chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Insomnia, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/6/06 from the pts parent. A five month old infant, with no significant past medial history, had received a first dose of Hib vaccine, a first dose of Pediarix vaccine and a first dose of Pneumococcal vaccine on 6/10/06. The trade names, manufacturers names, routes and sites of administration were not reported for the above mentioned vaccines. Approx nine hours post immunization, the pt experienced muscle twitching, a rigid body, excessive crying and a fever of 101.0 to 102.0 degrees F. The mother contacted the physician office after hours and spoke with the physician on call, and per the instructions of the physician there was no need for the pt to be medically evaluated at the physicians office, or referred to the ER. Per the mother the symptoms lasted four to five days. The mother stated the pt was developmentally on track and was diagnosed with lockjaw. Per the mother, the pt recovered from these adverse events.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Neurodevelopmental disorder, Pyrexia, Tenderness, Trismus
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/6/06 from the pts parent. A five month old infant, with no significant past medial history, had received a first dose of Hib vaccine, a first dose of Pediarix vaccine and a first dose of Pneumococcal vaccine on 6/10/06. The trade names, manufacturers names, routes and sites of administration were not reported for the above mentioned vaccines. Approx nine hours post immunization, the pt experienced muscle twitching, a rigid body, excessive crying and a fever of 101.0 to 102.0 degrees F. The mother contacted the physician office after hours and spoke with the physician on call, and per the instructions of the physician there was no need for the pt to be medically evaluated at the physicians office, or referred to the ER. Per the mother the symptoms lasted four to five days. The mother stated the pt was developmentally on track and was diagnosed with lockjaw. Per the mother, the pt recovered from these adverse events.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Bacterial infection, Crying, Muscle rigidity, Muscle twitching
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/6/06 from the pts parent. A five month old infant, with no significant past medial history, had received a first dose of Hib vaccine, a first dose of Pediarix vaccine and a first dose of Pneumococcal vaccine on 6/10/06. The trade names, manufacturers names, routes and sites of administration were not reported for the above mentioned vaccines. Approx nine hours post immunization, the pt experienced muscle twitching, a rigid body, excessive crying and a fever of 101.0 to 102.0 degrees F. The mother contacted the physician office after hours and spoke with the physician on call, and per the instructions of the physician there was no need for the pt to be medically evaluated at the physicians office, or referred to the ER. Per the mother the symptoms lasted four to five days. The mother stated the pt was developmentally on track and was diagnosed with lockjaw. Per the mother, the pt recovered from these adverse events.
Age: 0.41
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 10/6/06 from the pts parent. A five month old infant, with no significant past medial history, had received a first dose of Hib vaccine, a first dose of Pediarix vaccine and a first dose of Pneumococcal vaccine on 6/10/06. The trade names, manufacturers names, routes and sites of administration were not reported for the above mentioned vaccines. Approx nine hours post immunization, the pt experienced muscle twitching, a rigid body, excessive crying and a fever of 101.0 to 102.0 degrees F. The mother contacted the physician office after hours and spoke with the physician on call, and per the instructions of the physician there was no need for the pt to be medically evaluated at the physicians office, or referred to the ER. Per the mother the symptoms lasted four to five days. The mother stated the pt was developmentally on track and was diagnosed with lockjaw. Per the mother, the pt recovered from these adverse events.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site induration, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: Initial report received on 17/Aug/2006 from a health care professional.  A five-year-old patient with no current illnesses had received a fifth intramuscular dose of Tripedia, lot number U1615BA, in the left deltoid, on 08/Aug/2006 at 13:30 pm.  Eight hours post-vaccination. the patient's left deltoid became warm, swollen, and tender from the shoulder to the elbow.  A 1mm duration was at the injection site.  Treatment received was not reported. The recovery status of the patient was reported as recovered.  The reporter for this case is the same as for case 2006-02197.
Age: 5.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Injection site induration, Injection site warmth, Swelling, Tenderness
Clinical narrative: Initial report received on 17/Aug/2006 from a health care professional.  A five-year-old patient with no current illnesses had received a fifth intramuscular dose of Tripedia, lot number U1615BA, in the left deltoid, on 08/Aug/2006 at 13:30 pm.  Eight hours post-vaccination. the patient's left deltoid became warm, swollen, and tender from the shoulder to the elbow.  A 1mm duration was at the injection site.  Treatment received was not reported. The recovery status of the patient was reported as recovered.  The reporter for this case is the same as for case 2006-02197.
Age: 5.0
Sex: M
Vaccine: HEP, DTAP, DTAP, DTAP, HEP, HIBV, IPV
Symptoms: Anxiety, Autism, Insomnia, Laboratory test abnormal, Mental impairment
Clinical narrative: A seven year old male pt, with no identified part medical history, had received numerous vaccinations from 1/29/99 to 5/11/2004. The pt had received a 0.5 ml dose of ActHib, lot number U0173AA, combined with a 0.5ml dose of Tripedia, lot number U0173AA given together as one dose (Product trade name TRIHIBIT) on 4/4/2000, a 0.5 ml dose of IPOL, lot number W0332, on 1/2/03 a 0.5ml dose of Dtap, lot number 7890AA on 7/1/99, a 0.5 ml dose of Recombivax HB vaccine, lot number 630935/0994J on 9/29/1999, a 0.5ml dose of Infanrix lot number 890A2 on 3/3/99, a 0.5 ml dose of MMR II lot number 641627/0666N on 5/11/04, a 0.5 ml dose of Prevnar, lot number 472037 on 9/13/00, an oral dose of Rotashield lot number 4788145 on 7/1/99 and a 0.5ml dose of Varicella lot number 631772/1031J on 1/6/00. In August 2006, the pt was diagnosed with Autism and Tourett's syndrome. He was also diagnosed by another physician with anxiety disorder and OCD (obsessive compulsive disorder). One physician believed a possible cause of the above mentioned disorder could be exposure to thimerosal in the vaccines th pt received as an infant. The mother reported that all dairy products, wheat, and preservatives were cut from her sons diet. The pt showed some improvement in his behavior as a result. At current, the pt had difficulty making decisions and sleeping at night. Lab test revealed a mercury level of 0.001ug/g, zinc 8.9, and magnesium 41. Treatments and diagnostic test performed were not reported. Per the other manufacturer, the pts mother wanted her pediatric office to do a lot check. The other manufacturer had requested a lot check. The pt has not recovered from these adverse events. The other manufacturer considered these events other medically significant events (OMIC). Additional information has been requested by the other manufacturer.
Age: 5.0
Sex: M
Vaccine: HEP, DTAP, DTAP, DTAP, HEP, HIBV, IPV
Symptoms: Obsessive-compulsive disorder, Tourette's disorder
Clinical narrative: A seven year old male pt, with no identified part medical history, had received numerous vaccinations from 1/29/99 to 5/11/2004. The pt had received a 0.5 ml dose of ActHib, lot number U0173AA, combined with a 0.5ml dose of Tripedia, lot number U0173AA given together as one dose (Product trade name TRIHIBIT) on 4/4/2000, a 0.5 ml dose of IPOL, lot number W0332, on 1/2/03 a 0.5ml dose of Dtap, lot number 7890AA on 7/1/99, a 0.5 ml dose of Recombivax HB vaccine, lot number 630935/0994J on 9/29/1999, a 0.5ml dose of Infanrix lot number 890A2 on 3/3/99, a 0.5 ml dose of MMR II lot number 641627/0666N on 5/11/04, a 0.5 ml dose of Prevnar, lot number 472037 on 9/13/00, an oral dose of Rotashield lot number 4788145 on 7/1/99 and a 0.5ml dose of Varicella lot number 631772/1031J on 1/6/00. In August 2006, the pt was diagnosed with Autism and Tourett's syndrome. He was also diagnosed by another physician with anxiety disorder and OCD (obsessive compulsive disorder). One physician believed a possible cause of the above mentioned disorder could be exposure to thimerosal in the vaccines th pt received as an infant. The mother reported that all dairy products, wheat, and preservatives were cut from her sons diet. The pt showed some improvement in his behavior as a result. At current, the pt had difficulty making decisions and sleeping at night. Lab test revealed a mercury level of 0.001ug/g, zinc 8.9, and magnesium 41. Treatments and diagnostic test performed were not reported. Per the other manufacturer, the pts mother wanted her pediatric office to do a lot check. The other manufacturer had requested a lot check. The pt has not recovered from these adverse events. The other manufacturer considered these events other medically significant events (OMIC). Additional information has been requested by the other manufacturer.
Age: 5.0
Sex: M
Vaccine: HEP, DTAP, DTAP, DTAP, HEP, HIBV, IPV
Symptoms: Anxiety, Autism, Insomnia, Mental impairment, Obsessive-compulsive disorder
Clinical narrative: A seven year old male pt, with no identified part medical history, had received numerous vaccinations from 1/29/99 to 5/11/2004. The pt had received a 0.5 ml dose of ActHib, lot number U0173AA, combined with a 0.5ml dose of Tripedia, lot number U0173AA given together as one dose (Product trade name TRIHIBIT) on 4/4/2000, a 0.5 ml dose of IPOL, lot number W0332, on 1/2/03 a 0.5ml dose of Dtap, lot number 7890AA on 7/1/99, a 0.5 ml dose of Recombivax HB vaccine, lot number 630935/0994J on 9/29/1999, a 0.5ml dose of Infanrix lot number 890A2 on 3/3/99, a 0.5 ml dose of MMR II lot number 641627/0666N on 5/11/04, a 0.5 ml dose of Prevnar, lot number 472037 on 9/13/00, an oral dose of Rotashield lot number 4788145 on 7/1/99 and a 0.5ml dose of Varicella lot number 631772/1031J on 1/6/00. In August 2006, the pt was diagnosed with Autism and Tourett's syndrome. He was also diagnosed by another physician with anxiety disorder and OCD (obsessive compulsive disorder). One physician believed a possible cause of the above mentioned disorder could be exposure to thimerosal in the vaccines th pt received as an infant. The mother reported that all dairy products, wheat, and preservatives were cut from her sons diet. The pt showed some improvement in his behavior as a result. At current, the pt had difficulty making decisions and sleeping at night. Lab test revealed a mercury level of 0.001ug/g, zinc 8.9, and magnesium 41. Treatments and diagnostic test performed were not reported. Per the other manufacturer, the pts mother wanted her pediatric office to do a lot check. The other manufacturer had requested a lot check. The pt has not recovered from these adverse events. The other manufacturer considered these events other medically significant events (OMIC). Additional information has been requested by the other manufacturer.
Age: 5.0
Sex: M
Vaccine: HEP, DTAP, DTAP, DTAP, HEP, HIBV, IPV
Symptoms: Tourette's disorder
Clinical narrative: A seven year old male pt, with no identified part medical history, had received numerous vaccinations from 1/29/99 to 5/11/2004. The pt had received a 0.5 ml dose of ActHib, lot number U0173AA, combined with a 0.5ml dose of Tripedia, lot number U0173AA given together as one dose (Product trade name TRIHIBIT) on 4/4/2000, a 0.5 ml dose of IPOL, lot number W0332, on 1/2/03 a 0.5ml dose of Dtap, lot number 7890AA on 7/1/99, a 0.5 ml dose of Recombivax HB vaccine, lot number 630935/0994J on 9/29/1999, a 0.5ml dose of Infanrix lot number 890A2 on 3/3/99, a 0.5 ml dose of MMR II lot number 641627/0666N on 5/11/04, a 0.5 ml dose of Prevnar, lot number 472037 on 9/13/00, an oral dose of Rotashield lot number 4788145 on 7/1/99 and a 0.5ml dose of Varicella lot number 631772/1031J on 1/6/00. In August 2006, the pt was diagnosed with Autism and Tourett's syndrome. He was also diagnosed by another physician with anxiety disorder and OCD (obsessive compulsive disorder). One physician believed a possible cause of the above mentioned disorder could be exposure to thimerosal in the vaccines th pt received as an infant. The mother reported that all dairy products, wheat, and preservatives were cut from her sons diet. The pt showed some improvement in his behavior as a result. At current, the pt had difficulty making decisions and sleeping at night. Lab test revealed a mercury level of 0.001ug/g, zinc 8.9, and magnesium 41. Treatments and diagnostic test performed were not reported. Per the other manufacturer, the pts mother wanted her pediatric office to do a lot check. The other manufacturer had requested a lot check. The pt has not recovered from these adverse events. The other manufacturer considered these events other medically significant events (OMIC). Additional information has been requested by the other manufacturer.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pyrexia
Clinical narrative: Influenza vaccine administered at 10 am.  Developed headache and fever at approx 7 pm; maximum fever 102.3 (Rectal), subsided by 2 pm.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Throat tightness
Clinical narrative: Tightening of throat, sever pain at injection site, with lump at injection site.
Age: 1.34
Sex: F
Vaccine: RUB
Symptoms: Coma, Cough, Fatigue, Feeling hot, Hypotonia
Clinical narrative: 09/20/2006 rubella vaccine given, 9/26/06 mother reports she was not herself, 9/27/06 some cough and clear rhinorrhea, 6am nostrial given, 1pm 98.9 but felt warmer, tired, not herself. Nanny went to put her in for nap she began to shake in shoulder, she was unresponsive then flaccid taken to ER via 911, woke up in ER found to be 1016 in ER. ER MD reported some Left otitis but not bulging.
Age: 1.34
Sex: F
Vaccine: RUB
Symptoms: Malaise, Otitis media, Rhinorrhoea, Tremor
Clinical narrative: 09/20/2006 rubella vaccine given, 9/26/06 mother reports she was not herself, 9/27/06 some cough and clear rhinorrhea, 6am nostrial given, 1pm 98.9 but felt warmer, tired, not herself. Nanny went to put her in for nap she began to shake in shoulder, she was unresponsive then flaccid taken to ER via 911, woke up in ER found to be 1016 in ER. ER MD reported some Left otitis but not bulging.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion spontaneous, Laboratory test abnormal, Placental disorder, Unintended pregnancy
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 6/5/06 from a health care provider. A 22 year old female pt, with a history of endometriosis and polycystic ovaries, had received an injection of Adacel, lot number not reported, on 5/23/06. Route and site of administration were not reported. It was later determined that the pt was pregnant. Date of last menstrual period was 5/28/06, and the pts estimated date of delivery is 2/2/07. Per the reporter, lab work showed a low progesterone. It was indicated that the pt was placed on progesterone 200 mg, two times a week, to maintain the pregnancy. The reporter was not aware of any adverse events related to vaccination. Follow up information received on 10/6/06. This case was upgraded to serious as based upon the new information received. It was reported that the pt received the Adacel vaccine as a requirement for work. The had been maintained on progesterone 200 mg IM from 5/31/06 to 6/2/06 due to placental insufficiency. A quantitative HCG level was decreased on 6/1/06. Her past obstetric history was reported as negative, although prior information noted she had one previous pregnancy which resulted in spontaneous abortion. The pt experienced a spontaneous abortion on 1/9/06. Her recovery status was not reported.
Sex: U
Vaccine: MNQ
Symptoms: Asthenia, Muscular weakness
Clinical narrative: A healthy teenager had received a dose of Menactra. Three days post immunization, the pt developed lower leg weakness and was then admitted to the hospital. The demographics of the pt were not reported. The date of administration, route, site and lot number of the Menactra was not reported. The reporter indication that the hospital physicians did not think this was a case of Guillain Barre syndrome. At the time of this report, the recovery status of of the pt was unk. Follow up information has been requested from the reporter. Follow-up: I just called the doctor. He said that this 15-year-old boy definitely did not have GBS. The pt had an old fracture in the lumbosacral region of the vertebral column. Exam was normal.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Amnesia, Blood cholesterol increased, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: High cholesterol, Flu like symptoms, headaches, incontinence, urinary, memory loss, numbness and tingling fingers, Sleep problems and feel not refreshed upon waking up, urinary frequency.
Age: 49.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Paraesthesia, Pollakiuria, Sleep disorder, Urinary incontinence
Clinical narrative: High cholesterol, Flu like symptoms, headaches, incontinence, urinary, memory loss, numbness and tingling fingers, Sleep problems and feel not refreshed upon waking up, urinary frequency.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Muscle spasms
Clinical narrative: 08/23/06 pm L arm swollen, painful, 8/24/06 pm increased swelling L deltoid down L arm painful, Temp 100-101 red area deltoid to elbow having muscle spasms, 8/28/06 L deltoid red painful to touch hard.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: 08/23/06 pm L arm swollen, painful, 8/24/06 pm increased swelling L deltoid down L arm painful, Temp 100-101 red area deltoid to elbow having muscle spasms, 8/28/06 L deltoid red painful to touch hard.
Age: 1.29
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Asthma, Condition aggravated, Convulsion, Febrile convulsion, Pneumonia
Clinical narrative: 3 days after vaccines given (DTaP, IPV, MMR, Flu shot), pt had fever 103, seizure, URI SX and mild RAD exacerbation. ER DR DX with pneumonia but radiology reading of CXR is normal. PT HX has frequent URI and RAD. Unclear as to whether the febrile seizure was from vaccines or illness although illness was not fairly mild. Treatment included antipyretics, antibiotics, breathing treatments, antihistamine and decongestant.
Age: 1.29
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Pyrexia, Upper respiratory tract infection
Clinical narrative: 3 days after vaccines given (DTaP, IPV, MMR, Flu shot), pt had fever 103, seizure, URI SX and mild RAD exacerbation. ER DR DX with pneumonia but radiology reading of CXR is normal. PT HX has frequent URI and RAD. Unclear as to whether the febrile seizure was from vaccines or illness although illness was not fairly mild. Treatment included antipyretics, antibiotics, breathing treatments, antihistamine and decongestant.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives within 45 minutes of getting immunizations, referral to allergist, Benadryl PO 12.5mg PRN itching given. P90, RR 20, BP 88/54.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error, Rash
Clinical narrative: A 72 year old female pt with a medical history of asthma received an IM injection of Tripedia, lot number U1342DA, on 8/23/05 into a deltoid muscle. The product was administered out of indication to an adult. The reporter did not know which arm Tripedia was administered in. At an unk period of time later, the pt reported a rash around her mouth and chin. The pt was going to her personal care physician to be evaluated. At the time of this report, the pt had not recovered.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A 4 year old male child with with no known allergies and history of asthma developed a large reddened and warm area at the injection site at an unspecified time the day he received IM influenza vaccine (Fluzone SV 2005-2006), lot no U1838AA in the right thigh on 10/25/05. He had also received, the same day, IM Tripedia in the left thigh, IM inactivated poliomyelitis vaccine (IPOL) in the left thigh and SC MMR vaccine in the right thigh. He was concomitantly taking  albuterol PRN. Flovent and Singulair QD at the time of the report. The pt consulted the physician on 10/29/2005, and he was recovering slowly at the time of the report. Follow up information received on 1/30/06 from a health care provider. The pt had received two previous flu vaccinations without any reaction. At the time of this report, the pt had fully recovered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial report involving a cluster of four cases received from a registered nurse on 10/31/05. This case involves Twin A. A five year old twin developed red, warmth and induration of 13/08 at the injection site after receiving the IM injection of Tripedia, lot number U1348AA in the right thigh on 10/18/05. The pt received in concomitant the IM injection of IPOL, lot number W1582-2 in the left thigh. The pt was diagnosed with cellulitis and treatment with Augmentin. Recovery status was reported as unk. Follow up information received on 6/5/06 from a physician. The onset of symptoms was 10/19/2005. The pt was examined by a physician. The pt fully recovered after treatments. Same reporter in cases 2005-02249, 2005-02250, 2005-02252. Case 2005-02252 involves Twin B.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial report involving a cluster of four cases received from a registered nurse on 10/31/05. This case involves Twin B. A five year old twin developed red, warmth and induration of 13/08 at the injection site after receiving the IM injection of Tripedia, lot number U1348AA in the right thigh on 10/18/05. The pt received in concomitant the IM injection of IPOL, lot number W1582-2 in the left thigh. The pt was diagnosed with cellulitis and treatment with Augmentin. Recovery status was reported as unk. Follow up information received on 6/12/06. It was reported that the female pt had no significant past medical history. The pts symptoms developed one day post immunization. She was seen by a physician the following day and was diagnosed with cellulitis. No lab testing or cultures from the site were done. The pt fully recovered after treatment with Augmentin. Further information is not expected. Same reporter in cases 2005-02249, 2005-02250, 2005-0225, 200502252. Case 2005-02252 involves Twin A.
Age: 1.34
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Fluid retention, Injection site erythema, Injection site oedema, Injection site pain, Injection site rash
Clinical narrative: Initial report received on 1/31/06 from a health care professional. A 16 month old  male pt with no significant medical history had received an administration (route not reported) of Tripedia, lot number U1345BA, in the left thigh and an administration (route not reported) of another manufacturers varicella vaccine Varivax, lot number 1023R, in the right thigh on 1/30/2006. That same day (time not reported) the pt developed left upper thigh redness, rash, edema and complained of soreness at the site. At the time of this report the pt had recovered from these events. The reporter for this case is the same as for case number 2006-00226. Follow up information received on 4/10/06. Per responsible physician the pt had no adverse events reported after previous immunizations and no immunizations were received within 4 weeks of the administration of Tripedia on 1/30/06. After receiving the IM injection of Tripedia, which was the pts fourth dose, not fifth as previously reported, the phys reports that the pt was also feverish. On set time and temperature was not reported. An ultrasound was performed on 1/31/06 which showed some fluid in the area, but no abscess. Advised to use warm compresses QID and given Motrin 125 MG Q 8 hours for pain. No further information expected.
Age: 1.34
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Initial report received on 1/31/06 from a health care professional. A 16 month old  male pt with no significant medical history had received an administration (route not reported) of Tripedia, lot number U1345BA, in the left thigh and an administration (route not reported) of another manufacturers varicella vaccine Varivax, lot number 1023R, in the right thigh on 1/30/2006. That same day (time not reported) the pt developed left upper thigh redness, rash, edema and complained of soreness at the site. At the time of this report the pt had recovered from these events. The reporter for this case is the same as for case number 2006-00226. Follow up information received on 4/10/06. Per responsible physician the pt had no adverse events reported after previous immunizations and no immunizations were received within 4 weeks of the administration of Tripedia on 1/30/06. After receiving the IM injection of Tripedia, which was the pts fourth dose, not fifth as previously reported, the phys reports that the pt was also feverish. On set time and temperature was not reported. An ultrasound was performed on 1/31/06 which showed some fluid in the area, but no abscess. Advised to use warm compresses QID and given Motrin 125 MG Q 8 hours for pain. No further information expected.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: A five year old female pt developed redness at the injection site the evening the vaccination and the following day developed swelling and warmth at the injection site after receiving the injection of Tripedia, lot number U1774CA (expiry date 2/1/08) in the left deltoid on 5/15/06. The needle size was unk. The pt received in concomitant the injection of IPOL, lot number Y1068 (expiry date 11/23/07) in the right arm and MMR II, lot number 0240R, in the right arm. Per reporter the child had no illness at the time of vaccination and had to local reactions to previous Dtap immunizations. The pt was seen by a physician on th e5/17/06. There was an area 12cm x 9cm of local redness, swelling and warmth. The pt had no fever. Recovery status was reported as unk.
Age: 1.46
Sex: M
Vaccine: DTAP
Symptoms: Incorrect route of drug administration, Injection site induration
Clinical narrative: Initial report from a healthcare professional on 20/Jun/2006.  An 18-month-old male  baby developed a hardened lump at the injection site with 24 hours of receiving the subcutaneous injection of the fourth dose of Tripedia, lot number U1400DB (expiry date 24/May/2007) in the left thigh on 01/Jun/2006.  Per reporter the patient had no illness at the time of vaccination.  No diagnostic tests or laboratory work was performed.  Reporter stated that the injection was given subcutaneously instead of the recommended route of intramuscular.  At the time of this report the patient had not recovered.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Nonspecific reaction
Clinical narrative: A four-year-old patient had received an intra-muscular injection of Tripedia, lot number U1342BC; a subcutaneous dose of IPOL, lot number Y0324-2; and a dose of Measles Mumps and Rubella vaccine (manufacturer reported), lot number 0603R, on an unspecified date.  The site of administration was not reported for any of the vaccines administered, in addition, the route of administration was not reported for the  Measles Mumps and Rubella vaccine.  Approximately 24 to 48 hours post-immunization, the patient experienced a local reaction on the arm at the site of the Tripedia and IPOL injection.  The patient required an emergency room visit and may have received treatment with either an unspecified IV antibiotic, an unspecified oral antibiotic, or other treatment.  The reporter did not specify which treatment was given.  The recovery status of the patient was reported as unknown. The reporter for this case is the same as for case 2006-01726 where three other patients experienced similar local reactions requiring emergency room treatment.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Nonspecific reaction
Clinical narrative: Initial report received on 06/Jul/2006 from a health care professional.  Three, five-year-old patient's had received a subcutaneous dose of IPOL, lot number Y0324-2; an intra-muscular dose of Tripedia, lot number U1342BC; and a dose of Measles Mumps and Rubella vaccine (manufacturer reported), lot number 0603R on varies dates.  Approximately 24-48 hours post-immunization, the patient's all experienced a local reaction on the arm were the IPOL and Tripedia injections were administered.  All three patient's required emergency room visits.  The patient's may have received treatment with with IV antibiotics, oral antibiotics, or other unspecified treatment.  The reported did not specify which patient received what treatment.  The recovery status of the patient's was reported as unknown.  The reporter for this case in the same as for case 2006-01717, where a four-year-old patient experience a similar local reaction requiring an emergency room visit.
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Initial report received on 17/Aug/2006 from a health care professional.  A female patient (date of birth not reported) with no current illnesses had received a fifth intramuscular dose of Tripedia, lot number U16158A, in the left deltoid, and a fourth subcutaneous dose of IPOL, lot number, Y0991, in the left arm, on 07/Aug/2006 at 11:00 am.  Ten hours post-immunization, the patient experienced some upper arm swelling.  The next day, the swelling in the upper arm had increased, and the patient had erythema that was almost completely around the humerus bone, and she had pain.  The patient had not been evaluated by a physician at the time of the report.  Treatment received was not reported.  The recovery status of the patient was reported as recovered.  The reporter for this case is the same as for case 2006-02197.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Medication error, Myalgia, Pyrexia
Clinical narrative: Initial report received on 18/Aug/2006 from a nurse.  A 52-year-old female patient with no current illnesses had received a dose of Tripedia, lot number U1751CA, in the left deltoid, on 17/Aug/2006 at 13:00 pm.  The route of administration was not reported.  The manufacturer of the Tripedia vaccine does not recommend this vaccine in patient's 54 years of age.  The next day, the patient developed a fever of 102.8 degrees Fahrenheit, chills, burning sensation in her knees and hips, and generalized joint and muscle aches.  She also had injection site soreness.  Treatment was not reported.  The recovery status of the patient was reported as not recovered.   The reporter for this case is the as for case 2006-02201.
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: Chills, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Initial report received on 18/Aug/2006 from a nurse.  A 29-year-old male patient with no current illnesses had a received a dose of Tripedia, lot number U1857CC, in the right deltoid, on 14/Aug/2006 at 07:30 am.  The route of administration was not reported.  The manufacturer dose not recommend Tripedia in this age group.  Within hours of the immunization the patient experienced fever (Temperature unknown), chills, headache, muscle aches, and was unable to lift his right arm due to injection site pain and soreness.  The patient required medical evaluation but the treatment provided was not reported.  The recovery status of the patient was reported as recovered. The reporter for this case is the same as for case 2006-02200.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Injection site warmth, Pain
Clinical narrative: Patient developed erythema to L Deltoid, warm to touch and soreness. Vaccine administered 10/16/06 (4pm). Local skin reaction occurred within 24 hours. Patient given antihistamine to aid with allergic reaction 10/18/06. Patient is to take Benadryl 25mg at bedtime 10/18/06. Patient was asked to report "no change" in status or if condition worsens. Follow-up by Employee Health Nurse twice daily.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Patient reported local erythema with redness and induration approx 7cm circumferentially. Patient reported soreness and area warm to touch. Patient vaccinated 10/13/06 and had edema 10/14/06 in am. Patient states she took Tylenol for discomfort. Monday 10/16/06, patient signs and symptoms had subsided. Employee Health Nurse did review symptoms with patient, no further signs are present.
Age: 1.02
Sex: M
Vaccine: MMRV
Symptoms: Urticaria
Clinical narrative: DEVELOPED HIVE AT SITE WITHIN 5 MIN. SINCE HAS DEV. SYSTEMIC HIVES SCATTERED ALL OVER BODY AND HEAD. PARENT ADMINISTERED BENADRYL AT HOME. SCRIPT CALLED FOR ZYRTEC.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Vomiting projectile
Clinical narrative: 3-4 hours after rota virus vaccine, the patient vomited. He vomited 2-3 times next day, and continued to vomit @ 1 vomit per day until Day 11 when he was taken to the ER. The vomiting was projectile.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Hypokinesia, Muscle spasms, Pain
Clinical narrative: 10/12/06 daytime: c/o arm hurting, sore, & "cold symptoms"; 10/12/06 PM to emergency room with dizziness, spasms into neck and shoulder, decreased ability to move arm, heart beating fast.  At ER, BP was elevated, pulse 133. Many yrs prior had reaction to flu vaccine, but no problems in subsequent years.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngitis, Rhinitis
Clinical narrative: 10/12/06 daytime: c/o arm hurting, sore, & "cold symptoms"; 10/12/06 PM to emergency room with dizziness, spasms into neck and shoulder, decreased ability to move arm, heart beating fast.  At ER, BP was elevated, pulse 133. Many yrs prior had reaction to flu vaccine, but no problems in subsequent years.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Erythema
Clinical narrative: Patient had excessive cry from 1 pm to 11 pm. Her right thigh was very red for the same duration. She did not develop a fever.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Chills, Diarrhoea haemorrhagic, Pyrexia
Clinical narrative: Stomach pains, fever, chills, bloody diarrhea. Was seen in ER and given IV fluids.
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Arrived at our installation on 10/16/06 and reported c/o chest pain within 2 hours of arrival. He was taken to theER and evaluated. Apparently had received his smallpox vaccination on 05Oct06, approximately 8 days later he developed fever, aching and tender lymph nodes. 2 days following this he noted some pain in his left chest between the axilla and middle chest, symptoms did not increase in inhalation/exhalation. He has had past medical history of severe anxiety episodes with chest pain per patient. Soldier reported pain level at a 2 to 3 out of ten during ER visit. Lab testing done. Diagnosed as Chest pain, possibly associated with a smallpox vaccination but without any signs of any specific pericarditis or myocarditis. Patient was seen on follow up on 10/18/06 and soldier reported that he was feeling well. Released without limitations.  10/30/06 Received hospital ER medical records which reveal patient had received vax 10/5 & developed fever, achiness & axillary lymph node tenderness 8 days later.  Two days prior to ER, had left chest pain between axilla & mid chest. PMH: severe anxiety episodes with chest pain. Dx: chest pain, possible associated with smallpox vax but w/o any signs of pericarditis or myocarditis. Was to rest in ER over night & f/u with Troop medical clinic in AM.  No treatment rendered./ss
Age: 31.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Pain, Pyrexia, Tenderness
Clinical narrative: Arrived at our installation on 10/16/06 and reported c/o chest pain within 2 hours of arrival. He was taken to theER and evaluated. Apparently had received his smallpox vaccination on 05Oct06, approximately 8 days later he developed fever, aching and tender lymph nodes. 2 days following this he noted some pain in his left chest between the axilla and middle chest, symptoms did not increase in inhalation/exhalation. He has had past medical history of severe anxiety episodes with chest pain per patient. Soldier reported pain level at a 2 to 3 out of ten during ER visit. Lab testing done. Diagnosed as Chest pain, possibly associated with a smallpox vaccination but without any signs of any specific pericarditis or myocarditis. Patient was seen on follow up on 10/18/06 and soldier reported that he was feeling well. Released without limitations.  10/30/06 Received hospital ER medical records which reveal patient had received vax 10/5 & developed fever, achiness & axillary lymph node tenderness 8 days later.  Two days prior to ER, had left chest pain between axilla & mid chest. PMH: severe anxiety episodes with chest pain. Dx: chest pain, possible associated with smallpox vax but w/o any signs of pericarditis or myocarditis. Was to rest in ER over night & f/u with Troop medical clinic in AM.  No treatment rendered./ss
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Chills, Fatigue, Headache, Tremor
Clinical narrative: Approzimately seven hours after a flu shot was given (1:15P to 8:30P)patient started with the chills and unable to get warm, shortly after the patient along with the chills began to shake uncontrollably. Patient an LPN, took her blood pressure and it was in the low 200's, tempurature was 98.2.  We then called our Doctors office who advised we go the local hospital emergency room. Upon arriving at the hospital, patients blood pressure was taken and was 163/93 very high for the patient who usaully is in the low 120's over 60's, no change in temp.  Patient was seen and examined by a doctor who felt it was a adverse reaction to the flu shot, not an allergic reaction. By this time the shakes and chills had begun to calm down.  Doctor had patient relax laying down for an hour after which her blood pressure was taken again and it was normal, shakes had subsided, so was discharged to go home and told she should feel better winthin 24 to 48 hours and if she didn't contact her primary doctor.  She is feeling better this morning, but has headache and feels all washed out.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Erythema, Face oedema, Flushing, Pruritus
Clinical narrative: Patient received a dose of Influenza vaccine (as noted below) at approximately 8:00am.  At approximately 11:00am the patient notes the onset of "itchyness"  at 11:25am Clinic staff was notified. At that time the patient's BP was 156/96 Pulse 76, Resp 18 no distress.  the patient's face was flushed and scalp was red.  Her colleagues reported that her face appeared "puffy".  There was no respiratory distress or involvement.  Patient was monitored for 20 minutes and all symptoms resolved on their own.  Reaction was isolated to head and face.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient received a dose of Influenza vaccine (as noted below) at approximately 8:00am.  At approximately 11:00am the patient notes the onset of "itchyness"  at 11:25am Clinic staff was notified. At that time the patient's BP was 156/96 Pulse 76, Resp 18 no distress.  the patient's face was flushed and scalp was red.  Her colleagues reported that her face appeared "puffy".  There was no respiratory distress or involvement.  Patient was monitored for 20 minutes and all symptoms resolved on their own.  Reaction was isolated to head and face.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Headache, Injection site rash, Pyrexia
Clinical narrative: Cellulitis left deltoid; T 100.6 F; headache; localized swelling; erythema; raised rash 8-10 mm at injection site. Treated with Keflex.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Cellulitis left deltoid; T 100.6 F; headache; localized swelling; erythema; raised rash 8-10 mm at injection site. Treated with Keflex.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Breast cancer, Diarrhoea, Nausea, Vomiting
Clinical narrative: Employee reports Nausea, Vomiting, Diarrhea, Severe epigastric pain the evening after she took the flu vaccine earlier that morning. Symptoms subsided and she was ok by 5:00am the next morning. Is not sure it was related to vaccine but did want it reported.
Age: 5.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema, Injection site warmth, Nausea, Skin ulcer
Clinical narrative: Red lesions on back and abdomen, feels warm, complains of nausea.  Symptoms began 10-17-06.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site inflammation, Pain
Clinical narrative: Mother reports redness and inflamation of the entire L upper arm. Pt reports difficulty using the arm due to pain. Vaccine administered in L deltoid.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Myalgia
Clinical narrative: Patient reports erythema to L arm followed by muscle soreness and itching. There is induration noted approx 7cm. Patient reports reaction 10/17/06 around 5pm but states she applied topical cortisone to area for relief of itching. 10/18/06 am she noted that there was redness and edema to site with area warm to touch.  Area was assessed, no broken skin noted, and patient is afebrile (and has been throughout symptoms). Oral antihistamine (Claritin) given and area was assessed bid. Patient was asked to take oral Benadryl at bedtime and area will be reassessed in am. Advised to contact Employee Health for any other symptoms or concerns.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Patient reports erythema to L arm followed by muscle soreness and itching. There is induration noted approx 7cm. Patient reports reaction 10/17/06 around 5pm but states she applied topical cortisone to area for relief of itching. 10/18/06 am she noted that there was redness and edema to site with area warm to touch.  Area was assessed, no broken skin noted, and patient is afebrile (and has been throughout symptoms). Oral antihistamine (Claritin) given and area was assessed bid. Patient was asked to take oral Benadryl at bedtime and area will be reassessed in am. Advised to contact Employee Health for any other symptoms or concerns.
Age: 41.0
Sex: M
Vaccine: YF
Symptoms: Condition aggravated, Dyspnoea, Throat tightness
Clinical narrative: Client developed bronchoconstriction with shortness of breath 3-4 hours after administration of vaccine. Symptoms persist intermitently(3-4 times a day) for the past 9 days. Hx. of hay fever and asthma in childhood.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Injection given on 10-16-06 in Left deltoid - red, bruised, warm to touch reaction approx. six inches in length and mildly itchy.  Treatment at home with warm packs to area, over the counter anti-itch cream.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Crying, Dermatitis bullous, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Right arm has swelling, erythema, tenderness and pain since administration of vaccine on 10/16/06, area began to increasing site on day of administration yesterday (10/17/06)  bullae which continued to increase in number and weep today. Put on Keflex 10 day.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Right arm has swelling, erythema, tenderness and pain since administration of vaccine on 10/16/06, area began to increasing site on day of administration yesterday (10/17/06)  bullae which continued to increase in number and weep today. Put on Keflex 10 day.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Dry skin, Dyspnoea, Hypoxia, Lethargy, Pruritus
Clinical narrative: Within one minute of receiving immunization child had repeated sneezing, large amount of mucus discharge nasally, difficulty breathing, wretching. Became lethargic, skin warm and dry. Pulse ox 88% on R/A wheezing bilat, itching of feet.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Rhinorrhoea, Skin warm, Sneezing, Wheezing
Clinical narrative: Within one minute of receiving immunization child had repeated sneezing, large amount of mucus discharge nasally, difficulty breathing, wretching. Became lethargic, skin warm and dry. Pulse ox 88% on R/A wheezing bilat, itching of feet.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site reaction
Clinical narrative: Bruising on the arm the night after the injection.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pain, Pyrexia, Tachycardia
Clinical narrative: Woke in early AM with headache, sensation of tachycardia diffuse aching, fever to 101.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Eye oedema, Face oedema, Rash
Clinical narrative: Pt woke in the morning stating her eyes were swollen shut and face was swollen. No itching, no SOB, rash to face and chest.
Age: 67.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Had pneumonia shot at approx 1400 state around 1600 arm began to swell. In the evening felt chilled, had a low grade fever. Phoned health dept around 10:00 on 10/18 stating that are was red, warm and swollen, bigger than her head.
Age: 67.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Had pneumonia shot at approx 1400 state around 1600 arm began to swell. In the evening felt chilled, had a low grade fever. Phoned health dept around 10:00 on 10/18 stating that are was red, warm and swollen, bigger than her head.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt was seen on 10/16/06 was given Dtap, PCV, Hep A then returned to the clinic on 10/18/06 for reaction. Pt has red, swollen thighs.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Cellulitis of thigh around injection site swelling, redness, induration. Treated prophylactically with antibiotic, Keflex.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling at site of injection on left vastus lateralus.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Oedema, Petechiae
Clinical narrative: Pt received Dtap and Hib right thigh, IPV and Prevnar left thigh, within 10" both legs markedly erythematous. Erythema left resolved in <10" but erythema, warmth and swelling increased on right and was from thigh to toes. On the following day pt had petechial of left thigh.