chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Injection site erythema, 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 concerning to a 11 years old male patient with no history allergies. The patient was vaccinated IM into the left arm with the second dose of GARDASIL (Lot#672721/0101AE, dose unspecified) on 05-JUN-2012. Other suspect therapy given IM into the left arm included a first dose of MENACTRA (Lot#U4052AD, dose unspecified). No concomitant medications were reported. It was reported that the patient experienced local large (7 in x 5.5 in) local erythema, warmth, tense swelling of arm where injections given, systemic headache on 13-JUN-2012. It was unspecified whether the patient had sought medical attention. The outcome was unknown when reporting. The original reporting source was not provided. The VAERS ID # is 456999-1. No further information is available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Injection site discomfort, Injection site erythema, 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 concerning to a 11 years old male patient with no history allergies. The patient was vaccinated IM into the left arm with the second dose of GARDASIL (Lot#672721/0101AE, dose unspecified) on 05-JUN-2012. Other suspect therapy given IM into the left arm included a first dose of MENACTRA (Lot#U4052AD, dose unspecified). No concomitant medications were reported. It was reported that the patient experienced local large (7 in x 5.5 in) local erythema, warmth, tense swelling of arm where injections given, systemic headache on 13-JUN-2012. It was unspecified whether the patient had sought medical attention. The outcome was unknown when reporting. The original reporting source was not provided. The VAERS ID # is 456999-1. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Pyrexia, Urticaria
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 15 year old female with allergy to amoxicillin, AUGMENTIN, none of previous illness who on 08-JUN-2012 was vaccinated IM into left arm with third dose of GARDASIL (670050/1229AA). Other concomitant therapy included DTAP (Sanofi Pasteur, lot # C3900AA, IM, left arm); meningococcal conj vaccine (unspecified) (Sanofi Pasteur, lot # U4053AA, IM, right arm, first dose). On 10-JUN-2012, patient developed fever, hives on hands and feet. Mom gave child BENADRYL. On 11-JUN-2012 called health dept. That Symptom had gone on 10-JUN-2012. It was reported that all events were non-serious and did not require ER/Doctor visit. The original reporting source was not provided. The VAERS ID # is 457219.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Dysphagia, Headache, Nausea, Oropharyngeal pain, 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 12 year old male with none of previous illness and none of medical history who on 01-JUN-2012 was vaccinated into right arm with first dose of GARDASIL (lot # 672653/1860AA). Patient also vaccinated into right arm with first dose of Hepatitis A Vaccine, Inactivated (unknown route, right arm, lot # reported as 0100AE, first dose). Other concomitant therapy included BOOSTRIX (GlaxoSmithKline, lot # AC52B080CA, unknown route, left arm, first dose); MENVEO (Novartis, lot # M11066, unknown route, right arm, first dose). On the evening of 03-JUN-2012, patient had nausea and a headache (mild). On 04-JUN-2012 the headache continued and he had a low grade fever of 99, sore throat, and complained that it hurt to swallow. Saw doctor on 05-JUN-2012 for strep throat test that was (-) initially, but got official lab results on 06-JUN-2012. The original reporting source was not provided. The VAERS ID # is 457228-1. No further information is available.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Streptococcus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old male with none of previous illness and none of medical history who on 01-JUN-2012 was vaccinated into right arm with first dose of GARDASIL (lot # 672653/1860AA). Patient also vaccinated into right arm with first dose of Hepatitis A Vaccine, Inactivated (unknown route, right arm, lot # reported as 0100AE, first dose). Other concomitant therapy included BOOSTRIX (GlaxoSmithKline, lot # AC52B080CA, unknown route, left arm, first dose); MENVEO (Novartis, lot # M11066, unknown route, right arm, first dose). On the evening of 03-JUN-2012, patient had nausea and a headache (mild). On 04-JUN-2012 the headache continued and he had a low grade fever of 99, sore throat, and complained that it hurt to swallow. Saw doctor on 05-JUN-2012 for strep throat test that was (-) initially, but got official lab results on 06-JUN-2012. The original reporting source was not provided. The VAERS ID # is 457228-1. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Enuresis, Gaze palsy, Loss of consciousness, Posture abnormal
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with anxiety disorder and asthma who was vaccinated with a dose of GARDASIL lot # (672233/1561AA), left arm (route and dose not reported) on 11-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-JUN-2012, the patient experienced loss of consciousness for several seconds (medically significant, upon internal review), patient flexed arms in, experienced enuresis, collapsed, head extended back and eyes rolled back. No shaking was observed. No treatment information was reported. The outcome of loss of consciousness for several seconds, patient collapsed, patient flexed arms in, enuresis, head extended back and eyes rolled back 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 457244-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with anxiety disorder and asthma who was vaccinated with a dose of GARDASIL lot # (672233/1561AA), left arm (route and dose not reported) on 11-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-JUN-2012, the patient experienced loss of consciousness for several seconds (medically significant, upon internal review), patient flexed arms in, experienced enuresis, collapsed, head extended back and eyes rolled back. No shaking was observed. No treatment information was reported. The outcome of loss of consciousness for several seconds, patient collapsed, patient flexed arms in, enuresis, head extended back and eyes rolled back 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 457244-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Enuresis, Fall, Gaze palsy, Joint contracture, Loss of consciousness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with anxiety disorder and asthma who was vaccinated with a dose of GARDASIL lot # (672233/1561AA), left arm (route and dose not reported) on 11-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-JUN-2012, the patient experienced loss of consciousness for several seconds (medically significant, upon internal review), patient flexed arms in, experienced enuresis, collapsed, head extended back and eyes rolled back. No shaking was observed. No treatment information was reported. The outcome of loss of consciousness for several seconds, patient collapsed, patient flexed arms in, enuresis, head extended back and eyes rolled back 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 457244-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Posture abnormal, Syncope
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old female patient with anxiety disorder and asthma who was vaccinated with a dose of GARDASIL lot # (672233/1561AA), left arm (route and dose not reported) on 11-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 11-JUN-2012, the patient experienced loss of consciousness for several seconds (medically significant, upon internal review), patient flexed arms in, experienced enuresis, collapsed, head extended back and eyes rolled back. No shaking was observed. No treatment information was reported. The outcome of loss of consciousness for several seconds, patient collapsed, patient flexed arms in, enuresis, head extended back and eyes rolled back 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 457244-1. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, PPV, TDAP, HPV4, MNQ, PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, 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 concerning a 10 years old female patient with insulin-dependent diabetes mellitus (IDDM) and goiter. The patient was vaccinated IM into the left arm with the first dose of GARDASIL (Lot# 672652/0022AE). Other suspect therapy given IM into the right arm included a first dose of PNEUMOVAX  23 (Lot # 0491AE, dose unspecified) and a first dose of ADACEL with Lot # C4015AA (dose unspecified) on 12-JUN-2012. Concomitant medications included MENACTRA (Lot # U3906AA) and drug of HUMALOG and Multivitamins. It was reported that the patient experienced right shoulder with 9cm x 5cm blotchy red somewhat warm and slight firm swelling in area surrounding the shot on 13-JUN-2012. It was unspecified whether the patient had sought medical attention. The outcome was unknown when reporting. The original reporting source was not provided. The VAERS ID # is 457389-1. No further information is available.
Age: 10.0
Sex: F
Vaccine: HPV4, MNQ, PPV, TDAP, HPV4, MNQ, PPV, TDAP
Symptoms: Rash macular
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 concerning a 10 years old female patient with insulin-dependent diabetes mellitus (IDDM) and goiter. The patient was vaccinated IM into the left arm with the first dose of GARDASIL (Lot# 672652/0022AE). Other suspect therapy given IM into the right arm included a first dose of PNEUMOVAX  23 (Lot # 0491AE, dose unspecified) and a first dose of ADACEL with Lot # C4015AA (dose unspecified) on 12-JUN-2012. Concomitant medications included MENACTRA (Lot # U3906AA) and drug of HUMALOG and Multivitamins. It was reported that the patient experienced right shoulder with 9cm x 5cm blotchy red somewhat warm and slight firm swelling in area surrounding the shot on 13-JUN-2012. It was unspecified whether the patient had sought medical attention. The outcome was unknown when reporting. The original reporting source was not provided. The VAERS ID # is 457389-1. No further information is available.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Dyskinesia, Head injury, Incoherent, Loss of consciousness, Posture abnormal
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A female patient of unknown age with no previous illness and not known adverse events was vaccinated with a first dose of GARDASIL (lot # 668670/0476AA), Left arm, IM and a first dose of MENACTRA (Batch # U4096AA), Left arm, IM on 12-JUN-2012. Concomitant medications included: ORTHO TRI-CYCLEN and "birth control pills". It was reported that on 12-JUN-2012 pre witness, patient seemed to pass out (medically significant upon internal review) while checking out and hit her head, the patient was observe to be lying on ground unresponsive with bilateral hands contorted and neck jerked to right side, the physician on site described that within minutes patient sat up with minimal assist within minutes then appeared to begin breathing rapidly, a paper bag was used to help slow down breathing and prevent hyperventilation, it was also described that the patient was able to respond to commands within minutes but unable to speak coherently, EMS was called and patient was taken to ER. No treatment information was reported. The outcome of patient seemed to pass out, patient unable to speak coherently; hit her head was lying on ground unresponsive with bilateral hands contorted and neck jerked to right side and began to breathe rapidly was unknown. This report was considered not serious, ER visit by the agency. The original reporting source was not provided. The VAERS ID# is 457423-1. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A female patient of unknown age with no previous illness and not known adverse events was vaccinated with a first dose of GARDASIL (lot # 668670/0476AA), Left arm, IM and a first dose of MENACTRA (Batch # U4096AA), Left arm, IM on 12-JUN-2012. Concomitant medications included: ORTHO TRI-CYCLEN and "birth control pills". It was reported that on 12-JUN-2012 pre witness, patient seemed to pass out (medically significant upon internal review) while checking out and hit her head, the patient was observe to be lying on ground unresponsive with bilateral hands contorted and neck jerked to right side, the physician on site described that within minutes patient sat up with minimal assist within minutes then appeared to begin breathing rapidly, a paper bag was used to help slow down breathing and prevent hyperventilation, it was also described that the patient was able to respond to commands within minutes but unable to speak coherently, EMS was called and patient was taken to ER. No treatment information was reported. The outcome of patient seemed to pass out, patient unable to speak coherently; hit her head was lying on ground unresponsive with bilateral hands contorted and neck jerked to right side and began to breathe rapidly was unknown. This report was considered not serious, ER visit by the agency. The original reporting source was not provided. The VAERS ID# is 457423-1. Additional information is not expected.
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Head injury, Incoherent, Loss of consciousness, Posture abnormal, Respiratory rate increased
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A female patient of unknown age with no previous illness and not known adverse events was vaccinated with a first dose of GARDASIL (lot # 668670/0476AA), Left arm, IM and a first dose of MENACTRA (Batch # U4096AA), Left arm, IM on 12-JUN-2012. Concomitant medications included: ORTHO TRI-CYCLEN and "birth control pills". It was reported that on 12-JUN-2012 pre witness, patient seemed to pass out (medically significant upon internal review) while checking out and hit her head, the patient was observe to be lying on ground unresponsive with bilateral hands contorted and neck jerked to right side, the physician on site described that within minutes patient sat up with minimal assist within minutes then appeared to begin breathing rapidly, a paper bag was used to help slow down breathing and prevent hyperventilation, it was also described that the patient was able to respond to commands within minutes but unable to speak coherently, EMS was called and patient was taken to ER. No treatment information was reported. The outcome of patient seemed to pass out, patient unable to speak coherently; hit her head was lying on ground unresponsive with bilateral hands contorted and neck jerked to right side and began to breathe rapidly was unknown. This report was considered not serious, ER visit by the agency. The original reporting source was not provided. The VAERS ID# is 457423-1. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Dizziness, Grand mal convulsion, Loss of consciousness, Muscle twitching
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient information Act. This spontaneous report as received from a regulatory authority refers to a 16 years old female patient. The patient was vaccinated with dose 3 GARDASIL on 14-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 14-JUN-2012 the patient experienced loss of consciousness (medically significant), 1 day after onset of therapy, postictal state, grand mal convulsion (medically significant), dizziness and convulsion (medically significant). On an unknown date the patient experienced muscle twitching. No treatment information was reported. The outcome of loss of consciousness, muscle twitching, grand mal convulsion, dizziness and convulsion was reported as recovered/resolved. The relatedness for loss of consciousness, postictal state, muscle twitching, grand mal convulsion, dizziness and convulsion is unknown for GARDASIL. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Postictal state
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of the patient information Act. This spontaneous report as received from a regulatory authority refers to a 16 years old female patient. The patient was vaccinated with dose 3 GARDASIL on 14-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. On 14-JUN-2012 the patient experienced loss of consciousness (medically significant), 1 day after onset of therapy, postictal state, grand mal convulsion (medically significant), dizziness and convulsion (medically significant). On an unknown date the patient experienced muscle twitching. No treatment information was reported. The outcome of loss of consciousness, muscle twitching, grand mal convulsion, dizziness and convulsion was reported as recovered/resolved. The relatedness for loss of consciousness, postictal state, muscle twitching, grand mal convulsion, dizziness and convulsion is unknown for GARDASIL. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fear, Injection site discomfort, Vision blurred
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient with no previous illness and no medical history who on 11-JUN-2012 was vaccinated with dose 3 GARDASIL, lot # (668261/1397AA), left arm (route not reported). No other co-suspects were reported. On 11-JUN-2012, the patient began to feel scared dizzy with blurred vision and when vaccine was administered patient felt as though something was running down in the left arm. Patient was also anxious prior to administration. Resolved in 5 minutes. No treatment information was reported. The outcome of the reported events 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 457511-1. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fear, Feeling abnormal, Vision blurred
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient with no previous illness and no medical history who on 11-JUN-2012 was vaccinated with dose 3 GARDASIL, lot # (668261/1397AA), left arm (route not reported). No other co-suspects were reported. On 11-JUN-2012, the patient began to feel scared dizzy with blurred vision and when vaccine was administered patient felt as though something was running down in the left arm. Patient was also anxious prior to administration. Resolved in 5 minutes. No treatment information was reported. The outcome of the reported events 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 457511-1. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL, HPV4, VARCEL
Symptoms: Unevaluable event
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A  17 years old female patient who was vaccinated with dose a 2 dose GARDASIL, right arm, ((batch # 0459AC) (dose not reported), IM on 14-JUN-2012. Other suspect therapies included VAQTA (dose not reported), left arm, (batch # 0100AE), IM and on an unspecified dose of VARIVAX (Merck), SQ (batch # 1278AA) on 14-JUN-2012. It was reported that on an unknown date the patient experienced unevaluable event. No treatment information was reported. The outcome of unevaluable event 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 457519-1. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Computerised tomogram head, Dyskinesia, Electrocardiogram, Full blood count, Headache
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 was vaccinated on 06-JUN-2012 with the first dose of GARDASIL, (lot # 0101AE), I.M., in the left arm (dose not reported). On 10-JUN-2012, the patient had sudden onset of pressure in her head, four days later the patient felt vision closed and darkened. The patient lost consciousness and collapsed to the floor, generalized jerking while unconscious. At the time of the report, patient's outcome for all the events was unknown. This report was considered non-serious by the agency, it required ER/doctor visit. Laboratory tests performed included Complete blood count (CBC), Basic Metabolic Panel (BMP), urinalysis (UA), electrocardiogram (EKG) and brain computerized tomography (CT) without contrast (no lab results available). The original reporting source was not provided. The VAERS ID # is 457765. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Loss of consciousness, Metabolic function test, Syncope, Urine analysis, Visual impairment
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 was vaccinated on 06-JUN-2012 with the first dose of GARDASIL, (lot # 0101AE), I.M., in the left arm (dose not reported). On 10-JUN-2012, the patient had sudden onset of pressure in her head, four days later the patient felt vision closed and darkened. The patient lost consciousness and collapsed to the floor, generalized jerking while unconscious. At the time of the report, patient's outcome for all the events was unknown. This report was considered non-serious by the agency, it required ER/doctor visit. Laboratory tests performed included Complete blood count (CBC), Basic Metabolic Panel (BMP), urinalysis (UA), electrocardiogram (EKG) and brain computerized tomography (CT) without contrast (no lab results available). The original reporting source was not provided. The VAERS ID # is 457765. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 year old female patient was vaccinated on 06-JUN-2012 with the first dose of GARDASIL, (lot # 0101AE), I.M., in the left arm (dose not reported). On 10-JUN-2012, the patient had sudden onset of pressure in her head, four days later the patient felt vision closed and darkened. The patient lost consciousness and collapsed to the floor, generalized jerking while unconscious. At the time of the report, patient's outcome for all the events was unknown. This report was considered non-serious by the agency, it required ER/doctor visit. Laboratory tests performed included Complete blood count (CBC), Basic Metabolic Panel (BMP), urinalysis (UA), electrocardiogram (EKG) and brain computerized tomography (CT) without contrast (no lab results available). The original reporting source was not provided. The VAERS ID # is 457765. No further information is available.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 10 year old female patient with no medical history and no previous illnesses was vaccinated on 21-JUN-2012 with a dose of HPV vaccine, (lot #, site route and dose not reported). Secondary suspect vaccine given on the same date included a dose of Hepatitis A Vaccine, Inactivated, (Lot #, site, route and dose not reported). On 21-JUN-2012, the patient experienced fainting and convulsions. Patient's feet were put up, and water was given to her. Blood pressure was normal. At the time of the report, patient's outcome for all the events was unknown. This report was considered non-serious, no conditions by the agency. Upon internal review, convulsion was considered an other important medical event. Upon internal review, it was determined that convulsion was an other important medical event. The original reporting source was not provided. The VAERS ID # is 457824. No further information is available.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Nausea, Presyncope, Visual impairment
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 13 years old male patient with prophylaxis. The patient was vaccinated with dose 1 GARDASIL on 22-JUN-2012. No other co-suspects were reported. Concomitant medications included HAVRIX, ADACEL and MENACTRA. On 22-JUN-2012 the patient experienced visual impairment, 1 day after onset of therapy, presyncope, nausea and dizziness. No treatment information was reported. The outcome of visual impairment, presyncope, nausea and dizziness is unknown. The relatedness for visual impairment, presyncope, nausea and dizziness is unknown for GARDASIL. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site induration, Injection site mass, Pyrexia
Clinical narrative: Injection site cellulitis. Patient notice hard mass at injection site, presented with Wednesday morning, by afternoon of 8/1/12, fever of 101 degrees F, went to walk in care, diagnosed with cellulitis.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Axillary pain, Erythema, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: On 8-2-12 pt Re'd PNEUMOVAX (L) deltoid: on 8-3-12 pt calls with red, pain & swelling "local reaction to pneumonia vac" Rx: VICODIN 5/500 1 po q6 hours prn. Warm compresses; elevate.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Nausea, Swelling
Clinical narrative: On 8-2-12 pt Re'd PNEUMOVAX (L) deltoid: on 8-3-12 pt calls with red, pain & swelling "local reaction to pneumonia vac" Rx: VICODIN 5/500 1 po q6 hours prn. Warm compresses; elevate.
Age: 38.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Local reaction, Pain, Swelling, Vaccination complication
Clinical narrative: On 8-2-12 pt Re'd PNEUMOVAX (L) deltoid: on 8-3-12 pt calls with red, pain & swelling "local reaction to pneumonia vac" Rx: VICODIN 5/500 1 po q6 hours prn. Warm compresses; elevate.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Oedema peripheral, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Patient came to pharmacy on 08/04/12 starting she experienced on (L) arm about 6 inches developed red rash was swollen, pruritis, erythema and had bumps warmth also had headache. Pt still experienced swelling rash & warmth will be seeing MD Monday.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: - Swelling, redness from deltoid to elbow are 1 day after vaccine left arm (Tdap & MCV).
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Biopsy lymph gland, Histiocytosis, Inflammation, Lymphadenectomy, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient's medical history included a diagnosis of eczema. The patient was vaccinated orally with a dose of ROTATEQ on approximately 30-MAY-2012. Other suspect therapies included PREVNAR 13 and PENTACEL. The physician reported that the patient developed histiocytosis, another term for lymph node swelling after receiving ROTATEQ. The patient was 8 months old now but was 6 months old when they received ROTATEQ. The patient had a biopsy and surgery done to remove the lymph node that was inflamed. Hospital duration was unspecified. The outcome of events was reported as recovering/resolving. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8/3/12 Around injection site was red & swollen, & hot. 8/4/12 red & swollen area was considerably large & had a red line going up her arm. Went to ER & received a prescription for cephalexin.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Convulsion, Fall, Loss of consciousness, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A 14 years old female patient with prophylaxis and incomplete right bundle branch block was vaccinated IM into right arm with first dose of GARDASIL (lot # 669794/1400AA, expired date 11-OCT-2013) on 03-APR-2012. No other co-suspects were reported. Concomitant medications included ADACEL (lot# U4088AA) and MENACTRA (lot# U4099AA). On 03-APR-2012, 3 minutes after vaccination, the patient fainted and slump slowly down from sitting position. The patient was layed down on table. Patient was loss of consciousness about 10-15 seconds with brief seizure activity towards last 5 seconds. Smelling salt was put under patient's nose and she immediately awoke. Patient was monitored for 15-20 minutes afterward. On internal review, lost consciousness and seizure activity were determined to be an other important medical event. The original reporting source was not provided. No further information is available.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Palm sized redness to left thigh.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Retching, Syncope
Clinical narrative: Client fainted and felt nausea and dry heaves. Was put on Cot, gave sips of water and recovered quickly.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram, Hemiparesis, Hypotonia, Mental status changes, Nuclear magnetic resonance imaging brain
Clinical narrative: Hypotonia, decreased mental status, left-sided hemiparesis.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Electroencephalogram abnormal, Hypotonia, Mobility decreased, Nervous system disorder, Shock
Clinical narrative: Hypotonia, decreased mental status, left-sided hemiparesis.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Unresponsive to stimuli
Clinical narrative: Hypotonia, decreased mental status, left-sided hemiparesis.
Sex: F
Vaccine: FLUX
Symptoms: Cerebrovascular accident
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 27-Jul-2012) concerns a female patient, who had a medical history of rare autoimmune disorder in which her stomach did not make enough acid. She was allergic to eggs, sulfamethoxazole; trimethoprim combination and 'the flu shot'. Five or eight years ago the patient received flu vaccine (brand, manufacturer and batch number were not provided) and suffered a stroke. The event outcome was not reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt stated 2 days after administration injection site became swollen, red, & itchy.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Broke out in hives, all over body.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Malaise headache, local site injection swelling redness, heat area of 6 x 3 inches. Moderate pruritus and edema for 48 hours. Treatment: TYLENOL and ice packs --> symptoms began to reduce.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Oedema, Pruritus
Clinical narrative: Malaise headache, local site injection swelling redness, heat area of 6 x 3 inches. Moderate pruritus and edema for 48 hours. Treatment: TYLENOL and ice packs --> symptoms began to reduce.
Age: 1.92
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Convulsion, Postictal state, Sensory loss
Clinical narrative: He had a seizure lasting about 1-2 min with a post ictal phase of about 5 -10 min. I was generalized with no feeling about 4 hours after getting the vaccine.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure x 2 - seen in ER x 2 7/28 & 7/29.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: S/ Patient is in with complaint of right upper arm soreness since receiving tetanus booster about two weeks ago. She denies fever, chills, nausea, chest pain or shortness of breath. She also denies injection site swelling, redness, induration or warmth to touch. She reports improvement with Ibuprofen and warm compress.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema peripheral
Clinical narrative: 07/27/2012 Mild Other Patient had swollen arm.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash papular, Rash pruritic, Rash pustular
Clinical narrative: 20 y/o male w/ papular rash located to arms bilaterally belt line with feet. Symptoms started 5 days ago, described  as pruritic, non tender. No associated fever or chills. Only 1 small pustular lesion noted on (R) arm.
Age: 1.26
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blister, Pyrexia
Clinical narrative: Pt received imm on 7/18/12 and began with a fever on 7/26/12 and fluid filled blisters on 7/29/11.
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Dysphagia, Dyspnoea, Throat tightness
Clinical narrative: Patient complained of throat feeling as though it was trying to close & it was hard to swallow. She also stated that she felt light headed initially when she was at home. Administered the epi pen & pt stated she could easily again. Pt is going to ED to be seen. EMS came to evaluate the pt.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: 7/31/12 - given Tdap.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: ZOSTAVAX given 8/1/2012 at 3 pm as per protocol. (L) posterolateral SQ. 8/2/2012 pm c/o itching, hardness at SQ site, painful to touch client denies rash, denied headache, denied fever site 9 cm x 6 cm red raised, warm to touch area.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye haemorrhage, Foreign body sensation in eyes, Headache
Clinical narrative: Patient said blood vessels in her eyes popped out & her eyes felt very "gritty" for 2 days. Also said she had a headache.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Red at injection site, warm to touch. Red area about 2in x 3in & swollen at upper arm. Did have doctor visit. Dr. advised patient to continue with ice packs, ibuprofen, & BENADRYL. Dr. felt pt would be fine.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria within 10 minutes after Hep A, IPV, & VARIVAX. Given 25 mg BENADRYL, easily swallowed. VSS. Monitored 20 min., hives improved.
Age: 12.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Pt received 2 Varicella Vaccines years ago: 5-14-99 and 5-25-07. Today 8-6-2012 he came to my office and has shingles. No history of chicken pox disease.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness with increased warmth tenderness. Approx 6" x 4" with injection site in center. Sent to walk in clinic. Question cellulitis. Had previous reaction to bandaid. Treated with antibiotics x 10 days through walk in care. Symptoms resolved.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm became markedly swollen, red, warm to touch from shoulder to elbow.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Imm. on 7-23. On 7-27 at night arm was hurting and had a red raised area. Since then has been spreading and swelling. Very sore.
Age: 52.0
Sex: M
Vaccine: IPV, MNQ, PPV, TYP, YF
Symptoms: Muscle twitching
Clinical narrative: Vac. given 7/10/12. Pt called 7/23/12 - stated (LT) arm twitching near injection site. No pain, no swelling, no redness. Just occ twitching.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen (R) upper arm - warm to touch - Pt c/o N/V, generalized weakness & muscle pain. Unsteady gait.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: Red, swollen (R) upper arm - warm to touch - Pt c/o N/V, generalized weakness & muscle pain. Unsteady gait.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Red, warm, tender at site of injection. ZYRTEC for itching and ice to apply to site.
Age: 24.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: HBV (#5 - repeating series) (insufficient titer to 1st series) given on 7-23-12. 7-28-12 (early) broke out in hives over entire trunk of body. Took CLARITIN - rash disappeared for 23 hrs. Reappeared after CLARITIN wore off. Took a 2nd CLARITIN on Sat. 7-28-12; 2 Sun; and Monday. Seeing Dr. on Tues. 3PM.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Headache, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. states high fever up to 103 for 24 hours, starting 2 hours post administration, body aches and headache. Large red area around site. Left deltoid 6cm x 7cm, warm to touch and painful. Also c/o persistent backache since vaccine administered.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Pt. states high fever up to 103 for 24 hours, starting 2 hours post administration, body aches and headache. Large red area around site. Left deltoid 6cm x 7cm, warm to touch and painful. Also c/o persistent backache since vaccine administered.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Gianotti-Crosti syndrome, Pyrexia, Rash generalised
Clinical narrative: My daughter developed an extremely high fever greater than 103 and the next day once the fever broke she developed a rapidly spreading rash that looks very similar in nature to Gianotti Grosti Syndrome.
Age: 5.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: 4:35PM No none adverse reaction noted at this time.
Age: 13.0
Sex: M
Vaccine: DTAP
Symptoms: Burning sensation, Electrocardiogram, Gaze palsy, Pallor, Syncope
Clinical narrative: Patient received the shot complained of a burning and then within about a 1 or 2 minutes his eyes rolled back in his head turned extremely white and fainted. Blood pressure was taken reported at 68 and blood sugar was at 78. Ambulance was called and taken to Hospital. IV fluids was started in the ambulance.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Loss of consciousness
Clinical narrative: CLIENT RECEIVED HER MENACTRA AND VAQTA IN HER LEFT DELTOID THEN PASSED OUT.  CLIENT CAME TO THEN PASSED OUT AGAIN.  LOWERED CLIENT TO FLOOR AND ELEVATED LEGS WITH HELP OF FATHER, and RNs.  HER VITAL SIGNS STABILIZED, SHE WAS ALERT AND ORIENTED X 3 AND WAS ABLE TO SIP WATER AND COLA.  ONCE STABLE, ASSISTED CLIENT TO HER FATHER'S VEHICLE.  CLIENT STATED THAT SHE HAD JUST COMPLETED A RUNNING AND WEIGHT-LIFTING WORKOUT AND HAD ONLY EATEN 3 GRAPES FOR BREAKFAST.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dizziness, Hypotension, Pallor
Clinical narrative: Patient became dizzy, hypotensive and pale after vaccine administration. She felt better soon after with cool air and water.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV, MMR, PPV
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Fever began on August 2, 2012 at around 8:00 PM and then continued until August 4, 2012. It reached a high of 102.3 and was treated with Infant Advil. Then the fever seemed to just disappear and a rash appeared. First noticed rash on August 5, 2012 around 6:00 PM after a bath. It was just a couple red bumps on the lower stomach area. The next day on August 6, 2012 the rash covered the entire chest, stomach and back area. However, no fever or other symptoms are present. Child was given 2ml of liquid Benadryl.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Decreased appetite, Hypersomnia, Irritability, Pyrexia
Clinical narrative: 105.6 fever, crying, loss of appetite, sleeping a lot more, and cranky. Trips to the ER and private Doctors, they prescribed Tylenol and Motrin.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling and redness at site of injection. Spread out several inches around and down the point of injection. Very warm/hot to the touch.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever, shoulder joint pain, extensive swelling and erythema at injection site and extending to axilla, shoulder and within an inch of elbow. Skin at injeciton site painful to touch.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Fever, shoulder joint pain, extensive swelling and erythema at injection site and extending to axilla, shoulder and within an inch of elbow. Skin at injeciton site painful to touch.
Age: 55.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Fever, shoulder joint pain, extensive swelling and erythema at injection site and extending to axilla, shoulder and within an inch of elbow. Skin at injeciton site painful to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Mom reported hard knot that was red and raised about 3-4 inches in diameter top to bottom, and 6 inches toward inner thigh on left leg, and was c/o pain. Was scratching it, c/o itching, but playing normally.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Mom reported hard knot that was red and raised about 3-4 inches in diameter top to bottom, and 6 inches toward inner thigh on left leg, and was c/o pain. Was scratching it, c/o itching, but playing normally.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Myalgia
Clinical narrative: Four days of fever/chills, myalgias, arthralgias, severe headache, anorexia. Symptoms ongoing through current time.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Four days of fever/chills, myalgias, arthralgias, severe headache, anorexia. Symptoms ongoing through current time.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: Approximately 4 minutes after receiving vaccines, client told Mom she felt dizzy.  Before anyone could reach client she passed out and fell forward out of chair striking head on floor.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient described hand pain on the hand opposite the arm that the vaccine was given in.  There were no objective physical exam findings.  Pain persists to date.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Fever, body aches, large amount of swelling, redness and erythema at injection site from axilla to elbow which became painful to touch.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Ear infection, Lymphadenopathy, Pyrexia, Rash generalised
Clinical narrative: Shots given 07/19 MMR the one I'm worried about Swollen Lymph Node on neck 07/24 Fever 101-102 07/26-07/28 Ear Infection 07/27 Broken out in rash all over (comes and goes 07/31 to present 08/06)
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right arm deltoid area 8 cm width x 7 cm length; slightly warm to the touch; slightly erythemous; slightly tender. Prescribed: apply ice to the area; Motrin 600 mg one tab po every 8 hours as needed for pain & Keflex 500mg one cap po 4 times daily by Dr.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive
Clinical narrative: Patient started with cough and congestion on 7/17/12. Had episodes of post-tussive emesis. Mother also with similar symptoms at the same time. Patient had been adequately vaccinated for pertussis as an infant (five doses of DTaP from 2001-2005). She was at the office receiving TDap booster at 11 year old well visit on 8/1/2012.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, VARCEL
Symptoms: Cerebellar ataxia, Encephalitis, Nuclear magnetic resonance imaging brain abnormal, Viral infection
Clinical narrative: Acute cerebellar ataxia developing 24d following VZV vaccination.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP
Symptoms: Convulsion
Clinical narrative: Phone call from Dr. office requesting information on what vaccines given information supplied. It was later reported by a family member that infant was sent home from that office later went to a facility possibly on 08/04/2012 and was seen possibly at ER for seizures and transferred to another hospital by ambulance.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: At injection site: redness, hardness under skin, soreness.