chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Oedema peripheral, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female patient with no known drug reactions/allergies or medical history who on 09-OCT-2008 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 658556/1060U) and on 18-DEC-2008 with the second dose of GARDASIL (lot # 661044/0548X). Concomitant therapy included LEXAPRO. On 19-DEC-2008 the patient developed swollen feet. The patient was told to take BENADRYL and to go to the emergency room if her symptoms worsened. The nurse did not know the patient's present status but said, "The patient was told that if her symptoms did not improve then she should call the office. The nurse had not heard from her so she assumed the patient was recovered". Additional information has been requested. This is in follow-up to report(s) previuslysubmitted on 1/16/2009. Initial and follow-up information has been received from a physician and registered nurse concerning a 24 year old white female patient with no known drug reactions/allergies or medical history who on 09-OCT-2008 was vaccinated intramusculary with the first 0.5ml dose of GARDASIL (lot #658556/1060U) and intramuscularly into the right arm on 18-DEC-2008 with the second dose of GARDASIL (lot #651044/0548X) intramuscularly into the right armat 11:45 am. Concomitant therapy included LEXAPRO. On 19-DEC-2008 the patient developed swollen hands and swollen feet. The patient was told to take BENADRYL and to go to the emergency room if her symptoms worsened. The nurse did not know the patient's present status but said, "The patient was told that is their symptoms did not improve then she should call the office. The nurse had not heard from her so she assumed the patient was recovered". In the follow-up information the nurse reported that the patient called because of swellilng in hands and feet, and slight itch. The patient recovered on 20-DEC-2008. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Breast pain, Hemicephalalgia, Joint sprain, Sports injury
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female patient with no previous medical history reported who in 2007 was vaccinated, from another office, with the first and second dose of GARDASIL. As of 23-DEC-2008, the patient had not received the third dose. There was no concomitant medication. Subsequently, the patient developed headaches after her first dose of GARDASIL. The headaches are unilateral on the left side of her head and occur daily. The patient was referred to a neurologist. The patient's headaches persisted. The patient sought medical attention at office visit. Additional information has been requested.  2/3/09 Received OB/GYN medical records of 12/22/2008. FINAL DX: fibrocystic disease Patient had experienced enlarging right breast mass w/tenderness x 1 year.  During discussion of completing HPV vaccinations (had not had #3) patient revealed also had HA for approx 1 year.  3/11/09 Received PCP medical records of 7/19/07-11/1/2008. FINAL DX: fibrocystic breast disease; dysmenorrhea Records reveal patient experienced good health on 7/19.  RTC 10/25 w/sports injury & dx w/sprained right knee.  RTC 11/8/07 w/improving right knee.  RTC 6/20/08 for skin eval of moles on neck whose size had incresed x 1 year & were tender w/stinging sensation. Dx w/pigmented nevus & referred to Derm for eval.  RTC 8/13/08 w/right breast lump that was tender esp during menses.  Dx w/fibrocystic breast disease & dysmenorrhea.  RTC for breast pain recheck but patient refused exam.  No further records available. Information has been received from a registered nurse concerning a 13 year old female patient with a medical history of asthma when younger and who NAPROSYN caused breathing diffuculty, who in 2007 was vaccinated from another office, with the first and second dose of GARDASIL. As of 21-DEC-2008, the patient had not received the third dose. The registered nurse reported that the patient's mother stated that the patient had stopped GRDASIL after the second dose secondary to onset of headaches. There was no concomitant medication. Subsequently, the patient developed headaches after her first dose of GARDASIL. The headaches are unilateral on the left side of her head and occur daily. The reporter stated that after one year the headaches continued. The patient was referred to a neurologist. The patient sought medical attention at office visit. Additional information is not available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Fatigue, Pregnancy test positive
Clinical narrative: Information has been received from a physician for GARDASIL vaccine, concerning an 18 year old female patient with no previous medical history reported who on 09-SPR-2008 was vaccinated with the first dose of GARDASIL. On 15-JUN-2008 the patient was vaccinated with the second dose of GARDASIL and on 05-NOV-2008 with the third dose of GARDASIL. On 04-DEC-2008, a home pregnancy test was performed and the result was positive. The patient reported to the physician that she was tired. The patient sought medical attention, by phone call. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Local swelling
Clinical narrative: This is in follow-up to report (s) previously submitted on 01/16/2009. Information has been received from a medical assistant concerning a 20 year old female patient with no pertinent medical history, no drug reactions/allergies, who on 04-AUG-2008 was vaccinated intramuscularly with the 0.5 mL first and only dose of GARDASIL vaccine (Lot # 660391/0063X). There was no concomitant medication. On the same day, the patient experienced swelling on her neck. On 08-AUG-2008, the patient recovered. The patient did not seek medical attention. Follow up information received from a medical assistant on 27-JAN-2009. It was reported that the 20 year old female patient on 04-AUG-2008 was vaccinated into the left deltoid with the first of GARDASIL at 15:00. On the same day, patient had swelling in her neck on the side of the injection that started at around 22:00. The patient stated it was very painful and lasted for about 24 hours. On 05-AUG-2008, the patient recovered.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: Information has been received from a healthcare worker (also reported as a nurse) and physician concerning a 25 year old female patient who received second dose of GARDASIL and was found to have genital warts. The patient has stated to the physician that she was not sexually active. Follow up information received on 31-Dec-2008 from the Healthcare worker who reported the patient received her first dose of GARDASIL (lot# 660398/1968U) on 30-Oct-2008 and the second dose of GARDASIL (lot#660389/1968U) on 29-Dec-2008. At the time on the report on 31 Dec-2008 the patient was not recovered The patient sought medical attention was seen in the office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Additional information has been received from a physician concerning a patient with irritable bowel syndrome who on 30-OCT-2008 patient received first dose of GARDASIL (lot # 660389/1968U) intramuscularly left gluteus maximum in the morning. On 29-DEC-2008 she received second dose of GARDASIL (lot # 660389/1968U) intramuscularly left gluteus maximus in the morning. On 30-DEC-2008 patient was diagnosed developed genital warts. It was reported that the patient developed 2 lesion on outer genitalia. On 31-DEC-2008, the patient was seen in the physician's office and was treated with ALDANA cream but the lesions have not resolved.
Sex: F
Vaccine: HPV4
Symptoms: Injection site extravasation
Clinical narrative: Information has been received from a medical assistant concerning a patient who may had received a partial dose of GARDASIL. The patient did not report any pain upon injection and some vaccine ran down her arm. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blood pressure normal, Dizziness, Heart rate normal, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on 30-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot # 660616/0570X) 0.5 ml via IM route into her deltoid.  The patient fainted immediately after receiving the vaccine.  She also displayed twitching with tonic-clonic motions of her upper extremities.  This reaction resolved spontaneously.  It was also noted that the patient did not eat breakfast.  Unspecified medical attention was sought in the office.  The patient was observed resting for about 20 minutes after the episode and given a popsicle.  No other treatment and patient was considered fully recovered.  This is one of several reports received from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009.  Follow-up information was received from the nurse practitioner.  It was reported that the 14 year old female with allergic rhinitis and an allergy to nickel and a history of migraine headache who on 30-DEC-2008 was vaccinated with GARDASIL (lot # 660616/0570X) via IM route into her right deltoid.  Secondary suspect therapy included VARIVAX (Merck) (lot # 662454/1387X) via SC route into her right arm.  Immediately after GARDASIL, the patient felt lightheaded and she was positioned to supine.  The patient developed loss of consciousness with tonic-clonic movement of her upper extremities.  Duration was not more than 30seconds.  Her color was pale, pulse was thready.  The patient's heart rate was 82 beats/min by rapidly measured, which was fully alert.  Her blood pressure was stable with diet and fluid management (oral).  No diagnostic studies were undertaken.  All events were recovered in the same date.  The events were considered to be non-serious by the physician.  No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Muscle twitching, Pulse abnormal, Syncope, Tonic clonic movements
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 year old female who on 30-DEC-2008 was vaccinated with the first dose of GARDASIL (Lot # 660616/0570X) 0.5 ml via IM route into her deltoid.  The patient fainted immediately after receiving the vaccine.  She also displayed twitching with tonic-clonic motions of her upper extremities.  This reaction resolved spontaneously.  It was also noted that the patient did not eat breakfast.  Unspecified medical attention was sought in the office.  The patient was observed resting for about 20 minutes after the episode and given a popsicle.  No other treatment and patient was considered fully recovered.  This is one of several reports received from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009.  Follow-up information was received from the nurse practitioner.  It was reported that the 14 year old female with allergic rhinitis and an allergy to nickel and a history of migraine headache who on 30-DEC-2008 was vaccinated with GARDASIL (lot # 660616/0570X) via IM route into her right deltoid.  Secondary suspect therapy included VARIVAX (Merck) (lot # 662454/1387X) via SC route into her right arm.  Immediately after GARDASIL, the patient felt lightheaded and she was positioned to supine.  The patient developed loss of consciousness with tonic-clonic movement of her upper extremities.  Duration was not more than 30seconds.  Her color was pale, pulse was thready.  The patient's heart rate was 82 beats/min by rapidly measured, which was fully alert.  Her blood pressure was stable with diet and fluid management (oral).  No diagnostic studies were undertaken.  All events were recovered in the same date.  The events were considered to be non-serious by the physician.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Consciousness fluctuating, Nausea, Paraesthesia, Syncope
Clinical narrative: Information has been received from a nurse concerning a 19 year old female with asthma, hirsutism and polycystic ovarian syndrome and no known drug allergies, who 2 years ago was vaccinated with a first dose of GARDASIL. On 30-DEC-2008 the patient received a 0.5 mL second dose of GARDASIL (lot # 659184/0843X), intramuscularly. Concomitant therapy included Ocella. Ten minutes after the administration of the second dose the patient experienced syncope. The patient was "in and out of consciousness" for 4 to 5 minutes. She also experienced nausea and tingling sensation in her arm. There were no laboratory diagnostics studies performed. At the time of the report the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.65
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Initial and follow-up information has been received from a registered nurse and pediatrician concerning a 7 month old male who on 09-DEC-2008 was vaccinated orally with a dose of ROTATEQ vaccine (lot # 661579/0899X) stored in the freezer or refrigerator which temperature was not logged from 10-OCT-2008 to 18-DEC-2008. The nurse stated that people in the office switched positions and failed to document the temperatures. The freezer was working fine but there were no readings documented. No adverse effect reported. The pediatrician noted that the patient was to be followed. This is one of several reports from the same source. Additional information is not expected.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 30 days old patient who on 04-NOV-2008, was vaccinated with a dose of rotavirus G1 P1 vaccine live (89-12). On 23-DEC-2008, at the age of 16 weeks, the patient was inadvertently vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). The registered nurse reported that the inadvertent administration of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) was due to nursing error. No adverse effect was reported. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient "greater than 32 weeks of age", who on an unknown date was vaccinated with the third dose of ROTATEQ vaccine. No adverse effect was reported. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: RV5
Symptoms: Clostridium difficile toxin test, Culture stool, Gastroenteritis, Inappropriate schedule of drug administration, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 9 month old male patient with a history of birth weight low, who on 28-JUL-2008, was vaccinated with the first dose of ROTATEQ vaccine, orally, and on 02-OCT-2008 with the second dose of ROTATEQ, orally. The physician reported that the "fragile" preemie received 2 dosed of the vaccine and tested positive for rotavirus recently. The patient received the vaccine on 02-OCT-2008 and tested positive on 22-DEC-2008. The patient developed symptoms of gastroenteritis around 20-DEC-2008. The C-diff test was negative, rotavirus test positive and still waiting for the culture. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen at the physician's office. Additional information has been requested.
Age: 0.8
Sex: M
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 9 month old male patient with a history of birth weight low, who on 28-JUL-2008, was vaccinated with the first dose of ROTATEQ vaccine, orally, and on 02-OCT-2008 with the second dose of ROTATEQ, orally. The physician reported that the "fragile" preemie received 2 dosed of the vaccine and tested positive for rotavirus recently. The patient received the vaccine on 02-OCT-2008 and tested positive on 22-DEC-2008. The patient developed symptoms of gastroenteritis around 20-DEC-2008. The C-diff test was negative, rotavirus test positive and still waiting for the culture. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen at the physician's office. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 4 month old patient, who on 16-OCT-2008, was vaccinated with the first dose of ROTATEQ, orally; on 16-DEC-2008, with the second dose of ROTATEQ, orally, and on 26-DEC-2008 with the third dose of ROTATEQ, orally. No adverse symptoms reported. Additional information has been requested.
Age: 1.14
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 02-DEC-2008 was vaccinated with ROTATEQ vaccine. concomitant therapy included INFLUENZA vaccine (unspecified) and POLIOVIRUS vaccine (unspecified). The physical stated that the patient was administered with the third or possibly thee fourth dose as the family went from another practice without accurate records. Additional information has been requested. Follow-up information has been received from a physician concerning the patient who was supposed to be vaccinated with PREVENAR and on 02-DEC-2008 orally received ROTATEQ (LOT #662732/1100X) instead. No symptoms or problems were reported. No further information is available.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Regurgitation, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 2 month old male patient with no illness at time of vaccination who on 11-DEC-2008 was vaccinated with the first dose of ROTATEQ, orally. The nurse reported that the patient was breast fed prior to administering ROTATEQ, infant immediately regurgitated and vomited all of vaccine with large amount of breast milk. "No adverse reaction" followed. The patient did not seek medical attention. No additional information is expected.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 week old patient who was vaccinated with the first dose of ROTATEQ vaccine 2ml oral administration. The physician reported that patient received the first dose of ROTATEQ vaccine and 8 hours later had brown vomit. The patient sought medical attention "by phone". On unspecified date the patient recovered from brown vomit. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a Medical Assistant concerning a 16 week old female patient who on 21-NOV-2008 was vaccinated with first dose of ROTATEQ (Lot # not provided). On 05-DEC-2008 the patient received second dose of ROTATEQ (Lot # not provided). The child experienced diarrhea and vomiting. The patient also received (PREVNAR) on 05-DEC-2008. At the time on the report on 08-DEC-2008 the patient not recovered. The patient sought medical attention office visit. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009.  Follow-up information has been received from a physician who reported that a patient had not adverse events.  Two doses of vaccine were given 2 weeks apart.  On 21-NOV-2008 patient received first dose of ROTATEQ (Lot # not provided).  On 05-DEC-2008, at 14:30, the patient received second dose of ROTATEQ (Lot # 662603/1271X) orally.  Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ROTATEQ vaccine, oral, (lot # not provided). The patient's stool samples was tested after receiving ROTATEQ vaccine and Rotavirus was detected. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a female who on 05-DEC-2008 was vaccinated with her first dose of ROTATEQ (lot# not provided) at the age of 5 months. No adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an "about 9 weeks old" female who in October 2008, was vaccinated orally with a 2 ml dose of ROTATEQ vaccine. In October 2008, "a day after vaccination", the patient experienced severe diarrhea and vomiting, however, the patient did not have a fever. Unspecified medical attention was sought. At the time of this report, the outcomes were unknown. follow-up information has been received from a physician concerning the patient, who started with vomiting and diarrhea the day the vaccine was received, lasting for about 2 or 3 days. No further information is available.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Barium double contrast, Haematochezia, Intussusception, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 8 week male on 05-NOV-2008, was vaccinated with a dose of ROTATEQ (lot #660926/0308X) by mouth. Concomitant vaccination were ACTHIB (lot#UF445AA) IM in his right leg, DAPTACEL (lot# C2957AA) IM in his left leg; PREVNAR (lot# C733446) IM in his right leg and IPOL (lot#A10602) IM in his left leg. On 11-NOV-2008, the patient experienced intussusception. The patient had blood in stool and vomiting at 3:00 am. The patient went to the office with blood in his diaper after stool. The patient was sent to the hospital. Air contrast enema was given for reduction which was successful. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. The original reporting source was not provided. The VAERS ID # is 334339. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. This report was filed with the FDA. The ISR number is 334339.
Age: 20.0
Sex: M
Vaccine: DT, HEPAB, IPV, MEN, MMR, YF
Symptoms: Death, Meningitis bacterial
Clinical narrative: This serious case was originally noted by the sanofi-pasteur medical department on 19 November 2008.  Confirmation was received from the Centers for Disease Control and Prevention on 21 November 2008.  A male patient, with no reported medical history, received an injection of MENOMUNE A/C/Y/W-135 (lot number UE489AA) on 16 August 2007.  Approximately 14 months post vaccination, on 12 November 2008, he developed bacterial meningitis and was hospitalized.  The patient, who was 20 years old at the time of his illness, died on 17 November 2008.  According to the CDC, laboratory testing confirmed serogroup Y meningitis.  In addition to MENOMUNE A/C/Y/W-135, the patient also received the following vaccines on 16 August 2007: IPOL (lot number Z0001); DECAVAC (lot number U1949BA); and TWINRIX (SKB, lot number AHABB068AA).  On 17 August 2007, he received YF VAX (lot number UE816AA) and MMR (MSD, lot number 1470F).  Documents held by sender: None
Age: 11.0
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: Mom called 1/20/2009 to report patient has experienced 2-5-30 "dizzy, fainting spells" since may of 2008.  No untoward reaction noted at time of administration for all 3 doses
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: Mom called 1/20/2009 to report patient has experienced 2-5-30 "dizzy, fainting spells" since may of 2008.  No untoward reaction noted at time of administration for all 3 doses
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Mom called 1/20/2009 to report patient has experienced 2-5-30 "dizzy, fainting spells" since may of 2008.  No untoward reaction noted at time of administration for all 3 doses
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL, HPV4, HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Syncope
Clinical narrative: Mom called 1/20/2009 to report patient has experienced 2-5-30 "dizzy, fainting spells" since may of 2008.  No untoward reaction noted at time of administration for all 3 doses
Age: 11.0
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: Mom called 1/20/2009 to report patient has experienced 2-5-30 "dizzy, fainting spells" since may of 2008.  No untoward reaction noted at time of administration for all 3 doses
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Swelling
Clinical narrative: Severe swelling and pain. Took Cephalexin 500Mg 4x/day for 10days. Patient c/o pain periodically.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site mass, Injection site swelling, Pain in extremity
Clinical narrative: Severe swelling and pain. Took Cephalexin 500Mg 4x/day for 10days. Patient c/o pain periodically.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Feeling hot, Headache, Hemiparesis
Clinical narrative: Within a couple hours of receiving the Tdap booster (following a routine physical in which my daughter received an excellent bill of health), she developed a large, red hive at the site of the injection, that encompassed her shoulder/upper arm area and was excruciating to the touch. I gave her Benadryl and she wanted to ice the arm on and off constantly, but by the next day, she was also experiencing muscle weakness and some paralysis in the left arm.  The weakness/paralysis worsened then moved down her left side into her left hip making it difficult to weight bear.  She was taken to urgent care where a physician checked strength and reflexes in extremities telling me there was a "marked" difference between the left and right sides of her body and noting the hive which had receded somewhat but was still visible to the doctor.  Patient was also starting to experience headaches, fatigue and muscle/joint pain and weakness in additional areas of the body and would complain of feeling "hot on the inside" though she did not feel like she had a fever when I checked her.  The urgent care doctor suggested Tylenol and to see a neurologist if the symptoms did not resolve.  By late afternoon on 1/15/09, the muscle weakness was beginning to recede, but patient is still not feeling herself.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain, Injection site urticaria, Monoplegia
Clinical narrative: Within a couple hours of receiving the Tdap booster (following a routine physical in which my daughter received an excellent bill of health), she developed a large, red hive at the site of the injection, that encompassed her shoulder/upper arm area and was excruciating to the touch. I gave her Benadryl and she wanted to ice the arm on and off constantly, but by the next day, she was also experiencing muscle weakness and some paralysis in the left arm.  The weakness/paralysis worsened then moved down her left side into her left hip making it difficult to weight bear.  She was taken to urgent care where a physician checked strength and reflexes in extremities telling me there was a "marked" difference between the left and right sides of her body and noting the hive which had receded somewhat but was still visible to the doctor.  Patient was also starting to experience headaches, fatigue and muscle/joint pain and weakness in additional areas of the body and would complain of feeling "hot on the inside" though she did not feel like she had a fever when I checked her.  The urgent care doctor suggested Tylenol and to see a neurologist if the symptoms did not resolve.  By late afternoon on 1/15/09, the muscle weakness was beginning to recede, but patient is still not feeling herself.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Myalgia, Reflex test abnormal, Weight bearing difficulty
Clinical narrative: Within a couple hours of receiving the Tdap booster (following a routine physical in which my daughter received an excellent bill of health), she developed a large, red hive at the site of the injection, that encompassed her shoulder/upper arm area and was excruciating to the touch. I gave her Benadryl and she wanted to ice the arm on and off constantly, but by the next day, she was also experiencing muscle weakness and some paralysis in the left arm.  The weakness/paralysis worsened then moved down her left side into her left hip making it difficult to weight bear.  She was taken to urgent care where a physician checked strength and reflexes in extremities telling me there was a "marked" difference between the left and right sides of her body and noting the hive which had receded somewhat but was still visible to the doctor.  Patient was also starting to experience headaches, fatigue and muscle/joint pain and weakness in additional areas of the body and would complain of feeling "hot on the inside" though she did not feel like she had a fever when I checked her.  The urgent care doctor suggested Tylenol and to see a neurologist if the symptoms did not resolve.  By late afternoon on 1/15/09, the muscle weakness was beginning to recede, but patient is still not feeling herself.
Sex: F
Vaccine: HBHEPB
Symptoms: Wrong drug administered
Clinical narrative: 3 day old recieved comvax. Nurse was instructed to go give 1st hep b but instead gave comvax. No known symptoms. mom never called stating her baby was having a reaction.
Age: 54.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No known reaction because patient never returned or called stating she had a reaction to the immunization that was given to her. She recieved a Dtap instead of the Tdap the dr ordered.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: No knowm symptoms. She never called to say she is having a reaction to the immunization that was given. Dr ordered to give a Tdap but the nurse gave her a Dtap.
Age: 0.42
Sex: M
Vaccine: HEP, IPV, PNC, TDAP
Symptoms: Irritability, Wrong drug administered
Clinical narrative: The day after infant was given Tdap instead of Dtap he was irritable.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: PT RECEIVED EXPIRED FLUMIST DURING WELL CHILD CHECK. NO REPORTED ADVERSE EVENTS TO DATE OF COMPLETING REPORT.
Age: 2.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Expired drug administered
Clinical narrative: PT RECEIVED EXPIRED FLUMIST DURING WELL CHILD CHECK.  NO REPORTED ADVERSE EVENTS TO DATE OF CMOMPLETING REPORT.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Received HPV vaccine on January 15.  Aunt called on Jan. 16 and reported that her niece had swelling and redness from site of injection to her elbow.  Area was warm to touch.  Told to put ice on area and take Tylenol and call her Doctor.  This is her 2nd HPV dose.
Age: 33.0
Sex: M
Vaccine: SMALL
Symptoms: Contraindication to vaccination, Eczema
Clinical narrative: approximately 1100 1-20-08 given smallpox immunization w/o authorization by provider and with dx of eczema.
Age: 22.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Nodule, Skin lesion
Clinical narrative: PT is complaining of post smallpox reaction 18 Apr 2008 (8 months) Pimple and nodule formation 2 wks ago 7 Jan 09 around site
Age: 22.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Injection site nodule, Injection site papule
Clinical narrative: PT is complaining of post smallpox reaction 18 Apr 2008 (8 months) Pimple and nodule formation 2 wks ago 7 Jan 09 around site
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Blister, Tenderness
Clinical narrative: Soreness of skin on abdomen and legs.  Draining blister lesions on left side of back at beltline and Left leg blister lesions. From Shingles vaccine by Merck.
Age: 29.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Arthralgia, Asthenia, Dyspnoea, Fatigue, Pain in extremity
Clinical narrative: 16 Jan 09 arms were sore. 17 Jan 09 felt conjested. 18 Jan 09 more conjested 19 Jan 09 felt conjested and run down.  20 Jan had conjestion fever weakness fatigue dyspnea and joint pain, and went to the ER that night.
Age: 29.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: 16 Jan 09 arms were sore. 17 Jan 09 felt conjested. 18 Jan 09 more conjested 19 Jan 09 felt conjested and run down.  20 Jan had conjestion fever weakness fatigue dyspnea and joint pain, and went to the ER that night.
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Varicella
Clinical narrative: PATIENT CAME IN OFFICE ON 1-7-09 WITH CHICKENPOX
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Pain, Pruritus
Clinical narrative: Patient developed herpes zoster on 12.26.08.  Patient presented with grouped blisters on the right posterior neck, right upper chest and right upper back.  Patient stated a "burning sensation" and mild itching / pain.  Because of mild condition, suggested OTC hydrocortisone cream.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reactions on upper Lt. arm, red area, hot to touch, with some swelling in the area noted.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Child received the Flu vaccine between 9am & 10:30AM left the building with her mother and in the parking lot c/o being itchy and scratchy all over inside and out, even the mouth. Mother gave benedryl which she always carries and she got better within 20-30min. Mother stated no allergies, including eggs except bug bites. The father however has severe allergies to many things and she knows what an allergic reaction is. She called her PCP and he was going to note it in her chart so she does not get another Flu shot.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: RECEIVED VARICELLA VACCINE ( SECOND DOSE) LOWER PART OF LEFT UPPER ARM 1/19/09. SEEN 1/21/09 WITH 9CM BY 7 CM AREA OF ERYTHEMA AND MILD SWELLING AND MILD TENDERNESS AT SITE OF THE VARIVAX IMMUNIZTION NOT THE HEP A SITE.NO FEVER. REC RX TYLENOL AND BENADRYL RESOLUTION PENDING
Age: 23.0
Sex: M
Vaccine: HEP, TD
Symptoms: Body temperature increased, Headache, Pain
Clinical narrative: HA, temp of 104.8, B/P 168/80, ache all over-lasted for 24 hrs.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Expired drug administered
Clinical narrative: EXPIRED FLUMIST GIVEN TO CHILD DURING WELL CHILD EXAM.  NO REPORTED ADVERSE EVENTS TO DATE OF COMPLETING VAERS.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Electroencephalogram, Fatigue, Full blood count, Musculoskeletal stiffness
Clinical narrative: Mom phoned today 01/21/2009 @9:24am with c/o pt. was very tired last evening. She did well through the night. Mom states that today patient would stiffen her legs, blink her eyes hard and make a fist with both hands. We assesed the patient today in the office. The patient was scheduled with Neurology (appt. pending) and we are to obtain an EEG.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Impaired work ability, Myoclonus, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: Approximately 12 hours after vaccination; an onset of myoclonus seizures began.  During the first hour, as many as 16.  This continued from 10/15/08 through 10/19/08 when primary care on call contacted.  When arrived at his office on 10/20/08, sent to hospital where I remained for the next 3 days.  I still continue to be treated for the siezures with medication.  They have lesssened in severity and frequency but have not stopped as of yet.2/6/09-records received-presented on 10/20/08 with C/O twitching sensation in neck began 5 days ago and then 2 days ago developed episode of soliatry twitch and sudden jerking movements while walking and became disoriented and confused. MD informed patient to discontinue Lyrica, however twitiching and confusion returned. Impression:seizure like activity. Twitching. 2/13/09-records receive for DOS 10/20-10/21/08-neurology consult:anxious and high strung appearing and exam WNL. Impression, abnormal involuntary movements, perhaps myoclonic jerks versus ballistic movements verus seizures.  Follow-up: Still continue to have myoclonic jerks. Still under neurologist care and haven't been able to work since June '09 when doctors had exhausted all medication trials; none of which have been successful in controlling the symptoms.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray
Clinical narrative: Approximately 12 hours after vaccination; an onset of myoclonus seizures began.  During the first hour, as many as 16.  This continued from 10/15/08 through 10/19/08 when primary care on call contacted.  When arrived at his office on 10/20/08, sent to hospital where I remained for the next 3 days.  I still continue to be treated for the siezures with medication.  They have lesssened in severity and frequency but have not stopped as of yet.2/6/09-records received-presented on 10/20/08 with C/O twitching sensation in neck began 5 days ago and then 2 days ago developed episode of soliatry twitch and sudden jerking movements while walking and became disoriented and confused. MD informed patient to discontinue Lyrica, however twitiching and confusion returned. Impression:seizure like activity. Twitching. 2/13/09-records receive for DOS 10/20-10/21/08-neurology consult:anxious and high strung appearing and exam WNL. Impression, abnormal involuntary movements, perhaps myoclonic jerks versus ballistic movements verus seizures.  Follow-up: Still continue to have myoclonic jerks. Still under neurologist care and haven't been able to work since June '09 when doctors had exhausted all medication trials; none of which have been successful in controlling the symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Erythema, Lip swelling, Pruritus
Clinical narrative: itching, difficulty breathing, lips swelling, red face. About 10 minutes after vaccines were give dad noticed above symptoms patient was still in clinic. Dr evaluated 2.5mg neb of albuterol was given and 10cc of benadryl was given.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Activities of daily living impaired, Chills, Diarrhoea, Headache
Clinical narrative: Headache, Nausea, Vomiting, Diarrhea, Severe stomach ache, Chills, Body Aches. I was unable to perform usual activities and required medical attention. At the time I didn't realize I was sick from the shot till I got home and read the Vaccine information paper given to me at the time of the vaccine.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Headache, Nausea, Vomiting, Diarrhea, Severe stomach ache, Chills, Body Aches. I was unable to perform usual activities and required medical attention. At the time I didn't realize I was sick from the shot till I got home and read the Vaccine information paper given to me at the time of the vaccine.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Extreme weakness, fatigue, dizziness, severe mood changes, anxiety, low grade fever, severe headaches, chills.  1/30/09 Received PCP medical records of 1/22-1/30/2009. FINAL DX: Records reveal patient experienced weakness, dizziness, moody, decreased energy after HPV #1 & #2 given 7/10/2008 & 9/11/08.  Increased fatigue, moody, nervous, heaviness in legs, sensitive to touch, generalized aching, low grade fever, chills after HPV#3 1/20/09.  RTC 1/30 symptoms except dizziness persist & now w/tingling in back & arms.  Difficulty sleeping.  DTRs WNL.  Dx w/rhinitis & possible early sinusitis.  Tx w/nasal spray & given Rx for antibiotics if symptoms persist.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Mood altered, Pyrexia
Clinical narrative: Extreme weakness, fatigue, dizziness, severe mood changes, anxiety, low grade fever, severe headaches, chills.  1/30/09 Received PCP medical records of 1/22-1/30/2009. FINAL DX: Records reveal patient experienced weakness, dizziness, moody, decreased energy after HPV #1 & #2 given 7/10/2008 & 9/11/08.  Increased fatigue, moody, nervous, heaviness in legs, sensitive to touch, generalized aching, low grade fever, chills after HPV#3 1/20/09.  RTC 1/30 symptoms except dizziness persist & now w/tingling in back & arms.  Difficulty sleeping.  DTRs WNL.  Dx w/rhinitis & possible early sinusitis.  Tx w/nasal spray & given Rx for antibiotics if symptoms persist.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Pt felt fine after shot. 6 hrs later site of injection was very painful. Next day it was so painful she could not get dressed, could not go to work. Not swollen, not red, not warm. Just very painful. By 1/21/09, it was better and she was able to go to work. Took ASA q4h on 1/20 to help with pain but only got minimal relief.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Patient developed large area of erythema and induration at 48 hrs, s/p booster dose of varivax (given on 1-19-09). Area measured 7 cm x 4 cm and patient c/o itchiness at site. Area was marked with pen and mother of patient was advised to apply cool compresses on/off, apply hydrocortisone cream and give benedryl q6h prn and to call back in 1 day to give nurse update or sooner if new symptoms such as fever or vomiting or increased swelling.
Age: 27.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site vesicles
Clinical narrative: Client reports noticing itching and soreness @ right arm injection site and a "quarter-sized" area that felt hard and was yellowish in color @ 5PM on 1/8/09.  The area increased to the diameter of a "coke can".  Client phoned the 1-800-CDC-Info # on the VIS--was instructed to circle the area with a permanent marker.  1/9/09 AM the area was the same size with 6 pencil eraser-sized papular like "blisters" @ injection site and three to four tiny bumps.  There was some erythema below the circled area.  1/9/09 PM--client went to Hospital and was seen by Dr. and told that she had developed "chickenpox" @ injection site.  1/12/09--the blisters had dried and were sloughing.  Itching and soreness were gone.
Age: 27.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Yellow skin
Clinical narrative: Client reports noticing itching and soreness @ right arm injection site and a "quarter-sized" area that felt hard and was yellowish in color @ 5PM on 1/8/09.  The area increased to the diameter of a "coke can".  Client phoned the 1-800-CDC-Info # on the VIS--was instructed to circle the area with a permanent marker.  1/9/09 AM the area was the same size with 6 pencil eraser-sized papular like "blisters" @ injection site and three to four tiny bumps.  There was some erythema below the circled area.  1/9/09 PM--client went to Hospital and was seen by Dr. and told that she had developed "chickenpox" @ injection site.  1/12/09--the blisters had dried and were sloughing.  Itching and soreness were gone.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TD
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Myalgia, Pain
Clinical narrative: Passed out immediately after HPV shot.  Had stinging on right side above pelvic bone for a couple of days after.  Had full body muscle soreness for a couple of days after.  Had dizziness during first menstruation after.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abnormal behaviour, Fatigue, Headache, Hypersomnia, Menorrhagia
Clinical narrative: Headaches, periods were very erratic.  She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn't her normal spunky and happy self. She was very tired and the last few weeks before she passed away, sheslept alot during the day which she never did. Never had any other problems prior to the Gardasil shots.  She recieved all three shots in the series.  Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Menstrual disorder, Metrorrhagia, Muscle spasms
Clinical narrative: Headaches, periods were very erratic.  She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn't her normal spunky and happy self. She was very tired and the last few weeks before she passed away, sheslept alot during the day which she never did. Never had any other problems prior to the Gardasil shots.  She recieved all three shots in the series.  Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Abnormal behaviour, Death, Fatigue, Headache, Hypersomnia
Clinical narrative: Headaches, periods were very erratic.  She would have them every 14 days @times, and others just spotting. Very bad cramps and periods were heavier after the 1st Gardasil shot. Wasn't her normal spunky and happy self. She was very tired and the last few weeks before she passed away, sheslept alot during the day which she never did. Never had any other problems prior to the Gardasil shots.  She recieved all three shots in the series.  Last shot was 5-2-2007. 2/9/09-autopsy report received-COD-undetermined by autospy and toxicology.3/18/09-records received-well visit C/O contact dermatitis, nasal congestion, itchy sore throat times 2-3days. HPV4 lot#1424 F received 1/3/07 in right deltoid. Lot #0384U received 5/2/07 left deltoid and 12/2/08 lot#0955F left deltoid.