chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 17 years old patient who on04-SEP-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 33.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 33 years old patient who on 03-SEP-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting on a patient of unknown age who was administered the second dose of GARDASIL eight months after the first dose of GARDASIL. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 50 years old patient who on 03-SEP-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 46.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 46 years old patient who on 04-SEP-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 19 years old patient who on 22-AUG-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 40.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 40 years old patient who on 04-SEP-2012, was vaccinated subcutaneously with a dose of MMR II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 44.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 44 years old patient who on 03-SEP-2012, was vaccinated subcutaneously with a dose of M-M-R II subcutaneously (Lot number: 0234AE, expiry date: 26-JAN-2014, Lot number: 1003AA, expiry date: 28-JUN-2013) that was stored at 47 Fahrenheit for 13 hours. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to her 83 years old mother. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) on an unknown date in August 2012. The patient's relevant history, concomitant medications and past drug history were unknown. The consumer reported that on an unknown date in August 2012, the patient got the shingles. It was unknown if there was any relevant laboratory data. As of 15-SEP-2012, she had no had another ZOSTAVAX and her outcome of having the shingles in August 2012 was unknown. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. It was reported that RECOMBIVAX HB had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392 1210USA000958 1210USA000959 1210USA000961 1210USA000962. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse. It was reported that M-M-R II had been administered to an unspecified number of patients between 23-AUG-2012 and 04-SEP-2012 when the temperature had not been recorded and stability might have been compromised. Lot# was not provided. It was unspecified if the patients sought medical attention. No adverse events had been reported. This is one of several reports received from the same source: 1209USA002392, 1210USA000958, 1210USA000960, 1210USA00961, 1210USA000962. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with hypothyroid and with no relevant medical history. Her relevant past drug history was unknown. The patent was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously in the deltoid area of her left arm (lot number reported as 0242AE, expiration date 01-APR-2013) on 27-AUG-2012. No other co-suspects were reported. Concomitant medications included SYNTHROID, CYTOMEL and BONIVA. In August 2012, after receiving ZOSTAVAX, the patient developed a rash in a circular pattern around her left arm at the injection site which was warm to touch and a fever, possibly cellulitis. On 29-AUG-2012, the patient saw her physician and she was started on AUGMENTIN and hydrocortisone topically. The patient had no laboratory testing performed. As of 30-AUG-2012, she would not receive another ZOSTAVAX and the outcome of the events was unknown. The relatedness for rash in a circular pattern around left arm at the injection site which was warm to touch and a fever, possibly cellulitis was not reported for ZOSTAVAX. This is one of two reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with hypothyroid and with no relevant medical history. Her relevant past drug history was unknown. The patent was vaccinated with a dose of ZOSTAVAX 0.65 ml subcutaneously in the deltoid area of her left arm (lot number reported as 0242AE, expiration date 01-APR-2013) on 27-AUG-2012. No other co-suspects were reported. Concomitant medications included SYNTHROID, CYTOMEL and BONIVA. In August 2012, after receiving ZOSTAVAX, the patient developed a rash in a circular pattern around her left arm at the injection site which was warm to touch and a fever, possibly cellulitis. On 29-AUG-2012, the patient saw her physician and she was started on AUGMENTIN and hydrocortisone topically. The patient had no laboratory testing performed. As of 30-AUG-2012, she would not receive another ZOSTAVAX and the outcome of the events was unknown. The relatedness for rash in a circular pattern around left arm at the injection site which was warm to touch and a fever, possibly cellulitis was not reported for ZOSTAVAX. This is one of two reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site urticaria
Clinical narrative: Developed 4-5 hives around elbow on left arm about 1 hr after receiving immunization. Received BENADRYL.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Paraesthesia, Sensory loss
Clinical narrative: The patient complained of feeling nausea, tingling of hands and feeling of passing out after 5 minutes after injection. Patient layed on the floor with a bag of ice on her head. I stayed with patient and asked how she was feel any shortness of breath/difficulty breathing and she expressed feeling of nausea and no feeling in hands and feet. Patient was monitored and had an increase of symptoms. Patient did not show signs of anaphylaxis but complaints remained the same therefore I informed patients of injection Benadryl 50mg/ml IM shot would be given. 911 was called and arrived approximately 10 minutes. Patient felt better atfer 5-10 minutes from receiving Benadryl and was able to get of the floor on her own. EMS check vitals Blood pressure of 106. Was told she had an reation by EMS and to follow up with a visit to the ER.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Headache, Nausea, Vision blurred
Clinical narrative: Severe nausea, headache, dizziness, blurred vision.
Age: 1.58
Sex: F
Vaccine: HIBV, MEN
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Large knot, over 1 inch redness at vaccination site. Lasted over a week and a half.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphonia, Dyspnoea, Wheezing
Clinical narrative: Hoarseness, wheezing and trouble breathing. Called my doctor and was told to go to the emergency room. Treatment was an inhaler and Zyrtec over the next few days.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Pain, Paraesthesia
Clinical narrative: Initial report was received from a consumer on 19 September 2012, who is also the patient. A 57-year-old female received an intramuscular injection in the right deltoid of FLUZONE, lot number UH717AA, on 24 August 2012. On 26 August 2012, the patient developed tingling and numbness of the right arm from the shoulder to the "fold in arm". The numbness is worse at night "like your foot falling asleep." The symptoms have persisted. The patient can move her arm but experiences pain with heavy lifting. The primary physician recommended a cold compress. The chiropractor told the patient it "sounds like nerve damage." The patient had previous doses of the FLUZONE vaccination. The patient had no illness at the time of vaccination. The patient has no known allergies. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: Initial report was received from a consumer on 19 September 2012, who is also the patient. A 57-year-old female received an intramuscular injection in the right deltoid of FLUZONE, lot number UH717AA, on 24 August 2012. On 26 August 2012, the patient developed tingling and numbness of the right arm from the shoulder to the "fold in arm". The numbness is worse at night "like your foot falling asleep." The symptoms have persisted. The patient can move her arm but experiences pain with heavy lifting. The primary physician recommended a cold compress. The chiropractor told the patient it "sounds like nerve damage." The patient had previous doses of the FLUZONE vaccination. The patient had no illness at the time of vaccination. The patient has no known allergies. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Inappropriate schedule of drug administration, Laboratory test abnormal, Nasopharyngitis
Clinical narrative: Initial report received on 19 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. The report involved a case of misuse. A case of pertussis disease in a 2-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 received on the following dates: 20 April 2010, 27 May 2010, 01 September 2010 and 26 May 2011 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 03 September 2012, approximately 15 months after the last dose. On 04 September 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 04 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 17 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pertussis, Polymerase chain reaction, 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. The report involved a case of misuse. A case of pertussis disease in a 2-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 received on the following dates: 20 April 2010, 27 May 2010, 01 September 2010 and 26 May 2011 (lot numbers, route and sites of administration not reported). The subject developed a cough and cold-like symptoms on 03 September 2012, approximately 15 months after the last dose. On 04 September 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 04 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 04 September 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 17 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain, Pain in extremity, Skin warm
Clinical narrative: Left arm swollen red into armpit, painful, felt like a blister under arm, achy, hot to the touch. Took Advil and icing.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blister, Blood test, Dyspnoea, Oedema peripheral
Clinical narrative: Swelling in face, legs and short breath. Two days later blisters on feet and swelling in legs with joint pain and very short of breath. went back to Dr on Tuesday July 3. Again three weeks later, again a week later and several times since then. Referred to two more doctors and still having problems and it seems as if the Dr's want to just pass me to others. No one wants to claim and help.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Swelling face
Clinical narrative: Swelling in face, legs and short breath. Two days later blisters on feet and swelling in legs with joint pain and very short of breath. went back to Dr on Tuesday July 3. Again three weeks later, again a week later and several times since then. Referred to two more doctors and still having problems and it seems as if the Dr's want to just pass me to others. No one wants to claim and help.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Itching at injection site, no redness or swelling; @ approx. 2 pm, developed warm red rash on right cheek, right side of neck and under chin; offered Benadryl IM (subject was given vaccine as part of employee vaccination program and is an LPN) but refused Benadryl IM and took her own Benadryl 25 mg tab po @ approx. 3:30 pm; at approx 5:30pm, noticed one hive on upper right chest; the following day, woke with red warm rash on both upper arms, upper chest, entire neck and face, and with orbital edema and called off work.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Orbital oedema, Rash erythematous, Skin warm, Urticaria
Clinical narrative: Itching at injection site, no redness or swelling; @ approx. 2 pm, developed warm red rash on right cheek, right side of neck and under chin; offered Benadryl IM (subject was given vaccine as part of employee vaccination program and is an LPN) but refused Benadryl IM and took her own Benadryl 25 mg tab po @ approx. 3:30 pm; at approx 5:30pm, noticed one hive on upper right chest; the following day, woke with red warm rash on both upper arms, upper chest, entire neck and face, and with orbital edema and called off work.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Hyperhidrosis, Pyrexia
Clinical narrative: Fever of 101.3, sweats, chills through the night, early morning fever broke. No fever in AM.  Took a hot bath and feel much better.  Still a little out of balance but not enough to go to Doctor.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pyrexia, Vomiting
Clinical narrative: Hard to lift arm-continued for 3-4 days and then started to get better. Last few days worse again, pain 8 out of 10. Fever and vomiting 3-4 days after shot. Applying ice, heat and taking Tylenol.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Burning sensation, Chest discomfort, Coordination abnormal
Clinical narrative: Approx. 6 pm tired, went to sleep.  Woke around 9-10 pm in severe pain, very hot with fever. Got up to find thermometer.  Uncoordinated, could not think straight, couldn't find thermometer.  Everything hurt: teeth, skin, joints, back, headache.  Even felt like kidneys and liver areas were sore!  A little hard to breathe (tight chest). Dizzy and extremely exhausted, so went back to bed.  Took 1/2 Percocet.  Woke up later, felt I was burning up with fever. Took 1/2 Famvir (antiviral) and some Oscillococcinum a homeopathic remedy.  Called neighbor to check on me later.  Went back to sleep.  Slept until Saturday 9/29/2012, mid-day.  Fever broke.  I felt well enough to get up and find thermometer.  I thought fever was gone - but I had 2 thermometers.  One read just over 102 degrees.  The other read 102.5 degrees.  I felt cool to the touch - so my fever must have been very high before.  I felt much better Sunday, 9/30/2012, but developed a sore throat.  I take regular low-dose percocet for back pain, and the throat was still sore even with pain meds.  Also, I noticed on 9/30, there was a reactivation of an area on my right hip that tends to get recurrent shingles (?).  For that I started a regular dose of Famvir.  Have had flu shots for YEARS, and never had anything like this before.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Fatigue, Feeling cold, Feeling hot
Clinical narrative: Approx. 6 pm tired, went to sleep.  Woke around 9-10 pm in severe pain, very hot with fever. Got up to find thermometer.  Uncoordinated, could not think straight, couldn't find thermometer.  Everything hurt: teeth, skin, joints, back, headache.  Even felt like kidneys and liver areas were sore!  A little hard to breathe (tight chest). Dizzy and extremely exhausted, so went back to bed.  Took 1/2 Percocet.  Woke up later, felt I was burning up with fever. Took 1/2 Famvir (antiviral) and some Oscillococcinum a homeopathic remedy.  Called neighbor to check on me later.  Went back to sleep.  Slept until Saturday 9/29/2012, mid-day.  Fever broke.  I felt well enough to get up and find thermometer.  I thought fever was gone - but I had 2 thermometers.  One read just over 102 degrees.  The other read 102.5 degrees.  I felt cool to the touch - so my fever must have been very high before.  I felt much better Sunday, 9/30/2012, but developed a sore throat.  I take regular low-dose percocet for back pain, and the throat was still sore even with pain meds.  Also, I noticed on 9/30, there was a reactivation of an area on my right hip that tends to get recurrent shingles (?).  For that I started a regular dose of Famvir.  Have had flu shots for YEARS, and never had anything like this before.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Oropharyngeal pain, Pain, Pain of skin, Pyrexia
Clinical narrative: Approx. 6 pm tired, went to sleep.  Woke around 9-10 pm in severe pain, very hot with fever. Got up to find thermometer.  Uncoordinated, could not think straight, couldn't find thermometer.  Everything hurt: teeth, skin, joints, back, headache.  Even felt like kidneys and liver areas were sore!  A little hard to breathe (tight chest). Dizzy and extremely exhausted, so went back to bed.  Took 1/2 Percocet.  Woke up later, felt I was burning up with fever. Took 1/2 Famvir (antiviral) and some Oscillococcinum a homeopathic remedy.  Called neighbor to check on me later.  Went back to sleep.  Slept until Saturday 9/29/2012, mid-day.  Fever broke.  I felt well enough to get up and find thermometer.  I thought fever was gone - but I had 2 thermometers.  One read just over 102 degrees.  The other read 102.5 degrees.  I felt cool to the touch - so my fever must have been very high before.  I felt much better Sunday, 9/30/2012, but developed a sore throat.  I take regular low-dose percocet for back pain, and the throat was still sore even with pain meds.  Also, I noticed on 9/30, there was a reactivation of an area on my right hip that tends to get recurrent shingles (?).  For that I started a regular dose of Famvir.  Have had flu shots for YEARS, and never had anything like this before.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Thinking abnormal, Toothache
Clinical narrative: Approx. 6 pm tired, went to sleep.  Woke around 9-10 pm in severe pain, very hot with fever. Got up to find thermometer.  Uncoordinated, could not think straight, couldn't find thermometer.  Everything hurt: teeth, skin, joints, back, headache.  Even felt like kidneys and liver areas were sore!  A little hard to breathe (tight chest). Dizzy and extremely exhausted, so went back to bed.  Took 1/2 Percocet.  Woke up later, felt I was burning up with fever. Took 1/2 Famvir (antiviral) and some Oscillococcinum a homeopathic remedy.  Called neighbor to check on me later.  Went back to sleep.  Slept until Saturday 9/29/2012, mid-day.  Fever broke.  I felt well enough to get up and find thermometer.  I thought fever was gone - but I had 2 thermometers.  One read just over 102 degrees.  The other read 102.5 degrees.  I felt cool to the touch - so my fever must have been very high before.  I felt much better Sunday, 9/30/2012, but developed a sore throat.  I take regular low-dose percocet for back pain, and the throat was still sore even with pain meds.  Also, I noticed on 9/30, there was a reactivation of an area on my right hip that tends to get recurrent shingles (?).  For that I started a regular dose of Famvir.  Have had flu shots for YEARS, and never had anything like this before.
Age: 62.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Arthralgia, Mobility decreased, Myalgia, Pain, Pyrexia
Clinical narrative: Fever, muscle and joint pain, unable to lift right arm more than a few degrees due to excruciating pain. Pain and low grade fever persisted all night and most of next day.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Hyperhidrosis, Pyrexia
Clinical narrative: Started at 5:30 to 5:45 with sore joints and fever and continued at 4 a.m. with extreme dizziness and sweating. At this point, patient sought medical attention.
Age: 1.52
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Computerised tomogram head normal, Cyanosis, Electrocardiogram normal, Electroencephalogram normal, Oxygen saturation decreased
Clinical narrative: Pt sitting in highchair, then went unresponsive x 30 sec and turned blue, then self resolved.  Pt had 4 additional similar episodes that same day.  One was witnessed by an ER nurse and one was witnessed by a hospital resident after the child was admitted to Hospital.  One of the episodes was documented with a desaturation to 15%.  All spontaneously resolved.  The patient was admitted until 10/1/12 for observation.  The last episode was 9/29/12 mid afternoon.  The patient had normal EEG, normal EKG, and normal head CT.  Neurology consult felt this was unlikely to be seizures, but no explanation was found.  The patient was perfectly well inbetween the episodes.  No labs were done.  No history of trauma, illness, or ingestion.  He was discharged home on an oximeter and will follow up in the office tomorrow.
Age: 1.52
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Pt sitting in highchair, then went unresponsive x 30 sec and turned blue, then self resolved.  Pt had 4 additional similar episodes that same day.  One was witnessed by an ER nurse and one was witnessed by a hospital resident after the child was admitted to Hospital.  One of the episodes was documented with a desaturation to 15%.  All spontaneously resolved.  The patient was admitted until 10/1/12 for observation.  The last episode was 9/29/12 mid afternoon.  The patient had normal EEG, normal EKG, and normal head CT.  Neurology consult felt this was unlikely to be seizures, but no explanation was found.  The patient was perfectly well inbetween the episodes.  No labs were done.  No history of trauma, illness, or ingestion.  He was discharged home on an oximeter and will follow up in the office tomorrow.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient noticed erythema to injection site.
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Initial information received on 21 September 2012 from a consumer. A male patient (age not reported) received a dose of Influenza Vaccine on an unspecified date. An unknown amount of time following vaccination, the patient developed breathing difficulty and was hospitalized. Treatment information and duration of hospitalization was not reported. It was not reported if the patient recovered from his event. Documents held by sender: none.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood electrolytes normal, Cyanosis, Electrocardiogram normal, Full blood count normal, Gastrooesophageal reflux disease
Clinical narrative: Approximately 15 hrs after receiving immunizations & being fussy mom found him not breathing, mom stimulated him, he started breathing called 911 went to ER. Was lethargic. Arrived ER at 1 AM 4 month old male with cyanotic episode. Was admitted for observation. Discharged 9/26/12 at 10:13 am.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Irritability, Lethargy, Liver function test normal, Respiratory arrest, Ultrasound abdomen
Clinical narrative: Approximately 15 hrs after receiving immunizations & being fussy mom found him not breathing, mom stimulated him, he started breathing called 911 went to ER. Was lethargic. Arrived ER at 1 AM 4 month old male with cyanotic episode. Was admitted for observation. Discharged 9/26/12 at 10:13 am.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Approximately 15 hrs after receiving immunizations & being fussy mom found him not breathing, mom stimulated him, he started breathing called 911 went to ER. Was lethargic. Arrived ER at 1 AM 4 month old male with cyanotic episode. Was admitted for observation. Discharged 9/26/12 at 10:13 am.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Electromyogram normal, Immunoglobulin therapy, Muscular weakness, Nuclear magnetic resonance imaging spinal cord normal, Pain in extremity
Clinical narrative: Patient had onset of lower extremity pain, then weakness resulting in non weight bearing status. He had some lower extremity sensory loss, all of his symptoms resolved with IVIG treatment.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Sensory loss, Weight bearing difficulty
Clinical narrative: Patient had onset of lower extremity pain, then weakness resulting in non weight bearing status. He had some lower extremity sensory loss, all of his symptoms resolved with IVIG treatment.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blindness unilateral, Blood test, Computerised tomogram, Dysstasia
Clinical narrative: Tingling in hands & feet began appx 9/22, loss of feeling bottom of feet, no strength in hands, unable to stand for very long, sensitive to air on arms, loss of balance, all symptoms increased, back spasms began appx 10/1, Bell's palsy 10/2, loss of vision in right eye.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Grip strength decreased, Hyperaesthesia, Lumbar puncture, Muscle spasms
Clinical narrative: Tingling in hands & feet began appx 9/22, loss of feeling bottom of feet, no strength in hands, unable to stand for very long, sensitive to air on arms, loss of balance, all symptoms increased, back spasms began appx 10/1, Bell's palsy 10/2, loss of vision in right eye.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Sensory loss, VIIth nerve paralysis, X-ray
Clinical narrative: Tingling in hands & feet began appx 9/22, loss of feeling bottom of feet, no strength in hands, unable to stand for very long, sensitive to air on arms, loss of balance, all symptoms increased, back spasms began appx 10/1, Bell's palsy 10/2, loss of vision in right eye.
Sex: U
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Initial information received on 25 September 2012 from a company representative. The information was reported to the representative by a nurse, who was informed of the events by a student nurse practitioner. Three unidentified patients (no individual patient identifiers provided) received FLUZONE INTRADERMAL (lot number not reported) on an unspecified date. The patients subsequently developed cellulitis. It was not reported if the patients required treatment or if they recovered from the events. Documents held by sender: none.
Age: 91.0
Sex: M
Vaccine: FLUX
Symptoms: Necrotising fasciitis
Clinical narrative: Initial report was received on 17 September 2012 from a health care professional. A 91 year-old male patient with an unknown past medical history had received and Influenza vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later on 14 September, presented in the ER (emergency room) with necrotizing fasciitis in the left arm and was hospitalized. According to the reporter, the patient was unsure which arm he had been vaccinated in or on what date. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I increased, Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 19 September 2012. A 22-year-old male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) an an unspecified amount of time later was found to have on 20 January 2011 an elevated Troponin, central laboratory level of 0.27 ng/ml (also with as reported date of 26 January 2011). The subject had a rapid Troponin I level on 20 January 2011 that was within normal limits (negative). The subject denied chest pain and shortness of breath. Vitals included: BP 136/79, HR 80, RR 16, T 99.1, HT 68 in, WT 155 lbs, SpO2 98% and BMT 23.57. On 27 January 2011, an ECG was normal and Troponin I was <0.10 ng/mL. Concomitant medication included doxycycline. No further information was available at the time of the report. The subject's outcome was recovered. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase increased, Chest X-ray normal, Dyspnoea, Electrocardiogram abnormal, Haemoglobin decreased
Clinical narrative: This study case was received from the investigator in a trial on 19 September 2012. A 19 year-old male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) an an unspecified amount of time later was found to have on 25 January 2012 an elevated Troponin, central laboratory level of 0.38 ng/ml (also with as reported date of 27 January 2012). The subject had a rapid Troponin I level on 25 January 2012 that was within normal limits (negative). The subject's ECG on 27 January 2012 was normal. The subject had no concomitant medications. On study day nine, the subject was evaluated for an abnormal EKG and elevated Troponin I but asymptomatic. The subject's vitals included: BP 122/78, HR 56, RR 14, T 98/6 degrees F, HT 71 in, WT 175 lbs, BMI 24.41 and BSA 1.993 square meters. Laboratory and diagnostic testing included: a negative chest x-ray, an abnormal electrocardiogram, hemoglobin 13.7, lymphocytes 1.0, protein plasma 8.6 and creatine kinase serum 248. Treatments included methylprednisolone and naproxen. On study day 43, the subject had a normal ECG. On study day 49, the subject was evaluated and reported that he can feel short of breath at rest occasionally but it resolves with taking deep breaths. The subject also reported at the visit that he has difficulty sleeping through the night and had daytime somnolence. On study day 62, the subject was evaluated for clearance for deployment. No further information was available at the time of the report. The subject's outcome was ongoing (not recovered). According to the investigator, the event of elevated Troponin was considered another important medical event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Insomnia, Lymphocyte count normal, Protein total increased, Somnolence, Troponin I increased
Clinical narrative: This study case was received from the investigator in a trial on 19 September 2012. A 19 year-old male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) an an unspecified amount of time later was found to have on 25 January 2012 an elevated Troponin, central laboratory level of 0.38 ng/ml (also with as reported date of 27 January 2012). The subject had a rapid Troponin I level on 25 January 2012 that was within normal limits (negative). The subject's ECG on 27 January 2012 was normal. The subject had no concomitant medications. On study day nine, the subject was evaluated for an abnormal EKG and elevated Troponin I but asymptomatic. The subject's vitals included: BP 122/78, HR 56, RR 14, T 98/6 degrees F, HT 71 in, WT 175 lbs, BMI 24.41 and BSA 1.993 square meters. Laboratory and diagnostic testing included: a negative chest x-ray, an abnormal electrocardiogram, hemoglobin 13.7, lymphocytes 1.0, protein plasma 8.6 and creatine kinase serum 248. Treatments included methylprednisolone and naproxen. On study day 43, the subject had a normal ECG. On study day 49, the subject was evaluated and reported that he can feel short of breath at rest occasionally but it resolves with taking deep breaths. The subject also reported at the visit that he has difficulty sleeping through the night and had daytime somnolence. On study day 62, the subject was evaluated for clearance for deployment. No further information was available at the time of the report. The subject's outcome was ongoing (not recovered). According to the investigator, the event of elevated Troponin was considered another important medical event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Immediately following injection, patient became pale and faint.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness, extreme pain, swollen.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 23.0
Sex: F
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I increased, Troponin increased
Clinical narrative: This study case was received from the investigator on 19 September 2012. A 23-year-old female subject with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 22 February 2011 an elevated Troponin, central laboratory level of 10.07ng/ml (also with as reported date of 24 February 2011). The subject had a rapid Troponin I level on 22 February 2011 that was NOT within normal limits (Positive). An ECG on 22 February 2011 revealed normal results. Action taken was reported as none. On 24 February 2011, the subject had a Central Lab Troponin level drawn with result less than (<) 0.10ng/mL and an ECG with results reported as normal. The subject had no allergies to medications, no prior use of topical steroids to treat an eye problem or disease, no surgical history and no past medical history (also reported as never). The female patient had a history of prior pregnancy. The patient was reported as a smoker, less than half a pack per day, but has smoked greater than five packs of cigarettes in lifetime, with onset at age 18- years-old. The subject had no concomitant medications. No further information was available at the time of the report. The subject's outcome was recovered 24 February 2011. According to the investigator, the event of elevated Troponin was considered an other important medical event and possibly related to vaccination. Per the investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I, Troponin increased
Clinical narrative: This study case was received from the investigator in a trial on 19 September 2012. A 21-year-old male subject (date of birth not reported) with no reported past medical history had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later was found to have on 30 January 2012 an elevated Troponin, central laboratory level of 0.32 ng/ml (also with as reported date of 31 January 2012). The subject had a rapid Troponin I level on 30 January 2012 that was within normal limits (negative). The subject had no chest pain and no shortness of breath. Vitals included: BP 114/67, HR 53 regular, RR 16, T 98.6 oral, HT 74 in (stated), WT 210 lbs (states), BMI 29.29. An ECG on 07 March 2012 was normal. The subject had no concomitant medications., The subject did not use tobacco and alcohol use was yes. No further information was available at the time of the report. The subject's outcome was recovered 07 March 2012. According to the investigator, the event of elevated Troponin was considered an other important event and possibly related to vaccination. Per the Investigator, this represents a case of potential myopericarditis and was referred to the study's adjudication committee for assessment. Documents held by sender: none.
Age: 0.5
Sex: M
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 a post-marketing observational surveillance study. A case of pertussis disease in an 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance System electronic database. The subject had received 3 doses of PENTACEL; lot number C3978AA received on 02 November 2011, lot number C3999AA received on 06 January 2012 and lot number C4131AA received on 29 February 2012 (routes and sites of administration not reported). The subject developed a cough on 16 July 2012, approximately 5 months after the last dose. On 18 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 21 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 19 September 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in an 10-month-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance System electronic database. The subject had received 3 doses of PENTACEL; lot number C3978AA received on 02 November 2011, lot number C3999AA received on 06 January 2012 and lot number C4131AA received on 29 February 2012 (routes and sites of administration not reported). The subject developed a cough on 16 July 2012, approximately 5 months after the last dose. On 18 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 21 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 21 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 14 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 29 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Pain of skin, Pyrexia
Clinical narrative: Extreme achiness in back, touching of skin on legs and arms very painful, 100.3 fever. Took Aleve and Ibuprofen.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea
Clinical narrative: Shortness of breath, rise in BP, called primary doctor, took my PM meds at that time and Tramadol and within an hour BP returned to normal.  This is again repeated 10/02/2012 this time anti-histamine.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: Swelling, warmth, pain at injection site R upper arm above elbow where Pneumovax given. Trouble moving arm for a few days. Took Tylenol. During recheck 1 month later, c/o weakness fully lifting arm above head compared to other side of body but swelling/warmth/pain had resolved.
Age: 1.53
Sex: F
Vaccine: DTAP
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 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 3 doses of PENTACEL; lot number C3500AA received on 02 December 2009, lot number C3541AA received on 03 February 2010 and lot number C3591AA received on 07 April 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). The subject developed a cough in 14 July 2012, approximately 15 months after the last dose. On 21 July 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 26 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.53
Sex: F
Vaccine: DTAP
Symptoms: 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 3 doses of PENTACEL; lot number C3500AA received on 02 December 2009, lot number C3541AA received on 03 February 2010 and lot number C3591AA received on 07 April 2010 and 1 dose of DAPTACEL; lot number C3618AA received on 13 April 2011 (routes and sites of administration not reported). The subject developed a cough in 14 July 2012, approximately 15 months after the last dose. On 21 July 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 26 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 26 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 06 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 23 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Urticaria
Clinical narrative: Redness and swelling at injection site; hives on back and chest; itching on neck and chest; Benadryl taken.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lip swelling, Oedema mouth, Oral pain
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.