chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Hypotension, Laboratory test normal, Pallor, Unresponsive to stimuli
Clinical narrative: Hypotensive episode - pallor & unresponsiveness 4 hrs after 1st set of immun on 2/5/09 - labs normal, BP low, fine after.
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, White blood cell count normal
Clinical narrative: R arm pain, redness and swelling.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Pyrexia
Clinical narrative: Mom reported to -us on 6-30-09 that 24 hours after receiving vaccines pt had a fever of 104 for 48 hours.
Age: 33.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Asthenia, Hypoaesthesia, Pain
Clinical narrative: It happened around March 12 and to this date the illness persists.  The reaction is the loss of sensitivity in the thumb and later in the index finger.  It losses strength, it gets numb occasionally.  In the beginning it only lasted for 3 weeks the pain and the numbness of the fingers and loss of strength from the shoulder towards the arm.
Age: 0.7
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Incorrect drug dosage form administered
Clinical narrative: I did not mix the DTaP IPV solution with the Hib Powder for the PENTACEL vaccination. Gave the DTaP IPV part of the PENTACEL pt's mother notified he is to come back to complete the immunization.
Age: 15.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Alpha 1 foetoprotein normal, Amniocentesis normal, Anaemia, Caesarean section, Drug exposure during pregnancy
Clinical narrative: Information has been received from a nurse and a doctor for the Pregnancy Registry for GARDASIL regarding a 15 year old female with of depression and stress gastritis (no medication prescribed) who on 22-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # and site not reported). Concomitant therapy included VAQTA (Lot, site and route not reported). Other concomitant therapy included MENACTRA and Tdap (unspecified). Later on the evening of 22-APR-2008 the patient had a urine pregnancy test which was positive (not further specified). On 24-APR-2008, the patient returned to the office and a urine pregnancy test was performed which was positive (LMP "late February 2008"). No adverse effects were reported. The patient outcome was not reported. No additional information was provided. Follow-up information was received from a charge nurse who reported the patient delivered a male baby on 16-NOV-2008, at 38+1 weeks gestation. The patient was in labor, but experienced an "arrest of descent" in second stage, with a failed attempt at a vacuum delivery, and ultimately had a cesarean delivery. The baby weighed 6LBS 15oz. The baby was healthy and didn't have any problems. Upon internal review, arrest of descent was determined to be an other important medical events. No additional information was expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Face presentation, Failed trial of labour, Pregnancy test positive, Ultrasound scan
Clinical narrative: Information has been received from a nurse and a doctor for the Pregnancy Registry for GARDASIL regarding a 15 year old female with of depression and stress gastritis (no medication prescribed) who on 22-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # and site not reported). Concomitant therapy included VAQTA (Lot, site and route not reported). Other concomitant therapy included MENACTRA and Tdap (unspecified). Later on the evening of 22-APR-2008 the patient had a urine pregnancy test which was positive (not further specified). On 24-APR-2008, the patient returned to the office and a urine pregnancy test was performed which was positive (LMP "late February 2008"). No adverse effects were reported. The patient outcome was not reported. No additional information was provided. Follow-up information was received from a charge nurse who reported the patient delivered a male baby on 16-NOV-2008, at 38+1 weeks gestation. The patient was in labor, but experienced an "arrest of descent" in second stage, with a failed attempt at a vacuum delivery, and ultimately had a cesarean delivery. The baby weighed 6LBS 15oz. The baby was healthy and didn't have any problems. Upon internal review, arrest of descent was determined to be an other important medical events. No additional information was expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HEPA, HPV4, MNQ, TDAP
Symptoms: Arrested labour, Caesarean section, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a nurse and a doctor for the Pregnancy Registry for GARDASIL regarding a 15 year old female with of depression and stress gastritis (no medication prescribed) who on 22-APR-2008 was vaccinated intramuscularly with her first dose of GARDASIL (Lot # and site not reported). Concomitant therapy included VAQTA (Lot, site and route not reported). Other concomitant therapy included MENACTRA and Tdap (unspecified). Later on the evening of 22-APR-2008 the patient had a urine pregnancy test which was positive (not further specified). On 24-APR-2008, the patient returned to the office and a urine pregnancy test was performed which was positive (LMP "late February 2008"). No adverse effects were reported. The patient outcome was not reported. No additional information was provided. Follow-up information was received from a charge nurse who reported the patient delivered a male baby on 16-NOV-2008, at 38+1 weeks gestation. The patient was in labor, but experienced an "arrest of descent" in second stage, with a failed attempt at a vacuum delivery, and ultimately had a cesarean delivery. The baby weighed 6LBS 15oz. The baby was healthy and didn't have any problems. Upon internal review, arrest of descent was determined to be an other important medical events. No additional information was expected.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cardiac arrest, Electrocardiogram, Respiratory arrest
Clinical narrative: 10:03 am upon entering room patient became unresponsive and no palp pulse and no breathing. CPR was initiated and after 2nd cycle patient gasped and began breathing and responded appropriately. Once again her eyes rolled back in her head with no breathing or pulse and CPR was again initated and after first cycle she coughed and began breathing and had palp pulse, EKG rate of 42 and then increased to 60's. oxygen was applied at 6 liters per nasal cannula. she was  able to give contact information. She remained pale and lethargic but responsive to all questions and responses were appropriate. AMR arrived at 10:20am. Patient evaluated and transported to medical center. ER notified of transport and handoff information given.  Patient was lethargic but responsive when she left clinic.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cough, Dyspnoea, Gaze palsy, Lethargy, Pallor
Clinical narrative: 10:03 am upon entering room patient became unresponsive and no palp pulse and no breathing. CPR was initiated and after 2nd cycle patient gasped and began breathing and responded appropriately. Once again her eyes rolled back in her head with no breathing or pulse and CPR was again initated and after first cycle she coughed and began breathing and had palp pulse, EKG rate of 42 and then increased to 60's. oxygen was applied at 6 liters per nasal cannula. she was  able to give contact information. She remained pale and lethargic but responsive to all questions and responses were appropriate. AMR arrived at 10:20am. Patient evaluated and transported to medical center. ER notified of transport and handoff information given.  Patient was lethargic but responsive when she left clinic.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pulse absent, Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: 10:03 am upon entering room patient became unresponsive and no palp pulse and no breathing. CPR was initiated and after 2nd cycle patient gasped and began breathing and responded appropriately. Once again her eyes rolled back in her head with no breathing or pulse and CPR was again initated and after first cycle she coughed and began breathing and had palp pulse, EKG rate of 42 and then increased to 60's. oxygen was applied at 6 liters per nasal cannula. she was  able to give contact information. She remained pale and lethargic but responsive to all questions and responses were appropriate. AMR arrived at 10:20am. Patient evaluated and transported to medical center. ER notified of transport and handoff information given.  Patient was lethargic but responsive when she left clinic.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone normal, Pain, Red blood cell sedimentation rate normal, Tenderness, Thyroiditis
Clinical narrative: SHE WAS GIVEN GARDASIL 1 ST DOSE ON 16/6/2009 AND SHE HAS  THYOID SWELLING WHICH IS PATCHY BY DOPPLER CONFIRMATION AND PROBABLY THYROIDITIS WITH TSH AND T3, T4 NORMAL AND ESR ALSO WAS NORMAL, SWELLING IS MILD MILD PAINFUL AND MILD TENDERNESS OVER SWELLING
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Thyroxine normal, Tri-iodothyronine normal
Clinical narrative: SHE WAS GIVEN GARDASIL 1 ST DOSE ON 16/6/2009 AND SHE HAS  THYOID SWELLING WHICH IS PATCHY BY DOPPLER CONFIRMATION AND PROBABLY THYROIDITIS WITH TSH AND T3, T4 NORMAL AND ESR ALSO WAS NORMAL, SWELLING IS MILD MILD PAINFUL AND MILD TENDERNESS OVER SWELLING
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate decreased, Heart rate increased, Immediate post-injection reaction, Loss of consciousness, Memory impairment
Clinical narrative: Pt was also given T-DAP- MENACTRA, HEP A Pt was given GARASIL (LA), within 30 sec. Pt became pale. unresponsive arms & legs became rigid, lasted for aprox 2 min. After that Pt was pale for aprox 10 min. pulse cx 81 HR 113 pulse cx 91 H.R. 114, pulse cx 73, HR 81, pulse cx 71, HR. 46. B.P. 118/70 4:35 pt. States feeling better - 4:30 ambulance called, pulse cx in 70's H.R. in 40's - B.P. 106/72. Pt no longer pale & able to stand Pt was alert, conscious, coherent GCS (15) when sent to ER. Pt. received total total of 4 shots, #1 T-DAP (LA) #2 GARDASIL #3 HEP A, #4 MENACTRA. Pt states she doesn't remember the 4th shot. When she woke up, she didn't know where she was on the shots. After 10 min she did remember getting shots except for the 4th shot.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle rigidity, Oxygen saturation decreased, Pallor, Unresponsive to stimuli
Clinical narrative: Pt was also given T-DAP- MENACTRA, HEP A Pt was given GARASIL (LA), within 30 sec. Pt became pale. unresponsive arms & legs became rigid, lasted for aprox 2 min. After that Pt was pale for aprox 10 min. pulse cx 81 HR 113 pulse cx 91 H.R. 114, pulse cx 73, HR 81, pulse cx 71, HR. 46. B.P. 118/70 4:35 pt. States feeling better - 4:30 ambulance called, pulse cx in 70's H.R. in 40's - B.P. 106/72. Pt no longer pale & able to stand Pt was alert, conscious, coherent GCS (15) when sent to ER. Pt. received total total of 4 shots, #1 T-DAP (LA) #2 GARDASIL #3 HEP A, #4 MENACTRA. Pt states she doesn't remember the 4th shot. When she woke up, she didn't know where she was on the shots. After 10 min she did remember getting shots except for the 4th shot.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Neurological examination, Neuropathy peripheral
Clinical narrative: I am unsure if the lateral neuropathy of my daughters left leg is related to the GARDASIL vaccine, but after reading reports of numbness I feel obligated to report the numbness in her left leg. She has seen a neurologist who confirmed the lateral numbness and states there is no cure. 7/7/09 NCS report received DOS 4/8/09. Assessment: Left lateral femoral cutaneous neuropathy. Patient presents with loss of pain and temperature sensation of the left lateral femoral cutaneous nerve.  8/18/09 PCP medical records received DOS 7/21/06 to 4/6/09. Patient presents with leg pain, going numb & "probs' X 3 years. Paresthesias (L) lateral thigh.
Age: 0.1
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right deltoid area of redness, heat, and induration.  MOTRIN, ice, Benadryl advised
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Tenderness
Clinical narrative: Cluster of blisters on hand. Tender to touch on 6/28/09. Tx: VALTREX 1GM take 1 tablet 3x day # 15 ORF.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema around site and down media aspect of leg; no edema or induration or other rash. Developed day of immunization to next day. Reevaluated in clinic 3 days later.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tonic clonic movements
Clinical narrative: Immediately following immunization child lost consciousness and experienced tonic-clonic movements of arms, upper body and neck movements. Placed flat and regained consciousness in 20 sec. Color of mucosa remained pink. No resp distress. BP 110/60, HR 88. 911 called- To ER via ambulance, C 12:55 PM.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Crying, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain
Clinical narrative: Tetanus has been hurting since injection 1 week ago. Today (7/2/09) patient woke up in tears and hurts really bad into her shoulder and has hard time lifting her arm.
Age: 16.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Rash
Clinical narrative: Vaccines prior to 11:30 AM 7/1/2009. Represented in office with rash at 6:00pm
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Dizziness, light headed, fever, nausea, vomiting, joint pain, headache.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Dizziness, light headed, fever, nausea, vomiting, joint pain, headache.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Musculoskeletal pain
Clinical narrative: Red, swollen. Hard lump at injection site radiating into shoulder (Right). Mother was giving TYLENOL and BENADRYL and applying ice to site.
Age: 14.0
Sex: F
Vaccine: TYP
Symptoms: Antinuclear antibody negative, Arthralgia, Borrelia burgdorferi serology negative, C-reactive protein increased, Joint range of motion decreased
Clinical narrative: Developed pain, swelling and decrease ROM in both wrists one week after receiving Typhoid injection. She was told at a Sports Medicine facility that she was just tight and it was tendonitis and would respond to stretching. One week later, family "texted" me as they were leaving for the airport to go to foreign country. Pt now had swelling of her feet and toes as well as pain in her left shoulder. Mother was concerned that the stretching wasn't helping. She asked if I could recommend anything that might help with the discomfort for the duration of their trip. The only things I could suggest without seeing her were ibuprofen and OTC strength NAPROXEN. She tried both while travelling, with no relief. She was seen in my office within 24 hours of arriving back in town.
Age: 14.0
Sex: F
Vaccine: TYP
Symptoms: Joint swelling, Musculoskeletal pain, Oedema peripheral, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Developed pain, swelling and decrease ROM in both wrists one week after receiving Typhoid injection. She was told at a Sports Medicine facility that she was just tight and it was tendonitis and would respond to stretching. One week later, family "texted" me as they were leaving for the airport to go to foreign country. Pt now had swelling of her feet and toes as well as pain in her left shoulder. Mother was concerned that the stretching wasn't helping. She asked if I could recommend anything that might help with the discomfort for the duration of their trip. The only things I could suggest without seeing her were ibuprofen and OTC strength NAPROXEN. She tried both while travelling, with no relief. She was seen in my office within 24 hours of arriving back in town.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning his/her daughter's co-worker's daughter who on an unknown date was vaccinated with GARDASIL. It was reported that the patient died after receiving a dose of GARDASIL. The cause of death was not reported. Attempts to verify the existence of an identifiable patient and reporter have been unsuccessful. No further information is available.
Sex: F
Vaccine: PPV
Symptoms: Splenectomy
Clinical narrative: Information has been received from a physician concerning a female "in her 70s" who was vaccinated with a dose of PNEUMOVAX 23. The patient underwent a splenectomy 2 days after the vaccination. No AE was reported. Upon internal review, splenectomy was determined to be an other important medical event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Convulsion
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of seizure in a 5-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 24 June 2009 at 13:30 the subject received 1st dose of HAVRIX (.5 unknown, unknown, right thigh). On 24 June 2009, 30 minutes after vaccination with HAVRIX, the subject experienced seizure. This case was assessed as medically serious by GSK. The subject was treated with antihistamine. On 24 June 2009, the event was resolved. The nurse reported a subject experienced a seizure about 30 minutes after receiving HAVRIX. The subject was at home when this occurred. The office requested the subject come back into the office and be checked. He was treated with anti-histamine and they are not going to continue the vaccine series for this subject.
Age: 17.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Chest pain, Headache, Respiratory disorder, Somnolence
Clinical narrative: 4/20/09 Later in the day, respiratory problems, chest pain and severe headache-slept all day 4/21/09 and condition worsened. 4/23/09 taken to emergency room.  Client say treatment received for respiratory problems. Information reported 6/22/09.  9/1/09 ER records received DOS 4/30/09. Assessment: Asthma. Patient complains of constant pain affecting the anterior chest for 14 days. Pain radiates to back. Productive cough with yellow sputum and chest pain with breathing. Trouble breathing and short of breath. Hurts to cough. Wheezing.  ICD9-Codes: 493.90 Asthma type unspecified, 786.2 Cough.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Decreased appetite, Gaze palsy, Posture abnormal, Pyrexia, Vomiting
Clinical narrative: Patient was given Immunizations on 6-22-2009 (Pentacel, Engerix-B, Prevnar, & Rotarix).  He was hospitalized on 6-25-2009 when mom reported at our facility that he had fever up to 105.0 X3 days, decreased appetite, and vomiting. Mom also reported that his eyes would roll back in his head and he would draw his head back when these high fevers occurred, with the episodes lasting approximately 5 minutes & occuring approximately every 10 minutes.  Admission was for 2 days at Hospital.  7/21/09 MR received for DOS 6/25-27/09 with D/C DX:  Fever, Possible reaction to vaccines, which was reported to VAERS. Diarrhea. Pt presented with 3 day hx of fevers, emesis, watery stools, cough, fussiness, and decreased po intake. Pt also had episodes of eyes rolling back in the head, and head drawing back during fever.  Lethargic on PE. Admitted for fever & dehydration, r/o seizure, r/o sepsis. Improved with IVF but still with some watery mucus stool. ICD9 780.60, 787.91, E9499
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: I am experiencing itchiness--Thumb side of both arms; top of both thighs; back of neck; scalp; lower belly.  I do not see any rash
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, PPV, RV5
Symptoms: Abdominal pain upper, Colitis, Feeding disorder neonatal, Mucous stools, Stool analysis abnormal
Clinical narrative: Persistent (more than 3 weeks) mucous in stools; persistent belly pain; required hospitalization of 2 days; diagnosed with COLITIS; could no longer breast feed; had to feed baby only Nutramigen for next 9 months.  7/13/09 Hospital records received DOS 3/6/08 to 3/7/08. Final Diagnosis: Allergic Colitis Suspected, Gastroesophageal Reflux Disease Suspected. Parent reports child has diarrhea, colicky, 'pepper jelly stool', screaming, distended abdomen. Peripheral eosinophilia. Patient presents with irritability and mucoid stools. Cries after feeding. Greenish stools. Regurgitation, spitting up. Gassy.    7/13/09 PCP medical records received DOS 11/19/07 to 9/17/08. Assessment: Colitis Presents with mucousy stool, abdominal pain, colic. Diarrhea. Pasty green yellow stool.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Body temperature increased, Influenza serology negative
Clinical narrative: Mother reported temperature of 104.8 the morning of 7/1/09.  Low grade temperature the evening of the immunization.  Treated with Motrin every 6 hours.  No other symptoms or findings on medical examination.  Child was seen by physician 07/01/2009.  Physician felt temperature due to immunizations.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Fever began 6-4-09 with small red area per Mom. Increased reddness 6-5-09. 10cm x 12cm red, hot, tender, swollen deltoid area. No ecchymosis. Augmentin 400mg/5mL X10 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever began 6-4-09 with small red area per Mom. Increased reddness 6-5-09. 10cm x 12cm red, hot, tender, swollen deltoid area. No ecchymosis. Augmentin 400mg/5mL X10 days.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Crying, Irritability
Clinical narrative: Fussy, crying, hard to console, on awakening this morning
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site movement impairment, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Severe pain in upper arm at site of injection for 6 days. Swelling and inability to lift arm overhead. Pain went down both arms and across shoulders. The first 2 days it felt like she could not lift her arms at all. Unusual headache for 5 days. Remembers feeling this way the last time she had a Td vaccine nearly 20 years ago.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccine positive rechallenge
Clinical narrative: Severe pain in upper arm at site of injection for 6 days. Swelling and inability to lift arm overhead. Pain went down both arms and across shoulders. The first 2 days it felt like she could not lift her arms at all. Unusual headache for 5 days. Remembers feeling this way the last time she had a Td vaccine nearly 20 years ago.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Rash vesicular
Clinical narrative: generalize rash - chicken pox lesions, severe itching, it's been 3 month since symptoms began and still ongoing
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Bump and rash at injection site developed 24 hr after injection. Treated with ice bag and TYLENOL. Subsided after another 24 hrs.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pyrexia
Clinical narrative: Pt came for Adagio visit, HPV # 3 due.  Pt. states at this time she had reaction to HPV vaccine # 2, and didn't want # 3.  Pt. reports she developed fever of 102 within 2 hrs of getting vaccine.  Did not contact us at this time.  Pt. reports fever getting as high as 103 on Fri afternoon by Sunday was normal.  Pt. reports no rash or other symptoms, but felt "sick"
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Fatigue, Gastric disorder, Pyrexia
Clinical narrative: 6/15/09 Pt. to clinic to receive HPV #2. Pt described symptoms after receiving first GARDASIL IZ within 2 hours after injection experienced fever, gastric distress, fatigued & SOB. Went to ER had to wait 5 hours & was not seen. Symptoms resolved.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Asthenia, Dyspnoea, Pyrexia
Clinical narrative: 6/15/09 Pt. to clinic to receive HPV #2. Pt described symptoms after receiving first GARDASIL IZ within 2 hours after injection experienced fever, gastric distress, fatigued & SOB. Went to ER had to wait 5 hours & was not seen. Symptoms resolved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: RA swollen the whole length of the Rt upper arm L elbow + use referred KINRIX and VARIVAX on this arm.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Antinuclear antibody negative, Biopsy skin abnormal, Chest discomfort, Cold sweat, Hyperplasia
Clinical narrative: While abroad, patient received his AVA (1) vaccine. He received no other vaccines on that day. Within 15 minutes of vaccine receipt, patient experienced feeling "clammy" and noted tightness in his chest. He broke out in a pruritic rash in his anticubital areas, behind his knees and across his abdomen. He was given BENADRYL and monitored in the immunization clinic for 1 hour. When he was released, his symptoms had resolved except for the rash on his abdomen, which has changed in appearance, but persists to date. Skin symptoms - Within 2 weeks of receiving his anthrax vaccine in 1999, patient began noting rashes or "splotches" on his back, his face and along his hairline, behind his ears and on his buttocks. Because of mission priorities, evaluation and treatment were often delayed. He was initially treated with a variety of topicals, none of which were effective. He has seen at least 2 Dermatologists and has had at least 2 biopsies. Recently started on MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Inflammation, Lentigo, Parakeratosis, Rash pruritic, Red blood cell sedimentation rate normal
Clinical narrative: While abroad, patient received his AVA (1) vaccine. He received no other vaccines on that day. Within 15 minutes of vaccine receipt, patient experienced feeling "clammy" and noted tightness in his chest. He broke out in a pruritic rash in his anticubital areas, behind his knees and across his abdomen. He was given BENADRYL and monitored in the immunization clinic for 1 hour. When he was released, his symptoms had resolved except for the rash on his abdomen, which has changed in appearance, but persists to date. Skin symptoms - Within 2 weeks of receiving his anthrax vaccine in 1999, patient began noting rashes or "splotches" on his back, his face and along his hairline, behind his ears and on his buttocks. Because of mission priorities, evaluation and treatment were often delayed. He was initially treated with a variety of topicals, none of which were effective. He has seen at least 2 Dermatologists and has had at least 2 biopsies. Recently started on MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rheumatoid factor negative
Clinical narrative: While abroad, patient received his AVA (1) vaccine. He received no other vaccines on that day. Within 15 minutes of vaccine receipt, patient experienced feeling "clammy" and noted tightness in his chest. He broke out in a pruritic rash in his anticubital areas, behind his knees and across his abdomen. He was given BENADRYL and monitored in the immunization clinic for 1 hour. When he was released, his symptoms had resolved except for the rash on his abdomen, which has changed in appearance, but persists to date. Skin symptoms - Within 2 weeks of receiving his anthrax vaccine in 1999, patient began noting rashes or "splotches" on his back, his face and along his hairline, behind his ears and on his buttocks. Because of mission priorities, evaluation and treatment were often delayed. He was initially treated with a variety of topicals, none of which were effective. He has seen at least 2 Dermatologists and has had at least 2 biopsies. Recently started on MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Antinuclear antibody negative, Arthralgia, Arthroscopic surgery, Back pain, Joint injury
Clinical narrative: While abroad, patient received his AVA (1) vaccine. He received no other vaccines on that day. Within 15 minutes of vaccine receipt, patient experienced feeling "clammy" and noted tightness in his chest. He broke out in a pruritic rash in his anticubital areas, behind his knees and across his abdomen. He was given BENADRYL and monitored in the immunization clinic for 1 hour. When he was released, his symptoms had resolved except for the rash on his abdomen, which has changed in appearance, but persists to date. Skin symptoms - Within 2 weeks of receiving his anthrax vaccine in 1999, patient began noting rashes or "splotches" on his back, his face and along his hairline, behind his ears and on his buttocks. Because of mission priorities, evaluation and treatment were often delayed. He was initially treated with a variety of topicals, none of which were effective. He has seen at least 2 Dermatologists and has had at least 2 biopsies. Recently started on MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Psoriatic arthropathy, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: While abroad, patient received his AVA (1) vaccine. He received no other vaccines on that day. Within 15 minutes of vaccine receipt, patient experienced feeling "clammy" and noted tightness in his chest. He broke out in a pruritic rash in his anticubital areas, behind his knees and across his abdomen. He was given BENADRYL and monitored in the immunization clinic for 1 hour. When he was released, his symptoms had resolved except for the rash on his abdomen, which has changed in appearance, but persists to date. Skin symptoms - Within 2 weeks of receiving his anthrax vaccine in 1999, patient began noting rashes or "splotches" on his back, his face and along his hairline, behind his ears and on his buttocks. Because of mission priorities, evaluation and treatment were often delayed. He was initially treated with a variety of topicals, none of which were effective. He has seen at least 2 Dermatologists and has had at least 2 biopsies. Recently started on MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Antinuclear antibody negative, Biopsy skin abnormal, Chest discomfort, Cold sweat, Hyperplasia
Clinical narrative: Within 30 days of receiving his anthrax vaccine, patient noted the onset of joint pain. Initially, the pain was noted in his index fingers, then his ankles and feet, knees and his back. Pain varies in intensity but at it's worst is described as coming on "like a vengeance" and "like iron rods" pressing against joints. Because of mission priorities, patient opted to self treat alternating OTC medications including ibuprofen and TYLENOL ARTHRITIS. He did seek evaluation following a knee injury which later required arthroscopic surgery. He has also sought evaluation for lower back pain. Per Recent Rheum eval (6/11/09), + Gelling of knees, + arthralgias of hands, wrists, elbows, feet, knees. Knees ache if sits for a long time; occurred for the last 2-3 years. Pain in hands, thumbs, knees, feet and elbows. Also has chronic LBP. ASSESSMENT: Likely psoriatic arthritis (psoriasis on exam, + LBP, + synovitis on exam). PLAN: Start MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Inflammation, Lentigo, Parakeratosis, Rash pruritic, Red blood cell sedimentation rate normal
Clinical narrative: Within 30 days of receiving his anthrax vaccine, patient noted the onset of joint pain. Initially, the pain was noted in his index fingers, then his ankles and feet, knees and his back. Pain varies in intensity but at it's worst is described as coming on "like a vengeance" and "like iron rods" pressing against joints. Because of mission priorities, patient opted to self treat alternating OTC medications including ibuprofen and TYLENOL ARTHRITIS. He did seek evaluation following a knee injury which later required arthroscopic surgery. He has also sought evaluation for lower back pain. Per Recent Rheum eval (6/11/09), + Gelling of knees, + arthralgias of hands, wrists, elbows, feet, knees. Knees ache if sits for a long time; occurred for the last 2-3 years. Pain in hands, thumbs, knees, feet and elbows. Also has chronic LBP. ASSESSMENT: Likely psoriatic arthritis (psoriasis on exam, + LBP, + synovitis on exam). PLAN: Start MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Rheumatoid factor negative
Clinical narrative: Within 30 days of receiving his anthrax vaccine, patient noted the onset of joint pain. Initially, the pain was noted in his index fingers, then his ankles and feet, knees and his back. Pain varies in intensity but at it's worst is described as coming on "like a vengeance" and "like iron rods" pressing against joints. Because of mission priorities, patient opted to self treat alternating OTC medications including ibuprofen and TYLENOL ARTHRITIS. He did seek evaluation following a knee injury which later required arthroscopic surgery. He has also sought evaluation for lower back pain. Per Recent Rheum eval (6/11/09), + Gelling of knees, + arthralgias of hands, wrists, elbows, feet, knees. Knees ache if sits for a long time; occurred for the last 2-3 years. Pain in hands, thumbs, knees, feet and elbows. Also has chronic LBP. ASSESSMENT: Likely psoriatic arthritis (psoriasis on exam, + LBP, + synovitis on exam). PLAN: Start MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Antinuclear antibody negative, Arthralgia, Arthroscopic surgery, Back pain, Joint injury
Clinical narrative: Within 30 days of receiving his anthrax vaccine, patient noted the onset of joint pain. Initially, the pain was noted in his index fingers, then his ankles and feet, knees and his back. Pain varies in intensity but at it's worst is described as coming on "like a vengeance" and "like iron rods" pressing against joints. Because of mission priorities, patient opted to self treat alternating OTC medications including ibuprofen and TYLENOL ARTHRITIS. He did seek evaluation following a knee injury which later required arthroscopic surgery. He has also sought evaluation for lower back pain. Per Recent Rheum eval (6/11/09), + Gelling of knees, + arthralgias of hands, wrists, elbows, feet, knees. Knees ache if sits for a long time; occurred for the last 2-3 years. Pain in hands, thumbs, knees, feet and elbows. Also has chronic LBP. ASSESSMENT: Likely psoriatic arthritis (psoriasis on exam, + LBP, + synovitis on exam). PLAN: Start MTX.
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain in extremity, Psoriatic arthropathy, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: Within 30 days of receiving his anthrax vaccine, patient noted the onset of joint pain. Initially, the pain was noted in his index fingers, then his ankles and feet, knees and his back. Pain varies in intensity but at it's worst is described as coming on "like a vengeance" and "like iron rods" pressing against joints. Because of mission priorities, patient opted to self treat alternating OTC medications including ibuprofen and TYLENOL ARTHRITIS. He did seek evaluation following a knee injury which later required arthroscopic surgery. He has also sought evaluation for lower back pain. Per Recent Rheum eval (6/11/09), + Gelling of knees, + arthralgias of hands, wrists, elbows, feet, knees. Knees ache if sits for a long time; occurred for the last 2-3 years. Pain in hands, thumbs, knees, feet and elbows. Also has chronic LBP. ASSESSMENT: Likely psoriatic arthritis (psoriasis on exam, + LBP, + synovitis on exam). PLAN: Start MTX.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: (L) arm where he received MENACTRA is red & swollen 3-4" in diameter. Itchy, hard.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Hypotension, Immediate post-injection reaction, Pallor
Clinical narrative: TDAP administered, then MCV - 4 given & second after this injection Pt. stated "I'm dizzy".  Pt be came weak & pale.  Checked blood pressure & was low 60/00 & I couldn't hear it.  911 called & we lowered pt. to floor lying down & ambulance arrived 10-15 min later.  Pt. stayed weak, pale & dizzy & was brought to ER by ambulance.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. received vaccines Monday 6/29/09 and mom notice swelling and redness Wednesday morning on 7/1/09.  Pt. not complaining about arm, he said his arm itches.
Age: 1.8
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Erythema multiforme, Muscle spasms, Pruritus, Rash
Clinical narrative: Patient had bumps- Red on arm and legs. Itching and spreading, no fevers. Cramping two weeks ago. Dx Erythema Multiforme.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Induration, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema, edema, tenderness at injection site, sm area of induration.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & redness left arm @ site of VARICELLA -> cellulitis
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Paraesthesia, Rash generalised, Throat irritation
Clinical narrative: After administration of albuterol nebule, hepatitis a and varicella vaccines, patient developed rash on body and tingling in the back of her throat 06/10/2009 at 11:45.Itching denied by patient. Patient was given 10mg PO Benadryl.(Also with rx to benadryl and claritin). Mom called two days later to report continued use of albuterol and 30 hours after rash presented it has gone away. Mom denied any problems with breathing or throat/tongue swelling.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: child recieved dtap on 7\2\2009 was seen in office 7/3/2009 for site that was red, warm to touch, swollen, and painful.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Dark circles under eyes, Diet refusal, Lethargy, Pyrexia
Clinical narrative: Approximately 45 minutes after the DTaP shop was given to my daughter we arrived home from the doctor and she was floppy in my arms, would only lay down on the floor to rest and had a fever of 103.2. I gave her motrin and put her in for a nap. I knew she was fine that morning because she had her full 2 year old exam and she checked out as healthy & fine. I called the doctors office and spoke to a nurse regarding the fever and lethargy after the shot and she said, "Maybe she's coming down with something." I am also very disappointed because I didn't know I had any other recourse to report this as my doctor does not give any literature of possible side effects when a vaccine is given. I received the paper with your information from a friend who had gotten it from her pediatrician. Her fever continued throughout that day and evening but I was able to keep it around 99 to 100 with the motrin and tylenol. Her fever was gone the next morning but she was not herself, she still wouldn't eat, was very lethargic and had dark circles under her eyes. She was back to normal the next day, which was 48 hours after the vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Pallor
Clinical narrative: Pt. received HPV vaccine for 1st time on 6-17-09 at approximately 16:35 as part of P.E. (Pt. had received PPD in other forearm 5 min. prior).  At 16:40 pt. in seat & noted to be pale said she would "pass out" & was placed on table.  MD called.  Vitals assessed.  Pt. drank water, rested and walked out of clinic shortly after.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster involving the left side of face.
Age: 29.0
Sex: F
Vaccine: TTOX
Symptoms: Cellulitis
Clinical narrative: received tetanus shot and was diagnosed with cellulitis 2 days later, being treated with cephalexin 500mg 3x a day for 5 days
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Balance disorder, Crying, Dyskinesia, Feeding disorder, Irritability
Clinical narrative: Patient was unusually sleepy the day of and the day after the vaccinations; I noticed twitching in arms and legs, esp. hands; she moved wrists up and down and squeezed hands in and out, appeared to be involuntary; it took her a longer time to feed, although she did take a reasonable amount; cry sounded weaker; irritable; seemed to be off balance; Moro reflex noted a few times (it had disappeared two months prior).
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Muscle twitching, Reflexes abnormal, Somnolence
Clinical narrative: Patient was unusually sleepy the day of and the day after the vaccinations; I noticed twitching in arms and legs, esp. hands; she moved wrists up and down and squeezed hands in and out, appeared to be involuntary; it took her a longer time to feed, although she did take a reasonable amount; cry sounded weaker; irritable; seemed to be off balance; Moro reflex noted a few times (it had disappeared two months prior).
Age: 1.0
Sex: F
Vaccine: DTPHIB, HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Mild rash of varicella
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Injection site erythema
Clinical narrative: My left upper arm, where the injection was given, became very hot, achey, and swollen.  The entire area became red and extremely sensitive to touch.  I came down with a fever, headache and chills,and became very fatigued, with a low appetite.  The only medication I took was asperin, to relieve my fever and headache.
Age: 60.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: My left upper arm, where the injection was given, became very hot, achey, and swollen.  The entire area became red and extremely sensitive to touch.  I came down with a fever, headache and chills,and became very fatigued, with a low appetite.  The only medication I took was asperin, to relieve my fever and headache.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Demyelination, Eye pain, Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Vision blurred
Clinical narrative: The patient received Gardasil #1, Tdap and meningococcal conjugate vaccine (ACYW-135) on 01June 2009 -- administered at Pediatrics in facility.  On 23June she started having painful and blurred vision in the right eye, she was evaluated by us in the Pediatric Neurology clinic on 26June and found to have right optic neuritis.  Brain MRI showed periventricular white matter hyperintensities, one with enhancement.  She was admitted for IV steroids. The DDx includes multiple sclerosis vs demyelination triggered by the immunizations.  7/14/09 MR received for DOS 6/26-28/2009 with D/C DX:  Optic Neuritis (R retrobulbar).  Pt admitted for IV steroids for 4 day hx of blurry vision, vision loss, eye muscle strain and pain.  Neuro consult c/w ON. Will continue to watch for further signs of MS. Tx with IV steroids and d/c on steroid taper.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Visual acuity tests abnormal
Clinical narrative: The patient received Gardasil #1, Tdap and meningococcal conjugate vaccine (ACYW-135) on 01June 2009 -- administered at Pediatrics in facility.  On 23June she started having painful and blurred vision in the right eye, she was evaluated by us in the Pediatric Neurology clinic on 26June and found to have right optic neuritis.  Brain MRI showed periventricular white matter hyperintensities, one with enhancement.  She was admitted for IV steroids. The DDx includes multiple sclerosis vs demyelination triggered by the immunizations.  7/14/09 MR received for DOS 6/26-28/2009 with D/C DX:  Optic Neuritis (R retrobulbar).  Pt admitted for IV steroids for 4 day hx of blurry vision, vision loss, eye muscle strain and pain.  Neuro consult c/w ON. Will continue to watch for further signs of MS. Tx with IV steroids and d/c on steroid taper.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: TDAP used was ADACEL instead of BOOSTRIX.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Death
Clinical narrative: Information has been received from a consumer, via a transcript of TV program concerning her 20 year old daughter who in September 2008 was vaccinated with GARDASIL (lot# not reported). The mother stated that almost immediately after receiving the vaccine, the patient suffered "unusual symptoms". In November 2008, two months later, the patient died without any apparent reason. The mother reported the autopsy revealed an "undetermined cause of death". The mother stated that her daughter was complaining of having migraine headaches and she had severe stomach pains the night before she passed away. The mother suspected her daughter's death as a result of GARDASIL. No further information is available at this time.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Autopsy, Death, Migraine
Clinical narrative: Information has been received from a consumer, via a transcript of TV program concerning her 20 year old daughter who in September 2008 was vaccinated with GARDASIL (lot# not reported). The mother stated that almost immediately after receiving the vaccine, the patient suffered "unusual symptoms". In November 2008, two months later, the patient died without any apparent reason. The mother reported the autopsy revealed an "undetermined cause of death". The mother stated that her daughter was complaining of having migraine headaches and she had severe stomach pains the night before she passed away. The mother suspected her daughter's death as a result of GARDASIL. No further information is available at this time.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Convulsion, Death
Clinical narrative: Information has been received from a consumer, via a transcript of TV program concerning her 20 year old daughter who in September 2008 was vaccinated with GARDASIL (lot# not reported). The mother stated that almost immediately after receiving the vaccine, the patient suffered "unusual symptoms". In November 2008, two months later, the patient died without any apparent reason. The mother reported the autopsy revealed an "undetermined cause of death". The mother stated that her daughter was complaining of having migraine headaches and she had severe stomach pains the night before she passed away. The mother suspected her daughter's death as a result of GARDASIL. No further information is available at this time.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, DTAPIPVHIB, HEP, DTAPIPVHIB, HEP
Symptoms: Autopsy, Death
Clinical narrative: Initial report received 17 April 2009 from a health care professional in the country. A 10-week-old male patient with no previous medical history, had received an intramuscular left thigh injection of PENTACEL, lot number C3277AA and an intramuscular right thigh injection of RECOMBIVAX HB, lot number 1446X (manufacturer Merck) on 14 April 2009 and one day later, the patient died while napping. The patient had been taken to his parent place of business, a nail salon, on 15 April 2009. The patient was put down for a nap at approximately 11:00 am and never woke up. Prior to death, the patient was well and had no symptoms of illness. At the time of vaccination, he had no illness, no pre-existing medical conditions and he had not been taking any concomitant medications. He had not received any other vaccines within four weeks of PENTACEL and RECOMBIVAX HB vaccination. On 16 April, 2009, an autopsy had been performed, however results were pending. A cause of death was not reported. No additional information was provided at the time of the report. Documents held by sender: None.