chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 this 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. Follow-up information was received from the investigator on 01 July 2010. The subject had subsequently experienced several seizures and had been diagnosed with epilepsy, treated with KEPPRA. On 19 April 2010 the subject was seen by a neurologist, with the following impression: "A 9-month-old male with a history of multiple febrile and afebrile seizures over the last couple of months starting around 30 December 2009 who has not had further unprovoked seizures since shortly after the KEPRRA dose was increased to 2mL po twice a day. He has had several provoked events triggered by infection/fever. Head MRI and SCN1A gene testing were both normal." Per the investigator, the event is still considered to be "febrile seizure", although the subject was later diagnosed with epilepsy. He had no family history of seizures. The investigator considered the event to be medically significant and related to 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 this 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. Follow-up information was received from the investigator on 01 July 2010. The subject had subsequently experienced several seizures and had been diagnosed with epilepsy, treated with KEPPRA. On 19 April 2010 the subject was seen by a neurologist, with the following impression: "A 9-month-old male with a history of multiple febrile and afebrile seizures over the last couple of months starting around 30 December 2009 who has not had further unprovoked seizures since shortly after the KEPRRA dose was increased to 2mL po twice a day. He has had several provoked events triggered by infection/fever. Head MRI and SCN1A gene testing were both normal." Per the investigator, the event is still considered to be "febrile seizure", although the subject was later diagnosed with epilepsy. He had no family history of seizures. The investigator considered the event to be medically significant and related to 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 this 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. Follow-up information was received from the investigator on 01 July 2010. The subject had subsequently experienced several seizures and had been diagnosed with epilepsy, treated with KEPPRA. On 19 April 2010 the subject was seen by a neurologist, with the following impression: "A 9-month-old male with a history of multiple febrile and afebrile seizures over the last couple of months starting around 30 December 2009 who has not had further unprovoked seizures since shortly after the KEPRRA dose was increased to 2mL po twice a day. He has had several provoked events triggered by infection/fever. Head MRI and SCN1A gene testing were both normal." Per the investigator, the event is still considered to be "febrile seizure", although the subject was later diagnosed with epilepsy. He had no family history of seizures. The investigator considered the event to be medically significant and related to 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 this 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. Follow-up information was received from the investigator on 01 July 2010. The subject had subsequently experienced several seizures and had been diagnosed with epilepsy, treated with KEPPRA. On 19 April 2010 the subject was seen by a neurologist, with the following impression: "A 9-month-old male with a history of multiple febrile and afebrile seizures over the last couple of months starting around 30 December 2009 who has not had further unprovoked seizures since shortly after the KEPRRA dose was increased to 2mL po twice a day. He has had several provoked events triggered by infection/fever. Head MRI and SCN1A gene testing were both normal." Per the investigator, the event is still considered to be "febrile seizure", although the subject was later diagnosed with epilepsy. He had no family history of seizures. The investigator considered the event to be medically significant and related to 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 this 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. Follow-up information was received from the investigator on 01 July 2010. The subject had subsequently experienced several seizures and had been diagnosed with epilepsy, treated with KEPPRA. On 19 April 2010 the subject was seen by a neurologist, with the following impression: "A 9-month-old male with a history of multiple febrile and afebrile seizures over the last couple of months starting around 30 December 2009 who has not had further unprovoked seizures since shortly after the KEPRRA dose was increased to 2mL po twice a day. He has had several provoked events triggered by infection/fever. Head MRI and SCN1A gene testing were both normal." Per the investigator, the event is still considered to be "febrile seizure", although the subject was later diagnosed with epilepsy. He had no family history of seizures. The investigator considered the event to be medically significant and related to study vaccine. Documents held by sender: Discharge summary, physician notes.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Crying, Erythema, Eye swelling, Irritability, Screaming
Clinical narrative: Initial case was received on 23 June 2010 from a healthcare professional on a VAERS Report (E44356). A 1 year 6 month old female patient received a left leg intramuscular injection of PENTACEL (lot number C3609AB) at 10:30 a.m. on 23 June 2010. She experienced generalized hives and eyes swelling at 1:30 p.m. on 2- June 2010 (second number in date not legible). The patient's mother gave her BENADRYL and returned the child to the doctor's office, where she was treated with a 0.2 cc subcutaneous injection of epinephrine 1:1000. She experienced extreme fussiness and crying. The patient's birth weight was reported as 25 pounds 6 ounces. She patient had no pre-existing medical conditions, no reported concomitant medications and no illness at the vaccination. The patient recovered from the adverse events on an unspecified date. Follow-up information was received from the healthcare professional on 29 June 2010. The patient was treated with epinephrine and oral steroids for 3 days beginning on 23 June 2010. On 26 June 2010 the patient woke up screaming uncontrollably, and was noted to be covered with red welts. She was given BENADRYL, and taken to the emergency room. Treatment in the emergency room included a "steroid shot"; the patient was prescribed 5 additional days of oral steroids at that time. According to the reporter, who spoke with the parent of the patient on 28 June 2010, the patient had improved and welts were diminishing. Follow-up information was received from a health care professional on 27 July 2010 clarified that the patient's birth weight was 8 pounds 7 ounces and the patient's weight at time of injection was 25 pounds 6 ounces. The patient's date of birth was reported as 12 December 2008. The patient had no prior reactions to vaccines and no history of allergies (food, drug and environmental). diagnostic skin testing and/or ImmunoCAP were to be done (no results provided). The indication for giving the epinephrine was due to facial swelling after receiving the BENADRYL. The outcome remained recovered. Documents held by sender: None.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: Initial case was received on 23 June 2010 from a healthcare professional on a VAERS Report (E44356). A 1 year 6 month old female patient received a left leg intramuscular injection of PENTACEL (lot number C3609AB) at 10:30 a.m. on 23 June 2010. She experienced generalized hives and eyes swelling at 1:30 p.m. on 2- June 2010 (second number in date not legible). The patient's mother gave her BENADRYL and returned the child to the doctor's office, where she was treated with a 0.2 cc subcutaneous injection of epinephrine 1:1000. She experienced extreme fussiness and crying. The patient's birth weight was reported as 25 pounds 6 ounces. She patient had no pre-existing medical conditions, no reported concomitant medications and no illness at the vaccination. The patient recovered from the adverse events on an unspecified date. Follow-up information was received from the healthcare professional on 29 June 2010. The patient was treated with epinephrine and oral steroids for 3 days beginning on 23 June 2010. On 26 June 2010 the patient woke up screaming uncontrollably, and was noted to be covered with red welts. She was given BENADRYL, and taken to the emergency room. Treatment in the emergency room included a "steroid shot"; the patient was prescribed 5 additional days of oral steroids at that time. According to the reporter, who spoke with the parent of the patient on 28 June 2010, the patient had improved and welts were diminishing. Follow-up information was received from a health care professional on 27 July 2010 clarified that the patient's birth weight was 8 pounds 7 ounces and the patient's weight at time of injection was 25 pounds 6 ounces. The patient's date of birth was reported as 12 December 2008. The patient had no prior reactions to vaccines and no history of allergies (food, drug and environmental). diagnostic skin testing and/or ImmunoCAP were to be done (no results provided). The indication for giving the epinephrine was due to facial swelling after receiving the BENADRYL. The outcome remained recovered. Documents held by sender: None.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Crying, Erythema, Eye swelling, Irritability, No reaction on previous exposure to drug
Clinical narrative: Initial case was received on 23 June 2010 from a healthcare professional on a VAERS Report (E44356). A 1 year 6 month old female patient received a left leg intramuscular injection of PENTACEL (lot number C3609AB) at 10:30 a.m. on 23 June 2010. She experienced generalized hives and eyes swelling at 1:30 p.m. on 2- June 2010 (second number in date not legible). The patient's mother gave her BENADRYL and returned the child to the doctor's office, where she was treated with a 0.2 cc subcutaneous injection of epinephrine 1:1000. She experienced extreme fussiness and crying. The patient's birth weight was reported as 25 pounds 6 ounces. She patient had no pre-existing medical conditions, no reported concomitant medications and no illness at the vaccination. The patient recovered from the adverse events on an unspecified date. Follow-up information was received from the healthcare professional on 29 June 2010. The patient was treated with epinephrine and oral steroids for 3 days beginning on 23 June 2010. On 26 June 2010 the patient woke up screaming uncontrollably, and was noted to be covered with red welts. She was given BENADRYL, and taken to the emergency room. Treatment in the emergency room included a "steroid shot"; the patient was prescribed 5 additional days of oral steroids at that time. According to the reporter, who spoke with the parent of the patient on 28 June 2010, the patient had improved and welts were diminishing. Follow-up information was received from a health care professional on 27 July 2010 clarified that the patient's birth weight was 8 pounds 7 ounces and the patient's weight at time of injection was 25 pounds 6 ounces. The patient's date of birth was reported as 12 December 2008. The patient had no prior reactions to vaccines and no history of allergies (food, drug and environmental). diagnostic skin testing and/or ImmunoCAP were to be done (no results provided). The indication for giving the epinephrine was due to facial swelling after receiving the BENADRYL. The outcome remained recovered. Documents held by sender: None.
Age: 1.53
Sex: F
Vaccine: DTAPIPVHIB, DTAPIPVHIB, DTAPIPVHIB
Symptoms: Screaming, Swelling face, Urticaria
Clinical narrative: Initial case was received on 23 June 2010 from a healthcare professional on a VAERS Report (E44356). A 1 year 6 month old female patient received a left leg intramuscular injection of PENTACEL (lot number C3609AB) at 10:30 a.m. on 23 June 2010. She experienced generalized hives and eyes swelling at 1:30 p.m. on 2- June 2010 (second number in date not legible). The patient's mother gave her BENADRYL and returned the child to the doctor's office, where she was treated with a 0.2 cc subcutaneous injection of epinephrine 1:1000. She experienced extreme fussiness and crying. The patient's birth weight was reported as 25 pounds 6 ounces. She patient had no pre-existing medical conditions, no reported concomitant medications and no illness at the vaccination. The patient recovered from the adverse events on an unspecified date. Follow-up information was received from the healthcare professional on 29 June 2010. The patient was treated with epinephrine and oral steroids for 3 days beginning on 23 June 2010. On 26 June 2010 the patient woke up screaming uncontrollably, and was noted to be covered with red welts. She was given BENADRYL, and taken to the emergency room. Treatment in the emergency room included a "steroid shot"; the patient was prescribed 5 additional days of oral steroids at that time. According to the reporter, who spoke with the parent of the patient on 28 June 2010, the patient had improved and welts were diminishing. Follow-up information was received from a health care professional on 27 July 2010 clarified that the patient's birth weight was 8 pounds 7 ounces and the patient's weight at time of injection was 25 pounds 6 ounces. The patient's date of birth was reported as 12 December 2008. The patient had no prior reactions to vaccines and no history of allergies (food, drug and environmental). diagnostic skin testing and/or ImmunoCAP were to be done (no results provided). The indication for giving the epinephrine was due to facial swelling after receiving the BENADRYL. The outcome remained recovered. Documents held by sender: None.
Age: 0.76
Sex: F
Vaccine: DTAPIPVHIB, PNC, DTAPIPVHIB, PNC
Symptoms: Injection site necrosis, Injection site reaction
Clinical narrative: Initial case was received on 09 July 2010 from a healthcare professional. A nine month old female patient received on 28 June 2010, a left thigh intramuscular injection of PENTACEL (lot number C3658AA) and a right thigh intramuscular injection of PREVNAR (manufacturer Wyeth, lot number E60221). On 01 July 2010, the patient developed a "spot" at the left thigh injection site, which continued to "grow" and appeared necrotic. The reporter stated the patient had no fever or redness. She had no illness at the time of the vaccinations and had no pre-existing medical conditions, allergies or concomitant medications. She was given no vaccinations within 4 weeks prior. On an unspecified date, the patient was evaluated by a physician, but the results of the evaluation were not provided. The outcome of the adverse event was not reported. Follow-up information was received 30 July 2010 from a health care professional. The reporter verified that the same needle had not been used for both injections. Following vaccination, the injection site was covered and the patient was able to crawl. The patient received corrective treatment with "LOTRIMIN" and the spot at the injection site cleared by 15 July 2010. Outcome was recovered. The date of vaccination for PREVNAR was amended to 28 June 2010 in the therapy date field  (previously entered as 01 July 2010 in error). Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception, Laboratory test, X-ray
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 22-JUL-2010 an 8 weeks old female patient was vaccinated with the first dose of ROTATEQ (lot number 667461/0500Z) by mouth. Concomitant vaccinations given the same day included the first dose of PREVNAR (lot number E45350) given in the right leg and the first dose of PENTACEL (lot number C3529AA) given in the left leg. Other vaccination was reported as hepatitis virus vaccine (unspecified). The patient was diagnosed with intussusception to hepatic flexure on 12-AUG-2010 (at 3 months of age) and it was resolved by enema administration. The patient also experienced oral intake reduced, emesis, decreased urine output and decreased tears for 2 days. The patient was admitted for observation status post (s/p) enema and there was reduction of intussusception. The feeds progressed and tolerated well. The patient was discharged to go home with primary care physician follow up. Laboratories tests performed included: an X-ray of abdomen which was abnormal and a stool guaiac test which was positive. At the time of the report the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization and were considered to be life threatening. The original reporting source was not provided. The VAERS ID # 395889. A lot check has been initiated. A standard lot check investigation 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: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Abdominal X-ray, Enema administration, Hypophagia, Intussusception, Lacrimation 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. On 22-JUL-2010 an 8 weeks old female patient was vaccinated with the first dose of ROTATEQ (lot number 667461/0500Z) by mouth. Concomitant vaccinations given the same day included the first dose of PREVNAR (lot number E45350) given in the right leg and the first dose of PENTACEL (lot number C3529AA) given in the left leg. Other vaccination was reported as hepatitis virus vaccine (unspecified). The patient was diagnosed with intussusception to hepatic flexure on 12-AUG-2010 (at 3 months of age) and it was resolved by enema administration. The patient also experienced oral intake reduced, emesis, decreased urine output and decreased tears for 2 days. The patient was admitted for observation status post (s/p) enema and there was reduction of intussusception. The feeds progressed and tolerated well. The patient was discharged to go home with primary care physician follow up. Laboratories tests performed included: an X-ray of abdomen which was abnormal and a stool guaiac test which was positive. At the time of the report the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization and were considered to be life threatening. The original reporting source was not provided. The VAERS ID # 395889. A lot check has been initiated. A standard lot check investigation 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: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, DTAPIPVHIB, PNC, RV5
Symptoms: Occult blood positive, Urine output decreased, Vomiting, X-ray abnormal
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 22-JUL-2010 an 8 weeks old female patient was vaccinated with the first dose of ROTATEQ (lot number 667461/0500Z) by mouth. Concomitant vaccinations given the same day included the first dose of PREVNAR (lot number E45350) given in the right leg and the first dose of PENTACEL (lot number C3529AA) given in the left leg. Other vaccination was reported as hepatitis virus vaccine (unspecified). The patient was diagnosed with intussusception to hepatic flexure on 12-AUG-2010 (at 3 months of age) and it was resolved by enema administration. The patient also experienced oral intake reduced, emesis, decreased urine output and decreased tears for 2 days. The patient was admitted for observation status post (s/p) enema and there was reduction of intussusception. The feeds progressed and tolerated well. The patient was discharged to go home with primary care physician follow up. Laboratories tests performed included: an X-ray of abdomen which was abnormal and a stool guaiac test which was positive. At the time of the report the patient's outcome was unknown. The listing indicated that one or more of the events required hospitalization and were considered to be life threatening. The original reporting source was not provided. The VAERS ID # 395889. A lot check has been initiated. A standard lot check investigation 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: 26.0
Sex: M
Vaccine: FLU3, SMALL, FLUX, SMALL
Symptoms: Mononucleosis heterophile test negative, Rash erythematous, Streptococcus test, Streptococcus test negative
Clinical narrative: Developed painful, pustular eruption that started on the scalp, spreading to his whole head, forehead, neck and both upper extremities.  They were painful, itchy and also had a headache.
Age: 26.0
Sex: M
Vaccine: FLU3, SMALL, FLUX, SMALL
Symptoms: Headache, Pain, Pruritus, Rash pustular
Clinical narrative: Developed painful, pustular eruption that started on the scalp, spreading to his whole head, forehead, neck and both upper extremities.  They were painful, itchy and also had a headache.
Age: 74.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Dizziness, Dysphonia, Fatigue, Hyperhidrosis
Clinical narrative: High fever - Body was very weak - walked worse than a drunk - hoarse- breathing hard and fast - dizzy - never was so scared - finally 10-1-10 feeling better still have hoarseness/ will never have another flu shot.
Age: 74.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Dizziness, Dysphonia, Dyspnoea, Gait disturbance
Clinical narrative: High fever - Body was very weak - walked worse than a drunk - hoarse- breathing hard and fast - dizzy - never was so scared - finally 10-1-10 feeling better still have hoarseness/ will never have another flu shot.
Age: 74.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Pyrexia, Respiratory rate increased
Clinical narrative: High fever - Body was very weak - walked worse than a drunk - hoarse- breathing hard and fast - dizzy - never was so scared - finally 10-1-10 feeling better still have hoarseness/ will never have another flu shot.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bedridden, Headache, Nausea, Pyrexia, Rash
Clinical narrative: Nausea causing patient to be bed ridden. Rash down arm. fever. Headache.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chills, Fatigue, VIIth nerve paralysis
Clinical narrative: Tired on Saturday, chills and bone pain near the ear on sunday, and facial paralysis got progressive.
Age: 1.49
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Crying
Clinical narrative: Baby crying uncontrollably x few hrs - Stopped 30 min after ibuprofen.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: During the administration, there was a failure of the syringe/needle. The vaccine leaked out at the junction where the needle screws into the syringe. I don't believe the pt. received much if any of the dose so I administered a new full dose of the vaccine. No other adverse events occured.
Age: 4.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Culture wound positive, Herpes simplex, Rash
Clinical narrative: Notified about "rash" from PMD.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Blood pressure decreased, Cough, Diarrhoea, Heart rate decreased, Oxygen saturation decreased
Clinical narrative: 10 minutes after administration cough, diarrhea, decrease responsiveness, vomiting, itchy rash to ER - given BENADRYL in office prior to transport Alb 1.25 inject, O2.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Rash pruritic, Slow response to stimuli, Vomiting
Clinical narrative: 10 minutes after administration cough, diarrhea, decrease responsiveness, vomiting, itchy rash to ER - given BENADRYL in office prior to transport Alb 1.25 inject, O2.
Age: 6.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Myalgia, Pyrexia, Streptococcus test
Clinical narrative: 3 days myaglia of injected leg. Erythema of injection site, 7.5 x 10 cm. Fever 102 degrees F. Pain & tenderness at site. Difficulty to bear weight on affected leg.
Age: 6.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Streptococcus test negative, Weight bearing difficulty
Clinical narrative: 3 days myaglia of injected leg. Erythema of injection site, 7.5 x 10 cm. Fever 102 degrees F. Pain & tenderness at site. Difficulty to bear weight on affected leg.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site swelling, X-ray limb normal
Clinical narrative: Administered FLUVIRIN vaccine in deltoid muscle, within minutes patient developed swelling under the skin at injection site. Recommended patient get physician for evaluation that day.
Age: 1.55
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 80mmx60mm reddened swollen and warm to touch on (L) thigh.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine was administered 9/29/2010, 09/30/10 there was redness, swelling, and fever to sight. 10/1/10 the swelling and redness has moved down the arm.
Age: 16.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Urticaria
Clinical narrative: Left arm  was red, hot and (swollen at the injection site.) Hives all over. Seen by physician, no treatment.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Mobility decreased
Clinical narrative: Pt received injection (L) deltoid on Tuesday 9/21/10 @ 10 AM. Over the course of the day his mobility diminished to the point where he could not lift his arm to eat or drive. He slept in a chair Wed. Some improved. Today (Thur) more improved but still limited ROM for abduction.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen legs Rt and Lt at injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ecchymosis, Pain in extremity
Clinical narrative: Sharp 1-2 second pain medial Rt forearm. Sl superficial ecchymosis where pt pinched self at pain site. NT to palp, FROM, no nodule.
Age: 4.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site swelling
Clinical narrative: Injection site measures 55 mm x 70 mm to RT.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Blood culture negative, Computerised tomogram abdomen normal, Culture urine negative
Clinical narrative: 9/10/10 fever, mild to moderate headaches, at times severe, nausea, vomiting, poor appetite, ache in neck, joints and muscles, weak and mild dehydration. Admitted to hospital 9/23/10 with persistent symptoms.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dehydration, Headache, Hepatobiliary scan, Myalgia
Clinical narrative: 9/10/10 fever, mild to moderate headaches, at times severe, nausea, vomiting, poor appetite, ache in neck, joints and muscles, weak and mild dehydration. Admitted to hospital 9/23/10 with persistent symptoms.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: 9/10/10 fever, mild to moderate headaches, at times severe, nausea, vomiting, poor appetite, ache in neck, joints and muscles, weak and mild dehydration. Admitted to hospital 9/23/10 with persistent symptoms.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Syncope
Clinical narrative: Patient had mowed yard + weed eater work before receiving Pneumonia + Flu shots. Was no problem during waiting period at vaccination site. After patient drove home, he got out of truck, got dizzy and fainted. Awoke unharmed. Did more yardwork.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Client c/o arms/abdomen itching 10 mins after flu shot. BENADRYL 50 mg IM (R) deltoid @ 11:50 am No rash No difficulty breathing No difficulty swallowing B/P 134/70 AP=76 R=18
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Joint swelling, Rash
Clinical narrative: Telephone call- c/o rash on stomach + trunk area also unilateral ankle swollen (L ankle).
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Oedema peripheral, Pain, Sensory loss
Clinical narrative: Patient informed the clinic that, the evening following her immunizations she began to notice swelling of her right deltoid area. This spread to the rest of the right upper extremity. She then noted this on her left arm, as well as both legs. She states that this lasted for about 36 hours. She states this was some what painful and she had decreased sensation to those areas. She denied any spread to her trunk or head, denied any rash, respiratory distress or weakness.
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Feeling hot, Pallor, Syncope
Clinical narrative: Gave last shot, (HPV) and patient turned white, and said she was hot and patient fainted while sitting in chair, called for help, patient responsive and reoriented. Patient sat in clinic 30 min. afterwards and mother drove patient home.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt experienced swelling from his shoulder to his elbow, inability to move his left arm, redness from shoulder to elbow and heat from same area for 48 hrs following vaccination.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dizziness, Loss of consciousness, Vomiting
Clinical narrative: 4 hours after receiving FLUZONE HD patient began severe vomiting, dizziness and stomach cramping. Patient passed out and ambulance was called in to take him to ER. Patient appears to be recovered as of today 10-1-10. His primary Dr. told his wife this is the 2nd case they heard of with HD vaccine.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, PNC13
Symptoms: Breath holding, Crying, Grand mal convulsion, Haemoglobin normal, Postictal state
Clinical narrative: Pt cried and held breath during immunizations and then began at tonic-clonic seizure. Pt was immediately turned to her side, positioned to maintain airway, O2 per mask and continuous pulse OX until EMS arrived. Seizure lasted <1 min followed by >10 min of post-ictal.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Syncope
Clinical narrative: Syncopy after TDap and HPV vaccines. Pt seated, evaluated by FNP. Pt quickly regained consciousness. Left clinic with mom 15 minutes later asymptomatic.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching began 2 hr after administration. Used ZYRTEC/BENADRYL.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal surgery, Herpes zoster, Hypoaesthesia, Rash
Clinical narrative: Information has been received from a 68 year old female patient with IVP dye allergy, esophageal problem requiring surgery in November 2010 and hypertension who on 09-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route not reported). Concomitant therapy included aspirin, CRESTOR and "medication for hypertension" (unspecified). The consumer reported that despite vaccination, she had developed shingles. The rash was on her face and eyes and included numbness in her neck. She had seen a pain management specialist and an ophthalmologist. She was initially prescribed with NEURONTIN and then changed to LYRICA. The consumer reported that she had not seen improvement of her condition since it started. The reporter felt that shingles needed intervention to prevent serious criteria and were significant disability or incapacity. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: Information has been received from a physician concerning a 16 week old male patient with no pertinent medical history, no drug reactions or allergies, who on 20-SEP-2010 was vaccinated with a second dose of ROTATEQ (Lot # 663696/0017Y, exp: 31-OCT-2010). There was no concomitant medication. On 22-SEP-2010 the child presented with diarrhea with blood and mucus within the stools. At the time of this report, the patient's adverse event persisted. The patient sought unspecified medical attention. Diarrhea with blood and mucus within the stools was reported by a physician to be an other important medical event. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Dizziness, Erythema, Nausea, Syncope
Clinical narrative: He felt dizzy, nauseated and he noticed diffuse redness.  He was seen later that night in an ER and treated with Benadryl.  He was discharged home.  The day after vaccination at about 1 PM he began to feel weak, dizzy and nausea.  At 1:30PM he had a witnessed syncopal event.  He was brought into our clinic and treated with intravenous fluids and intramuscular phenergan.  At 4:30 PM he felt much better and was discharge home.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Chest discomfort, Chills, Cough, Eye discharge
Clinical narrative: Tightness in the chest, dry cough, runny nose, aches, chills, eyes red and oozing, severe headache, sore throat started within two hours of having the shot.  Patient otherwise healthy with no problems prior to the shot.  Feel slightly better the next morning, but unable to go to work and still not well.  No treatment at this time.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Ocular hyperaemia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Tightness in the chest, dry cough, runny nose, aches, chills, eyes red and oozing, severe headache, sore throat started within two hours of having the shot.  Patient otherwise healthy with no problems prior to the shot.  Feel slightly better the next morning, but unable to go to work and still not well.  No treatment at this time.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Hot flush, Nasal congestion, Pain
Clinical narrative: runny nose, body aches/pain, low-grade fever, nasal congestion, sneezing, coughing, chills/hot flashes
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: runny nose, body aches/pain, low-grade fever, nasal congestion, sneezing, coughing, chills/hot flashes
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Lt bicep swelling under injection site with redness and hot to touch. Pain when flexing muscle.
Age: 0.18
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Pain in extremity, Vomiting
Clinical narrative: We did a school vaccination clinic that morning. The client came home from school on a Friday c/o HA and sore arm. Up at 2 am vomiting, and severe HA went to ER and Dr next day missed school on Monday c/o HA
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Fatigue
Clinical narrative: Fatigue, intense chills.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: hives on abdomen and back, improved with Benadryl
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chills, Cough, Dysgeusia, Feeling hot, Lung disorder
Clinical narrative: 3 hours after the shot at 3PM. 30 minutes later I had a wrird taste in my mouth.  At 4PM I noticed my head was stuffy so I took an allergy pill.  But, at 6PM my body just shut down and the symptoms were aches from head to toe, fever, sore throat, coughing, stuffy head (completely), my lungs were hurting and I had cold shivers but was hot.  My feet felt like ice and I started coughing. This lasted until midnight when the Nyquil kicked in. I had to put a heating pad on my feet they were so cold.  I was sore all over and couldn't move much. I had some chicken soup to help.  Other than a stuffy head the next morning, some soreness in my body, I took a Dayquil to help with those symptoms.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nasal congestion, Oropharyngeal pain, Pain, Peripheral coldness, Pyrexia
Clinical narrative: 3 hours after the shot at 3PM. 30 minutes later I had a wrird taste in my mouth.  At 4PM I noticed my head was stuffy so I took an allergy pill.  But, at 6PM my body just shut down and the symptoms were aches from head to toe, fever, sore throat, coughing, stuffy head (completely), my lungs were hurting and I had cold shivers but was hot.  My feet felt like ice and I started coughing. This lasted until midnight when the Nyquil kicked in. I had to put a heating pad on my feet they were so cold.  I was sore all over and couldn't move much. I had some chicken soup to help.  Other than a stuffy head the next morning, some soreness in my body, I took a Dayquil to help with those symptoms.