chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Brain injury, Computerised tomogram, Convulsion, Electroencephalogram, Hypotonia
Clinical narrative: She was limp and unresponsive and I called EMS and she was taken to facility were we found out that she had permanent brain damage and was having seizures.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Hypoxic-ischaemic encephalopathy, Nuclear magnetic resonance imaging, Unresponsive to stimuli
Clinical narrative: She was limp and unresponsive and I called EMS and she was taken to facility were we found out that she had permanent brain damage and was having seizures.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Biopsy artery normal, Bone pain, Feeling abnormal, Injection site pain
Clinical narrative: Felt bad after shot. Went to eat at food court. Then went to car, shot was in the right arm, painful and hurt to try to raise her arm to the steering wheel. Started having neck pain within a few hours. This was Friday 3/4/2011. Called and saw me, Monday, 3/7/2011. Pain by Saturday very painful in neck and shoulders. Moved down spine but still worst in neck by Monday. By Tues hurting in left knee (replaced). No fever, didn't act meningeal, discussed with Health Dept on Monday, rheumatologist on Monday (patient refused steroids), Dr. (ID for the health dept) on Tuesday. He suspects rheumatological disorder flared by the flu shot, so did rheumatology. Friday 3/11/11 she had a temporal artery biopsy, which today came back negative. Seeing rheumatology for consult on 3/13/11.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Neck pain, Pain, Pain in extremity, Rheumatoid arthritis
Clinical narrative: Felt bad after shot. Went to eat at food court. Then went to car, shot was in the right arm, painful and hurt to try to raise her arm to the steering wheel. Started having neck pain within a few hours. This was Friday 3/4/2011. Called and saw me, Monday, 3/7/2011. Pain by Saturday very painful in neck and shoulders. Moved down spine but still worst in neck by Monday. By Tues hurting in left knee (replaced). No fever, didn't act meningeal, discussed with Health Dept on Monday, rheumatologist on Monday (patient refused steroids), Dr. (ID for the health dept) on Tuesday. He suspects rheumatological disorder flared by the flu shot, so did rheumatology. Friday 3/11/11 she had a temporal artery biopsy, which today came back negative. Seeing rheumatology for consult on 3/13/11.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Depressed level of consciousness, Irritability, Pyrexia, Speech disorder developmental
Clinical narrative: Fever (101-103) and fussy for 3 days. Tylenol
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt with c/o redness, swelling, warmth, pain at site of injections. Treated with Oral Doxycycline 100 mg BID.
Age: 1.26
Sex: M
Vaccine: DPP, FLUX
Symptoms: Body temperature increased, Crying
Clinical narrative: MY SON CAME DOWN WITH A 103.4 TEMPERATURE AND WOKE UP CRYING.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Culture throat negative, Headache, Nausea, Rash generalised, Vomiting
Clinical narrative: DIFFUSE RASH OF TRUNK, UPPER + LOWER EXTREMITIES TO INCLUDE PALMS AND SOLES. PT WAS ALSO C/O HEADACHE, NAUSEA, AND VOMITING
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Rash pustular
Clinical narrative: Pt. started breaking out yesterday - trunk & all extremities - red pustules. Low grade temp x 2 days. Normal appetite. Complains of "itching".
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Oropharyngeal pain, Rash erythematous, Urticaria
Clinical narrative: 3/9-11 - sore throat & headache was seen Dr her family Dr, 3/11 -> 3/12 developed red raised rash - red bumps & hives on her hands to her upper arms bilaterally, also on her feet & ankles also hips, parent gave her TYLENOL. She also had c/o great fatigue starting on Thursday. No fever - 3/14-11 rash light on hands & elbows & ankles.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: (L) Deltoid with swelling, erythema & warmth, 6cm x 8cm, headache, & vomit x 1.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Diarrhoea, Urticaria
Clinical narrative: Urticaria diarrhea > within 24 hrs vaccines, tx with antihistamines, ? infectious diarrhea with resultant urticaria.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Presyncope, Syncope
Clinical narrative: Syncopal episode following vaccination with GARDASIL - full vasovagal reaction, unconscious for 30 seconds. BP initially 62/30.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: Syncope vs convulsions. Pt appeared to have syncopal episode s/p administration of HPV vaccine. I was not present, *see RN note. Spoke with mother following incident and she states observed convulsions (?) and gurgling sound in throat/gasping for air, pt was laid back onto exam table, no falls. Sister experienced a similar episode following administration of the same vaccine prior to this appt. Pt still with nausea, dizziness, pale clammy skin, pt resting in exam room until recovered. Much improved following vomiting episode. Sent home with mother and sister stable.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cold sweat, Convulsion, Dizziness, Dyspnoea, Gaze palsy
Clinical narrative: Syncope. Arrived to pt side at 1419. Pt sitting in chairs next to lab. Staff assisting. Pt's mother states pt had a seizure, and lost consciousness mother in chair next to her witnessed, first to arrive at chairside MA. Mother states pt c/o dizziness/lighthheadness and "her eyes rolled back in her head", states body position was with neck extended to left rigidly, gasped for air a few times with arms bent at elbow does not recall if hands were opened or closed and extension of the legs with toes pointed. Pt did not have bowel or bladder incontinence. Eyes: 3mm/3mm PERRL Skin: pale, cool and clammy. When asked her name and dob answered appropriately, conversing with staff and mother denies pain, HA, nausea, SOB, HR 54 RA O2sat: 100% pt tearful states is embarassed. Pt had just received four vaccines and was awaiting labwork. Mother and pt state that pt has an "intense" needle phobia. Pt also states has only eaten a couple pretzels today and nothing else. Juice given. Dr at chairside 1425 examining pt. 1455: HR 59 BP: 108/62. States a little dizzy but improving. 1510: HR 60 BP: 96/60. States feeling "back to normal" with mild dizziness.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Loss of consciousness, Nuchal rigidity, Pallor, Posture abnormal, Syncope
Clinical narrative: Syncope. Arrived to pt side at 1419. Pt sitting in chairs next to lab. Staff assisting. Pt's mother states pt had a seizure, and lost consciousness mother in chair next to her witnessed, first to arrive at chairside MA. Mother states pt c/o dizziness/lighthheadness and "her eyes rolled back in her head", states body position was with neck extended to left rigidly, gasped for air a few times with arms bent at elbow does not recall if hands were opened or closed and extension of the legs with toes pointed. Pt did not have bowel or bladder incontinence. Eyes: 3mm/3mm PERRL Skin: pale, cool and clammy. When asked her name and dob answered appropriately, conversing with staff and mother denies pain, HA, nausea, SOB, HR 54 RA O2sat: 100% pt tearful states is embarassed. Pt had just received four vaccines and was awaiting labwork. Mother and pt state that pt has an "intense" needle phobia. Pt also states has only eaten a couple pretzels today and nothing else. Juice given. Dr at chairside 1425 examining pt. 1455: HR 59 BP: 108/62. States a little dizzy but improving. 1510: HR 60 BP: 96/60. States feeling "back to normal" with mild dizziness.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: See patient's attached letter. Patient seen by Dr. 3-10-11 & treated with prednisone 20mg 2 tabs BID x 3 days.
Age: 13.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bordetella test, Bordetella test positive, Cough, Pertussis, Productive cough
Clinical narrative: Initial report was received from a health care professional on 24 January 2011. A 13 year-old patient with no reported past medical history, had received ADACEL, lot number U3051CA (sanofi pasteur Ltd lot number CC3312, route and site of administration not reported) on 14 July 2010 and approximately six months later on 18 January 2011, had a positive B pertussis IgM Ab of 1.3 (minimal and maximum values that establish the normal range were not reported). No further information was available at the time of the report. The patient's outcome was not reported. Follow-up information was received on 07 March 2011 from a health care professional who provided the normal range values of B pertussis IgM Ab which were a negative of less than 1.0 and a positive of greater than 1.1. The patient's B pertussis IgM Ab was 1.3. Based upon this new information received, it was determined this case now meets seriousness criteria and it has been upgraded from non-serious to serious. The female patient who had no reported illness at the time of vaccination, had received a left deltoid injection of ADACEL on 14 July 2010. She presented with a persistent productive cough for six weeks on 10 January 2011. She had a confirmed positive B pertussis IgM Ab result on 18 January 2011. She was treated with Cefdinir, MYTUSSIN AC, Prednisone and Fluticasone. Concomitant medications were listed as none. Her vaccine history included: Five doses of DTaP (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 01/May/1998, 23/Jul/2002); Four doses of OPVor IPV (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 23/Jul/2002); Two doses of MMR (01/May/1998, 23/July/2002); Four doses of HIB (30/Jun/1997, 15/Aug/1997, 29/Oct/1997, 01/May/1998); Three doses of Hepatitis B (28/Apr/1997, 30/Jun/1997, 29/Oct/1997) and a dose of Varicella (01/May/1998). No further information was provided at the time of this report. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 1.88
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling on leg. Redness around site of injection. No fever. Walking on leg. Given 1/2 tsp of BENADRYL in Dr. office. Noticed it on 4:45pm 3/8/11.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Vomiting, diarrhea, fever 102 degrees, bright red rash x1 week. Diarrhea x2 weeks. Seen by urgent care 2/28/11. Prescribed steroids, antiemetic. Muscle aches & pain on (R) side of body.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Lethargy, Nausea, Pallor, Pyrexia
Clinical narrative: Vomiting, diarrhea, fever 102 degrees, bright red rash x1 week. Diarrhea x2 weeks. Seen by urgent care 2/28/11. Prescribed steroids, antiemetic. Muscle aches & pain on (R) side of body.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rash, Vomiting
Clinical narrative: Vomiting, diarrhea, fever 102 degrees, bright red rash x1 week. Diarrhea x2 weeks. Seen by urgent care 2/28/11. Prescribed steroids, antiemetic. Muscle aches & pain on (R) side of body.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Diarrhoea, Myalgia, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: Vomiting, diarrhea, fever 102 degrees, bright red rash x1 week. Diarrhea x2 weeks. Seen by urgent care 2/28/11. Prescribed steroids, antiemetic. Muscle aches & pain on (R) side of body.
Age: 1.64
Sex: F
Vaccine: DTAPIPVHIB, MMR, PPV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever hours later. Rash all over body several days later.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Blood test, Chemotherapy, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no drug allergies and no pertinent medical history who on 21-SEP-2010 was vaccinated with her only dose of GARDASIL (lot# 666162/0565Z, expired date on 15-SEP-2012) IM. Concomitant therapy included HAVRIX (Lot #AHAVB446BA) on the same day as GARDASIL. On 18-NOV-2010 the patient was diagnosed with idiopathic thrombocytopenic purpura (ITP). After this she was hospitalized. She had not recovered. She had experienced "weight gain with prednisone use". The patient was considered to be disabling as she was not able to play contact sports. Blood test was performed (but no results were provided). Patient's platelet count on 18-NOV-2010 was 1 (1, 000). Since that time the platelet count had gone up and down based on the prednisone dosing. Patient had already received a few doses of intravenous immune globulin (IVIG) and recently was placed on a chemotherapeutic agent (no cancer involved). In February 2011, patient underwent a splenectomy. When asked if the event was life threatening, the physician said she did not know. The physician gave the location of the hospital and reported that the patient was initially referred to another pediatric hematology/oncology physician. The patient was also being seen by another specialist at another hospital, but the physician did not have that contact information available. Additional information has been expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Splenectomy, Weight increased
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no drug allergies and no pertinent medical history who on 21-SEP-2010 was vaccinated with her only dose of GARDASIL (lot# 666162/0565Z, expired date on 15-SEP-2012) IM. Concomitant therapy included HAVRIX (Lot #AHAVB446BA) on the same day as GARDASIL. On 18-NOV-2010 the patient was diagnosed with idiopathic thrombocytopenic purpura (ITP). After this she was hospitalized. She had not recovered. She had experienced "weight gain with prednisone use". The patient was considered to be disabling as she was not able to play contact sports. Blood test was performed (but no results were provided). Patient's platelet count on 18-NOV-2010 was 1 (1, 000). Since that time the platelet count had gone up and down based on the prednisone dosing. Patient had already received a few doses of intravenous immune globulin (IVIG) and recently was placed on a chemotherapeutic agent (no cancer involved). In February 2011, patient underwent a splenectomy. When asked if the event was life threatening, the physician said she did not know. The physician gave the location of the hospital and reported that the patient was initially referred to another pediatric hematology/oncology physician. The patient was also being seen by another specialist at another hospital, but the physician did not have that contact information available. Additional information has been expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature labour, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a health professional, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female patient with no pertinent medical history and allergic to latex and DEMEROL who on 21-APR-2010 was vaccinated with her first 0.5 ml IM dose of GARDASIL (lot# 663559/1178Y). Concomitant therapy included vitamins (unspecified) and LO/OVRAL. On 21-APR-2010 the patient was seen in Family Planning and a urine pregnancy test was performed which was positive. The patient's LMP was 17-MAR-2010 and her EDD was 22-Dec-2010. Follow up information has been received via telephone call from a registered nurse, who reported that the patient had been "into see them" on 28-OCT-2010 (no reason was provided). The registered nurse reported that the patient had delivered on 14-SEP-2010 and the baby had been in the Neonatal Intensive Care Unit (NICU) (WAES # 1004USA03561B1). At the time of the report the gestational age of the baby at birth was unknown. Upon internal review premature labour was considered to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Premature delivery
Clinical narrative: Information has been received from a registered nurse, concerning a patient's mother who on 21-APR-2010 was vaccinated with a dose of GARDASIL (lot # not reported).  (Mother experience reported in WAES # 1004USA03561).  The registered nurse reported that on 14-SEP-2010, at 26 gestational weeks, the mother had a baby.  The baby had been in the Neonatal Intensive Care Unit (NICU).  At the time of the report the gestational age of the patient at birth was unknown.  Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity
Clinical narrative: Pt received pneumococcal vaccine on 2/16/11 as part of an annual exam. On 2/17/11 he went to the ED with pain & swelling of the left tricep area. Diagnosed with cellulitis & treated with Clindamycin 300mg 4 times /day for 10 days.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Erythematous. Swelling over right leg measuring 7x7 cm (with 2x3 cm in diameter area of induration).
Age: 1.65
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Had 5 cm. hard red lump (R) thigh.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Allergic site reaction, possible infection. Site was red, inflamed, swollen, and warm to touch.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Influenza, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Was given 3 immunizations while in for her physical on Friday 2/11/11. Developed flu symptoms, low grade elevated temp, & chills, left arm pain & swelling on 2/12/11 Sat. Went to medical center where she was started on KEFLEX 500mg PO BID x 7 days and BENADRYL 12.5 mg/5ml elixir 25mg po prn. Returned to clinic on 2/14/11- LA arm feeling better, still quite swollen. Returned began to cinic 2/16/11 Lt arm still swollen & having pain, increased KEFLEX to qid. Recommend f/u in 2 days - no f/u appt occurred.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Red blood cell sedimentation rate increased, White blood cell count normal
Clinical narrative: Was given 3 immunizations while in for her physical on Friday 2/11/11. Developed flu symptoms, low grade elevated temp, & chills, left arm pain & swelling on 2/12/11 Sat. Went to medical center where she was started on KEFLEX 500mg PO BID x 7 days and BENADRYL 12.5 mg/5ml elixir 25mg po prn. Returned to clinic on 2/14/11- LA arm feeling better, still quite swollen. Returned began to cinic 2/16/11 Lt arm still swollen & having pain, increased KEFLEX to qid. Recommend f/u in 2 days - no f/u appt occurred.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Received RA PNEUMOVAX, LA Tetanus & LA Influenza immunizations 11/1/10. Noticed right upper arm redness, warmth and soreness & itching 8-10 hrs. later. 11/2/10 saw MD in clinic visit, BENADRYL Rx given. Called clinic triage nurse on 11/4/10 with c/o redness is now down to elbow & up to armpit, area is warm to touch & she "feels achy all the time" - Pt directed to ER. ER ordered Cephalexin 500mg 4 x/day & Ibuprofen 600mg tid.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain, Skin warm
Clinical narrative: Received RA PNEUMOVAX, LA Tetanus & LA Influenza immunizations 11/1/10. Noticed right upper arm redness, warmth and soreness & itching 8-10 hrs. later. 11/2/10 saw MD in clinic visit, BENADRYL Rx given. Called clinic triage nurse on 11/4/10 with c/o redness is now down to elbow & up to armpit, area is warm to touch & she "feels achy all the time" - Pt directed to ER. ER ordered Cephalexin 500mg 4 x/day & Ibuprofen 600mg tid.
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Joint range of motion decreased, Oedema peripheral, Pain in extremity
Clinical narrative: The patient recieved the Pneumovax in her right arm from an outside facility on 3/10/11. Within 24 hours she presented to an outside hospital and then was transferred to another hospital with severe pain in her right arm, decreased range of motion at the shoulder, and swelling of the entire right arm to two times the size of her left arm.
Age: 18.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Loss of consciousness, Pain, Urinary incontinence
Clinical narrative: Pt c/o pain. Blacked out. Voided on herself and came to within 30 seconds.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom noticed redness and swelling at site of Varivax injection before pt went to school on 3/1/11. While at school mom received a phone call from the school nurse that it was worse. School nurse applied Benadryl spray. On 3/2/11 swelling and redness was worse 3" by 5" area advised to give Benadryl by mouth per Dr. Improvment was noticed by 3/3/11.
Age: 0.91
Sex: M
Vaccine: FLU3
Symptoms: Abdominal X-ray, Abdominal pain, Enema administration, Intussusception, Viral infection
Clinical narrative: At visit on 3/2/11, parent gave history of Rx for ileocolic intussusception at hospital with 2 air contrast enemas an hr apart on 12/21/10. Child had receive flu vaccine - amt. not documented on 12/17/10. About 5 hrs. later, abd. pain started. Took to local ER & other ER on 3 separate days with dx viral syndrome. On 2/21 return to hospital & obstructive series of abd done & dx made. Parents said the doctors thought it could have been from the vaccine.
Age: 0.91
Sex: M
Vaccine: FLU3
Symptoms: X-ray abnormal
Clinical narrative: At visit on 3/2/11, parent gave history of Rx for ileocolic intussusception at hospital with 2 air contrast enemas an hr apart on 12/21/10. Child had receive flu vaccine - amt. not documented on 12/17/10. About 5 hrs. later, abd. pain started. Took to local ER & other ER on 3 separate days with dx viral syndrome. On 2/21 return to hospital & obstructive series of abd done & dx made. Parents said the doctors thought it could have been from the vaccine.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Musculoskeletal stiffness, Postictal state, Pyrexia, Unresponsive to stimuli
Clinical narrative: 4-5 min episode of stiffening, unresponsiveness, no clonic movements, eyes open, with post-ictal period, in presence of fever (100.8) after TYLENOL.
Age: 64.0
Sex: F
Vaccine: HEPAB, IPV, PPV
Symptoms: Injection site anaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had received Pneumovax lot# 1314y to the right arm. She developed swelling over right upper arm, shoulder to mid right upper arm, hot to touch, painful, numbness and red. She had applied cold compress to right arm. She was seen and examined by FNP. Patient was instructed to keep applying cold compress and elevate arm. If problem persists to be evaluated by MD/NP at Urgent Care.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Oedema peripheral, Pain in extremity
Clinical narrative: Client states pain in joint of right index finger starting 3/11/11 evening, and swelling of bilateral hands at joint starting morning of 3/12/11. Has only taken ibuprofen. States no fever, SOB, difficulty breathing. May have had pain prior to vaccine, but swelling started after. Describes pain as arthritic-type, but says didn't have arthritis in hands before.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dysphagia, Face oedema, Injection site macule, Injection site pruritus, Injection site rash
Clinical narrative: Facial and lip edema, mild dysphagia diffuse macular rash to legs, trunk, face with intense pruritus.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Lip oedema, Pruritus, Rash, Rash macular
Clinical narrative: Facial and lip edema, mild dysphagia diffuse macular rash to legs, trunk, face with intense pruritus.
Sex: F
Vaccine: FLU3, HEP, HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Premature delivery
Clinical narrative: This medically confirmed spontaneous report (initial receipt 14-DEC-2010) concerns a new born male infant.  The patient's mother received her first AFLURIA on 13-OCT-2010 during pregnancy.  She also received her third dose of GARDASIL (intramuscular, batch number: 0766z, exp: 15-OCT-2012) for immunisation and third dose of HEP B on the same day.  Her first dose of HEP B was administered on 02-MAR-2009.  Her first dose of GARDASIL was administered on 07-AUG-2009.  On, the patient was born at gestation age of 36 weeks and 5 days.  He was admitted to NICU for oxygen desaturation and was diagnosed with severe laryngomalacia.  Epiglottis prolapse was present as well.  The patient's outcome was unknown.  However the patient was first seen at the Paediatric Clinic at one month of age and continued to be seen for scheduled 'well-baby' check-ups.  Follow-up (03-MAR-2011): patient's initials, additional adverse event, event outcome, company causality.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dysphagia, Ear discomfort, Pain, Pyrexia
Clinical narrative: Throat closing - difficulty in swallowing - 4hrs after shot ears feeling full, 6hrs after shot -> 102.3 fever, chills, body aches until 4am - next day still achy but much improved.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Throat closing - difficulty in swallowing - 4hrs after shot ears feeling full, 6hrs after shot -> 102.3 fever, chills, body aches until 4am - next day still achy but much improved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Feeling abnormal, Injection site erythema, Pruritus
Clinical narrative: Patient received shingles shot (ZOSTAVAX) on Thursday 3/10/2011 got redness at site itching & patient described it as cellulitis. Swollen, stretching feeling, red about top shape about quarter size.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient received shingles shot (ZOSTAVAX) on Thursday 3/10/2011 got redness at site itching & patient described it as cellulitis. Swollen, stretching feeling, red about top shape about quarter size.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Menorrhagia, Surgery
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, had an outpatient surgical procedure due to worsened menorrhagia. Vaccination took place 2.5.2009. According to the physician the relationship is none. We would be happy to fax you the studys SAE report.
Age: 10.0
Sex: M
Vaccine: FLU3, HEPA, TDAP
Symptoms: Skin lesion
Clinical narrative: GLS, resembling cellulitis on right arm. Lesion is about 10cm x 6cm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Basophil percentage decreased, Haematocrit normal, Haemoglobin normal, Injection site erythema, Injection site induration
Clinical narrative: Erythematous indurated area on (L) upper arm, from 1" below injection site (not involving actual site) to elbow. Painful, not warm. No pustules or other breaks in skin.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Lymphocyte percentage, Neutrophil percentage, Platelet count normal, White blood cell count normal
Clinical narrative: Erythematous indurated area on (L) upper arm, from 1" below injection site (not involving actual site) to elbow. Painful, not warm. No pustules or other breaks in skin.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Local swelling, erythema & tenderness in deltoid - administration site - onset day after.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Anxiety, Cardiac function test normal, Cyanosis, Neurological examination normal, Tremor
Clinical narrative: Approx 1-2 min after pt received vaccine and administering person left the exam room, mom opened exam room & called for help. State pt had brief shaking in left arm and mouth/(L) arm looked "blue." Staff & I arrived immediately to find pt awake, alert, anxious - appearing in mom's arms, HR 80, BP / , O2 sat 100% RA. Pt interactive, denied complaints. Neuro exam normal, cardiac exam nl.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lt thigh red, warm to touch with lg amt of swelling.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Event reported to me through nurse.  Pt reported to MD's office on 3/07/11 stating sore arm still ~ 2.5 mos after vaccine.  The pt remembers it given high on the arm, over the deltoid area.  MD recommends NSAIDs, wrapping the arm, & warm compress.  He states pain should be self-limited.  I (immunizer) do not believe that the location where the patient states she received the vaccine is accurate. I have a precedure that I follow: Explain to pt Zostavax is sub-q, that it is given in fat in back of arm, (continued in relevant diag test box)
Age: 20.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Rash
Clinical narrative: Pain after injection later at night. Developed rash.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Dyspnoea, Fall, Injection site cellulitis, Local reaction
Clinical narrative: 3/4/11 fell in B/R PPV given (L) deltoid 3/7/11 at 1930 - no ASE doc until 1400 on 3/9/11 when hes spiked temp 102 - SOB - O2 sats 88% R/A - course crackles (R) upper lobes - sent to ER for eval of S/S and arm swelling - to hosp at 1600 = admitted - returnes 3/12/11 with diagnosis (L) upper arm cellulitis "(R) rotator cuff improvement - provider documents suspected local reaction to PNEUMOVAX injection".
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging abnormal, Oedema, Oedema peripheral, Oxygen saturation abnormal, Rales
Clinical narrative: 3/4/11 fell in B/R PPV given (L) deltoid 3/7/11 at 1930 - no ASE doc until 1400 on 3/9/11 when hes spiked temp 102 - SOB - O2 sats 88% R/A - course crackles (R) upper lobes - sent to ER for eval of S/S and arm swelling - to hosp at 1600 = admitted - returnes 3/12/11 with diagnosis (L) upper arm cellulitis "(R) rotator cuff improvement - provider documents suspected local reaction to PNEUMOVAX injection".
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Rotator cuff syndrome, Vaccination complication
Clinical narrative: 3/4/11 fell in B/R PPV given (L) deltoid 3/7/11 at 1930 - no ASE doc until 1400 on 3/9/11 when hes spiked temp 102 - SOB - O2 sats 88% R/A - course crackles (R) upper lobes - sent to ER for eval of S/S and arm swelling - to hosp at 1600 = admitted - returnes 3/12/11 with diagnosis (L) upper arm cellulitis "(R) rotator cuff improvement - provider documents suspected local reaction to PNEUMOVAX injection".
Age: 4.0
Sex: F
Vaccine: HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Flushing, Injection site erythema, Rash macular, Vaccination site rash
Clinical narrative: Vaccines given, rash - red, no raised, around vaccine sites - all the same, then she had some red, flat spots on chest & back & then a few minutes later on her face, cheeks flushed. Not itchy when mom & I asked her & did not scratch. No respiratory difficulty, no swelling. Called Drs office. Did give BENADRYL 20 mg IM. Mother was going to take her to an urgent care. Instructed mother to observe her for further possible allergic reaction. 1/27/11 Child was taken to see grandfather 1/26/11 who is a doctor & he said patient was fine. Mom said rash cleared up within 45 min. of being here & leaving.
Age: 77.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site urticaria, Pruritus
Clinical narrative: Pt (R) arm with urticaria from site of injection to midway to elbow. Pt does not complain of pain, just itching. Pt denies shortness of breath or difficulty breathing. Pt treated with BENADRYL and Hydrocortisone cream 0.5%.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 12cm - 15cm area of erythema, warmth & induration at injection site (R thigh) beginning approx. 30 hr after administration.
Age: 22.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Chills, Feeling hot, Pyrexia, Swelling
Clinical narrative: Hot, swelling, chills, fever.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: Began with vomiting/diarrhea, headache, dizziness & fever at midnight following vaccination, lasting approx 12 hrs. Reported continued mild headaches off & on 3/5 & 3/6, gave TYLENOL (1 cap). Fever subsided Sat am, nausea persisted until Sat 3/5 pm. Feeling better 3/6. Also reports shortness of breath & HA when climbing stairs 3/5, 3/6 & 3/9.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Began with vomiting/diarrhea, headache, dizziness & fever at midnight following vaccination, lasting approx 12 hrs. Reported continued mild headaches off & on 3/5 & 3/6, gave TYLENOL (1 cap). Fever subsided Sat am, nausea persisted until Sat 3/5 pm. Feeling better 3/6. Also reports shortness of breath & HA when climbing stairs 3/5, 3/6 & 3/9.
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPH, FLUX, IPV, PNC, RVX
Symptoms: Dyskinesia
Clinical narrative: Abnormal movements of body (possible seizures).
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPH, FLUX, IPV, PNC, RVX
Symptoms: Childhood disintegrative disorder, Computerised tomogram, Crying, Decreased eye contact, Dyskinesia
Clinical narrative: Abnormal movements of body (possible seizures).
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, DTAPH, FLUX, IPV, PNC, RVX
Symptoms: Electroencephalogram, Inability to crawl, Muscle twitching, Seizure like phenomena, Staring
Clinical narrative: Abnormal movements of body (possible seizures).
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Pruritus, Rash generalised
Clinical narrative: Body rash, itching from 2-23 until now. Received medical treatment 2-28-11. Symptoms improving.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal pain, Nausea, Neck pain
Clinical narrative: Radiating pain from shoulder to neck and down into elbow. Inability to raise arm past 90 degrees, 24 hours after receiving injection. Ibuprofen & ice to area provide little relief. Nausea for 1st week because of pain. Pain has not subsided since rec'd shot.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Electromyogram normal, Local swelling, Muscular weakness, Nerve conduction studies normal, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Radiating pain from shoulder to neck and down into elbow. Inability to raise arm past 90 degrees, 24 hours after receiving injection. Ibuprofen & ice to area provide little relief. Nausea for 1st week because of pain. Pain has not subsided since rec'd shot.
Age: 37.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Paraesthesia, X-ray normal
Clinical narrative: Radiating pain from shoulder to neck and down into elbow. Inability to raise arm past 90 degrees, 24 hours after receiving injection. Ibuprofen & ice to area provide little relief. Nausea for 1st week because of pain. Pain has not subsided since rec'd shot.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Emotional distress, Lethargy, Pyrexia
Clinical narrative: Fever greater than or equal to 102 degrees. Inconsolable then lethargic.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Injection site swelling, Injection site warmth, Irritability, Pyrexia
Clinical narrative: 1900 - leg (left) is swollen "size of golf ball from thigh to knee. Area is warm to touch. Fever 101 degrees. Gave TYLENOL. He fell asleep at 2200 after hours of irritability. Slept all night. Next morning mom reports she repeated TYLENOL. "Swelling has gone down". She called her physician.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Influenza virus test negative, Pyrexia, Urticaria
Clinical narrative: Received 4 yo immunizations on 3-4-11 KINRIX (DTAP, IPV), PCV 13, Varicella, MMR. Fever up to 103.5 degrees F began on 3-5-11, lasted 2 days. Hives started 3-6-11, BENADRYL per mom seemed to help. No hives in office & well-appearing.
Age: 0.84
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 102.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: PPV vaccine given on 2-28-11 pt is complaining of left arm pain since then. No redness or swelling where shot was given.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Diarrhoea, Ileus, Ultrasound abdomen normal
Clinical narrative: Abdominal pain, diarrhea, ileus - 2/21/11 - 3/11/11.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: X-ray abnormal
Clinical narrative: Abdominal pain, diarrhea, ileus - 2/21/11 - 3/11/11.
Age: 64.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Vaccine administered on 3/12/11. Patient called on 3/14/11 to complain of swelling at site of injection. Told patient we'll check with manufacturer to see if this is normal or not. Called patient back but no answer so left msg to call us back. Next day patient called back to say it got worse & painful. Per manufacturer pt be directed to MD for treatment. Pt will go see MD.
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Rash pustular, Swelling
Clinical narrative: Red pustule, swollen.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Injection site pain, Joint range of motion decreased, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Soreness at site, arm, shoulder and back under the arm on right side became sore and remains this way. Limited range of motion. Has become a chronic condition. Thought it was like bursitis. Got to thinking what could have cause it! No injury to area. Ice helps temporarly but I have limited range of motion. Symptoms are like an impingment or torn rotator cuff..pain and muscle spasms going from the right side of the neck clear under the right arm. I have not sought tx for this yet..but after reading about this adverse effect..I may have to IF there is a tx for it. Some of my co-workers have been affected the same way.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Soreness at site, arm, shoulder and back under the arm on right side became sore and remains this way. Limited range of motion. Has become a chronic condition. Thought it was like bursitis. Got to thinking what could have cause it! No injury to area. Ice helps temporarly but I have limited range of motion. Symptoms are like an impingment or torn rotator cuff..pain and muscle spasms going from the right side of the neck clear under the right arm. I have not sought tx for this yet..but after reading about this adverse effect..I may have to IF there is a tx for it. Some of my co-workers have been affected the same way.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Inflammation, Injection site erythema, Skin warm
Clinical narrative: Localized erythema at injection site, pain, inflammation of lymph nodes in right axillary region, chills, area warm to the touch.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Oedema peripheral
Clinical narrative: Left hand swelling, erythema at injection site, induration, warm to the touch.
Age: 1.26
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Bacterial test negative, Body temperature increased, Dyskinesia, Febrile convulsion, Nervous system disorder
Clinical narrative: Febrile seizure and temp of 101 degrees. Weird neck jerking motions began 3 days after the vaccinations.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site urticaria
Clinical narrative: Dime size welt at injection site.
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Infantile spitting up, Irritability, Screaming, Vomiting
Clinical narrative: Extreme fussiness, inconsolable screaming, excessive spitting up/vomiting.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: My son came down with the shingles rash and it appears that my son passed a rashless case of shingles to my daughter through a towel. My daughter passed out the same week from severe pain and all of the initial symptoms of shingles. All ER tests revealed she was healthy, no concussion etc.  I believe the original shot has something to do with this since shingles to shingles is not normally passed.  I also believe that a severe case of strep and an antibiotic shot to the butt activated this in patient's nerves back in late January.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: rash under location of bandage, as well as proximally on shoulder.  Pruritic.  Was on face, but by 3/11, had cleared from face and was starting to improve.  No facial swelling, SOB, D, or other systemic reactions.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Burning sensation, Discomfort, Nerve injury, Neuropathy peripheral, Pain
Clinical narrative: The bottom of his feet starting burning.  No redness or difference to touch, he just felt it.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Restless legs syndrome
Clinical narrative: The bottom of his feet starting burning.  No redness or difference to touch, he just felt it.
Age: 59.0
Sex: F
Vaccine: DT
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Injection site haematoma, Injection site induration, Injection site pain
Clinical narrative: Gradual swelling of tissue in left deltoid with emergence of circular type hematoma at injection site mid deltoid muscle with induration of the muscle with tenderness no heat, no erythema to mid upper arm to elbow.
Age: 59.0
Sex: F
Vaccine: DT
Symptoms: Injection site reaction, Injection site swelling, Metabolic function test normal
Clinical narrative: Gradual swelling of tissue in left deltoid with emergence of circular type hematoma at injection site mid deltoid muscle with induration of the muscle with tenderness no heat, no erythema to mid upper arm to elbow.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Quarter size welt at injection site.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Dime size welt at injection site.
Age: 1.04
Sex: M
Vaccine: MMR
Symptoms: Pallor, Rash erythematous
Clinical narrative: Blanching, punctuate, erythematous rash on torso, back & proximal extremities. No vesicles no crusted lesions.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Measles, Rash morbilliform
Clinical narrative: Measles rash.
Age: 26.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: 24 hrs post immunization pt. reported back to clinic with dyspnea & throat tightness was assessed by HCP at clinic. HCP referred pt. to an urgent care for possible rxn to SEPTRA or Immunizations and anxiety.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Foaming at mouth, Loss of consciousness
Clinical narrative: Within one minute post administering second in series of Hep A pediatric doses pt. lost consciousness, foaming at lips, no tonic or clonic movement.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC13
Symptoms: No adverse event
Clinical narrative: Pt received (PEDIARIX) DTaP, IPV, Hep B and separate dose of Hep B (RECOMBIVAX) during this visit 2/14/2011. 2/15/11 - followed up with parent. No ill effects reported.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: Pt. was given the ZOSTAVAX injection at our pharmacy on 2.23.11. Approx. 7-8 days later, she developed a rash on the face - her MD confirmed it was shingles. Pt. undergoing treatment with her MD.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Ear pain, Facial pain, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Pt. was given the ZOSTAVAX injection at our pharmacy on 2.23.11. Approx. 7-8 days later, she developed a rash on the face - her MD confirmed it was shingles. Pt. undergoing treatment with her MD.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Pt. was given the ZOSTAVAX injection at our pharmacy on 2.23.11. Approx. 7-8 days later, she developed a rash on the face - her MD confirmed it was shingles. Pt. undergoing treatment with her MD.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt. was given the ZOSTAVAX injection at our pharmacy on 2.23.11. Approx. 7-8 days later, she developed a rash on the face - her MD confirmed it was shingles. Pt. undergoing treatment with her MD.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Thinking abnormal, Vertigo
Clinical narrative: Initial report was received from a health care professional on 08 March 2011. A 56 year-old female with an allergy to morphine, had received an intramuscular right deltoid injection of ADACEL, lot number U3042AA (sanofi pasteur Ltd. lot number C3257) on 30 December 2010 and the next day (also reported as 01 January 2011) experienced severe ataxia, thought process impairment and vertigo. The patient was evaluated by a neurologist and was diagnosed with meningeal encephalitis. According to the reporter the thought process impairment and vertigo continue to persist. Treatments and concomitant medications were not reported. The patient had no reported illness at the time of vaccination and had no other vaccines within four weeks of the suspect vaccine. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Ataxia, Encephalitis, Thinking abnormal, Vertigo
Clinical narrative: Initial report was received from a health care professional on 08 March 2011. A 56 year-old female with an allergy to morphine, had received an intramuscular right deltoid injection of ADACEL, lot number U3042AA (sanofi pasteur Ltd. lot number C3257) on 30 December 2010 and the next day (also reported as 01 January 2011) experienced severe ataxia, thought process impairment and vertigo. The patient was evaluated by a neurologist and was diagnosed with meningeal encephalitis. According to the reporter the thought process impairment and vertigo continue to persist. Treatments and concomitant medications were not reported. The patient had no reported illness at the time of vaccination and had no other vaccines within four weeks of the suspect vaccine. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myelitis transverse
Clinical narrative: Transverse myelitis and temporally related to flu shot. Flu shot administered 11/30/2009. Hospitalized 12/4/2009, symptoms developing over 3 days prior.
Age: 53.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abasia, Disability, Myelitis transverse
Clinical narrative: Transverse myelitis and temporally related to flu shot. Flu shot administered 11/30/2009. Hospitalized 12/4/2009, symptoms developing over 3 days prior.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Hives noted (L) upper arm. Advised to give BENADRYL & go to ER if any facial swelling or itchy throat.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Abnormal faeces, Blood culture, Blood test, Culture urine, Decreased appetite
Clinical narrative: High fevers 102.7  103.8 104.4  Lethargy, loss or appetite, hives covering face and upper body, foul smelling bowel movement, high pitch screaming, stiff muscle in her right leg, restlessness. Treatment:  Nose and Throat Swab performed, blood tests done.  Though she did not have the flu, Tamiflu was prescribed.  14th March 2011 at 3:15 am Emergency visit made to Hospital.