chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: It was reported that a 4 year old female patient received a Tripedia, and IPOL and a MMR vaccination on 11/19/01. Reportedly 2/3 of the patient's right upper arm became swollen with indurated erythema, was warm to the touch and painful. This severe local reaction was located at the Tripedia vaccination site. The patient was seen by a physician and treatment of Prelone, ice and elevation was given. Reportedly, the patient recovered from this experience. From follow up info received on 11/19/02, it was reported that the adverse event onset was sometime in November 2001, the same month the vaccines were given. Vasodilation and injection site pain were added as codes. Peripheral edema was corrected to injection site edema. No other info was provided. The case is closed.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Eye movement disorder, Muscle spasms
Clinical narrative: A nurse reported that a 3 month old female received Prevnar, IPOL, Infanrix, and Act-Hib vaccines in August 2002. On 9/8/02, she experienced right extremity clonic jerking with persistent right eye deviation, generalized tonic/clonic activity, spasms, and a fever which peaked at 101.6 degrees F. She was taken to the ER where a diagnosis of status epilepticus was made. She was treated with diazepam per rectum and IV phenobarbital. Subsequently, she was hospitalized. A computerized tomogram of the head was unremarkable. An electroencephalogram revealed normal background save for the right occipital region which had high amplitude slowing throughout. It was not epileptiform. No fluid was obtained from a spinal tap. The reporter stated that the events were possibly related to Infanrix administration. The events resolved on 9/8/02. The reporter indicated that she submitted a report. This report was received from manufacturer.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Epilepsy, Pyrexia, Strabismus
Clinical narrative: A nurse reported that a 3 month old female received Prevnar, IPOL, Infanrix, and Act-Hib vaccines in August 2002. On 9/8/02, she experienced right extremity clonic jerking with persistent right eye deviation, generalized tonic/clonic activity, spasms, and a fever which peaked at 101.6 degrees F. She was taken to the ER where a diagnosis of status epilepticus was made. She was treated with diazepam per rectum and IV phenobarbital. Subsequently, she was hospitalized. A computerized tomogram of the head was unremarkable. An electroencephalogram revealed normal background save for the right occipital region which had high amplitude slowing throughout. It was not epileptiform. No fluid was obtained from a spinal tap. The reporter stated that the events were possibly related to Infanrix administration. The events resolved on 9/8/02. The reporter indicated that she submitted a report. This report was received from manufacturer.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Muscle spasms, Pyrexia, Status epilepticus, Strabismus
Clinical narrative: A nurse reported that a 3 month old female received Prevnar, IPOL, Infanrix, and Act-Hib vaccines in August 2002. On 9/8/02, she experienced right extremity clonic jerking with persistent right eye deviation, generalized tonic/clonic activity, spasms, and a fever which peaked at 101.6 degrees F. She was taken to the ER where a diagnosis of status epilepticus was made. She was treated with diazepam per rectum and IV phenobarbital. Subsequently, she was hospitalized. A computerized tomogram of the head was unremarkable. An electroencephalogram revealed normal background save for the right occipital region which had high amplitude slowing throughout. It was not epileptiform. No fluid was obtained from a spinal tap. The reporter stated that the events were possibly related to Infanrix administration. The events resolved on 9/8/02. The reporter indicated that she submitted a report. This report was received from manufacturer.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Headache, Hypersensitivity, Pruritus, Rash, Rash erythematous
Clinical narrative: Information has been received from a health care professional concerning a 74 year old female was vaccinated with a dose of Fluzone (lot number U0911BA) on 10/11/02. The next day, patient noticed a small rash on her abdomen. On 10/13/02, the sunburn like rash extended from the back of her neck to the buttocks and from both of her shoulders down to the wrists. She was presented to hospital and hospitalized for 3 days with the treatment of antibiotics and Benadryl. The rash resolved. Patient also received a dose of pneumonia vaccine. Per reporter, this information has been reported verbally tot he FDA. Follow up correspondence received on 11/4/02 confirmed that the pt's date of birth is 8/11/27. The pt's age is 75 years, not 74 years as previously reported. This case is closed. Follow up on 11/18/2003: "From additional correspondence received on 08/27/2003, the route and site information for both products were provided, as well as the lot number and manufacturer of the pneumococcal vaccine.  The responsible physician information was also provided.  No further information is anticipated, this case is considered closed.  From additional information received on 11/07/2003 from another manufacturer (Merck), no new medical information was provided.  The other manufacturer reference number is WAES0309USA00237.  No further information is anticipated, this case is considered closed."
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Rash
Clinical narrative: Information has been received from a health care professional concerning a 74 year old female was vaccinated with a dose of Fluzone (lot number U0911BA) on 10/11/02. The next day, patient noticed a small rash on her abdomen. On 10/13/02, the sunburn like rash extended from the back of her neck to the buttocks and from both of her shoulders down to the wrists. She was presented to hospital and hospitalized for 3 days with the treatment of antibiotics and Benadryl. The rash resolved. Patient also received a dose of pneumonia vaccine. Per reporter, this information has been reported verbally tot he FDA. Follow up correspondence received on 11/4/02 confirmed that the pt's date of birth is 8/11/27. The pt's age is 75 years, not 74 years as previously reported. This case is closed. Follow up on 11/18/2003: "From additional correspondence received on 08/27/2003, the route and site information for both products were provided, as well as the lot number and manufacturer of the pneumococcal vaccine.  The responsible physician information was also provided.  No further information is anticipated, this case is considered closed.  From additional information received on 11/07/2003 from another manufacturer (Merck), no new medical information was provided.  The other manufacturer reference number is WAES0309USA00237.  No further information is anticipated, this case is considered closed."
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain upper, Arthralgia, Balance disorder, Cerebrovascular accident, Dizziness
Clinical narrative: According to health room records, patient missed 5 days of school from 8/01 to 1/16/02. On 1/16/02, he was absent with clinic log showing an episode of bronchitis. Patient's mother took him to his doctor on the 17th for treatment of the bronchitis. While they were there, patient received the first in the series of hepatitis B vaccinations. He was absent the 18th with complaints of fever, stomach ache, vomiting, and diarrhea. He tried to return the 19th, but clinic log shows he went home in the late morning with worsening symptoms. Patient was absent 12 days in February and March with unresolved flu-like symptoms and fever. On 4/2/02, patient had another doctor's appointment and received the #2 hepatitis B vaccine. The next day he came to school , but had to leave late in the morning because of increasing symptoms of nausea, vomiting, diarrhea, and stiffness in neck and shoulders, fever, fatigue, pain in neck, shoulders, knees and back, and severe right side pain under ribs. Patient continued to have unrelieved symptoms the entire week. On 4/5, patient was taken to the ER with complaint of pain all over the left side of the body, left sided limpness, numbness, and weakness, slurred speech, and severe right side pain, tender to tough. Hepatitis tests were negative. Liver enzymes elevated. Sclera of eyes slightly jaundiced. 4/6 Patient was taken again to ER with increasing severity of above symptoms. Symptoms continued throughout the next week with increasing fatigue and joint pain. On 4/10 the school received a doctor's excuse for absences for the previous week due to flu. Patient was only able to attend school two days during the month of April and was placed on home bound instruction starting 5/2/02. Patient continued through May and June with episodes of severe right side pain, collapsing on several occasions due to sudden, severe onset of pain that caused him to double over and fall. 5/26 he was taken to ER with an episode of vomiting diarrhea and doubling over with right side pain. Patient was referred to a li...Per 60 day follow up: Pt did not recover. Pt has not recovered from this. He has some days he can't move without a lot of pain. He has missed a lot of school because of this. The doctors are not able to help him much. They can only give him pain killers. There are days that I can't even touch him softly without him crying out in pain. He goes to school only 1/2 days. Pt has been in and out of ER many times with liver, joint pain and stroke like problems. Can you help in finding some help to get him better? Thank you for your help. 01/04/2003. An annual report received 11/14/2003 adds: He now gets headaches 2 or more a week. Microstrokes keep him from learning at a higher level. He has pain in all of his jointes. Misses a lot of school from the Hep B vaccine. No doctor will help him get better.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Dysarthria, Gait disturbance, Headache, Hemiparesis, Hypoaesthesia
Clinical narrative: According to health room records, patient missed 5 days of school from 8/01 to 1/16/02. On 1/16/02, he was absent with clinic log showing an episode of bronchitis. Patient's mother took him to his doctor on the 17th for treatment of the bronchitis. While they were there, patient received the first in the series of hepatitis B vaccinations. He was absent the 18th with complaints of fever, stomach ache, vomiting, and diarrhea. He tried to return the 19th, but clinic log shows he went home in the late morning with worsening symptoms. Patient was absent 12 days in February and March with unresolved flu-like symptoms and fever. On 4/2/02, patient had another doctor's appointment and received the #2 hepatitis B vaccine. The next day he came to school , but had to leave late in the morning because of increasing symptoms of nausea, vomiting, diarrhea, and stiffness in neck and shoulders, fever, fatigue, pain in neck, shoulders, knees and back, and severe right side pain under ribs. Patient continued to have unrelieved symptoms the entire week. On 4/5, patient was taken to the ER with complaint of pain all over the left side of the body, left sided limpness, numbness, and weakness, slurred speech, and severe right side pain, tender to tough. Hepatitis tests were negative. Liver enzymes elevated. Sclera of eyes slightly jaundiced. 4/6 Patient was taken again to ER with increasing severity of above symptoms. Symptoms continued throughout the next week with increasing fatigue and joint pain. On 4/10 the school received a doctor's excuse for absences for the previous week due to flu. Patient was only able to attend school two days during the month of April and was placed on home bound instruction starting 5/2/02. Patient continued through May and June with episodes of severe right side pain, collapsing on several occasions due to sudden, severe onset of pain that caused him to double over and fall. 5/26 he was taken to ER with an episode of vomiting diarrhea and doubling over with right side pain. Patient was referred to a li...Per 60 day follow up: Pt did not recover. Pt has not recovered from this. He has some days he can't move without a lot of pain. He has missed a lot of school because of this. The doctors are not able to help him much. They can only give him pain killers. There are days that I can't even touch him softly without him crying out in pain. He goes to school only 1/2 days. Pt has been in and out of ER many times with liver, joint pain and stroke like problems. Can you help in finding some help to get him better? Thank you for your help. 01/04/2003. An annual report received 11/14/2003 adds: He now gets headaches 2 or more a week. Microstrokes keep him from learning at a higher level. He has pain in all of his jointes. Misses a lot of school from the Hep B vaccine. No doctor will help him get better.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Hypotonia, Influenza like illness, Liver function test abnormal, Musculoskeletal stiffness, Nausea
Clinical narrative: According to health room records, patient missed 5 days of school from 8/01 to 1/16/02. On 1/16/02, he was absent with clinic log showing an episode of bronchitis. Patient's mother took him to his doctor on the 17th for treatment of the bronchitis. While they were there, patient received the first in the series of hepatitis B vaccinations. He was absent the 18th with complaints of fever, stomach ache, vomiting, and diarrhea. He tried to return the 19th, but clinic log shows he went home in the late morning with worsening symptoms. Patient was absent 12 days in February and March with unresolved flu-like symptoms and fever. On 4/2/02, patient had another doctor's appointment and received the #2 hepatitis B vaccine. The next day he came to school , but had to leave late in the morning because of increasing symptoms of nausea, vomiting, diarrhea, and stiffness in neck and shoulders, fever, fatigue, pain in neck, shoulders, knees and back, and severe right side pain under ribs. Patient continued to have unrelieved symptoms the entire week. On 4/5, patient was taken to the ER with complaint of pain all over the left side of the body, left sided limpness, numbness, and weakness, slurred speech, and severe right side pain, tender to tough. Hepatitis tests were negative. Liver enzymes elevated. Sclera of eyes slightly jaundiced. 4/6 Patient was taken again to ER with increasing severity of above symptoms. Symptoms continued throughout the next week with increasing fatigue and joint pain. On 4/10 the school received a doctor's excuse for absences for the previous week due to flu. Patient was only able to attend school two days during the month of April and was placed on home bound instruction starting 5/2/02. Patient continued through May and June with episodes of severe right side pain, collapsing on several occasions due to sudden, severe onset of pain that caused him to double over and fall. 5/26 he was taken to ER with an episode of vomiting diarrhea and doubling over with right side pain. Patient was referred to a li...Per 60 day follow up: Pt did not recover. Pt has not recovered from this. He has some days he can't move without a lot of pain. He has missed a lot of school because of this. The doctors are not able to help him much. They can only give him pain killers. There are days that I can't even touch him softly without him crying out in pain. He goes to school only 1/2 days. Pt has been in and out of ER many times with liver, joint pain and stroke like problems. Can you help in finding some help to get him better? Thank you for your help. 01/04/2003. An annual report received 11/14/2003 adds: He now gets headaches 2 or more a week. Microstrokes keep him from learning at a higher level. He has pain in all of his jointes. Misses a lot of school from the Hep B vaccine. No doctor will help him get better.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Neck pain, Pyrexia, Vomiting
Clinical narrative: According to health room records, patient missed 5 days of school from 8/01 to 1/16/02. On 1/16/02, he was absent with clinic log showing an episode of bronchitis. Patient's mother took him to his doctor on the 17th for treatment of the bronchitis. While they were there, patient received the first in the series of hepatitis B vaccinations. He was absent the 18th with complaints of fever, stomach ache, vomiting, and diarrhea. He tried to return the 19th, but clinic log shows he went home in the late morning with worsening symptoms. Patient was absent 12 days in February and March with unresolved flu-like symptoms and fever. On 4/2/02, patient had another doctor's appointment and received the #2 hepatitis B vaccine. The next day he came to school , but had to leave late in the morning because of increasing symptoms of nausea, vomiting, diarrhea, and stiffness in neck and shoulders, fever, fatigue, pain in neck, shoulders, knees and back, and severe right side pain under ribs. Patient continued to have unrelieved symptoms the entire week. On 4/5, patient was taken to the ER with complaint of pain all over the left side of the body, left sided limpness, numbness, and weakness, slurred speech, and severe right side pain, tender to tough. Hepatitis tests were negative. Liver enzymes elevated. Sclera of eyes slightly jaundiced. 4/6 Patient was taken again to ER with increasing severity of above symptoms. Symptoms continued throughout the next week with increasing fatigue and joint pain. On 4/10 the school received a doctor's excuse for absences for the previous week due to flu. Patient was only able to attend school two days during the month of April and was placed on home bound instruction starting 5/2/02. Patient continued through May and June with episodes of severe right side pain, collapsing on several occasions due to sudden, severe onset of pain that caused him to double over and fall. 5/26 he was taken to ER with an episode of vomiting diarrhea and doubling over with right side pain. Patient was referred to a li...Per 60 day follow up: Pt did not recover. Pt has not recovered from this. He has some days he can't move without a lot of pain. He has missed a lot of school because of this. The doctors are not able to help him much. They can only give him pain killers. There are days that I can't even touch him softly without him crying out in pain. He goes to school only 1/2 days. Pt has been in and out of ER many times with liver, joint pain and stroke like problems. Can you help in finding some help to get him better? Thank you for your help. 01/04/2003. An annual report received 11/14/2003 adds: He now gets headaches 2 or more a week. Microstrokes keep him from learning at a higher level. He has pain in all of his jointes. Misses a lot of school from the Hep B vaccine. No doctor will help him get better.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pain
Clinical narrative: 10/17 Weakness progressing to complete flacidity in legs. Diagnosis - acute transverse myelitis. No CNS involvement. 10/22 Some recovery noted, not fully recovered yet. Pt began it experience same back pain/ weakness within 2-3 days at injection (oct 3-4th) Discahrged from hospital 11/29/2002.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Apnoea, Feeling hot, Pallor, Pulse absent, Syncope
Clinical narrative: A report was received a health professional on 10/15/02, concerning a 45year old female patient who experienced no cartoid pulse, stopped breathing and collapsed, immediately after receiving Fluvirin on 10/15/2002. The patient had no relevant medical history and was not taking any other medications. She had receive the influenza vaccine in the past  ( Fall 2001) but could not confirm whether or not it had been Fluvirin. On 10/15/02, the patient received Fluvirin. Immediately after, the patient complained that she felt very warm. The patient's face then turned ashen and she slumped over. The nurse administering the Fluvirin could not detect a cartoid pulse and noted that the patient had stopped breathing for approximately one minute. At that time, emergency paramedics were called. the nurse was initiating CPR when the patient roused and asked what was going on. She was then taken by the paramedics to hospital for observation. The patient recovered without sequalae on the same day. The patient was described as being healthy and an endurance runner, and had a baseline blood pressure of 127/80 with a pulse of 48. The reporter has assessed the relationship of Fluvirine to the event as probable. The follow up states apical rate dropped to 42, and the vaccinee was transported to hospital by ambulance. The vaccinee was admitted to a coronary care unti under the care of a cardiologist for 1.5 days. An EKG, MRI, and EEG were performed. The diagnosis was of severe vasodilation leading to shock resulting in lack of oxygen to the brain, which resulted in the vaccinee's heart stopping. At the time of the report the vaccinee had recovered. There was insufficient info to determine the reporter's causality assessment.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Injection site reaction, Injection site swelling
Clinical narrative: Dose given 10/4/02 about 17:00. On 10/05/02, awoke with local reaction at site of injection approximately 2 inches in diameter. Extreme soreness in shoulder muscle treated with Acetaminophen 1000mg. 17:00-18:00--Nausea, diarrhea 3 times, excessive sweating followed by chills and rigors. Rigors continued until about 20:00 with treatment of hot bath, acetaminophen 1000mg, and bed rest. Excessive sweating continued until 03:00. Local reaction at site with swelling approximately 5 inches in diameter continues as of reporting time with shoulder soreness and tenderness at site of injection. No fever reported at any time.
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Shoulder pain
Clinical narrative: Dose given 10/4/02 about 17:00. On 10/05/02, awoke with local reaction at site of injection approximately 2 inches in diameter. Extreme soreness in shoulder muscle treated with Acetaminophen 1000mg. 17:00-18:00--Nausea, diarrhea 3 times, excessive sweating followed by chills and rigors. Rigors continued until about 20:00 with treatment of hot bath, acetaminophen 1000mg, and bed rest. Excessive sweating continued until 03:00. Local reaction at site with swelling approximately 5 inches in diameter continues as of reporting time with shoulder soreness and tenderness at site of injection. No fever reported at any time.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Hives, urticaria.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red, swollen, hot to touch "band" across width of left arm above elbow approximately 4" below where vaccine was given.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red, swollen, hot 4" band across width of arm (right) above elbow. Approximately 3" below hwere Pneumovax was given. 1 week later, it is gone.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Chest pain, Neck pain
Clinical narrative: A report was received from a health professional on 10/15/02, concerning a 34 year old male patient who experienced pinching chest pain and neck pain after receiving Fluvirin on 10/14/02. the patient had been in excellent health and has no known drug allergies. At 09:15 on 10/14/02, the patient experienced pinching chest pain and neck pain, after receiving the Fluvirin vaccine 15 minutes earlier. The patient complained of severe pinching  chest pain on the upper left chest and severe pain on the left side of the neck. The patient had a weak pulse and was admitted to the ER. At the time of the ambulance arriving the patient's heart rate was 146/100. At the ER the patient was given four tablets of aspirin and one tablet of Nitroglycerin which relieved the chest discomfort. On the same day, the patient recovered and was discharged from the ER. The reporter has assessed the relationship of study medication to the event as possible.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Condition aggravated, Dysphonia
Clinical narrative: Hoarseness (one-day after I received the vaccine) on the 3rd day I began to take Bactrim DS because of asthma condition. One week later I am still hoarse.
Age: 14.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Fatigue, Heart rate increased, Pyrexia
Clinical narrative: 8 hours post inj. temp 102.6 x 3 days. Rapid pulse, fatigue, day 4 temp down 99.8 c/o extreme fatigue x 4 days. 10/21/02 saw pediatrician-no diagnosis other than "let it run its course" child back in school still c/o fatigue and rapid pulse. To f/u with provider within 48 hours.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypokinesia, Injection site hypersensitivity, Injection site pain, Pain
Clinical narrative: Five minutes after vaccine (flu) given in L deltoid, severe pain show down from site of injection to L ring finger. Complains of severe pain, hypersensitivity, tingling and some numbness. Has seen PCP, ortho. Now pt is on Neurontin and Mohic, unable to use left arm.  As per follow up: Neurologist diagnosed of brachial neuritis . On Vioxx and Percocet. Excruciating pain, numbeness, and tingling in left side of the neck. Doing physical therapy three times a week. Could last up to one year.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Radiculitis brachial
Clinical narrative: Five minutes after vaccine (flu) given in L deltoid, severe pain show down from site of injection to L ring finger. Complains of severe pain, hypersensitivity, tingling and some numbness. Has seen PCP, ortho. Now pt is on Neurontin and Mohic, unable to use left arm.  As per follow up: Neurologist diagnosed of brachial neuritis . On Vioxx and Percocet. Excruciating pain, numbeness, and tingling in left side of the neck. Doing physical therapy three times a week. Could last up to one year.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Red, swollen area left deltoid, 60cmx45cm for 2 days. Left arm pain.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Injection site reaction
Clinical narrative: Mom called 10/21/02 stating that on morning of 10/19/02 patient got blister like spot at sight of chicken pox vaccination with a large red spot around it. Patient now also has eight red spots on abdomen. Advised mother to take him to see family physician today.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria, Wheezing
Clinical narrative: Hives and wheezing. Received shot in morning; went to hospital at 12:30AM; received cortisone shot and allergy pill to take at home.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: 1PM Phone call from patient states arm red, hot and swollen. 4PM Phone call from son states mom at doctor; arm is very swollen. Talked to patient at 4:30PM at home; got shot of Decadron and oral Benadryl. Talked with doctor 10/17/02 states severe local reaction.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: R thigh red spot where DTaP given, redness, warmth, tense.
Age: 2.25
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site oedema
Clinical narrative: L thigh swollen from knee to inguinal region-none on back.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dyskinesia, Staring
Clinical narrative: DTaP received at 11:00AM on 10/21/02. Patient developed staring spells and jerking movements later in the evening 10/21/02. Three episodes total as of 10/22/02 at 11:00AM. Patient was afebrile.
Age: 4.6
Sex: F
Vaccine: HEP
Symptoms: Irritability, Myalgia, Pain, Pyrexia, Rhinitis
Clinical narrative: Mother called on 10/16/02. Hep B vaccine was administered 9/26/02. She states that on 9/27, pt became irritable and began complaining of intermittent arm and leg pain, to the point that she needed to be carried by her parents. There was no redness, warmth or swelling noted by parents. On 10/11, the pt developed fever followed by cold symptoms. We agreed that was viral. She still had myalgias as well. I spoke with 10/22/02-she no longer is complaining of muscle pain, is not irritable and getting over her cold. Mom is afraid to give her another dose of vaccine.
Age: 11.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Asthenia, Facial palsy, Hypoaesthesia
Clinical narrative: Weakness, right facial numbness, right orbicularis oculi; right bells palsy.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Abdominal pain upper, Ear pain, Neck pain, Pain, Pharyngolaryngeal pain
Clinical narrative: Rapid onset within 3 hours: pain first, stomach; 2nd back; third arms; fourth legs; fifth neck (sequentially). Ear ache and sore throat. MD Dx: Throat infection and reaction to immunization. Tx: ABX, medicated with codeine. No injection site trauma. As of 10/21, complaints resolving, only minor discomfort remains.
Age: 1.08
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Immediately after immunization dime sized hive noticed directly below injection site. Gave hcild 12.5mg po liq Benadryl-after 20 min. decreased in size of hive.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: It was reported that a 15 month old male patient received a Tripedia vaccination on 1/18/02. Reportedly the patient developed a large, local reaction the next day, seen by physician on Monday, the reaction measured 2cm in diameter.
Age: 43.0
Sex: U
Vaccine: TTOX
Symptoms: Discomfort, Feeling hot, Headache, Injection site urticaria, Pain
Clinical narrative: I was given the flu and PPV vaccine on same arm and same sight. Severe arm discomfort for 2 days. It was so much that it would wake me up when sleeping. Area was warm and on I had body aches, headache and on the 2nd day large red hives developed on the injection sight and the area was very warm to touch. I have gotten the flu shot for the past 7 years and never had this type of reaction. This is first time for PPV shot.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site hypersensitivity, Oedema
Clinical narrative: Site of injection very red ,swollen,warm to touch
Age: 0.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity
Clinical narrative: baseball sized reddened hot area at injection site
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema
Clinical narrative: Severe swelling and redness in upper arm No treatment given by PCP
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Swollen upper left arm (elbow to shoulder) red in appearance, warm to the touch.  Childrens Tylenol recommended per package instructions for age, cool compresses to affected area (wet wash cloth).
Age: 1.25
Sex: F
Vaccine: DTAP, PNC
Symptoms: Antinuclear antibody positive, Irritability, Joint swelling, Musculoskeletal stiffness, Rheumatoid arthritis
Clinical narrative: About 2 days after DTaP and Prevnar administered, patient developed JRA symptoms--stiff leg, fussy; swollen joints. Patient is still undergoing treatment. Mom is convinced these vaccines gave her JRA even though there is a history in family. Per 60 day follow up: Pt has not recovered. Still stiffness and joint swelling in extremities (continues JRA Sx's) No further comments
Sex: M
Vaccine: DTP, IPV
Symptoms: Congenital brain damage, Crying, Eye disorder, Neurodevelopmental disorder, Screaming
Clinical narrative: High pitch screaming, screamed until his voice gave out, screamed between 6-8 hours. Per 60 day follow up:The pt has not recovered. Brain damage, eye problems, motor skills. They need to do away with the vac. program, it damages children and adults. Also talk to follow up nurse on 01/02/2003, they have all missing info.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Tenderness and induration-mother took baby to the doctor on 10/7/02, mother received instructions to apply hot and cold compresses to child's thigh.
Age: 1.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Erythema, swelling, rash slightly raised hot, tender to touch L thigh.
Age: 1.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site warmth
Clinical narrative: Erythema, swelling, rash slightly raised hot, tender to touch L thigh.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site swelling
Clinical narrative: Received vaccine Wednesday; light itchy only Thursday. Friday evening, site was hard, red, itchy and swelling 4 inches in diameter. Rx with ice. Yesterday and today, site is itchy, red, and very warm. Advised to continue to observe. No systemic symptoms reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Received vaccine Wednesday; light itchy only Thursday. Friday evening, site was hard, red, itchy and swelling 4 inches in diameter. Rx with ice. Yesterday and today, site is itchy, red, and very warm. Advised to continue to observe. No systemic symptoms reported.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Approximately one hour after vaccine administration, pt c/o numbness and tingling of R cheek and jaw along with numbness and tingling of R shoulder extending to R elbow. Symptoms disappeared post 24 hours.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Received dose from pre-filled syringe provided by manufacturer. Returned to clinic site approx 20 min later, c/o pain in upper shoulder, neck area with tingling in face and jaw, side of injection. BP, HR wnl for pt. Evaluated throughout day. No resp symptoms. Status checked 10/21 resolved.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Hypoaesthesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: I work as a nurse. I took the annual flu shot offered by our hospital for employees. Several hours after the injection I developed some soreness to injection site and upper arm-which I expected. Later in evening as I was working in the hospital I felt my left arm going numb and some tingling. I mentioned this to other workers at the time. During the night I awakened many times due to numbness in my arm and the inability to lie on my left side due to arm pain, severe swelling of deltoid area. I went to a mirror to check on the site and the area was swollen greatly and a large-size of a Progresso soup can-reddened circular area at injection site was highly visible. My fingers went from tingling during the day t complete numbness by day's end on the 12th of October. The numbness resolved on Tuesday the 15th. I was very nervous about this, called my personal physician on Saturday morning, the MD on call returned my phone call and told me it would just resolve itself-and offered me pain killers. I told him the discomfort was NOT the problem, I just needed reassurance that my arm would be okay. He told me to keep an eye on it. I have received the flu shot other years since the age of 25 or so. I have never had any reaction before to a flu shot other than minor discomfort at injection site for a few hours Never had a bullseye mark either.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: I work as a nurse. I took the annual flu shot offered by our hospital for employees. Several hours after the injection I developed some soreness to injection site and upper arm-which I expected. Later in evening as I was working in the hospital I felt my left arm going numb and some tingling. I mentioned this to other workers at the time. During the night I awakened many times due to numbness in my arm and the inability to lie on my left side due to arm pain, severe swelling of deltoid area. I went to a mirror to check on the site and the area was swollen greatly and a large-size of a Progresso soup can-reddened circular area at injection site was highly visible. My fingers went from tingling during the day t complete numbness by day's end on the 12th of October. The numbness resolved on Tuesday the 15th. I was very nervous about this, called my personal physician on Saturday morning, the MD on call returned my phone call and told me it would just resolve itself-and offered me pain killers. I told him the discomfort was NOT the problem, I just needed reassurance that my arm would be okay. He told me to keep an eye on it. I have received the flu shot other years since the age of 25 or so. I have never had any reaction before to a flu shot other than minor discomfort at injection site for a few hours Never had a bullseye mark either.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: Had difficulty breathing.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Pruritus
Clinical narrative: Patient was given flu shot at 13:58 and instructed to wait 20 minutes in the clinic rest area in case of any reactions. Patient came back at 14:15 with complaints of itching on the face, around the nose and at vaccine site. Vital signs checked: temperature 98.9; pulse 63; respiratory rate 20; BP 109/53. Benadryl 50mg PO given. No respiratory distress. Patient told to wait 30 minutes and was discharged.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pruritus
Clinical narrative: Left arm red, grapefruit size area, slight itching, not warm to touch. Treatment with cool compresses, Benadryl and Tylenol.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: Left arm red; lemon size. Few other areas. Slight warmth to touch. Patient booked with doctor.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Swelling
Clinical narrative: 10/22/02 Received pneumococcal vaccine right deltoid. Came in on 10/23/02 right arm swollen from shoulder down to elbow. Red and warm to touch. Had fever last night. Husband stated all this started last night. Gave Zyrtec in office. Took Tylenol last night. Prescription written for antibiotic, Zyrtec and Tylenol.
Age: 82.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Received both flu and pneumococcal shot in same arm. About one hour after receiving shots, arm began to hurt, turned red and hot. Required medical attention by doctor the next day. Arm was red, hot and swollen.
Age: 11.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 9/27/02: 7am-two spots with pruritis. 7pm-head to toe hives/pruritis. Benadryl 25mg with relief from pruritis only. 9/28/02: hives head to toe remain. 10am Benadryl 25mg-relieved pruritis only. 9pm increase in hives and pruritis-Benadryl 50mg and hives faded and prutitis relieved. 9/29/02 8am, Benadryl 25mg-hives and pruritis relieved. 8pm hives head to toe-Benadryl 25mg relieved itching only. 9/30/02 8:30 am hives worse head to toe and more of facial hives/pruritis. Mother called family practice and spoke with PA, instructed to give Benadryl 25-50mg q 4h relieved 50mg at 8:30am 25mg at 12:30pm 25mg at 4:30pm 50mg at 8:30 pm 10/1/02 awoke and symptom-free.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Numerous vesicle like lesions upper chest/back. R shoulder area. Some on both arms, lower abd.
Age: 4.7
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pharyngitis, Pyrexia, Rhinitis
Clinical narrative: Cold sx 1 1/2 wks. Fever blisters, 2 scabbed over.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Sensation of heaviness
Clinical narrative: 3 days after Td shot, arm felt heavier, sharp pain "like a knife stuck in my bones." Called nurse to take Tylenol call back if sx continue. Called back 1 wk later-states pain in arm wsa worse, encouraged to see MD. Nurse at MD's office to take Tylenol scheduled appt. in 1wk. Pt did not keep appt because the pain went away. In office today, states no pain/no pain arm movement. No swelling or redness or knot noticed at site.
Age: 51.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site abscess sterile, Injection site erythema
Clinical narrative: Right deltoid got sterile abscess/redness at site.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Swelling, redness, hot to touch. Tx-reassurance.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Arthritis, Hypokinesia, Joint stiffness, Pain
Clinical narrative: C/O pain and stiffness to arms and shoulders after vaccines bad enough that some days he couldn't raise his arms above head. Reports he has followed up with physician and received steroid shots in each shoulder resulting in pain relief to L side but not to R. Still in care. The follow up received on 9/24/03 states stiffness in shoulders resulting into arthritis. Shot dates for hep B 6/13/01, 12/19/01 and 4/15/02.
Age: 0.1
Sex: F
Vaccine: HEP, HIBV
Symptoms: Irritability
Clinical narrative: 2hrs after vaccine-extremely fussy for ~ 1hr 15mins.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain
Clinical narrative: DT given 10/15/02-redness, achiness into arm, back, axilla on 10/16 and 10/17. Decreased redness 10/18/02 achiness continued.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cough, Diarrhoea, Injection site erythema, Injection site induration, Nasal congestion
Clinical narrative: 2 days after vaccination, diarrhea started; red, firm spot at injection site DTaP. Rubbing his eyes. Rash all over trunk, mild cough and congestion. Given Zyrtec and Keflex.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash
Clinical narrative: 2 days after vaccination, diarrhea started; red, firm spot at injection site DTaP. Rubbing his eyes. Rash all over trunk, mild cough and congestion. Given Zyrtec and Keflex.
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Immunization site: swollen, induration, erythema, and local liproline increased. Tenderness at site.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Cold sweat, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Buzzing feeling in diaphragm. Sweating, calminess, chills, and shortness of breath, and dizziness occurred for about 5 minutes for a period of 30 minutes.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Hypotonia, Loss of consciousness, Nausea, Pallor, Tremor
Clinical narrative: Paleness, limp, passed out, incontinent nausea, trembling and shaking. Mother stated she took child to hospital. Continue to see MD. Pale for about one hour.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Lt thigh swollen-red area 4x4inch lump inside of red area 2x2. No fever. Pt  rev in 2d if swelling has not gone down.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site rash
Clinical narrative: Rash at the site of injection approx 8-10 hrs to giving shot. Resolved the next day.
Age: 2.5
Sex: F
Vaccine: PPV
Symptoms: Anorexia, Laboratory test abnormal, Lethargy, Pyrexia, Red blood cell abnormality
Clinical narrative: Father requested findings be reported: 2 weeks after the vaccine, a CBC showed echinocytes, basophilic stippling and polychromasia. The follow up received on 11/5/02 states, "9/11/02-lethargy, loss of appetite, fever of 102 F, duration 12 hrs. 9/13/02-pre-op CBC for cochlear implant showed echimocytes basophilic stippling and polychromasia. 10/9/02-Dr calls with results, suspects lead poisoning. 10/11/02-lead test and CBC slides showed no lead and blood abnormalities disappeared."
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin ulcer
Clinical narrative: Doctor's nurse practitioner called in on 10/18 as vaccine failure. Mom called back on 10/14: < 20 lesions right arm pit 5 lesions there and another few in left arm pit. Itching.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site infection, Pyrexia, Swelling
Clinical narrative: A report was received from a health professional on 10/15/02, concerning a 71 year old female patient who experienced injection site redness, infection and fever requiring medical intervention, after receiving Fluvirin on 10/8/02. On 10/11/02, the patient experienced redness at left arm, injection site and fever after receiving Fluvirin in the left arm on 10/8/02. On examination the left arm was red and swollen, with a streak running down her entire left arm. The patient had a temperature of 38.33 degrees C. The patient was treated with an unknown dose of oral ciprofloxacin and was sent home. At the time of this report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as probable.
Age: 46.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Red blood cell sedimentation rate increased, Rheumatoid arthritis
Clinical narrative: Report A0357280A (formerly 2002000436-1) describes possible rheumatoid arthritis or osteoarthritis in a 46 year old female who received Lyme disease vaccine recombinant OspA (LYMErix). There was no relevant medical history or concurrent medication. The vaccinee did not have gout, psoriasis, Crohn's disease, or history of Lyme disease. There was no family history of rheumatoid arthritis or lupus. In June 2000 (exact date unknown), the vaccinee received her third injection of LYMErix. The vaccinee reported to the physician that she began to experience joint pain in her knee, neck, shoulder, and legs in January 2001, approximately 6 months post immunization. On physical examination, no joints were noted to be warm or swollen. Serology for Lyme disease was positive initially, then negative. erythrocyte sedimentation rate was increased. Bone scan demonstrated mild arthritis changes in several joints. The physician stated that the diagnostic considerations were osteoarthritis, rheumatoid arthritis, polyarthralgia, polyarthritis secondary to LYMErix injections. The arthralgia was treated with celecoxib and ibuprofen. The reporter stated that the arthralgia was moderate in severity and was possibly related to LYMErix administration. As of 2/4/02, the arthralgia persisted. The adverse events of rheumatoid arthritis and osteoarthritis do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Pain in muscle area on top. Pain went on until 2am and went down to the elbow.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Epistaxis, Oedema, Pain, Pharyngolaryngeal pain
Clinical narrative: Initial pain and swelling.  2-3 hours later post nasil drip followed that evening by sore throat.  Increased the next day with a slight nose bleed at night.  Some light-headed-ness and dizziness. Health facility provided cold medication (OTC).  Also two spots on chest they said may symbolize bacteria infection.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Postnasal drip
Clinical narrative: Initial pain and swelling.  2-3 hours later post nasil drip followed that evening by sore throat.  Increased the next day with a slight nose bleed at night.  Some light-headed-ness and dizziness. Health facility provided cold medication (OTC).  Also two spots on chest they said may symbolize bacteria infection.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Feeling hot, Oedema
Clinical narrative: Vaccine was administered to left deltoid on 10/22.  Pt returned to physician's office on 10/23 complaining of discomfort in left upper arm.  Area was swollen, red, and warm.  Patient was treated with 1 gm of Ceftriaxone administered IM in the gluteal region.  The patient was also prescribed Ceftin to take orally.  Patient returne to the office on 10/24 for a follow-up.  The redness and swelling was still present, but somewhat diminshed.  Patient described pain to be greatly reduced.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Diabetes mellitus, Pollakiuria, Thirst, Vision blurred
Clinical narrative: Blurred vision, thirst, increased unination in mid-August 2002. Developed diabetes mellitis (type 1) 2.5 to 3 monthes after vaccine.