chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Pruritus
Clinical narrative: Vaccinated 10/10 - reported to RPh 10/13/12. Reports initial swelling & redness of entire upper arm & itching. At time of patient report, swelling diminished - now 2-3 inches of redness & swelling around injection site. Patient was examined by dermatologist. Advised Hydrocortisone cream & ice pack (per MD) - helping - per patient.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Arachnoid cyst, Atrial flutter, Electrocardiogram abnormal, Head injury, Hypersensitivity
Clinical narrative: 8/23/2011 -> Hep A #1 given - BP decreased, nausea - > resolved after G'ade/ 8/27/2012 -> Hep A #2 given - syncope, head bang on floor, BP ok but weak, at 1229, nauseated - > in atrial flutter lasting for > 1 hour. CT - minor or arachnoid cyst. Cardiac evaluation - normal neuro eval - normal >> allergic reaction.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea, Syncope
Clinical narrative: 8/23/2011 -> Hep A #1 given - BP decreased, nausea - > resolved after G'ade/ 8/27/2012 -> Hep A #2 given - syncope, head bang on floor, BP ok but weak, at 1229, nauseated - > in atrial flutter lasting for > 1 hour. CT - minor or arachnoid cyst. Cardiac evaluation - normal neuro eval - normal >> allergic reaction.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Patient was in pharmacy 10/9/12 and reported her left arm was swollen and painful the evening she was administered PNEUMOVAX for which she sought medical treatment. Patient reported on 10/9/12 she had made full recovery.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness & swollen at injection site, given clindamycin large for first 4 days & 2 inch in diameter & hot to touch after 5 days.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: (L) upper arm with redness, warmth and tenderness, positive indurated approximately 4 1/2 inches x 2 1/2 inches.
Age: 22.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Chest discomfort, Dyspnoea, Headache, Throat tightness
Clinical narrative: Tightness in chest couldn't breathe, headache, tightness in throat, went to ER was given steroids & BENADRYL.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 3 hours after vaccine, started to itch and developed very sm. red raised bumps on (L) leg, then back, abdomen, breast & (R) arm.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Pallor, Paraesthesia
Clinical narrative: Pt anxious prior to vaccinations. Stated felt ok afterward, sat in chair 5-10 min afterward. As pt. was walking out to car in hallway became dizzy, weak did not lose consciousness. Client pale in color, c/o tingling (L) arm & entire face. Given OJ. Cold compress BP 76/42 & 90/62. Verbalized 'none now' before leaving facility.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Pt arm is warm to touch and red. No c/o pain received shot on 10-24-12 (shingles vacc.) came in on 10-25-12 with presentation of arm. Advised to use cool compress to area and take TYLENOL. Called patient at lunch time stated she was doing fine and that her arm was getting better.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site reaction, Injection site swelling, Musculoskeletal stiffness, Rash erythematous
Clinical narrative: Swelling and red patch at injection site (still expanding). Headache x 4 days (till Tuesday). Stiff Neck.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Activities of daily living impaired, Cellulitis
Clinical narrative: Pt stated she had cellulitis in arm and could not work. Stated ER physician told her she would have to wait it out.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Granulocyte percentage, Headache, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Pt stated she had cellulitis in arm and could not work. Stated ER physician told her she would have to wait it out.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLU3, PPV, TDAP
Symptoms: Laboratory test, Lymphocyte percentage decreased, Myalgia, Pyrexia, White blood cell count increased
Clinical narrative: Pt stated she had cellulitis in arm and could not work. Stated ER physician told her she would have to wait it out.
Age: 56.0
Sex: M
Vaccine: FLU3, HEPAB, TDAP
Symptoms: Blood test, Contusion, Pain in extremity, X-ray
Clinical narrative: Patient presented to PCP on 11/2/11 with a c/o pain and bruising on the lateral side of the left foot. No injury also c/o pain in the left hand. Concerned that it could be from his hepatitis vaccine.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Flushing, Vomiting
Clinical narrative: 10/23/12 2:40pm Pt. c/o dizziness, cheeks flushed and c/o stomach "hurt" - states he vomited (not witnessed). Layed down on cot at school and flushing improved and stated stomach was better. Talked with mom today 10/25/12 and he is "fine" did feel "tired" the evening of flu shot. Mom states he is ok today (10/25/12).
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives - started 10-17 about 6 of them and lasted one week.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Malaise, Nausea, Pyrexia
Clinical narrative: Mother reports today that child became ill after vaccine was given on 10-18-12. She states her fever went to 102. She reports nausea and mild redness at injection site. Mother did call primary Dr and was told to use TYLENOL. Child was well on 10-22-12 and went to school.
Age: 11.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: Pt. noticed swollen, hive like, raised area at site of injection, approximately 20 hrs after injection.
Age: 11.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site rash, Swelling, Urticaria
Clinical narrative: Pt. noticed swollen, hive like, raised area at site of injection, approximately 20 hrs. after injection.
Age: 0.84
Sex: M
Vaccine: FLU3
Symptoms: Blood immunoglobulin G, Rash, Rash erythematous, Swelling
Clinical narrative: Day after flu vaccine - red bumps neck, face, swelling around eyes - seen at UC - BENADRYL. Never had eggs.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Movement disorder, Pain in extremity, Periarthritis, Ultrasound scan normal
Clinical narrative: Pt called on 10/15/12 to inform she is still having arm pain when she lifts her arm. I informed her to call her Dr. She saw him the next day and was given a steroid pack and has had an ultrasound with no sign of a clot. Orthopedic Dr. says Frozen Shoulder Syndrome.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis (L) arm 1 day post pneumonia vaccine.
Age: 66.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was administered MENVEO vaccine outside of age guidelines.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Injection site haematoma
Clinical narrative: Patient got a bruise under her arm that tracked up from injection site from her elbow. Did not bruise at site - stated it looked like track marks. Also had headache and was tired that evening of vaccine.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema
Clinical narrative: Looks like a sunburn at the injection site extending to top of shoulder. Then turned white around injection site. Difficulty lifting or raising arm.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt had PNEUMOVAX / with swelling redness on left arm. No trouble breathing or hypotension. Warm to the touch. Became redder and more painful that night. Saw nurse practitioner who diagnosed cellulitis. Given cephalexin 500mg and MEDROL dose pak.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dyspnoea, Feeling hot, Flushing
Clinical narrative: Patient started feeling warm and was flushed. Then patient stated she had trouble breathing. Within 5 minutes of vaccine administration.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cardiac arrest, Erythema, Feeling hot, Hepatic enzyme abnormal, Influenza
Clinical narrative: Patient started feeling warm and was flushed. Then patient stated she had trouble breathing. Within 5 minutes of vaccine administration.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pneumonia, Psychogenic seizure, Pyrexia, Respiratory gas exchange disorder, Throat tightness
Clinical narrative: Patient started feeling warm and was flushed. Then patient stated she had trouble breathing. Within 5 minutes of vaccine administration.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Patient started feeling warm and was flushed. Then patient stated she had trouble breathing. Within 5 minutes of vaccine administration.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Fever (101.1 degrees), ache in arm, injection site pain, arm pain, lower back pain.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV2
Symptoms: Abdominal pain, Blood test normal, Epistaxis, Laboratory test normal
Clinical narrative: 10/10/12: Received phone call from mother: Child woke on 10/9/12 with nosebleed and abdominal pain. Nosebleed intermittent, abdominal pain intermittent. Denies: fever, "cold", cough, rhinorrhea, nausea, vomiting, diarrhea, other symptoms. Unable to return to this clinic so mother took child to a nearby clinic.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Swollen tongue
Clinical narrative: Pt had throat and tongue swelling. Presented to the ER given 2 doses of epinephrine. Which reversed the reaction. Pt was held for observation. Total treatment time about 5 hours.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Pt developed rash on left inside of arm in which she received the vaccine. Redness, raised rash on inner arm, no pain or discomfort other symptoms reported by patient.
Age: 1.65
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, DTAPIPVHIB, HEP, MMR, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizures x 2 on 10/24/12. Patient was seen at hospital after having a seizure. Prescription for MOTRIN & ? KEFLEX was given later on the same day he had another seizure. His parents took him to ER. Noted to have fever there as well.
Age: 1.65
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, DTAPIPVHIB, HEP, MMR, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures x 2 on 10/24/12. Patient was seen at hospital after having a seizure. Prescription for MOTRIN & ? KEFLEX was given later on the same day he had another seizure. His parents took him to ER. Noted to have fever there as well.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: 2nd day - rash below the administration site. Saw MD on the 4th day - was given triamcinolone and ciprofloxacin (made the condition worse), now given cetirizine and prednisone.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Neck pain, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: After 7 days, pt developed HA, fever, vomiting & neck ache. Pt went to pediatrician & he told the mom it was due to the vaccine.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: Patient presents with hard oval shaped knot, red, radiation, heat, approximately 2 inches x 1 inch at the site of varicella injection. Also circular red spot 1 inch diameter at the site of TDAP injection.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Cellulitis, Diabetic foot
Clinical narrative: Diabetic with ulceration on foot, now has cellulitis. Saw foot Dr., seeing ID, to see PMD 10/23/12. 10/25/12 Client is being treated for cellulitis in leg not related to flu shot.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a 17 years old female patient. The patient's history of previous pregnancies and live births is not known. The patient was vaccinated with the first dose GARDASIL (lot number not reported) on 25-SEP-2008. The physician reported that the patient received the third dose in the GARDASIL immunization series on 03-OCT-2012, while she was 14 weeks pregnant. No adverse effect reported. Physician reports that the patient is due on 03-APR-2013. The patient had sought medical attention, the AE occurred in provider's office. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from Nurse Practitioner refers to a patient who was vaccinated with the first dose of GARDASIL, intramuscular, in 2007 (sometime in 2007). On 18-OCT-2012 the patient was vaccinated with the second dose of GARDASIL, intramuscular. No adverse effect reported. The patient present status was other: no known adverse effect. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician refers to a 20 years old female patient with allergy to sulfa and minocin. The patient was vaccinated with the first dose of GARDASIL (route, dose and lot # were unknown) on 31-DEC-2007, the second on 06-MAR-2008 and the third on 05-JUN-2008. No other co-suspects were reported. Concomitant medications included: hormonal contraceptives (unspecified) (Birth control pills). The patient completed GARDASIL series, recently had Pap test done and result came back positive. The test result read: "HPV high risk positive, HPV type 6, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68". PAP test was done on 08-OCT-2012. No treatment was given for adverse event. The outcome of the event was unknown. The patient sought medical attention via visiting office. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received via a company representative from a registered nurse refers to a 12 years old female patient with milk allergy. The patient was vaccinated with dose 2 GARDASIL; (reported lot number H009746, expiry date 11-JAN-2015, route and dose not reported) on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-OCT-2012 the patient fainted after receiving the 2nd dose of GARDASIL. The patient had previously received her first dose (date, dose and route not reported) without experiencing an adverse event. The patient did not receive any treatment. No relevant tests were performed. The patient seemed recovered after a few minutes. A reporter causality for fainted was not provided for GARDASIL. The registered nurse reported about 2 patients (sisters) who fainted after receiving the 2nd dose of GARDASIL: Linked case report is 1210USA008937. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Gianotti-Crosti syndrome, Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: This spontaneous report as received from a physician refers to a 12 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with his first dose of GARDASIL (0.5 ml, intramuscularly, Lot# unspecified) on 07-AUG-2012 and second dose (Lot#, dose, route unspecified) today, on 19-OCT-2012. There was no concomitant medication. It was reported that after the first dose vaccination, patient had developed a rash localized to his right anterior upper thigh on an unknown date in 2012. The lesions were papular/pustular at the onset of the rash but were now red, papular lesions. The lesions were slightly pruritic. The physician had diagnosed the rash as Gianotti-Crosti Syndrome. The patient had sought medical attention via office visit. No lab diagnostics studies performed and no treatment was given for the event. The outcome of gianotti-crosti symptom was reported as not recovered/not resolved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Rash pustular, Skin lesion
Clinical narrative: This spontaneous report as received from a physician refers to a 12 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with his first dose of GARDASIL (0.5 ml, intramuscularly, Lot# unspecified) on 07-AUG-2012 and second dose (Lot#, dose, route unspecified) today, on 19-OCT-2012. There was no concomitant medication. It was reported that after the first dose vaccination, patient had developed a rash localized to his right anterior upper thigh on an unknown date in 2012. The lesions were papular/pustular at the onset of the rash but were now red, papular lesions. The lesions were slightly pruritic. The physician had diagnosed the rash as Gianotti-Crosti Syndrome. The patient had sought medical attention via office visit. No lab diagnostics studies performed and no treatment was given for the event. The outcome of gianotti-crosti symptom was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.14
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB, HEP, RV5
Symptoms: Crying, Drug administered at inappropriate site, Drug administered to patient of inappropriate age, Emotional distress, Incorrect dose administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crying in a 7-week-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PENTACEL (non-GSK manufacturer), ENGERIX B (GlaxoSmithKline) and ROTATEQ (Merck) all given on 30 April 2012. On 30 April 2012 the 7 week old subject inadvertently received a dose of KINRIX at 0.5ml in the left leg. The subject experienced inappropriate age at vaccine administration, wrong vaccine administered, vaccine administered at inappropriate site and overdose. The subject received a dose of KINRIX instead of PREVNAR which resulted in overdose given that she received PENTACEL as well. KINRIX is indicated for administration in the deltoid. On 06 May 2012, less than one week after vaccination with KINRIX, the mother of the subject called the office to report that the baby was crying for 1 and a half hours and was difficult to console. At the time of reporting the outcome of the events was unspecified.
Age: 0.14
Sex: F
Vaccine: DTAPIPV, DTAPIPVHIB, HEP, RV5
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of crying in a 7-week-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included PENTACEL (non-GSK manufacturer), ENGERIX B (GlaxoSmithKline) and ROTATEQ (Merck) all given on 30 April 2012. On 30 April 2012 the 7 week old subject inadvertently received a dose of KINRIX at 0.5ml in the left leg. The subject experienced inappropriate age at vaccine administration, wrong vaccine administered, vaccine administered at inappropriate site and overdose. The subject received a dose of KINRIX instead of PREVNAR which resulted in overdose given that she received PENTACEL as well. KINRIX is indicated for administration in the deltoid. On 06 May 2012, less than one week after vaccination with KINRIX, the mother of the subject called the office to report that the baby was crying for 1 and a half hours and was difficult to console. At the time of reporting the outcome of the events was unspecified.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of 0.5 ml of GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that in her office had recently been administering GARDASIL "in the butt muscle". Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). On 13 August 2011 the subject received 1st dose of KINRIX (.5 ml, unknown route, left arm). On an unspecified date, less than one week after vaccination with KINRIX, the subject experienced injection site redness, injection site warmth, swelling injection site and injection site pruritus. The healthcare professional noted that there was no fever or pain. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with KINRIX. Follow-up information was received on 27 September 2011. It was reported that the subject experienced a "vaccine reaction" at an unspecified time following administration with KINRIX. Vaccine reaction and previously reported events of injection site redness, injection site warmth, swelling injection site and injection site pruritus were improved at the time of follow-up and attribution of the events to KINRIX was probable.
Age: 0.51
Sex: M
Vaccine: DTAPIPV, HIBV
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of high fever in a child male subject who was vaccinated with KINRIX (GlaxoSmithKline), haemophilus influenzae type b vaccine (non-gsk). Concurrent medications included Vitamin D (Vitamin D supplement). On 31 January 2012 the subject received 1st dose of KINRIX (.5 ml, unknown route) and experienced inappropriate age at vaccination administration, and the subject received 3rd dose of Haemophilus influenzae type b vaccine (Non-GSK) (unknown route). It was reported that the subject was younger than the indicated age for KINRIX administration. On 31 January 2012, "that evening" within hours of vaccination with Haemophilus influenzae type b vaccine (Non-GSK) and KINRIX, the subject experienced high fever of 102.0 degrees. The subject was seen at the physician's office "yesterday" (1 February 2012) with continued fever. The physician reports the fever was decreased, but the subject was not afebrile. The physician reported that he was unsure which vaccine may have caused the reaction. At the time of reporting the outcome of the events were unknown. The physician considered the events were possibly related to vaccination with KINRIX and Haemophilus influenzae type b vaccine (Non-GSK). Follow up information received from the physician on 13 March 2012. The physician reported that on 01 February 2012, one day after vaccination with KINRIX, the 6-month-old subject experienced fever. The fever resolved on 03 February 2012. The only diagnosis was fever. The physician noted that the events could have been associated with the erroneous administration of KINRIX. The subject was younger than the indicated age of KINRIX. The physician noted that the event was not serious.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Decreased appetite, Extensive swelling of vaccinated limb, Injection site discolouration, Injection site erythema, Injection site haemorrhage
Clinical narrative: This case was reported by a consumer (also the subject's mother) and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). A physician or other health care professional has not verified this report. Historic vaccinations included PEDIARIX (GlaxoSmithKline) for the first 3 doses of the series given on unspecified dates. When the subject was 15 months old, he was given INFANRIX (GlaxoSmithKline) as the 4th dose of the series on an unspecified date. On 6 December 2011 at 14:30 the subject received a dose of KINRIX (unknown route, left arm) as the 5th dose in the series and a 2nd dose of Varicella virus vaccine (Non-GSK) (unknown route, right arm). On 6 December 2011, during vaccination with KINRIX, same day as vaccination with Varicella virus vaccine (Non-GSK), the subject experienced injection site bleeding. He also experienced extensive swelling of vaccinated limb that started the same day. On 7 December 2011 the subject experienced upper arm red, mottled skin and arms itching. On 8 December 2011 he experienced skin hot to touch and decreased appetite. The mother reported that at the time of KINRIX injection there was bleeding at the site due to the subject's unwillingness to get the vaccine. Even before leaving the doctor's office, the bleeding stopped. When she got home, there was swelling noted at the site. In the afternoon on 7 December 2011, the mother noticed the left arm from the elbow to the shoulder was swollen and discolored in that the front of the arm from the elbow up to the shoulder was red and the back of the arm was mottled. The subject also complained of itching of the entire area from the elbow to the shoulder. She contacted her physician who recommended cool packs and to notify them if the area got larger. The mother reported that on 8 December 2011, the swelling was the same, has pink coloring, the skin was "hot to touch" and the subject had a decrease in appetite, but no limitations to his daily activities. The subject was treated with cool compress (Cool pack) which did not help but the "area did not increase". At the time of reporting the outcome of the event of injection site bleeding was resolved. The events of extensive swelling of vaccinated limb, upper arm red, mottled skin and skin hot to touch were unresolved. The outcomes of the events arms itching and decreased appetite were unspecified.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Livedo reticularis, Skin warm
Clinical narrative: This case was reported by a consumer (also the subject's mother) and described the occurrence of extensive swelling of vaccinated limb in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline), varicella virus vaccine (non-gsk). A physician or other health care professional has not verified this report. Historic vaccinations included PEDIARIX (GlaxoSmithKline) for the first 3 doses of the series given on unspecified dates. When the subject was 15 months old, he was given INFANRIX (GlaxoSmithKline) as the 4th dose of the series on an unspecified date. On 6 December 2011 at 14:30 the subject received a dose of KINRIX (unknown route, left arm) as the 5th dose in the series and a 2nd dose of Varicella virus vaccine (Non-GSK) (unknown route, right arm). On 6 December 2011, during vaccination with KINRIX, same day as vaccination with Varicella virus vaccine (Non-GSK), the subject experienced injection site bleeding. He also experienced extensive swelling of vaccinated limb that started the same day. On 7 December 2011 the subject experienced upper arm red, mottled skin and arms itching. On 8 December 2011 he experienced skin hot to touch and decreased appetite. The mother reported that at the time of KINRIX injection there was bleeding at the site due to the subject's unwillingness to get the vaccine. Even before leaving the doctor's office, the bleeding stopped. When she got home, there was swelling noted at the site. In the afternoon on 7 December 2011, the mother noticed the left arm from the elbow to the shoulder was swollen and discolored in that the front of the arm from the elbow up to the shoulder was red and the back of the arm was mottled. The subject also complained of itching of the entire area from the elbow to the shoulder. She contacted her physician who recommended cool packs and to notify them if the area got larger. The mother reported that on 8 December 2011, the swelling was the same, has pink coloring, the skin was "hot to touch" and the subject had a decrease in appetite, but no limitations to his daily activities. The subject was treated with cool compress (Cool pack) which did not help but the "area did not increase". At the time of reporting the outcome of the event of injection site bleeding was resolved. The events of extensive swelling of vaccinated limb, upper arm red, mottled skin and skin hot to touch were unresolved. The outcomes of the events arms itching and decreased appetite were unspecified.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included MMR II (non-gsk); non-GSK manufacturer given on 18 August 2011; varicella virus vaccine (non-gsk); non-GSK manufacturer given on 18 August 2011. On 18 August 2011 the subject received a dose of KINRIX (unknown route, right thigh) as the final Dtap dose in the series. On 18 August 2011, within 12 hours after vaccination with KINRIX, the subject experienced injection site redness, hotness at injection site and swelling injection site. The subject was treated with diphenhydramine hydrochloride. At the time of reporting the events were improved. The healthcare professional considered the events were probably related to vaccination with KINRIX. Follow-up information received on 27 September 2011 indicated that the events were not considered to be serious. They were improved at the time of reporting and probably related to vaccination with KINRIX.
Age: 0.34
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a 4 month old patient of unknown gender. The patient was vaccinated with a dose of ROTATEQ, oral, lot number was 1556Z expiration date 12-SEP-2012) on 17-SEP-2012. Concomitant medications were not reported. The expired dose of ROTATEQ was to be the second dose of ROTATEQ. The patient received the first dose of ROTATEQ on 11-JUL-2012 at 2 months of age. No adverse event was reported. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Incorrect route of drug administration, Pyrexia, Vomiting, Wrong technique in drug usage process
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of high fever in  a 6-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date in 2011 (approximately 3-4 months prior to the time of reporting) the subject received 1st dose of KINRIX (oral). The vaccine had been mixed with chocolate milk and the subject was instructed to drink all of the contents (inappropriate route of vaccination and inappropriate preparation of medication). The subject received the vaccine at a physician's office. In 2011 (approximately 3-4 months prior to the time of reporting), the same year after vaccination with KINRIX, the subject experienced high fever of 105 degrees Fahrenheit, bright red cheeks and vomited yellow bile. The subject's mother consulted a physician who asked to see the subject and instructed her to keep the subject hydrated. At the time of reporting the events were resolved. The high fever and bright red cheeks resolved 2-3 days later without intervention. The vomiting yellow bile resolved in hours without intervention.
Age: 0.43
Sex: M
Vaccine: DTAPIPV, HIBV, PPV
Symptoms: Pain in extremity, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of leg pain in a 5-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included atopic dermatitis. Concurrent vaccinations on 14 November 2011 included Haemophilus influenzae type b vaccine;manufacturer unspecified and Pneumococcal vaccine  (non-gsk);manufacturer unspecified. On 14 November 2011 at 12:00 the subject received a dose of KINRIX (unknown route, unknown thigh) as the 2nd dose of the series and experienced leg pain and wrong vaccine administered. KINRIX was given instead of PEDIARIX and the subject was younger than that indicated age for KINRIX administration. The mother did not notice anything unusual about the baby or his behavior. The baby did not have a fever and was not sick. He did have a little pain in the leg after the injection. On an unspecified date. the leg pain resolved.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Blister, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of swelling injection site in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on 24 July 2012; MMR vaccine (non-gsk); Merck; unknown; unknown given on 24 July 2012; VARIVAX (non-gsk); Merck; unknown, right arm given on 24 July 2012. There were no concurrent medications. On 24 July 2012 the subject received 1st dose of KINRIX (.5 ml, unknown, right deltoid). On 25 July 2012, 24 hours after vaccination with KINRIX, the subject experienced swelling injection site, injection site redness, injection site pain, pain in r arm on elevation, injection site blisters and blisters on arm. The subject received vaccinations on 24 July 2012, 24 hours later the subject had redness, swollen, multiple blisters and on large blister at the injection site. Pain occurred when the arm was extended above her head. The subject had lab work performed including white blood cell count that was within normal limits, ATB (antibiotic) was given. Demarcated region on arm. On 28 July 2012 the subject returned and arm had largely improved. Large blister ruptured and no other blisters except tiny ones. On 30 July 2012, the healthcare professional called the subject and was found to continue to improve. No further follow up information. On an unspecified date in 2012, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with KINRIX.
Age: 3.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Laboratory test, Pain in extremity, White blood cell count normal
Clinical narrative: This case was reported by a healthcare professional via sales representative and described the occurrence of swelling injection site in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on 24 July 2012; MMR vaccine (non-gsk); Merck; unknown; unknown given on 24 July 2012; VARIVAX (non-gsk); Merck; unknown, right arm given on 24 July 2012. There were no concurrent medications. On 24 July 2012 the subject received 1st dose of KINRIX (.5 ml, unknown, right deltoid). On 25 July 2012, 24 hours after vaccination with KINRIX, the subject experienced swelling injection site, injection site redness, injection site pain, pain in r arm on elevation, injection site blisters and blisters on arm. The subject received vaccinations on 24 July 2012, 24 hours later the subject had redness, swollen, multiple blisters and on large blister at the injection site. Pain occurred when the arm was extended above her head. The subject had lab work performed including white blood cell count that was within normal limits, ATB (antibiotic) was given. Demarcated region on arm. On 28 July 2012 the subject returned and arm had largely improved. Large blister ruptured and no other blisters except tiny ones. On 30 July 2012, the healthcare professional called the subject and was found to continue to improve. No further follow up information. On an unspecified date in 2012, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with KINRIX.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of ROTATEQ (lot # 1236AA; exp date 15-OCT-2012) (dose and route not reported) on 19-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a nurse via a sales representative and described the occurrence of injection site rash in a subject aged between 4 to 6 years old of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine (manufacturer unspecified) and varicella virus vaccine (manufacturer unspecified) both given in 2011. In 2011 the subject received unspecified dose of KINRIX in an unknown shoulder. In 2011, less than one year after vaccination with KINRIX, the subject experienced injection site rash and swelling injection site. At the time of reporting the events were resolved. The sales representative indicated that a nurse reported 4 to 5 instances of rash and swelling at the injection site following administration of KINRIX. Specifics for each subject were not available. It was reported that the subject were between 4 to 6 years of age and included males and females. There were 3 to 4 instances in 2011 and 1 in 2012. The KINRIX vaccinations were given in the right or left shoulder. The subjects all received MMR and Varicella vaccines concurrently, but the rash and swelling were only noticed with the KINRIX vaccine. Linked case for episode in 2012 - A0973638A.
Sex: U
Vaccine: DTAPIPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of red, swollen arm in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of KINRIX (details unknown). At an unspecified time after vaccination with KINRIX, the subject experienced red and swollen arm. The reporter refused to provide any additional information. It was unspecified whether the event was systemic or localized. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAPIPV
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a healthcare professional (nurse) and a consumer (mother of another subject at the nurse's office) and described the occurrence of injection site reaction in a child subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of KINRIX (details unknown). At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction. The mother of another subject at the nurse's office reported that her daughter (see case A0987998A) and other children had the "same reaction". The nurse in the physician's office informed that they have different information from what was provided by the consumer reporter. The nurse stated that she conferred with the physician. According to the nurse, there were a total of 3 children (including the subject whose mother had called) with local reactions, but not confirmed to be systemic and the other two were different lot numbers. The nurse did not have the lot numbers of the two subjects or their information. This is case one of the two subjects. See case A0989133A for the second subject and A0987998A for the daughter of the consumer reporter. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a nurse via a sales representative and described the occurrence of injection site rash in a subject aged between 4 to 6 years old of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine (manufacturer unspecified) and varicella virus vaccine (manufacturer unspecified) both given in 2012. In 2012 the subjects received unspecified dose of KINRIX in an unknown shoulder. An unspecified amount of time after vaccination with KINRIX (within a few months), the subject experienced injection site rash and swelling injection site. At the time of reporting the events were resolved. The sales representative indicated that a nurse reported 4 to 5 instances of rash and swelling at the injection site following administration of KINRIX. Specifics for each subject were not available. It was reported that the subjects were between 4 to 6 years of age and included males and females. There were 3 to 4 instances in 2011 and 1 in 2012. The KINRIX vaccinations were given in the right or left shoulder. The subjects all received MMR and Varicella vaccines concurrently, but the rash and swelling were only noticed with the KINRIX vaccine. Linked case for episodes in 2011 - A0973627A.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. Concurrent vaccination included MMR vaccine (non-gsk); Merck; subcutaneous; left arm given on 22 May 2012; varicella virus vaccine (non-gsk); Merck; subcutaneous; right arm given on 22 May 2012. Concurrent medications included CLARITIN. On 23 May 2012, one day after vaccination with KINRIX, the subject experienced swelling at injection site, hotness at injection site, injection site redness, and redness spreading. The subject was administered KINRIX and by the next morning he had swelling of ten centimeters, redness and heat at the injection site. The redness spared toward the subject's groin area and he was then seen in the office. The redness extended about three inches by two inches from the site toward the groin area. It was reported that the subject still had on the band aid from the date of vaccination. The subject was prescribed KEFLEX for 10 days. The reporter stated the KINRIX vial was used, by they do use latex band aids. At the time of reporting the swelling at injection site, hotness at injection site, injection site redness, and redness spreading were unresolved. This is the second of two reports regarding KINRIX; please see A0978807A.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of urticaria in a 5-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). There were not concurrent medications. On 23 January 2012 the subject received 1st dose of KINRIX in the left arm. On 30 January 2012, 7 days after vaccination with KINRIX, the subject experienced urticaria and injection site redness (a symmetrical, circular, nonraised, red site reaction, 1 inch from the injection site). At the time of reporting the events were unresolved. The physician considered the events were probably related to vaccination with KINRIX. Follow up information received from the physician on 14 February 2012. Concurrent vaccination included diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined ;GlaxoSmithKline; unknown; unknown given on an unspecified date; diphtheria and tetanus toxoids and acellular pertussis vaccine ;manufacturer unspecified; unknown; unknown given on an unspecified date. The physician noted that the events were not serious. The KINRIX was administered as the 5th dose in the DTaP series as indicated. The physician reported that the subject developed "hives around the injection site 7 days after the injection". On 31 January 2012, the events were resolved. According to the physician, the events only lasted one day. The physician selected that the KINRIX immunization series was not discontinued or delayed.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received via a company representative from a registered nurse refers to a 14 years old female patient with milk allergy. The patient was vaccinated with dose 2 GARDASIL (reported lot number H009746, expiry date 11-JAN-2015, route and dose not reported) on 08-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 08-OCT-2012 the patient fainted after receiving the 2nd dose of GARDASIL. The patient had previously received her first (date, dose and route not reported) without experiencing an adverse event. The patient did not receive any treatment. No relevant tests were performed. The patient seemed recovered after a few minutes. A reporter causality for fainted was not provided for GARDASIL. The registered nurse reported about 2 patients (sisters) who fainted after receiving the 2nd dose of GARDASIL: Linked case report is 1210USA005725. Additional information is not expected.