chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site induration, Injection site pain, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a nurse concerning a 26 year old female who on an unspecified date was vaccinated with first dose of GARDASIL vaccine (yeast) and had no reaction. On an unspecified date the patient was vaccinated with a second dose of GARDASIL vaccine (yeast). On approximately 07-MAY- 2008, "about 3 weeks ago" the patient experienced a swollen, painful and hard injection site. The patient sought medical attention at the physician's office. At the time of report, the patient was not recovered. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DPP, HBHEPB, HEP, MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Communication disorder, Convulsion, Developmental delay
Clinical narrative: Fever with mild seizure within 2-3 days of vaccination. Dr. himself diagnosed him as developmental delay on 6-6-2003. Later on we found in him that he was not able to communicate properly, writing in the air, laughing himself without reason, he do not know about his surroundings, not playing with other kids, repeated his grade 1, and concluded by school officials as autistic kid.  5/23/2008 MR received from PCP for OVs 3/22/1999-6/2003.  Normal exam with URI sx on 3/22/99. Developmental delays noted 2/13/2003 with speech and occupational tx services recommended. Significant verbal communication and inter-relationship problems as well refusal to urinate in school toilet noted. 7/28/2008 MR received form parent which show severe receptive and expressive language delays as well as a mild articulation disorder. Follow-up: He is 12 years of age, he is fifth grader, he has been held back one grade lower, he does not have communication skills. He does not know responsibility, he does not talk himself. Some body force him to say some thing, then he say 'yes' or 'no'. Some time he talks himself on his own word and do some weird things on his own world. This is a big tragedy for us, he does not talk or play with his sibling and not talk in the class every time he shuts his mouth and keep him quite. I am totally confident that five (5) shots(vaccines) in a single day had hurt him.
Age: 3.0
Sex: M
Vaccine: DPP, HBHEPB, HEP, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever with mild seizure within 2-3 days of vaccination. Dr. himself diagnosed him as developmental delay on 6-6-2003. Later on we found in him that he was not able to communicate properly, writing in the air, laughing himself without reason, he do not know about his surroundings, not playing with other kids, repeated his grade 1, and concluded by school officials as autistic kid.  5/23/2008 MR received from PCP for OVs 3/22/1999-6/2003.  Normal exam with URI sx on 3/22/99. Developmental delays noted 2/13/2003 with speech and occupational tx services recommended. Significant verbal communication and inter-relationship problems as well refusal to urinate in school toilet noted. 7/28/2008 MR received form parent which show severe receptive and expressive language delays as well as a mild articulation disorder. Follow-up: He is 12 years of age, he is fifth grader, he has been held back one grade lower, he does not have communication skills. He does not know responsibility, he does not talk himself. Some body force him to say some thing, then he say 'yes' or 'no'. Some time he talks himself on his own word and do some weird things on his own world. This is a big tragedy for us, he does not talk or play with his sibling and not talk in the class every time he shuts his mouth and keep him quite. I am totally confident that five (5) shots(vaccines) in a single day had hurt him.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Deep vein thrombosis, Dyspnoea, Factor V Leiden mutation, Pulmonary embolism
Clinical narrative: Shortness of breath.DVT, Right leg. DVT Showered into lungs, Multiple Bilateral Pulmonary Emboli.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: aPPROXIMATELY 36 HOURS AFTER INNOCULATION, THE INNOCUALTED AREA WAS FEVERED AND SORE. THE FEVERED AREA SPREAD DOWN MY ARM ABOUT 6 INCHES. THE DOCTOR DID NOT GIVE ME THE SHOT. HER NURSE DID BUT I DO NOT KNOW THE NURSES NAME. I AM REPORTING THIS BECAUSE MU HUSBAND HAD THE SAME SYMPTOMS WHNE HE HAD THE SHOT IN APRIL OF THIS YEAR. WE WERE BOTH TOLD THAT THERE HAD BEEN NO ADVERSE REACTIONS REPORTED BY THE PATIENTS AT THE CLINIC WHERE WE WERE INNOCULATED. EVEN THOUGH THIS WAS NOT A SEVERE REACTION, IT WAS INCONVENIENT AND  THIS WAS A SHINGLES VACCINE. IT IS NOT SHOWN IN THE LIST OF VACCINES.
Age: 37.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red raised itchy patch 2" long by 1/2" wide both arms.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Erythema, Oedema peripheral, Skin discolouration
Clinical narrative: Information has been received from a mother concerning her 19 year old daughter who was vaccinated with a second dose of GARDASIL about 4 months ago.  There was no concomitant medication.  Subsequently the day following the second dose of GARDASIL the patient's hands became swollen, red and purple colored and uncomfortable.  Medical attention was sought.  The patient recovered from these adverse events about 24 hours after the AE (also reported as 48 hours after vaccination).  No other information was available.  Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Information has been received on request from the FDA under the act regarding a 15 year old female with no previous illnesses, who on 28-JAN-2008 was vaccinated IM in the left arm with a first dose of GARDASIL (Lot# 658554/0928U).  Concomitant therapy included ADACEL (Lot# C2771AA) administered in the right arm, and MENACTRA (Lot# U2405AA) administered in the left arm.  On 28-JAN-2008 GARDASIL was misadministered.  It was documented on the patient's immunization record by the office assistant for the patient to receive GARDASIL and MENACTRA when the patient's parent had requested MENACTRA and ADACEL.  The ADACEL was administered later.  The parent was upset over the administration of GARDASIL.  No laboratory diagnostics were performed.  At the time of the report, the outcome of the patient was unknown.  The VAERS ID# is 305701.  Additional information is not available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood glucose normal, Bradycardia, Nausea, Oxygen saturation, Pallor
Clinical narrative: Information has been received on request from the FDA under the act regarding a 16 year old female with a history of seizure with local anesthesia at the dentist office, who on 20-FEB-2008 was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 659180/1758U).  There were no concomitant medications.  On 20-FEB-2008 post vaccination the patient walked immediately to the check out counter and became pale, nauseous, and had a syncopal episode in which she became bradycardic.  The patient was treated with an adult EPIPEN, BENADRYL 50mg, and oxygen.  The patient was then sent to the emergency room via EMS.  The patient's glucose was 94 and pulse oximetry was 100%. At the time of the report, the outcome of the patient was unknown.  The VAERS ID# is 305703.  Additional information is not available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received on request from the FDA under the act regarding a 16 year old female with a history of seizure with local anesthesia at the dentist office, who on 20-FEB-2008 was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 659180/1758U).  There were no concomitant medications.  On 20-FEB-2008 post vaccination the patient walked immediately to the check out counter and became pale, nauseous, and had a syncopal episode in which she became bradycardic.  The patient was treated with an adult EPIPEN, BENADRYL 50mg, and oxygen.  The patient was then sent to the emergency room via EMS.  The patient's glucose was 94 and pulse oximetry was 100%. At the time of the report, the outcome of the patient was unknown.  The VAERS ID# is 305703.  Additional information is not available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Blood glucose normal, Bradycardia, Nausea, Oxygen saturation, Oxygen saturation normal
Clinical narrative: Information has been received on request from the FDA under the act regarding a 16 year old female with a history of seizure with local anesthesia at the dentist office, who on 20-FEB-2008 was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 659180/1758U).  There were no concomitant medications.  On 20-FEB-2008 post vaccination the patient walked immediately to the check out counter and became pale, nauseous, and had a syncopal episode in which she became bradycardic.  The patient was treated with an adult EPIPEN, BENADRYL 50mg, and oxygen.  The patient was then sent to the emergency room via EMS.  The patient's glucose was 94 and pulse oximetry was 100%. At the time of the report, the outcome of the patient was unknown.  The VAERS ID# is 305703.  Additional information is not available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Information has been received on request from the FDA under the act regarding a 16 year old female with a history of seizure with local anesthesia at the dentist office, who on 20-FEB-2008 was vaccinated in the left deltoid with a second dose of GARDASIL (Lot# 659180/1758U).  There were no concomitant medications.  On 20-FEB-2008 post vaccination the patient walked immediately to the check out counter and became pale, nauseous, and had a syncopal episode in which she became bradycardic.  The patient was treated with an adult EPIPEN, BENADRYL 50mg, and oxygen.  The patient was then sent to the emergency room via EMS.  The patient's glucose was 94 and pulse oximetry was 100%. At the time of the report, the outcome of the patient was unknown.  The VAERS ID# is 305703.  Additional information is not available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site atrophy
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL.  Subsequently the patient developed a tissue necrosis.  The outcome was unknown.  Additional information has been requested. 02/18/2010 In follow up information the physician explained that the patient had no initial reaction to the vaccine. He reported that the patient had a history of very severe eczema as a child which had improved but was still a problem for her as a teenager. He stated that when observed her a few months after the injection,  he noted that she had a "concave" stie at the site of the dose which was approximately the size of a quarter or might be a little bigger. He stated that patient had reported no pain, no redness or swelling at any time and this reaction which appeared to be tissue necrosis under the skin was "cosmetic" only but disturbing to the patient, her family and the physician. The physician decided not to complete the vaccination series in the patient. The outcome was unknown.  Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of GARDASIL.  Subsequently the patient developed a tissue necrosis.  The outcome was unknown.  Additional information has been requested. 02/18/2010 In follow up information the physician explained that the patient had no initial reaction to the vaccine. He reported that the patient had a history of very severe eczema as a child which had improved but was still a problem for her as a teenager. He stated that when observed her a few months after the injection,  he noted that she had a "concave" stie at the site of the dose which was approximately the size of a quarter or might be a little bigger. He stated that patient had reported no pain, no redness or swelling at any time and this reaction which appeared to be tissue necrosis under the skin was "cosmetic" only but disturbing to the patient, her family and the physician. The physician decided not to complete the vaccination series in the patient. The outcome was unknown.  Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Labia enlarged, Vaginal swelling
Clinical narrative: Information has been received from a nurse concerning her 20 year old daughter with no medical history and no known drug reactions or allergies who on 03-MAR-2008 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot # 655620/0171U).  There was no concomitant medication.  On 03-MAR-2008 the patient experienced swelling of the vagina and labia.  The patient began to experience the swelling two hours after receiving the vaccination.  The swelling was reduced with the administration of BENADRYL.  The patient recovered 05-MAR-2008.  Patient did not seek medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Genital swelling, Vaginal swelling
Clinical narrative: Information has been received from a nurse concerning her 20 year old daughter with no medical history and no known drug reactions or allergies who on 03-MAR-2008 was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot # 655620/0171U).  There was no concomitant medication.  On 03-MAR-2008 the patient experienced swelling of the vagina and labia.  The patient began to experience the swelling two hours after receiving the vaccination.  The swelling was reduced with the administration of BENADRYL.  The patient recovered 05-MAR-2008.  Patient did not seek medical attention.  No product quality complaint was involved.  Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Haematochezia, Intussusception, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 week old female with no pre-existing medical conditions or allergies who on 04-MAR-2008 at 09:00 was vaccinated PO with her first dose of Rotateq (lot# 657670/1108U). There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 09:00 included the first IM dose of ActHib (lot# UF342AB) in the lower left vastus lateralis, the first IM dose of Pediarix (lot# AC21B138BA) in the upper left vastus lateralis and the first IM dose of Prevnar (lot# C45887) in the right vastus lateralis. On the evening of 10-MAR-2008 the patient began to have blood in her stool and some vomiting. The patient was seen in the physician's office and then in a nationwide children's ER. Subsequently the patient was diagnosed with intussusception, failed air reduction and had surgery to reduce it. Subsequently, the patient recovered. Intussusception was also considered to be immediately life-threatening by the physician. A lot check has been initiated. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Colectomy, Haematochezia, Intussusception, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 week old female with no pre-existing medical conditions or allergies who on 04-MAR-2008 at 09:00 was vaccinated PO with her first dose of Rotateq (lot# 657670/1108U). There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 09:00 included the first IM dose of ActHib (lot# UF342AB) in the lower left vastus lateralis, the first IM dose of Pediarix (lot# AC21B138BA) in the upper left vastus lateralis and the first IM dose of Prevnar (lot# C45887) in the right vastus lateralis. On the evening of 10-MAR-2008 the patient began to have blood in her stool and some vomiting. The patient was seen in the physician's office and then in a nationwide children's ER. Subsequently the patient was diagnosed with intussusception, failed air reduction and had surgery to reduce it. Subsequently, the patient recovered. Intussusception was also considered to be immediately life-threatening by the physician. A lot check has been initiated. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Surgery, Vomiting
Clinical narrative: Information has been received from a physician concerning a 11 week old female with no pre-existing medical conditions or allergies who on 04-MAR-2008 at 09:00 was vaccinated PO with her first dose of Rotateq (lot# 657670/1108U). There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 09:00 included the first IM dose of ActHib (lot# UF342AB) in the lower left vastus lateralis, the first IM dose of Pediarix (lot# AC21B138BA) in the upper left vastus lateralis and the first IM dose of Prevnar (lot# C45887) in the right vastus lateralis. On the evening of 10-MAR-2008 the patient began to have blood in her stool and some vomiting. The patient was seen in the physician's office and then in a nationwide children's ER. Subsequently the patient was diagnosed with intussusception, failed air reduction and had surgery to reduce it. Subsequently, the patient recovered. Intussusception was also considered to be immediately life-threatening by the physician. A lot check has been initiated. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Chest pain, Heart rate irregular, Hypotension
Clinical narrative: Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated with a 0.5 mL dose of GARDASIL and fainted. No further information was provided. Outcome was not reported. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a registered nurse concerning a 14 year old patient with a history of chest pain, who on 03-APR-2008 at 17:25 was vaccinated IM in the right deltoid with a 0.5 mL first dose of GARDASIL (Lot# 659655/1486U). Concomitant suspect vaccination included VARIVAX (Oka/Merck) (Lot# 659724/1660U) administered SQ in the left arm. Other concomitant vaccinations included HEP A (unspecified) (Lot# AHAVB222AA) administered IM in the right deltoid. On 03-APR-2008 the patient fainted. Ten minutes post vaccination the patient complained of chest pain. The patient's blood pressure was 78/20. The patient was assisted to lay down and her blood pressure was rechecked with a result of 128/90. The patient's heart rate was 100. The patient was transported to the emergency room by EMS. A MRI was performed for the chest pain with no findings. The patient recovered on 04-APR-2008. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Chest pain, Condition aggravated, Nuclear magnetic resonance imaging normal, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who, on an unspecified date, was vaccinated with a 0.5 mL dose of GARDASIL and fainted. No further information was provided. Outcome was not reported. Additional information has been requested. 10/08/08 This is in follow-up to report(s) previously submitted on 5/14/2008. Initial and follow-up information has been received from a registered nurse concerning a 14 year old patient with a history of chest pain, who on 03-APR-2008 at 17:25 was vaccinated IM in the right deltoid with a 0.5 mL first dose of GARDASIL (Lot# 659655/1486U). Concomitant suspect vaccination included VARIVAX (Oka/Merck) (Lot# 659724/1660U) administered SQ in the left arm. Other concomitant vaccinations included HEP A (unspecified) (Lot# AHAVB222AA) administered IM in the right deltoid. On 03-APR-2008 the patient fainted. Ten minutes post vaccination the patient complained of chest pain. The patient's blood pressure was 78/20. The patient was assisted to lay down and her blood pressure was rechecked with a result of 128/90. The patient's heart rate was 100. The patient was transported to the emergency room by EMS. A MRI was performed for the chest pain with no findings. The patient recovered on 04-APR-2008. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Haemorrhage, Head injury, Skin laceration
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with a history of syncope who on 22-APR-2008 was vaccinated with a second dose of GARDASIL 0.5 IM. On 22-APR-2008 the patient fainted, hit her head in the office after the second dose of GARDASIL. The patient received stitches to the head at this office and was diagnosed with a concussion. At the time of reporting it was unknown if the patient had recovered. No other information was available at this time. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Follow-up information was received from a health acre professional. Approximately 5 minutes after receiving the second GARDASIL (lot# "0063Y") the patient was standing at an appointment desk and suddenly fell backwards and hit head on a window ledge. The patient moved to the exam room for evaluation. The bleeding was controlled, 1 and 1/2 inch "c" shaped laceration noted to back of head. "1" staple was placed by physician. Physician was covering for attending. The patient was alert and oriented. The patient stated she did not have much to eat. Drink and snack was given in the office. On an unspecified date the patient recovered. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Concussion, Head injury, Suture insertion, Syncope
Clinical narrative: Information has been received from a physician concerning a female (age not reported) with a history of syncope who on 22-APR-2008 was vaccinated with a second dose of GARDASIL 0.5 IM. On 22-APR-2008 the patient fainted, hit her head in the office after the second dose of GARDASIL. The patient received stitches to the head at this office and was diagnosed with a concussion. At the time of reporting it was unknown if the patient had recovered. No other information was available at this time. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2008. Follow-up information was received from a health acre professional. Approximately 5 minutes after receiving the second GARDASIL (lot# "0063Y") the patient was standing at an appointment desk and suddenly fell backwards and hit head on a window ledge. The patient moved to the exam room for evaluation. The bleeding was controlled, 1 and 1/2 inch "c" shaped laceration noted to back of head. "1" staple was placed by physician. Physician was covering for attending. The patient was alert and oriented. The patient stated she did not have much to eat. Drink and snack was given in the office. On an unspecified date the patient recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who was vaccinated with a dose of GARDASIL (Lot # 658556/1060U). The patient experienced shingles and rash after her first dose. The patient called the office indicating a rash on her abdomen and was seen in the office with a rash on her back after the second dose. During her office visit she also complained of pain in her arm. The nurse practitioner advised the patient to take Naprosyn. She also advised the patient not to receive the third dose of GARDASIL. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES #0804USA01372). Additional information has been requested. This is in follow-up to report previously submitted on 5/14/2008. Initial and follow-up information has been received from a nurse concerning a 15 year old female who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL. On 04-APR-2008, the patient was vaccinated with the second IM dose of GARDASIL in the left deltoid muscle (lot#658556/1060U). The patient experienced pain, shingles and rash after her first dose. The patient called the office indicated a rash on her abdomen and was seen in the office on 02-FEB-2008. The nurse practitioner advised the patient to take Naprosyn. She also advised the patient not to receive the third dose of GARDASIL. It was later reported that on 04-FEB-2008 the patient returned to the office and was diagnosed with Herpes Zoster. She was treated with ZOVIRAX 200mg. 5 tablets per day, for 7 days. It was reported that the patient recovered on 08-FEB-2008. On 11-APR-2008, the patient reported to the office that she had an itchy rash on her abdomen and back and reported that the rash on her abdomen went away. The patient also complained of pain in her left arm and was treated with NAPROSYN. It was reported that on 14-APR-2008, the patient returned to the office complaining of pain in her left arm and the patient reported that the NAPROSYN did not help her pain. The patient was referred to a neurologist. On 24-APR-2008, it was reported that her neurologist told the patient to get the third dose of GARDASIL. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES0804USA01372). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Herpes zoster, Pain in extremity, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who was vaccinated with a dose of GARDASIL (Lot # 658556/1060U). The patient experienced shingles and rash after her first dose. The patient called the office indicating a rash on her abdomen and was seen in the office with a rash on her back after the second dose. During her office visit she also complained of pain in her arm. The nurse practitioner advised the patient to take Naprosyn. She also advised the patient not to receive the third dose of GARDASIL. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES #0804USA01372). Additional information has been requested. This is in follow-up to report previously submitted on 5/14/2008. Initial and follow-up information has been received from a nurse concerning a 15 year old female who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL. On 04-APR-2008, the patient was vaccinated with the second IM dose of GARDASIL in the left deltoid muscle (lot#658556/1060U). The patient experienced pain, shingles and rash after her first dose. The patient called the office indicated a rash on her abdomen and was seen in the office on 02-FEB-2008. The nurse practitioner advised the patient to take Naprosyn. She also advised the patient not to receive the third dose of GARDASIL. It was later reported that on 04-FEB-2008 the patient returned to the office and was diagnosed with Herpes Zoster. She was treated with ZOVIRAX 200mg. 5 tablets per day, for 7 days. It was reported that the patient recovered on 08-FEB-2008. On 11-APR-2008, the patient reported to the office that she had an itchy rash on her abdomen and back and reported that the rash on her abdomen went away. The patient also complained of pain in her left arm and was treated with NAPROSYN. It was reported that on 14-APR-2008, the patient returned to the office complaining of pain in her left arm and the patient reported that the NAPROSYN did not help her pain. The patient was referred to a neurologist. On 24-APR-2008, it was reported that her neurologist told the patient to get the third dose of GARDASIL. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES0804USA01372). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Flank pain, Full blood count, Herpes simplex serology, Herpes zoster, Metabolic function test
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who was vaccinated with a dose of GARDASIL (Lot # 658556/1060U). The patient experienced shingles and rash after her first dose. The patient called the office indicating a rash on her abdomen and was seen in the office with a rash on her back after the second dose. During her office visit she also complained of pain in her arm. The nurse practitioner advised the patient to take Naprosyn. She also advised the patient not to receive the third dose of GARDASIL. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES #0804USA01372). Additional information has been requested. This is in follow-up to report previously submitted on 5/14/2008. Initial and follow-up information has been received from a nurse concerning a 15 year old female who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL. On 04-APR-2008, the patient was vaccinated with the second IM dose of GARDASIL in the left deltoid muscle (lot#658556/1060U). The patient experienced pain, shingles and rash after her first dose. The patient called the office indicated a rash on her abdomen and was seen in the office on 02-FEB-2008. The nurse practitioner advised the patient to take Naprosyn. She also advised the patient not to receive the third dose of GARDASIL. It was later reported that on 04-FEB-2008 the patient returned to the office and was diagnosed with Herpes Zoster. She was treated with ZOVIRAX 200mg. 5 tablets per day, for 7 days. It was reported that the patient recovered on 08-FEB-2008. On 11-APR-2008, the patient reported to the office that she had an itchy rash on her abdomen and back and reported that the rash on her abdomen went away. The patient also complained of pain in her left arm and was treated with NAPROSYN. It was reported that on 14-APR-2008, the patient returned to the office complaining of pain in her left arm and the patient reported that the NAPROSYN did not help her pain. The patient was referred to a neurologist. On 24-APR-2008, it was reported that her neurologist told the patient to get the third dose of GARDASIL. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES0804USA01372). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 19 year old female who was vaccinated with a dose of GARDASIL (Lot # 658556/1060U). The patient experienced shingles and rash after her first dose. The patient called the office indicating a rash on her abdomen and was seen in the office with a rash on her back after the second dose. During her office visit she also complained of pain in her arm. The nurse practitioner advised the patient to take Naprosyn. She also advised the patient not to receive the third dose of GARDASIL. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES #0804USA01372). Additional information has been requested. This is in follow-up to report previously submitted on 5/14/2008. Initial and follow-up information has been received from a nurse concerning a 15 year old female who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL. On 04-APR-2008, the patient was vaccinated with the second IM dose of GARDASIL in the left deltoid muscle (lot#658556/1060U). The patient experienced pain, shingles and rash after her first dose. The patient called the office indicated a rash on her abdomen and was seen in the office on 02-FEB-2008. The nurse practitioner advised the patient to take Naprosyn. She also advised the patient not to receive the third dose of GARDASIL. It was later reported that on 04-FEB-2008 the patient returned to the office and was diagnosed with Herpes Zoster. She was treated with ZOVIRAX 200mg. 5 tablets per day, for 7 days. It was reported that the patient recovered on 08-FEB-2008. On 11-APR-2008, the patient reported to the office that she had an itchy rash on her abdomen and back and reported that the rash on her abdomen went away. The patient also complained of pain in her left arm and was treated with NAPROSYN. It was reported that on 14-APR-2008, the patient returned to the office complaining of pain in her left arm and the patient reported that the NAPROSYN did not help her pain. The patient was referred to a neurologist. On 24-APR-2008, it was reported that her neurologist told the patient to get the third dose of GARDASIL. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES0804USA01372). Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Back pain, Herpes zoster, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with a history of "absent periods" who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included YASMIN. On 02-FEB-2008 the patient thought she had a bug bite. On 04-FEB-2008 the patient went to the doctor's office and was diagnosed with herpes zoster. The patient was prescribed ZOVIRAX and recovered a few days later. Follow up information was received. A nurse called to report patient received the second dose of GARDASIL (lot # not reported) 0.5 mL IM in the left deltoid on 04-APR-2008 and experienced left arm pain for 2 days. On days 3 through 5 the patient was pain free. On day 5 the patient had increased pain down her left arm. The patient was concerned the herpes zoster had come back because she was experiencing the same type of pain. The patient also noticed one mark on her back but a physician later determined this was an old lesion from the initial herpes zoster occurrence. The patient was given NAPROSYN for the pain. The patient was seen in the physician's office on 14-APR-2008 and informed the nurse the NAPROSYN was not helping with the pain. The patient had a "CBC, chem scan and herpes zoster panel done on 14-APR-2008 - results unknown. The nurse mentioned after the first dose of GARDASIL (lot # not reported), the location of what the patient thought was bug bites was on the middle of her back and on the side. There was also pain on the side. Unspecified which side it was. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Herpes zoster, Pain in extremity, Rash, Vaccine positive rechallenge
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with a history of "absent periods" who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included YASMIN. On 02-FEB-2008 the patient thought she had a bug bite. On 04-FEB-2008 the patient went to the doctor's office and was diagnosed with herpes zoster. The patient was prescribed ZOVIRAX and recovered a few days later. Follow up information was received. A nurse called to report patient received the second dose of GARDASIL (lot # not reported) 0.5 mL IM in the left deltoid on 04-APR-2008 and experienced left arm pain for 2 days. On days 3 through 5 the patient was pain free. On day 5 the patient had increased pain down her left arm. The patient was concerned the herpes zoster had come back because she was experiencing the same type of pain. The patient also noticed one mark on her back but a physician later determined this was an old lesion from the initial herpes zoster occurrence. The patient was given NAPROSYN for the pain. The patient was seen in the physician's office on 14-APR-2008 and informed the nurse the NAPROSYN was not helping with the pain. The patient had a "CBC, chem scan and herpes zoster panel done on 14-APR-2008 - results unknown. The nurse mentioned after the first dose of GARDASIL (lot # not reported), the location of what the patient thought was bug bites was on the middle of her back and on the side. There was also pain on the side. Unspecified which side it was. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Flank pain, Full blood count, Herpes simplex serology, Herpes zoster, Metabolic function test
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with a history of "absent periods" who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included YASMIN. On 02-FEB-2008 the patient thought she had a bug bite. On 04-FEB-2008 the patient went to the doctor's office and was diagnosed with herpes zoster. The patient was prescribed ZOVIRAX and recovered a few days later. Follow up information was received. A nurse called to report patient received the second dose of GARDASIL (lot # not reported) 0.5 mL IM in the left deltoid on 04-APR-2008 and experienced left arm pain for 2 days. On days 3 through 5 the patient was pain free. On day 5 the patient had increased pain down her left arm. The patient was concerned the herpes zoster had come back because she was experiencing the same type of pain. The patient also noticed one mark on her back but a physician later determined this was an old lesion from the initial herpes zoster occurrence. The patient was given NAPROSYN for the pain. The patient was seen in the physician's office on 14-APR-2008 and informed the nurse the NAPROSYN was not helping with the pain. The patient had a "CBC, chem scan and herpes zoster panel done on 14-APR-2008 - results unknown. The nurse mentioned after the first dose of GARDASIL (lot # not reported), the location of what the patient thought was bug bites was on the middle of her back and on the side. There was also pain on the side. Unspecified which side it was. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with a history of "absent periods" who on 18-JAN-2008 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included YASMIN. On 02-FEB-2008 the patient thought she had a bug bite. On 04-FEB-2008 the patient went to the doctor's office and was diagnosed with herpes zoster. The patient was prescribed ZOVIRAX and recovered a few days later. Follow up information was received. A nurse called to report patient received the second dose of GARDASIL (lot # not reported) 0.5 mL IM in the left deltoid on 04-APR-2008 and experienced left arm pain for 2 days. On days 3 through 5 the patient was pain free. On day 5 the patient had increased pain down her left arm. The patient was concerned the herpes zoster had come back because she was experiencing the same type of pain. The patient also noticed one mark on her back but a physician later determined this was an old lesion from the initial herpes zoster occurrence. The patient was given NAPROSYN for the pain. The patient was seen in the physician's office on 14-APR-2008 and informed the nurse the NAPROSYN was not helping with the pain. The patient had a "CBC, chem scan and herpes zoster panel done on 14-APR-2008 - results unknown. The nurse mentioned after the first dose of GARDASIL (lot # not reported), the location of what the patient thought was bug bites was on the middle of her back and on the side. There was also pain on the side. Unspecified which side it was. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood product transfusion, CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Headache
Clinical narrative: Information has been received from a physician concerning an 80 year old male who on 29-APR-2008 was vaccinated subcutaneously (SC) with ZOSTAVAX in the left deltoid (Lot #658844/0204X). On 30-APR-2008 the patient developed generalized muscle weakness. On 02-May-2008 the patient presented to the emergency room with profound muscle weakness thought to be Guillain-Barre syndrome or transverse myelitis. At the time of this report, the outcome of the events of Guillain Barre syndrome and transverse myelitis were unknown. Upon internal review, Guillain Barre syndrome and transverse myelitis were considered other important medical event. Additional information received from the physician regarding this patient with no known allergies reported that this patient's concurrent conditions included hypothyroidism, gastroesophageal reflux disease (GERD), bipolar disorder, depression, benign prostatic hyperplasia, dyslipidemia, and a history of hip replacement, cataract, and chickenpox in approximately 1940. There was no history of shingles. Concomitant medications included levothyroxine sodium, pantoprazole, and divalproex sodium. Within 24-48 hours of vaccination with ZOSTAVAX, the patient noticed the onset of weakness in his hands (while driving), followed by gait disturbance and some difficulty with balance. The patient was admitted to the hospital a few days later for evaluation. A lumbar puncture performed on 03-May-2008 (also reported as 04-May-2008) revealed cerebrospinal fluid results as follows: protein "59"l, glucose 67, red blood ells 83, and white blood cells 1. The physician reported that the patient had not worsened, but was still decreased from his baseline. The patient had bilateral foot drop and 3/5 motor strength in both arms and legs. He was receiving IVIG while hospitalized. Hospitalization continued at the time of the report. The physician reported the leading diagnosis was Guillain Barre syndrome; "however they are still working up the patient, and it might change". Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Immunoglobulins, Muscular weakness, Polymerase chain reaction, Red blood cells CSF positive, Viral DNA test negative
Clinical narrative: Information has been received from a physician concerning an 80 year old male who on 29-APR-2008 was vaccinated subcutaneously (SC) with ZOSTAVAX in the left deltoid (Lot #658844/0204X). On 30-APR-2008 the patient developed generalized muscle weakness. On 02-May-2008 the patient presented to the emergency room with profound muscle weakness thought to be Guillain-Barre syndrome or transverse myelitis. At the time of this report, the outcome of the events of Guillain Barre syndrome and transverse myelitis were unknown. Upon internal review, Guillain Barre syndrome and transverse myelitis were considered other important medical event. Additional information received from the physician regarding this patient with no known allergies reported that this patient's concurrent conditions included hypothyroidism, gastroesophageal reflux disease (GERD), bipolar disorder, depression, benign prostatic hyperplasia, dyslipidemia, and a history of hip replacement, cataract, and chickenpox in approximately 1940. There was no history of shingles. Concomitant medications included levothyroxine sodium, pantoprazole, and divalproex sodium. Within 24-48 hours of vaccination with ZOSTAVAX, the patient noticed the onset of weakness in his hands (while driving), followed by gait disturbance and some difficulty with balance. The patient was admitted to the hospital a few days later for evaluation. A lumbar puncture performed on 03-May-2008 (also reported as 04-May-2008) revealed cerebrospinal fluid results as follows: protein "59"l, glucose 67, red blood ells 83, and white blood cells 1. The physician reported that the patient had not worsened, but was still decreased from his baseline. The patient had bilateral foot drop and 3/5 motor strength in both arms and legs. He was receiving IVIG while hospitalized. Hospitalization continued at the time of the report. The physician reported the leading diagnosis was Guillain Barre syndrome; "however they are still working up the patient, and it might change". Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Body temperature increased, CSF cell count, CSF glucose, CSF test abnormal, CSF white blood cell count
Clinical narrative: Information has been received from a physician concerning an 80 year old male who on 29-APR-2008 was vaccinated subcutaneously (SC) with ZOSTAVAX in the left deltoid (Lot #658844/0204X). On 30-APR-2008 the patient developed generalized muscle weakness. On 02-May-2008 the patient presented to the emergency room with profound muscle weakness thought to be Guillain-Barre syndrome or transverse myelitis. At the time of this report, the outcome of the events of Guillain Barre syndrome and transverse myelitis were unknown. Upon internal review, Guillain Barre syndrome and transverse myelitis were considered other important medical event. Additional information received from the physician regarding this patient with no known allergies reported that this patient's concurrent conditions included hypothyroidism, gastroesophageal reflux disease (GERD), bipolar disorder, depression, benign prostatic hyperplasia, dyslipidemia, and a history of hip replacement, cataract, and chickenpox in approximately 1940. There was no history of shingles. Concomitant medications included levothyroxine sodium, pantoprazole, and divalproex sodium. Within 24-48 hours of vaccination with ZOSTAVAX, the patient noticed the onset of weakness in his hands (while driving), followed by gait disturbance and some difficulty with balance. The patient was admitted to the hospital a few days later for evaluation. A lumbar puncture performed on 03-May-2008 (also reported as 04-May-2008) revealed cerebrospinal fluid results as follows: protein "59"l, glucose 67, red blood ells 83, and white blood cells 1. The physician reported that the patient had not worsened, but was still decreased from his baseline. The patient had bilateral foot drop and 3/5 motor strength in both arms and legs. He was receiving IVIG while hospitalized. Hospitalization continued at the time of the report. The physician reported the leading diagnosis was Guillain Barre syndrome; "however they are still working up the patient, and it might change". Additional information has been requested.