chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.38
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity, Rash maculo-papular
Clinical narrative: This spontaneous report as received from a nurse refers to a approximately 4 months old male patient with no pertinent medical history. The patient was vaccinated with dose 1, dose 2 and dose 3 RECOMBIVAX HB on 27-OCT-2011, 27-DEC-2011 and 14-MAR-2012, respectively. There was no concomitant medications. The nurse reported that the patient was administered the first dose of RECOMBIVAX HB (lot number and expiration date were unknown) and did not experience any problems. When the second dose of RECOMBIVAX HB (lot #: 670231/1155AA, expiration date: 17-DEC-2013) was administered, the patient experienced extremely sore leg all the way down his leg. When the third dose of RECOMBIVAX HB (lot #: 669599/0231AA, expiration date; 14-OCT-2013) was administered, the patient experienced extremely sensitive leg with a macular papular rash all the way down his leg. The nurse did not know how long after the second and third doses that the adverse experiences occurred. The patient was seen by his pediatrician. No treatment information was reported. No lab diagnostics studies were performed. The nurse reported that the patient did recover from the adverse experiences after the second and third doses but she did not know how long it took the patient to recover. The nurse noted the patient experienced similar reactions with PENTACEL and PREVNAR. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a 14 years old female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (lot # not reported). No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Chills, Influenza like illness, Musculoskeletal discomfort, Pain, Pyrexia
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. A 18 year old male patient with no pre-existing illness and with chronic low back pain was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 670049/1171AA) in his right arm on 02-MAR-2012. Suspect therapy included a second dose of VAQTA (Lot #671897/1288AA) given intramuscularly in left arm. No other medications were given. "The day after vaccines given" on 03-MAR-2012 the patient developed flu-like symptoms: fever, chills, body aches. Then had generalized upper body pain/tenderness with movement for 5 days; raising arms to shoulder level was painful. No lab diagnostic studies were performed. Therapy with ibuprofen 600 mg as needed for muscle discomfort. Final outcome was not reported. The original reporting source was not provided. The VAERS ID # is 451774-1. No further information is available.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Tenderness
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. A 18 year old male patient with no pre-existing illness and with chronic low back pain was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 670049/1171AA) in his right arm on 02-MAR-2012. Suspect therapy included a second dose of VAQTA (Lot #671897/1288AA) given intramuscularly in left arm. No other medications were given. "The day after vaccines given" on 03-MAR-2012 the patient developed flu-like symptoms: fever, chills, body aches. Then had generalized upper body pain/tenderness with movement for 5 days; raising arms to shoulder level was painful. No lab diagnostic studies were performed. Therapy with ibuprofen 600 mg as needed for muscle discomfort. Final outcome was not reported. The original reporting source was not provided. The VAERS ID # is 451774-1. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Amenorrhoea, Hormone level abnormal
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. A 18 years old female with no medical history and no preexisting illness was vaccinated IM into left arm with lot # (666598/0786Z) dose 1 GARDASIL on 09-MAY-2011. Other suspect therapies included VARIVAX (Merck) lot # 668456/0925Z) vaccinated SC into right arm on 09-MAY-2011. Concomitant medications included MENACTRA (lot # U3464AA) vaccinated IM into right arm and BOOSTRIX (lot # AC52B060CA) vaccinated IM into left arm. The next day (on 10-MAY-2011) the patient had abdominal cramping but no menses. After no menses for two months, mother took patient to the doctor. Mother stated that doctor had drawn blood to check the patient's hormones, before stating pills. She was told that they were abnormal. The outcome of the events was unknown. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID # is 452070. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Amenorrhoea, Blood test abnormal, Hormone level abnormal
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. A 18 years old female with no medical history and no preexisting illness was vaccinated IM into left arm with lot # (666598/0786Z) dose 1 GARDASIL on 09-MAY-2011. Other suspect therapies included VARIVAX (Merck) lot # 668456/0925Z) vaccinated SC into right arm on 09-MAY-2011. Concomitant medications included MENACTRA (lot # U3464AA) vaccinated IM into right arm and BOOSTRIX (lot # AC52B060CA) vaccinated IM into left arm. The next day (on 10-MAY-2011) the patient had abdominal cramping but no menses. After no menses for two months, mother took patient to the doctor. Mother stated that doctor had drawn blood to check the patient's hormones, before stating pills. She was told that they were abnormal. The outcome of the events was unknown. The report was considered to be no condition and non serious. The original reporting source was not provided. The VAERS ID # is 452070. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Hallucination, visual, Pain in extremity
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. A 15 years old female patient with asthma and no previous illness and history of "AR" on 18-MAR-2012 was vaccinated with lot # (672233/1561AA) dose 1 GARDASIL into right arm. At the same date, within 2-3 hours, the patient developed pain in arm that vaccine was given. Pain radiated down mid chest (pain midline) and stay froze. The patient also experienced visual hallucination, "seeing spiders in the room". No lab test was performed. There was no conditions. At the time of reporting, the outcome of above events was unknown. The original reporting source was not provided. The VAERS ID # is 452981. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Hallucination, visual, Injection site pain
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. A 15 years old female patient with asthma and no previous illness and history of "AR" on 18-MAR-2012 was vaccinated with lot # (672233/1561AA) dose 1 GARDASIL into right arm. At the same date, within 2-3 hours, the patient developed pain in arm that vaccine was given. Pain radiated down mid chest (pain midline) and stay froze. The patient also experienced visual hallucination, "seeing spiders in the room". No lab test was performed. There was no conditions. At the time of reporting, the outcome of above events was unknown. The original reporting source was not provided. The VAERS ID # is 452981. No further information is available.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Convulsion, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
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. A 13 years old male patient with no conditions, no history and no previous illness was vaccinated IM in the right arm with the first dose of GARDASIL (lot # 672232/1495AA) on 02-APR-2012. No other co-suspects were reported. Concomitant vaccine included: MENACTRA (lot# U4096AA, Dose 1) IM in the left arm on 02-APR-2012. On 02-APR-2012, patient became slightly pale and diaphoretic after vaccines were administered. Patient was advised to lay down and wait in the room with his mom for 15 minutes. After approximately 10 minutes, mom requested if they could finish their "wait time" in the waiting room and was advised by the doctor that that would be OK. While in the waiting room the patient got up from chair and advised mom he needed some water then passed out into his mom's arms. He had convulsion like movements for a few seconds then was assisted to the floor by staff. The patient lay supine on the floor. Slowly became aware of his surrounding and fully oriented after about 30-60 seconds. After a few minutes, patient was assisted to a chair in the waiting room and complained of nausea. After a few minutes, the patient was wheeled into an exam room where he lay down and drank water and soda for approximately another 10 minutes. He then sat up for another 5 minutes. Doctor cleared the patient to leave. Patient was escorted to their car by a staff member. No further symptoms were noted. Child stated he "felt fine". No treatment information was reported. A Tuberculosis Skin Test Purified Protein Derivative (PPD) was also administered during this visit. The agency felt that all the events were non-serious. Upon internal review, passed out into his moms arms and convulsion like movements for a few seconds were considered as other important medical events. The original reporting source was not provided. The VAERS ID # is 452994-1. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL, HEPA, HPV4, VARCEL
Symptoms: Activities of daily living impaired, Headache, Vision blurred
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 18 years old male patient with no previous illness was vaccinated IM with the second dose of GARDASIL (lot # 670048/0963) on 16-APR-2012. Other suspect vaccine included the second dose of VARIVAX (Merck) (lot # 670583/0707AA) SC in right arm on 16-APR-2012. Concomitant vaccine included the first dose of HAVRIX (lot # AHAVB39DA) IM in right arm. On 17 APR-2012 the patient experienced kept out of school 2 days, blurred vision and severe headache. No treatment information was reported. The patient did not seek medical attention. The reporter felt that kept out of school 2 days, blurred vision and severe headache were non-serious. The outcome of kept out of school 2 days, blurred vision and severe headache was unknown. The original reporting source was not provided. The VAERS ID # is 454354-1. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Activities of daily living impaired, Erythema, Oedema peripheral, Skin warm
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 11 years old female patient was i.m. vaccinated with the second dose of GARDASIL (lot number 669795/1317AA) in the left arm on 21-MAY-2012. And she was also vaccinated i.m. with the first dose of BOOSTRIX (lot number: AC52B076BA) on the right arm and i.m. the first dose of MENVEO (lot number: M11065) on the left arm.  On 22-MAY-2012, the patient's left arm swollen, turned red, warm to touch. Her mother gave MOTRIN orally to her on 22-MAY-2012 pm. She went to school on 23-MAY-2012 but was sent home by school nurse. The outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram abnormal, Dizziness, Epistaxis, Facial bones fracture, Fall
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. A 15 year old female patient was i.m. vaccinated the third dose of GARDASIL (lot number 671994/1537AA) on 21-MAY-2012. Patient's mother was in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, the patient felt dizzy and she fell on the floor. She sustained a rugged laceration on nasal bridge and her nose bleed. The EMS took her to hospital. The medical history of the patient showed she had previous syncope few years ago after getting shot. The ER showed CAT; syncope and nasal laceration; the scan showed nasal fracture. The outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laceration
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. A 15 year old female patient was i.m. vaccinated the third dose of GARDASIL (lot number 671994/1537AA) on 21-MAY-2012. Patient's mother was in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, the patient felt dizzy and she fell on the floor. She sustained a rugged laceration on nasal bridge and her nose bleed. The EMS took her to hospital. The medical history of the patient showed she had previous syncope few years ago after getting shot. The ER showed CAT; syncope and nasal laceration; the scan showed nasal fracture. The outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram abnormal, Dizziness, Endoscopic retrograde cholangiopancreatography, Epistaxis, Facial bones fracture
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. A 15 year old female patient was i.m. vaccinated the third dose of GARDASIL (lot number 671994/1537AA) on 21-MAY-2012. Patient's mother was in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, the patient felt dizzy and she fell on the floor. She sustained a rugged laceration on nasal bridge and her nose bleed. The EMS took her to hospital. The medical history of the patient showed she had previous syncope few years ago after getting shot. The ER showed CAT; syncope and nasal laceration; the scan showed nasal fracture. The outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Laceration
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. A 15 year old female patient was i.m. vaccinated the third dose of GARDASIL (lot number 671994/1537AA) on 21-MAY-2012. Patient's mother was in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, the patient felt dizzy and she fell on the floor. She sustained a rugged laceration on nasal bridge and her nose bleed. The EMS took her to hospital. The medical history of the patient showed she had previous syncope few years ago after getting shot. The ER showed CAT; syncope and nasal laceration; the scan showed nasal fracture. The outcome was unknown. No further information is available. The original reporting source was not provided.
Age: 11.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
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 11 year old female patient who on 02-MAY-2012 was vaccinated with dose 3 GARDASIL (Lot # 1495A) into the left arm by intramuscular route. Concomitant medications included VENTOLIN. On 04-MAY-2012, the child was seen 9cm x 10cm area of left upper arm red and hard warm to touch but without cellulitis or lymph involvement. There were no conditions. The outcome of the above events is unknown. The original reporting source was not provided. The VAERS ID # is 456625. No further information is available.
Age: 37.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: This spontaneous report was received from a nurse (L.P.N.) refers to a 37 years old female patient with none pertinent medical history and non allergies. The patient was vaccinated intramuscularly with three doses of 0.5 GARDASIL respectively on 12-JAN-2012, 13-MAR-2012 and 17-JUL-2012. Concomitant medications included birth control pill. It was reported that the patient developed diarrhea, severe stomach pain, dizziness, numbness and tingling of her lips, "right away" after her third GARDASIL. Nurse states the patient had no reactions after the first two dose of GARDASIL. There was no treatment given for the AE. The patient's outcome was unknown at the time of  reporting. The patient sought medical attention by calling the office on 23-JUL-2012. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Hypoaesthesia oral, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a nurse (L.P.N.) refers to a 37 years old female patient with none pertinent medical history and non allergies. The patient was vaccinated intramuscularly with three doses of 0.5 GARDASIL respectively on 12-JAN-2012, 13-MAR-2012 and 17-JUL-2012. Concomitant medications included birth control pill. It was reported that the patient developed diarrhea, severe stomach pain, dizziness, numbness and tingling of her lips, "right away" after her third GARDASIL. Nurse states the patient had no reactions after the first two dose of GARDASIL. There was no treatment given for the AE. The patient's outcome was unknown at the time of  reporting. The patient sought medical attention by calling the office on 23-JUL-2012. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: HEP, HPV4, HEP, HPV4
Symptoms: Paraesthesia oral
Clinical narrative: This spontaneous report was received from a nurse (L.P.N.) refers to a 37 years old female patient with none pertinent medical history and non allergies. The patient was vaccinated intramuscularly with three doses of 0.5 GARDASIL respectively on 12-JAN-2012, 13-MAR-2012 and 17-JUL-2012. Concomitant medications included birth control pill. It was reported that the patient developed diarrhea, severe stomach pain, dizziness, numbness and tingling of her lips, "right away" after her third GARDASIL. Nurse states the patient had no reactions after the first two dose of GARDASIL. There was no treatment given for the AE. The patient's outcome was unknown at the time of  reporting. The patient sought medical attention by calling the office on 23-JUL-2012. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Cardiac disorder, Fatigue, Feeling abnormal
Clinical narrative: My daughter received the GARDASIL shot in December of 2008 she received the first and second shot. About two weeks after receiving the shots she began having hives I took her to the doctor they could not find a reason for her hives she was tested for everything, that was 4 years ago she is still receiving treatments for hives no known cause. A little while later she started with muscle and joint pain took her to the doctor. Test were ran no known cause. She is still under doctors care at this time for that, a short while later the headaches started, test were run no known cause, she is still under doctors care for the headaches, next, heart problems, went to the doctor test were ran no known cause, she is still under doctors care for her heart, she is also seeing a Gyn doctor because her hormones are messed up, my daughter is currently on medicine for all of these problems, 5 pills a day, severe fatigue, never feels good. My daughter was a happy healthy girl that was active she also played sports, now she can't do any of it! My daughter was fine until she took the GARDASIL shot! No health problems are in our family, and patient was very healthy. I know this GARDASIL shot has changed my daughter's life. I hope they will find a way to prove that this shot is what's doing this to all these girls and stop the use of it! I really hate to see what is going to be next on the list of health problems for my daughter in the future!
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hormone level abnormal, Myalgia, Urticaria
Clinical narrative: My daughter received the GARDASIL shot in December of 2008 she received the first and second shot. About two weeks after receiving the shots she began having hives I took her to the doctor they could not find a reason for her hives she was tested for everything, that was 4 years ago she is still receiving treatments for hives no known cause. A little while later she started with muscle and joint pain took her to the doctor. Test were ran no known cause. She is still under doctors care at this time for that, a short while later the headaches started, test were run no known cause, she is still under doctors care for the headaches, next, heart problems, went to the doctor test were ran no known cause, she is still under doctors care for her heart, she is also seeing a Gyn doctor because her hormones are messed up, my daughter is currently on medicine for all of these problems, 5 pills a day, severe fatigue, never feels good. My daughter was a happy healthy girl that was active she also played sports, now she can't do any of it! My daughter was fine until she took the GARDASIL shot! No health problems are in our family, and patient was very healthy. I know this GARDASIL shot has changed my daughter's life. I hope they will find a way to prove that this shot is what's doing this to all these girls and stop the use of it! I really hate to see what is going to be next on the list of health problems for my daughter in the future!
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head, Electroencephalogram, Fall, Gaze palsy, Head injury
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. This spontaneous report as received from a regulatory authority refers to a 16 years old female patient with no medical history and no pre-existing illness. The patient was vaccinated IM with dose 2 GARDASIL (lot # 669795/1317AA) on 30-MAY-2012. No other co-suspects were reported. There was no concomitant medications. On 30-MAY-2012 the patient was a check out and passed out. She fell backward and Hit her head on door frame. Her eye rolled back and she started to shake for 20 seconds. The patient had ordered a CT of head and an EEG. At the time of the report, the outcome was unknown. Upon internal review, passed out was considered to be a medically significant. The original reporting source was not provided. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Tremor
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. This spontaneous report as received from a regulatory authority refers to a 16 years old female patient with no medical history and no pre-existing illness. The patient was vaccinated IM with dose 2 GARDASIL (lot # 669795/1317AA) on 30-MAY-2012. No other co-suspects were reported. There was no concomitant medications. On 30-MAY-2012 the patient was a check out and passed out. She fell backward and Hit her head on door frame. Her eye rolled back and she started to shake for 20 seconds. The patient had ordered a CT of head and an EEG. At the time of the report, the outcome was unknown. Upon internal review, passed out was considered to be a medically significant. The original reporting source was not provided. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Viral infection, Vomiting
Clinical narrative: My doctor vomited in bed that evening all over her covers and pillow.  Overnight 8/2, she had vomited all over herself and had a bad case of diarrhea. I looked up Hep A vaccine information on cdc.gov and it said that diarrhea and vomiting could be a side effect, but the doctor's office said when I called that the vaccine wouldn't cause this and that they felt she had a virus that needed to run its course even though it originated right after the shot to my daughter.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: At injection site - redness, hardness under skin, soreness.
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Pt started having rash around the injection site.  Over the next few days, the rash progressed, became slightly raised, itchy, and red. The symptoms continued up until August 3rd (when the pt visited our office). The measurement of rash was 7X9 cm.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Slight swelling, rash, redness in area per patient on 8/1/12.  Redness noted when patient presented on 8/2/12--no swelling or rash.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Discomfort, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: 38 y/o male, presented today with a reaction to his 3rd anthrax vaccination.  He has been in-country for about 4 months.  This was his third dose, other doses were 9/2011, 1/2012 and then again 48 hours ago. No previous complaints following any previous vaccinations. I saw him initially this morning about 48 hours after his vaccination. He works the night shift and came in directly after his shift.  He developed an erythematous, edematous, indurated reaction.  It has continued to worsen over the last 24 hours.  His right upper arm measured around his upper bicep is about 2 CM larger compared to the contralateral arm.  The erythema is not circumferential, only about 60% of his arm upper arm is involved. On the lateral aspect of his arm there is a large area of firm induration measuring about the size of his palm.  He is relatively non-tender.  He feels mild discomfort from the tightness/edema. I marked it, gave him 15mg of Mobic and asked him to return after he sleeps or sooner if he worsens. I just saw him again today 12 hours later.  The only change is a slightly larger area of erythema.  No additional tenderness.  He has no functional complaints. Distal neurovascular exam is WNL.  Measurements include the erythematous area of 18 proximal to distal x 20cm (total bicep circumference is 32cm). The area of induration is 9cm x 9cm.
Age: 26.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left arm become swollen and red.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed erythema, swelling. Warmth inferior to site of Tdap vaccination on Lt deltoid. Reaction appeared 1-2 days after injection treatment ice, ADVIL. Daughter had reaction to pertussis. Pt had Td in past - no reaction.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Arthralgia, Malaise, Presyncope, Pyrexia
Clinical narrative: Presyncopal event - upon laying back & juice felt better w/in 10 minutes. That evening fever to 102 degrees, arthralgia, sick feeling.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Feeling hot, Headache, Hyperhidrosis, Nausea, Somnolence
Clinical narrative: Pt was nauseous in the morning 7/18/12, had slight headache around 1pm 7/18/12, then parents left the house. When they returned around 6pm pt was on the sofa & felt very hot. They stood him up & he was not answering questions & appeared to struggle to stay awake. Parents out him in the car to go to ED & he broke out into a sweat then returned to normal. PE normal in office 7/19/12.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt was nauseous in the morning 7/18/12, had slight headache around 1pm 7/18/12, then parents left the house. When they returned around 6pm pt was on the sofa & felt very hot. They stood him up & he was not answering questions & appeared to struggle to stay awake. Parents out him in the car to go to ED & he broke out into a sweat then returned to normal. PE normal in office 7/19/12.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Patient called stating a red area around site, a bump under the skin, & itching. Md was called told pt to monitor.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Erythema, Hyperhidrosis, Loss of consciousness
Clinical narrative: Pt noted light headedness about 2 min after immunizations, pt's color redness from face, became diaphoretic, passed out. Pulse oximetry applied & feet elevated. VS stable, ammonia smelling salts provided. Pt responsive within 1 min. Moved to supine position & monitored for 20 mins. Pt noted feeling better. Color back in face. No nausea or vomiting vs stable
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blister, Headache, Nausea, Rash erythematous
Clinical narrative: Raised red bumps about 50 lesions, blister like within 24 hrs of HPV vaccine, then 48 hrs later became nauseated, weak, c/o headache.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dyspnoea, Secretion discharge
Clinical narrative: Mother describes an increasing amount of "slimy" oral secretions. Baby appeared to stop breathing/couldn't catch her breath. EMS was called, examined baby and said he was OK.
Age: 1.02
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Blister, Herpes zoster
Clinical narrative: Mom called 7-23 to she was diagnosed with shingles on 7-19. On 7-20 this child with 5-10 pox vesicles on trunk. By 7-22 child increased of vesicles up to 25-30. By 7-30 completely resolved.
Age: 3.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Pruritus, Sensory loss, Swelling
Clinical narrative: Pt c/o losing sensation immediately upon administration. Redness developed at site. Reports temp 100.3 Evaluated in office 48 hrs later (R) thigh with redness extending to posterior aspect included & swelling & complaints & itching. Treated with prednisolone 15mg/5ml 1 tsp po qd x 3d. Talked with mom (FU).
Age: 1.95
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Mydriasis, Syncope
Clinical narrative: Patient had a syncope episode on 7/20/12 at around 7:30pm, her pupils were dilated during & after episode, patient was sent to ER that night, from there they were sent to tx. for further testing.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: ZOSTAVAX administered 7/2/12. Pt complained of arm pain 3 days later. Pt met with PCP Dr. to received treatment for pain. I received call today (7/21/12) informing me.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pain, Pyrexia, Skin warm
Clinical narrative: Pt. states developed fever 7/25/12 pm - did not take but knew she felt hot. Very achy, hot & raised induration 4"x3" on back of arm. Talked with her on 7-27-12 & told her to apply cold compresses, take TYLENOL Ibuprofen. As directed - she can also take --> one antihistamine - called back 7/30 - client doing better - did not follow any of my instructions. She was out gardening, she took ASA & did not apply cold compresses.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Swelling face, Throat tightness, Urticaria
Clinical narrative: After receiving PNEUMOVAX and ZOSTAVAX pt developed throat constriction 20 minutes later - resolved in 1 hour after antihistamine. Next am awakened with facial swelling (L) arm (upper) swelling (site of ZOSTAVAX) and hives lower arm. Pt reported on 7/25 these reactions which were almost resolved by antihistamine use. Never came in day of shots or called 911.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a company representative concerning her 59 years old mother (a registered nurse) who on 17-JUL-2012 was vaccinated with 0.65 ml dose of ZOSTAVAX (lot # not reported). No other co-suspects were reported. No concomitant medications were reported. In July, the patient had a rash on her arm above where the shot was given. No lab diagnostics studies were performed. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Induration, Pain in extremity, Skin warm
Clinical narrative: Mom reported patient had a 4" x 3" area on her upper bicep which was warm to touch & firm x 3-4 days. Soreness only to touch. No fever & did not favor arm.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Body temperature increased, Differential white blood cell count normal, Full blood count abnormal, Grunting, Lethargy
Clinical narrative: Approx 6 h after vaccines, patient had 20 minute episode of grunting, gray color and lethargy w/o LOC or seizure like activity. On eval in office after event, found to have T 100.2 R, resolved with TYLENOL but per parent still not back to normal self. Admitted for O/N obs for ?ALTE. Progressively more alert, active, only w/o recurrence of event. Discharged 24 hours after event. Seen am 8/2 in office still back to normal baby self.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Platelet count increased, Skin discolouration
Clinical narrative: Approx 6 h after vaccines, patient had 20 minute episode of grunting, gray color and lethargy w/o LOC or seizure like activity. On eval in office after event, found to have T 100.2 R, resolved with TYLENOL but per parent still not back to normal self. Admitted for O/N obs for ?ALTE. Progressively more alert, active, only w/o recurrence of event. Discharged 24 hours after event. Seen am 8/2 in office still back to normal baby self.
Age: 0.2
Sex: U
Vaccine: DTAP
Symptoms: Death, Pertussis
Clinical narrative: Initial case received via search of scientific literature on 26 July 2012. The following is verbatim from the article abstract: "Objective: In 2010, an area experienced the highest number of pertussis cases in >60 years, with >9000 cases, 809 hospitalizations, and 10 deaths. This report provides a descriptive epidemiologic analysis of this epidemic and describes public health mitigation strategies that were used, including expanded pertussis vaccine recommendations. STUDY DESIGN: Clinical and demographic information were evaluated for all pertussis cases with onset from January 1, 2010 through December 31, 2010, and reported to the Department of Public Health. RESULTS: Infants younger than 6 months had the highest disease rates; all deaths and most hospitalizations occurred in infants younger than 3 months. Most pediatric cases were vaccinated according to national recommendations, although 9% of those aged 6 months to 18 years were completely unvaccinated against pertussis. High disease rates also were observed in fully vaccinated preadolescents, especially 10-year-olds. Mitigation strategies included expanded tetanus, diphtheria, and acellular pertussis vaccine recommendations, public and provider education, distribution of free vaccine for postpartum women and contacts of infants, and clinical guidance on diagnosis and treatment of pertussis in young infants. CONCLUSIONS: Infants too young to be fully vaccinated against pertussis remain at highest risk of severe disease and death. Data are needed to evaluate strategies offering direct protection of this vulnerable population, such as immunization of pregnant women and of newborns. The high rate of disease among preadolescents suggests waning of immunity from the diphtheria, tetanus, and acellular pertussis series; additional studies are warranted to evaluate the efficacy and duration of protection of the diphtheria, tetanus, and acellular pertussis series and the tetanus, diphtheria, and acellular pertussis series." The following is verbatim from the article: "The remaining fatality was a 2-month-old infant born prematurely at 28 weeks gestational age who had received the first dose of diphtheria, tetanus, and accelular pertussis (DTaP) vaccine 15 days prior to disease onset." A two-month-old infant (date of birth and gender not reported), who was born at 28 weeks gestation, received dose one injection of DTaP, manufacturer unknown, (lot number, route and site not reported) on an unspecified date. On an unspecified date, 15 days after vaccination, the patient developed Pertussis. Other than premature birth, the patient's past medical history, concomitant medications or vaccinations were not reported. Hospitalization, laboratory/diagnostic studies, treatments and date of death were not reported. The patient's outcome was reported as fatal. Documents held by sender: None.
Sex: U
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Initial report received via search of scientific literature on 20 March 2012. The following is verbatim from the article abstract: "PURPOSE: A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain-Barre syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Centers for Disease Control and Prevention and the Food and Drug Administration requested the evaluation of GBS risk after MCV4 vaccination. We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases. METHODS: Retrospective cohort study among 12.6 million 11- to 21-year-old members of five health plans with a total membership of 50 million. Automated enrollment and medical claims data from March 2005 through August 2008 were used to identify the population, the vaccinations administered, and the medical services associated with possible GBS. Medical records were reviewed and adjudicated by a neurologist panel to confirm cases of GBS. The study used distributed data analysis methods that minimized sharing of protected health information. RESULTS: We confirmed 99 GBS cases during 18,322,800 person-years (5.4/1,000,000 person-years). More than 1.4 million MCV4 vaccinations were observed. No confirmed cases of GBS occurred within 6 weeks after vaccination. The upper 95% CI for the attributable risk of GBS associated with MCV4 is estimated as 1.5 cases per 1,000,000 doses. CONCLUSIONS: Among members of five health plans, MCV4 vaccination was not associated with increased GBS risk." Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Chills, Dyspnoea, Feeling hot, Headache, Intensive care
Clinical narrative: Initial reported received from a Health Care professional on 14 June 2012. A 59- years-old male patient with medical history of Knee Replacement and pulmonary emboli following Knee replacement, whose concomitant medications were not reported received a intramuscular dose of TYPHIM VI vaccine (Batch lot number: G0508-1, Route and site of administration: Not reported), Intramuscular 1st dose of ADACEL vaccine (Batch lot number: U4325AA, Route and site of administration: Not reported) and Hepatitis A vaccine (Batch lot number. Route and site of Administration not reported) on 08 June 2012. On 11 June 2012, the patient presented with complains of headache, feeling hot, having chills and labored breathing. The patient was treated with Forcing Fluids, TYLENOL or Ibuprofen and cool showers as corrective measures and the temperature was monitored. On 12 June 2012, the patient developed fever of 104 F, sore throat, red, raised, itchy rash. The outcome of headache, feeling hot, having chills, labored breathing, fever of 104 F, sore throat and red, raised, itchy rash was not reported. As of 14 June 2012, the patient had not recovered. Follow-up was received from a healthcare professional on 20 July 2012. Product screen two was amended from Td2cP to ADACEL, sanofi pasteur Ltd., (as reported and mentioned in narrative) sanofi pasteur Inc. lot number U4325AA, (corresponding sanofi pasteur Ltd. lot number C4105) dose one, intramuscular, (site not reported) on 08 June 2012. Based upon the new information provided, this case has been upgraded to serious. On 15 June 2012, the patient's symptoms were getting worse. The patient's wife contacted healthcare provider who encouraged patient to go to the emergency room (ER). The patient was evaluated in the emergency room and was admitted to an Intensive Care Unit (ICU) at another hospital with the diagnosis (Dx) of Borderline Steven Johnson Syndrome. According to the doctor (MD), Borderline Steven Johnson Syndrome was a result of the patient's treatment of SEPTRA DS, and not related to the vaccine. The patient was discharged from the hospital on 19 June 2012, with report that patient was much improved. The patient's outcome was reported as recovered on unspecified date. Documents held by sender: None.
Age: 59.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Oropharyngeal pain, Pyrexia, Rash erythematous, Rash pruritic, Stevens-Johnson syndrome
Clinical narrative: Initial reported received from a Health Care professional on 14 June 2012. A 59- years-old male patient with medical history of Knee Replacement and pulmonary emboli following Knee replacement, whose concomitant medications were not reported received a intramuscular dose of TYPHIM VI vaccine (Batch lot number: G0508-1, Route and site of administration: Not reported), Intramuscular 1st dose of ADACEL vaccine (Batch lot number: U4325AA, Route and site of administration: Not reported) and Hepatitis A vaccine (Batch lot number. Route and site of Administration not reported) on 08 June 2012. On 11 June 2012, the patient presented with complains of headache, feeling hot, having chills and labored breathing. The patient was treated with Forcing Fluids, TYLENOL or Ibuprofen and cool showers as corrective measures and the temperature was monitored. On 12 June 2012, the patient developed fever of 104 F, sore throat, red, raised, itchy rash. The outcome of headache, feeling hot, having chills, labored breathing, fever of 104 F, sore throat and red, raised, itchy rash was not reported. As of 14 June 2012, the patient had not recovered. Follow-up was received from a healthcare professional on 20 July 2012. Product screen two was amended from Td2cP to ADACEL, sanofi pasteur Ltd., (as reported and mentioned in narrative) sanofi pasteur Inc. lot number U4325AA, (corresponding sanofi pasteur Ltd. lot number C4105) dose one, intramuscular, (site not reported) on 08 June 2012. Based upon the new information provided, this case has been upgraded to serious. On 15 June 2012, the patient's symptoms were getting worse. The patient's wife contacted healthcare provider who encouraged patient to go to the emergency room (ER). The patient was evaluated in the emergency room and was admitted to an Intensive Care Unit (ICU) at another hospital with the diagnosis (Dx) of Borderline Steven Johnson Syndrome. According to the doctor (MD), Borderline Steven Johnson Syndrome was a result of the patient's treatment of SEPTRA DS, and not related to the vaccine. The patient was discharged from the hospital on 19 June 2012, with report that patient was much improved. The patient's outcome was reported as recovered on unspecified date. Documents held by sender: None.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Mom states child had chicken pox 3 years ago.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Mom said child had chicken pox 3 years ago after having both varicellas.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Redness, hot to touch, swollen, painful.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Bordetella test, Erythema, Injection site pain, Swelling
Clinical narrative: Patient developed pain at the site of injection. He developed redness and swelling on 08/03/2012.
Age: 1.55
Sex: M
Vaccine: DTPIHI, HEPA, PNC13, VARCEL
Symptoms: Pyrexia, Rash papular, Rash pruritic, Varicella post vaccine
Clinical narrative: Diffuse papulovesicular rash starting on face and progressing down to entire body.  Very pruritic.  Fever.  Determined to be post vaccine Varicella infection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy bumps (hives?) on toes and feet, spreading to ankles and legs.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Throat tightness
Clinical narrative: Shortness of breath. Throat tightening. Dizzy. Patient called covering MD. Told to go to ER with worsening symptoms.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site where varicella vaccine was given was red, sore, and swollen.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Body temperature increased, Chest pain, Full blood count, Headache, Pain
Clinical narrative: He developed temperature greater than 102, body aches, headache and chest pain.  He was seen in the Emergency room and was felt to have a reaction to the vaccine.  He continued to run a fever the following day with same symptoms.  The second day, his fever seems to be resolving as well as the symptoms.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site rash, Myalgia
Clinical narrative: Patient developed rash around the sight, low grade temp, and muscle aches for about 48 hours.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Bone scan, Computerised tomogram, Groin pain
Clinical narrative: Excruciating pain in hip and groin area. She was admitted twice to hospital from emergency room and on home health for 6 days in between.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Nerve injury, Nuclear magnetic resonance imaging, Spinal pain
Clinical narrative: Excruciating pain in hip and groin area. She was admitted twice to hospital from emergency room and on home health for 6 days in between.
Age: 1.03
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Irritable, fever.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Blister, Pyrexia, Varicella
Clinical narrative: He developed a full case of the chicken pox. He had multiple blisters (15-20) all over his body including abdomen, back, arms and legs. He also had a fever of about 101. I admistered ibuprofen to him and rubbed Benadryl lotion on his blisters.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: 3 minutes after getting vaccine while drawing blood from a fingerstick patient started feeling dizzy, a few minutes later she became pale but still coherent and conscious. Water was given and she was able to drink while sitting up, she was later laid down and given a lollipop and ice pack was placed under her neck, BP was 100/70 @ 4:20 pm, her color return and Dr. was informed and saw the patient. RN recheck BP 112/66  @ 4:43 pm - Mom and patient both said that patient was fine and Dr. was informed and patient was released. Patient waited 25 minutes after vaccine and cbc (fingerstick).