chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.63
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pneumonia, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 17-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3840AA received on 02 May 2011, C3893AA received on 05 July 2011 and C3930AA received on 19 September 2011 (routes and sites of administration not reported). The subject developed paroxysmal cough (without whoop) and cold-like symptoms on 05 July 2012, approximately 9 months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 15 July 2012. Chest x-ray was positive, indicating pneumonia, but the subject was not hospitalized. Corrective treatment consisted of azithromycin starting on 15 July 2012 for 5 days. At the time of final contact on 22 August 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 35 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis
Clinical narrative: Initial report received on 30 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a seven-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4143AA received on 23 February 2012, C4156AB received on 26 April 2012 and C4193AA received on 21 June 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough with a whoop on 19 July 2012, 28 days after the last dose. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 26 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 31 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 30 August 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a seven-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C4143AA received on 23 February 2012, C4156AB received on 26 April 2012 and C4193AA received on 21 June 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough with a whoop on 19 July 2012, 28 days after the last dose. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 26 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 31 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 13 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: F
Vaccine: DTAP
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 31 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3542AA received on 01 March 2012, C3579AA received on 30 April 2010 and C3608AA received on 06 July 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, approximately 15 months after the last dose. On 14 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 19 July 2012 for unknown duration. The subject was not hospitalized. At the time of final contact on 23 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.28
Sex: F
Vaccine: DTAP
Symptoms: Pertussis, Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report received on 31 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3542AA received on 01 March 2012, C3579AA received on 30 April 2010 and C3608AA received on 06 July 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 09 July 2012, approximately 15 months after the last dose. On 14 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 19 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin starting on 19 July 2012 for unknown duration. The subject was not hospitalized. At the time of final contact on 23 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 31 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 16-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3613AA received on 19 May 2011, C3686AA received on 14 July 2011 and C3913AB received on 06 September 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 July 2012, approximately 10 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 23 July 2012. Chest x-ray findings were unknown. Corrective treatment consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 31 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 16-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3613AA received on 19 May 2011, C3686AA received on 14 July 2011 and C3913AB received on 06 September 2011 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 20 July 2012, approximately 10 months after the last dose. On 23 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 23 July 2012. Chest x-ray findings were unknown. Corrective treatment consisted of azithromycin starting on 24 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 09 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Failure to thrive, Laboratory test normal, Vomiting, Weight decreased
Clinical narrative: Vomiting 1-2 x1 day 6/15/12 - 8/12/12, non-projectile wgt loss, failure to thrive 6/14/12 13# 3oz wgt 8/3/12 12# 2oz wgt Mother nursing q1-2 hrs dur day with full milk supply. Started to regain growth 8/23/12 13# 5 oz 9/6/12 15# 6 oz.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Disorientation, Syncope
Clinical narrative: Vaccines administered. Patient at elevator and fainted. Did not hit head. Disoriented for seconds per parent report. Patient A & O x3. To ED in wheelchair for observation.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Oliguria, Urine analysis normal
Clinical narrative: On Friday 08/10/12, patient started to experience oliguria told mom 8/15/12. Visited PA on 08/16/12. UA came back clear. Started on Antibiotic & Tamsulosin 8/17/12. By 8/19/12, symptoms subsided & medication stopped.
Sex: U
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Pyrexia, Rash maculo-papular, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a healthcare professional, author of the published article, referring to one vaccinated student, with a pre-existing immunocompromising condition, who was admitted to the hospital for observation for suspected varicella because of fever and a maculopapular rash with 14 lesions, involving the back, torso and buttocks. A lesion specimen from the one hospitalized case-patient was tested at the hospital laboratory by polymerase chain reaction (PCR). Information regarding laboratory results were not specified. Additional information has been requested. This is one of several reports received from the same source.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt developed raised red rash 2 x 2 1/2" over left deltoid within 24 hours.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: Felt faint, light headed, felt nauseated.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Head injury, Loss of consciousness
Clinical narrative: Patient passed out from standing position about 5 minutes after administration of influenza vaccination. Pt hit head on floor so EMT were called to be evaluated. Pt was then released by EMTS. Pt reports passing out previously from giving blood (>3 occasions).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pruritus
Clinical narrative: Got DAPTACEL (L) deltoid 9/5/12, came to office 9/7 c/o itching that started on 9/6/12. Parent tried OTC hydrocortisone & BENADRYL creams to relieve itching.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Administered IM instead of subcutaneously as recommended. No adverse reaction to report.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, VARCEL
Symptoms: Erythema, Feeling hot, Oedema peripheral, Pain in extremity
Clinical narrative: Pt felt swelling, stinging pain, redness & warm sensation on (L) arm 9/6/12 at school around 9 AM. "Swelling & redness got bigger 9/7/12" as per pt. Measured firm swelling 2 x 2 inches as of 9/07/12 4:00 PM. Advised to apply warm compress, TYLENOL for fever & to watch for blisters. Advised to go clinic 9/8/12 if worsens.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cellulitis, Drug hypersensitivity, Erythema, Swelling
Clinical narrative: Child give MMR 8/29/12. Developed redness, swelling 4 days after administration of vaccine. Seen in ER 8/31/12. Dx cellulitis given AUGMENTIN -> developed allergic reaction to med -> on clindamycin.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient received FLUZONE on 09/02 and on 09/04 she started developing a rash on her abdomen, she tried using hydrocortisone cream which didn't help, the rash started spreading on extremities she was seen by MD & prescribed a prednisone taper.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, MNQ, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt. received 4th dose of Hepatitis B pt. received 1st dose 10/26/2000 2nd dose 11/30/2000 3rd dose 7/25/2001 4th 8/29/12 no adverse event (just 4th dose).
Age: 63.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching at injection site Dx of cellulitis Tx with BACTRIM DS 1 tab by mouth 2 x daily for 10 days.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Redness, swelling, left arm. Dx of cellulitis. Tx AUGMENTIN 875-125 1 tab 2x daily.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Apnoea, Bradycardia, Endotracheal intubation, Resuscitation, Syncope
Clinical narrative: Patient "collapsed" in grocery store; CPR initiated, ambulance called & was intubated. MD available - noted pt. to be apneic & bradycardic but responded to epinephrine. Transported to hospital & discharged home next day.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site rash, Pyrexia
Clinical narrative: Throbbing headache 9/5/12 AM, EXCEDRIN migraine. Rash at injection site left deltoid 9/6/12 AM 9/6/12 fever.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Irritability, Vomiting
Clinical narrative: Temp - 99 degrees F. Irritability. Vomiting x 1.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dermatitis contact, Pruritus generalised, Rash generalised
Clinical narrative: Raised rash all over body, started 8/31/12 no fever but itching over body no blister formation. Child not sick but mom plans to seek care of PMD.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Cellulitis, Decreased appetite, Immunisation reaction, Injection site erythema, Injection site swelling
Clinical narrative: Received vaccines on 9/4. Dad noted redness on 9/5 pm (+ swelling) location was where KINRIX was administered. Seen by MD 9/6. Dad stated on 9/5 pt had emesis, decreased appet, increased sleep, T 99.5. Arm hot & painful to touch. ? Severe immun rxn Dx cellulitis Rx AUGMENTIN.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pain in extremity, Skin warm, Somnolence, Tenderness, Vomiting
Clinical narrative: Received vaccines on 9/4. Dad noted redness on 9/5 pm (+ swelling) location was where KINRIX was administered. Seen by MD 9/6. Dad stated on 9/5 pt had emesis, decreased appet, increased sleep, T 99.5. Arm hot & painful to touch. ? Severe immun rxn Dx cellulitis Rx AUGMENTIN.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Joint stiffness, Nausea, Pyrexia, Throat tightness
Clinical narrative: Fever, "throat closing" relieved w/ BENADRYL.  Rigoring, jaw locked. (L) axillary LAD/pain - nausea.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pain
Clinical narrative: On 9/5/2012 patient called that he had body aches & might feel temperature. Today he showed up swelling in his arm up to elbow. The arm was red too.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Local redness and swelling. Warm to touch. No tx.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Pt received flu shot from local pharmacy on 8/27 & has had 5 days of chills, myalgias & fevers up to 101 in absence of any other causes.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling left upper arm but minimal in the shoulder.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt was given DTAP #5/Polio #4 (KINRIX) IM, (R) deltoid on 8/28/12. He developed swelling & redness at inj site at 7 pm on 8/29/12. Was seen at urgent care today - 8-30-12. Per Dr, a 3-4 inch indurated red area has developed at inj site no other sx.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: 8-30-12: Tired, low appetite, sort of "out of it". 8-31-12: 11:00 am high fever, weakness in legs, low appetite 10 pm trouble sleeping through the night and still high fever. 9-1-12: 12 pm slept longer than usual and high fever, crying, low appetite - I gave her liquid generic TYLENOL. 9-2-12: 5 am she woke up screaming with 103 degrees fever; I gave her a cool bath. PM - she broke out with a rash on head, face, neck, chest, back, fever gone. 9-3- and 9-4: Still has spotted rash and more spotted dots, cranky so I have been nursing her a lot more to comfort her.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Insomnia, Irritability, Muscular weakness, Pyrexia, Rash
Clinical narrative: 8-30-12: Tired, low appetite, sort of "out of it". 8-31-12: 11:00 am high fever, weakness in legs, low appetite 10 pm trouble sleeping through the night and still high fever. 9-1-12: 12 pm slept longer than usual and high fever, crying, low appetite - I gave her liquid generic TYLENOL. 9-2-12: 5 am she woke up screaming with 103 degrees fever; I gave her a cool bath. PM - she broke out with a rash on head, face, neck, chest, back, fever gone. 9-3- and 9-4: Still has spotted rash and more spotted dots, cranky so I have been nursing her a lot more to comfort her.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Screaming
Clinical narrative: 8-30-12: Tired, low appetite, sort of "out of it". 8-31-12: 11:00 am high fever, weakness in legs, low appetite 10 pm trouble sleeping through the night and still high fever. 9-1-12: 12 pm slept longer than usual and high fever, crying, low appetite - I gave her liquid generic TYLENOL. 9-2-12: 5 am she woke up screaming with 103 degrees fever; I gave her a cool bath. PM - she broke out with a rash on head, face, neck, chest, back, fever gone. 9-3- and 9-4: Still has spotted rash and more spotted dots, cranky so I have been nursing her a lot more to comfort her.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: (L) thigh injection site with erythema, slight swelling, bruising & warmth. Pt is crying & inconsolable irritability. TYLENOL given 80mg & bfeeding in office. Pt did calm after this.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Irritability
Clinical narrative: (L) thigh injection site with erythema, slight swelling, bruising & warmth. Pt is crying & inconsolable irritability. TYLENOL given 80mg & bfeeding in office. Pt did calm after this.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt came to clinic on 9-7-12 states her (L) upper arm is painful due to HD FLUZONE she received 09/06/12 (L) upper arm warm, red, tender, able to move. 2+ pulse, 3" x 5 1/2" in measurement. Pt sent to urgent care clinic due to feeling a little off & dizzy.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Generalized pruritic rash. Pt was given BENADRYL 25 mg 0.5 ml IM.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Headache, Nausea, Nervousness, Pyrexia
Clinical narrative: Patient complained of fever, headache, nausea & weakness. Also felt shaky (for about two hours). All other sx cleared up within two to three days.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) arm upper side hot and red. (L) arm upper & lower side hot and red. Cool compress, TYLENOL.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Pt had flu vaccine at pharmacy. 20 mins after vaccine pt developed urticaria all over arms and chest no SOB. Came to UC for treatment. Has had flu shot in past. W/O reaction. Pt respond to steroid and antihistamine.
Age: 61.0
Sex: F
Vaccine: YF
Symptoms: Ear discomfort, Eye pain, Headache, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Yellow fever given about 1:30 pm 9-4-12, morning of 9-6-12 pt noted headache, stiff & tight neck muscles, full ears and eyes hurt. Has been taking ADVIL every 4 hrs. for temporary relief. On 9-6-12 pt was working in garden. No breathing problems, no hives.
Age: 1.86
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: Mother reported "Hives" 24 hours after vaccine administration - "Hives" on neck - chest - back. Denies fever, resp. distress. Mother gave child oatmeal baths. Mom reports hives dissipated after 6 hours.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site exfoliation, Injection site swelling
Clinical narrative: Redness & swelling at injection site. Mild peeling of skin (superficial) where swelling is most prominent. Warm compress to site.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Urticaria
Clinical narrative: Pt developed urticarial reaction 1 mo. after vaccines. A similar episode happened 1 yr ago, also after receiving vaccines.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site rash, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Arm became red, swollen, rash at injection site the afternoon after receiving vaccine in AM. Was painful/itchy. Took BENADRYL.
Age: 1.11
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Rash maculo-papular
Clinical narrative: Five days post vaccines pt developed macular/papular rash on posterior neck at 7 days post vaccine rash noted at axillary region & had Temp 99-100.
Age: 15.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Pt experienced a seizure in the car on the way home after receiving vaccine. Pt has hx of epilepsy & has had seizures after other injections (not vaccines) possibly triggered by stress of inj. due to mother. Pt's Dr okayed vaccines according to mother.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mother called concerned about high fever (no thermometer) and vomiting.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Headache, Induration, Pain
Clinical narrative: Large hard swelling, red & hot - began within the hour - still present & sore 30 hours later. Dull headache. 7 x 7 cm 30 hours later.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Large hard swelling, red & hot - began within the hour - still present & sore 30 hours later. Dull headache. 7 x 7 cm 30 hours later.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Had vomiting and diarrhea 8 days after receiving Rotavirus vaccine. No treatment needed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Chicken pox like rash at or near the injection site. Rash did heal up.
Age: 58.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, soreness, swelling, itch and bruising at injection site of ZOSTAVAX.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Nausea, Pain, Pyrexia
Clinical narrative: 9/4/12 pm body aches, fever, severe stomach cramps and nausea 9/5/12 AM & continued.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an over 65 years old patient. The patient was vaccinated with PNEUMOVAX 23 (lot# was unknown) on 13-AUG-2012 and reported that the injection arm, the left arm, was reddened that evening. On 16-AUG-2012 the patient consulted physician because of the left arm redness. The nurse reported that the injection site was not the primary site of the redness, the redness was more toward elbow. The physician prescribed TYLENOL and an unspecified antibiotic for the patient to treat the adverse event. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse to a patient of unknown age. The patient was vaccinated with an expired 0.6 ml dose of ZOSTAVAX (lot # 670547/0659AA expiration date 04-AUG-2012) SQ on 22-AUG-2012. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. The patient was vaccinated intramuscularly with an expired dose of PNEUMOVAX 23 (H010515; 30-AUG-2012) on 31-AUG-2012. No other co-suspects or concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to an approximately 69 years old female patient with penicillin, allergy to benzodiazepines, macrolides, metformin, codeine and quinolones. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) on approximately 30-AUG-2010 "2 years ago". No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on unspecified date in 2012, the patient experienced shingles. The outcome of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old male patient. The patient was intramuscularly vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) on 03-SEP-2012 that showed an expiry date of 30-AUG-2012. It was unspecified whether the patient had sought medical attention or not. Reporter stated the patient was fine. The outcome of the event was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age. The patient was vaccinated intramuscularly with lot # (667445/0993Z exp date 05-JAN-2012), 0.5 ml dose of PNEUMOVAX 23 on 31-AUG-2012. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of VAQTA (lot number, dose and injection site were not known) intramuscularly on 09-APR-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced patient received VAQTA on 09-APR-2012 and on 28-AUG-2012. No known adverse effects. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 65 years old female patient with no pertinent medical history or any drug reactions/allergies. The patient was vaccinated subcutaneously with ZOSTAVAX (lot number 0071AE, expiration date 03-APR-2013) on 27-AUG-2012. No other co-suspects were reported. Concomitant medications included simvastatin, XALANTAN and FOSAMAX. On 29-AUG-2012 the patient experienced warm, pink area around the injection site after receiving ZOSTAVAX. The patient had contacted pharmacist for medical attention. No treatment or any laboratory diagnostics studies were performed. The outcome of the events was reported as not recovered/not resolved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as healthcare worker) refers to a patient of unknown age and unknown gender. The patient was vaccinated subcutaneously with an expired dose of 0.65 ml ZOSTAVAX (lot # 669405/1416Z, expiration date 21-JAN-2012) on 30-AUG-2012. No other co-suspects or concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a patient who was vaccinated with a dose of VARIVAX. No other co-suspects were reported. No concomitant medications were reported. The reporter stated that the patient had no titers for varicella with antibody titers test performed. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 1 years old patient. The patient was intended to receive VARIVAX (Merck), was inadvertently administered ZOSTAVAX (single dose, Subcutaneous, lot # not reported) on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to several patients of unknown age who was vaccinated with a dose of MMR II which were exposed to 51 degrees F for 9 hours. There was no adverse effected reported. It was unknown if the patients had sought medical attention. At the time of report, the patient's status was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Pain in extremity, Pruritus
Clinical narrative: Pt. complained erythema, tenderness, almost half of his arm was red and tenderness, and itchy, cant tell if pt's arm was swollen. He complained no shortness of breath, no dyspnea or any other parts of the body like lips, mouth etc are swollen, and no swelling of throat or bleeding. pt didn't complain of any nausea, vomiting or diarrhea. Pt. only complained of erythema,redness,and tenderness, palpable at the injection site. On 09/07/12 at 9:30 we called and followed up on the pt., pt. said he is fine, but his arm still feels sore and itching.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Intestinal obstruction, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: FEVER, SWOLLEN GLANDS, RASH, DIARRHEA, VOMITING, BLOCKAGE IN INTESTINES.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: FEVER, SWOLLEN GLANDS, RASH, DIARRHEA, VOMITING, BLOCKAGE IN INTESTINES.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Feeling hot, Hypersomnia, Insomnia, Nausea
Clinical narrative: As time progressed, my symptoms seemed to get worse. At first it was just fatigue and sleeping up to 10 hours per night. Then I felt extremely warm and nauseous and my arm developed a large lump that was very sensitive and painful. I had interrupted sleep the second night somewhat, but the third night I was up almost all night. This is the fifth day and I feel more nauseous and fatigued than ever.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Sleep disorder, Upper extremity mass
Clinical narrative: As time progressed, my symptoms seemed to get worse. At first it was just fatigue and sleeping up to 10 hours per night. Then I felt extremely warm and nauseous and my arm developed a large lump that was very sensitive and painful. I had interrupted sleep the second night somewhat, but the third night I was up almost all night. This is the fifth day and I feel more nauseous and fatigued than ever.
Age: 45.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Abnormal sensation in eye, Arthralgia, Dizziness, Headache, Musculoskeletal stiffness
Clinical narrative: Sore, Joints ache, Stiff, Stiff neck, Fever of 99-100 at evening, dizzy, eyes feel gummy, blurry vision, headache.
Age: 45.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pain, Pyrexia, Vision blurred
Clinical narrative: Sore, Joints ache, Stiff, Stiff neck, Fever of 99-100 at evening, dizzy, eyes feel gummy, blurry vision, headache.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Arrhythmia, Asthenia, Atrial flutter, C-reactive protein, Dyspnoea
Clinical narrative: 2hr ECG documented atrial flutter; day 7 profound weakness & increasing dyspnea followed by marked gluteal and flank pain. Dyspnea improved over several weeks. There was one recurrent arrhythmia .
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Electrocardiogram abnormal, Flank pain, Haemoglobin decreased, Light chain analysis increased, Musculoskeletal pain
Clinical narrative: 2hr ECG documented atrial flutter; day 7 profound weakness & increasing dyspnea followed by marked gluteal and flank pain. Dyspnea improved over several weeks. There was one recurrent arrhythmia .
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Pericardial effusion, Red blood cell sedimentation rate, Urobilinogen urine increased
Clinical narrative: 2hr ECG documented atrial flutter; day 7 profound weakness & increasing dyspnea followed by marked gluteal and flank pain. Dyspnea improved over several weeks. There was one recurrent arrhythmia .
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Raised, itchy, spotty rash starting at ankles. Covered trunk and torso within 24 hours. No headache. No fever.
Age: 1.45
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting the first night and then vomiting started the following day. No fevers.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Pyrexia, Screaming
Clinical narrative: High Fever (103), screaming, limping.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain, Injection site erythema, Injection site swelling, Rash generalised, Rash macular
Clinical narrative: Pt was administered Fluzone intra-dermal vaccine.  About 30 min after administration - pt came back to pharmacy w/ a lot of redness on the upper arm and a raised area where the medication was administered.  Approximately another 15 min later, pt came back to pharmacy again w/ red, blotchy patches on skin from neck down to legs.  Pt reported no itching, no severe allergic reactions, only slight pain at site of administration.  Pt was administered 25 mg liquid Benadryl and 500 mg Tylenol.  Within 30-45 min after treatment - all redness was gone.  Pt reported no other problems post-vaccination.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Finger tips and palms turned pink.  Gave patient 25 mg liquid diphenhydramine and observed for 30 minutes.  Pinkness in hands went away and patient was sent to follow up with physician, although patient later called back to say they did not wait at physician's office and went home.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.  Rash slowly spread over the day.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Generalized seizure without fever.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth, Rash
Clinical narrative: Patient states she developed a rash approximately two hours after receiving Hepatitis B vaccine to left deltoid and to inner middle arm. She denies any other symptoms. Today patient presents to clinic with redness and cellulitis to left deltoid about two inches from injection site area is warm to touch. Mild papular rash appears to inner middle arm and patient reports itching at site. Patient advised to seek prompt medical attention of symptoms persist or worsen, recommended patient apply cold compresess for relief.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Rash papular
Clinical narrative: Patient states she developed a rash approximately two hours after receiving Hepatitis B vaccine to left deltoid and to inner middle arm. She denies any other symptoms. Today patient presents to clinic with redness and cellulitis to left deltoid about two inches from injection site area is warm to touch. Mild papular rash appears to inner middle arm and patient reports itching at site. Patient advised to seek prompt medical attention of symptoms persist or worsen, recommended patient apply cold compresess for relief.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site haematoma, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: During morning shower noticed pain in left shoulder as I raised my arms to towel dry my hair.  Area of injection site swollen and hot and feels bruised. Significant pain in the front of the shoulder when moving the left arm.  Cannot fasten seatbelt.  Achy feeling in left arm down to elbow and also radiating into left side of neck.  Vaguely achy feeling all over.  Taking ibuprofen which helps the achiness, but the shoulder pain is still significant when trying to use the arm.  There was a lot of itching at the injection site right after the shot which the pharmacist said was normal.  My daughter got an injection the same time as I, and she had no adverse effects, just a little hive at injection site.  I have not called a doctor, but I will if it doesn't get better in a couple of days.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: During morning shower noticed pain in left shoulder as I raised my arms to towel dry my hair.  Area of injection site swollen and hot and feels bruised. Significant pain in the front of the shoulder when moving the left arm.  Cannot fasten seatbelt.  Achy feeling in left arm down to elbow and also radiating into left side of neck.  Vaguely achy feeling all over.  Taking ibuprofen which helps the achiness, but the shoulder pain is still significant when trying to use the arm.  There was a lot of itching at the injection site right after the shot which the pharmacist said was normal.  My daughter got an injection the same time as I, and she had no adverse effects, just a little hive at injection site.  I have not called a doctor, but I will if it doesn't get better in a couple of days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Sleep disorder
Clinical narrative: pt reported "migraine"-like pain starting in left hip on 8/31/12. Pain continued and then developed into right hip on 9/1/12. Pain was continually and interrupted sleep. Warm compresses did not relieve pain. Acetaminophen 1000mg as needed resolved pain. Pain completely resolved on 9/6/12.
Age: 14.0
Sex: F
Vaccine: HEPA, HPVX, MMR, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Pt relocated from another state, no prior h/o any problems. I gave MCV, Tdap, MMR on left arm. I gave HPV on rt arm. I was administering Hep A, when pt felt dizzy and fainted on the exam table. Pt recovered within 10 secs. Vitals at the time were WNL. Pt had not eaten breakfast. I gave pt oral juice and fluids, water. Explained to mother and pt.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Influenza like illness
Clinical narrative: This spontaneous report as received from a physician reporting a 53 years old male patient with hypertension and diabetes and a medical history of insertion of stents who on 21-AUG-2012, was vaccinated SQ with 0.65 ml dose of ZOSTAVAX (lot# not reported). No other co-suspects were reported. No concomitant medications were reported. On 22-AUG-2012 the patient had "chest pain and flu like system". The patient went to the emergency room (ER) and was admitted to hospital. The patient had unspecified lab work in hospital and received an unspecified treatment. At the time of the report, the patient recovered (date not reported). The relatedness for chest pain and flu like system was unknown for ZOSTAVAX. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Pain, Pyrexia
Clinical narrative: Redness, fever, pain, and inflammation.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Raised are of erythema, induration and pain at injection site (deltoid region bilaterally).
Age: 61.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Headache, Oral mucosal erythema, Pyrexia, Rash
Clinical narrative: 2 -3 hrs after vaccine - fever, HA took a day ADVIL. 3-4 hrs post - okay. 2-3 days felt better. 97 Developed oral redness/rash - spreading shoulder -> elbow wide/flat hot to temperature.
Age: 61.0
Sex: M
Vaccine: MNQ
Symptoms: Skin warm
Clinical narrative: 2 -3 hrs after vaccine - fever, HA took a day ADVIL. 3-4 hrs post - okay. 2-3 days felt better. 97 Developed oral redness/rash - spreading shoulder -> elbow wide/flat hot to temperature.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Somnolence
Clinical narrative: 0830- Pt received immunization. 0835- Pt complains of dizziness and nausea. Pt is pale, diaphoretic, and sleepy. 0848- BP 90/40, HR 68, RR 20. No c/o SOB or difficulty breathing. 0855 - Pt. skin color normal. No diaphoresis, & states "I'm feeling better" & is smiling. 0857 - Pt. ambulating. Given instructions to call PCP for any further problems or concerns.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: Swollen area, redness, itching slightly painful.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The patient was vaccinated with lot # (670542/0619AA) ZOSTAVAX (single dose, Subcutaneous) on 23-AUG-2012 which had expired on 26-JUL-2012. No adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. The outcome of expired vaccine used is unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Pruritus, Upper extremity mass
Clinical narrative: This spontaneous report as received from a 60 years old female consumer refers to herself. The patient had none pertinent medical history. The patient had none drug allergies. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # not reported) on "Monday", 27-AUG-2012. Concomitant medications included: metoprolol tartrate. It was reported that then "the next night", on 28-AUG-2012 the patient had some itching. On the morning of 29-AUG-2012 the patient then noticed a hard lump on her arm about 3 to 4 inches in diameter. The patient was going to a medical clinic on 29-AUG-2012 to treat this adverse event and had no specific doctor that she saw. No treatment was given. No lab diagnostics studies was performed. The adverse event did not improve. The outcome was reported as not recovered. Additional information is not expected.
Age: 23.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a consumer refers to her son, a 23 years old male patient. The patient's drug reaction and allergies were reported as unspecified "many allergies". The patient was vaccinated with unspecified number of doses of M-M-R II (lot # not reported) as a child. It was reported that the patient had negative titers for mumps at the time of reporting. The patient did not seek medical attention. No treatment was given. The outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (lot # 0168AE, expiration date 06-MAR-2013) on an unknown date. It was reported that the patient developed swelling and redness on her arm at the injection site after receiving ZOSTAVAX. This dose of ZOSTAVAX had been stored in the refrigerator for an unspecified amount of time prior to administration to the patient. The patient sought for medical attention by calling to pharmacy department. The outcome was unknown. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Constipation, Diarrhoea, Dizziness, Vaginal haemorrhage
Clinical narrative: Severe abdominal pain and cramping, diarrhea, constipation, dizziness, vaginal spotting.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site discolouration, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Swelling, red (size of an orange) RT deltoid area of injection. Black and blue size of two fingers. No treatment needed. Will follow up with primary MD to check on local  allergic reaction?
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Decreased appetite, Vomiting
Clinical narrative: Loss of appetite and subsequent vomiting, 24 hrs and more after shots.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Mobility decreased, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Sore arm, unable to move it. Pain stayed at vaccination site and is still warm to touch on 9/9/12. Low grade fever onset on 9/6/12 and still continues through 9/9/12. Taken ibuprofen (800-1000mg daily for pain). Rest. Missed work (left at half day) on 9/8/12 due to symptoms. Able to complete full day work on 9/9/12.