chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Redness & warmth surrounding the injection site involving front of thigh, c/o itching, no pain, walking without difficulty, no fever, warmth on touch. Plan: Start CEPHALEXIN 250/5ud 3/4 by po Tid x10 day. BENADRYL ELIXIR 1 1/2 Po Tid-QD.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Blood glucose normal, Computerised tomogram normal, Eye movement disorder, Mobility decreased, Tonic clonic movements
Clinical narrative: Unresponsive shaking, trembling x 1 minute child to ER - mom stated R side of mouth started to quiver & then her eyes wandered a bit and then she became quite tonic when event stopped she couldn't use her R arm for a few moments she did not respond for a moment.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Unresponsive shaking, trembling x 1 minute child to ER - mom stated R side of mouth started to quiver & then her eyes wandered a bit and then she became quite tonic when event stopped she couldn't use her R arm for a few moments she did not respond for a moment.
Age: 51.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Muscle spasms, Neuropathy peripheral, Pyrexia
Clinical narrative: Peripheral neuropathy. Persistent fever. Muscle spasms.
Age: 51.0
Sex: M
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Hot flush, Paraesthesia, Skin warm
Clinical narrative: Peripheral neuropathy. Persistent fever. Muscle spasms.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt has red swollen arm, (L) triceps area. Tender, taking long time to improve despite heat, ice, rest, BENADRYL cream. 15x10cm.
Age: 48.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Muscle spasms, Myalgia, Nausea
Clinical narrative: 1 day after Td vaccine patient states developed fatigue, muscle aching arms and legs with a couple cramps in calf muscles. Slight nausea.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Rash
Clinical narrative: Patient given Tdap L deltoid without complaint, upon rising from chair 4-5 minutes later, pt's mother noted rash on L, R arm, chest, redness, no itching. Given BENADRYL 50 mg IM R deltoid 0956.
Age: 5.0
Sex: M
Vaccine: PPV, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: seen by dr wasserman 04/03/10 and told normal reaction to vaccine, seen 04/05/10 by Dr. So-skin-eythema-warm, right lateral thigh 9 x 13 cm and warm left anterior thigh 14 x 16cm, primary diagnosis: Cellulitis rx cephalexin , followup in 2 days
Age: 24.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Blood creatine phosphokinase increased, Headache, Injection site pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Lt. arm sore; unable to lift; pain radiates to neck; headache; unable to turn head. Took Tylenol & Ibuprofen without relief. Went to ER on 4/4/10; I.V. pain meds, home with oxycodone.
Age: 24.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Lt. arm sore; unable to lift; pain radiates to neck; headache; unable to turn head. Took Tylenol & Ibuprofen without relief. Went to ER on 4/4/10; I.V. pain meds, home with oxycodone.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized hardening at location of Immunization administration L arm deltoid muscle with erythema.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Bordetella test positive, Cough, Culture
Clinical narrative: Case developed cough on 3/25/10 which worsened to a paroxsysmal cough on 3/31/10.  Doctor prescribed Azithromycin po x5 days.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Headache, Pain, Throat tightness, Urticaria
Clinical narrative: Chills, body aches, hives, headache, throat tightening
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Headache, Malaise, Palpitations
Clinical narrative: Onset chills, headache, malaise, heart racing continued through the night with resolving symptoms in the morning.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash, Rash pruritic
Clinical narrative: Developed rash approx 3 weeks after vaccination on bilateral arms. Very pruritic, provided ATARAX for treatment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash papular
Clinical narrative: Rash-papular, diffuse-3 days after vaccinations. Second occurrence. Treated with antihistamines. Child's mom called office 4-4-10 stating child had rash for 2 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to left deltoid. *4/5/10 called parent back and no swelling no redness to site.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Cardiac enzymes normal, Computerised tomogram, Computerised tomogram normal, Electrocardiogram normal, Full blood count normal
Clinical narrative: Sinus surgery 12/12/09 - Few days later (L) chest wall pain and subsequent (L) shoulder pain. ER visit 12/28/09 - CBC, chem profile, cardiac enzymes - all NL -EKG, chest CT for PE- NL. Neuro consult 3/23/10. Dx. Parsonage Turner Syndrome.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Laboratory test normal, Musculoskeletal chest pain, Musculoskeletal pain, Neuralgic amyotrophy
Clinical narrative: Sinus surgery 12/12/09 - Few days later (L) chest wall pain and subsequent (L) shoulder pain. ER visit 12/28/09 - CBC, chem profile, cardiac enzymes - all NL -EKG, chest CT for PE- NL. Neuro consult 3/23/10. Dx. Parsonage Turner Syndrome.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Face oedema, Lymphadenopathy, Neck pain, Pruritus
Clinical narrative: 3 hr after injection, had pain in the neck, on March 25 in lower arm rash B, March 29 became generalised, became weak, in papules itchy, took PREDNISONE 2 days without improvement. 4/2 oedema of face and around eyes then took CLARITIN. 4/3 swollen lymph nodes. Still take CLARITIN
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Rash papular
Clinical narrative: 3 hr after injection, had pain in the neck, on March 25 in lower arm rash B, March 29 became generalised, became weak, in papules itchy, took PREDNISONE 2 days without improvement. 4/2 oedema of face and around eyes then took CLARITIN. 4/3 swollen lymph nodes. Still take CLARITIN
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness, Feeling drunk, Reaction to previous exposure to any vaccine, Thinking abnormal
Clinical narrative: Pt became dizzy, felt balance was "off", complained of feeling "drunk". Symptoms persisted throughout the weekend and on Tuesday, 4/6/10, she reported she still felt dizzy and that she was not thinking clearly. When I saw her on 04/06/2010, her blood pressure was 120/80, no rash observed, breathing normal. No ataxia noted. Pt. states that her granddaughter developed similar symptoms after recieving Varicella vaccine when she was a child. Pt. has made an appt. to see her physician on Friday, April 9th.  Pt. states no alcohol consumed since the vaccination. No immediate side effects after vaccination. Pt is unsure events are connected to Zostavax administration. Patient's physician had recommended that she get the vaccine if it was available.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Body temperature increased, Diarrhoea, Lethargy, Staphylococcus test
Clinical narrative: Patient vomited 8 times in 3 hour time period starting 3/24/10.  Patient vomited multiple times daily for 13 days with the exception of two days.  Patient had intermittent diarrhea for 13 days and 102 degree temperature on days 8 through 10 after vaccination.  Patient was lethargic for 13 days after vaccination.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Streptococcus test, Viral test, Vomiting
Clinical narrative: Patient vomited 8 times in 3 hour time period starting 3/24/10.  Patient vomited multiple times daily for 13 days with the exception of two days.  Patient had intermittent diarrhea for 13 days and 102 degree temperature on days 8 through 10 after vaccination.  Patient was lethargic for 13 days after vaccination.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Ocular hyperaemia, Rash papular
Clinical narrative: 2 day after injection, had headache, rash papulous on cheeks and both lower arms, redness of eye, took ~= TYELONL and CLARITIN,  LASIX, took 3-4 days to recover, took some meds every day until better.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: Throbbing pain and tingling at injection site and in entire left UE
Age: 1.3
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC
Symptoms: Diarrhoea, Injection site urticaria, Urticaria
Clinical narrative: Patient had onset of body-wider diffuse urticaria with adolescent area and hives at site of PREVENAR but mostly all over body. 1 diarrheal stool 2 hrs later, no respiratory distress and no mucous membrane swelling.
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Erythema, Pruritus, Swelling
Clinical narrative: Pt has itching, swelling, erythema about 3in. long/wide. Advice to apply ice, give BENADRYL 25ml. Discuss sign and symptom of cellulitis advice to return if sign and symptom get worse. Mother verbalize understanding.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Decreased appetite, Injection site pain, Irritability, Malaise, Pyrexia
Clinical narrative: Fever and malaise since H1N1 booster vaccination one week ago. Very sleepy, irritated easily, anorexic, pain at injection site.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Somnolence
Clinical narrative: Fever and malaise since H1N1 booster vaccination one week ago. Very sleepy, irritated easily, anorexic, pain at injection site.
Age: 1.28
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Allergy test, Cyanosis, Erythema, Full blood count, Hypoxia
Clinical narrative: Within 10 minutes of vaccination patient developed vomiting closely followed by irritability and hives. At about 1230 patient developed circumoral cyanosis and hypoxia. 1248 swelling to left thigh. 1302 hives gone but skin red from knees to head (patient received 7.5 mg Benadryl, blow-by oxygen and was admitted for observation).
Age: 1.28
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Irritability, Tryptase, Urticaria
Clinical narrative: Within 10 minutes of vaccination patient developed vomiting closely followed by irritability and hives. At about 1230 patient developed circumoral cyanosis and hypoxia. 1248 swelling to left thigh. 1302 hives gone but skin red from knees to head (patient received 7.5 mg Benadryl, blow-by oxygen and was admitted for observation).
Age: 1.28
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Within 10 minutes of vaccination patient developed vomiting closely followed by irritability and hives. At about 1230 patient developed circumoral cyanosis and hypoxia. 1248 swelling to left thigh. 1302 hives gone but skin red from knees to head (patient received 7.5 mg Benadryl, blow-by oxygen and was admitted for observation).
Age: 0.53
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B, No therapeutic response, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis B in a 9-month-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline), RECOMBIVAX (non-gsk). On 30 November 2009 and 23 June 2009 the subject received 3rd and 2nd dose of ENGERIX B (unknown), In 2009 the subject received 1st dose of RECOMBIVAX (unknown). On 1 March 2010, 91 days after vaccination with ENGERIX B, 8 months after vaccination with ENGERIX B, 1 year after vaccination with RECOMBIVAX, the subject experienced hepatitis B, not responding to therapy and vaccination failure. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Augmentin 250mg 1 1/2 tsp Bio x 10 days
Age: 0.53
Sex: M
Vaccine: FLU(H1N1), FLU3, HEP, PNC
Symptoms: Injection site discolouration
Clinical narrative: Doctor observed a "silver looking tatooing about period size" at visit on 3/31/10. Mom took child to doc after noticing dark spot @ 2 injection sites wasn't going away after receiving imms. on 3/10/10. Area was not red, tender, or swollen and no foreign body under skin. One spot on (L) leg and one spot on (R) Leg.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1), FLUN3, HEPA, HIBV
Symptoms: Feeling abnormal, Nausea, Pyrexia, Vomiting
Clinical narrative: T. C. from MD stating client had nausea/vomiting starting @ 9 pm and continuing through the night. Fever in am - no thermometer available. Con't to feel peeky through following day - then resolved.
Age: 41.0
Sex: F
Vaccine: MMR, TTOX
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Complaints of high fever 102-102.3 with swelling to left arm arm hot to touch and painful.
Age: 1.31
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash
Clinical narrative: Vaccines administered 2/5/2010. About 5 days later fever mild with spikes T 100 at night x 3 days. Mild rash @ 10 days post injections. Client lethargic with poor appetite. 3 weeks after injections. Client taken to ER with fever T 104, lethargic, poor appetite (2/27/10) has rash again over torso - fasting today - 3/2/10. Appetite improving.
Age: 1.76
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Mild localized cellulitis R thigh.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Hepatitis A vaccine given when VARICELLA was needed.  Patient's mother contacted.  Patient scheduled to receive correct vaccine 4-1-10.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Blood gases normal, Chest X-ray normal, Computerised tomogram normal, Influenza serology negative, Lumbar puncture normal
Clinical narrative: On 10/29 Pt had 2 episodes of jerking at 6 pm and again the following day, no resp distress, no cyanosis and seemed alert. Taken to ER the evening of 10/30. CT & CXR (-), LP (-), RSV & Flu (-), WBC 22.6, ABG WNL.  Bld, urine & CSF cultures pending. Noted desat in ER decreased 80's, self recovered on increase  . Admitted to hospital for poss Sz activity. EEG WNL, Boca virus (+). Discharged 11/1 - see attached.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Oxygen saturation decreased, Respiratory syncytial virus test negative, White blood cell count increased
Clinical narrative: On 10/29 Pt had 2 episodes of jerking at 6 pm and again the following day, no resp distress, no cyanosis and seemed alert. Taken to ER the evening of 10/30. CT & CXR (-), LP (-), RSV & Flu (-), WBC 22.6, ABG WNL.  Bld, urine & CSF cultures pending. Noted desat in ER decreased 80's, self recovered on increase  . Admitted to hospital for poss Sz activity. EEG WNL, Boca virus (+). Discharged 11/1 - see attached.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Computerised tomogram normal, Convulsion, Dyskinesia, Electroencephalogram normal, Lumbar puncture normal
Clinical narrative: On 10/29 Pt had 2 episodes of jerking at 6 pm and again the following day, no resp distress, no cyanosis and seemed alert. Taken to ER the evening of 10/30. CT & CXR (-), LP (-), RSV & Flu (-), WBC 22.6, ABG WNL.  Bld, urine & CSF cultures pending. Noted desat in ER decreased 80's, self recovered on increase  . Admitted to hospital for poss Sz activity. EEG WNL, Boca virus (+). Discharged 11/1 - see attached.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Myoclonus, Respiratory tract congestion, Viral infection
Clinical narrative: On 10/29 Pt had 2 episodes of jerking at 6 pm and again the following day, no resp distress, no cyanosis and seemed alert. Taken to ER the evening of 10/30. CT & CXR (-), LP (-), RSV & Flu (-), WBC 22.6, ABG WNL.  Bld, urine & CSF cultures pending. Noted desat in ER decreased 80's, self recovered on increase  . Admitted to hospital for poss Sz activity. EEG WNL, Boca virus (+). Discharged 11/1 - see attached.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Fall, Head injury, Syncope
Clinical narrative: Patient received 4 shots. Faint start having a seizure 30 seconds, hit the head when she fell. Patient recovery after 30 seconds PCP check patient, vital are good.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis
Clinical narrative: DTAP given left deltoid. Developed cellulitis at the site, resolved on antibiotics.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Dysphonia
Clinical narrative: Hoarseness
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Pruritus generalised, Urticaria
Clinical narrative: itching head to toe, hives, stomach ache
Age: 64.0
Sex: M
Vaccine: FLU(H1N1), PPV
Symptoms: Abasia, Asthenia, Balance disorder, Blood test, Urinary tract infection
Clinical narrative: Felt more weak and wobbly until I was unable to walk. Emergency room physician diagnosed urinary tract infection and sent me home. Went back following day and was admitted
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Arthralgia, Dizziness, Hyperhidrosis, Injected limb mobility decreased
Clinical narrative: Pain in joint of arm, shot was given in.  By 5:00PM could not move arm, pain very severe, arm hung like the shoulder had been dislocated.  5:30 PM nausea, lightheadness, sweating, probably from anxiety.  Called CDC for help, advised to wipe injection site with clean damp cloth and use as compress and to take aspirin, Advil or Tylenol.  Also used ice pack.  Pain subsided but could not raise arm above 45 degrees until 4/4/10.  As of 4/6/10 there is still mild pain with motion.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nausea, Pain
Clinical narrative: Pain in joint of arm, shot was given in.  By 5:00PM could not move arm, pain very severe, arm hung like the shoulder had been dislocated.  5:30 PM nausea, lightheadness, sweating, probably from anxiety.  Called CDC for help, advised to wipe injection site with clean damp cloth and use as compress and to take aspirin, Advil or Tylenol.  Also used ice pack.  Pain subsided but could not raise arm above 45 degrees until 4/4/10.  As of 4/6/10 there is still mild pain with motion.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Skin warm
Clinical narrative: Red arm hot to the touch.
Age: 52.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Erythema, Eye swelling, Pruritus, Pyrexia, Tinnitus
Clinical narrative: Hives, skin turned red, itching, fever, eyes swelled, and ringing in ears
Age: 52.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives, skin turned red, itching, fever, eyes swelled, and ringing in ears
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Decreased appetite, Diarrhoea, Induration, Nausea, Nodule
Clinical narrative: Had low grade fever (100.9) which continues to now, decreased appetite, pain x 3 days, swelling with hard, raised knot still in place, nausea, diarrhea starting 4/4/2010, vomiting starting 4/6/2010
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia, Swelling, Vomiting
Clinical narrative: Had low grade fever (100.9) which continues to now, decreased appetite, pain x 3 days, swelling with hard, raised knot still in place, nausea, diarrhea starting 4/4/2010, vomiting starting 4/6/2010
Age: 18.0
Sex: F
Vaccine: FLU(H1N1), FLUX, HEPA
Symptoms: Activated partial thromboplastin time normal, Full blood count normal, Haematocrit decreased, Haemoglobin decreased, International normalised ratio normal
Clinical narrative: Papular, erythematous rash to cheeks, neck, upper anterior torso with some petichiae that started about 6 hours after vaccine administration and lasted until about 5 days after administration
Age: 18.0
Sex: F
Vaccine: FLU(H1N1), FLUX, HEPA
Symptoms: Metabolic function test, Petechiae, Prothrombin time normal, Rash papular, Red blood cell count decreased
Clinical narrative: Papular, erythematous rash to cheeks, neck, upper anterior torso with some petichiae that started about 6 hours after vaccine administration and lasted until about 5 days after administration
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Colitis ulcerative
Clinical narrative: patient developed ulcerative colitis
Age: 3.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Hypotonia, Petit mal epilepsy, Pupil fixed, Tardive dyskinesia, Unresponsive to stimuli
Clinical narrative: My daughter had an absent seizure, (pupils were fixed and dilated, her body was limp, she was smacking her lips and was unresponsive for 1-2 minutes) waiting to see if it happens again before starting diagnostic testing
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Gait disturbance, Pyrexia, Weight bearing difficulty
Clinical narrative: A 2-year-old female patient with no concurrent illness and no pre-existing medical conditions had received an intramuscular right thigh injection of ActHIB, lot number UF568AA (Sanofi Pasteur, SA lot number D0050-1) on 15 June 2009 and four days later, she refused to hear weight on and refused to use her right leg, had difficulty walking and had a fever (temperature not reported). She had not experienced any adverse vents following prior vaccinations. The patient recovered from the event (date of recovery not reported). Follow-up information was received from the health care professional on 03 August 2009. The patient began experiencing symptoms one day post-vaccination, on 16 June 2009 (previously reported as 19 June 2009). Symptoms included fever of 101 degrees, and difficulty walking. Her mother was advised to administer Tylenol, and to rest her legs. The following day, the patient's grandmother reported that the patient's fever had broken, and that she was feeling better.
Age: 0.4
Sex: M
Vaccine: HIBV, PNC, RV1
Symptoms: Pyrexia, Vomiting, Wrong technique in drug usage process
Clinical narrative: Initial report was received 05 February 2010 from a health care provider. This report involves a case of misuse (i.e., reconstitution error). A 4-month-old male patient had received an injection of ActHIB (reconstituted with MMR diluent in error), lot number C3482AB (invalid ActHIB lot number), and an injection of PCV7, manufacturer Wyeth, lot number D90887, and an injection of ROTARIX, manufacturer GSK, lot number A411SB0038 on 04 February 2010 and the following day (also reported as 24 hours), he developed a fever of 100.2 degrees and vomiting. The patient was scheduled to be evaluated by their physician on the day of the report. The patient had a pasty history of bronchiolitis and a heart murmur and concomitant medications include albuterol PRN and PULMACORT. Outcome was not recovered.
Age: 52.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Initial report was received 25 June 2009 from another manufacturer (document number 974869), who received the report from a health care professional. A 52-year-old female patient with a history of non-hodgkins lymphoma and a bone marrow transplant, had received a second dose of right arm injection of ACTHIB, lot number UF615AD (Sanofi Pasteur, SA lot number B0408-1) on 09 June 2009 at 08:30 hours, and one day later, she developed induration, erythema, mild tenderness to palpation and pruritic area 12.5 cm x 10 cm at the deltoid (right arm) area. She recovered corrective treatment with Claritin once daily or Atarax every six hours prn. She had been taking Allopurinol, Benadryl, Robaxin and Iodine at the time of vaccination. The patient's recovery status was not reported. Follow up information received on 30 July 2009 from a health care professional who reported that in April 2005 the patient was diagnosed with Non-Hodgkin's Lymphoma. In January 2008 the patient had a bone marrow transplant. Route of administration for ActHib was confirmed as intramuscular. The patient recovered from the pruritis and induration. Follow-up information was received from the health care professional on 24 August 2009. The patient was seen on 11 June 2009 in the walk-in clinic. She was subsequently contacted via telephone, and at that time reported that she had fully recovered (date not provided). Documents held sender: None.
Age: 1.92
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV
Symptoms: Incorrect dose administered, Injection site erythema, Injection site induration
Clinical narrative: A health 23 month-old male patient, had received in error a 0.5 mL intramuscular left outer deltoid adult dose of Fluzone SV 2009-2010, lot number U3189AA on 02 September 2009 instead of 0.25 mL pediatric dose of Fluzone. The patient had also received on the same day a fourth intramuscular right deltoid injection of ActHIB, lot number UF566AA (Sanofi Pasteur SA lot number D0021-1); an intramuscular right deltoid injection of HAVRIX, lot number AHAVB326AA (manufacturer GSK); and an intramuscular left deltoid injection of INFANRIX, lot number AC14B0690. The next day after receiving the vaccinations, the mother reported , and a physician observed a two inch (5cm) pink firm area with no depth at the Fluzone injection site on the left outer deltoid area. The patient had no fever, but was started on antibiotics (not specified) that day. At the time of this report, it was "unknown" if the patient had recovered. Follow-up information was received 06 October 2009 from a health care professional. The patient had received Fluzone, ActHIB, HAVRIX and INFANRIX on 01 September 2009 (previously reported as 02 September 2009) and the event onset was amended to 02 September 2009 (previously reported as 03 September 2009). The patient was prescribed Omnicef 125/5mL for 14 days; however the patient went on a trip with his father and did not complete  the 14 day regimen. The patient's mother was unsure of the stop date for Omnicef. The pink firm area increased from 4 cm x 3 cm to an additional 1 cm by the next day and no further treatments were required. The event began to resolve after the third day, and by on week, the patient fully recovered with no residual effect.
Age: 1.21
Sex: F
Vaccine: HIBV, MMR, FLU(H1N1), HIBV, MMR
Symptoms: Urticaria
Clinical narrative: Initial report was received 04 December 2009 from a health care professional. A 14-month-old female patient had received a fourth dose thigh injection of ActHIB, lot number UF754AA (sanofi pasteur SA lot number D0200-1) and a first dose thigh injection of MMR (manufacturer Merck, lot number 0423Y) on 24 October 2009 and an unspecified amount of time later, the patient developed hives. No further information was provided at the time of the report. This patient experienced a subsequent event of hives after receiving Influenza A (H1N1) 2009 Monovalent Vaccine-Preservation on which has been captured in case 2009-05052. Follow-up information was received on 11 January 2010 from a healthcare professional. It was reported the patient had recovered on an unspecified date.
Age: 38.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Amniocentesis, Drug exposure during pregnancy, Incorrect dose administered, No adverse event, Ultrasound scan
Clinical narrative: Information has been received from a nurse practitioner concerning a 38 year old pregnant female with allergy to DEMEROL and a history of gastric bypass in 1996 who on 31-OCT-2008 at 08:40 was vaccinated IM into deltoid with the second dose of RECOMBIVAX HB (lot# 660461/0401X). There was no concomitant medication. Dose 1 was administered at a different facility and the date that dose 1 was administered was unspecified. Dose 2 was given as 2 combined pediatric doses of RECOMBIVAX HB. As of 18-DEC-2008, the patient was 7 and 1/2 months pregnant (estimated LMP was 18-MAY-2008 and EDD was 22-FEB-2009). No symptoms reported. The patient sought medical attention in the office. Follow-up information received from a licensed practical nurse indicated that the patient was a female with sun damaged skin who received her first dose of (previously reported by the nurse practitioner as second dose) of RECOMIVAX HB (lot# 66041/0401X) IM into the left deltoid on 31-OCT-2008. Concomitant vaccine included FLUZONE, (lot # UT2882FA) IM into the right deltoid as 2 combined pediatric doses during the same visit. The patient did not seek medical attention (previously reported by the nurse practitioner as sought medical attention). The nurse practitioner's office had not seen patient since injection given on 31-OCT-2008 and could not provide any information regarding the outcome of the pregnancy. Follow-up information has been received from a healthcare professional who reported that the patient had 2 previous pregnancies and 1 live birth. No birth defect but a miscarriage or stillbirth occurred 5-6 weeks from last menstrual period during previous pregnancies.  It was reported that the date of LMP was 01-APR-2008. On 31-OCT-2008, 30 weeks after the LMP, the patient went to her primary care physician (PCP) for a flu shot and was given the RECOMIVAX HB instead in error (patient was pregnant at that time). During pregnancy, the patient took FLINSTONES MULTIVITAMINS and 2 doses of injection RHOGAM. No prescription drug was taken. The patient had no infections/illnesses during pregnancy. Ultrasounds were performed (results unknown) on 11-MAY-2008 (5 weeks 5 days from LMP), 27-JUN-2008 (12 weeks 3 days from LMP), 27-AUG-2008 (21 weeks 1 day from LMP) and 10-DEC-2008 (36 weeks 1 day from LMP). A nuchal translucency (results unknown) was performed on 27-JUN-2008 (12 weeks 3 days from LMP). An amniocentesis (results unknown) was performed on 26-AUG-2008 (21 weeks from LMP). On 30-DEC-2008, 39 weeks after the LMP, the patient delivered a normal, healthy female baby weighing 8 pounds 7 ounces with no congenital anomalies. Additional information is not expected.
Age: 38.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 38 year old pregnant female with allergy to DEMEROL and a history of gastric bypass in 1996 who on 31-OCT-2008 at 08:40 was vaccinated IM into deltoid with the second dose of RECOMBIVAX HB (lot# 660461/0401X). There was no concomitant medication. Dose 1 was administered at a different facility and the date that dose 1 was administered was unspecified. Dose 2 was given as 2 combined pediatric doses of RECOMBIVAX HB. As of 18-DEC-2008, the patient was 7 and 1/2 months pregnant (estimated LMP was 18-MAY-2008 and EDD was 22-FEB-2009). No symptoms reported. The patient sought medical attention in the office. Follow-up information received from a licensed practical nurse indicated that the patient was a female with sun damaged skin who received her first dose of (previously reported by the nurse practitioner as second dose) of RECOMIVAX HB (lot# 66041/0401X) IM into the left deltoid on 31-OCT-2008. Concomitant vaccine included FLUZONE, (lot # UT2882FA) IM into the right deltoid as 2 combined pediatric doses during the same visit. The patient did not seek medical attention (previously reported by the nurse practitioner as sought medical attention). The nurse practitioner's office had not seen patient since injection given on 31-OCT-2008 and could not provide any information regarding the outcome of the pregnancy. Follow-up information has been received from a healthcare professional who reported that the patient had 2 previous pregnancies and 1 live birth. No birth defect but a miscarriage or stillbirth occurred 5-6 weeks from last menstrual period during previous pregnancies.  It was reported that the date of LMP was 01-APR-2008. On 31-OCT-2008, 30 weeks after the LMP, the patient went to her primary care physician (PCP) for a flu shot and was given the RECOMIVAX HB instead in error (patient was pregnant at that time). During pregnancy, the patient took FLINSTONES MULTIVITAMINS and 2 doses of injection RHOGAM. No prescription drug was taken. The patient had no infections/illnesses during pregnancy. Ultrasounds were performed (results unknown) on 11-MAY-2008 (5 weeks 5 days from LMP), 27-JUN-2008 (12 weeks 3 days from LMP), 27-AUG-2008 (21 weeks 1 day from LMP) and 10-DEC-2008 (36 weeks 1 day from LMP). A nuchal translucency (results unknown) was performed on 27-JUN-2008 (12 weeks 3 days from LMP). An amniocentesis (results unknown) was performed on 26-AUG-2008 (21 weeks from LMP). On 30-DEC-2008, 39 weeks after the LMP, the patient delivered a normal, healthy female baby weighing 8 pounds 7 ounces with no congenital anomalies. Additional information is not expected.
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinated with a dose of RECOMBIVAX HB (lot # not reported between 1993 and 1997. Subsequently the patient experienced hives from the vaccine. It was reported that no further information was provided from the caller as the vaccine was not given in this physician's office. As of 07-JAN-2009, the patient's outcome was unknown.
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Wrong technique in drug usage process
Clinical narrative: Information has been received from a medical assistant concerning a female who on 09-JAN-2009 was vaccinated with a dose of RECOMBIVAX HB, mixed with ADACEL into the same syringe. On approximately 09-JAN-2009, after vaccination, the patient experienced redness at injection site. The patient was seen at in the office on 12-JAN-2009 and the injection site of the right arm was red. At the time of this report, the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant and a physician who reported that a female consumer, age unknown, started RECOMBIVAX HB on 07-Jan-2009 for unknown indication. The patient's relevant medical history, relevant concomitant medications and relevant past drug history was unknown. On 08-JAN-2009 the patient experienced a rash around her trunk area. It was unknown if there was any relevant laboratory data. As of 12-Jan-2009, the patient continued to experience having a rash around her trunk area. It was unknown if she continued to take the RECOMBIVAX HB.  Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody positive, Hepatitis B surface antigen positive
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of RECOMBIVAX HB. The nurse reported that a serology testing showed that the patient had a positive hepatitis B surface antigen test. The nurse stated that she was gathering information on whether there could be a false positive HBsAg for a certain time period after receiving RECOMBIVAX HB. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Immediate post-injection reaction, Malaise, Throat irritation
Clinical narrative: Information has been received from a physician concerning a 42 (also reported as 34) year old female patient with allergy to "several antibiotics" (tetracycline, erythromycin) who on 16-DEC-2008, was vaccinated with a first dose of RECOMBIVAX HB and a second dose of RECOMBIVAX HB on 19-JAN-2009, (lot #, dose and route of administration unknown). It was reported that the patient after receiving her first dose of hepatitis vaccine noticed her throat "itched" but went away shortly (within minutes) after with no treatment. When she received her second dose, she immediately experienced difficulty breathing. The physician stated that this "got worse" and the patient went to an unspecified Emergency Room where she received antihistamines, an "H2 blocker", and steroids (all drugs unspecified). Patient was not admitted. The patient "did not feel well" for 24 hours after receiving the vaccine. Patient is recovering now but she is still on steroids. The physician considered difficulty breathing to be immediately life threatening. Follow up information was received from a physician concerning the 42 year old female nurse with allergy to penicillin, sulfa, codeine, LODINE, tetracycline and erythromycin who was given the vaccine in another office and seen in another emergency room (ER) after reaction. On 22-JAN-2009 the patient recovered. The physician had no further information to provide. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a patient who in 2005, was vaccinated with a dose of RECOMBIVAX HB. The patient was supposed to be vaccinated with VAQTA. The patient was given two separate doses of RECOMBIVAX HB. The patient had not experienced any known symptoms. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: Information has been received from a physician concerning a female patient with no pertinent medical history and no known drug allergies who on 14-JAN-2003 was vaccinated with a dose of RECOMBIVAX HB (lot# not provided) 0.5ml intramuscularly. There was no concomitant medication. On 13-MAR-2003 patient received a dose of COMVAX (lot# not provided). On 20-MAY-2003 patient received a second dose of COMVAX (lot# not provided) and on 28-JUL-2003 patient received a third dose of COMVAX (lot# not provided). Patient is a non-responder after getting 4 doses of hepatitis b vaccine. Patient sought medical attention via an office visit. "Non-responder status from a hepatitis tilter from the last few days". At the time of this report patient had not yet recovered. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Information has been received via litigation article regarding a case in litigation concerning a female who was vaccinated with RECOMBIVAX HB (date, dose, route not reported). Subsequently the patient experienced chronic inflammatory demyelinating polyneuropathy. The patient outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Dermatomyositis
Clinical narrative: Information has been received via litigation article regarding a case in litigation concerning a female who was vaccinated with RECOMBIVAX HB. Subsequently the patient experienced juvenile dermatomyositis. The outcome of juvenile dermatomyositis was not reported. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Psoriatic arthropathy
Clinical narrative: Information has been received via litigation article regarding a case in litigation concerning a male who was vaccinated with RECOMBIVAX HB. Subsequently the patient experienced psoriatic arthritis. The outcome of psoriatic arthritis was not reported. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 19 year old patient who was vaccinated with a dose of adult formulation of RECOMBIVAX HB (lot # not reported).  The patient has not experienced any known symptoms.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a 18 year old female student nurse with bipolar disorder, allergic reaction to CECLOR, PROZAC and SEPTRA concerning herself who on 14-AUG-2008 was vaccinated IM with the first dose of RECOMBIVAX HB 1ml (LOT# not reported), on 15-SEP-2008, was vaccinated IM with the second dose of RECOMBIVAX HB 1ml (LOT# not reported), on 16-FEB-2009, was vaccinated SQ with the third dose of RECOMBIVAX HB 1ml (LOT# not reported). Concomitant therapy included LAMICTAL, metformin (manufacturer unknown), SEROQUEL, CLOZARIL, atenolol (manufacturer unknown) and LOESTRIN. Several hours after administered the third dose of RECOMBIVAX HB, on 16-FEB-2009, the patient developed soreness of the right upper arm. No treatment had been recommended. The patient was not recovered from adverse events. It was reported that the patient sought medical attention: office visit. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: Information has been received from a nurse practitioner concerning a 29 year old female smoker with allergies who on 17-FEB-2009 was vaccinated IM with her initial dose of RECOMBIVAX HB (Lot # not reported) 1.0ml in deltoid.  Concomitant therapy included ZYRTEC.  On 17-FEB-2009, within 30 minutes of receiving the RECOMBIVAX HB, the patient developed dizziness.  The patient's dizziness persisted.  The patient called the office on 19-FEB-2009 to report the ongoing dizziness.  The nurse practitioner was considering discontinuing the series.  It was reported that the patient sought medical attention:  called the office.  Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort
Clinical narrative: Information has been received from a medical assistant concerning a 32 year old female patient who on 23-JAN-2009 was vaccinated with the first dose of RECOMBIVAX HB and on 23-FEB-2009 received IM the second 0.5 mL dose of RECOMBIVAX HB (LOT # 662115/1263X thimerosal free).  Approximately two hours after receiving the second dose of hepatitis B vaccine, the patient experienced stomach upset.  The patient was seen by the physician.  It is unknown if the patient recovered.  It was also reported that on the same date two other patients were vaccinated and experienced the same adverse event.  Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Culture urine, Injection site rash, Irritability, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old male with no pertinent medical history or drug allergies who on 17-FEB-2009 was vaccinated with the second dose of RECOMBIVAX HB (lot #: 662421/1040X) and the first dose of ROTATEQ (lot #: 661358/1522X). On 18-FEB-2009 the patient developed rash at injection site. It was reported that some lesions were papular and others resembled hives. The patient was seen in the office on 24-FEB-2009, the rash was not recovered at that time. It was reported that the patient received his first dose of RECOMBIVAX HB in the hospital after birth. Follow up information was received from a registered nurse (R.N.) and medical records reported that the patient was a 10 weeks old male with no pre-existing allergies, birth defects, medical conditions who on 10-DEC-2008 and 17-FEB-2009 was vaccinated intramuscularly in his right upper thigh with a first and second dose of RECOMBIVAX HB (lot# 662421/1040X). Secondary suspect vaccination included a first dose of ROTATEQ (lot# 661358/1522X) given orally on 17-FEB-2009. Concomitant therapy included a first dose of PREVNAR (lot# D07543) vaccinated intramuscularly in his left lower thigh and a first dose of PENTACEL (lot# C3186AA) vaccinated intramuscularly in his left upper thigh on 17-FEB-2009. There was no illness at the time of vaccination. On 18-FEB-2009 the patient developed whole body rash which was possibly erythema multiforme. On 04-MAR-2009 the patient went to ER accompanied by his parents, with a chief complaint of fever. The patient was in H until that day at noon, when FOC felt he was warmer than normal. His temperature was 100.4. The patient was more fussy at that day than before, only additional associated symptom was rash which was discrete, erythematous lesions, initially on face and all four extremities, it was only found on extremities at that day. No central clearing, almost urticarial in appearance. No evidence of super infection. The patient appeared alert and interactive, grossly nonfocal. Urine analysis and urine culture were performed but the results were pending. The diagnosis was fever. The patient's parents insisted on leaving despite discussion of risk of possible underlying urine infection. At the time of reporting, the events persisted. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Rash generalised, Rash papular, Skin lesion, Skin warm, Urine analysis
Clinical narrative: Information has been received from a registered nurse concerning a 10 week old male with no pertinent medical history or drug allergies who on 17-FEB-2009 was vaccinated with the second dose of RECOMBIVAX HB (lot #: 662421/1040X) and the first dose of ROTATEQ (lot #: 661358/1522X). On 18-FEB-2009 the patient developed rash at injection site. It was reported that some lesions were papular and others resembled hives. The patient was seen in the office on 24-FEB-2009, the rash was not recovered at that time. It was reported that the patient received his first dose of RECOMBIVAX HB in the hospital after birth. Follow up information was received from a registered nurse (R.N.) and medical records reported that the patient was a 10 weeks old male with no pre-existing allergies, birth defects, medical conditions who on 10-DEC-2008 and 17-FEB-2009 was vaccinated intramuscularly in his right upper thigh with a first and second dose of RECOMBIVAX HB (lot# 662421/1040X). Secondary suspect vaccination included a first dose of ROTATEQ (lot# 661358/1522X) given orally on 17-FEB-2009. Concomitant therapy included a first dose of PREVNAR (lot# D07543) vaccinated intramuscularly in his left lower thigh and a first dose of PENTACEL (lot# C3186AA) vaccinated intramuscularly in his left upper thigh on 17-FEB-2009. There was no illness at the time of vaccination. On 18-FEB-2009 the patient developed whole body rash which was possibly erythema multiforme. On 04-MAR-2009 the patient went to ER accompanied by his parents, with a chief complaint of fever. The patient was in H until that day at noon, when FOC felt he was warmer than normal. His temperature was 100.4. The patient was more fussy at that day than before, only additional associated symptom was rash which was discrete, erythematous lesions, initially on face and all four extremities, it was only found on extremities at that day. No central clearing, almost urticarial in appearance. No evidence of super infection. The patient appeared alert and interactive, grossly nonfocal. Urine analysis and urine culture were performed but the results were pending. The diagnosis was fever. The patient's parents insisted on leaving despite discussion of risk of possible underlying urine infection. At the time of reporting, the events persisted. Additional information has been requested.