chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: DT
Symptoms: Injection site pain, Muscle spasms, Muscle tightness, Muscle twitching, Peripheral coldness
Clinical narrative: From initial information received on 17/Jun/2005 from a physician, it was reported that a 22-year-old male patient received a dose DECAVAC, lot number U1563BA, administered intra-muscular in the left deltoid on 15/Jun/2005. The next day at 12:00pm, the patient developed injection site pain, joint pain, tight muscles, the jitters, warm flushes, cold hands, cramping and muscle twitching in his abdomen. The patient was seen by a physician who prescribed Valium. The patient's recovery status is listed as unknown. Follow-up information received on 11-July-2005. The patient was fully vaccinated as a child (last dose at age 4). The patient experienced cramping of the finger and hand flexors. He experienced muscle twitching - especially of the abdominal flexors. He had spontaneous remission of symptoms within approximately 18 hours. The case is closed.
Age: 26.0
Sex: M
Vaccine: DT
Symptoms: Erythema, Local reaction, Skin striae, Skin warm, Staphylococcal infection
Clinical narrative: From initial information received on 13/Jun/2005 from a registered nurse regarding an adverse event, it was reported that a 26-year-old male patient received a dose of DECAVAC, lot number U1206CA, administered in the right deltoid.  The route of administration was not reported.  The following day, the patient developed local redness, warmth and streaking along the right arm.  He was seen in the emergency room on 17/Jun/2005 and was diagnosed with staph infection.  Reportedly, KEFLEX was prescribed.  The patient did not recover from these events.  From additional information received on 05/Jul/2005 from a physician, it was reported that the patient received DECAVAC intra-muscularly.  Per the reporter, this was the patient's first dose of DECAVAC.  The patient received his last tetanus shot nine years ago with no adverse reactions.  It was also reported that no culture was obtained.  The patient fully recovered on 16/Jun/2005.  No further information is anticipated.  This case is considered closed.
Age: 46.0
Sex: F
Vaccine: DT
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: From initial information received on 06/Jun/2005 from a health care professional regarding an adverse event occurring, it was reported that a 46-year-old female patient received a dose of DECAVAC, lot number U1213AA, administered intra-muscularly in the left deltoid on 01/Jun/2005 due to a cut on her finger. That same day, the patient developed a fever of 101 degrees Fahrenheit, general malaise and numbness from the injection site down to her fingers. Additionally, she had a local reaction of redness and swelling, measuring approximately four inches in diameter, at the injection site. The patient was evaluated by a physician and ice was applied to the site. Per the reporter, the patient recovered from the events. The reporter of this case is the same reporter as case 2005-01072. Follow-up received on 04-Oct-2005. As per the additional information, the injection sie redness and swelling occurred with in 8 hours following the vaccination. She did not have any illness at the time of the vaccination.
Age: 46.0
Sex: F
Vaccine: DT
Symptoms: Malaise, Pyrexia
Clinical narrative: From initial information received on 06/Jun/2005 from a health care professional regarding an adverse event occurring, it was reported that a 46-year-old female patient received a dose of DECAVAC, lot number U1213AA, administered intra-muscularly in the left deltoid on 01/Jun/2005 due to a cut on her finger. That same day, the patient developed a fever of 101 degrees Fahrenheit, general malaise and numbness from the injection site down to her fingers. Additionally, she had a local reaction of redness and swelling, measuring approximately four inches in diameter, at the injection site. The patient was evaluated by a physician and ice was applied to the site. Per the reporter, the patient recovered from the events. The reporter of this case is the same reporter as case 2005-01072. Follow-up received on 04-Oct-2005. As per the additional information, the injection sie redness and swelling occurred with in 8 hours following the vaccination. She did not have any illness at the time of the vaccination.
Age: 36.0
Sex: F
Vaccine: DT
Symptoms: Hyperhidrosis, Hypokinesia, Neurological examination, Nuclear magnetic resonance imaging, Physical examination
Clinical narrative: From initial information received on 27/Apr/2005 from a health care professional regarding an adverse event, it was reported that a 36 year old female patient received a dose of DECAVAC, lot number U1210BA, administered intra-muscularly in the afternoon on 25/Apr/2005. The site of administration was unknown as per the reporter. One day later, on 26/Apr/2005, the patient phoned the physician's office and complained that she was unable to lift her arm and was sweating. She was sent to the emergency room. At the time of this report, the patient had not recovered from these events. Follow-up information received on 11/Oct/2005 from a physician. Per the reporter, the patient did not have any illnesses at the time of the vaccination. She had a neurology and orthopedic surgeon consult on 03/May/2005 and a magnetic resonance imaging test on 04/May/2005. The patient had a full recovery from these events as of August 2005. No further information is expected.
Age: 54.0
Sex: F
Vaccine: DT
Symptoms: Erythema, Local reaction, Local swelling
Clinical narrative: From initial information received on 24/Mar/2005 from a health care professional regarding an adverse event, it was reported that a 54-year-old female patient received a dose of DECAVAC vaccine, lot number U1209BA, administered subcutaneously in error in the mid-upper area of her left arm on 20/Mar/2005. She received the vaccine as part of treatment for a dog bite. Two days later, on 22/Mar/2005, the patient developed a large local reaction of redness and swelling, measuring 15cm from the injection site above the elbow and 10cm below the elbow. The patient was seen by a physician and was treated with compresses and ibuprofen. The patient was on antibiotics for the dog bite. At the time of this report, the patient had not recovered from the events. Follow-up information received on 24/Oct/2005 from a health care professional. The physician reviewed the case and reports that the patient had an uneventful full recovery from these events, date not reported. No further information is expected.
Age: 45.0
Sex: F
Vaccine: DT
Symptoms: Dermatitis contact, Injection site erythema, Injection site induration, Injection site nodule, Injection site oedema
Clinical narrative: From initial information received on 07/Mar/2005 from a health care professional regarding an adverse event, it was reported that a forty-five-year-old female patient received a booster dose of DECAVAC vaccine, lot number U1215CA, administered in the deltoid on 03/Mar/2005.  The route of administration was not reported.  An unspecified amount of hours later, on 03/Mar/2005, the patient developed a red raised area 25cm x 10cm at the injection site.  She also complained of pruritis.  The patient was seen by a physician again on unspecified date.  At the time of this report, no other symptoms were reported.  The patient has not recovered from these events.  Follow-up received on 05-Oct-2005.  As per the additional information, the patient presented with complaints of left deltoid pain on 07-Mar-2005.  She had developed injection site erythema, induration tenderness and edema at the injection site.  The area of the erythema and induration was 6 x 6 cms in size.  It was reported that the patient does receive tetanus shots on regular basis and she never had any reaction in the past.  As corrective treatment the patient was placed on MEDROL dose-pack and KEFLEX for an unspecified short period of time.  The patient presented again on 14-Mar-2005 for the re-evaluation, the large erythematous area that was questionably indurated, and erythema was roughly 85% resolved.  There was very small hard mobile nodule under the area of the injection and there was no warmth but there was erythema.  The patient denied any pain but there was intermittent itching.  It was reported that the contact dermatitis to the tetanus vaccine injection nearly resolved.
Age: 45.0
Sex: F
Vaccine: DT
Symptoms: Injection site pain, Injection site swelling, Pruritus
Clinical narrative: From initial information received on 07/Mar/2005 from a health care professional regarding an adverse event, it was reported that a forty-five-year-old female patient received a booster dose of DECAVAC vaccine, lot number U1215CA, administered in the deltoid on 03/Mar/2005.  The route of administration was not reported.  An unspecified amount of hours later, on 03/Mar/2005, the patient developed a red raised area 25cm x 10cm at the injection site.  She also complained of pruritis.  The patient was seen by a physician again on unspecified date.  At the time of this report, no other symptoms were reported.  The patient has not recovered from these events.  Follow-up received on 05-Oct-2005.  As per the additional information, the patient presented with complaints of left deltoid pain on 07-Mar-2005.  She had developed injection site erythema, induration tenderness and edema at the injection site.  The area of the erythema and induration was 6 x 6 cms in size.  It was reported that the patient does receive tetanus shots on regular basis and she never had any reaction in the past.  As corrective treatment the patient was placed on MEDROL dose-pack and KEFLEX for an unspecified short period of time.  The patient presented again on 14-Mar-2005 for the re-evaluation, the large erythematous area that was questionably indurated, and erythema was roughly 85% resolved.  There was very small hard mobile nodule under the area of the injection and there was no warmth but there was erythema.  The patient denied any pain but there was intermittent itching.  It was reported that the contact dermatitis to the tetanus vaccine injection nearly resolved.
Age: 34.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Dysgeusia
Clinical narrative: Initial report received on 07/Nov/2005 from another manufacturer.  Manufacturer report #: A0580377A.  A 34-year-old male patient had received an administration (route not reported) of TETANUS TOXOID (lot number and site of administration not reported); A first dose (route not reported) of ENGERIX-B (manufacturer, GlaxoSmithKline), lot number AHBVB013BA (site not reported) and an administration (route not reported) of HAVRIX (manufacturer, GlaxoSmithKline) (lot number and site not reported) on 07/Sep/2005.  At an unspecified time later the patient experienced a metallic taste in his mouth.  The event resolved some time prior to 01/Oct/2005.  The patient subsequently received a second dose of ENGERIX B (manufacturer, GlaxoSmithKline) lot number AHBV171AA (Incorrect lot number), route and site not reported, on 01/Oct/2005.  This is sooner than the recommended interval of one month between the first and second doses of ENGERIX B.  He once again experienced a metallic taste that evolved to a rusty taste.  The event resolved prior to 01/Nov/2005.  Follow-up information received on 26/Jan/2006 from a health care provider.  The patient received an intramuscular injection of TDS ADULT (not TETANUS TOXOID as previously reported), manufacturer sanofi pasteur, lot number U1019AA.  ENGERIX B and HAVRIX were also administered intramuscularly.  Sites of administration were not reported.  The subsequent dose of ENGERIX B was administered intramuscularly on 01/Nov/2005, (not on 01/Oct/2005 as previously reported and not within four weeks of the original vaccination).  All corrections have been amended in the case.  Relevant diagnostic/laboratory tests were none.  The patient is recovered, and additional information is not expected.
Age: 32.0
Sex: M
Vaccine: TD
Symptoms: Blood test normal, Chills, Lymph node pain, Lymphadenopathy
Clinical narrative: From initial information received on 28/Mar/2005 from a registered nurse regarding an adverse event, it was reported that a 32-year-old male patient, who is a physician, received a dose of TD ADS ADULT, lot number U1341AA, administered intra-muscularly in the right deltoid on 25/Mar/2005.  That same day, the patient developed swelling and tenderness of the supraclavicular and axillary lymph nodes on the right side.  He also experienced chills, but did not have a fever.  He self-medicated with ibuprofen.  The patient received the vaccine for wound management following a needlestick.  At the time of this report, he had not recovered from these events.  Follow-up information was received on 26/AUG/2005 from a physician.  He reported that all of the lab work performed was within normal limits.  The symptoms were treated with ibuprofen and the patient recovered from these events.  No further information is expected.
Age: 1.1
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Immunisation reaction, Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 13-month-old female with no pre-existing allergies, birth defect of medical conditions who on 20-SEP-2006 at 10 AM was vaccinated intramuscularly in the left thigh with a first dose of VAQTA (lot# 654337/0510F).  Suspect vaccination included an intramuscular third dose in the right thigh of PEDVAXHIB (lot# 652866/0083F), and a subcutaneous first dose in the left thigh of PROQUAD (lot# "0814").  Concomitant vaccination included an intramuscular third dose in the left thigh of DAPTACEL (lot# U1774CA) and an intramuscular fourth dose in the right thigh of PREVNAR (lot# B08672H).  Concomitant therapy included TYLENOL.  At the time of vaccination the patient had a mild cold and a runny nose.  On 27-SEP-2006 (also reported as 02-Oct-2006) at 12 PM, the patient experienced a flat, red circular rash on the head and trunk which then spread to arms.  It was not itchy.  On 30-Sep-2006, the rash was bright red, circular and slightly raised on the head, trunk, arms.  On 04-Oct-2006, there was more of the rash on the face and it spread down to the legs, on palms, sides of feet.  There were no other signs or symptoms.  On 05-Oct-2006, the rash was head to toe and still very visible, but very light in color, and it appeared to be clearing.  The patient went to see a dermatologist who diagnosed her with an immune reaction to the vaccination, and no treatment was necessary.  The outcome was not reported.  Follow-up information has been received which indicated that further information is not available.
Age: 39.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Erythema, Lip swelling, Paraesthesia, Paraesthesia oral, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 39 year old female with a history of arthritis and no drug reactions/allergies, who on 09-APR-2007 was vaccinated with IM with a second dose of VAQTA (lot # 656318/1278F). Suspect therapy that day at 8:15 AM included a third dose of VAQTA (lot # 656680/0010U) administered IM. The vaccines were co-administered at different sites. There were no other concomitant medication. On 09-APR-2007, the patient reported redness of the cheeks with a hot feeling in the cheeks and tingling around the cheeks and lips without hives. The reaction started an hour and 15 minutes after the vaccinations. The injections sites were reported to be fine on 09-APR-2007, without redness or hematoma. The patient woke up with hives on the face and the lips were swollen and tingly on 10-APR-2007. The patient went to her family physician and was treated with BENADRYL and MEDROL DOSEPAK on 10-APR-2007. The patient was examined by the reporter on 11-APR-2007 and the outcome was reported as recovered. No lab diagnostics studies were performed. There were no AE following prior vaccinations of the patient or her siblings. There was no product quality complaint. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 39 year old female with a history of arthritis and no drug reactions/allergies, who on 09-APR-2007 was vaccinated with IM with a second dose of VAQTA (lot # 656318/1278F). Suspect therapy that day at 8:15 AM included a third dose of VAQTA (lot # 656680/0010U) administered IM. The vaccines were co-administered at different sites. There were no other concomitant medication. On 09-APR-2007, the patient reported redness of the cheeks with a hot feeling in the cheeks and tingling around the cheeks and lips without hives. The reaction started an hour and 15 minutes after the vaccinations. The injections sites were reported to be fine on 09-APR-2007, without redness or hematoma. The patient woke up with hives on the face and the lips were swollen and tingly on 10-APR-2007. The patient went to her family physician and was treated with BENADRYL and MEDROL DOSEPAK on 10-APR-2007. The patient was examined by the reporter on 11-APR-2007 and the outcome was reported as recovered. No lab diagnostics studies were performed. There were no AE following prior vaccinations of the patient or her siblings. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Cyanosis, Flushing, Hyperhidrosis, Oxygen saturation decreased
Clinical narrative: Information has been received from a registered nurse concerning her 4 year old granddaughter with a history of constipation who on 01-MAY-2007 was vaccinated at 10:30 with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 655270/1409F).  Concomitant therapy included MIRALAX as needed.  On 01-MAY-2007 during the drive home the patient became excessively diaphoretic and flushed. Shortly after arriving home, she turned blue starting with her neck and eventually to her cheeks, eyes and temple area.  The patient returned to the physician's office the same day at 14:00 for evaluation.  Her oxygen level was 92 (which was determined low) but eventually, during the visit, it went up to an unspecified level.  On 03-MAY-2007 "yesterday", the nurse visited her granddaughter and she had a tint of blue around her eyes and cheeks.  The blueness was starting to go away and she was reported to be recovering.  There was no product quality complaint.  Follow up information was received from a physician who reported that on 01 MAY 2007 the patient was vaccinated intramuscularly into the left thigh with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (Lot # 655270/1409F).  Subsequently the patient developed periorbital/ orbital discoloration with bluish dissemination which lasted a few hours and resolved that same day.  There were no lab diagnostic studies performed.  No further information is expected.
Age: 11.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Chest X-ray normal, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female with no medical history or allergies who on 18-MAY-2007 was vaccinated IM on deltoid muscle with a first dose of hepatitis A virus vaccine inactivated. Concomitant therapy on same day included an IM first dose diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) (Lot # C2631AA). There was no illness at the time of vaccination. On 19-MAY-2007 the patient experienced nausea, fever, headache and dizziness. The nurse reported that the patient went to the ER and had a chest x-ray that came back negative. The patient had fever with body temperature of 101.5. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that patient experienced nausea, fever, headache, and dizziness on 19-MAY-2007. No further information is expected.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Headache, Lacrimation increased, Lethargy, Ocular hyperaemia, Swelling face
Clinical narrative: Information has been received from a doctor's office concerning a healthy 4-year-old caucasian female, with no known allergies, who on 18-May-2007 at 12:10 in the afternoon was vaccinated in the right arm with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 654444/0986F). The first dose was given on 15-Mar-2004. There was no concomitant medication. Within 20 minutes, at 12:30 in the afternoon, the patient complained of a severe headache, vomited, became lethargic, and then developed red, watery eyes, a puffy face and was covered in hives. Medical attention was sought. The patient was given steroids and antihistamines and the events resolved within a few hours. There was no diagnostic testing and laboratory data done. It is unspecified if a product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria, Vomiting
Clinical narrative: Information has been received from a doctor's office concerning a healthy 4-year-old caucasian female, with no known allergies, who on 18-May-2007 at 12:10 in the afternoon was vaccinated in the right arm with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 654444/0986F). The first dose was given on 15-Mar-2004. There was no concomitant medication. Within 20 minutes, at 12:30 in the afternoon, the patient complained of a severe headache, vomited, became lethargic, and then developed red, watery eyes, a puffy face and was covered in hives. Medical attention was sought. The patient was given steroids and antihistamines and the events resolved within a few hours. There was no diagnostic testing and laboratory data done. It is unspecified if a product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Chills, Cough, Dizziness, Ear pain
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 25 year old male with unspecified allergies who on 04-JUN-2007 at approximately 09:00 was vaccinated subcutaneously in the left upper arm with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot#655103/0862F). There was no known illness at the time of vaccination. Concomitant therapy included montelukast sodium (MSD). On 05-JUN-2007, at 12:00 the patient developed a persistent cough. At around 22:00 on 05-JUN-2007 the patient developed a fever of 102 degrees Fahrenheit, chills, dizziness, bilateral ear aches, body aches, and a sore throat in addition to the cough. The patient was evaluated on 06-JUN-2007 and was diagnosed with a upper respiratory tract infection. The patient was prescribed Z-Pak. At the time of this report the patient was recovering. No other information was provided. There was no product quality complaint involved. Additional information information has been requested.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Pain, Pharyngolaryngeal pain, Pyrexia, Upper respiratory tract infection
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 25 year old male with unspecified allergies who on 04-JUN-2007 at approximately 09:00 was vaccinated subcutaneously in the left upper arm with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot#655103/0862F). There was no known illness at the time of vaccination. Concomitant therapy included montelukast sodium (MSD). On 05-JUN-2007, at 12:00 the patient developed a persistent cough. At around 22:00 on 05-JUN-2007 the patient developed a fever of 102 degrees Fahrenheit, chills, dizziness, bilateral ear aches, body aches, and a sore throat in addition to the cough. The patient was evaluated on 06-JUN-2007 and was diagnosed with a upper respiratory tract infection. The patient was prescribed Z-Pak. At the time of this report the patient was recovering. No other information was provided. There was no product quality complaint involved. Additional information information has been requested.
Sex: U
Vaccine: DTAP, HEPA
Symptoms: Erythema, No reaction on previous exposure to drug, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a patient (age and gender unknown) with eczema who on 07-JUN-2007 was vaccinated with  the second dose of hepatitis A virus vaccine inactivated, IM, in right lateral thigh (lot number "00011A", 11/09). Other vaccinations received on 07-JUN-2007 included the 5th dose of TRIPEDIA (C2254AA-7/08). Concomitant medications included TAC. Illnesses reported at the time of vaccination included "local , none." On 08-JUN-2007, the patient experienced erythema right lateral erythema with moderate swelling 7 cm in diameter with small, 4 mm erythema spots "landing" around it. It was reported that on an unspecified date, the patient recovered. It was also reported that the patient and sibling (brother) experienced no adverse events following prior vaccinations. No further information is available.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Information has been received from a medical assistant concerning a 35 year old female who on 01-JUN-2007 was vaccinated subcutaneously in the left arm with a 0.5 mL dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 656034/0182U). There was no concomitant medication. On 07-JUN-2007 the patient experienced generalized lymphadenopathy. The patient had enlarged lymph nodes all over the body in the groin, arm pit area and neck area. the physician treated the patient with unspecified anti-inflammatory medications and fluids. The patient status was reported as recovering. There were no laboratory testing performed. There was no product quality complaint involved. Follow-up information indicates that the patient had no pre-existing allergies, birth defects or medical conditions, and the vaccination occurred at 9 AM. There was no illness at the time of vaccination. On 08-Jun-2007 (previously reported as 07-Jun-2007), the patient noticed the enlarged lymph nodes that were very painful. On 18-Jun-2007 the patient recovered. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Blister, Blood test, Haemoglobin, Injection site erythema, Pallor
Clinical narrative: Information has been received from a nurse concerning a 12 month old male with a history of upper respiratory tract infection and no allergies who on 18-JUN-2007 was vaccinated with a 0.5ml subcutaneous dose of MMR II (Lot #654379/0706F). Secondary suspect vaccine included  a 0.5ml subcutaneous dose of VARIVAX (Lot # 6571000/0454U). Concomitant vaccines administered included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus and VAQTA (MSD). On 18-JUN-2007 the patient developed a white, blanching blister below the injection site and bright redness around the blister and injection site. The nurse was not specified if it was MMR II or the VARIVAX injection site. The patient was treated with BENADRYL. Unspecified medical attention was sought. No further information was available. This is patient 1 of 3. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/10/2008.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site vesicles, Pallor
Clinical narrative: Information has been received from a nurse concerning a 12 month old male with no medical history and no allergies who on 18-JUN-2007 was vaccinated with a 05.ml subcutaneous dose of MMR II  (lot # 654379/0706F) in the right thigh. Suspect vaccines administered on the same day included a 0.5ml subcutaneous dose of VARIVAX (Lot number # 657100/0454U) in the left thigh and VAQTA in the left thigh. On 18-JUN-2007 the patient developed a white blanching blister (which injection site unknown) and bright redness at the injection site on both thighs. No laboratory or diagnostic tests were performed. The patient was treated with BENADRYL. Unspecified medical attention was sought. No further information was available. This is one of several reports from the same source. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirement of the center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Blood lead, Haemoglobin, Injection site discolouration, Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a 13 month old male who on 18-JUN-2007 was vaccinated with MMR II (Lot # 654379/0706F) 0.5 ml SQ in the left thigh at a one year well check up. Concomitant therapy included VARIVAX (Lot # 657100/0454U) in the right thigh, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid in the left thigh and VAQTA in the right thigh. On 18-JUN-2007, the injection site was bright red where the patient received MMR II. Subsequently, the patient recovered. The patient had lead and hemoglobin stick at this visit. Results not provided. This patient also experienced a white blister below the injection site that turned purplish shortly therefore after receiving with VARIVAX (WAES # 0707USA02085). The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirement of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Blood alkaline phosphatase increased, Blood immunoglobulin G normal, Blood immunoglobulin M, Cough, Enterovirus serology test negative
Clinical narrative: Information has been received from a health professional concerning a 12 month old white male with no pre-existing physician diagnosed allergies, birth defects, or medical conditions who on 13-JUN-2007, received a subcutaneous dose in his upper right thigh of MMR II (lot# 654180/0479F). Concomitant vaccines included 0.5 ml subcutaneous dose in right upper thigh of VARIVAX (lot# 657100/0454U) and 0.5 ml intramuscular dose in his upper right thigh of PREVNAR (lot# B08670C). There was no reported illness at the time of the vaccinations and no adverse effect following prior vaccination. On 17-JUN-2007, he developed rash and was seen in the office. He also had developed a runny nose and cough. On 21-JUn-2007, it was reported that he was fussy and vomited times two. He was seen again on 22-JUN-2007, for reported rash and fever that was worse. A physician reported that the patient's incubation period was too short to be from the vaccines. It was reported that the rash looked like Rubeola but other symptoms were missing. It was reported that the patient was not miserable and there was no Koplick spots. On 26-JUN-2007, diagnostic studies were obtained including complete blood count and basic metabolic panel (normal results), alkaline phosphatase (902), IgM (1535), IgG (1483) and Enterovirus antibodies profile (interpretation reported as positive for acute infection). It was reported based on the laboratory results that the patient had EBV, even though a negative mono test was reported. He has recovered from the rash and fever (27-JUN-2007, 26-JUn-2006 respectively). Additional information is not expected. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Epstein-Barr virus infection, Irritability, No reaction on previous exposure to drug, Pyrexia, Rash
Clinical narrative: Information has been received from a health professional concerning a 12 month old white male with no pre-existing physician diagnosed allergies, birth defects, or medical conditions who on 13-JUN-2007, received a subcutaneous dose in his upper right thigh of MMR II (lot# 654180/0479F). Concomitant vaccines included 0.5 ml subcutaneous dose in right upper thigh of VARIVAX (lot# 657100/0454U) and 0.5 ml intramuscular dose in his upper right thigh of PREVNAR (lot# B08670C). There was no reported illness at the time of the vaccinations and no adverse effect following prior vaccination. On 17-JUN-2007, he developed rash and was seen in the office. He also had developed a runny nose and cough. On 21-JUn-2007, it was reported that he was fussy and vomited times two. He was seen again on 22-JUN-2007, for reported rash and fever that was worse. A physician reported that the patient's incubation period was too short to be from the vaccines. It was reported that the rash looked like Rubeola but other symptoms were missing. It was reported that the patient was not miserable and there was no Koplick spots. On 26-JUN-2007, diagnostic studies were obtained including complete blood count and basic metabolic panel (normal results), alkaline phosphatase (902), IgM (1535), IgG (1483) and Enterovirus antibodies profile (interpretation reported as positive for acute infection). It was reported based on the laboratory results that the patient had EBV, even though a negative mono test was reported. He has recovered from the rash and fever (27-JUN-2007, 26-JUn-2006 respectively). Additional information is not expected. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rhinorrhoea, Viral test negative, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 12 month old white male with no pre-existing physician diagnosed allergies, birth defects, or medical conditions who on 13-JUN-2007, received a subcutaneous dose in his upper right thigh of MMR II (lot# 654180/0479F). Concomitant vaccines included 0.5 ml subcutaneous dose in right upper thigh of VARIVAX (lot# 657100/0454U) and 0.5 ml intramuscular dose in his upper right thigh of PREVNAR (lot# B08670C). There was no reported illness at the time of the vaccinations and no adverse effect following prior vaccination. On 17-JUN-2007, he developed rash and was seen in the office. He also had developed a runny nose and cough. On 21-JUn-2007, it was reported that he was fussy and vomited times two. He was seen again on 22-JUN-2007, for reported rash and fever that was worse. A physician reported that the patient's incubation period was too short to be from the vaccines. It was reported that the rash looked like Rubeola but other symptoms were missing. It was reported that the patient was not miserable and there was no Koplick spots. On 26-JUN-2007, diagnostic studies were obtained including complete blood count and basic metabolic panel (normal results), alkaline phosphatase (902), IgM (1535), IgG (1483) and Enterovirus antibodies profile (interpretation reported as positive for acute infection). It was reported based on the laboratory results that the patient had EBV, even though a negative mono test was reported. He has recovered from the rash and fever (27-JUN-2007, 26-JUn-2006 respectively). Additional information is not expected. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HEPA
Symptoms: Body temperature, Drug toxicity, Heart rate, Rash macular
Clinical narrative: Information has been received from a healthcare worker concerning a 16-month-old male with no allergies, who on 20-JUL-2007 was vaccinated with a first dose of hepatitis A virus vaccine inactivated. The next day, on 21-JUL-2007, the patient experienced a "head to toe rash." Unspecified medical attention was sought. The outcome was reported as not resolved. No product quality complaint was involved. Follow-up information has been received which indicates that the patient does not have any pre-existing allergies, birth defects or medical conditions. It was reported that the patient, his brother and sister have never had an adverse event to any pervious vaccinations. On 20-Jul-2007, at approximately 2:30 PM, the patient was vaccinated in the left thigh with a dose of hepatitis A virus vaccine inactivated (lot# 657304/0246U). There was no illness at the time of vaccination. On 23-Jul-2007, the patient was seen at the doctor's office with a rash all over his body that had macular patches of "ery." He had no other symptoms. Tympanic membrane temperature was 96.8 F, pulse rate 106BPM. The assessment was reported as "toxicity from vaccinee's reaction to hepatitis A virus vaccine inactivated." The plan was to check recommendations concerning the second dose of hepatitis A virus vaccine inactivated. The outcome was reported as unknown. Additional information is expected.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Local swelling, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning an approximately 35 year old female with unknown specified pertinent medical history and drug reactions/allergies including: Penicillin, Nickel and Bee stings, who on 19-JUL-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot number: 655270/1409F). Concomitant therapy included varicella virus vaccine live (MSD). Subsequently, the patient presented with a maculopapular rash that looked like measles. The patient has swelling around the neck. The outcome is reported as not recovered. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Chest X-ray, Febrile convulsion, Pneumonia
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 02-AUG-2007, at 3:00 p.m., was vaccinated with a first subcutaneous dose in the left arm of MMR II (Lot# 655414/1470F).  Concomitant vaccines administered at the same time included a first subcutaneous dose in the right arm of VARIVAX (Lot# 658024/0833U) and a fourth intramuscular dose in the left thigh of PREVNAR (Lot# B58845H).  There was no illness at the time of vaccination.  On 10-AUG-2007, at 10:00 a.m., the patient experienced febrile seizure with pneumonia.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  Upon internal review, the patient's febrile convulsion was considered to be an other important medical event.  The patient's twin brother also experienced a febrile seizure with pneumonia following vaccination with MMR II (WAES# 0709USA04262).  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL, MMR, PNC, VARCEL
Symptoms: Chest X-ray, Febrile convulsion, Pneumonia
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 02-AUG-2007, at 3:00 p.m., was vaccinated with a first subcutaneous dose in the left arm of MMR II (Lot# 655414/1470F). Concomitant vaccines administered at the time included a first subcutaneous dose in the right arm of VARIVAX (Oka/Merck) (Lot# 658024/0833U) and a fourth intramuscular dose in the left thigh of PREVNAR (Lot# B58845H). There was no illness at the time of vaccination. On 10-AUG-2007, at 10:15 a.m., the patient experienced febrile seizure with pneumonia. Subsequently, the patient recovered. Unspecified medical attention was sought. Upon internal review, the patient's febrile convulsion was considered to be an other important medical event. The patient's twin brother also experienced a febrile seizure with pneumonia following vaccination with MMR II (WAES# 0709USA04262). Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Body temperature increased, No reaction on previous exposure to drug, Pyrexia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 13 month old female, with no known medical history, who on 10-AUG-2007, was vaccinated intramuscularly (site not specified) with 0.5 ml dose of MMR II lot # 656033/0280U.  Concomitant vaccines administered on the same day included, ACT HIB (lot #UF10488) intramuscularly in the left leg, TRIPEDIA (lot #C255288) intramuscular in the right leg, and PREVNAR (lot# B086578) intramuscularly in the left leg.  There was no reported adverse events following prior vaccination, and no illness at the time of vaccination.  On 10-AUG-2007 within 5 to 6 hours of the vaccinations, the patient experienced wheals, hives and a fever of 102F that lasted on and off for 5 to 6 days.  He was seen in the office by his physician, specific treatment not reported.  The patient has recovered.  No product quality complaint was reported.  No further information was available.  Follow up information from the physician reported there were no diagnostic tests or laboratory data.  Treatment included BENADRYL.  It was reported that as of 17-AUG-2007, the patient had recovered.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a county health nurse practitioner concerning a 5-year-old female who on 10-AUg-2007 in the evening was vaccinated in the right upper arm with a second dose of MMR II (Lot # 655346/1324F). On 17-AUG-2007 (previously reported as three to four days post vaccination) the patient developed wheal at the injection site that was described as a red raised area at the injection site. The patient returned to the health department for follow-up but did not require treatment . Nurse stated "she has never seen such a reaction before". On an unspecified date the patient recovered. Lot check has been requested. This is one of several reports the same source. The records of testing prior to release of lot 655346/1324F have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 6-month-old white male who on 11-OCT-2007 at 10:30 hours was vaccinated subcutaneous in the thigh with his first dose of MMR II (lot # 654607/0807F) instead of PEDIARIX. There were no illnesses at the time vaccination. No adverse experience was reported. No diagnostic labs were performed. A product quality complaint was not involved. Additional information is not expected.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Burning sensation, Headache, Hypoaesthesia, Injection site irritation, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 40 year old male who on 02-OCT-2007, in PM, was vaccinated SC into the left arm with a dose of MMR II (lot number: 657249/0526U).  Other vaccine therapy included the following: 01 OCT 2007, in the AM, FLUARIX AFLUAZ98BA, administered intramuscularly into the right deltoid, and HEPACCINE-B AHBVB413AA, administered intramuscularly into the left deltoid in the AM, on 19 SEP 2007.  Concomitant therapy included Ibuprofen, "Zedia", PERCOCET, XANAX, and OXYCONTIN.  On 09-OCT-2007 (about one week after MMRII) the patient experienced shooting pain down the injection arm.  The pain was "almost making the arm feel numb all the way down to his hand".  The patient also developed swelling and experienced a burning pain at the injection site along with a headache.  Illness at time of vaccination included: chronic back pain.  No further information was provided.  Unspecified medical attention was sought.  The outcome was reported as not recovered.  There was no product quality complaint.  Follow up information was received from a nurse who reported that "the MMR II caused a headache, burning pain down arm, and numbness down arm".  No further information is expected.  It was also reported that the patient's niece developed an adverse event after vaccination.  (WAES#: 0711USA03260).  Additional information is not expected.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 40 year old male who on 02-OCT-2007, in PM, was vaccinated SC into the left arm with a dose of MMR II (lot number: 657249/0526U).  Other vaccine therapy included the following: 01 OCT 2007, in the AM, FLUARIX AFLUAZ98BA, administered intramuscularly into the right deltoid, and HEPACCINE-B AHBVB413AA, administered intramuscularly into the left deltoid in the AM, on 19 SEP 2007.  Concomitant therapy included Ibuprofen, "Zedia", PERCOCET, XANAX, and OXYCONTIN.  On 09-OCT-2007 (about one week after MMRII) the patient experienced shooting pain down the injection arm.  The pain was "almost making the arm feel numb all the way down to his hand".  The patient also developed swelling and experienced a burning pain at the injection site along with a headache.  Illness at time of vaccination included: chronic back pain.  No further information was provided.  Unspecified medical attention was sought.  The outcome was reported as not recovered.  There was no product quality complaint.  Follow up information was received from a nurse who reported that "the MMR II caused a headache, burning pain down arm, and numbness down arm".  No further information is expected.  It was also reported that the patient's niece developed an adverse event after vaccination.  (WAES#: 0711USA03260).  Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: DTAPH, MMRV, PNC
Symptoms: Body temperature increased, Pyrexia, Rash erythematous, Rash macular, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 14 month old male who on 26-JUN-2007 was vaccinated on left thigh with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot # 657265/0293U). Concomitant therapy on left thigh included Prevnar (Lot # B25610C) and a dose on right thigh of TriHIBit (lot # UF105AB). There was no illness at the time of vaccination. On 07-JUL-2007, (previously reported as 05-JUL-2007), the patient developed measles like rash that started behind the ears that spread to the neck and them to face, arms, back and legs. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the physician who stated that on 07-JUL-2007, 10 days after vaccination the patient developed fever of 102.6 and facial rash. The rash was described as erythematous and macular. On 16-JUL-2007, the patient recovered. No further information is expected.