chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Patient developed rash on face with bumps along with rash on arms & legs within 2 minutes of receiving all 6 vaccines. Doctor evaluated patient was given ORAPRED and monitor for 45 mins in office.
Age: 0.39
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Body temperature increased
Clinical narrative: Rec'd phone call 803A 3.10.11 mother of above infant. Immunization rec'd 3.9.11 at 1pm at 5pm noted baby warm temp 98.9, Rec'd - 4 mL inf TYLENOL and tepid bath. 8pm temp 102. Increased use cool towel on head. Mom and inf slept from 8pm - 5A at 5AM temp 102.9 cool towels 8AM - temp 100.3. No doctor 3.10.11 ref to clinic. No medical insurance.
Age: 76.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: Client states that a week after he received the vaccine he noticed it was swollen, red and sore. He states the site on the left deltoid has continued to be red, swollen, and tender. A reddened area approximately 15mm noted with a 4 mm scabbed area in the middle noted on left deltoid.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Injection site cellulitis
Clinical narrative: Pt developed a cellulitis to site of injection measuring 7-8cm in diameter - (L) arm (deltoid) started on BACTRIM DS 1 twice a day x 10 days.
Age: 15.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: None per group home. 3 Hep A's given (inadvertently) Misadministration rather than any adverse event.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy test, Blood immunoglobulin A, Chest discomfort, Computerised tomogram, Condition aggravated
Clinical narrative: Vaccinated 08/03/2009 at work; from this time to early Spring to early Summer increased SOB, coughing, chest discomfort, intermittent dizziness then in Sept '09 extreme fatigue activity intolerance & exacerbation of above symptoms, XS antibiotics. Referrals to cardiologist, pulmonologist, allergist. Lab testing, X-rays, radiology.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Decreased activity, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Vaccinated 08/03/2009 at work; from this time to early Spring to early Summer increased SOB, coughing, chest discomfort, intermittent dizziness then in Sept '09 extreme fatigue activity intolerance & exacerbation of above symptoms, XS antibiotics. Referrals to cardiologist, pulmonologist, allergist. Lab testing, X-rays, radiology.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Pulmonary function test, X-ray
Clinical narrative: Vaccinated 08/03/2009 at work; from this time to early Spring to early Summer increased SOB, coughing, chest discomfort, intermittent dizziness then in Sept '09 extreme fatigue activity intolerance & exacerbation of above symptoms, XS antibiotics. Referrals to cardiologist, pulmonologist, allergist. Lab testing, X-rays, radiology.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Red, swollen, bump on (L)-(R) leg 2 cm around inj site bil.
Age: 0.41
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Pyrexia, Rash macular
Clinical narrative: 2 hrs. after receiving 4 month old vaccine child with generalized erythematous macular rash with subjective fever.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Feeling abnormal, Injection site erythema, Injection site pain
Clinical narrative: Pt developed fever up to 101.3 evening of vaccination to (L) arm. General malaise, chills. Pt had significant cellulitis of upper requiring IM & PO antibiotics. ROCEPHIN IM & AUGMENTIN 875mg bid x 10 days & Prednisone 40mg x 5 days. Required 2 office visits. Had complete recovery. See attached OV notes. The patient is a 24-year-old female who presents to the office today with onset of fever last evening of 101.3 axillary which was persisted through the night and today. She has generalized malaise and chills, feeling like she got "hit by a bus". Her upper right arm is gradually getting more tender and sore. She looked at it at the time of the office visit and noticed that it was red. She did receive PNEUMOVAX immunization in this office yesterday in that arm. She is mildly nauseous. No vomiting, diarrhea, runny nose, cough, cold, or sore throat symptoms. The patient is a 24-year-old female who is here today for followup on a fairly significant brisk cellulitis from a PNEUMOVAX immunization that was received on 01/25/2011. She voices that overall, she is feeling 75% better. Has not had fever since being in the office yesterday. Really began to feel better approximately 9:00 last evening. She has had no further body aches, chills, nausea, or general malaise. She voiced that her arm is still slightly sore and tender but is also improving. She is utilizing the BENADRYL as we had discussed and also has started on the AUGMENTIN and prednisone. Denies other symptoms.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt developed fever up to 101.3 evening of vaccination to (L) arm. General malaise, chills. Pt had significant cellulitis of upper requiring IM & PO antibiotics. ROCEPHIN IM & AUGMENTIN 875mg bid x 10 days & Prednisone 40mg x 5 days. Required 2 office visits. Had complete recovery. See attached OV notes. The patient is a 24-year-old female who presents to the office today with onset of fever last evening of 101.3 axillary which was persisted through the night and today. She has generalized malaise and chills, feeling like she got "hit by a bus". Her upper right arm is gradually getting more tender and sore. She looked at it at the time of the office visit and noticed that it was red. She did receive PNEUMOVAX immunization in this office yesterday in that arm. She is mildly nauseous. No vomiting, diarrhea, runny nose, cough, cold, or sore throat symptoms. The patient is a 24-year-old female who is here today for followup on a fairly significant brisk cellulitis from a PNEUMOVAX immunization that was received on 01/25/2011. She voices that overall, she is feeling 75% better. Has not had fever since being in the office yesterday. Really began to feel better approximately 9:00 last evening. She has had no further body aches, chills, nausea, or general malaise. She voiced that her arm is still slightly sore and tender but is also improving. She is utilizing the BENADRYL as we had discussed and also has started on the AUGMENTIN and prednisone. Denies other symptoms.
Age: 81.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: Redness & itching below injection site. Cold compress & hydrocortisone cream used.
Age: 4.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site warmth, Pyrexia, Vaccination site swelling
Clinical narrative: Fever, pain, swelling at vaccine site. Improved the following day 3-9-11 with treatment of BENADRYL & TYLENOL.
Age: 1.91
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC13
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Friday morning 02/25/2011 had a dime size swelling at the injection site, that night increased to a nickle size and Saturday Left thigh was double in size and had a fever of 104.  Monday 2/28/11 went to see their family MD.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B, Hepatitis B DNA assay positive, No therapeutic response, Polymerase chain reaction, Vaccination failure
Clinical narrative: This case was reported by a physician and described the occurrence of vaccination failure in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose, 3rd dose and 4th dose of ENGERIX B (unknown). On an unspecified date, four years after 1st dose, 2nd dose, 3rd dose vaccination with ENGERIX B, the subject experienced not responding to therapy. The subject then received a Booster dose, one month after the Booster (4th) dose of ENGERIX B the subject experienced presence of DNA PCR load (hepatitis b dna detectable), possible hepatitis b or vaccine not effective. This case was assessed as medically serious by GSK. At the time of reporting the outcome of vaccination failure, possible hepatitis b, not responding to therapy and hepatitis b dna detectable was unspecified.
Age: 1.29
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Aphasia, Condition aggravated, Drooling, Hypotonia, Lethargy
Clinical narrative: Initial report received from a consumer's parent on 04 March 2011. A 15 month-old female patient with a history of asthma, received on 08 October 2010 an injection (route and site not reported) of FLUZONE, sanofi pasteur Inc. lot number U3581BA, an injection of TRIPEDIA, sanofi pasteur Inc. lot number U3470CA, an injection (route and site not reported) of ACTHIB, sanofi pasteur SA lot number E0833-1 and sanofi pasteur Inc. UH122AB, and injection (route and site not reported) of MMR, Merck lot number 0578Z. She had no known allergies and took no other medications. It was not reported if the patient had any illnesses at the time of vaccination. The mother reported that the patient in the past had "minor" fevers associated with childhood vaccine series. On 19 October 2010, the patient had a fever (temperature not reported) and vomited. On 20 October 2010, the mother found the patient in the bed with eyes open, lethargic, no muscle tone in arms and legs, drooling, unresponsive, no reaction to the mother, could not focus and could not talk. The patient had no fever on 20 October 2010. The patient was seen the Emergency Room (ER) and hospitalized for several days. The mother stated that the physician did not call this a seizure since a seizure was not witnessed by anyone. The diagnosis was possible restrictive airway disease. The outcome was reported as recovered. The report in this case is the same as case 2011-00987. Documents held by sender: None.
Age: 1.29
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR
Symptoms: Pyrexia, Staring, Unresponsive to stimuli, Vision blurred, Vomiting
Clinical narrative: Initial report received from a consumer's parent on 04 March 2011. A 15 month-old female patient with a history of asthma, received on 08 October 2010 an injection (route and site not reported) of FLUZONE, sanofi pasteur Inc. lot number U3581BA, an injection of TRIPEDIA, sanofi pasteur Inc. lot number U3470CA, an injection (route and site not reported) of ACTHIB, sanofi pasteur SA lot number E0833-1 and sanofi pasteur Inc. UH122AB, and injection (route and site not reported) of MMR, Merck lot number 0578Z. She had no known allergies and took no other medications. It was not reported if the patient had any illnesses at the time of vaccination. The mother reported that the patient in the past had "minor" fevers associated with childhood vaccine series. On 19 October 2010, the patient had a fever (temperature not reported) and vomited. On 20 October 2010, the mother found the patient in the bed with eyes open, lethargic, no muscle tone in arms and legs, drooling, unresponsive, no reaction to the mother, could not focus and could not talk. The patient had no fever on 20 October 2010. The patient was seen the Emergency Room (ER) and hospitalized for several days. The mother stated that the physician did not call this a seizure since a seizure was not witnessed by anyone. The diagnosis was possible restrictive airway disease. The outcome was reported as recovered. The report in this case is the same as case 2011-00987. Documents held by sender: None.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Acute myeloid leukaemia, Anaemia, Full blood count abnormal, Haematocrit decreased, Haemoglobin
Clinical narrative: Information has been received from a physician concerning a 75 year old female on 16-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported).  Concomitant therapy included losartan potassium (manufacture unknown), ibuprofen, simvastatin (manufacture unknown), aspirin, L-Thyroxin.  The patient developed monocytosis and anemia after administration of ZOSTAVAX (Merck).  On 28-FEB-2011 the patient reported to the office complaining of malaise.  A complete blood count revealed White blood count 13,200, Hemoglobin 9.8, Hematocrit 29.9, monocyte 72%, lymphocytes 18%, neutrophils 7.1%.  A preliminary diagnosis of acute myeloid leukemia was made.  The patient was given unspecified treatment.  The patient was scheduled to see an unspecified hematologist later "today", 02-MAR-2011.  As of the reporting time, the patient present status was unknown.  Upon internal review, acute myeloid leukemia considered to be an other important medical event.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphocyte percentage decreased, Malaise, Monocyte percentage increased, Monocytosis, Neutrophil percentage decreased
Clinical narrative: Information has been received from a physician concerning a 75 year old female on 16-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported).  Concomitant therapy included losartan potassium (manufacture unknown), ibuprofen, simvastatin (manufacture unknown), aspirin, L-Thyroxin.  The patient developed monocytosis and anemia after administration of ZOSTAVAX (Merck).  On 28-FEB-2011 the patient reported to the office complaining of malaise.  A complete blood count revealed White blood count 13,200, Hemoglobin 9.8, Hematocrit 29.9, monocyte 72%, lymphocytes 18%, neutrophils 7.1%.  A preliminary diagnosis of acute myeloid leukemia was made.  The patient was given unspecified treatment.  The patient was scheduled to see an unspecified hematologist later "today", 02-MAR-2011.  As of the reporting time, the patient present status was unknown.  Upon internal review, acute myeloid leukemia considered to be an other important medical event.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 75 year old female on 16-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported).  Concomitant therapy included losartan potassium (manufacture unknown), ibuprofen, simvastatin (manufacture unknown), aspirin, L-Thyroxin.  The patient developed monocytosis and anemia after administration of ZOSTAVAX (Merck).  On 28-FEB-2011 the patient reported to the office complaining of malaise.  A complete blood count revealed White blood count 13,200, Hemoglobin 9.8, Hematocrit 29.9, monocyte 72%, lymphocytes 18%, neutrophils 7.1%.  A preliminary diagnosis of acute myeloid leukemia was made.  The patient was given unspecified treatment.  The patient was scheduled to see an unspecified hematologist later "today", 02-MAR-2011.  As of the reporting time, the patient present status was unknown.  Upon internal review, acute myeloid leukemia considered to be an other important medical event.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Dyspnoea, Haemorrhage, Nervous system disorder
Clinical narrative: Information has been received from a physician concerning a male child patient who approximately 5-6 month ago, in September 2010, shortly following the birth, was vaccinated with a pediatric/adolescent dose of RECOMBIVAX HB (lot number not provided).  It was reported that the patient was vaccinated and developed seizures and difficulty breathing approximately 6-8 hour later, in the hospital.  Physician reported that the child was diagnosed with "CNS bleeding".  On an unspecified date, the patient appeared to have recovered, though the long term effects were not assessable at that time.  Upon internal review CNS bleeding was considered to be other important medical event.  No further information is available.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: cellulitis
Age: 3.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 2 inch red, raised area on right thigh, hot/pain to touch. Denies fever. Given Tylenol/ibuprofen for pain.  Dtap given in the right thigh and MMR/Varicella in the left thigh.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoaesthesia facial, Injection site anaesthesia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Progressive numbness developed at site of injection in left deltoid area. Spread down to fingers of left hand, up side of neck on left and onto left side of face. Progressed to maximum area over two week period, lasted about 2 weeks, then retreated spontaneously over 2-3 weeks.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood culture, Chest X-ray, Crying, Culture, Culture urine
Clinical narrative: Crying, fever of 104. Fussiness. E.R. Tx - TYLENOL F/U with Dr.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Full blood count, Influenza virus test, Irritability, Metabolic function test, Pyrexia
Clinical narrative: Crying, fever of 104. Fussiness. E.R. Tx - TYLENOL F/U with Dr.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Respiratory syncytial virus test, Urine analysis
Clinical narrative: Crying, fever of 104. Fussiness. E.R. Tx - TYLENOL F/U with Dr.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Injection site warmth
Clinical narrative: Pt. was given vaccine on 3/4/11, came back in to office 3/8/11 with approximately 4in x 4in circular - warm area to L thigh Mom said gradually got bigger over past few day. Tx with AUGMENTIN for cellulitis.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Received injection (flu) at school Nov 8, 2010. Had pain and a little redness at site. Mother stated about a week later a lump formed & there is pain at the lump. Went to Pediatrician and pediatrician not sure so referred to dermatologist. Waiting for approval from agency.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Vaccine positive rechallenge
Clinical narrative: 33 female who has had the flu-shot today at 8 am. She now states she is itching, there is no visible rash. She had similar itching last year after the shot and the a visible hives the next morning and had visible hives. She today slowly develops itching this afternoon, there is no lip swelling, mental status change, wheezing nausea or other sign of allergy. Symptoms began gradually and she finished some of her duties then presents to the Emergency Department as and arm of the Employee Health Clinic. Had the same symptoms last year that resolved with diphenhydramine, but did not like the sedation with diphenhydramine. Ranitidine was dispensed with recurrence of symptoms not found in notes.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: Intially came to Public Health reporting nausea, vomiting x1.  Body aches and sore right arm.  Reviewed VIS.  Advised to seek medical care if persists.  Returned to PH 3/10/2011 reporting she still has constant dull pain in right arm radiating to fingers.  Has seen medical provider who sent back to PH.  Taking ibuprofen and Vicodin for pain.  Reports today felt a "twang" at time of administration that went to two middle fingers and small finger.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Vaccination site pain, Vaccination site rash
Clinical narrative: Patient experienced vaccine site reaction resulting in very bad pain, skin itching and skin pain. She also developed a moderate rash and used VALTREX to treat it. Resolved quickly.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture negative, Campylobacter test positive, Computerised tomogram head, Computerised tomogram normal, Culture stool positive
Clinical narrative: 5 hypotonic/hyporesponsive episodes starting 3-4 hrs post immunizations, ending  21 hrs after vaccines. 4 episodes associated with vomiting & diarrhea, 5th was not. Stool cx had no WBC, (-) campylobacter Ag but culture grew campylobacter. Remainder of work up including CBC, blood Cx, LP, culture, urine, EEG, head CT all neg. Pt was started on KEPPRA but episodes had already stopped.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Electroencephalogram normal, Full blood count normal, Hypotonic-hyporesponsive episode, Lumbar puncture normal
Clinical narrative: 5 hypotonic/hyporesponsive episodes starting 3-4 hrs post immunizations, ending  21 hrs after vaccines. 4 episodes associated with vomiting & diarrhea, 5th was not. Stool cx had no WBC, (-) campylobacter Ag but culture grew campylobacter. Remainder of work up including CBC, blood Cx, LP, culture, urine, EEG, head CT all neg. Pt was started on KEPPRA but episodes had already stopped.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: 5 hypotonic/hyporesponsive episodes starting 3-4 hrs post immunizations, ending  21 hrs after vaccines. 4 episodes associated with vomiting & diarrhea, 5th was not. Stool cx had no WBC, (-) campylobacter Ag but culture grew campylobacter. Remainder of work up including CBC, blood Cx, LP, culture, urine, EEG, head CT all neg. Pt was started on KEPPRA but episodes had already stopped.
Age: 26.0
Sex: F
Vaccine: JEV1
Symptoms: Unevaluable event
Clinical narrative: Waiting under observation in Urgent Care Dept. 2 hours after injection IXIARO.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram, Guillain-Barre syndrome, Headache, Hypoaesthesia, Lumbar puncture
Clinical narrative: Guillain-Barre - h/a, numbness, plasmapheresis, rehab.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Plasmapheresis
Clinical narrative: Guillain-Barre - h/a, numbness, plasmapheresis, rehab.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 03/02/11 -> Tdap and ZOSTAVAX administered. 03/07/11 -> Pt. called - reports awakened with redness & swelling left deltoid area where Tdap given. Area about 3 in. round, red, tender. Satellite area of redness also noted about 1" round. Treated by PCP with KEFLEX and Prednisone.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Full blood count, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Cellulitis to (L) arm site red swollen & painful.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Injection site pain, Injection site pruritus, Swelling
Clinical narrative: Erythema and swelling; approximately 7 cm x 12 cm. Itchiness around the injection site. Pain over injection site and extending down the upper arm. Burning sensation at injection site and extending down arm. No treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Joint swelling, Rash, Rash pustular, Similar reaction on previous exposure to drug
Clinical narrative: Swelling of elbow and shoulder. Rash on neck. Pustule of shingles on cheek.
Age: 45.0
Sex: F
Vaccine: HEPAB, TDAP, YF
Symptoms: Body temperature increased, Gastrointestinal haemorrhage, Headache, Myalgia, Nausea
Clinical narrative: Day 4 s/p vaccinations developed T 103, GI bleeding, muscle pain, nausea, headache, hospitalized x 5 days at Med. Ctr. Was given IV steroids, antibiotics, acidophillus. Symptoms have now resolved.
Age: 1.63
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Incorrect drug dosage form administered
Clinical narrative: After I administered ACTHIB I realized I had just given the diluent. I did not mix. I gave a second injection of the ACTHIB & diluent mix. I called & spoke with immunization rep who suggested I fill out VAERS form.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Erythema, Injection site erythema, Rash, Rash macular
Clinical narrative: About 5-10 min after imz administered, mom brought her out of the room with a red, blotchy macular rash on her head, face, neck, trunk & (L) leg. No resp. distress or wheezing noted. Taking a bottle in NAD. There was a large red area in the (L) upper thigh where the PREVNAR & Hep B was given. After 15 min observation the rash was clearing & still no resp. symptoms. Inc mom to give ZYRTEC.
Age: 1.98
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left thigh induration measuring 10.5cm x 19cm, nontender, warm erythroderma around left thigh punctum, no vesicles, no pustules, no LA streaking, no inguinal LA, no other rashes. Improved w/ cool compresses.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case is 1 of a cluster of 3 patients who experienced similar adverse events following vaccination with MENACTRA. Initial report received from a health care professional on 25 May 2010. A 16-year-old female child, with no medical history, received the following injections on 18 May 2010: A right deltoid intramuscular injection of MENACTRA, lot number U3357BA, a left deltoid intramuscular injection of ADACEL, lot number sanofi pasteur Ltd. C3312 and lot number sanofi pasteur Inc. U3051AA, and subcutaneous injection to the right lateral upper arm of VARIVAX (Merck), lot number 1659Y. The patient developed redness, swelling, itchiness at the injection site on the right upper arm which was also warm to the touch on 19 May 2010. The patient was given AUGMENTIN for 10 days and BENADRYL for itching. The patient diagnosis was cellulitis. The outcome for the events was reported as recovered. Follow-up information was received from a health care professional on 19 July 2010 reported that the patient had zero (0) degree of limited mobility to the arm. The patient had no laboratory work ordered or needed. The outcome remained recovered for the events. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case is 1 of a cluster of 3 patients' who experienced similar adverse events following vaccination with MENACTRA. Initial report received from a health care professional on 25 May 2010. An 11-year-old male child, with cellulitis of the toe at time of vaccination and no other pre-existing medical history, receiving the following injections on 18 May 2010: A right deltoid intramuscular injection of MENACTRA, lot number U3357BA, and a left deltoid intramuscular injection of ADACEL, lot number sanofi pasteur Ltd. C3312 and lot number sanofi pasteur Inc. U3051AA. The patient developed redness, swelling, itchiness at the injection site on the right upper arm which was also warm to the touch. The patient was given AUGMENTIN for 10 days. The patient's diagnosis was cellulitis. The outcome for the events was reported as recovered. Follow-up information was received from a health care professional on 19 July 2010 reported that the patient had no limitation to the arms. The patient had no laboratory work ordered. The onset date for the event was reported as 20 May 2010. The outcome remained recovered for the events. Documents held by sender: None.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Malaise, Musculoskeletal stiffness
Clinical narrative: Initial reported received from a health care professional on 25 June 2010. A 13-year-old male patient, with no known allergies and no illness at the time of vaccination, received an intramuscular (IM) left arm injection on 22 June 2010 of MENACTRA, lot number U2933AA, and returned on 23 June 2010 to the doctors office with erythema at the injection site, malaise and stiffness in the arms and legs. The patient had no fever. The outcome was reported as not recovered. Follow-up information received on 21 July 2010 from a health care professional. The patient was reported to require no treatment, no further evaluation and recovered from the adverse events (erythema at the injection site, malaise and stiffness in the arms and legs) "the day after onset". The reporter requested no further follow-up. Follow-up information received on 23 July 2010 from a health care professional. The patient was reported by parent to be "100% better" as of 24 June 2010. According to reporter, they had no additional information at the time of the report. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional on 28 June 2010. A 22-year-old female patient, with no known allergies, no illness at the time of vaccination and medical history not available, received on 25 June 2010 an intramuscular injection to the left deltoid of MENACTRA, lot number U3081AA. On 26 June 2010, one day after vaccination, the patient developed a reddened and swollen left arm from the shoulder area to the elbow. The area was warm to the touch. The patient did not receive any vaccinations within 4 weeks prior to the MENACTRA vaccination. She was not seen by a health care professional (HCP) and received no treatment at this time. The outcome was reported as unknown. Documents held by sender: None.
Age: 12.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Alopecia, Alopecia totalis
Clinical narrative: Initial case received from a physician on 12 July 2010. A 12-year-old patient received injections of ADACEL (lot number C3357AA) and MENACTRA (lot number reported as C3069AA; not a valid sanofi pasteur lot number) on 25 May 2010. Medical history and concomitant medications were not reported. Approximately 3 weeks post-vaccination, the patient began experiencing patches of alopecia. Symptoms later progressed to alopecia totalis. The patient was seen by a physician; testing and treatment were not reported. At the time of the report, the outcome was unknown. Follow-up information received from a health care professional on 16 September 2010 reported that the patient had no adverse events following prior vaccinations. The patient received the ADACEL, lot number C3357AA intramuscularly (IM) in the left deltoid and the MENACTRA, corrected lot number U3069AA (previously reported as C3069A) IM in the right deltoid. The patient was under the treatment by a dermatologist. The outcome remained unknown. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Myalgia, Oropharyngeal pain
Clinical narrative: Initial report received on 18 August 2010 from a health care professional. A 19-year-old male patient had received a first intramuscular left arm injection of MENACTRA (lot number U3510AA) on 16 August 2010. A one inch 25 gauge needle was used for the injection. That evening after receiving the vaccination the patient developed a temperature of 100.5 degrees Fahrenheit and complained of site soreness, redness, congestion, sore throat, and muscle aches. The patient received medical evaluation two days later on 18 August 2010 with continued complaint of sore throat and congestion. Rapid strep test was negative that day, and WBCs were 18.4. The patient was started on antibiotic therapy (trade name not reported). The patient was noted to have a "tickly throat" at the time of vaccination; and medical history included seasonal allergies. At the time of this report, the patient had not recovered. Follow-up information was received on 20 September 2010 from a health care professional. The patient's congestion was reported to be upper respiratory. He was treated with OMNICEF 300 mg one tablet twice a day for ten days (previously reported as "antibiotic"). The patient did not have any additional follow-up with the physician. No further information was provided at the time of this report. The patient's outcome was reported as recovered (date unknown by reporter). Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Streptococcus test, Streptococcus test negative, Upper respiratory tract congestion, White blood cell count increased
Clinical narrative: Initial report received on 18 August 2010 from a health care professional. A 19-year-old male patient had received a first intramuscular left arm injection of MENACTRA (lot number U3510AA) on 16 August 2010. A one inch 25 gauge needle was used for the injection. That evening after receiving the vaccination the patient developed a temperature of 100.5 degrees Fahrenheit and complained of site soreness, redness, congestion, sore throat, and muscle aches. The patient received medical evaluation two days later on 18 August 2010 with continued complaint of sore throat and congestion. Rapid strep test was negative that day, and WBCs were 18.4. The patient was started on antibiotic therapy (trade name not reported). The patient was noted to have a "tickly throat" at the time of vaccination; and medical history included seasonal allergies. At the time of this report, the patient had not recovered. Follow-up information was received on 20 September 2010 from a health care professional. The patient's congestion was reported to be upper respiratory. He was treated with OMNICEF 300 mg one tablet twice a day for ten days (previously reported as "antibiotic"). The patient did not have any additional follow-up with the physician. No further information was provided at the time of this report. The patient's outcome was reported as recovered (date unknown by reporter). Documents held by sender: None.
Sex: M
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Initial report received on 27 August 2010 from a company representative who received the original report from a health care professional. A male patient had received a dose of MENACTRA vaccine (lot number not reported) on an unspecified date. Two to three days after receiving the vaccination the patient experienced bumps on his arm. Final diagnosis with treatments and outcome of events were not reported. Documents held by sender: None.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Chest pain
Clinical narrative: Initial report was received 29 September 2010 from a health care professional. A 16-year-old female patient had received an injection of MENACTRA (lot number, route and site of administration unknown) on 27 September 2010 and on the day of vaccination, she experienced chest pain after playing basketball for one hour. At the time of the report, the reporter stated the patient would be returning to the doctor's office for follow-up visit that day. Outcome was reported as unknown. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Lymph node pain, Pyrexia, Vaccination site inflammation
Clinical narrative: Chills; Lymph node pain; Vaccination site inflammation; Fever.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site mass, Similar reaction on previous exposure to drug
Clinical narrative: Initial report received from a health care professional on 22 December 2010. A 15 year-old female patient had received on an unknown day in 2006 a right deltoid dose of ADACEL (lot number C2384AA, expiration date 04 May 2008, route not reported), and subsequently received a first intramuscular right deltoid injection of MENACTRA (lot number U2230AA) on 04 May 2007; and on 02 November 2007 she received an intramuscular right deltoid injection of FLUZONE (lot number U2436AA), and an intramuscular left arm (also documented as right arm in patient's chart) injection of GARDASIL (manufacturer Merck, lot number unknown). The patient was in the physician's office around 22 December 2010 and during her physical examination it was noted she had a 6 x 6.5 cm lump under the skin at the right deltoid. It was reported by the patient's mother that the lump had been there since the patient's last vaccinations 3-4 years ago. The event had not been reported to the physician prior to that time. Relevant medical history was unknown. Per the reporter, no relevant diagnostic tests/laboratory data were performed. Documents held by sender: None.
Sex: F
Vaccine: MNQ
Symptoms: Expired drug administered, Injection site pain, Muscle spasms
Clinical narrative: Initial report received from the patient on 28 October 2010. A female patient (demographics not reported) had received an intramuscular right deltoid injection of expired MENACTRA vaccine (lot number not reported, expiration date 07 October 2010) on 27 October 2010, and the same day experienced pain at the injection site and cramping in the right. Random pain level was 4 out of a scale of 10. At the time of this report, the pain and cramping was a 2 out of a scale of 10. The patient had not recovered. Documents held by sender: None.
Age: 41.0
Sex: M
Vaccine: HEP, YF
Symptoms: Back pain, Fatigue, Pyrexia
Clinical narrative: Initial case received on 28 January 2010 from a healthcare professional. A 41 year old male received a right deltoid intramuscular injection of YF VAX (lot number UF626AA) and a left deltoid intramuscular injection of ENGERIX B (GSK lot number AHBVB722EA) at 11:50 a.m. on 22 January 2010. Vaccinations given within 4 weeks prior were: a left deltoid intramuscular injection of FLUZONE (lot number U3254EA), a right deltoid intramuscular injection of H1N1 (lot number UP001AA) and a right deltoid intramuscular injection of MENACTRA (lot number U3099AA) on 14 January 2010. The patient experienced a fever of "101.5", aches and pains in lower back and fatigue at 9:00 a.m. on 26 January 2010. His medical history included hypothyroidism, diabetes, hypertension and high cholesterol. Concomitant medications included SYNTHROID, VYTORIN, MICARDIS and JANUMET. He had no known allergies. The patient had no illness at the time of the vaccinations and he had no adverse event following prior vaccinations. The outcome of the patient's adverse events was not reported. Follow-up information was received from a health care provider on 12 May 2010 reported that the patient fully recovered on 02 February 2010. The patient required no treatment. Documents held by sender: None.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Eyelid oedema, Eyelid ptosis, Hordeolum, Ocular hyperaemia, Swelling face
Clinical narrative: Initial report received from a health care provider on 13 May 2010. An 18-year-old female patient, with a history of weekend alcohol and marijuana use, had received an intramuscular left deltoid injection of MENACTRA, lot number U3341AA, and an intradermal left forearm injection of TUBERSOL, lot number C3566AB, on 11 May 2010 and when the patient returned to have PPD read, it was noticed that she developed swelling of the left eyelid, eyelid droopy, skin around eye reddened and puffiness to the left cheek and side of face. The issue with the patient's left eye was confirmed to be a sty. The outcome was reported as not recovered. Follow-up information was received from the health care professional on 21 June 2010. The patient reported eyelid swelling beginning the day of vaccination (11 May 2010). She was seen by a physician and determined not to have a "vaccine adverse event", but instead coincidentally had a sty on her left eyelid causing swelling. She was treated with warm compresses and POLYTRIM solution. Outcome was unknown. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: HEP, IPV
Symptoms: Convulsion, Gaze palsy, Immediate post-injection reaction, Musculoskeletal stiffness, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old female patient with no known drug reactions or allergies and reactive airways disease who on 01-FEB-2010 was intramuscularly vaccinated in the left deltoid with a dose of 0.5 mL RECOMBIVAX HB (Lot# 663281/1678X) and with a dose of poliovirus vaccine inactivated (unspecified). Concomitant therapy included albuterol PRN. Immediately post vaccination the child became stiff and her eyes rolled into the back of her head, which lasted for a total of 1 minute. The patient was observed and monitored for 30 minutes and then was released to go home. The medical assistant stated that physician diagnosed the patient with syncope/ seizure episode. No lab tests were performed. Subsequently, the patient recovered from syncope episode and seizure episode and had not experienced any other adverse effect. Follow up information has been received from the medical assistant regarding the female patient with no illness at the time of vaccination. The medical assistant reported that after received the dose of RECOMBIVAX HB, the child's body was stiff with her eyes rolling back in her head, for approximately 30 seconds, the patient was laid on the exam table and her body was normal. The patient was answering questions and she just wanted to lie down. The patient's blood pressure was 100/60 and her heart rate was 97. Subsequently, after resting for about 15 to 20 minutes the patient's color came back and was walking and playing. On 01-FEB-2010, the patient recovered from the events. Upon internal review, seizure episode was determined to be an other important medical event. No further information is available.
Age: 25.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness at the injection site progressed rapidly into extensive swelling, redness, heat at the injection site, and pain.
Age: 1.02
Sex: M
Vaccine: DTAP, IPV
Symptoms: Crying, Pyrexia, Vomiting
Clinical narrative: fever of 102, vomiting, incessant crying for over 3 hours
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Local reaction, Pyrexia
Clinical narrative: Cellulitis, fever, local reaction at deltoid, temp 102 degrees.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chest X-ray, Erythema, Feeling of body temperature change, Immune system disorder
Clinical narrative: Cellulitis, fever, local reaction at deltoid, temp 102 degrees.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Local reaction, Lymphadenopathy, Oedema peripheral, Oral herpes, Pyrexia
Clinical narrative: Cellulitis, fever, local reaction at deltoid, temp 102 degrees.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Cellulitis, fever, local reaction at deltoid, temp 102 degrees.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Tdap was given today and then I saw that she had this vaccine in 2007 (9/18/07).
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received for VARIVAX (Merck), a Pregnancy Registry product from a 21 year old female consumer with no known drug reaction/allergies or pertinent medical history who on 02-FEB-2010 was vaccinated with a dose of VARIVAX (Merck) while she was pregnant.  There was no concomitant medication.  It was reported that the patient LMP was three or four weeks ago, approximately on 04-JAN-2010 and the estimated date of delivery (EDD) is on approximately 11-OCT-2010.  A pregnancy test was performed.  The patient sought her physician for medical attention.  Follow up information was received on 01-MAR-2011 from a Registered nurse who reported that the patient had an elective termination on 19-FEB-2010, due to concerns with having received the VARIVAX (Merck), while pregnant (therapy date 02-FEB-2010).  She also reported that the patient was pregnant (LMP 01-JAN-2011 and EDD 07-OCT-2011) (WAES#1103USA00869).  The patient had an appointment on 02-MAR-2011.  No additional information was provided at the time of this call.  Upon internal review elective termination was determined to be an other important medical event.  Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (route and lot # were unspecified). The physician reported that in approximately 2010 ("about 1 year ago") the patient was hospitalized for neuro cardio "gen" syncope after vaccination with PNEUMOVAX 23. The patient was passing out. The reporter felt that the patient's condition would exist regardless of vaccination with PNEUMOVAX 23. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a 26 year old female consumer with no pertinent medical history or drug reactions/allergies, who on 31-MAR-2010 was vaccinated with the second dose of GARDASIL and was pregnant (gestation= 5 weeks), method of confirmation: urine pregnancy test. There was no concomitant medication. At the time of the report, the patient's outcome was unknown. The patient sought medical attention (office visit). Follow up information was received via telephone call from a Registered Nurse, who indicated that the patient did not have any delivery or pregnancy information from December 2010, the last delivery date for this patient was 19-AUG-2009. The patient had been seen in the office on 18-JAN-2010 for an annual visit and at that time her baby was 5 months old. The nurse then found in the chart a note from 23-JUN-2010 that said the patient had been advised that GARDASIL was not a live virus vaccine and that the patient and her husband felt it would be better to terminate the pregnancy. As far as the Registered Nurse knew this pregnancy was terminated sometime after that but did not have any additional information to provide. There was not a LMP listed for this pregnancy. She did provide the dates of the patient's GARDASIL vaccinations: 1st dose in Feb 2010 (specific date not given), 2nd dose on 31-MAR-2010 and 3rd dose on 14-JUL-2010. Upon internal review elective termination was considered to be an other important medical event. No further information is available.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection, Surgery
Clinical narrative: Information has been received from a health care professional in a medical conference reporting an 8 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot # unspecified). Subsequently it was reported that on an unspecified date, the patient developed the pneumococcal infection and it was also reported that the patient received surgery for an unspecified reason. At the time of the report patient was hospitalized for an unknown amount of time. Patient received surgery for an unspecified reason was determined to be an other important medical event by the physician. This is a hearsay report in the absence of an identifiable patient and reporter. Attempts made to verify the existence of an identifiable patient and reporter were unsuccessful.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Pneumonia viral
Clinical narrative: Information has been received from a 76 year old male patient who "in October of about 4 or 5 years ago" was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (dose, route and lot #unspecified), and then " the following March ("about 4 or 5 years ago" (approximately in March 2007)), he got viral pneumonia and was hospitalized for an unspecified number of days. It was reported that the patient received unspecified treatment at the hospital. It was reported that the patient's adverse event had improved after he was hospitalized. The patient recovered "some months later", but he stated he was "not sure when he felt 100% recovered". Additional information has been requested.