chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site discomfort, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: 1-2 days following injection a rash at site of injection noted. No discomfort. Rash resolved within 24 hrs. 3 wks at one day later redness, swelling and discomfort at site of injection (about 50 cent piece size in redness and spot in center appeared swollen (seen by phone picture).
Age: 12.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Erythema, Infection, Oedema peripheral, Skin reaction, Tenderness
Clinical narrative: Ck TDAP reaction. Here for swelling and redness in (R) arm after TDAP shot Weds. He is feeling well otherwise. He notes some tenderness in (R) axillary nodes. He denies any respiratory or airway sx. Patient denies any fever, lightheadedness, confusion, chills, or malaise. Feeling generally well. Local skin reaction V infection. Favor former. Discussed monitoring. MOC and pt to monitor for expansion of lesion. Lower border inked at encounter. F/U immediately (or ER d/o severity) if fever, respiratory sx or other concerning sx develop.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at reaction site. Diameter was about 4. Gave BENADRYL cleared up in 3 days.
Age: 16.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Received MENACTRA and GARDASIL. 5 min. later passed out for "10 seconds" per dad.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Blindness transient, Cold sweat, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Cold/clammy to touch, dizziness, fatigue, difficulty breathing, temporary vision loss. Treatment: Epipen done to right thigh w/in 2 minutes of patient symptoms.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 5/22/13 noticed large baseball sized area on left thigh red, hot to touch. Painful, treated with Clinda r/o cellulitis on 5/23/13 mom took her to hospital. Admitted for 23 hr obs. Sent home diagnosis - Normal reaction to vaccines. Stopped Clinda no cellulitis.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, CSF culture negative, Chest X-ray normal, Electroencephalogram normal, Gaze palsy
Clinical narrative: 3 episodes of eye rolling and unresponsiveness in 1st 24 hours after vaccine.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Herpes simplex serology negative, Polymerase chain reaction, Unresponsive to stimuli, Viral test negative
Clinical narrative: 3 episodes of eye rolling and unresponsiveness in 1st 24 hours after vaccine.
Age: 49.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Blood culture, Chest discomfort, Chills, Neutrophil count decreased, Positron emission tomogram
Clinical narrative: Developed 12 hours after vaccine administration. First chest discomfort, then with fever to 103 with rigors. Admitted to Hospital, cultures drawn and IV antibiotics administers and fever came down slowly over first 36 hours. Discharged on oral antibiotics.
Age: 49.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Positron emission tomogram normal, Pyrexia
Clinical narrative: Developed 12 hours after vaccine administration. First chest discomfort, then with fever to 103 with rigors. Admitted to Hospital, cultures drawn and IV antibiotics administers and fever came down slowly over first 36 hours. Discharged on oral antibiotics.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Within about 24 hours of vaccines, child had redness, swelling and approximately 14cm knot to left thigh.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Apnoea, Chest X-ray, Computerised tomogram head, Cyanosis, Electroencephalogram
Clinical narrative: Patient presented with apnea and respiratory distress accompanied by cyanosis. Prior to episode patient had a period of staring with hand shaking. Patient had 3 episodes of apnea at home night of event. Patient had run low grade fever immediately following vaccines.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Laboratory test, Pyrexia, Respiratory distress, Staring
Clinical narrative: Patient presented with apnea and respiratory distress accompanied by cyanosis. Prior to episode patient had a period of staring with hand shaking. Patient had 3 episodes of apnea at home night of event. Patient had run low grade fever immediately following vaccines.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Tremor
Clinical narrative: Patient presented with apnea and respiratory distress accompanied by cyanosis. Prior to episode patient had a period of staring with hand shaking. Patient had 3 episodes of apnea at home night of event. Patient had run low grade fever immediately following vaccines.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Dehydration, Diarrhoea, Faeces discoloured, Infantile spitting up
Clinical narrative: Child ran fever of 101-102 F and became lethargic. Mom called MD, advised to call back if fever continues. Diarrhea started on 5/17, looser than normal then turned green with over 12 diarrhea diapers in 24 hours. Child went to MD on 5/23, dx'd with dehydration, to continue breastfeeding and Pedialyte. Went to ER on 5/24, was given IV fluids. Blood collected for testing, staff unable to get a stool specimen for testing. Mom returning to MD today, 5/28/13. Mom said child has no hx of spitting up but is now doing so.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lethargy, Pyrexia
Clinical narrative: Child ran fever of 101-102 F and became lethargic. Mom called MD, advised to call back if fever continues. Diarrhea started on 5/17, looser than normal then turned green with over 12 diarrhea diapers in 24 hours. Child went to MD on 5/23, dx'd with dehydration, to continue breastfeeding and Pedialyte. Went to ER on 5/24, was given IV fluids. Blood collected for testing, staff unable to get a stool specimen for testing. Mom returning to MD today, 5/28/13. Mom said child has no hx of spitting up but is now doing so.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Swelling and rash at site.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of left thigh injection site.
Age: 51.0
Sex: F
Vaccine: HEPAB, MMR, TD, VARCEL
Symptoms: Contusion, Excoriation, Haemorrhage, Injection site discharge, Pain in extremity
Clinical narrative: Right lower arm became very sore and was oozing blood and clear fluid from injection site. Area appears bruised and excoriated-not warm to the touch, but remains sore. Area measures 1&1/4" long and 1&1/4" wide. Patient applied ice packs and too Acetaminophen for pain. It has been 2 months since receiving vaccine and area is not improving, though there has been no more drainage. Patient instructed to see MD to have area evaluated.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Mobility decreased, Pain
Clinical narrative: Pain, limited mobility in arm. Went to urgent care. Was told not to get the second MMR shot.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Flushing, Immediate post-injection reaction, Injection site reaction, Multiple sclerosis
Clinical narrative: Immediately flush, breathing rapid. Feeling of shock when you touch live electric wire's injection site throughout body.  Felt like passing out, nearly did.  Got laid down in Nurses office.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia, Respiratory rate increased
Clinical narrative: Immediately flush, breathing rapid. Feeling of shock when you touch live electric wire's injection site throughout body.  Felt like passing out, nearly did.  Got laid down in Nurses office.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt presented to emergency room for pain, redness and swelling in L deltoid.
Age: 46.0
Sex: F
Vaccine: HEPAB
Symptoms: Blister, Rash generalised
Clinical narrative: Pt had rash/blisters throughout her body on her arms and legs.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: MEDICATION INJECTED IN GLUTEAL REGION INSTEAD OF DELTOID. NO REACTIONS REPORTED PER PATIENT.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Headache, Myalgia, Rash
Clinical narrative: Developed a period of dizziness 30 mins after recieving MMR vaccine, later in the evening started to develop a rash. 4 days later, had muscle pain and a headache. Took 650mg of Tylenol.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Expired drug administered
Clinical narrative: Child got Pentacel which was expired.
Age: 43.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema
Clinical narrative: Patient was seen in ED for RLE burn from exhaust on 5/25/13.  Tetanus vaccine was given.  Redness noted to the injection site after vaccination. Patient was discharged home.  The redness worsened at home and the patient returned to ED on 5/27/13.  Patient was seen and discharged home on Keflex and Motrin.
Age: 55.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Lymphadenopathy, Swelling
Clinical narrative: Redness, warmth, swelling, lymph node enlargement in axillae.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Large red rash; itching and burning at injection site.
Age: 13.0
Sex: F
Vaccine: YF
Symptoms: Abdominal discomfort, Dizziness postural, Loss of consciousness, Nausea, Rash
Clinical narrative: Pt received the yellow fever vaccine at around 1:30PM. Approximately 10 minutes later, she stated she was feeling nauseous and dizzy while standing. She then lost consciousness and was laid back on the floor, feet raised in a chair. She regained consciousness within 15-20 seconds. Her blood pressure was 120/80. There was a slight rash on her arms and stomach that went away after several minutes and she denied itching. After 20 minutes of having received vaccine, pt stated stomach was feeling better and color returned.
Age: 1.4
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Agitation, Rash
Clinical narrative: 5-28-13: Child received her second dose of HIB and her second dose of PCV13 vaccine at 1240 today. No reactions were noted during the 15 minute waiting period after vaccine administration. At 4:50pm, the parents called to report patient had "spots" on her feet. We advised them to return to our office for evaluation. At 1655 our regional manager was contacted via phone to be notified of the situation. Upon visual exam, at 1710 today, we noted white circular raised areas to her bilateral feet, left knee, left arm and right wrist. No "spots" were noted to her right knee, trunk (stomach or back), neck, face or behind her ears. We attempted to obtain a blood pressure and pulse but were unsuccessful due to child being uncooperative. Her respirations were 21 breaths per minute. She does not appear to be in any acute distress. Her parents agree that she is acting "normal" aside from becoming agitated upon re-entering our office building. Her parents state the child ate salmon, shrimp, rice and celery today. None of these were new foods for her. They deny giving her any medications today. The last time she received medications was antibiotics in early March. They report the child went directly home and to bed after leaving our office. Her bed is a mattress placed on the floor. At 1740, regional manager was contacted for updates. We attempted to take the child's temperature but the father refused stating he did not want to upset the child. We recommended they take the child to the doctor and facility of their choosing for further evaluation if they desire. They voiced understanding and verbalized they would take the child home and monitor for the time being. We discussed signs of respiratory and/or cardiac distress and signs of illness of when to seek further medical care. After being present in our office tonight for this evaluation, the parents noted at 1800 that the "spots" on her feet had disappeared. Upon re-examination, we noted that the white circulare raised areas to her bilateral feet, left knee and left arm were gone. We noted that the white circular raised areas to her right wrist was still present.  We plan to contact Dr. by phone tomorrow morning with parent's written consent to inform him of this situation. We will also contact patient's parents tomorrow for follow up.
Age: 17.0
Sex: F
Vaccine: HEPA, HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL and other 18 children received PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 17 years old, female patient with no pertinent medical history reported. On 21-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Other suspect therapies included PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). Concomitant medications included Hep A vaccine (manufacturer unknown) administered on 21-AUG-2012 (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 1.47
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Pt. developed generalized erythematous rash with hives and had low grade fever (100 degrees F).
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 79 year old female patient. On 20-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot# unspecified), intramuscular. The patient "currently" had soreness at the injection site as well as a red hard bump that looked like a mosquito bite at the injection site. The outcome of soreness the events was reported as not recovered. The patient had sought medical attention via calling the pharmacy. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. In approximately July 2012 the patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and indication were not reported). On 22-MAY-2013 the patient was vaccinated with the second dose of GARDASIL (lot number, dose, route and indication were not reported) 10 months after she received the first dose of GARDASIL. No adverse event reported. The outcome and action taken were not provided. It was unspecified if the patient sought any medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 14-APR-2013 the patient was vaccinated with a dose of RECOMBIVAX HB lot # reported a 0231AA, expiration 02-NOV-2014 (dose and route unknown). The healthcare worker reported that RECOMBIVAX HB had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 26-APR-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JAN-2015 and a dose of RECOMBIVAX HB lot # reported as 0231AA, expiration 02-NOV-2014 (dose and route unknown for both vaccines). The medical assistant reported that VAQTA and RECOMBIVAX HB had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 06-MAY-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot #0628AE, expiration 26-JAN-2015 and a dose of RECOMBIVAX HB lot # reported as 0231AA, expiration 02-NOV-2014 (dose and route unknown for both vaccines). The Healthcare worker reported that VAQTA and RECOMIVAX HB had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursion was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 14-MAY-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JUN-2015 (dose and route unknown). The Healthcare worker reported that VAQTA had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 24-APR-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JAN-2015 (dose and route unknown). The Healthcare worker reported that VAQTA had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning a female patient of unknown age. Approximately on 24-MAY-2012 (reported as exactly one year ago), the patient was vaccinated with the first dose of 0.5 milliliter (ml) of GARDASIL (lot number and expiry date unspecified), intramuscularly. On 23-MAY-2013, the patient was vaccinated with the second dose of 0.5 ml of GARDASIL (lot number and expiry date unspecified), intramuscularly. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Erythema, Feeling hot, Injection site pain, Mobility decreased
Clinical narrative: This spontaneous report was received from an approximately 71 year old female patient with no pertinent medical history. Current condition of the patient included codeine allergy. On 19-JUN-2012, the patient, was vaccinated with dose 1 of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) without any symptoms. On 20-MAY-2013, the patient was vaccinated with dose 2 of PNEUMOVAX23 (lot number and expiry date reported as H017759 and 04-JUL-2014 respectively, dose and route unspecified) in the left arm. Concomitant medication included blood pressure medicine (unspecifie). Approximately on 20-MAY-2013, the patient reported that it was extremely hurtful going in with a warm tingling sensation. Within 3 hours hour, arm began to turn beet red and swell. Within the next 24 hours she had severe muscle aches, could barely life her arm. She was drowsy, severe arm pain from elbow to neck, stiff neck, felt feverish, total discomfort, restlessness. It was painful to walk or move. The patient sought medical attention (called the doctor) and she was prescribed with cold compress and ADVIL (dose and manufacturer unspecified). Routine blood work was performed prior to the injection on the same day (20-MAY-20130 and the result was unknown. The patient was recovering from all the events at the time of reporting. The relatedness for all the events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Neck pain, Oedema peripheral, Pain, Paraesthesia
Clinical narrative: This spontaneous report was received from an approximately 71 year old female patient with no pertinent medical history. Current condition of the patient included codeine allergy. On 19-JUN-2012, the patient, was vaccinated with dose 1 of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) without any symptoms. On 20-MAY-2013, the patient was vaccinated with dose 2 of PNEUMOVAX23 (lot number and expiry date reported as H017759 and 04-JUL-2014 respectively, dose and route unspecified) in the left arm. Concomitant medication included blood pressure medicine (unspecifie). Approximately on 20-MAY-2013, the patient reported that it was extremely hurtful going in with a warm tingling sensation. Within 3 hours hour, arm began to turn beet red and swell. Within the next 24 hours she had severe muscle aches, could barely life her arm. She was drowsy, severe arm pain from elbow to neck, stiff neck, felt feverish, total discomfort, restlessness. It was painful to walk or move. The patient sought medical attention (called the doctor) and she was prescribed with cold compress and ADVIL (dose and manufacturer unspecified). Routine blood work was performed prior to the injection on the same day (20-MAY-20130 and the result was unknown. The patient was recovering from all the events at the time of reporting. The relatedness for all the events was unknown for PNEUMOVAX23. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Restlessness, Somnolence
Clinical narrative: This spontaneous report was received from an approximately 71 year old female patient with no pertinent medical history. Current condition of the patient included codeine allergy. On 19-JUN-2012, the patient, was vaccinated with dose 1 of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) without any symptoms. On 20-MAY-2013, the patient was vaccinated with dose 2 of PNEUMOVAX23 (lot number and expiry date reported as H017759 and 04-JUL-2014 respectively, dose and route unspecified) in the left arm. Concomitant medication included blood pressure medicine (unspecifie). Approximately on 20-MAY-2013, the patient reported that it was extremely hurtful going in with a warm tingling sensation. Within 3 hours hour, arm began to turn beet red and swell. Within the next 24 hours she had severe muscle aches, could barely life her arm. She was drowsy, severe arm pain from elbow to neck, stiff neck, felt feverish, total discomfort, restlessness. It was painful to walk or move. The patient sought medical attention (called the doctor) and she was prescribed with cold compress and ADVIL (dose and manufacturer unspecified). Routine blood work was performed prior to the injection on the same day (20-MAY-20130 and the result was unknown. The patient was recovering from all the events at the time of reporting. The relatedness for all the events was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 17-MAY-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JAN-2015 (dose and route unknown). The Healthcare worker reported that VAQTA had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 14-MAY-2013 the patient was vaccinated with a dose of VAQTA 50/1.0 U/ML lot # 0628AE, expiration 26-JAN-2015 and a dose of RECOMBIVAX HB lot # reported as 0231AA, expiration 02-NOV-2014 (dose and route unknown for both vaccines). The Healthcare worker reported that VAQTA and RECOMBIVAX HB had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 14-MAY-2013 the patient was vaccinated with a dose of RECOMBIVAX HB lot # reported as 0231AA, expiration 02-NOV-2014 (dose and route unknown). The Healthcare worker reported that RECOMBIVAX HB had multiple excursions from 20-FEB-2013 to 13-MAY-2013. The lowest temperature the vaccines reached was 24F. The total time of hours for the excursions was 253 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Acne, Musculoskeletal stiffness, Neck pain
Clinical narrative: Noticed pimply type of rash on neck and back. Neck seemed stiff and sore after the shot.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Grunting, Nasal flaring, Pyrexia, Respiratory rate increased
Clinical narrative: Developed fever to 103 and had reported increased respiratory rate, grunting and nasal flaring. No hypoxia.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented with red raised, hot areas on both arms at injection sites. Stated it like burning. Pt placed on AUGMENTIN 500/125 BID x 10 days.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Eye movement disorder, Pyrexia
Clinical narrative: Fever. Pt seen less than 1 hr ago, per mom pt's eyes rolled to the back of his head, for about 4 min in the car.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Throat tightness, Urticaria
Clinical narrative: Area of injection was red and itchy 2/4/13 she was seen in the ER and reported throat tightness but no difficulty breathing. She had urticarial rash and was treated with 5 day steroid burst. 2/5/13 no symptoms except local redness they held additional steroids. Was seen by allergist w/ prolonged urticaria to vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Eyelids pruritus, Headache, Pruritus
Clinical narrative: Headache 5-22-2013 till present. Dizziness 5-22-2013 till present. Chills 5-22-2013 evening only. Itching around neck 5-22-2013 to 5-25-2013. Itching around eyes and mattering till present.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture, Injection site abscess
Clinical narrative: Abscess at site of injection (left thigh).
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Influenza like illness, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: The weekend after felt flu like symptoms tenderness at the site, burning sensation down side of torso and arm pit, shoulder pain radiating to neck. Pain gets sharper bit localized on neck area only.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Local swelling
Clinical narrative: 14 hours later, 2 inches cm red and swelling.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Chicken pox type rash on legs and arms. Started 5/24/13, still experieincing 5/28/13 using BENADRYL and calamine lotion.
Age: 40.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Vomiting, nausea, diarrhea after 2nd dose.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). Certified medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 17 years old, female patient with no pertinent medical history reported. On 21-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 20-FEB-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 15 years old, male patient with no pertinent medical history reported. On 29-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified nurse practitioner, refers to two patients of unknown age and gender. The nurse practitioner reported that the patients received their first dose of RECOMBIVAX HB on an unspecified date in October 2012 and would be receiving their second dose on an unspecified date in the near future. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant concerning a male patient of unknown age who on 23-MAY-2013 was vaccinated with an expired dose of VARIVAX (Merck), SQ, lot # 669845/0345AA, exp date 07-MAR-2013 (dose and site not provided). No adverse effect was reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 16 years old, male patient with no pertinent medical history reported. On 29-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 14-NOV-2012 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 31-DEC-2012 the patient received the third dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, indication, route and lot number were not reported) instead of VARIVAX (Merck). No concomitant medications were reported. No symptoms reported. The outcome of the patient at the moment of the report was not reported. Additional information has been reported.
Age: 12.0
Sex: M
Vaccine: HEPA, HIBV, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL and other 18 children received PEDVAXHIB. Follow up information has been received from the certified medical assistant regarding a 12 years old, male patient with no pertinent medical history reported. On 14-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included the first dose of PEDVAXHIB (lot number and expiration date not reported) administered on 14-NOV-2012 (intramuscular on the left arm, dose not reported). Concomitant therapies included the second dose of Hep A vaccine (manufacturer unknown) (intramuscular on the right arm, second dose) on 14-NOV-2012. It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 year old, male patient with no pertinent medical history reported. On 18-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On an unknown date the patient received the another dose of GARDASIL (lot number and expiration date not reported) (route and dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a pharmacist refers to an unspecified number of female patients of unknown age. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date and route was not reported) when pregnant. No symptoms reported and no adverse foetal outcomes reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported) and LIQUID PEDVAXHIB (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL and other 18 children received LIQUID PEDVAXHIB. Follow up information has been received from the medical assistant regarding a 13 years old, male patient with no pertinent medical history reported. On 07-DEC-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). Other suspect therapies included LIQUID PEDVAXHIB (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 15-MAR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: DTAP, HPV4, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from an office staff member who is also the vaccine coordinator and the administrator of the vaccine for the patients, who reported that on an unspecified date in 2013 (within the last 30 days), an adverse reaction occurred for 2 males patients and 2 female patients (ages ranged from 18 months old to 21 years old), that received a doses of VARIVAX (Merck) subcutaneously, "standard dose" (exact doses not reported), for prevention of VARICELLA. Each of the 4 patients were given the VARIVAX (Merck) from one of two lots: lot # H017243 (Exp: 17-SEP-2014) and lot # H018791 (Exp: 15-OCT-2014). Also it has been reported that one of the patient received the VARIVAX (Merck) with MMR II (dose, route and lot # not reported) at separate injection sites; one patient received the VARIVAX (Merck) with MMR II (dose, route and lot # not reported), and diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid vaccine (injection sites unspecified); one patient received the VARIVAX (Merck) with INFANRIX (injection sites unspecified); one patient received the VARIVAX (Merck) with GARDASIL (dose, route, site and lot # not reported). The reporter stated that within 2-3 days of injection, all of these patients developed red, hot, itchy, sore, areas around their injection site after receiving the vaccine. "Some" of the patients also developed blistering areas that were raised and one of the patients had also developed a 101 degree fever. Two above mentioned lots of VARIVAX (Merck) have been pulled from use at the office. These were all "VFC doses". The physician was also told to pull the diluents used for administration, however the diluents had already been depleted. All patients were given BENADRYL and 2 also received an unspecified antibiotic. At the time of the report the outcome of the events was unknown. The patients sought medical attention - they talked with doctor. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDSIL. Follow up information has been received from the certified medical assistant regarding an unknown age (previously reported as child), male patient with no pertinent medical history reported. On 23-JAN-2013 the patient was vaccinated with GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). Certified Medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 27-AUG-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (route, anatomical location and dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age and gender (previously reported as child), patient with no pertinent medical history reported. On 21-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 14 years old, male patient with no pertinent medical history reported. On 18-FEB-2013 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular, dose not reported). On an unspecified date the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding a 13 year old, female patient with no pertinent medical history reported. On 31-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 04-MAR-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to three unspecified patients of unknown age. Within the "last month or so", approximately in April 2013, the patients were vaccinated with a dose of PNEUMOVAX23 lot number H022062, expiring 28-FEB-2014 (dose and route not provided). On unspecified dates, in 2013, the patients experienced chills, fever and swelling at injection site after receiving the vaccine. The outcome of swelling at injection site, fever and chills was unknown. The causal relationship was not provided. Additional information has been requested.