chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Occult blood negative, Rotavirus test negative, Rotavirus test positive, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 13 week old (reported as 3 month) female patient with a history of vomiting, diarrhoea, dehydration and hospitalization (the patient was hospitalized from 11-MAY-2012 to 14-MAY-2012 due to vomiting, diarrhoea, dehydration) with a negative results of medical test including stool cultures, "rotavirus", fecal blood cell, urine, blood, cerebral spinal fluid and respiratory cultures (the patient was administered unspecified antibiotics and was rehydrated) who on 15-MAY-2012 was vaccinated with a 2.0 ml first dose of ROTATEQ, (Lot # not reported). There was no concomitant medication. On 18-MAY-2012 the patient was found unresponsive at home after a nap. The patient was admitted to the hospital. Her rectal temperature was 100.01 and blood tests reflected dehydration. The patient was given IV fluids and supportive measures. The patient was pronounced dead on 18-MAY-2012. The physician reported, at autopsy, negative stool culture and positive rotavirus antigen ID. The caused of death has not yet been determined. Additional information has been requested. All adverse events were determined as significant disability, life threatening and other important medical events.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Local reaction
Clinical narrative: Local reaction at site of injection. Red, tender, itchy area approx 2 1/2 inches. Rx with ice. Resolved in 2 days.
Age: 0.76
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Crying, Erythema, Rash
Clinical narrative: 9 mos. old infant had vaccines this am and the only different vaccine was the flu. Mom noticed rash on the baby 2 minutes after vaccines given and notified the clerical staff. The clerical staff came and got me to check the baby. There was a flat splotching red discoloration under skin on forehead, back of neck an dface and also on upper chest area. No respiratory distress and the baby was taking his bottle. The rash increased when the baby cried. No respiratory problems noted and once he stopped crying the rash disappeared some what. Dr. notified about the rash and ordered to give the Benadryl. Benadryl 12.5 mg/5cc given orally to infant. Mother given instruction on Benadryl dosages for the next 24 hours and to call 911 if baby developed respiratory distress and to call private physician for follow-up. Infant monitored 12-20 minutes post medication. Rash disappeared.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction at site of injection tenderness, redness, swelling. No Rx- resolved less than 1 week.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: A few minutes after the last injection (TB test) pt states she feels faint. Face turned pale and she passed out while sitting up for about 20 seconds. She came to, I laid her on the floor and elevated face with a cool cloth x5 min. Felt better and left office at 11:15AM.
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 06/12/2012 - Patient c/o soreness and sharp pain to right arm upper sq area.  Patient woke up this morning (06/22/2012) with 3 inch diameter swollen area to right upper sq area of arm.
Age: 27.0
Sex: F
Vaccine: FLU3, HEP, HEPA, MNQ, TDAP
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Pallor
Clinical narrative: At 15:30 patient was administered MCV4, Tdap, HepA, Influenza. Immediately after pt c/o feeling dizzy. Patient pale, slight diophoretic, oriented to person, place time. Pt's skin clammy to touch. Nurse assisted pt to sitting position. v/s 90/60 60 pulse, resp 18 regular. Patient answering questions when asked. SN monitored pt for 30 min. No other incident noted. Patient oriented x3. All time monitored. After mom arrived pt escorted to car. Followed up for the remainder of the week by SN.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a health care professional on 18 June 2012. This reporter reported another adverse event which was captured in case number 2012-06240. A 58-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C3989AA, on 08 May 2012. On 09 May 2012 (also reported as 22 May 2012), the patient experienced redness, swelling, heat and itchiness at the injection site. The doctor determined it was cellulitis but no defining culture was obtained. The patient was treated with KEFLEX 500mg twice daily (BID) for seven days. The patient had no illness at the time of vaccination and a past medical history of migraines, anxiety, depression, gastroesophageal reflux disease (GERD), seasonal allergies, osteopenia and vitamin D and vitamin B12 deficiencies. No additional information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report was received from a health care professional on 18 June 2012. This reporter reported another adverse event which was captured in case number 2012-06239. A 58-year-old female patient had received a dose one intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4105 (corresponding sanofi pasteur Inc. lot number U4325AA), on 24 April 2012. On 26 April 2012, the patient experienced a headache and site reaction of redness, swelling and heat. The doctor diagnosed the patient with cellulitis without any confirmed culture being obtained. The patient was treated with KEFLEX 500 mg three times a day (TID) for seven days. The patient had no illness at the time of vaccination with a past medical history of hypothyroidism, depression and gastroesophageal reflux disease (GERD). No additional information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Blood test normal, Computerised tomogram head normal, Convulsion, Dyskinesia, Electrocardiogram normal
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 19 June 2012. A 40-year-old male patient had received a dose one injection in the right deltoid of TENIVAC, sanofi pasteur Ltd. (lot number unknown) on 14 June 2012 and an unspecified amount of time later experienced a sore right arm, "like getting punched". The sore arm resolved on 17 June 2012. On 18 June 2012, the patient was sitting in a chair when he began to jerk, lost consciousness and was incoherent for 10 minutes. A friend of the patient stated the seizure lasted for 10 minutes. The patient was transported by ambulance to the hospital. The patient was seen in the emergency room (ER). A CT scan of the head, blood work and EKG were done. The physician told the patient "all tests were clean" and referred him to a neurologist. The patient was receiving wound care at the time of vaccination. The patient had no known allergies (NKA). No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Incoherent, Loss of consciousness, Pain in extremity
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 19 June 2012. A 40-year-old male patient had received a dose one injection in the right deltoid of TENIVAC, sanofi pasteur Ltd. (lot number unknown) on 14 June 2012 and an unspecified amount of time later experienced a sore right arm, "like getting punched". The sore arm resolved on 17 June 2012. On 18 June 2012, the patient was sitting in a chair when he began to jerk, lost consciousness and was incoherent for 10 minutes. A friend of the patient stated the seizure lasted for 10 minutes. The patient was transported by ambulance to the hospital. The patient was seen in the emergency room (ER). A CT scan of the head, blood work and EKG were done. The physician told the patient "all tests were clean" and referred him to a neurologist. The patient was receiving wound care at the time of vaccination. The patient had no known allergies (NKA). No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Injection site swelling
Clinical narrative: On 6/29/12 the patient reported a headache, bump (swelling) and a rash to me at the injection site. I reported it to the prescriber and was told to tell the patient to take OTC BENADRYL and TYLENOL.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Crying, Fatigue, Irritability, Muscular weakness, Paraesthesia
Clinical narrative: Patient complained of weak, tingly arm, then upon returning home from clinic put her pajamas on and went to bed stating she felt tired.  Mom states she is irritable and crying.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Oedema peripheral, Urticaria
Clinical narrative: Pt developed soreness at site of injections, over next several hours, developed swelling and redness of arm, followed by hives, spreading to trunk 2 days later.
Age: 1.02
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: Ear infection, Pyrexia, Rash generalised
Clinical narrative: Started with a fever of 103, kept it for days. Went back to DR. 6/19 he advised she had an ear infection gave amoxicillin. Rash showed up on 6/26 on her trunk, went back to DR. He advised looked like some type of reaction but was not sure it was vaccine. Stopped amoxicillin and advised rash would begin to clear up if it was amoxicillin. Rash has spread is covering her entire body and face.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dysarthria, Hypoaesthesia, Paraesthesia, VIIth nerve paralysis
Clinical narrative: Received ADACEL and MENACTRA on Wednesday 6/27/12. Thursday afternoon c/o numbness & tingling ie Lt  hand, arm & face. Left side of face droopy. Woke this AM 6/29 c/o Rt side numbness & tingling. Speech slurred as with dental work. No fever, visual change, intermittent & presenting symptoms as of 11:30.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion, Hunger, Loss of consciousness, Somnolence
Clinical narrative: Initial report was received from a healthcare professional on 21 June 2012. A 17 year-old-male patient received an injection of MENACTRA, sanofi pasteur Inc., lot number U4002AA (route, site, and number of previous doses not reported) on 21 June 2012. Approximately 10 minutes after vaccine on 21 June 2012, the reporter stated the patient became "very sleepy, passed out, one min. later woke up and was OK." The reporter stated during the time the patient was "passed out"; he had a "small convulsion". The reporter stated upon "waking", the patient was hungry and was provided a snack. The patient was "OK" when discharged from facility, per reporter. The patient's past medical history was not reported. Illness at time of vaccination was reported as none. The patient's mother called his primary care physician (PCP), and the patient was seen at own PCP office (date not specified), where the patient's mother stated the patient had follow-up testing scheduled. The patient was reported as recovered on 21 June 2012. Documents held by sender: None.
Age: 0.13
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 6/26/2012 Mother asked at pts six mo well child ck if any reactions to previous vaccines. Mom told Dr: Eve after shot -leg / warm thigh knee to hip swelled up with redness/warmth (Lt leg). T 102 degrees F; swell decreased after 2d.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Pain in arm & redness to the site.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea
Clinical narrative: 10 or more loose stools per day x's 1 week so far. Given Pedialyte & put on ISOMIL DF formula.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-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 4 doses of PENTACEL; received on 08 October 2010, 08 December 2010, 11 February 2011 and 15 November 2011 (lot number, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 23 May 2012, approximately six months after the dose. On 01 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 07 June 2012. Corrective treatments consisted of azithromycin starting on 07 June 2012 for 5 days. The subject was not hospitalized. At the final contact on 11 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder, Vaccination failure
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-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 4 doses of PENTACEL; received on 08 October 2010, 08 December 2010, 11 February 2011 and 15 November 2011 (lot number, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 23 May 2012, approximately six months after the dose. On 01 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 07 June 2012. Corrective treatments consisted of azithromycin starting on 07 June 2012 for 5 days. The subject was not hospitalized. At the final contact on 11 June 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on pt's back and shoulders.
Age: 0.55
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational study under the reference number M5A16. A case of pertussis disease in a six-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 C3952AA received on 09 December 2011, lot number C4130AA received on 01 February 2012 and lot number C4081AA received on 24 April 2012 (routes and sites of administration not reported). The subject developed a cough on 03 May 2012, approximately 9 days after the last dose and a paroxysmal cough on an unspecified date with a whoop. The subject also experienced posttussive vomiting. Laboratory testing included negative PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 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: 0.55
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational study under the reference number M5A16. A case of pertussis disease in a six-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 C3952AA received on 09 December 2011, lot number C4130AA received on 01 February 2012 and lot number C4081AA received on 24 April 2012 (routes and sites of administration not reported). The subject developed a cough on 03 May 2012, approximately 9 days after the last dose and a paroxysmal cough on an unspecified date with a whoop. The subject also experienced posttussive vomiting. Laboratory testing included negative PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 24 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 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: 78.0
Sex: M
Vaccine: PPV
Symptoms: Rash generalised
Clinical narrative: 77 y.o. M w/ PMH of Psoriasis, Dermatitis and HTN presents to primary care for a follow up. Pt was overdue to receive Pneumococcal vaccine. Pt received 0.5ml Pneumococcal inj on 2/21/12. A rash appeared all over arms, chest, abdomen and back after receiving the vaccine. Pt had no previous allergies listed. Treatment Drugs Used: 1. Prednisone Dose: 40 Units: Every day Route: PO. 2. Hydroxyzine Dose: 25 Units: MG Freq: QID Route: PO.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a seven-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; received on 05 December 2011, 06 February 2012 and 10 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 20 May 2012, approximately 40 days after the last dose and a paroxysmal cough on 26 May 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 26 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder, Vaccination failure
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a seven-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; received on 05 December 2011, 06 February 2012 and 10 April 2012 (lot numbers, routes and sites of administration not reported). The subject developed a cough on 20 May 2012, approximately 40 days after the last dose and a paroxysmal cough on 26 May 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 26 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 17 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Onset of erythema, induration, and warmth at injection site measuring 23 x 17 cm extending from shoulder to elbow. Onset was 6 days post vaccine administration.
Sex: M
Vaccine: FLU3
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Cough, Death, Hypotension
Clinical narrative: Case number PHHY2012US054673 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient's medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations. With his neurologic impairment, he was able to make sounds but unable to speak or move on his own volition. He had multiple prior admissions for aspiration pneumonia and a history of abnormalities noted on chest radiography. He was vaccinated with season influenza vaccine 2010/2011 (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 19 Feb 2011, he had fever of 101.2 F (38.4 C), and his oxygen saturation was 88% on room air. Empiric treatment with ciprofloxacin was initiated. On illness day 2, he developed mild cough and wheezing and was given supplemental oxygen. On illness day 3, he became tachypneic and required increased respiratory suctioning. On illness day 5, he was hospitalized with fever of 101.3 F (38.5 C) and respiratory rate of 24 breaths-per-minute; empiric treatment with piperacillin/tazobactam and vancomycin was initiated. On illness day 6, he tested positive for influenza A by rapid influenza diagnostic test (RIDT) and was treated with oseltamivir (60 mg twice daily). On the same day, he developed both acute respiratory distress syndrome requiring mechanical ventilation and sepsis with hypotension requiring vasopressor support. On illness day 7, chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. He died on illness day 8, Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Sex: M
Vaccine: FLU3
Symptoms: Influenza A virus test positive, Mechanical ventilation, Oxygen saturation decreased, Pyrexia, Sepsis
Clinical narrative: Case number PHHY2012US054673 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient's medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations. With his neurologic impairment, he was able to make sounds but unable to speak or move on his own volition. He had multiple prior admissions for aspiration pneumonia and a history of abnormalities noted on chest radiography. He was vaccinated with season influenza vaccine 2010/2011 (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 19 Feb 2011, he had fever of 101.2 F (38.4 C), and his oxygen saturation was 88% on room air. Empiric treatment with ciprofloxacin was initiated. On illness day 2, he developed mild cough and wheezing and was given supplemental oxygen. On illness day 3, he became tachypneic and required increased respiratory suctioning. On illness day 5, he was hospitalized with fever of 101.3 F (38.5 C) and respiratory rate of 24 breaths-per-minute; empiric treatment with piperacillin/tazobactam and vancomycin was initiated. On illness day 6, he tested positive for influenza A by rapid influenza diagnostic test (RIDT) and was treated with oseltamivir (60 mg twice daily). On the same day, he developed both acute respiratory distress syndrome requiring mechanical ventilation and sepsis with hypotension requiring vasopressor support. On illness day 7, chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. He died on illness day 8, Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Sex: M
Vaccine: FLU3
Symptoms: Tachypnoea, Wheezing
Clinical narrative: Case number PHHY2012US054673 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient's medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations. With his neurologic impairment, he was able to make sounds but unable to speak or move on his own volition. He had multiple prior admissions for aspiration pneumonia and a history of abnormalities noted on chest radiography. He was vaccinated with season influenza vaccine 2010/2011 (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 19 Feb 2011, he had fever of 101.2 F (38.4 C), and his oxygen saturation was 88% on room air. Empiric treatment with ciprofloxacin was initiated. On illness day 2, he developed mild cough and wheezing and was given supplemental oxygen. On illness day 3, he became tachypneic and required increased respiratory suctioning. On illness day 5, he was hospitalized with fever of 101.3 F (38.5 C) and respiratory rate of 24 breaths-per-minute; empiric treatment with piperacillin/tazobactam and vancomycin was initiated. On illness day 6, he tested positive for influenza A by rapid influenza diagnostic test (RIDT) and was treated with oseltamivir (60 mg twice daily). On the same day, he developed both acute respiratory distress syndrome requiring mechanical ventilation and sepsis with hypotension requiring vasopressor support. On illness day 7, chest radiography showed diffuse lung opacities that progressed to complete opacity of both lungs. He died on illness day 8, Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Sex: M
Vaccine: FLU3
Symptoms: Breath sounds abnormal, Chest X-ray abnormal, Cough, Increased upper airway secretion, Influenza A virus test positive
Clinical narrative: Case number PHHY2012US055009 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient's medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations, cerebral palsy and intellectual disability. His neurologic impairment rendered him unable to move, make sounds, or speak. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 24 Feb 2011, he developed fever of 102.2 F (39.0 C), nonproductive cough, rhonchi, tachypnea, increased tracheostomy secretions, and oxygen saturation of 84% on room air. On illness day 2, he developed wheezing and had diminished left lower lung breath sounds. He was hospitalized with temperature of 98.8 F (37.1 C), elevated white blood cell count, tachycardia, and respiratory failure requiring mechanical ventilation. Chest radiography showed hazy opacities with low lung volume. He tested positive for influenza A, and treatment with oseltamivir (75 mg once daily) was initiated. He recovered from the acute illness and was discharged to the residential facility after 8 days of hospitalization. Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Sex: M
Vaccine: FLU3
Symptoms: Mechanical ventilation, Oxygen saturation decreased, Pyrexia, Respiratory failure, Rhonchi
Clinical narrative: Case number PHHY2012US055009 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient's medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations, cerebral palsy and intellectual disability. His neurologic impairment rendered him unable to move, make sounds, or speak. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 24 Feb 2011, he developed fever of 102.2 F (39.0 C), nonproductive cough, rhonchi, tachypnea, increased tracheostomy secretions, and oxygen saturation of 84% on room air. On illness day 2, he developed wheezing and had diminished left lower lung breath sounds. He was hospitalized with temperature of 98.8 F (37.1 C), elevated white blood cell count, tachycardia, and respiratory failure requiring mechanical ventilation. Chest radiography showed hazy opacities with low lung volume. He tested positive for influenza A, and treatment with oseltamivir (75 mg once daily) was initiated. He recovered from the acute illness and was discharged to the residential facility after 8 days of hospitalization. Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Sex: M
Vaccine: FLU3
Symptoms: Tachycardia, Tachypnoea, Wheezing, White blood cell count increased
Clinical narrative: Case number PHHY2012US055009 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient's medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations, cerebral palsy and intellectual disability. His neurologic impairment rendered him unable to move, make sounds, or speak. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 24 Feb 2011, he developed fever of 102.2 F (39.0 C), nonproductive cough, rhonchi, tachypnea, increased tracheostomy secretions, and oxygen saturation of 84% on room air. On illness day 2, he developed wheezing and had diminished left lower lung breath sounds. He was hospitalized with temperature of 98.8 F (37.1 C), elevated white blood cell count, tachycardia, and respiratory failure requiring mechanical ventilation. Chest radiography showed hazy opacities with low lung volume. He tested positive for influenza A, and treatment with oseltamivir (75 mg once daily) was initiated. He recovered from the acute illness and was discharged to the residential facility after 8 days of hospitalization. Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3616AA received on 02 August 2011, lot number not reported received on 06 September 2011 and lot number not reported received on 27 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 12 May 2012, approximately 6 months after the last dose. On 13 May 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and apnea. Laboratory testing included positive PCR on 29 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 05 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 24 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, Vaccination failure
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a 12-month-old female subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3616AA received on 02 August 2011, lot number not reported received on 06 September 2011 and lot number not reported received on 27 October 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 12 May 2012, approximately 6 months after the last dose. On 13 May 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and apnea. Laboratory testing included positive PCR on 29 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 05 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 24 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 12-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; received on 28 June 2011, 30 August 2011 and 18 November 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 May 2012, approximately five months after the last dose. On 15 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 03 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.57
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder, Vaccination failure
Clinical narrative: Initial report received on 18 June 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 12-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; received on 28 June 2011, 30 August 2011 and 18 November 2011 (lot numbers, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 01 May 2012, approximately five months after the last dose. On 15 May 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 03 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 05 June 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Pain, Pyrexia
Clinical narrative: 10x12 redness & warmth around injection site. Fever of 102 degrees on 6-27-12 & 101 degrees on 6-28-12 body aches severe.
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, MNQ
Symptoms: Dizziness, Fall, Pallor, Syncope
Clinical narrative: After receiving the vaccines he fainted and rolled out of the chair to the floor to his side. Nurse placed client on his back and elevated his legs. Client's legs elevated and BP 100/50 at 11:20. Client color pale. Client stated he felt dizzy before he fainted. Client states he saw "black" before he rolled out of the chair. Client's color improved and lips pink and states he is not dizzy anymore. Client placed in sitting position and then placed in rolling chair for transport to an exam table for observation. BP 110/60 at 11:40, 100/60 at 11:50. Client place in sitting position at 12:15 and BP 100/62 and client reports he is a little dizzy. Client left clinic at 12:20 and BP 110/60. He reports "I feel good and not dizzy." Mother and client were told to inform other healthcare provider about fainting after an injection. I also explained to mother that she should contact her son's medical provider to inform him about the fainting episode.
Age: 0.54
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever 103-104 with seizure. Occurred 12 hours after immunizations given. Seizure lasted 3-5 minutes.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness, Loss of consciousness
Clinical narrative: Became dizzy and passed out.  Blood pressure dropped.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Local reaction at injection site; & pain redness, swelling of upper arm expanding several inches from injection site (upper arm to elbow). Pruritis. Tx - cold compress & diphenhydramine 25-50mg Q6 prn.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Local reaction at injection site; & pain redness, swelling of upper arm expanding several inches from injection site (upper arm to elbow). Pruritis. Tx - cold compress & diphenhydramine 25-50mg Q6 prn.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: (L) Side pain - from neck to foot. Describes as an ache. x1wk. Exam several point tenderness to trapezius muscle & Sl joint. Do not believe vaccination related but pt was concerned about. Report filed at her request.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Swelling face
Clinical narrative: 03/08/2012 - Facial swelling one day after vaccine given - seen by dr prescribed ORAPRED 3 ml qd x's 4 days and ZYRTEC 5 mg/5 ml 2.5 ml q-day. 03/09/12 - Facial swelling resolved per dr.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Irritability, Pruritus, Rash
Clinical narrative: Rash developed 24 hrs after shots. Pt very irritable. Scratching skin. BENADRYL was rx to relief itching.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient experienced swelling and redness that extended down her upper arm. Painful as well. Patient took TYLENOL on a scheduled basis and used cold packs TID to help with swelling. Symptoms lasted approx 10 days.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Facial pain, Pain in jaw
Clinical narrative: MMR 6/7/12 c/o right ear/jaw/face pain started on 6/27/12.
Age: 25.0
Sex: M
Vaccine: DT
Symptoms: Chills, Dehydration, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 1 hr after vaccine had intractable emesis, nausea, chills, sweating; presented with dehydration next day and sent to emerg. dept for rehydration.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Local swelling, Rash, Swelling face
Clinical narrative: Patient presented to clinic on 6/29/12 with swelling and rash to face and neck area. Mom states symptoms began the morning after receiving his vaccines. Mom treated patient with BENADRYL.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Got dizzy and passed out.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Pt. received vaccines on 4-16-12 and returned to clinic on 4-18-12 with L forearm swollen and red. Pt was treated for cellulitis with clindamycin. Pt with fever m 4/17. Per phone call via mother patient recovered.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Abdominal pain, Barium enema, Clostridium difficile colitis, Enema administration, Haematochezia
Clinical narrative: On above date and approximate time, infant began with fussiness, abdominal pain and bilious vomiting and was taken to the ED.  Was later admitted to the hospital and had grossly blood stools.  Diagnosed with intussusception of colon and C. difficile colitis.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Intussusception, Irritability, Stool analysis, Vomiting
Clinical narrative: On above date and approximate time, infant began with fussiness, abdominal pain and bilious vomiting and was taken to the ED.  Was later admitted to the hospital and had grossly blood stools.  Diagnosed with intussusception of colon and C. difficile colitis.
Age: 43.0
Sex: M
Vaccine: HEP, TYP, YF
Symptoms: Chest pain, Cough, Respiratory tract congestion
Clinical narrative: Pt developed a cough and congestion that worsened over 3-4 days. Required physician visit due to chest pain.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Local swelling
Clinical narrative: Child with localized swelling, tenderness at site of injection.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Chest pain
Clinical narrative: Pt states she is have recurring chest pain that comes and goes, about 2 hours after receiving the MCV4 vaccine.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Area around injection site became extremely tender, hard to the touch, hot to the touch, itchy, tingly and swollen about 2 inches wide by 3 inches across covering nearly the entire deltoid muscle area. On 06/28/12, I awoke with a splotchy rash covering entire chest area, most pronounced on both breasts and partially down my stomach. Symptoms have not yet resolved.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Paraesthesia, Rash, Rash macular
Clinical narrative: Area around injection site became extremely tender, hard to the touch, hot to the touch, itchy, tingly and swollen about 2 inches wide by 3 inches across covering nearly the entire deltoid muscle area. On 06/28/12, I awoke with a splotchy rash covering entire chest area, most pronounced on both breasts and partially down my stomach. Symptoms have not yet resolved.