chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Poikilocytosis, Proctalgia, Pyrexia, Red blood cell anisocytes present, Red blood cell count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Red blood cell hypochromic morphology present, Red blood cell macrocytes present, Red blood cell nucleated morphology present, Red blood cell poikilocytes present, Red cell distribution width increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tearfulness, White blood cell count increased, White blood cell disorder
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old female with no previous illness was vaccinated intramuscularly with a third dose of GARDASIL (lot # 662404/0312Y) on 30-DEC-2009. The patient was diagnosed with acute lymphocytic leukaemia (ALL) on 31-DEC-2009. The following information was obtained through follow-up: On 15-JUN-2011, hospital records and discharge summary were received: Service dates 31-DEC-2009 to 31-JAN-2010. Diagnosis: Patient presented with 1 month general weakness, pallor, petechial rash. Decreased appetite. Hematological studies consistent with pre-B-cell acute lymphocytic leukaemia. The patient was admitted to the pediatric intensive care unit. Patient had transfusion packed RBC's. Nasal congestion, fever, constipation. Induction chemotherapy. Steroid induced hyperglycaemia. Tongue pain, rectal pain. Patient was tearful and upset. The following labs and diagnostics were performed: CBC - WBC >300.000x10*9 (H), RBC 2.40x10*9 (L), HGB 6.7 (L), HCT 20.1% (L), RDW 18% (H), PLT 24x10*9 (L), Neut 4% (L), Mono 1% (L), Myelocytes 1% (H), Atypical lymph 8% (H), WBC smudge cells seen, Anisocytosis, Poikilocytosis, Hypochrmia, Macrocytes, nucleated RBCs; CHEM - glucose 389 (H), potassium 2.7 (L), phosphorus 5.8 (H), uric acid 11.2 (H), LD 886 (H). The patient was discharged to follow-up with oncology clinic. At the time of the report, the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization, extended hospital stay and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 425321. A standard lot check lot check investigation has been finalized. All in-process quality checks for the lot number 662404/0312Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Completed suicide, Death
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 28-APR-2011, a 18 year old female patient with chronic depression, attention deficit/hyperactivity disorder and severe acne was vaccinated IM in the left arm with the first dose of GARDASIL (lot number 666948/0886Z) and with a dose of VARIVAX (Merck) (lot number 668976/1492Z) given IM in the right arm. Concomitant therapy included ORTHO-CYCLEN. It was reported that there was no known symptom. The patient denied suicidal ideation at visit on 26-APR-2011. The patient had a known chronic depression and she elected to stop her medications when she turned 18. The patient committed suicide on 28-APR-2011. The patient hung herself. The following information was obtained through follow up and/or provided by the government. The autopsy report was received. The cause of death (COD) was attributed to asphyxia due to hanging by ligature with : ligature mark of neck; hemorrhage in left cricothyroid muscle and at base of left thyroid cornu and fractures of right and left sides of hyoid bone. The report revealed that the patient made statement of intent to hurt/kill themselves. The patient was found by the police hanging from deck. No laboratory tests were performed. The listing indicated that one or more of the events resulted in death. The original reporting source was not provided. The VAERS ID # 425513. A lot check has been initiated. A standard lot check investigation for VARIVAX (Merck) (lot number 668976/1492Z) has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Asphyxia, Autopsy, Completed suicide, Death, Fracture
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 28-APR-2011, a 18 year old female patient with chronic depression, attention deficit/hyperactivity disorder and severe acne was vaccinated IM in the left arm with the first dose of GARDASIL (lot number 666948/0886Z) and with a dose of VARIVAX (Merck) (lot number 668976/1492Z) given IM in the right arm. Concomitant therapy included ORTHO-CYCLEN. It was reported that there was no known symptom. The patient denied suicidal ideation at visit on 26-APR-2011. The patient had a known chronic depression and she elected to stop her medications when she turned 18. The patient committed suicide on 28-APR-2011. The patient hung herself. The following information was obtained through follow up and/or provided by the government. The autopsy report was received. The cause of death (COD) was attributed to asphyxia due to hanging by ligature with : ligature mark of neck; hemorrhage in left cricothyroid muscle and at base of left thyroid cornu and fractures of right and left sides of hyoid bone. The report revealed that the patient made statement of intent to hurt/kill themselves. The patient was found by the police hanging from deck. No laboratory tests were performed. The listing indicated that one or more of the events resulted in death. The original reporting source was not provided. The VAERS ID # 425513. A lot check has been initiated. A standard lot check investigation for VARIVAX (Merck) (lot number 668976/1492Z) has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Muscle haemorrhage, Pharyngeal haemorrhage, Self-injurious ideation, Suicidal ideation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 28-APR-2011, a 18 year old female patient with chronic depression, attention deficit/hyperactivity disorder and severe acne was vaccinated IM in the left arm with the first dose of GARDASIL (lot number 666948/0886Z) and with a dose of VARIVAX (Merck) (lot number 668976/1492Z) given IM in the right arm. Concomitant therapy included ORTHO-CYCLEN. It was reported that there was no known symptom. The patient denied suicidal ideation at visit on 26-APR-2011. The patient had a known chronic depression and she elected to stop her medications when she turned 18. The patient committed suicide on 28-APR-2011. The patient hung herself. The following information was obtained through follow up and/or provided by the government. The autopsy report was received. The cause of death (COD) was attributed to asphyxia due to hanging by ligature with : ligature mark of neck; hemorrhage in left cricothyroid muscle and at base of left thyroid cornu and fractures of right and left sides of hyoid bone. The report revealed that the patient made statement of intent to hurt/kill themselves. The patient was found by the police hanging from deck. No laboratory tests were performed. The listing indicated that one or more of the events resulted in death. The original reporting source was not provided. The VAERS ID # 425513. A lot check has been initiated. A standard lot check investigation for VARIVAX (Merck) (lot number 668976/1492Z) has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Ataxia, Back pain, CSF culture, Computerised tomogram head
Clinical narrative: Initial report was received via the company's corporate website on 13 August 2011 from a consumer, who is also the patient. A 44-year-old female patient who had no reported concurrent illness, past medical history or concomitant medication usage, had received an intramuscular injection of FLUZONE, lot number U3572DA on 21 October 2010 (site not reported) and two days later, she experienced tremors, involuntary movements, generalized weakness, back and head pain, urinary incontinence, sensory problems and uncoordinated movement. The patient was hospitalized and had been evaluated by several neurologists. After many treatments and studies, she received a final "diagnostic" of myopathy. The patient had not received any other vaccines within four weeks of receiving FLUZONE. Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Coordination abnormal, Dyskinesia, Electrocardiogram, Electroencephalogram, Electromyogram
Clinical narrative: Initial report was received via the company's corporate website on 13 August 2011 from a consumer, who is also the patient. A 44-year-old female patient who had no reported concurrent illness, past medical history or concomitant medication usage, had received an intramuscular injection of FLUZONE, lot number U3572DA on 21 October 2010 (site not reported) and two days later, she experienced tremors, involuntary movements, generalized weakness, back and head pain, urinary incontinence, sensory problems and uncoordinated movement. The patient was hospitalized and had been evaluated by several neurologists. After many treatments and studies, she received a final "diagnostic" of myopathy. The patient had not received any other vaccines within four weeks of receiving FLUZONE. Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electrophoresis protein, Encephalomyelitis, Guillain-Barre syndrome, Headache, Herpes simplex serology
Clinical narrative: Initial report was received via the company's corporate website on 13 August 2011 from a consumer, who is also the patient. A 44-year-old female patient who had no reported concurrent illness, past medical history or concomitant medication usage, had received an intramuscular injection of FLUZONE, lot number U3572DA on 21 October 2010 (site not reported) and two days later, she experienced tremors, involuntary movements, generalized weakness, back and head pain, urinary incontinence, sensory problems and uncoordinated movement. The patient was hospitalized and had been evaluated by several neurologists. After many treatments and studies, she received a final "diagnostic" of myopathy. The patient had not received any other vaccines within four weeks of receiving FLUZONE. Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity, Laboratory test, Myelopathy, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain
Clinical narrative: Initial report was received via the company's corporate website on 13 August 2011 from a consumer, who is also the patient. A 44-year-old female patient who had no reported concurrent illness, past medical history or concomitant medication usage, had received an intramuscular injection of FLUZONE, lot number U3572DA on 21 October 2010 (site not reported) and two days later, she experienced tremors, involuntary movements, generalized weakness, back and head pain, urinary incontinence, sensory problems and uncoordinated movement. The patient was hospitalized and had been evaluated by several neurologists. After many treatments and studies, she received a final "diagnostic" of myopathy. The patient had not received any other vaccines within four weeks of receiving FLUZONE. Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Sensory disturbance, Tremor, Urinary incontinence
Clinical narrative: Initial report was received via the company's corporate website on 13 August 2011 from a consumer, who is also the patient. A 44-year-old female patient who had no reported concurrent illness, past medical history or concomitant medication usage, had received an intramuscular injection of FLUZONE, lot number U3572DA on 21 October 2010 (site not reported) and two days later, she experienced tremors, involuntary movements, generalized weakness, back and head pain, urinary incontinence, sensory problems and uncoordinated movement. The patient was hospitalized and had been evaluated by several neurologists. After many treatments and studies, she received a final "diagnostic" of myopathy. The patient had not received any other vaccines within four weeks of receiving FLUZONE. Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Back pain, Coordination abnormal, Dyskinesia, Headache
Clinical narrative: Initial report was received via the company's corporate website on 13 August 2011 from a consumer, who is also the patient. A 44-year-old female patient who had no reported concurrent illness, past medical history or concomitant medication usage, had received an intramuscular injection of FLUZONE, lot number U3572DA on 21 October 2010 (site not reported) and two days later, she experienced tremors, involuntary movements, generalized weakness, back and head pain, urinary incontinence, sensory problems and uncoordinated movement. The patient was hospitalized and had been evaluated by several neurologists. After many treatments and studies, she received a final "diagnostic" of myopathy. The patient had not received any other vaccines within four weeks of receiving FLUZONE. Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test abnormal, Myopathy, Sensory disturbance, Tremor, Urinary incontinence
Clinical narrative: Initial report was received via the company's corporate website on 13 August 2011 from a consumer, who is also the patient. A 44-year-old female patient who had no reported concurrent illness, past medical history or concomitant medication usage, had received an intramuscular injection of FLUZONE, lot number U3572DA on 21 October 2010 (site not reported) and two days later, she experienced tremors, involuntary movements, generalized weakness, back and head pain, urinary incontinence, sensory problems and uncoordinated movement. The patient was hospitalized and had been evaluated by several neurologists. After many treatments and studies, she received a final "diagnostic" of myopathy. The patient had not received any other vaccines within four weeks of receiving FLUZONE. Outcome was not recovered. Documents held by sender: None.
Age: 1.48
Sex: F
Vaccine: MMR
Symptoms: Fall, Injection site rash
Clinical narrative: Noticed a rash to her left arm (where injection site was) and it spread somewhat along her upper arm. It is raised and white, similar to what psoriasis looks like, but feels bumpy. I noticed also today she keeps falling down a lot more than her usual.  There are no other signs of illness.
Age: 31.0
Sex: F
Vaccine: MEN
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itching red pin-prick looking rash on face and chin
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Pupillary light reflex tests normal
Clinical narrative: 19 y/o male into clinic for MCV4 to complete college entrance immunizations.  Denied any problems with vaccine in past - actually had MCV4 on 8/5/05 @ 13 y/o.  Administered vaccine and as PHN applying Band-Aid, client began to slump over.  Ammonia wafted below nose and another PHN assisted in lowering client to floor.  Woke up during transfer.  BP 128/66, P 76,reg.  Kept client lying still for 10 minutes. BP 120/70; pupils reactive to light.  Slowly assisted to sit, then to stand.  Had not eated breakfast - crackers and juice given.  Client left clinc on own.  Called end of day - doing well.  Called 8/9/11 - doing well.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Chills, Influenza virus test, Injection site erythema, Injection site nodule
Clinical narrative: Temperature up to 104, chills, large red knot at site of injection
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Streptococcus test, Urine analysis
Clinical narrative: Temperature up to 104, chills, large red knot at site of injection
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: reports redness, welt, and itching at site of injection
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Abdominal pain upper, Dyspnoea, Pyrexia
Clinical narrative: severe stomach pain, fever, labored breathing  cold compresses
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Blindness transient, Headache
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old male patient, with autistic disorder and no known drug allergies, who on 08-AUG-2011 was vaccinated with a first dose of 0.5 ml of GARDASIL (lot # 669308/0636AA, expiration date unknown, route not reported). There was no concomitant medication or vaccines. The licensed practical nurse reported that on 08-AUG-2011 the patient experienced temporary loss of peripheral vision (the reporter did not know if it was total loss or just decreased vision loss) and headache. The adverse events did not develop until that evening after the patient returned home from football practice. The reporter did not know if any trauma was sustained during practice, but assumed the mother would have said something if it had occurred. At the time of the report no testing was done, no treatment was provided, the event was not disabling or life threatening and the patient sought unspecified medical attention. On 09-AUG-2011 the patient recovered from vision loss and the headache persisted. The licensed practical nurse could not provide any environmental details (temperature, whether patient had eaten, etc). Upon internal review, total vision loss was determined to be an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site pain, Screaming, Seizure like phenomena
Clinical narrative: This is a spontaneous report from a contactable consumer (mother of the patient) with follow-up from the same consumer (listed as other health care professional on follow-up). This is the first report of two reports from this same reporter. A 2-month-old male patient (son of reporter) received the first dose of PREVNAR in the left leg on 05Aug2011 for the prevention of pneumonia. There was no relevant medical history. Relevant concomitant medication included a dose of PENTACEL administered in right leg on 05Aug2011. According to the mother, the right leg did not hurt and the patient did not really cry after injection. On 05Aug2011 the patient experienced uncontrollable screaming and crying due to excessive pain (reported like a seizure) for almost 15 minutes after injection of PREVNAR in left leg. Outcome was unknown. Follow up (09Aug2011): New information reported from the same contactable consumer (listed as other health care professional on follow-up) includes: patient demographics, change in product from PREVNAR 13 to PREVNAR, product details, concomitant medication, medical history and course of event details.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diarrhoea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (mother of the patient) with follow-up from the same consumer (listed as other health care professional on follow-up). This is the first report of two reports from this same reporter. A 2-month-old male patient (son of reporter) received the first dose of PREVNAR in the left leg on 05Aug2011 for the prevention of pneumonia. There was no relevant medical history. Relevant concomitant medication included a dose of PENTACEL administered in right leg on 05Aug2011. According to the mother, the right leg did not hurt and the patient did not really cry after injection. On 05Aug2011 the patient experienced uncontrollable screaming and crying due to excessive pain (reported like a seizure) for almost 15 minutes after injection of PREVNAR in left leg. Outcome was unknown. Follow up (09Aug2011): New information reported from the same contactable consumer (listed as other health care professional on follow-up) includes: patient demographics, change in product from PREVNAR 13 to PREVNAR, product details, concomitant medication, medical history and course of event details.
Age: 0.82
Sex: M
Vaccine: HEP, MMR
Symptoms: Blood culture, C-reactive protein, Differential white blood cell count, Febrile convulsion, Full blood count
Clinical narrative: Febrile seizures.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Back pain, Muscular weakness, Pain in extremity, Pyrexia
Clinical narrative: Had Tdap on Friday. Arm was sore and warm. Saturday am, woke up and had severe pain in back, weakness in legs and felt like had a fever. Had to have someone help her walk, because felt so weak. By Sunday, was able to walk by self. Went to chiropractor Saturday am and today. About 90% better today as opposed to Saturday am.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Walking aid user
Clinical narrative: Had Tdap on Friday. Arm was sore and warm. Saturday am, woke up and had severe pain in back, weakness in legs and felt like had a fever. Had to have someone help her walk, because felt so weak. By Sunday, was able to walk by self. Went to chiropractor Saturday am and today. About 90% better today as opposed to Saturday am.
Age: 11.0
Sex: F
Vaccine: FLUN3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red and painful a site. Left arm.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site papule, Nausea, Papule, Pyrexia, Vaccinia virus infection
Clinical narrative: Patient presented to medical clinic with papules extending from vaccination site onto his chest and beneath his eyes bilaterally. He had received smallpox vaccination 2 weeks prior. He had nausea/fever since Friday (2 days prior to doctor's visit). Started on SEPTRA and sent for optometry, emergency room eval. Vaccinia virus diagnosed. Patient quarantined in barracks and followed in clinic.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Developed "stinging" sensation on that (L) upper few hrs after vaccination. Got worsened on Saturday with erythema, swelling and large bullae. Seen at ER and here at the office on 8/15/11. On ZITHROMAX, BENADRYL PO and VICODIN prn for pain.
Age: 44.0
Sex: F
Vaccine: RAB
Symptoms: Rash papular, Urticaria
Clinical narrative: Generalized papular, urticarial rash the evening after receiving 1st Rabies vaccine for post-exposure.
Age: 1.42
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Blood culture negative, Culture urine negative, Flushing, Grunting, Malaise
Clinical narrative: Grunting, flushed, fever, generally looking unwell. Seen in ER twice/ultimately admitted d/t persistent grunting. Blood cx neg, urine cx neg, abd U/S neg. Placed on Ceftriaxone while cx's pending. Discharged home in good health, sx resolved.
Age: 1.42
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia, Ultrasound abdomen normal
Clinical narrative: Grunting, flushed, fever, generally looking unwell. Seen in ER twice/ultimately admitted d/t persistent grunting. Blood cx neg, urine cx neg, abd U/S neg. Placed on Ceftriaxone while cx's pending. Discharged home in good health, sx resolved.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Full blood count normal, Joint swelling, Metabolic function test normal, Oedema
Clinical narrative: On 19AUG, pt presented as a transient pt, complaining of 2 day history of bilateral ankle swelling.  Also complains of exquisite pain in bilateral malleolar region, edema in achilles region.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: On 19AUG, pt presented as a transient pt, complaining of 2 day history of bilateral ankle swelling.  Also complains of exquisite pain in bilateral malleolar region, edema in achilles region.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient reported a reddened area about 3 inches in diameter, raised, hard to the touch, and bumpy, on her right arm in the mid-back of upper part of arm. Reported it was very tender and slowly went away after 2 months.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Red rash at injection site, swelling, warm to touch.  Mother took patient to facility to have it checked out.  Returned home.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: SEIZURE...APPROXIMATELY 30 SECONDS FAINTING....APPROXIMATELY 1-2 MINUTES
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Apnoea, Crying, Erythema, Fear, Lumbar puncture abnormal
Clinical narrative: Per mom, has been crying for 2 days - ever since getting his 2 month old shots yesterday.  Today, he started having episodes where he would stop breathing for approx 5-7 seconds, his face turns bright red, his arms go stiff and he appears frightened; happening more frequently this afternoon; no fever.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, PNC13, RV1
Symptoms: Musculoskeletal stiffness
Clinical narrative: Per mom, has been crying for 2 days - ever since getting his 2 month old shots yesterday.  Today, he started having episodes where he would stop breathing for approx 5-7 seconds, his face turns bright red, his arms go stiff and he appears frightened; happening more frequently this afternoon; no fever.
Age: 65.0
Sex: M
Vaccine: BCG
Symptoms: Testicular swelling
Clinical narrative: Testicular swelling
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood culture negative, Blood electrolytes normal, Convulsion, Electroencephalogram, Endotracheal intubation
Clinical narrative: Patient presented to the ED with status epilepticus. The initial seizure lasted 15-20 minutes prior to arrival in ED. In ED, he was given Ativan, Phenobarbital, and fosphenytoin which were successful in stopping the seizure. Patient was intubated and placed on ventilator. He was admitted to the PICU and stayed for 3 days prior to transfering to the hospitalist floor. He remained seizure free after his initial insult.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Enterovirus test negative, Intensive care, Lumbar puncture normal, Mechanical ventilation, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient presented to the ED with status epilepticus. The initial seizure lasted 15-20 minutes prior to arrival in ED. In ED, he was given Ativan, Phenobarbital, and fosphenytoin which were successful in stopping the seizure. Patient was intubated and placed on ventilator. He was admitted to the PICU and stayed for 3 days prior to transfering to the hospitalist floor. He remained seizure free after his initial insult.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Polymerase chain reaction, Status epilepticus
Clinical narrative: Patient presented to the ED with status epilepticus. The initial seizure lasted 15-20 minutes prior to arrival in ED. In ED, he was given Ativan, Phenobarbital, and fosphenytoin which were successful in stopping the seizure. Patient was intubated and placed on ventilator. He was admitted to the PICU and stayed for 3 days prior to transfering to the hospitalist floor. He remained seizure free after his initial insult.
Age: 0.22
Sex: M
Vaccine: HIBV, PPV
Symptoms: Crying, Emotional distress, Irritability, Pyrexia
Clinical narrative: Patient was fussy, extremely sensitive and cried hysterically for 24 hours while awake.  Fever of 100.0 degrees.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Burning sensation, Erythema, Facial pain, Heart rate normal, Pruritus
Clinical narrative: Immunizations were administered at Health Dept. aprox. 4:00pm. At Aprox. 4:30pm Mother reports child begin to complain of left side of face itching and red spots appeared around her left eye and jawline.  At aprox 8:30pm child begin to complain of face burning and very painful and red. Mother gave child 1 25mg Benadryl tablet and took to ER.  child was triaged at Medical Center at aprox 20:51. No SOB, Normal heart rate andy rhythm noted on ER report. Tx'd with Zofran 8mg IV, SoluMedrol 125MG IV. Pt was discharged 23:33
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Rash, Rash erythematous
Clinical narrative: Immunizations were administered at Health Dept. aprox. 4:00pm. At Aprox. 4:30pm Mother reports child begin to complain of left side of face itching and red spots appeared around her left eye and jawline.  At aprox 8:30pm child begin to complain of face burning and very painful and red. Mother gave child 1 25mg Benadryl tablet and took to ER.  child was triaged at Medical Center at aprox 20:51. No SOB, Normal heart rate andy rhythm noted on ER report. Tx'd with Zofran 8mg IV, SoluMedrol 125MG IV. Pt was discharged 23:33
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Patient noticed a lump on her arm at the site of the injection.  She was not sure when it started.  About a 2-in. diameter area around the site of injection is red, raised, and warm.  Patient reports no pain.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hemiparesis, Loss of consciousness, Neurological examination abnormal, Tremor
Clinical narrative: PATIENT WAS SEEN AT THE EMERGENCY ROOM OF HOSPITAL, NO FURTHER SYMPTOMS REPORTED, PATIENT WAS REFERRED TO FOR NEUROLOGY FOLLOWUP.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dizziness, Fall
Clinical narrative: Child was administered Hepatitis A, Varicella, MCV-4 and TB Test. Once he was in lobby to leave, he felt dizzy and fell. He was brought in to pt. room, vital signs taken; 116/64 69hr 18r. He was placed on exam table, mom stated he had not eaten, he was given some orange juice. After approx. 10 minutes, vital signs repeated; 114/64 83hr 18r. Child stated he felt better and was hungry. He walked around room, no further dizziness or complains. Discharged ambulatory with mom at side.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Crying, Decreased appetite, Diarrhoea, Emotional distress, Feeding disorder neonatal
Clinical narrative: Extreme pain, crying, unconsolable, would stretch out and shake violently and grunt while staring with wide eyes that looked horrified. Diarrhea and lessening of bowel movements. Loss of appetite with fewer and shorter length of time of nursing periods
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Grunting, Infrequent bowel movements, Pain, Staring, Tremor
Clinical narrative: Extreme pain, crying, unconsolable, would stretch out and shake violently and grunt while staring with wide eyes that looked horrified. Diarrhea and lessening of bowel movements. Loss of appetite with fewer and shorter length of time of nursing periods
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Neurological examination, Vomiting
Clinical narrative: Parent was driving patient home when patient had a seizure with vomiting. Parent called 911 - patient was tranported to Emergency Department
Age: 43.0
Sex: M
Vaccine: DT, RAB
Symptoms: Cold sweat, Dizziness, Injection site pain, Joint swelling, Malaise
Clinical narrative: Dizziness, feeling unwell/nauseated, joints feel swollen (fingers, face, hands, feet, posterior knee joint), neck pain, cold night sweats, injection site pain. Symptoms come and go.
Age: 43.0
Sex: M
Vaccine: DT, RAB
Symptoms: Nausea, Neck pain, Night sweats
Clinical narrative: Dizziness, feeling unwell/nauseated, joints feel swollen (fingers, face, hands, feet, posterior knee joint), neck pain, cold night sweats, injection site pain. Symptoms come and go.
Age: 27.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Nervousness, Throat irritation
Clinical narrative: PATIENT RETURNED TO CLINIC AT 1310 STATING SHE FELT SHAKY AND DIZZY AS TIME WENT ON HER THROAT BECAME ITCHY. RAPID RESPONSE WAS CALLED AND PATIENT RECEIVED OXYGEN, BENADRYL, SOLUMEDROL, RELEASED TO FOLLOW UP WITH PROVIDER 19 AUG 2011.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Given ZOSTAVAX at pharmacy 8/13/2011. Seen in MD office today. Patient c/o 50 cent size red/hard swollen warm to touch area at injection site.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Redness, and swelling. Hot & tender to touch next day after vaccine administered. Med: Cephalex/Ibuprofen.
Age: 81.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's doctor recommended pneumonia and pertussis vaccination. Patient received shots on 8/16/11, and came back to pharmacy on 8/18/11 reporting her arm was red, swollen, and painful where she received PNEUMOVAX shot. She reported she didn't have any problems the 1st time she received PNEUMOVAX, and it turns out she didn't even need the shot a 2nd time. Recommended TYLENOL, ice, and BENADRYL, and to follow up with doctor if not improved.
Age: 1.57
Sex: F
Vaccine: HEPA
Symptoms: Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Joint effusion, Red blood cell sedimentation rate
Clinical narrative: Right knee joint effusion started approx 2 days after immunization. No fever or other sx. Effusion continued to persist at 2-3 wks after vaccination.
Age: 1.57
Sex: F
Vaccine: HEPA
Symptoms: Rheumatoid factor negative, Streptococcus test
Clinical narrative: Right knee joint effusion started approx 2 days after immunization. No fever or other sx. Effusion continued to persist at 2-3 wks after vaccination.
Age: 0.6
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red quarter size swollen circle on (R) leg.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mom states the (L) arm that he received his Tdap in on 8-10-11 became fire red and hot on Fri and during weekend 8-12 Thru.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Oval red spot under shot site.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Nausea, Vomiting
Clinical narrative: Erythema & swelling of injection site and diffuse skin erythema & nausea & vomiting.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema of skin over (L) deltoid/site of vaccine.
Age: 1.31
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site vesicles
Clinical narrative: Rash at immunization site left leg per family began 8/2/11. Area red and indurated with cluster of very small vesicles. Seen at office 8/17/11.
Age: 47.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Biopsy skin abnormal, C-reactive protein increased, Full blood count, Pyrexia, Vasculitic rash
Clinical narrative: Vasculitis rash (biopsy proven), fever. Vaccines 8/5. Rash 8/7
Age: 70.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Flushing
Clinical narrative: Approximately 5 min after administration, patient felt flushing upper face & dizzy, he remained seated at the pharmacy for 30 minutes & then recovered.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Balance disorder, Blood glucose, Blood pressure decreased, Disorientation
Clinical narrative: Pt fainted (syncopal episode), fell into arm of vaccine administrator and eyes rolled up. After child was lifted up, she fell back on exam table and eyes rolled up again. Then child "came around" and asked "Where am I?" appeared weak, unstable on legs, BP decreased 108/90 to 90/50.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Gaze palsy, Laboratory test, Syncope
Clinical narrative: Pt fainted (syncopal episode), fell into arm of vaccine administrator and eyes rolled up. After child was lifted up, she fell back on exam table and eyes rolled up again. Then child "came around" and asked "Where am I?" appeared weak, unstable on legs, BP decreased 108/90 to 90/50.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Hyperhidrosis, Nausea, Pallor
Clinical narrative: 1/2 hr after administration of vaccine, sweating, nausea, pale, abd cramping.
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Cyanosis, Hypoaesthesia, Injection site anaesthesia, Injection site pain, Injection site pustule
Clinical narrative: States about 15 min after vaccine - (R) thumb turned blue then had pain & numbness in arm. Now 1 1/2 wks later c/o pus coming out of injection site, intermittent tingling & numbness, pain, hot & swollen inj site area.
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: States about 15 min after vaccine - (R) thumb turned blue then had pain & numbness in arm. Now 1 1/2 wks later c/o pus coming out of injection site, intermittent tingling & numbness, pain, hot & swollen inj site area.
Age: 78.0
Sex: M
Vaccine: TYP
Symptoms: Arthralgia, Chills, Hyperhidrosis, Lethargy, Myalgia
Clinical narrative: Febrile, chills, myalgias, arthralgias, lethargy, nausea, sweating.
Age: 78.0
Sex: M
Vaccine: TYP
Symptoms: Nausea, Pyrexia
Clinical narrative: Febrile, chills, myalgias, arthralgias, lethargy, nausea, sweating.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Mass
Clinical narrative: Red golf ball size lump, blisters. Seen in urgent care prednisone, antibiotics ordered.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Parent returned to Health Department on 8/19/11 to show an area of redness and induration on her daughter arm - approx 1 1/2". Explained this was a common side effect of shots. She ha been applying ice. Reports that the day after the vaccine it was 4 inches in diameter. Parent requested it be reported as an adverse side effect.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Patient complained of vision problems, about an hour later. "Eyes felt like they were dilated". Reported today vision is fine now, but still present today just for a few minutes (not all day).
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Gaze palsy, Pallor, Seizure like phenomena
Clinical narrative: Shortly after receiving vaccinations patient's eyes rolled back became pale and began seizure like activity. Patient was evaluated by provider. Vitals stable. Seizure like activity lasted approx. 30-45 seconds.
Age: 1.89
Sex: F
Vaccine: HEP
Symptoms: Convulsion, Depressed level of consciousness, Fall, Gaze palsy, Loss of consciousness
Clinical narrative: After driving home from doctor's appt (where she was seen for dermatis and got a Hep B vaccine) - pt had a seizure. Ambulance arrived at home and pt was afebrile. Transported to ED - labs were drawn -then pt discharged home. Upon discharge, mom was told to make appt for EEG and MRI. Mom states after her appt she drove home (approximately 15min) then upon arrival noted that her kids were bickering. Things got quiet suddenly and mom saw that patient had fallen to the ground and was "turning purple" and was "shaking". Mom picked her up and she stopped shaking, but her eyes were rolled back and she was "out" - unconscious. Mom ran out the door screaming and neighbor call 911. Mom continued to hold patient until the Fire Dept arrived (appx 3-5 min). When she handed patient to the fire man, she "came to" but seemed dazed. The ambulance arrived and she still seemed dazed, although conscious, until arrival to the ED. No sibs with vaccine problems. No family history of seizures. Mom has been nervous about vaccines and has only been getting 1-2 at a time. Vaccine record attached.
Age: 1.89
Sex: F
Vaccine: HEP
Symptoms: Skin discolouration, Tremor
Clinical narrative: After driving home from doctor's appt (where she was seen for dermatis and got a Hep B vaccine) - pt had a seizure. Ambulance arrived at home and pt was afebrile. Transported to ED - labs were drawn -then pt discharged home. Upon discharge, mom was told to make appt for EEG and MRI. Mom states after her appt she drove home (approximately 15min) then upon arrival noted that her kids were bickering. Things got quiet suddenly and mom saw that patient had fallen to the ground and was "turning purple" and was "shaking". Mom picked her up and she stopped shaking, but her eyes were rolled back and she was "out" - unconscious. Mom ran out the door screaming and neighbor call 911. Mom continued to hold patient until the Fire Dept arrived (appx 3-5 min). When she handed patient to the fire man, she "came to" but seemed dazed. The ambulance arrived and she still seemed dazed, although conscious, until arrival to the ED. No sibs with vaccine problems. No family history of seizures. Mom has been nervous about vaccines and has only been getting 1-2 at a time. Vaccine record attached.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Initial onset of a seizure lasting approximately one minute.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Drug exposure during pregnancy
Clinical narrative: MMR vaccine given to woman 19 wks pregnant.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen, erythema at site of injection.