chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.4
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction
Clinical narrative: This is one case out of a cumulative total of 210 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 August 2013. These 210 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old female subject (initials not collected) 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 (lot numbers not reported) on 21 January 2011, 01 April 2011, 06 June 2011, and on 25 April 2012. The subject developed a cough on 29 July 2013, approximately 15 months after the last dose, and a paroxysmal cough without a whoop on 03 August 2013. The subject also developed cold like symptoms on 29 July 2013. Laboratory testing included positive PCR on 01 August 2013. Chest x-ray findings were negative. Corrective treatments consisted of azithromycin starting on 01 August 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 12 August 2013, the subject's cough had resolved. 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: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Breath holding, Crying, Gaze palsy, Hypotonia, Musculoskeletal stiffness
Clinical narrative: Initial report received on 21 August 2013 from a non-healthcare provider. A four month old male patient was immunized on 20 August 2013 with PENTACEL, Batch # C4486AA into the right thigh and PREVNAR (Wyeth), batch # H04467 into the right thigh. Route and site for PENTACEL was also reported as 10/10/2014 and PREVNAR 03/01/2015 (to be clarified). It was reported that the patient had no illness at the time of vaccination or pre-existing physician diagnosed allergies or medical conditions. At an unspecified time on 20 August 2013, after giving PENTACEL and then PREVNAR, the baby began crying and having breath holding spells. After he stopped crying, he went limp, eyes rolled back, body got stiff, and his arms were shaking. He was sent to the hospital for observation and was discharged on an unreported date. He was doing well at the time of discharge with no further incidents reported. It was reported that he was first given PENTACEL and then given PREVNAR, times not reported. It was unknown if diagnostic tests and laboratory tests were performed. The patient outcome was reported as recovered on an unreported date. No further details were available at the time of this report. Documents held by sender: None.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Tremor
Clinical narrative: Initial report received on 21 August 2013 from a non-healthcare provider. A four month old male patient was immunized on 20 August 2013 with PENTACEL, Batch # C4486AA into the right thigh and PREVNAR (Wyeth), batch # H04467 into the right thigh. Route and site for PENTACEL was also reported as 10/10/2014 and PREVNAR 03/01/2015 (to be clarified). It was reported that the patient had no illness at the time of vaccination or pre-existing physician diagnosed allergies or medical conditions. At an unspecified time on 20 August 2013, after giving PENTACEL and then PREVNAR, the baby began crying and having breath holding spells. After he stopped crying, he went limp, eyes rolled back, body got stiff, and his arms were shaking. He was sent to the hospital for observation and was discharged on an unreported date. He was doing well at the time of discharge with no further incidents reported. It was reported that he was first given PENTACEL and then given PREVNAR, times not reported. It was unknown if diagnostic tests and laboratory tests were performed. The patient outcome was reported as recovered on an unreported date. No further details were available at the time of this report. Documents held by sender: None.
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Myocardial infarction, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 20 August 2013. An 42 year-old male subject with no significant past medical history was found to have "subendocardial infarction" 15 days after the subject had received the following vaccine on 30 May 2013: an injection of ACAM2000 (lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I on 15 June 2013 recorded highest value of 01.50 and a normal Echocardiogram on 16 June 2013. An ECG was not available. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MEN
Symptoms: Death
Clinical narrative: Initial report was received 26 August 2013 from a health care professional. A 17-year-old female patient with no known allergies had received a second dose intramuscular injection of MENACTRA, lot number U4584BA and a first dose intramuscular injection of GARDASIL (manufacturer Merck, lot number H020848) (sites of administration not reported) on 09 August 2013, and 13 days later on 22 August 2013, the patient died. There was no contact with the physician after MENACTRA had been given. The patient had previously received a first dose injection of MENACTRA on 04 September 2008. The reporter had been contacted by the county medical examiner who informed the reporter about the death and requested the patient's medical history. The reporter contacted the CDC (Centers for Disease Control and Prevention) who told them to call and report the event to VAERS. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MEN
Symptoms: Autopsy, Death
Clinical narrative: Initial report was received 26 August 2013 from a health care professional. A 17-year-old female patient with no known allergies had received a second dose intramuscular injection of MENACTRA, lot number U4584BA and a first dose intramuscular injection of GARDASIL (manufacturer Merck, lot number H020848) (sites of administration not reported) on 09 August 2013, and 13 days later on 22 August 2013, the patient died. There was no contact with the physician after MENACTRA had been given. The patient had previously received a first dose injection of MENACTRA on 04 September 2008. The reporter had been contacted by the county medical examiner who informed the reporter about the death and requested the patient's medical history. The reporter contacted the CDC (Centers for Disease Control and Prevention) who told them to call and report the event to VAERS. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MEN
Symptoms: Fatigue, Headache, Pain in extremity, Vomiting
Clinical narrative: Initial report was received 26 August 2013 from a health care professional. A 17-year-old female patient with no known allergies had received a second dose intramuscular injection of MENACTRA, lot number U4584BA and a first dose intramuscular injection of GARDASIL (manufacturer Merck, lot number H020848) (sites of administration not reported) on 09 August 2013, and 13 days later on 22 August 2013, the patient died. There was no contact with the physician after MENACTRA had been given. The patient had previously received a first dose injection of MENACTRA on 04 September 2008. The reporter had been contacted by the county medical examiner who informed the reporter about the death and requested the patient's medical history. The reporter contacted the CDC (Centers for Disease Control and Prevention) who told them to call and report the event to VAERS. No additional information was provided at the time of the report. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Hypoaesthesia, Muscle spasms, Muscle twitching, Pain
Clinical narrative: Initial information received from a healthcare professional (physician) on 26 August 2013. A 30 year old female patient was vaccinated intramuscularly on 08 August 2013 with ADACEL batch C4426AA, into the right deltoid. On 10 August 2013 the patient experienced unspecified pain and swelling initially and within the first week, developed numbness and tingling in her arm and cheek, but no weakness. The patient also had muscle spasm and twitching, joint pains and arthralgias on a date not reported. The patient was diagnosed with serum sickness by a travel MD on an unreported date. Laboratory tests were not reported. The patient's medical history was reported as having an unspecified allergy to Sulfa. The patient was not ill at the time of vaccination. The patient is to be seen by an allergist reported as tomorrow. The patient outcome was reported as not recovered. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Serum sickness, Swelling
Clinical narrative: Initial information received from a healthcare professional (physician) on 26 August 2013. A 30 year old female patient was vaccinated intramuscularly on 08 August 2013 with ADACEL batch C4426AA, into the right deltoid. On 10 August 2013 the patient experienced unspecified pain and swelling initially and within the first week, developed numbness and tingling in her arm and cheek, but no weakness. The patient also had muscle spasm and twitching, joint pains and arthralgias on a date not reported. The patient was diagnosed with serum sickness by a travel MD on an unreported date. Laboratory tests were not reported. The patient's medical history was reported as having an unspecified allergy to Sulfa. The patient was not ill at the time of vaccination. The patient is to be seen by an allergist reported as tomorrow. The patient outcome was reported as not recovered. Documents held by sender: None.
Age: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray, Cough, Culture positive, Laboratory test abnormal, Pertussis
Clinical narrative: This is one case out of a cumulative total of 210 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 August 2013. These 210 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 03-year-old male subject (initials not collected) 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 07 April 2010 (batch number C3591AA), 28 June 2010 (batch number C3591AA), and 17 September 2010 (batch number C3633AA) and 1 dose of DAPTACEL (batch number C3380AA) on 27 May 2011. The subject developed a cough on 01 July 2013, i.e. 766 days after the last dose, and a paroxysmal cough with a whoop on 01 July 2013. The subject also developed post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included positive PCR and positive culture on 22 July 2013. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 22 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 14 August 2013, the subject's cough was still persisting. 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: 1.29
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: This is one case out of a cumulative total of 210 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 23 August 2013. These 210 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 23 August 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 03-year-old male subject (initials not collected) 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 07 April 2010 (batch number C3591AA), 28 June 2010 (batch number C3591AA), and 17 September 2010 (batch number C3633AA) and 1 dose of DAPTACEL (batch number C3380AA) on 27 May 2011. The subject developed a cough on 01 July 2013, i.e. 766 days after the last dose, and a paroxysmal cough with a whoop on 01 July 2013. The subject also developed post-tussive vomiting and sleep disturbance on an unspecified date. Laboratory testing included positive PCR and positive culture on 22 July 2013. Chest x-ray findings were unknown. Corrective treatments consisted of azithromycin starting on 22 July 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 14 August 2013, the subject's cough was still persisting. 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: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Eyelid ptosis, IIIrd nerve paralysis, Inflammation, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: On 9/1/13 pt awakened with complete ptosis of his right eye and developed complete 3rd nerve palsy.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Eye movement disorder, Eyelid oedema, Eyelid ptosis, Incorrect route of drug administration
Clinical narrative: On 9/1/13 pt awakened with complete ptosis of his right eye and developed complete 3rd nerve palsy.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Local swelling, Pain
Clinical narrative: Injection site redness and pain (R. arm). Diffuse redness and swelling and pain w/ movement of R. arm. 5 days after injection. Tx tried; Ibuprofen, cold packs and hot compresses with minimal relief.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Swelling, redness, severe itching/pain.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Condition aggravated
Clinical narrative: Initial report was received from a healthcare professional on 20 August 2013. A 73-year-old female patient, with a history of arthritis, received an injection of ADACEL (lot number, route and site unknown) on 13 August 2013. One day later on 14 August 2013, the patient had a flare up of arthritis in her knee. The patient received a cortisone injection in the knee one week prior to receiving ADACEL. The patient is following up with her orthopedic physician. The patient had no known allergies (NKA). Outcome was reported as unknown. Documents held by sender: None.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient had no drug reaction/allergies. On 20-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001694, Exp date: 08-MAY-2014) 0.65 ml, subcutaneously. Concomitant therapies included ADVAIR, SIMCOR, and metoprolol. ON 21-AUG-2013, the patient experienced throat hoarseness during the late afternoon which became worse in the evening of 21-AUG-2013. No treatment was reported (also reported as no treatment was given to the event). Patient did not seek medical attention. The outcome of throat hoarseness was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Malaise, Nausea
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age. On 03-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On an unknown date, the patient experienced nausea, headaches, malaise and flu like symptoms. The outcome of nausea, headaches, malaise and flu like symptoms was reported was not recovered. The patient sought medical attention. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route, lot #, expiration date not reported), the patient experienced syncope in the office. The patient did not seek medical attention. The outcome of the patient was unknown. This is one of several cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
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 gender. On 19-AUG-2013 the patient was vaccinated with an expired dose of M-M-R II (lot # 1119AA, expiration date 12-JUL-2013), (dose and route not reported). No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a male patient of unknown age. The nurse stated that the patient was vaccinated with the first dose of GARDASIL, injection, intramuscularly, dose 0.5 ml (lot number and exp. date not reported) on 13-AUG-2012 and second dose GARDASIL injection, intramuscularly, dose 0.5 ml (lot number and exp. date not reported) on 12-AUG-2013. No adverse event was reported. The outcome of events was unknown. Additional information is not expected.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Fall, Pallor
Clinical narrative: Gave FLUZONE intradermal at 10:00 - patient sat in waiting area as I went over side effects etc. At 10:05 pt got up to go get a Gatorade (as I was talking to his wife) when he got back to pharmacy area he fell face down he caught himself with his knee and hands and was laying face down with eyes wide open. I rolled him on his side he immediately came to consciousness. I propped his feet up; pt felt clammy, very pale, I took BP -100/60 - Fire and Rescue arrived and he began to get his color back - pt refused transport.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Joint hyperextension, Pain, Posture abnormal, Screaming, Seizure like phenomena
Clinical narrative: Abnormal tongue movements seizure like symptoms like legs straightened and pt twisting his arms and screaming in pain.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Tongue paralysis
Clinical narrative: Abnormal tongue movements seizure like symptoms like legs straightened and pt twisting his arms and screaming in pain.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Aggression, Aphagia, Arthralgia, Compulsive lip biting, Computerised tomogram
Clinical narrative: Abnormal tongue movements seizure like symptoms like legs straightened and pt twisting his arms and screaming in pain.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Confusional state, Crying, Dyskinesia, Electroencephalogram, Feeding disorder neonatal
Clinical narrative: Abnormal tongue movements seizure like symptoms like legs straightened and pt twisting his arms and screaming in pain.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Irritability, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain in extremity, Screaming
Clinical narrative: Abnormal tongue movements seizure like symptoms like legs straightened and pt twisting his arms and screaming in pain.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, DTAP, HEPAB
Symptoms: Tongue disorder
Clinical narrative: Abnormal tongue movements seizure like symptoms like legs straightened and pt twisting his arms and screaming in pain.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site pruritus, Lip swelling
Clinical narrative: Within 5 mins after administering the shot patient had itching around the injection site and after few minutes she had dizziness and her lips started swelling. She went to the ER right away where she got prednisone shot and she is fine after that.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Insomnia, Pain in extremity
Clinical narrative: Arm very sore (prevented patient from sleeping that night) and slight pink coloration at injection site.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site rash, Rash generalised, Urticaria
Clinical narrative: Received vaccines that morning and upon waking from nap at 4:30PM was noted to have hive like rash to left arm, both legs, abdomen, chest and back.  Rash was worse to the left arm where he received the MMR and Varicella vaccine.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dyskinesia, Fall, Syncope
Clinical narrative: Anthrax and typhoid vaccinations administered without incident, then approx. 3-4 minutes later smallpox vaccine administered; @ 13th scarification pt began to faint. Ammonia inhaler administered. Pt did not respond. His arms and legs were jerking and pt slumped to floor. After approx 30 seconds he became more alert and was oriented to person and place.  A office worker and one corpman were present @ time of reaction. He was already sitting in a chair when vaccine was administered. Several other corpmen responded immediately. Pt was assisted back in chair without incident. Vital signs stable. Pt monitored for 30 minutes then dismissed to return to his squadron.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Dyskinesia, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Anthrax and typhoid vaccinations administered without incident, then approx. 3-4 minutes later smallpox vaccine administered; @ 13th scarification pt began to faint. Ammonia inhaler administered. Pt did not respond. His arms and legs were jerking and pt slumped to floor. After approx 30 seconds he became more alert and was oriented to person and place.  A office worker and one corpman were present @ time of reaction. He was already sitting in a chair when vaccine was administered. Several other corpmen responded immediately. Pt was assisted back in chair without incident. Vital signs stable. Pt monitored for 30 minutes then dismissed to return to his squadron.
Age: 17.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Fever > 101 F, Cellulitis.
Age: 11.0
Sex: F
Vaccine: FLUX, MEN, FLUN4, MEN
Symptoms: Confusional state, Dizziness, Fatigue, Hypotonia, Immediate post-injection reaction
Clinical narrative: Patient fainted within 1 minute after administration.  Face turned white, body limp, then body began shaking.  Patient woke up about 20 seconds later.  Confused, dizzy, nauseous.  Patient fainted again about 2 minutes later with the same symptoms and woke up about 20 seconds later.  Supportive treatment was given.  Remained in doctors office for another hour +.  Then patient was discharged.  Dizziness and fatigue persisted for another 24 hours.
Age: 11.0
Sex: F
Vaccine: FLUX, MEN, FLUN4, MEN
Symptoms: Nausea, Pallor, Syncope, Tremor
Clinical narrative: Patient fainted within 1 minute after administration.  Face turned white, body limp, then body began shaking.  Patient woke up about 20 seconds later.  Confused, dizzy, nauseous.  Patient fainted again about 2 minutes later with the same symptoms and woke up about 20 seconds later.  Supportive treatment was given.  Remained in doctors office for another hour +.  Then patient was discharged.  Dizziness and fatigue persisted for another 24 hours.
Age: 11.0
Sex: F
Vaccine: FLUX, MEN, FLUN4, MEN
Symptoms: Confusional state, Dizziness, Fatigue, Hypotonia, Nausea
Clinical narrative: Patient fainted within 1 minute after administration.  Face turned white, body limp, then body began shaking.  Patient woke up about 20 seconds later.  Confused, dizzy, nauseous.  Patient fainted again about 2 minutes later with the same symptoms and woke up about 20 seconds later.  Supportive treatment was given.  Remained in doctors office for another hour +.  Then patient was discharged.  Dizziness and fatigue persisted for another 24 hours.
Age: 11.0
Sex: F
Vaccine: FLUX, MEN, FLUN4, MEN
Symptoms: Pallor, Syncope, Tremor
Clinical narrative: Patient fainted within 1 minute after administration.  Face turned white, body limp, then body began shaking.  Patient woke up about 20 seconds later.  Confused, dizzy, nauseous.  Patient fainted again about 2 minutes later with the same symptoms and woke up about 20 seconds later.  Supportive treatment was given.  Remained in doctors office for another hour +.  Then patient was discharged.  Dizziness and fatigue persisted for another 24 hours.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Local swelling, Pyrexia
Clinical narrative: Fever of 38-39 degrees Celsius. Swelling of right hand.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electrocardiogram normal, Hypotonic-hyporesponsive episode
Clinical narrative: Hypotonic hyporesponsive episode, required blow by O2 to recover. Sent to ED for further care and was discharged later in the afternoon.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Face injury, Fall, Loss of consciousness, Tonic clonic movements, Tooth fracture
Clinical narrative: PATIENT WALKED TO FRONT DESK APPROXIMATELY 5 MINUTES AFTER VACCINES ADMINISTERED TO SCHEDULE APPT FOR NEXT VACCINES. THE NURSE OPENED THE CHECK OUT WINDOW AND NOTICED PT FALLING DOWN AND HIT FACE ON COUNTER. BOTH DOCTOR AND NURSE IMMEDIATELY WENT AROUND TO FRONT LOBBY AND NOTICED PT PASSED OUT ON FLOOR WITH 2-3 SECONDS OF TONIC/CLONIC MOVEMENT. SHE WAS AWAKE AND ANSWERING QUESTIONS WITHIN 30 SECONDS. EMS CALLED. MD NOTICED TOOTH WAS CHIPPED. EMS TRANSPORTED PT TO HOSPITAL VIA AMBULANCE.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Insomnia, Pain, Pyrexia
Clinical narrative: Fever up to 100.4.  Body aches.  Difficulty sleeping.  Shoftness of breath - relieved with Albuterol Inhaler.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had redness around injection site that felt warm to touch.  Pt called vaccine administrator who recommended that he go be evaluated for possible cellulitis.  Pt complied and went to see doctor who prescribed 500mg Cephalexin to take orally four times daily for 10 days, and to come in again if redness spreads or streaks.
Age: 13.0
Sex: M
Vaccine: HPVX
Symptoms: Injection site pruritus, Injection site reaction, Pruritus, Urticaria
Clinical narrative: Itchy welts at site of injection and down arm of injection site.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cough, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: Swollen red eyes, cough, fever, headache, difficulty breathing, difficulty swallowing, fast heartbeat, dizziness, fatigue and weakness.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Eye swelling, Fatigue, Headache, Heart rate increased, Ocular hyperaemia
Clinical narrative: Swollen red eyes, cough, fever, headache, difficulty breathing, difficulty swallowing, fast heartbeat, dizziness, fatigue and weakness.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Swollen red eyes, cough, fever, headache, difficulty breathing, difficulty swallowing, fast heartbeat, dizziness, fatigue and weakness.
Age: 47.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Urticaria (rash all over upper body, front and back, arms, thighs, buttocks).  Rash onset 8/15, worsened 8/16, on 8/17 took Allegra and used Witch Hazel.  Symptoms started to abate 8/18 and were gone by 8/19.
Age: 1.29
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: 104.8 degree fever and then a resulting seizure because we could not get the fever down.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Throat irritation
Clinical narrative: Pt states 2 hrs post vaccine her throat started to itch and had uncontrollable hacking cough. States no difficulty breathing.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Patient reports swelling and redness around the area of the vaccine. Patient also experienced dizziness, vomiting and a fever the night after the vaccine. Symptoms improved by 9/6/13, when she came into the pharmacy. The redness on her arm was still there on 9/6/13, taking up a large portion of her upper arm, but the swelling had gone down.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Local swelling, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Arm pain and swelling, nausea and vomiting, diarrhea, fever.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Arm pain and swelling, nausea and vomiting, diarrhea, fever.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Smallpox site checked on 09/03/2013 and was normal. On 9/5/2013 started to become red and very swollen with a raised break in middle of site. Seen in clinic and treated for possible infection on 9/6/2013 by Dr.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given three shots all in one day Fluvirin, Pneumovax and Shingles, on the site of injection of Pneumovax shot, she had a lump size 6 inches long and 4 inches wide which is red, swollen, hot and very painful.  She took Benadryl and the pharmacist advised her to take Ibuprofen and put Ice on the lesion.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Immediate post-injection reaction, Injection site pruritus, Injection site swelling
Clinical narrative: Immediate itching at injection site.  Later swelling occured from site to elbow. Patient complained of worsening asthma symptoms over the next four days.
Age: 0.76
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria, Vomiting
Clinical narrative: Developed hive like rash on neck, back and trunk, hive-like rash on upper body, bottom and thighs.  No change in eating, drinking or behavior.  No fever.  Vomited x1.  Rash resolved in morning.
Age: 19.0
Sex: M
Vaccine: HEPAB, IPV, YF
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Records indicate patient received typhoid vaccine on 12Sep2011 and again on 14Oct2011. Uncertain if this was administrative error or acutal event.
Age: 80.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: On visit to MD office on 09/06/2013, pt reports that she has an area of redness after receiving vaccination on 09/03/2013. Left upper forearm (anterior portion) shows area of erythema with irregular edges - with 20 cm at its greatest length and 14 cm at is greatest width. Area feels warm to touch.  No open areas, exudate noted. Denies itching; states "it hurts a little." Report given to MD. MD reports he will order prednisone for pt to take.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Fatigue, Irritability, Pyrexia
Clinical narrative: Blister like rash, fever, no appetite, whining, tiredness.
Age: 0.37
Sex: F
Vaccine: 6VAX-F, RVX
Symptoms: Crying, Decreased appetite, Pain, Pyrexia, Rash
Clinical narrative: 101 fever for 2 days.  Temperature lower with Tylenol. Decreased appetite for 3 days. Cried when moved for 2 days. Rash on face and chest developed 2 days after shots.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Incomplete course of vaccination, Migraine
Clinical narrative: This spontaneous report as received from a physician refers to a 23 year old female patient. The physician reported that on 13-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H020692, expiration date 15-AUG-2015). On 13-JUN-2013, the patient experienced significant migraines that lasted two days (until 15-JUN-2013) after receiving her first dose in the series of GARDASIL. The physician reported that the patient's migraines were disabling and she could not leave the house for two days. The patient went to the physician's office on 14-AUG-2013 to receive her second dose in the series of GARDASIL, however it was reported that the physician discontinued therapy with GARDASIL and the second dose was not administered, because the patient experienced significant migraines after receiving the first dose. At the time of the report, the outcome of significant migraines was reported as recovered/resolved. GARDASIL was not reintroduced. The physician considered significant migraines to be disabling. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding a male patient of unknown age with no pertinent medical history reported and no drug reactions or allergies. Approximately in September 2011, reported as "2 years ago", the patient was vaccinated with PNEUMOVAX23 (lot number and expiration date not reported) (dose and route not reported). No other suspect therapies or concomitant medications were reported. It was reported that the patient stated that on an unspecified date the injection site became very red and swollen, the patient was admitted at an unspecified hospital and was diagnosed with upper extremity cellulitis. The patient was given unspecified intravenous (IV) antibiotics and the infection "resolved rapidly, within a day or so", date of recovery not specified by the reporter. The pharmacist did not assess the causality between upper extremity cellulitis and PNEUMOVAX23. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient said she has aversion to needles and may faint prior to given shots. Exhibited paleness about 15 seconds after second shot. Lost consciousness for about 30 seconds and came back.
Age: 1.43
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Red, rash, swollen (L) x 2-3 ds ago reaction began 2 hrs. after receiving shot.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Left upper arm redness, swelling, and itching. Warm to touch. 30x45m in size.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Rash
Clinical narrative: Mild rash, no treatment needed.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash within 24 hours, trested with steroids.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site nodule, Skin warm
Clinical narrative: "Knot" day after injection at site, erythema and warmth in diffuse area on arm 2 days after vaccination.
Age: 1.48
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Pt had 4th DTaP administered on 9/5/13. Woke with fever 9/6/13. Tmax 104-105. Eval in office, temp 101.3, exam.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dizziness, Headache, Injection site pain, Lethargy
Clinical narrative: Day after site - painful; pt felt lethargic, HA (severe), cold/chills, dizzy, nausea 2nd day after pt felt HA using new to APAP.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nasopharyngitis, Nausea
Clinical narrative: Day after site - painful; pt felt lethargic, HA (severe), cold/chills, dizzy, nausea 2nd day after pt felt HA using new to APAP.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient received FLUZONE HD in right arm on 9/3/13. That same day patient experienced swelling where the injection site was. It blistered and was red and raised. Blister popped and now it is about 1/4 inch raised and is still red by 9/6/13. Patient but BACTINE/NEOSPORIN on it but did not help.
Age: 51.0
Sex: F
Vaccine: MNQ
Symptoms: Axillary pain, Back pain, Erythema, Injection site pain, Musculoskeletal pain
Clinical narrative: Rash, redness shoulder back pain/back pain/under arm pain tender to touch injection site. Red from shoulder.
Age: 51.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Rash, redness shoulder back pain/back pain/under arm pain tender to touch injection site. Red from shoulder.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Day following vaccine mother called stating client at home experiencing illness with nausea, vomiting, fever. Unsure of what temperature is has not taken antipyretic medication due to vomiting. Highest temp 102 degrees. No doctor visit. Recovered after 3 days. No other family/friends reported illness.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Blood lactate dehydrogenase normal, Full blood count normal, Injection site mass, Injection site pain, Metabolic function test normal
Clinical narrative: 1.5 cm painful mass at injection site (R) deltoid developed after he received injection. Shoulder X-ray negative, CBC, LMP, LDH normal. Pt. noticed reaction about one month after receiving injection.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: X-ray limb normal
Clinical narrative: 1.5 cm painful mass at injection site (R) deltoid developed after he received injection. Shoulder X-ray negative, CBC, LMP, LDH normal. Pt. noticed reaction about one month after receiving injection.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV
Symptoms: Cellulitis, Vaccination site erythema, Vaccination site warmth
Clinical narrative: (L) leg vaccine site red on 9-4-13 3:00 pm outlined by mom spread today (9-5-13) warm to touch. Cellulitis-afebrile 20x20 cm area - Rx AUGMENTIN.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site haemorrhage, Injection site rash, Injection site warmth
Clinical narrative: Rash (petechiae), redness, warmth in area starting on injection site and going down to the middle of the forearm. Headache resolved with ADVIL.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Skin warm
Clinical narrative: Rash (petechiae), redness, warmth in area starting on injection site and going down to the middle of the forearm. Headache resolved with ADVIL.
Age: 1.58
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site warmth
Clinical narrative: 9 days after varicella vaccine pt developed redness and warmth of the injection iste. 2 small papules below that
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 17-AUG-2013 the patient was vaccinated with an expired dose of vaccine: M-M-R II (lot # 670618/0567AA, exp. date 15-APR-2013), 0.5 milliliters (ml) injection, subcutaneously. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 05-AUG-2013 the patient was vaccinated with an expired dose of vaccine: M-M-R II (lot # 670618/0567AA, exp.date 15-APR-2013), 0.5 milliliters (ml) injection, subcutaneously. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus
Clinical narrative: PNEUMOVAX and FLUZONE HD was administered and patient is complaining of redness and itching on arm.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 06-AUG-2013 the patient was vaccinated with an expired dose of vaccine: M-M-R II (lot # 670618/0567AA, exp. date 15-APR-2013). No adverse effect was reported. The outcome of event was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Swelling, inflammation, induration and tenderness at site of injection.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Erythema, Induration, Injection site erythema, Injection site inflammation
Clinical narrative: This 50 yo female dependant received her ZOSTAVAX vaccine subq to her left tricep area on 8/20/2013. On day 2 (8/22/2013) evening, she noted her left tricep region was red, itchy, hot, swollen and had a large knot at the vaccination site. She denied any fever, headache or other systemic symptoms, trauma, or any injury to vaccination site. The next day the vaccine site area was more inflamed with a single white pimple like spot with secondary ring of redness surrounding the initial red site. She presented on 8/23/2013 (day 3) with a 12 cm x 8 cm pale red indurated region that extended down and around posterior region left upper arm that had a 4cmx3cm oval shaped warm indurated redden center at injection site area. She had 1 white fatty tissue like skin macule to upper outer edge of central reddened area. She was afebrile (98.7) and had no systemic symptoms. She had full ROM to her left shoulder, elbow, wrist and fingers. Her grip was equal to right. She had no axillary or cervical lymphadenopathy. There were no other skin rashes, nodules or macules noted. On 8/26/213 the hive like red area has resolved with use of Ibuprofen and topical steroid cream leaving a paler red central region. The itching is also better. She continues to deny any fever or other systemic symptoms (headache, malaise, fatigue, joint pain, etc).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth, Pallor
Clinical narrative: This 50 yo female dependant received her ZOSTAVAX vaccine subq to her left tricep area on 8/20/2013. On day 2 (8/22/2013) evening, she noted her left tricep region was red, itchy, hot, swollen and had a large knot at the vaccination site. She denied any fever, headache or other systemic symptoms, trauma, or any injury to vaccination site. The next day the vaccine site area was more inflamed with a single white pimple like spot with secondary ring of redness surrounding the initial red site. She presented on 8/23/2013 (day 3) with a 12 cm x 8 cm pale red indurated region that extended down and around posterior region left upper arm that had a 4cmx3cm oval shaped warm indurated redden center at injection site area. She had 1 white fatty tissue like skin macule to upper outer edge of central reddened area. She was afebrile (98.7) and had no systemic symptoms. She had full ROM to her left shoulder, elbow, wrist and fingers. Her grip was equal to right. She had no axillary or cervical lymphadenopathy. There were no other skin rashes, nodules or macules noted. On 8/26/213 the hive like red area has resolved with use of Ibuprofen and topical steroid cream leaving a paler red central region. The itching is also better. She continues to deny any fever or other systemic symptoms (headache, malaise, fatigue, joint pain, etc).
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria, Vaccination site nodule
Clinical narrative: This 50 yo female dependant received her ZOSTAVAX vaccine subq to her left tricep area on 8/20/2013. On day 2 (8/22/2013) evening, she noted her left tricep region was red, itchy, hot, swollen and had a large knot at the vaccination site. She denied any fever, headache or other systemic symptoms, trauma, or any injury to vaccination site. The next day the vaccine site area was more inflamed with a single white pimple like spot with secondary ring of redness surrounding the initial red site. She presented on 8/23/2013 (day 3) with a 12 cm x 8 cm pale red indurated region that extended down and around posterior region left upper arm that had a 4cmx3cm oval shaped warm indurated redden center at injection site area. She had 1 white fatty tissue like skin macule to upper outer edge of central reddened area. She was afebrile (98.7) and had no systemic symptoms. She had full ROM to her left shoulder, elbow, wrist and fingers. Her grip was equal to right. She had no axillary or cervical lymphadenopathy. There were no other skin rashes, nodules or macules noted. On 8/26/213 the hive like red area has resolved with use of Ibuprofen and topical steroid cream leaving a paler red central region. The itching is also better. She continues to deny any fever or other systemic symptoms (headache, malaise, fatigue, joint pain, etc).
Age: 1.46
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Agitation, Cough, Hypersensitivity, Swelling face
Clinical narrative: Starting cough about 5 min post administration - face swelling about 15 min later, agitation allergic reaction.
Sex: U
Vaccine: HIBV, HPV4, PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The pharmacist reported that on an unknown date the patients were vaccinated with PNEUMOVAX23 (lot #, expiration date, dose, route and anatomical located unspecified), GARDASIL (lot #, expiration date, dose, route and anatomical location unspecified) and PEDVAX HIB (lot #, expiration date, dose, route and anatomical location unspecified). The pharmacist reported that vaccines were possibly administered after being stored improperly. No adverse effects reported. The patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient with no drug reactions, allergies or pertinent medical history. On approximately 20-AUG-2013 (about two weeks ago) the patient was vaccinated with ZOSTAVAX 19400 PFU (0.65 ml, lot number and expiration date not reported), subcutaneous for immunization. There was no concomitant medication reported. On an unknown date in August 2013 the patient experienced redness, swelling, and pain at the injection site. Patient was given an unspecified topical steroid cream by his unspecified primary care physician. Patient stated that the cream resolved the redness, swelling and pain at the injection site. The patient called the pharmacist for medical attention. No lab diagnostics studies were performed. The outcomes of the events were reported as recovered on an unspecified date in approximately August 2013. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Decreased activity, Erythema, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 9/4/13 6 PM - Quarter size redness and rash - slight pain. 95/13 3:30 AM - Fever, complained of sore throat. Rash and redness size of palm - some pain - swelling. Mother gave Ibuprofen. 9/5/13 Night - More swollen - redness about 5" diameter. 9/6/13 AM - Not as active - Pt seen - Rx - KEFLEX 250/5 1 tsp TID for 10 days - warm compresses - BENADRYL PRN.