chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, Premature baby
Clinical narrative: A spontaneous report of a non serious event of 22 week pregnant woman got a dose of H1N1 and a serious event of premature birth has been received from a registered nurse/health professional concerning a 26-year-old female, subsequent to H1N1, Intranasal. This case is linked to MEDI-0011247. The patient had no relevant medical history and obstetrical history included gravida three and para two. The patient's gestation period was 17 weeks at time of vaccination, LMP was 30-Jul-2009 and EDD was 06-May-2010. The concomitant medications included prenatal vitamins (oral, taken once daily) and iron tablets (oral, taken once daily). On 10-Dec-2009, the patient received H1N1, Intranasal, for an unknown indication. The patient did very well with the vaccine and did not develop any flu-like illness or symptoms. On 27-Mar-2010, the patient delivered a premature baby girl. The outcome of the events of vaccine exposure during pregnancy and premature birth was considered resolved. Additional information was received on 23-Dec-2009 and incorporated into the narrative: patient ethnic group, Expected delivery date, gravida, para and concomitant medication. Additional information was received on 07-Jun-2010 and incorporated into the narrative: Pregnancy outcome received, which was premature birth and it is captured as new event; therefore the case is upgrade to 15-day.
Age: 26.0
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Blood bilirubin increased
Clinical narrative: A spontaneous report of a non serious event of 22 week pregnant woman got a dose of H1N1 and a serious event of premature birth has been received from a registered nurse/health professional concerning a 26-year-old female, subsequent to H1N1, Intranasal. This case is linked to MEDI-0011247. The patient had no relevant medical history and obstetrical history included gravida three and para two. The patient's gestation period was 17 weeks at time of vaccination, LMP was 30-Jul-2009 and EDD was 06-May-2010. The concomitant medications included prenatal vitamins (oral, taken once daily) and iron tablets (oral, taken once daily). On 10-Dec-2009, the patient received H1N1, Intranasal, for an unknown indication. The patient did very well with the vaccine and did not develop any flu-like illness or symptoms. On 27-Mar-2010, the patient delivered a premature baby girl. The outcome of the events of vaccine exposure during pregnancy and premature birth was considered resolved. Additional information was received on 23-Dec-2009 and incorporated into the narrative: patient ethnic group, Expected delivery date, gravida, para and concomitant medication. Additional information was received on 07-Jun-2010 and incorporated into the narrative: Pregnancy outcome received, which was premature birth and it is captured as new event; therefore the case is upgrade to 15-day.
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Drug exposure during pregnancy, Premature baby
Clinical narrative: A serious spontaneous report of increased bilirubin has been received from a health professional/registered nurse concerning a newly born baby girl, subsequent to H1N1, Intranasal. This case was linked to MEDI-0009908. The patient was prematurely born. No concomitant medications have been reported for this patient. The patient did not received H1N1, Intranasal. On 10-Dec-2009, the patient's mother received H1N1 vaccine for an unknown indication. On 27-Mar-2010, the patient stayed in the hospital for increased bilirubin. The patient was discharged on 29-Mar-2010. The outcome of the event increased bilirubin was unknown.
Sex: F
Vaccine: FLUN(H1N1), FLUN(H1N1)
Symptoms: Blood bilirubin increased
Clinical narrative: A serious spontaneous report of increased bilirubin has been received from a health professional/registered nurse concerning a newly born baby girl, subsequent to H1N1, Intranasal. This case was linked to MEDI-0009908. The patient was prematurely born. No concomitant medications have been reported for this patient. The patient did not received H1N1, Intranasal. On 10-Dec-2009, the patient's mother received H1N1 vaccine for an unknown indication. On 27-Mar-2010, the patient stayed in the hospital for increased bilirubin. The patient was discharged on 29-Mar-2010. The outcome of the event increased bilirubin was unknown.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for the pregnancy registry for GARDASIL, concerning a 15 year old female patient who on 28-APR-2010 was vaccinated with the first dose of GARDASIL (dose and route not reported; lot number 663573/0969Y). Nurse reported that the patient became pregnant after receiving GARDASIL approximately 15-MAR-2010 and she had 9 weeks of gestation at the time of the report (EDD: 20-DEC-2010 approx.). Therapy with the vaccine was discontinued and it was not reintroduced. The patient sought unspecified medical attention. Follow up information has been received from the health care provider who reported that the 15 year old female on 27-MAY-2010 had an elective termination of her pregnancy. The patient does not want to participate in the pregnancy registry for GARDASIL. Upon internal review, abortion was considered to be an other important medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abortion induced, Drug exposure before pregnancy
Clinical narrative: Information has been received from a registered nurse, for the pregnancy registry for GARDASIL, concerning a 15 year old female patient who on 28-APR-2010 was vaccinated with the first dose of GARDASIL (dose and route not reported; lot number 663573/0969Y). Nurse reported that the patient became pregnant after receiving GARDASIL approximately 15-MAR-2010 and she had 9 weeks of gestation at the time of the report (EDD: 20-DEC-2010 approx.). Therapy with the vaccine was discontinued and it was not reintroduced. The patient sought unspecified medical attention. Follow up information has been received from the health care provider who reported that the 15 year old female on 27-MAY-2010 had an elective termination of her pregnancy. The patient does not want to participate in the pregnancy registry for GARDASIL. Upon internal review, abortion was considered to be an other important medical event. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Areflexia, Arthralgia, Back pain, Fall, Gait disturbance
Clinical narrative: On 5/24/2010 he had a localized reaction. Developed rash, redness, swelling and warmth at injection site. He was seen on 5/27/2010 and treated with Zysol and topical steroid from his PCP. On 5/31/2010 he had profound weakness in his lower extremeties which resulted in a fall. He was admitted to ICU. He was also noted to have weakness that spread to upper extremities. He was given IV IG. He required BIPAP but did not require intubation. He was transferred to another hospital for Rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Injection site erythema, Injection site pain
Clinical narrative: On 5/24/2010 he had a localized reaction. Developed rash, redness, swelling and warmth at injection site. He was seen on 5/27/2010 and treated with Zysol and topical steroid from his PCP. On 5/31/2010 he had profound weakness in his lower extremeties which resulted in a fall. He was admitted to ICU. He was also noted to have weakness that spread to upper extremities. He was given IV IG. He required BIPAP but did not require intubation. He was transferred to another hospital for Rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Injection site swelling, Lumbar puncture abnormal, Muscular weakness, Musculoskeletal pain, Neurological examination abnormal
Clinical narrative: On 5/24/2010 he had a localized reaction. Developed rash, redness, swelling and warmth at injection site. He was seen on 5/27/2010 and treated with Zysol and topical steroid from his PCP. On 5/31/2010 he had profound weakness in his lower extremeties which resulted in a fall. He was admitted to ICU. He was also noted to have weakness that spread to upper extremities. He was given IV IG. He required BIPAP but did not require intubation. He was transferred to another hospital for Rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: On 5/24/2010 he had a localized reaction. Developed rash, redness, swelling and warmth at injection site. He was seen on 5/27/2010 and treated with Zysol and topical steroid from his PCP. On 5/31/2010 he had profound weakness in his lower extremeties which resulted in a fall. He was admitted to ICU. He was also noted to have weakness that spread to upper extremities. He was given IV IG. He required BIPAP but did not require intubation. He was transferred to another hospital for Rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Anti-SS-A antibody positive, Antinuclear antibody positive, Blood product transfusion, Epstein-Barr virus antibody negative, Fall
Clinical narrative: On 5/24/2010 he had a localized reaction. Developed rash, redness, swelling and warmth at injection site. He was seen on 5/27/2010 and treated with Zysol and topical steroid from his PCP. On 5/31/2010 he had profound weakness in his lower extremeties which resulted in a fall. He was admitted to ICU. He was also noted to have weakness that spread to upper extremities. He was given IV IG. He required BIPAP but did not require intubation. He was transferred to another hospital for Rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Immunoglobulin therapy, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: On 5/24/2010 he had a localized reaction. Developed rash, redness, swelling and warmth at injection site. He was seen on 5/27/2010 and treated with Zysol and topical steroid from his PCP. On 5/31/2010 he had profound weakness in his lower extremeties which resulted in a fall. He was admitted to ICU. He was also noted to have weakness that spread to upper extremities. He was given IV IG. He required BIPAP but did not require intubation. He was transferred to another hospital for Rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Intensive care, Local reaction, Muscular weakness, Rheumatoid factor positive
Clinical narrative: On 5/24/2010 he had a localized reaction. Developed rash, redness, swelling and warmth at injection site. He was seen on 5/27/2010 and treated with Zysol and topical steroid from his PCP. On 5/31/2010 he had profound weakness in his lower extremeties which resulted in a fall. He was admitted to ICU. He was also noted to have weakness that spread to upper extremities. He was given IV IG. He required BIPAP but did not require intubation. He was transferred to another hospital for Rehab.
Age: 68.0
Sex: M
Vaccine: TD, TD, TD
Symptoms: Oedema peripheral
Clinical narrative: On 5/24/2010 he had a localized reaction. Developed rash, redness, swelling and warmth at injection site. He was seen on 5/27/2010 and treated with Zysol and topical steroid from his PCP. On 5/31/2010 he had profound weakness in his lower extremeties which resulted in a fall. He was admitted to ICU. He was also noted to have weakness that spread to upper extremities. He was given IV IG. He required BIPAP but did not require intubation. He was transferred to another hospital for Rehab.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: On 12May2010, this 69 year old female patient received an injection of 0.5mL of pneumococcal vaccine into her right arm at a local health center. The patient's relevant medical history includes no prior allergic reaction to pneumococcal vaccine. On 12May2010, the patient developed redness of her right upper arm and inflammation and swelling of her right arm from below the injection site to the elbow was noted. On 12May2010, no additional rescue drugs were used and no additional laboratory testing was performed.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, pain, heat, itching at vaccination site. Left deltoid region.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Chills, Dizziness, Fatigue, Headache, Musculoskeletal stiffness
Clinical narrative: Sun 6/13 - moderate fatigue, elevated temperature, treatment none. Mon 6/14 - extreme fatigue, fever (no data), dizziness, headache, treatment ibuprofen. Tues 6/14 - extreme fatigue 103 degrees F fever, headache, treatment ibuprofen. Wed 6/15 - extreme fatigue, fever (no data), uncontrollable shivering, treatment ibuprofen. Thurs 6/16 - moderate fatigue, slight fever, headache, pain under left lung, treatment naproxon. Fri 6/17 - pressure in hand especially when moving eyes to extreme positions, neck stiffness, pain under left lung, treatment none.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Pain, Pyrexia
Clinical narrative: Sun 6/13 - moderate fatigue, elevated temperature, treatment none. Mon 6/14 - extreme fatigue, fever (no data), dizziness, headache, treatment ibuprofen. Tues 6/14 - extreme fatigue 103 degrees F fever, headache, treatment ibuprofen. Wed 6/15 - extreme fatigue, fever (no data), uncontrollable shivering, treatment ibuprofen. Thurs 6/16 - moderate fatigue, slight fever, headache, pain under left lung, treatment naproxon. Fri 6/17 - pressure in hand especially when moving eyes to extreme positions, neck stiffness, pain under left lung, treatment none.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), HEPAB, IPV, TYP
Symptoms: Throat tightness
Clinical narrative: Pt states approx 3 hours after vaccines she experienced tightening in her throat...she went to a local facility.
Age: 0.41
Sex: F
Vaccine: IPV, PNC
Symptoms: Erythema
Clinical narrative: Developed redness of skin (trunk/face) approximately 20 mins after injection. Lasted approximately 20 mins. No fever, cough, irritability, V, crying.
Age: 8.0
Sex: F
Vaccine: HEPA, IPV, TDAP
Symptoms: Expired drug administered
Clinical narrative: Patient received an expired dose of IPV (polio vaccine). No adverse reactions. Vaccine must be reported (advised by agency to complete this form).
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash mostly on back and abdomen, some on whole body. Prescribed Diphenhydramine
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Colitis, Diarrhoea, Discomfort, Faeces discoloured, Flatulence
Clinical narrative: Information has been received from a consumer concerning her 13 week old daughter with no pertinent medical history and no known drug reactions/allergies who on 13-APR-2010 was vaccinated orally with her first dose ROTATEQ (dose not reported, lot number 665252/0021Z). There was no concomitant medication. It was reported the patient developed diarrhea on 15-APR-2010 and since then, she has had 7 greenish stools per day and had not gained weight. No lab studies were performed. The physician was contacted by phone and an evaluation was scheduled. At the time of the report, the patient had not recovered from the events. Follow up information was received from a physician via medical records concerning a 12 month old female with no pertinent medical history reported and no illness at the time of vaccination who on 13-APR-2010 at 15:30, was vaccinated orally with a first dose of ROTATEQ (lot number 665252/0021Z). Other vaccines given within 28 days included PENTACEL (first dose, IM into right thigh, lot number C3564AA). It was reported that on 14-APR-2010, the patient had an increased frequency of stools, up to ten stools per day. The patient was feeling uncomfortable, fussy, gassy and irritable for at least a week. Colitis was diagnosed. Laboratory test performed included stool culture (with normal flora isolated after 24 and 48 hours, no OVA and parasites seen and 1 WBC) and stool occult blood (2+ positive). The patient recovered on 01-JUN-2010. Upon internal review stool occult blood (2+ positive) was determined to be an other important medical event. Additional information is not expected. All available medical records will be provided upon request.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Frequent bowel movements, Irritability, Occult blood positive, Stool analysis normal, Weight gain poor
Clinical narrative: Information has been received from a consumer concerning her 13 week old daughter with no pertinent medical history and no known drug reactions/allergies who on 13-APR-2010 was vaccinated orally with her first dose ROTATEQ (dose not reported, lot number 665252/0021Z). There was no concomitant medication. It was reported the patient developed diarrhea on 15-APR-2010 and since then, she has had 7 greenish stools per day and had not gained weight. No lab studies were performed. The physician was contacted by phone and an evaluation was scheduled. At the time of the report, the patient had not recovered from the events. Follow up information was received from a physician via medical records concerning a 12 month old female with no pertinent medical history reported and no illness at the time of vaccination who on 13-APR-2010 at 15:30, was vaccinated orally with a first dose of ROTATEQ (lot number 665252/0021Z). Other vaccines given within 28 days included PENTACEL (first dose, IM into right thigh, lot number C3564AA). It was reported that on 14-APR-2010, the patient had an increased frequency of stools, up to ten stools per day. The patient was feeling uncomfortable, fussy, gassy and irritable for at least a week. Colitis was diagnosed. Laboratory test performed included stool culture (with normal flora isolated after 24 and 48 hours, no OVA and parasites seen and 1 WBC) and stool occult blood (2+ positive). The patient recovered on 01-JUN-2010. Upon internal review stool occult blood (2+ positive) was determined to be an other important medical event. Additional information is not expected. All available medical records will be provided upon request.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: 7:30 pm the same night, hive bilateral upper arms - responded to BENADRYL, but next am hives again present.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Oedema
Clinical narrative: OV 6/17/10 - red, edema. 0930 Mother had called office on 6-16-10 she spoke with office to inform us of rt posteria arm has about 2" annular reddened area with warmth at site tenderness - I instructed mother to be told to given BENADRYL 25 mg po (OTC) with 4 degrees - RTC in am if area enlarges.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Localized redness Rt upper arm - mom reports "it was the size of a small goldfish".
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash to trunk. BENADRYL
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Local reaction
Clinical narrative: 4cm elliptical fashion localized left upper outer arm. 1-2 cm reddened area in ea. armpit. SOLUMEDROL IM & prednisone taper.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13
Symptoms: Injection site erythema
Clinical narrative: None-Dad reports slight redness of injection area-subsided within 24 hrs.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Abdominal pain upper, Hyperhidrosis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Hives head to toe, confluent areas in groin area, face, itchy and sweating, vomiting, stomach pain. Left arm at 3 vaccine sites pea sized swelling and induration larger area of redness around PCV13 site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Pruritus, Urticaria, Vomiting
Clinical narrative: Hives head to toe, confluent areas in groin area, face, itchy and sweating, vomiting, stomach pain. Left arm at 3 vaccine sites pea sized swelling and induration larger area of redness around PCV13 site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis
Clinical narrative: (R) upper arm cellulitis. Rx Abx (Keflex) 250mg tid x 10 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Large red circle on arm -> location of vaccine.
Age: 1.5
Sex: M
Vaccine: HEPA, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Administered MMR vaccine-pt developed pain, redness and swelling in vaccine site. BENADRYL and ice given, TYLENOL give before vaccine.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5
Symptoms: Condition aggravated, Febrile convulsion, Grand mal convulsion, Malaise, Nasal congestion
Clinical narrative: Initial report received on 02 June 2010 from an investigator participating in a study under the reference number M5A11. A 6-month-old male subject experienced a febrile seizure 1 day after receiving the following vaccines: a third dose of PENTACEL (lot number C3481AA); a first dose of MONOVALENT FLU A/H1N1 NO PRESERV.-U (lot number UT030EA); a first dose of FLUZONE (lot number U3262FA); a third dose of ENGERIX-B (GSK, lot number AHBVB769AA); a third dose of PREVNAR (Wyeth, lot number D78697); and a third dose of ROTATEQ (Merck, lot number 1056Y). On 30 December 2009, the subject experienced a seizure episode at daycare. That evening he experienced a generalized tonic-clonic seizure, witnessed by his mother. The episodes were characterized by generalized shaking, lasting an average of 1 minute. The subject had no recent history of head injury. He was taken to the emergency department, where he was noted to have a fever of 102.5 degrees per rectum, and a history of cough prior to the seizure episodes. Physical exam was otherwise normal. The subject was treated with TYLENOL and fever resolved. Subject was discharged to home in stable condition with impression of acute febrile illness and febrile seizure. He was seen the following day by his physician and physical exam noted nasal congestion and throat pink. He was diagnosed with viral syndrome. The subject was considered to be recovered from febrile seizure on the 30 December 2009. The investigator considered the event medically significant because technically, any patient experiencing complex febrile seizure should have been admitted to the hospital. Since the event, the subject experienced additional episodes of seizure with fever (dates unspecified) and seizure without fever (21 February and 05 March 2010); these seizures were not considered to be part of the episode reported after vaccination. According to the investigator, the event was related to the study vaccine. Documents held by sender: Discharge summary, physician notes.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5
Symptoms: Pharyngeal disorder, Pyrexia, Tremor, Viral infection
Clinical narrative: Initial report received on 02 June 2010 from an investigator participating in a study under the reference number M5A11. A 6-month-old male subject experienced a febrile seizure 1 day after receiving the following vaccines: a third dose of PENTACEL (lot number C3481AA); a first dose of MONOVALENT FLU A/H1N1 NO PRESERV.-U (lot number UT030EA); a first dose of FLUZONE (lot number U3262FA); a third dose of ENGERIX-B (GSK, lot number AHBVB769AA); a third dose of PREVNAR (Wyeth, lot number D78697); and a third dose of ROTATEQ (Merck, lot number 1056Y). On 30 December 2009, the subject experienced a seizure episode at daycare. That evening he experienced a generalized tonic-clonic seizure, witnessed by his mother. The episodes were characterized by generalized shaking, lasting an average of 1 minute. The subject had no recent history of head injury. He was taken to the emergency department, where he was noted to have a fever of 102.5 degrees per rectum, and a history of cough prior to the seizure episodes. Physical exam was otherwise normal. The subject was treated with TYLENOL and fever resolved. Subject was discharged to home in stable condition with impression of acute febrile illness and febrile seizure. He was seen the following day by his physician and physical exam noted nasal congestion and throat pink. He was diagnosed with viral syndrome. The subject was considered to be recovered from febrile seizure on the 30 December 2009. The investigator considered the event medically significant because technically, any patient experiencing complex febrile seizure should have been admitted to the hospital. Since the event, the subject experienced additional episodes of seizure with fever (dates unspecified) and seizure without fever (21 February and 05 March 2010); these seizures were not considered to be part of the episode reported after vaccination. According to the investigator, the event was related to the study vaccine. Documents held by sender: Discharge summary, physician notes.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5
Symptoms: Convulsion, Cytogenetic analysis normal, Epilepsy, Febrile convulsion, Grand mal convulsion
Clinical narrative: Initial report received on 02 June 2010 from an investigator participating in a study under the reference number M5A11. A 6-month-old male subject experienced a febrile seizure 1 day after receiving the following vaccines: a third dose of PENTACEL (lot number C3481AA); a first dose of MONOVALENT FLU A/H1N1 NO PRESERV.-U (lot number UT030EA); a first dose of FLUZONE (lot number U3262FA); a third dose of ENGERIX-B (GSK, lot number AHBVB769AA); a third dose of PREVNAR (Wyeth, lot number D78697); and a third dose of ROTATEQ (Merck, lot number 1056Y). On 30 December 2009, the subject experienced a seizure episode at daycare. That evening he experienced a generalized tonic-clonic seizure, witnessed by his mother. The episodes were characterized by generalized shaking, lasting an average of 1 minute. The subject had no recent history of head injury. He was taken to the emergency department, where he was noted to have a fever of 102.5 degrees per rectum, and a history of cough prior to the seizure episodes. Physical exam was otherwise normal. The subject was treated with TYLENOL and fever resolved. Subject was discharged to home in stable condition with impression of acute febrile illness and febrile seizure. He was seen the following day by his physician and physical exam noted nasal congestion and throat pink. He was diagnosed with viral syndrome. The subject was considered to be recovered from febrile seizure on the 30 December 2009. The investigator considered the event medically significant because technically, any patient experiencing complex febrile seizure should have been admitted to the hospital. Since the event, the subject experienced additional episodes of seizure with fever (dates unspecified) and seizure without fever (21 February and 05 March 2010); these seizures were not considered to be part of the episode reported after vaccination. According to the investigator, the event was related to the study vaccine. Documents held by sender: Discharge summary, physician notes.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5
Symptoms: Nasal congestion, Nuclear magnetic resonance imaging normal, Pharyngeal erythema, Pyrexia, Tremor
Clinical narrative: Initial report received on 02 June 2010 from an investigator participating in a study under the reference number M5A11. A 6-month-old male subject experienced a febrile seizure 1 day after receiving the following vaccines: a third dose of PENTACEL (lot number C3481AA); a first dose of MONOVALENT FLU A/H1N1 NO PRESERV.-U (lot number UT030EA); a first dose of FLUZONE (lot number U3262FA); a third dose of ENGERIX-B (GSK, lot number AHBVB769AA); a third dose of PREVNAR (Wyeth, lot number D78697); and a third dose of ROTATEQ (Merck, lot number 1056Y). On 30 December 2009, the subject experienced a seizure episode at daycare. That evening he experienced a generalized tonic-clonic seizure, witnessed by his mother. The episodes were characterized by generalized shaking, lasting an average of 1 minute. The subject had no recent history of head injury. He was taken to the emergency department, where he was noted to have a fever of 102.5 degrees per rectum, and a history of cough prior to the seizure episodes. Physical exam was otherwise normal. The subject was treated with TYLENOL and fever resolved. Subject was discharged to home in stable condition with impression of acute febrile illness and febrile seizure. He was seen the following day by his physician and physical exam noted nasal congestion and throat pink. He was diagnosed with viral syndrome. The subject was considered to be recovered from febrile seizure on the 30 December 2009. The investigator considered the event medically significant because technically, any patient experiencing complex febrile seizure should have been admitted to the hospital. Since the event, the subject experienced additional episodes of seizure with fever (dates unspecified) and seizure without fever (21 February and 05 March 2010); these seizures were not considered to be part of the episode reported after vaccination. According to the investigator, the event was related to the study vaccine. Documents held by sender: Discharge summary, physician notes.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU(H1N1), FLU3, HEP, PNC, RV5
Symptoms: Viral infection
Clinical narrative: Initial report received on 02 June 2010 from an investigator participating in a study under the reference number M5A11. A 6-month-old male subject experienced a febrile seizure 1 day after receiving the following vaccines: a third dose of PENTACEL (lot number C3481AA); a first dose of MONOVALENT FLU A/H1N1 NO PRESERV.-U (lot number UT030EA); a first dose of FLUZONE (lot number U3262FA); a third dose of ENGERIX-B (GSK, lot number AHBVB769AA); a third dose of PREVNAR (Wyeth, lot number D78697); and a third dose of ROTATEQ (Merck, lot number 1056Y). On 30 December 2009, the subject experienced a seizure episode at daycare. That evening he experienced a generalized tonic-clonic seizure, witnessed by his mother. The episodes were characterized by generalized shaking, lasting an average of 1 minute. The subject had no recent history of head injury. He was taken to the emergency department, where he was noted to have a fever of 102.5 degrees per rectum, and a history of cough prior to the seizure episodes. Physical exam was otherwise normal. The subject was treated with TYLENOL and fever resolved. Subject was discharged to home in stable condition with impression of acute febrile illness and febrile seizure. He was seen the following day by his physician and physical exam noted nasal congestion and throat pink. He was diagnosed with viral syndrome. The subject was considered to be recovered from febrile seizure on the 30 December 2009. The investigator considered the event medically significant because technically, any patient experiencing complex febrile seizure should have been admitted to the hospital. Since the event, the subject experienced additional episodes of seizure with fever (dates unspecified) and seizure without fever (21 February and 05 March 2010); these seizures were not considered to be part of the episode reported after vaccination. According to the investigator, the event was related to the study vaccine. Documents held by sender: Discharge summary, physician notes.
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Limb discomfort, Local reaction, Pain in extremity, Skin warm
Clinical narrative: Patient has right arm discomfort, pain and redness for the past couple of days, no fevers. Vaccine administered on 5/14 and patient reports to clinic on 5/17 (Monday). PCP exam results: right arm mild localized reaction over biceps, mild warmth and no induration, swelling, or abscess.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema multiforme, Oedema peripheral, Pain in extremity, Rash erythematous
Clinical narrative: Erythematous rash consistent with Erythema Multiforme Minor, swelling and pain of hands and feet. Seen by MD on 6/18/2010 at 10:00am. Started on Orapred and Zyrtec and Ibuprofen.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site reaction
Clinical narrative: Started as a small knot in her leg with redness.  By 6/17/2010 at 9:00 AM the knot was the size of my fist.  By 6/18/2010 the knot is even bigger.  I took her to her pediatrician's office and was told by 3 nurses and the doctor available, that it was a normal reaction and to just use cold compresses and Tylenol.
Age: 11.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Large circular raised swelling around injection site.  Hot and hard to the touch.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness and swelling at injection site.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 4.5 x 6 cm erythema, induration, swelling posterior left arm-anterior to injection site.  No tenderness, no lymphadenopathy.
Age: 0.6
Sex: F
Vaccine: HEP, HIBV, PNC
Symptoms: Body temperature increased, Diarrhoea, Hypersensitivity, Rash generalised, Swelling face
Clinical narrative: Initial spontaneous case received from a physician on 08 June 2010. A 7-month old female patient received her first doses of ACTHIB, PREVNAR (Wyeth) and hepatitis B vaccine (manufacturer not reported) on 07 June 2010; lot numbers were not reported. The patient had a history of "strange, unexplained pneumonia up to 3 months of age", and so vaccine administration had been delayed. Per the reporter, no explanation had been found for the pneumonia, and the child had seemed normal since 3 months. She received the vaccines in the afternoon of 07 June 2010, and that evening developed a temperature of 104 degrees and a rash. The following morning, the rash had spread to her entire body, and she had developed facial swelling. She was seen by her physician on 08 June 2010 and at that time was noted to have a whole body rash, facial swelling, a temperature of 102 degrees, and 3 watery stools. The physician was planning to coordinate with an allergist for possible skin testing due to a presumed allergy, and planned to give shots separately in 2 months. No additional information was reported. Of note, no serious criteria were reported by the physician. However, this case was considered serious by the company according to internal guidelines. Documents held by sender: None.
Age: 1.66
Sex: M
Vaccine: HEPA
Symptoms: Rhinorrhoea, Urticaria
Clinical narrative: Urticaria. Mild runny nose at first, then just urticaria that continued at least until 6/18 at 13:30 PM.  No other symptoms.  Treated just with Benadryl (generic).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: Pt presented her left arm on 6/18/10 -> Thurs 6/17/10 pt saw no signs of reaction -  PC 6/18/10 AM - Pt noted a "silver dollar sized" bright red circle at injection site with slight inflammation. Rash still present, has not progressed.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Staring, Suture removal, Unresponsive to stimuli
Clinical narrative: Vaccine given at 1600, immediately after pt had blank stare and was unresponsive to verbal stimulation. Pt unable to fix gaze and respond to verbal or stimuli for 60 seconds. Vitals taken. Pt started making eye contact and speaking, juice and chips given. Pt then playful.
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: RL - Bright red area 2x2cm. warm to touch, firm and tender. LL - Pale pink area 6x8cm not warm not tender.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine was administered to patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine was administered to patient.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine was administered to patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine was administered to patient.
Age: 3.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area surrounding injection site became larger, redder, and more swollen from day 1 to day 3 following DT shot. (5 X 6 inch area)
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: PT HAD RECEIVED TDAP ON 4/20/2010 AS A NEW EMPLOYEE.  WHEN ASKED IN THE ER WHEN HER LAST TETANUS SHOT WAS SHE STATED "I HAVE NO IDEA".  WE WERE INSTRUCTED TO REPORT THIS AS AN ADVERSE EVENT.
Age: 0.44
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Pyrexia
Clinical narrative: Woke from an unusually long 3 hour nap at above time with fever of 102.3 F. Administered 0.8 ml infant Acetaminophen, fever reduced in one hour to 99.9. Awoke this morning and fever back to 101.6; administered more Acetaminophen around 8:00 AM (same dose) and fever reduced to 99.6 F. This afternoon, fever is back to 101.3, again gave same dose at 2:45 PM (few minutes ago).
Age: 65.0
Sex: F
Vaccine: FLU(H1N1), PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swollen, redness, warm to the touch. Patient treated for cellulitis prescribed Keflex 500 mg four times a day and Motrin 600 mg for pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Pt was administered expired vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Patient received expired vaccine.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Patient received expired vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Pt was administered expired vaccine.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP, VARCEL
Symptoms: Computerised tomogram, Fall, Head injury, Syncope
Clinical narrative: Approx 5 minutes after receiving vaccines, child and father walked to lobby and child fainted, striking his head on the floor.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Patient received expired vaccine.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: Pt received expired vaccine.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Contusion, Erythema, Injection site oedema, Injection site pain, Injection site pruritus
Clinical narrative: He had significant pain with fever the afternoon and evening after the vaccine with warmth and tenderness of the thigh.  He awoke several times that evening with a low grade fever.  24 hours after the vaccine, his entire left thigh swelled with edema from thigh to the knee (see photo).  The fever resolved with less pain 24-48 hours after the vaccine, but then he has complained of mild itching at the vaccine site.  3-4 days later the swelling has improved slightly, with less pain but mild bruising of the thigh tissue where the erythema was previously.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: He had significant pain with fever the afternoon and evening after the vaccine with warmth and tenderness of the thigh.  He awoke several times that evening with a low grade fever.  24 hours after the vaccine, his entire left thigh swelled with edema from thigh to the knee (see photo).  The fever resolved with less pain 24-48 hours after the vaccine, but then he has complained of mild itching at the vaccine site.  3-4 days later the swelling has improved slightly, with less pain but mild bruising of the thigh tissue where the erythema was previously.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Fall, Head injury, Heart rate normal, Hypotension, Syncope
Clinical narrative: Patient had a syncopal reaction to her immunizations, Tdap and Varivax, that she received at 12:15 pm on 06/09/2010 in the clinic. The patient fell on the floor and hit her head.  This was witnessed by the patient's mother and this writer, both were in the room with the patient when it happened. Her vital signs were checked and blood pressure was found to be low.  Heart rate was normal.  She was transferred upstairs for intravenous fluids and observation.  She received one liter of normal saline.  She had an episode of emesis after she ate some food.  She was observed until about 4:00 pm.  The patient felt better and was ready to be discharged home.  She will follow-up with family physician as needed.  Patient was advised to eat food next time before she comes for immunizations and also to lay down while she is getting the immunizations to avoid a vasovagal reaction.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Patient had a syncopal reaction to her immunizations, Tdap and Varivax, that she received at 12:15 pm on 06/09/2010 in the clinic. The patient fell on the floor and hit her head.  This was witnessed by the patient's mother and this writer, both were in the room with the patient when it happened. Her vital signs were checked and blood pressure was found to be low.  Heart rate was normal.  She was transferred upstairs for intravenous fluids and observation.  She received one liter of normal saline.  She had an episode of emesis after she ate some food.  She was observed until about 4:00 pm.  The patient felt better and was ready to be discharged home.  She will follow-up with family physician as needed.  Patient was advised to eat food next time before she comes for immunizations and also to lay down while she is getting the immunizations to avoid a vasovagal reaction.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Dizziness
Clinical narrative: Dizziness upon rising and getting back into bed. Dizziness upon changing the state of balance such as standing after being seated. No treatment.
Age: 11.0
Sex: F
Vaccine: HEPA, MEN, TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pt woke up and stated her arm was sore, she then looked and noticed it was swollen. Pt called in and was told to take Benadryl and put ice on and mark the swollen area of arm. As the day went on swelling went out of the marked outline.
Age: 65.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Large swelling in right arm from shoulder to elbow, hot to touch, rather painful. Could not sleep from pain first night. Treated with ice and Benadryl. Swelling and pain still present but somewhat diminished by 6/18/2010. Area of maximum swelling moved down arm from shoulder to below elbow.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: As mom leaving office she noted redness and some hives on left leg, then went down to knee area at about 10:15 A 6-17-10. Notified ordering physician and applied cold compress and observed for 20 min.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site erythema
Clinical narrative: Immunizations administered at 11:25 approximately 10 minutes later, child had redness at injection sites, extremities x 4 and trunk of body. No difficulty breathing. BENADRYL & MOTRIN administered per MD. Patient recovered & discharged home.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema noticed by parent this AM 6/18/10. Per doctor pt to start BACTRIM 400/5 2 tsp BID x 10 days, BACTROBAN ointment to inj site QID; and maternal anxiety; pt going out of town with grandparent.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Decreased appetite, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Lost appetite approximately 11 hours after ADACEL injection developed chills, headache, and vomited. Fever of 102.3. Also sore throat.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Lost appetite approximately 11 hours after ADACEL injection developed chills, headache, and vomited. Fever of 102.3. Also sore throat.
Age: 59.0
Sex: F
Vaccine: YF
Symptoms: Activities of daily living impaired, Back pain, Pain
Clinical narrative: Received YF vaccine 6 hours later describes lower back pain "band across lower waist area" "feels like has a brace on, can't bend over hard to get up and down from a sitting or lying position and in and out of car" 7-8/10 pain scale when attempting above mentioned activities.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Around 500AM - She started itching and after her shower noticed hives, 5 good size ones over body and few small ones. Arms and torso - treated with CLARITIN and STERAPRED DS 12 days.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: 4x4 cm induration, no fluctuation (+) erythema on (R) deltoid area.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort
Clinical narrative: C/o abdominal discomfort approximately 2 hrs after administration of hep B vaccine. Follow up received: 1. Date of birtth; 2. Age 23; 3. Adverse event onset date 6/10/10 at 1400 (given) reaction at 1630 6/10/10; 4. Did not require hospitalization or visit to her doctor; 5. Given 6/10/10 at 1400
Age: 2.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site induration, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Local reaction of (L) arm with swelling, warmth, induration with blisters.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Influenza serology negative, Malaise, Pain, Pyrexia
Clinical narrative: Next day developed rash - area became swollen and tender. Since immunization developed headache, body aches, malaise and subjective fever this am 6-18-10 per mom. See copy of visit notes.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash, Swelling, Tenderness
Clinical narrative: Next day developed rash - area became swollen and tender. Since immunization developed headache, body aches, malaise and subjective fever this am 6-18-10 per mom. See copy of visit notes.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: RED, ITCHY, BLOTCHY RASH SPREAD FROM CHEST TO FACE. DENIES ANY SOB.
Age: 60.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Food allergy, Swelling face, Swollen tongue
Clinical narrative: Face and tongue swelling, three times to the emergency room during a three month period. Swelling occurring about every week or two. Had an allergy test done and find I'm now allergic to everything in the book, never allergic to anything prior.
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness of the entire right thigh (where the vaccine was given) and knee. Also warmth.
Age: 1.55
Sex: M
Vaccine: IPV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, C-reactive protein, Full blood count, Irritability
Clinical narrative: Woke around 6am and was fussy. Took a bottle, was given Motrin, and then slept some more. Woke around 8am and was noted to have right-sided facial swelling. Seen in the office same morning with marked right parotid swelling. Titers pending.