chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Convulsion, Cough, Febrile convulsion, Influenza, Influenza serology positive
Clinical narrative: Information has been received from a nurse concerning a 12 month old male patient with a history of gastrooesophageal reflux, eczema and a slight cough for the week prior to the vaccination, who on 30-SEP-2009 was vaccinated subcutaneously in the right triceps with a dose of VARIVAX (Merck) (lot number 664619/0974Y). Secondary suspect vaccination therapy on the same day included a dose of MMR (MSD, lot number 664981/0825Y) (subcutaneously in the left triceps). Concomitant therapy on the same day included a dose of flu vaccine (unspecified). On 01-OCT-2009 the patient developed a fever of 101 F with slight lethargy. The patient was given fluids and TYLENOL. Later that day the patient had a seizure with fever and lethargy. The patient was transferred to the emergency room. On an unspecified date the office was called. It was unknown if there were lab studies performed. At the time of the report, the patient had recovered. Follow-up information has been received from the registered nurse concerning the 12 month male patient who on 30-SEP-2009 was vaccinated subcutaneously in the right triceps with the first dose of VARIVAX (Merck) (lot number 664619/0974Y). Secondary suspect vaccination therapy on the same day included the first dose of MMR (MSD, lot number 664981/0825Y) (subcutaneously in the left triceps). Concomitant therapy on the same day included the first dose of FLUZONE IM in left deltoid. At the time of vaccination the patient had a slight cough from a cold one week prior. The patient developed fever 101 (Ax) on 01-OCT-2009 while at daycare in the afternoon with slight lethargy; the patient called the office at 15:45 pm to report the fever. The patient was recommended treatment with TYLENOL fluids. Supportive treatment with appointment if the patient acting ill with decreased fever. At 16:40 pm parent of the patient called to report that the patient had seizure and paramedics transported the patient to local emergency room. On 02-OCT-2009 the patient was seen in office with rhinitis and fever, follow up to ER visit for febrile seizure. On 05-OCT-2009, the patient was seen in the with Upper Respiratory Infection. On 06-OCT-2009, the patient was seen in the office with cough, recurrent fever, rhinitis, fussiness and influenza A positive. On 09-OCT-2009, the patient was seen in the office with bilateral otitis media. On 20-OCT-2009, the patient was seen in the office with rhinitis. There was lab studies performed (results not provided). At the time of the report the outcome for febrile seizure, fever and lethargy were reported as recovered (date not reported) and for URI, influenza type A, BOM and rhinitis the outcome was not reported. Follow up information was received from the registered nurse who indicated that the patient had a liver panel done on 17-NOV-2009. Results were within normal limits. The patient has not been seen or called the office since that time. It was reported that the patient recovered on 17-NOV-2009. No further information is available. The VAERS ID number was 359309.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Irritability, Lethargy, Liver function test normal, Otitis media, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 12 month old male patient with a history of gastrooesophageal reflux, eczema and a slight cough for the week prior to the vaccination, who on 30-SEP-2009 was vaccinated subcutaneously in the right triceps with a dose of VARIVAX (Merck) (lot number 664619/0974Y). Secondary suspect vaccination therapy on the same day included a dose of MMR (MSD, lot number 664981/0825Y) (subcutaneously in the left triceps). Concomitant therapy on the same day included a dose of flu vaccine (unspecified). On 01-OCT-2009 the patient developed a fever of 101 F with slight lethargy. The patient was given fluids and TYLENOL. Later that day the patient had a seizure with fever and lethargy. The patient was transferred to the emergency room. On an unspecified date the office was called. It was unknown if there were lab studies performed. At the time of the report, the patient had recovered. Follow-up information has been received from the registered nurse concerning the 12 month male patient who on 30-SEP-2009 was vaccinated subcutaneously in the right triceps with the first dose of VARIVAX (Merck) (lot number 664619/0974Y). Secondary suspect vaccination therapy on the same day included the first dose of MMR (MSD, lot number 664981/0825Y) (subcutaneously in the left triceps). Concomitant therapy on the same day included the first dose of FLUZONE IM in left deltoid. At the time of vaccination the patient had a slight cough from a cold one week prior. The patient developed fever 101 (Ax) on 01-OCT-2009 while at daycare in the afternoon with slight lethargy; the patient called the office at 15:45 pm to report the fever. The patient was recommended treatment with TYLENOL fluids. Supportive treatment with appointment if the patient acting ill with decreased fever. At 16:40 pm parent of the patient called to report that the patient had seizure and paramedics transported the patient to local emergency room. On 02-OCT-2009 the patient was seen in office with rhinitis and fever, follow up to ER visit for febrile seizure. On 05-OCT-2009, the patient was seen in the with Upper Respiratory Infection. On 06-OCT-2009, the patient was seen in the office with cough, recurrent fever, rhinitis, fussiness and influenza A positive. On 09-OCT-2009, the patient was seen in the office with bilateral otitis media. On 20-OCT-2009, the patient was seen in the office with rhinitis. There was lab studies performed (results not provided). At the time of the report the outcome for febrile seizure, fever and lethargy were reported as recovered (date not reported) and for URI, influenza type A, BOM and rhinitis the outcome was not reported. Follow up information was received from the registered nurse who indicated that the patient had a liver panel done on 17-NOV-2009. Results were within normal limits. The patient has not been seen or called the office since that time. It was reported that the patient recovered on 17-NOV-2009. No further information is available. The VAERS ID number was 359309.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Rhinitis, Upper respiratory tract infection
Clinical narrative: Information has been received from a nurse concerning a 12 month old male patient with a history of gastrooesophageal reflux, eczema and a slight cough for the week prior to the vaccination, who on 30-SEP-2009 was vaccinated subcutaneously in the right triceps with a dose of VARIVAX (Merck) (lot number 664619/0974Y). Secondary suspect vaccination therapy on the same day included a dose of MMR (MSD, lot number 664981/0825Y) (subcutaneously in the left triceps). Concomitant therapy on the same day included a dose of flu vaccine (unspecified). On 01-OCT-2009 the patient developed a fever of 101 F with slight lethargy. The patient was given fluids and TYLENOL. Later that day the patient had a seizure with fever and lethargy. The patient was transferred to the emergency room. On an unspecified date the office was called. It was unknown if there were lab studies performed. At the time of the report, the patient had recovered. Follow-up information has been received from the registered nurse concerning the 12 month male patient who on 30-SEP-2009 was vaccinated subcutaneously in the right triceps with the first dose of VARIVAX (Merck) (lot number 664619/0974Y). Secondary suspect vaccination therapy on the same day included the first dose of MMR (MSD, lot number 664981/0825Y) (subcutaneously in the left triceps). Concomitant therapy on the same day included the first dose of FLUZONE IM in left deltoid. At the time of vaccination the patient had a slight cough from a cold one week prior. The patient developed fever 101 (Ax) on 01-OCT-2009 while at daycare in the afternoon with slight lethargy; the patient called the office at 15:45 pm to report the fever. The patient was recommended treatment with TYLENOL fluids. Supportive treatment with appointment if the patient acting ill with decreased fever. At 16:40 pm parent of the patient called to report that the patient had seizure and paramedics transported the patient to local emergency room. On 02-OCT-2009 the patient was seen in office with rhinitis and fever, follow up to ER visit for febrile seizure. On 05-OCT-2009, the patient was seen in the with Upper Respiratory Infection. On 06-OCT-2009, the patient was seen in the office with cough, recurrent fever, rhinitis, fussiness and influenza A positive. On 09-OCT-2009, the patient was seen in the office with bilateral otitis media. On 20-OCT-2009, the patient was seen in the office with rhinitis. There was lab studies performed (results not provided). At the time of the report the outcome for febrile seizure, fever and lethargy were reported as recovered (date not reported) and for URI, influenza type A, BOM and rhinitis the outcome was not reported. Follow up information was received from the registered nurse who indicated that the patient had a liver panel done on 17-NOV-2009. Results were within normal limits. The patient has not been seen or called the office since that time. It was reported that the patient recovered on 17-NOV-2009. No further information is available. The VAERS ID number was 359309.
Age: 1.43
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Facial palsy, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician concerning a 17 month old male with a history of congenital neutropenia who on 23-SEP-2009 was vaccinated with a dose of MMR II and a dose of VARIVAX. The patient was seen in a local emergency room and diagnosed with Bell's palsy on 28-SEP-2009. The patient was prescribed unspecified steroid therapy. The patient was scheduled for an office evaluation on 01-OCT-2009. At the time of reporting, the outcome was unknown. Follow-up information has been received from a registered nurse concerning a male child with a history of benign neutropenia who on 21-SEP-2009 was vaccinated intramuscularly with the first dose of MMR II (lot # 664658/0679Y) into his right thigh at 2:00 PM. Suspect vaccination on the same day at 2:00 PM included the first dose of VARIVAX (lot# 665181/1007Y) subcutaneously into his left thigh. The patient had an upper respiratory tract infection (URI) at the time of vaccination. On 29-SEP-2009 at 8:00 PM the patient's mother noticed that the patient's face was asymmetric with poor movement of the right side of the face. The patient was seen in the emergency department and diagnosed with Bell's Palsy. At the time of the report, the patient's status was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female patient with no pertinent medical history and no known drug reactions or allergies who on 31-OCT-2008 was vaccinated subcutaneously with her first 0.5 ml dose of MMR II. On 26-OCT-2009, the patient received subcutaneously her second 0.5 ml dose of MMR II (Lot # 661680/0906X). There was no concomitant medication. According to the nurse, on 27-OCT-2009 the patient developed cough and fever of 105F. The patient's parent called the office and was suggested to give the patient TYLENOL. It was also reported that the community had a significant outbreak of H1N1. At the time of the report the patient had not recovered. No further information is available.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a licensed practical nurse concerning a 8 year old female with no medical history or drugs allergies, who on 29-MAR-2002 was vaccinated with a first dose of VARIVAX (Merck). On 24-NOV-2009 the patient received a second dose of VARIVAX (Merck) (lot #664022/0925Y) subcutaneously into the left arm. Concomitant vaccination included a second dose of hepatitis A virus vaccine inactivated (manufacturer unknown) into the right arm on 24-NOV-2009. The patient developed hives at the injection site. The patient was observed in the office for 30 minutes and given BENADRYL and cold compresses. The nurse stated that the patient did not experience any issue following the first dose of VARIVAX (Merck). No laboratories studies performed. The hives resolved on the same day and the patient was discharged home. This is one of three reports from the same source. A lot check has been initiated. Follow up information has been received from a licensed practical nurse/registered nurse concerning an 8 year old female with learning disorder and no illness at the time of vaccination who on 24-NOV-2009 at 16:10 was vaccinated with a second dose of VARIVAX (Merck) (lot #664022/0925Y) subcutaneously into the left arm. On the same day on 24-NOV-2009 at 16:10 she received second dose of HAVRIX (lot # AHAYB327AA) intramuscularly into right arm. On 24-NOV-2009 at 16:12 two minutes after receiving the injection she had redness and hives with a size of a nickel at the site of the VARIVAX (Merck). She was given BENADRYL and observed in their office for 30 minutes without any further difficulties. On 24-NOV-2009 the patient recovered from redness and hives at the injection site. No further information is available.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site urticaria, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 year old female with no medical history or drugs allergies, who on 06-AUG-2008 was vaccinated with a first dose of VARIVAX (Merck). On 24-NOV-2009 the patient received a second dose of VARIVAX (Merck) (lot #664022/0925Y) subcutaneously into the right arm. The patient developed hives at the injection site. The patient was observed in the office for 30 minutes and given BENADRYL and cold compresses. The nurse stated that the patient did not experience any issue following the first dose of VARIVAX (Merck). No laboratories studies performed. The hives resolved on the same day and the patient was discharged home. Follow-up information was received from a Registered Nurse who reported that on 24-NOV-2009 at 16:00, the patient had redness and hives the size of (2) 25 diameter at the injection site within 5 minutes of receiving VARIVAX (Merck) injection. The patient was given BENADRYL and observed in our office for 30 minutes within any further difficulties. This is one of three reports from the same source. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site urticaria, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old male with no medical history or drug allergies, who on 19-MAR-2001 was vaccinated with a first dose of VARIVAX. On 24-NOV-2009 the patient received a second dose of VARIVAX (lot #664022/0925Y) subcutaneously into the left arm. Concomitant vaccination included a second dose of hepatitis A virus vaccine inactivated (manufacturer unknown) in the right arm on 24-NOV-2009. The patient developed hives at injection site. The patient was observed in the office for 30 minutes and give BENADRYL and cold compresses. The nurse stated that the patient did not experience any issue following the first dose of VARIVAX. No laboratories studies performed. The hives resolved on the same day and the patient was discharged home. Follow-up information has been received from a registered nurse/certified pediatrics nurse who reported that the patient has ADHD, depression and mood disorder and was 52 inches and weighed 80 pounds at the time of vaccination. The patient received the second dose of HAVRIX. Within 2-7 minutes of the vaccination with the second dose of VARIVAX patient also experienced hives and redness at injection site. Patient's sibling had a history of hives after vaccination with the second dose of VARIVAX, at 7 and 8 years of age. This is one of three reports from the same source. Additional information is not expected.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, Irritability, Medication error
Clinical narrative: Information has been received from a nurse concerning a 19 week old patient who on 30-NOV-2009 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) in the left thigh and a 0.5 ml dose of MMR II (MSD) (WAES# 0912USA00835) in the right thigh. It was reported that the patient was not experiencing any known symptoms. Follow up information has been received from the registered nurse concerning the male child born preterm at 31 5/7 weeks with no illness at the time of vaccination who on 30-NOV-2009 at 1:15 pm was vaccinated with a first 0.5 ml dose of VARIVAX (Merck) (Lot # 665007/1088Y) in his right leg and a first 0.5 ml dose of MMR II (rHA) (MSD) (Lot # 664886/0776Y) (WAES# 0912USA00835) in his right leg. Concomitant vaccinations administered the same day at 1:15 pm included a first dose of PREVNAR (Lot# D66586) in his left leg, a first dose of PEDIARIX (Lot# AC218210AA) in his right leg and a first dose of ACTHIB (Lot# UF753AA) in his left leg. On 30-NOV-2009 the child's mother complained of her child being fussy after receiving "shots". On 07-DEC-2009 the mother denied rash, fever, or any other adverse reactions. The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. This is one of two reports concerning the same patient. Additional information is not expected.
Age: 1.42
Sex: F
Vaccine: DTAP, FLU(H1N1), FLU3, MMR
Symptoms: Blood culture negative, Erythema multiforme, Full blood count normal
Clinical narrative: Information has been received from a medical assistant concerning a 17 month old female patient with no medical history or drug allergies who on 23-NOV-2009 was vaccinated SQ a 0.5 ml dose of MMR II (Lot number 664798/0773Y). Concomitant therapy included TRIPEDIA, FLUZONE and influenza virus A (antigen type unspecified) vaccine (H1N1). On 01-DEC-2009 the patient developed rash from head to toe. The patient was diagnosed with "erythema multiforme". Laboratory tests performed included: "complete blood cell count (CBC), cultures" with no results available. At the time of the report the patient was recovering. The physician saw the patient. Follow-up information was received from the nurse who reported that the patient was a female with no illness at time of vaccination or pre-existing allergies, birth defects or medical conditions. On 23-NOV-2009 the patient was vaccinated her first dose of MMR II (Lot number 664798/0773Y), 0.5 ml AQ into the left arm, her fourth dose of TRIPEDIA (Lot number C3192AA) IM into her left arm, her first dose of FLUZONE (Lot number 63266AA) IM into the right arm, and her first dose of influenza virus A (antigen type unspecified) vaccine (H1N1) (Lot number 6T023CA) IM into the right arm. On 01-DEC-2009 the patient started with rash. The rash presented "bruised" look by 03-DEC-2009. The patient was seen in office and was diagnosed with erythema multiforme. Labs performed included CBC with differential and blood cultures, results of which were all within normal levels. On 07-DEC-2009 the patient recovered. No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL, RUB
Symptoms: Cough, Pneumonia, Pyrexia, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 24 month old daughter with a history of rash and high fever while on prior therapy with measles virus vaccine live (Enders-Edmonston) (MSD, WAES #1001USA02978) and a history of hives while on prior therapy with rubella virus vaccine live (Wistar RA 27/3) (MSD, WAES#1001USA02979) who on 14-JAN-2010 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (lot # 661671/0971X).  There was no concomitant medication.  After being vaccinated the patient developed a fever of 104 degrees and was throwing up.  She also developed a cough and her physician diagnosed her with pneumonia and prescribed her AUGMENTIN.  At the time of the report, the patient was recovering.  This is one of several reports from the same source.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL, RUB
Symptoms: Pneumonia, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 24 month old daughter with a history of rash and high fever while on prior therapy with measles virus vaccine live (Enders-Edmonston) (MSD, WAES #1001USA02978) and a history of hives while on prior therapy with rubella virus vaccine live (Wistar RA 27/3) (MSD, WAES#1001USA02979) who on 14-JAN-2010 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (lot # 661671/0971X).  There was no concomitant medication.  After being vaccinated the patient developed a fever of 104 degrees and was throwing up.  She also developed a cough and her physician diagnosed her with pneumonia and prescribed her AUGMENTIN.  At the time of the report, the patient was recovering.  This is one of several reports from the same source.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a medical assistant concerning an approximately 16 year old female patient with an allergy to amoxicillin who on 23-APR-1998 was vaccinated subcutaneously with the first dose of VARIVAX (Merck). On 15-DEC-2009 the the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot# 665644/1205Y). There was no concomitant medication. Subsequently the patient experienced red, itchy area at the injection site and red, itchy area at the injection site. The patient sought medical attention via office visit. No laboratory diagnostic studies were performed. On an unspecified date, the patient had recovered from these events. This is one of several reports received from the same source. The office request a lot check. A lot check has been initiated. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Eye pain, Headache, Pain, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a consumer concerning her daughter, a 5 year old female who 12-JUN-2009 was vaccinated with a dose of MMR II (0.5 ml, lot # 662349/1671X). About 10 days after vaccination, on approximately 22-JUN-2009 the patient developed a full blown measles rash and a fever of 104 degrees. The next day the patient's fever broke and the rash started to go away. There were no lab diagnostics studies performed. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Streptococcal identification test negative
Clinical narrative: Information has been received from a consumer concerning her daughter, a 5 year old female who 12-JUN-2009 was vaccinated with a dose of MMR II (0.5 ml, lot # 662349/1671X). About 10 days after vaccination, on approximately 22-JUN-2009 the patient developed a full blown measles rash and a fever of 104 degrees. The next day the patient's fever broke and the rash started to go away. There were no lab diagnostics studies performed. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Measles, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her daughter, a 5 year old female who 12-JUN-2009 was vaccinated with a dose of MMR II (0.5 ml, lot # 662349/1671X). About 10 days after vaccination, on approximately 22-JUN-2009 the patient developed a full blown measles rash and a fever of 104 degrees. The next day the patient's fever broke and the rash started to go away. There were no lab diagnostics studies performed. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, FLU3, HEPA, MMR, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a Licensed Visiting Nurse concerning a 12 month old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 08-JAN-2010 was vaccinated with the first 0.5 mL dose of VARIVAX (Lot # 665194/1126Y) subcutaneously into the left arm.  Secondary suspect vaccines given on the same day included a dose of MMR II into the right arm, a dose of AFLURIA (manufacturer unknown) into the right thigh, and a dose of VAQTA (manufacturer unknown) into the left thigh.  It was reported that the same evening, on 08-JAN-2010, parents of child noticed a rash starting at the injection site of the left arm and then rash erupted at all the injection sites of arms and legs.  It was reported that by next day, on 09-JAN-2010, child had rash all over her body.  The child was seen at the doctor office on 11-JAN-2010, and was diagnosed with chickenpox.  There were no laboratory diagnostic tests performed.  Treatment recommended comfort measures, and TYLENOL if needed.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site rash, Varicella
Clinical narrative: Information has been received from a Licensed Visiting Nurse concerning a 12 month old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 08-JAN-2010 was vaccinated with the first 0.5 mL dose of VARIVAX (Lot # 665194/1126Y) subcutaneously into the left arm.  Secondary suspect vaccines given on the same day included a dose of MMR II into the right arm, a dose of AFLURIA (manufacturer unknown) into the right thigh, and a dose of VAQTA (manufacturer unknown) into the left thigh.  It was reported that the same evening, on 08-JAN-2010, parents of child noticed a rash starting at the injection site of the left arm and then rash erupted at all the injection sites of arms and legs.  It was reported that by next day, on 09-JAN-2010, child had rash all over her body.  The child was seen at the doctor office on 11-JAN-2010, and was diagnosed with chickenpox.  There were no laboratory diagnostic tests performed.  Treatment recommended comfort measures, and TYLENOL if needed.  At the time of the report the patient had not recovered.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, VARCEL, MMR, VARCEL
Symptoms: Arthralgia, Laboratory test, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old female patient with allergy to pertussis vaccine and Amoxicillin and no pertinent medical history who on 01-FEB-2010 was vaccinated subcutaneously with a second 0.5ml dose of VARIVAX vaccine (Merck) (lot#65200/1151Y) and a second dose of MMR II vaccine (lot# 665214/0887Y). Concomitant therapy included poliovirus vaccine and tuberculin purified protein derivative. It was reported that the patient had received the first dose of VARIVAX (Merck) and MMR II at some time in the past. On 02-FEB-2010 the patient developed severe knee pain (no swelling) and a fever of 39. 3 degrees C. The patient was unable to bear weight on the affected leg. The patient was being evaluated in the emergency room. At the time of this report, the patient had not recovered. Severe knee pain was considered to be disabling. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: IPV, MMR, VARCEL, MMR, VARCEL
Symptoms: Arthralgia, Body temperature increased, Pyrexia, Weight bearing difficulty
Clinical narrative: Information has been received from a licensed practical nurse concerning a 4 year old female patient with allergy to pertussis vaccine and Amoxicillin and no pertinent medical history who on 01-FEB-2010 was vaccinated subcutaneously with a second 0.5ml dose of VARIVAX vaccine (Merck) (lot#65200/1151Y) and a second dose of MMR II vaccine (lot# 665214/0887Y). Concomitant therapy included poliovirus vaccine and tuberculin purified protein derivative. It was reported that the patient had received the first dose of VARIVAX (Merck) and MMR II at some time in the past. On 02-FEB-2010 the patient developed severe knee pain (no swelling) and a fever of 39. 3 degrees C. The patient was unable to bear weight on the affected leg. The patient was being evaluated in the emergency room. At the time of this report, the patient had not recovered. Severe knee pain was considered to be disabling. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old male patient with no pertinent medical history who on 16-MAR-1998 was vaccinated subcutaneously with the first dose of VARIVAX (Merck). On 17-FEB-2010 the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot# 665644/1205Y). There was no concomitant medication. Subsequently the patient developed red itchy areas with swelling at the injection site. On 19-FEB-2010, the patient was seen in the office. No laboratory diagnostics studies were performed. At the time of the report, the patient had not recovered from these events. This is one of several reports received from the same source. The office request a lot check. A lot check has been initiated. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old male patient with no pertinent medical history who on 16-MAR-1998 was vaccinated subcutaneously with the first dose of VARIVAX (Merck). On 17-FEB-2010 the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot# 665644/1205Y). There was no concomitant medication. Subsequently the patient developed red itchy areas with swelling at the injection site. On 19-FEB-2010, the patient was seen in the office. No laboratory diagnostics studies were performed. At the time of the report, the patient had not recovered from these events. This is one of several reports received from the same source. The office request a lot check. A lot check has been initiated. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse concerning a 14 year old male patient with no pertinent medical history and no known allergies who on 29-JAN-2010 was vaccinated SQ with the first dose of VARIVAX (Merck) (lot number not reported). There was no concomitant medication. On 08-FEB-2010 the patient developed "full blown chicken pox all over his body". Medical attention was sought via office visit. On 08-FEB-2010 blood work was obtained and "Varicella zoster virus" (VZV) samples were taken. The samples were positive for "VZV". The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: Information has been received from a nurse concerning a 14 year old male patient with no pertinent medical history and no known allergies who on 29-JAN-2010 was vaccinated SQ with the first dose of VARIVAX (Merck) (lot number not reported). There was no concomitant medication. On 08-FEB-2010 the patient developed "full blown chicken pox all over his body". Medical attention was sought via office visit. On 08-FEB-2010 blood work was obtained and "Varicella zoster virus" (VZV) samples were taken. The samples were positive for "VZV". The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Rash, Upper respiratory tract infection
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient with unspecified medical history, drug reactions or allergies, who on 22-FEB-2010 was vaccinated with a first dose of MMR II (route and lot # unknown). Suspect therapy included VARIVAX (route and lot # unknown) and hepatitis A virus vaccine (manufacturer unknown) (route and lot # unknown) also administered on 22-FEB-2010. Concomitant therapy included PREVNAR. On 05-MAR-2010, the patient developed a serious case of petechial rash that started on the abdomen and moved to the trunk and to the patient's entire face. Lab diagnostic studies performed were unspecified. On 08-MAR-2010, the patient went to see the physician who sent him to the emergency room. The physician reported that the patient was watched at the emergency room for several hours before being released and going home. The physician reported that the patient is recovering as 10-MAR-2010. No further information is available.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Laboratory test, Petechiae
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient with unspecified medical history, drug reactions or allergies, who on 22-FEB-2010 was vaccinated with a first dose of MMR II (route and lot # unknown). Suspect therapy included VARIVAX (route and lot # unknown) and hepatitis A virus vaccine (manufacturer unknown) (route and lot # unknown) also administered on 22-FEB-2010. Concomitant therapy included PREVNAR. On 05-MAR-2010, the patient developed a serious case of petechial rash that started on the abdomen and moved to the trunk and to the patient's entire face. Lab diagnostic studies performed were unspecified. On 08-MAR-2010, the patient went to see the physician who sent him to the emergency room. The physician reported that the patient was watched at the emergency room for several hours before being released and going home. The physician reported that the patient is recovering as 10-MAR-2010. No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old female patient with known drug reactions or allergies or pertinent medical history who on 18-FEB-2010 was subcutaneously vaccinated in the left thigh with the first dose of VARIVAX (Lot# 665028/1068Y). There was no concomitant medication. The certified medical assistant reported that following the VARIVAX, on an unspecified date, the patient developed lesions at the injection site. No lab tests were performed. The patient sought medical attention by an office visit. The patient's parent was told to use BENADRYL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL, VARCEL
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 month old female patient with known drug reactions or allergies or pertinent medical history who on 18-FEB-2010 was subcutaneously vaccinated in the left thigh with the first dose of VARIVAX (Lot# 665028/1068Y). There was no concomitant medication. The certified medical assistant reported that following the VARIVAX, on an unspecified date, the patient developed lesions at the injection site. No lab tests were performed. The patient sought medical attention by an office visit. The patient's parent was told to use BENADRYL. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.21
Sex: F
Vaccine: HIBV, MMR, FLU(H1N1), HIBV, MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 14 month old female patient with no pertinent medical history who on 24-OCT-2009 was vaccinated with a dose of MMR II (lot# 663796/0423Y). Concomitant vaccination at the same visit included a dose of ACTHIB (unspecified carrier). On 31-OCT-2009 the patient experienced hives. The patient recovered on an unknown date. On 12-NOV-2009 the patient received the H1N1 (manufactured by Sanofi Pasteur). Five days after receiving the H1N1 the patient developed hives again. The physician thought the patient might have an allergy to pork based gelatin. The patient was seen by another physician. Follow up information has been received from the medical assistant concerning the infant with no illness at the time of vaccination and no medical conditions or known allergies who developed hives five days after vaccination with H1N1. On 24-OCT-2009 the patient was vaccinated with a first dose of MMR II (rHA) (lot# 663796/0423Y) in her thigh. Concomitant vaccination given on the same day included a fourth dose of ACTHIB (manufactured by Sanofi Pasteur) (Lot # UF754AA) in her thigh and a first dose of H1N1  (manufactured by Sanofi Pasteur) (Lot # UP021AA) on her thigh. It was reported that on 31-OCT-2009 the patient experienced hives. On an unknown date the patient recovered. No laboratory or diagnostic studies were performed. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Death
Clinical narrative: Initial report was received 11 May 2010 from a health care professional. A six-month-old male patient had received PENTACEL, lot number C3450AA (lot number valid for DTaP/IPV component, route and site not reported) and PREVNAR (manufacturer lot number, route and site not reported) on 07 May 2010 and a few hours later, the patient passed away. According to the reporter, the patient took a nap after leaving the clinic around 2:30pm and did not wake up. Emergency medical services were called and the patient was pronounced dead on site. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13, DTAPIPVHIB, PNC13
Symptoms: Autopsy, Death
Clinical narrative: Initial report was received 11 May 2010 from a health care professional. A six-month-old male patient had received PENTACEL, lot number C3450AA (lot number valid for DTaP/IPV component, route and site not reported) and PREVNAR (manufacturer lot number, route and site not reported) on 07 May 2010 and a few hours later, the patient passed away. According to the reporter, the patient took a nap after leaving the clinic around 2:30pm and did not wake up. Emergency medical services were called and the patient was pronounced dead on site. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Blood pressure increased, Blood test normal, Cardiac stress test normal, Chest discomfort, Chest pain
Clinical narrative: 3rd dose of anthrax vaccine was given while in another country. Patient developed flushing, increased pulse, SOB, muscle pain, forgetfulness, trouble finding words, exhauastion, fever and stiff neck. Over 1 month later, patient improving, but still reports headache and trouble finding words.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: 3rd dose of anthrax vaccine was given while in another country. Patient developed flushing, increased pulse, SOB, muscle pain, forgetfulness, trouble finding words, exhauastion, fever and stiff neck. Over 1 month later, patient improving, but still reports headache and trouble finding words.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Fatigue, Headache, Heart rate increased, Hypoaesthesia, Migraine
Clinical narrative: 3rd dose of anthrax vaccine was given while in another country. Patient developed flushing, increased pulse, SOB, muscle pain, forgetfulness, trouble finding words, exhauastion, fever and stiff neck. Over 1 month later, patient improving, but still reports headache and trouble finding words.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Muscle spasms, Nausea, Palpitations, Paraesthesia, Sleep apnoea syndrome
Clinical narrative: 3rd dose of anthrax vaccine was given while in another country. Patient developed flushing, increased pulse, SOB, muscle pain, forgetfulness, trouble finding words, exhauastion, fever and stiff neck. Over 1 month later, patient improving, but still reports headache and trouble finding words.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Throat tightness, Tremor, Urine analysis normal, Weight decreased
Clinical narrative: 3rd dose of anthrax vaccine was given while in another country. Patient developed flushing, increased pulse, SOB, muscle pain, forgetfulness, trouble finding words, exhauastion, fever and stiff neck. Over 1 month later, patient improving, but still reports headache and trouble finding words.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Aphasia, Dyspnoea, Fatigue, Flushing, Headache
Clinical narrative: 3rd dose of anthrax vaccine was given while in another country. Patient developed flushing, increased pulse, SOB, muscle pain, forgetfulness, trouble finding words, exhauastion, fever and stiff neck. Over 1 month later, patient improving, but still reports headache and trouble finding words.
Age: 24.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Heart rate increased, Memory impairment, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: 3rd dose of anthrax vaccine was given while in another country. Patient developed flushing, increased pulse, SOB, muscle pain, forgetfulness, trouble finding words, exhauastion, fever and stiff neck. Over 1 month later, patient improving, but still reports headache and trouble finding words.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Soreness and swelling at injection site (immediately after - duration 5 days). Fever of 101 (24 hrs after - duration 1 day). Redness (3 days after - duration 3 days).
Age: 16.0
Sex: U
Vaccine: RAB
Symptoms: Infectious mononucleosis
Clinical narrative: Initial spontaneous report received from a nurse via Professional Information Ltd on 07 May 2010: This patient received his first dose of RABIPUR for a pre-exposure vaccination schedule three weeks prior to this report. One week after receiving RABIPUR the patient developed glandular fever. At the time of reporting the patient was still not well enough to receive the following two doses of RABIPUR. No further details were provided, and the reporter did not wish to be contacted for follow-up information.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injected limb mobility decreased, Injection site pain
Clinical narrative: 104 degree temp evening of 5-06-10.  No redness or swelling of shot site but arm painful and difficulty in using it.  99.9 degree temp this am and will talk with physician.  5-11-10 Mom states fever remained til evening 5-8-10.  Is moving arm over head now.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mom reports she put ice pack on left upper arm after some redness occured on 4/29/10.  The next day 4/30/10 (Friday) the left arm was swollen from shoulder to elbow, warm to touch and more redness.  Went to Clinic and saw PNP.  Treated with Benadryl 12.5/5ml and Tuck pads were applied.  T/C to mom 5/12/109 for follow up, child doing ok, swelling and redness went away the next day.
Age: 33.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pruritus, Nausea, Pain, Vomiting
Clinical narrative: CLIENT COMPLAINS OF NAUSEA AND VOMITING EVERY 1 TO 2 HOURS ON DAY OF VACCINATION. ON THIS DATE, 05/18/2010, CLIENT REPORTS VOMITING EVERY 30 MINUTES.  ALSO, COMPLAINS OF ITCHING AT INJECTION SITE AND GENERAL MUSCLE ACHES.
Age: 1.06
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Urticaria
Clinical narrative: 5-18-10 Mother reports hive like rash that appears/disappears over different parts of body. Never all over @ the same time. Started 5-16-10 no temp no crying or acting like she feels bad. Denies any new soaps/detergents for skin care or laundry, denies any new foods in diet. Vaccines given 5-11-10.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Rash, Rash papular
Clinical narrative: 1) Erythematous, nonpruritic papules on left anterior thigh noticed 2 days after vaccination.  2) Hydrocortisone cream (0.1%) BID X 7 days.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin negative
Clinical narrative: Information has been received from a nurse, for the Pregnancy Registry for GARDASIL, concerning a 21 year old female who on 26-JUN-2007 was received her first dose of GARDASIL, and the second dose on 11-JUN-2009, and just found out she was pregnant again. No information on status of pregnancy or whether she would continue the pregnancy. Follow up information received from a nurse concerning the patient was seen at their Clinic on 26-Jun-2007, and not again until 11-JUN-2009. On 11-JUN-2009 a urine pregnancy test was performed. And it was negative. Follow up information received from a registered nurse concerning the patient electively terminated the pregnancy for personal reasons, not related to the GARDASIL vaccination. Upon internal review abortion induced was considered an other important medical event. The patient had a history of pregnancy while on prior therapy with the 1st dose of GARDASIL (MSD, WAES#0906USA05568). No further information is available.
Age: 3.0
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 36 month old female patient who on 13-SEP-2007 received the first dose of ROTATEQ (Lot # 657659/0969U) and on unspecified dates received the second and third (2 mL, Oral) doses of ROTATEQ (Lot # 657511/0553U and 657672/0903U respectively). The patient started experiencing vomiting and diarrhea 5 days prior to visiting the physician's office (on 30-APR-2010). On 05-MAY-2010 the patient was brought to the office and on that day experienced 12 vomiting episodes and the physician sent the patient to ER. The patient was admitted and kept for 2 days and she was given IV hydration. On an unspecified date, a specimen test was positive for Rotavirus. The patient followed up with the physician on 11-MAY-2010 and was recovering well. Additional information has been requested.