chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.12
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Blood lead, Haemoglobin, Injection site discolouration, Injection site urticaria
Clinical narrative: Noted small wheal like area below injection site with "purplish" hue around injection site.  Dr. looked at site and stated it was a normal reaction.  Benedryl was not given like the other patients were given.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Received Gardasil vaccine first, then HAV and within appx. 1 minute after vaccines client slumped to side while sitting in chair and was unresponsive for appx. 10 seconds. Staff assisted to floor and client became responsive prior to this. No injury occured. Given soda to drink. Client very thin. Oatmeal for breakfast but no dinner the night before. Blood pressure laying 104/60 Pulse 76. B.P.sitting 94/60 pulse 74
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Heat therapy, Injection site erythema, Malaise
Clinical narrative: Patient received vaccines on 6/8/07.  Patient returned to clinic for a viral illness as well as complaints of redness to left leg.  Patient was instructed to apply warm compresses to area and administer Tylenol PRN.  Patient was also instructed to return to clinic for signs and syptoms of infection.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Heat therapy, Injection site vesicles, Scab
Clinical narrative: Mom contacted me (immunization program supervisor) on 6/7/07 re:left arm "blister w/clear fluid in it, 1/4 in. square about 1-1/2 in." from injection site, no fever, no hx rxn to bandaids; mom to apply warm compress. On 6/8 mom reported area larger, "throbbing & red spots in the blister liquid," & that blister is not in same place as bandaid was applied after the shot. On 6/12, mom reported that on 6/8, PCP aspirated fluid from blister & told her "nothing in it;" area bleeding when pressed on, swollen, soft scab covering area.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Within 24 hours of receiving DTaP and IPV in left arm, the left deltoid became very swollen warm to touch and a rash appeared in the injection site area.Child was taken to Medical Center on Sunday where he was given prescription for Qdryl qid, Cephalexin qid and Tylenol prn.  Child was seen at Health Center on Monday for follow-up, where the doctor diagnosed it a reaction to DTaP and ordered DT for future diphtheria tetanus injections.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Injection site anaesthesia, Injection site discomfort
Clinical narrative: After receiving first dose of Hep B vaccination series in her Right arm intramuscular patient reported her entire arm feeling heavy and numb, "like it was asleep," for about 5 hours after injection. She also had trouble writing with her right hand and had to use her left hand to support her right wrist when she was writing.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, HPV4
Symptoms: Syncope
Clinical narrative: ADMIN HPV AND TDAP VACCINE, WITHIN ONE MIN OF ADMIN CHILD FAINTED INTO FATHERS ARMS, PT OBSERVED FOR 15 ADDITIONAL MIN WITH NO PROBLEMS. VITALS WNL. This is in follo-up to report (s) previously submitted on 10/12/2007. Information has been received from a registered nurse concerning a 15 year old female with no medical history or allergies who on 18-JUN-2007 was vaccinated IM into the left deltoid with a first 0.5 ml dose of GARDASIL (lot# 657622/0388U). Concomitant medication given IM into the left deltoid included the first dose of ADACEL (batch c2632AA). Approximately one minute after getting the vaccine the patient fainted for a few seconds. The patient was observed in the office for 15 minutes and fully recovered. Unspecified medical attention was sought and no treatment was needed. No diagnostic laboratory studies were performed. It was reported that the patient was vaccinated with a second dose of the vaccine on 20-AUG-2007 amd experienced no events. No quality complaint was involved. Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: The day folowing pt developed cellulitis in triceps area. by 6/18/07 cellulitis on antecubital area and forearm.
Age: 1.0
Sex: F
Vaccine: IPV, MMRV, PPV
Symptoms: Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Fevers of 102.9 to 102 axillary for 3 days starting 7 days after MMRV and rash: macular pink diffuse blanching concentrated on the trunk 10 days after vaccine. Resolution of fever
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian cyst
Clinical narrative: ovarain cyst developed 6-8 weeks after first vaccination with gaurdisil
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Urticaria
Clinical narrative: Child had Dtap and Hib vaccines the morning of 06/14 at 0956. mother reports that child broke out with hives at about noon that day. Mother further reports that child had hives until Saturday, 06/16. Reports would give Benedryl and hives would go away, but would return after medication wore off. All hives were on his chest and belly.
Age: 0.17
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Angioedema, Urticaria
Clinical narrative: Child developed urticaria and peripheral angioedema approx 2-3 hours after 2-month immunizations given (DTaP, IPV, Comvax, PCV-7).  Treated with Orapred, 5-day ubrst at 2 mg/kg/day
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Rash generalised
Clinical narrative: Generalized sunburn like red rash all over the body 4 hours after the vaccines. Got better after 50mg of Benadryl.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Aspartate aminotransferase increased, Dermatitis, Full blood count, Oedema peripheral, Otitis media
Clinical narrative: Broke out with slight rash on his chest 2 days after shots. The rash became more pronounced 6-11-07. Swelling of face hands and feet with fever of 102.7. On 6-12-07 seen in ER on 6/12/07 (regional hospital) Admitted for observation for with referral to dermatologist for (1) erythema multiforme major (2) otitis media (3) Dermatitis NOS.  06/19/2007 MR received for ER visit 6/12/07 for fever and rash.  Feet and hands swollen. PE:  (+) for bulging, red TM and yellow rhinorrhea.  Strawberry tongue.  Puplish macular rash on trunk with scalded appearance.  Purpuric lesions on buttocks and chest.  Target lesions on lower extremities. Conjunctivae red and eyes swollen.  Otherwise WNL. Impression:  Erythema multiforme major.  Left otitis media.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Stevens-Johnson syndrome, Streptococcal identification test
Clinical narrative: Broke out with slight rash on his chest 2 days after shots. The rash became more pronounced 6-11-07. Swelling of face hands and feet with fever of 102.7. On 6-12-07 seen in ER on 6/12/07 (regional hospital) Admitted for observation for with referral to dermatologist for (1) erythema multiforme major (2) otitis media (3) Dermatitis NOS.  06/19/2007 MR received for ER visit 6/12/07 for fever and rash.  Feet and hands swollen. PE:  (+) for bulging, red TM and yellow rhinorrhea.  Strawberry tongue.  Puplish macular rash on trunk with scalded appearance.  Purpuric lesions on buttocks and chest.  Target lesions on lower extremities. Conjunctivae red and eyes swollen.  Otherwise WNL. Impression:  Erythema multiforme major.  Left otitis media.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMRV, PNC
Symptoms: Swelling face
Clinical narrative: Broke out with slight rash on his chest 2 days after shots. The rash became more pronounced 6-11-07. Swelling of face hands and feet with fever of 102.7. On 6-12-07 seen in ER on 6/12/07 (regional hospital) Admitted for observation for with referral to dermatologist for (1) erythema multiforme major (2) otitis media (3) Dermatitis NOS.  06/19/2007 MR received for ER visit 6/12/07 for fever and rash.  Feet and hands swollen. PE:  (+) for bulging, red TM and yellow rhinorrhea.  Strawberry tongue.  Puplish macular rash on trunk with scalded appearance.  Purpuric lesions on buttocks and chest.  Target lesions on lower extremities. Conjunctivae red and eyes swollen.  Otherwise WNL. Impression:  Erythema multiforme major.  Left otitis media.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Asthenia, Body temperature increased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Fever and swelling of right upper arm 6/13, increase redness and pain, felt weakness on 6/14 on 6/15 seen by MD, temp 100.3, redness and induration 4 x 5cm right upper arm.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Fever and swelling of right upper arm 6/13, increase redness and pain, felt weakness on 6/14 on 6/15 seen by MD, temp 100.3, redness and induration 4 x 5cm right upper arm.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Muscle spasms, Neck pain, Rash
Clinical narrative: Rash on face, chest, arms - resolved, joint pain in fingers and feet - resolved, neck pain - seeing massage therapists for muscle spasms - not parotid glands.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Syncope
Clinical narrative: Given vaccine 6/18/07 / 2-3 minutes later patient was standing in hallway, felt weak and fainted. Did not lose consciousness. Allowed to rest, felt better and walked out of clinic in 5 minutes. Vitals ok.
Age: 11.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Oedema peripheral
Clinical narrative: Patient developed swelling in the left arm the morning after receiving Tdap vaccine and Varivax vaccine.
Age: 18.0
Sex: F
Vaccine: HEP, MMR, MNQ
Symptoms: Rash
Clinical narrative: Patient developed a rash on arms and back seven days after receiving vaccines.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at site of immunization x 2 days.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Flushing, Throat tightness
Clinical narrative: Immediate SOB, throat tightening, face flush
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: TC pts mother - pt presented with 50 cent red area, slight swelling and slight discomfort on 6-16-07 2 days after receiving Varicella booster
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, IPV, MNQ, PNC
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: None  Lot # U2170AA Sanofi Menactra given accidentally. No reactions reported received
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (L) deltoid area of redness/warmth and slight induration
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus
Clinical narrative: Bruising at injection site-Erythema and pruritis of dorsal aspect of entire left upper arm.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain, Abnormal faeces, Gastroenteritis, Mucous stools, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 week old female with a history of being born prematurely at 36 weeks who on 29-MAR-2007 was vaccinated with Rotateq PO first dose. On 25-APR-2007 the patient developed fever, abdominal cramping, jelly like stools, 27 days after receiving her first dose of Rotateq. The patient was evaluated in the emergency room an it was determined that the gastroenteritis was not due to rotavirus. Hospitalization was not required. The symptoms subsided after one to tow days, on approximately 27-APR-2007 and the patient is now fully recovered. Additional information is expected.
Age: 0.42
Sex: F
Vaccine: HBHEPB, RV5
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 19 week female patient with no medical history or allergies reported who on 26-APR-2007 was vaccinated with Rotateq (Lot # 656191/1365F). Concomitant therapy included Comvax (LOT# 654992/0984F) given in the right leg, diphtheria toxoid (+) pertussis acellular vaccine (unspecified), poliovirus vaccine and Prevnar. On 27-APR-2007 the patient developed a papular, red, "sandpaper" like rash. The rash appeared on the left side of the body, from about 3 inches below the nipple line to the top of the left thigh. The patient sought medical attention and was treated with BENADRYL. There was no product quality complaint involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Blood test, Gastroenteritis rotavirus
Clinical narrative: Information has been received from a mother concerning her 9-week-old daughter with no medical history or allergies who on 26-APR-2007 was vaccinated with a 2.0 mL dose of Rotateq. There was no concomitant therapy. On 02-MAY-2007, the patient developed rotavirus. Unspecified medical attention was sought and "blood work" was done. At the time of this report, the patient's rotavirus persisted. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old patient who on 03-APR-2007 was vaccinated with a 2mL oral third dose of Rotateq. On 02-MAY-2007, two days after vaccination, the patient developed severe diarrhea and vomiting. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 0.08
Sex: F
Vaccine: RV5
Symptoms: Abdominal pain
Clinical narrative: Information has been received from a physician concerning a 33 day old female who on 06-FEB-2007 was vaccinated with an oral dose of Rotateq (Lot# 653981/0411F). Later that same night, on 06-FEB-2007 the patient experienced colic. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal distension, Chills, Diarrhoea, Dysgeusia, Eructation
Clinical narrative: Initial report received on 21 February 2007 from a health care professional. A 65-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Adacel, lot number C2689AA, and a left deltoid injection of Pneumovax, lot number 1005F; on 22 January 2007 during a routine physical. The next day, the patient experienced fever, chills, sore arm, and "upset stomach." These symptoms resolved the following day. The patient also reported a sore, red left deltoid and skin "sloughed at the injection site." At the time of this report, the patient had not recovered. Follow up information received on 22 Marcy 2007. The patient visited a doctor on 20 February 2007 with complaint of lower abdominal bloating. After receiving the vaccines on 22 January 2007, she had swelling and erythema of the left arm that took over a week to improve. It was so erythematous that the skin actually peeled after the inflammation remitted. During that time she noted some metallic taste in her mouth, some nausea, which gradually improved over the following two weeks, slightly loose stools. The arm is completely resolved, but she still had a slightly queasy stomach and lower abdominal bloating. She had belching. She has tried some Pepcid Complete with partial relief of symptoms. Her bowel movements are generally quite regular. No melena. She does take Metamucil and that has not changes. The physician's impression was abdominal bloating and belching. Certainly consistent with acide reflux, but may also have some lower gastrointestinal symptoms as well. A trial of Prilosec 20 mg b.i.d. was prescribed.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Gastrointestinal disorder, Gastrooesophageal reflux disease, Injection site desquamation, Injection site erythema, Injection site inflammation
Clinical narrative: Initial report received on 21 February 2007 from a health care professional. A 65-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Adacel, lot number C2689AA, and a left deltoid injection of Pneumovax, lot number 1005F; on 22 January 2007 during a routine physical. The next day, the patient experienced fever, chills, sore arm, and "upset stomach." These symptoms resolved the following day. The patient also reported a sore, red left deltoid and skin "sloughed at the injection site." At the time of this report, the patient had not recovered. Follow up information received on 22 Marcy 2007. The patient visited a doctor on 20 February 2007 with complaint of lower abdominal bloating. After receiving the vaccines on 22 January 2007, she had swelling and erythema of the left arm that took over a week to improve. It was so erythematous that the skin actually peeled after the inflammation remitted. During that time she noted some metallic taste in her mouth, some nausea, which gradually improved over the following two weeks, slightly loose stools. The arm is completely resolved, but she still had a slightly queasy stomach and lower abdominal bloating. She had belching. She has tried some Pepcid Complete with partial relief of symptoms. Her bowel movements are generally quite regular. No melena. She does take Metamucil and that has not changes. The physician's impression was abdominal bloating and belching. Certainly consistent with acide reflux, but may also have some lower gastrointestinal symptoms as well. A trial of Prilosec 20 mg b.i.d. was prescribed.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Nausea, Pain in extremity, Pyrexia, Skin exfoliation
Clinical narrative: Initial report received on 21 February 2007 from a health care professional. A 65-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Adacel, lot number C2689AA, and a left deltoid injection of Pneumovax, lot number 1005F; on 22 January 2007 during a routine physical. The next day, the patient experienced fever, chills, sore arm, and "upset stomach." These symptoms resolved the following day. The patient also reported a sore, red left deltoid and skin "sloughed at the injection site." At the time of this report, the patient had not recovered. Follow up information received on 22 Marcy 2007. The patient visited a doctor on 20 February 2007 with complaint of lower abdominal bloating. After receiving the vaccines on 22 January 2007, she had swelling and erythema of the left arm that took over a week to improve. It was so erythematous that the skin actually peeled after the inflammation remitted. During that time she noted some metallic taste in her mouth, some nausea, which gradually improved over the following two weeks, slightly loose stools. The arm is completely resolved, but she still had a slightly queasy stomach and lower abdominal bloating. She had belching. She has tried some Pepcid Complete with partial relief of symptoms. Her bowel movements are generally quite regular. No melena. She does take Metamucil and that has not changes. The physician's impression was abdominal bloating and belching. Certainly consistent with acide reflux, but may also have some lower gastrointestinal symptoms as well. A trial of Prilosec 20 mg b.i.d. was prescribed.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Stomach discomfort
Clinical narrative: Initial report received on 21 February 2007 from a health care professional. A 65-year-old female patient, with no illness at the time of vaccination, had received a left deltoid injection of Adacel, lot number C2689AA, and a left deltoid injection of Pneumovax, lot number 1005F; on 22 January 2007 during a routine physical. The next day, the patient experienced fever, chills, sore arm, and "upset stomach." These symptoms resolved the following day. The patient also reported a sore, red left deltoid and skin "sloughed at the injection site." At the time of this report, the patient had not recovered. Follow up information received on 22 Marcy 2007. The patient visited a doctor on 20 February 2007 with complaint of lower abdominal bloating. After receiving the vaccines on 22 January 2007, she had swelling and erythema of the left arm that took over a week to improve. It was so erythematous that the skin actually peeled after the inflammation remitted. During that time she noted some metallic taste in her mouth, some nausea, which gradually improved over the following two weeks, slightly loose stools. The arm is completely resolved, but she still had a slightly queasy stomach and lower abdominal bloating. She had belching. She has tried some Pepcid Complete with partial relief of symptoms. Her bowel movements are generally quite regular. No melena. She does take Metamucil and that has not changes. The physician's impression was abdominal bloating and belching. Certainly consistent with acide reflux, but may also have some lower gastrointestinal symptoms as well. A trial of Prilosec 20 mg b.i.d. was prescribed.
Age: 21.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: A 21 year old, female patient with a history of autoimmune hepatitis, became light headed and passed out twice, about 20 hours after she received Adacel (lot number C2644AA) intramuscularly in the left deltoid and Gardasil (lot number 0954F) intramuscularly in the right arm, on 15 February 2007. She did not have any illness at the time of the vaccinations. She fully recovered and is stable. Follow-up information received on 26 March 2007. The patient had no illness at the time of vaccination and had received no other vaccinations within four weeks of the 15 February 2007 immunization. The event required a doctor visit. No relevant diagnostic testing was performed.
Age: 37.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Hypokinesia, Injection site bruising, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: A 37 year old, female patient (with no known allergies) developed a bruise at the injection site, stiffness in the left arm and pain the clavicle and left scapular area, approximately 8 hours after she received Adacel (lot number C2688AA) intramuscularly in the left deltoid on 19 March 2007. She also received Engerix B (GSK, lot number AHBVB28BA) intramuscular in the right deltoid and PPD (Parkdale, lot number 30723) in the left forearm on the same day. At the time of the vaccinations, she denied any illness and was not on any medications. She has difficulty lifting and states it is progressively getting worse.  At the time of the report, she had not recovered. Follow-up information received on 18 April 2007. The patient did not have any illness at the time of the vaccination. The reporter left several messages to check on the patient, however she did not return the calls. As far as the reporter was concerned, the patient is recovered.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Initial report received from a nurse on 26 March 2007. A 37 year old, female patient (with on known allergies) developed a "persistent knot"at the injection site (firm nodule about the size of a quarter), 5 days after she received Adacel (lot number C2720AA) sub-cutaneously (instead of intramuscularly) on 15 March 2007. She also has a red, painful 20 mm area at the injection site. At the time of the report, she had not recovered. This case has the same reporter as case 2007-00964.
Sex: U
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Cluster of 2 patients (no individual identification provided) developed a "cellulitis type reaction" on the left deltoid after Adacel (lot number C2610AA) on 11 April 2007, received from a health care professional in the USA on 12 April 2007. No description available except sites red, swollen and the patients were treated with antibiotics. The patients had not recovered.
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Full blood count normal, Hyperaesthesia, Injection site mass
Clinical narrative: Initial report received from a physician in the USA on 17 April 2007. A  female patient (age, date of birth not reported) developed nausea, fatigue, injection site knot, 3 hours post administration not reported). The next day, the patient also developed fever, "no chills", raised and tender area, muscle ache, joint pain and severe local pain at the injection site, stiff neck, a dime rash on arms and breast and swollen lymph nodes. The physician stated the patient was treated with Allegra and Benadryl, a CBC test was also done and all negative. Her fatigue has resolved, but still has skin sensitivity and aches that has lasted up to 8 to 10 days. It was not reported if the patient recovered.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Initial report received from a physician in the USA on 17 April 2007. A  female patient (age, date of birth not reported) developed nausea, fatigue, injection site knot, 3 hours post administration not reported). The next day, the patient also developed fever, "no chills", raised and tender area, muscle ache, joint pain and severe local pain at the injection site, stiff neck, a dime rash on arms and breast and swollen lymph nodes. The physician stated the patient was treated with Allegra and Benadryl, a CBC test was also done and all negative. Her fatigue has resolved, but still has skin sensitivity and aches that has lasted up to 8 to 10 days. It was not reported if the patient recovered.
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash
Clinical narrative: Initial report received from a physician in the USA on 17 April 2007. A  female patient (age, date of birth not reported) developed nausea, fatigue, injection site knot, 3 hours post administration not reported). The next day, the patient also developed fever, "no chills", raised and tender area, muscle ache, joint pain and severe local pain at the injection site, stiff neck, a dime rash on arms and breast and swollen lymph nodes. The physician stated the patient was treated with Allegra and Benadryl, a CBC test was also done and all negative. Her fatigue has resolved, but still has skin sensitivity and aches that has lasted up to 8 to 10 days. It was not reported if the patient recovered.
Age: 23.0
Sex: M
Vaccine: HEP, HEPA, TDAP, YF
Symptoms: Body temperature increased, Chills, Full blood count normal, Laboratory test normal, Pain
Clinical narrative: Initial report received from a health care professional in the USA on 18 April 2007. A 23 year old, male patient complained of a temperature of 100F overnight, chills, aching arm and generalized achiness, after he received Adacel (lot number not known, route and site of administration not known) and YF-Vax (lot number UE998AC, route and site administration not known) on 21 March 2007. He also received Hepatitis A vaccine and Hepatitis B vaccine (lot number (s) not known, tradename (s), route (s) and site (s) of administration not known) on the same day. He did not have ant medical history, was not on any medications and did not have any illness at the time of the vaccinations. He was not treated with medications. His symptoms resolved within 24 hours and he recovered. Follow-up information received on 14 May 2007 from a health care professional provided the following batch numbers: Adacel (C2632AA) given intramuscularly in the left deltoid, YF-Vax (UE998AC) given subcutaneously in the left arm, Hepatitis A (1278F) given intramuscularly in the right upper deltoid, and Hepatitis B (0904F) given intramuscularly in the right lower deltoid. A complete metabolic panel and complete blood count were noted to be unremarkable, and no treatment was given. No given information is expected. This case has the same reporter as case 2007-01315.
Age: 23.0
Sex: M
Vaccine: HEP, HEPA, TDAP, YF
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a health care professional in the USA on 18 April 2007. A 23 year old, male patient complained of a temperature of 100F overnight, chills, aching arm and generalized achiness, after he received Adacel (lot number not known, route and site of administration not known) and YF-Vax (lot number UE998AC, route and site administration not known) on 21 March 2007. He also received Hepatitis A vaccine and Hepatitis B vaccine (lot number (s) not known, tradename (s), route (s) and site (s) of administration not known) on the same day. He did not have ant medical history, was not on any medications and did not have any illness at the time of the vaccinations. He was not treated with medications. His symptoms resolved within 24 hours and he recovered. Follow-up information received on 14 May 2007 from a health care professional provided the following batch numbers: Adacel (C2632AA) given intramuscularly in the left deltoid, YF-Vax (UE998AC) given subcutaneously in the left arm, Hepatitis A (1278F) given intramuscularly in the right upper deltoid, and Hepatitis B (0904F) given intramuscularly in the right lower deltoid. A complete metabolic panel and complete blood count were noted to be unremarkable, and no treatment was given. No given information is expected. This case has the same reporter as case 2007-01315.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Neck pain, Pain in extremity
Clinical narrative: Initial report received from a parent (who is also a nurse) in the USA on 09 May 2007. An 18 year old, female patient experienced pain spreading up to neck and down top of arm after she received Adacel (lot number and route of administration not reported) on 30 April 2007. The reporter stated the vaccine appeared to be administered high on the arm, in the shoulder area (in the shoulder joint) and the patient experienced the pain as soon as the vaccine was given. It was reported the pain was becoming progressively worse. At the time of the report, the patient had not recovered.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Initial report received from a health care professional in the USA on 09 May 2007. A 44 year old, female patient (with a medical history of allergy to penicillin and sinusitis) developed swelling and redness around the injection site, body aches, tingling and hand and finger pain on the left side and a red rash on the injection site arm (spots) - inferior to the injection site, one day after she received Adacel (lot number C2731AA) intramuscularly in the left deltoid on 01 May 2007. She did not have any laboratory or diagnostic tests done. She did not have any illness at the time of the vaccination. At the time of the report, she had not recovered. Same reporter as cases 2007-01632, 2007-01633 and 2007-01634.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia
Clinical narrative: Initial report received from a health care professional in the USA on 09 May 2007. A 44 year old, female patient (with a medical history of allergy to penicillin and sinusitis) developed swelling and redness around the injection site, body aches, tingling and hand and finger pain on the left side and a red rash on the injection site arm (spots) - inferior to the injection site, one day after she received Adacel (lot number C2731AA) intramuscularly in the left deltoid on 01 May 2007. She did not have any laboratory or diagnostic tests done. She did not have any illness at the time of the vaccination. At the time of the report, she had not recovered. Same reporter as cases 2007-01632, 2007-01633 and 2007-01634.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pain, Pain in extremity
Clinical narrative: Initial report received from a health care professional in the USA on 09 May 2007. A 44 year old, female patient (with a medical history of known allergies, hypertension, non insulin dependent diabetes mellitus and hypercholesterolemia) developed body aches, redness and edema around the injection site, and pain from the injection site down the arm to fingers, one day after she received Adacel (lot number C2731AA) intramuscularly in the right deltoid on 07 May 2007. She did not have any laboratory or diagnostic tests done. She did not have any illness at the time of the vaccination. At the time of the report, she had not recovered. Same reporter as cases 2007-01631, 2007-01633 and 2007-01634.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Paraesthesia
Clinical narrative: Initial report received from a health care professional in the USA on 09 May 2007. A 53 year old, female patient (with a medical history of allergies to IVP dye, Reglan and Codeine and elevated cholesterol) developed redness, a knot and swelling at the injection site and tingling down the arm to fingers, one day after she received Adacel (lot number C2731AA) intramuscularly in the left deltoid on 01 May 2007. She did not have any laboratory or diagnostic tests done. She did not have any illness at the time of the vaccination. At the time of the report, she had not recovered. Same reporter as cases 2007-01631, 2007-01632 and 2007-01634.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Influenza, Injection site erythema, Oedema peripheral
Clinical narrative: Initial report received from a health care professional in the USA on 09 May 2007. A 48 year old, female patient (with a medical history of no known allergies, hypertension and depression) developed fatigue, weakness, "flu like symptoms", body aches, redness around the injection site, edema (large amount) in the entire left arm and pain and tingling from the injection site down the arm to the fingers, one day after she received Adacel (lot number C2731AA) intramuscularly in the left deltoid on 03 May 2007. She did not have any laboratory or diagnostic tests done. She did not have any illnesses at the time of the vaccination. At the time of the report, she had not recovered. Same reporter as cases 2007-01632 and 2007-01633.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Paraesthesia
Clinical narrative: Initial report received from a health care professional in the USA on 09 May 2007. A 48 year old, female patient (with a medical history of no known allergies, hypertension and depression) developed fatigue, weakness, "flu like symptoms", body aches, redness around the injection site, edema (large amount) in the entire left arm and pain and tingling from the injection site down the arm to the fingers, one day after she received Adacel (lot number C2731AA) intramuscularly in the left deltoid on 03 May 2007. She did not have any laboratory or diagnostic tests done. She did not have any illnesses at the time of the vaccination. At the time of the report, she had not recovered. Same reporter as cases 2007-01632 and 2007-01633.
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Myalgia
Clinical narrative: Initial report received from a health care professional on 10 May 2007. A female patient (age, date of birth not reported) complained of a sore, painful "lump" at the injection site and muscle aches, after she received Adacel (lot number, route, site and date of administration not provided. At the time of the report, the patient had not recovered. Same reporter as case 2007-01666.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Axillary pain, Blood amylase, Blood creatine phosphokinase, Blood test
Clinical narrative: Initial report received from a patient on 16 May 2007. A 66 year old male patient (with a medical history of allergy to sulfas, hypertension and seasonal allergies) complained of pain and swelling in the left axillary region. approximately one week after she received Adacel (lot number not reported) intramuscularly in the left deltoid on 26 March 2007. Two weeks after vaccination, she experienced generalized muscle aches, weakness and increased aching in the left axillary region. She had her blood drawn on 15 May 2007 for "CMP, CPK, sed rate and amylase". She did not have any illness at the time of vaccination. At the time of the report, the symptoms continue and she had not recovered.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Metabolic function test, Myalgia, Red blood cell sedimentation rate, Swelling
Clinical narrative: Initial report received from a patient on 16 May 2007. A 66 year old male patient (with a medical history of allergy to sulfas, hypertension and seasonal allergies) complained of pain and swelling in the left axillary region. approximately one week after she received Adacel (lot number not reported) intramuscularly in the left deltoid on 26 March 2007. Two weeks after vaccination, she experienced generalized muscle aches, weakness and increased aching in the left axillary region. She had her blood drawn on 15 May 2007 for "CMP, CPK, sed rate and amylase". She did not have any illness at the time of vaccination. At the time of the report, the symptoms continue and she had not recovered.
Age: 0.28
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Abdominal distension, Crying, Limb discomfort, Pain, Ultrasound abdomen normal
Clinical narrative: Information has been received from a physician concerning a 15 week old female who was vaccinated with a first and second 2 ml oral dose of Rotateq (Lot# 655864/1082F) on 20-FEB-2007 and 20-APR-2007, respectively. It was reported that there were no problems after the first dose of Rotateq. On 28-APR-2007 the patient was lifting her legs in discomfort, and crying in pain and there was abdominal distension with pain after a feeding. Two ultrasounds were performed and neither showed any signs of intussusception. Intussusception was suspected but was never formally diagnosed. Subsequently, the patient recovered. It was noted that the physician did not want to give the third dose of Rotateq. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested. 08/31/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a physician concerning a 15 week old female, with no medical history and no allergies, who was vaccinated with a first and second 2 ml oral dose of ROTATEQ (Lot# 655864/1082F) on 20-FEB-2007 and 20-APR-2007, respectively. It was reported that there were no problems after the first dose of ROTATEQ. Concomitant vaccines administered on 20-APR-2007 included a second intramuscular dose in the right upper leg of PEDIARIX (Lot# AC21B07AB) and a second intramuscular dose in the left lower leg of ACTHIB (Lot# UF119AA). There was no illness at the time of vaccination. On 28-APR-2007 the patient was lifting her legs in discomfort, and crying in pain and there was abdominal distension with pain after a feeding. Two ultrasounds were performed and neither showed any signs of intussusception. Intussusception was suspected but was never formally diagnosed. Subsequently, the patient recovered. It was noted that the physician did not want to give the third dose of ROTATEQ. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that the patient had abdominal pain for 2-3 days and then recovered. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a second dose of Rotateq two weeks late, twelve weeks after the first dose. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a first and second dose of Rotateq (Lot# 655407/1115F and 656194/0024U) on 11-JAN-2007 and 04-MAY-2007, respectively. It was reported that the patient was not experiencing any known symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Rotateq PO possibly the "third dose". The physician reported that, the patient developed vomiting and diarrhea. The patient recovered from the vomiting and diarrhea on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old patient who on 19-JAN-2007 was vaccinated PO with the second dose of Rotateq. It was noted that this second dose was given 3 months after the first. No problems were reported. No further information was available. There was no product quality complaint. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a health professional concerning a 6 month old female who on 05-FEB-2007 was vaccinated with a first dose of Rotateq (Lot# 656102/1165F). No symptoms were reported. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/14/2007.  Information has been received from a certified medical assistant (CMA) concerning a 6-month-old female with no medical history who on 05-FEB-2007, at 1112, was vaccinated PO with the first dose of ROTATEQ (Lot # 656102/1165F).  There was no illness at the time of vaccination.  No laboratory/diagnostic tests were performed as medical attention was not sought.  There were no symptoms/adverse experience reported.  Additional information is not expected.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximately 2-month-old male with reflux who on 04-MAY-2007 was vaccinated PO with a 2.0 ml dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of DTaP, IPOL, a dose of ACTHIB and a dose of Prevnar. There was no other concomitant drug therapy. The physician reported that on 05-MAY-2007, the patient developed a fever. The patient was seen in the Emergency Room (ER), but was sent home after six or seven hours without being admitted. In May 2007, the patient's fever resolved. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/14/2007. Initial and followup Information has been received from a physician concerning a 4 month old patient who on 08-MAY-2007 was vaccinated with Rotateq second dose (LOT #656189/1239F). Concomitant therapy included PEDVAXHIB (MSD LOT # 6553961437F), PEDIARIX (Lot # AC218096CA) and PREVNAR (lot # B08690C). On 08-MAY-2007 about 20 minutes after receiving the vaccine the patient developed vomiting (also reported at 10 minutes after vaccine administration). Subsequently, the patient recovered from vomiting on 08-MAY-2007.  It was reported that the patient sought unspecified medical attention. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus test positive
Clinical narrative: Information has been received from a registered nurse concerning a patient (age and gender not reported) who on unspecified dates was vaccinated with 3 doses of Rotateq (Lot #'s were not available). Subsequently the patient tested positive for rotavirus. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: No adverse effect
Clinical narrative: Information has been received from a physician concerning a 4 month old female who on 08-MAY-2007 was vaccinated with a 2 ml oral dose of Rotateq. No adverse effect was reported. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Crying, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning a male infant who was vaccinated with a dose of Rotateq. suspect vaccination administered that day included a dose of Dtap and a dose of poliovirus vaccine. Subsequently the patient developed a high fever, inconsolable crying and irritability. Subsequently, the patient recovered. It was unknown if medical attention was sought. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated with a first PO dose of Rotateq. Subsequently the patient experienced explosive diarrhea which lasted 3-4 days. The series of doses was discontinued. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a 6 month old female who was vaccinated with a first and second dose of Rotateq on 15-JAN-2007 and 27-APR-2007, respectively. On 11-MAY-2007 the patient was vaccinated with third 2 ml oral dose of Rotateq (Lot# 656391/0238U). No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse (RN) concerning an infant who was vaccinated PO with a dose of Rotateq. The RN reported that the patient vomited immediately after being vaccinated. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Blood test, Diarrhoea, Stool analysis
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a first or second dose of Rotateq. Subsequently the patient developed diarrhea. It was reported that the physician did blood work and tested a stool sample from the patient. No other information was provided. Additional information has been requested.
Age: 0.58
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 7-month-old female who on 15-DEC-2006 and 16-MAY-2007 was vaccinated PO with the first and second dose, respectively, of Rotateq. Unspecified medical attention was sought. No problems were reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5, UNK
Symptoms: Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 6-month-male who on 20-MAR-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq. Concomitant vaccinations administered on that same day included "other vaccinations". There was no other concomitant drug therapy. The physician reported that on 20-MAR-2007, the patient developed diarrhea. The patient was seen in the Emergency Room (ER) (not admitted to the hospital) and multiple clinic visits. The patient was never dehydrated. At both the ER visit and clinic visit it was determined that the patient had a mild case of diarrhea and the parents were instructed to give Pedialite to prevent dehydration. On approximately 03-ARP-2007, the patient's diarrhea resolved. The physician noted that she would not be administering any further doses of Rotateq to the patient. Additional information has been requested.