chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: This report was received from the investigator of a trial on 06 May 2010. A 25 year-old male subject received ACAM2000 (lot number not reported) on 22 July 2009. Fourteen days after vaccination, the subject was diagnosed with non-specific myocarditis. Twenty-two days after vaccination, the diagnosis of acute myocarditis was reported. The subject had a history of elevated cholesterol, shortness of breath, asthma, eczema, headaches and psychiatric illness. On Day 14 (05 August 2009), the subject's Troponin I was 4.66 (abnormal). The subject had a normal echocardiogram on Day 15 (06 August 2009) and a normal electrocardiogram on Day 22 (13 August 2009). The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram normal, Prinzmetal angina
Clinical narrative: This report was received from the investigator in a trial on 06 May 2010. A 29 year-old male subject received the following vaccines on 11 May 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). The subject previously received TYPHIM VI (lot number not reported on 20 April 2009. Twenty eight days after receiving the smallpox vaccine, the subject was diagnosed with prinzmetal angina. The subject had a history of hypertension. An echocardiogram performed on 08 June 2009 and an electrocardiogram performed on June 2009 were both normal. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: States 3 days after receiving injection her right arm became red, swollen, raised at the injection site. One week later it became hard for her to move her arm. States now her right arm is more difficult to move and she has difficulty picking things up and her arm feels weak and sore. During visit was able to raise arm, move around and take out of jacket sleeve. No redness or swelling noted; at spot where client states injection was administered a slightly dark, raised, spot (approx. size of a pinhead) was noted. Denies any home treatments. Instructed to follow up with PMD.
Age: 1.87
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood immunoglobulin E decreased, Erythema multiforme, Gait disturbance, Radioallergosorbent test negative, Rash
Clinical narrative: Extensive hives noted in office 4-30. Gave ZYRTEC (ate walnuts which prompted RAST tests). In AM 5/1 rash purplish and hurt to walk. Went to Pediatric ER and was hospitalized about 48 hours. Dx with Erythema multiforme. Given ORAPRED, BENADRYL, TYLENOL. By evening day of discharge 5/3 he was all recovered.
Age: 1.87
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Extensive hives noted in office 4-30. Gave ZYRTEC (ate walnuts which prompted RAST tests). In AM 5/1 rash purplish and hurt to walk. Went to Pediatric ER and was hospitalized about 48 hours. Dx with Erythema multiforme. Given ORAPRED, BENADRYL, TYLENOL. By evening day of discharge 5/3 he was all recovered.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Swelling face, Urticaria
Clinical narrative: Facial swelling, urticarial rash about 8 hrs after receiving varicella. Treated with Benadryl.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: 8 minutes - seizure. Child had a 8 minute long seizure, 10 days following vaccine. No temperature at time of seizure.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis left arm at injection site. Antibiotics given - CEPHALEXIN 500 mg x 5 days.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 30.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Headache
Clinical narrative: Ongoing headaches.
Age: 30.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Arthralgia, Computerised tomogram normal, Confusional state, Feeling abnormal, Headache
Clinical narrative: Ongoing headaches.
Age: 30.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Lumbar puncture normal, Migraine, Myalgia, Nausea, Neck pain
Clinical narrative: Ongoing headaches.
Age: 30.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Ongoing headaches.
Age: 48.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, aching right upper arm.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, & diarrhea. Did not have an elevated temp. per parent.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Rash erythematous
Clinical narrative: Has red welt about the size of a quarter at injection site. Has a mild red rash on other parts of body.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Rash vesicular
Clinical narrative: Imm on 4/29 - macro-vesicular rash inside ( L ) elbow- 4/2-spread to rash - also spread to inside ( R ) knee 5/6/10 & ( R ) cheek today.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received PNEUMOVAX 05/03/10 - started to develop swelling by end of day at injection site. Which came on 05/04/10 for us to see, it had swollen up from injection site to mid arm - red, some warmth.
Age: 1.63
Sex: M
Vaccine: DTAP
Symptoms: Lethargy, Pyrexia, Urticaria
Clinical narrative: 5-4-10 DTAP #4 (L) arm -> fever and lethargy within 2hrs -> hives 24 hours later. No illness. 5-7-10 - Exam -> Urticaria trunk, limbs, palms, and soles. Remainder of exam benign. Treatment: BENADRYL, Topical HYDROCORTISONE cream.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Ataxia, Laboratory test normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Acute ataxia onset 5/3/10.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Drug exposure during pregnancy, Ruptured ectopic pregnancy
Clinical narrative: Initial case was received on 29 March 2010 from a healthcare professional. A 24 year old female received an intramuscular injection of ADACEL (Sanofi Pasteur Inc. lot number UF499BA, Sanofi Pasteur Ltd. Lot number C3107) on 04 March 2010. At the time of the vaccination the patient was pregnant. Her last menstrual period (IMP) and estimated date of confinement (EDC) were unknown. She had no previous pregnancies, no known allergies, no concomitant medications and no medical history. At the time of this report she had no adverse event. Follow-up information was received on 07 May 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient experienced a "ruptured tubal pregnancy" on 20 April 2010. No further information was provided. The patient was reported to recover on an unspecified date. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Pt. presents with complaints of ( R ) arm pain/swelling at injection site area. ( R ) delt/upper arm swollen, warm to touch, lg area upper arm reddened. Pt. noted yesterday small amt redness-now has spread to lger area. Also nausea/vomiting thru night.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Vomiting
Clinical narrative: Pt. presents with complaints of ( R ) arm pain/swelling at injection site area. ( R ) delt/upper arm swollen, warm to touch, lg area upper arm reddened. Pt. noted yesterday small amt redness-now has spread to lger area. Also nausea/vomiting thru night.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: MCV4 site patient right arm (deltoid) near/around injection site was red and swollen. This area was measured to be 7X7 cm. This is improved from last night when mom noticed the reaction. Last night it was worse, more swollen and painful.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Balance disorder, Coordination abnormal, Gait disturbance, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Acute onset neurologic deterioration with ascending paralysis to T7. Numbness, weakness weakness arms. Flaccid paralysis both lower ext resolving. Continues with problems in coordination, difficulty walking impaired balance.
Age: 56.0
Sex: M
Vaccine: FLU(H1N1), FLU3
Symptoms: Muscular weakness, Neurological decompensation, Paralysis flaccid
Clinical narrative: Acute onset neurologic deterioration with ascending paralysis to T7. Numbness, weakness weakness arms. Flaccid paralysis both lower ext resolving. Continues with problems in coordination, difficulty walking impaired balance.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: The patient received varicella #1 on 04May10 and noticed swelling on 06May10. The site was examined on 07May10. There were signs of swelling and warmth to the touch.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Myocarditis, Nuclear magnetic resonance imaging normal, Troponin I increased
Clinical narrative: This study case was received from the investigator on 06 May 2010. A 20 year-old male subject with no significant medical history was vaccinated with ACAM2000 on 07 August 2009. Fifteen days post-vaccination on 27 August 2009, the subject was diagnosed with other and unspecified acute myocarditis (ICD-9 code 422.9) and the following day on 28 August 2009 a diagnosis of non-specific myocarditis (ICD-9 code 429.0) was reported. The subject had an abnormal troponin I (8.9) on 18 August 2009, an abnormal electrocardiogram on 18 August 2009, an abnormal echocardiogram on 19 August 2009 and a normal MRI of the heart on 01 September 2009. No other information was provided. The outcome of the subject was not reported. List of documents held by sender: None. Note: Additional Information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance study.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site swelling, Urticaria
Clinical narrative: Unable to lift arm above head, some swelling & hardness at the injection site. Consulted her doctor on 4/16/10-received penicillin, then broke out in hives. 2 courses of oral steroids, ibuprofen. Went back to doctor 1 week later.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood culture, Full blood count normal, Pyrexia, Rash generalised
Clinical narrative: Fever 102.7, rash on trunk and extremities.
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose increased, Chills, Tremor, Type 1 diabetes mellitus, Vomiting
Clinical narrative: Initial report received from a consumer's parent on 05 May 2010. A male patient, with medical history not reported, had received an injection of MENACTRA, lot number not reported, on unknown date ("three weeks ago") and developed severe trembling, chills, vomiting and three weeks later developed type 1 diabetes. The patient was reported as being extremely healthy until he received the vaccine three weeks ago. That night he woke up with severe trembling and chills so bad that he could not get out of bed. His temperature was not taken but he did not appear to be feverish. He was given TYLENOL and he calmed down after about 45 minutes, however, he then vomited several times before he was able to go back to sleep. Three weeks later, the patient's blood sugar was over 400 (units not provided) and was told he had type I diabetes. The outcome for the events was not reported. Documents held by sender: None.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Urticaria
Clinical narrative: Hives approximately 2-3 hours after and continuous headache/"migraine" per patient for 2 months.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt thigh swollen, warm to touch & very red.  Pt crying and mom had not been able to calm him. Mom already gave Tylenol. Patient given 1cc  Benadryl per request of Dr. Mom instructed to give Tylenol q4h prn & Benadryl q6h prn.
Age: 28.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Abdominal pain, Computerised tomogram
Clinical narrative: PT WENT TO ER FOR SEVERE ABDOMINAL PAIN, APPENDICITIS WAS RULED OUT VIA CAT SCAN.  PT WAS GIVEN IV THERAPY AND REST TO TREAT SYMPTOMS.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed swelling, warmth and tenderness with some induration (about the size of a golfball) on left thigh. Family visiting out of town when mom called-rec. getting seen for it.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 5yr old female s/p KINRIX immunization left deltoid last week, and mom noticed redness, swelling of left upper arm. Treatment-application of warm compress and non-steroidal anti inflammatory for pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: 4y.o. CPE done 4/27/10 no H/o previous RXN to immunizations. Immunizations given DTAP #5 and IPV #4 and PPD left forearm received or core 4/28/10 patient awakened with hives.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt. developed vomiting and fever after receiving 2nd ROTATEQ.
Age: 8.0
Sex: M
Vaccine: HEP, HEPA, VARCEL
Symptoms: Cough, Oropharyngeal pain, Urticaria, Wheezing
Clinical narrative: Cough, Wheezing, feeling of throat discomfort ("pain"), 2 hives on chin all within 8-10 minutes of vaccine administration.  Patient returned to exam room, was examined, above findings were noted, pulse ox was 95%.  Given 0.3ml of 1:1000 adrenaline im into left deltoid.  Patient was then transported to Medical Center by EMS.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Hypoaesthesia, Swelling, Tenderness
Clinical narrative: Erythematous areas on right and left lateral thighs left area 2.5 cm in diameter, right thigh 5-6 cm diameter, tenderness, swelling, and numbness.
Age: 4.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Redness, swelling, tenderness
Age: 0.59
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Child received DTaP, Hep B, IPV, (PEDIARIX) HIB, PCV on 5/6/10. Mother stated that child had hives on the night of 5/6/10. Next morning he had a fever of 101 axilliary. He was seen at physician tx center and tied to increase fluids.
Age: 0.22
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Wrong drug administered
Clinical narrative: There were no signs or symptoms of any adverse reactions, from administering the injection.  Patient was given the PCV23, instead of PCV7.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Ecchymosis, Erythema, Induration
Clinical narrative: Left thigh with 11 cm area of erythema with 3 cm induration in center: slight echymotic area near injection site.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chest pain, Decreased appetite, Discomfort, Sensation of pressure
Clinical narrative: Chest/upper abdominal pain/discomfort (crushing feeling), does not radiate and occurs intermittently. Decrease in appetite.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of injection on right thigh.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Onset of shingles rash; ER visit May 9, 2010; diagnosed as shingles by dermatologist May 10, 2010 and by primary care physician May 11, 2010.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Breast pain, Dizziness, Erythema, Hyperhidrosis, Pruritus
Clinical narrative: Was changing clothes for bed and noticed under my left breast it was real red and some rash. At first, I thought it was because I had sweated that day, but it was just my left side. The next day, I noticed when I brushed my arm against my left side, it was really sore. That evening, I changed clothes early, around 8:00 PM, and there was more rash around my nipple and a red streak that went up. It was so sore that it hurt to go and sleep without a bra. I planned on calling my doctor the next morning, but by then it had started to fade and was light pink in color. I had just been to her the morning before we got the shot. Today, it is still sore, fading in color and now itching. I get periods that I just don't feel right, some lightheadness, but do not run a fever.
Age: 62.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Was changing clothes for bed and noticed under my left breast it was real red and some rash. At first, I thought it was because I had sweated that day, but it was just my left side. The next day, I noticed when I brushed my arm against my left side, it was really sore. That evening, I changed clothes early, around 8:00 PM, and there was more rash around my nipple and a red streak that went up. It was so sore that it hurt to go and sleep without a bra. I planned on calling my doctor the next morning, but by then it had started to fade and was light pink in color. I had just been to her the morning before we got the shot. Today, it is still sore, fading in color and now itching. I get periods that I just don't feel right, some lightheadness, but do not run a fever.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hot and firm to touch, upper left arm, area where Dtap was administered.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Child passed out twice after vaccines administered. Ammonia was swept in front of nostrils and child came out of it, placed flat on floor with feet elevated, juice administered, child kept in office for twenty minutes.
Age: 80.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Appearance of shingles - rash, sharp pain.  Rash below waist from naval area to middle of back.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Varicella, Varicella virus test negative
Clinical narrative: Full Chicken Pox outbreak/infection with numerous blisters over entire body and fever.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Skin warm, Swelling
Clinical narrative: SWOLLEN PAIN IT WARMNESS 3CM X 3CM.
Age: 23.0
Sex: F
Vaccine: IPV, MEN, TDAP
Symptoms: Axillary pain, Chills, Headache, Lymphadenopathy, Nausea
Clinical narrative: Chills, body aches, nausea, headache, sore throat, swollen lymph nodes in neck and armpits, lasting for about 12 hours. Sore armpits continue through 05/12/2010.
Age: 23.0
Sex: F
Vaccine: IPV, MEN, TDAP
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Chills, body aches, nausea, headache, sore throat, swollen lymph nodes in neck and armpits, lasting for about 12 hours. Sore armpits continue through 05/12/2010.
Age: 0.53
Sex: M
Vaccine: HIBV, IPV
Symptoms: Crying, Decreased appetite, Pyrexia
Clinical narrative: Fever of 101.5 degrees F, continuing through until morning of 5/6/2010.  Treated fever with infant Motrin every 6 hours.  Up and down crying the night of 5/4/2010.  Falling asleep during normal wake times.  Ate very little.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Lymph node palpable
Clinical narrative: Positive erythema edema TTP left deltoid at injection site. Spread in to left axillary. (+) Palp lymph node very TTP. Dx: Cellulitis.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right upper ext. warm, red, slight induration 18 X 20 cm at vaccine site 2 days after vaccine.
Age: 4.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Injection site erythema, Injection site macule, Injection site urticaria, Injection site warmth, Pyrexia
Clinical narrative: ( R ) deltoid  - two visible wheals with central clearing. ( + ) erythematous macule 12cm X 9cm from deltoid region to elbow and warm to touch. ( + ) fevers of 102-103 since IZ admin. Tx MOTRIN, BENADRYL.
Age: 18.0
Sex: M
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Cold sweat, Gaze palsy, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Patient said I don't feel very well.... and fell over into a seizure.  The nurse started working with him I went for the doctor.  As the doctor came in - patient came out of the seizure but was extremely drowsy.  He then started scratching around his neck and had hives. Then he started complaining of his throat feeling tight and his tongue feeling thick.  At that time, the doctor and the nurse just observed him for several hours until he was able to get up and walk.  The rest of the day and the next day he did not feel well and had a dull headache.  The doctor had stated that if patient did not get to feeling better soon - he was going to call an ambulance and send him to the hospital.
Age: 18.0
Sex: M
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Musculoskeletal stiffness, Pallor, Pruritus generalised, Tremor
Clinical narrative: Patient said I don't feel very well.... and fell over into a seizure.  The nurse started working with him I went for the doctor.  As the doctor came in - patient came out of the seizure but was extremely drowsy.  He then started scratching around his neck and had hives. Then he started complaining of his throat feeling tight and his tongue feeling thick.  At that time, the doctor and the nurse just observed him for several hours until he was able to get up and walk.  The rest of the day and the next day he did not feel well and had a dull headache.  The doctor had stated that if patient did not get to feeling better soon - he was going to call an ambulance and send him to the hospital.
Age: 18.0
Sex: M
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Convulsion, Headache, Malaise, Scratch, Somnolence
Clinical narrative: Patient said I don't feel very well.... and fell over into a seizure.  The nurse started working with him I went for the doctor.  As the doctor came in - patient came out of the seizure but was extremely drowsy.  He then started scratching around his neck and had hives. Then he started complaining of his throat feeling tight and his tongue feeling thick.  At that time, the doctor and the nurse just observed him for several hours until he was able to get up and walk.  The rest of the day and the next day he did not feel well and had a dull headache.  The doctor had stated that if patient did not get to feeling better soon - he was going to call an ambulance and send him to the hospital.
Age: 18.0
Sex: M
Vaccine: HEPA, MEN, HEPA, MEN
Symptoms: Throat tightness, Tongue disorder, Urticaria
Clinical narrative: Patient said I don't feel very well.... and fell over into a seizure.  The nurse started working with him I went for the doctor.  As the doctor came in - patient came out of the seizure but was extremely drowsy.  He then started scratching around his neck and had hives. Then he started complaining of his throat feeling tight and his tongue feeling thick.  At that time, the doctor and the nurse just observed him for several hours until he was able to get up and walk.  The rest of the day and the next day he did not feel well and had a dull headache.  The doctor had stated that if patient did not get to feeling better soon - he was going to call an ambulance and send him to the hospital.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PPV, UNK
Symptoms: Injection site swelling, Mood altered, Pyrexia, Restlessness, Tremor
Clinical narrative: Swelling in both legs fever in leg where shot was given. Shaky legs.  Mood changes and restlessness. Put ice packs on and gave Motrin.
Age: 41.0
Sex: M
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Acoustic stimulation tests normal, Blood test normal, Electrocardiogram normal, Insomnia, Nuclear magnetic resonance imaging normal
Clinical narrative: Tinnitus - ongoing; Insomnia.
Age: 41.0
Sex: M
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Tinnitus
Clinical narrative: Tinnitus - ongoing; Insomnia.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Visual impairment
Clinical narrative: Headache (pain: 2 out of 10). Affected vision: as if just looked into bright light bulb.  Pixellated, some parts of the picture were smudged.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt came to clinic on 5/12/10 states (L) upper arm red & swollen & tender & painful. Injection site fine but below still warm, tender to palpation.
Age: 1.26
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration
Clinical narrative: Leg where shot was given turned deep purple.  Entire leg.  I took her to her ped and to a dermatologist, neither could pinpoint why her leg was purple. I did not think about her shot, since it had been a week prior, but then my other daughter's arm did it in a smaller scale.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Decreased appetite, Headache, Hyperventilation
Clinical narrative: Around 3 pm felt chills, HA. Took TYLENOL. Few hours later temp was 102 degrees F and at 7 pm was 104. took MOTRIN 400 mg. Called in sick (work night shift). Did not eat much. 10 am temp was 101 degrees F; vomited yellow liquid. C/o ringing in ears body ache. Had to take deep breaths. By noon felt well. No localized reaction.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Pain, Tinnitus, Vomiting
Clinical narrative: Around 3 pm felt chills, HA. Took TYLENOL. Few hours later temp was 102 degrees F and at 7 pm was 104. took MOTRIN 400 mg. Called in sick (work night shift). Did not eat much. 10 am temp was 101 degrees F; vomited yellow liquid. C/o ringing in ears body ache. Had to take deep breaths. By noon felt well. No localized reaction.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Drug exposure during pregnancy
Clinical narrative: Pt received shots, TDAP, MCV4 and HPV on 5/3/10, pt stated had her last menstrual period on 4/27/10, and had no suspicion of pregnancy on prequestionnaire before shots given. On 5/2/10 received a call from pt mom stating pt revealed on today is pregnant.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site reaction, Skin tightness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR (Merck) and VARIVAX (Merck) both given on 2 April 2010. There were no concurrent medications. On 2 April 2010, between 09:30 and 10:00, the subject received 1st dose of KINRIX at 0.5 ml in the left thigh. On 5 April 2010, 3 days after vaccination with KINRIX, the subject experienced an allergic reaction on his thigh that was tight, red and spreading. The subject was treated with BENADRYL. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported two other cases, see case A0855336A and A0855505A.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, UNK
Symptoms: Drug administration error, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous and/or concurrent vaccination included MMR vaccine (non-gsk); manufacturer unspecified; unknown; right thigh given on 20 April 2010; unspecified vaccine; manufacturer unspecified; unknown; right thigh given on 20 April 2010. On 20 April 2010 the subject received unspecified dose of KINRIX (.5 ml, unknown, right thigh). On 20 April 2010, less than one day after vaccination with KINRIX, the subject experienced injection site redness, swelling injection site, injection site warmth, nodule injection site, injection site pain and maladministration. The injection site was warm, red with raise knot but not painful. At the time of the report, it remained red, but was no longer warm, swollen or painful. The subject also received an MMR vaccine and another vaccine in the same leg. At the time of reporting the injection site redness was unresolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, UNK
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Previous and/or concurrent vaccination included MMR vaccine (non-gsk); manufacturer unspecified; unknown; right thigh given on 20 April 2010; unspecified vaccine; manufacturer unspecified; unknown; right thigh given on 20 April 2010. On 20 April 2010 the subject received unspecified dose of KINRIX (.5 ml, unknown, right thigh). On 20 April 2010, less than one day after vaccination with KINRIX, the subject experienced injection site redness, swelling injection site, injection site warmth, nodule injection site, injection site pain and maladministration. The injection site was warm, red with raise knot but not painful. At the time of the report, it remained red, but was no longer warm, swollen or painful. The subject also received an MMR vaccine and another vaccine in the same leg. At the time of reporting the injection site redness was unresolved.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Condition aggravated, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a physician and described the occurrence of swelling injection site in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included VARIVAX (Merck); unknown; unknown given on 21 April 2010. On 21 April 2010 at 11:30 the subject received 5th dose of KINRIX (.5 ml, unknown, right arm). On an unspecified date in April 2010, approximately 24 to 36 hours after vaccination with KINRIX, the subject experienced swelling injection site and injection site redness. After approximately 48 hours the events worsened and the subject also experienced "rubbery" at injection site (rubbery feeling in muscle). The physician reported a local reaction of swelling and redness that started approximately 24-36 hours following administration of KINRIX and became worse at 48 hours. At 48 hours the subject now had enlarged, swollen, rubbery but not indurated at the injection site. Varicella vaccine was administered at a different site and was not considered co-suspect. At the time of reporting the swelling injection site, injection site redness and rubbery at injection site were worse. Follow-up received from reporting physician on 10 May 2010: The events resolved on an unspecified date. The physician considered the events were non-serious.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Apparent death, Endotracheal intubation, Extubation, Speech disorder, Status epilepticus
Clinical narrative: This case was considered medically important. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 29-month-old female patient who experienced status epilepticus, almost died and struggled to speak. At 29 months of age, the patient received a dose on 01-May-2010. The patient also received a dose of Hepatitis A Vaccine (manufacturer unknown) on 01-May-2010. The patient experienced status epilepticus on 02-May-2010 as described by her mother as seizing for about one hour and almost died. The patient was hospitalized and had to be intubated. That evening, the patient was extubated. The following day, the patient struggled to speak, however some words were coming back. Outcome was reported as recovering. No additional information was available at the time of this report.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TDAP
Symptoms: Chromatopsia, Dizziness, Visual impairment
Clinical narrative: Patient stated she had trouble seeing for a few mins, color changed, dizzy.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MEN, TDAP
Symptoms: Blindness, Cyanosis, Nervous system disorder
Clinical narrative: Patient stated she had trouble seeing for a few mins, color changed, dizzy.
Age: 2.0
Sex: M
Vaccine: FLU(H1N1), PNC13
Symptoms: Injection site erythema
Clinical narrative: Mother states child developed a large red area on right leg where PCV13 shot was given.  And that is spread down his leg and up toward his back.  She states he has never had a reaction to a vaccine in the past.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Convulsion
Clinical narrative: Patient temp elevated to 104 suddenly and patient started to have a seizure was taken to ER where temperature was reduced and seizures stopped.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Pt c/o left arm 3-4" red swollen area - following Tdap given on 4-29-10. (+) warmth, resolved by 5/6/2010.
Age: 65.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Fatigue, Injection site pruritus, Pyrexia, Vaccination complication
Clinical narrative: 4-20-10 Tel. call from client. States she developed fever on 4-12-10, of 101, and also had fatigue. Client took TYLENOL. Fever continued. By 3rd day 4/15/10, fever down to 99. Itching at site of injection, left arm started on 4-15/10 and continued thru 4-20-10. NO apparent swelling at site. Saw MD on 4-21-10, who advised anti-itch cream. He stated it looked like a reaction to a vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Chills, Electrocardiogram, Fall, Flank pain
Clinical narrative: Pt felt normal until 3:00 pm. Started with heavy head feeling similar to allergy's, progressed to pain in (L) side arm and flank. 5:45 - unable to move arm due to intense ache. 6:30p pt lays down with shivers and is in and out of sleep 8:p. went to BR to void; LOC. Doesn't remember falling on floor. Husband helps her up - unable to walk. Nausea and chills continue. Does not want to go to ER. Next day back to baseline except pain in posterior head and neck d/t fall.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Head discomfort, Headache, Loss of consciousness, Movement disorder, Nausea
Clinical narrative: Pt felt normal until 3:00 pm. Started with heavy head feeling similar to allergy's, progressed to pain in (L) side arm and flank. 5:45 - unable to move arm due to intense ache. 6:30p pt lays down with shivers and is in and out of sleep 8:p. went to BR to void; LOC. Doesn't remember falling on floor. Husband helps her up - unable to walk. Nausea and chills continue. Does not want to go to ER. Next day back to baseline except pain in posterior head and neck d/t fall.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pt felt normal until 3:00 pm. Started with heavy head feeling similar to allergy's, progressed to pain in (L) side arm and flank. 5:45 - unable to move arm due to intense ache. 6:30p pt lays down with shivers and is in and out of sleep 8:p. went to BR to void; LOC. Doesn't remember falling on floor. Husband helps her up - unable to walk. Nausea and chills continue. Does not want to go to ER. Next day back to baseline except pain in posterior head and neck d/t fall.
Age: 15.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Blood test, Computerised tomogram head, Headache, Muscle spasms
Clinical narrative: Headache, muscle spasms, weakness 24 hours after receiving shot of H1N1. Went to ER. Had CT scan, blood work and sent home after about 7 hours.
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Accidental exposure, Eye burns, Eye irritation, Eye pruritus, Nasal discomfort
Clinical narrative: Information has been received from a medical assistant concerning another female medical assistant, at the age of 37 year old, with diabetes and high triglycerides and a history of heart attack in 2005 who on 06-MAY-2010 was administered VARIVAX (Merck) (lot# 665909/1648Y) and MMR II (Lot# 665874/1335Y) to a patient and some of the vaccines got in her right eye and nose. Concomitant therapy included metoprolol, enalapril maleate, aspirin, insulin, metformin and niacin. On 06-MAY-2010 the patient was experiencing burning in the right eye and burning in the nose. She flushed her eye out with water. The medical assistant stated that the nose was better, eyes were still irritated and itchy but now she felt like her throat was burning. She sought medical attention in the office. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. The patient's conditions were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Throat irritation
Clinical narrative: Information has been received from a medical assistant concerning another female medical assistant, at the age of 37 year old, with diabetes and high triglycerides and a history of heart attack in 2005 who on 06-MAY-2010 was administered VARIVAX (Merck) (lot# 665909/1648Y) and MMR II (Lot# 665874/1335Y) to a patient and some of the vaccines got in her right eye and nose. Concomitant therapy included metoprolol, enalapril maleate, aspirin, insulin, metformin and niacin. On 06-MAY-2010 the patient was experiencing burning in the right eye and burning in the nose. She flushed her eye out with water. The medical assistant stated that the nose was better, eyes were still irritated and itchy but now she felt like her throat was burning. She sought medical attention in the office. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. The patient's conditions were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Chest X-ray abnormal, Pneumonia, Wheezing
Clinical narrative: Patient had acute onset of wheezing approx 18 hrs after vaccines. Was diagnosed with pneumonia by CXR overnight (approx 4 hr) hospitalization for O2, antibiotic and bronchodilators.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Asthma, Borrelia test, Cough, Deafness unilateral
Clinical narrative: On October 2, 2009 a technician at a Medical Group gave me a shingles shot (Merck's ZOSTAVAX NDC 0006-4963-00) that had been ordered by pharmacy on 9/24/00. I imagine you would call my reaction in October normal: warm arm and a little coughing. In mid  February I developed a cough that went on to wheezing and what felt like "stopped up, full ear" in my left ear. I visited my family doctor, three times over about six weeks. she told me  I had fluid in my ears and prescribed over the counter drugs MUCINEX DM, CLARITIN D, as well finally a course of a five day Z Pas although she suspected a virus since nothing was helping me. On April 12, 2010 I visited Dr. after a check up of my chest and series of hearing tests, doctor told me I had asthma and also that a virus had struck the nerves in the Eustachian tube of my left ear causing substantial hearing loss. Dr. ordered an MRI and put me on prednisone to see if it would relieve or diminish my hearing loss and asked me to return in three weeks' time. On Monday, May 3, 2010 I returned to doctor's office to undergo a second set of hearing tests and to learn the results of my MRI. Dr. told me that prednisone had not improved the hearing in my left ear and that it has experienced a permanent 50% hearing loss. I told Dr. that I had read on the web that a possible cause of "ear fullness" hearing loss is the reaction of chickenpox virus, explaining to him that because I was covered from head to foot and down my throat chickenpox when I was eleven years old (1952). I had though it wise to have a shingles shot. I asked Dr. if I should report my hearing loss to the pharmaceutical company . He replied that it was doubtful that a direct correlation could be proven but if I wanted to report it to do so. Hopefully information will be helpful to Merck's research scientist - After my first inhalation of ADVAIR, my coughing and wheezing stopped and after taking ADVAIR for its full course, one week. I have not had to take anymore.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Middle ear effusion, Skin warm, Viral infection, Wheezing
Clinical narrative: On October 2, 2009 a technician at a Medical Group gave me a shingles shot (Merck's ZOSTAVAX NDC 0006-4963-00) that had been ordered by pharmacy on 9/24/00. I imagine you would call my reaction in October normal: warm arm and a little coughing. In mid  February I developed a cough that went on to wheezing and what felt like "stopped up, full ear" in my left ear. I visited my family doctor, three times over about six weeks. she told me  I had fluid in my ears and prescribed over the counter drugs MUCINEX DM, CLARITIN D, as well finally a course of a five day Z Pas although she suspected a virus since nothing was helping me. On April 12, 2010 I visited Dr. after a check up of my chest and series of hearing tests, doctor told me I had asthma and also that a virus had struck the nerves in the Eustachian tube of my left ear causing substantial hearing loss. Dr. ordered an MRI and put me on prednisone to see if it would relieve or diminish my hearing loss and asked me to return in three weeks' time. On Monday, May 3, 2010 I returned to doctor's office to undergo a second set of hearing tests and to learn the results of my MRI. Dr. told me that prednisone had not improved the hearing in my left ear and that it has experienced a permanent 50% hearing loss. I told Dr. that I had read on the web that a possible cause of "ear fullness" hearing loss is the reaction of chickenpox virus, explaining to him that because I was covered from head to foot and down my throat chickenpox when I was eleven years old (1952). I had though it wise to have a shingles shot. I asked Dr. if I should report my hearing loss to the pharmaceutical company . He replied that it was doubtful that a direct correlation could be proven but if I wanted to report it to do so. Hopefully information will be helpful to Merck's research scientist - After my first inhalation of ADVAIR, my coughing and wheezing stopped and after taking ADVAIR for its full course, one week. I have not had to take anymore.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Screaming
Clinical narrative: Child very fussy. Screams for 20 mins. inconsolable.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Patient came to walk-in visit on 05-06-10 with 6cm X 6cm red wheal on right upper arm. T. 98.8. Loratadine 5mg/ml give 10ml PRN for allergy symptoms qd.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Rash macular
Clinical narrative: Patient was given PCV 23 on 5/5/10 and developed blotchy rash 48 hours later surrounding injection site.
Age: 1.2
Sex: U
Vaccine: RV5
Symptoms: Malaise, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 14 month old patient (gender unspecified) who on 23-MAR-2009 was vaccinated with 2 ml of the first dose of ROTATEQ (Lot number 663359/1661X) orally and on 15-MAY-2009 the patient received 2 ml of the second dose of ROTATEQ (Lot number 663461/0285Y) orally. On 01-MAY-2010 the patient became ill and was hospitalized. On an unspecified date the patient was positive for rotavirus antigen. A of 05-MAY-2010, the patient's was still hospitalized and not recovered. This is one report from two reports from the same source, the twin patient's experienced was reported on WAES 1005USA00434. Became ill and positive for rotavirus antigen were considered as other important medical event. Additional information has been requested.
Age: 1.2
Sex: U
Vaccine: RV5
Symptoms: Malaise, Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 14 month old patient (gender unspecified) who on 23-MAR-2009 was vaccinated with 2 ml of the first dose of ROTATEQ (Lot number 663359/1661X) orally and on 15-MAY-2009 the patient received 2 ml of the second dose of ROTATEQ (Lot number 663461/0285Y) orally. On 01-MAY-2010 the patient became ill and was hospitalized. On an unspecified date the patient was positive for rotavirus antigen. As of 05-MAY-2010, the patient's was still hospitalized and not recovered. This is one report from two reports from the same source, the twin patient's experienced was reported on WAES 1005USA00434. Became ill and positive for rotavirus antigen were considered as other important medical event. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: On the Tetanus injection site . C/o pain, swelling, knot formation and redness.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: CSF protein increased, CSF white blood cell count increased, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Swollen (R) thigh. 6-8 cm of erythema with 3/4 cm of induration.
Sex: U
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced erythema and swelling. The healthcare professional reported that they are seeing more redness and swelling attributed to KINRIX that what they have seen in past. No subject specific information was available. At the time of the report no other details were available. At the time of reporting the outcome of the erythema and swelling was unspecified.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red spot at injection site in a 5-year-old female subject who was vaccinated with KINRIX, GlaxoSmithKline. Previous and/or concurrent vaccination included MMR vaccine (non-GSK) (Merck; unknown; left arm given on 9 April 2010; varicella virus vaccine (non-GSK); Merck; unknown; right arm given on 9 April 2010. Concurrent medications included Multivitamin + fluoride. On 9 April 2010 at 15:30 the subject received 5th dose of KINRIX (unknown, right arm). On 12 April 2010, 3 days after vaccination with KINRIX, the subject experienced red spot at injection site. According to the mother, the redness was not there on the night of 11 April 2010 when the subject went to bed, but was there when she woke up on 12 April 2010. The red spot at injection site was described as three inches in diameter red spot around the injection site. At the time of reporting the red spot at injection site was unresolved. Follow-up information received on 07 May 2010 confirmed onset of the event to be 12 April 2010 with resolution on an unspecified date. It was corrected that VARIVAX was given in the right arm rather than the left as originally reported.