chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Experience itching, rash, after 12 hours of administration of MENVEO and hives.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Vertigo
Clinical narrative: Declining blood glucose. Vertigo. Symptoms were relayed by the patient's daughter-in-law.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt. given PNEUMOVAX vaccine on 7-24-12. She returned a few days later to complain of redness and soreness in arm. I looked at her arm - no redness or swelling. I told her that was common for vaccines to experienced soreness/redness for a few days. She returned on 8-16-12 and told another RPh of her "extremely swollen arm and red all over". That RPh filled out VAERS. I don't think it is a true AE.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse practitioner concerning a patient who in July 2011 "one year ago" was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided) and on 13-JUL-2012 received the second dose of GARDASIL (dose, route and lot # not provided). The nurse wanted to know when the third dose should be given or if the series would need to be restarted. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Cough, Dyspnoea
Clinical narrative: This spontaneous report was received from a physician concerning a female patient in her early twenties who on 06-JUL-2012 was vaccinated with the first dose of GARDASIL (dose, route and lot # not provided). The physician reported that the patient experienced shortness of breath and cough within hours of receiving the first dose of GARDASIL on 06-JUL-2012. The patient received treatment with cough suppressants (unspecified) and an inhaler (unspecified) for the cough and shortness of breath. No laboratory tests were performed. On 09-JUL-2012, the patient visited the physician's office. At the time of the report, the patient had not recovered from the events. The relatedness for shortness of breath and cough was unknown for GARDASIL. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from an approximately 65 year old female registered nurse with amoxicillin allergy and no pertinent medical history reporting on herself, who in approximately 2007, "5 years ago", was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) SQ. Concomitant therapy included LEVOXYL, DIOVAN and multivitamins (unspecified). The nurse reported that In approximately 2007, the same day of the vaccination, she experienced fever, headaches and redness at the site of injection after receiving a dose of PNEUMOVAX23. She had fever of 101 degrees F and large painful red area on the arm where she got the injection. The patient saw a physician and was treated with oral steroid. There were no Lab diagnosis/studies performed. The patient was fully recovered about 4 days after the vaccination. Follow up information has been from the 67 year female patient (registered nurse) (previously reported as 65) year old - at the time of the report 71 year old - with none illness ant time of vaccination and none pre-existing allergies (previously reported that the patient had allergy to amoxicillin refers to her self who in October 2008 (previously reported in 2007, was vaccinated with a first dose of PNEUMOVAX23, (dose duration and lot # not reported) (vaccination jour was reported as 11:00). In October 2008, about 4 hours after vaccination (at 14:00), the patient developed headache, redness, swollen site (reported also as cellulitis at site) and temperature of 101. No lab tests were performed. The patient was seen by PMD for adverse events (cellulitis at site, headache, and fever) and received unspecified steroid (oral) for 5 days. The patient recovered on an unknown date in 2008 (reported as 1 week later). Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from an approximately 65 year old female registered nurse with amoxicillin allergy and no pertinent medical history reporting on herself, who in approximately 2007, "5 years ago", was vaccinated with a dose of PNEUMOVAX23 (Lot # not reported) SQ. Concomitant therapy included LEVOXYL, DIOVAN and multivitamins (unspecified). The nurse reported that In approximately 2007, the same day of the vaccination, she experienced fever, headaches and redness at the site of injection after receiving a dose of PNEUMOVAX23. She had fever of 101 degrees F and large painful red area on the arm where she got the injection. The patient saw a physician and was treated with oral steroid. There were no Lab diagnosis/studies performed. The patient was fully recovered about 4 days after the vaccination. Follow up information has been from the 67 year female patient (registered nurse) (previously reported as 65) year old - at the time of the report 71 year old - with none illness ant time of vaccination and none pre-existing allergies (previously reported that the patient had allergy to amoxicillin refers to her self who in October 2008 (previously reported in 2007, was vaccinated with a first dose of PNEUMOVAX23, (dose duration and lot # not reported) (vaccination jour was reported as 11:00). In October 2008, about 4 hours after vaccination (at 14:00), the patient developed headache, redness, swollen site (reported also as cellulitis at site) and temperature of 101. No lab tests were performed. The patient was seen by PMD for adverse events (cellulitis at site, headache, and fever) and received unspecified steroid (oral) for 5 days. The patient recovered on an unknown date in 2008 (reported as 1 week later). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a patient's friend refers to a patient of unknown age. It was reported that the patient may have received ZOSTAVAX that was already expired (lot#, route and date were unspecified). The patient advised the reporter that there was a date of 08-APR-2012, but there were no further details regarding the date. No adverse event was reported. No further information was reported. The outcome of patient was unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with 3 doses of GARDASIL (lot # not reported) at the same time, via a single injection on 09-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood test normal, Gait disturbance, Joint swelling
Clinical narrative: Initial case received from a consumer, non-healthcare professional, on 10 March 2012. A male patient (birth date and age not reported) received a right arm injection (route not reported) of FLUZONE, sanofi pasteur Inc., lot number UH493AA on 11 January 2012. The patient's past medical history, allergies, concomitant medications, any illness at time of vaccination, and any other vaccinations within four weeks prior to event were not reported. The patient stated he had several doses of Influenza Vaccine in the past, but he did not mention any past adverse events. On 11 January 2012, the patient received FLUZONE as part of his annual physical, and immediately after Flu shot, the patient experienced ankle and knee joint pain and swelling, which has persisted two months. The patient states the joint pain is continuous and floats between the joints. The patient stated his blood work was all normal. The patient's outcome is not recovered. Follow-up information was received from a health care professional on 13 August 2012. Based upon the new information provided, this case has been upgraded to serious. The patient was a 49-year-old male. The injection of FLUZONE was given intramuscularly in the left arm (previously reported as right arm). The patient had no illness at the time of vaccination and received no other vaccines within 12 months of FLUZONE. Past medical history included controlled hypertension, overweight, hyperlipidemia, benign prostatic hyperplasia and prostatitis. The patient had no known allergies. Concomitant medications included chlorthalidone, multivitamin and fish oil. Influenza vaccines were previously given on 12 January 2011, 23 December 2009, 28 January 2009, 16 January 2008 and 24 January 2007 with no adverse effects. Treatments included ibuprofen and indomethacin. Sedimentation rate on 20 January 2012 was 90. On 23 April 2012, x-rays of the feet showed small erosion of the left first metatarsal, CRP increased at 1.27, Lyme's antibody negative, uric acid 8.9, rheumatoid factor (RF) negative, antinuclear antibody (ANA) positive at 1:40 and ultrasound of ankles showed posterior tibialis tendinopathy. The patient continued to have some pain and swelling in his ankles. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Antinuclear antibody positive, Arthralgia, Blood uric acid increased, Bone erosion, Borrelia test negative
Clinical narrative: Initial case received from a consumer, non-healthcare professional, on 10 March 2012. A male patient (birth date and age not reported) received a right arm injection (route not reported) of FLUZONE, sanofi pasteur Inc., lot number UH493AA on 11 January 2012. The patient's past medical history, allergies, concomitant medications, any illness at time of vaccination, and any other vaccinations within four weeks prior to event were not reported. The patient stated he had several doses of Influenza Vaccine in the past, but he did not mention any past adverse events. On 11 January 2012, the patient received FLUZONE as part of his annual physical, and immediately after Flu shot, the patient experienced ankle and knee joint pain and swelling, which has persisted two months. The patient states the joint pain is continuous and floats between the joints. The patient stated his blood work was all normal. The patient's outcome is not recovered. Follow-up information was received from a health care professional on 13 August 2012. Based upon the new information provided, this case has been upgraded to serious. The patient was a 49-year-old male. The injection of FLUZONE was given intramuscularly in the left arm (previously reported as right arm). The patient had no illness at the time of vaccination and received no other vaccines within 12 months of FLUZONE. Past medical history included controlled hypertension, overweight, hyperlipidemia, benign prostatic hyperplasia and prostatitis. The patient had no known allergies. Concomitant medications included chlorthalidone, multivitamin and fish oil. Influenza vaccines were previously given on 12 January 2011, 23 December 2009, 28 January 2009, 16 January 2008 and 24 January 2007 with no adverse effects. Treatments included ibuprofen and indomethacin. Sedimentation rate on 20 January 2012 was 90. On 23 April 2012, x-rays of the feet showed small erosion of the left first metatarsal, CRP increased at 1.27, Lyme's antibody negative, uric acid 8.9, rheumatoid factor (RF) negative, antinuclear antibody (ANA) positive at 1:40 and ultrasound of ankles showed posterior tibialis tendinopathy. The patient continued to have some pain and swelling in his ankles. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: C-reactive protein increased, Immediate post-injection reaction, Joint swelling, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Initial case received from a consumer, non-healthcare professional, on 10 March 2012. A male patient (birth date and age not reported) received a right arm injection (route not reported) of FLUZONE, sanofi pasteur Inc., lot number UH493AA on 11 January 2012. The patient's past medical history, allergies, concomitant medications, any illness at time of vaccination, and any other vaccinations within four weeks prior to event were not reported. The patient stated he had several doses of Influenza Vaccine in the past, but he did not mention any past adverse events. On 11 January 2012, the patient received FLUZONE as part of his annual physical, and immediately after Flu shot, the patient experienced ankle and knee joint pain and swelling, which has persisted two months. The patient states the joint pain is continuous and floats between the joints. The patient stated his blood work was all normal. The patient's outcome is not recovered. Follow-up information was received from a health care professional on 13 August 2012. Based upon the new information provided, this case has been upgraded to serious. The patient was a 49-year-old male. The injection of FLUZONE was given intramuscularly in the left arm (previously reported as right arm). The patient had no illness at the time of vaccination and received no other vaccines within 12 months of FLUZONE. Past medical history included controlled hypertension, overweight, hyperlipidemia, benign prostatic hyperplasia and prostatitis. The patient had no known allergies. Concomitant medications included chlorthalidone, multivitamin and fish oil. Influenza vaccines were previously given on 12 January 2011, 23 December 2009, 28 January 2009, 16 January 2008 and 24 January 2007 with no adverse effects. Treatments included ibuprofen and indomethacin. Sedimentation rate on 20 January 2012 was 90. On 23 April 2012, x-rays of the feet showed small erosion of the left first metatarsal, CRP increased at 1.27, Lyme's antibody negative, uric acid 8.9, rheumatoid factor (RF) negative, antinuclear antibody (ANA) positive at 1:40 and ultrasound of ankles showed posterior tibialis tendinopathy. The patient continued to have some pain and swelling in his ankles. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 48.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Tendon disorder, Ultrasound scan abnormal, X-ray limb abnormal
Clinical narrative: Initial case received from a consumer, non-healthcare professional, on 10 March 2012. A male patient (birth date and age not reported) received a right arm injection (route not reported) of FLUZONE, sanofi pasteur Inc., lot number UH493AA on 11 January 2012. The patient's past medical history, allergies, concomitant medications, any illness at time of vaccination, and any other vaccinations within four weeks prior to event were not reported. The patient stated he had several doses of Influenza Vaccine in the past, but he did not mention any past adverse events. On 11 January 2012, the patient received FLUZONE as part of his annual physical, and immediately after Flu shot, the patient experienced ankle and knee joint pain and swelling, which has persisted two months. The patient states the joint pain is continuous and floats between the joints. The patient stated his blood work was all normal. The patient's outcome is not recovered. Follow-up information was received from a health care professional on 13 August 2012. Based upon the new information provided, this case has been upgraded to serious. The patient was a 49-year-old male. The injection of FLUZONE was given intramuscularly in the left arm (previously reported as right arm). The patient had no illness at the time of vaccination and received no other vaccines within 12 months of FLUZONE. Past medical history included controlled hypertension, overweight, hyperlipidemia, benign prostatic hyperplasia and prostatitis. The patient had no known allergies. Concomitant medications included chlorthalidone, multivitamin and fish oil. Influenza vaccines were previously given on 12 January 2011, 23 December 2009, 28 January 2009, 16 January 2008 and 24 January 2007 with no adverse effects. Treatments included ibuprofen and indomethacin. Sedimentation rate on 20 January 2012 was 90. On 23 April 2012, x-rays of the feet showed small erosion of the left first metatarsal, CRP increased at 1.27, Lyme's antibody negative, uric acid 8.9, rheumatoid factor (RF) negative, antinuclear antibody (ANA) positive at 1:40 and ultrasound of ankles showed posterior tibialis tendinopathy. The patient continued to have some pain and swelling in his ankles. The patient's outcome remained not recovered. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Nervousness, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female patient with no pre existing illness, asthma and a medical history of eczema was vaccinated with dose 1 of GARDASIL (Lot # 671006/1291AA), Right arm, IM on 06-APR-2012. No other co-suspects were reported. Concomitant medications included MENACTRA and BOOSTRIX and "only over the counter multivitamin and vitamin D that she had been on for some time". It was reported that on 06-APR-2012 the patient fainted immediately was pale and nervous for several minutes and was monitored with feet up in recumbent position until felt better. It was also reported that the patient was caught by Medical assistant and aroused immediately. The patient was observed in clinic for 15 minutes until walked out comfortably. There were no labs performed. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 453149-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dyspnoea, Injection site rash, Rash, Rash pruritic, Throat irritation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old male patient with asthma, allergies and a pre existing illness of allergic rhinitis was vaccinated with dose 1 of GARDASIL (lot # 670050/1229AA), Right arm, IM on 06-APR-2012. No other co-suspects were reported. Concomitant medications included HAVRIX, PROAIR, CETRIZIN, NASONEX, SINGULAIR and PRILOSEC. It was reported that on 06-APR-2012, the patient developed rash on both arms at injection site spread to neck and back starting the evening after getting immunizations, patient complained of it, being very itchy also experienced any itchy throat, and slight trouble breathing; the patient's mom gave him BENADRYL every 4 to 6 hours through the weekend and albuterol breathing treatments and called our office reporting that symptoms were already improving, the patient's mom was instructed to continue BENADRYL and albuterol and gave follow up if not improving or symptoms worsening. There were no labs performed. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # 453239-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dyspnoea, Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old male patient with asthma, allergies and a pre existing illness of allergic rhinitis was vaccinated with dose 1 of GARDASIL (lot # 670050/1229AA), Right arm, IM on 06-APR-2012. No other co-suspects were reported. Concomitant medications included HAVRIX, PROAIR, CETRIZIN, NASONEX, SINGULAIR and PRILOSEC. It was reported that on 06-APR-2012, the patient developed rash on both arms at injection site spread to neck and back starting the evening after getting immunizations, patient complained of it, being very itchy also experienced any itchy throat, and slight trouble breathing; the patient's mom gave him BENADRYL every 4 to 6 hours through the weekend and albuterol breathing treatments and called our office reporting that symptoms were already improving, the patient's mom was instructed to continue BENADRYL and albuterol and gave follow up if not improving or symptoms worsening. There were no labs performed. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # 453239-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Throat irritation
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old male patient with asthma, allergies and a pre existing illness of allergic rhinitis was vaccinated with dose 1 of GARDASIL (lot # 670050/1229AA), Right arm, IM on 06-APR-2012. No other co-suspects were reported. Concomitant medications included HAVRIX, PROAIR, CETRIZIN, NASONEX, SINGULAIR and PRILOSEC. It was reported that on 06-APR-2012, the patient developed rash on both arms at injection site spread to neck and back starting the evening after getting immunizations, patient complained of it, being very itchy also experienced any itchy throat, and slight trouble breathing; the patient's mom gave him BENADRYL every 4 to 6 hours through the weekend and albuterol breathing treatments and called our office reporting that symptoms were already improving, the patient's mom was instructed to continue BENADRYL and albuterol and gave follow up if not improving or symptoms worsening. There were no labs performed. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # 453239-1. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Abdominal X-ray, Faeces discoloured, Intestinal operation, Intussusception, Lethargy
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 months old male patient with a history of premature birth, hypoglycemia at birth, Gastrooesophageal reflux disease (GERD) and apparent life-threatening event (ALTE) who was vaccinated orally with the first dose of ROTATEQ (Lot# 0680AA) on 27-MAR-2012. No other co-suspects were reported. Concomitant medications included: ACTHIB (lot# UH522AA) which was vaccinated IM on the left leg on 27-MAR-2012. On 31-MAR-2012 the patient presented with abdominal pain, crying, vomiting, lethargy, refusing to eat, sleepiness, black stool, decreased activity and was admitted. The patient developed diarrhea in ER. X-ray of abdomen and abdominal ultrasound (US) were performed. Air enema abnormal was noted on US and right upper quadrant intussusception was diagnosed. The patient was treated with successful air enema reduction. Other Lab tests included: Hemoccult (+), WBC 18.8 K/uL (H), neutro 72% & 13.5 K/uL (H), lymphs 16.9% (L), monos 10% & 1.9 K/uL (H). The original reporting source was not provided VAERS ID was 453343. Additional information is not requested.
Age: 0.3
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Ultrasound abdomen, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 months old male patient with a history of premature birth, hypoglycemia at birth, Gastrooesophageal reflux disease (GERD) and apparent life-threatening event (ALTE) who was vaccinated orally with the first dose of ROTATEQ (Lot# 0680AA) on 27-MAR-2012. No other co-suspects were reported. Concomitant medications included: ACTHIB (lot# UH522AA) which was vaccinated IM on the left leg on 27-MAR-2012. On 31-MAR-2012 the patient presented with abdominal pain, crying, vomiting, lethargy, refusing to eat, sleepiness, black stool, decreased activity and was admitted. The patient developed diarrhea in ER. X-ray of abdomen and abdominal ultrasound (US) were performed. Air enema abnormal was noted on US and right upper quadrant intussusception was diagnosed. The patient was treated with successful air enema reduction. Other Lab tests included: Hemoccult (+), WBC 18.8 K/uL (H), neutro 72% & 13.5 K/uL (H), lymphs 16.9% (L), monos 10% & 1.9 K/uL (H). The original reporting source was not provided VAERS ID was 453343. Additional information is not requested.
Age: 0.3
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Crying, Decreased activity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 months old male patient with a history of premature birth, hypoglycemia at birth, Gastrooesophageal reflux disease (GERD) and apparent life-threatening event (ALTE) who was vaccinated orally with the first dose of ROTATEQ (Lot# 0680AA) on 27-MAR-2012. No other co-suspects were reported. Concomitant medications included: ACTHIB (lot# UH522AA) which was vaccinated IM on the left leg on 27-MAR-2012. On 31-MAR-2012 the patient presented with abdominal pain, crying, vomiting, lethargy, refusing to eat, sleepiness, black stool, decreased activity and was admitted. The patient developed diarrhea in ER. X-ray of abdomen and abdominal ultrasound (US) were performed. Air enema abnormal was noted on US and right upper quadrant intussusception was diagnosed. The patient was treated with successful air enema reduction. Other Lab tests included: Hemoccult (+), WBC 18.8 K/uL (H), neutro 72% & 13.5 K/uL (H), lymphs 16.9% (L), monos 10% & 1.9 K/uL (H). The original reporting source was not provided VAERS ID was 453343. Additional information is not requested.
Age: 0.3
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Diarrhoea, Diet refusal, Enema administration, Faeces discoloured, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 months old male patient with a history of premature birth, hypoglycemia at birth, Gastrooesophageal reflux disease (GERD) and apparent life-threatening event (ALTE) who was vaccinated orally with the first dose of ROTATEQ (Lot# 0680AA) on 27-MAR-2012. No other co-suspects were reported. Concomitant medications included: ACTHIB (lot# UH522AA) which was vaccinated IM on the left leg on 27-MAR-2012. On 31-MAR-2012 the patient presented with abdominal pain, crying, vomiting, lethargy, refusing to eat, sleepiness, black stool, decreased activity and was admitted. The patient developed diarrhea in ER. X-ray of abdomen and abdominal ultrasound (US) were performed. Air enema abnormal was noted on US and right upper quadrant intussusception was diagnosed. The patient was treated with successful air enema reduction. Other Lab tests included: Hemoccult (+), WBC 18.8 K/uL (H), neutro 72% & 13.5 K/uL (H), lymphs 16.9% (L), monos 10% & 1.9 K/uL (H). The original reporting source was not provided VAERS ID was 453343. Additional information is not requested.
Age: 0.3
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Lethargy, Lymphoblast count, Monoblast count increased, Monocyte percentage increased, Neutrophil count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 months old male patient with a history of premature birth, hypoglycemia at birth, Gastrooesophageal reflux disease (GERD) and apparent life-threatening event (ALTE) who was vaccinated orally with the first dose of ROTATEQ (Lot# 0680AA) on 27-MAR-2012. No other co-suspects were reported. Concomitant medications included: ACTHIB (lot# UH522AA) which was vaccinated IM on the left leg on 27-MAR-2012. On 31-MAR-2012 the patient presented with abdominal pain, crying, vomiting, lethargy, refusing to eat, sleepiness, black stool, decreased activity and was admitted. The patient developed diarrhea in ER. X-ray of abdomen and abdominal ultrasound (US) were performed. Air enema abnormal was noted on US and right upper quadrant intussusception was diagnosed. The patient was treated with successful air enema reduction. Other Lab tests included: Hemoccult (+), WBC 18.8 K/uL (H), neutro 72% & 13.5 K/uL (H), lymphs 16.9% (L), monos 10% & 1.9 K/uL (H). The original reporting source was not provided VAERS ID was 453343. Additional information is not requested.
Age: 0.3
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Neutrophil percentage increased, Occult blood positive, Somnolence, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 months old male patient with a history of premature birth, hypoglycemia at birth, Gastrooesophageal reflux disease (GERD) and apparent life-threatening event (ALTE) who was vaccinated orally with the first dose of ROTATEQ (Lot# 0680AA) on 27-MAR-2012. No other co-suspects were reported. Concomitant medications included: ACTHIB (lot# UH522AA) which was vaccinated IM on the left leg on 27-MAR-2012. On 31-MAR-2012 the patient presented with abdominal pain, crying, vomiting, lethargy, refusing to eat, sleepiness, black stool, decreased activity and was admitted. The patient developed diarrhea in ER. X-ray of abdomen and abdominal ultrasound (US) were performed. Air enema abnormal was noted on US and right upper quadrant intussusception was diagnosed. The patient was treated with successful air enema reduction. Other Lab tests included: Hemoccult (+), WBC 18.8 K/uL (H), neutro 72% & 13.5 K/uL (H), lymphs 16.9% (L), monos 10% & 1.9 K/uL (H). The original reporting source was not provided VAERS ID was 453343. Additional information is not requested.
Age: 0.3
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: White blood cell count increased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 months old male patient with a history of premature birth, hypoglycemia at birth, Gastrooesophageal reflux disease (GERD) and apparent life-threatening event (ALTE) who was vaccinated orally with the first dose of ROTATEQ (Lot# 0680AA) on 27-MAR-2012. No other co-suspects were reported. Concomitant medications included: ACTHIB (lot# UH522AA) which was vaccinated IM on the left leg on 27-MAR-2012. On 31-MAR-2012 the patient presented with abdominal pain, crying, vomiting, lethargy, refusing to eat, sleepiness, black stool, decreased activity and was admitted. The patient developed diarrhea in ER. X-ray of abdomen and abdominal ultrasound (US) were performed. Air enema abnormal was noted on US and right upper quadrant intussusception was diagnosed. The patient was treated with successful air enema reduction. Other Lab tests included: Hemoccult (+), WBC 18.8 K/uL (H), neutro 72% & 13.5 K/uL (H), lymphs 16.9% (L), monos 10% & 1.9 K/uL (H). The original reporting source was not provided VAERS ID was 453343. Additional information is not requested.
Age: 0.3
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 3 months old male patient with a history of premature birth, hypoglycemia at birth, Gastrooesophageal reflux disease (GERD) and apparent life-threatening event (ALTE) who was vaccinated orally with the first dose of ROTATEQ (Lot# 0680AA) on 27-MAR-2012. No other co-suspects were reported. Concomitant medications included: ACTHIB (lot# UH522AA) which was vaccinated IM on the left leg on 27-MAR-2012. On 31-MAR-2012 the patient presented with abdominal pain, crying, vomiting, lethargy, refusing to eat, sleepiness, black stool, decreased activity and was admitted. The patient developed diarrhea in ER. X-ray of abdomen and abdominal ultrasound (US) were performed. Air enema abnormal was noted on US and right upper quadrant intussusception was diagnosed. The patient was treated with successful air enema reduction. Other Lab tests included: Hemoccult (+), WBC 18.8 K/uL (H), neutro 72% & 13.5 K/uL (H), lymphs 16.9% (L), monos 10% & 1.9 K/uL (H). The original reporting source was not provided VAERS ID was 453343. Additional information is not requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Disturbance in attention, Fatigue, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (671463/1359AA) dose 1 of GARDASIL (dose not reported) on 10-APR-2012. No other co-suspects were reported. Concomitant medications included dose 1 of MENVEO (lot # A10127) IM in the left arm and dose 1 of BOOSTRIX (lot # AC52B073CA) IM in the right arm. There were no other concomitant medications. On 11-APR-2012, the patient developed redness and swelling around entire left upper arm. The patient was tired, unable to concentrate and had bilateral leg pain. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provided for GARDASIL. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 453586-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 12 years old male patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (669795/1317AA) dose 3 of GARDASIL (dose not reported) on 24-APR-2012 at 3:45pm. No other co-suspects and no concomitant medications were reported. On 24-APR-2012 at 4:05pm the patient complained of dizziness, 20 min after onset of therapy. The patient was placed in partial Trendelenburg for 5 minutes and this relieved this dizziness. At 4:12pm he was not dizzy, got up and walked well. No treatment information was reported. The relatedness for complained of dizziness was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 455013-1. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 years old female patient who on 22-JUN-2011 was vaccinated IM in the right arm with the first dose of GARDASIL (lot # not provided). On 22-AUG-2011, the patient was vaccinated with the second dose of GARDASIL (lot # not provided) and on 14-DEC-2011, the patient was vaccinated with the third dose of GARDASIL (lot # not provided). Concomitant therapy included DEPO-PROVERA. It was reported that on 14-DEC-2011, the patient had her first ever abnormal pap smear. All prior paps were normal. The patient had no sexual contact over course of vaccines. At the time of the report, the patient's outcome was unknown. This report was considered non serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 455203-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Abdominal pain, Headache, Musculoskeletal stiffness, Pain, Vomiting
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient with no previous illness who was vaccinated IM in the left arm with the first dose of GARDASIL (lot # 671994/1537AA, exp 21-JUN-2014). Concomitant vaccines given on the same day included the sixth dose of ADACEL (lot# U3874BA) given IM and the first dose of MENVEO (lot# M10047) given IM. It was reported that on 11-MAY-2012, the patient complained of vomiting, severe headache, body aches, body stiffness and abdominal cramping. The patient's outcome was unknown. The patient sought medical attention. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 455398-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old male patient on 09-MAY-2012, was vaccinated IM in the right arm with the third dose of GARDASIL (lot# 672232/1495AA, exp 22-AUG-2014). It was reported that on 10-MAY-2012, the patient developed swelling, itching, redness, hardness, and hot to touch around injection site. The area of reaction measured 90mm wide and 90 mm in length. This report was considered non serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 455402-1. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Joint swelling, Oedema peripheral
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old male patient with amoxicillin allergy and no pre-existing illness on 31-JAN-2012, was intramuscularly vaccinated in the left arm with the first dose of GARDASIL (lot# 672193/1524AA, exp 23-AUG-2014). It was reported that on 14-FEB-2012, the patient experienced painless swelling of left hand and wrist. Evaluation in process as symptoms persisted. Negative orthopedic, vascular and rheumatology evaluations. The patient would be seen for possible lymphedema. At the time of the report, the patient's outcome was unknown. This report was considered non serious with no conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 455479-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with no medical history and no pre-existing illness on an unspecified date was vaccinated IM in the left arm with the first dose of GARDASIL (lot# 671463/1359AA, exp 23-JUN-2014). Concomitant vaccine included the third dose of MENACTRA (lot# U4073BA). It was reported that on an unspecified date, the patient was given both vaccines at the end of her annual well visit, the patient was waiting the standard 15 minutes, and then broke out in several large hives on her face and trunk. BENADRYL was given and symptoms relieved. At the time of the report, the patient's outcome was unknown. This report was considered non serious with no conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 455532-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient on 09-MAY-2012, was vaccinated IM in the right arm with the third dose of GARDASIL (lot# 671994/1537AA, exp 21-JUN-2014). Concomitant vaccine given on the same day included the second dose of HAVRIX (lot# AHAVB539CA) given IM in the left arm. On 11-MAY-2012, the patient's mother called stated that her son's right deltoid was red, swollen, painful and hot to touch. The patient's mother stated that (cc) was pruritus. The mother gave ibuprofen, ice pack and BENADRYL cream. The patient's mother was advised to seek medical attention if worsens. Patient's outcome was unknown. This report was considered non serious with no conditions by the Agency. The original reporting source was not provided. The VAERS ID# is 455579-1. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TYP, YF, HEPA, HPV4, MNQ, TYP, YF
Symptoms: Flushing, Laboratory test normal, Muscle twitching, Musculoskeletal stiffness, Pallor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 years old female patient with no previous illness and no medical history who on 14-MAY-2012, was vaccinated IM in the right arm with the second dose of GARDASIL (lot# 671994/1537AA, exp 21-JUN-2012). Concomitant vaccines given on the same day included the first dose of TYPHIM VI (lot# G11241) given IM in the left arm, the second dose of HAVRIX (lot# AHAVB550AA) given IM in the right arm, the first dose of YF-VAX (lot# UH276AA) given SQ in the left arm and the second dose of MENVEO (lot# M10031) given IM in the left arm and desogestrel, APRI. It was reported that on 14-MAY-2012, the patient's face color turned pale, nonresponsive, her upper body stiffened and her right hand twitched. The registered nurse applied smelling salts to nasal area and the patient was responsive post-3 seconds. The face became flushed. Post 10 seconds the patient's face became pale, and the patient was again nonresponsive, her entire body stiffened and upper and lower body in seizure posturing position. It was applied smelling salts and the patient was responsive port 7 seconds. The face flushed once again. The patient stated "I do not know what happened but I think I just wet my pants". The patient lost urinary control during seizure and urinated on self. The patient was observed for 30 minutes. The registered nurse effected to contact family member but the patient declined. Once the patient was stable escorted the patient out of immunization room and the patient insistent on ambulating out of building by self. The patient again declined registered nurse repeated offer to contact emergency contact. On 14-MAY-2012 the patient went to emergency room and the patient had "several test" done per her primary physician's recommendations. Results came back normal. This report was considered non serious by the Agency. The original reporting source was not provided. The VAERS ID# is 455606-1. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TYP, YF, HEPA, HPV4, MNQ, TYP, YF
Symptoms: Posture abnormal, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 years old female patient with no previous illness and no medical history who on 14-MAY-2012, was vaccinated IM in the right arm with the second dose of GARDASIL (lot# 671994/1537AA, exp 21-JUN-2012). Concomitant vaccines given on the same day included the first dose of TYPHIM VI (lot# G11241) given IM in the left arm, the second dose of HAVRIX (lot# AHAVB550AA) given IM in the right arm, the first dose of YF-VAX (lot# UH276AA) given SQ in the left arm and the second dose of MENVEO (lot# M10031) given IM in the left arm and desogestrel, APRI. It was reported that on 14-MAY-2012, the patient's face color turned pale, nonresponsive, her upper body stiffened and her right hand twitched. The registered nurse applied smelling salts to nasal area and the patient was responsive post-3 seconds. The face became flushed. Post 10 seconds the patient's face became pale, and the patient was again nonresponsive, her entire body stiffened and upper and lower body in seizure posturing position. It was applied smelling salts and the patient was responsive port 7 seconds. The face flushed once again. The patient stated "I do not know what happened but I think I just wet my pants". The patient lost urinary control during seizure and urinated on self. The patient was observed for 30 minutes. The registered nurse effected to contact family member but the patient declined. Once the patient was stable escorted the patient out of immunization room and the patient insistent on ambulating out of building by self. The patient again declined registered nurse repeated offer to contact emergency contact. On 14-MAY-2012 the patient went to emergency room and the patient had "several test" done per her primary physician's recommendations. Results came back normal. This report was considered non serious by the Agency. The original reporting source was not provided. The VAERS ID# is 455606-1. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TYP, YF, HEPA, HPV4, MNQ, TYP, YF
Symptoms: Convulsion, Flushing, Laboratory test normal, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 18 years old female patient with no previous illness and no medical history who on 14-MAY-2012, was vaccinated IM in the right arm with the second dose of GARDASIL (lot# 671994/1537AA, exp 21-JUN-2012). Concomitant vaccines given on the same day included the first dose of TYPHIM VI (lot# G11241) given IM in the left arm, the second dose of HAVRIX (lot# AHAVB550AA) given IM in the right arm, the first dose of YF-VAX (lot# UH276AA) given SQ in the left arm and the second dose of MENVEO (lot# M10031) given IM in the left arm and desogestrel, APRI. It was reported that on 14-MAY-2012, the patient's face color turned pale, nonresponsive, her upper body stiffened and her right hand twitched. The registered nurse applied smelling salts to nasal area and the patient was responsive post-3 seconds. The face became flushed. Post 10 seconds the patient's face became pale, and the patient was again nonresponsive, her entire body stiffened and upper and lower body in seizure posturing position. It was applied smelling salts and the patient was responsive port 7 seconds. The face flushed once again. The patient stated "I do not know what happened but I think I just wet my pants". The patient lost urinary control during seizure and urinated on self. The patient was observed for 30 minutes. The registered nurse effected to contact family member but the patient declined. Once the patient was stable escorted the patient out of immunization room and the patient insistent on ambulating out of building by self. The patient again declined registered nurse repeated offer to contact emergency contact. On 14-MAY-2012 the patient went to emergency room and the patient had "several test" done per her primary physician's recommendations. Results came back normal. This report was considered non serious by the Agency. The original reporting source was not provided. The VAERS ID# is 455606-1. Additional information is not expected.