrative: Local skin reaction at injection site, redness and swelling, few hives. Irritated area measures 2.5 inches long by 2 inches wide. Patient claims it hurts and at touch it is warm and hard. Flushed face and increased tiredness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt states site of injection is warm and sore.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Headache, nausea and fatigue post vaccines.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Infection, Pain in extremity, Peripheral swelling, Skin warm, Ultrasound scan
Clinical narrative: Swollen upper limb, hot to touch, painful, went to ER and was diagnosed as infected and ultrasound done.  Treated with Keflex.
Age: 23.0
Sex: M
Vaccine: VARCEL
Symptoms: Erectile dysfunction
Clinical narrative: Difficulty getting and maintaining an erection post varicella vaccination.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain in extremity, Periarthritis
Clinical narrative: Left upper arm pain, left shoulder pain, can not raise left arm to sideway (arm pain when raised to 45 degree). Diagnosed as shoulder adhesive capsulitis.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: X-ray
Clinical narrative: Left upper arm pain, left shoulder pain, can not raise left arm to sideway (arm pain when raised to 45 degree). Diagnosed as shoulder adhesive capsulitis.