chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Pharyngolaryngeal pain, Pyrexia, Viral infection, Vomiting
Clinical narrative: The patient states that he began feeling ill on 03/08/2005.  On 03/09/2005 he had a headache, fever, and chills.  On 03/10/2005 he complained of difficulty breathing, stating that it felt as though someone was sitting on his chest.  He also experienced sore throat, productive cough, vomited once, and felt dizzy.  Headache, fever, and chills continued.  Patient went to the ER - diagnosis of viral syndrome with headache.  Completely recovered on 03/15/2005.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Eczema, Pruritus, Rash erythematous, Upper respiratory tract infection
Clinical narrative: Patient has a red, raised, circular, itchy spot on left upper arm.  The spot has increased in size.  A second spot has developed on his left upper arm with the same symptoms.  The patient took an antibiotic for an upper respiratory infection after the spot appeared with no change in the affected area.  He saw a dermatologist on 04/13/2005 and the spots were diagnosed as Eczema.  On 04/23/2005 the patient reported that he now had a few spots on the right forearm.  He was prescribed a steroid lotion and the eczema is now gone.  The patient states that where the spots were has a slightly darker area of pigmentation.  On 07/28/2005, the patient reported that he has noticed the spots appear after waxing the hairs off his arms.  He noted that this has been a pattern and feels that the spots may be related to waxing, possibly not related to the vaccination.  At this time, his condition is stable.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Awoke from sleeping at 11:30PM on day the shot was administered with chills, headache, and body aches.  She took her temperature and noted a fever of 102 degrees.  She stated that it felt like flu symptoms.  She took Nyquil and Aleve as treatment.  She felt better when she awoke on 06/29/2005, but still had headache and body aches.  She felt completely recovered when she awoke on 06/30/2005.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Crying, Depression, Headache, Herpes zoster, Infection
Clinical narrative: Developed shingles after receiving 6th dose AVA.  Had received primary series of immunization in July 1997.  Then in 2000, subject was administered the primary series again because the original paperwork couldn't be found.  Sought treatment for shingles on 11/27/2000.  Around this same time he developed severe headaches, depression with sobbing uncontrollably and an inability to think clearly.  He began to self medicate with alcohol and street drugs 2 1/2 years ago.  His wife left him 06/01/2005.  His father realized he needed help and took him to the emergency room to ensure immediate treatment.  Substance abuse is no longer a problem following an outpatient treatment program that the subject attended.  At this time the expectation is that there is no need for further treatment.  The patient was evaluated and sent for psychological and medical referrals.  The patient has also been receiving counseling for post traumatic stress disorder and the counseling is expected to continue.  The patient had diagnostic workup in mid-June and is now taking Bupropion HCL to correct his serotonin levels and he sees his doctors frequently.  His father reports that the patient had improved 3000% since beginning the medication and his headache have improved drastically.  This information was received from the patient. Follow-up information received May 2, 2006. BioPort has not further informatino on this case. In the event that additional relevant medical information is received, a follow-up report will be submitted.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Thinking abnormal
Clinical narrative: Developed shingles after receiving 6th dose AVA.  Had received primary series of immunization in July 1997.  Then in 2000, subject was administered the primary series again because the original paperwork couldn't be found.  Sought treatment for shingles on 11/27/2000.  Around this same time he developed severe headaches, depression with sobbing uncontrollably and an inability to think clearly.  He began to self medicate with alcohol and street drugs 2 1/2 years ago.  His wife left him 06/01/2005.  His father realized he needed help and took him to the emergency room to ensure immediate treatment.  Substance abuse is no longer a problem following an outpatient treatment program that the subject attended.  At this time the expectation is that there is no need for further treatment.  The patient was evaluated and sent for psychological and medical referrals.  The patient has also been receiving counseling for post traumatic stress disorder and the counseling is expected to continue.  The patient had diagnostic workup in mid-June and is now taking Bupropion HCL to correct his serotonin levels and he sees his doctors frequently.  His father reports that the patient had improved 3000% since beginning the medication and his headache have improved drastically.  This information was received from the patient. Follow-up information received May 2, 2006. BioPort has not further informatino on this case. In the event that additional relevant medical information is received, a follow-up report will be submitted.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia
Clinical narrative: Patient reports pain in deltoid muscle of both arms.  Cannot tolerate pressure over muscle without pain.  Symptoms resolved on or about 11/15/2005.  Information received received May 2, 2006. The year of 2003 is the only information regarding the AE onset date/time that we have. 07/09/03 is the date of the vaccination (time is unknown).
Age: 57.0
Sex: F
Vaccine: ANTH
Symptoms: Decreased appetite, Fatigue, Liver disorder, Pain, Sleep disorder
Clinical narrative: On 02/28/2005 patient had labs drawn and was subsequently notified of her elevated liver enzymes.  Medical workup revealed inflammation of liver.  Tests indicated Primary Biliary Cirrhosis.  The subject had a liver biopsy done on 05/18/2005 that indicated autoimmune hepatitis.  Her doctor believes there is a crossover disease process involved.  In May, fluid was noted surrounding her liver within her peritoneal cavity.  80cc of fluid was drained from this area on 06/30/2005.  All tests on this fluid, including cultures, were negative.  Symptoms include right sided pain at waist, fatigue, decreased appetite and sleep disruption due to pain.  Treated with Ursodiol.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Fatigue, Headache, Nasal congestion
Clinical narrative: Patient complained of a temporal headache and fatigue beginning day after immunization and continuing daily since that date.  She has taken Tylenol and green tea with some relief.  She also has purposefully rested more often as treatment.  As of 08/30/2005 the patient states that she has an additional symptoms of nasal congestion.  She sought medical care and had blood work done.  She reports that her symptoms gradually went away and that as of 11/07/2005 there was a complete resolution of symptoms.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Injection site nodule, Pain, Pruritus
Clinical narrative: Patient states that he immediately experienced burning/stinging at the injection site.  Other complaints following vaccination include redness from his elbow to his shoulder in the injected arm, a subcutaneous knot that would come and go, itching at the injection site and that the injected arm was warm to the touch.
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Hypoaesthesia, Movement disorder, Paraesthesia, Pruritus
Clinical narrative: On 11/09/1999 the patient received his 4th dose of AVA along with IPPD.  Sometime in December 1999 he noticed that both of his hands would itch.  He then noted that his left hand had numbness and tingling in his thumb and the tips of his index finger.  He also noticed weakness in his hands and that he had a tendency to drop things.  He noted that these symptoms were getting worse as time passed and he reported that he went to the doctor who could not find anything wrong.  He stated that for 4-8 weeks these same symptoms would keep coming and going and that the symptoms never resolved completely before his 5th dose of AVA.
Age: 41.0
Sex: F
Vaccine: ANTH
Symptoms: Contusion
Clinical narrative: Bruise at site of immunization approximately 2x1 inch in size.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Fatigue, Myalgia, Pruritus, Skin burning sensation
Clinical narrative: Patient states that he received his 4th dose of AVA on 01/07/2003.  He reports that as the vaccine was being injected he immediately experienced burning at the site.  Following the injection, the subject reports redness, swelling, itching, tenderness and muscle aches following vaccination.  He states that he went home and fell asleep.  After one week, all of his symptoms went away except for the extreme fatigue.  He reports that all he wanted to do was sleep.  He reports that he experienced a decrease of about 30% in his physical activity.  At the time he thought the fatigue was jet lag, but states that it continued up until his 5th dose on 07/30/2003 and has never gone away.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Swelling, Tenderness
Clinical narrative: Patient states that he received his 4th dose of AVA on 01/07/2003.  He reports that as the vaccine was being injected he immediately experienced burning at the site.  Following the injection, the subject reports redness, swelling, itching, tenderness and muscle aches following vaccination.  He states that he went home and fell asleep.  After one week, all of his symptoms went away except for the extreme fatigue.  He reports that all he wanted to do was sleep.  He reports that he experienced a decrease of about 30% in his physical activity.  At the time he thought the fatigue was jet lag, but states that it continued up until his 5th dose on 07/30/2003 and has never gone away.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Headache, Injection site mass, Paraesthesia, Skin burning sensation
Clinical narrative: Patient reports redness 5-12cm lasting 72 hours.  Mild lump lasting 10 days.  Patient reports headache lasting 4 hours and numbness and or tingling and or burning in arm of shot site.  Considered mild reaction.  Subject states no treatment or medication for reaction.
Age: 0.38
Sex: F
Vaccine: HIBV, PNC, TDAP
Symptoms: Medication error, Pyrexia
Clinical narrative: Fever in a 4 month old female who was inadvertently vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, absorbed for prophylaxis.  Patients medical history included cold and sinus infection. On 12/19/2005 the patient inadvertently received a dose of Boostrix rather than the intended 1st dose of diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined.  Bootrix is recommended for immunizing individuals 10 through 18 years of age.  On 12/19/2005, the subject also received injections of 7-valent pneumococcal conjugate vaccine.  Approximately one day later, on 12/20/2005, the patient experienced a fever of 101 degrees.  The fever resolved on 12/21/2005.  The nurse considered the events to possibly be related to vaccination with Boostrix.  The nurse also reported that, the fever could have been from the vaccinations or from the cold and sinus infection.
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: On 09/14/2005 the patient received 1st dose of Boostrix in the left arm.  On 09/15/2005, 1st day after vaccination with Boostrix, the patient experienced pain in her thighs and arms.  At the time of initial reporting, 01/13/2006, the pain was ongoing.
Sex: U
Vaccine: TYP
Symptoms: Arthralgia, Pruritus, Swelling
Clinical narrative: A patient took the first capsule of Vivotif on 07/01/2005.  On 06/30/2005 he received Hepatitis A, Di-Te and polio immunization.  Following intake of the second and third Vivotif capsule he developed joint pain, swelling of arms and hands and itchy fingers.
Age: 6.0
Sex: M
Vaccine: TYP
Symptoms: Headache, Pain, Pyrexia, Skin disorder, Staring
Clinical narrative: 16 year old male started oral vaccination against typhus with Vivotif on 06/26/2005, 3 days later, on 06/29/2005 the patient developed fever with glassy eyes, severe headache, faint, increased skin sensitivity and body aches.  The reported symptoms required an emergency room visit.  The patient recovered and all symptoms resolved with sequelae.
Age: 6.0
Sex: M
Vaccine: TYP
Symptoms: Syncope
Clinical narrative: 16 year old male started oral vaccination against typhus with Vivotif on 06/26/2005, 3 days later, on 06/29/2005 the patient developed fever with glassy eyes, severe headache, faint, increased skin sensitivity and body aches.  The reported symptoms required an emergency room visit.  The patient recovered and all symptoms resolved with sequelae.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Asthenia, Headache
Clinical narrative: 62 year old female took her first capsule of Vivotif on 12/06/2004.  One day later, on 12/07/2004 she developed abdominal pain, headache and generalized weakness.  On 12/08/2004 she took the second capsule.  The symptoms continued in same intensity, they did not increase nor decrease.  5 years ago the patient was vaccinated with Vivotif without any problems.  At the time of reporting outcome was unknown.
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Patient developed a rash mostly on the lower portion of the leg from his knee to the ankle after intake of the third Vivotif capsule.  The nurse noted the rash to be multiform.  At the time of reporting the patient was on his way to Africa for several weeks.  He completed the immunization course with the fourth capsule.  Outcome is unknown.
Sex: M
Vaccine: TYP
Symptoms: Pyrexia
Clinical narrative: This male took the first dose of Vivotif before going to bed.  Several hours later he woke with a fever.  Outcome is unknown, further information is expected.  More information has been requested.
Sex: U
Vaccine: DTAP
Symptoms: Injection site reaction, Swelling
Clinical narrative: From initial information received on 14/Jan/2005 regarding an adverse event occurring in the USA, it was reported that two patients (no specified identification provided) received DAPTACEL, lot number C2131AA, on an unspecified data. The route and site of administration were not reported. An unspecified amount of time later, both patients experienced severe local reactions at the sites of injection. One of patients also experienced swelling of the entire limb. It was not reported whether either of the patients recovered from these events.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site swelling, Injection site warmth
Clinical narrative: From initial information received on 11/Mar/2005 from a registered nurse regarding an adverse event occurring in the USA. It was reported that a five year old male patient received his fifth dose of DAPTACEL, lot number C2131AA, administered in the deltoid on the morning of 01/Mar/2005. The route of administration was not reported. Four to six hours later, the patient's arm become red, hot, and swollen. He was treated with ice packs and antipyretics. The patient was seen by the physician on 09/Mar/2005 and again on 10/Mar/2005. At that time there did not seem to be any improvement in the reaction. The patient's recovery status was reported as unknown. Follow-up information received on 12-August-2005. The patient recovered. The reporter was unable to provide any further information.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: From initial information received on 18/Mar/2005 from a health care professional regarding an adverse event occurring in the USA, it was reported that a four year old female patient received a fifth dose of DAPTACEL, lot number C1696AA, administered in the right deltoid, a dose of IPOL, lot number X0367, administered in the left deltoid; and a dose of Measle, Mumps and Rubella Vaccination lot number 1035N, administered in the left deltoid on 02/Jan/2004. The route of administration were not reported. Two days later on 04/Jan/2004, the patient developed redness, swelling and blisters at the sight of the DAPTACEL injection. The reactions site measured approximately the size of quarter. As per the reporter, the symptoms resolved and the patient recovered from these events. From additional information received on 14/Apr/2005 from responsible physician, it was reported that the DAPTACEL vaccine was administered intra-muscularly in the right deltoid, IPOL vaccine was administered subcutaneously in the right arm and Measles, Mumps and Rubella vaccine MMR was administered subcutaneously in the left arm with no reaction. Reportedly, the patient had an area of induration greater than one and half inches at the site of injection and also had sore small vesicles in fold of her right arm. She was treated with Benadryl by mouth for two days. Additional information received from a physician on 07/Nov/2005. The patient has had no additional problems and "is fine." Further information is not expected.
Sex: U
Vaccine: DTAP, IPV, MM
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site swelling, Tenderness
Clinical narrative: From initial information received on 11/Apr/2005 from a health are professional regarding an adverse event occurring in the USA, it was reporting that four patients (no specific identification provided) received a fourth dose of DAPTACEL, lot number C218AA, administered intra-muscularly, and a dose of IPOL, lot number not reported, as well as a dose of MMR/Measles, Mumps and Rubella vaccine lot number not reported, on an unspecified date. None of sites of administration were reported. Within two weeks, four patients developed a large local reactions with pain, tenderness, swelling and redness at unspecified site of injection. Reportedly the redness raised approximately 1 inches in diameter. It was not reported whether any of the patients recovered from these events. From additional information received on 12/Apr/2005 from an internal communication. It was reported that the four patients had a reaction to DAPTACEL vaccine but no specific patient information could be provided. From additional information received on 14/Apr/2005 from the internal communication, it was reported that one additional patient (no specific identification provided) also received a dose of DAPTACEL, lot number C218AA, on an unspecified date. An unspecified amount of time later, the patient developed entire limb swelling and also had the same reaction as the other four patients. Patient's recovery status was not reported. Follow up information received on 16/Sep/2005 and 27/Oct/2005. As per reporting physician the patients have recovered from the event. The reporting physician was contacted for the individual patient identified and he stated that he completed a report for each patient and submitted it to manufacturer. The physician was asked to resend the information, as a search in the database did not locate any additional causes from this reporter. The physician stated that he will try to complete the information again and report it to the company. Follow up information received on 04-November-2005. The reporting physician stated that he no longer had the list of patients involved in this report and therefore, would not be able to provide any additional information.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: 5 year old female patient received a dose of Daptacel on an unspecified date.  The route and site of administration were not reported.  An unspecified amount of time later, the patient developed Cellulitis at the site of injection.  As per the reporter, it is unknown if the patient recovered from this event.   The reporter stated that this patient was one of a total of 3 patient who experienced an adverse event following the receipt of this lot number.  No information was provided for the other two patients.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site swelling
Clinical narrative: From initial information received on 18/May/2005 from a health care professional regarding an adverse event occurring in the USA. It was reported that a four year old female patient received a dose of DAPTACEL, lot number C2103AA, administered intra-muscularly in the left arm, a dose of IPOL, lot number Y0218-2, administered subcutaneously in the right arm and a dose of MMR/Measles, Mumps and Rubella vaccine, lot number 0777P, administered subcutaneously in the left arm on 16/May/2005. The following day, on 17/May/2005, the patient developed redness and swelling of her entire left arm. She was diagnosed with cellulitis. The patient was seen by a physician and was treated with Omnicef orally for seven days and Atarax orally twice a day. At the time of this report, the patient had not recovered from these events. Follow-up information received on 03-November-2005. No additional information was provided.
Sex: U
Vaccine: DTAP
Symptoms: Swelling
Clinical narrative: From initial information received on 20/May/2005 from a physician regarding an adverse event occurring in the USA, it was reported that a cluster of four patients (ages, dates of birth and genders not reported) received a fifth dose of DAPTACEL, lot number C163AA, administered on unspecified dates. The routes and sites of administration were not reported. An unspecified amount of time later all four patients developed swelling of the entire limb. It was not reported whether any of the patients recovered from the events.
Sex: U
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site swelling
Clinical narrative: From initial information received on 31/May/2005 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a cluster of ten five year old patients (individual patient information not provided) received a dose of DAPTACEL, lot number C2221AA, on unspecified dates. The routes and sites of administration were not reported. An unspecified amount of time following vaccination, all of the patients experienced swelling and redness from the shoulder to the elbow. All of the patients recovered from these events.
Age: 1.26
Sex: F
Vaccine: DTAP
Symptoms: Cough
Clinical narrative: 6 months after received Daptacel, in May of 2005, the patient experienced a cough.  She was seen in a physician's office.  The physician stated that there is an outbreak of pertussis in Tucson.  Due to the outbreak of pertussis, the patient was tested for antibodies to pertussis.  Subsequently on 05/24/2005 the results of the pertussis antibody titer was negative.  The patient's outcome was not reported.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: From initial information received on 09/Jun/2005 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a five year old male patient received his fifth dose of DAPTACEL, lot number C2221AA, administered in the left deltoid as well as a dose of MMR/Measle, Mumps and Rubella vaccine, lot number 0029R, administered in the right deltoid, on 25/May/2005. The routes of administration were not reported. The following day, the patient developed pain, swelling, redness, and warmth at the site of injection of the left arm. Reportedly, the swelling spread from the shoulder to the elbow. The reporter did not know the exact duration of the events. Reportedly, the patient recovered from the events. The reporter of this case is the same reporter as case 2005-01112. Follow-up information received on 22/Sep/2005. Per reporter there is no additional information at this time. Follow-up information received on 02/Dec/2005. As per reporter the patient is doing well at this time. Other than symptomatic care, nothing else was required.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site swelling
Clinical narrative: Initial report received from a health care professional on 19/Jul/2005. A cluster of "several" four year olds (no specific patient identification provided), had received injections of Daptacel, lot number not reported, on an unspecified date. An unspecified amount of time later, the patients developed large area of redness and swelling at the injection site. They were subsequently diagnosed with cellulitis. It was not reported whether the patients recovered from these events.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional in the USA on 03-August-2005. A 5 year old, female patient developed injection site inflammation after receiving Daptacel, lot number C2243AA, in the left thigh on 01-August-2005 (route of administration not reported). The patient also received IPOL, lot number Y0424-2 in the right thigh on the same day. At the left thigh site of the Daptacel injection, she had "golf ball sized redness, warmth, swelling and knot on the evening of vaccination." The reporter states that the office "routinely uses needles size 25 g 5/8." At the time of reporting, the patient did not recover. The case has the same reporting facility as cases 2005-01488; 2005-01497 and 2005-01498.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site hypersensitivity, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a health care professional in the USA on 05-August-2005. A 4 year old female child developed redness, swelling (11x16cm), warmth and slight pain at the injection site four hours after receiving Daptacel lot number C169AA in the left thigh, (route of administration not reported) on 01-August-2005. The patient received concomitant injections of IPOL lot #X1040-2 in the right arm and MMR lot #0314P in the left arm. (Route of administration not reported for either product). There was clear erythremic lesions on the left leg. Patient did not have vomiting, no nausea and no fever present. At the time of this report the patient had not recovered. Follow-up information received on 14/Oct/2005. There were no diagnostic test or lab work performed. As per the reporter, there is no additional information at this time. Follow-up information received on 31/Oct/2005. As per reporter the reaction involved the injection site of the left thigh when Daptacel was administered. The patient recovered. As per the reporter, there is no additional information at this time.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Skin ulcer
Clinical narrative: Initial report received from a health care professional in the USA on 05-August-2005. A 4 year old female child developed redness, swelling (11x16cm), warmth and slight pain at the injection site four hours after receiving Daptacel lot number C169AA in the left thigh, (route of administration not reported) on 01-August-2005. The patient received concomitant injections of IPOL lot #X1040-2 in the right arm and MMR lot #0314P in the left arm. (Route of administration not reported for either product). There was clear erythremic lesions on the left leg. Patient did not have vomiting, no nausea and no fever present. At the time of this report the patient had not recovered. Follow-up information received on 14/Oct/2005. There were no diagnostic test or lab work performed. As per the reporter, there is no additional information at this time. Follow-up information received on 31/Oct/2005. As per reporter the reaction involved the injection site of the left thigh when Daptacel was administered. The patient recovered. As per the reporter, there is no additional information at this time.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Agitation, Injection site hypersensitivity, Nasal congestion, Tension
Clinical narrative: Initial report received from a health care professional in the USA on 10-August-2005. A 4 year old child became inconsolable, "wired," had a stuffy nose and his left arm was red at the injection site on the evening of the day he received Daptacel, lot number C220AA in the left deltoid. Patient received concomitant IPOL lot number 4032-5 in the left arm and MMR lot number 0150R in the right arm. Site and route of administration for vaccines was not reported. The patient has a history of mild asthma and allergies to Bactroban, penicillin and peanuts. He had no illness at the time of the vaccination. Concomitant drugs included Zovirax, Albuterol and Epipen. The patient's mother state the child appears to have less symptoms in the morning. There was no fever or hives reported. The mother phoned in the report and the child was not seen by a physician. Recovery status of the child was reported as unknown. Follow-up report received on 21-Sep-2005 from a health care professional. The onset date of the adverse events was confirmed as 08-Aug-2005. It was reported that the Daptacel was given intra-muscularly in the left arm and the IPOL subcutaneously in the left arm. The physician recommended the symptoms be treated with a steroid, and an allergist be contacted but the parent refused. The parent's primary concern during this adverse event was that the child was having a reaction to latex. The patient recovered from these events. No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site induration, Injection site oedema, Injection site reaction
Clinical narrative: A 5 year old, male patient experienced injection site cellulitis, one day after receiving a number of vaccinations on 8/2/2005. The patient received the following injections: Daptacel lot number C2220AA intramuscularly in the upper left thigh, IPOL lot number Y0325 intramuscularly in the lower left thigh and MMR lot number 0033R subcutaneously in the right thigh. On 8/3/05, the patient presented with a hard, red, swollen, reaction of 1 1/2" in diameter. On 8/4/05, the patient was seen at the doctors office with a reaction of 4" where the Daptacel was given. It was diagnosed as cellulitis and treated with an antibiotic. The patient recovered from the adverse event. Follow up received on 9/28/2005 the patient experienced 4 episodes since 2000 of cough and wheeze that required office visit and treatment by medicines. It was never coincided with vaccine administration. There were never any other reactions to previous vaccines. Cultures were not done on reaction site. The patient had received the antibiotic for 10 days. The patient recovered from this adverse event. Data complete. Case is closed.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Lethargy, Pallor, Vomiting
Clinical narrative: Initial report received from a health care professional on 8/17/05. A 2 month old male patient developed lethargy, pallor and vomiting the evening after receiving vaccination with Daptacel lot number C2220AA, Act Hib lot number Y0879, IPOL lot number Y0326 and Prevnar on 7/21/05 1st doses. He was taken to ER by his parents and was treated with Tylenol (acetaminophen). He was seen by pediatrician on 7/22/2005 and his complaint was resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Swelling, Tenderness
Clinical narrative: A 4 year old, female patient developed injection site reaction after receiving Daptacel, in the left leg on 08/15/2005.  The patient also received Ipol and MMR, in the left leg on the same day.  On 08/16/2005 she had left leg swelling, tenderness and itchiness.  There was a swollen length of the leg.  She was seen by her doctor on 08/17/2005 and treated with Tylenol and Benadryl.  It was not reported if the patient recovered. Followup information received on 09/12/2005.  The patient recovered from this event.  No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: 4 year old female patient developed injection site inflammation after receiving Daptacel, in the left leg on 08/11/2005.  The patient also received IPOL, in the right leg on the same day.  On 08/19/2005, she had swelling leg, tenderness and redness.  She did not have a fever.  She was seen by doctor on 08/14/2005 and was still found with swelling.  She was treated with Tylenol.  At the time of reporting, the patient did not recover. Follow up information received on 09/12/2005.  The gender of the patient has been corrected to male.  He had no illness at the time of vaccination.  The patient recovered.  No further information is expected.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: 5 year old male patient developed injection site inflammation after received Daptacel, in the left leg on 08/16/2005.  The patient also received Ipol, in the right leg on the same day.  On 08/17/2005, he had left leg swelling and redness.  He did not have a fever.  His leg was hot to touch.  There was a swollen length of the leg.  He was seen by his doctor on 08/19/2005 and treated with Tylenol.  At the time of reporting, the patient did not recover. Follow up information received from a healthcare professional on 09/12/2005.  At the time of this report, the patient had recovered.
Age: 0.22
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Crying, Somnolence, Swelling
Clinical narrative: 11 week old female patient received a first dose of Acthib, and first dose of Daptacel.  The routes of administration were not reported.  As per the reporter, it was not known which leg the vaccines were given in.  3 days later, the patient experienced crying, sleepiness, and swelling in the left and right legs.  The patient was seen by a physician and recovered from the events.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 5 year old female had received a left arm injection of Daptacel, site not reported on 08/22/2005.  The following day she experienced left arm swelling in the length of the arm with tenderness and redness.  It was not reported whether the reaction occurred at the site of the Daptacel or Ipol vaccination.  She received corrective treatment with Benadryl and Tylenol.  The patient had not recovered from these events at the time of this report.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Initial report was received on 08/24/2005 from a healthcare professional.  A six year old female child was vaccinated with Daptacel in the left arm, and Ipol, on 08/22/2005.  The following day the patient experienced left arm swelling and redness the length of the arm, the areas was hot to touch and tender.  It was not specified whether the events occurred at the site of the vaccination.  She was subsequently treated with Tylenol and Benadryl.  the patient had not recovered from these events at the time of this report.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Initial report was received on 08/24/2005 from a healthcare professional.  A five year old male child received an injection of Daptacel in the left arm, and Ipol route and site not reported, on 08/20/2005.  One day later the patient developed length of arm swelling and redness.  The area was also hot to the touch.  The patient was seen by a physician on 08/23/2005 and was treated with Benadryl and Tylenol.  The patient recovered from these events.
Age: 0.52
Sex: F
Vaccine: DTAP, IPV
Symptoms: Eye movement disorder
Clinical narrative: 6 month old female patient experienced head bobbing and some eye rolling within 12 hours after she received her third dose of Daptacel and Ipol on 08/25/2005.  The patient's alertness decreased with these incidents.  The patient had an MRI performed with normal results.  At the time of the report, the reporter stated the symptoms were improving, but they still persist.   Follow up information received on 12/05/2005.  Per responsible physician the patient had no pre-existing medical conditions or allergies and had no illness at the time of the vaccination.  As per reporter, the patient had recovered from reaction from dose 3 as of 11/29/2005.
Sex: U
Vaccine: DTAP, IPV
Symptoms: Swelling
Clinical narrative: A cluster of 7 patients developed entire limb swelling after they received their 5 dose of Daptacel.  At the time of reporting, it was not reported if the patients recovered.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Contusion, Hypersensitivity, Injection site hypersensitivity, Injection site induration, Injection site pain
Clinical narrative: Initial report received from a health care professional in the USA on 28-September-2005. A 5 year old, male patient developed injection site bruising and swelling at the Daptacel injection site, within 24 hours after he received a fifth dose, intra-muscular injection in the left deltoid of Daptacel, lot number C2243Aa and a fourth dose, subcutaneous injection in the right arm of IPOL, lot number Y0324, on 24-September-2005. Within 24 hours, the "injection site appeared purple, swollen and redness spread to elbow as well as around the back of the shoulder. :Slight pain was reported and the patient's mother stated that he had a low grade fever on 25-September-2005. At the patient;s office visit on 27-September-2005, there was decreased swelling, no warmth but still pink." At the time of the report, the patient did no recover. Follow-up information received on 21/Nov/2005. The patient had no illness at the time of a vaccination. The physician reported the patient had an allergic reaction to the immunization. The Daptacel and IPOL were administered in the daytime on the 24/Sep/2005 and the reaction started that night. The patient was seen on the 27/Sep/2005 and was afebrile at the time. The rash was 15cm, lacy pink, blanches well. There was no warmth, only mild induration with front of arm. It was reported the patient recovered. As per physician the patient had a previous reaction on 06/Jan/2002 after receiving DPT lot #542A2 in the left arm on 30/May/2002 with erythema which spread to the axilla and chest. The patient was treated with Ancef. No further information is expected.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Pyrexia, Rash, Similar reaction on previous exposure to drug
Clinical narrative: Initial report received from a health care professional in the USA on 28-September-2005. A 5 year old, male patient developed injection site bruising and swelling at the Daptacel injection site, within 24 hours after he received a fifth dose, intra-muscular injection in the left deltoid of Daptacel, lot number C2243Aa and a fourth dose, subcutaneous injection in the right arm of IPOL, lot number Y0324, on 24-September-2005. Within 24 hours, the "injection site appeared purple, swollen and redness spread to elbow as well as around the back of the shoulder. :Slight pain was reported and the patient's mother stated that he had a low grade fever on 25-September-2005. At the patient;s office visit on 27-September-2005, there was decreased swelling, no warmth but still pink." At the time of the report, the patient did no recover. Follow-up information received on 21/Nov/2005. The patient had no illness at the time of a vaccination. The physician reported the patient had an allergic reaction to the immunization. The Daptacel and IPOL were administered in the daytime on the 24/Sep/2005 and the reaction started that night. The patient was seen on the 27/Sep/2005 and was afebrile at the time. The rash was 15cm, lacy pink, blanches well. There was no warmth, only mild induration with front of arm. It was reported the patient recovered. As per physician the patient had a previous reaction on 06/Jan/2002 after receiving DPT lot #542A2 in the left arm on 30/May/2002 with erythema which spread to the axilla and chest. The patient was treated with Ancef. No further information is expected.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Wrong drug administered
Clinical narrative: Initial report received from a physician in the USA on 05-October-2005.  A cluster of 6 patients was administered Daptacel in error instead of Adacel vaccine. Case 2: A female patient, (the wife of the reporting physician, age not reported) who received the Daptacel vaccine in error, complained of soreness at the injection site. It was unknown if she recovered. Further information is expected. The details of the reporting physician (the husband) who received the Daptacel vaccine in error is provided in case 2005-02037. Follow-up information received on 27/Dec/2005 from a health care professional. The patient received the Daptacel vaccine in the left upper arm intra-muscularly on 21/Sep/2005 at 15:00. At 15:05 she experienced a sore arm that lasted seven days. Per the reporter, the adverse event had resolved at the time of this report. No further information is expected.
Sex: U
Vaccine: FLUN3, FLUN3
Symptoms: Erythema, Nasal congestion
Clinical narrative: MEDI-0003701 is a non serious spontaneous case from a physician in the USA involving Redness Around The Nose: (Unlabelled USA). The reporter causality is not provided to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A physician from a pediatric clinic reported that a child received FluMist in 2004 and later in the day experienced nasal congestion and redness around the nose. The patient completely recovered. No other information is available. The reporter causality is not provided. Vaccine was not administered at this facility and child has not been seen since then. Therefore, patient's date of birth; age at time of vaccination; adverse event onset date/time; lot number for vaccine and vaccine administration date/time are not available and not retrievable as per reporter.  1/5/10 follow up - Erythema facial (Erythema) Nasal congestion (Nasal congestion)
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chills, Erythema, Headache, Influenza like illness, Injection site pustule
Clinical narrative: Patient developed clinical signs of pericarditis that responded well to Indomethacin.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Nausea, Pain, Pyrexia, Rhinorrhoea, Skin nodule
Clinical narrative: Patient developed clinical signs of pericarditis that responded well to Indomethacin.
Age: 23.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pericarditis
Clinical narrative: Patient developed clinical signs of pericarditis that responded well to Indomethacin.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Rash, Swelling, Urticaria
Clinical narrative: Eczematoid reaction overlying injection site. RX Kenalog 0.1% cream.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Eczema, Injection site reaction
Clinical narrative: Eczematoid reaction overlying injection site. RX Kenalog 0.1% cream.
Age: 1.05
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Eye swelling, Urticaria
Clinical narrative: Developed rash (hives), swollen eyelids.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, FLU3, MMR
Symptoms: Anaphylactic shock, Face oedema, Hypersensitivity, Hypoxia
Clinical narrative: Information has been received from a infectious diseases pediatrician concerning her 5 year old daughter who, at her 5 year old check-up, was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant vaccinations included a dose of influenza virus vaccine (unspecified) and a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (ver0) (+) tetanus toxoid (Pediarix). The pediatrician reported that after receiving the dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live her daughter went into anaphylactic shock. 911 was subsequently called to the child's pediatrician's office. It was noted that the child's face swelled around an oxygen mask and head such that her ears could not be seen. The patient was treated with epinephrine. The child was rushed to a hospital via ambulance, but it was not reported if she was kept overnight. Allergy testing revealed that the child had a severe allergy to gelatin. The child was noted to be recovered as she responded well to the epinephrine. Anaphylactic shock was considered to be immediately life-threatening. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: TD
Symptoms: Fatigue, Pain, Swelling
Clinical narrative: Pain, swelling R shoulder. Fatigue.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pyrexia
Clinical narrative: Fever 105.0. Tylenol given.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Choking, Coma, Intestinal obstruction, Lethargy, Vaccination complication
Clinical narrative: Mother states child became lethargic and unresponsive around 7:30pm. Mother reasoned lethargy from vaccines; gave Tylenol (2nd dose) at 8pm. Mother states child would not cry when pinched, eyes did not open. Child had projectile vomiting around 9:30pm and began to choke. Child was not breathing. Parents called 911. EMT's arrived and gave O2 and tried to stimulate child. Child was taken to Hospital around 10pm. Hospital took blood; checked o2 saturation, temperature, gave IV fluids and performed a chest x-ray. Child had also been given a rectal suppository since mother stated child had no bowel movement in two days. All tests were negative. Mother brought child home around 2:30AM.  Child was taken to private physician 1/16/06 for follow up. Findings within normal limits at primary physician appointment. Private physician requesting vaccines be given separately when child is due at 4 months of age.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Vomiting projectile
Clinical narrative: Mother states child became lethargic and unresponsive around 7:30pm. Mother reasoned lethargy from vaccines; gave Tylenol (2nd dose) at 8pm. Mother states child would not cry when pinched, eyes did not open. Child had projectile vomiting around 9:30pm and began to choke. Child was not breathing. Parents called 911. EMT's arrived and gave O2 and tried to stimulate child. Child was taken to Hospital around 10pm. Hospital took blood; checked o2 saturation, temperature, gave IV fluids and performed a chest x-ray. Child had also been given a rectal suppository since mother stated child had no bowel movement in two days. All tests were negative. Mother brought child home around 2:30AM.  Child was taken to private physician 1/16/06 for follow up. Findings within normal limits at primary physician appointment. Private physician requesting vaccines be given separately when child is due at 4 months of age.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: Sharp stomach pains for approximately 24 hours after taking the 1st Typhoid pill.
Age: 16.0
Sex: F
Vaccine: DPP
Symptoms: Fatigue, Lethargy, Loss of consciousness, Muscular weakness
Clinical narrative: On the day of vaccination, she passed out after shot administered.  Since the shot, she has expressed weakness in both arms and a general lethargic feeling.  She has also been very fatigued and unable to attend school.
Age: 22.0
Sex: F
Vaccine: HEP, SMALL
Symptoms: Pruritus, Rash pustular
Clinical narrative: LOCALIZED VACCINIA REACTION. PAPULES, EMERGING PUSTULES ON LEFT UPPER ARM, RIGHT UPPER EXTREMITY AND ABDOMEN. ADVISED ORAL DIPHENHYDRAMINE (OTC) AS NEEDED FOR PRURITIS, IF THIS OCCURS.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Patient broke out with a measles rash 7 days after immunization.