chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lip swelling
Clinical narrative: Pt. experienced slight swelling of (R) lip  spreading to (L) lip throughout the evening.  By morning of 10/2/2012 entire area around the mouth is noticeably swollen.  Some mouth soreness.  Pt. able to eat.  Feels the swelling is decreasing with time.  Did not call his PCP, although he was encouraged to do so.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Patient said she experienced arm pain with flu-like symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: SWELLING AT INJECTION SITE REDNESS WHOLE THIGH AREA WITH WARMTH AND PAIN.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Apnoea, Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 19 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL on the following dates: 03 December 2009, 11 March 2010, 11 May 2010 and 28 December 2010 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 07 July 2012, approximately 19 months after the last dose. On 17 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 20 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 46 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 19 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of PENTACEL on the following dates: 03 December 2009, 11 March 2010, 11 May 2010 and 28 December 2010 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 07 July 2012, approximately 19 months after the last dose. On 17 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 20 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 22 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 22 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 46 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.35
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Pertussis, Polymerase chain reaction
Clinical narrative: Initial report received on 19 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. This report also involved a case of misuse. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 2 doses of DAPTACEL; lot number C2957BA received on 26 June 2008 and an unknown lot number received on 04 May 2009 and 2 doses of PENTACEL; lot number C3176AA received on 26 August 2008 and lot number C3431AA received on 02 September 2009 (routes and sites of administration not reported). The subject developed a cough on 03 August 2012, approximately 3 years after the last dose. On 10 August 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 29 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 32 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.35
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 19 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. This report also involved a case of misuse. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 2 doses of DAPTACEL; lot number C2957BA received on 26 June 2008 and an unknown lot number received on 04 May 2009 and 2 doses of PENTACEL; lot number C3176AA received on 26 August 2008 and lot number C3431AA received on 02 September 2009 (routes and sites of administration not reported). The subject developed a cough on 03 August 2012, approximately 3 years after the last dose. On 10 August 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 29 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 29 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 04 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 32 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report was received on 19 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of DAPTACEL received on the following dates: 15 October 2007, 23 January 2008, 01 April 2008 and 18 February 2009 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 17 August 2012, approximately 42 months after the last dose. On 21 August 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 27 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 05 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Polymerase chain reaction, Sleep disorder
Clinical narrative: Initial report was received on 19 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 4-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) electronic database. The subject had received 4 doses of DAPTACEL received on the following dates: 15 October 2007, 23 January 2008, 01 April 2008 and 18 February 2009 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 17 August 2012, approximately 42 months after the last dose. On 21 August 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 27 August 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 27 August 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 05 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Feeling hot, Pruritus, Throat tightness
Clinical narrative: Pt came in and received TDaP (R) /flu (L)/Zoster (R) around 1540. Pt was told to sit and wait 15 mins. Pt started to report she was hot, itchy scalp and tight throat around 1552. Cold blue was called and pt was given O2 at 1655. 911 was called 1559. Vitals was given thru out and ambulance arrived at 1603.
Age: 62.0
Sex: F
Vaccine: DTP, FLUX, HEPA
Symptoms: Dyspnoea, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Productive cough
Clinical narrative: Rash with hives, swelling, itching on both arms, neck, chest, face, hands, and right thigh. Itching lungs, some difficulty breathing. Cold symptoms -- sore throat, runny/clogged nose and sinuses, coughing up dark-yellow phlegm. Cold symptoms improved after approx 4 days. Rash worsened and itching lungs developed. On 10/02/12 emergency room physician prescribed 50 mg Prednisone daily for 7 days. Patient began first dose 10/2, today.
Age: 62.0
Sex: F
Vaccine: DTP, FLUX, HEPA
Symptoms: Pruritus, Rash, Respiratory tract irritation, Rhinorrhoea, Sinus congestion
Clinical narrative: Rash with hives, swelling, itching on both arms, neck, chest, face, hands, and right thigh. Itching lungs, some difficulty breathing. Cold symptoms -- sore throat, runny/clogged nose and sinuses, coughing up dark-yellow phlegm. Cold symptoms improved after approx 4 days. Rash worsened and itching lungs developed. On 10/02/12 emergency room physician prescribed 50 mg Prednisone daily for 7 days. Patient began first dose 10/2, today.
Age: 62.0
Sex: F
Vaccine: DTP, FLUX, HEPA
Symptoms: Swelling, Urticaria
Clinical narrative: Rash with hives, swelling, itching on both arms, neck, chest, face, hands, and right thigh. Itching lungs, some difficulty breathing. Cold symptoms -- sore throat, runny/clogged nose and sinuses, coughing up dark-yellow phlegm. Cold symptoms improved after approx 4 days. Rash worsened and itching lungs developed. On 10/02/12 emergency room physician prescribed 50 mg Prednisone daily for 7 days. Patient began first dose 10/2, today.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Rash on right side of abdomen, then left side of abdomen, then midline abdomen consistent with varicella outbreak.
Age: 32.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abdominal pain upper, Catheterisation cardiac, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: Fatigue, abdominal epigastric pain, dizziness, omeprazole from prn to daily use, labs ordered, call is symptoms persist, seen again 9/26/12 sent to emergency room.
Age: 32.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hepatitis, Laboratory test, Liver function test abnormal
Clinical narrative: Fatigue, abdominal epigastric pain, dizziness, omeprazole from prn to daily use, labs ordered, call is symptoms persist, seen again 9/26/12 sent to emergency room.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Numbness & Tingling (N/T) started in left foot on 9/25/12 (thought was due to tight shoes). By morning, 9/26 was progressing into both feet, started having a headache, took Ibuprofen, some relief but headache returned and N/T progressed into left hand. That night, 9/26 began to feel achy all over. Thurs. morning 9/27 N/T progressing further into ankles and knew something was wrong. Went to PMD and then admitted into hospital. Diagnosed with Guillain-Barre and treated with IGG IV medication for 5 days. Has progressively improved and will probably be discharged today.  Patient has a niece 22yrs. old, by marriage that was diagnosed with Guillain-Barre in May from what they thought started as a virus. She has had prolonged effect in ambulation and speech. This patient states she was last with her one to two weeks ago.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging brain, Pain, Paraesthesia
Clinical narrative: Numbness & Tingling (N/T) started in left foot on 9/25/12 (thought was due to tight shoes). By morning, 9/26 was progressing into both feet, started having a headache, took Ibuprofen, some relief but headache returned and N/T progressed into left hand. That night, 9/26 began to feel achy all over. Thurs. morning 9/27 N/T progressing further into ankles and knew something was wrong. Went to PMD and then admitted into hospital. Diagnosed with Guillain-Barre and treated with IGG IV medication for 5 days. Has progressively improved and will probably be discharged today.  Patient has a niece 22yrs. old, by marriage that was diagnosed with Guillain-Barre in May from what they thought started as a virus. She has had prolonged effect in ambulation and speech. This patient states she was last with her one to two weeks ago.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test, Confusional state, Convulsion, Gaze palsy, Loss of consciousness
Clinical narrative: Patient passed out and then went into convulsions his eyes rolled into the back of his head like he was having a seizure. He has never had any reaction like this before with any other vaccine about a month later he was hospitalized with weak legs he couldn't support his weight.  Very confused and forgetful.  He has had "spells" of confusion.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Memory impairment, Weight bearing difficulty
Clinical narrative: Patient passed out and then went into convulsions his eyes rolled into the back of his head like he was having a seizure. He has never had any reaction like this before with any other vaccine about a month later he was hospitalized with weak legs he couldn't support his weight.  Very confused and forgetful.  He has had "spells" of confusion.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Respiratory tract congestion, Urticaria
Clinical narrative: Hives all over body, cough, congestion within 5 min of injection. Mom called-brought child back to office. Given Duo Neb, Benadryl, Prednisone.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lacrimation increased, Nasal congestion, Oropharyngeal pain, Stomatitis, Throat irritation
Clinical narrative: Pt. noted sore throat, scratchy feeling; roof of mouth sore.  Nose stuffy, eyes watery, need to clear throat frequently.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lacrimation increased, Nasal congestion, Throat irritation
Clinical narrative: Pt. noted sore throat, scratchy feeling; roof of mouth sore.  Nose stuffy, eyes watery, need to clear throat frequently.
Age: 1.29
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Fever, chicken pox.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Shortly after receiving vaccines Lot UH746AC Sanofi Pasteur flu vaccine (exp 6/20/13) in left deltoid about flu vaccine below left lateral shoulder felt a numbness pain level #3 to #1 in intensity as of 2pm 10/1/12 F.U. 10/2/12 yesterday eve tingling went away but when she raised lft arm, area surrounding injection site is sore.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Atonic seizures, Convulsion, Hypotonia, Intensive care, Laboratory test normal
Clinical narrative: mo female had immunization on 8/27/12. Healthy at the time. Had fever <101 that night. Next day appeared well breast fed, no fever, then went limp. Call the ambulance - hospital. Received ATIVAN. Dx afebrile atonic seizure. Transferred to major hospital, admitted. Septic work up done, all negative. 3 days in hospital. Came to office on 9/11/12. This child received vaccines on 8/27/12 and had an afebrile seizure the following day and was hospitalized in ICU and regular unit for three days. Unable to get lot # for vaccines.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: mo female had immunization on 8/27/12. Healthy at the time. Had fever <101 that night. Next day appeared well breast fed, no fever, then went limp. Call the ambulance - hospital. Received ATIVAN. Dx afebrile atonic seizure. Transferred to major hospital, admitted. Septic work up done, all negative. 3 days in hospital. Came to office on 9/11/12. This child received vaccines on 8/27/12 and had an afebrile seizure the following day and was hospitalized in ICU and regular unit for three days. Unable to get lot # for vaccines.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Bedridden, Headache, Injection site rash, Nausea
Clinical narrative: Patient received the PNEUMOVAX and FLUZONE HD on Thursday 09/20/12 in the same arm. Patient reported that once he went home after about 30 minutes after receiving the shots that he got a extremely bad headache and eventually nausea. This lasted for 3 days and he was bed-ridden. A rash started developing at the site administration as well. Rash was still present on day 4. Since the pharmacist placed both shots in the arm - patient preference at the time of administration, we are unable to tell which shot caused this or if the combination of the two caused it. Patient has never a reaction to a shot before. Patient was referred to primary care.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dizziness, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: 2-3 hours after receiving the flu vaccine, c/o lightheaded, dizzy, spinning, headache, head pressure, shaky, tired. Seen in the E.R.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Metabolic function test, Nuclear magnetic resonance imaging, Pregnancy test, Renal function test
Clinical narrative: 2-3 hours after receiving the flu vaccine, c/o lightheaded, dizzy, spinning, headache, head pressure, shaky, tired. Seen in the E.R.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Ultrasound scan, Urine analysis, Vertigo
Clinical narrative: 2-3 hours after receiving the flu vaccine, c/o lightheaded, dizzy, spinning, headache, head pressure, shaky, tired. Seen in the E.R.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema
Clinical narrative: Left thigh became red 9-13-12. Parents had taken pt. to urgent care at beach after noticing redness. Pt started on antibiotics for cellulitis. Rechecked at our office 9-17-12. Redness better. Recheck today 10-1-12. Left thigh with skin color change, not hot, not tender.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Myalgia, Photophobia, Pyrexia
Clinical narrative: Fever, myalgia, headache, photophobia with in 12 hours of vaccine administration.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Dyspnoea, Nausea, Pyrexia
Clinical narrative: After eating immediately felt like vomiting. Breathing hard and had chills and slight fever. Lasted about 2 hours.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Dyspnoea
Clinical narrative: On 11/06/10 severe chest pain mostly right upper backside under rib area and shortness of breath at school around 1:00 PM. Picked up at school 2:00 Pm and brought to Dr's office. He sent us to ER where they took chest xray and EKG. Gave her Motrin at 4:00 pm. Nothing significant showed. They diagnosed chondochostritis ? but she had no fall or hit to the chest. She did have her last Gardasil shot 11/02/10.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Severe upper arm swelling and redness. Duration one week.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site anaesthesia, Muscle spasms, Pain
Clinical narrative: Muscle is spasming, forward cone of pain, numbness from injection site to back of elbow.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Death, Moaning, Nasal flaring, Pain
Clinical narrative: 11AM-O2 sats @74%, HR 204, temp 97.7, moaning, upper extremities cold. Tylenol given for pain. 1:10PM-nasal flaring, O2 sats @ 74%, HR 82, temp 99.9, RR 42. EMS called and subsequent code blue. Chest compressions and ambu-bagged, epinephrine given. Transferred to hospital. Pronounced dead at hospital.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Peripheral coldness, Resuscitation
Clinical narrative: 11AM-O2 sats @74%, HR 204, temp 97.7, moaning, upper extremities cold. Tylenol given for pain. 1:10PM-nasal flaring, O2 sats @ 74%, HR 82, temp 99.9, RR 42. EMS called and subsequent code blue. Chest compressions and ambu-bagged, epinephrine given. Transferred to hospital. Pronounced dead at hospital.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dysgeusia
Clinical narrative: About 10 minutes after vaccine administration, patient presented w/ c/o feeling of "tightness" in diaphragm and metallic taste in mouth.  Asked if she could take Benadryl, which she did, after which she went home.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Upper arm pain which is sharp and severe.
Age: 8.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: Approximately 5 minutes after administration of vaccination, child broke out in red hives on bilateral arms and cheeks, assessed by PA-C, and RN.  Benadryl 30 mg given intramuscular in right deltoid.  Patient observed for 30 minutes after injection with no further complications.  Educated father to give child Benadryl if worsened and if life threatening to seek treatment at a local emergency room.  Verbal understanding noted by father.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Chills, Decreased appetite, Headache
Clinical narrative: Starting the evening of Friday, 9/28, I experienced severe body aches, headache, chills, fever of 100.6 taken under the arm w/digital thermometer, lack of appetite, weakness, shakiness, heavy sweating.  The worst was all day Saturday, then midway through Sunday I noticed a lessening of the body aches and the increase of an extreme headache which lasted through Monday and slightly less on Tuesday. The level of severity of the symptoms was such that I had to be in bed from Friday night through Tuesday morning.  This is unusual for me, as I rarely am sick enough to stay in bed and/or miss work.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Hyperhidrosis, Pain, Pyrexia, Tremor
Clinical narrative: Starting the evening of Friday, 9/28, I experienced severe body aches, headache, chills, fever of 100.6 taken under the arm w/digital thermometer, lack of appetite, weakness, shakiness, heavy sweating.  The worst was all day Saturday, then midway through Sunday I noticed a lessening of the body aches and the increase of an extreme headache which lasted through Monday and slightly less on Tuesday. The level of severity of the symptoms was such that I had to be in bed from Friday night through Tuesday morning.  This is unusual for me, as I rarely am sick enough to stay in bed and/or miss work.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Vomiting
Clinical narrative: Fever, chills, body ache, vomit, 24 hours. Anti emetic medicine, Tylenol.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cold sweat, Feeling abnormal, Injection site pain, Loss of consciousness
Clinical narrative: Patient reports cold sweat, aching around injection site, occurring 4-6 hrs after vaccination.  Patient reports passing out that night after getting up from bed.  Patient did not feel 100% for 24-48 hr after vaccination.  Patient was seen at Pharmacy Care on 10/1/2012 at which time he appeared to be back to his baseline and reported no further adverse effects.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Body temperature fluctuation, Breath sounds abnormal, Bronchitis, Chills
Clinical narrative: Hot flashes and fevers alternating with cold and shivers and low temperatures.  Progressed on 9/20/12 to sore throat, fatigue, muscle aches.  Progresed on 9/21/12 to head and chest congestion, severe cough, rattling in chest. 9/26/12 Continued symptoms with worsening breathing issues, chest rattle, cough, fluctuating temperatures, etc.  Progressed to low oxygen sats (92%) severe bronchitis, etc. on 9/29/12.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Feeling cold, Hot flush, Myalgia
Clinical narrative: Hot flashes and fevers alternating with cold and shivers and low temperatures.  Progressed on 9/20/12 to sore throat, fatigue, muscle aches.  Progresed on 9/21/12 to head and chest congestion, severe cough, rattling in chest. 9/26/12 Continued symptoms with worsening breathing issues, chest rattle, cough, fluctuating temperatures, etc.  Progressed to low oxygen sats (92%) severe bronchitis, etc. on 9/29/12.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Oxygen saturation decreased, Pyrexia, Respiratory tract congestion, Sinus congestion
Clinical narrative: Hot flashes and fevers alternating with cold and shivers and low temperatures.  Progressed on 9/20/12 to sore throat, fatigue, muscle aches.  Progresed on 9/21/12 to head and chest congestion, severe cough, rattling in chest. 9/26/12 Continued symptoms with worsening breathing issues, chest rattle, cough, fluctuating temperatures, etc.  Progressed to low oxygen sats (92%) severe bronchitis, etc. on 9/29/12.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Gaze palsy, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: As is protocol with anyone having not received a FLU vaccine in the past year, we have them wait with us for approx 10 minutes after vaccine administration. After approx 8 minutes the client complained of feeling "dizzy" and had "tremors". Patient appeared pale, and diaphoretic. Client then was witnessed to lose consciousness and eyes rolling in back of head. Client moved with assist of 2 nurses to floor and pulse felt thready. 911 called. BP 106/60 pulse 54. Patient came to after approx 30-45 seconds and spoke coherently then again lost consciousness for approx 10-15 seconds. Bp remained stable at 107/58-56. Oxygen applied via NC at 3 l/min. At this point client awake and alert, paramedics arrived. Client refused to go to ER. Client then went to Nurses office via WC and eventually driven home by employer.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: As is protocol with anyone having not received a FLU vaccine in the past year, we have them wait with us for approx 10 minutes after vaccine administration. After approx 8 minutes the client complained of feeling "dizzy" and had "tremors". Patient appeared pale, and diaphoretic. Client then was witnessed to lose consciousness and eyes rolling in back of head. Client moved with assist of 2 nurses to floor and pulse felt thready. 911 called. BP 106/60 pulse 54. Patient came to after approx 30-45 seconds and spoke coherently then again lost consciousness for approx 10-15 seconds. Bp remained stable at 107/58-56. Oxygen applied via NC at 3 l/min. At this point client awake and alert, paramedics arrived. Client refused to go to ER. Client then went to Nurses office via WC and eventually driven home by employer.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Severe headache and nausea, low grade fever.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Severe headache and nausea, low grade fever.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Severe headache and nausea, low grade fever.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain
Clinical narrative: Large area of erythema (10x20cm) and pain- persists 9 days after administration of vaccine.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Feeling hot, Local swelling
Clinical narrative: Localized redness, warmth & swelling to dorsal side of the right arm arm.  Cool Compress applied to the area.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Chills, Computerised tomogram head abnormal, Dizziness, Dyskinesia, Epistaxis
Clinical narrative: After getting vaccinated with GARDASIL, patient within seconds just passed out in front of nurse and landed face down on concrete floor and while she was unconscious was having jerking body movements while at the same time was having heavy bleeding of nose and mouth..doctor was called immediately performed first aid with cold ice compresses and lay her down on floor until she regained consciousness again. But she was still having chills and headaches and dizziness and was unaware of what had happened to her and why is she still on floor, but all she kept complaing the most was the pain and discomfort of her nose, she also stated that she feels pain in her front teeth as well and still having headache.  Doctor sent us to another hospital to have a cat scan done, and then sent to ENT specialist to get her nose checked, and he said based on CAT scan nose is broken and dented towards the side she fell off to the floor..but since its a big swelling he gave her appointment to come back on Friday 10/05/2012. And will also set up procedure/surgery date for patient. Even now she was told to put ice packs around face area for 15 minutes, but even at home she is sad and crying because of the incident and she is still in shock and traumatized.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Face injury, Facial bones fracture, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: After getting vaccinated with GARDASIL, patient within seconds just passed out in front of nurse and landed face down on concrete floor and while she was unconscious was having jerking body movements while at the same time was having heavy bleeding of nose and mouth..doctor was called immediately performed first aid with cold ice compresses and lay her down on floor until she regained consciousness again. But she was still having chills and headaches and dizziness and was unaware of what had happened to her and why is she still on floor, but all she kept complaing the most was the pain and discomfort of her nose, she also stated that she feels pain in her front teeth as well and still having headache.  Doctor sent us to another hospital to have a cat scan done, and then sent to ENT specialist to get her nose checked, and he said based on CAT scan nose is broken and dented towards the side she fell off to the floor..but since its a big swelling he gave her appointment to come back on Friday 10/05/2012. And will also set up procedure/surgery date for patient. Even now she was told to put ice packs around face area for 15 minutes, but even at home she is sad and crying because of the incident and she is still in shock and traumatized.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Mouth haemorrhage, Nasal discomfort, Nasal inflammation, Rhinalgia, Toothache
Clinical narrative: After getting vaccinated with GARDASIL, patient within seconds just passed out in front of nurse and landed face down on concrete floor and while she was unconscious was having jerking body movements while at the same time was having heavy bleeding of nose and mouth..doctor was called immediately performed first aid with cold ice compresses and lay her down on floor until she regained consciousness again. But she was still having chills and headaches and dizziness and was unaware of what had happened to her and why is she still on floor, but all she kept complaing the most was the pain and discomfort of her nose, she also stated that she feels pain in her front teeth as well and still having headache.  Doctor sent us to another hospital to have a cat scan done, and then sent to ENT specialist to get her nose checked, and he said based on CAT scan nose is broken and dented towards the side she fell off to the floor..but since its a big swelling he gave her appointment to come back on Friday 10/05/2012. And will also set up procedure/surgery date for patient. Even now she was told to put ice packs around face area for 15 minutes, but even at home she is sad and crying because of the incident and she is still in shock and traumatized.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: X-ray abnormal
Clinical narrative: After getting vaccinated with GARDASIL, patient within seconds just passed out in front of nurse and landed face down on concrete floor and while she was unconscious was having jerking body movements while at the same time was having heavy bleeding of nose and mouth..doctor was called immediately performed first aid with cold ice compresses and lay her down on floor until she regained consciousness again. But she was still having chills and headaches and dizziness and was unaware of what had happened to her and why is she still on floor, but all she kept complaing the most was the pain and discomfort of her nose, she also stated that she feels pain in her front teeth as well and still having headache.  Doctor sent us to another hospital to have a cat scan done, and then sent to ENT specialist to get her nose checked, and he said based on CAT scan nose is broken and dented towards the side she fell off to the floor..but since its a big swelling he gave her appointment to come back on Friday 10/05/2012. And will also set up procedure/surgery date for patient. Even now she was told to put ice packs around face area for 15 minutes, but even at home she is sad and crying because of the incident and she is still in shock and traumatized.
Age: 15.0
Sex: F
Vaccine: HPV4, MEN, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: After getting vaccinated with GARDASIL, patient within seconds just passed out in front of nurse and landed face down on concrete floor and while she was unconscious was having jerking body movements while at the same time was having heavy bleeding of nose and mouth..doctor was called immediately performed first aid with cold ice compresses and lay her down on floor until she regained consciousness again. But she was still having chills and headaches and dizziness and was unaware of what had happened to her and why is she still on floor, but all she kept complaing the most was the pain and discomfort of her nose, she also stated that she feels pain in her front teeth as well and still having headache.  Doctor sent us to another hospital to have a cat scan done, and then sent to ENT specialist to get her nose checked, and he said based on CAT scan nose is broken and dented towards the side she fell off to the floor..but since its a big swelling he gave her appointment to come back on Friday 10/05/2012. And will also set up procedure/surgery date for patient. Even now she was told to put ice packs around face area for 15 minutes, but even at home she is sad and crying because of the incident and she is still in shock and traumatized.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Insomnia, Nausea
Clinical narrative: HEADACHE, NAUSEA, CHILLS, INSOMNIA UNTIL 10/01/2012. TOOK ADVIL (6 PILLS DAILY).
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Limb discomfort, Pain in extremity, Pyrexia
Clinical narrative: Fever of 100F, cough, headache, extreme pain/discomfort on entire right arm. The symptoms lasted 12 hours.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia, Pharyngeal oedema, Throat tightness
Clinical narrative: Patient felt throat start to swell and get tight but never lost ability to breathe. Her face felt numb and tingling. Patient took Claritin and within an hour throat was fine but face felt tingly for several more hours.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Mild red raised rash with no itching. Not hot to touch, but was blotchy. About a 1/2 inch to 1 inch from actual injection site. Some pain when significant pressure added. Took some Benadryl and has seen it stop getting worse.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Hypersomnia, Pyrexia, Tremor
Clinical narrative: Chills, shakes, 99.8 fever. Slept almost 24 hours. No specific treatment.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: FLUMIST administered 9/28/12. That evening student began coughing. Throughout Sat. and Sun student was coughing, had wheezing and SOB. Admitted to hospital with SpO2 89-90. Released from hospital 10/1/12.
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Blood test, Clostridium difficile colitis, Culture stool, Haematochezia, Scan normal
Clinical narrative: Meckel's diverticulum r/o - sent to medical center - bld in stool evening after vaccines. Meckel's scan unremarkable - Dx Colitis C. diff (H).
Age: 1.01
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Ultrasound abdomen, Ultrasound scan abnormal
Clinical narrative: Meckel's diverticulum r/o - sent to medical center - bld in stool evening after vaccines. Meckel's scan unremarkable - Dx Colitis C. diff (H).
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysphagia, Dyspnoea, Full blood count, Metabolic function test, Pruritus
Clinical narrative: Tongue swelling, difficulty swallowing, slight difficulty breathing, itching.
Age: 85.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling, difficulty swallowing, slight difficulty breathing, itching.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Hypertension, Pharyngeal oedema
Clinical narrative: Swollen throat, chest pressure, high blood pressure, shortness of breath.
Age: 84.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Flu shot administered 9-19-12 - pt had episode of vomiting 9-20-12.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Culture, Discomfort, Injection site vesicles, Nausea, Pyrexia
Clinical narrative: Pt. noticed fluid filled blisters (yellow) the morning of 9/19/12 around the shot, uncomfortable. Fever and nausea. Physician ordered culture. IM inj. of Lincocin and Clindamycin, Rx Bactroban oint.
Age: 10.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash macular
Clinical narrative: Rash - area blotchy, redness around vaccine site, swollen, warm to touch, soreness.
Age: 61.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Pt received ZOSTAVAX on 9/14/12. Pt presented to pharmacy on 9/16/12 with soreness in left arm. Upon exam, arm was red and tender in a lateral line across bicep muscle.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 11 years old male patient with no history of seizure. The patient was vaccinated with dose 1 GARDASIL in August 2012 (dose, site of administration and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that two weeks after receiving the dose, the patient experienced 1 episode of a seizure (medically significant). Approximately 1 week later, the patient experienced a second seizure. The patient did see a neurologist and the office had just received the results. There were EEG changes seen. No treatment information was reported. The outcome of the patient is unknown. The relatedness for seizure is unknown for GARDASIL. Additional information has been requested.
Age: 1.06
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Developed hive like rash at site of flu and PENTACEL. 24 hr later fever 99 degrees - seen at clinic 9/22/12. On BENADRYL. Cleared in 2 days.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Had High Dose Flu shot in (L) delt. on 9/25/12. On 9/26/12 woke in AM with soreness, redness, warmth and itching in that area. Today - 9/27/12 - states the area is smaller, there is no pain, but itching continues. Area is seen as red, warm to touch, 2 1/2" diameter, upper delt area (L) arm. Pt. denies all generalized systemic symptoms. Is alert, oriented x 3, in no acute distress. Localized reaction only.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Injection site mass, Swelling
Clinical narrative: 9/23 845 PM Patient reports lump at injection site, told to contact physician & call us. 9/24- Dr called in prednisone Rx. Patient say swelling down, feeling better.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Feeling hot, Injection site oedema, Injection site swelling
Clinical narrative: Fever/chill/malaise overnight (8hrs) onset 2-3 hrs post vaccine. Swelling (edema) in deltoid region on arm vaccinated (R) onset 2-3 hrs post vaccine. Redness/ heat in arm vaccinated (R) onset 2-3 hrs post vaccine. pain upon movement pt report 7 out of 10 dissipated overnight.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Fever/chill/malaise overnight (8hrs) onset 2-3 hrs post vaccine. Swelling (edema) in deltoid region on arm vaccinated (R) onset 2-3 hrs post vaccine. Redness/ heat in arm vaccinated (R) onset 2-3 hrs post vaccine. pain upon movement pt report 7 out of 10 dissipated overnight.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site rash
Clinical narrative: Red rash and swelling at site of injection, fatigue, loss of appetite, headaches and sinus congestion w/ clear discharge.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Paranasal sinus hypersecretion, Sinus congestion
Clinical narrative: Red rash and swelling at site of injection, fatigue, loss of appetite, headaches and sinus congestion w/ clear discharge.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Dizziness, Gait disturbance, Headache, Pain
Clinical narrative: Diarrhea, headache, aching all over, pt states "felt like I was going to fall over, walked like I was drunk" - Lasted 3-4 days. "Much better now".
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Erythema, Fatigue, Headache, Injection site inflammation
Clinical narrative: Nausea - headache - dizziness - exhaustion - injection site inflammation - swelling, redness and pain.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Swelling
Clinical narrative: Nausea - headache - dizziness - exhaustion - injection site inflammation - swelling, redness and pain.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Headache, Peripheral coldness
Clinical narrative: His feet are cold, weak & headache several hours after getting the vaccines.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea 24 hrs. following vaccination - continuing day # 4.
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Eye pain, Headache, Neck pain
Clinical narrative: Pt. reported feeling "dizzy" and "woozy". Then worsening pain in neck, eyes, and head.
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site warmth, Local swelling
Clinical narrative: Pt. experienced localized swelling, redness and heat (R) side at injection site 15-24 hours after injection. After 4 doses of BENADRYL 25mg pt. no better and was seen by Dr. for eval and treat.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral
Clinical narrative: Patient received vaccination on 9/12/12 and called on 9/24/12 with a swollen hand. She was told it might not be the shot. Try BENADRYL & see her Dr.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling and redness.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Musculoskeletal stiffness
Clinical narrative: Redness on site of injection, RA circle size 1 1/2" inch. No pain but stiffness. BENADRYL cream was given.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at injection site.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site warmth, Mobility decreased, Pain
Clinical narrative: Patient states by 3:00 P site was warm and tender. By bedtime she couldn't lift her arm at all and had 10/10 pain. Took TYLENOL with min. relief. Made follow up appt but cancelled - pain lessened by mid morning. Still exp. some sharp/shooting pains once in a while.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid oedema, Oropharyngeal swelling, Throat irritation
Clinical narrative: Symptoms: nasopharyngeal itching and swelling bilateral eyelids swelling. Treatment: ZYRTEC 10 mg oral once daily (x 10 days), Prednisone 10mg oral once daily (x 10 days).
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Patient came in with erythema along both shins from ankle to knee. It was rash-like however had no bumps that would suggest blisters or pustules.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Mass, Pain
Clinical narrative: 9/28 pt developed a slight ache. Swollen and red spots (not raised) at injection site. 9/29 began to itch and pt noticed a lump. 9/30 sx's disappeared but still warm to touch.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Skin warm
Clinical narrative: 9/28 pt developed a slight ache. Swollen and red spots (not raised) at injection site. 9/29 began to itch and pt noticed a lump. 9/30 sx's disappeared but still warm to touch.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Feeling of body temperature change, Hypoaesthesia, Oedema peripheral, Paraesthesia
Clinical narrative: Pins & needles, cold & hot, feeling in arm of injection. Started in hand and worked its way up the arm. Fingers became numb, joints were painful, arm swollen - 60 mg prednisone given at ER advised BENADRYL as needed.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Received ZOSTAVAX 9/12/12. Seen again in office 9/21 c/o itchy rash (vesicular) on arms, abdomen and fingers. No fever. Treatment was to monitor. Returns on 9/27/12 with Varicella like rash on abd, arms, legs. Treated with BENADRYL and TIAMVIR.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Adverse drug reaction, Biopsy, Rash, Rash erythematous, Rash papular
Clinical narrative: Received ZOSTAVAX 9/12/12. Seen again in office 9/21 c/o itchy rash (vesicular) on arms, abdomen and fingers. No fever. Treatment was to monitor. Returns on 9/27/12 with Varicella like rash on abd, arms, legs. Treated with BENADRYL and TIAMVIR.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pustular, Rash vesicular
Clinical narrative: Received ZOSTAVAX 9/12/12. Seen again in office 9/21 c/o itchy rash (vesicular) on arms, abdomen and fingers. No fever. Treatment was to monitor. Returns on 9/27/12 with Varicella like rash on abd, arms, legs. Treated with BENADRYL and TIAMVIR.