chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Axillary pain, Decreased activity, Dizziness, Erythema, Lymph node pain
Clinical narrative: Tdap given 3/25/10 Increased swelling, pain and redness in arm also hot to the touch.  Severe pain and tenderness traveled to underarm and left side of torso over next 24 hours.  About 30 hours after vaccination marked dizziness required cessation of activity lasting several hours.  The following day pain continued though dizziness had subsided.  Currently at 80 hours post-vaccine.  Still redness and swelling (3" diameter) tender to touch and still considerable soreness of underarm and lymph areas.  Symptoms seem to be diminishing slowly.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Tdap given 3/25/10 Increased swelling, pain and redness in arm also hot to the touch.  Severe pain and tenderness traveled to underarm and left side of torso over next 24 hours.  About 30 hours after vaccination marked dizziness required cessation of activity lasting several hours.  The following day pain continued though dizziness had subsided.  Currently at 80 hours post-vaccine.  Still redness and swelling (3" diameter) tender to touch and still considerable soreness of underarm and lymph areas.  Symptoms seem to be diminishing slowly.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, FLUN3, HPV4, TDAP
Symptoms: Alpha 1 foetoprotein normal, Anaemia, Drug exposure during pregnancy, Nausea, Ovarian cancer
Clinical narrative: Initial report was received from a health care professional on 24 September 2009. A 15-year-old pregnant female patient had received a 0.5 mL intramuscular left deltoid injection of ADACEL, lot number C2773AA, and a 0.5 mL intramuscular left deltoid injection of GARDASIL (manufacturer Merck), lot number 0653X) and a intranasal dose of FLUMIST (manufacturer MedImmune, lot number 500687P) on 17 September 2009. The vaccine was administered by a school nurse and it was unknown at the time of vaccination that the patient was pregnant. The patient had no pre-existing medical conditions and no prior pregnancies. Her last menstrual period occurred on 01 August 2009 and her expected date of confinement was 09 May 2010. At the time of the report, the patient had not experienced any adverse event since vaccination. Follow-up information was received 19 March 2010 from a health care professional. From new information received, it was reported that the patient had received ZOFRAN 4mg since 28 September 2009 for "ovarian carcinoma refractory (nausea)". Based upon this new information, this case has been upgraded from nonserious to serious. Additional maternal drug exposure included iron 325 mg beginning 16 December 2009 for anemia, and supplemental prenatal vitamins beginning 28 September 2009. The patient's last menstrual period occurred on 02 August 2009 (previously reported as 01 August 2009). Significant medical conditions were reported as "teen, anemia" and the patient was also noted to have had a family history of diabetes and HTN. Prenatal tests included alpha feto protein on 18 November 2009 and an ultrasound on 23 December 2009, both with normal findings. An outcome was not reported for the event of ovarian carcinoma refractory nausea and anemia. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: FLUN3, HPV4, TDAP, FLUN3, HPV4, TDAP
Symptoms: Ultrasound scan normal
Clinical narrative: Initial report was received from a health care professional on 24 September 2009. A 15-year-old pregnant female patient had received a 0.5 mL intramuscular left deltoid injection of ADACEL, lot number C2773AA, and a 0.5 mL intramuscular left deltoid injection of GARDASIL (manufacturer Merck), lot number 0653X) and a intranasal dose of FLUMIST (manufacturer MedImmune, lot number 500687P) on 17 September 2009. The vaccine was administered by a school nurse and it was unknown at the time of vaccination that the patient was pregnant. The patient had no pre-existing medical conditions and no prior pregnancies. Her last menstrual period occurred on 01 August 2009 and her expected date of confinement was 09 May 2010. At the time of the report, the patient had not experienced any adverse event since vaccination. Follow-up information was received 19 March 2010 from a health care professional. From new information received, it was reported that the patient had received ZOFRAN 4mg since 28 September 2009 for "ovarian carcinoma refractory (nausea)". Based upon this new information, this case has been upgraded from nonserious to serious. Additional maternal drug exposure included iron 325 mg beginning 16 December 2009 for anemia, and supplemental prenatal vitamins beginning 28 September 2009. The patient's last menstrual period occurred on 02 August 2009 (previously reported as 01 August 2009). Significant medical conditions were reported as "teen, anemia" and the patient was also noted to have had a family history of diabetes and HTN. Prenatal tests included alpha feto protein on 18 November 2009 and an ultrasound on 23 December 2009, both with normal findings. An outcome was not reported for the event of ovarian carcinoma refractory nausea and anemia. Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Immediate post-injection reaction, Nuclear magnetic resonance imaging, Pain, Tremor
Clinical narrative: Bilateral hand tremor began within 6 weeks. Pain began within 4 weeks of second dose (12/31/2008). Systemic pain began immediate with third dose in August of 2009.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis, Vaccine positive rechallenge, X-ray
Clinical narrative: Bilateral hand tremor began within 6 weeks. Pain began within 4 weeks of second dose (12/31/2008). Systemic pain began immediate with third dose in August of 2009.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Abortion spontaneous, Contraindication to vaccination, Drug exposure during pregnancy
Clinical narrative: A serious spontaneous report of a pregnant woman who got FLUMIST miscarried, after she received FLUMIST while "three months pregnant"; was received from a physician's assistant concerning a 15-year-old female. Medical history and concomitant medications were not reported. On 28-Sep-2009, the patient received FLUMIST. The patient's last menstrual period was on 28-Aug-2009, however, on 22-Oct-2009, the patient reported that she was almost three months pregnant. Laboratory tests, estimated date of delivery and number of weeks gestation were not reported. On 07-Nov-2009, the patient miscarried. No other adverse reactions have been reported. Treatment information was not reported. The outcome for the events was considered to be resolved. The sponsor considered miscarriage to be an other important medical event. Additional information was received on 10-Dec-2009 and incorporated into the narrative: event of miscarriage and outcome.
Age: 37.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, UNK, ANTH, FLU3, TYP
Symptoms: Rash
Clinical narrative: 38 y/o male, ANG, who received primary smallpox vaccine (SPV) left upper arm, anthrax (AVA) dose #1, typhoid, & seasonal influenza vaccines on 3/6/2010 at AFB. Per report, he developed typical lake reaction left deltoid around 3/10; however from 3/14 he noted increased itching/redness at site & development of other lesions over neck & left cheek. SM denied feeling ill, fever/chills, headache or other systemic symptoms. He was seen at a Doctors Care site on 3/17 at which time he was afebrile & non-toxic, but treated for cellulitis using IM & oral antibiotics. He was advised to take BENADRYL. No tests were done. On 3/17 telederm consultation (with derm photos) yielded diagnosis of localized vaccinia reaction with recommendation for supportive therapy (antihistamines) & f/u if sxs worsened. On 3/29/2010, SM reported to VHC that rash was gone, some mild itching still present, SPV site healing.
Age: 37.0
Sex: M
Vaccine: ANTH, FLUX, SMALL, UNK, ANTH, FLU3, TYP
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Skin lesion, Vaccinia virus infection
Clinical narrative: 38 y/o male, ANG, who received primary smallpox vaccine (SPV) left upper arm, anthrax (AVA) dose #1, typhoid, & seasonal influenza vaccines on 3/6/2010 at AFB. Per report, he developed typical lake reaction left deltoid around 3/10; however from 3/14 he noted increased itching/redness at site & development of other lesions over neck & left cheek. SM denied feeling ill, fever/chills, headache or other systemic symptoms. He was seen at a Doctors Care site on 3/17 at which time he was afebrile & non-toxic, but treated for cellulitis using IM & oral antibiotics. He was advised to take BENADRYL. No tests were done. On 3/17 telederm consultation (with derm photos) yielded diagnosis of localized vaccinia reaction with recommendation for supportive therapy (antihistamines) & f/u if sxs worsened. On 3/29/2010, SM reported to VHC that rash was gone, some mild itching still present, SPV site healing.
Age: 27.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site macule, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: (L) upper arm at injection site (SubQ) 7.5 cm x 7 cm erythematous, warm, tender macular rash with b/c, rash x 1 day, observe, with nasios or ASA, ice to arm.
Age: 27.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Rash macular
Clinical narrative: (L) upper arm at injection site (SubQ) 7.5 cm x 7 cm erythematous, warm, tender macular rash with b/c, rash x 1 day, observe, with nasios or ASA, ice to arm.
Age: 27.0
Sex: F
Vaccine: HEP, HEP, VARCEL
Symptoms: Viral titre
Clinical narrative: (L) upper arm at injection site (SubQ) 7.5 cm x 7 cm erythematous, warm, tender macular rash with b/c, rash x 1 day, observe, with nasios or ASA, ice to arm.
Age: 1.01
Sex: M
Vaccine: MMR
Symptoms: Blood test, Pyrexia, Rash, White blood cell count normal
Clinical narrative: Rash that started on face and spread to rest of body over 3 days.  Rash was accompanied by a fever ranging from 100 - 103 degrees.  Rash and fever lasted for 3 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Bruxism, Crying, Electroencephalogram, Eye rolling, Fatigue
Clinical narrative: Pt has episode of vomiting and noted to be limp while asleep in bed. Parents pushed her up and pt was limp with eyes rolled back and teeth clenched. After few minutes, pt started to cry and was tired. No fever, no further episodes observed.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypotonia, Vomiting
Clinical narrative: Pt has episode of vomiting and noted to be limp while asleep in bed. Parents pushed her up and pt was limp with eyes rolled back and teeth clenched. After few minutes, pt started to cry and was tired. No fever, no further episodes observed.
Age: 60.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abdominal discomfort, Nausea, Pyrexia
Clinical narrative: Feverish, upset stomach, feeling like I'm going to throw up.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Swelling face, Urticaria
Clinical narrative: None stated.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Mobility decreased, Musculoskeletal pain, Neck pain
Clinical narrative: 2 weeks after shot woke up sore shoulder & neck pain. Then started loosing use of arm & hand.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: 2" red lump right upper arm
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: 03/25/2010 - redness below area where vaccine was injected - somewhat larger than a dollar coin - soreness, swelling, itching.  03/26/2010 - Area of swelling around initial area of swelling was twice the size.  However, this area had a pinkish color rather than a deep red color and the swelling was less obvious. The itching and general discomfort became more of a problem.  03/28/2020 - There are signs of moderate improvement.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: 03/25/2010 - redness below area where vaccine was injected - somewhat larger than a dollar coin - soreness, swelling, itching.  03/26/2010 - Area of swelling around initial area of swelling was twice the size.  However, this area had a pinkish color rather than a deep red color and the swelling was less obvious. The itching and general discomfort became more of a problem.  03/28/2020 - There are signs of moderate improvement.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4 cm X 4 cm spread erythema, tender to touch, hot, swollen at the site of injection.  Symptoms appeared 3 days after injection.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Left arm was swollen from the elbow to the armpit and was very sore.
Age: 84.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient had H1N1 immunization on 11/20/2009. At the end of January, 2010, patient began having pain at injection site, and has become worse, spreading down right arm. Patient saw PCP late February 2010.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Crying, Fatigue, Pallor
Clinical narrative: Pale, tired, crying a lot.
Age: 1.27
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Coxsackie viral infection, Drooling, Lethargy, Pain
Clinical narrative: Pain started within 2 hours of imm's. lethargy and drooling. Seen on 3/20/2010 with classic Coxsachive infection. Felt viral immun. cause of sx's. Dad requested VAERS reporting.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: 3/19/10 Left arm soreness at site of PNEUMOVAX vaccine unmediated. The next day warmth and redness appeared and lasted 2-3 days. This has resolved.
Age: 64.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: Onset 1-22-10- Weakness and feeling in arms/legs "like sand paper rubbing together" states girlfriend and her daughter had same sx- all rec'd H1N1 together same lot number.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: Risen appeared on right arm, not on the sight of infection. A rash is surrounding it and it is painful and red. It is also causing some itching.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dyspnoea, Rash
Clinical narrative: The day after receiving Hep. A and Hep B pt developed a rash on his hands, arms and feet. He also had trouble breathing. His mother took him to his primary physician and he advised pt to never take Hep A or Hep B again.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Large, Red rash, raised, itchy
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Disturbance in social behaviour, Pyrexia, Staring
Clinical narrative: Fever 102 degrees F. For two days parents report infant staring episodes and less interactive, difficult to engage, then improved gradually until at on week was normal.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction, Similar reaction on previous exposure to drug
Clinical narrative: - Large local reaction to 7days, L deltoid area. - Subcutaneous golf-ball sized induration beneath overlying erythema 5cm in diameter, with increased warmth and increased / darker red in center.
Age: 41.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Abdominal pain, Nausea
Clinical narrative: Nausea after taking pill.  Abdominal cramps after 4th pill - nausea / abdominal cramps occur sporadically now.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Varicella, Varicella post vaccine
Clinical narrative: Varicella vaccine given on 11/24/2004 and 2/21/08. Chicken pox disease dx on 3/25/10 >50 erythematous macules.
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Inappropriate schedule of drug administration, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Headache, nausea, fever of 100 degrees for a day, arm swelled up, sore for 3 days.  Missed work the following day due to illness.  Very red & hot at injection point.
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Headache, nausea, fever of 100 degrees for a day, arm swelled up, sore for 3 days.  Missed work the following day due to illness.  Very red & hot at injection point.
Age: 0.68
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Received ENERGIX B vaccine on 3/17/10. Approx 24 hours later mother noticed circular area of redness at site of vaccination. No raised swelling. No fever, irritability, or diminished movement of leg. Local reaction confluent redness round mildly induration 6 cm diameter.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU(H1N1), HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Skin induration, Skin warm
Clinical narrative: Patient had redness on bilateral thighs. Skin warm to the touch. Skin felt hard. Patient started on cephalexin. Was seen and tx by pediatrician.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Urticaria
Clinical narrative: Had HPV #1 approximately 4pm. -6-7 hours later developed hives and stomachache ate shrimp for dinner- has eaten again without hives.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, red, warm deltoid on left arm. No fever.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Intussusception, Lethargy, Surgery, Vomiting
Clinical narrative: Intussusception - open reduction on 12-22-09. Sx's assoc. were: V (bileous)/lethargy.
Age: 0.27
Sex: F
Vaccine: RV1
Symptoms: C-reactive protein, Diarrhoea, Full blood count, Gastrointestinal sounds abnormal, Metabolic function test
Clinical narrative: Vomiting and diarrhea. Emesis x 4 (projectile) with hypoactive bowel sounds for 1 - 2 days then diarrhea.
Age: 0.27
Sex: F
Vaccine: RV1
Symptoms: Urinary system X-ray, Vomiting projectile
Clinical narrative: Vomiting and diarrhea. Emesis x 4 (projectile) with hypoactive bowel sounds for 1 - 2 days then diarrhea.
Age: 65.0
Sex: M
Vaccine: PPV, TD
Symptoms: Chills, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient c/o fever, chills, body aches and slight swelling at injection site 6 hrs after receiving PNEUMOVAX injection.
Age: 25.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Disturbance in attention, Dizziness, Dysarthria, Dysphagia, Dyspnoea
Clinical narrative: Directly following vaccine, while driving home, I got really dizzy and had trouble focusing. I pulled the car over and called a friend and could barely follow our conversation. When I got home, I slurred my speech and my hands and legs went tingly and numb. My face grew numb too. I had an episode a week later where I couldn't move. Since then I grew faint and have had difficulty breathing, swallowing, and concentrating. Doctors cannot find anything wrong. Went to the ER that night and another ER visit a month later.
Age: 25.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Movement disorder, Paraesthesia, Syncope
Clinical narrative: Directly following vaccine, while driving home, I got really dizzy and had trouble focusing. I pulled the car over and called a friend and could barely follow our conversation. When I got home, I slurred my speech and my hands and legs went tingly and numb. My face grew numb too. I had an episode a week later where I couldn't move. Since then I grew faint and have had difficulty breathing, swallowing, and concentrating. Doctors cannot find anything wrong. Went to the ER that night and another ER visit a month later.
Age: 25.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: Directly following vaccine, while driving home, I got really dizzy and had trouble focusing. I pulled the car over and called a friend and could barely follow our conversation. When I got home, I slurred my speech and my hands and legs went tingly and numb. My face grew numb too. I had an episode a week later where I couldn't move. Since then I grew faint and have had difficulty breathing, swallowing, and concentrating. Doctors cannot find anything wrong. Went to the ER that night and another ER visit a month later.
Age: 25.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Disorientation, Dizziness, Dysarthria, Headache
Clinical narrative: Directly following vaccine, while driving home, I got really dizzy and had trouble focusing. I pulled the car over and called a friend and could barely follow our conversation. When I got home, I slurred my speech and my hands and legs went tingly and numb. My face grew numb too. I had an episode a week later where I couldn't move. Since then I grew faint and have had difficulty breathing, swallowing, and concentrating. Doctors cannot find anything wrong. Went to the ER that night and another ER visit a month later.
Age: 25.0
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Nausea
Clinical narrative: Directly following vaccine, while driving home, I got really dizzy and had trouble focusing. I pulled the car over and called a friend and could barely follow our conversation. When I got home, I slurred my speech and my hands and legs went tingly and numb. My face grew numb too. I had an episode a week later where I couldn't move. Since then I grew faint and have had difficulty breathing, swallowing, and concentrating. Doctors cannot find anything wrong. Went to the ER that night and another ER visit a month later.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Admin ADACEL 3/16/10 and patient developed warm erythatus rash.
Age: 1.75
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood culture, Convulsion, Culture urine, Irritability, Urine analysis
Clinical narrative: Fussy; Approx 20 sec seizure with no post Ictal state.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash papular, Rash pruritic, Vaccination complication
Clinical narrative: Mom reported noticed fine rash at diaper line on 3/16/20, spread onto chest, arms, neck-itchy papular rash. Returned to clinic 3/18/10 for MD visit. No fever. MD, tyi 2.5 w/c qd, BENADRYL 12.5mg/5ml PRN. Rash upper body different? measles vaccine rxn.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching of left leg using Benadryl after 6 hrs, mild improvement.
Age: 37.0
Sex: F
Vaccine: DT
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Developed redness/swelling in about 20 hours post-injection: induration 4x5cm; redness 10x10cm mid arm. Empirically started on DURICEF went to ER. beginning better slowly-? Cellulltis vs local rash.
Age: 38.0
Sex: F
Vaccine: YF
Symptoms: Gait disturbance, Hypoaesthesia, Malaise, Muscle contractions involuntary, Pain
Clinical narrative: Low grade fever, malaise at day 5 - uncontrollable muscle contractions in lower legs & feet lasting 2 days, then numbness and severe pain and difficulty walking.  It got resolved 3 days later.  I am fine now.
Age: 38.0
Sex: F
Vaccine: YF
Symptoms: Pyrexia
Clinical narrative: Low grade fever, malaise at day 5 - uncontrollable muscle contractions in lower legs & feet lasting 2 days, then numbness and severe pain and difficulty walking.  It got resolved 3 days later.  I am fine now.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Pt is employee, TDAP given on Friday 3/26/2010.  Employee reported Monday 3/29/2010.  RD with redness, swelling, & slight edema silver dollar size.
Age: 33.0
Sex: F
Vaccine: FLUX(H1N1), TDAP
Symptoms: Asthenia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: 33 y/o female, nurse who received Tdap (right arm) and  inactivated H1N1 vaccine (left arm) on 3/13/2010 at about 1100 hrs. She noted that both injections seemed to have been given "a little too high up", especially on her right arm - she felt a strong pinch at time of injection. SM had taken a dose of OTC MOTRIN at time of vaccination. About 11 hrs later, around 2200 hrs, she developed severe pain in bilateral upper arms, R>L, Inability to lift arms over head due to pain, shooting pain throughout the right arm, and numbness/tingling in her right hand. There was no obvious swelling, rash discoloration, changes in skin temperature in either UE; there were no systemic or constitutional symptoms. She continued self-treatment with OTC MOTRIN and ice application over upper arms. She presented to local hospital ED on 3/15 at which time, neuro exam was reportedly normal; she had "low-grade temp" o/w normal VS. No diagnostic tests were done. ULTRAM and FLEXERIL were prescribed. ON/about 3/17 an oral steroid pulse was initiated. By 3/19 there was no improvement. She has persistent b/l arm pain (L>R), decreased shoulder RON, decreased arm strength (unable to lift a gallon of milk), intermittent arm muscle spasms and numbness/tingling in fingers both hands. She is being referred to military neuro for further evaluation. SM is right hand-dominate: she denied overuse/injury prior to vaccination; she was well day of and prior; no previous vaccine reactions.
Age: 33.0
Sex: F
Vaccine: FLUX(H1N1), TDAP
Symptoms: Muscle spasms, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: 33 y/o female, nurse who received Tdap (right arm) and  inactivated H1N1 vaccine (left arm) on 3/13/2010 at about 1100 hrs. She noted that both injections seemed to have been given "a little too high up", especially on her right arm - she felt a strong pinch at time of injection. SM had taken a dose of OTC MOTRIN at time of vaccination. About 11 hrs later, around 2200 hrs, she developed severe pain in bilateral upper arms, R>L, Inability to lift arms over head due to pain, shooting pain throughout the right arm, and numbness/tingling in her right hand. There was no obvious swelling, rash discoloration, changes in skin temperature in either UE; there were no systemic or constitutional symptoms. She continued self-treatment with OTC MOTRIN and ice application over upper arms. She presented to local hospital ED on 3/15 at which time, neuro exam was reportedly normal; she had "low-grade temp" o/w normal VS. No diagnostic tests were done. ULTRAM and FLEXERIL were prescribed. ON/about 3/17 an oral steroid pulse was initiated. By 3/19 there was no improvement. She has persistent b/l arm pain (L>R), decreased shoulder RON, decreased arm strength (unable to lift a gallon of milk), intermittent arm muscle spasms and numbness/tingling in fingers both hands. She is being referred to military neuro for further evaluation. SM is right hand-dominate: she denied overuse/injury prior to vaccination; she was well day of and prior; no previous vaccine reactions.
Age: 33.0
Sex: F
Vaccine: FLUX(H1N1), TDAP
Symptoms: Wrong technique in drug usage process
Clinical narrative: 33 y/o female, nurse who received Tdap (right arm) and  inactivated H1N1 vaccine (left arm) on 3/13/2010 at about 1100 hrs. She noted that both injections seemed to have been given "a little too high up", especially on her right arm - she felt a strong pinch at time of injection. SM had taken a dose of OTC MOTRIN at time of vaccination. About 11 hrs later, around 2200 hrs, she developed severe pain in bilateral upper arms, R>L, Inability to lift arms over head due to pain, shooting pain throughout the right arm, and numbness/tingling in her right hand. There was no obvious swelling, rash discoloration, changes in skin temperature in either UE; there were no systemic or constitutional symptoms. She continued self-treatment with OTC MOTRIN and ice application over upper arms. She presented to local hospital ED on 3/15 at which time, neuro exam was reportedly normal; she had "low-grade temp" o/w normal VS. No diagnostic tests were done. ULTRAM and FLEXERIL were prescribed. ON/about 3/17 an oral steroid pulse was initiated. By 3/19 there was no improvement. She has persistent b/l arm pain (L>R), decreased shoulder RON, decreased arm strength (unable to lift a gallon of milk), intermittent arm muscle spasms and numbness/tingling in fingers both hands. She is being referred to military neuro for further evaluation. SM is right hand-dominate: she denied overuse/injury prior to vaccination; she was well day of and prior; no previous vaccine reactions.
Age: 1.49
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Rash
Clinical narrative: =Rash - started 3/25/10. Started on face spread to trunk & limbs in 24 hours.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1), FLU3, HEPA
Symptoms: Febrile convulsion
Clinical narrative: Febrile Seizure.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: I noticed a large red area at the injection site (upper arm).  Within 3 or 4 hours, there was considerable redness and swelling in the area which continued to increase. By evening, the redness covered most of the back side of the upper arm with a very hot, hard center about 2.5 inches in diameter with an irregular shape. I used Benadryl cream, hydrocortisone cream and cold pack on the site.  By evening, I was developing a slight headache and the shoulder joint and elbow were aching.  The following day, the swelling was about the same, and by evening I had a raging headache.  At this time, 3/29/2010, the redness and swelling has subsided some, but is still there with some discomfort.  There has been NO respiratory problems or anything that I would consider life threatening.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Musculoskeletal discomfort
Clinical narrative: I noticed a large red area at the injection site (upper arm).  Within 3 or 4 hours, there was considerable redness and swelling in the area which continued to increase. By evening, the redness covered most of the back side of the upper arm with a very hot, hard center about 2.5 inches in diameter with an irregular shape. I used Benadryl cream, hydrocortisone cream and cold pack on the site.  By evening, I was developing a slight headache and the shoulder joint and elbow were aching.  The following day, the swelling was about the same, and by evening I had a raging headache.  At this time, 3/29/2010, the redness and swelling has subsided some, but is still there with some discomfort.  There has been NO respiratory problems or anything that I would consider life threatening.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: ACTH stimulation test normal, Abdomen scan normal, Blood thyroid stimulating hormone normal, Cytomegalovirus test negative, Decreased appetite
Clinical narrative: Within 15 min of receiving the H1N1 vaccine the pt had SOB, & a skin eruption on the surface of the R arm, (the vaccine was given in the L arm). The next day her tongue had anesthesias, which still exist, but, now the anesthesias are more toward the back of her tongue instead of the tip. She also started getting stabbing pain in her neck, both shoulders, L buttock, and also paresthesias in her feet. These have resolved. She has a loss of appetite.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dyspnoea, HIV antibody negative, Haematocrit normal, Haemoglobin normal, Hypoaesthesia oral
Clinical narrative: Within 15 min of receiving the H1N1 vaccine the pt had SOB, & a skin eruption on the surface of the R arm, (the vaccine was given in the L arm). The next day her tongue had anesthesias, which still exist, but, now the anesthesias are more toward the back of her tongue instead of the tip. She also started getting stabbing pain in her neck, both shoulders, L buttock, and also paresthesias in her feet. These have resolved. She has a loss of appetite.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Lipids normal, Low density lipoprotein normal, Musculoskeletal pain, Neck pain, Neutrophil percentage
Clinical narrative: Within 15 min of receiving the H1N1 vaccine the pt had SOB, & a skin eruption on the surface of the R arm, (the vaccine was given in the L arm). The next day her tongue had anesthesias, which still exist, but, now the anesthesias are more toward the back of her tongue instead of the tip. She also started getting stabbing pain in her neck, both shoulders, L buttock, and also paresthesias in her feet. These have resolved. She has a loss of appetite.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nuclear magnetic resonance imaging brain normal, Ophthalmological examination abnormal, Paraesthesia, Platelet count normal, Rash
Clinical narrative: Within 15 min of receiving the H1N1 vaccine the pt had SOB, & a skin eruption on the surface of the R arm, (the vaccine was given in the L arm). The next day her tongue had anesthesias, which still exist, but, now the anesthesias are more toward the back of her tongue instead of the tip. She also started getting stabbing pain in her neck, both shoulders, L buttock, and also paresthesias in her feet. These have resolved. She has a loss of appetite.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Red blood cell sedimentation rate normal, Vitamin B12 normal, Vitamin D, White blood cell count normal
Clinical narrative: Within 15 min of receiving the H1N1 vaccine the pt had SOB, & a skin eruption on the surface of the R arm, (the vaccine was given in the L arm). The next day her tongue had anesthesias, which still exist, but, now the anesthesias are more toward the back of her tongue instead of the tip. She also started getting stabbing pain in her neck, both shoulders, L buttock, and also paresthesias in her feet. These have resolved. She has a loss of appetite.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Local, confluent, erythemic, itchy, raised area confined to upper, left arm/deltoid.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, FLUN(H1N1), HEP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Foster parents brought child in for physical, immunizations. H1N1 requested, not on immunization record foster parent had, did not see on back of immunization sheet in chart. Also, KINRIX used in error.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right arm with 14 cm X 13 1/2 cm erythema and warm to touch.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Anorectal disorder, Blood sodium decreased, Congenital anomaly, Drug exposure during pregnancy, Hydrocephalus
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a pregnancy Registry product. It was reported that on 30-AUG-2006, a male baby born on 10-MAY-2007 (birth weight 7 pounds 10 ounces) was exposed in utero to a dose of VARIVAX (Merck) (Lot #652664/1033R) and MMR II. The nurse reported that the baby was born 2 weeks early. The baby was born without a rectum. The baby then had hyposodiumia secondary to surgery so he was in the ICU for 1 week. Slight hydrocephaly was noted, along with auto temp regulation problems. During pregnancy, it was noted that the mother had high stress. She is a single mother G4P3 prior to delivery. She was in school and worked. Infidelity with husband was noted. No other medications were used during this pregnancy. Anorectal disorder and hydrocephaly were considered to be congenital anomalies. The mother's experience has been captured in WAES0610USA10729. No additional information is expected. This information was originally reported in WAES0610USA10729 which was sent on 16-AUG-2007.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Intensive care, Surgery, Temperature regulation disorder
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a pregnancy Registry product. It was reported that on 30-AUG-2006, a male baby born on 10-MAY-2007 (birth weight 7 pounds 10 ounces) was exposed in utero to a dose of VARIVAX (Merck) (Lot #652664/1033R) and MMR II. The nurse reported that the baby was born 2 weeks early. The baby was born without a rectum. The baby then had hyposodiumia secondary to surgery so he was in the ICU for 1 week. Slight hydrocephaly was noted, along with auto temp regulation problems. During pregnancy, it was noted that the mother had high stress. She is a single mother G4P3 prior to delivery. She was in school and worked. Infidelity with husband was noted. No other medications were used during this pregnancy. Anorectal disorder and hydrocephaly were considered to be congenital anomalies. The mother's experience has been captured in WAES0610USA10729. No additional information is expected. This information was originally reported in WAES0610USA10729 which was sent on 16-AUG-2007.
Age: 91.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Death, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Patient received H1N1virus shot late AM 11-20-2009. On the way home she was tired, near lunch I gave her peaches & a little soup. Heart rate high, dizzy, short of breath, paleness, weakness went in & laid down. Got up & went to bathroom & died.
Age: 91.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Heart rate increased, Pallor
Clinical narrative: Patient received H1N1virus shot late AM 11-20-2009. On the way home she was tired, near lunch I gave her peaches & a little soup. Heart rate high, dizzy, short of breath, paleness, weakness went in & laid down. Got up & went to bathroom & died.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Blood human chorionic gonadotropin positive, Caesarean section, Drug exposure during pregnancy
Clinical narrative: Information has been received from a physician's assistant for the merck pregnancy registry, concerning a 18 year old female who on 04-MAR-2008 was vaccinated IM with a 0.5 ml dose of GARDASIL (lot# 659441/1446U). It was reported that the patient now is pregnant. Medical attention was sought via office visit. The patient's outcome is unknown. Follow-up information was received from an Office Worker who reported that the patient received on 17-APR-2008 a dose of GARDASIL (previously reported as 04-MAR-2008) and had a pregnancy test done, the reporter stated "she had a positive hCG (serum beta-human chorionic gonadotropin) that day". Follow-up information was received from the Medical Assistant who reported that the patient had a Cesarean Section on 24-NOV-2008 but did not know the indication for the Cesarean. It was reported that there were no prenatal complications. The Medical Assistant added that the patient never returned to the office for her 2 week post-operatory check up nor her 6 week post-operatory check. The last time the patient was seen in their office was on 18-NOV-2009 (as reported), prior to the Cesarean. The Medical Assistant was unable to provide any information about the baby. Upon internal review, cesarean section was considered an other important medical event. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: FLU(H1N1), PPV
Symptoms: Chills, Hypotension, Night sweats
Clinical narrative: 3 days of night sweats/chills/hypotension.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh red and swollen
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient received injection SQ in left arm on 3/25. Injection site was a little itchy and tender but no redness.  On 3/26, injection site had a large, firm, red area about an inch in size. No pain, a little itch. On 3/27, the area was much larger. Firm red center about 1 inch in size, with fainter red circle extending 6 inches in diameter. Area is slightly swollen, firm and warm to touch. No pain but discomfort because skin "feels tight" and is itchy. No signs of blister, rash, streaking of redness, or discharge. Pt reports rest of arm feels fine and works fine. No rash elsewhere. No fever. No other symptoms or complaints. Patient told to manage with compresses, oral and topical Benadryl. Call if worsens, fever develops, blistering, red streaks on arm. Checked on patient 3/29, arm seems to be improving. Red area is still warm and firm to touch but is smaller than yesterday. More itchy, though.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Skin tightness
Clinical narrative: Patient received injection SQ in left arm on 3/25. Injection site was a little itchy and tender but no redness.  On 3/26, injection site had a large, firm, red area about an inch in size. No pain, a little itch. On 3/27, the area was much larger. Firm red center about 1 inch in size, with fainter red circle extending 6 inches in diameter. Area is slightly swollen, firm and warm to touch. No pain but discomfort because skin "feels tight" and is itchy. No signs of blister, rash, streaking of redness, or discharge. Pt reports rest of arm feels fine and works fine. No rash elsewhere. No fever. No other symptoms or complaints. Patient told to manage with compresses, oral and topical Benadryl. Call if worsens, fever develops, blistering, red streaks on arm. Checked on patient 3/29, arm seems to be improving. Red area is still warm and firm to touch but is smaller than yesterday. More itchy, though.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, Injection site anaesthesia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain, numbness and swelling at the injection site. Second day: hot red area of about 3 inches developed below the injection site. More severe swelling and pain followed. The muscle became hard. Is not getting better after three days. More red blotches developed below the injection site that were not connected to the original redness.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Pain, numbness and swelling at the injection site. Second day: hot red area of about 3 inches developed below the injection site. More severe swelling and pain followed. The muscle became hard. Is not getting better after three days. More red blotches developed below the injection site that were not connected to the original redness.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Right thigh where she received vaccinations looked very red and swollen (itchy but does not hurt).
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm at injection site seems to be red and swollen
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site looked red and swollen and hot to touch left arm
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Neuropathy peripheral, X-ray
Clinical narrative: Pain at local injection site, followed by persistent neuropathy in left arm/shoulder for 2 months afterwards.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: + non blanching erythematous patch with spotting darker erythema in center about 3cm x 5 cm diameter in left arm. Warm to touch. Treated with KEFLEX 250/s 1 1/2 tsp PO BID X 10  days.
Age: 1.14
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 1 day after vaccination, patient had erythema and induration at vaccination site. No tenderness, no warmth, no d/c or other lesion, no systemic involvement.
Age: 18.0
Sex: M
Vaccine: DTP, MNQ
Symptoms: Axillary pain, Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site swelling, Injection site warmth
Clinical narrative: Received DTaP in (L) arm 3/23/2010. Onset of (L) arm swelling (L) axillary swelling and pain started that evening and continued to worsen x 36 hours. On exam 3/26/2010 - (L) shoulder noticeably swollen and hot (no red) axilla swollen with enlarging lymph nodes. Pain described as troubling and keeping him from sleeping/moving arm.
Age: 18.0
Sex: M
Vaccine: DTP, MNQ
Symptoms: Lymphadenopathy, Oedema peripheral, Sleep disorder, Swelling
Clinical narrative: Received DTaP in (L) arm 3/23/2010. Onset of (L) arm swelling (L) axillary swelling and pain started that evening and continued to worsen x 36 hours. On exam 3/26/2010 - (L) shoulder noticeably swollen and hot (no red) axilla swollen with enlarging lymph nodes. Pain described as troubling and keeping him from sleeping/moving arm.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Hives began on arms about 8 hrs after receiving Hep A vaccine. Hives spread to chest, abdomen, neck & back. No respiratory issues. TX with BENADRYL.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Contusion, Gingival pain, Gingival swelling, Oral pain, Pain in jaw
Clinical narrative: Started to take capsules on 03/04/2010. 3/19/2010 the client informed me of the problems he had while taking the oral TYPHOID capsules. The day after taking first capsule client reports he noted some soreness in his gums and behind his teeth on the left side. He continued taking the capsules, 03/06/2010, after the second capsule he noted increased pain, swelling, and a bruise on his gums. On 03/08/2010, client had taken the third dose and later he saw his dentist, who noted: teeth #10,11, 12 "tissue swollen and bruised, very sore, swelling mostly between #11 and 12 lingual". On 03/10/2010 client took the fourth and last dose. The pain, swelling, tenderness was more generalized through the upper and lower jaw, teeth and gums. On 03/11/2010 client saw the dentist again "more areas tender, puffy and itchy" and was given the attached note to make an appointment with dentist if the symptoms continued. On 03/19/2010 client reported to me the problems he had and that the symptoms continued to increase then on 03/13/2010 the symptoms started to subside and by 03/19/2010 the symptoms were almost gone.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Pruritus, Tenderness, Toothache
Clinical narrative: Started to take capsules on 03/04/2010. 3/19/2010 the client informed me of the problems he had while taking the oral TYPHOID capsules. The day after taking first capsule client reports he noted some soreness in his gums and behind his teeth on the left side. He continued taking the capsules, 03/06/2010, after the second capsule he noted increased pain, swelling, and a bruise on his gums. On 03/08/2010, client had taken the third dose and later he saw his dentist, who noted: teeth #10,11, 12 "tissue swollen and bruised, very sore, swelling mostly between #11 and 12 lingual". On 03/10/2010 client took the fourth and last dose. The pain, swelling, tenderness was more generalized through the upper and lower jaw, teeth and gums. On 03/11/2010 client saw the dentist again "more areas tender, puffy and itchy" and was given the attached note to make an appointment with dentist if the symptoms continued. On 03/19/2010 client reported to me the problems he had and that the symptoms continued to increase then on 03/13/2010 the symptoms started to subside and by 03/19/2010 the symptoms were almost gone.
Age: 8.0
Sex: F
Vaccine: VARCEL
Clinical narrative: Patient broke out in a chicken pox-like rash on 3/25/2010. She had received VARIVAX on 3/19/10.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood culture, Chest X-ray, Computerised tomogram, Convulsion, Electroencephalogram
Clinical narrative: 6 hours after 4 month-old vaccines (incl. Hep B, PENTACEL, PREVNAR, oral ROTATEK), baby had fever and a 20 minute-long generalized seizure. Taken to the emergency and required x2 ATIVAN IV dose. Transferred to PICU after full work up.