chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Human chorionic gonadotropin positive, Maternal exposure during pregnancy, Menstruation irregular, Pregnancy test 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 29 year old female patient of unknown age with not pre-existing illnesses, irregular menses, Gastroesophageal reflux disease (GERD), seasonal allergies (self diagnosed), benzoyl peroxide and mint/ginger allergies, family risk factor: Cousin (male; mother's brother's son) with "whole in heart" repaired as an adult with a pertinent medical history/past surgical history of 1 normal vaginal delivery, C-section (due to recent diagnosis of Human papilloma virus (HPV) and Herpes simplex virus (HSVII) without maternal or infant complications, loop electrosurgical excision procedure (LEEP) in October 2009, 1 therapeutic abortion, ovarian cyst drained in 1998 and pyelonephritis who was vaccinated with dose 1 of GARDASIL lot # (668819/0477AA), Left arm (unknown route and dose) on 17-MAR-2012. NO other co-suspects were reported. Concomitant medications included: anthrax vaccine. The patient was in none other medications. On 13-APR-2012 patient was given "TAD" orders off the ship on 13-APR-2012. On 24-APR-2012 a Human chorionic gonadotropin urine hCG (qualitative) was performed which resulted positive. Subsequently, the patient became pregnant with a LMP (light) that was sometime between of 25-FEB-2012 and an EDD of 01-DEC-2012. It was reported that on 12-APR-2012 the patient experienced menstruation irregular, patient used condoms for birth control (not consistently). Patient was demonstrated how to perform a home pregnancy test for a friend which was positive. The patient repeated the home pregnancy test 4 more times which were all positive. Patient contacted the center on 19-APR-2012 and desired pregnancy follow-up. The outcome of the events mentioned above was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID# is 454843-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
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 abnormal thyroid. The patient was vaccinated in the right arm with lot # (672232/1495AA) dose 2 of GARDASIL (dose and route not reported) on 30-APR-2012. Other suspect therapies included dose 2 VARIVAX (Merck) (lot # 1796AA) dose not reported) subcutaneously in the left arm, on 30-APR-2012. No concomitant medications were reported. It was reported that on 30-APR-2012 the patient's left upper arm red, swollen and had fever at injection site. The patient reported having highest temp (oral) at 101.3. The patients mother stated the patient always had fever with vaccinations. The site was 5 1/2 inch x 6 1/2 inch. The patient was given BENADRYL oral every 6 hours. Border margin lines were drawn with marker. The mother was told it should shrink in size, and was advised if it got bigger to call the office back. There was no pain with flexion/extension of elbow or rotation of shoulder. The outcome of fever at injection site, left upper arm red and swollen was unknown. The relatedness for the reported events was not provided for GARDASIL and VARIVAX (Merck). This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 454931-1. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Body temperature increased, Injection site erythema, 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. This spontaneous report as received from a regulatory authority refers to a 12 years old female patient with abnormal thyroid. The patient was vaccinated in the right arm with lot # (672232/1495AA) dose 2 of GARDASIL (dose and route not reported) on 30-APR-2012. Other suspect therapies included dose 2 VARIVAX (Merck) (lot # 1796AA) dose not reported) subcutaneously in the left arm, on 30-APR-2012. No concomitant medications were reported. It was reported that on 30-APR-2012 the patient's left upper arm red, swollen and had fever at injection site. The patient reported having highest temp (oral) at 101.3. The patients mother stated the patient always had fever with vaccinations. The site was 5 1/2 inch x 6 1/2 inch. The patient was given BENADRYL oral every 6 hours. Border margin lines were drawn with marker. The mother was told it should shrink in size, and was advised if it got bigger to call the office back. There was no pain with flexion/extension of elbow or rotation of shoulder. The outcome of fever at injection site, left upper arm red and swollen was unknown. The relatedness for the reported events was not provided for GARDASIL and VARIVAX (Merck). This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 454931-1. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Mass, Pain, Skin warm
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 11 years old female patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated in the right arm with dose 1 of GARDASIL (lot number, dose and route not reported) on 30-APR-2012. Other suspect therapies included dose 2 of VARIVAX (manufacturer unknown) (lot #, dose and route not reported) on 30-APR-2012. Concomitant medications included dose 1 of MENACTRA and dose 1 of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) administered on 30-APR-2012. On 01-MAY-2012 the patient developed a 3 inch x 2 inch lump, very warm to the touch, painful and extremely red. No treatment information was reported. The outcome of the events was unknown. The relatedness for the reported events was not provided for VARIVAX (Merck) and GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 455039-1. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, Incorrect dose administered, 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. An 11 years old female patient with no pre existing illnesses and not pertinent medical history who was vaccinated with an unknown dose of GARDASIL lot # (670048/0963AA), right arm, unknown route and a dose 1 of VAQTA lot # 666550/1537Y, left arm, unknown route and dose on 28-APR-2012. Concomitant medications included first dose of ADACEL, (lot # C3475AA) in the left arm, first dose of, MENACTRA (lot # U4053AA) in the right arm and meningococcal conj vaccine (unspecified). All three concomitants vaccines administered on 28-APR-2012. There was no other concomitant medications. It was reported that on 28-APR-2012 the patient had headaches, dizziness and fever, symptoms began same day a 6:00 pm. Patient was given MCV4 (unspecified) twice same day. The outcome of the events mentioned above was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID is 455054-1. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Headache, 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. An 11 years old female patient with no pre existing illnesses and not pertinent medical history who was vaccinated with an unknown dose of GARDASIL lot # (670048/0963AA), right arm, unknown route and a dose 1 of VAQTA lot # 666550/1537Y, left arm, unknown route and dose on 28-APR-2012. Concomitant medications included first dose of ADACEL, (lot # C3475AA) in the left arm, first dose of, MENACTRA (lot # U4053AA) in the right arm and meningococcal conj vaccine (unspecified). All three concomitants vaccines administered on 28-APR-2012. There was no other concomitant medications. It was reported that on 28-APR-2012 the patient had headaches, dizziness and fever, symptoms began same day a 6:00 pm. Patient was given MCV4 (unspecified) twice same day. The outcome of the events mentioned above was unknown. This report was considered non serious with not conditions by the agency. The original reporting source was not provided. The VAERS ID is 455054-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Morphoea
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 17 years old female patient with migraines, no other medical history, no known drug allergies or pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (672547/1745AA) dose 1 of GARDASIL (dose not reported) on 19-APR-2012. No other co-suspects were reported. Concomitant medications included: dose 2 of MENACTRA (lot # U3906AA) IM in the right arm. The following information was obtained through follow up and/or provided by the government (white spot syndrome MENDS): On 23-APR-2012 the patient was seen and was diagnosed with chorioretinitis of the right eye (OD). The patient's clinical course included declining vision, haziness and darkening of vision in OD; visual field loss OD; blurred vision OD; vision distortion OD. Results of physical exam included: macula abnormal OD with orange foveal medeling; peripheral retina abnormal OD with multiple greyish to white dots deep to the retina; OD not confluent 360 degrees. The patient was treated medically (unspecified). Upon return to the clinic on 30-APR-2012 the patient was diagnosed with disseminated retinitis; chorioretinitis OD. It was stated that the diagnosis was possibly decreasing. The patient's clinical course follow up included occasional ocular headache. The patient returned to the clinic on 07-MAY-2012 and had the same diagnosis. The clinical course included eye pain OD. At the time of the report the conditions were improving with medical management. The relatedness for the reported event 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 455202-1. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Chorioretinitis, Eye pain, Headache, Maculopathy, Metamorphopsia
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 17 years old female patient with migraines, no other medical history, no known drug allergies or pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (672547/1745AA) dose 1 of GARDASIL (dose not reported) on 19-APR-2012. No other co-suspects were reported. Concomitant medications included: dose 2 of MENACTRA (lot # U3906AA) IM in the right arm. The following information was obtained through follow up and/or provided by the government (white spot syndrome MENDS): On 23-APR-2012 the patient was seen and was diagnosed with chorioretinitis of the right eye (OD). The patient's clinical course included declining vision, haziness and darkening of vision in OD; visual field loss OD; blurred vision OD; vision distortion OD. Results of physical exam included: macula abnormal OD with orange foveal medeling; peripheral retina abnormal OD with multiple greyish to white dots deep to the retina; OD not confluent 360 degrees. The patient was treated medically (unspecified). Upon return to the clinic on 30-APR-2012 the patient was diagnosed with disseminated retinitis; chorioretinitis OD. It was stated that the diagnosis was possibly decreasing. The patient's clinical course follow up included occasional ocular headache. The patient returned to the clinic on 07-MAY-2012 and had the same diagnosis. The clinical course included eye pain OD. At the time of the report the conditions were improving with medical management. The relatedness for the reported event 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 455202-1. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Ophthalmological examination abnormal, Vision blurred, Visual acuity reduced, Visual field defect, Visual impairment
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 17 years old female patient with migraines, no other medical history, no known drug allergies or pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (672547/1745AA) dose 1 of GARDASIL (dose not reported) on 19-APR-2012. No other co-suspects were reported. Concomitant medications included: dose 2 of MENACTRA (lot # U3906AA) IM in the right arm. The following information was obtained through follow up and/or provided by the government (white spot syndrome MENDS): On 23-APR-2012 the patient was seen and was diagnosed with chorioretinitis of the right eye (OD). The patient's clinical course included declining vision, haziness and darkening of vision in OD; visual field loss OD; blurred vision OD; vision distortion OD. Results of physical exam included: macula abnormal OD with orange foveal medeling; peripheral retina abnormal OD with multiple greyish to white dots deep to the retina; OD not confluent 360 degrees. The patient was treated medically (unspecified). Upon return to the clinic on 30-APR-2012 the patient was diagnosed with disseminated retinitis; chorioretinitis OD. It was stated that the diagnosis was possibly decreasing. The patient's clinical course follow up included occasional ocular headache. The patient returned to the clinic on 07-MAY-2012 and had the same diagnosis. The clinical course included eye pain OD. At the time of the report the conditions were improving with medical management. The relatedness for the reported event 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 455202-1. No further information is available.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Diarrhoea, Dizziness, Headache, Pyrexia, Tremor
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 year old male patient with sulfonamide allergy, migraines, lupus, attention deficit hyperactivity disorder (ADHD) was vaccinated with dose 1 GARDASIL lot # (672233/1561AA), right arm, IM on 07-MAY-2012. No other co-suspects were reported. Concomitant medications included BOOSTRIX, MENACTRA, TOLECTIN, PLAQUENIL, PRILOSEC, amitriptyline hydrochloride and sumatriptan. It was reported that on 08-MAY-2012 the patient experienced shaking, fever, headache, vomiting, dizziness and diarrhoea. No treatment information was reported. The outcome of events mentioned above was unknown. The patient was seen in the office on 09-MAY-2012. This report was considered not serious and required ER visit by the agency. The original reporting source was not provided. The VAERS ID # is 455324-1. Additional information is not expected.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: 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 17 year old male patient with sulfonamide allergy, migraines, lupus, attention deficit hyperactivity disorder (ADHD) was vaccinated with dose 1 GARDASIL lot # (672233/1561AA), right arm, IM on 07-MAY-2012. No other co-suspects were reported. Concomitant medications included BOOSTRIX, MENACTRA, TOLECTIN, PLAQUENIL, PRILOSEC, amitriptyline hydrochloride and sumatriptan. It was reported that on 08-MAY-2012 the patient experienced shaking, fever, headache, vomiting, dizziness and diarrhoea. No treatment information was reported. The outcome of events mentioned above was unknown. The patient was seen in the office on 09-MAY-2012. This report was considered not serious and required ER visit by the agency. The original reporting source was not provided. The VAERS ID # is 455324-1. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Blood cortisol normal, Blood thyroid stimulating hormone normal, Borrelia test negative, C-reactive protein normal
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Complement factor C3, Complement factor C4, Cytomegalovirus test negative, Disturbance in attention, Dizziness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Epstein-Barr virus test negative, Fatigue, Full blood count normal, Gait disturbance, Joint stiffness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Laboratory test normal, Metabolic function test normal, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Parvovirus B19 test positive, Red blood cell sedimentation rate normal, Serum ferritin normal, Thyroxine normal, Treponema test negative
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Complement factor C3, Complement factor C4, Complement factor normal, Cytomegalovirus test negative, Disturbance in attention
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Epstein-Barr virus test negative, Fatigue, Full blood count normal, Gait disturbance
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Joint stiffness, Laboratory test normal, Metabolic function test normal, Musculoskeletal stiffness, 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 refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia, Parvovirus B19 test positive, Red blood cell sedimentation rate normal, Serum ferritin normal, Thyroxine normal
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Treponema test negative
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report refers to a 14 years old male patient with penicillin allergy, allergy to VYVANSE and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with GARDASIL (lot #, dose and route not reported) on 08-MAR-2012. No other co-suspects and no concomitant medications were reported. On 11-MAR-2012, the patient had pain radiating down his right arm (the arm in which he was vaccinated). The next day on 12-MAR-2012, the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness and difficult concentrating. No treatment information was reported. The patient had normal CBC, CMP, CRP, ferritin, celiac panel AM cortisol, C3, C4, TSH, T4 RPR. Serology was negative for Lyme, EBV and CMV. Parvovirus resulted IgG-6 and IgM-1.4. The events lasted through early May 2012 and then resolved. 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 not provided. The VAERS ID# is 455396-1. No further information is available.
Age: 17.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Electroencephalogram, Loss of consciousness, Postictal state, Seizure like phenomena, Tonic clonic movements
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 male patient with mild allergic rhinitis was vaccinated IM on the left arm with the second dose of GARDASIL lot # (672653/1860AA) on 05-JUN-2012. On 05-JUN-2012 the patient experienced loss of consciousness, postictal state, seizure-like phenomena and tonic-clonic movements. The patient experienced loss of consciousness with tonic-clonic seizure-like activity after 20 minutes after vaccination, lasting 20 seconds but with post-ictal phase. No illness at the time of vaccination. EEG pending was reported as lab data. The outcome of loss of consciousness, post-ictal phase and tonic-clonic seizure-like activity was unknown. The patient required an emergency room visit and the reporter considered the events were non-serious. Upon internal review, loss of consciousness was required intervention to prevent permanent damage/impairment. Additional information is not expected. The original reporting source was not provided. The VAERS ID# is 457043-1.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, 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. An 18 year old female patient with obesity, irregular menses and headache and no pre existing illnesses was vaccinated with a unknown dose of GARDASIL (lot # (666595/0992Z), Left arm (unknown route) and an unknown dose of VARIVAX (Merck), Left arm, (unknown route) on 12-JUN-2012. Concomitant medications included: MENACTRA. There were no other medications included. It was reported that on 13-JUN-2012, the patient had swelling, hot area, itching, redness and tenderness around site. No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered not serious with no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 457344-1. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 32 years old female patient with drug allergy to gentamicin. The patient's medical history included thrombocytopenia. The patient was vaccinated with a dose of VARIVAX (merck) (lot# not reported) subcutaneous on 25-JUL-2012. No other co-suspects were reported. Concomitant medications included DILANTIN, calcium carbonate, magnesia [milk of], vitamin D (unspecified), and multivitamin. On 15-AUG-2012 the patient developed lesions of itchy varicella like rash on back, face, and under her arm. Treatment information was reported as calamine lotion. No laboratory performed. The patient had sought unspecified medical attention. The outcome was reported as recovering. Additional information is not expected.
Age: 32.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 32 years old female patient with drug allergy to gentamicin. The patient's medical history included thrombocytopenia. The patient was vaccinated with a dose of VARIVAX (merck) (lot# not reported) subcutaneous on 25-JUL-2012. No other co-suspects were reported. Concomitant medications included DILANTIN, calcium carbonate, magnesia [milk of], vitamin D (unspecified), and multivitamin. On 15-AUG-2012 the patient developed lesions of itchy varicella like rash on back, face, and under her arm. Treatment information was reported as calamine lotion. No laboratory performed. The patient had sought unspecified medical attention. The outcome was reported as recovering. Additional information is not expected.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Blood test, Rash generalised, White blood cell count increased
Clinical narrative: Pt started forming rash all over body.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: I have typed in GREAT DETAIL the events only to have your stupid system erase ALL of my work!!!
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: In the evening of 21Aug2012 after Dtap was administered in the Left thigh child had edema, pain and erythema to left left where immunization was placed.  Area was from thigh to knee. The child came back to clinic and Benadryl RX was issued.  Child came back about 1 hour later and s/s had somewhat resolved better.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Deafness
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 79 years old female patient with trouble with hearing. The patient was vaccinated with 0.65 ml ZOSTAVAX (lot# was unknown) between April and August in 2012. The doctor reported "the patient was given vaccine by an unspecified HCP". The patient had preexisting trouble with hearing at the time of the vaccination". Between April and August 2012 "she was given the vaccine, and later that day she lost all her hearing". "The patient has recovered and her hearing was at the same level it was at before she got the vaccine". The representative stated that "the problem she had with hearing was a significant disability/incapacity". The patient sought medical attention and got unspecified steroid to treat the adverse event. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Acute disseminated encephalomyelitis, Emotional distress, Hypoaesthesia, Paralysis
Clinical narrative: Information was received from a lawyer regarding a case in litigation. It is alleged in litigation that a male patient, on or about 01SEP2010 was vaccinated with a dose of ZOSTAVAX (Merck) for its intended purpose. On or about 07SEP2010, he began to experience various neurological symptoms. As a direct and proximate result of ZOSTAVAX (Merck), the patient was diagnosed with acute disseminating encephalomyelitis (ADEM) on or about 28SEP2010. The patient continues to experience ongoing neurological symptoms, such as numbness and paralysis. His neurological symptoms have resulted in physical limitations not present prior to the vaccine. Patient experiences mental and emotional distress due to physical limitations and seriousness of his condition. Upon internal review, acute disseminating encephalomyelitis was determined to be a significant medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: Administered Varicella vaccine to patient who had chickenpox as a child. Patient had no reaction was made aware of incident.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Received call 12:10 pm. Pt's mother called saying "he's breaking out in hives". No distress advised BENADRYL: go to hospital if worsens.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rashes on injection site (2 inch diameter).
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Rash generalised
Clinical narrative: Rashes (arms, hands, chest, face & neck), shortness of breath, itching.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Area became warm last night - this am increased swelling & redness.
Age: 11.0
Sex: M
Vaccine: FLU3, HEPA, HPV4, TDAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hive reaction centered around right arm. Hives on face. BENADRYL Allergy, inj (50m/1ml) 0.5 ml IM. MENACTRA Sanofi Pasteur (L) U3906AA.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Child had DTaP given on (L) deltoid on 08/21/12. Relative returned to clinic 08/23/12 with child stating childs arm was red, itching, swollen. Deltoid area was warm, red, and swollen in area shot given. Radio medicine/doc phoned. Child was given BENADRYL liquid to take Q6h. Informed to ice area as need, given TYLENOL Q6h as needed. Child was running around active.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Pruritus
Clinical narrative: Child had DTaP given on (L) deltoid on 08/21/12. Relative returned to clinic 08/23/12 with child stating childs arm was red, itching, swollen. Deltoid area was warm, red, and swollen in area shot given. Radio medicine/doc phoned. Child was given BENADRYL liquid to take Q6h. Informed to ice area as need, given TYLENOL Q6h as needed. Child was running around active.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Pyrexia
Clinical narrative: Within 5 minutes of receiving vaccine, patient's (L) shoulder was red, swollen & had hives. BENADRYL given & ice applied. This halted the spread. Monitored x 20 min. & released home. Phone update next day - no further spread, but had fever of 104. (area of DTaP injection).
Age: 27.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Had headache, myalgias, joint pain and fever for 102 degrees F oral.
Age: 52.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Drug administered to patient of inappropriate age, Guillain-Barre syndrome
Clinical narrative: This spontaneous report as received from a 52 year old nurse with allergic reaction to KEFLEX and no other pertinent medical history, reporting on herself. The patient stated that about a month ago, on approximately 17-JUL-2012, she received the first dose of GARDASIL (lot# not reported) and experienced isolated periods of pain in her knee and felt like she had stress fracture in her leg. Concomitant medications included: SYNTHROID. The patient was informed that she was outside the indicated age for the vaccine and she stated she thought the situation in the operating room where she was a nurse warranted it. She stated that on an unspecified date she was exposed to HPV from electrocautery smoke from a patient who had it in the operating room. On an unspecified date, reported as "three days", the patient experienced isolated periods of pain in her knee and felt like she had a stress fracture in her leg. She also mentioned she had symptoms like Guillain-Barre syndrome. The patient was not sure if she would get the second dose of GARDASIL and would be contact her physician to discuss. The symptoms she experienced come and go. No lab diagnostic tests were performed. At the time of the report the patient was recovering from the adverse events. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest X-ray normal, Full blood count, Mass, Metabolic function test, Red blood cell sedimentation rate normal
Clinical narrative: Office visit 6/19/12 - given MENACTRA & GARDASIL. 10 days later - developed a left supraclavicular mass. Office visit 7/6/12 - 2 cm (L) supraclavicular mass. Placed on cephalexin 7/6/12, 250 mg QID x 10 days. Office visit 7/23/12 - mass smaller. Office visit 8/20/12 - mass resolved, no longer present.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Herpes zoster, Injection site pain, Rash
Clinical narrative: Pt was given booster for PNEUMOVAX 8-10-12. On 8-11-12, she awake with sore lt. arm (in area of shot) no redness; had facial redness & was treated for facial cellulitis. Pt. seen 8-15-12 facial rash more consistent with shingles, treated with antiviral rash, by Dr.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient was dizzy, felt like fainting. However, she remained conscious & was talking. She felt OK after 10 minutes.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and Swelling at the injection sith with some itching.  Induration did not extend past shoulder or below elbow.  Consistent with a Robust Take.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: LOCAL REACTION-REDNESS WITH SIGNIFICANT INDURATION.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Deafness unilateral, Dizziness, Face and mouth X-ray, Laboratory test
Clinical narrative: Dizziness, vertigo and left ear hearing loss.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Dizziness, vertigo and left ear hearing loss.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Area very swollen, red, itchy, painful for 5 days after. Unable to sleep on arm for 5 days. HDC cream applied often, but site still itchy and very painful.
Age: 0.26
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Local reaction, Pruritus
Clinical narrative: Minor local reaction - erythema, induration and itching.
Age: 37.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pain, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Client reported to this office on 8/20/12 with hx of having flu like symptoms with diarrhea which started on 8/16/2012. These symptoms continued and progressed to a full body rash by 8/18. On 8/20/12 when he presented to this office he c/o of having all over muscle aches and continued to have the all over body rash that was red and itchy.
Age: 1.77
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Reddened, swollen area.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Head injury, Spinal column injury, Syncope
Clinical narrative: Vaccine administered was HPV.  Moments afterward, the patient fainted and collapsed, injuring her tailbone on the floor and her head on the wall.  She was helped onto the patient examining table and did not regain full consciousness for more than an hour.  What's particularly upsetting is that usually when any shots are given, patients are asked if they have an aversion to needles or a history of fainting.  In this case, the patient (my daughter) does, so we would have said "Yes."  At that point, the administering nurse should have informed us that a common side-affect of HPV vaccine's is fainting.  She did not.  If we would have known this, we would certainly have elected not to have her subjected to this vaccine, particularly since it is new and quite controversial.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Muscle soreness today. Patient has also noted the presence of a red teardrop shaped area less than one inch in size that is located about three inches from the injection site going into her axilla area. The injection site is tender to the touch.  Minor swelling.  Patient was instructed to use OTC Hydrocortisone cream and prescribed Ceftin by a provider at an appointment.
Age: 0.47
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Raised, slightly red rash around injection site.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Rash pruritic, Urticaria
Clinical narrative: About 2 hours after receiving the vaccine, patient developed a "hive-live rash" per mom.  It is now 3 days later, and the rash persists.  It is itchy.  The rash is on the patient's chin, extremities, and abdomen.  No fever or other symptoms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tachycardia
Clinical narrative: 51 y/o female presents with reaction to flu shot given 24hours earlier. Raised red area on left upper arm. Height 60cm x length 40cm. Warm to touch. Able to move arm with ease. C/o tachycardia. Heart rate was around 120 bpm.