chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Ear pain, Headache, Increased upper airway secretion, Myalgia, Nasal congestion
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02350. Initial report was received from a health care professional on 24 February 2012. A 10-year-old female patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of DTaP (manufacturers, lot numbers, routes and sites not reported) on 28 August 2001, 25 November 2001, 13 December 2001 and 26 December 2002. The patient had received a 0.5ml dose 5 injection of DTaP (manufacturer, lot number, route and site not reported) on 15 May 2006. On the same date, the patient also received a 0.5ml dose 4 injection of IPV and a 0.5ml dose 2 injection of MMR (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 24 January 2012 with complaints of coughing fits for over a week, congestion only at nose, bringing up mucus with cough, feels nauseous after cough, shortness of breath (SOB), sore throat, achy, dizzy, ear pain, headache, poor appetite, diarrhea, croup and asthma. Upon examination, the patient had nasal congestion and lungs were clear to auscultation bilaterally with no wheeze or crackles. The physician's assessment was bronchitis, cough, reactive airways disease (RAD) and diarrhea. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, FLOVENT and albuterol. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of MRSA, refractive error, infantile asthma, influenza, allergic rhinitis, strep, otitis media (OM), vomiting, breast milk allergy and soy allergy. The patient was up-to-date with HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father had a medical history of environmental allergies, asthma and sinus infections. The patient's mother had a medical history of sinus infections, environmental allergies and eczema. The patient's brother had a medical history of asthma. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Nausea, Oropharyngeal pain, Pain, Pertussis, Polymerase chain reaction
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02350. Initial report was received from a health care professional on 24 February 2012. A 10-year-old female patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of DTaP (manufacturers, lot numbers, routes and sites not reported) on 28 August 2001, 25 November 2001, 13 December 2001 and 26 December 2002. The patient had received a 0.5ml dose 5 injection of DTaP (manufacturer, lot number, route and site not reported) on 15 May 2006. On the same date, the patient also received a 0.5ml dose 4 injection of IPV and a 0.5ml dose 2 injection of MMR (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 24 January 2012 with complaints of coughing fits for over a week, congestion only at nose, bringing up mucus with cough, feels nauseous after cough, shortness of breath (SOB), sore throat, achy, dizzy, ear pain, headache, poor appetite, diarrhea, croup and asthma. Upon examination, the patient had nasal congestion and lungs were clear to auscultation bilaterally with no wheeze or crackles. The physician's assessment was bronchitis, cough, reactive airways disease (RAD) and diarrhea. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, FLOVENT and albuterol. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of MRSA, refractive error, infantile asthma, influenza, allergic rhinitis, strep, otitis media (OM), vomiting, breast milk allergy and soy allergy. The patient was up-to-date with HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father had a medical history of environmental allergies, asthma and sinus infections. The patient's mother had a medical history of sinus infections, environmental allergies and eczema. The patient's brother had a medical history of asthma. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Productive cough, Rhinorrhoea
Clinical narrative: This case is a cluster of 6 patients who tested positive for pertussis following administration of DTaP. The 5 other patients are captured in case numbers 2012-01240, 2012-02345, 2012-02347, 2012-02348 and 2012-02350. Initial report was received from a health care professional on 24 February 2012. A 10-year-old female patient had received 4 previous injections of DTaP: Doses 1, 2, 3 and 4 of DTaP (manufacturers, lot numbers, routes and sites not reported) on 28 August 2001, 25 November 2001, 13 December 2001 and 26 December 2002. The patient had received a 0.5ml dose 5 injection of DTaP (manufacturer, lot number, route and site not reported) on 15 May 2006. On the same date, the patient also received a 0.5ml dose 4 injection of IPV and a 0.5ml dose 2 injection of MMR (manufacturers, lot numbers, routes and sites not reported). The patient was seen on 24 January 2012 with complaints of coughing fits for over a week, congestion only at nose, bringing up mucus with cough, feels nauseous after cough, shortness of breath (SOB), sore throat, achy, dizzy, ear pain, headache, poor appetite, diarrhea, croup and asthma. Upon examination, the patient had nasal congestion and lungs were clear to auscultation bilaterally with no wheeze or crackles. The physician's assessment was bronchitis, cough, reactive airways disease (RAD) and diarrhea. A nasopharyngeal swab was performed. The patient's nasopharyngeal swab PCR results on 26 January 2012 were "Bordetella pertussis DNA detected. (Does not distinguish between B. pertussis and B. holmesii)." The patient was treated with azithromycin, FLOVENT and albuterol. The patient had no known drug allergies (NKDA) and took no concomitant medications. The patient had a past medical history of MRSA, refractive error, infantile asthma, influenza, allergic rhinitis, strep, otitis media (OM), vomiting, breast milk allergy and soy allergy. The patient was up-to-date with HepB, Hib, IPV/OPV, PREVNAR, MMR, Varicella, HepA and Flu vaccinations. The patient's father had a medical history of environmental allergies, asthma and sinus infections. The patient's mother had a medical history of sinus infections, environmental allergies and eczema. The patient's brother had a medical history of asthma. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: Medical records.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Culture positive, Laboratory test abnormal
Clinical narrative: Initial report received on 23 February 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 22-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3614AA received on 01 June 2010, lot number C3683AA received on 18 August 2010 and lot number C3669AA received on 11 October 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 19 January 2012, approximately 1 year and 3 months after the last dose. The subject also experienced paroxysmal cough, posttussive vomiting and apnea (onset dates not reported). Laboratory testing included positive PCR on 02 February 2012 and positive culture on 03 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 February 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 February 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL. This patient had not received the booster dose that is recommended at 15-18 months of age. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 51 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 February 2012. These 51 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Nasopharyngitis, Pertussis, Polymerase chain reaction, Post-tussive vomiting
Clinical narrative: Initial report received on 23 February 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 22-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3614AA received on 01 June 2010, lot number C3683AA received on 18 August 2010 and lot number C3669AA received on 11 October 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms and a cough on 19 January 2012, approximately 1 year and 3 months after the last dose. The subject also experienced paroxysmal cough, posttussive vomiting and apnea (onset dates not reported). Laboratory testing included positive PCR on 02 February 2012 and positive culture on 03 February 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 03 February 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 February 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL. This patient had not received the booster dose that is recommended at 15-18 months of age. Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 51 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 February 2012. These 51 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Sex: F
Vaccine: DTAP
Symptoms: Respiratory distress
Clinical narrative: Initial report was received from another manufacturer on 22 February 2012 (Service Request Number 1-4886311402). A female patient had received a dose 3 injection of DTAP (manufacturer, lot number, date, site and route of administration not reported) and an unspecified amount of time later went into respiratory distress. The patient was taken to the emergency room and released. The patient also developed hives and swollen lips with other vaccines (unspecified). Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Bordetella test positive, Chest X-ray normal, Cough, Laboratory test abnormal
Clinical narrative: Initial report received on 23 February 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3635AA received on 24 August 2010, lot number C3664AA received on 11 October 2010 and lot number C3732AA received on 13 December 2010 (routes and sites of administration not reported). On 08 December 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 21 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 01 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 55 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL (this patient was due for a booster dose). Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 51 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 February 2012. These 51 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder, Vaccination failure
Clinical narrative: Initial report received on 23 February 2012 from the Investigator participating in a study under the reference number M5A16. A case of pertussis disease in a 17-month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3635AA received on 24 August 2010, lot number C3664AA received on 11 October 2010 and lot number C3732AA received on 13 December 2010 (routes and sites of administration not reported). On 08 December 2011, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance, and apnea. Laboratory testing included positive PCR on 21 December 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 December 2011 for 5 days. The subject was not hospitalized. At the time of final contact on 01 February 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 55 days. Investigator causality assessment is not required as per protocol. Company Medical Assessment: No vaccine protects 100% of individuals against infection and it is not unexpected to find cases of pertussis after only 3 doses of PENTACEL (this patient was due for a booster dose). Because this case was solicited from an electronic database, medical records are not available so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. This is one case out of a cumulative total of 51 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 February 2012. These 51 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test normal, Lumbar puncture, Nerve conduction studies
Clinical narrative: Good health and active up until 1st of December 2011. Received the flu shot 11/16/2011. Started feeling tingling in hands & feet, nose, left ear and then all over. Had an electrified feeling all over. Went to doctor 12/14/11. Emergency room 12/17/11, neurologist 12/29/11, hospital 12/30/11. Was released on 1/3/12. Treated for "GBS" with "IVIG" drug. Still have most of the tingling all over.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia
Clinical narrative: Good health and active up until 1st of December 2011. Received the flu shot 11/16/2011. Started feeling tingling in hands & feet, nose, left ear and then all over. Had an electrified feeling all over. Went to doctor 12/14/11. Emergency room 12/17/11, neurologist 12/29/11, hospital 12/30/11. Was released on 1/3/12. Treated for "GBS" with "IVIG" drug. Still have most of the tingling all over.
Age: 59.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome, Nerve conduction studies abnormal, Sensory loss
Clinical narrative: Good health and active up until 1st of December 2011. Received the flu shot 11/16/2011. Started feeling tingling in hands & feet, nose, left ear and then all over. Had an electrified feeling all over. Went to doctor 12/14/11. Emergency room 12/17/11, neurologist 12/29/11, hospital 12/30/11. Was released on 1/3/12. Treated for "GBS" with "IVIG" drug. Still have most of the tingling all over.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Aphasia, Computerised tomogram head, Computerised tomogram normal, Condition aggravated
Clinical narrative: Information has been received from an office manager and a doctor of pharmacy concerning the pharmacist's 15 year old daughter with drug allergy to CEFZIL and a history of migraine, headaches and allergies who on 27-DEC-2011 (also reported as 25-JAN-2012, by the pharmacist) was vaccinated IM with the first and only 0.5ml dose of GARDASIL (lot #670048/0963AA) (site not reported). No other vaccines were given concomitantly. Concomitant therapy included ZYRTEC as needed. The doctor of pharmacy reported that on 24-FEB-2012 (also reported as "last week"), the patient had her first migraine-induced seizure and was taken to ER. An electrocardiogram, electroencephalogram and computed tomography (CT) scan of the brain were normal. The patient was unable to walk, talk and her vision was blurred for several hours after the seizure. On 27-FEB-2012 the patient experienced her second seizure but with only blurred vision for a shorter period of time. The patient was prescribed TOPAMAX. A repeat CT scan and electroencephalogram were scheduled. The patient was scheduled to see a neurologist on 19-MAR-2012. The doctor of pharmacy did not consider the events to be disabling or life threatening. The physician's office manager stated that she was not aware of the adverse event. At the time of the report, the patient's outcome was unknown. Upon internal review, migraine-induced seizure and seizure were determined to be other important medical events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electrocardiogram normal, Electroencephalogram normal, Migraine, Vision blurred
Clinical narrative: Information has been received from an office manager and a doctor of pharmacy concerning the pharmacist's 15 year old daughter with drug allergy to CEFZIL and a history of migraine, headaches and allergies who on 27-DEC-2011 (also reported as 25-JAN-2012, by the pharmacist) was vaccinated IM with the first and only 0.5ml dose of GARDASIL (lot #670048/0963AA) (site not reported). No other vaccines were given concomitantly. Concomitant therapy included ZYRTEC as needed. The doctor of pharmacy reported that on 24-FEB-2012 (also reported as "last week"), the patient had her first migraine-induced seizure and was taken to ER. An electrocardiogram, electroencephalogram and computed tomography (CT) scan of the brain were normal. The patient was unable to walk, talk and her vision was blurred for several hours after the seizure. On 27-FEB-2012 the patient experienced her second seizure but with only blurred vision for a shorter period of time. The patient was prescribed TOPAMAX. A repeat CT scan and electroencephalogram were scheduled. The patient was scheduled to see a neurologist on 19-MAR-2012. The doctor of pharmacy did not consider the events to be disabling or life threatening. The physician's office manager stated that she was not aware of the adverse event. At the time of the report, the patient's outcome was unknown. Upon internal review, migraine-induced seizure and seizure were determined to be other important medical events. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site swelling, Oedema peripheral, Swelling face
Clinical narrative: Parent reported that patient woke from nap with swelling of right leg and puffiness of right arm and right face.  There were no problems with breathing or swallowing and no rash.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Nausea; Vomiting; fever; chills; fatigue; malaise; arthralgias; arm soreness; Dizziness; Headache; Tongue edema.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Tongue oedema
Clinical narrative: Nausea; Vomiting; fever; chills; fatigue; malaise; arthralgias; arm soreness; Dizziness; Headache; Tongue edema.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; fever; chills; fatigue; malaise; arthralgias; arm soreness; Dizziness; Headache; Tongue edema.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (also the subject's aunt), via a sales representative, and described the occurrence of arm pain after injection in a 6-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), MMRV vaccine (non-gsk). On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, unknown route, left arm), unspecified dose of MMRV vaccine (Non-GSK) (unknown route, left arm). Less than one day after vaccination with KINRIX and MMRV vaccine (Non-GSK), "within 24 hours", the subject experienced arm pain after injection, arm red after injection, swelling of arm following injection and skin rash on injection area. The KINRIX and MMRV were administered at different sites in the left arm. Within 24 hours from receiving the vaccines, the subject experienced "severe" pain in left arm, "looks like a diffuse rash from left shoulder to elbow", and redness and swollen from the left shoulder to elbow. The subject was taken to the emergency department and was treated with non-steroidal anti-inflammatory (Nsaid), prednisone and antihistamine. The subject was seen by his pediatrician the next day and the symptoms were improved. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). The subject was treated with non-steroidal and anti-inflammatory (Nsaid), prednisone and antihistamine. At the time of reporting the events were improved.
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Foetal disorder, Maternal exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of ligament laxity in a male newborn exposed to BOOSTRIX (GlaxoSmithKline) taken by the mother during pregnancy. The mother of the subject's medical history included one previous pregnancy resulting in normal birth of a full-term infant. On 4 October 2011 the mother of the subject received a dose of BOOSTRIX (.5 ml, intramuscular, unknown site). The baby experienced maternal vaccine exposure during the third trimester of the pregnancy. The mother was approximately 29 weeks gestation at the time of vaccination. The conception was reported as normal. The mother's date of last menstrual period was 17 February 2011 and her estimated date of delivery was 15 December 2011. Unspecified prenatal testing had revealed no evidence of a defect. Follow-up information was received on 28 February 2012. The mother's conception was reported to be normal. Concurrent medication taken by the mother included FLUVIRIN (starting at 29 weeks), Ranitidine (starting at 29 weeks), Prenatal Plus Vitamins (starting at 20 weeks), Acetaminophen (starting at 20 weeks), FLAGYL (starting at 29 weeks) and Amoxicillin (starting at 10 6/7 weeks). The mother of the subject had a history of one, normal vaginal delivery. There was no relevant, maternal, family medical history. No maternal history of alcohol or tobacco use. There was no relevant, paternal, family medical history including no illnesses, no birth defects (genetic or chromosomal disorders), no substance abuse and no vaccinations. It was reported that the male neonate was delivered on 21 December 2011, at 40 weeks gestation via normal vaginal delivery. The neonate weighed 8 pounds and 7 ounces. APGAR scores at 1 and 5 minutes following birth were 09 and 09 respectively. A defect of left foot ligament laxity, inverted, but easily reducing to midline was reported. The event was reported to be mild (not serious) and it was noted that the condition would be monitored. Not reported to have been related to vaccination. Mother case linked, A0948554A.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Within 2 days of administration of vaccine developed erythematous warm annular patch at site of injection - area tender to the touch.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site swelling
Clinical narrative: Per mom Hep A given to (L) thigh on 3/6/12 and swelling at site greater than 4 quarter. Mom applied ice, and by day 3 (today) sx improved to swelling size of 2 quarters. No fever or other sx.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Father states: day after vaccine, very painful, 3 inch diameter redness, firm, hot, left deltoid. On 3/8/12 in PM pt went with father to E.R. Tx: cold compress & ALLEGRA.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: (Lt) deltoid w/some erythema & edema. Has decreased since yesterday (pt had long sleeve shirt on, swelling noticed yesterday).
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Abnormal faeces, Blood immunoglobulin E normal, Culture stool negative, Diarrhoea, Feeling abnormal
Clinical narrative: Diarrhea 7-8 stools/in 8 hours, frank blood, mucous in stool. Denies fever, (+) fussiness, mom noticed approx 18 hours after administration. Prior to vacc. had slightly loose, odorous stools.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Haematochezia, Irritability, Metabolic function test normal, Mucous stools, Parasite stool test negative
Clinical narrative: Diarrhea 7-8 stools/in 8 hours, frank blood, mucous in stool. Denies fever, (+) fussiness, mom noticed approx 18 hours after administration. Prior to vacc. had slightly loose, odorous stools.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, FLUX, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Muscular weakness, Myelitis transverse, Paraesthesia
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 28-Feb-2012) concerns an 11-year-old female patient. On 05-Jan-2012 the patient received flu vaccine (manufacturer unknown). On the same day she also received MENACTRA, Tdap and the first dose of 0.5 mL GARDASIL injection. On 29-Jan-2012 the patient was evaluated by a physician for complaints of weakness and paresthesis in the legs. The patient was referred to another physician at a local hospital who diagnosed her with acute transverse myelitis. The patient was subsequently admitted to hospital. The patient was improving and attending physical therapy. The reporter considered events to be serious due to hospitalisation.
Sex: U
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received from a consumer concerning unspecified patients who on unspecified dates were vaccinated with doses of RECOMBIVAX HB. The consumer commented: "Was it true you made the hepatitis B shot they caused multiple sclerosis that you made the medicine that helped with sclerosis." At the time of the report, the patients' outcome was unknown. Upon internal review, multiple sclerosis was determined to be an other important medical event. This is one of the several reports received from the same source. No further information is available.
Sex: F
Vaccine: HEP
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received from a consumer concerning a female patient who on an unspecified date was vaccinated with an adult dose of RECOMBIVAX HB. The consumer reported that my baby's mother ended in the hospital with multiple sclerosis 6 months after the shot. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: HEP
Symptoms: Convulsion, Dyspnoea
Clinical narrative: Information has been received from an unspecified source concerning a child who on an unspecified date was vaccinated with a dose of pediatric RECOMBIVAX HB in hospital at discharge. Within 16 hours the patient developed dyspnea (shortness of breath) and convulsions. It was unknown if the patient sought medical attention. At the time of reporting, the status of the patient was unknown. Upon internal review, convulsions was considered to be an other important medical event. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Alanine aminotransferase normal, Blood albumin normal, Blood creatinine normal, Blood smear test normal, Borrelia test
Clinical narrative: Initial report received from a health care professional on 25 April 2011. A 14-year-old male patient with a medical history of vasovagal syncope on 09 September 2010 (case 2011-01493) after receiving MENACTRA and an allergy to penicillin, received on 09 September 2010 a left deltoid injection of MENACTRA, sanofi pasteur lot number U3515AA. On 23 March 2011, the patient was taken to the Emergency Room (ER) where his mother stated the patient had complained of lightheadedness, loss of consciousness (LOC), palpitations, staring, and slurred speech episodes which were unrelated to exercise. This episode lasted for one minute. There was no trauma, no shortness of breath, no nausea or vomiting and no chest pain. The mother stated that this occurred also last Sunday. Upon arrival the patient stated to the physician that he felt well, was awake and oriented to time, place and person. His vital signs upon arrival to the ER were as follows: blood pressure (B/P) 110/81, heart rate (HR) 76, respiratory rate (16), temperature (temp) 98.3 and an oxygen saturation of 100%. On 23 March 2011, the patient had a basic metabolic panel which showed a low creatinine of 0.6 mg/dL, a complete blood count which was normal, blood parasite smear which was negative (none observed), estimated glomerular filtration rate which was normal, liver panel which showed a high albumin of 5.2 g/dL and high alanine transaminase (ALT) 29 U/L, Lyme IGM AB, Lyme IGG AB and Lyme IGA A which were all negative. The patient on 23 March 2011 had a normal electrocardiogram (EKG), and a normal computed tomography (CT) scan. Upon discharge he was awake, alert and oriented to time, place and person and no seizure activity or neurological deficit was observed. The patient was to follow-up with the neurologist to have an EEG and has a schedule magnetic resonance imaging (MRI) for Friday. The ER discharge diagnosis was seizures and syncope. On 25 March 2011, the patient had an MRI of the brain which showed a normal study. The mother was concerned that the patient may be having "absence" seizures because the patient was having very brief blank stares for which he was being evaluated by a pediatric neurologist. The outcome was not reported. The patient had another event on 09 September 2010 which was reported in case 2011-01493 (vasovagal syncopal episode, seizure activity). Documents held by sender: Emergency Room records.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Borrelia test negative, Computerised tomogram normal, Convulsion, Dizziness, Dysarthria
Clinical narrative: Initial report received from a health care professional on 25 April 2011. A 14-year-old male patient with a medical history of vasovagal syncope on 09 September 2010 (case 2011-01493) after receiving MENACTRA and an allergy to penicillin, received on 09 September 2010 a left deltoid injection of MENACTRA, sanofi pasteur lot number U3515AA. On 23 March 2011, the patient was taken to the Emergency Room (ER) where his mother stated the patient had complained of lightheadedness, loss of consciousness (LOC), palpitations, staring, and slurred speech episodes which were unrelated to exercise. This episode lasted for one minute. There was no trauma, no shortness of breath, no nausea or vomiting and no chest pain. The mother stated that this occurred also last Sunday. Upon arrival the patient stated to the physician that he felt well, was awake and oriented to time, place and person. His vital signs upon arrival to the ER were as follows: blood pressure (B/P) 110/81, heart rate (HR) 76, respiratory rate (16), temperature (temp) 98.3 and an oxygen saturation of 100%. On 23 March 2011, the patient had a basic metabolic panel which showed a low creatinine of 0.6 mg/dL, a complete blood count which was normal, blood parasite smear which was negative (none observed), estimated glomerular filtration rate which was normal, liver panel which showed a high albumin of 5.2 g/dL and high alanine transaminase (ALT) 29 U/L, Lyme IGM AB, Lyme IGG AB and Lyme IGA A which were all negative. The patient on 23 March 2011 had a normal electrocardiogram (EKG), and a normal computed tomography (CT) scan. Upon discharge he was awake, alert and oriented to time, place and person and no seizure activity or neurological deficit was observed. The patient was to follow-up with the neurologist to have an EEG and has a schedule magnetic resonance imaging (MRI) for Friday. The ER discharge diagnosis was seizures and syncope. On 25 March 2011, the patient had an MRI of the brain which showed a normal study. The mother was concerned that the patient may be having "absence" seizures because the patient was having very brief blank stares for which he was being evaluated by a pediatric neurologist. The outcome was not reported. The patient had another event on 09 September 2010 which was reported in case 2011-01493 (vasovagal syncopal episode, seizure activity). Documents held by sender: Emergency Room records.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Electrocardiogram normal, Full blood count normal, Glomerular filtration rate normal, Loss of consciousness, Metabolic function test
Clinical narrative: Initial report received from a health care professional on 25 April 2011. A 14-year-old male patient with a medical history of vasovagal syncope on 09 September 2010 (case 2011-01493) after receiving MENACTRA and an allergy to penicillin, received on 09 September 2010 a left deltoid injection of MENACTRA, sanofi pasteur lot number U3515AA. On 23 March 2011, the patient was taken to the Emergency Room (ER) where his mother stated the patient had complained of lightheadedness, loss of consciousness (LOC), palpitations, staring, and slurred speech episodes which were unrelated to exercise. This episode lasted for one minute. There was no trauma, no shortness of breath, no nausea or vomiting and no chest pain. The mother stated that this occurred also last Sunday. Upon arrival the patient stated to the physician that he felt well, was awake and oriented to time, place and person. His vital signs upon arrival to the ER were as follows: blood pressure (B/P) 110/81, heart rate (HR) 76, respiratory rate (16), temperature (temp) 98.3 and an oxygen saturation of 100%. On 23 March 2011, the patient had a basic metabolic panel which showed a low creatinine of 0.6 mg/dL, a complete blood count which was normal, blood parasite smear which was negative (none observed), estimated glomerular filtration rate which was normal, liver panel which showed a high albumin of 5.2 g/dL and high alanine transaminase (ALT) 29 U/L, Lyme IGM AB, Lyme IGG AB and Lyme IGA A which were all negative. The patient on 23 March 2011 had a normal electrocardiogram (EKG), and a normal computed tomography (CT) scan. Upon discharge he was awake, alert and oriented to time, place and person and no seizure activity or neurological deficit was observed. The patient was to follow-up with the neurologist to have an EEG and has a schedule magnetic resonance imaging (MRI) for Friday. The ER discharge diagnosis was seizures and syncope. On 25 March 2011, the patient had an MRI of the brain which showed a normal study. The mother was concerned that the patient may be having "absence" seizures because the patient was having very brief blank stares for which he was being evaluated by a pediatric neurologist. The outcome was not reported. The patient had another event on 09 September 2010 which was reported in case 2011-01493 (vasovagal syncopal episode, seizure activity). Documents held by sender: Emergency Room records.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Nuclear magnetic resonance imaging brain normal, Palpitations, Parasite blood test, Staring, Syncope
Clinical narrative: Initial report received from a health care professional on 25 April 2011. A 14-year-old male patient with a medical history of vasovagal syncope on 09 September 2010 (case 2011-01493) after receiving MENACTRA and an allergy to penicillin, received on 09 September 2010 a left deltoid injection of MENACTRA, sanofi pasteur lot number U3515AA. On 23 March 2011, the patient was taken to the Emergency Room (ER) where his mother stated the patient had complained of lightheadedness, loss of consciousness (LOC), palpitations, staring, and slurred speech episodes which were unrelated to exercise. This episode lasted for one minute. There was no trauma, no shortness of breath, no nausea or vomiting and no chest pain. The mother stated that this occurred also last Sunday. Upon arrival the patient stated to the physician that he felt well, was awake and oriented to time, place and person. His vital signs upon arrival to the ER were as follows: blood pressure (B/P) 110/81, heart rate (HR) 76, respiratory rate (16), temperature (temp) 98.3 and an oxygen saturation of 100%. On 23 March 2011, the patient had a basic metabolic panel which showed a low creatinine of 0.6 mg/dL, a complete blood count which was normal, blood parasite smear which was negative (none observed), estimated glomerular filtration rate which was normal, liver panel which showed a high albumin of 5.2 g/dL and high alanine transaminase (ALT) 29 U/L, Lyme IGM AB, Lyme IGG AB and Lyme IGA A which were all negative. The patient on 23 March 2011 had a normal electrocardiogram (EKG), and a normal computed tomography (CT) scan. Upon discharge he was awake, alert and oriented to time, place and person and no seizure activity or neurological deficit was observed. The patient was to follow-up with the neurologist to have an EEG and has a schedule magnetic resonance imaging (MRI) for Friday. The ER discharge diagnosis was seizures and syncope. On 25 March 2011, the patient had an MRI of the brain which showed a normal study. The mother was concerned that the patient may be having "absence" seizures because the patient was having very brief blank stares for which he was being evaluated by a pediatric neurologist. The outcome was not reported. The patient had another event on 09 September 2010 which was reported in case 2011-01493 (vasovagal syncopal episode, seizure activity). Documents held by sender: Emergency Room records.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: This case is part of a cluster of three children who received DAPTACEL (lot number C3718AA) and each developed vaccination site and/or localized reactions. Initial report received on 27 April 2011 from a health professional. A 15 month old female patient, with no known allergies and no concomitant medications, received a fourth intramuscular dose of DAPTACEL (lot number C3718AA) at an unknown site and a fourth left deltoid intramuscular injection of ACT-HIB (lot number UH318AA, which corresponds to sanofi pasteur SA lot number G1103-1) on 25 April 2011. The patient had no illness at the time of vaccination. On 26 April 2011, the patient had swelling and firmness at the vaccine site (arm unknown). The patient's recovery status was unknown. Follow-up information was received from a health care professional on 27 May 2011. The patient's outcome was reported as recovered (date not reported). The events for the other two children are captured in cases 2011-02509 and 2011-02508. Documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a nurse concerning a 24 year old female who on an unknown date was vaccinated with 3 dose series of RECOMBIVAX HB (dose, route and lot # not reported). It was reported that the patient "had a negative titer" after completing the 3 dose series of RECOMBIVAX HB. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. Follow up information has been received from the nurse who did not have any information the person was hired. She stated that she had the series of RECOMBIVAX HB (dose, route and lot# not reported) injection, but she had no immunity on the blood work. This is an amended report. The trade name for primary therapy was changed from RECOMBIVAX to RECOMBIVAX HB. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B
Clinical narrative: Information has been received from a registered nurse concerning a 17 year old female patient who on unspecified dates was vaccinated with the full set of RECOMBIVAX HB (lot number, dose and site of administration not reported). On an unspecified date, after vaccination, it was found that the patient had Hepatitis B. It was not known whether the patient had Hepatitis B since before vaccinations. The patient contacted health department. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. No further information is available.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Injury associated with device
Clinical narrative: Information has been received from a 57 year old female registered nurse consumer who in 2000 was vaccinated with the 3 dose series of RECOMBIVAX HB (lot #s not reported) (manufacturer unknown). The consumer experienced another needle stick 10 years later and a titer was drawn. The titer was negative and she received another 3 dose series of RECOMBIVAX HB (lot #s not reported) (manufacturer unknown). Not titer was drawn after the series. The consumer sought medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on unspecified dates was vaccinated with three doses of RECOMBIVAX HB (dose, route, and lot # not reported). The registered nurse stated that later the patient did not have protective titer levels. No medical intervention was needed. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response, Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients who "during the past two years" was vaccinated with dose of RECOMBIVAX HB (route, dose and lot number not reported) for the treatment for liver disease. Nurse reported that the multiple unspecified patient being treated for liver disease and failed to seroconvert after being vaccinated. Nurse reported that patients who failed to seroconvert were administered a second series of hepatitis B vaccine, it was unknown whether all affected patients received the second series with RECOMBIVAX HB or with another hepatitis B vaccine. Nurse stated she did not have any patient specified information available. Patients had sought unspecified medical attention and at the time of reporting, outcome of the events were unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is an amended report. Upon internal review, the low level term of adverse event has been changed from "Anti-Hbs antibody negative" to "Hepatitis B antibody negative", the preferred term has been changed from "Hepatitis B surface antibody negative" to "Hepatitis b antibody negative". The lab test term has been changed from "serum hepatitis B surface antibody screen" to "serum hepatitis B antibody test". Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site mass, Myalgia, Wrong drug administered
Clinical narrative: Initial report was received on 23 March 2011 from a health care professional which involves the administration of the wrong vaccine. A 50 year-old female patient with no known allergies had received a left arm injection of DAPTACEL, lot number C3515AA on 21 March 2011 and the next day developed a knot at the injection site and generalized muscle aches. Concomitant medications included EFFEXOR. Treatments were not reported. Illness at the time of vaccination was none. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: None.