chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Fatigue, Headache, Injection site reaction, Pain
Clinical narrative: It was reported that an 18 year old female pt received Menomune on 9/9/03. The next day, on 9/10/03, the pt developed a local reaction at the site, as well as headache, body aches and fatigue. The pt was seen by a physician on 9/12/03. Reportedly, the symptoms resolved on an unspecified date and the pt recovered.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Headache, Pain, Pharyngolaryngeal pain, Rash, Urticaria
Clinical narrative: From initial information received on 09/23/03 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that an 18 year old male pt received a dose of Menomune, Lot # UB226AB, administered in the left deltoid on 09/18/03.  On 09/19/03, the pt was achy and developed a sore throat, headache, and an all over rash.  In the ER, the pt was treated with Prednisone and Atarax for rash.  The pt is to come in for a visit on 09/23/03.  The pt's recovery status is unknown.  From additional information received on 10/14/03 from a health care professional, it was reported that the pt described the rash as hives on his arms, which measured the size of a baseball.  The pt's full address, past medical history and concomitant medications were provided.  The pt was seen in an ER room on 09/21/03.  A throat culture was done on 09/25/03, which was negative.  The pt reportedly recovered from these events.  No further information is anticipated, this case is considered closed.
Sex: U
Vaccine: MEN, TD
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: From initial information received on 10/09/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a pt (age and gender not reported) received a third dose of TD ADS Adult, Lot # U0991AA, administered IM in the left deltoid, and a first dose of Menomune, Lot # UB483AA, administered SC in the left arm on 09/02/03 at 8:15pm.  The following day, at 8:00am, the pt experienced stiffness and achiness.  The pt's recovery status was not reported.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Malaise, Nausea, Photophobia, Pyrexia
Clinical narrative: From initial information received on 11/07/03 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 19 year old female pt received a dose of Menomune, Lot # UB335AB, administered SC in the left arm on 10/31/03.  Two days later, the pt complained of headache, malaise, low grade temperature, photophobia, and nausea.  The pt also experienced these symptoms on the third and fourth days after vaccination.  She did not have any vomiting, but did complain of photophobia.  The pt was examined by a physician on 11/05/03.  At that time the pt felt slightly better, but the symptoms persisted.  The pt denied shortness of breath, chest pain and stiff neck.  She returned to school on 11/07/03.  Reportedly, the events were still resolving at the time of this report.
Age: 51.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Periorbital oedema, Rash
Clinical narrative: rash, periorbital edema, respiratory distress.
Age: 51.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Periorbital oedema, Rash, Respiratory distress
Clinical narrative: rash, periorbital edema, respiratory distress.
Age: 1.4
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Rash
Clinical narrative: about 3 hours after recieving immunizations got a a bright red rash bilateral arms,thighs and chest returned to clinic 6 hours after immunizations and seen by doctor and given RX Benadryl po.
Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Adenoma benign, Agitation, Arthralgia, Arthritis, Confusional state
Clinical narrative: Within weeks of the Lymerix vaccine I began to feel stiff and experience joint pain.I began having headaches and found it difficult to concentrate.These symptoms have persisted and increased over the years so that I find it difficult to get through my day at work , as I constantly feel fatigued. Due to joint swelling,pain and arthritis  my activity levelis greatly reduced.I sleep alot.I have problems remembering things and have short attention span.I find myself feeling agitated,impulsive frustrated and moody with shortness of breath. I suffered a long period of sexual dysfunction that required the medical attention in 2000. After blood tests and MRI scans I was found to have developed a very uncommon hormonal imbalance hyperprolactinemia and now take Dostinex regularly.I developed arthritis and am under the care of a doctor who found that I had a certain positive genetic marker HLA. My immune system now seems compromised and I have almost constant sinus infections and/or colds. Testing has found no particular allergies and prescriptions for antibiotics,anti-inflamatories,antihistamines,pseudoephedrines have not helped. The 2nd dose of Lymerix was received in the four weeks after vaccination 10/09/1999. Medical records on 04/28/04 states: pituitary microadenoma, confusion, hyperlipidemia. Severe arthritis, hyperprolactinemia, fatiuge, short attention span, allergy like symptoms, headache.
Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Disturbance in attention, Dyspnoea, Fatigue, Headache, Hormone level abnormal
Clinical narrative: Within weeks of the Lymerix vaccine I began to feel stiff and experience joint pain.I began having headaches and found it difficult to concentrate.These symptoms have persisted and increased over the years so that I find it difficult to get through my day at work , as I constantly feel fatigued. Due to joint swelling,pain and arthritis  my activity levelis greatly reduced.I sleep alot.I have problems remembering things and have short attention span.I find myself feeling agitated,impulsive frustrated and moody with shortness of breath. I suffered a long period of sexual dysfunction that required the medical attention in 2000. After blood tests and MRI scans I was found to have developed a very uncommon hormonal imbalance hyperprolactinemia and now take Dostinex regularly.I developed arthritis and am under the care of a doctor who found that I had a certain positive genetic marker HLA. My immune system now seems compromised and I have almost constant sinus infections and/or colds. Testing has found no particular allergies and prescriptions for antibiotics,anti-inflamatories,antihistamines,pseudoephedrines have not helped. The 2nd dose of Lymerix was received in the four weeks after vaccination 10/09/1999. Medical records on 04/28/04 states: pituitary microadenoma, confusion, hyperlipidemia. Severe arthritis, hyperprolactinemia, fatiuge, short attention span, allergy like symptoms, headache.
Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Hyperlipidaemia, Hyperprolactinaemia, Joint stiffness, Joint swelling, Memory impairment
Clinical narrative: Within weeks of the Lymerix vaccine I began to feel stiff and experience joint pain.I began having headaches and found it difficult to concentrate.These symptoms have persisted and increased over the years so that I find it difficult to get through my day at work , as I constantly feel fatigued. Due to joint swelling,pain and arthritis  my activity levelis greatly reduced.I sleep alot.I have problems remembering things and have short attention span.I find myself feeling agitated,impulsive frustrated and moody with shortness of breath. I suffered a long period of sexual dysfunction that required the medical attention in 2000. After blood tests and MRI scans I was found to have developed a very uncommon hormonal imbalance hyperprolactinemia and now take Dostinex regularly.I developed arthritis and am under the care of a doctor who found that I had a certain positive genetic marker HLA. My immune system now seems compromised and I have almost constant sinus infections and/or colds. Testing has found no particular allergies and prescriptions for antibiotics,anti-inflamatories,antihistamines,pseudoephedrines have not helped. The 2nd dose of Lymerix was received in the four weeks after vaccination 10/09/1999. Medical records on 04/28/04 states: pituitary microadenoma, confusion, hyperlipidemia. Severe arthritis, hyperprolactinemia, fatiuge, short attention span, allergy like symptoms, headache.
Age: 48.0
Sex: M
Vaccine: LYME
Symptoms: Mood altered, Pharyngitis, Rhinitis, Sexual dysfunction, Sinusitis
Clinical narrative: Within weeks of the Lymerix vaccine I began to feel stiff and experience joint pain.I began having headaches and found it difficult to concentrate.These symptoms have persisted and increased over the years so that I find it difficult to get through my day at work , as I constantly feel fatigued. Due to joint swelling,pain and arthritis  my activity levelis greatly reduced.I sleep alot.I have problems remembering things and have short attention span.I find myself feeling agitated,impulsive frustrated and moody with shortness of breath. I suffered a long period of sexual dysfunction that required the medical attention in 2000. After blood tests and MRI scans I was found to have developed a very uncommon hormonal imbalance hyperprolactinemia and now take Dostinex regularly.I developed arthritis and am under the care of a doctor who found that I had a certain positive genetic marker HLA. My immune system now seems compromised and I have almost constant sinus infections and/or colds. Testing has found no particular allergies and prescriptions for antibiotics,anti-inflamatories,antihistamines,pseudoephedrines have not helped. The 2nd dose of Lymerix was received in the four weeks after vaccination 10/09/1999. Medical records on 04/28/04 states: pituitary microadenoma, confusion, hyperlipidemia. Severe arthritis, hyperprolactinemia, fatiuge, short attention span, allergy like symptoms, headache.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Gastrointestinal disorder, Grand mal convulsion, Infantile spasms, Muscle spasms
Clinical narrative: My daughter was given her two month shots on 9/22/03 and on 11/07/03 she had two Grand Mal seizures within one hour of each other.  She was then sent to the hospital where they did every test under the sun including several EEG's, a CAT Scan,MRI, and several blood tests. All of them came back negative except for the EEG's which showed infantile spasms (the worst form of childhood seizures)we have been in and out of the hospital for three months. She has gone through 5 anti-convulsant drugs(Phenobarbitol,Dilatin,Adivant,Topamax,& ACTH)none of them worked, she is now on Zonegran, which has helped control some of the seizures. Today she had a cluster of 8 break through spasms so it looks like the 6th drug might be failing.  The EEG shows that a lot of seizure activity is not seen, so she very well could have had unseen seizure activity soon after recieving her first series of shots. Her neurologist does not want her to receive any vaccines until we know more. When he feels that it is safe to get her shots her primary doctor has special ordered shots without the   Pertussis vaccine.  I had a normal and healthy pregnancy and a normal delivery. Before she got her shots she was a healthy baby. The discharge summary received on 2/26/04 states reflux. Follow up information 05/04/2004: She is still having seizures and as a result her development is delayed. She is still on two anti-epileptic medications Topamax and Zoneglan. She is still being seen by a neurologist.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Left delotid swelling itching, local pain, area not hot.  Vaccine was administered on 13 Feb 04, approximately 0930 hrs.  Symptoms subsided until 21 Feb 04.  Member reports on 22 Feb 04 to inform clinic of reaction.  Member instructed to use benadryl as needed and return if symptoms persist.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Face oedema, Rash, Urticaria
Clinical narrative: Information has been received from a consumer concerning her husband who on 12/18/03 was vaccinated with a dose of pneumococcal 23v polysacchardie vaccine (lot # 645853/0256N). On 12/22/03 the patient began breaking out in a rash and experienced facial swelling. At first, he thought his teeth were bothering him and he went to a dentist. The dentist took x-rays and examined him and said that his teeth were fine and perhaps it was a medical problem. The patient then went to his family doctor and by then he had a visible rash and facial swelling. The doctor gave him a methylprednisolone dose pack and hydroxyzine hydrochloride. The rash basically affected his arms and legs but it really was not around the site of injection. As of 2/5/04, the swelling went away and there is only a trace of the rash left, but most of January he felt poorly. The patient had no prior history of any allergies. There was no product quality complaint involved. Upon internal review, the patient's facial swelling was considered to be other important medical event (OMIC). Additional information has been requested. On 30AUG2004 the physician reproted six months post vaccination the patient has had recurring hives and a rash. The patient has complained several times and has been treated for hives/ rash on his ankles and elbows. Treatment included steroid cream and methylprednisolone (MEDROL) dose pack. Subsequently, the patient recovers. However, the hives/ rash outbreaks are monthly now and the patient insist "the rash is from the pneumococcal 23v polysaccharide vaccine".
Age: 0.63
Sex: F
Vaccine: FLUX
Symptoms: Eye disorder, Pyrexia, Strabismus
Clinical narrative: High fever per pediatrician. Stress could of caused strabismus to occur earlier. May or may not be related to shot.  Per annual follow up report surgery was requried in both eyes to tighten the muscles of her eyes. Her physican told us the high fever that was a reaction to the shot brought about a wandering eye.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Swelling, pain, redness at right upper arm for 2 days since given DTAP, MMR.  Getting worse, no anaphylaxis.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Rash
Clinical narrative: Since receiving vaccines, has had red rash near vaccine site right arm.  Received on 02/03/04 or on 02/18/04.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Blood pressure increased, Dyspnoea, Headache, Sensation of heaviness
Clinical narrative: Headache, shortness of breath, elevated blood pressure, feeling of heaviness. Seen in ER, continued to have increased blood pressure, medicated.  Returned to ER same night for increased blood pressure sent home with treatment.  Saw her regular MD next day.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Fever 102F and moderate swelling, redness and warmth 6x6cm and severe pain right (vaccine site) deltoid.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Mother stated 01/27 left arm red and bigger over area that the shots were given.  On 01/28 area looked worse.  Hard to touch and he complained of pain. She called her pediatrician, the receptionist told her he needed to be seen.  She told me that she took him to the ER at a hospital.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Cough, Irritability, Pyrexia, Rash
Clinical narrative: Fever, coughing, rash, irritability.  Seen 11/21/03 and 11/06/03.  Chronic cough 12/08/03.  Recurrent M/P rash 02/16/04.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swelling of entire left anterior thigh strotical by mother next day 12 noon.  Came for PPD reading; leg still swollen, decreased redness and is better mother stated.  02/16/04-leg back to normal.
Sex: M
Vaccine: FLUX, HEP, HEPA, MEN
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (101), generalized aches
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Rash maculo-papular, Rash pruritic
Clinical narrative: One month after Hep B #1 immunization, abdomen began to itch.  1-2 days later, red patches began to appear.  In subsequent weeks they grew in number and spread to arms and neck.  Large patch at spot of immunization which expanded from an initial patch present from the time of injection.  All patches began to develop a light center with a red outer ring after 2 weeks.  Condition prevails.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 4x2inch red, raised area on left arm, warm to touch and tender to touch.
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Nasal congestion, Pyrexia, Rash
Clinical narrative: Fever 101-103F; Developed pinpoint red rash all over body.  Nasal congestion.  Supportive treatment given.
Age: 17.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Face oedema, Vaccine positive rechallenge
Clinical narrative: Received IPV, MMR, HEP B, VARICELLA 10-12 hours later developed swollen upper lip, no shortness of breath, difficulty breathing, when to ER.
Age: 0.25
Sex: F
Vaccine: DT
Symptoms: Convulsion, Dehydration, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Received vaccine at 12:45pm on 02/04/04.  At the time of vaccination child was asymptomatic and afebrile.  Mom called to report symptoms of vomiting, diarrhea and fever 100.6 at 15:00.  Mom stated she had been giving the child Tylenol.  Mom stated child was stable at this time and she was also going to call the pediatrician.  Both the pediatrician and the health department nurse told mom to continue to watch for further changes and go to the hospital immediately if child becomes worse.  Child woke up the next day in the AM with a fever of 100.8.  The child had vomiting x3 and diarrhea x2.  Child had first seizure at 10:00am and mom took child immediately to the hospital.  Upon arriving at the hospital around 11:50 the child had second seizure and two more after that before discharge at 15:00 on 02/05/04.  Mom stated tests were done but they are unknown.  Child was sent home after being stabilized and dehydration was resolved.  Spoke with mom at 14:00 on 02/17/04.  Mom stated child has been fine since coming home from the hospital on 02/05/04.  The Hep B vaccine was given at birth also Hib, IPV, PVC7 and 2nd Hep B on 02/16/03 by the pediatrician with no adverse reaction.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, TD, VARCEL
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: 16 year old white male with history of spina bifida; shunt and latex allergy.  No shot records, came in for update.  Given Td, Hep B2, varicella #1, MMR2, IPV2.  Approximately given 9:45am. School called approximately 11:15 stating itching; hives, shortness of breath, called 911.
Age: 2.7
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Redness, swollen, hardness to left deltoid, arm was also warm.  Per NP, warm compresses and cold may be alternated and Tylenol for pain.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Swollen arm; Redness;
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema, Rash
Clinical narrative: Swollen left arm; rash;
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left deltoid red, swollen, hot.  No accompanying 5x IE: fever or malaise, child very stoic.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: Swelling and tenderness to left lateral deltoid.  Tenderness to left supraclavicular.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Hypoaesthesia, Injection site erythema, Injection site oedema
Clinical narrative: Swelling, patchy redness of entire left arm.  Also area of numbness at place where shot was administered.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Swelling, patchy redness of entire left arm.  Also area of numbness at place where shot was administered.
Age: 11.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Convulsion
Clinical narrative: Patient had a seizure like reaction versus a diptonic reaction after receiving the shot. She recovered within 15 minutes and after 1/2 hour, she completely recovered.
Age: 68.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF, IPV, TD, YF
Symptoms: Aphasia, Asthenia, Balance disorder, Difficulty in walking, Encephalitis
Clinical narrative: 2/3/04: Weakness in legs, difficulty walking Approximately 2/11/04 had fever, mild HA, difficulty speaking. 2/18/04 hospitalized for aphasia, difficulty walking, weakness, poor balance. Currently still hospitalized.Labs will be sent to CDC. From CDC: 2 samples were sent for testing: 1 is serum, 1 is CSF. 2/19/04 is serum: PCR is negative for YF RNA. IgM Elisa to YF P/N 3.0 SLE and West Nile Virus IgM negative. Igg Elisa is negative for YF, SLE, West Nile Virus, LAC and EEE. CSF collected 2/21/04. PCR negative for YF 17D RNA. IgM Elisa results consistent with an aseptic meningitis.  60 day follow up:Pt had a diagnosis of aseptic meningitis and encephalitis. It appears that the pt was sent to a rehab facility after discharge from the hospital on 12Mar04.
Age: 68.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF, IPV, TD, YF
Symptoms: Headache, Meningitis, Pyrexia, Speech disorder
Clinical narrative: 2/3/04: Weakness in legs, difficulty walking Approximately 2/11/04 had fever, mild HA, difficulty speaking. 2/18/04 hospitalized for aphasia, difficulty walking, weakness, poor balance. Currently still hospitalized.Labs will be sent to CDC. From CDC: 2 samples were sent for testing: 1 is serum, 1 is CSF. 2/19/04 is serum: PCR is negative for YF RNA. IgM Elisa to YF P/N 3.0 SLE and West Nile Virus IgM negative. Igg Elisa is negative for YF, SLE, West Nile Virus, LAC and EEE. CSF collected 2/21/04. PCR negative for YF 17D RNA. IgM Elisa results consistent with an aseptic meningitis.  60 day follow up:Pt had a diagnosis of aseptic meningitis and encephalitis. It appears that the pt was sent to a rehab facility after discharge from the hospital on 12Mar04.
Age: 68.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF, IPV, TD, YF
Symptoms: Aphasia, Difficulty in walking, Encephalitis, Gait disturbance, Headache
Clinical narrative: 2/3/04: Weakness in legs, difficulty walking Approximately 2/11/04 had fever, mild HA, difficulty speaking. 2/18/04 hospitalized for aphasia, difficulty walking, weakness, poor balance. Currently still hospitalized.Labs will be sent to CDC. From CDC: 2 samples were sent for testing: 1 is serum, 1 is CSF. 2/19/04 is serum: PCR is negative for YF RNA. IgM Elisa to YF P/N 3.0 SLE and West Nile Virus IgM negative. Igg Elisa is negative for YF, SLE, West Nile Virus, LAC and EEE. CSF collected 2/21/04. PCR negative for YF 17D RNA. IgM Elisa results consistent with an aseptic meningitis.  60 day follow up:Pt had a diagnosis of aseptic meningitis and encephalitis. It appears that the pt was sent to a rehab facility after discharge from the hospital on 12Mar04.
Age: 68.0
Sex: F
Vaccine: HEPAB, TD, TYP, YF, IPV, TD, YF
Symptoms: Laboratory test abnormal, Meningitis aseptic, Muscular weakness, Pyrexia, Speech disorder
Clinical narrative: 2/3/04: Weakness in legs, difficulty walking Approximately 2/11/04 had fever, mild HA, difficulty speaking. 2/18/04 hospitalized for aphasia, difficulty walking, weakness, poor balance. Currently still hospitalized.Labs will be sent to CDC. From CDC: 2 samples were sent for testing: 1 is serum, 1 is CSF. 2/19/04 is serum: PCR is negative for YF RNA. IgM Elisa to YF P/N 3.0 SLE and West Nile Virus IgM negative. Igg Elisa is negative for YF, SLE, West Nile Virus, LAC and EEE. CSF collected 2/21/04. PCR negative for YF 17D RNA. IgM Elisa results consistent with an aseptic meningitis.  60 day follow up:Pt had a diagnosis of aseptic meningitis and encephalitis. It appears that the pt was sent to a rehab facility after discharge from the hospital on 12Mar04.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Temperature of 102 degrees.  Site very red and swollen.  Had had a reaction previously but 3 immunizations had been given at reaction site and we were unable to know which had caused the reaction.  Mother called and talked to private physician who felt this was a reaction to the Pertussis but did not see the child.  Child is currently doing ok with no lasting symptoms.
Age: 2.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis
Clinical narrative: Locanized cellutis left arm.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Dyspnoea, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Pneumococcal vaccine given on 2/11/04 at 5:30PM> fever of 101.2/chills reported by preschool staff and request to pick up at 8:30AM on 2/12/04. Child experiencing fever as high as 104.2 later that evening and chills. At injection site, redness and swelling present at the time of first reports of fever. Child reporting tenderness, pain at injection site and overall muscle aches with first reports of fever. Physician that administered injection contact at 0900 on 2/12/04 with this writer concerns that this was an adverse reaction to the vaccine give only hours before. No office visit at this time, instructed to provide child dose of Mortrin 5 cc every 4-6 hrs. Due to continued high fever (as high as 104.2), increasing sleepiness, some compliants of "hard to breathe"  and continued swelling/redress at injection site the child was taken to local emergency room at 6:20PM on 2/12/05. At ER, drug reaction dx with increase in children's dose of Mortrin to 8cc alternating with children's dose of Tylentol 8cc every 3 hours and instructions to return if arm became worst or other symptoms appeared. Returned to ER after telephone call with nurse to return at 2:20AM on 2/13/2004, fever of 103.9, increasing compliants of arm pain. Arm at injection site redress and swelling 2 times the sign of normal.  Cellulitis dx provided with instructions to stop Cefazil given for ongoing sinus infection (21 day course on day 14 at the time), add Augmentin, Zyrtec and continue alternating Tylenol/Mortin as needed for pain/fever. Attempts to reach physician that administered vaccine and provided course of antibiotics unsuccessful until late on 2/13/04 6:00PM (after hours office visit). Treatment changed to Keflex 10 day course to stop Cefazil, added 6 day course of Orapred with Benadryl, and Mortrin for itching/pain. Likely dx of drug reaction or serum sickness. The child did well until 2/19/04 (when Orapred last given on morning of 2/18) redness reappeared with c/o of itching on 2/19/04 at 6:00AM. Physician contacted again and another course of Orapred started for next 7-10 days. The child has also been given Benadryl daily for c/o of itching at injection site and arm. The arm continues to become red with very marked area about 6X10 inches in diameter.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pruritus, Pyrexia
Clinical narrative: Pneumococcal vaccine given on 2/11/04 at 5:30PM> fever of 101.2/chills reported by preschool staff and request to pick up at 8:30AM on 2/12/04. Child experiencing fever as high as 104.2 later that evening and chills. At injection site, redness and swelling present at the time of first reports of fever. Child reporting tenderness, pain at injection site and overall muscle aches with first reports of fever. Physician that administered injection contact at 0900 on 2/12/04 with this writer concerns that this was an adverse reaction to the vaccine give only hours before. No office visit at this time, instructed to provide child dose of Mortrin 5 cc every 4-6 hrs. Due to continued high fever (as high as 104.2), increasing sleepiness, some compliants of "hard to breathe"  and continued swelling/redress at injection site the child was taken to local emergency room at 6:20PM on 2/12/05. At ER, drug reaction dx with increase in children's dose of Mortrin to 8cc alternating with children's dose of Tylentol 8cc every 3 hours and instructions to return if arm became worst or other symptoms appeared. Returned to ER after telephone call with nurse to return at 2:20AM on 2/13/2004, fever of 103.9, increasing compliants of arm pain. Arm at injection site redress and swelling 2 times the sign of normal.  Cellulitis dx provided with instructions to stop Cefazil given for ongoing sinus infection (21 day course on day 14 at the time), add Augmentin, Zyrtec and continue alternating Tylenol/Mortin as needed for pain/fever. Attempts to reach physician that administered vaccine and provided course of antibiotics unsuccessful until late on 2/13/04 6:00PM (after hours office visit). Treatment changed to Keflex 10 day course to stop Cefazil, added 6 day course of Orapred with Benadryl, and Mortrin for itching/pain. Likely dx of drug reaction or serum sickness. The child did well until 2/19/04 (when Orapred last given on morning of 2/18) redness reappeared with c/o of itching on 2/19/04 at 6:00AM. Physician contacted again and another course of Orapred started for next 7-10 days. The child has also been given Benadryl daily for c/o of itching at injection site and arm. The arm continues to become red with very marked area about 6X10 inches in diameter.
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Somnolence
Clinical narrative: Pneumococcal vaccine given on 2/11/04 at 5:30PM> fever of 101.2/chills reported by preschool staff and request to pick up at 8:30AM on 2/12/04. Child experiencing fever as high as 104.2 later that evening and chills. At injection site, redness and swelling present at the time of first reports of fever. Child reporting tenderness, pain at injection site and overall muscle aches with first reports of fever. Physician that administered injection contact at 0900 on 2/12/04 with this writer concerns that this was an adverse reaction to the vaccine give only hours before. No office visit at this time, instructed to provide child dose of Mortrin 5 cc every 4-6 hrs. Due to continued high fever (as high as 104.2), increasing sleepiness, some compliants of "hard to breathe"  and continued swelling/redress at injection site the child was taken to local emergency room at 6:20PM on 2/12/05. At ER, drug reaction dx with increase in children's dose of Mortrin to 8cc alternating with children's dose of Tylentol 8cc every 3 hours and instructions to return if arm became worst or other symptoms appeared. Returned to ER after telephone call with nurse to return at 2:20AM on 2/13/2004, fever of 103.9, increasing compliants of arm pain. Arm at injection site redress and swelling 2 times the sign of normal.  Cellulitis dx provided with instructions to stop Cefazil given for ongoing sinus infection (21 day course on day 14 at the time), add Augmentin, Zyrtec and continue alternating Tylenol/Mortin as needed for pain/fever. Attempts to reach physician that administered vaccine and provided course of antibiotics unsuccessful until late on 2/13/04 6:00PM (after hours office visit). Treatment changed to Keflex 10 day course to stop Cefazil, added 6 day course of Orapred with Benadryl, and Mortrin for itching/pain. Likely dx of drug reaction or serum sickness. The child did well until 2/19/04 (when Orapred last given on morning of 2/18) redness reappeared with c/o of itching on 2/19/04 at 6:00AM. Physician contacted again and another course of Orapred started for next 7-10 days. The child has also been given Benadryl daily for c/o of itching at injection site and arm. The arm continues to become red with very marked area about 6X10 inches in diameter.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cough, Feeling hot, Pharyngitis, Pyrexia, Rash
Clinical narrative: 2-13 cold symptoms, noted fever(felt warm) not temp taken. 2-20 noted flat rash over most of her body, temp 102, conts. with cold like symptoms and cough. 2-23 rash and fever resolved. Cough conts.
Age: 1.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rhinitis
Clinical narrative: 2-13 cold symptoms, noted fever(felt warm) not temp taken. 2-20 noted flat rash over most of her body, temp 102, conts. with cold like symptoms and cough. 2-23 rash and fever resolved. Cough conts.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Cow pox
Clinical narrative: Disseminated vaccinia, mild, treated symptomatically with oral Benadryl.
Age: 1.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Patient was vaccinated on 02-09-04 and presented to the clinic ten days later with scattered discrete macropapular rash over face, chest, abdomen, and back, no history of fever or respiratory difficulties.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Pt. developed a case of chickenpox illness in Feb 04.
Age: 2.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Rash on right shoulder, chest, and back. Afebrile and asymptomatic 2/20-2/23.  Digital photos examined by Infectious Disease Doctor.  Diagnosis is erythema multiforme.
Age: 21.0
Sex: F
Vaccine: MER, MER, MER
Symptoms: Abortion spontaneous, Immune system disorder, Laboratory test abnormal
Clinical narrative: Patient experienced miscarriage due to abnormal immune system response to pregnancy. Labs confirm that ANA, previously negative, went positive during pregnancy.  Natural killer cell assay showed high killing power of cellular immune response to placental cells in vitro.  Missed abortion resulted in D&C procedure on 1/16/2004.  Possible long term side effect of RA27/3 rubella vaccine which contained live virus derived from, attenuated in and grown in human fetal cells.  Such vaccines are known to include human DNA and protein from the cell culture growth medium. Patient suspects her immune system mediated termination of pregnancy may be result of developing immunity not only to rubella vaccine but also to human fetal proteins and "other human" DNA as a result of the rubella vaccine.  This is the patient's 3rd miscarriage.
Age: 21.0
Sex: F
Vaccine: MER, MER, MER
Symptoms: Abortion spontaneous, Laboratory test abnormal, Medication error
Clinical narrative: Patient experienced miscarriage due to abnormal immune system response to pregnancy. Labs confirm that ANA, previously negative, went positive during pregnancy.  Natural killer cell assay showed high killing power of cellular immune response to placental cells in vitro.  Missed abortion resulted in D&C procedure on 1/16/2004.  Possible long term side effect of RA27/3 rubella vaccine which contained live virus derived from, attenuated in and grown in human fetal cells.  Such vaccines are known to include human DNA and protein from the cell culture growth medium. Patient suspects her immune system mediated termination of pregnancy may be result of developing immunity not only to rubella vaccine but also to human fetal proteins and "other human" DNA as a result of the rubella vaccine.  This is the patient's 3rd miscarriage.
Age: 21.0
Sex: F
Vaccine: MER, MER, MER
Symptoms: Abortion spontaneous, Medication error
Clinical narrative: Patient experienced miscarriage due to abnormal immune system response to pregnancy. Labs confirm that ANA, previously negative, went positive during pregnancy.  Natural killer cell assay showed high killing power of cellular immune response to placental cells in vitro.  Missed abortion resulted in D&C procedure on 1/16/2004.  Possible long term side effect of RA27/3 rubella vaccine which contained live virus derived from, attenuated in and grown in human fetal cells.  Such vaccines are known to include human DNA and protein from the cell culture growth medium. Patient suspects her immune system mediated termination of pregnancy may be result of developing immunity not only to rubella vaccine but also to human fetal proteins and "other human" DNA as a result of the rubella vaccine.  This is the patient's 3rd miscarriage.
Age: 1.58
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cough, Oedema peripheral, Pyrexia
Clinical narrative: From initial info received on 2/13/04 from a health care professional regarding an adverse event, it was reported that a 19 month old female pt received an IPOL (K0146), and a DTaP (610A2) on 2/9/04. On the same day the pt's hands and feet swelled. It was also reported that the pt experienced a fever. The pt was admitted to the hospital on 2/10/04 and was discharged on 2/12/04. No other info was reported. The pt recovered from these events.  From additional information received on 26Feb2004, it was reported that the other manufacturer's vaccine was Infanrix, administered in the left arm. An adverse event of cough was also reported which began on 09Feb2004. The swelling improved. The medical assistant considered the events to be possiby related to vaccination with Infanrix. No other information was provided. Follow up on 05/19/04 states: "From additional information received on 05/13/04 from a health care professional, the correct IPOL Lot # was provided (X0146). The expiration date for IPOL was reported as 02/03/06 and the expiration date for INFANRIX as 03/13/06."
Age: 15.0
Sex: F
Vaccine: HEPA, MEN, RAB, TYP, YF
Symptoms: Abdominal pain, Headache, Pain, Photophobia
Clinical narrative: Mother called (2/18/04) to report 2 days of headache (not relieved with over-the-counter analgesics); photophobia; abdominal pain; diffuse body aches minus fever; symptoms resolving at present; patient to see pediatrician during evening of 2/18/04; abdominal pain relieve with Ranitadine.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Asthenia, Laboratory test abnormal, Pneumonia, Sinus bradycardia
Clinical narrative: Patient developed clinical pneumonia 5 days after receiving Flumist. Diagnosed by private medical doctor 12/24/03. Prescription Zithromax for 5 days. Medical record states asthenia. msv
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Pneumonia, Unevaluable event
Clinical narrative: Patient developed clinical pneumonia 5 days after receiving Flumist. Diagnosed by private medical doctor 12/24/03. Prescription Zithromax for 5 days. Medical record states asthenia. msv
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Dyspnoea, Headache, Malaise, Nasal congestion
Clinical narrative: Administered Flumist to 4 children on 1-14-04. Children sneezed with administration- started having increased tightness in chest, and shortness of breath. Low grade fever headache, sore throat, nasal stuffiness on 1-17 to 1-19-04 was confined to bed. Went to doctor on 1-22-04 and felt like I was going to die. Started on antibiotics, inhalants and Predinisone.
Age: 52.0
Sex: F
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Pyrexia, Sneezing
Clinical narrative: Administered Flumist to 4 children on 1-14-04. Children sneezed with administration- started having increased tightness in chest, and shortness of breath. Low grade fever headache, sore throat, nasal stuffiness on 1-17 to 1-19-04 was confined to bed. Went to doctor on 1-22-04 and felt like I was going to die. Started on antibiotics, inhalants and Predinisone.
Age: 42.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Administered flu mist to me client in morning. By afternoon had bad headache. Sore throat. Low grade fever.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Cardiac arrest, Respiratory arrest
Clinical narrative: Pt received a yearly influenza vaccination. Pt received this years flu shot at the pharmacy. Pt was taken to ER by ambulance. Death certificate states "anaphylaxis, respiratory and cardiac arrest, influenza vaccination." Body released to funeral home no autopsy.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Sudden infant death syndrome
Clinical narrative: None stated. Autopsy report on 05/05/04 states: SIDS.
Age: 1.04
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Convulsion, Epilepsy, Irritability, Vomiting
Clinical narrative: Developed seizure disorder within 24-48 hrs of receiving 12 month vaccines. Seizures have been very difficult to control with medication. Per discharge summary, pt experienced emesis and fussiness. Follow up information received 06/09/2004: Continues to have retractory seizures.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Pain
Clinical narrative: From initial info received on 2/18/04 from a nurse practitioner, regarding an adverse event, it was reported that a 33 year old male pt received Fluzone (u1137HA), administered IM in the left deltoid on 10/29/03. During December 2003 (exact date of onset is unknown) the pt experienced pain in his arms and legs, and extreme fatigue. The pt was hospitalized in December. The pt partially recovered from this event and was able to go back to work in January 2004. From additional information received on 01Jun04 from a health care professional it was reported, No additional information at this time. From additional information received on 21Sep04 from a registered nurse, it was reported that there is no additional information at this time. It was not reported whether the pt recovered from these events. No further information is anticipated, this case is considered closed. Follow up 01/06/05: Medical Assessment: File to be completed.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema multiforme, Eye oedema, Injection site erythema, Injection site pain
Clinical narrative: This case was initially reported from the pt on 11/25/03 and was considered non-serious. From additional info received from the responsible physician on 2/13/04 this case has been upgraded to serious. No seriousness criteria was reported. Based upon medical judgment this case is considered serious: medically significant event (OMIC). From initial info received on 11/25/03 from the pt regarding an adverse event, it was reported that the 49 year old female pt received a dose of Fluzone (U1122AA), administered in the left arm on 11/10/03. Two days later, on 11/12/03, the pt developed SOB, rash and swelling of her eyes. The pt took Benadryl, prednisone, and used an Epipen to treat the symptoms. The pt has a history of asthma. Her recovery status is currently unknown. From additional info received on 2/13/04 from the responsible physician, it was reported that the pt developed erythema multiforme, which lasted almost 2 months. She then experienced mild recurrent rash relapses. Additionally, the injection site would become red and tender with rash flare-ups. At the time of this report, the erythema multiforme was slowly subsiding, however, she continued to experience the recurrent mild rash and was still on antihistamines. Her medications included Allegra 120mg daily, Singulair 10mg daily and Advair as needed. The pt has not recovered from these adverse events.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: This case was initially reported from the pt on 11/25/03 and was considered non-serious. From additional info received from the responsible physician on 2/13/04 this case has been upgraded to serious. No seriousness criteria was reported. Based upon medical judgment this case is considered serious: medically significant event (OMIC). From initial info received on 11/25/03 from the pt regarding an adverse event, it was reported that the 49 year old female pt received a dose of Fluzone (U1122AA), administered in the left arm on 11/10/03. Two days later, on 11/12/03, the pt developed SOB, rash and swelling of her eyes. The pt took Benadryl, prednisone, and used an Epipen to treat the symptoms. The pt has a history of asthma. Her recovery status is currently unknown. From additional info received on 2/13/04 from the responsible physician, it was reported that the pt developed erythema multiforme, which lasted almost 2 months. She then experienced mild recurrent rash relapses. Additionally, the injection site would become red and tender with rash flare-ups. At the time of this report, the erythema multiforme was slowly subsiding, however, she continued to experience the recurrent mild rash and was still on antihistamines. Her medications included Allegra 120mg daily, Singulair 10mg daily and Advair as needed. The pt has not recovered from these adverse events.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dyspnoea, Hypotension, Nausea, Orthopnoea
Clinical narrative: 51 year old white female admitted with a chief complain of fever after receiving the flu vaccine 10/27/93. Patient had a fever (103.4F) and was found to be hypotensive in the ER. Patient's past medical history includes End-stage cirrhosis (hepatitis B-C), diabetes, asthma, and portal hypertension. Patient also complains of intermittent nausea vomiting and diarrhea for 3 weeks, increased dyspnea on exertion and orthopnea. Patient treat with Ceftriaxone empirically. Chest x-ray no definite infiltrate. Bleeding of left custophrachic angle consistent with left pleural effusion- no change from previous study. Blood culture negative,  urine analysis equal to many bacteria. Patient became afebrile 10/30/98 and discharged.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Pleural effusion, Pyrexia, Urine analysis abnormal, Vomiting
Clinical narrative: 51 year old white female admitted with a chief complain of fever after receiving the flu vaccine 10/27/93. Patient had a fever (103.4F) and was found to be hypotensive in the ER. Patient's past medical history includes End-stage cirrhosis (hepatitis B-C), diabetes, asthma, and portal hypertension. Patient also complains of intermittent nausea vomiting and diarrhea for 3 weeks, increased dyspnea on exertion and orthopnea. Patient treat with Ceftriaxone empirically. Chest x-ray no definite infiltrate. Bleeding of left custophrachic angle consistent with left pleural effusion- no change from previous study. Blood culture negative,  urine analysis equal to many bacteria. Patient became afebrile 10/30/98 and discharged.
Age: 68.0
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Hypersensitivity reaction to flu vaccine.  Action: admit to ER, diphenkyloxima and cephalexin were prescribed.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Chest discomfort, Chest pain, Chills, Cough
Clinical narrative: AM after flu shot both my husband and I woke with a headache with stayed with me all day even with use of Ibuprofen. Within 24 hours tickle cough started with chest tightness. By weekend fever, chills, coughing increased. Chest cough very painful. Don't have asthma but started using and proventil inhaler. Called Center for Disease Control they recommended see doctor. Doctor said Bronchitis and watch/call if worse. Now 10 days later, still coughing, this remained all respiratory. Very thick mucous coughed up, very stubborn spells of coughing; still present and very hard to stop coughing spasm. Taking antibiotic drug to loosen tightness and this still persists.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Pyrexia
Clinical narrative: AM after flu shot both my husband and I woke with a headache with stayed with me all day even with use of Ibuprofen. Within 24 hours tickle cough started with chest tightness. By weekend fever, chills, coughing increased. Chest cough very painful. Don't have asthma but started using and proventil inhaler. Called Center for Disease Control they recommended see doctor. Doctor said Bronchitis and watch/call if worse. Now 10 days later, still coughing, this remained all respiratory. Very thick mucous coughed up, very stubborn spells of coughing; still present and very hard to stop coughing spasm. Taking antibiotic drug to loosen tightness and this still persists.
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy, HIV infection, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness, tingling, drooping left side of face. Bell's Palsy
Age: 18.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient felt slightly nauseous and light headed approximately 1 minute after administration of Flumist- asked patient to stay seated for approximately 5 minutes, had patient drink fluid. After approximately 2 minutes, patient still light headed. Had patient lay on ground supporting head and elevating legs. After approximately 5 minutes patient felt fine. Had patient wait approximately 10 more minutes and patient was ok.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Hypokinesia
Clinical narrative: Discomfort, decreased movement of extremity. Doctor care and physical therapy analgesics.