chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Diarrhoea, Expired drug administered, Vomiting
Clinical narrative: A non-serious, spontaneous report of administration of expired product, vomiting and diarrhea was received from a nurse in concerning a 33-month-old female subsequent to FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 year to 59 months of age for FLUMIST.  Neither relevant medical history nor concomitant medication has been reported for this patient.  The patient received expired FLUMIST intranasal on 23-Dec-2008 for Flu Vaccination.  The lot of FLUMIST expired 18-Dec-2008.  The patient began vomiting and diarrhea the morning of 06-Jan-2009.  The patient was without fever, was not taken to the emergency room and did not receiver any treatment other than fluids.  The patients sibling experienced similar events of vomiting and diarrhea over the same time period which required a visit to the emergency room, reference case MEDI-0007733.  As of 09-Jan-2009 the events resolved. based on the results of the investigation , the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring durin the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009 that included the results of a root cause investigation of the medication error.
Age: 3.8
Sex: F
Vaccine: FLUN3
Symptoms: Dehydration, Diarrhoea, Expired drug administered, Lethargy, Vomiting
Clinical narrative: A non-serious, spontaneous report of administration of expired product, dehydrated, elevated white blood cell, vomiting, diarrhea and lethargic was received from a nurse concerning a 46-month-old female subsequently to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received expired FLUMIST, intranasal on 23-Dec-2008 for Flu Vaccination. The lot of FLUMIST expired on 18-Dec-2008. On 06-Jan-2009 the patient began experiencing vomiting and diarrhea the morning of 06-Jan-2009. The patients mother contacted the pediatricians office and stated she was also lethargic and dehydrated although without fever. The nurse instructed the mother to take the patient to the emergency room where blood work was taken which was normal with the exception of elevated WBC. The patient sibling experienced similar events of vomiting and diarrhea on the same day which did not require a visit to the emergency room, reference case MEDI0007734. As of 09-Jan-2009 the events resolved.
Age: 3.8
Sex: F
Vaccine: FLUN3
Symptoms: White blood cell count increased
Clinical narrative: A non-serious, spontaneous report of administration of expired product, dehydrated, elevated white blood cell, vomiting, diarrhea and lethargic was received from a nurse concerning a 46-month-old female subsequently to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received expired FLUMIST, intranasal on 23-Dec-2008 for Flu Vaccination. The lot of FLUMIST expired on 18-Dec-2008. On 06-Jan-2009 the patient began experiencing vomiting and diarrhea the morning of 06-Jan-2009. The patients mother contacted the pediatricians office and stated she was also lethargic and dehydrated although without fever. The nurse instructed the mother to take the patient to the emergency room where blood work was taken which was normal with the exception of elevated WBC. The patient sibling experienced similar events of vomiting and diarrhea on the same day which did not require a visit to the emergency room, reference case MEDI0007734. As of 09-Jan-2009 the events resolved.
Age: 4.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of "six patients received expired FLUMIST "was received from a nurse concerning a four-year-old (unknown gender). The patient's' medical history included previous dose of FLUMIST. Concomitant medications were not available. On 01-Jan-2009, six patients from a large pediatric office were administered expired FLUMIST (23-Dec-2008). The product was expired by 10 days. There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. This case is submitted in accordance with MedImmune's post-markings commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
Age: 9.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A spontaneous non-serious report of administration of expired product was received from a certified medical assistant in a physician's concerning a child of unknown age and gender.  On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a certified medical assistant in a physician's office concerning a child of unknown age and gender. On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, Medication error
Clinical narrative: A  spontaneous non-serious report of administration of expired product was received from a certified medical assistant in a physician's office concerning a child of unknown age and gender. On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during flu season resulting in some medication errors that occurred shortly after teh product expired. Additional information was received on 09-Apr-2009 that included the results of root cause investigation for the medication error.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine used Expired drug administered) A non-serious spontaneous report of administration of expired product s received from a registered nurse concerning a four-year-old male who received FLUMIST. The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 21-Dec-2008, three on 02-Jan-2009,  six on 05-Jan-2009 and one on 06-Jan-2009. Neither the patient's medical history nor concomitant medications were reported. The patient is one of a pair of sibling who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008. All the expired FLUMIST vaccine were part of the 300 units with same lot # delivered to the pediatric clinic on 21-Oct-2008. All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccines. The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on that day that expired FLUMIST were given to the 16 patients. There was no adverse events associated with this medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marking commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a registered nurses concerning a 24-month-old female who received FLUMIST.  The patient is one of 16 pediatric patients who was administered expired product with six patients receiving the vaccine on 31-Dec-2008, three on 02-Jan-2009, six on 05-Jan-2009 and one on 06-Jan-2009.  Neither the patient's medical history nor concomitant medications were reported.  The patient is one of a pair of siblings who received the FLUMIST on 31-Dec-2008, which expired on 30-Dec-2008.  All the expired FLUMIST vaccines were part of the 309 units with same lot # delivered to the pediatric clinic on 21-Oct-2008.  All the vaccines were kept in one refrigeration equipment in the clinic and only immunization nurses who work on rotation give the vaccine.  The clinic did an inventory of the FLUMIST vaccines on 06-Jan-2009 and it was discovered on the day that expired FLUMIST were given to the 16 patients.  There was no adverse event associated with the medication error as of 15-Jan-2009; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Additional information received on 15-Jan-2009 and incorporated into the narrative: patient's demographics and outcome of adverse event.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious report of "gave patient expired FLUMIST" was received from a nurse concerning a four year old male patient. On 30-Dec-2008, the patient received expired FLUMIST (expiration date not reported). There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Follow-up information received on 04-Aug-2009 included Product complaint Investigative results. Based on the results of the investigation, the root cause for the medication errors were caused by 13 customers not in some medications errors that occurred shortly after the product expired.
Age: 0.5
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Abdominal discomfort, Abdominal pain, Abnormal faeces, Culture stool positive, Diarrhoea
Clinical narrative: Patient received the three doses of ROTATEQ #1 dose on 09/13/07, #2 dose on 11/19/07, #3 dose on 01/18/08 Diagnosed on 08/06/08 with ROTA VIRUS antigen in stool
Age: 0.5
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Ear discomfort, Feeling hot, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
Clinical narrative: Patient received the three doses of ROTATEQ #1 dose on 09/13/07, #2 dose on 11/19/07, #3 dose on 01/18/08 Diagnosed on 08/06/08 with ROTA VIRUS antigen in stool
Age: 0.5
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Parasite blood test, Rotavirus infection, Rotavirus test, Stool analysis
Clinical narrative: Patient received the three doses of ROTATEQ #1 dose on 09/13/07, #2 dose on 11/19/07, #3 dose on 01/18/08 Diagnosed on 08/06/08 with ROTA VIRUS antigen in stool
Age: 0.5
Sex: M
Vaccine: RV5, RV5, RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Patient received the three doses of ROTATEQ #1 dose on 09/13/07, #2 dose on 11/19/07, #3 dose on 01/18/08 Diagnosed on 08/06/08 with ROTA VIRUS antigen in stool
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC
Symptoms: Anaphylactic reaction, Hypersensitivity, Inappropriate schedule of drug administration, Off label use, Periorbital oedema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA.  A 4 year old male patient was vaccinated on 17-APR-2007 with GARDASIL in the right leg.  Concomitant suspect therapy included the fourth dose of DAPTACEL (lot #C2605AA), in the left leg, the third dose of IPOL (lot #20547) in the left leg and the first dose of PREVNAR (lot #B068699F) in the right leg.  On 17-APR-2007, the patient experienced anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face.  Subsequently, the patient recovered from anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face.  The listing indicated that one or more of the events were considered to be immediately life-threatening.  Follow-up information has been received from the FDA on 27-AUG-2007.  On 17-JUL-2007, ER medical records were received from the hospital which revealed that the patient was seen on 19-APR-2007 after being seen by their PCP for vaccination that same day.  The patient developed facial swelling, rash and periorbital edema.  The patient was treated at the PCPs office and then transported to the ER by EMS.  The edema improved by arrival in the ER per the patient's parents but still noted to be significant by ER.  The patient was treated with additional steroids and antihistamines and observed in the ER.  The patient's status improved and he was discharged to home.  The final diagnosis reported was acute allergic reaction.  No further information is available.  Additional information has been received on request from the FDA.  It was reported that a 4 year old male patient who on 17-APR-2007 was vaccinated with a dose of PROQUAD (Oka/Merck upgrade process), the third dose of DTAP (unspecified), the third dose of IPOL and the first dose of PREVNAR.  On 17-APR-2007 the patient experienced anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face.  At the time of the report the patient was recovered.  One or more of the events were considered to be immediately life-threatening.  This is an amended report.  The primary Merck therapy now reads PROQUAD (Oka/Merck upgrade process) instead of GARDASIL.  Standard lot check investigations were performed on lot # 656307/1391F.  All in-process quality checks for the lot numbers in question were satisfactory.  In addition, expanded lot check investigations were performed.  The testing performed on the batch prior to release met all release specifications.  The lots met the requirements of the research center and were released.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, PNC
Symptoms: Rash, Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA.  A 4 year old male patient was vaccinated on 17-APR-2007 with GARDASIL in the right leg.  Concomitant suspect therapy included the fourth dose of DAPTACEL (lot #C2605AA), in the left leg, the third dose of IPOL (lot #20547) in the left leg and the first dose of PREVNAR (lot #B068699F) in the right leg.  On 17-APR-2007, the patient experienced anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face.  Subsequently, the patient recovered from anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face.  The listing indicated that one or more of the events were considered to be immediately life-threatening.  Follow-up information has been received from the FDA on 27-AUG-2007.  On 17-JUL-2007, ER medical records were received from the hospital which revealed that the patient was seen on 19-APR-2007 after being seen by their PCP for vaccination that same day.  The patient developed facial swelling, rash and periorbital edema.  The patient was treated at the PCPs office and then transported to the ER by EMS.  The edema improved by arrival in the ER per the patient's parents but still noted to be significant by ER.  The patient was treated with additional steroids and antihistamines and observed in the ER.  The patient's status improved and he was discharged to home.  The final diagnosis reported was acute allergic reaction.  No further information is available.  Additional information has been received on request from the FDA.  It was reported that a 4 year old male patient who on 17-APR-2007 was vaccinated with a dose of PROQUAD (Oka/Merck upgrade process), the third dose of DTAP (unspecified), the third dose of IPOL and the first dose of PREVNAR.  On 17-APR-2007 the patient experienced anaphylactic reaction, hypersensitivity, inappropriate schedule of drug administered, periorbital oedema, rash and swelling face.  At the time of the report the patient was recovered.  One or more of the events were considered to be immediately life-threatening.  This is an amended report.  The primary Merck therapy now reads PROQUAD (Oka/Merck upgrade process) instead of GARDASIL.  Standard lot check investigations were performed on lot # 656307/1391F.  All in-process quality checks for the lot numbers in question were satisfactory.  In addition, expanded lot check investigations were performed.  The testing performed on the batch prior to release met all release specifications.  The lots met the requirements of the research center and were released.  Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre diagnosed 11/8/08. 02/01/2010 Still recovering from Guillian Barre' syndrome. Still not back to work. Patient has not returned to our facility.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female patient with no pertinent medical history and no known drug allergies who on 16-OCT-2008 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot # 661530/0575X). On 22-DEC-2008 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL (lot # 661764/0650X). There was no concomitant medication. On 23-DEC-2008 ("within a day after administration of her second dose") the patient developed tremors which resemble a shudder from chills. No lab diagnostics studies were performed. On 06-JAN-2009 the patient was examined in the office and she was still experiencing tremors, although less frequent, at least once a day. At the time of reporting, the patient was recovering. Additional information has been requested. 3/4/09 MR received from PCP. Received HPV #2 on 12/22/09. Later that day pt noticed tremors of arms, hands, fingers and knees. Seen by PCP on 1/6/09 for persistant tremors, decreasing somewhat in frequency and intensity. No change in awareness, no associated sensory phenomenon, no post-ictal state. PE WNL. No tx at this time.  Will watch.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Child reported 2 days following vaccine administration w/cellulitis at site of DTaP/MMR administration. Redness, swelling and warmth noted to area
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child reported 2 days following vaccine administration w/cellulitis at site of DTaP/MMR administration. Redness, swelling and warmth noted to area
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: Had convulsion 1/2/09 at 10:30 am. To ER, then another hospital by ambulance. Had undiagnosed kidney infection when received vaccine. Had total 14 convulsions - tried seizure meds - no help. Negative EEG. Heart palpitations - on holter monitor. To following up with doctor.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion, Kidney infection
Clinical narrative: Had convulsion 1/2/09 at 10:30 am. To ER, then another hospital by ambulance. Had undiagnosed kidney infection when received vaccine. Had total 14 convulsions - tried seizure meds - no help. Negative EEG. Heart palpitations - on holter monitor. To following up with doctor.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram normal, Palpitations
Clinical narrative: Had convulsion 1/2/09 at 10:30 am. To ER, then another hospital by ambulance. Had undiagnosed kidney infection when received vaccine. Had total 14 convulsions - tried seizure meds - no help. Negative EEG. Heart palpitations - on holter monitor. To following up with doctor.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Dermatitis/rash - the client has been to 3 Drs who have diagnoses her with unrelated dermatologically condition.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis, Rash
Clinical narrative: Dermatitis/rash - the client has been to 3 Drs who have diagnoses her with unrelated dermatologically condition.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Lethargy, Nausea
Clinical narrative: High fever, Dizziness, Weak-ness, Nausea.  CLARITIN + BENADRYL+TYLENOL.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: High fever, Dizziness, Weak-ness, Nausea.  CLARITIN + BENADRYL+TYLENOL.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dizziness, Nausea, Pyrexia
Clinical narrative: High fever, Dizziness, Weak-ness, Nausea.  CLARITIN + BENADRYL+TYLENOL.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Balance disorder, Blood test normal, Computerised tomogram normal, Dizziness, Syncope
Clinical narrative: Information has been received from a nurse concerning a "less than 18 years old" female patient who was vaccinated with the third dose of GARDASIL (lot # not provided).  Subsequently, patient fainted multiple times and became weak.  Patient sought unspecified medical attention by seeing the nurse.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ultrasound scan normal, Visual impairment
Clinical narrative: Information has been received from a nurse concerning a "less than 18 years old" female patient who was vaccinated with the third dose of GARDASIL (lot # not provided).  Subsequently, patient fainted multiple times and became weak.  Patient sought unspecified medical attention by seeing the nurse.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a nurse concerning a "less than 18 years old" female patient who was vaccinated with the third dose of GARDASIL (lot # not provided).  Subsequently, patient fainted multiple times and became weak.  Patient sought unspecified medical attention by seeing the nurse.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Syncope
Clinical narrative: Information has been received from a nurse concerning a "less than 18 years old" female patient who was vaccinated with the third dose of GARDASIL (lot # not provided).  Subsequently, patient fainted multiple times and became weak.  Patient sought unspecified medical attention by seeing the nurse.  Additional information has been requested.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Inappropriate schedule of drug administration, Syncope
Clinical narrative: Information has been received from a nurse concerning a "less than 18 years old" female patient who was vaccinated with the third dose of GARDASIL (lot # not provided).  Subsequently, patient fainted multiple times and became weak.  Patient sought unspecified medical attention by seeing the nurse.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Ultrasound scan normal, Visual impairment
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a 12 year old female patient who on 28-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 659962/1740U), intramuscularly. On 25-JUL-2008, was vaccinated with the second dose of GARDASIL vaccine (Lot # 656055/0070X) and on 04-NOV-2008, was vaccinated with the third dose of GARDASIL vaccine (Lot# 660555/0279X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, VARIVAX (MSD) and MENACTRA.  The pharmacist reported that the patient had been experiencing dizzy spells since receiving her first dose of GARDASIL.  The dizzy spells began on 15-05-2008 and she had had 25-30 dizzy spells since that time.  The pharmacist reported that GARDASIL series had been completed, the dates of those immunizations was unknown by the pharmacist.  At the time of the report, the patient had not recovered.  The patient sought medical attention through an office visit.  No further information is available.  This is in follow-up to report (s) previously submitted on 2/13/2009. On 28-APR-2008, the patient also received the following vaccines dipetheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot # AC52H020AA), VARIVAX vaccince (MSD) (Lot # 15840), and MENACTRA (Lot # U2848AA). Other vaccine given on 04-NOV-2008: influenza virus vaccine (unspecified) (Lot # U2848AA). On 21-JAN-2009, the pharmacist reported that the patient had been experiencing dizzy spells since receiving her first dose of GARDASIL vaccine. The dizzy spells began on 15-MAY-2008 and she had had 25-30 dizzy spells since that time. The pharmacist reported that GARDASIL vaccination series had been completed, the dates of those immunizatins were unknown by the pharmacist. The pharmacist reported that the patient had not recovered from the event and that she sought medical attention through an office visit. On 23-JAN-2009, the registered nurse reported that the patient had fainted several times and became weak after completing the GARDASIL vaccination series. Follow-up information received fromthe registered nurse via phone call indicated that she was 12 year old patient , with no personal of family history of seizures and no known drug reaction/allergies. The nurse stated that in January 2009, the patient's mother called the clinic requesting the HPV vaccine' lot numbers and it was during that call that the clinic learned of the adverse experiences. The event was described as "dizzy spells with patient seeing spots then going black". The patient did not actually faint. There has been many spells since then. The mother reproted that the onset of the first spell was in mid-May 2008. The mother further reported to clinic that the doctor was running test and that her daugther had been referred to a neurologist (no names provided to the clinic). This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a 12 year old female patient who on 28-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 659962/1740U), intramuscularly. On 25-JUL-2008, was vaccinated with the second dose of GARDASIL vaccine (Lot # 656055/0070X) and on 04-NOV-2008, was vaccinated with the third dose of GARDASIL vaccine (Lot# 660555/0279X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, VARIVAX (MSD) and MENACTRA.  The pharmacist reported that the patient had been experiencing dizzy spells since receiving her first dose of GARDASIL.  The dizzy spells began on 15-05-2008 and she had had 25-30 dizzy spells since that time.  The pharmacist reported that GARDASIL series had been completed, the dates of those immunizations was unknown by the pharmacist.  At the time of the report, the patient had not recovered.  The patient sought medical attention through an office visit.  No further information is available.  This is in follow-up to report (s) previously submitted on 2/13/2009. On 28-APR-2008, the patient also received the following vaccines dipetheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot # AC52H020AA), VARIVAX vaccince (MSD) (Lot # 15840), and MENACTRA (Lot # U2848AA). Other vaccine given on 04-NOV-2008: influenza virus vaccine (unspecified) (Lot # U2848AA). On 21-JAN-2009, the pharmacist reported that the patient had been experiencing dizzy spells since receiving her first dose of GARDASIL vaccine. The dizzy spells began on 15-MAY-2008 and she had had 25-30 dizzy spells since that time. The pharmacist reported that GARDASIL vaccination series had been completed, the dates of those immunizatins were unknown by the pharmacist. The pharmacist reported that the patient had not recovered from the event and that she sought medical attention through an office visit. On 23-JAN-2009, the registered nurse reported that the patient had fainted several times and became weak after completing the GARDASIL vaccination series. Follow-up information received fromthe registered nurse via phone call indicated that she was 12 year old patient , with no personal of family history of seizures and no known drug reaction/allergies. The nurse stated that in January 2009, the patient's mother called the clinic requesting the HPV vaccine' lot numbers and it was during that call that the clinic learned of the adverse experiences. The event was described as "dizzy spells with patient seeing spots then going black". The patient did not actually faint. There has been many spells since then. The mother reproted that the onset of the first spell was in mid-May 2008. The mother further reported to clinic that the doctor was running test and that her daugther had been referred to a neurologist (no names provided to the clinic). This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Syncope
Clinical narrative: Information has been received from a pharmacist and a registered nurse concerning a 12 year old female patient who on 28-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 659962/1740U), intramuscularly. On 25-JUL-2008, was vaccinated with the second dose of GARDASIL vaccine (Lot # 656055/0070X) and on 04-NOV-2008, was vaccinated with the third dose of GARDASIL vaccine (Lot# 660555/0279X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, VARIVAX (MSD) and MENACTRA.  The pharmacist reported that the patient had been experiencing dizzy spells since receiving her first dose of GARDASIL.  The dizzy spells began on 15-05-2008 and she had had 25-30 dizzy spells since that time.  The pharmacist reported that GARDASIL series had been completed, the dates of those immunizations was unknown by the pharmacist.  At the time of the report, the patient had not recovered.  The patient sought medical attention through an office visit.  No further information is available.  This is in follow-up to report (s) previously submitted on 2/13/2009. On 28-APR-2008, the patient also received the following vaccines dipetheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot # AC52H020AA), VARIVAX vaccince (MSD) (Lot # 15840), and MENACTRA (Lot # U2848AA). Other vaccine given on 04-NOV-2008: influenza virus vaccine (unspecified) (Lot # U2848AA). On 21-JAN-2009, the pharmacist reported that the patient had been experiencing dizzy spells since receiving her first dose of GARDASIL vaccine. The dizzy spells began on 15-MAY-2008 and she had had 25-30 dizzy spells since that time. The pharmacist reported that GARDASIL vaccination series had been completed, the dates of those immunizatins were unknown by the pharmacist. The pharmacist reported that the patient had not recovered from the event and that she sought medical attention through an office visit. On 23-JAN-2009, the registered nurse reported that the patient had fainted several times and became weak after completing the GARDASIL vaccination series. Follow-up information received fromthe registered nurse via phone call indicated that she was 12 year old patient , with no personal of family history of seizures and no known drug reaction/allergies. The nurse stated that in January 2009, the patient's mother called the clinic requesting the HPV vaccine' lot numbers and it was during that call that the clinic learned of the adverse experiences. The event was described as "dizzy spells with patient seeing spots then going black". The patient did not actually faint. There has been many spells since then. The mother reproted that the onset of the first spell was in mid-May 2008. The mother further reported to clinic that the doctor was running test and that her daugther had been referred to a neurologist (no names provided to the clinic). This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Syncope
Clinical narrative: Information has been received from a practice manager concerning a 21 year old female with no pertinent medical history, drug reactions or allergies who on 20-JAN-2009 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot#660616/0570X). Concomitant therapy included YAZ. On 20-JAN-2009, "within 30seconds of receiving her first dose of GARDASIL vaccine", the patient fainted. she revived after a few minutes her fainted again "15 minutes later". It was reported that the patient revived and was given juice and crackers, and left the office in stable condition. A follow-up phone call was placed to the patient on 21-JAN-2009 and the patient stated that she felt "tired and weak". No lab diagnostic studies were performed. At time of the report, 21-JAN-2009, the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Fatigue, Syncope
Clinical narrative: Information has been received from a practice manager concerning a 21 year old female with no pertinent medical history, drug reactions or allergies who on 20-JAN-2009 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot#660616/0570X). Concomitant therapy included YAZ. On 20-JAN-2009, "within 30seconds of receiving her first dose of GARDASIL vaccine", the patient fainted. she revived after a few minutes her fainted again "15 minutes later". It was reported that the patient revived and was given juice and crackers, and left the office in stable condition. A follow-up phone call was placed to the patient on 21-JAN-2009 and the patient stated that she felt "tired and weak". No lab diagnostic studies were performed. At time of the report, 21-JAN-2009, the patient had not recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Joint swelling, Pruritus, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with a history of drug hypersensitivity to MYNOCYCLINE who on 05-JAN-2009 was vaccinated with a first dose of GARDASIL.  Concomitant therapy included YASMIN 3 mg everyday and BENADRYL.  On 07-JAN-2009 the patient experienced allergic reaction including itching, redness and welts and hives.  At the time of reporting, the patient's allergic reaction persisted.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow up information was received from a health professional. It was reported that female with no illness at time of vaccination was vaccinated with a first dose of GARDASIL (lot # 0947X) in the right deltoid at 16:00 (reported as "4:00 pm"). The patient reported swelling in both wrists, itching on palms of hands and sole of feet and welts on hip bones and one breast. On 08-JAN-2009, the patient recovered. No further information was available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Hypersensitivity, Joint swelling, Pruritus, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with a history of drug hypersensitivity to MYNOCYCLINE who on 05-JAN-2009 was vaccinated with a first dose of GARDASIL.  Concomitant therapy included YASMIN 3 mg everyday and BENADRYL.  On 07-JAN-2009 the patient experienced allergic reaction including itching, redness and welts and hives.  At the time of reporting, the patient's allergic reaction persisted.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009. Follow up information was received from a health professional. It was reported that female with no illness at time of vaccination was vaccinated with a first dose of GARDASIL (lot # 0947X) in the right deltoid at 16:00 (reported as "4:00 pm"). The patient reported swelling in both wrists, itching on palms of hands and sole of feet and welts on hip bones and one breast. On 08-JAN-2009, the patient recovered. No further information was available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Arthralgia, Erythema, Joint swelling
Clinical narrative: Information has been received from a Registered Nurse concerning a 14 year old female patient with Flu vaccine allergy and gastroesophageal reflux disease who on 23-JAN-2009 was vaccinated with first dose of GARDASIL vaccine (Lot # 659964/1978U) 0.5ml, intramuscularly and first dose VARIVAX vaccine (Oka/Merck) (Lot#662184/1398Xs). There were no concomitants medications. On 23-Jan-2009 approximately 20 minutes after the patient received vaccines she experienced red and swollen knee. There were no Laboratory diagnostics studies Performed. At the time of the report on 23-Jan-2009 the patient was not recovered. Patient sought medical attention was saw by a nurse. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Erythema, Joint swelling
Clinical narrative: Information has been received from a Registered Nurse concerning a 14 year old female patient with Flu vaccine allergy and gastroesophageal reflux disease who on 23-JAN-2009 was vaccinated with first dose of GARDASIL vaccine (Lot # 659964/1978U) 0.5ml, intramuscularly and first dose VARIVAX vaccine (Oka/Merck) (Lot#662184/1398Xs). There were no concomitants medications. On 23-Jan-2009 approximately 20 minutes after the patient received vaccines she experienced red and swollen knee. There were no Laboratory diagnostics studies Performed. At the time of the report on 23-Jan-2009 the patient was not recovered. Patient sought medical attention was saw by a nurse. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL, HPV4, VARCEL
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: L upper arm became red, warm, swollen, painful and itchy 2hrs after varicella vaccine.  Pt took BENADRYL po and topical and applied ice packs.  Returned to clinic 1/26/09, seen by provider, given MEDROL dose pack.
Age: 17.0
Sex: F
Vaccine: VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: L upper arm became red, warm, swollen, painful and itchy 2hrs after varicella vaccine.  Pt took BENADRYL po and topical and applied ice packs.  Returned to clinic 1/26/09, seen by provider, given MEDROL dose pack.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Pneumonia
Clinical narrative: HPV #1 on 10/15/08- within 1wk- sharp, midsection abdominal pain that would come and go.  12/22/08 Same abdominal pain with greater severity.  Pain in upper back and neck radiating down arms.  Pain upper thigh down legs.  Hospitalized 1/5/09-1/7/09 for pneumonia unable to attend school.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Back pain, Full blood count normal, Mononucleosis heterophile test, Neck pain
Clinical narrative: HPV #1 on 10/15/08- within 1wk- sharp, midsection abdominal pain that would come and go.  12/22/08 Same abdominal pain with greater severity.  Pain in upper back and neck radiating down arms.  Pain upper thigh down legs.  Hospitalized 1/5/09-1/7/09 for pneumonia unable to attend school.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain in extremity, Pneumonia, Streptococcal identification test negative
Clinical narrative: HPV #1 on 10/15/08- within 1wk- sharp, midsection abdominal pain that would come and go.  12/22/08 Same abdominal pain with greater severity.  Pain in upper back and neck radiating down arms.  Pain upper thigh down legs.  Hospitalized 1/5/09-1/7/09 for pneumonia unable to attend school.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Migraine, Visual impairment, Vomiting
Clinical narrative: According to mother, patient developed headache accompanied by visual disturbances a few hours after vaccines.  Pt. has been c/o of occasional migraines since that episode.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL, MNQ, VARCEL
Symptoms: Headache, Migraine, Nuclear magnetic resonance imaging brain, Visual impairment
Clinical narrative: According to mother, patient developed headache accompanied by visual disturbances a few hours after vaccines.  Pt. has been c/o of occasional migraines since that episode.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Depressed level of consciousness, Somnolence, Unresponsive to stimuli
Clinical narrative: Parent went to make f/u apt child not responding to parent when she call child's name, PCR to parent to shake baby's arm and PCR called nurse. Baby appeared sleepy less responsive. Ask parent if baby takes nap, per parent child had nap didn't act this way before. Called ambulance took child's VS doctor seen pt, child sent to ER for eval.   2/23/09 Received hospital consult medical records of 7/7/2008 which are only records available. FINAL DX: altered mental status & possible vaccine reaction Record reveals patient had been seen in PCP office for vaccinations & was healthy at that time.  Within 10-15 min became limp in parent's arms when checking out & appeared cyanotic, difficult to arouse, drowsy but became alert in about 10 min.  Taken to ER where exam WNL.  Admitted overnight for observation & d/c to home in AM.  2/25/09 Received Neuro consult of 7/18/2008. FINAL DX: single paroxymal episode s/p 4 mo immunizations; possible seizure Records reveal patient experienced floppy, unresponsive approx 10 min after vaccines.  Returned to baseline afterward.  Seen in ER where w/u neg.  Neuro exam WNL except for pseudostrabismus vs strabismus.  Referred for head US & to Ophtho.
Age: 0.8
Sex: F
Vaccine: FLU3
Symptoms: Gastroenteritis, Vomiting
Clinical narrative: Vomiting that started several hours after receiving her booster flu shot.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Soreness
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Contusion, Fall, Loss of consciousness
Clinical narrative: 11 year boy passed out suddenly after receiving vaccines on 1/17/09 @ around 6 pm.  I turned around to dispose of the needle, when he suddenly went to the floor bruised his forehead & upper lip ~1/4" bruise.  He was only out for few secs then recovered quickly & completely.  No treatment needed.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Several hours after receiving the vaccine had chills, fever, myalgias, vomiting and headache. Sxs were severe enough that she was admitted to the hospital for 24 hours for hydration. Fever, Nausea w/vomiting, Headache, general  2/25/09 Received medical records of 2/6/2009. FINAL DX: none provided Records reveal patient experienced chills, fevers, myslgias, vomiting, HA within few hours of 2005 flu vaccine.  24 hr admission for rehydration.  Allergy consult done.  Recommended to have previously tolerated Flu-Mist vaccine(2007) in future.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Several hours after receiving the vaccine had chills, fever, myalgias, vomiting and headache. Sxs were severe enough that she was admitted to the hospital for 24 hours for hydration. Fever, Nausea w/vomiting, Headache, general  2/25/09 Received medical records of 2/6/2009. FINAL DX: none provided Records reveal patient experienced chills, fevers, myslgias, vomiting, HA within few hours of 2005 flu vaccine.  24 hr admission for rehydration.  Allergy consult done.  Recommended to have previously tolerated Flu-Mist vaccine(2007) in future.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Antinuclear antibody increased, Arthralgia, Autoimmune disorder, Pyrexia, Swelling
Clinical narrative: Autoimmune-type disorder. Fever, joint pain, diffuse swelling.  4/6/09 Received chiropractor medical records of 11/14/2008. FINAL DX: sciatica, DJD, kyphosis acquired, cervical & thoracic segmental/somatic dysfunction Records reveal patient experienced fever, body & joint pain, fatigue x 3 wks.  S/S temporarily relieved by NSAIDs.  Patient states had gone to bed 3 wks prior & awoken in night w/fever, then developed body & joint pain & fatigue.  Had been unable to exercise & had been taking oral antibiotic.  6/15/09 Received vaccine & PCP medical records of 7/16-11/8/2008. FINAL DX: Rhinitis, fever, healed fibular fracture. Records reveal patient experienced fever, post nasal drip, nasal congestion, allergic rhinitis. Rhinorrhea, sneezing. Aching pain right ankle. Tenderness, swelling deformity, right distal fibula. Edema - feet.   ICD-9 Codes 477.9 Rhinitis, allergic cause unspec. 729.5 Pain in limb 780.60 Fever NOS 823.81 Fx closed fibula NOS.