chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Chest discomfort, Dizziness, Dyspnoea, Headache
Clinical narrative: A non-serious spontaneous report of breathing difficulty, chest discomfort, dizziness, sore throat and headache has been received from a nurse concerning an adult female, subsequent to administering FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient did not receive FLUMIST. A registered nurse who worked in an area remote to city, reported that on specific days when she was involved in administering FLUMIST to 30 or more students at school vaccination clinics, she developed sore throat, dizziness, headache and chest discomfort that resulted in breathing difficulty. The events resolved about an hour after she left the school. The events, breathing difficulty, chest discomfort, dizziness, sore throat and headache, were resolved. The reporter indicated that these schools have been flooded in the past and has considered the possibility that the events were related to mold exposure that may have developed in these schools.
Sex: F
Vaccine: FLUN3
Symptoms: Oropharyngeal pain
Clinical narrative: A non-serious spontaneous report of breathing difficulty, chest discomfort, dizziness, sore throat and headache has been received from a nurse concerning an adult female, subsequent to administering FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient did not receive FLUMIST. A registered nurse who worked in an area remote to city, reported that on specific days when she was involved in administering FLUMIST to 30 or more students at school vaccination clinics, she developed sore throat, dizziness, headache and chest discomfort that resulted in breathing difficulty. The events resolved about an hour after she left the school. The events, breathing difficulty, chest discomfort, dizziness, sore throat and headache, were resolved. The reporter indicated that these schools have been flooded in the past and has considered the possibility that the events were related to mold exposure that may have developed in these schools.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 26-Jan-2011. On 27-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a health professional concerning a seven-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 02-Feb-2011. The patient received the expired FLUMIST on 04-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 23-Mar-2011: Reported confirmed that there was no late occurrence of adverse events.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Nasal congestion, Sleep apnoea syndrome, Snoring
Clinical narrative: A non-serious spontaneous report of sleep apnea, snoring and nasal congestion has been received from a physician concerning a 24-month-old male patient, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. On an unknown date in Jan-2011, the patient received FLUMIST. On 03-Jan-2011, the patient experienced nasal congestion. In Jan-2011, the patient experienced sleep apnea and snoring. The outcome of the events sleep apnea, snoring and nasal congestion was unknown.
Age: 56.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, Cough, Immobile, Malaise, Pyrexia
Clinical narrative: A non-serious spontaneous report of one day after giving FLUMIST I think I got H1N1 and H1N1 with symptoms of became ill, very sick, high temperature of 103 F, cough and absolutely immobilized has been received from a health professional concerning a 56-year-old female, subsequent to FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The patient did not receive FLUMIST. The patient whose was an nurse, administered a substantial number of seasonal and H1N1 FLUMIST in November 2009. About one day after giving FLUMIST, she thought she got H1N1. The patient was very sick and never tested for H1N1. The symptoms were high temperature of 103 F, cough and absolutely immobilized on the couch. The symptoms resolved by the next Monday morning. The outcome of both the events was resolved.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema, Nasal discomfort, Skin irritation
Clinical narrative: A non-serious spontaneous report of redness and irritation around nose, mouth and eyebrows has been received from a consumer concerning a 14-year-old male patient, subsequent to FLUMIST. Patient has a history of asthma as a kid but hasn't taken asthma medication in 9-10 years. No concomitant medication has been reported for this patient. On 27-Nov-2010, the patient received FLUMIST. On 28-Nov-2010, the patient experienced redness and irritation around his nose, mouth, and eyebrows. Since then he had been to doctor and dermatologist and "they could not find anything wrong". He visited physician about 4-5 days after the symptoms began. He has been given prednisone (worked but came right back) and miconazole and both seemed to help. The outcome of the events redness and irritation around nose, mouth and eyebrows was unknown.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a health professional concerning a seven-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 06-Feb-2011. On 09-Feb-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 11-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received form a health professional concerning a four-year-old female. Neither past medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 05-Feb-2011. On 01-Feb-2011, the patient received the expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of administration of expired product was received from a health professional concerning a five-year-old male. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 02-Dec-2010. On 06-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 21-Apr-2011 and incorporated into case: no late occurring adverse events.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning an adult patient. Neither the patient's past medical history nor the concomitant medications were reported. The product expired in Feb-2010. The patient received the expired FLUMIST on 17-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Age: 11.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of influenza has been received from a physician concerning a 12-year-old male patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 19-Oct-2010, the patient received FLUMIST. On 15-Feb-2011, the patient tested positive for Flu. On an unknown date, the influenza resolved. The outcome of the event of influenza was resolved. Additional information was received on 08-Jun-2011 and incorporated into the narrative: Outcome of the event. Reporter also confirmed that the patient did not have any other AEs.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of tested positive for Flu has been received from a physician concerning a seven-year-old male patient, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 25-Oct-2010, the patient received FLUMIST. On 15-Feb-2011, the patient was tested positive for Flu. On an unknown date, the influenza resolved. The outcome of the event tested positive for Flu was resolved. Additional information was received on 08-Jun-2011 and incorporated into the narrative: the outcome of the event. Reporter also confirmed that the patient did not have any other AEs.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a five-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Jan-2011. On 03-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Mar-2011 and incorporated into case: no late occurring adverse events.
Age: 6.0
Sex: U
Vaccine: FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A non-serious spontaneous report of influenza A has been received from a health professional concerning a seven-year-old, subsequent to FLUMIST. The patient had no significant medical history. The patient was not taking any concomitant medications and did not receive any other vaccinations on the day that FLUMIST was administered. The patient received FLUMIST on 25-Oct-2010. On 17-Feb-2011, the patient contracted Influenza A. The outcome for the reported adverse event was resolved. Additional information was received on 09-May-2011 and incorporated in the narrative: reporter information, patient's medical history, concomitant medications and outcome of the event.
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Pharyngitis streptococcal, Pruritus, Streptococcus test, Streptococcus test positive, Urticaria
Clinical narrative: A non-serious spontaneous report of strep throat, itching and hives has been received from a health professional concerning a five-year-old male, subsequent to receiving FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On 16-Feb-2011, patient's sister came to doctor's office for an ear infection. On 16-Feb-2011, patient received FLUMIST. On 17-Feb-2011, patient experienced hives and itching. On 18-Feb-2011, patient was seen in Dr's office. A rapid strep test was done and the results were lightly positive. Treatment included cephalexin 375 mg twice a day times ten days for strep throat and he received 7.5 cc of diphenhydramine once for the hives and itching. On 19-Feb-2011, the patient had no fever and felt better. On 19-Feb-2011, the hives and itching resolved. The event of strep throat was resolving.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A non-serious spontaneous report of a patient received expired FLUMIST was received from a health professional concerning a four-year-old male. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 02-Feb-2011. The patient received the expired FLUMIST on 15-Feb-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Hyponatraemia, Pain, Trigeminal neuralgia
Clinical narrative: Increasing pain from previously well controlled Trigeminal Neuralgia. This led to increased consumption of Oxcarbasepine in attempt to control, resulting in Hyponatremia. Admitted to Medical Center at 8:00 PM on 08/04/2011. Treated for Hyponatremia and administered Morphine and Baclofen for pain control. Released from hospital at 5:00 PM on 08/09/2011. Sought and received treatment with Curaelase Laser. Complete relief of symptoms resulted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Abdominal pain upper, Body temperature fluctuation, Decreased activity, Diet refusal, Dizziness
Clinical narrative: Started low grade fever Thursday afternoon. Still wanted to eat and play. Friday early in the day he was warm to the touch but still playing and eating and drinking. Complained of headache about 4pm. The fever was still present - measured 101.F around 5pm. And glands in neck looked swollen. Overnight felt very hot. Woke up and gave Tylenol. Saturday the fever was still present yet low grade (100F) still eating, drinking and playing. Saturday evening around 7pm the fever spiked to 104F. Put in a tepid bath. Gave Tylenol and ice water. Cool washcloths and layed on couch together. He was responsive yet complained of dizzy. Sunday a.m. - fever still present. He was tired and general malaise. Not wanting to eat or drink much. Not very active. Temp varied throughout the day between 100F and 103F. Alternating Ibuprofen and Tylenol every 4 hours. Pushing fluids, and he showed me a sore in his mouth on the inside of his lip that looked like a cold sore. Glands in neck swollen. Sunday night still fever overnight. Still using Tylenol and ibuprofen alternating every 4 hrs. Monday morning I called the doctor. Child didn't want to eat or drink. Said his belly hurt. Still fever. 11:45am appt with pediatric NP.  She was not convinced this was vaccine related, although the Strep test was negative. His ears looked good. No coughing, no sneezing, no vomiting or diarrhea. Urinalysis was normal. Temp measured 101F in office. Blood drawn for CBC to look at WBC and rule out bacterial infection. Went home to continue nursing care of fever. Gave Tylenol after he ate some apples and drank milk. The temp was 102F. Waited for Dr office to call. At 4pm I was told that the CBC was normal. And, no other signs of bacterial infection.  Again, I asked if this is vaccine related given I have read the package insert for the MMRII vaccine and been on the CDC website indicating this as a side effect. The NP said she wasn't sure, and that if the fever hadn't broke by lunch time on Tuesday that she would need to re-evaluate him. As it is, Monday evening he did drink and eat and played. Temp was 100F with Ibuprofen on board. At bed time, he felt low grade fever, but we woke up at 3am to a 103.7F fever. Gave Milk and Tylenol. Some ice water. A cool cloth on forehead.  I am convinced this is vaccine related.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Fatigue, Feeling hot, Full blood count normal, Headache, Lymphadenopathy
Clinical narrative: Started low grade fever Thursday afternoon. Still wanted to eat and play. Friday early in the day he was warm to the touch but still playing and eating and drinking. Complained of headache about 4pm. The fever was still present - measured 101.F around 5pm. And glands in neck looked swollen. Overnight felt very hot. Woke up and gave Tylenol. Saturday the fever was still present yet low grade (100F) still eating, drinking and playing. Saturday evening around 7pm the fever spiked to 104F. Put in a tepid bath. Gave Tylenol and ice water. Cool washcloths and layed on couch together. He was responsive yet complained of dizzy. Sunday a.m. - fever still present. He was tired and general malaise. Not wanting to eat or drink much. Not very active. Temp varied throughout the day between 100F and 103F. Alternating Ibuprofen and Tylenol every 4 hours. Pushing fluids, and he showed me a sore in his mouth on the inside of his lip that looked like a cold sore. Glands in neck swollen. Sunday night still fever overnight. Still using Tylenol and ibuprofen alternating every 4 hrs. Monday morning I called the doctor. Child didn't want to eat or drink. Said his belly hurt. Still fever. 11:45am appt with pediatric NP.  She was not convinced this was vaccine related, although the Strep test was negative. His ears looked good. No coughing, no sneezing, no vomiting or diarrhea. Urinalysis was normal. Temp measured 101F in office. Blood drawn for CBC to look at WBC and rule out bacterial infection. Went home to continue nursing care of fever. Gave Tylenol after he ate some apples and drank milk. The temp was 102F. Waited for Dr office to call. At 4pm I was told that the CBC was normal. And, no other signs of bacterial infection.  Again, I asked if this is vaccine related given I have read the package insert for the MMRII vaccine and been on the CDC website indicating this as a side effect. The NP said she wasn't sure, and that if the fever hadn't broke by lunch time on Tuesday that she would need to re-evaluate him. As it is, Monday evening he did drink and eat and played. Temp was 100F with Ibuprofen on board. At bed time, he felt low grade fever, but we woke up at 3am to a 103.7F fever. Gave Milk and Tylenol. Some ice water. A cool cloth on forehead.  I am convinced this is vaccine related.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Malaise, Oral disorder, Oral herpes, Pyrexia, Skin warm
Clinical narrative: Started low grade fever Thursday afternoon. Still wanted to eat and play. Friday early in the day he was warm to the touch but still playing and eating and drinking. Complained of headache about 4pm. The fever was still present - measured 101.F around 5pm. And glands in neck looked swollen. Overnight felt very hot. Woke up and gave Tylenol. Saturday the fever was still present yet low grade (100F) still eating, drinking and playing. Saturday evening around 7pm the fever spiked to 104F. Put in a tepid bath. Gave Tylenol and ice water. Cool washcloths and layed on couch together. He was responsive yet complained of dizzy. Sunday a.m. - fever still present. He was tired and general malaise. Not wanting to eat or drink much. Not very active. Temp varied throughout the day between 100F and 103F. Alternating Ibuprofen and Tylenol every 4 hours. Pushing fluids, and he showed me a sore in his mouth on the inside of his lip that looked like a cold sore. Glands in neck swollen. Sunday night still fever overnight. Still using Tylenol and ibuprofen alternating every 4 hrs. Monday morning I called the doctor. Child didn't want to eat or drink. Said his belly hurt. Still fever. 11:45am appt with pediatric NP.  She was not convinced this was vaccine related, although the Strep test was negative. His ears looked good. No coughing, no sneezing, no vomiting or diarrhea. Urinalysis was normal. Temp measured 101F in office. Blood drawn for CBC to look at WBC and rule out bacterial infection. Went home to continue nursing care of fever. Gave Tylenol after he ate some apples and drank milk. The temp was 102F. Waited for Dr office to call. At 4pm I was told that the CBC was normal. And, no other signs of bacterial infection.  Again, I asked if this is vaccine related given I have read the package insert for the MMRII vaccine and been on the CDC website indicating this as a side effect. The NP said she wasn't sure, and that if the fever hadn't broke by lunch time on Tuesday that she would need to re-evaluate him. As it is, Monday evening he did drink and eat and played. Temp was 100F with Ibuprofen on board. At bed time, he felt low grade fever, but we woke up at 3am to a 103.7F fever. Gave Milk and Tylenol. Some ice water. A cool cloth on forehead.  I am convinced this is vaccine related.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Streptococcus test negative, Urine analysis normal, White blood cell count normal
Clinical narrative: Started low grade fever Thursday afternoon. Still wanted to eat and play. Friday early in the day he was warm to the touch but still playing and eating and drinking. Complained of headache about 4pm. The fever was still present - measured 101.F around 5pm. And glands in neck looked swollen. Overnight felt very hot. Woke up and gave Tylenol. Saturday the fever was still present yet low grade (100F) still eating, drinking and playing. Saturday evening around 7pm the fever spiked to 104F. Put in a tepid bath. Gave Tylenol and ice water. Cool washcloths and layed on couch together. He was responsive yet complained of dizzy. Sunday a.m. - fever still present. He was tired and general malaise. Not wanting to eat or drink much. Not very active. Temp varied throughout the day between 100F and 103F. Alternating Ibuprofen and Tylenol every 4 hours. Pushing fluids, and he showed me a sore in his mouth on the inside of his lip that looked like a cold sore. Glands in neck swollen. Sunday night still fever overnight. Still using Tylenol and ibuprofen alternating every 4 hrs. Monday morning I called the doctor. Child didn't want to eat or drink. Said his belly hurt. Still fever. 11:45am appt with pediatric NP.  She was not convinced this was vaccine related, although the Strep test was negative. His ears looked good. No coughing, no sneezing, no vomiting or diarrhea. Urinalysis was normal. Temp measured 101F in office. Blood drawn for CBC to look at WBC and rule out bacterial infection. Went home to continue nursing care of fever. Gave Tylenol after he ate some apples and drank milk. The temp was 102F. Waited for Dr office to call. At 4pm I was told that the CBC was normal. And, no other signs of bacterial infection.  Again, I asked if this is vaccine related given I have read the package insert for the MMRII vaccine and been on the CDC website indicating this as a side effect. The NP said she wasn't sure, and that if the fever hadn't broke by lunch time on Tuesday that she would need to re-evaluate him. As it is, Monday evening he did drink and eat and played. Temp was 100F with Ibuprofen on board. At bed time, he felt low grade fever, but we woke up at 3am to a 103.7F fever. Gave Milk and Tylenol. Some ice water. A cool cloth on forehead.  I am convinced this is vaccine related.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray, Dyspnoea, Dyspnoea exertional, Fatigue, Rhonchi
Clinical narrative: SOB with & without exertion, rhonchi, increased fatigue, wheezing; tx: Albuterol, antibiotic, Prednisone (low dose). Others with similar symptoms (employees) with a few hospitalized & others with continuous treatment currently. No cont. meds needed for me.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: SOB with & without exertion, rhonchi, increased fatigue, wheezing; tx: Albuterol, antibiotic, Prednisone (low dose). Others with similar symptoms (employees) with a few hospitalized & others with continuous treatment currently. No cont. meds needed for me.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspepsia, Injection site pain, Nausea, Rash, Rash macular
Clinical narrative: -Blotchy skin rash on torso, legs, neck, arms.  -Nausea, heartburn.  -Ache at site of injection  (50mg Diphenhydramine, 400mg Ibuprofen)
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: -Blotchy skin rash on torso, legs, neck, arms.  -Nausea, heartburn.  -Ache at site of injection  (50mg Diphenhydramine, 400mg Ibuprofen)
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspepsia, Injection site pain, Nausea, Rash, Rash macular
Clinical narrative: Hives on upper part of body. Patient took diphenhydramine, and hives were gone the next morning.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Hives on upper part of body. Patient took diphenhydramine, and hives were gone the next morning.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, C-reactive protein increased, Fatigue, Laboratory test, Myalgia
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient having mononucleosis previously who in June 2011, was vaccinated with a first dose of GARDASIL (lot# unspecified). The physician reported that, in June 2011 while on GARDASIL, the patient presented with a rash that began at the head and appeared to work its way down her body. The patient also experienced muscle aches, arthralgia and fatigue. The patient had slightly elevated sedimentation (SED) and C-reactive protein (CRP) rates. The patient might have also had a low-grade fever. The patient had sought medical attention and the physician tested the patient regarding additional viral cause of the rash. At the time of report, the patient's condition was resolving. The adverse events were considered to be significant disability or incapacity. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Rash generalised, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient having mononucleosis previously who in June 2011, was vaccinated with a first dose of GARDASIL (lot# unspecified). The physician reported that, in June 2011 while on GARDASIL, the patient presented with a rash that began at the head and appeared to work its way down her body. The patient also experienced muscle aches, arthralgia and fatigue. The patient had slightly elevated sedimentation (SED) and C-reactive protein (CRP) rates. The patient might have also had a low-grade fever. The patient had sought medical attention and the physician tested the patient regarding additional viral cause of the rash. At the time of report, the patient's condition was resolving. The adverse events were considered to be significant disability or incapacity. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Condition aggravated, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female with seizures, hyperlipidemia, osteoporosis, gastric ulcer and no drug reactions/allergies and a history of cerebrovascular accident in 2008 and syncope who on 27-JUL-2011 was vaccinated subcutaneously with a 0.5ml dose of PNEUMOVAX 23 (Lot # 667995/1150Z). Concomitant therapy included TOPAMAX, CYMBALTA, PLAVIX, aspirin, simvastatin (manufacturer unknown), fenofibrate, omeprazole (MSD), PERCOCET, gabapentin, vitamin D (unspecified) and calcium (unspecified). The nurse reported that the patient was hospitalized two days after receiving PNEUMOVAX 23 on 27-JUL-2011. The patient was seen in her primary care physician's office on 27-JUL-2011, and received a dose of PNEUMOVAX 23. The next day, the patient traveled to another city, a few hours away from her home. On 29-JUL-2011, the patient experienced syncope, and went to the emergency room. The patient was admitted on 29-JUL-2011, for episodes of syncope, fever, redness and swelling at the injection site. According to the report that was sent to the patient's primary care doctor, the patient was diagnosed with cellulitis and treated with IV antibiotics. Length of stay in the hospital and release date were unavailable. Patient was scheduled for a follow-up visit with her primary care physician on 04-AUG-2011. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female with seizures, hyperlipidemia, osteoporosis, gastric ulcer and no drug reactions/allergies and a history of cerebrovascular accident in 2008 and syncope who on 27-JUL-2011 was vaccinated subcutaneously with a 0.5ml dose of PNEUMOVAX 23 (Lot # 667995/1150Z). Concomitant therapy included TOPAMAX, CYMBALTA, PLAVIX, aspirin, simvastatin (manufacturer unknown), fenofibrate, omeprazole (MSD), PERCOCET, gabapentin, vitamin D (unspecified) and calcium (unspecified). The nurse reported that the patient was hospitalized two days after receiving PNEUMOVAX 23 on 27-JUL-2011. The patient was seen in her primary care physician's office on 27-JUL-2011, and received a dose of PNEUMOVAX 23. The next day, the patient traveled to another city, a few hours away from her home. On 29-JUL-2011, the patient experienced syncope, and went to the emergency room. The patient was admitted on 29-JUL-2011, for episodes of syncope, fever, redness and swelling at the injection site. According to the report that was sent to the patient's primary care doctor, the patient was diagnosed with cellulitis and treated with IV antibiotics. Length of stay in the hospital and release date were unavailable. Patient was scheduled for a follow-up visit with her primary care physician on 04-AUG-2011. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chest pain, Herpes zoster, Pain, Pleuritic pain
Clinical narrative: Information has been received from the physician concerning a current 80 year old retired caterer, female patient with no pre-existing allergies or other medical conditions, "none" illness at time of vaccination and with a history of chickenpox in the childhood and with no recent exposure to chickenpox or Herpes Zoster (also reported as having developed shingles resulting in a post-herpetic neuralgia after prior vaccination with the first dose of ZOSTAVAX (Merck), on an unspecified date at the age of 79 year old). On 19-JUN-2010, at an unknown time, the patient was vaccinated with the second "usual adult dose" of ZOSTAVAX (Merck) at the local pharmacy. There were no concomitant medications. After the second dose of ZOSTAVAX (Merck), on 20-JUN-2010, the patient experienced pain. On 22-JUN-2010, the patient developed a rash. On 23-JUN-2010, the patient developed classic shingles (also reported as grouped clusters and vesicles) that appeared along dermatomes right thoracic 5-6 from back to lower breast/chest. Other symptoms included pleuritic chest pain in a grade of 10 (scale 0 to 10). Then patient developed a "severe and persistent" post-herpetic neuralgia which interfered her sleep for months and persisted for months. The patient had multiple attempts at pain control (unspecified). Diagnostic tests included a clinical exam (results not provided). No direct fluorescent antibody test and PCR test were done. At the time of the report the patient had not recovered. The patient required emergency room/doctor visits. The patient's shingles pain was considered disabling by the reporting physician. This is one of several reports received from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Rash, Sleep disorder, Vaccine positive rechallenge
Clinical narrative: Information has been received from the physician concerning a current 80 year old retired caterer, female patient with no pre-existing allergies or other medical conditions, "none" illness at time of vaccination and with a history of chickenpox in the childhood and with no recent exposure to chickenpox or Herpes Zoster (also reported as having developed shingles resulting in a post-herpetic neuralgia after prior vaccination with the first dose of ZOSTAVAX (Merck), on an unspecified date at the age of 79 year old). On 19-JUN-2010, at an unknown time, the patient was vaccinated with the second "usual adult dose" of ZOSTAVAX (Merck) at the local pharmacy. There were no concomitant medications. After the second dose of ZOSTAVAX (Merck), on 20-JUN-2010, the patient experienced pain. On 22-JUN-2010, the patient developed a rash. On 23-JUN-2010, the patient developed classic shingles (also reported as grouped clusters and vesicles) that appeared along dermatomes right thoracic 5-6 from back to lower breast/chest. Other symptoms included pleuritic chest pain in a grade of 10 (scale 0 to 10). Then patient developed a "severe and persistent" post-herpetic neuralgia which interfered her sleep for months and persisted for months. The patient had multiple attempts at pain control (unspecified). Diagnostic tests included a clinical exam (results not provided). No direct fluorescent antibody test and PCR test were done. At the time of the report the patient had not recovered. The patient required emergency room/doctor visits. The patient's shingles pain was considered disabling by the reporting physician. This is one of several reports received from the same source. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain
Clinical narrative: Pain at injection sight.  (Sore Arm)  Taking OTC Pain Med.   Still sore on 8/16/2011.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Nausea
Clinical narrative: Passed out after vaccine was given. Pt did c/o nausea but no vomiting. Pt was instructed to lay down for 10 minutes. At that time B/P was normal and was able to sit. Pt was able to leave unassisted.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Hepatic neoplasm malignant, Histiocytosis haematophagic, Intensive care, Respiratory failure
Clinical narrative: Initial report was received on 09 August 2011 from another manufacturer national service center (service request number 1-4381506938), who received the report from a health care professional. A female patient (age and date of birth not reported) with a history of HLH syndrome and liver cancer had received on 08 October 2009 a dose of H1N1 vaccine (manufacturer, lot number, route and site of administration not reported) and eight days later on 16 October 2009, the patient experienced respiratory failure. The patient was hospitalized in the pediatric ICU (dates not reported). According to the reporter, the patient developed HLH syndrome and liver cancer (also reported as history) from the vaccine. Treatments were not reported. According to the report, the liver cancer was in remission and the patient had not died. No further information was available at the time of the report. The patient's outcome was reported as recovering. Documents held by sender: none.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: abdominal pain, cramping. fever to 104.5
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Blood test, Clonus, Muscle contractions involuntary, Muscle twitching
Clinical narrative: Tingling in Hands and Feet Loss of core strength Clonus apparent during sustained muscle contractions Muscle twitching and shaking Lack of muscular strength
Age: 38.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Paraesthesia, Tremor
Clinical narrative: Tingling in Hands and Feet Loss of core strength Clonus apparent during sustained muscle contractions Muscle twitching and shaking Lack of muscular strength
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: PATIENT HAD REDNESS TO RIGHT ARM AND WARMTH TO TOUCH AFTER RECEIVING HEP A, HEP B, AND MMR ON THAT ARM. PATIENT HAD NOT HAD ANY SHOTS PRIOR TO VACCCINE ADMINISTRATION. NO SIGNS OF SEVERE REACTION TO VACCINES. CHILD RECEIVED PENTACEL, PCV13, AND VARICELLA ON LEFT ARM. TELEPHONED MOTHER THE NEXT DAY TO FOLLOW UP ON CHILD, MOTHER STATED CHILD WAS DOING FINE WITH NO COMPLICATIONS. THE REDNESS HAD GONE AWAY.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Muscular weakness, Nausea, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: nausea for several days, severe injection site pain for 1 week, then pain lessened but persisted, led to L arm weakness, then frozen shoulder, 2 ortho referrals, now diagnosed with chemical impingement syndrome requiring surgery
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Periarthritis, Rotator cuff syndrome, Surgery
Clinical narrative: nausea for several days, severe injection site pain for 1 week, then pain lessened but persisted, led to L arm weakness, then frozen shoulder, 2 ortho referrals, now diagnosed with chemical impingement syndrome requiring surgery
Age: 25.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site pain
Clinical narrative: Patient of refugee status presented to clinic 6/6/11 complaining of upper Right arm pain since immunized 5/3/11. Physical exam normal - see progress notes from date. 8/5/11 patient returned still complaining Right arm pain see progress notes from date. He denies ever having swelling, redness or rash from site. Shot record enclosed. Patient did not have/bring shot record from other state.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Injection site pruritus, Pruritus
Clinical narrative: Itching reported by patient at site of varicella vaccine approximately 10 minutes after injection - ice pack was applied, itching & redness.
Age: 1.74
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Today, parent reported that evening of vaccination on 5/2/2011, child had fever for several hours at 104 degrees F. Highest temp. 106 degrees F, unrelieved with TYLENOL. Mother reported ER visit but could not state what treatment was given other than more TYLENOL.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Moaning, Muscle rigidity, Pallor, Unresponsive to stimuli
Clinical narrative: Patient heard moaning, leaning against father's shoulders, extremities drawn up and rigid, unresponsive, pale, Respirations normal. Child laid on floor and cold compress applied. Remained unresponsive for 2 minutes, slowly awakened able to answer questions appropriately. Remained in clinic lying down for 45 min. Drank 6 oz of water and piece of candy. Father states child had a similar episode after a penicillin shot at physician's office. Child able to walk out of clinic without assistance.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site mass, Injection site swelling
Clinical narrative: Patient recieved Immunization at 1207 PM.  Immediately after vaccination was administered within left deltoid swelling within the injection site was severe enough to warrant nurses attention.  No signs of anaphylactic shock.  No shortness of breath/hives etc.  Just a firm sizable lump within injection site.  Size of lump was equivalent to a golfball.  Patient has full range of motion with left deltoid.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Pt complaining of severe pain in left upper arm around area of injection site. States it is  "hot to touch".
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Blood test, Confusional state, Loss of consciousness, Malaise, Syncope
Clinical narrative: Patient woke up and was not feeling well, went into parents room and collapsed lost consciousness briefly then was confused until seen in ER.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Urine analysis, White blood cell count increased
Clinical narrative: Patient woke up and was not feeling well, went into parents room and collapsed lost consciousness briefly then was confused until seen in ER.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Dyskinesia, Electroencephalogram, Infantile spasms, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: jerking movements - Infantile Spasms
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Blood test, Dyskinesia, Infantile spasms, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: jerking movements - Infantile Spasms
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, DTAPIPVHIB
Symptoms: Seizure like phenomena, Staring
Clinical narrative: jerking movements - Infantile Spasms
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: RED AND SWELLING AT THE VARICELLA INJECTION SITE
Age: 0.75
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Hypersomnia, Lethargy, Pyrexia
Clinical narrative: Slept for over 3 hours at nap, and woke up with a low grade temp. Fever progressed to 102.5 under the arm. Been giving Tylenol every 4-6 hours to control. Fever has been at least 100 for 24 hours now. He slept for 4 hours today during his nap. He is very lethargic, and just not himself.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received VZ vaccine #2 0.5ml SC to L arm @ 11:45am, and pt experienced swelling to site immediately. Pt c/o to itching to area. Denies pain, SOB, itching throat, dizziness. Pt appeared with good skin color, stable. Pt is accompanied with mom and siblings. Ice packed applied to area.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Exercise tolerance decreased, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Developed flu-like symptoms, lethargy, muscle pain over a period of 2 weeks with increasing fatigue and inability to perform normal activities.  Occasional feeling of mild fever, but most severe problems were chronic fatigue becoming limiting for work at about 1 month after vaccination.  Exercise ability limited to walking at a slow pace less than 10 minutes at a time compared to normal daily brisk walks of 40 minutes.  Disrupted and poor sleep.  Symptoms now continuing for 3 months after vaccination, perhaps with some minor improvement.  Additional symptoms included constant headache and minor gastrointestinal problems.  At 5 weeks after vaccination, husband developed severe case of shingles.  This was associated with rash and severe back pain, involvement of GI system requiring hospitalization.  Some post-herpetic neuralgia remaining after 6 weeks, and chronic fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Influenza like illness, Lethargy, Myalgia, Poor quality sleep
Clinical narrative: Developed flu-like symptoms, lethargy, muscle pain over a period of 2 weeks with increasing fatigue and inability to perform normal activities.  Occasional feeling of mild fever, but most severe problems were chronic fatigue becoming limiting for work at about 1 month after vaccination.  Exercise ability limited to walking at a slow pace less than 10 minutes at a time compared to normal daily brisk walks of 40 minutes.  Disrupted and poor sleep.  Symptoms now continuing for 3 months after vaccination, perhaps with some minor improvement.  Additional symptoms included constant headache and minor gastrointestinal problems.  At 5 weeks after vaccination, husband developed severe case of shingles.  This was associated with rash and severe back pain, involvement of GI system requiring hospitalization.  Some post-herpetic neuralgia remaining after 6 weeks, and chronic fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sleep disorder, Vaccine virus shedding
Clinical narrative: Developed flu-like symptoms, lethargy, muscle pain over a period of 2 weeks with increasing fatigue and inability to perform normal activities.  Occasional feeling of mild fever, but most severe problems were chronic fatigue becoming limiting for work at about 1 month after vaccination.  Exercise ability limited to walking at a slow pace less than 10 minutes at a time compared to normal daily brisk walks of 40 minutes.  Disrupted and poor sleep.  Symptoms now continuing for 3 months after vaccination, perhaps with some minor improvement.  Additional symptoms included constant headache and minor gastrointestinal problems.  At 5 weeks after vaccination, husband developed severe case of shingles.  This was associated with rash and severe back pain, involvement of GI system requiring hospitalization.  Some post-herpetic neuralgia remaining after 6 weeks, and chronic fatigue.
Age: 18.0
Sex: M
Vaccine: HEPAB
Symptoms: Joint swelling
Clinical narrative: SHOULDER WAS SIGNIFICANTLY SWOLLEN
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Culture, Skin lesion
Clinical narrative: I developed cowpox like lesions, 2 on my right wrist, 1 on my left wrist, and one on my left temple.  I was placed on Bactrim and Bactroban to prevent possible secondary bacterial infection.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: Red rash that spread out 1.5 inches from injection site. Arm that was injected warm to touch at injection site DTaP was given.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Rash, Somnolence, Tachycardia, Throat tightness
Clinical narrative: Patient was given PNEUMOVAX 23 vaccine. After 5 minutes, patient started to complain of throat narrowing and difficulty breathing. Patient also developed urticarial rash on face. Oxygen sat was 93% with HR 113/min. Patient was given 7.5 ml Diphenhydramine HCl 12.5 mg/5 ml suspension. Patient's O2 sat improved to 98% on room air a few minutes after, but feeling drowsy. Patient was tachycardiac with good air entry and mild wheezing. EMS arrived thereafter.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria, Wheezing
Clinical narrative: Patient was given PNEUMOVAX 23 vaccine. After 5 minutes, patient started to complain of throat narrowing and difficulty breathing. Patient also developed urticarial rash on face. Oxygen sat was 93% with HR 113/min. Patient was given 7.5 ml Diphenhydramine HCl 12.5 mg/5 ml suspension. Patient's O2 sat improved to 98% on room air a few minutes after, but feeling drowsy. Patient was tachycardiac with good air entry and mild wheezing. EMS arrived thereafter.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium enema, Intestinal operation, Intussusception, Ultrasound abdomen, Urinary system X-ray
Clinical narrative: Patient developed intussusception with bilious emesis. Barium enema failed to relieve the intussusception and require surgery.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting, X-ray
Clinical narrative: Patient developed intussusception with bilious emesis. Barium enema failed to relieve the intussusception and require surgery.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Throat irritation
Clinical narrative: Patient began to have an itchy throat after leaving the pharmacy. The discomfort continued and she went to the ER at 8:00 pm on 8/12/11 where an EPIPEN was administered. Dr. believes pt had unknown egg allergy.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Myalgia, Swelling
Clinical narrative: Pt experiencing swelling and muscle pain. Went to PCP and confirmed as "injection site infection".