chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blister, Erythema, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient with no previous illnesses and no medical history, patient was vaccinated with a dose 1 of GARDASIL, (Lot # 669308/0636AA), Left arm, IM, and a second dose of VARIVAX (Merck) (Lot # 1438AA), Right arm, SQ on 27-MAR-2012. Concomitant medications included ADACEL, MENACTRA AND HAVRIX. There were no other concomitant medications. It was reported that on 28-MAR-2012 the patient experienced increased redness and developed at 3x4 centimeters patch of clear vesicles on back of right arm, symptoms developed 24 hours after vaccine, it was described that the redness progressed with 10 x 5 cm surrounding erythema with swelling. 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 453267-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cognitive disorder, Dyskinesia, Gaze palsy, Muscle rigidity, Pallor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female patient with no medical history and no previous illness was vaccinated dose 3 GARDASIL (batch number 0006404541). Left arm, IM on 24-ApR-2012. No other co-suspects were reported. No concomitant medications were reported. On 13-APR-20211 the patient had an historical vaccine administration of MENACTRA, a dose of Human papilloma vaccine (unspecified) and a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. It was reported that on 24-APR-2012 the patient became pale with rigid jerking arms and legs, eyes rolled back, the patient was unaware surroundings that lasted < 20 seconds. No postical phase, vital signals stable. 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 454606-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Disorientation, Dyskinesia, Gaze palsy, Laboratory test, Muscle rigidity
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female patient with no medical history and no previous illness was vaccinated dose 3 GARDASIL (batch number 0006404541). Left arm, IM on 24-ApR-2012. No other co-suspects were reported. No concomitant medications were reported. On 13-APR-20211 the patient had an historical vaccine administration of MENACTRA, a dose of Human papilloma vaccine (unspecified) and a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. It was reported that on 24-APR-2012 the patient became pale with rigid jerking arms and legs, eyes rolled back, the patient was unaware surroundings that lasted < 20 seconds. No postical phase, vital signals stable. 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 454606-1. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female patient with no medical history and no previous illness was vaccinated dose 3 GARDASIL (batch number 0006404541). Left arm, IM on 24-ApR-2012. No other co-suspects were reported. No concomitant medications were reported. On 13-APR-20211 the patient had an historical vaccine administration of MENACTRA, a dose of Human papilloma vaccine (unspecified) and a dose of diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. It was reported that on 24-APR-2012 the patient became pale with rigid jerking arms and legs, eyes rolled back, the patient was unaware surroundings that lasted < 20 seconds. No postical phase, vital signals stable. 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 454606-1. Additional information is not expected.
Age: 0.3
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Irritability
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 3.6 months old female patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated in the left leg with lot # (671994/1537AA) dose 1 of GARDASIL on 23-APR-2012. No other co-suspects and no concomitant medications were reported. On 27-APR-2012 the patient experienced increased fussiness, 5 days after onset of therapy. No treatment information was reported. The outcome of increased fussiness was unknown. The relatedness for increased fussiness 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 454857-1. No further information is available.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Fall, Head injury, Seizure like phenomena, 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. This spontaneous report as received from a regulatory authority refers to a 13 years old male patient. The patient was vaccinated intramuscularly in the right arm with lot # (669313/0692AA) dose 1 of GARDASIL on 02-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-MAY-2012 the patient felt dizzy and had syncope, fell back and hit his head in occipital area and experienced seizure like activity in right upper side of arm for 30 seconds. The patient was laid in the floor and then responded and was transferred to a room. Vitals were taken and were stable, an "accucheck" (blood glucose) was performed which resulted 90, blood pressure was 123/76 and a TB skin test-PPD Mantoux was performed (results not provided). No treatment information was reported. The outcome of the events dizziness, fall, head injury and syncope was unknown. The relatedness for the reported events was not provided for GARDASIL. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 454935-1. No further information is available.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Unresponsive to stimuli
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. The patient was vaccinated intramuscularly in the right arm with lot # (669313/0692AA) dose 1 of GARDASIL on 02-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-MAY-2012 the patient felt dizzy and had syncope, fell back and hit his head in occipital area and experienced seizure like activity in right upper side of arm for 30 seconds. The patient was laid in the floor and then responded and was transferred to a room. Vitals were taken and were stable, an "accucheck" (blood glucose) was performed which resulted 90, blood pressure was 123/76 and a TB skin test-PPD Mantoux was performed (results not provided). No treatment information was reported. The outcome of the events dizziness, fall, head injury and syncope was unknown. The relatedness for the reported events was not provided for GARDASIL. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 454935-1. No further information is available.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Dizziness, Fall, Head injury, Seizure like phenomena
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. The patient was vaccinated intramuscularly in the right arm with lot # (669313/0692AA) dose 1 of GARDASIL on 02-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-MAY-2012 the patient felt dizzy and had syncope, fell back and hit his head in occipital area and experienced seizure like activity in right upper side of arm for 30 seconds. The patient was laid in the floor and then responded and was transferred to a room. Vitals were taken and were stable, an "accucheck" (blood glucose) was performed which resulted 90, blood pressure was 123/76 and a TB skin test-PPD Mantoux was performed (results not provided). No treatment information was reported. The outcome of the events dizziness, fall, head injury and syncope was unknown. The relatedness for the reported events was not provided for GARDASIL. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 454935-1. No further information is available.
Age: 13.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Syncope, Tuberculin test, Unresponsive to stimuli
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. The patient was vaccinated intramuscularly in the right arm with lot # (669313/0692AA) dose 1 of GARDASIL on 02-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 02-MAY-2012 the patient felt dizzy and had syncope, fell back and hit his head in occipital area and experienced seizure like activity in right upper side of arm for 30 seconds. The patient was laid in the floor and then responded and was transferred to a room. Vitals were taken and were stable, an "accucheck" (blood glucose) was performed which resulted 90, blood pressure was 123/76 and a TB skin test-PPD Mantoux was performed (results not provided). No treatment information was reported. The outcome of the events dizziness, fall, head injury and syncope was unknown. The relatedness for the reported events was not provided for GARDASIL. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 454935-1. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Head injury, 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 17 years old female patient with no pertinent medical history or pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly with lot # (668260/1570Z) dose 1 GARDASIL (dose not reported) on 14-MAY-2012. No other co-suspects and no concomitant medications were reported. On 14-MAY-2012 the patient experienced a syncopal episode lasting less than 10 seconds. A computerized tomography (CT) of the patient's head was performed due to the patient hitting her head when she had the syncopal episode (results not provided). No treatment information was reported. The outcome of hitting her head was unknown. The relatedness for the reported events was not provided for GARDASIL. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 455523-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration
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 14 years old male patient. The patient was vaccinated intramuscularly in the right arm with lot # (672233/1561AA) of GARDASIL (dose not reported) on 23-APR-2012. It was reported that the patient was given a third dose of GARDASIL at an invalid interval. There was not 12 weeks between the second and the third dose even though there was 24 weeks between dose one and three. There was no adverse event. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 455578-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
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 14 years old male patient. The patient was vaccinated intramuscularly in the right arm with lot # (672233/1561AA) of GARDASIL (dose not reported) on 23-APR-2012. It was reported that the patient was given a third dose of GARDASIL at an invalid interval. There was not 12 weeks between the second and the third dose even though there was 24 weeks between dose one and three. There was no adverse event. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 455578-1. No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Injection site cellulitis
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 18 years old female patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (671006/1291AA) dose 1 of GARDASIL (dose not reported) on 12-MAY-2012. Other suspect therapies included dose 2 of VARIVAX (Merck) (lot # 668486/1402AA) (dose not reported) subcutaneously in the left arm on 12-MAY-2012. There were no concomitant medications. On an unknown date the patient developed cellulitis around injection site. No treatment information was reported. The outcome of cellulitis around injection site was unknown. The relatedness for the reported event 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 455620-1. No further information is available.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unevaluable event
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 23 years old female patient. The patient was vaccinated with lot # (15102) GARDASIL (dose and route not reported) on 17-APR-2012. No other co-suspects and no concomitant medications were reported. On an unknown date the patient experienced an unevalualble event. No treatment information was reported. The outcome of the event was unknown. The relatedness for unevaluable event 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 455625-1. No further information is available.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Pyrexia, Rash, Rash macular
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 9 years old female patient diagnosed with rash to CILOXAN in 2006. The patient was vaccinated in the left arm with lot # (672547/1745AA) dose 2 of GARDASIL (dose and route not reported) on 16-MAY-2012. No other co-suspects were reported. Concomitant medications included: MICROLAX 17 grams Qday PRN. After receiving the 2nd dose on 16-MAY-2012, the patient broke out with blotchy rash on trunk, arms, and upper thighs and had chills. Fever started and was highest at 102.5. The patient's mother gave her TYLENOL and the fever resolved by 10pm. When the patient woke in the morning of 17-MAY-2012 she felt better. 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 455697-1. No further information is available.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chills, Pyrexia, Rash macular
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 9 years old female patient diagnosed with rash to CILOXAN in 2006. The patient was vaccinated in the left arm with lot # (672547/1745AA) dose 2 of GARDASIL (dose and route not reported) on 16-MAY-2012. No other co-suspects were reported. Concomitant medications included: MICROLAX 17 grams Qday PRN. After receiving the 2nd dose on 16-MAY-2012, the patient broke out with blotchy rash on trunk, arms, and upper thighs and had chills. Fever started and was highest at 102.5. The patient's mother gave her TYLENOL and the fever resolved by 10pm. When the patient woke in the morning of 17-MAY-2012 she felt better. 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 455697-1. No further information is available.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor, Vomiting
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report was received from a regulatory authority refers to a 12 years old male patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the right arm with lot # (670050/1229AA) of GARDASIL (dose not reported) on 21-MAY-2012. No other co-suspects were reported. Concomitant vaccines given on the same day included a dose of BOOSTRIX (lot # AC52B066AA) IM in the left arm, a dose of MENACTRA (lot # U3837AA) IM in the left arm and a dose of HAVRIX (lot # AHAVB522AA) IM in the right arm. There was no other concomitant medications. On 21-MAY-2012, after vaccinations were given the patient complained of dizziness, became pale and diaphoretic and vomited. The patient was placed in a reclined position in a recliner and a cold pack was placed on the back of his neck. The patient began to return to normal skin color and he denied any nausea or dizziness after 15 minutes of recovery in the recliner. The patient was placed in the sitting position for 5 minutes without any dizziness or nausea. He was bale to stand and ambulate out of clinic without difficulty. No treatment information was reported. The outcome of became pale and diaphoretic and vomited was unknown. The outcome of dizziness was reported as recovered. 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 455917-1. No further information is available.
Age: 18.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Blood potassium decreased, Cold sweat, Dizziness, Dyspnoea
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 18 years old male patient with no medical history and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (671463/1359AA) dose 2 of GARDASIL (dose not reported) on 10-MAY-2012. No other co-suspects and no concomitant medications were reported. On 10-MAY-2012 the patient was complaining of feeling dizzy, clammy and difficulty breathing. The patient was diagnosed with low potassium in the emergency department of the local hospital. The patient was discharged alive. No treatment information was reported. The outcome of feeling dizzy, clammy and difficulty was unknown. The relatedness for the reported events was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is455927. This report was considered non serious by the agency. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, 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. This spontaneous report as received from a regulatory authority refers to a 11 years old female patient with overweight and no pre-existing illness at the time of vaccination. The patient was vaccinated intramuscularly in the left arm with lot # (671994/1537AA) dose 1 of GARDASIL (dose not reported) on 18-MAY-2012. Other suspect therapies included dose 1 of ADACEL (lot # C3927AA) (dose not reported) IM in the right arm on 18-MAY-2012. Concomitant medications included: MENACTRA. There was no other concomitant medications. On 19-MAY-2012 the patient developed a 2cm x 2cm area of redness with local increase in temperature at right upper arm ADACEL intramuscular site. No treatment information was reported and no lab diagnostic tests were performed. The outcome of the event was unknown. The relatedness for the reported events for GARDASIL. The original reporting source was not provided. The VAERS ID # is 455970. This report was considered non serious and no conditions by the agency. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Pain
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 18 years old female patient allergic to dibrompropamidine isethionate, PHENERGAN and CECLOR; with no birth defects and no chronic medical conditions. The patient was vaccinated with dose 1 of GARDASIL (lot #, dose and route not reported) on 13-MAR-2012 and was vaccinated intramuscularly in the left arm with lot # (1658AA) dose 2 of GARDASIL (dose not reported) on 21-MAY-2012. No other co-suspects were reported. Concomitant medications included: dose 1 of MENVEO (lot # A10058) IM in the right arm (dose not reported). On 22-MAY-2012 the patient experienced Aches, soreness and headaches. The symptoms started less than 24 hours after receiving GARDASIL. It was stated that the reporter felt it could be possible serum sickness secondary to GARDASIL. No treatment information was reported, the patient visited the emergency room. The outcome of the events was unknown for GARDASIL. The original reporting source was not provided. The VAERS ID # is 456019. This report was considered non serious by the agency. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old male patient. The patient was vaccinated intramuscularly in the right arm with lot # (672233/1561AA) dose 1 of GARDASIL (dose not reported) on 17-MAY-2012. No other co-suspects and no concomitant medications were reported. On 22-MAY-2012 the patient experienced swelling of right arm for 5 days. No treatment information was reported and no lab diagnostic tests were performed. The outcome of swelling of right arm was recovered/resolved on 26-MAY-2012. The relatedness for swelling of right arm was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is 456100. This report was considered non serious and no conditions by the agency. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Oedema peripheral
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 11 years old male patient. The patient was vaccinated intramuscularly in the right arm with lot # (672233/1561AA) dose 1 of GARDASIL (dose not reported) on 17-MAY-2012. No other co-suspects and no concomitant medications were reported. On 22-MAY-2012 the patient experienced swelling of right arm for 5 days. No treatment information was reported and no lab diagnostic tests were performed. The outcome of swelling of right arm was recovered/resolved on 26-MAY-2012. The relatedness for swelling of right arm was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is 456100. This report was considered non serious and no conditions by the agency. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: 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. This spontaneous report as received from a regulatory authority refers to a 14 years old male patient. The patient was vaccinated intramuscularly in the right arm with lot # (671463/1359AA) dose 2 of GARDASIL (dose not reported) on 18-MAY-2012. No other co-suspects and no concomitant medications were reported. On 19-MAY-2012 the patient developed hives covering entire body. The patient sought medical attention and was treated with ZYRTEC (OTC) and the event resolved within 72 hours on approximately 22-MAY-2012. The relatedness for hives covering entire body was not provided for GARDASIL. The original reporting source was not provided. The VAERS ID # is 456113. This report was considered non serious by the agency. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 year old male patient with no previous illness and previous vaccination illness of swelling with PREVNAR, was vaccinated with dose 1 of GARDASIL, (lot # 672547/1745AA), right arm (unknown route) on 13-JUN-2012. Suspect vaccine included a first dose of MENACTRA (Lot # U4256AA), in the right arm. Concomitant medications included ADACEL, and HAVRIX. There were no other concomitant medications. Past drug history included BACTRIM and CECLOR. It was reported that on 14-JUN-2012 the patient experienced swelling, redness, tenderness and itching on right deltoid. No treatment information was reported. The outcome of the events mentioned above was unknown. This report was considered non serious with ER doctor visit by the agency. The original reporting source was not provided. The VAERS ID # is 457853-1. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Agitation, Dizziness, Syncope, Vomiting
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old male patient with no previous illnesses and no medical history was vaccinated with dose 1 of GARDASIL (batch # 0420AE), right arm, IM. No other co-suspects were reported. Concomitant medications included BOOSTRIX and MENACTRA. It was reported that on 21-JUN-2012, the patient experienced vomiting, syncope, dizziness 5 minutes after the vaccines and agitation. No treatment information was reported. There were no labs performed. 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 457874-1. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Pt states she awakened in the morning at approximately 7:00 am on 8/10/12 itching with a fine flat red rash over chest, abd, thighs and arms.  She noticed slight hives on abdomen as the day wore on.  She denied Dyspnea, dysphagia, or edema around face.  She called Immunizations and was told to call her medical provider immediately and come to the clinic.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion, Electroencephalogram abnormal, Grand mal convulsion
Clinical narrative: Nocturnal Seizure. Now experiencing generalized clonic tonic seizures.  Needs medication to suppress.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Abnormal behaviour, Choking, Crying, Emotional distress, Muscle rigidity
Clinical narrative: Patient woke from nap with unconsolable screaming and crying with knees rigid, choking on own saliva from being so upset. Remained like this the rest of the day and continued to be timid and not engaged like his normal self for three days.
Age: 0.16
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Screaming
Clinical narrative: Patient woke from nap with unconsolable screaming and crying with knees rigid, choking on own saliva from being so upset. Remained like this the rest of the day and continued to be timid and not engaged like his normal self for three days.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Alopecia
Clinical narrative: Unexplained hair loss.
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blood test, Chills, Headache, Musculoskeletal stiffness
Clinical narrative: Painful arm; headache; chills; fever of 100.2; stiff neck; nausea; fainting; overall muscle aches; weakness.
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Pain in extremity, Pregnancy test, Pyrexia
Clinical narrative: Painful arm; headache; chills; fever of 100.2; stiff neck; nausea; fainting; overall muscle aches; weakness.
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Streptococcus test, Syncope, Urine analysis
Clinical narrative: Painful arm; headache; chills; fever of 100.2; stiff neck; nausea; fainting; overall muscle aches; weakness.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Had dizziness after injection. Felt better that night.
Age: 71.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling
Clinical narrative: The patient complained of swelling at the injection site and had seen a doctor who prescribed Augmentin.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Blood test, Cerebral disorder, Computerised tomogram head abnormal, Dizziness
Clinical narrative: I was sitting when the Gardasil vaccine was administered IM in the left shoulder.  Immediately after the vaccine was injected, I felt like I might pass out so I put my head down on my lap.  The nurse then woke me up.  She said that it had looked like I was having a seizure. She said I was shaking for 10-15 seconds and would have fallen out of the chair if she hadn't caught me.  After the event I felt cold and wanted to lie down.  I also felt like I was having weak heart palpitations.  After I lay down vital signs were taken and they were stable.  My blood sugar level was 120 non-fasting (I am not diabetic).  I went to the ER and got a glucose reading, blood tests, EKG and CT scan (without contrast).  The ER doctor thought I didn't have a seizure because I was aware of feeling faint before losing consciousness, didn't bite my tongue, didn't urinate on myself, and because it didn't take very long after I woke up for me to know where I was.  The only abnormal results on the CT scan were mild prominence of the lateral ventricles and 3mm of cerebellar tonsillar ectopia.  After I went home I had a headache and vomited twice.  Since the day of vaccination I have had no further side effects.  No history of seizures.  I have never fainted in the past after an injection or blood draw.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Electrocardiogram, Feeling cold, Headache, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: I was sitting when the Gardasil vaccine was administered IM in the left shoulder.  Immediately after the vaccine was injected, I felt like I might pass out so I put my head down on my lap.  The nurse then woke me up.  She said that it had looked like I was having a seizure. She said I was shaking for 10-15 seconds and would have fallen out of the chair if she hadn't caught me.  After the event I felt cold and wanted to lie down.  I also felt like I was having weak heart palpitations.  After I lay down vital signs were taken and they were stable.  My blood sugar level was 120 non-fasting (I am not diabetic).  I went to the ER and got a glucose reading, blood tests, EKG and CT scan (without contrast).  The ER doctor thought I didn't have a seizure because I was aware of feeling faint before losing consciousness, didn't bite my tongue, didn't urinate on myself, and because it didn't take very long after I woke up for me to know where I was.  The only abnormal results on the CT scan were mild prominence of the lateral ventricles and 3mm of cerebellar tonsillar ectopia.  After I went home I had a headache and vomited twice.  Since the day of vaccination I have had no further side effects.  No history of seizures.  I have never fainted in the past after an injection or blood draw.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Palpitations, Seizure like phenomena, Tremor, Vomiting
Clinical narrative: I was sitting when the Gardasil vaccine was administered IM in the left shoulder.  Immediately after the vaccine was injected, I felt like I might pass out so I put my head down on my lap.  The nurse then woke me up.  She said that it had looked like I was having a seizure. She said I was shaking for 10-15 seconds and would have fallen out of the chair if she hadn't caught me.  After the event I felt cold and wanted to lie down.  I also felt like I was having weak heart palpitations.  After I lay down vital signs were taken and they were stable.  My blood sugar level was 120 non-fasting (I am not diabetic).  I went to the ER and got a glucose reading, blood tests, EKG and CT scan (without contrast).  The ER doctor thought I didn't have a seizure because I was aware of feeling faint before losing consciousness, didn't bite my tongue, didn't urinate on myself, and because it didn't take very long after I woke up for me to know where I was.  The only abnormal results on the CT scan were mild prominence of the lateral ventricles and 3mm of cerebellar tonsillar ectopia.  After I went home I had a headache and vomited twice.  Since the day of vaccination I have had no further side effects.  No history of seizures.  I have never fainted in the past after an injection or blood draw.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: HIVES
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Lymph node pain, Neck pain, Oropharyngeal pain, Pyrexia, Swelling
Clinical narrative: Severe neck/gland pain, swelling, throat pain. Called doc morning following vaccine, he called in a Z pak in case unrelated, we KNEW it was due to vaccine, but didn't see how it culd hurt. Fever today, 102 degrees. Constant pain with intermittent Severe Shooting pain in gland/neck area.
Age: 1.27
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Diet refusal, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: High fever (up to 103.4). Patient refusing to eat any solid foods or take bottle, only wishing to nurse, for 2 days now.  Patient developed rash of tiny red dots all over her body on 08/18/2012.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Rash erythematous, Rash generalised, Wheezing
Clinical narrative: This spontaneous report as received from a physician refers to a 4 years old male patient with allergy to penicillin and other allergies. The patient's medical history included an episode of asthma 1st time on 17-MAY-2011 and chickenpox disease at 10 months. The patient was vaccinated with dose 1 of MMR II (lot #, dose and route not reported) in 2008 and was then vaccinated subcutaneously with (lot # 0075AE exp 01-JAN-2014) dose 2 of MMR II on 30-JUL-2012. No other co-suspects were reported. Concomitant medications included ALLEGRA and ZYRTEC as needed but was not on these medications at the time of vaccination. On 30-JUL-2012 the patient had an anaphylaxis reaction (life threatening and disabling). The patient had a red rash all over that was from the face down and wheezing badly. The patient was given a nebulizer and 30mg of a steroid. The patient was in the office for 2-3 hours and recovered. The physician stated the patient had no allergy to eggs and received a flu vaccine twice without any problems. No lab diagnostic tests were performed. The outcome of anaphylaxis reaction was reported as recovered on 30-JUL-2012. The relatedness for anaphylaxis reaction was not provided for MMR II. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Patient had seizure & was hospitalized.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash
Clinical narrative: Patient states rash and pain at injection site. Physician states to patient it is "shingles." Treating pain as needed per patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Erythema, itching on injection site Diphenhydramine 25 mg 2 tabs Q6h.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Patient received vaccine on 8/16/12. The next morning RUA was very tender, sore, swollen, warm & red. Put cool compresses on it & took ALEVE. Became worse and followed up at clinic. Examination of injection site revealed edematous, hot, red arm. 4x3 inches, tender when touching. No drainage. Dx of cellulitis vs. reaction to vaccine. KEFLEX 500 mg tid PO x 10 days initiated.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site warmth, Vaccination complication
Clinical narrative: Patient received vaccine on 8/16/12. The next morning RUA was very tender, sore, swollen, warm & red. Put cool compresses on it & took ALEVE. Became worse and followed up at clinic. Examination of injection site revealed edematous, hot, red arm. 4x3 inches, tender when touching. No drainage. Dx of cellulitis vs. reaction to vaccine. KEFLEX 500 mg tid PO x 10 days initiated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Oedema peripheral
Clinical narrative: Some sort of allergic reaction: redness, swelling down to elbow.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Vomiting
Clinical narrative: Patient reported vomiting twice and feeling lightheaded. Patient also reported feeling hot and sweating. Patient ate some food and felt better later that afternoon. Patient also started taking ARICEPT the same morning as the ZOSTAVAX was administered.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 8x8 cm red, warm, swollen area at injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. The patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) on 10-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced a temperature and rash at the injection site. No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of experienced a temperature and rash at the injection site was unknown. The relatedness for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a 14 years old male patient with no medical history and no pertinent medical history. The patient was vaccinated intramuscularly with lot # (673256/0629AE: exp date December 2014) dose 1, 0.5 ml dose of GARDASIL on 01-AUG-2012. No other co-suspects were reported. Concomitant medications included: a dose of MENACTRA at the same time. On 02-AUG-2012, the patient fainted 24 hours after vaccination. The patient sought medical attention by calling the physician, no treatment was given for the events and no lab diagnostic tests were performed. The patient recovered on 02-AUG-2012. The relatedness for fainted was not provided for GARDASIL. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a female consumer reporting on herself of unknown age. The patient was vaccinated with a dose of ZOSTAVAX on 26-JUL-2012 on the upper right arm, near the shoulder (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer stated that two days post vaccination, on 28JUL2012, she developed a swollen circular area about 1 1/2 inches at the injection site of the right arm. The site was itchy and warm to the touch, but no rash. The patient stated that the injection site reaction "flared off and on". The patient sought medical attention by emailing her doctor when prescribed cortisone cream. At the time of the report, the patient had not recovered from swollen circular area about 1 1/2 inches at the injection site of the right arm and from site was itchy and warm to the touch, but no rash. The patient was treated with cortisone cream. No other information was provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated subcutaneously with lot # (670816/0693AA exp date 11-AUG-2012), 0.65 ml dose of ZOSTAVAX on 13-AUG-2012. The only patient identifier that the nurse had available at the time of the report was the prescription number 175715. The pharmacist stated that to her knowledge the patient had not reported or exhibited any adverse effects. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from certified medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (lot #, dose and route not reported) on an unspecified date in 2011. The patient received dose 2 of GARDASIL (lot #, dose and route not reported) on an unspecified date in July 2012. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a female patient with no drug reactions or allergies who on 24-JUL-2012 was vaccinated SQ with a dose of ZOSTAVAX (lot # reported as 0562AE). No other co-suspects were reported. No concomitants were reported. The patient had been experiencing itching and induration around injection site after receiving ZOSTAVAX. No treatment was given for the adverse events. The patient spoke to pharmacist. At the time of the report, the patient had not recovered. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified patients who on an unspecified dates were vaccinated with a dose of GARDASIL (lot #, dose and site of administration were not reported) that had been exposed to temperatures not lower that -2.5 degrees Celsius for unspecified periods of time. No adverse effect was reported. This is one of the several reports of the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age who in August 2011 was vaccinated with the first dose of GARDASIL (lot #, and dose were not reported). On 06-AUG-2012, the patient was vaccinated with the second dose of GARDASIL. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients who on an unknown dates might have received improperly stored M-M-R II (dose and route not provided) (lot # 669840/0446AA, expiration date on 28-MAR-2013) albumin status. The nurse stated that the vaccines were exposed to 47-48 F for 72 hours and 32 F for 24 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a male patient of unknown age with no pertinent medical history, drug reactions or allergies. The patient was vaccinated subcutaneously with a standard dose of GARDASIL (lot # and dose not reported) last week approximately on 07-AUG-2012. No other co-suspects were reported. There was no concomitant medications. The patient developed swelling, redness and tenderness at the injection site after receiving the vaccination dose. The patient saw the nurse and MOTRIN was given as treatment for the events. No lab diagnostic tests were performed. The outcome of swelling, redness and tenderness at the injection site was reported as not recovered. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 1 and dose 2 GARDASIL on 29-SEP-2010 and 01-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Face oedema, Lip swelling, Ocular hyperaemia, Rash generalised
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 male patient was vaccinated IM into left arm with the second dose of GARDASIL (lot #"9725106") on 22-FEB-2012. No other co-suspects were reported. Concomitant medications included: ROBITUSSIN. On 22-FEB-2012 the patient experienced lip swelling, facial edema, entire body rash and eye redness. The patient's outcome was unknown. This report was considered not serious, required ER visit by agency. The original reporting source was not provided. The VAERS ID # is 450794-1. No further information is available.