chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MMR, MNQ, TD, TDAP, VARCEL, HPV4, MNQ
Symptoms: White blood cell count increased
Clinical narrative: 07-08-2009 Patient came home with chills and fever; started vomiting during night. Fever was up to 103.5. Also had lower back pain and headache. Vomiting and fever continued and went to Dr. on 7-10-2009 and was diagnosed with viral illness and started on antibiotic and compazine. Was admitted to Hospital later that day because of elevated WBC, and was diagnosed with Kidney infection, Sepsis and Disseminated Vascular Deterioration. Was in hospital for 5 days.  7/22/09 Hospital records received DOS 7/11/09 to 7/15/09. Final Diagnoses: Pyelonephritis, Disseminated intravascular coagulation, Hypokalemia, Thrombocytopenia, Acute anemia due to disseminated intravascular coagulation. Patient presented with fever and persistent vomiting. Generalized pain back and neck. Abdominal tenderness and right constovertebral angle tenderness. Heart rate 120. Pharyngeal erythema. Decreased urinary flow. Blood per rectum, vaginal bleeding, nosebleeds.  7/24/09 ICD-9 Codes: 590.80  286.6  287.5  276.8  285.9
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MMR, MNQ, TD, TDAP, VARCEL, HPV4, MNQ
Symptoms: Abdominal pain upper, Autoimmune disorder, Bacterial test positive, Body temperature increased, Chills
Clinical narrative: 07-08-2009 Patient came home with chills and fever; started vomiting during night. Fever was up to 103.5. Also had lower back pain and headache. Vomiting and fever continued and went to Dr. on 7-10-2009 and was diagnosed with viral illness and started on antibiotic and compazine. Was admitted to Hospital later that day because of elevated WBC, and was diagnosed with Kidney infection, Sepsis and Disseminated Vascular Deterioration. Was in hospital for 5 days.  7/22/09 Hospital records received DOS 7/11/09 to 7/15/09. Final Diagnoses: Pyelonephritis, Disseminated intravascular coagulation, Hypokalemia, Thrombocytopenia, Acute anemia due to disseminated intravascular coagulation. Patient presented with fever and persistent vomiting. Generalized pain back and neck. Abdominal tenderness and right constovertebral angle tenderness. Heart rate 120. Pharyngeal erythema. Decreased urinary flow. Blood per rectum, vaginal bleeding, nosebleeds.  7/24/09 ICD-9 Codes: 590.80  286.6  287.5  276.8  285.9
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MMR, MNQ, TD, TDAP, VARCEL, HPV4, MNQ
Symptoms: Cystitis, Disseminated intravascular coagulation, Escherichia sepsis, Incorrect route of drug administration, Injection site pain
Clinical narrative: 07-08-2009 Patient came home with chills and fever; started vomiting during night. Fever was up to 103.5. Also had lower back pain and headache. Vomiting and fever continued and went to Dr. on 7-10-2009 and was diagnosed with viral illness and started on antibiotic and compazine. Was admitted to Hospital later that day because of elevated WBC, and was diagnosed with Kidney infection, Sepsis and Disseminated Vascular Deterioration. Was in hospital for 5 days.  7/22/09 Hospital records received DOS 7/11/09 to 7/15/09. Final Diagnoses: Pyelonephritis, Disseminated intravascular coagulation, Hypokalemia, Thrombocytopenia, Acute anemia due to disseminated intravascular coagulation. Patient presented with fever and persistent vomiting. Generalized pain back and neck. Abdominal tenderness and right constovertebral angle tenderness. Heart rate 120. Pharyngeal erythema. Decreased urinary flow. Blood per rectum, vaginal bleeding, nosebleeds.  7/24/09 ICD-9 Codes: 590.80  286.6  287.5  276.8  285.9
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MMR, MNQ, TD, TDAP, VARCEL, HPV4, MNQ
Symptoms: Kidney infection, Malaise, Nausea, Platelet count decreased, Pyrexia
Clinical narrative: 07-08-2009 Patient came home with chills and fever; started vomiting during night. Fever was up to 103.5. Also had lower back pain and headache. Vomiting and fever continued and went to Dr. on 7-10-2009 and was diagnosed with viral illness and started on antibiotic and compazine. Was admitted to Hospital later that day because of elevated WBC, and was diagnosed with Kidney infection, Sepsis and Disseminated Vascular Deterioration. Was in hospital for 5 days.  7/22/09 Hospital records received DOS 7/11/09 to 7/15/09. Final Diagnoses: Pyelonephritis, Disseminated intravascular coagulation, Hypokalemia, Thrombocytopenia, Acute anemia due to disseminated intravascular coagulation. Patient presented with fever and persistent vomiting. Generalized pain back and neck. Abdominal tenderness and right constovertebral angle tenderness. Heart rate 120. Pharyngeal erythema. Decreased urinary flow. Blood per rectum, vaginal bleeding, nosebleeds.  7/24/09 ICD-9 Codes: 590.80  286.6  287.5  276.8  285.9
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MMR, MNQ, TD, TDAP, VARCEL, HPV4, MNQ
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: 07-08-2009 Patient came home with chills and fever; started vomiting during night. Fever was up to 103.5. Also had lower back pain and headache. Vomiting and fever continued and went to Dr. on 7-10-2009 and was diagnosed with viral illness and started on antibiotic and compazine. Was admitted to Hospital later that day because of elevated WBC, and was diagnosed with Kidney infection, Sepsis and Disseminated Vascular Deterioration. Was in hospital for 5 days.  7/22/09 Hospital records received DOS 7/11/09 to 7/15/09. Final Diagnoses: Pyelonephritis, Disseminated intravascular coagulation, Hypokalemia, Thrombocytopenia, Acute anemia due to disseminated intravascular coagulation. Patient presented with fever and persistent vomiting. Generalized pain back and neck. Abdominal tenderness and right constovertebral angle tenderness. Heart rate 120. Pharyngeal erythema. Decreased urinary flow. Blood per rectum, vaginal bleeding, nosebleeds.  7/24/09 ICD-9 Codes: 590.80  286.6  287.5  276.8  285.9
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Arm swelling, redness, pain, itching
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: 2 X 3 inch reddened area on left arm. C/O itching
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right arm swollen at sight of injection with redness and pain
Age: 59.0
Sex: F
Vaccine: DTP
Symptoms: Erythema, Pain, Pruritus, Rash erythematous, Rash papular
Clinical narrative: EXTENSIVE REEDNESS AND PAIN BEGINNING THE DAY AFTER THE SHO PERSISTING OVER HEREE WEEKS.  iTCHING BEGAN 5 OR 6 DAYS AFTER THE VACCINE RESULTING IN A RASH SHORTLY THEREAFTER WITH SMALL ERYTHEMATOUS APULES AND OCC VESSICLES
Age: 59.0
Sex: F
Vaccine: DTP
Symptoms: Rash vesicular
Clinical narrative: EXTENSIVE REEDNESS AND PAIN BEGINNING THE DAY AFTER THE SHO PERSISTING OVER HEREE WEEKS.  iTCHING BEGAN 5 OR 6 DAYS AFTER THE VACCINE RESULTING IN A RASH SHORTLY THEREAFTER WITH SMALL ERYTHEMATOUS APULES AND OCC VESSICLES
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Received Varivax and had a local reaction at the site approximately 11.5 cm wide by 12.5 cm high   Seen by pcp  no treatment except for Tylenol for pain if needed
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Skin irritation
Clinical narrative: redness streaks from scratching irritation from adhesive bandaide
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site macule, Injection site swelling, Pallor
Clinical narrative: On 7/8/09 patient received following vaccinations:  L leg - IPV and Varicella.   R leg - MMR and DTaP.  Grandma reported that the evening after vaccination patient began having localize swelling.  I saw patient in clinic on 7/10/09 for large localized swelling at the vaccine sites.  On L leg at vaccine injection sites, he had a 10x14cm region of erythema and swelling with some induration, slightly pale skin circumferentially but not tender to touch.  On R leg he had a 3x4cm of swelling at one vaccine site, small red macule at other vaccine site.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Received Varivax on 7/13/09 on 7/14 at injection site a mild erythemia appeared as approximately 4cm circle.   no treatment needed
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Chest X-ray normal, Full blood count normal, Pyrexia
Clinical narrative: Mother called office at 8:30 am on 7-15-09 reported that her daughter had fever of 104 F that morning (approx 24 hours after vaccines).  Mother gave tylenol and temp came down to 102 F. Mother advised to call pt's PCP or go to ER ASAP.  Mother unable to reach PCP.  Mother took child to local ER and was told that she probably had a reaction to vaccines.  Pt was discharged to home. At 4:00pm child developed fever of 105 F.  No other s/s reported.  Mother took child back to ER and had infection ruled out.  Child had lab drawn, chest x-ray, throat culture, etc.  Called mom this afternoon (7-16-09) she reports that pt feeling better and work-up on pt came back negative.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was vaccinated on July 14, 2009, Developed reaction with in 12 hours of vaccines given, Meningococcal IM left deltoid muscle and Varicella SQ given to left deltoid (outer lateral). Has redness, swelling and pain to left deltoid area lateral area.  Was seen by Pediatrician June 16, 2009, was prescribed Medication topical Hydrocortison 1% w/ lidocaine to apply to affected area for 7 - 10 days. and Atarax 10mg PO Prn. patient to F/U in one week or sooner if need to.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Mumps titer came back too low on 5/27/09.6/12/09 I received the first of a two-part series MMR vacination. 6/15/09 I noticed a raised,red,hard,warm,itchy area on my arm where I was given the vacine. Over the course of a week the red,hard spot disappeared. 7/14/09 I received the second dose of the MMR vacine at approximately 1200pm. 7//15/09 at 1500 I noticed that my arm itched and realized that was where I received the vacine. My arm also was warm,red,raised,hard and itchy. Spoke with employee health nurse and she advised me to fill out this form and to use a topical hydrocorticone to releive the symptoms.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Back pain, Chest discomfort, Dizziness, Electrocardiogram normal
Clinical narrative: Approx 2 minutes after pneumococcal vaccine at 1125 a.m., pt c/o dizziness. Pt's face turned red. Pt c/o chest tightness and back pain 11/10. Doctor notified. New orders received. 25 mg Benadryl IV and 4 mg morphine IV given. Stat EKG done. Pain, flushing and dizziness lessened in 15 minutes to 5/10 back pain. Pain in R abd around to back reported around 1215 at 4/10. At 1300 Pt reported R abd pain 2/10.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Approx 2 minutes after pneumococcal vaccine at 1125 a.m., pt c/o dizziness. Pt's face turned red. Pt c/o chest tightness and back pain 11/10. Doctor notified. New orders received. 25 mg Benadryl IV and 4 mg morphine IV given. Stat EKG done. Pain, flushing and dizziness lessened in 15 minutes to 5/10 back pain. Pain in R abd around to back reported around 1215 at 4/10. At 1300 Pt reported R abd pain 2/10.
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Nausea
Clinical narrative: fever, chills, shakiness, nausea, joing pain, overall teirdness/feeling of sickness
Age: 36.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Tremor
Clinical narrative: fever, chills, shakiness, nausea, joing pain, overall teirdness/feeling of sickness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Dizziness and profuse sweating for approximately 20 minutes
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus, Pyrexia
Clinical narrative: Pt received vaccine on Mon 7/13/09. Pt called on 7/16 saying that Tues afternoon after playing golf she noticed her arm was swollen, red, itchy, , had fever of 102 degrees. Took ADVIL says she's OK just wanted to notify me b/c  I asked her to if any SX.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Back pain, Dyspnoea, Hypokinesia, Injection site pain
Clinical narrative: Pt received GARDASIL #2 on 7/10/09.  No complaints at visit.  Phone call to clinic Mon 7/13/09 08:10am.  Pt reported to RN pains swelling and unable to move (L) arm, neck (L) side, pain to back area since 7/11/09 sat.  Appt @ clinic 7/14/09 Pt states also felt short of breath sat 7/11/09 along with pain back, neck, arm.  Shortness of breath went away, + weakness + pain (L) arm + (L) neck.  No edema no erythema.  Recommended ibuprofen 600g massage, heat.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Pain in extremity, Swelling
Clinical narrative: Pt received GARDASIL #2 on 7/10/09.  No complaints at visit.  Phone call to clinic Mon 7/13/09 08:10am.  Pt reported to RN pains swelling and unable to move (L) arm, neck (L) side, pain to back area since 7/11/09 sat.  Appt @ clinic 7/14/09 Pt states also felt short of breath sat 7/11/09 along with pain back, neck, arm.  Shortness of breath went away, + weakness + pain (L) arm + (L) neck.  No edema no erythema.  Recommended ibuprofen 600g massage, heat.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia, Rash, Urine analysis normal
Clinical narrative: June 16th onset of fever and child complaining of pain taken to doctors. June 20th taken to ER for high fever 103.7 and examined. Illness continued. June 22nd appearance of rash on face, back, shoulders, stomach. Child still complaining of pain. Another visit to doctor on June 25th. Child still complaining of occasional pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area surrounding injection site reddened, tender to touch and slight swelling
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Wrong drug administered
Clinical narrative: None Known
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diet refusal, Dyskinesia, Hyperreflexia, Irritability, Pallor
Clinical narrative: Increased "startle reflex" every few seconds X 30 min sticking tongue out and increased salivation. Fussy and pale. Refusing to eat. As reported by parent
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Salivary hypersecretion
Clinical narrative: Increased "startle reflex" every few seconds X 30 min sticking tongue out and increased salivation. Fussy and pale. Refusing to eat. As reported by parent
Age: 1.2
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Urticaria, Viral rash
Clinical narrative: MOC brought child to clinic 7 days after shots she had viral exanthem & hives.  Present to allergist for final dx & recommendation.
Age: 28.0
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Cardiac enzymes normal, Chest pain, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: 28 y/o male ADSM is referred from a research site with c/o recent diarrhea, decreased appetite, dehydration and chest pain. Symptoms: Dizziness, chest pain, diarrhea, fatigue, malaise <60 days.
Age: 28.0
Sex: M
Vaccine: HEPAB, SMALL, TYP
Symptoms: Dizziness, Fatigue, Full blood count normal, Laboratory test normal, Malaise
Clinical narrative: 28 y/o male ADSM is referred from a research site with c/o recent diarrhea, decreased appetite, dehydration and chest pain. Symptoms: Dizziness, chest pain, diarrhea, fatigue, malaise <60 days.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count, Lymphocyte percentage increased, Rash macular, Viral upper respiratory tract infection
Clinical narrative: Pt with macular rash on trunk - antihistamine - steroid injection  40mg DEPOMEDROL - 2mg DECADRON IM
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Acne, Erythema, Eyelid oedema, Headache, Influenza like illness
Clinical narrative: I was given the shingles vaccination as part of my physical examination - recommended. It was administered along with the pneumonia vaccination - one in each arm. I have never had the chicken pox to the best of my knowledge. The doctor said they could conduct a test to determine if I did or did not have the chicken pox, but either way he advised I receive the vaccine. Four days after the injection I had a few pimples on my face, my left eyelid swelled and was very red and my left cheek became swollen. No other marks. I had headaches almost daily, ached like the flu virus - particularly back, spine & neck - and had little stamina/endurance. My face cleared up completely in about 10 days. The aching continued and it took about 6 weeks before I felt fully recovered.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Swelling face
Clinical narrative: I was given the shingles vaccination as part of my physical examination - recommended. It was administered along with the pneumonia vaccination - one in each arm. I have never had the chicken pox to the best of my knowledge. The doctor said they could conduct a test to determine if I did or did not have the chicken pox, but either way he advised I receive the vaccine. Four days after the injection I had a few pimples on my face, my left eyelid swelled and was very red and my left cheek became swollen. No other marks. I had headaches almost daily, ached like the flu virus - particularly back, spine & neck - and had little stamina/endurance. My face cleared up completely in about 10 days. The aching continued and it took about 6 weeks before I felt fully recovered.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Pt was given TDAP and VARIVAX vaccines on 6/26/09. Reports that on 6/27/09, she began to have body aches, low grade temp up to 99.8 and neck gland swelling. Pt reports that symptoms lasted 3 days and then improved. Pt denies any redness, swelling or warmth at either injection sites. Pt reports that she had been taking MOTRIN and Hall throat lozenges with good relief of symptoms. Advised pt to call back if symptoms persisted or worsened; pt agreed. No further contact from pt.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site urticaria
Clinical narrative: Immediately after giving vaccines - VARIVAX, in right arm subcutaneously deltoid area, patient developed urticaria at injection site, had itching.  Benadryl 25 mg PO given.  Urticarial rash resolved within 20 min.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: 24 hrs after injection outer aspect of (R) arm from deltoid to just above elbow red, warm and swollen
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: Red & swollen at injection site.  Ice packs & ibuprofen as treatment.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Mom states hot, red and painful induration larger than the "palm of her hand"
Age: 64.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site pain, Oedema peripheral, Pruritus, Rash
Clinical narrative: Pt. called on 7/16/09 self reported event. Stated she thinks she had a reaction to the PNEUMOVAX vaccine. she had swelling under her arm, soreness at injection site - Small rash - States is better now - Took BENADRYL - Still has some itching - Denies any respiratory distress at any time with this.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea, Vomiting
Clinical narrative: '15min episode of nausea then vomiting about 10 - 15min after receiving HAVRIX
Age: 17.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Swelling around injection sight, erythema and hives just distal to shot sight.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of left upper arm and elbow.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Injection site pain, Injection site swelling, Injection site warmth, Nuclear magnetic resonance imaging
Clinical narrative: Friday after injection arm became extremely swollen & painful.  Saturday was started on PREONISONE.  Monday swelling decreasing also taking NAPROXEN.  Twice daily saw doctor on Monday swelling mild & mild pain in area.  7/8/09 Saw MD.  NAPROXEN continue pain present yet, warm to touch.  Some swelling (mild) start on DARVOCET stop NAPROXEN.  7/13 arm pain unchanged 7/13 - Patient admitted to hospital for unrelated issue seen by neurology & rhumetalogy; given FENTEYL for discomfort in arm.  Then 7/15 switched pain med to DILAUDID and MRI ordered.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan
Clinical narrative: Friday after injection arm became extremely swollen & painful.  Saturday was started on PREONISONE.  Monday swelling decreasing also taking NAPROXEN.  Twice daily saw doctor on Monday swelling mild & mild pain in area.  7/8/09 Saw MD.  NAPROXEN continue pain present yet, warm to touch.  Some swelling (mild) start on DARVOCET stop NAPROXEN.  7/13 arm pain unchanged 7/13 - Patient admitted to hospital for unrelated issue seen by neurology & rhumetalogy; given FENTEYL for discomfort in arm.  Then 7/15 switched pain med to DILAUDID and MRI ordered.
Age: 46.0
Sex: M
Vaccine: YF
Symptoms: Abdominal pain, Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase decreased
Clinical narrative: A 46-year-old male, with no illness at the time of vaccination, received a first dose of YF-VAX (Lot number UF30AA; route/site of administration not reported) on 10 July 2008. Two days later, the patient developed severe mid gastric abdominal pain. The patient was evaluated in the emergency room but was not admitted to the hospital. At the time of the report, the patient continued to complain of n, which he descried as right upper quadrant pain. follow up information was received on 11 August 2008 from a health care professional. The patient received a first dose of YF-VAX (Lot number UF340AA) subcutaneously in the left deltoid on 08 July 2008 (previously reported as 10 July 2008). The patient's date of birth was amended to 23 May1962 (previously reported as 23 March 1962). The patient had a ALT value of 171 on 12 July 2008. On 15 July 2008 her ALT value was 100 with a significant decrease in RUQ pain. No other labs were performed. There was no definitive diagnosis made other than abdominal pain. The patient had fully recovered from the events. Follow up information was received on 29 August 2008 from a health care professional. The patient's final diagnosis was abdominal pain with an unknown etiology. There was no treatment provided. The patient dose not have a prior history of abdominal pain. The patient's abdominal pain resolved after one week.
Age: 22.0
Sex: M
Vaccine: YF
Symptoms: Chills, Irritability, Pain, Pyrexia
Clinical narrative: Initial information was received on 03 December 2008 from a health care professional. A 22 year old male patient received a right arm subcutaneous injection of YF-VAX (lot number UF427AA) on 26 November 2008 at 1:15 pm. On 28 November 2008 at 10:00 pm the patient developed aches, chills, a fever and irritability. The recovery status was unknown. No further information was provided. Follow-up information received on 22 January 2009 from a health care professional. Per the reporter, the patient required a doctors visit on 05 December 2008 and was treated with Tylenol and Motrin as needed. At the time of this report, the patient had fully recovered; however a recovery date was not provided. No further information is expected. List of Documents by Sender: None.
Age: 56.0
Sex: M
Vaccine: HEPA, IPV, YF
Symptoms: Cough, Headache, Joint swelling, Mass, Nasal congestion
Clinical narrative: Initial report was received 03 December 2008 from a health care professional. A 56-year-old male patient with no known allergies and no past medical history, had received a subcutaneous left arm injection of VF VAX, lot number UF432AA, and a subcutaneous left arm injection of IPOL, lot number A0836-2, and an intramuscular left deltoid injection of HAVRIX, lot number AHAVB251CA (manufactured by GlaxoSmithKline) on 28 October 2008, and one week later, he developed a cough, nasal congestion, a headache and swelling at the elbow without pain (left or right not specified). The patient was evaluated by their physician, however their recovery status was not reported. The patient had no concurrent illnesses at the time of vaccination and had not been taking any concomitant medications. No additional information was provided. Follow-up information was received 29 December 2008 from a health care professional. The patient had swelling of the left elbow with a five cm diameter lump noted. The patient had been checked by their private medical doctor (PMD) however no relevant laboratory and diagnostic tests were performed and no treatments were prescribed. The patient recovered on 03 December 2008. No further information was provided. Follow-up information received on 24 March 2009 from a health care professional. The patient was reported to have been fine. However, he still had a small mass at his left elbow, which had decreased in size and was not causing him any discomfort. The patient did go on his trip without any problems from the lump. According to the reporter, the patient's physician did not know what caused the lump and couldn't state if it was from the vaccines that he had received. Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Anorexia, Body temperature increased, Erythema, Fatigue, Myalgia
Clinical narrative: This case was received from a health care professional on 09 March 2009. A 29-year-old patient received a subcutaneous left arm injection of YF-Vax (lot number UF430AA) ON 06 March 2009. Within 24 hours of vaccination, she developed an elevated temperature, muscle aches, anorexia, fatigue, and a two-inch area of redness and swelling on the left deltoid. She was seen in the emergency room relevant testing and treatment were not reported.
Age: 29.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Swelling
Clinical narrative: This case was received from a health care professional on 09 March 2009. A 29-year-old patient received a subcutaneous left arm injection of YF-Vax (lot number UF430AA) ON 06 March 2009. Within 24 hours of vaccination, she developed an elevated temperature, muscle aches, anorexia, fatigue, and a two-inch area of redness and swelling on the left deltoid. She was seen in the emergency room relevant testing and treatment were not reported.
Age: 21.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: This non serious case was received on 27 March 2009 from a health care professional.  A 21 year old male patient received IPOL (lot number B0476-2), TYPHIM VI (lot number B0347-2), and YF VAX (lot number UF427A) all intramuscularly on 16 March 2009.  One week post vaccination the patient developed stomach tightness and diarrhea.  No other symptoms were reported.  Recovery status was not reported.  List of Documents held by Sender:  None.
Age: 22.0
Sex: F
Vaccine: IPV, MNQ, YF
Symptoms: Arthralgia, Asthenia, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: This non serious case was received on 24 April 2009 from a health care professional. A 22 year old female patient received IPOL intramuscularly in the right arm (lot number A1218-2), MENACTRA intramuscularly in the right deltoid (lot number U2841BA), and YF VAX subcutaneously in the left arm (lot number UF430AA) on 21 April 2009. On 22 April 2009 the patient developed weakness, aches, joint pain, and a low grade fever. The patient had arm pain when trying to lift a book. At the time of the report the patient was improving. Follow up information was received on 20 May 2009 from a health care professional who clarified that the patient experienced pain in both arms. The patient recovered on 24 April 2009. No further information was reported. List of Documents held by Sender: none.
Age: 22.0
Sex: F
Vaccine: IPV, MNQ, YF
Symptoms: Pyrexia
Clinical narrative: This non serious case was received on 24 April 2009 from a health care professional. A 22 year old female patient received IPOL intramuscularly in the right arm (lot number A1218-2), MENACTRA intramuscularly in the right deltoid (lot number U2841BA), and YF VAX subcutaneously in the left arm (lot number UF430AA) on 21 April 2009. On 22 April 2009 the patient developed weakness, aches, joint pain, and a low grade fever. The patient had arm pain when trying to lift a book. At the time of the report the patient was improving. Follow up information was received on 20 May 2009 from a health care professional who clarified that the patient experienced pain in both arms. The patient recovered on 24 April 2009. No further information was reported. List of Documents held by Sender: none.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Pyrexia
Clinical narrative: Information has been received from an office manager for the pregnancy registry for GARDASIL concerning a 20 year old female with no medical history and no known allergies who on 28-FEB-2008 was vaccinated with the second dose of GARDASIL (Lot # 655327/1287U).  There was no concomitant medication.  The reporter indicated that the patient was pregnant with an expected due date of 02-DEC-2008.  Unknown medical attention was sought in the office.  Patient outcome was unknown.  No product quality complaint was involved.  Follow up information received from a nurse revealed that the patient had a spontaneous vaginal birth on 25-NOV-2008 and delivered a healthy, normal, female weighing 7 pounds and 4 ounces.  There were no prenatal complications.  The only additional note was that of "maternal fever" in labor, with no further explanatory information.  The patient was seen for her post partum visit and was fine.  No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Induration, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Information has been received from a physician concerning a 13-year-old female with no medical history or allergies who on 14-OCT-2008 was vaccinated with the first dose of GARDASIL (Lot# 661044/0548X) 0.5ml. There were no concomitant medications. Patient didn't experience an AE after first dose. On 16-DEC-2008 the patient received the second dose of GARDASIL (Lot# 661764/0650X) 0.5ml. Subsequently, the patient developed pain at the injection site. The patient was recovered in January 2009. Additional information provided from a nurse indicated that the patient received her first dose of GARDASIL (Lot# 661044/0548X) 0.5ml on 14-OCT-2008. Following that injection she experienced "soreness to the touch" for 2 months (injection site reaction). The patient received her second dose of GARDASIL (Lot# 661764/0650X) 0.5ml on 17-DEC-2008. Right after the injection the patient experienced "shooting pains from the injection site to her fingertips". This had continued for several months. The patient was currently stating that the "shooting pain" has resolved, but she is not able to keep her arm raised because it bothers her. "It feels weird." The example the nurse provided is "she can not keep her arm raised while she is in school." The patient had sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injected limb mobility decreased, Injection site pain, No reaction on previous exposure to drug, Pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 13-year-old female with no medical history or allergies who on 14-OCT-2008 was vaccinated with the first dose of GARDASIL (Lot# 661044/0548X) 0.5ml. There were no concomitant medications. Patient didn't experience an AE after first dose. On 16-DEC-2008 the patient received the second dose of GARDASIL (Lot# 661764/0650X) 0.5ml. Subsequently, the patient developed pain at the injection site. The patient was recovered in January 2009. Additional information provided from a nurse indicated that the patient received her first dose of GARDASIL (Lot# 661044/0548X) 0.5ml on 14-OCT-2008. Following that injection she experienced "soreness to the touch" for 2 months (injection site reaction). The patient received her second dose of GARDASIL (Lot# 661764/0650X) 0.5ml on 17-DEC-2008. Right after the injection the patient experienced "shooting pains from the injection site to her fingertips". This had continued for several months. The patient was currently stating that the "shooting pain" has resolved, but she is not able to keep her arm raised because it bothers her. "It feels weird." The example the nurse provided is "she can not keep her arm raised while she is in school." The patient had sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Face and mouth X-ray, Facial bones fracture, Fall, Syncope
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.  It has been received from a physician concerning a 13 year old female with none preexisting illness who on 17-APR-2009 was vaccinated intramuscularly into the left arm with the second 0.5ml dose of GARDASIL (lot # 661846/1312X).  Concomitant therapy included the first dose of MENACTRA (Lot # U2877AA), given intramuscularly into the right arm,  Post vaccines administration the patient experienced a syncope, fell and fractured nose during syncope event (hit office counter during fall).  On an unspecified date a X-ray of nasal bones was performed (results not provided).  The listing indicates that one or more of the events required ER visit.  At the time of the report, the patient had recovered.  The VAERS ID # 344486.  In follow-up received 22-JUN-2009, a physician reported that "a few months ago", when a 15 year old female was given 0.5 ml dose of GARDASIL, the child passed out and fell face first resulting in a broken nose.  The patient was brought to an unspecified hospital but was not admitted.  An x-ray was performed (results not reported).  On an unspecified date, the patient recovered.  The doctor reported this to VAERS back when it happened.  The doctor does not wish to be contacted about this adverse experience.  This is a consolidation of two reports concerning the same patient.  No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Facial bones fracture, Fall, Loss of consciousness, Syncope, X-ray
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.  It has been received from a physician concerning a 13 year old female with none preexisting illness who on 17-APR-2009 was vaccinated intramuscularly into the left arm with the second 0.5ml dose of GARDASIL (lot # 661846/1312X).  Concomitant therapy included the first dose of MENACTRA (Lot # U2877AA), given intramuscularly into the right arm,  Post vaccines administration the patient experienced a syncope, fell and fractured nose during syncope event (hit office counter during fall).  On an unspecified date a X-ray of nasal bones was performed (results not provided).  The listing indicates that one or more of the events required ER visit.  At the time of the report, the patient had recovered.  The VAERS ID # 344486.  In follow-up received 22-JUN-2009, a physician reported that "a few months ago", when a 15 year old female was given 0.5 ml dose of GARDASIL, the child passed out and fell face first resulting in a broken nose.  The patient was brought to an unspecified hospital but was not admitted.  An x-ray was performed (results not reported).  On an unspecified date, the patient recovered.  The doctor reported this to VAERS back when it happened.  The doctor does not wish to be contacted about this adverse experience.  This is a consolidation of two reports concerning the same patient.  No further information is available.
Age: 19.0
Sex: F
Vaccine: HEP, HPV4, HPV4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with drug reaction/allergy to SUPRAX who on 24-FEB-2009 as vaccinated with the first dose of GARDASIL (lot # 661703/0651X), intramuscularly. On 29-APR-2009, the patient received the second dose of GARDASIL (lot # 661703/0651X). Concomitant therapy included RECOMBIVAX. On 29-APR-2009 the patient developed a shoulder pain and their arm went numb after receiving her second dose of GARDASIL. The pain disappeared for 2 days and it came back again. The patient had trouble lifting her arm. At the time of reporting, the patient had not recovered. The patient contacted nurse by phone. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HEP, HPV4, HPV4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with drug reaction/allergy to SUPRAX who on 24-FEB-2009 as vaccinated with the first dose of GARDASIL (lot # 661703/0651X), intramuscularly. On 29-APR-2009, the patient received the second dose of GARDASIL (lot # 661703/0651X). Concomitant therapy included RECOMBIVAX. On 29-APR-2009 the patient developed a shoulder pain and their arm went numb after receiving her second dose of GARDASIL. The pain disappeared for 2 days and it came back again. The patient had trouble lifting her arm. At the time of reporting, the patient had not recovered. The patient contacted nurse by phone. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4, MNQ, TDAP, HEP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Nausea, Retching
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., concerning an 18 year old female patient with hypoglycaemia and sulfonamide allergy who on 20-MAY-2009 was vaccinated with the first dose of GARDASIL (lot n. 658271/0558X), intramuscularly in the right arm.  Secondary suspect therapy included the first dose of RECOMBIVAX HB (lot n. 662421/1040X), intramuscularly in the left arm.  Concomitant therapy included BOOSTRIX (lot n. AC52B030AA) and MENACTRA (lot. U2819AA0029).  On 21-MAY-2009, the patient complained of dizziness, nausea and dry heaves.  The symptoms lasted approximately 8 hours.  The patient did not receive any treatment.  The original reporting source was not provided.  The VAERS ID # 347002.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an 18 year old female with no pertinent medical history and no drug reactions or allergies who on 27-MAY-2009 was vaccinated IM with the first dose of GARDASIL (lot # not reported). She also received a dose of MENACTRA and her first dose of HAVRIX. On 27-MAY-2009 about 1/2 hour to 1 hour after the vaccination the patient developed hives. The patient was seen in the office on 01-JUN-2009 for intermittent hives for a week. No lab diagnostics studies were performed. The patient's outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Presyncope, Syncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no pertinent medical history or no known drug allergies, who on 08-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot: 661846/1312X) intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). After vaccination, while checking out she had a "vasovagal response" and passed out. The patient was observed in the office prior to checking out. The patient hit her head in the fall. She was sent to the emergency room for evaluation and was discharged home. The office was going to contact her for follow up. At the time of reporting the patient's status was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Head injury, Loss of consciousness, Presyncope
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no pertinent medical history or no known drug allergies, who on 08-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot: 661846/1312X) intramuscularly. Concomitant therapy included hormonal contraceptives (unspecified). After vaccination, while checking out she had a "vasovagal response" and passed out. The patient was observed in the office prior to checking out. The patient hit her head in the fall. She was sent to the emergency room for evaluation and was discharged home. The office was going to contact her for follow up. At the time of reporting the patient's status was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Deafness bilateral, Hearing aid user
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 23-JAN-2007 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # 653736/0014U), on 29-MAR-2007 was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot # 653736/0868F), and 06-AUG-2007 was vaccinated IM with the third 0.5 mL dose of GARDASIL (lot # 653736/0014U). Concomitant vaccine administered on 21-AUG-2007 included Tdap. It was reported that on an unspecified date, the patient started experiencing hearing problems and was wearing a hearing aid. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hearing aid user, Hearing impaired
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 23-JAN-2007 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # 653736/0014U), on 29-MAR-2007 was vaccinated IM with the second 0.5 mL dose of GARDASIL (lot # 653736/0868F), and 06-AUG-2007 was vaccinated IM with the third 0.5 mL dose of GARDASIL (lot # 653736/0014U). Concomitant vaccine administered on 21-AUG-2007 included Tdap. It was reported that on an unspecified date, the patient started experiencing hearing problems and was wearing a hearing aid. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Fatigue, Gastric disorder, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 21 year old female patient with no medical history or allergies who on 09-APR-2009 received her first and "only" dose (0.5 ml, IM) of GARDASIL (lot # 661953/1130X). There was no concomitant medication. On 09-APR-2009 after the patient was vaccination with GARDASIL the patient experienced upper gastric pain and shortness of breath. The patient also experienced fever and decreased strength. At the time of this report, the patient had recovered. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Asthenia, Dyspnoea, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 21 year old female patient with no medical history or allergies who on 09-APR-2009 received her first and "only" dose (0.5 ml, IM) of GARDASIL (lot # 661953/1130X). There was no concomitant medication. On 09-APR-2009 after the patient was vaccination with GARDASIL the patient experienced upper gastric pain and shortness of breath. The patient also experienced fever and decreased strength. At the time of this report, the patient had recovered. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Blood culture negative, Complement factor C3, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male who on 27-MAY-2009 was vaccinated with ZOSTAVAX (Merck). On 16-JUN-2009, the patient went to an urgent care center, reporting an unspecified rash. The patient was prescribed Prednisone. On 19-JUN-2009, the patient was hospitalized for 2 days for angioedema. The angioedema might have been from the Prednisone. The physician who saw the patient in the hospital though it might also be due to ZOSTAVAX (Merck). On an unknown date, the patient recovered. Follow-up information was received on 13-JUL-2009. The pharmacist reported that the patient was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 664029/0196Y). Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Rash generalised, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male who on 27-MAY-2009 was vaccinated with ZOSTAVAX (Merck). On 16-JUN-2009, the patient went to an urgent care center, reporting an unspecified rash. The patient was prescribed Prednisone. On 19-JUN-2009, the patient was hospitalized for 2 days for angioedema. The angioedema might have been from the Prednisone. The physician who saw the patient in the hospital though it might also be due to ZOSTAVAX (Merck). On an unknown date, the patient recovered. Follow-up information was received on 13-JUL-2009. The pharmacist reported that the patient was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 664029/0196Y). Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARCEL, VARZOS, VARZOS
Symptoms: Angioedema, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male who on 27-MAY-2009 was vaccinated with ZOSTAVAX (Merck). On 16-JUN-2009, the patient went to an urgent care center, reporting an unspecified rash. The patient was prescribed Prednisone. On 19-JUN-2009, the patient was hospitalized for 2 days for angioedema. The angioedema might have been from the Prednisone. The physician who saw the patient in the hospital though it might also be due to ZOSTAVAX (Merck). On an unknown date, the patient recovered. Follow-up information was received on 13-JUL-2009. The pharmacist reported that the patient was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 664029/0196Y). Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 24-JUN-2009 was vaccinated with the third dose of GARDASIL (0.5ml, intramuscular administration, lot# and site of administration not reported). Subsequently the patient experienced redness and soreness around the injection site. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 17 year old female who on 24-JUN-2009 was vaccinated with the third dose of GARDASIL (0.5ml, intramuscular administration, lot# and site of administration not reported). Subsequently the patient experienced redness and soreness around the injection site. Unspecified medical attention was sought. The patient's outcome was unknown. Additional information has been requested.