chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Swelling face, Vision blurred
Clinical narrative: Initial report received on 15 January 2009 from a consumer. A 65-year-old patient, who had no concurrent illnesses, but who has allergy to tree pollen, plums, hazelnuts and Red Delicious apples, had received on 15 December 2008 a dose of FLUZONE SV 2008-2009 (lot number U2803AA). The route and site of administration was not provided. The patient had not received any other vaccinations within four weeks of 15 December 2008; and had not experienced any adverse events with prior vaccination including several flu vaccines. The patient was taking PRILOSEC at the time of vaccination on 15 December 2008; however the indication for this medication was not provided. Approximately one week after receiving the FLUZONE vaccine, the patient starting having eye and facial swelling with facial numbness and pain on the right side of his face. He also experienced headache. Per the patient, he subsequently developed a "shadow" in his peripheral vision which has continued to worsen. He stated he had lost 80% of vision of the right eye. The patient was evaluated by a health care professional and had numerous tests/procedures including a Magnetic Resonance Imaging (MRI) test and computed axial tomography (CAT) scan; however the results were not provided. the patient is to be evaluated by a neuro-ophthalmolosgist the week of 19 January 2009. It was not reported whether the patient had received any treatment at this time, or if any diagnostic laboratory data had been performed. At the time of this report, it was "unknown" whether the patient had recovered. Documents held by sender: None.  2/5/09 Received PCP, vaccine ophtho & neurooptho medical records of 12/15/08-1/27/2009.  Ophtho records reveal patient seen 1/2/09 for c/o floaters OD x 1 week which worsened over next 6 days with vision decrease OD.  Dx: vitreous detachment/floater OD & subsequent non-arteritic anterior ischemic optic neuropathy.   PCP records of 1/8/09-1/27/09 reveal patient in usual state of health except for vision decrease OD.  RTC 1/27 & dx w/anxiety disorder generalized.  Neuro-ophtho records of 1/22/09 FINAL DX: anterior ischemic optic neuropathy, right side; disk at risk, left eye; no evidence of corneal anesthesia either side; & history of low-normal BP.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Oxygen saturation normal
Clinical narrative: Initial report was received 16 January 2009 from another manufacturer; document number 927258.  The other manufacturer received the report from a health care professional.  A 16-year-old male patient had received a left deltoid injection of MENACTRA, lot number U2728AA (route not reported) on 19 December 2008 at 12:15am and shortly afterwards, the patient complained that they could not breathe.  The patient's mother had been present at the time of vaccination and the patient was fine.  According to the reporter, the patient was quiet so the nurse asked the patient if he felt okay.  The patient replied "yes".  The nurse then left the patient to wait for the doctor to perform a physical exam.  An unspecified amount of time later, the patient's mother came out of the room yelling for help.  The nurse went in the room and the patient "was grabbing at surrounding cords".  The patient's mother stated that the patient couldn't breathe.  The nurse told the patient to relax and had him lay down; then went to get ice and report to the doctor.  Oxygen sats were 98% on room air.  The patient recovered from the event on 19 December 2008 (duration of the event and time of recovery were not reported).  No additional information was provided at the time of the report.  Documents held by sender: None
Age: 14.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Coma, No reaction on previous exposure to drug, Pyrexia, Renal failure acute, Septic shock
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 17-NOV-2008 was vaccinated with the second 0.5 ml dose of GARDASIL (lot #660553/0070X). Concomitant vaccine included FLUMIST intranasal (cold adapted Ann Arbor master strain). On 22-NOV-2008 the patient developed sepsis shock, high fever, acute renal failure and coma after getting the second dose of GARDASIL and was hospitalized. It was unknown how many days the patient stayed in hospital. Subsequently, the patient recovered on unspecified dates. It was also reported that the patient did not experience any AE after getting the first dose. No additional information was provided. Additional information has been requested.  3/9/09 Received PCP medical records of 11/17/08-12/19/08 as well as partial hospital records. FINAL DX: encephalitis, septic shock Records reveal patient had sore throat & dx w/URI on 11/17/08 when received HPV #2 & flumist vaccines.  RTC 12/19 for hospital recheck w/residual hemipalsy.  Hospital records of 11/22-12/3/2008: FINAL DX: toxic shock syndrome of unknown etiology, posibly menstrual associated vs post vaccination; acute disseminated encephalomyelitis. Records reveal patient had 2 siblings w/N/V/D 1 week prior to her experienced right frontal HA, chills, fever, bilious emesis, right monocular blurred vision, abdominal pain, diarrhea.  Developed increasing confusion, lethargy, photophobia, emesis & became unconscious w/agonal breathing within 24 hours.  Intubated by EMS for respiratory failure, temp 103.3, posturing, pinpoint unreactive pupils.  Neuro, Neurosurgery, Ophtho, Heme & Renal consults done.  Developed DIC likely related to urosepsis & multiorgan failure, acute renal failure, right hypertropia.  Admitted to ICU & tx w/multiple IV antibiotics, steroids & pressors for low BP. Extubated 11/24.  Remained febrile w/injected eyes, swollen red tongue, rsh & abdominal tenderness.  Improved & transferred to inpatient neurorehab center.  3/12/09 Received additional hospital medical records of 11/22-12/3/2008 admit. Neurorehab consult revealed encephalitis of unknown cause w/cognitive impairment, gait disorder & visual deficits.  Accepted to rehab.
Sex: F
Vaccine: HPV4
Symptoms: LE cells, Systemic lupus erythematosus
Clinical narrative: Information has been received from a physician concerning a female patient who on 25-FEB-2008 was vaccinated with the third dose of GARDASIL. No lot number was provided. The physician reported that the patient had a positive lab test for lupus about six months (August 2008) after the date of the third dose of GARDASIL. Physician does not wish to be contacted. The patient sought unspecified medical attention. Upon internal review, lupus was determined to be an other important medical event. No further information is available.
Age: 0.4
Sex: F
Vaccine: RV5
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ (Lot not provided) although it was not confirmed. The patient developed intussusception after receiving ROTATEQ. The patient had to be hospitalized for an unspecified period of time. As of 21-JAN-2009 the outcome of the patient was unknown. Additional information has been requested. 2/9/09-records received for DOS 10/15-10/26/08-Admitted with some rectal bleeding. Bronchiolitis.  3/23/09-records received for DOS 11/7/08- presented to ED with vomiting, fussy and bloody stool. Esophagogastroduodenoscopy performed diagnosis GERD. History of mild protein intolerance and feeding problems.
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Abasia, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: muscle spasm at injection site, diffuse myalgias, headache, diaphoresis, nausea, gait instability, dizziness, fatigue, arthralgias, stiff neck- no treatments required
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: Hyperhidrosis, Muscle spasms, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: muscle spasm at injection site, diffuse myalgias, headache, diaphoresis, nausea, gait instability, dizziness, fatigue, arthralgias, stiff neck- no treatments required
Age: 45.0
Sex: F
Vaccine: ANTH
Symptoms: White blood cell count
Clinical narrative: muscle spasm at injection site, diffuse myalgias, headache, diaphoresis, nausea, gait instability, dizziness, fatigue, arthralgias, stiff neck- no treatments required
Age: 34.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TD, TYP, SMALL
Symptoms: Computerised tomogram, Erythema, Eye oedema, Metamorphopsia, Slit-lamp examination
Clinical narrative: erythema, edema of the eye, distorted vision; possible auto-inoculation
Age: 34.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TD, TYP, SMALL
Symptoms: Conjunctival oedema, Corneal disorder, Corneal lesion, Eyelid oedema, Purulence
Clinical narrative: erythema, edema of the eye, distorted vision; possible auto-inoculation
Age: 34.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TD, TYP, SMALL
Symptoms: Secondary transmission, Skin lesion, Vaccinia, Viral infection
Clinical narrative: erythema, edema of the eye, distorted vision; possible auto-inoculation
Age: 34.0
Sex: M
Vaccine: SMALL, ANTH, SMALL, TD, TYP, SMALL
Symptoms: Erythema, Eye oedema, Metamorphopsia, Scan brain
Clinical narrative: erythema, edema of the eye, distorted vision; possible auto-inoculation
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Headache, Nausea, Syncope
Clinical narrative: About 7 minutes after patient had the shot, we were standing at the receptionist's area and she fainted and fell down.  She remembers getting very dizzy and seeing black dots, but doesn't remember falling.  She was awake by the time she was on the floor.  We let her lie down, then she was able to walk into a room, and just sat, had water, and we were able to leave about 15 minutes later.  Once at home, her head hurt from the fall, she rested, and seemed much better.  At night, around 10 pm, she felt slightly nauseous, but then went to sleep for the night.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Visual impairment
Clinical narrative: About 7 minutes after patient had the shot, we were standing at the receptionist's area and she fainted and fell down.  She remembers getting very dizzy and seeing black dots, but doesn't remember falling.  She was awake by the time she was on the floor.  We let her lie down, then she was able to walk into a room, and just sat, had water, and we were able to leave about 15 minutes later.  Once at home, her head hurt from the fall, she rested, and seemed much better.  At night, around 10 pm, she felt slightly nauseous, but then went to sleep for the night.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Cough, Dyspnoea, Haematocrit decreased
Clinical narrative: coughing, wheezing, hives, dyspnea occured at 12 noon. tourniquet applied when patient had first cough and saw first hive on arm. injected epinephrine 0.1 cc into right arm above tourniquet. injected 0.1 cc on other side (left side). benadryl injected (25 MG)into left arm. decadron injected into right arm. ems called during the first few seconds and arrived within a few minutes. pulse ox of 97 % and oxygen was started  to prevent any drop in saturations. albuterol given.  3/9/09 MR received for DOS 1/26-27/09 with D/C DX:  Anaphylactic reaction to MMR, Varivax. Stridor, swelling of entire body. Pt presented following immunizations where pt immediately developed urticarial rash, cough, stridor and increased WOB. Tx Benadryl, solumedrol, albuterol, zantac. Improved and d/c next day.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Haemoglobin decreased, Oxygen saturation normal, Urticaria, Wheezing, White blood cell count decreased
Clinical narrative: coughing, wheezing, hives, dyspnea occured at 12 noon. tourniquet applied when patient had first cough and saw first hive on arm. injected epinephrine 0.1 cc into right arm above tourniquet. injected 0.1 cc on other side (left side). benadryl injected (25 MG)into left arm. decadron injected into right arm. ems called during the first few seconds and arrived within a few minutes. pulse ox of 97 % and oxygen was started  to prevent any drop in saturations. albuterol given.  3/9/09 MR received for DOS 1/26-27/09 with D/C DX:  Anaphylactic reaction to MMR, Varivax. Stridor, swelling of entire body. Pt presented following immunizations where pt immediately developed urticarial rash, cough, stridor and increased WOB. Tx Benadryl, solumedrol, albuterol, zantac. Improved and d/c next day.
Age: 30.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Rash
Clinical narrative: Received Hepatitis B #2 and TdaP.  Developed rash on neck, right and left upper arm.  Denied rash prior to injections.  Denied itching, SOB, edema.  VS remained stable.  Benadryl 50 mg given IM.  Symtoms improved and patients sister arrived to take her home. Referral form was given for patient to take to PCP.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dry skin, Gaze palsy, Hypoaesthesia, Hypotonia, Pallor
Clinical narrative: Few minutes after vaccine administered client was standing ready to leave, and client later reported felt extremities getting numb.  Client sat down in chair behind her, and appears to have fainted. Noted by Mom and Rn that client in chair and not responding to verbal commands.  Eyes open, but rolled back, extremities lax, color pale.  Skin warm and dry.  RN gently shook clients arm and client returned to alertness within two to three minutes. Clients sibling fainted within about 1 minute of patient fainting as well.  Mother and RN and HD staff all at both clients side.  After incident client reported she could hear Mom and RN calling her name.  Gave client Orange drink to sip and ice pack to neck.  Client remained under staff observation for 15 more minutes after above incident. Mom instructed to feed client when arrives home.  No other treatment administered.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Skin warm, Syncope, Unresponsive to stimuli
Clinical narrative: Few minutes after vaccine administered client was standing ready to leave, and client later reported felt extremities getting numb.  Client sat down in chair behind her, and appears to have fainted. Noted by Mom and Rn that client in chair and not responding to verbal commands.  Eyes open, but rolled back, extremities lax, color pale.  Skin warm and dry.  RN gently shook clients arm and client returned to alertness within two to three minutes. Clients sibling fainted within about 1 minute of patient fainting as well.  Mother and RN and HD staff all at both clients side.  After incident client reported she could hear Mom and RN calling her name.  Gave client Orange drink to sip and ice pack to neck.  Client remained under staff observation for 15 more minutes after above incident. Mom instructed to feed client when arrives home.  No other treatment administered.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Back pain, Blood test, Fatigue
Clinical narrative: I had my first injection on 7/10/2008.  Since my second injection (9/26/2008), I haven't had a regular menstrual cycle, even while on birth control.  I am very tired and weak all the time. I was also diagnosed with autoimmune thyroiditis (10/20/2008). Prior to the injection, I had hypothyroidism. I have had urinary tract infections/kidney infections.  I have had pain in my left hip area/leg and back. The pain shoots down my left leg, also injection leg. The pain is so annoying and constant it keeps me up at night.  2/2/09 Received OB/GYN medical records 7/10/08-1/28/2009. FINAL DX: dysuria, irregular menses Records reveal patient experienced good health on 7/10/08 & requested to resume BCP(yasmin) after being off x 6 mo.  RTC 11/20/08 w/irregular menses.   Had self d/c'd BCP & thyroid med had been adjusted recently as well.  Contraception changed to nuvaring.  RTC 1/28/09 w/leg pain since 7/08, continued irregular menses & UTI s/s.  Had self d/c nuvaring & bcp.  Recently dx w/Hashimoto's thyroiditis  05/07/09 Received Internal Medicine records 12/10/07-01/14/09 FINAL DX: Hypothyroidism Well patient visits. Adjustment of levothyroxine dosage
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Kidney infection, Menstrual disorder, Pain, Pain in extremity, Sleep disorder
Clinical narrative: I had my first injection on 7/10/2008.  Since my second injection (9/26/2008), I haven't had a regular menstrual cycle, even while on birth control.  I am very tired and weak all the time. I was also diagnosed with autoimmune thyroiditis (10/20/2008). Prior to the injection, I had hypothyroidism. I have had urinary tract infections/kidney infections.  I have had pain in my left hip area/leg and back. The pain shoots down my left leg, also injection leg. The pain is so annoying and constant it keeps me up at night.  2/2/09 Received OB/GYN medical records 7/10/08-1/28/2009. FINAL DX: dysuria, irregular menses Records reveal patient experienced good health on 7/10/08 & requested to resume BCP(yasmin) after being off x 6 mo.  RTC 11/20/08 w/irregular menses.   Had self d/c'd BCP & thyroid med had been adjusted recently as well.  Contraception changed to nuvaring.  RTC 1/28/09 w/leg pain since 7/08, continued irregular menses & UTI s/s.  Had self d/c nuvaring & bcp.  Recently dx w/Hashimoto's thyroiditis  05/07/09 Received Internal Medicine records 12/10/07-01/14/09 FINAL DX: Hypothyroidism Well patient visits. Adjustment of levothyroxine dosage
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Urinary tract infection
Clinical narrative: I had my first injection on 7/10/2008.  Since my second injection (9/26/2008), I haven't had a regular menstrual cycle, even while on birth control.  I am very tired and weak all the time. I was also diagnosed with autoimmune thyroiditis (10/20/2008). Prior to the injection, I had hypothyroidism. I have had urinary tract infections/kidney infections.  I have had pain in my left hip area/leg and back. The pain shoots down my left leg, also injection leg. The pain is so annoying and constant it keeps me up at night.  2/2/09 Received OB/GYN medical records 7/10/08-1/28/2009. FINAL DX: dysuria, irregular menses Records reveal patient experienced good health on 7/10/08 & requested to resume BCP(yasmin) after being off x 6 mo.  RTC 11/20/08 w/irregular menses.   Had self d/c'd BCP & thyroid med had been adjusted recently as well.  Contraception changed to nuvaring.  RTC 1/28/09 w/leg pain since 7/08, continued irregular menses & UTI s/s.  Had self d/c nuvaring & bcp.  Recently dx w/Hashimoto's thyroiditis  05/07/09 Received Internal Medicine records 12/10/07-01/14/09 FINAL DX: Hypothyroidism Well patient visits. Adjustment of levothyroxine dosage
Age: 65.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Myalgia, Stomach discomfort
Clinical narrative: Upset Stomach, sore Muscles, joint pain
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Hypotonia, Loss of consciousness, Pallor, Skin warm, Syncope
Clinical narrative: Client received two vaccines after older sibling received vaccine. Client standing and awake and alert and putting on coat to leave facility when sibing apparently fainted.  About 2  minutes after sibling fainted, this client sat in chair and lost consiousness as well.  Eyes open, muscles flacid, skin warm and dry, color pale.  Client responded to gentle shaking of arm by RN and calling of name within 1 minute.  Gave client juice drink to sip and ice pack to back of neck.  Client remained under staff observation for another 15 minutes after incident occured. Mom instructed to feed client when returns home.  No other treatent administered.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging normal, Ultrasound scan normal
Clinical narrative: Left upper arm pain that remains severe in mid upper arm where the injection was given on left since 10/20/2008 flu shot. NSAIDs nto helpful. US neg for DVT. MRI neg.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: Mild cellulitis and soreness in left arm, where vaccine administered. treated with Tylenol and cold packs.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Heart rate, Loss of consciousness, Mydriasis, Neck pain
Clinical narrative: Within 5 minutes of receiving the Tdap immunization, patient had passed out on the floor and started seizureing. She convulsed for approximately 45 seconds. Her pupils were dilated and she seemed to be in a shock-like state staring off at nothing. After a few minutes, she was able to walk with assistance to a room where she could lay down. After 15 minutes, she felt much better but had pain and soreness in neck and in arm where the shot was administered. Blood pressure, pupils, heart rate were checked twice by Dr, then by nurse and I was told everything was ok. Neck and arm were very sore for 3 days. She was given Advil every 4-6 hours.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Staring
Clinical narrative: Within 5 minutes of receiving the Tdap immunization, patient had passed out on the floor and started seizureing. She convulsed for approximately 45 seconds. Her pupils were dilated and she seemed to be in a shock-like state staring off at nothing. After a few minutes, she was able to walk with assistance to a room where she could lay down. After 15 minutes, she felt much better but had pain and soreness in neck and in arm where the shot was administered. Blood pressure, pupils, heart rate were checked twice by Dr, then by nurse and I was told everything was ok. Neck and arm were very sore for 3 days. She was given Advil every 4-6 hours.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Anorexia, Chills, Crying, Cyanosis, Diarrhoea
Clinical narrative: Approximately 6 minutes after receiving the Tdap vaccine in left arm, patient had difficulty breathing and felt dizzy, nauseous, and light headed. I layed her down on the floor and wiped her face and neck down with a damp cloth. After a few minutes, she was helped into a wheel chair and taken to a room where she layed down. The Dr and nurse took her blood pressure twice and told me she was fine. Around her lips were still blue and the Dr told her she needed to lay down for a few more minutes. She had pain and soreness from her neck down her left arm and to her pointer finger. She was very sick of her stomach. I gave her a piece of ice and she felt better. We left about 10 minutes later, and she developed a headache, more nausea, chills and cried from the constant pain in her neck and arm. I gave her Advil. The next day she still had the pain in her neck and arm, and also diarrhea, headache, fatigue, chills, and loss of appetite. This lasted for 2 days.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Nausea
Clinical narrative: Approximately 6 minutes after receiving the Tdap vaccine in left arm, patient had difficulty breathing and felt dizzy, nauseous, and light headed. I layed her down on the floor and wiped her face and neck down with a damp cloth. After a few minutes, she was helped into a wheel chair and taken to a room where she layed down. The Dr and nurse took her blood pressure twice and told me she was fine. Around her lips were still blue and the Dr told her she needed to lay down for a few more minutes. She had pain and soreness from her neck down her left arm and to her pointer finger. She was very sick of her stomach. I gave her a piece of ice and she felt better. We left about 10 minutes later, and she developed a headache, more nausea, chills and cried from the constant pain in her neck and arm. I gave her Advil. The next day she still had the pain in her neck and arm, and also diarrhea, headache, fatigue, chills, and loss of appetite. This lasted for 2 days.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity, Stomach discomfort
Clinical narrative: Approximately 6 minutes after receiving the Tdap vaccine in left arm, patient had difficulty breathing and felt dizzy, nauseous, and light headed. I layed her down on the floor and wiped her face and neck down with a damp cloth. After a few minutes, she was helped into a wheel chair and taken to a room where she layed down. The Dr and nurse took her blood pressure twice and told me she was fine. Around her lips were still blue and the Dr told her she needed to lay down for a few more minutes. She had pain and soreness from her neck down her left arm and to her pointer finger. She was very sick of her stomach. I gave her a piece of ice and she felt better. We left about 10 minutes later, and she developed a headache, more nausea, chills and cried from the constant pain in her neck and arm. I gave her Advil. The next day she still had the pain in her neck and arm, and also diarrhea, headache, fatigue, chills, and loss of appetite. This lasted for 2 days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Tinnitus
Clinical narrative: PT CLAIMS TO HAVE FLU AFTER 3 DAYS OF RECEIVING VACCINE AND ABOUT AFTER 5 DAYS SHE DEVELOPED TINNITUS AND PATIENT THINKS THAT THIS MIGHT BE RELATED TO THE VACCINE
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt Received Anthrax vaccine 10 Dec 2008, # 3 of 6 shots. Pt found that she was pregnant on 13 Jan 2009. Pt had no reaction to the Vaccine.  Reporting for administrative reasons.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Blood pressure increased, Drug exposure during pregnancy, Pregnancy induced hypertension
Clinical narrative: Pt Received Anthrax vaccine 10 Dec 2008, # 3 of 6 shots. Pt found that she was pregnant on 13 Jan 2009. Pt had no reaction to the Vaccine.  Reporting for administrative reasons.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site haematoma, Injection site pain, Injection site streaking
Clinical narrative: Redness, swelling, heat, bruising & pain at injection site,  along with headache. Patient also stated a red band from injection site down the back of her arm. Patient reported symptoms two days, (48 hrs.), after receiving vaccine. Instructed patient to report symptoms to her physician. Followed up with patient 24 hrs. later. Patient reported that Dr. had prescribed antibiotic, and that the symptoms where subsiding.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat, bruising & pain at injection site,  along with headache. Patient also stated a red band from injection site down the back of her arm. Patient reported symptoms two days, (48 hrs.), after receiving vaccine. Instructed patient to report symptoms to her physician. Followed up with patient 24 hrs. later. Patient reported that Dr. had prescribed antibiotic, and that the symptoms where subsiding.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood immunoglobulin G normal, Dyspnoea, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: approximately 3-6 wks after vaccination number 2 in september 2008. i had migraines, nausea, vomitting, fatique with no probable cause that lasted 3-4 times a week for about 3 months. followed by severe sob with no probable cause in jan 2009. i recieved vaccine number 3, 3 days ago and pain and redness at injection site.shortness of breath continues. no other symptoms have occured since 3rd vaccination
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Migraine, Nausea, Vomiting
Clinical narrative: approximately 3-6 wks after vaccination number 2 in september 2008. i had migraines, nausea, vomitting, fatique with no probable cause that lasted 3-4 times a week for about 3 months. followed by severe sob with no probable cause in jan 2009. i recieved vaccine number 3, 3 days ago and pain and redness at injection site.shortness of breath continues. no other symptoms have occured since 3rd vaccination
Age: 17.0
Sex: F
Vaccine: VARCEL, HPV4, VARCEL
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: Localized inflamation at injection site, with increasing cellulitis
Age: 17.0
Sex: F
Vaccine: VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Localized inflamation at injection site, with increasing cellulitis
Age: 23.0
Sex: F
Vaccine: HEP, HEPA, HPV4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 12X12 can area of redness + swelling +warm painful to touch on Rt med thigh esp where TETNUS / ADACEL was given GARDASIL suspect + TDAP.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: Patient had injury to left arm and came to clinic requesting a TD.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling at injection site; some itching in body.  Recommended Benadryl and then pt to medical center if anything else.
Age: 18.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Patient presented in Health Department one day after receiving Tdap. C/O back pain in Left deltoid. Slightly red at injection site. No swelling noted.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: TDAP administered 1-21-09 pt wife notified us that w/in a few days he had broke out in rash on trunk which then spread, treated w/OTC Benadryl.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Hives + fever on arms and legs 1/21, woke up 1/22 with very bad rash on right lower leg. Seen by PCP 1/22 treated with BENADRYL for rash and TYLENOL for fever.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Started with redness on 01/23/09 and severe pain and redness which increased with time. Was very red, swollen and painful and spread to elbow 1/25/09. Seen 1/26 and was decreasing - Is recovering
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Body temperature increased, Full blood count normal, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Large red swollen area at injection site, hot to touch very itchy- 104 degrees-105 degrees Temp.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site warmth, Streptococcal identification test negative
Clinical narrative: Large red swollen area at injection site, hot to touch very itchy- 104 degrees-105 degrees Temp.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Localized reaction to MMR & VARIVAX - Lo causing erythema onis
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with GARDASIL (Lot # not reported). After patient received the vaccine, she died. The patient sought unspecified medical attention. The reporting physician considered died after GARDASIL  to be immediately life-threatening. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Abortion spontaneous, Blood test, Drug exposure during pregnancy, Dysmenorrhoea, Thrombosis
Clinical narrative: 26 y/o, 12 wk EGA SM inadvertently administered FLUMIST by tech @ Immunization clinic.  Pregnancy question on screening form not answered by patient or signed by tech.  Dr. notified call center 15 Jan 09 that SM had a spontaneous miscarriage on 12 JAN 09 @ 17 weeks gestation.  Vaginal spotting began the afternoon that the FLUMIST was administered (12/08/08) and continued through termination of pregnancy.  This is the member's third pregnancy.  She had an elective abortion at age 16 and a spontaneous miscarriage at age 19.
Age: 26.0
Sex: F
Vaccine: FLUN3
Symptoms: Ultrasound scan abnormal, Vaginal haemorrhage
Clinical narrative: 26 y/o, 12 wk EGA SM inadvertently administered FLUMIST by tech @ Immunization clinic.  Pregnancy question on screening form not answered by patient or signed by tech.  Dr. notified call center 15 Jan 09 that SM had a spontaneous miscarriage on 12 JAN 09 @ 17 weeks gestation.  Vaginal spotting began the afternoon that the FLUMIST was administered (12/08/08) and continued through termination of pregnancy.  This is the member's third pregnancy.  She had an elective abortion at age 16 and a spontaneous miscarriage at age 19.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthma, Blood culture negative, Consciousness fluctuating, Cough, Culture stool negative
Clinical narrative: A serious post-marketed study report of dehydration, pneumonia and acute gastroenteritis has been received from a study investigator concerning a three-year old female subject, patient ID 43450393, participating in a post-marketing study. The subject's past medical history includes asthma beginning 21-Nov-2005 and previous hospitalization for asthma and pneumonia in May 2006. Concomitant medications include albuterol and fluticasone propionate since 2005. The subject received FLUMIST intranasal on 14-Dec-2008 for influenza immunization. On 05-Jan-2008 the subject presented with vomiting, lethargy, poor oral intake for three days and two loose non bloody stools the day before. The subject was seen in the pediatric clinic and diagnosed with viral gastroenteritis. A trial of clear fluid and PEDIALYTE was not successful and the vomiting persisted. The subject's mother was concerned as she seemed to go in and out of consciousness and slept a lot. The subject had a slight upper respiratory infection with symptoms of coughing. It was noted the subject had a recent history of a plane flight on 04-Jan-2008. On 05-Jan-2008 the subject was brought into the emergency department for evaluation and given 40 ml/kg fluid bolus, albuterol nebulizer, intravenous steroids and ipratropium inhalation. Lethargy persisted and the patient was hospitalized for dehydration and altered mental status with secondary diagnoses of asthma, viral gastroenteritis and pneumonia. By the second day of hospitalization the gastroenteritis and dehydration resolved and her mental status returned to normal. On 07-Jan-2008 the subject developed more respiratory symptoms consisting of cough and wheeze without fever. Asthma treatment was initiated and she responded well and was started on cefuroxime for possible bacterial pneumonia. The chest xray was normal although there was persistent left upper lobe rhonchi. The subjects RSV PCR was positive from 07-Jan-2008. The subject did not require supplemental oxygen during hospitalization. On the morning of 09-Jan-2008 the subject was stable and well appearing and her appetite was almost back to baseline along with her level of activity. The subject was discharged and was considered recovered from the events. The investigator assessed the events of dehydration, pneumonia and acute gastroenteritis as not related to FLUMIST and provided an alternative etiology of viral. The sponsor assessed the relationship of the events to FLUMIST as not related. Additional information was received on 16-Jan-2009 and incorporated into the narrative: medical history, clinical course.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Dehydration, Diarrhoea, Full blood count normal, Gastroenteritis, Gastroenteritis viral
Clinical narrative: A serious post-marketed study report of dehydration, pneumonia and acute gastroenteritis has been received from a study investigator concerning a three-year old female subject, patient ID 43450393, participating in a post-marketing study. The subject's past medical history includes asthma beginning 21-Nov-2005 and previous hospitalization for asthma and pneumonia in May 2006. Concomitant medications include albuterol and fluticasone propionate since 2005. The subject received FLUMIST intranasal on 14-Dec-2008 for influenza immunization. On 05-Jan-2008 the subject presented with vomiting, lethargy, poor oral intake for three days and two loose non bloody stools the day before. The subject was seen in the pediatric clinic and diagnosed with viral gastroenteritis. A trial of clear fluid and PEDIALYTE was not successful and the vomiting persisted. The subject's mother was concerned as she seemed to go in and out of consciousness and slept a lot. The subject had a slight upper respiratory infection with symptoms of coughing. It was noted the subject had a recent history of a plane flight on 04-Jan-2008. On 05-Jan-2008 the subject was brought into the emergency department for evaluation and given 40 ml/kg fluid bolus, albuterol nebulizer, intravenous steroids and ipratropium inhalation. Lethargy persisted and the patient was hospitalized for dehydration and altered mental status with secondary diagnoses of asthma, viral gastroenteritis and pneumonia. By the second day of hospitalization the gastroenteritis and dehydration resolved and her mental status returned to normal. On 07-Jan-2008 the subject developed more respiratory symptoms consisting of cough and wheeze without fever. Asthma treatment was initiated and she responded well and was started on cefuroxime for possible bacterial pneumonia. The chest xray was normal although there was persistent left upper lobe rhonchi. The subjects RSV PCR was positive from 07-Jan-2008. The subject did not require supplemental oxygen during hospitalization. On the morning of 09-Jan-2008 the subject was stable and well appearing and her appetite was almost back to baseline along with her level of activity. The subject was discharged and was considered recovered from the events. The investigator assessed the events of dehydration, pneumonia and acute gastroenteritis as not related to FLUMIST and provided an alternative etiology of viral. The sponsor assessed the relationship of the events to FLUMIST as not related. Additional information was received on 16-Jan-2009 and incorporated into the narrative: medical history, clinical course.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Hypersomnia, Hypophagia, Lethargy, Mental status changes, Pneumonia
Clinical narrative: A serious post-marketed study report of dehydration, pneumonia and acute gastroenteritis has been received from a study investigator concerning a three-year old female subject, patient ID 43450393, participating in a post-marketing study. The subject's past medical history includes asthma beginning 21-Nov-2005 and previous hospitalization for asthma and pneumonia in May 2006. Concomitant medications include albuterol and fluticasone propionate since 2005. The subject received FLUMIST intranasal on 14-Dec-2008 for influenza immunization. On 05-Jan-2008 the subject presented with vomiting, lethargy, poor oral intake for three days and two loose non bloody stools the day before. The subject was seen in the pediatric clinic and diagnosed with viral gastroenteritis. A trial of clear fluid and PEDIALYTE was not successful and the vomiting persisted. The subject's mother was concerned as she seemed to go in and out of consciousness and slept a lot. The subject had a slight upper respiratory infection with symptoms of coughing. It was noted the subject had a recent history of a plane flight on 04-Jan-2008. On 05-Jan-2008 the subject was brought into the emergency department for evaluation and given 40 ml/kg fluid bolus, albuterol nebulizer, intravenous steroids and ipratropium inhalation. Lethargy persisted and the patient was hospitalized for dehydration and altered mental status with secondary diagnoses of asthma, viral gastroenteritis and pneumonia. By the second day of hospitalization the gastroenteritis and dehydration resolved and her mental status returned to normal. On 07-Jan-2008 the subject developed more respiratory symptoms consisting of cough and wheeze without fever. Asthma treatment was initiated and she responded well and was started on cefuroxime for possible bacterial pneumonia. The chest xray was normal although there was persistent left upper lobe rhonchi. The subjects RSV PCR was positive from 07-Jan-2008. The subject did not require supplemental oxygen during hospitalization. On the morning of 09-Jan-2008 the subject was stable and well appearing and her appetite was almost back to baseline along with her level of activity. The subject was discharged and was considered recovered from the events. The investigator assessed the events of dehydration, pneumonia and acute gastroenteritis as not related to FLUMIST and provided an alternative etiology of viral. The sponsor assessed the relationship of the events to FLUMIST as not related. Additional information was received on 16-Jan-2009 and incorporated into the narrative: medical history, clinical course.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Respiratory syncytial virus test positive, Upper respiratory tract infection, Vomiting, Wheezing
Clinical narrative: A serious post-marketed study report of dehydration, pneumonia and acute gastroenteritis has been received from a study investigator concerning a three-year old female subject, patient ID 43450393, participating in a post-marketing study. The subject's past medical history includes asthma beginning 21-Nov-2005 and previous hospitalization for asthma and pneumonia in May 2006. Concomitant medications include albuterol and fluticasone propionate since 2005. The subject received FLUMIST intranasal on 14-Dec-2008 for influenza immunization. On 05-Jan-2008 the subject presented with vomiting, lethargy, poor oral intake for three days and two loose non bloody stools the day before. The subject was seen in the pediatric clinic and diagnosed with viral gastroenteritis. A trial of clear fluid and PEDIALYTE was not successful and the vomiting persisted. The subject's mother was concerned as she seemed to go in and out of consciousness and slept a lot. The subject had a slight upper respiratory infection with symptoms of coughing. It was noted the subject had a recent history of a plane flight on 04-Jan-2008. On 05-Jan-2008 the subject was brought into the emergency department for evaluation and given 40 ml/kg fluid bolus, albuterol nebulizer, intravenous steroids and ipratropium inhalation. Lethargy persisted and the patient was hospitalized for dehydration and altered mental status with secondary diagnoses of asthma, viral gastroenteritis and pneumonia. By the second day of hospitalization the gastroenteritis and dehydration resolved and her mental status returned to normal. On 07-Jan-2008 the subject developed more respiratory symptoms consisting of cough and wheeze without fever. Asthma treatment was initiated and she responded well and was started on cefuroxime for possible bacterial pneumonia. The chest xray was normal although there was persistent left upper lobe rhonchi. The subjects RSV PCR was positive from 07-Jan-2008. The subject did not require supplemental oxygen during hospitalization. On the morning of 09-Jan-2008 the subject was stable and well appearing and her appetite was almost back to baseline along with her level of activity. The subject was discharged and was considered recovered from the events. The investigator assessed the events of dehydration, pneumonia and acute gastroenteritis as not related to FLUMIST and provided an alternative etiology of viral. The sponsor assessed the relationship of the events to FLUMIST as not related. Additional information was received on 16-Jan-2009 and incorporated into the narrative: medical history, clinical course.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram, Diagnostic procedure, Eye swelling, Facial pain, Headache
Clinical narrative: Pt recieved a flu shot 12/15/08. 7 days later he developed cold like symptoms which only lasted 3 days and developed into facial swelling and what he described as a smudge over his right eye. By 1/2/09 25% of his vision was gone. By 1/15/09 he has totally lost his vision in the right eye which he described as having a "tan nylon stocking over the eye".  He "can see through it but it is mottled with lighter and more dense areas that impede his vision". On 1/4, 1/5 and 1/8 he saw his eye doctor (these reports will be sent to you). On 1/8 he was also seen by PCP.  A CT of the orbits was done 1/9/09 and an MRI on 1/14/09 (both will be forwarded).  On 1/22/09 he was seen by Dr. (report will be forwarded) and on 1/27/09 he was back in our office with continued complaints of vision loss, needle like pain in ear, pins and needle feeling over body. To-date his symptoms remain the same.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia facial, Nuclear magnetic resonance imaging, Swelling face, Visual acuity reduced, Visual field defect
Clinical narrative: Pt recieved a flu shot 12/15/08. 7 days later he developed cold like symptoms which only lasted 3 days and developed into facial swelling and what he described as a smudge over his right eye. By 1/2/09 25% of his vision was gone. By 1/15/09 he has totally lost his vision in the right eye which he described as having a "tan nylon stocking over the eye".  He "can see through it but it is mottled with lighter and more dense areas that impede his vision". On 1/4, 1/5 and 1/8 he saw his eye doctor (these reports will be sent to you). On 1/8 he was also seen by PCP.  A CT of the orbits was done 1/9/09 and an MRI on 1/14/09 (both will be forwarded).  On 1/22/09 he was seen by Dr. (report will be forwarded) and on 1/27/09 he was back in our office with continued complaints of vision loss, needle like pain in ear, pins and needle feeling over body. To-date his symptoms remain the same.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blindness unilateral, Computerised tomogram, Ear pain, Nasopharyngitis, Nuclear magnetic resonance imaging
Clinical narrative: Pt recieved a flu shot 12/15/08. 7 days later he developed cold like symptoms which only lasted 3 days and developed into facial swelling and what he described as a smudge over his right eye. By 1/2/09 25% of his vision was gone. By 1/15/09 he has totally lost his vision in the right eye which he described as having a "tan nylon stocking over the eye".  He "can see through it but it is mottled with lighter and more dense areas that impede his vision". On 1/4, 1/5 and 1/8 he saw his eye doctor (these reports will be sent to you). On 1/8 he was also seen by PCP.  A CT of the orbits was done 1/9/09 and an MRI on 1/14/09 (both will be forwarded).  On 1/22/09 he was seen by Dr. (report will be forwarded) and on 1/27/09 he was back in our office with continued complaints of vision loss, needle like pain in ear, pins and needle feeling over body. To-date his symptoms remain the same.
Age: 65.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Swelling face, Vision blurred
Clinical narrative: Pt recieved a flu shot 12/15/08. 7 days later he developed cold like symptoms which only lasted 3 days and developed into facial swelling and what he described as a smudge over his right eye. By 1/2/09 25% of his vision was gone. By 1/15/09 he has totally lost his vision in the right eye which he described as having a "tan nylon stocking over the eye".  He "can see through it but it is mottled with lighter and more dense areas that impede his vision". On 1/4, 1/5 and 1/8 he saw his eye doctor (these reports will be sent to you). On 1/8 he was also seen by PCP.  A CT of the orbits was done 1/9/09 and an MRI on 1/14/09 (both will be forwarded).  On 1/22/09 he was seen by Dr. (report will be forwarded) and on 1/27/09 he was back in our office with continued complaints of vision loss, needle like pain in ear, pins and needle feeling over body. To-date his symptoms remain the same.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Local reaction
Clinical narrative: Local reaction to Tdap
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Culture stool negative, Diarrhoea, Faeces discoloured, Flatulence, Irritability
Clinical narrative: Baby was fussy and very gassy for 2 days following vaccine.  Day 3 brought diarrhea 10-15 times a day, watery, green, positive for occult blood, no frank blood seen.  All stool studies were negative.  Diarrhea lasted for 6 days.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Occult blood positive
Clinical narrative: Baby was fussy and very gassy for 2 days following vaccine.  Day 3 brought diarrhea 10-15 times a day, watery, green, positive for occult blood, no frank blood seen.  All stool studies were negative.  Diarrhea lasted for 6 days.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: redness, inflammation and pain at injection site extending 4" from site and half-way around arm. Pt told to apply cold compresses x1 day then warm compresses the next
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Presented 1/27/09 with Zoster L1 dermatome.Recieved Varivax 4/27/04 and ProQuad 11/14/06