chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, MNQ, TDAP, HEP, HPV9, IPV, MMR, MNQ, TDAP
Symptoms: Hyperhidrosis, Somnolence
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 677722 ) refers to a 12 years old male patient. The patient had no current illness. The patient's medical history, other medications, drug allergies and concomitant medications were unknown. On 11-JAN-2017 the patient was vaccinated with M-M-R II rHA(recombinant human albumin) (lot # M004305, expiry date not reported), 1 dose unit, subcutaneous in the right arm for prophylaxis. Other suspect therapies included ADACEL (Batch # U5533BA, expiry date not reported), ENGERIX-B (Batch #DA22F, expiry date not reported), poliovirus vaccine inactivated (vero)(IPOL) (Batch # N1A46, expiry date not reported), GARDASIL 9 (Lot # L040054, expiry date not reported) and MENACTRA (Batch # U5415AA, expiry date not reported). On 11-JAN-2017, the patient became diaphoretic and sleepy after vaccines. On an unknown date, blood pressure was 118/86 (units not specified) at the time of recovery. The outcome of hyperhidrosis and somnolence was reported as recovered/resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 16.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Pallor, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 678015) concerning a 16 year old male patient. On 12-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M030380) intramuscularly in the left arm. On 12-JAN-2017, the patient was light head, pale and had vomiting. On an unspecified date in 2017, the patient recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, HPV9
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 (VAERS # 678273) concerning a 14 year old male patient with no concurrent conditions or medical history. On 16-JAN-2017, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M032650) intramuscularly in the left arm. On 16-JAN-2017, 2 minutes after receiving GARDASIL 9, the patient experienced a brief episode of syncope. On an unspecified date in 2017, the patient recovered.       Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lip swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 678577) under the Freedom of Information Act on 10-MAY-2017 and refers to a 11 year old male patient. The patient's medical history included anxiety and Tourette's. The patient's concomitant therapies included aripiprazole(ABILIFY), loratadine(CLARITIN), clonidine, folic acid lamotrigine(LAMICTAL) and vitamins (unspecified)(MVI). There were no concurrent conditions. On 13-JAN-2017, the patient was vaccinated in a private office with his first dose of GARDASIL 9, intramuscularly in the left arm, which had a lot # of L037554 (concentration, dose, frequency and indication were not provided). Other suspect therapies included his first dose of MENVEO intramuscularly in the right arm, which had a lot # of Al6013 (concentration, dose, frequency and indication were not provided), HAVRIX intramuscularly in the left arm, which had a lot # of 9TS3T (concentration, dose, frequency and indication were not provided) and BOOSTRIX intramuscularly in the right arm, which had a lot # of 7RJ9B (concentration, dose, frequency and indication were not provided).  On 14-JAN-2017, the patient  presented to the emergency department (ED) with redness /pruritus to right deltoid without fever. The symptoms did not improve and was seen again for additional lip swelling on 16-JAN-2017. Therefore, an X-ray was given for it and prednisolone (ORAPRED)/clindamycin. Subsequently, on 17-JAN-2017, little improvement and seen again for similar. At the time of reporting, the outcome of injection site erythema, lip swelling, injection site swelling and injection site pruritus was unknown. The reporter did not provide a causality assessment between the suspect therapies and the events.   The original reporter was not provided. Additional information is not expected, as no further information could be obtained from the Agency.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Lip swelling, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 678577) under the Freedom of Information Act on 10-MAY-2017 and refers to a 11 year old male patient. The patient's medical history included anxiety and Tourette's. The patient's concomitant therapies included aripiprazole(ABILIFY), loratadine(CLARITIN), clonidine, folic acid lamotrigine(LAMICTAL) and vitamins (unspecified)(MVI). There were no concurrent conditions. On 13-JAN-2017, the patient was vaccinated in a private office with his first dose of GARDASIL 9, intramuscularly in the left arm, which had a lot # of L037554 (concentration, dose, frequency and indication were not provided). Other suspect therapies included his first dose of MENVEO intramuscularly in the right arm, which had a lot # of Al6013 (concentration, dose, frequency and indication were not provided), HAVRIX intramuscularly in the left arm, which had a lot # of 9TS3T (concentration, dose, frequency and indication were not provided) and BOOSTRIX intramuscularly in the right arm, which had a lot # of 7RJ9B (concentration, dose, frequency and indication were not provided).  On 14-JAN-2017, the patient  presented to the emergency department (ED) with redness /pruritus to right deltoid without fever. The symptoms did not improve and was seen again for additional lip swelling on 16-JAN-2017. Therefore, an X-ray was given for it and prednisolone (ORAPRED)/clindamycin. Subsequently, on 17-JAN-2017, little improvement and seen again for similar. At the time of reporting, the outcome of injection site erythema, lip swelling, injection site swelling and injection site pruritus was unknown. The reporter did not provide a causality assessment between the suspect therapies and the events.   The original reporter was not provided. Additional information is not expected, as no further information could be obtained from the Agency.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Autonomic nervous system imbalance, Disturbance in attention, Dizziness, Fatigue, 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 (Agency # 678754) on 10-MAY-2017. This spontaneous report was received from a health professional referring to a 13 year old female patient. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 21-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M011117), intramuscular in the left arm, for prophylaxis (dose and expiration date were not provided). Other suspect therapies included MENACTRA (lot # U5282BB), intramuscular in the right arm, for prophylaxis (dose and expiration date were not provided). The patient was vaccinated at private Doctor's office/Hospital. On 04-AUG-2016 (reported as about 2 weeks post vaccine), the patient experienced dizziness. On 11-AUG-2016 (reported as about a week later), the patient experienced headache and had been fatigued continues to feel dizzy every day several times a day, her headache was daily all day long. On 15-AUG-2016, the patient experienced autonomic nervous system imbalance, tachycardia, nuclear magnetic resonance imaging normal, memory impairment, laboratory test normal and disturbance in attention and was hospitalized due to all events reported. At the time of reporting, the outcome of autonomic nervous system imbalance, tachycardia, nuclear magnetic resonance imaging normal, memory impairment, laboratory test normal, headache, fatigue, dizziness and disturbance in attention was unknown. The causal relationship between the suspect therapies and the events was not provided by the agency. The original reporting source was not provided. Additional information is not expected because no further information could be obtained from the health authority.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Laboratory test normal, Memory impairment, Nuclear magnetic resonance imaging normal, Tachycardia
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 (Agency # 678754) on 10-MAY-2017. This spontaneous report was received from a health professional referring to a 13 year old female patient. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 21-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M011117), intramuscular in the left arm, for prophylaxis (dose and expiration date were not provided). Other suspect therapies included MENACTRA (lot # U5282BB), intramuscular in the right arm, for prophylaxis (dose and expiration date were not provided). The patient was vaccinated at private Doctor's office/Hospital. On 04-AUG-2016 (reported as about 2 weeks post vaccine), the patient experienced dizziness. On 11-AUG-2016 (reported as about a week later), the patient experienced headache and had been fatigued continues to feel dizzy every day several times a day, her headache was daily all day long. On 15-AUG-2016, the patient experienced autonomic nervous system imbalance, tachycardia, nuclear magnetic resonance imaging normal, memory impairment, laboratory test normal and disturbance in attention and was hospitalized due to all events reported. At the time of reporting, the outcome of autonomic nervous system imbalance, tachycardia, nuclear magnetic resonance imaging normal, memory impairment, laboratory test normal, headache, fatigue, dizziness and disturbance in attention was unknown. The causal relationship between the suspect therapies and the events was not provided by the agency. The original reporting source was not provided. Additional information is not expected because no further information could be obtained from the health authority.
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pruritus, Sensation of foreign body
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not provided. Historical drugs included an unspecified penicillin. On 16-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the right arm, route of administration was reported as unknown (lot # M023169, expiration date was not provided), for prophylaxis. On the same day, the patient was also vaccinated with a dose of MENACTRA in the left arm, route of administration was reported as unknown (lot # U5415AA, expiration date was not provided), for prophylaxis. On 19-JAN-2017, the patient developed itchiness, redness, swelling of hands, knees, and feet. Also he claimed he was feeling like there was a ball in his throat but he had no difficulty swallowing and breathing. He was sent out to the emergency room for treatment. The outcome of the events was reported as recovered. The causality relationship between the events and GARDASIL 9 and MENACTRA was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Autonomic nervous system imbalance, Chills, Fatigue
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not provided. Historical drugs included an unspecified penicillin. On 16-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the right arm, route of administration was reported as unknown (lot # M023169, expiration date was not provided), for prophylaxis. On the same day, the patient was also vaccinated with a dose of MENACTRA in the left arm, route of administration was reported as unknown (lot # U5415AA, expiration date was not provided), for prophylaxis. On 19-JAN-2017, the patient developed itchiness, redness, swelling of hands, knees, and feet. Also he claimed he was feeling like there was a ball in his throat but he had no difficulty swallowing and breathing. He was sent out to the emergency room for treatment. The outcome of the events was reported as recovered. The causality relationship between the events and GARDASIL 9 and MENACTRA was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Headache, Postural orthostatic tachycardia syndrome, Pyrexia, Serum ferritin decreased, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not provided. Historical drugs included an unspecified penicillin. On 16-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the right arm, route of administration was reported as unknown (lot # M023169, expiration date was not provided), for prophylaxis. On the same day, the patient was also vaccinated with a dose of MENACTRA in the left arm, route of administration was reported as unknown (lot # U5415AA, expiration date was not provided), for prophylaxis. On 19-JAN-2017, the patient developed itchiness, redness, swelling of hands, knees, and feet. Also he claimed he was feeling like there was a ball in his throat but he had no difficulty swallowing and breathing. He was sent out to the emergency room for treatment. The outcome of the events was reported as recovered. The causality relationship between the events and GARDASIL 9 and MENACTRA was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Vitamin D decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not provided. Historical drugs included an unspecified penicillin. On 16-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the right arm, route of administration was reported as unknown (lot # M023169, expiration date was not provided), for prophylaxis. On the same day, the patient was also vaccinated with a dose of MENACTRA in the left arm, route of administration was reported as unknown (lot # U5415AA, expiration date was not provided), for prophylaxis. On 19-JAN-2017, the patient developed itchiness, redness, swelling of hands, knees, and feet. Also he claimed he was feeling like there was a ball in his throat but he had no difficulty swallowing and breathing. He was sent out to the emergency room for treatment. The outcome of the events was reported as recovered. The causality relationship between the events and GARDASIL 9 and MENACTRA was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Asthenia, Autonomic nervous system imbalance, Chills
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not provided. Historical drugs included an unspecified penicillin. On 16-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the right arm, route of administration was reported as unknown (lot # M023169, expiration date was not provided), for prophylaxis. On the same day, the patient was also vaccinated with a dose of MENACTRA in the left arm, route of administration was reported as unknown (lot # U5415AA, expiration date was not provided), for prophylaxis. On 19-JAN-2017, the patient developed itchiness, redness, swelling of hands, knees, and feet. Also he claimed he was feeling like there was a ball in his throat but he had no difficulty swallowing and breathing. He was sent out to the emergency room for treatment. The outcome of the events was reported as recovered. The causality relationship between the events and GARDASIL 9 and MENACTRA was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Fatigue, Headache, Postural orthostatic tachycardia syndrome, Pyrexia, Serum ferritin decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not provided. Historical drugs included an unspecified penicillin. On 16-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the right arm, route of administration was reported as unknown (lot # M023169, expiration date was not provided), for prophylaxis. On the same day, the patient was also vaccinated with a dose of MENACTRA in the left arm, route of administration was reported as unknown (lot # U5415AA, expiration date was not provided), for prophylaxis. On 19-JAN-2017, the patient developed itchiness, redness, swelling of hands, knees, and feet. Also he claimed he was feeling like there was a ball in his throat but he had no difficulty swallowing and breathing. He was sent out to the emergency room for treatment. The outcome of the events was reported as recovered. The causality relationship between the events and GARDASIL 9 and MENACTRA was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Tremor, Vitamin D decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not provided. Historical drugs included an unspecified penicillin. On 16-JAN-2017, the patient was vaccinated with a dose of GARDASIL 9 in the right arm, route of administration was reported as unknown (lot # M023169, expiration date was not provided), for prophylaxis. On the same day, the patient was also vaccinated with a dose of MENACTRA in the left arm, route of administration was reported as unknown (lot # U5415AA, expiration date was not provided), for prophylaxis. On 19-JAN-2017, the patient developed itchiness, redness, swelling of hands, knees, and feet. Also he claimed he was feeling like there was a ball in his throat but he had no difficulty swallowing and breathing. He was sent out to the emergency room for treatment. The outcome of the events was reported as recovered. The causality relationship between the events and GARDASIL 9 and MENACTRA was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pruritus, Sensation of foreign body
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 16 year old female patient. The patient's medical history included eczema. Concurrent conditions and pertinent medical history was not provided. On 15-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Concomitant therapies included fluoxetine. On 18-SEP-2016, the patient experienced Extreme joint pain, dysautonomia, postural orthostatic tachycardia syndrome POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever, serum ferritin decreased and vitamin D decreased. An Antinuclear antibody (ANA 9 PANEL) was performed and showed SS-B antibiotics present with screen reflex (positive). The patient had not recovered from the events and at the reporting time still had all symptoms. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Autonomic nervous system imbalance, Chills, Fatigue
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 16 year old female patient. The patient's medical history included eczema. Concurrent conditions and pertinent medical history was not provided. On 15-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Concomitant therapies included fluoxetine. On 18-SEP-2016, the patient experienced Extreme joint pain, dysautonomia, postural orthostatic tachycardia syndrome POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever, serum ferritin decreased and vitamin D decreased. An Antinuclear antibody (ANA 9 PANEL) was performed and showed SS-B antibiotics present with screen reflex (positive). The patient had not recovered from the events and at the reporting time still had all symptoms. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Headache, Postural orthostatic tachycardia syndrome, Pyrexia, Serum ferritin decreased, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 16 year old female patient. The patient's medical history included eczema. Concurrent conditions and pertinent medical history was not provided. On 15-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Concomitant therapies included fluoxetine. On 18-SEP-2016, the patient experienced Extreme joint pain, dysautonomia, postural orthostatic tachycardia syndrome POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever, serum ferritin decreased and vitamin D decreased. An Antinuclear antibody (ANA 9 PANEL) was performed and showed SS-B antibiotics present with screen reflex (positive). The patient had not recovered from the events and at the reporting time still had all symptoms. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Vitamin D decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 16 year old female patient. The patient's medical history included eczema. Concurrent conditions and pertinent medical history was not provided. On 15-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Concomitant therapies included fluoxetine. On 18-SEP-2016, the patient experienced Extreme joint pain, dysautonomia, postural orthostatic tachycardia syndrome POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever, serum ferritin decreased and vitamin D decreased. An Antinuclear antibody (ANA 9 PANEL) was performed and showed SS-B antibiotics present with screen reflex (positive). The patient had not recovered from the events and at the reporting time still had all symptoms. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Asthenia, Autonomic nervous system imbalance, Chills
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 16 year old female patient. The patient's medical history included eczema. Concurrent conditions and pertinent medical history was not provided. On 15-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Concomitant therapies included fluoxetine. On 18-SEP-2016, the patient experienced Extreme joint pain, dysautonomia, postural orthostatic tachycardia syndrome POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever, serum ferritin decreased and vitamin D decreased. An Antinuclear antibody (ANA 9 PANEL) was performed and showed SS-B antibiotics present with screen reflex (positive). The patient had not recovered from the events and at the reporting time still had all symptoms. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Fatigue, Headache, Postural orthostatic tachycardia syndrome, Pyrexia, Serum ferritin decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 16 year old female patient. The patient's medical history included eczema. Concurrent conditions and pertinent medical history was not provided. On 15-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Concomitant therapies included fluoxetine. On 18-SEP-2016, the patient experienced Extreme joint pain, dysautonomia, postural orthostatic tachycardia syndrome POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever, serum ferritin decreased and vitamin D decreased. An Antinuclear antibody (ANA 9 PANEL) was performed and showed SS-B antibiotics present with screen reflex (positive). The patient had not recovered from the events and at the reporting time still had all symptoms. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ, HPV9, HPV9
Symptoms: Tremor, Vitamin D decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 679347) under the Freedom of Information Act referring to a 16 year old female patient. The patient's medical history included eczema. Concurrent conditions and pertinent medical history was not provided. On 15-SEP-2016, the patient was vaccinated with a first dose of GARDASIL 9 in the left arm, route of administration was reported as unknown (lot # L036301, expiration date was not provided), for prophylaxis. Concomitant therapies included fluoxetine. On 18-SEP-2016, the patient experienced Extreme joint pain, dysautonomia, postural orthostatic tachycardia syndrome POTS, chronic fatigue, daily debilitating headaches, constant shaking, chills, fever, serum ferritin decreased and vitamin D decreased. An Antinuclear antibody (ANA 9 PANEL) was performed and showed SS-B antibiotics present with screen reflex (positive). The patient had not recovered from the events and at the reporting time still had all symptoms. The causality relationship between the events and GARDASIL 9 was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency# 679941). Information was received regarding a 14 year old male patient. The patient's medical history and current illness was not reported. On 09-JAN-2017, the patient was vaccinated with GARDASIL 9 (Strength, dose, frequency, batch# and expiration date were not reported) of lot# M028323 in the left arm, intramuscularly for prophylaxis. Other suspect therapy included MENVEO vaccine. There were no concomitant therapies reported. On 10-JAN-2017, the next day, the patient experienced redness and swelling in the upper arm below the site of injection. On an unknown date, the patient visited the emergency room. The outcome of the events, redness and swelling in the upper arm was reported to be recovered/resolved. The causal relationship between the suspect therapy, GARDASIL 9 and the events was not reported. Additional information is not expected as no further information could be obtained from the regulatory authority.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Syncope, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency# 680086). Information was received regarding a 11 year old female patient. The patient's medical history and current illness was not reported. On 26-JAN-2017, the patient was vaccinated with GARDASIL 9 (Strength, dose, frequency, route, batch# and expiration date were not reported) of lot# M0013636 in the left arm for prophylaxis. Other suspect therapies included MENACTRA and ADACEL. There were no concomitant therapies reported. On the same day of vaccine administration, the patient fainted for 5 seconds and experienced shaking for 3 minutes. The outcome of the events was reported to be recovered/resolved. The causal relationship between the suspect therapy, GARDASIL 9 and the events was not reported. Additional information is not expected as no further information could be obtained from the regulatory authority.
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL, FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Eye swelling, Macule, Ocular hyperaemia, Papule, 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 (HA# 680138). This spontaneous report refers to a 12 year old female patient. The patent did not have current illnesses or medical history. The patient did not take other medications. It was reported that the patient arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Her family with no obtainable vaccine records. The vaccines were given on 09-JAN-2017. A rash started to the upper chest on 16-JAN-2017, the rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. The patient was seen in the clinic on 18-JAN-2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back; the lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The patient was restricted from school entrance for 7 days. The Epidemiology department (County) was contacted and provided the timeline symptoms and history. They concurred and the child remained in isolation at home. The patient's mother appeared to the clinic without the patient on 20-JAN-2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the emergency room at Medical Center for R/O periorbital cellulitis. The patient's mother returned to the school on 24-JAN-2017 with an emergency room note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic nurse practitioner. It was reported that there was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The patient was evaluated on 25-JAN-2017 and all lesions were scabbed. The patient had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequel. The reporter did not assess the relatedness between all adverse events and suspect therapies. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL, FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Rash, Scab, Skin lesion, Varicella post vaccine
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 (HA# 680138). This spontaneous report refers to a 12 year old female patient. The patent did not have current illnesses or medical history. The patient did not take other medications. It was reported that the patient arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Her family with no obtainable vaccine records. The vaccines were given on 09-JAN-2017. A rash started to the upper chest on 16-JAN-2017, the rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. The patient was seen in the clinic on 18-JAN-2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back; the lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The patient was restricted from school entrance for 7 days. The Epidemiology department (County) was contacted and provided the timeline symptoms and history. They concurred and the child remained in isolation at home. The patient's mother appeared to the clinic without the patient on 20-JAN-2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the emergency room at Medical Center for R/O periorbital cellulitis. The patient's mother returned to the school on 24-JAN-2017 with an emergency room note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic nurse practitioner. It was reported that there was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The patient was evaluated on 25-JAN-2017 and all lesions were scabbed. The patient had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequel. The reporter did not assess the relatedness between all adverse events and suspect therapies. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL, FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema of eyelid, Eyelid oedema, Macule, Papule, 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 (HA# 680138). This spontaneous report refers to a 12 year old female patient. The patent did not have current illnesses or medical history. The patient did not take other medications. It was reported that the patient arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Her family with no obtainable vaccine records. The vaccines were given on 09-JAN-2017. A rash started to the upper chest on 16-JAN-2017, the rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. The patient was seen in the clinic on 18-JAN-2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back; the lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The patient was restricted from school entrance for 7 days. The Epidemiology department (County) was contacted and provided the timeline symptoms and history. They concurred and the child remained in isolation at home. The patient's mother appeared to the clinic without the patient on 20-JAN-2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the emergency room at Medical Center for R/O periorbital cellulitis. The patient's mother returned to the school on 24-JAN-2017 with an emergency room note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic nurse practitioner. It was reported that there was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The patient was evaluated on 25-JAN-2017 and all lesions were scabbed. The patient had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequel. The reporter did not assess the relatedness between all adverse events and suspect therapies. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL, FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Rash, Scab, Skin lesion
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 (HA# 680138). This spontaneous report refers to a 12 year old female patient. The patent did not have current illnesses or medical history. The patient did not take other medications. It was reported that the patient arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Her family with no obtainable vaccine records. The vaccines were given on 09-JAN-2017. A rash started to the upper chest on 16-JAN-2017, the rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. The patient was seen in the clinic on 18-JAN-2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back; the lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The patient was restricted from school entrance for 7 days. The Epidemiology department (County) was contacted and provided the timeline symptoms and history. They concurred and the child remained in isolation at home. The patient's mother appeared to the clinic without the patient on 20-JAN-2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the emergency room at Medical Center for R/O periorbital cellulitis. The patient's mother returned to the school on 24-JAN-2017 with an emergency room note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic nurse practitioner. It was reported that there was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The patient was evaluated on 25-JAN-2017 and all lesions were scabbed. The patient had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequel. The reporter did not assess the relatedness between all adverse events and suspect therapies. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash pruritic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 680480) refers to a 12 year old female patient. There was no medical history, concurrent conditions and other medications. On 23-JAN-2017 the patient was vaccinated with GARDASIL 9 (lot # M023169, expiry date not reported) 1 dose unit, intramuscular in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (Batch # B4SD9, expiry date not reported) and MENACTRA (Batch # U5415AA, expiry date not reported). No concomitant medications were reported. On 24-JAN-2017 the patient noticed pain, redness and some swelling around injection sites (bilateral deltoids). Mother provided Ibuprofen for comfort. On 25-JAN-2017 approximately mid day, the patient began to develop rash from just below shoulder, down to approximately 2 inches above elbow bilaterally. Rash has been itchy. mom has treated with over the counter (OTC) anti-itch cream (unknown brand) with minimal improvement. Rash still remained 8 days after vaccination. The outcome of the events was reported as not recovered/not resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site abscess, Injection site pain, Injection site rash, Injection site swelling, Rash pruritic
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 680480) refers to a 12 year old female patient. There was no medical history, concurrent conditions and other medications. On 23-JAN-2017 the patient was vaccinated with GARDASIL 9 (lot # M023169, expiry date not reported) 1 dose unit, intramuscular in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (Batch # B4SD9, expiry date not reported) and MENACTRA (Batch # U5415AA, expiry date not reported). No concomitant medications were reported. On 24-JAN-2017 the patient noticed pain, redness and some swelling around injection sites (bilateral deltoids). Mother provided Ibuprofen for comfort. On 25-JAN-2017 approximately mid day, the patient began to develop rash from just below shoulder, down to approximately 2 inches above elbow bilaterally. Rash has been itchy. mom has treated with over the counter (OTC) anti-itch cream (unknown brand) with minimal improvement. Rash still remained 8 days after vaccination. The outcome of the events was reported as not recovered/not resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: unevaluable event; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 11 year old male patient. The patient's medical history includes mood disorder and Attention deficit/hyperactivity disorder. Concomitant therapies included ABILIFY, guanfacine hydrochloride and trazodone hydrochloride. On 31-JAN-2017, the patient was vaccinated with GARDASIL 9 (dosage details were not reported) (lot # M016193, and expiration date was not reported) intramuscular in the left arm vaccinated at private doctor office/hospital for prophylaxis. Other suspect therapies included MENACTRA (lot # U5460BA) intramuscular route in right arm, BOOSTRIX (lot # GS5BR)intramuscular route in right arm, and FLUZONE Quadrivaelnt (lot # UT5686MA) intramuscular route in left arm. On 01-FEB-2017, 2 days after onset of therapy the patient experienced unevaluable event. The outcome of unevaluable event was unknown. Causality assessment was not provided. Additional information is not expected, because no further information can be obtained from the local regulatory authority.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Endometrial thickening, Fatigue, Fungal infection, Ovarian cyst
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 681137) refers to a 16 years old female patient. There was no medical history and other medications. The patient's current illness was unknown. On 12-JUL-2016 the patient was vaccinated with 3rd dose of GARDASIL 9 1 dose unit, route of administration: needle and syringe (not specified further) in the right arm (lot # and expiry date was not reported) for prophylaxis. No concomitant medications were reported. On 12-JAN-2017, the patient experienced abdominal pain, persistent urinary tract infections, ovarian cyst, yeast infection, fatigue and endometrial thickening. The outcome of the events was reported as not recovered/not resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.