chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Immune system disorder, Lethargy, Malaise, Medication error, Multiple sclerosis
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Mydriasis, Neurotoxicity, Pain, Parkinsonism, Personality disorder
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Pharyngolaryngeal pain, Retching
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Dehydration, Drug toxicity, Eye irritation, Headache, Immune system disorder
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Lethargy, Malaise, Medication error, Personality disorder, Pharyngolaryngeal pain
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Retching
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Dehydration, Drug toxicity, Eye irritation, Headache, Laryngitis
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Lethargy, Malaise, Medication error, Pain, Personality disorder
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Laryngitis, Lethargy, Malaise, Medication error, Pain
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Personality disorder, Pharyngitis, Retching
Clinical narrative: This report was received from manf and was assigned manf report number HQWYE866626JAN05 concerning a female pt who on 12May04 was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live  (+) rubella virus vaccine live (RA 27/3). Concomitant therapy included a dose of varicella virus vaccine live. Subsequently, in 2004, the pt developed dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal, adverse event NOS and a medication error. The pt's outcome was unk. Dehydration, malaise, personality change, lethargy, metal poisoning, neurotoxicity, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, feeling abnormal and adverse event NOS were considered other important medical events.  (OMIC) This was originally reported by a female reporter. Additional information has been requested.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Dehydration, Drug toxicity, Eye irritation, Feeling abnormal, Headache
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Immune system disorder, Lethargy, Malaise, Medication error, Multiple sclerosis
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Mydriasis, Neurotoxicity, Pain, Parkinsonism, Personality disorder
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Pharyngolaryngeal pain, Retching
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Dehydration, Drug toxicity, Eye irritation, Headache, Immune system disorder
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Lethargy, Malaise, Medication error, Personality disorder, Pharyngolaryngeal pain
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Retching
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Dehydration, Drug toxicity, Eye irritation, Headache, Laryngitis
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Lethargy, Malaise, Medication error, Pain, Personality disorder
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Laryngitis, Lethargy, Malaise, Medication error, Pain
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL, MMR, VARCEL, IPV, IPV
Symptoms: Personality disorder, Pharyngitis, Retching
Clinical narrative: From initial information received on 3/10/05 from another manufacturer (reference number HQWYE866626JAN05) regarding an adverse event occurring in the USA, it was initially reported by a consumer that a female patient (date of birth and age not reported) received a dose of IPOL on 5/12/04. The lot number, route and site of administration were not reported. Sometime later that same year, the patient developed metal poisoning, neurotoxicity, personality change, feeling abnormal, lethargy, malaise, dehydration, retching, headache, predisposition to disease, eye irritation, pharyngolaryngeal pain, pain in extremity and medication error. It is unknown whether the patient recovered from any of the events. The reporter of this case is the same reporter as case 200500528. (OMIC)
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Skin reaction
Clinical narrative: From initial information received on 07/08/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received his 5th dose of DAPTACEL, lot number C1663AA, administered intra muscularly in the right thigh his fourth dose of IPOL, lot number X0707, administered subcutaneously in the left thigh and 2nd dose of MMR (manufactured by MERCK) lot number, 0181N, administered subcutaneously in the right thigh at 11:00 AM 06/29/2004. The next day, at 7:42 pm on 06/30/2004, the patient developed a red, itchy rash with pain. Reportedly the patient recovered from the event. Per the reporter this information has already been submitted to VAERS. The reporter of this case is the same reporter of cases:200402322, 200202304, 200402305, 200402306, 200402308, 200402309, 200402310, 200402311, 200402312, and 200402313. From additional information received 08/23/2004 from the initial reporter, it was reported that a "large area surrounding red area, slightly warm surrounding DAPTACEL, and MMR site on right anterior thigh". No further information is anticipated this case is considered closed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: From initial information received on 07/08/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received his 5th dose of DAPTACEL, lot number C1663AA, administered intra muscularly in the right thigh his fourth dose of IPOL, lot number X0707, administered subcutaneously in the left thigh and 2nd dose of MMR (manufactured by MERCK) lot number, 0181N, administered subcutaneously in the right thigh at 11:00 AM 06/29/2004. The next day, at 7:42 pm on 06/30/2004, the patient developed a red, itchy rash with pain. Reportedly the patient recovered from the event. Per the reporter this information has already been submitted to VAERS. The reporter of this case is the same reporter of cases:200402322, 200202304, 200402305, 200402306, 200402308, 200402309, 200402310, 200402311, 200402312, and 200402313. From additional information received 08/23/2004 from the initial reporter, it was reported that a "large area surrounding red area, slightly warm surrounding DAPTACEL, and MMR site on right anterior thigh". No further information is anticipated this case is considered closed.
Age: 0.85
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Irritability, Tremor
Clinical narrative: From initial information received on 08/11/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 10 month old female patient received her third dose of ACTHIB, Lot number UE313AA (French lot number X0718) administered in the left thigh; her third dose of Daptacel, lot number C1663AA, administered in the left thigh and her third doses  of Prevnar, lot number A57553E, administered in the right thigh on 08/09/04. The next morning, on 08/10/04, the patient was seen in the physician's office. The patient was more fussy than normal and she had episodes of "shaking of her head for a few seconds". Additionally, the patient had a local reaction on her left thigh. The site was indurated and erythematous and was thought to possibly be cellulitis. Patient had no fever. The patient was treated with Duricef and her recovery status was reported as unknown. From additional information received on 12/08/04 from a health care professional, it was reported that the patient recovered from the events. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter of cases 200402656, 200402657 and 200402658.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site erythema, Oedema, Rash
Clinical narrative: From initial information received on 09/02/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 5 year old female patinet received a DAPTACEL vaccination, lot number C1698AA, administered intra muscularly in the right thigh on 08/19/2004. On 08/22/2004 the patient developed a rash, swelling, redness encompassing an area of 3x3 inches and hot to the touch with streaking around the injection site. The patient was seen at urgent care and put on antibiotics for cellulitis. From additional information received on 10/11/2004 from a health care professional, the patient also received a dose of IPOL, lot number X1040-3, administered intra muscularly in the left thigh and a dose of MMR, manufactured by MERCK, lot number 0101N, also administered intramuscularly in the left thigh on 08/19/2004. The event of injection site cellulitis resolved and the patient recovered. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter for cases 200402938, 200402947, 200402949 and 200402950.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Difficulty in walking, Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: From initial information received from a health care professional regarding an adverse event occurring in the USA, it is reported that a 5 year old male patient received a Daptacel vaccination, lot number C1698AA, administered intra muscularly in the right thigh on 08/30/2004. Some time after the vaccination, onset date illegible on source document, it was reported that the patient experienced swelling of the entire right thigh that was red, hot to the touch and painful. He also experienced difficulty walking and a fever. He was placed on antibiotics for cellulitis three days after receiving the vaccination. The patients recovery status is currently unknown. From additional information received on 10/11/2004 from a health care professional. the patients full name, address, and telephone number were provided. Reportedly, in addition to Daptacel, the patient also received his fourth dose of IPOL, lot number X1040, administered intra muscularly in the left thigh as well as his second dose of MMR, lot number 1038M, manufacturer Merck, administered intra muscularly in the left thigh on 08/30/2004. It was reported that the patient improved after antibiotic treatment. It was not reported whether the patinet recovered from the events. From additional information received on 11/12/2004 from a health care professional, it was reported that no measurement of the injection site reaciton was taken. Per the reporter, symptoms were treated with Duracef, taken twice daily, for a period of ten days. Reportedly, the patient recovered form the events. No further information is anticipated. This case is considered closed. The reporter of this case is the same reporter for cases 200402938, 200402947, 200402948, and 200402949.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pain
Clinical narrative: From initial information received from a health care professional regarding an adverse event occurring in the USA, it is reported that a 5 year old male patient received a Daptacel vaccination, lot number C1698AA, administered intra muscularly in the right thigh on 08/30/2004. Some time after the vaccination, onset date illegible on source document, it was reported that the patient experienced swelling of the entire right thigh that was red, hot to the touch and painful. He also experienced difficulty walking and a fever. He was placed on antibiotics for cellulitis three days after receiving the vaccination. The patients recovery status is currently unknown. From additional information received on 10/11/2004 from a health care professional. the patients full name, address, and telephone number were provided. Reportedly, in addition to Daptacel, the patient also received his fourth dose of IPOL, lot number X1040, administered intra muscularly in the left thigh as well as his second dose of MMR, lot number 1038M, manufacturer Merck, administered intra muscularly in the left thigh on 08/30/2004. It was reported that the patient improved after antibiotic treatment. It was not reported whether the patinet recovered from the events. From additional information received on 11/12/2004 from a health care professional, it was reported that no measurement of the injection site reaciton was taken. Per the reporter, symptoms were treated with Duracef, taken twice daily, for a period of ten days. Reportedly, the patient recovered form the events. No further information is anticipated. This case is considered closed. The reporter of this case is the same reporter for cases 200402938, 200402947, 200402948, and 200402949.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: From initial information received on 09/12/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 2 year old male patient received DAPTACEL vaccination, lot number C16988AA, administered intramuscularly in the left thigh on 09/31/2004. An unspecified time later (exact date could not be determined due to legibility of report), the patient experienced a reaction to the DAPTACEL injection on his left leg. The site was warm to the touch and swollen with a 4x3 inch area of induration accompanied with pain. The patient was put on antibiotics for cellulitis. He recovered from these events. From additional information received on 10/11/2004 from the initial reporter, it was reported that the Hib vaccine administered is manufactured by MERCK. Per the reporter, the patient did not take any concomitant medications at the time of vaccination. Aslo, the patient had no illnesses at the time of vaccination. The site was assessed by the physician only. Reportedly, the patient previously received 3 doses of DAPTACEL, with no reactions. The patinet recovered on 09/09/2004. Per the reporter, the information has been  reviewed and no additional information is available at this time. No further information is anticipatied. This case is considered closed. The reporter of this case is the same reporter of cases 200402936, 200402948, 200402949, ans 200402950.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Application site oedema, Cellulitis, Erythema, Injection site warmth, Tenderness
Clinical narrative: From initial information received on 07/08/2004 from a registered nurse regarding n adverse event occurring in the USA it was reported that a 2 year old female patient received her fourth dose of DAPTACEL, lot number C1614AA, administered subcutaneously in the right thigh, and her third dose of IPOL, lot number X0772, administered subcutaneously in the left thigh on 06/01/2004. The next day at 11:20 pm the patient developed redness, edema, and tenderness to the right thigh. Four days post-immunization the patient presented in the doctor's office for follow up after an emergency room visit. She had a 6x6 cm area  on the right thigh with redness, edema and tenderness, she was diagnosed with cellulitis. The patient recovered from these events. Per reporter this case has been submitted to VAERS. The reporter of this case is the same reporter of cases: 200402304, 200402305, 200402306, 200402307, 200402308, 200402309, 200402311, 200402312, 200402313 and 200402322. From additional information received on 08/30/2004 from a telephone contact with the initial reporter, it was asked whether the injection site cellulitis reported for this patient has been confirmed with a culture. The reporter stated that  the site was not cultured. The reporter also verified that upon calling a program representative at VAERS she was advised to submit this report by fax rather than electronically. No VAERS number has been communicated back to the reporter.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: From initial information received on 11/19/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old male patient received Daptacel, lot number C2044AA, administered intra muscularly in the left arm, Fluzone SV '2004-'2005 USP, lot number U1380AA, administered intra muscularly in the left arm, Ipol, lot number X1040, administered subcutaneously in the right arm, and MMR/Measles, mumps Rubella vaccine, lot number 1039N, manufactured by Merck and administered subcutaneously in the right arm on 11/05/2004 at 11:00am. The next day on 11/06/2004, the patient developed a severely swollen left arm from the elbow to the shoulder with redness. The patient recovered from these events. The reporter in this case is the same reporter as for case 200403768.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema peripheral
Clinical narrative: From initial information received on 11/19/2004 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a four year old female patient received Daptacel, lot number C1996AA, administered intra-muscularly in the left deltoid, IPOL, lot number X0800, administered subcutaneously in the right arm, and MMR/ Measles, Mumps, and Rubella Vaccine, lot number 1187N, manufactered by Merck, and administered subcutaneously in the right arm on 11/17/2004 at 3:00 PM. The next day on 11/18/2004, the patinet developed a red and swollen left arm from the elbow to the shoulder. The patient recovered from these events. The reporter of this case is the same as for case 200403767.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: From initial information received on 28Jan04 from a physician's office, regarding an adverse event occurring in it was reported that approx four or five pt's received Daptacel, lot number C1612AA, on an unspecified date. The pt's ranged in age from 15 to 18 months and four to five years. During the two week time period (exact dates not specified), the pt returned to the clinic with cellulitis at the sit of the Daptacel injection. It was not reported whether the pts recovered. The reporter of this case is the same as for case 200400378.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site swelling, Injection site warmth, Skin reaction, Tenderness
Clinical narrative: From initial information received on 04/28/2004 from a pharmacist regarding an adverse event occurring in the USA it was reported that a cluster of five patients, all children (ages and sexes not reported), received DAPTACEL vaccination, lot number C1696AA (route of administration not reported) on an unspecified date. An unknown time later the patients developed warmth, swelling, and tenderness at the site of injection. The pharmacist reported that the clinicians thought the reactions to be cellulitis however, no diagnostics were done. The patients were treated with antibiotics and improved. The recovery status of the patients were not reported. From additional information received on 01/07/2004 through internal e-mail, the facility name, address and telephone number for the initial reporter were provided. Per the reporter, all five adverse events came from different doctors within the system and have previously been reported to VAERS. Copies of the VAERS reports had not been submitted to Aventis Pasteur Inc at the time of this report.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: From initial information received on 07/20/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that four patients, ages 15 months and two years (gender unknown) received a DAPTACEL vaccination, lot number C1697AA, administered intramuscularly in the deltoid on an unknown date. An unspecified time later patients developed a large, red, and swollen area on the deltoid and were diagnosed with cellulitis. It was reported that the patients recovered from this event. From additional information received on 08/27/2004 from the initial reporter, additional patient, vaccine, and adverse event information were provided. This patient was a a five year old male, who on 07/14/2004 was vaccinated with his fifth dose of DAPTACEL, given intramuscularly in the deltoid (side not reported and previously reported 4th dose), a fourth dose of IPOL, lot number X0553, administered sub sq in the left arm, a first dose of Hepatitis A  vaccine, lot number 0292P, manufactured by MERCK, administered intramuscularly in the right deltoid, and a second dose of MMR, lot number 0823N, manufactured by MERCK, and administered subq in the left arm. Two days later, on 07/16/2004,  the patinet developed cellulitis on his right upper arm extending from his shoulder to his elbow accompanied with warmth, tenderness, and erythema. The patient was treated with Keflex for 10 days and recovered from this event. No further information is anticipated, this case is considered closed.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Tenderness
Clinical narrative: From initial information received on 07/20/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that four patients, ages 15 months and two years (gender unknown) received a DAPTACEL vaccination, lot number C1697AA, administered intramuscularly in the deltoid on an unknown date. An unspecified time later patients developed a large, red, and swollen area on the deltoid and were diagnosed with cellulitis. It was reported that the patients recovered from this event. From additional information received on 08/27/2004 from the initial reporter, additional patient, vaccine, and adverse event information were provided. This patient was a a five year old male, who on 07/14/2004 was vaccinated with his fifth dose of DAPTACEL, given intramuscularly in the deltoid (side not reported and previously reported 4th dose), a fourth dose of IPOL, lot number X0553, administered sub sq in the left arm, a first dose of Hepatitis A  vaccine, lot number 0292P, manufactured by MERCK, administered intramuscularly in the right deltoid, and a second dose of MMR, lot number 0823N, manufactured by MERCK, and administered subq in the left arm. Two days later, on 07/16/2004,  the patinet developed cellulitis on his right upper arm extending from his shoulder to his elbow accompanied with warmth, tenderness, and erythema. The patient was treated with Keflex for 10 days and recovered from this event. No further information is anticipated, this case is considered closed.
Age: 0.61
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site vesicles
Clinical narrative: From intital information received on 07/20/04 from a NP regarding an adverse event occurring in the USA, it was reported that a six month old male patient received a does of Daptacel, lot number C1383AA, administered in the left thigh and a dose of Prevnar, lot number 492408, administered in the right thigh on 06/27/03. The routes of administration were not reported. An unspecified amount of time later, the patient developed three vesicles measuring two to three millimeters in size at the site of injection. The patient was not seen by a physician. Reportedly, the patient recovered from this event. From additional information received on 08/30/04 from the initial reporter, additional patient and vaccine information was provided. The Daptacel and Prevnar vaccinations were administered intra muscularly. It was reported that the onset date of event was 06/28/03, the day after vaccination and duration of symptoms lasted three to four days. The patient's mother did not call the doctor's office about symptoms. She reported the symptoms at the 19 month exam. No further information is anticipated, this case is considered closed.
Age: 18.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Medication error
Clinical narrative: From initial information received on 07/23/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that two patients (no patient identification provided) may have received a does of Daptacel, lot number C1699AA, in error instead of a Tubersol 5TU skin test on an unspecified date. Sometime after the administration of the product, both patients developed large positive reactions, which were described as induration at the injection site. One area of induration measured 40mm and the other measured 50mm. It was not reported whether the patients recovered from these events. From additional correspondence received on 09/07/04 from the initial reporter, the patient's full name, date of birth, age date of vaccination and adverse event onset, and recovery status were provided. Also, this patient had no pre-existing conditions or allergies and no illnesses at the time of the vaccination. The Daptacel vaccine was given intra-dermal in error instead of Tubersol 5TU. This vaccine was given at a private doctor's office with private funds. This event was not previously reported. From telephone correspondence on 09/08/04, it was reported that the number of patients who experienced reactions after receiving Daptacel in error instead of Tubersol 5TU was only one patient and the information for this patient is included in the follow up information received by the manufacture on 09/07/04. She stated that the second patient originally identified did not receive Daptacel, but did in fact received Tubersol 5TU and had a positive reaction. The second patient did not experience an adverse event. No further information is anticipated, this case is considered closed.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Petechiae, Purpura
Clinical narrative: From initial information received on 08/09/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a two month old male patient received his first doses of Daptacel, ACTHIB, IPOL and Prevnar, administered on an unspecified date in 2004. The lot numbers, routes and sites of administration were not provided. Within 48 hours post administration the patient developed petechiae and purpura around his foot and ankle. No other complaints were reported. The patient's recovery status was not reported.
Age: 0.23
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: From initial information received on 08/11/04 from a physician regarding an adverse event occurring in the USA, it was reported that a two month old female patient received an ACTHIB vaccination, lot number and rout and site of administration were not reported, "about one month ago" (exact date was not reported). An unspecified time later, the patient's mother stated that the child cried fro several hours, developed redness at the injection site and experienced a low grade fever of 100 degrees Fahrenheit. The patient recovered from these events. From additional information received on 09/21/04 from the initial reporter, the patient's date of birth was provided. The patient received a first dose of ACTHIB, lot number UA797AB (French lot number W0795), administered intra-muscularly in the left thigh and a first does of Daptacel, lot number C1663AA, administered intra muscularly in the right thigh on 07/14/04. No other information was provided at this time. No further information is anticipated, this case is considered closed.
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: From initial information received on 09/02/2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that a patient (one of five) in the age range of 15-18 months, received DAPTACEL vaccination, lot number C1698AA on an unspecified date. No specifics were provided regarding the dose, route, or site of the vaccine. Reportedly sometime after the vaccination the patient was treated with antibiotics fro injection site cellulitis. The patients recovery status is currently unknown. The reporter of this case is the same reporter of cases: 200402947, 200402948, 200402949, and 200402950.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Body temperature increased, Cellulitis, Erythema, Hypersensitivity, Injection site erythema
Clinical narrative: From initial information received from a health care professional, regarding an adverse event occurring in the USA, it was reported that a 5 year old female patient received Daptacel vaccination, lot number C1698AA, administered intra muscularly in the right thigh on 08/11/2004. Some time after the vaccination, onset date illegible on source document, it was reported that the patient developed a swollen, red, indurated area over her right anterior thigh that was warm to the touch. The patient was placed on antibiotics for Cellulitis with allergic reaction to DTaP. Reportedly the patient also developed a temperature. Reportedly the patient recovered from this experience. From additional information received on 10/11/2004 from a health care professional,  the patients full name,address and telephone number were provided. Reportedly the patient received her fourth dose of IPOL, lot number 409030, administered intramuscularly in the left thigh as well as her second dose of MMR, lot number 0101N, manufactured by Merck, administered intramuscularly in the right thigh in addition to Daptacel on 08/11/2004. The patient experienced the above mentioned symptoms the next day, on 08/12/2004. Symptoms resolved with Keflex regimen on 08/16/2004. The reporter of this case is the same reporteer for cases 200402938, 200402947, 200402948, 2004002949, and 200402950. From additional information received on 11/12/2004 from the initial reporter, the IPOL lot number was confirmed as 904030, which is not an Aventis lot number. No further information is anticipitated, this case is considered closed.