chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: One week after the injection,my daughter broke out with big hives,rash and itching. She was put on predizone.That did not sseem to help very much. It is a little over a month and she is better but still breaks out with red bumps and  hives.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mom stated on 1/30 child's left arm started showed marked swelling, and redness and was hot to the touch.The child ran a fever of 101. Mom took the child to her physician who stated it was an unusual vaccine reaction. He told her to give the cild Tylenol and Benadryl
Age: 15.0
Sex: F
Vaccine: DT
Symptoms: Vomiting
Clinical narrative: Pt. began to vomit @ 12:55 p.m.  approximately 1/2 an hour after the injection was given.
Age: 1.32
Sex: F
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: RIGHT THIGH SWOLLEN, RED AND WARM TO TOUCH SINCE VACCINES WERE GIVEN ON 01-24-07.  TYLENOL AND WARM COMPRESSES GIVEN BY MOTHER.  PER DR. DIAGNOSIS IS RIGHT THIGH CELLULITIS 2ND TO REACTION TO DTAP VACCIN.  MOTHER TO CONTINUE WARM COMPRESSES AND GIVE MOTRIN.
Age: 40.0
Sex: M
Vaccine: HEP
Symptoms: Feeling hot, Flushing, Tremor
Clinical narrative: the patient had the vaccine at 0800 at approx 0930 he became very hot and flush.  He reported to the clinic at 0945 and was extremely flushing and shaking only on his left side.  He is immediately given Dexamethasone 10mg and Benadryl 50mg IM.  He was asymptomatic at 1100 hours.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt presented with HIVES and itching after Flu Vaccine given about 20 minutes after vaccine.Pt given 50 mg IM of Benadryl.  Pt monitored for 30 minutes after reaction.  Pt ambulated to vehicle, husband drove home, no further problems.  Counseled on S/SX to watch for and when to present to ER.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Convulsion, Cyanosis, Dyskinesia, Hypotonic-hyporesponsive episode, Mydriasis
Clinical narrative: Patient had a Hypotonic-hyporesponsive episode (HHE) in which he became limp, pale, had blue lips, and dilated pupils and was unresponsive. As we called his name, he began to jerk his arms, legs and head convulsively. The health department nurse waved ammonia under his nose and patted him on the cheek and he became conscious again after a few minutes. The nurses had him lie down and once he was coherent, gave him juice and crackers. He seemd to be his normal self again after about 10 minutes and we returned home within 30 minutes.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Patient had a Hypotonic-hyporesponsive episode (HHE) in which he became limp, pale, had blue lips, and dilated pupils and was unresponsive. As we called his name, he began to jerk his arms, legs and head convulsively. The health department nurse waved ammonia under his nose and patted him on the cheek and he became conscious again after a few minutes. The nurses had him lie down and once he was coherent, gave him juice and crackers. He seemd to be his normal self again after about 10 minutes and we returned home within 30 minutes.
Age: 14.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Blood test normal, Full blood count normal, Gait disturbance, Headache, Laboratory test normal
Clinical narrative: patient developed weakness in legs, arms and headaches with lethargy starting 8 days after shots, then sore throat and ascending paresis with difficulty walking but no fever.Strep and mono test were negative and patient was treated with frequent small eedings, bedrest and analgesics. he made 3 office visits over 6 days and showed signs of reduced weakness by early Feb.07. reflexes were 3+and symetric and he had mild foot parethesias. 02/02/07-Received records  GBS is mentioned in the notes but he is not 100% sure that he had GBS based on the fact that he did not have decreased reflexes. However, he also indicated that the lack of decreased reflexes could be related to the fact that he did not perform reflex testing until 9 days after initial symptoms. Reporter contacted a neurologist and discussed case, no referral to neurologist at this point. Will see patient again on Tuesday 2/6/07 . C/O tired, weakness in legs, tingling in feet.Headache, no stif neck. Possibly GBS.
Age: 14.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Lethargy, Mononucleosis heterophile test negative, Muscular weakness, Paraesthesia, Paresis
Clinical narrative: patient developed weakness in legs, arms and headaches with lethargy starting 8 days after shots, then sore throat and ascending paresis with difficulty walking but no fever.Strep and mono test were negative and patient was treated with frequent small eedings, bedrest and analgesics. he made 3 office visits over 6 days and showed signs of reduced weakness by early Feb.07. reflexes were 3+and symetric and he had mild foot parethesias. 02/02/07-Received records  GBS is mentioned in the notes but he is not 100% sure that he had GBS based on the fact that he did not have decreased reflexes. However, he also indicated that the lack of decreased reflexes could be related to the fact that he did not perform reflex testing until 9 days after initial symptoms. Reporter contacted a neurologist and discussed case, no referral to neurologist at this point. Will see patient again on Tuesday 2/6/07 . C/O tired, weakness in legs, tingling in feet.Headache, no stif neck. Possibly GBS.
Age: 14.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Pharyngolaryngeal pain, Streptococcal serology negative
Clinical narrative: patient developed weakness in legs, arms and headaches with lethargy starting 8 days after shots, then sore throat and ascending paresis with difficulty walking but no fever.Strep and mono test were negative and patient was treated with frequent small eedings, bedrest and analgesics. he made 3 office visits over 6 days and showed signs of reduced weakness by early Feb.07. reflexes were 3+and symetric and he had mild foot parethesias. 02/02/07-Received records  GBS is mentioned in the notes but he is not 100% sure that he had GBS based on the fact that he did not have decreased reflexes. However, he also indicated that the lack of decreased reflexes could be related to the fact that he did not perform reflex testing until 9 days after initial symptoms. Reporter contacted a neurologist and discussed case, no referral to neurologist at this point. Will see patient again on Tuesday 2/6/07 . C/O tired, weakness in legs, tingling in feet.Headache, no stif neck. Possibly GBS.
Age: 14.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Fatigue, Gait disturbance, Guillain-Barre syndrome, Headache, Lethargy
Clinical narrative: patient developed weakness in legs, arms and headaches with lethargy starting 8 days after shots, then sore throat and ascending paresis with difficulty walking but no fever.Strep and mono test were negative and patient was treated with frequent small eedings, bedrest and analgesics. he made 3 office visits over 6 days and showed signs of reduced weakness by early Feb.07. reflexes were 3+and symetric and he had mild foot parethesias. 02/02/07-Received records  GBS is mentioned in the notes but he is not 100% sure that he had GBS based on the fact that he did not have decreased reflexes. However, he also indicated that the lack of decreased reflexes could be related to the fact that he did not perform reflex testing until 9 days after initial symptoms. Reporter contacted a neurologist and discussed case, no referral to neurologist at this point. Will see patient again on Tuesday 2/6/07 . C/O tired, weakness in legs, tingling in feet.Headache, no stif neck. Possibly GBS.
Age: 14.0
Sex: M
Vaccine: MNQ, TD, MNQ, TD
Symptoms: Muscular weakness, Paraesthesia, Paresis, Pharyngolaryngeal pain
Clinical narrative: patient developed weakness in legs, arms and headaches with lethargy starting 8 days after shots, then sore throat and ascending paresis with difficulty walking but no fever.Strep and mono test were negative and patient was treated with frequent small eedings, bedrest and analgesics. he made 3 office visits over 6 days and showed signs of reduced weakness by early Feb.07. reflexes were 3+and symetric and he had mild foot parethesias. 02/02/07-Received records  GBS is mentioned in the notes but he is not 100% sure that he had GBS based on the fact that he did not have decreased reflexes. However, he also indicated that the lack of decreased reflexes could be related to the fact that he did not perform reflex testing until 9 days after initial symptoms. Reporter contacted a neurologist and discussed case, no referral to neurologist at this point. Will see patient again on Tuesday 2/6/07 . C/O tired, weakness in legs, tingling in feet.Headache, no stif neck. Possibly GBS.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient had L arm swelling, redness and itching
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Croup infectious, Dyspnoea, Urticaria
Clinical narrative: Vaccine was administered on the afternoon of January 19, 2007.  The following evening Zoey developed croup like symptoms and showed signs of difficulty breathing.  On the morning of January 21, 2007, Zoey was given liquid Benedryl and responded well.  The following day Zoey continued having trouble breathing and was no longer responding to the Benedryl.  Zoey was prescribed liquid steroids.  Before taking the steroids, at about 6:00pm on January 22, 2007, Zoey broke out in hives.  The steroid was ingested and the difficulty breathing subsided on the following morning.  The hives were still present on the 23rd and were very mild for the following two days (24th & 25th).  On the 26th Zoey's hives were covering her body and were very severe.  They have continue to come and go since then.  In December, 2006, Zoey had her 4 month vaccines and had the same reaction of difficulty breathing a day and a half later.  She did not get the hives and both the doctor and patient's parrents assumed it was due to the croup, however when Zoey had the same reaction after her 6 month shots, it was agreed that she must be allergic to something.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Allergy test, Croup infectious, Urticaria
Clinical narrative: Vaccine was administered on the afternoon of January 19, 2007.  The following evening Zoey developed croup like symptoms and showed signs of difficulty breathing.  On the morning of January 21, 2007, Zoey was given liquid Benedryl and responded well.  The following day Zoey continued having trouble breathing and was no longer responding to the Benedryl.  Zoey was prescribed liquid steroids.  Before taking the steroids, at about 6:00pm on January 22, 2007, Zoey broke out in hives.  The steroid was ingested and the difficulty breathing subsided on the following morning.  The hives were still present on the 23rd and were very mild for the following two days (24th & 25th).  On the 26th Zoey's hives were covering her body and were very severe.  They have continue to come and go since then.  In December, 2006, Zoey had her 4 month vaccines and had the same reaction of difficulty breathing a day and a half later.  She did not get the hives and both the doctor and patient's parrents assumed it was due to the croup, however when Zoey had the same reaction after her 6 month shots, it was agreed that she must be allergic to something.
Age: 0.53
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Croup infectious, Dyspnoea, Urticaria
Clinical narrative: 4 month Vax croup dev 24-36 hours later, Decadron. 6 month Vax Stridor Dev 36 hours later then hives 36-48 hours after that Benadryl and Decadron. Atarax and Oraped.
Age: 0.53
Sex: F
Vaccine: DTAP, PNC, DTAP, PNC
Symptoms: Allergy test, Croup infectious, Urticaria
Clinical narrative: 4 month Vax croup dev 24-36 hours later, Decadron. 6 month Vax Stridor Dev 36 hours later then hives 36-48 hours after that Benadryl and Decadron. Atarax and Oraped.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Biopsy skin, Biopsy skin abnormal, Blood cholesterol increased
Clinical narrative: This report described joint swelling in a 59 year old female who received Lymerix. This report was received as part of the litigation proceedings, with forwarding of medical records. Significant medical history concurrent conditions and concurrent medications taken were not clear from the medical records received. On 16 March 1999 and 18 February 1999 the subject received injections (intramuscularly, in the left deltoid) of Lymerix vaccine. The lot numbers were not recorded. The subject refused a 3rd injection of Lymerix after developing flu like symptoms on 21 march 1999, three days after the 2nd dose of Lymerix. In a statement of injuries, the subject's attorney alleged that the subject suffers and has suffered from joint swelling, joint pain, flu like symptoms, fatigue, gastrointestinal problems, headache, muscle pain, weakness, cognitive difficulty, decreased physical activity, rheumatological symptoms, neurological impairment and immune system disorder following administration of Lymerix. Limited information was available from medical records received on 26 Oct 2006. Details concerning the subjects condition and outcome of the alleged events was not provided. it was reported in the medical records that the events are considered to be related to treatment with Lymerix vaccine. Follow up was received via medical records on 30 January 2007. Medical history included smoker and hyperlipidemia. Medical records dated 08 August 2001 noted that the subject was on Baycol (Cerivastatin) and did have muscle soreness. A neuropathology report from a skin biopsy from the right distal leg performed on 06 February 2006 noted that the skin has significantly reduced epidermal nerve fiber density (2.8 to 3.0 epidermal nerve fiber per millimeter versus 5.0 per millimeter for reference value 5th percentile) consistent with a diagnosis of small nerve fiber neuropathy. The clinical information from the neuropathology report indicated that the subject experienced auto immune post vaccination sensory neuropathy. This case was assessed as medically serious by manufacturer.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Blood triglycerides increased, Cognitive disorder, Computerised tomogram normal, Decreased activity, Echocardiogram normal
Clinical narrative: This report described joint swelling in a 59 year old female who received Lymerix. This report was received as part of the litigation proceedings, with forwarding of medical records. Significant medical history concurrent conditions and concurrent medications taken were not clear from the medical records received. On 16 March 1999 and 18 February 1999 the subject received injections (intramuscularly, in the left deltoid) of Lymerix vaccine. The lot numbers were not recorded. The subject refused a 3rd injection of Lymerix after developing flu like symptoms on 21 march 1999, three days after the 2nd dose of Lymerix. In a statement of injuries, the subject's attorney alleged that the subject suffers and has suffered from joint swelling, joint pain, flu like symptoms, fatigue, gastrointestinal problems, headache, muscle pain, weakness, cognitive difficulty, decreased physical activity, rheumatological symptoms, neurological impairment and immune system disorder following administration of Lymerix. Limited information was available from medical records received on 26 Oct 2006. Details concerning the subjects condition and outcome of the alleged events was not provided. it was reported in the medical records that the events are considered to be related to treatment with Lymerix vaccine. Follow up was received via medical records on 30 January 2007. Medical history included smoker and hyperlipidemia. Medical records dated 08 August 2001 noted that the subject was on Baycol (Cerivastatin) and did have muscle soreness. A neuropathology report from a skin biopsy from the right distal leg performed on 06 February 2006 noted that the skin has significantly reduced epidermal nerve fiber density (2.8 to 3.0 epidermal nerve fiber per millimeter versus 5.0 per millimeter for reference value 5th percentile) consistent with a diagnosis of small nerve fiber neuropathy. The clinical information from the neuropathology report indicated that the subject experienced auto immune post vaccination sensory neuropathy. This case was assessed as medically serious by manufacturer.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Full blood count normal, Gastrointestinal disorder, Headache, Immune system disorder
Clinical narrative: This report described joint swelling in a 59 year old female who received Lymerix. This report was received as part of the litigation proceedings, with forwarding of medical records. Significant medical history concurrent conditions and concurrent medications taken were not clear from the medical records received. On 16 March 1999 and 18 February 1999 the subject received injections (intramuscularly, in the left deltoid) of Lymerix vaccine. The lot numbers were not recorded. The subject refused a 3rd injection of Lymerix after developing flu like symptoms on 21 march 1999, three days after the 2nd dose of Lymerix. In a statement of injuries, the subject's attorney alleged that the subject suffers and has suffered from joint swelling, joint pain, flu like symptoms, fatigue, gastrointestinal problems, headache, muscle pain, weakness, cognitive difficulty, decreased physical activity, rheumatological symptoms, neurological impairment and immune system disorder following administration of Lymerix. Limited information was available from medical records received on 26 Oct 2006. Details concerning the subjects condition and outcome of the alleged events was not provided. it was reported in the medical records that the events are considered to be related to treatment with Lymerix vaccine. Follow up was received via medical records on 30 January 2007. Medical history included smoker and hyperlipidemia. Medical records dated 08 August 2001 noted that the subject was on Baycol (Cerivastatin) and did have muscle soreness. A neuropathology report from a skin biopsy from the right distal leg performed on 06 February 2006 noted that the skin has significantly reduced epidermal nerve fiber density (2.8 to 3.0 epidermal nerve fiber per millimeter versus 5.0 per millimeter for reference value 5th percentile) consistent with a diagnosis of small nerve fiber neuropathy. The clinical information from the neuropathology report indicated that the subject experienced auto immune post vaccination sensory neuropathy. This case was assessed as medically serious by manufacturer.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Joint swelling, Low density lipoprotein increased, Mean cell haemoglobin increased, Mean cell volume abnormal
Clinical narrative: This report described joint swelling in a 59 year old female who received Lymerix. This report was received as part of the litigation proceedings, with forwarding of medical records. Significant medical history concurrent conditions and concurrent medications taken were not clear from the medical records received. On 16 March 1999 and 18 February 1999 the subject received injections (intramuscularly, in the left deltoid) of Lymerix vaccine. The lot numbers were not recorded. The subject refused a 3rd injection of Lymerix after developing flu like symptoms on 21 march 1999, three days after the 2nd dose of Lymerix. In a statement of injuries, the subject's attorney alleged that the subject suffers and has suffered from joint swelling, joint pain, flu like symptoms, fatigue, gastrointestinal problems, headache, muscle pain, weakness, cognitive difficulty, decreased physical activity, rheumatological symptoms, neurological impairment and immune system disorder following administration of Lymerix. Limited information was available from medical records received on 26 Oct 2006. Details concerning the subjects condition and outcome of the alleged events was not provided. it was reported in the medical records that the events are considered to be related to treatment with Lymerix vaccine. Follow up was received via medical records on 30 January 2007. Medical history included smoker and hyperlipidemia. Medical records dated 08 August 2001 noted that the subject was on Baycol (Cerivastatin) and did have muscle soreness. A neuropathology report from a skin biopsy from the right distal leg performed on 06 February 2006 noted that the skin has significantly reduced epidermal nerve fiber density (2.8 to 3.0 epidermal nerve fiber per millimeter versus 5.0 per millimeter for reference value 5th percentile) consistent with a diagnosis of small nerve fiber neuropathy. The clinical information from the neuropathology report indicated that the subject experienced auto immune post vaccination sensory neuropathy. This case was assessed as medically serious by manufacturer.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Myalgia, Nervous system disorder, Neuropathy, Red blood cell count decreased, Red blood cell sedimentation rate increased
Clinical narrative: This report described joint swelling in a 59 year old female who received Lymerix. This report was received as part of the litigation proceedings, with forwarding of medical records. Significant medical history concurrent conditions and concurrent medications taken were not clear from the medical records received. On 16 March 1999 and 18 February 1999 the subject received injections (intramuscularly, in the left deltoid) of Lymerix vaccine. The lot numbers were not recorded. The subject refused a 3rd injection of Lymerix after developing flu like symptoms on 21 march 1999, three days after the 2nd dose of Lymerix. In a statement of injuries, the subject's attorney alleged that the subject suffers and has suffered from joint swelling, joint pain, flu like symptoms, fatigue, gastrointestinal problems, headache, muscle pain, weakness, cognitive difficulty, decreased physical activity, rheumatological symptoms, neurological impairment and immune system disorder following administration of Lymerix. Limited information was available from medical records received on 26 Oct 2006. Details concerning the subjects condition and outcome of the alleged events was not provided. it was reported in the medical records that the events are considered to be related to treatment with Lymerix vaccine. Follow up was received via medical records on 30 January 2007. Medical history included smoker and hyperlipidemia. Medical records dated 08 August 2001 noted that the subject was on Baycol (Cerivastatin) and did have muscle soreness. A neuropathology report from a skin biopsy from the right distal leg performed on 06 February 2006 noted that the skin has significantly reduced epidermal nerve fiber density (2.8 to 3.0 epidermal nerve fiber per millimeter versus 5.0 per millimeter for reference value 5th percentile) consistent with a diagnosis of small nerve fiber neuropathy. The clinical information from the neuropathology report indicated that the subject experienced auto immune post vaccination sensory neuropathy. This case was assessed as medically serious by manufacturer.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor, Total cholesterol/HDL ratio normal
Clinical narrative: This report described joint swelling in a 59 year old female who received Lymerix. This report was received as part of the litigation proceedings, with forwarding of medical records. Significant medical history concurrent conditions and concurrent medications taken were not clear from the medical records received. On 16 March 1999 and 18 February 1999 the subject received injections (intramuscularly, in the left deltoid) of Lymerix vaccine. The lot numbers were not recorded. The subject refused a 3rd injection of Lymerix after developing flu like symptoms on 21 march 1999, three days after the 2nd dose of Lymerix. In a statement of injuries, the subject's attorney alleged that the subject suffers and has suffered from joint swelling, joint pain, flu like symptoms, fatigue, gastrointestinal problems, headache, muscle pain, weakness, cognitive difficulty, decreased physical activity, rheumatological symptoms, neurological impairment and immune system disorder following administration of Lymerix. Limited information was available from medical records received on 26 Oct 2006. Details concerning the subjects condition and outcome of the alleged events was not provided. it was reported in the medical records that the events are considered to be related to treatment with Lymerix vaccine. Follow up was received via medical records on 30 January 2007. Medical history included smoker and hyperlipidemia. Medical records dated 08 August 2001 noted that the subject was on Baycol (Cerivastatin) and did have muscle soreness. A neuropathology report from a skin biopsy from the right distal leg performed on 06 February 2006 noted that the skin has significantly reduced epidermal nerve fiber density (2.8 to 3.0 epidermal nerve fiber per millimeter versus 5.0 per millimeter for reference value 5th percentile) consistent with a diagnosis of small nerve fiber neuropathy. The clinical information from the neuropathology report indicated that the subject experienced auto immune post vaccination sensory neuropathy. This case was assessed as medically serious by manufacturer.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Eye swelling, Incorrect route of drug administration
Clinical narrative: This case reported by a physician and described the occurrence of anaphylactic reaction in a 5 year old male subject who was vaccinated with Havrix for prophylaxis. There was no relevant medical history or concurrent medications. concurrent vaccination included Varivax given on 27 January 2007. On 27 January 2007 at 12:54 PM, the subject received 1st dose of Havrix (720 Elisa unit, left gluteal). Within one hour of receiving the vaccinations with Havrix and Varivax the subject experienced puffiness on face, eyes almost closed, wheezing, coughing, and said he could not breath. The subject experienced an anaphylactic reaction. In addition, the Havrix was administered at an inappropriate site of administration. Medical attention was required at the subject's doctor's office. The physician considered the events were disabling and life threatening. The subject was treated with adrenaline (Epinephrine) and breathing treatments. The physician prescribed steroids and diphenhydramine hydrochloride (Benadryl) for the subject. At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with Havrix.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Swelling face, Wheezing
Clinical narrative: This case reported by a physician and described the occurrence of anaphylactic reaction in a 5 year old male subject who was vaccinated with Havrix for prophylaxis. There was no relevant medical history or concurrent medications. concurrent vaccination included Varivax given on 27 January 2007. On 27 January 2007 at 12:54 PM, the subject received 1st dose of Havrix (720 Elisa unit, left gluteal). Within one hour of receiving the vaccinations with Havrix and Varivax the subject experienced puffiness on face, eyes almost closed, wheezing, coughing, and said he could not breath. The subject experienced an anaphylactic reaction. In addition, the Havrix was administered at an inappropriate site of administration. Medical attention was required at the subject's doctor's office. The physician considered the events were disabling and life threatening. The subject was treated with adrenaline (Epinephrine) and breathing treatments. The physician prescribed steroids and diphenhydramine hydrochloride (Benadryl) for the subject. At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with Havrix.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Lymphadenopathy, Pain, Swelling, Tenderness
Clinical narrative: Severe local erythema, swelling and pain within 24 hours of vaccine. Worsening with right thigh axillary tenderness and lymph node enlargement.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL, HPV4, VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Started with signs of chicken pox 8 days after vaccine over entire back, neck, front, abdomen. No comitant symptoms no fever, no stomach symptoms, no pain, no cough, no runny nose, no sore throat. Positive puritis.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL, HPV4, VARCEL
Symptoms: Papilloedema, Rash generalised, Varicella
Clinical narrative: Started with signs of chicken pox 8 days after vaccine over entire back, neck, front, abdomen. No comitant symptoms no fever, no stomach symptoms, no pain, no cough, no runny nose, no sore throat. Positive puritis.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL, HPV4, VARCEL
Symptoms: Pruritus, Varicella
Clinical narrative: Started with signs of chicken pox 8 days after vaccine over entire back, neck, front, abdomen. No comitant symptoms no fever, no stomach symptoms, no pain, no cough, no runny nose, no sore throat. Positive puritis.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: 1/30/07-swollen, indurated on left thigh area.
Age: 4.0
Sex: F
Vaccine: DTAPH, IPV, MMR
Symptoms: Eyelid oedema, Petechiae
Clinical narrative: Mild erythematous pinpoint petechial rash around eyelids and mild intra orbital lid edema. No urticaria, no pruritus. Patient given one tsp of Benadryl and 2 tsp Prelone and monitored in office.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Varicella
Clinical narrative: Developed Clinical varicella
Age: 1.03
Sex: F
Vaccine: HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Had Seizure (Grand Mal), then developed fever. Taken to RE following seizure lasted 3", temp 102.2, child Afebrile when vaccines given.
Age: 2.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: 01/26/2007 pt at after hours clinic with reddened left leg, hot to touch, hard, treatment Benadryl 1 T. 01/29/07 F/U phone call to mother redness, swelling mostly gone now. Afebrile.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: This case was reported by a physician and described the occurrence of arm tremor in an 83 year old female subject who was vaccinated with FluLaval for prophylaxis. Concurrent medication included Enalapril, Atorvastin calcium, Warfarin sodium, Lexapro. Losartan potassium, Oxybutynin hydrochloride and Donepezil hydrochloride. On 28 November 2006, the subject received a dose of FluLaval intramuscularly in the left deltoid. On 02 December 2006, four days following vaccination with FluLaval, the subject experienced left arm tremor. The outcome of the event was not reported. Follow-up information received on 02 January 2006 indicated that the event resolved by 09 December 2006. In the reporter's opinion, the event was related to treatment with FluLaval.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Depressed level of consciousness, Eye swelling, Lethargy, Ocular hyperaemia
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no allergies or medical history who on 22-JAN-2007 was vaccinated with a 0.5 ml dose of Proquad vaccine. Suspect vaccination at the same time a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. On 22-JAN-2007, within one hour, the patient's eyes were pink and swollen. He was given Benadryl 12.5 mg orally. Ten minutes later he was lethargic and unresponsive. He was given an Epi-pen and was observed for hours in the emergency room. It was noted that previous vaccinations with Proquad vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine were well tolerated with no adverse symptoms. Subsequently, the patient recovered. He was scheduled to be seen at a clinic in a hospital on 24-JAN-2007. No diagnostic laboratory tests were performed. A product quality complaint was not involved. The patient's experience's were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Eye swelling, Lethargy, Ocular hyperaemia, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no allergies or medical history who on 22-JAN-2007 was vaccinated with a 0.5 ml dose of Proquad vaccine. Suspect vaccination at the same time a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. On 22-JAN-2007, within one hour, the patient's eyes were pink and swollen. He was given Benadryl 12.5 mg orally. Ten minutes later he was lethargic and unresponsive. He was given an Epi-pen and was observed for hours in the emergency room. It was noted that previous vaccinations with Proquad vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine were well tolerated with no adverse symptoms. Subsequently, the patient recovered. He was scheduled to be seen at a clinic in a hospital on 24-JAN-2007. No diagnostic laboratory tests were performed. A product quality complaint was not involved. The patient's experience's were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Autism, Developmental delay, Eye swelling, Lethargy, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no allergies or medical history who on 22-JAN-2007 was vaccinated with a 0.5 ml dose of Proquad vaccine. Suspect vaccination at the same time a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. On 22-JAN-2007, within one hour, the patient's eyes were pink and swollen. He was given Benadryl 12.5 mg orally. Ten minutes later he was lethargic and unresponsive. He was given an Epi-pen and was observed for hours in the emergency room. It was noted that previous vaccinations with Proquad vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine were well tolerated with no adverse symptoms. Subsequently, the patient recovered. He was scheduled to be seen at a clinic in a hospital on 24-JAN-2007. No diagnostic laboratory tests were performed. A product quality complaint was not involved. The patient's experience's were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV, DTAP, IPV, MMRV, DTAP, IPV, MMRV
Symptoms: Ocular hyperaemia, Unresponsive to stimuli
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no allergies or medical history who on 22-JAN-2007 was vaccinated with a 0.5 ml dose of Proquad vaccine. Suspect vaccination at the same time a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine. On 22-JAN-2007, within one hour, the patient's eyes were pink and swollen. He was given Benadryl 12.5 mg orally. Ten minutes later he was lethargic and unresponsive. He was given an Epi-pen and was observed for hours in the emergency room. It was noted that previous vaccinations with Proquad vaccine, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine were well tolerated with no adverse symptoms. Subsequently, the patient recovered. He was scheduled to be seen at a clinic in a hospital on 24-JAN-2007. No diagnostic laboratory tests were performed. A product quality complaint was not involved. The patient's experience's were considered to be other important medical events by the reporter. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: ANTH, HEP, PNC, SMALL
Symptoms: Oedema peripheral
Clinical narrative: Swelling on the arm
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Convulsion, Electrocardiogram
Clinical narrative: On Dec. 5, 2006 seizure lasting approx 20-40 secs at home. Took by squad to hospital. Seizures again at 7pm, 10pm and 4am on Dec. 6, 2006. Phenobarb given at hospital at 10pm. 1 more dose given then no more seizure activity. Currently on Phenobarb 3cc BID PO.  2/6/07 Received medical records from hospital which reveal patient experienced apnea spells with circumoral cyanosis & leftward gaze.  Parents took patient to ambulatory care center when had another spell.  Currently had cold s/s & cough & has been fussy.  Tx w/IV antibiotics & was admitted for monitoring.   FINAL DX: Acute life threatening episode & questionable seizures.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Electroencephalogram, Lumbar puncture
Clinical narrative: On Dec. 5, 2006 seizure lasting approx 20-40 secs at home. Took by squad to hospital. Seizures again at 7pm, 10pm and 4am on Dec. 6, 2006. Phenobarb given at hospital at 10pm. 1 more dose given then no more seizure activity. Currently on Phenobarb 3cc BID PO.  2/6/07 Received medical records from hospital which reveal patient experienced apnea spells with circumoral cyanosis & leftward gaze.  Parents took patient to ambulatory care center when had another spell.  Currently had cold s/s & cough & has been fussy.  Tx w/IV antibiotics & was admitted for monitoring.   FINAL DX: Acute life threatening episode & questionable seizures.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Eyelid disorder, Facial palsy, Physical examination
Clinical narrative: Patients states he started feeling blockage in the right side of his nose, patient could not close right eye with using his hand, patient mouth dropped to left side. Patient has been diagnosed with Bells Palsy. 02/15/07-records received and reviewed for DOS 01/30/07.  Chief complaint-right side of face, nostril feel strange patient states that the right eye cannot close without his assistance, also mouth drops down to the left. Started 2 days after receiving Menactra. PE:WNL WNL except for Cranial nerves-normal facial sensation, intact corneal reflexes, Bell's palsy noted with reduced left facial movement and loss of right forehead wrinkling, normal hearing bilaterally, palate is midline tongue is midline. Assessment:Patient's Bell's palsy has worsened. To call office with concerns for changes.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV, PNC
Symptoms: Decreased appetite, Injection site erythema, Insomnia, Irritability, Pyrexia
Clinical narrative: 3 days after vaccinated became cranky, then 4 after developed fever up to 101 with decreased appetite, sleep activity.  Transient redness at site of Pediarix, Proquad.
Age: 13.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Full blood count, Pharyngolaryngeal pain, Pyrexia, Rash
Clinical narrative: Fever, rash face, neck, chest, legs, hands, sore throat, See attached office notes and Hosp D/C. DC Summary 11/18/-11/19/06. DC DX Streptococcal pharyngitis, leukocytosis, disorder volume depletion, dehydration. Chronic ITP with complaints of fever, sore throat rash and petechiae s/p splenectomy prior to vaccines
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching on left arm from shoulder to mid-forearm (8 inches in length covered the circumference of the arm)
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Anorexia, Bedridden, Chills, Disturbance in attention, Headache
Clinical narrative: High fever and headache which began within 10 mins of receiving Tdap. Change in mental status and inability to concentrate. By 1700 hr on 17Jan2007-felt terribly ill with chills, bodyache over entire body including soles of feet.  Lethargic. No appetite. Patient states that she felt very ill and was only willing to stay in bed and did not work on Jan 18 or 19, 2007. She did not go to the doctor or emergency room, but has scheduled an appt to go on 26 Jan as she is still not quite recuperated.  Left arm was noted to be warm and red. She states that she still has a headache. Rec'd Tdap on 16 Jan 2007.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Lethargy, Malaise, Mental status changes
Clinical narrative: High fever and headache which began within 10 mins of receiving Tdap. Change in mental status and inability to concentrate. By 1700 hr on 17Jan2007-felt terribly ill with chills, bodyache over entire body including soles of feet.  Lethargic. No appetite. Patient states that she felt very ill and was only willing to stay in bed and did not work on Jan 18 or 19, 2007. She did not go to the doctor or emergency room, but has scheduled an appt to go on 26 Jan as she is still not quite recuperated.  Left arm was noted to be warm and red. She states that she still has a headache. Rec'd Tdap on 16 Jan 2007.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: High fever and headache which began within 10 mins of receiving Tdap. Change in mental status and inability to concentrate. By 1700 hr on 17Jan2007-felt terribly ill with chills, bodyache over entire body including soles of feet.  Lethargic. No appetite. Patient states that she felt very ill and was only willing to stay in bed and did not work on Jan 18 or 19, 2007. She did not go to the doctor or emergency room, but has scheduled an appt to go on 26 Jan as she is still not quite recuperated.  Left arm was noted to be warm and red. She states that she still has a headache. Rec'd Tdap on 16 Jan 2007.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: 11/16/06 flu vaccine 1:10 am flu clinic, left arm numbness started about 5-10 min later whole arm. Seen by doctor 11/22/2006 numbness lasted or more than 13 days from elbow completely numbness
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: pt complained off "sharp pain upon injection followed by severe pain for 3 days after injection until present"
Sex: M
Vaccine: FLU3, HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Urticarial-like rash beginning day after shots and worse at night 3d later, no resp. difficulty. Lesions did not wax/wane. Most rash is on legs/abdomen; also on arms and torso.  2/22/07 T/C to reporter & call returned.  States patient seen x 2 since report submitted.  Yearly labs done 2/8 were WNL.  seen 2/19 & had continued rash.  Continued treatment w/Benadryl.  Seen on 2/21 for continued mild scattered rash now diagnosed as mild eczema & left occiput adenopathy.  Afebrile & developmentally on target.  No other symptoms.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Injection site urticaria
Clinical narrative: "hives around injection site approx 1 1/2 wk after injection of ProQuad
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: On 1/4/2007, pt was given first dose of Gardasil vaccine. Also, on that day, changed OCP from Lo-ovral to Ovcon-35 because of spotting. Presnted 1/22/07 with pruitic rash consisting of tine erythematous papules on arms/legs/trunk
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: seizure 2 days post immunizations, fever > 102
Age: 1.35
Sex: F
Vaccine: DTAP, HEPA, PNC
Symptoms: Injection site induration
Clinical narrative: 11x8cm induration on left thigh from Dtap vaccination and PCV left thigh.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: According to mother patient has a red raised area in right arm size of 50 cent piece. Warm to touch. Local reaction slightly above site of injection. Immunization given subcutaneous. PHN recommended cool compress and consult primary medical doctor.
Age: 7.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Urticaria
Clinical narrative: Mom reports the AM after shot, arm red, swollen and noted welts to arm and on back. By the PM welts gone. No respiratory difficulty.
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema
Clinical narrative: Patient developed 8x10 cm reddish discolorization around injection site. Irregular configuration. No warmth non tender. Seen 1/2/07 some on 1/10/07.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Pregnancy, Pregnancy test positive, Ultrasound scan
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 20 year old female patient with a history of 2 therapeutic abortions (2000 and 2004) abdominal pain, mild rectal bleeding, papilloma viral infection and sexually transmitted disease who on 08-JAN-2007 was vaccinated IM into the left deltoid with a second 0.5 ml of Gardasil vaccine (yeast) (lot#655619/1427F). Concomitant therapy included Risperdal and Celexa. The patient was reportedly pregnant at this time and did not tell the office. An HCG pregnancy test was done. The patient is scheduled for a prenatal visit on 19-JAN-2007. Her LMP was approximately 11-OCT-2006 and EDD 19-JUL-2007. An ultrasound on 18-JAN-2007 for gestational dates revealed of 7 weeks of 7 weeks and 3 days. The patient had an elective termination on 23-JAN-2007. There was no further information available. The patient received a first 0.5 ml dose of Gardasil vaccine (yeast) (lot#654540/0800F) on 23-OCT-2006 IM into the left deltoid. Upon internal review, elective termination was considered to be an other important medical event. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Urine human chorionic gonadotropin positive
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 20 year old female patient with a history of 2 therapeutic abortions (2000 and 2004) abdominal pain, mild rectal bleeding, papilloma viral infection and sexually transmitted disease who on 08-JAN-2007 was vaccinated IM into the left deltoid with a second 0.5 ml of Gardasil vaccine (yeast) (lot#655619/1427F). Concomitant therapy included Risperdal and Celexa. The patient was reportedly pregnant at this time and did not tell the office. An HCG pregnancy test was done. The patient is scheduled for a prenatal visit on 19-JAN-2007. Her LMP was approximately 11-OCT-2006 and EDD 19-JUL-2007. An ultrasound on 18-JAN-2007 for gestational dates revealed of 7 weeks of 7 weeks and 3 days. The patient had an elective termination on 23-JAN-2007. There was no further information available. The patient received a first 0.5 ml dose of Gardasil vaccine (yeast) (lot#654540/0800F) on 23-OCT-2006 IM into the left deltoid. Upon internal review, elective termination was considered to be an other important medical event. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Inguinal hernia, Surgery
Clinical narrative: Information has been received from a physician concerning a 9-week-old male who on 05-DEC-2006 was vaccinated PO with the first 2.0 ml dose of Rotateq vaccine (human-bovine) (lot#655082/0779F). Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine and a dose of Hib conj vaccine (manufacturer unknown). The physician reported that on 06-DEC-2006, the patient developed a inguinal hernia. Unspecified medical attention was sought and the patient was subsequently hospitalized and underwent surgery. After surgery, the patient was considered to be recovered as he was noted to be fine. Additional information has been requested.