chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV2
Symptoms: Activities of daily living impaired, Asthma, Condition aggravated, Dyspnoea exertional, Fatigue
Clinical narrative: This case was reported by a physician and described the occurrence of chronic fatigue in a teenager female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included asthma. On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site and batch number). At an unspecified time after vaccination with CERVARIX, the subject experienced chronic fatigue in the first year of high school until the third year of high school. Tests in the orthopedic surgery department showed no abnormalities. Although the subject regularly attended clinic for symptoms such as asthmatic attack during the period, the subject made no complaints of chronic fatigue. At the time of reporting, the event was resolved. The causal relationship to CERVARIX was unknown. Follow-up information received on 12 May 2014: On an unknown date, the subject had chronic fatigue until the third year of high school after receiving vaccinations (unknown number of vaccinations) in the first year of high school. No further information was available, therefore, the case was closed. Follow-up information received on 07 July 2014: A201404982 was identified as a duplicate of A201403509. A201404982 was voided and all future information shall be reported to A201403509. Concurrent medical conditions included asthma. Concurrent vaccination included CERVARIX; GlaxoSmithKline; intramuscular; left arm given on 29 January 2011 and 2 August 2011. On 4 March 2011, the subject received 2nd dose of CERVARIX (intramuscular, right deltoid). Less than one month after vaccination with CERVARIX, the subject experienced chronic fatigue, chronic pain, generalized pain, exertional dyspnea and malaise. On March 2011, around this month, the subject had chronic pain (generalised aching) and chronic fatigue after the vaccination. She experienced exertional dyspnoea while she was walking. She had malaise, and could not climb stairs. She could not attend classes because of fatigue. On 02 August 2011, the subject was vaccinated with the third dose of CERVARIX at clinic A. On an unknown date, the subject underwent detailed examination at the department of orthopedics in hospital B, which revealed no abnormalities. On 01 May 2014, as of this date, the symptoms persisted. The causal relationship to CERVARIX was not provided for chronic fatigue, chronic pain, generalised aching, dyspnoea exertional, malaise). On an unknown date, detailed examination at the department of orthopedics in hospital B revealed no abnormalities. At the time of reporting, the events were unresolved. Follow-up information received on 05 August 2014: On 04 August 2014, as of this date, the subject was referred to Hospital C in the spring, the outcome was unknown. Follow up information was received on 29 Sep 2014. On 25 April 2014, at the time of pain, the patient used BRUFEN (100) 2 tablets on an as needed basis. Poultices including LOXONIN poultice and MS poultice were applied to the site of pain.
Sex: F
Vaccine: HPV2
Symptoms: Laboratory test normal, Malaise, Mobility decreased, Pain
Clinical narrative: This case was reported by a physician and described the occurrence of chronic fatigue in a teenager female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included asthma. On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown injection site and batch number). At an unspecified time after vaccination with CERVARIX, the subject experienced chronic fatigue in the first year of high school until the third year of high school. Tests in the orthopedic surgery department showed no abnormalities. Although the subject regularly attended clinic for symptoms such as asthmatic attack during the period, the subject made no complaints of chronic fatigue. At the time of reporting, the event was resolved. The causal relationship to CERVARIX was unknown. Follow-up information received on 12 May 2014: On an unknown date, the subject had chronic fatigue until the third year of high school after receiving vaccinations (unknown number of vaccinations) in the first year of high school. No further information was available, therefore, the case was closed. Follow-up information received on 07 July 2014: A201404982 was identified as a duplicate of A201403509. A201404982 was voided and all future information shall be reported to A201403509. Concurrent medical conditions included asthma. Concurrent vaccination included CERVARIX; GlaxoSmithKline; intramuscular; left arm given on 29 January 2011 and 2 August 2011. On 4 March 2011, the subject received 2nd dose of CERVARIX (intramuscular, right deltoid). Less than one month after vaccination with CERVARIX, the subject experienced chronic fatigue, chronic pain, generalized pain, exertional dyspnea and malaise. On March 2011, around this month, the subject had chronic pain (generalised aching) and chronic fatigue after the vaccination. She experienced exertional dyspnoea while she was walking. She had malaise, and could not climb stairs. She could not attend classes because of fatigue. On 02 August 2011, the subject was vaccinated with the third dose of CERVARIX at clinic A. On an unknown date, the subject underwent detailed examination at the department of orthopedics in hospital B, which revealed no abnormalities. On 01 May 2014, as of this date, the symptoms persisted. The causal relationship to CERVARIX was not provided for chronic fatigue, chronic pain, generalised aching, dyspnoea exertional, malaise). On an unknown date, detailed examination at the department of orthopedics in hospital B revealed no abnormalities. At the time of reporting, the events were unresolved. Follow-up information received on 05 August 2014: On 04 August 2014, as of this date, the subject was referred to Hospital C in the spring, the outcome was unknown. Follow up information was received on 29 Sep 2014. On 25 April 2014, at the time of pain, the patient used BRUFEN (100) 2 tablets on an as needed basis. Poultices including LOXONIN poultice and MS poultice were applied to the site of pain.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described the occurrence of interval too short in a 17-year-old female patient who received HAVRIX (batch number A7HC5, expiry date 13th August 2016). Concomitant products included HAVRIX. On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced interval too short. On an unknown date, the outcome of the interval too short was unknown. It was unknown if the reporter considered the interval too short to be related to HAVRIX. Additional details: The booster dose of HAVRIX was administered inadvertently at 3 months after the first dose of HAVRIX.
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a infant male patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to KINRIX. Additional details: No AE was reported.
Sex: F
Vaccine: HPV2
Symptoms: Activities of daily living impaired, Dyskinesia, Encephalitis brain stem, Headache, Memory impairment
Clinical narrative: GSK receipt date was 22 September 2014. A subject was healthy before the vaccination, and had no symptoms such as epilepsy. Unknown date: The subject was vaccinated with the first dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was vaccinated with the second dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was vaccinated with the third dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was diagnosed with brain stem encephalitis after the vaccination. The subject had involuntary movements as a sequela of the brain stem encephalitis, with symptoms of headache and generalised muscle aches, and sometimes complained of photophobia. In addition, the subject had mild memory impairment when she had attack of the involuntary movements, forgetting what happened a short time ago. 22 September 2014: [As of this date] Two years passed since the vaccination. The subject was frequently absent from the school. [Reporter's comment] (Encephalitis brain stem, movements involuntary, headache, generalised muscle aches, photophobia and memory impairment): The causal relationship to CERVARIX was not provided. [Other] Follow-up is now requested including some discrepancy.
Sex: F
Vaccine: HPV2
Symptoms: Myalgia, Photophobia
Clinical narrative: GSK receipt date was 22 September 2014. A subject was healthy before the vaccination, and had no symptoms such as epilepsy. Unknown date: The subject was vaccinated with the first dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was vaccinated with the second dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was vaccinated with the third dose of CERVARIX. Lot number: Unknown. Vaccination site: Unknown. Unknown date: The subject was diagnosed with brain stem encephalitis after the vaccination. The subject had involuntary movements as a sequela of the brain stem encephalitis, with symptoms of headache and generalised muscle aches, and sometimes complained of photophobia. In addition, the subject had mild memory impairment when she had attack of the involuntary movements, forgetting what happened a short time ago. 22 September 2014: [As of this date] Two years passed since the vaccination. The subject was frequently absent from the school. [Reporter's comment] (Encephalitis brain stem, movements involuntary, headache, generalised muscle aches, photophobia and memory impairment): The causal relationship to CERVARIX was not provided. [Other] Follow-up is now requested including some discrepancy.
Sex: U
Vaccine: FLU3, HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This case was reported by a consumer and described the occurrence of incorrect storage of drug in a unk patient who received ENGERIX B. Co-suspect products included FLUARIX. On 23 September 2014, the patient received ENGERIX B and FLUARIX. On an unknown date, an unknown time after receiving ENGERIX B and FLUARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the incorrect storage of drug to be related to ENGERIX B and FLUARIX. Additional details: Apparently the event occurred at an offsite vaccination clinic, no vaccine or patient details were available currently.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Blood test normal, Eye irritation, Headache, Mydriasis, Nausea
Clinical narrative: This case was reported by a physician and described the occurrence of vomiting in a 15-year-old female subject who was vaccinated with CERVARIX. On 25 April 2011 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 25 April 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced vomiting, headache and mydriasis. At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 17 May 2011: Concurrent medical conditions included asthma and seasonal allergy. Lot number was provided. The vaccine was administered in right deltoid. On 25 April 2011, less than one day after vaccination with CERVARIX, the subject experienced vomiting, and mydriasis. On 26 April 2011, one day after vaccination with CERVARIX, the subject experienced headache, queasy, vision disturbance and irritation when opening the eyes. A blood test was performed and showed no abnormality. On 28 April 2011, the events were improved. On 6 May 2011, the headache and queasy recurred. Follow-up information received on 18 May 2011: Previous vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 25 March 2011. This case has been linked to case B0718792A because it was a duplicate. All future correspondence will be submitted to B0716098A. Follow-up information received on 26 May 2011: The subject was treated with unknown (Infusion) and unknown (Unknown medication).
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Visual impairment, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of vomiting in a 15-year-old female subject who was vaccinated with CERVARIX. On 25 April 2011 the subject received unspecified dose of CERVARIX (.5 ml, intramuscular). On 25 April 2011, at an unspecified time after vaccination with CERVARIX, the subject experienced vomiting, headache and mydriasis. At the time of reporting the events were unresolved. The physician considered the events were related to vaccination with CERVARIX. Follow-up information received on 17 May 2011: Concurrent medical conditions included asthma and seasonal allergy. Lot number was provided. The vaccine was administered in right deltoid. On 25 April 2011, less than one day after vaccination with CERVARIX, the subject experienced vomiting, and mydriasis. On 26 April 2011, one day after vaccination with CERVARIX, the subject experienced headache, queasy, vision disturbance and irritation when opening the eyes. A blood test was performed and showed no abnormality. On 28 April 2011, the events were improved. On 6 May 2011, the headache and queasy recurred. Follow-up information received on 18 May 2011: Previous vaccination included 1st dose of CERVARIX (GlaxoSmithKline, intramuscular, unknown injection site) given on 25 March 2011. This case has been linked to case B0718792A because it was a duplicate. All future correspondence will be submitted to B0716098A. Follow-up information received on 26 May 2011: The subject was treated with unknown (Infusion) and unknown (Unknown medication).
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Blood calcium increased, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood potassium decreased
Clinical narrative: This report refers to a 6 month old male patient enrolled in a study. On 08-MAY-2014, the patient was enrolled and vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015, dose 1, 2 ml, oral. On 11-JUL-2014, the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 2, 2 ml, oral and on 12-SEP-2014 the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 3, 2 ml, oral. On 16-SEP-2014 the patient experienced gastroenteritis. On 26-SEP-2014, the patient was admitted to the hospital for gastroenteritis. The parents reported a 10 day history of vomiting and diarrhea. The admission was thought likely due to prolonged viral gastroenteritis with possible post infection lactose intolerance. On presentation to the emergency department (ED), the patient was afebrile and vital signs were stable. Physical exam was significant to dehydration with dry mucosa membrane and crying without tears. While in the ED, the patient received 20 cc/kg bolus of normal saline, ZOFRAN and was the started on maintenance intravenous fluids (IVF). On 26-SEP-2014, the following lab test were performed: complete blood count: white blood cells 17.1, platelet 432.000, hemoglobin 14.3, Differential: 13 segmented neutrophils, 60 lymphocytes and 22 variant lymphocytes; metabolic panel Sodium 136 mmol/L; Chloride 110 mmol/L; potassium 4.0 mmol/L; Carbon Dioxide 17 mmol/L; urea nitrogen 9 mg/dL; creatinine 0.3 mg/dL; Calcium 10.8 mg/dl and glucose 92 mg/dL. On 27-SEP-2014 the following lab test were performed: Urine culture 100.000 Colonies/ml Escherichia Coli,10.000-100.0000 Colonies/ml Mixed flora and stool culture no salmonella, Shigella or Campylobacter isolated, No E. coli O157:H7 Isolate; Fecal leukocytes absent. After rehydration overnight, he had improvement in activity and tolerated multiple feeds of PEDIALYTE off fluids. He was discharged home on 27-SEP-2014 and recommended primary care follow-up within 1 week. It was recommended that feeding include PEDIALYTE with reintroduction of formula as he tolerates. The patient was seen by PCP on 01-OCT-2014 and symptoms had resolved. The outcome of gastroenteritis was reported as Recovered. The event was not unexpected. This event is possibly related to vaccine ROTATEQ but more likely related to a viral gastroenteritis, per the opinion of investigator. Twin sibling (also enrolled in study) had wild gastroenteritis symptoms at the same time. Note that in package insert diarrhea and vomiting are solicited symptoms that can occur after vaccine ROTATEQ. Also in package insert gastroenteritis was reported as one of the more common following vaccine ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide decreased, Crying, Culture stool negative
Clinical narrative: This report refers to a 6 month old male patient enrolled in a study. On 08-MAY-2014, the patient was enrolled and vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015, dose 1, 2 ml, oral. On 11-JUL-2014, the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 2, 2 ml, oral and on 12-SEP-2014 the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 3, 2 ml, oral. On 16-SEP-2014 the patient experienced gastroenteritis. On 26-SEP-2014, the patient was admitted to the hospital for gastroenteritis. The parents reported a 10 day history of vomiting and diarrhea. The admission was thought likely due to prolonged viral gastroenteritis with possible post infection lactose intolerance. On presentation to the emergency department (ED), the patient was afebrile and vital signs were stable. Physical exam was significant to dehydration with dry mucosa membrane and crying without tears. While in the ED, the patient received 20 cc/kg bolus of normal saline, ZOFRAN and was the started on maintenance intravenous fluids (IVF). On 26-SEP-2014, the following lab test were performed: complete blood count: white blood cells 17.1, platelet 432.000, hemoglobin 14.3, Differential: 13 segmented neutrophils, 60 lymphocytes and 22 variant lymphocytes; metabolic panel Sodium 136 mmol/L; Chloride 110 mmol/L; potassium 4.0 mmol/L; Carbon Dioxide 17 mmol/L; urea nitrogen 9 mg/dL; creatinine 0.3 mg/dL; Calcium 10.8 mg/dl and glucose 92 mg/dL. On 27-SEP-2014 the following lab test were performed: Urine culture 100.000 Colonies/ml Escherichia Coli,10.000-100.0000 Colonies/ml Mixed flora and stool culture no salmonella, Shigella or Campylobacter isolated, No E. coli O157:H7 Isolate; Fecal leukocytes absent. After rehydration overnight, he had improvement in activity and tolerated multiple feeds of PEDIALYTE off fluids. He was discharged home on 27-SEP-2014 and recommended primary care follow-up within 1 week. It was recommended that feeding include PEDIALYTE with reintroduction of formula as he tolerates. The patient was seen by PCP on 01-OCT-2014 and symptoms had resolved. The outcome of gastroenteritis was reported as Recovered. The event was not unexpected. This event is possibly related to vaccine ROTATEQ but more likely related to a viral gastroenteritis, per the opinion of investigator. Twin sibling (also enrolled in study) had wild gastroenteritis symptoms at the same time. Note that in package insert diarrhea and vomiting are solicited symptoms that can occur after vaccine ROTATEQ. Also in package insert gastroenteritis was reported as one of the more common following vaccine ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Culture urine positive, Dehydration, Diarrhoea, Escherichia test, Gastroenteritis viral
Clinical narrative: This report refers to a 6 month old male patient enrolled in a study. On 08-MAY-2014, the patient was enrolled and vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015, dose 1, 2 ml, oral. On 11-JUL-2014, the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 2, 2 ml, oral and on 12-SEP-2014 the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 3, 2 ml, oral. On 16-SEP-2014 the patient experienced gastroenteritis. On 26-SEP-2014, the patient was admitted to the hospital for gastroenteritis. The parents reported a 10 day history of vomiting and diarrhea. The admission was thought likely due to prolonged viral gastroenteritis with possible post infection lactose intolerance. On presentation to the emergency department (ED), the patient was afebrile and vital signs were stable. Physical exam was significant to dehydration with dry mucosa membrane and crying without tears. While in the ED, the patient received 20 cc/kg bolus of normal saline, ZOFRAN and was the started on maintenance intravenous fluids (IVF). On 26-SEP-2014, the following lab test were performed: complete blood count: white blood cells 17.1, platelet 432.000, hemoglobin 14.3, Differential: 13 segmented neutrophils, 60 lymphocytes and 22 variant lymphocytes; metabolic panel Sodium 136 mmol/L; Chloride 110 mmol/L; potassium 4.0 mmol/L; Carbon Dioxide 17 mmol/L; urea nitrogen 9 mg/dL; creatinine 0.3 mg/dL; Calcium 10.8 mg/dl and glucose 92 mg/dL. On 27-SEP-2014 the following lab test were performed: Urine culture 100.000 Colonies/ml Escherichia Coli,10.000-100.0000 Colonies/ml Mixed flora and stool culture no salmonella, Shigella or Campylobacter isolated, No E. coli O157:H7 Isolate; Fecal leukocytes absent. After rehydration overnight, he had improvement in activity and tolerated multiple feeds of PEDIALYTE off fluids. He was discharged home on 27-SEP-2014 and recommended primary care follow-up within 1 week. It was recommended that feeding include PEDIALYTE with reintroduction of formula as he tolerates. The patient was seen by PCP on 01-OCT-2014 and symptoms had resolved. The outcome of gastroenteritis was reported as Recovered. The event was not unexpected. This event is possibly related to vaccine ROTATEQ but more likely related to a viral gastroenteritis, per the opinion of investigator. Twin sibling (also enrolled in study) had wild gastroenteritis symptoms at the same time. Note that in package insert diarrhea and vomiting are solicited symptoms that can occur after vaccine ROTATEQ. Also in package insert gastroenteritis was reported as one of the more common following vaccine ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Haemoglobin normal, Lymphocyte count increased, Lymphocyte morphology abnormal, Mucosal dryness, Neutrophil count increased
Clinical narrative: This report refers to a 6 month old male patient enrolled in a study. On 08-MAY-2014, the patient was enrolled and vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015, dose 1, 2 ml, oral. On 11-JUL-2014, the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 2, 2 ml, oral and on 12-SEP-2014 the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 3, 2 ml, oral. On 16-SEP-2014 the patient experienced gastroenteritis. On 26-SEP-2014, the patient was admitted to the hospital for gastroenteritis. The parents reported a 10 day history of vomiting and diarrhea. The admission was thought likely due to prolonged viral gastroenteritis with possible post infection lactose intolerance. On presentation to the emergency department (ED), the patient was afebrile and vital signs were stable. Physical exam was significant to dehydration with dry mucosa membrane and crying without tears. While in the ED, the patient received 20 cc/kg bolus of normal saline, ZOFRAN and was the started on maintenance intravenous fluids (IVF). On 26-SEP-2014, the following lab test were performed: complete blood count: white blood cells 17.1, platelet 432.000, hemoglobin 14.3, Differential: 13 segmented neutrophils, 60 lymphocytes and 22 variant lymphocytes; metabolic panel Sodium 136 mmol/L; Chloride 110 mmol/L; potassium 4.0 mmol/L; Carbon Dioxide 17 mmol/L; urea nitrogen 9 mg/dL; creatinine 0.3 mg/dL; Calcium 10.8 mg/dl and glucose 92 mg/dL. On 27-SEP-2014 the following lab test were performed: Urine culture 100.000 Colonies/ml Escherichia Coli,10.000-100.0000 Colonies/ml Mixed flora and stool culture no salmonella, Shigella or Campylobacter isolated, No E. coli O157:H7 Isolate; Fecal leukocytes absent. After rehydration overnight, he had improvement in activity and tolerated multiple feeds of PEDIALYTE off fluids. He was discharged home on 27-SEP-2014 and recommended primary care follow-up within 1 week. It was recommended that feeding include PEDIALYTE with reintroduction of formula as he tolerates. The patient was seen by PCP on 01-OCT-2014 and symptoms had resolved. The outcome of gastroenteritis was reported as Recovered. The event was not unexpected. This event is possibly related to vaccine ROTATEQ but more likely related to a viral gastroenteritis, per the opinion of investigator. Twin sibling (also enrolled in study) had wild gastroenteritis symptoms at the same time. Note that in package insert diarrhea and vomiting are solicited symptoms that can occur after vaccine ROTATEQ. Also in package insert gastroenteritis was reported as one of the more common following vaccine ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Platelet count normal, Urine analysis normal, Vital capacity normal, Vomiting, White blood cell count normal
Clinical narrative: This report refers to a 6 month old male patient enrolled in a study. On 08-MAY-2014, the patient was enrolled and vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015, dose 1, 2 ml, oral. On 11-JUL-2014, the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 2, 2 ml, oral and on 12-SEP-2014 the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 3, 2 ml, oral. On 16-SEP-2014 the patient experienced gastroenteritis. On 26-SEP-2014, the patient was admitted to the hospital for gastroenteritis. The parents reported a 10 day history of vomiting and diarrhea. The admission was thought likely due to prolonged viral gastroenteritis with possible post infection lactose intolerance. On presentation to the emergency department (ED), the patient was afebrile and vital signs were stable. Physical exam was significant to dehydration with dry mucosa membrane and crying without tears. While in the ED, the patient received 20 cc/kg bolus of normal saline, ZOFRAN and was the started on maintenance intravenous fluids (IVF). On 26-SEP-2014, the following lab test were performed: complete blood count: white blood cells 17.1, platelet 432.000, hemoglobin 14.3, Differential: 13 segmented neutrophils, 60 lymphocytes and 22 variant lymphocytes; metabolic panel Sodium 136 mmol/L; Chloride 110 mmol/L; potassium 4.0 mmol/L; Carbon Dioxide 17 mmol/L; urea nitrogen 9 mg/dL; creatinine 0.3 mg/dL; Calcium 10.8 mg/dl and glucose 92 mg/dL. On 27-SEP-2014 the following lab test were performed: Urine culture 100.000 Colonies/ml Escherichia Coli,10.000-100.0000 Colonies/ml Mixed flora and stool culture no salmonella, Shigella or Campylobacter isolated, No E. coli O157:H7 Isolate; Fecal leukocytes absent. After rehydration overnight, he had improvement in activity and tolerated multiple feeds of PEDIALYTE off fluids. He was discharged home on 27-SEP-2014 and recommended primary care follow-up within 1 week. It was recommended that feeding include PEDIALYTE with reintroduction of formula as he tolerates. The patient was seen by PCP on 01-OCT-2014 and symptoms had resolved. The outcome of gastroenteritis was reported as Recovered. The event was not unexpected. This event is possibly related to vaccine ROTATEQ but more likely related to a viral gastroenteritis, per the opinion of investigator. Twin sibling (also enrolled in study) had wild gastroenteritis symptoms at the same time. Note that in package insert diarrhea and vomiting are solicited symptoms that can occur after vaccine ROTATEQ. Also in package insert gastroenteritis was reported as one of the more common following vaccine ROTATEQ. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: White blood cells stool negative
Clinical narrative: This report refers to a 6 month old male patient enrolled in a study. On 08-MAY-2014, the patient was enrolled and vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015, dose 1, 2 ml, oral. On 11-JUL-2014, the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 2, 2 ml, oral and on 12-SEP-2014 the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 3, 2 ml, oral. On 16-SEP-2014 the patient experienced gastroenteritis. On 26-SEP-2014, the patient was admitted to the hospital for gastroenteritis. The parents reported a 10 day history of vomiting and diarrhea. The admission was thought likely due to prolonged viral gastroenteritis with possible post infection lactose intolerance. On presentation to the emergency department (ED), the patient was afebrile and vital signs were stable. Physical exam was significant to dehydration with dry mucosa membrane and crying without tears. While in the ED, the patient received 20 cc/kg bolus of normal saline, ZOFRAN and was the started on maintenance intravenous fluids (IVF). On 26-SEP-2014, the following lab test were performed: complete blood count: white blood cells 17.1, platelet 432.000, hemoglobin 14.3, Differential: 13 segmented neutrophils, 60 lymphocytes and 22 variant lymphocytes; metabolic panel Sodium 136 mmol/L; Chloride 110 mmol/L; potassium 4.0 mmol/L; Carbon Dioxide 17 mmol/L; urea nitrogen 9 mg/dL; creatinine 0.3 mg/dL; Calcium 10.8 mg/dl and glucose 92 mg/dL. On 27-SEP-2014 the following lab test were performed: Urine culture 100.000 Colonies/ml Escherichia Coli,10.000-100.0000 Colonies/ml Mixed flora and stool culture no salmonella, Shigella or Campylobacter isolated, No E. coli O157:H7 Isolate; Fecal leukocytes absent. After rehydration overnight, he had improvement in activity and tolerated multiple feeds of PEDIALYTE off fluids. He was discharged home on 27-SEP-2014 and recommended primary care follow-up within 1 week. It was recommended that feeding include PEDIALYTE with reintroduction of formula as he tolerates. The patient was seen by PCP on 01-OCT-2014 and symptoms had resolved. The outcome of gastroenteritis was reported as Recovered. The event was not unexpected. This event is possibly related to vaccine ROTATEQ but more likely related to a viral gastroenteritis, per the opinion of investigator. Twin sibling (also enrolled in study) had wild gastroenteritis symptoms at the same time. Note that in package insert diarrhea and vomiting are solicited symptoms that can occur after vaccine ROTATEQ. Also in package insert gastroenteritis was reported as one of the more common following vaccine ROTATEQ. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 08-JUN-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: J009706, expiration date: 15-AUG-2015. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Axillary pain, Blood test, Culture urine, Injection site pain, Injection site vesicles
Clinical narrative: Blister inflammation on the site of injection. Pain on the site, latter patient feverish. Temp 104F - Patient went to ER took BENADRYL, BRUFEN, TYLENOL for fever.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Blood test, Injection site inflammation, Injection site pain, Injection site vesicles, Pyrexia
Clinical narrative: Blister inflammation on the site of injection. Pain on the site, latter patient feverish. Temp 104F - Patient went to ER took BENADRYL, BRUFEN, TYLENOL for fever.
Age: 0.15
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 8 week old infant patient of unknown gender. The patient was born prematurely (term not specified) and had a twin (twin case captured in MARRS# 1409USA014180). On 08-SEP-2014 the patient was vaccinated intramuscularly with a first dose of RECOMBIVAX HB (0.5ml, lot# and expiration date were not reported). The reporter stated that the patient inadvertently received the second dose of RECOMBIVAX HB (0.5 ml, intramuscular, lot# reported as K004989, expiration date 14-NOV-2015) on 26-SEP-2014 (19 days from the first dose). No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of two reports received from the same reporter. Additional information has been requested.
Age: 0.15
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 8 week old infant patient of unknown gender. The patient was born prematurely (term not specified) and had a twin (twin case captured in MARRS# 1409USA014180). On 08-SEP-2014 the patient was vaccinated intramuscularly with a first dose of RECOMBIVAX HB (0.5ml, lot# and expiration date were not reported). The reporter stated that the patient inadvertently received the second dose of RECOMBIVAX HB (0.5 ml, intramuscular, lot# reported as K004989, expiration date 14-NOV-2015) on 26-SEP-2014 (19 days from the first dose). No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of two reports received from the same reporter. Additional information has been requested.
Age: 0.15
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 8 week old infant patient of unknown gender. The patient was born prematurely (term not specified) and had a twin case captured in MARRS#1410USA003002). On 08-SEP-2014 the patient was vaccinated intramuscularly with a first dose of RECOMBIVAX HB (0.5ml, lot# and expiration date were not reported). The reporter stated that the patient inadvertently received the second dose of RECOMBIVAX HB (0.5ml, intramuscular, lot# reported as K004989, expiration date 14-NOV-2015) on 26-SEP-2014 (19 days from the first dose). No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of two reports received from the same reporter. Additional information has been requested.
Age: 0.15
Sex: U
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 8 week old infant patient of unknown gender. The patient was born prematurely (term not specified) and had a twin case captured in MARRS#1410USA003002). On 08-SEP-2014 the patient was vaccinated intramuscularly with a first dose of RECOMBIVAX HB (0.5ml, lot# and expiration date were not reported). The reporter stated that the patient inadvertently received the second dose of RECOMBIVAX HB (0.5ml, intramuscular, lot# reported as K004989, expiration date 14-NOV-2015) on 26-SEP-2014 (19 days from the first dose). No adverse effects were reported. No PQC (product quality complaint) was involved. This is the one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX reported as (vial 19,400 unit 1 standard package vial of 1) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored ZOSTAVAX was administered to patients and no adverse effects were noted. Follow up information was received from the registered nurse. The registered nurse stated that she did not have patient identifiers or dates of vaccine administration available at that time. On an unknown date unspecified number of patients were vaccinated with ZOSTAVAX (lot# reported as J014567, expiration date reported as 18-FEB-2015). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 14 year old male patient. On an unknown date the patient started therapy with of M-M-R II (route, dose, frequency and lot # not reported). It was reported that the patient was administered two doses of M-M-R II as indicated (on an unspecified dates) and subsequently had titers drawn on an unspecified date which came back negative for Rubella. The physician reported that the patient was administered then with the third dose of M-M-R II on an unspecified date because of this. The outcomes of the events and relatedness between the events and M-M-R II were not reported. Additional information is not expected as there is no consent to contact physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients who have received improperly stored doses of PROQUAD (Merck). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no drug reactions or allergies and with no medical history. On 26-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered subcutaneously (0.65 ml, lot # K007989 with expiry date: 03-SEP-2015, reported as: 20-SEP-2015), therapy reason for use: vaccination. No concomitant medications were reported. Post administration of ZOSTAVAX, on 01-OCT-2014, the patient noticed red spots/rash the size of a dime, one above and one below injection sites. On 02-OCT-2014 (reported as this morning), an additional red spot/rash appeared on her bicep. Then, on 02-OCT-2014, the physician assistant called and reported that the patient presented to her with the VZVID packet, and the physician assistant stated that the patient's rash "definitely looks like shingles". The outcome of the event was unknown. No laboratory test were performed and no treatment was given. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no drug reactions or allergies and with no medical history. On 26-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered subcutaneously (0.65 ml, lot # K007989 with expiry date: 03-SEP-2015, reported as: 20-SEP-2015), therapy reason for use: vaccination. No concomitant medications were reported. Post administration of ZOSTAVAX, on 01-OCT-2014, the patient noticed red spots/rash the size of a dime, one above and one below injection sites. On 02-OCT-2014 (reported as this morning), an additional red spot/rash appeared on her bicep. Then, on 02-OCT-2014, the physician assistant called and reported that the patient presented to her with the VZVID packet, and the physician assistant stated that the patient's rash "definitely looks like shingles". The outcome of the event was unknown. No laboratory test were performed and no treatment was given. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. Approximately on 25-SEP-2014, (as reported that the patient was now in her office) the patient was vaccinated with GARDASIL dose 3 (dose strength unknown). No concomitant medication was reported. Nurse practitioner reports that the patient was administered the 1st and 2nd doses in the GARDASIL series in April 2009 and June 2009 respectively. Nurse practitioner reports that the patient was now (approximately on 25-SEP-2014) in her office to receive the 3rd dose of the GARDASIL series. No adverse effect was reported. No further information was provided. The outcome of inappropriate schedule of vaccine administration was unknown. No PQC involved. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 year old patient. On 02-OCT-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot # H018014, expiry date: 01-OCT-2014), 0.5 ml, subcutaneous. The (Oka/Merck) VARIVAX had expired on 01-OCT-2014. No adverse effects were reported. The outcome of the event was unknown. Additional information is not expected since the reporter could not be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients who have received improperly stored doses of VARIVAX (Merck). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a health care worker refers to a 17 year old female patient with no medical history and with no drug reactions or allergies. On 18-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (lot #: J009166, expiration date: 24-JUL-2014; subcutaneous, dose, anatomical location not reported) to prevent chickenpox. There were no concomitant medications. On 19-SEP-2014 the patient went to see the physician with a complaint of cough. While the patient was at the physician office, she mentioned that she was pregnant (first trimester of exposure). The date of last menstrual period (LMP), estimated delivery date (EDD) and the gestation age was not reported. There were no laboratory test performed. The outcome of "while she was at the physician's office she also mentioned that she was pregnant was" unknown. The pregnancy outcome was outcome pending. The outcome of cough was reported as not recovered/not resolved. There was no treatment given for the cough. The relatedness between the event of cough and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker refers to a 14 year old patient of unknown gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. The patient was vaccinated with doses of VARIVAX (Merck) subsequently on 05-DEC-2000, 11-JUL-2011 and 26-SEP-2014 (doses, routes and sites of injection, lot# and expiration dates unknown). No adverse symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unkonwn age (the reporter's spouse). It was reported that the reporter's spouse had been exposed (date unspecified) and on an unspecified date, at age of 41 years, was vaccinated with a dose of GARDASIL injection (dose, dose number, lot/batch number, expiration date were not reported) through an obstetrics and gynecology (OB-GYN). No product quality complaint (PQC) involved. The reporter asked for guidance as stated he needed to get the vaccine but from where he contacted it was only provided to those under age 26. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker, (medical assistant (M.A.), also reported as registered nurse (RN)) refers to a patient of unkown age and gender. Medical history and drug reactions or allergies were not specified. On 27-AUG-2014, the patient was vaccinated with a dose of PROQUAD (Merck) injection, lot number K005645, expiration date 17-OCT-2015, 0.5 ml once, subcutaneously, that was stored at 42.9 (also reported as 43) degrees Fahrenheit for 744 hours (temperature excursion date reported as 25-AUG-2014). No adverse effects were reported. Concomitant medications were not specified. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report as received from a physician via field representative refers to a 18 year old male patient. On an unknown date the patient was vaccinated with the third dose in the series of GARDASIL (route, dose and lot # not reported). One week later the patient presented with genital warts. The reporting physician referred the patient to a dermatologist. Treatment was given. The patient was evaluated by the physician. Outcome of the event was not reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Breast enlargement, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a nurse practitioner via field representative refers to a female patient of unknown date. No pertinent history was reported. On 04-DEC-2013 (also reported as 05-DEC-2013) the patient was vaccinated with MMR II 1 single shot for the prevention of MMR II. Concomitant medications was reported as none. On an unknown date, the patient experienced lymph node enlargement in the sub occipital region on the left side of her neck and on the left auxillary, mammary gland enlargement on the left side and the lymph nodes in the post cervical region was enlarged. Patient sought medical attention. No treatment was given. The outcome of events was reported as recovered on an unknown date. Causality assessment was not provided by the reporter. No Product Quality Complaint (PQC) was involved. Additional information has been requested.