chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Nausea, Neutrophil percentage increased, Protein total increased, Retching, Ultrasound abdomen abnormal
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 17 years old with history of obesity and no known allergies was vaccinated into left arm with lot # (672233/1561AA) dose 2 GARDASIL on 16-APR-2012. No other co-suspects were reported. The patient was also vaccinated into left arm with lot # (U4237AA) dose 2 MENACTRA. Appendicitis developed the morning after vaccination requiring appendectomy on 17-APR-2012. The following information was obtained through follow-up and/or by the government on 29-MAY-2012. Hospital records date of service on 17-APR-2012 - 18-APR-2012. Diagnosis: acute non-perforated appendicitis. Concurrent condition: Right Lower Quadrant abdominal pain; diarrhea; headache; nausea; dry heaves. Admitted and underwent laparoscopic appendectomy. Discharge in stable condition to follow up with surgery. Labs/diagnostics: Ultrasound abdomen: findings concerning for acute appendicitis. Urine ketone body: 15 mg/dL (H), White blood cells urine 5-10/hpf (H). White blood cell count 9.6 K/mm3 (N), Neutrophil count 81% (H), Lymphocyte count 12% (L). Tot protein 9.6 g/dL (H), total bilirubin 2.3 mg/dL (H), Aspartate aminotransferase 82 u/l (H), amylase 160 u/L (H). The original reporting source was not provided. The VAERS ID # is 453946-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Urine ketone body present, White blood cell count normal, White blood cells urine positive
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 17 years old with history of obesity and no known allergies was vaccinated into left arm with lot # (672233/1561AA) dose 2 GARDASIL on 16-APR-2012. No other co-suspects were reported. The patient was also vaccinated into left arm with lot # (U4237AA) dose 2 MENACTRA. Appendicitis developed the morning after vaccination requiring appendectomy on 17-APR-2012. The following information was obtained through follow-up and/or by the government on 29-MAY-2012. Hospital records date of service on 17-APR-2012 - 18-APR-2012. Diagnosis: acute non-perforated appendicitis. Concurrent condition: Right Lower Quadrant abdominal pain; diarrhea; headache; nausea; dry heaves. Admitted and underwent laparoscopic appendectomy. Discharge in stable condition to follow up with surgery. Labs/diagnostics: Ultrasound abdomen: findings concerning for acute appendicitis. Urine ketone body: 15 mg/dL (H), White blood cells urine 5-10/hpf (H). White blood cell count 9.6 K/mm3 (N), Neutrophil count 81% (H), Lymphocyte count 12% (L). Tot protein 9.6 g/dL (H), total bilirubin 2.3 mg/dL (H), Aspartate aminotransferase 82 u/l (H), amylase 160 u/L (H). The original reporting source was not provided. The VAERS ID # is 453946-1. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dyspnoea, Full blood count normal, Metabolic function test normal, Vision blurred
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 16 years old female patient with preexisting illness of whitehead or daughter nipple (it) breast was vaccinated with lot # (670050/1229AA) dose 1 GARDASIL into left arm on 22-FEB-2012. No other co-suspects were reported. Concomitant medications included: dose 1 of HAVRIX (lot # AHAVB539CA) into left arm on 22-FEB-2012. On 13-MAR-2012 the patient experienced hard to breath, 21 days after onset of therapy and vision is foggy but she can still see. No treatment information was reported. The lab date included: Electrocardiogram (EKG) and chest x-ray (CXR) pending, Full blood count (CBC) and Complete Metabolic Panel (CMP) normal, Thyroid-stimulating hormone (TSH) and Triiodothyronine (T3) pending. The outcome of the events is unknown. The relatedness for the events is unknown for GARDASIL. The original reporting source was not provided. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Antibody test negative, Blood glucose normal, Chest X-ray, Culture negative, Dehydration
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 14 years old female patient was vaccinated with a dose of GARDASIL (lot # 660393/0067X) on 23-DEC-2008. No other co-suspects were reported. The patient was also vaccinated with a dose of MENACTRA (lot # U2729AA) on 23-DEC-2008. The patient's medical history was not reported. On 06-OCT-2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine hydrochloride and EPI drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06-OCT-2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13-OCT-2011. The outcome was reported as recovered. Initial report received from a health care professional on 12-APR-2012. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Full blood count normal, Gram stain negative, Headache, Hypotension, Intensive care
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 14 years old female patient was vaccinated with a dose of GARDASIL (lot # 660393/0067X) on 23-DEC-2008. No other co-suspects were reported. The patient was also vaccinated with a dose of MENACTRA (lot # U2729AA) on 23-DEC-2008. The patient's medical history was not reported. On 06-OCT-2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine hydrochloride and EPI drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06-OCT-2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13-OCT-2011. The outcome was reported as recovered. Initial report received from a health care professional on 12-APR-2012. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Lumbar puncture normal, Meningococcal infection, Protein total decreased, Pyrexia, Rash erythematous
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 14 years old female patient was vaccinated with a dose of GARDASIL (lot # 660393/0067X) on 23-DEC-2008. No other co-suspects were reported. The patient was also vaccinated with a dose of MENACTRA (lot # U2729AA) on 23-DEC-2008. The patient's medical history was not reported. On 06-OCT-2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine hydrochloride and EPI drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06-OCT-2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13-OCT-2011. The outcome was reported as recovered. Initial report received from a health care professional on 12-APR-2012. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Rash generalised, Vomiting, 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 14 years old female patient was vaccinated with a dose of GARDASIL (lot # 660393/0067X) on 23-DEC-2008. No other co-suspects were reported. The patient was also vaccinated with a dose of MENACTRA (lot # U2729AA) on 23-DEC-2008. The patient's medical history was not reported. On 06-OCT-2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine hydrochloride and EPI drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06-OCT-2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13-OCT-2011. The outcome was reported as recovered. Initial report received from a health care professional on 12-APR-2012. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Laboratory test normal, Lumbar puncture normal, Meningococcal bacteraemia, Protein total increased, Pyrexia
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 14 years old female patient was vaccinated with a dose of GARDASIL (lot # 660393/0067X) on 23-DEC-2008. No other co-suspects were reported. The patient was also vaccinated with a dose of MENACTRA (lot # U2729AA) on 23-DEC-2008. The patient's medical history was not reported. On 06-OCT-2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine hydrochloride and EPI drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06-OCT-2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13-OCT-2011. The outcome was reported as recovered. Initial report received from a health care professional on 12-APR-2012. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Rash erythematous, Rash generalised, Vomiting, 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 14 years old female patient was vaccinated with a dose of GARDASIL (lot # 660393/0067X) on 23-DEC-2008. No other co-suspects were reported. The patient was also vaccinated with a dose of MENACTRA (lot # U2729AA) on 23-DEC-2008. The patient's medical history was not reported. On 06-OCT-2011 the patient went to the Emergency Department (ED) with a fever, headache, vomiting and raised red rash which was generalized. The patient was treated with dopamine hydrochloride and EPI drip for hypotension and dehydration, post fluid challenge. She was admitted to the hospital intensive care unit (ICU) on 06-OCT-2011 and started on vancomycin one gram every six hours and ROCEPHIN two grams every 12 hours. The patient was diagnosed with meningococcemia Y-strain. Her laboratory and diagnostic testing was as follows: Complete blood count (CBC), cultures, lumbar puncture and gram stain were negative. The patient had a white blood cell (WBC) count of 33.8, glucose of 79, protein of 27 and a chest x-ray (result not reported). Her meningococcal vaccine titers were negative and found to be zero. She was discharged from the hospital on 13-OCT-2011. The outcome was reported as recovered. Initial report received from a health care professional on 12-APR-2012. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Oedema peripheral, Pruritus
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 14 year old female patient with no medical history and no pre-existing illness was vaccinated intramuscularly with a third dose of GARDASIL (Lot # 672232/1495AA) in her right arm on 16-APR-2012. Suspect therapy included a first dose of MENVEO (Lot # M00544) vaccinated intramuscularly in left arm. On 16-APR-2012 the patient experienced arm itching when walking to car. Subsequently her arm was swollen size of softball. Final outcome was not reported. The original reporting source was not provided. The VAERS ID # is 454401-1. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
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 13 year old female patient with allergies and with no medical history was vaccinated intramuscularly with a first dose of GARDASIL (Lot# 671994/1537AA) in her right arm on 17-Apr-2012. Suspect therapy included a second dose of VAQTA (Lot# 671517/1068AA) and a first dose of ADACEL (Lot# C3899AA) vaccinated intramuscularly in left arm. Concomitant therapy included VYVANSE. On 19-APR-2012 the patient developed 1 1/2- 2" indurated hot, red, tender and pruritic area at site of ADACEL. On 20-APR-2012 there was much smaller, less tender, less red and smaller area of induration with BENADRYL only. The patient's mother had given her BENADRYL, which was changed to loratadine. The original reporting source was not provided. The VAERS ID# is 454435-1. No further information is available.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, HEPA, HPV4, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
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 13 year old female patient with allergies and with no medical history was vaccinated intramuscularly with a first dose of GARDASIL (Lot# 671994/1537AA) in her right arm on 17-Apr-2012. Suspect therapy included a second dose of VAQTA (Lot# 671517/1068AA) and a first dose of ADACEL (Lot# C3899AA) vaccinated intramuscularly in left arm. Concomitant therapy included VYVANSE. On 19-APR-2012 the patient developed 1 1/2- 2" indurated hot, red, tender and pruritic area at site of ADACEL. On 20-APR-2012 there was much smaller, less tender, less red and smaller area of induration with BENADRYL only. The patient's mother had given her BENADRYL, which was changed to loratadine. The original reporting source was not provided. The VAERS ID# is 454435-1. No further information is available.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Blindness, Dark circles under eyes, Hyperhidrosis, Hypoaesthesia, Pallor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient of with no previous illness and no medical history who was vaccinated with a first dose of GARDASIL, (lot # 670048/0963AA), Left arm, IM, a first dose of BOOSTRIX (Batch # AC52B078BA), Right arm, IM and a first dose of MENACTRA, Left arm, IM (Batch # 010054) on 30-APR-2012. There were no other concomitant meds included. It was reported that on 30-APR-2012, the patient sudden loss vision (medically significant, upon internal review) "seeing dark circles", not being able to feel legs and hands, within seconds of vaccine administration. It was mentioned that the patient was diaphoretic, pale and trembling 3-5 minutes after the vaccination. It was also mentioned patient being able to see clear without problem and also able to feel legs and hands,  except for some numbness on Right Leg, the vital symptoms were monitored for 30-40 min, patient was taken to family doctor. The outcome of sudden loss of vision, patient pale 3-5 minutes after vaccination, patient diaphoretic and patient was trembling 3-5 minutes after vaccination 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 454763-1. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Sensory loss, Tremor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient of with no previous illness and no medical history who was vaccinated with a first dose of GARDASIL, (lot # 670048/0963AA), Left arm, IM, a first dose of BOOSTRIX (Batch # AC52B078BA), Right arm, IM and a first dose of MENACTRA, Left arm, IM (Batch # 010054) on 30-APR-2012. There were no other concomitant meds included. It was reported that on 30-APR-2012, the patient sudden loss vision (medically significant, upon internal review) "seeing dark circles", not being able to feel legs and hands, within seconds of vaccine administration. It was mentioned that the patient was diaphoretic, pale and trembling 3-5 minutes after the vaccination. It was also mentioned patient being able to see clear without problem and also able to feel legs and hands,  except for some numbness on Right Leg, the vital symptoms were monitored for 30-40 min, patient was taken to family doctor. The outcome of sudden loss of vision, patient pale 3-5 minutes after vaccination, patient diaphoretic and patient was trembling 3-5 minutes after vaccination 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 454763-1. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Hyperhidrosis, Hypoaesthesia, Immediate post-injection reaction, Pallor, Sensory loss
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient of with no previous illness and no medical history who was vaccinated with a first dose of GARDASIL, (lot # 670048/0963AA), Left arm, IM, a first dose of BOOSTRIX (Batch # AC52B078BA), Right arm, IM and a first dose of MENACTRA, Left arm, IM (Batch # 010054) on 30-APR-2012. There were no other concomitant meds included. It was reported that on 30-APR-2012, the patient sudden loss vision (medically significant, upon internal review) "seeing dark circles", not being able to feel legs and hands, within seconds of vaccine administration. It was mentioned that the patient was diaphoretic, pale and trembling 3-5 minutes after the vaccination. It was also mentioned patient being able to see clear without problem and also able to feel legs and hands,  except for some numbness on Right Leg, the vital symptoms were monitored for 30-40 min, patient was taken to family doctor. The outcome of sudden loss of vision, patient pale 3-5 minutes after vaccination, patient diaphoretic and patient was trembling 3-5 minutes after vaccination 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 454763-1. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Sudden visual loss, Tremor, Visual impairment
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient of with no previous illness and no medical history who was vaccinated with a first dose of GARDASIL, (lot # 670048/0963AA), Left arm, IM, a first dose of BOOSTRIX (Batch # AC52B078BA), Right arm, IM and a first dose of MENACTRA, Left arm, IM (Batch # 010054) on 30-APR-2012. There were no other concomitant meds included. It was reported that on 30-APR-2012, the patient sudden loss vision (medically significant, upon internal review) "seeing dark circles", not being able to feel legs and hands, within seconds of vaccine administration. It was mentioned that the patient was diaphoretic, pale and trembling 3-5 minutes after the vaccination. It was also mentioned patient being able to see clear without problem and also able to feel legs and hands,  except for some numbness on Right Leg, the vital symptoms were monitored for 30-40 min, patient was taken to family doctor. The outcome of sudden loss of vision, patient pale 3-5 minutes after vaccination, patient diaphoretic and patient was trembling 3-5 minutes after vaccination 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 454763-1. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
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. This spontaneous report as received from a regulatory authority refers to a 11 years old male patient with rhinitis, ADHD, asthma, and bipolar. The patient's medical history included insect bite and cough. The patient was vaccinated with dose 1 GARDASIL on 01-MAY-2012. Other suspect therapies included BOOSTRIX with dosage information as (UNK) on 01-MAY-2012, MENACTRA on 01-MAY-2012 and BACTRIM. Concomitant medications included DAYTRANA, BROVEX and LEXAPRO. On 02-MAY-2012 the patient experienced injection site erythema, 2 days after onset of therapy, injection site swelling and injection site induration. No treatment information was reported. The outcome of injection site erythema, injection site swelling and injection site induration is unknown. The relatedness for injection site erythema, injection site swelling and injection site induration is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: This report was identified from line listing 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. The patient was vaccinated with 3 dose GARDASIL on 02-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-MAY-2012 the patient experienced dizziness, 1 day after onset of therapy, pyrexia and headache. No treatment information was reported. The outcome of dizziness, pyrexia and headache is unknown. The relatedness for dizziness, pyrexia and headache is unknown for GARDASIL. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: 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. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient. The patient was vaccinated with dose 1 GARDASIL on 23-APR-2012. No other co-suspects were reported. Concomitant medications included: ADACEL. On an unknown date the patient experienced pruritus and rash. No treatment information was reported. The outcome of pruritus and rash was reported as not recovered/not resolved. The relatedness for pruritus and rash is unknown for GARDASIL. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Culture throat, Laboratory test normal, Rash, Rash pruritic, Streptococcus test
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old male patient with asthma and seasonal allergies and no pre-existing illness who on 05-MAY-2012, was vaccinated IM in the left arm with the first dose of GARDASIL (lot# 668229/1569Z, exp 05-APR-2013). Secondary suspect vaccine given on the same day included the second dose of VAQTA (lot# 672220/1416AA, exp 05-AUG-2014) given IM in the right arm. There was no concomitant medication. It was reported that on 05-MAY-2012, the patient experienced pruritic rash on arms. The rash was not on the trunk. The rash was developed within 2 hours of receiving the vaccines. The patient was given 7.5 ml of diphenhydramine in office. The patient went to the emergency room. A throat culture was sent for a rapid strep test and it was negative. This report was considered non serious with by the Agency. The original reporting source was not provided. The VAERS ID# is 455235-1. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Culture throat negative, Rash, Rash pruritic, Streptococcus test
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old male patient with asthma and seasonal allergies and no pre-existing illness who on 05-MAY-2012, was vaccinated IM in the left arm with the first dose of GARDASIL (lot# 668229/1569Z, exp 05-APR-2013). Secondary suspect vaccine given on the same day included the second dose of VAQTA (lot# 672220/1416AA, exp 05-AUG-2014) given IM in the right arm. There was no concomitant medication. It was reported that on 05-MAY-2012, the patient experienced pruritic rash on arms. The rash was not on the trunk. The rash was developed within 2 hours of receiving the vaccines. The patient was given 7.5 ml of diphenhydramine in office. The patient went to the emergency room. A throat culture was sent for a rapid strep test and it was negative. This report was considered non serious with by the Agency. The original reporting source was not provided. The VAERS ID# is 455235-1. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Nerve block
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pre-existing illness and no medical history who on 19-AUG-2011, was vaccinated IM in the right arm with the first dose of GARDASIL (lot# 669308/0636AA, exp 11-AUG-2013). There was no concomitant therapy. It was reported that on 14-SEP-2011,  the patient experienced headache and obesity. The patient complained 5 days of headaches, pounding, pressure, throughout head. Since October/November, the patient was having two headaches weekly and it was controllable with OTC medicines. Starting December, the patient was waking daily with headaches and was not responding well to OTC medicines. The patient tried massages, vitamin/herbal supplements and OTC analgesics. An ophthalmologist prescribed to the patient reading glasses with minimal relief. Headaches became severe in March with sensitive to noise, neck pain, photophobia, ringing in ears, difficulty sleeping, unable to participate in routine activities, fatigue and decreased activity. Physical examination determined headache and pedal edema. The patient was admitted to hospital for treatment for intracranial hypertension and intractable headache. Psych consult within normal limits. The patient was transferred for higher level care. The patient had relieved after getting steroid nerve block in back of head. The patient went back within 3 days and had them ever since. The patient had constant severe daily headaches. Lab/diagnostic records included: Magnetic Resonance Imaging (MRI) brain: 3 cm adnexal cyst, Computerised tomogram head (CAT scan) within normal limits,  urine pregnancy test negative, CSF: Red blood cell 2 (H), Herpes simplex test (HSV) negative, Varicella Zoster virus (VZV) negative, enterovirus negative and blood culture negative. The patient's outcome was unknown. This report was considered serious by the Agency because the events caused hospitalization. The original reporting source was not provided. The VAERS ID# is 455308-1. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Blood culture negative, Cerebral cyst, Computerised tomogram head normal, Decreased activity
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pre-existing illness and no medical history who on 19-AUG-2011, was vaccinated IM in the right arm with the first dose of GARDASIL (lot# 669308/0636AA, exp 11-AUG-2013). There was no concomitant therapy. It was reported that on 14-SEP-2011,  the patient experienced headache and obesity. The patient complained 5 days of headaches, pounding, pressure, throughout head. Since October/November, the patient was having two headaches weekly and it was controllable with OTC medicines. Starting December, the patient was waking daily with headaches and was not responding well to OTC medicines. The patient tried massages, vitamin/herbal supplements and OTC analgesics. An ophthalmologist prescribed to the patient reading glasses with minimal relief. Headaches became severe in March with sensitive to noise, neck pain, photophobia, ringing in ears, difficulty sleeping, unable to participate in routine activities, fatigue and decreased activity. Physical examination determined headache and pedal edema. The patient was admitted to hospital for treatment for intracranial hypertension and intractable headache. Psych consult within normal limits. The patient was transferred for higher level care. The patient had relieved after getting steroid nerve block in back of head. The patient went back within 3 days and had them ever since. The patient had constant severe daily headaches. Lab/diagnostic records included: Magnetic Resonance Imaging (MRI) brain: 3 cm adnexal cyst, Computerised tomogram head (CAT scan) within normal limits,  urine pregnancy test negative, CSF: Red blood cell 2 (H), Herpes simplex test (HSV) negative, Varicella Zoster virus (VZV) negative, enterovirus negative and blood culture negative. The patient's outcome was unknown. This report was considered serious by the Agency because the events caused hospitalization. The original reporting source was not provided. The VAERS ID# is 455308-1. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Enterovirus test negative, Fatigue, Headache, Herpes simplex serology negative, Hyperacusis
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pre-existing illness and no medical history who on 19-AUG-2011, was vaccinated IM in the right arm with the first dose of GARDASIL (lot# 669308/0636AA, exp 11-AUG-2013). There was no concomitant therapy. It was reported that on 14-SEP-2011,  the patient experienced headache and obesity. The patient complained 5 days of headaches, pounding, pressure, throughout head. Since October/November, the patient was having two headaches weekly and it was controllable with OTC medicines. Starting December, the patient was waking daily with headaches and was not responding well to OTC medicines. The patient tried massages, vitamin/herbal supplements and OTC analgesics. An ophthalmologist prescribed to the patient reading glasses with minimal relief. Headaches became severe in March with sensitive to noise, neck pain, photophobia, ringing in ears, difficulty sleeping, unable to participate in routine activities, fatigue and decreased activity. Physical examination determined headache and pedal edema. The patient was admitted to hospital for treatment for intracranial hypertension and intractable headache. Psych consult within normal limits. The patient was transferred for higher level care. The patient had relieved after getting steroid nerve block in back of head. The patient went back within 3 days and had them ever since. The patient had constant severe daily headaches. Lab/diagnostic records included: Magnetic Resonance Imaging (MRI) brain: 3 cm adnexal cyst, Computerised tomogram head (CAT scan) within normal limits,  urine pregnancy test negative, CSF: Red blood cell 2 (H), Herpes simplex test (HSV) negative, Varicella Zoster virus (VZV) negative, enterovirus negative and blood culture negative. The patient's outcome was unknown. This report was considered serious by the Agency because the events caused hospitalization. The original reporting source was not provided. The VAERS ID# is 455308-1. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Insomnia, Intracranial pressure increased, Neck pain, Nerve block, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pre-existing illness and no medical history who on 19-AUG-2011, was vaccinated IM in the right arm with the first dose of GARDASIL (lot# 669308/0636AA, exp 11-AUG-2013). There was no concomitant therapy. It was reported that on 14-SEP-2011,  the patient experienced headache and obesity. The patient complained 5 days of headaches, pounding, pressure, throughout head. Since October/November, the patient was having two headaches weekly and it was controllable with OTC medicines. Starting December, the patient was waking daily with headaches and was not responding well to OTC medicines. The patient tried massages, vitamin/herbal supplements and OTC analgesics. An ophthalmologist prescribed to the patient reading glasses with minimal relief. Headaches became severe in March with sensitive to noise, neck pain, photophobia, ringing in ears, difficulty sleeping, unable to participate in routine activities, fatigue and decreased activity. Physical examination determined headache and pedal edema. The patient was admitted to hospital for treatment for intracranial hypertension and intractable headache. Psych consult within normal limits. The patient was transferred for higher level care. The patient had relieved after getting steroid nerve block in back of head. The patient went back within 3 days and had them ever since. The patient had constant severe daily headaches. Lab/diagnostic records included: Magnetic Resonance Imaging (MRI) brain: 3 cm adnexal cyst, Computerised tomogram head (CAT scan) within normal limits,  urine pregnancy test negative, CSF: Red blood cell 2 (H), Herpes simplex test (HSV) negative, Varicella Zoster virus (VZV) negative, enterovirus negative and blood culture negative. The patient's outcome was unknown. This report was considered serious by the Agency because the events caused hospitalization. The original reporting source was not provided. The VAERS ID# is 455308-1. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Obesity, Oedema peripheral, Pain, Photophobia, Pregnancy test urine negative
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pre-existing illness and no medical history who on 19-AUG-2011, was vaccinated IM in the right arm with the first dose of GARDASIL (lot# 669308/0636AA, exp 11-AUG-2013). There was no concomitant therapy. It was reported that on 14-SEP-2011,  the patient experienced headache and obesity. The patient complained 5 days of headaches, pounding, pressure, throughout head. Since October/November, the patient was having two headaches weekly and it was controllable with OTC medicines. Starting December, the patient was waking daily with headaches and was not responding well to OTC medicines. The patient tried massages, vitamin/herbal supplements and OTC analgesics. An ophthalmologist prescribed to the patient reading glasses with minimal relief. Headaches became severe in March with sensitive to noise, neck pain, photophobia, ringing in ears, difficulty sleeping, unable to participate in routine activities, fatigue and decreased activity. Physical examination determined headache and pedal edema. The patient was admitted to hospital for treatment for intracranial hypertension and intractable headache. Psych consult within normal limits. The patient was transferred for higher level care. The patient had relieved after getting steroid nerve block in back of head. The patient went back within 3 days and had them ever since. The patient had constant severe daily headaches. Lab/diagnostic records included: Magnetic Resonance Imaging (MRI) brain: 3 cm adnexal cyst, Computerised tomogram head (CAT scan) within normal limits,  urine pregnancy test negative, CSF: Red blood cell 2 (H), Herpes simplex test (HSV) negative, Varicella Zoster virus (VZV) negative, enterovirus negative and blood culture negative. The patient's outcome was unknown. This report was considered serious by the Agency because the events caused hospitalization. The original reporting source was not provided. The VAERS ID# is 455308-1. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Psychiatric evaluation normal, Red blood cell count decreased, Tinnitus, Varicella virus test negative
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old female patient with no pre-existing illness and no medical history who on 19-AUG-2011, was vaccinated IM in the right arm with the first dose of GARDASIL (lot# 669308/0636AA, exp 11-AUG-2013). There was no concomitant therapy. It was reported that on 14-SEP-2011,  the patient experienced headache and obesity. The patient complained 5 days of headaches, pounding, pressure, throughout head. Since October/November, the patient was having two headaches weekly and it was controllable with OTC medicines. Starting December, the patient was waking daily with headaches and was not responding well to OTC medicines. The patient tried massages, vitamin/herbal supplements and OTC analgesics. An ophthalmologist prescribed to the patient reading glasses with minimal relief. Headaches became severe in March with sensitive to noise, neck pain, photophobia, ringing in ears, difficulty sleeping, unable to participate in routine activities, fatigue and decreased activity. Physical examination determined headache and pedal edema. The patient was admitted to hospital for treatment for intracranial hypertension and intractable headache. Psych consult within normal limits. The patient was transferred for higher level care. The patient had relieved after getting steroid nerve block in back of head. The patient went back within 3 days and had them ever since. The patient had constant severe daily headaches. Lab/diagnostic records included: Magnetic Resonance Imaging (MRI) brain: 3 cm adnexal cyst, Computerised tomogram head (CAT scan) within normal limits,  urine pregnancy test negative, CSF: Red blood cell 2 (H), Herpes simplex test (HSV) negative, Varicella Zoster virus (VZV) negative, enterovirus negative and blood culture negative. The patient's outcome was unknown. This report was considered serious by the Agency because the events caused hospitalization. The original reporting source was not provided. The VAERS ID# is 455308-1. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Fall, Loss of consciousness, Syncope
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 13 years old female patient. The patient was vaccinated intramuscularly in the left arm with lot # (671463/1359AA) dose 1 of GARDASIL (dose not reported) on 09-APR-2012. No other co-suspects were reported. Concomitant medications included: dose 2 of HAVRIX (lot # AHAVB5866A) intramuscularly (dose not reported). It was reported that the patient was sitting on the exam table, the registered nurse who administered the vaccines had her back to the patient while talking with the patient's mother; 1-2 minutes after vaccine was administered also reported as on 19-APR-2012, the patient fainted and fell face first off the exam table. The patient lost consciousness (medically significant upon internal review) for 5-10 seconds, the doctor summoned to the room immediately and the patient was moved to the exam table and examined by the doctor. The outcome of the events was unknown. The relatedness for fainted, fell face first off the exam table and loss consciousness for 5-10 seconds was not provided for GARDASIL. This report was considered no conditions non serious by the agency. The original reporting source was not provided. The VAERS ID# is 455364. No further information is available.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Apnoea, Loss of consciousness, Slow response to stimuli, Unresponsive to stimuli
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 25 year old female patient with no pre-existing illness who on 11-MAY-2012, was vaccinated IM in the left arm with the third dose of GARDASIL (lot# 1668AA, exp 15-AUG-2014). It was reported that on 11-MAY-2012, the patient was observed for 15 minutes after injection. Upon checking out the patient with loss of consciousness (Medically significant, upon internal review). The patient was lowering to ground. She was unresponsive. The patient presented with a short period of apnea, was slow to respond to facial stimuli and smelling salts. The patient was evaluated and transported to the emergency room via ambulance. The patient's outcome was unknown. This report was considered not serious by the Agency. The original reporting source was not provided. The VAERS ID# is 455492-1. Additional information is not expected.
Age: 12.0
Sex: U
Vaccine: HPV4, IPV, MNQ, TDAP, HPV4, IPV, MNQ, TDAP
Symptoms: Haemoglobin normal, Loss of consciousness, Pallor, Posture abnormal
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 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 # (672232/1495AA) dose 1 of GARDASIL (dose not reported) on 10-MAY-2012. No other co-suspects were reported. Concomitant medications included dose 7 of IPOL (lot # G1145), dose 1 of ADACEL (lot # U4103BA) and dose 1 of MENVEO (lot # M10065). On the same day the patient got very pale and head back; loss of consciousness (medically significant upon internal review) but woke up right away. Put head down between legs and doctor came and assisted the patient to the exam table and sat the patient up reverse trendelenburg. At the time of the event the patient also had Hgb 11.3. The patient went home in good spirit walking fine. On 15-MAY-2012 a telephone call was done to the mother and the patient was doing well. There was no signs and symptoms of reaction after event on 10-MAY-2012. No treatment information was reported. The outcome of loss of consciousness, head back and got very pale was recovered. The relatedness for the reported events was not provided for GARDASIL. This report was considered no conditions and non serious by the agency. The original reporting source was not provided. The VAERS ID# is 455649. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Loss of consciousness
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 13 years old female patient with no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly with lot # (665607/1332Y) dose 2 of GARDASIL (dose not reported) on 17-APR-2012. No other co-suspects were reported. Concomitant medications included: PPD. The patient's mother reported that on 17-APR-2012, after the vaccine was administered to the patient she passed out (medically significant upon internal review) while sitting on the exam table. The mother said she caught the patient. The patient was held in the mother's arm on evaluation the patient was alert and stable with no distress. The mother said the patient's arms jerked as when she passed out. No treatment information was reported and no lab diagnostic tests were performed. The outcome of passed out while sitting on the exam table and arms jerked was unknown. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was the patient's mother. The VAERS ID# is 455698. No further information is available.