chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Decreased appetite, Diarrhoea, Diarrhoea haemorrhagic, Malaise
Clinical narrative: Patient had about 2 weeks of diarrhea - towards the end developing blood & mucous in it along with not feeling well [and eating less].  She was seen in my office 12 days after having received her scheduled 4mos set of immunizations [Pediarix, hib-omp, Prevnar, Rotarix].  Diaper brought from home showed stool mixed with mucous and blood.  Clinically looked ok, and was released home with symptomatic care and observation.  Prior to having received these vaccines, mom noted that after the 2mos set of vaccines [same set] that patient had diarrhea that lasted 2 weeks as well [but no blood or mucous noted]. These both resolved spontaneously.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site rash, Rash generalised
Clinical narrative: Child had induration and redness warmth on left arm where injection was given then rash and induration spread throughout whole body face to feet with induration and warmth to touch.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Child had induration and redness warmth on left arm where injection was given then rash and induration spread throughout whole body face to feet with induration and warmth to touch.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nodule, Rash
Clinical narrative: Patient developed a rash that spread. On April 28,2016 he felt run down and tired. The rash grew and has a knot. On April 29, 2016, the rash was approximately 3 by 5 inches. He stated he feels better today, April 29, 2016. He refused to go to a doctor or urgent care.  He said he will watch the rash.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Swelling face
Clinical narrative: Swollen arm leading to swollen face (per son looks like "the elephant man"). Dr. prescribed Prednisone 50 mg once daily for 5 days.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site swelling, Pyrexia
Clinical narrative: Severe headache and shot site swelling. Next day, 100.2 Fever and severe headache.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Petechiae, Vomiting projectile
Clinical narrative: Forceful and repeated vomiting, continuing for at least 12 hours, with subsequent facial petechiae.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Erythema multiforme, Urticaria
Clinical narrative: Urticaria multiforme. Rash.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, pain, heat at immunization site.
Age: 35.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Patient reported having no reaction the day that the vaccine was administered. However, the morning after administration, she developed a circular red rash around the injection site. The next day (4/29/16) she presented to the pharmacy after going to urgent care because the rash had gotten bigger and was slightly swollen. Patient denied fever, itching, or swelling of any other body parts (symptoms were localized to injection site area). Rash was about 3" in diameter.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site reaction, Injection site swelling
Clinical narrative: Swelling, redness, warmth, hardness, inflammation, shingles-like pustular rash at injection site (left arm), low grade fever.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia, Rash pustular
Clinical narrative: Swelling, redness, warmth, hardness, inflammation, shingles-like pustular rash at injection site (left arm), low grade fever.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Local swelling, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph node under arm shot given in, swelling back of neck, severe body aches.  Sx lasted 3 days. Severe enough to miss work.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Nausea, Pain in extremity
Clinical narrative: Got light headed, and nausea, then couple of hours later is still having the problem along with arm soreness if continues I will bring her to emergency room.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local reaction, Pyrexia, Swelling
Clinical narrative: Local reaction with erythema, swelling, and fever. Prednisone 1 tab every day, sodium chloride infuse over 1 hour once.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain, left deltoid, circumference of redness 3 inch by 3 inch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis - left arm (deltoid) 2 " x 2.5" swelling with warmth.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Blood lactic acid normal, Chills, Full blood count normal, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Erythema, warmth, induration immediately around injection site. No abscess or purulent discharge. Associated chills, shaking, body aches, malaise. Pt reported to ED concerned about sepsis. States that above sx similar to previous sepsis for unrelated reason.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site induration, Injection site warmth, Lipase normal, Malaise, Metabolic function test normal
Clinical narrative: Erythema, warmth, induration immediately around injection site. No abscess or purulent discharge. Associated chills, shaking, body aches, malaise. Pt reported to ED concerned about sepsis. States that above sx similar to previous sepsis for unrelated reason.
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Tremor
Clinical narrative: Erythema, warmth, induration immediately around injection site. No abscess or purulent discharge. Associated chills, shaking, body aches, malaise. Pt reported to ED concerned about sepsis. States that above sx similar to previous sepsis for unrelated reason.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Muscle twitching
Clinical narrative: Left deltoid with tenderness and slight pain. Left middle hand finger twitching. Seen by Dr.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Tdap given, itching started that night. Swelling and pain the next day with redness 99 degrees temp. The next day redness and swelling in shoulder and upper arm with 102 degree fever. Sx resolving today.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Throat irritation, Wheezing
Clinical narrative: Immediately after vaccines were give (R) deltoid became red and redness spread up into neck and face. Child said her throat felt a little itchy, and she started wheezing but was not in resp. distress. Given 2 tsp BENADRYL (25 mg), oral steroid 38mg and albuterol neb with good result. Observed for 1 hour.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Erythema, Hypoaesthesia, Injection site hypoaesthesia, Pain in extremity
Clinical narrative: Swelling - red arm - numb vaccination site - numb upper arm - pain in arm - loss of feeling hand and wrist - constant needles feeling in arm and hand.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Peripheral swelling, Sensory loss
Clinical narrative: Swelling - red arm - numb vaccination site - numb upper arm - pain in arm - loss of feeling hand and wrist - constant needles feeling in arm and hand.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Contusion, Hypoaesthesia, Injection site bruising, Injection site discharge, Injection site erythema
Clinical narrative: Swelling - red arm - numb vaccination site - numb upper arm - pain in arm - loss of feeling hand and wrist - constant needles feeling in arm and hand.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Peripheral nerve operation, Secretion discharge
Clinical narrative: Swelling - red arm - numb vaccination site - numb upper arm - pain in arm - loss of feeling hand and wrist - constant needles feeling in arm and hand.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Skin discolouration, Skin fissures
Clinical narrative: Swelling - red arm - numb vaccination site - numb upper arm - pain in arm - loss of feeling hand and wrist - constant needles feeling in arm and hand.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray, Dyspnoea, Electroencephalogram, Electromyogram, Lumbar puncture
Clinical narrative: Progressive shortness of breath and muscle weakness.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Progressive shortness of breath and muscle weakness.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Nausea, Pain, Pyrexia
Clinical narrative: All joint pain, body ache, low grade fever, light nausea.
Age: 16.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Cough, Headache, Malaise, Viral infection, Wheezing
Clinical narrative: Patient reports having a headache, coughing, and wheezing by the evening time. Went to friend's house to sleepover, and he had symptoms that night. Reports he has been to this friend's house before in the past without any issues. Mother noticed this was not his baseline, and he was feeling ill.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain lower, Abdominal pain upper
Clinical narrative: Patient stated she has stomach pains on the lower part of abdomen.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. No treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Skin warm, Urticaria
Clinical narrative: Thursday noticed itching, raised welt, hot and red.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site rash
Clinical narrative: Rash which appeared consistent with Id reaction on left upper arm near site of Menactra vaccination.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: Will go to the Outpatient Clinic tomorrow AM.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Marked swelling, erythema and pain extending circumferentially around injection site with tense bullae formation centrally.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Injection site hot, swollen, red, and extremely painful. Back pain, chills, body aches, headache, fatigue, weakness, drowsiness. I used ice on site, ibuprofen for inflammation and pain. Can't sleep or lay on arm. Didn't get off couch for 1.5 days.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site hot, swollen, red, and extremely painful. Back pain, chills, body aches, headache, fatigue, weakness, drowsiness. I used ice on site, ibuprofen for inflammation and pain. Can't sleep or lay on arm. Didn't get off couch for 1.5 days.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Sleep disorder, Somnolence
Clinical narrative: Injection site hot, swollen, red, and extremely painful. Back pain, chills, body aches, headache, fatigue, weakness, drowsiness. I used ice on site, ibuprofen for inflammation and pain. Can't sleep or lay on arm. Didn't get off couch for 1.5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 2 days after injection site was red and warm to the touch, slightly painful. On Saturday, April 23, redness had spread to elbow. Patient called doctor's office on Monday and described situation and was told to take leftover AMOXIL 875. Patient took for 5 days and is much better and improved. Patient applied BENADRYL as well ADVIL helped.
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Cyanosis, Dizziness, Pallor, Vision blurred
Clinical narrative: Dizziness/pale skin/blue lips blurred vision.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red, itchy spot at injection site that has increased in size gradually.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Patient complained of a headache, feeling a little lightheaded immediately after shot. Approximately an hour to an hour and a half after the injection, patient became very dizzy lightheaded chilled cold and shivering and felt as though she were having an out of body  experience. She at this time also began to have diarrhea and vomiting, vomited three times.  Patient felt tired the rest the evening but slowly improved. And at this time has no problems.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling cold, Headache, Vomiting
Clinical narrative: Patient complained of a headache, feeling a little lightheaded immediately after shot. Approximately an hour to an hour and a half after the injection, patient became very dizzy lightheaded chilled cold and shivering and felt as though she were having an out of body  experience. She at this time also began to have diarrhea and vomiting, vomited three times.  Patient felt tired the rest the evening but slowly improved. And at this time has no problems.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site nodule, Injection site warmth, Rash
Clinical narrative: KNOT FROM INJECTION SITE, GREW TO 4" IN DIAMETER. RAISED RASH THAT STARTED 5 DAYS AFTER VACCINE WAS GIVEN. RASH IS STILL PRESENT 10 DAYS AFTER INJECTION, KNOT IS ABOUT 1CM IN DIAMETER. KNOT WAS WARM TO TOUCH DAYS 5-8 AFTER VACCINE.
Age: 1.77
Sex: M
Vaccine: MMRV
Symptoms: Discomfort, Pruritus, Urticaria
Clinical narrative: All over body hives which dissipate with the use of antihistamine and return after 6-10 hours.  Accompanied by discomfort and itching. Continuing on May 1st and has not abated.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Malaise
Clinical narrative: Patient reported malaise the night following the injection, then soreness, redness and a little knot at the site of injection, which started several days after. Shot was administered on 4/25/16, the arm symptoms began 5/1/16.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Ssmall red rash around injection site; large red rash later in day- almost 2-3 inches in diameter.
Age: 10.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Dizziness, Vomiting
Clinical narrative: Dizziness, Vomiting, Stomach pains.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Paraesthesia
Clinical narrative: In arm where shot was given. Tingling in 3 middle fingers (and sore shoulder) 30 days after FLUZONE HIGH DOSE vaccine given.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from Licensed Practical Nurse regarding 5 unspecified patients of unknown age and gender. The pertinent medical history of patients and their concurrent conditions were not reported. On an unknown date in April 2016 (also reported as last past two weeks from report time) 5 unspecified patients were vaccinated with improperly stored M-M-R II (lot # L020188, expiry date 03-JUN-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccines were subjected to temperature excursion of 47.1 Fahrenheit for a time frame of 6 minutes and these vaccines were administered to the patients. It was reported that there were no previous temperature excursions. Product quality complaint (PQC) was not filed. 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 initial spontaneous report was received from a Licensed Practical Nurse, concerning to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) injection (lot # K020760 with expiration date 31-OCT-2016; dose and route were not reported). The vaccine was exposed to temperature of 24.80 degrees F for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. It was unknown if the patient sought medical attention. A product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination failure
Clinical narrative: Information had been received in a published article. This literature marketed report refers to male child patient (currently 16-year-old). The patient was born with intra-uterine growth retardation (birth weight: 1.296 kg) at 33-week gestation. A presumptive diagnosis of the Finnish type of CNS was made, since genetic testing was not commercially available when he was diagnosed, based on his early and severe presentation. After a 12-month stay in the Neonatal Intensive Care Unit, the was discharged on home infusions of intravenous albumin via a right subclavian catheter along with anticoagulation, thyroid-hormone replacement, angiotensin converting enzyme inhibitors and multiple mineral and dietary supplements. The patient had been slow in gaining weight and had a short stature. In an attempt to reduce his risk of infections, all routine childhood immunizations (IZ) were administered to him, contrary to practice often followed in centers with extensive experience caring for babies with CNS. The patient received his primary series of IZ starting at the age of 3 months. At this time, his renal function was normal and he was profoundly hypoalbuminemic (serum albumin varying from 1.2 to 2.4 gm/dL) due to his massive urine protein losses. Other laboratory analyses, demonstrated low antithrombin III on a functional assay, low levels of IgG and normal IgA and IgM levels. Approximately in 2002 (reported as 2 years of age), the patient was vaccinated with first dose of Varicella vaccine (manufacturer unknown) (dosing details were not reported), while he was still nephrotic (NS). The patient had not seroconverted with the 1st dose (vaccination failure), which was not uncommon in healthy children and even more common in children with NS. The patient was again vaccinated with varicella vaccine (manufacturer unknown) after 8 months of 1st dose. The outcome of vaccination failure was unknown. The reporter considered vaccination failure to be related to varicella vaccine (manufacturer unknown). Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Body temperature increased, Haematochezia, Melaena, Somnolence
Clinical narrative: This spontaneous report was received from registered nurse concerning a 2 month old female patient. The patient did not have medical history and drug reactions or allergies. On 21-APR-2016, the patient was vaccinated with the first dose of ROTATEQ, orally, 1 vial once, (lot number L047185 and expiration date 17-SEP-2017) (dose and strength were not provided). Concomitant therapies were not provided. On the same date, later in the evening, the patient was taken to a pediatric facility because she presented three episodes of blood in the stool which also appeared tarry. According to the reporter, a health care professional at the facility looked at the stool and saw visible blood. Since that same date, the patient's sleep increased and she presented a temperature of 100.0 F. No treatment was given for the event and no laboratory diagnostic studies were performed; however, the reporting nurse scheduled a follow up appointment for the patient. At the time of reporting, the outcome of the events haematochezia, malaena, body temperature abnormal and hypersomnia was unknown. The reporter did not assess the causality between the reported events and vaccination with ROTATEQ. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous report as received from a consumer (patient's daughter) refers to a 74 year old male patient with high blood pressure, diabetes, heart disease and allergy to sulfa. On 25-APR-2016, the patient was vaccinated with one dose of ZOSTAVAX (route of administration, lot# and expiration date were not reported). Concomitant therapies included DEMADEX, AVAPRO and NORVASC. On 25-APR-2016, after receiving ZOSTAVAX, the patient experienced stroke-like symptoms such as slurred speech, numbness and weakness on one side of the body, and headache. On the same day, the patient was admitted to the hospital. Magnetic resonance imaging (MRI), echocardiogram, electrocardiogram (EKG), unspecified blood work and computerized tomography (CT scan) were performed but no results were provided. The patient received more unspecified blood pressure medications as a treatment. The patient was still in the hospital at the time of reporting. The patient was recovering from the event at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review the event of stroke-like symptoms was considered to be medically significant. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report as received from a consumer (patient's daughter) refers to a 74 year old male patient with high blood pressure, diabetes, heart disease and allergy to sulfa. On 25-APR-2016, the patient was vaccinated with one dose of ZOSTAVAX (route of administration, lot# and expiration date were not reported). Concomitant therapies included DEMADEX, AVAPRO and NORVASC. On 25-APR-2016, after receiving ZOSTAVAX, the patient experienced stroke-like symptoms such as slurred speech, numbness and weakness on one side of the body, and headache. On the same day, the patient was admitted to the hospital. Magnetic resonance imaging (MRI), echocardiogram, electrocardiogram (EKG), unspecified blood work and computerized tomography (CT scan) were performed but no results were provided. The patient received more unspecified blood pressure medications as a treatment. The patient was still in the hospital at the time of reporting. The patient was recovering from the event at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review the event of stroke-like symptoms was considered to be medically significant. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Echocardiogram
Clinical narrative: This spontaneous report as received from a consumer (patient's daughter) refers to a 74 year old male patient with high blood pressure, diabetes, heart disease and allergy to sulfa. On 25-APR-2016, the patient was vaccinated with one dose of ZOSTAVAX (route of administration, lot# and expiration date were not reported). Concomitant therapies included DEMADEX, AVAPRO and NORVASC. On 25-APR-2016, after receiving ZOSTAVAX, the patient experienced stroke-like symptoms such as slurred speech, numbness and weakness on one side of the body, and headache. On the same day, the patient was admitted to the hospital. Magnetic resonance imaging (MRI), echocardiogram, electrocardiogram (EKG), unspecified blood work and computerized tomography (CT scan) were performed but no results were provided. The patient received more unspecified blood pressure medications as a treatment. The patient was still in the hospital at the time of reporting. The patient was recovering from the event at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review the event of stroke-like symptoms was considered to be medically significant. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Electrocardiogram, Headache, Hemiparesis, Hypoaesthesia, Nuclear magnetic resonance imaging
Clinical narrative: This spontaneous report as received from a consumer (patient's daughter) refers to a 74 year old male patient with high blood pressure, diabetes, heart disease and allergy to sulfa. On 25-APR-2016, the patient was vaccinated with one dose of ZOSTAVAX (route of administration, lot# and expiration date were not reported). Concomitant therapies included DEMADEX, AVAPRO and NORVASC. On 25-APR-2016, after receiving ZOSTAVAX, the patient experienced stroke-like symptoms such as slurred speech, numbness and weakness on one side of the body, and headache. On the same day, the patient was admitted to the hospital. Magnetic resonance imaging (MRI), echocardiogram, electrocardiogram (EKG), unspecified blood work and computerized tomography (CT scan) were performed but no results were provided. The patient received more unspecified blood pressure medications as a treatment. The patient was still in the hospital at the time of reporting. The patient was recovering from the event at the time of the report. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review the event of stroke-like symptoms was considered to be medically significant. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersomnia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Burning sensation. Painful to lift arm. TTP in left deltoid.
Age: 62.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Burning sensation, Injection site pain, Pain
Clinical narrative: Burning sensation. Painful to lift arm. TTP in left deltoid.
Age: 1.02
Sex: F
Vaccine: DTAP
Symptoms: Crying, Gait disturbance, Irritability, Peripheral swelling, Pyrexia
Clinical narrative: Fever at 105 degrees, leg swelling (4/30/16), irritable, fussy, dragging leg, crying.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Head injury, Seizure like phenomena, Syncope, Tooth fracture
Clinical narrative: HE FAINTED WHILE IN THE ELEVATOR, STRUCK HIS HEAD, AND SEVERLY CHIPPED BOTH FRONT TEETH. RESEMBLED A SEIZURE.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Neoplasm malignant, Stem cell transplant
Clinical narrative: This spontaneous report was received from a registered nurse regarding a currently 8 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. It was reported that the patient who, received the VARIVAX (Merck) dose 1 on 23-DEC-2008 (reported as 23-DEC-2018), dose 2 on 20-DEC-2011 and M-M-R II dose 1 on 02-OCT-2008 and dose 2 on 20-DEC-2011. Concomitant medications were not reported. On an unknown date the patient developed unspecified cancer. On an unknown date the patient was hospitalized. The patient sought the medical attention. Nurse reported that on an unknown date, 6 months ago approximately in November 2015, the patient received hematopoietic cell transplant as a treatment. The outcome of the event was unknown. Causality assessment was not provided. The reporter considered the event cancer to be life threatening and disabling. Upon internal review the event cancer was determined to be medically significant. Additional information has been requested.
Age: 0.83
Sex: M
Vaccine: HEP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Dehydration, Gastroenteritis viral
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and the patient's mother reporting to a 10 month old male. Medical history and concurrent conditions were not provided. On 08-APR-2016, the patient was vaccinated with a dose of RECOMBIVAX HB lot # L023387, intramuscularly (dose and expiration date were not reported). The patient had no concomitant medication. After the administration of RECOMBIVAX HB approximately in April 2016, the patient developed a stomach bug with dehydration on an unspecified date (also reported as on 22-APR-2016) for which the patient was admitted to the hospital on 22-APR-2016. The patient received unspecified intravenous fluids. Additionally, the patient developed elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels (units and values not provided) that were just above the normal range (on an unspecified date in April 2016). Then, the patient was subsequently discharged from the hospital (in April 2016). The patient was recovering from dehydration, aspartate aminotransferase increased, alanine aminotransferase increased and gastroenteritis viral. Relatedness between the therapy with RECOMBIVAX HB and the events was not reported. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm swelling, redness/pain 3d prior to 2/1/16 visit.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal discomfort, Activities of daily living impaired, Blood test normal, Electrocardiogram normal, Headache
Clinical narrative: Headaches, upset stomach, nausea, vomiting, vision problems, can't sleep. Went to her doc 02/18/2016 got sent to another Dr may have POTS. 03/31 back to primary doctor sent to Neuro and Cardio blood work negative has a stress test and brain MRI scheduled. Having heart palpitations and missing a lot of school and effecting her daily activities.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Insomnia, Nausea, Palpitations, Visual impairment, Vomiting
Clinical narrative: Headaches, upset stomach, nausea, vomiting, vision problems, can't sleep. Went to her doc 02/18/2016 got sent to another Dr may have POTS. 03/31 back to primary doctor sent to Neuro and Cardio blood work negative has a stress test and brain MRI scheduled. Having heart palpitations and missing a lot of school and effecting her daily activities.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 81-year-old female patient. The patient's concurrent conditions included hypertension and heart murmur. On 26-APR-2016, the patient was vaccinated with PNEUMOVAX 23 0.5 ml via intramuscular route, lot # L014420 (dose number, expiration date and vaccination site were not reported). The patient's concomitant therapies included CARDIZEM. On 26-APR-2016, after vaccination with PNEUMOVAX 23, the patient developed redness and swelling down her arm and her breast. The patient visited the physician's office and was treated with MEDROL. The patient was going to visit the physician on the day of the report. The outcome of the events was not reported. The causality assessment between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Pt was given Hep A peds 1 ml by mistake - he was to get Hep B 1 ml.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with an improperly stored (Oka/Merck) VARIVAX (therapy type: digital data logger). No adverse effects were reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. The vaccine for stored at -14 Celsius for an unspecified time and data logger was involved. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored GARDASIL 9 (lot # L045711, expiration date 18-MAY-2017: dose, route and dose number were not reported; temperature/time frame: 49.1 Fahrenheit / 4 hours and 30 minutes; therapy type: Digital Data Logger; previous temperature excursion: 65.2 Fahrenheit for 8 hours and 15 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored VAQTA (lot # L026600, expiration date 15-MAR-2017; dose, route and dose number were not reported; temperature/time frame: 49.1 Fahrenheit / 4 hours and 30 minutes; therapy type: Digital Data Logger; previous temperature excursion: 65.2 Fahrenheit for 8 hours and 15 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L044694, expiration date 04-FEB-2018; dose, route and dose number were not reported; temperature/time frame: 49.1 Fahrenheit/4 hours and 30 minutes; therapy type: Digital Data Logger; previous temperature excursion: 65.2 Fahrenheit for 8 hours and 15 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patient were vaccinated with improperly stored GARDASIL (lot # K06966, expiration date 10-MAY_2017; dose, route and dose number were not reported; temperature/time frame: 49.1 Fahrenheit / 4 hours and 30 minutes; therapy type: Digital Data Logger; previous temperature excursion: 65.2 Fahrenheit for 8 hours and 15 minutes. No adverse effect was reported. This is one of 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: Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored oral ROTATEQ (lot# reported as M002254, expiration date 15-NOV-2017; dose and dose number were not reported; temperature/time frame: 49.1 Fahrenheit/4 hours and 30 minutes; therapy type: Digital Data Logger; previous temperature excursion: 65.2 Fahrenheit for 8 hours and 15 minutes) orally. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue, Insomnia
Clinical narrative: This spontaneous report as received from a physician refers to a 68 year old male patient. The patient did not have any pertinent medical history or drug reactions or allergies. On an unknown date approximately in February 2015 (also reported as approximately 14 months back) the patient was vaccinated with first dose of ZOSTAVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) for shingles prevention. The patient was not taking any medications concomitantly. The physician stated that the patient did not experience any adverse events following the first dose. On 13-APR-2016 the patient was inadvertently vaccinated with second dose of ZOSTAVAX (lot # L015414 and expiry date 01-AUG-2016) (dosing regimen and frequency unknown) for shingles prevention. On an unknown date approximately in April 2016 (after the administration of the second dose) the patient experienced fatigue and insomnia. It was reported that the patient sought medical attention and called the physician. No lab diagnostics studies were performed. No treatment was given for the events. The action taken with the therapy with ZOSTAVAX was unknown. The outcome of fatigue and insomnia was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Herpes zoster, Impetigo, Rash
Clinical narrative: This spontaneous report as received from a physician, pharmacist and health professional, refers to a 2 year old male patient with allergy to dogs and cats but no food allergies. On 26-MAR-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # K009757, expiration date 09-JUL-2016) 0.5 ml in the right thigh. None concomitant therapy or medical history were reported. On 02-APR-2016, the patient was presented with 3 or 4 pimples on the left side, on the front left abdomen area extending into the upper groin area above the pubic area. The rash extended to the back on the left side only. The patient was afebrile. Only pain as other systemic symptoms was reported. On the same day, 02-APR-2016, the patient was seen in the office by a physician. On 04-APR-2016, the patient had grew quarter size, raised bumps like a rash/burn. On 05-APR-2016, the patient was seen again at the office with vesicles on the rash and the patient was diagnosed with shingles. The patient was placed on ZOVIRAX 200mg/5ml with dose of 6 ml PO four times per day (5 day treatment). On 08-APR-2016, the rash had progressed to an "iron size rash" and "it was now had expanded from left side of belly to his left rear end cheek". The rash did not occur at the site of injection. The patient had numerous to count rash, grouped vesicles, erythematous base and the patient was seen again to another primary doctor and ZOVIRAX dose was changed to 4.5ml PO, 5 times per day (another round of 5 day treatment). On 14-APR-2016, the patient was seen in the office by physician and a specimen was collected to send to the Varicella Zoster Virus Identification Program (VZVIP) for polymerase chain reaction (PCR) testing. The patient was also diagnosed with impetigo at this time and placed on an antibiotics as KEFLEX 250/5ml PO, 3.5ml twice daily for 10 days and BACTROBAN 2% topical ointment: 1 application 3x daily for 10 days. At the time of report, the patient was not recovered at this time and no follow-up was planned. The relatedness between vaccination of VARIVAX (Merck) and shingles and impetigo was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, 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 medical history or concurrent condition were not provided. On 17-FEB-2016 the patient was vaccinated with an expired dose of MMR II (batch/lot # K001997, expired date as 10-FEB-2016, rHA (recombinant human albumin), dose and route were unspecified). No adverse effect was reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site papule, Injection site reaction, Injection site warmth
Clinical narrative: Arm is red, blotchy, warm at site of immunization starting yesterday. Tenderness/soreness was since shot was given. Right upper arm - multiple raised erythematous areas with one central red papule, very warm to touch, tender to palpation.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Rash macular, Tenderness
Clinical narrative: Arm is red, blotchy, warm at site of immunization starting yesterday. Tenderness/soreness was since shot was given. Right upper arm - multiple raised erythematous areas with one central red papule, very warm to touch, tender to palpation.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Swelling
Clinical narrative: Localized reaction to patients Right arm. Patient has slight redness and swelling. Patient stated itchiness to affected area.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with improperly stored PROQUAD (Merck) (therapy type: digital data logger). No adverse effects were reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). The vaccine for stored at -14 Celsius for an unspecified time and data logger was involved. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Full blood count, Injection site rash, Nausea, Pyrexia
Clinical narrative: Rash developed around injection site, fever as high as 102 degrees, rash developed all over body as well, chills, nausea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash generalised
Clinical narrative: Rash developed around injection site, fever as high as 102 degrees, rash developed all over body as well, chills, nausea.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Within 10 minutes pt had slight redness and itching. She was given oral BENADRYL 25 mg tablet. I called pt 2 hours later and she felt somewhat better. She complained of more swelling/itching. Eventually went to ER and got a steroid shot on 4/30/16.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were mistakenly vaccinated with the second dose of ZOSTAVAX (lot #, expiration date, exact dose and route of administration were not reported). This was outside the recommendations per the ZOSTAVAX prescribing information. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). The reporter stated that the vaccines reached a temperature of -11 Celsius degrees for an unspecified amount of time (dates were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/ allergies and concomitant therapy were unspecified. On an unknown date in April 2016 (reported as on or after 06-APR-2016), the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L040422, expiry date: 15-OCT-2017). Nurse reported that the vaccine underwent temperature excursion at -10.2 degree Celsius for a duration of 15 hours, 37 minutes and 30 seconds. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 19-APR-2016, the patient was vaccinated with an expired dose of VARIVAX (Merck) lot # K005426, expiration date reported as 15-APR-2016 (dose, route and site of administration were not reported). Concomitant medication were not reported. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received registered nurse regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II (lot # L040960, expiry date 16-OCT-2017) dosing details and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of 10.5 degree C for a time frame of 2 hours and 33 minutes. It was reported that there was no previous temperature excursions. No other symptoms reported. Product quality complaint (PQC) was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received registered nurse regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB (therapy type digital data logger) (lot # L051124, expiry date 14-OCT-2018) dosing details and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of 10.5 degrees C for a time frame of 2 hours and 33 minutes. It was reported that there were no previous temperature excursions. No other symptoms reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received registered nurse regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (therapy type digital data logger) (lot # L040459, expiry date 06-APR-2017) dosing details and route unknown. Concomitant medications were not reported. The vaccines were subjected to temperature excursion of 10.5 degrees C for a time frame of 2 hours and 33 minutes. It was reported that there were no previous temperature excursions. No other symptoms reported. Product quality complaint was not filed. This is one of the four reports received from the same reporter. Additional information has been requested.