chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 5/9/17 - 4:45 PM - child given PROQUAD to (L) arm sc. Child returned on 5/10/17 with (L) upper arm red, swollen, hot to touch - measured 5 cm in length and 2 1/2 cm wide. Painful to touch. Provider, RX'd hydrocortisone cream 1%, TYLENOL 120 mg prn suppository.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Urticaria on arms and legs 20 mins after vaccines given - given prednisolone and BENADRYL in office.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Rash pruritic
Clinical narrative: LVN administered flu vaccine prior to PCP visit, developed rashy itchy traveling up arm injection site to left chest; no acute dyspnea or tachycardia.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Periarthritis, Ultrasound scan
Clinical narrative: Left frozen shoulder.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site 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 (VAERS # 616896). This spontaneous report refers to a 11 year old female patient. Information on patient's concurrent illnesses, medical history and other medications were not reported. On 03-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L017407, dose 3, route: unknown in the left deltoid for prophylaxis. On 26-DEC-2015, approximately 23 days after administration of GARDASIL 9 in left deltoid, patient noted a painful lump at the site of injection and she had no systemic symptoms. No treatment was recommended. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Detoxification, Exposure to toxic agent, Facial pain, Neck pain, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 622942) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included latex contact allergy. Patient's other medications included PRN Calcium supplement and the patient's mother could not recall any illnesses at the time of vaccination or immediately preceding vaccination. There were no prior vaccinations reported. On 07-OCT-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026247, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 2, vaccinated date: 07-OCT-2015, intramuscularly in the left arm, lot# U5178AA; dose and expiration date unknown). On 12-OCT-2015, the patient experienced detoxification, rash erythematous, rash, rash pruritic, and exposure to toxic agent. The patient's mother described that within one week of vaccination, the patient developed a rash on her neck and face that both hurt and itched. The rash was described as also being red and swollen and about the size of acne without the pustule. Patient's mother gave the patient BENADRYL and the rash went away, but returned as soon as the BENADRYL was stopped. The patient underwent testing at her chiropractor who determined that she was exposed to chemicals and needed to be detoxified. She was "chemically detoxified" 3 times, with the rash returning after each treatment. At this time, the chiropractor told the patient to take Adrenal Cortex, ADB5, and Bio D daily as the patient could no longer have the chemical detoxification treatments and the rash was no longer present with these daily supplements. The outcome of detoxification, rash erythematous, rash, rash pruritic and exposure to toxic agent was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Rash erythematous, Rash pruritic, 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 (VAERS # 622942) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included latex contact allergy. Patient's other medications included PRN Calcium supplement and the patient's mother could not recall any illnesses at the time of vaccination or immediately preceding vaccination. There were no prior vaccinations reported. On 07-OCT-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026247, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 2, vaccinated date: 07-OCT-2015, intramuscularly in the left arm, lot# U5178AA; dose and expiration date unknown). On 12-OCT-2015, the patient experienced detoxification, rash erythematous, rash, rash pruritic, and exposure to toxic agent. The patient's mother described that within one week of vaccination, the patient developed a rash on her neck and face that both hurt and itched. The rash was described as also being red and swollen and about the size of acne without the pustule. Patient's mother gave the patient BENADRYL and the rash went away, but returned as soon as the BENADRYL was stopped. The patient underwent testing at her chiropractor who determined that she was exposed to chemicals and needed to be detoxified. She was "chemically detoxified" 3 times, with the rash returning after each treatment. At this time, the chiropractor told the patient to take Adrenal Cortex, ADB5, and Bio D daily as the patient could no longer have the chemical detoxification treatments and the rash was no longer present with these daily supplements. The outcome of detoxification, rash erythematous, rash, rash pruritic and exposure to toxic agent was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Chills, Fatigue, Gastrooesophageal reflux disease, 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 (VAERS # 624351) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included allergies to AUGMENTIN and sulfa drugs. Other medications included QVAR, ZYRTEC and albuterol. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L025737, intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 20-JAN-2016, intramuscularly in the right arm, lot# 4R3MJ; dose and expiration date unknown) MENVEO (vaccinated date: 20-JAN-2016, intramuscularly in the right arm, lot# A14136; dose and expiration date unknown) and HAVRIX (vaccinated date: 20-JAN-2016, intramuscularly in the left arm, lot# 2PC5H; dose and expiration date unknown). On 21-JAN-2016, the patient experienced abdominal pain upper, urticaria, swelling, pruritus, nausea, injection site swelling, injection site rash, injection site induration, injection site erythema, induration, headache, gastrooesophageal reflux disease, fatigue and chills. Patient also developed hives around the vaccinated site on the same day followed by itching. Patient's mother treated her with ZYRTEC and ZANTAC. Hives were resolved and returned again on 25-JAN-2016 to 26-JAN-2016. Patient's mother called the pediatric office and was advised to treat with BENADRYL which seemed to help the hives and itching. Rash remained with residual hives, swelling and induration. On 27-JAN-2016, patient developed headache, nausea and stomach ache. Patient had reflux but no vomiting, was tired and had chills without fever. Patient visited the doctor's office on 29-JAN-2016. Patient was mildly ill while appearing for exam and was tired and could not focus on the exam. Patient's right upper arm had induration with a serpiginous rash and resolving hives. There was no discrete wheal and flare. Patient was treated with supportive care. The outcome of abdominal pain upper, urticaria, swelling, pruritus, nausea, injection site swelling, injection site rash, injection site induration, injection site erythema, induration, headache, gastrooesophageal reflux disease, fatigue and chills was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 624351) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included allergies to AUGMENTIN and sulfa drugs. Other medications included QVAR, ZYRTEC and albuterol. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L025737, intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 20-JAN-2016, intramuscularly in the right arm, lot# 4R3MJ; dose and expiration date unknown) MENVEO (vaccinated date: 20-JAN-2016, intramuscularly in the right arm, lot# A14136; dose and expiration date unknown) and HAVRIX (vaccinated date: 20-JAN-2016, intramuscularly in the left arm, lot# 2PC5H; dose and expiration date unknown). On 21-JAN-2016, the patient experienced abdominal pain upper, urticaria, swelling, pruritus, nausea, injection site swelling, injection site rash, injection site induration, injection site erythema, induration, headache, gastrooesophageal reflux disease, fatigue and chills. Patient also developed hives around the vaccinated site on the same day followed by itching. Patient's mother treated her with ZYRTEC and ZANTAC. Hives were resolved and returned again on 25-JAN-2016 to 26-JAN-2016. Patient's mother called the pediatric office and was advised to treat with BENADRYL which seemed to help the hives and itching. Rash remained with residual hives, swelling and induration. On 27-JAN-2016, patient developed headache, nausea and stomach ache. Patient had reflux but no vomiting, was tired and had chills without fever. Patient visited the doctor's office on 29-JAN-2016. Patient was mildly ill while appearing for exam and was tired and could not focus on the exam. Patient's right upper arm had induration with a serpiginous rash and resolving hives. There was no discrete wheal and flare. Patient was treated with supportive care. The outcome of abdominal pain upper, urticaria, swelling, pruritus, nausea, injection site swelling, injection site rash, injection site induration, injection site erythema, induration, headache, gastrooesophageal reflux disease, fatigue and chills was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site swelling, Injection site urticaria, Malaise, Nausea, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 624351) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included allergies to AUGMENTIN and sulfa drugs. Other medications included QVAR, ZYRTEC and albuterol. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L025737, intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 20-JAN-2016, intramuscularly in the right arm, lot# 4R3MJ; dose and expiration date unknown) MENVEO (vaccinated date: 20-JAN-2016, intramuscularly in the right arm, lot# A14136; dose and expiration date unknown) and HAVRIX (vaccinated date: 20-JAN-2016, intramuscularly in the left arm, lot# 2PC5H; dose and expiration date unknown). On 21-JAN-2016, the patient experienced abdominal pain upper, urticaria, swelling, pruritus, nausea, injection site swelling, injection site rash, injection site induration, injection site erythema, induration, headache, gastrooesophageal reflux disease, fatigue and chills. Patient also developed hives around the vaccinated site on the same day followed by itching. Patient's mother treated her with ZYRTEC and ZANTAC. Hives were resolved and returned again on 25-JAN-2016 to 26-JAN-2016. Patient's mother called the pediatric office and was advised to treat with BENADRYL which seemed to help the hives and itching. Rash remained with residual hives, swelling and induration. On 27-JAN-2016, patient developed headache, nausea and stomach ache. Patient had reflux but no vomiting, was tired and had chills without fever. Patient visited the doctor's office on 29-JAN-2016. Patient was mildly ill while appearing for exam and was tired and could not focus on the exam. Patient's right upper arm had induration with a serpiginous rash and resolving hives. There was no discrete wheal and flare. Patient was treated with supportive care. The outcome of abdominal pain upper, urticaria, swelling, pruritus, nausea, injection site swelling, injection site rash, injection site induration, injection site erythema, induration, headache, gastrooesophageal reflux disease, fatigue and chills was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Swelling, 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 (VAERS # 624351) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included allergies to AUGMENTIN and sulfa drugs. Other medications included QVAR, ZYRTEC and albuterol. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L025737, intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 20-JAN-2016, intramuscularly in the right arm, lot# 4R3MJ; dose and expiration date unknown) MENVEO (vaccinated date: 20-JAN-2016, intramuscularly in the right arm, lot# A14136; dose and expiration date unknown) and HAVRIX (vaccinated date: 20-JAN-2016, intramuscularly in the left arm, lot# 2PC5H; dose and expiration date unknown). On 21-JAN-2016, the patient experienced abdominal pain upper, urticaria, swelling, pruritus, nausea, injection site swelling, injection site rash, injection site induration, injection site erythema, induration, headache, gastrooesophageal reflux disease, fatigue and chills. Patient also developed hives around the vaccinated site on the same day followed by itching. Patient's mother treated her with ZYRTEC and ZANTAC. Hives were resolved and returned again on 25-JAN-2016 to 26-JAN-2016. Patient's mother called the pediatric office and was advised to treat with BENADRYL which seemed to help the hives and itching. Rash remained with residual hives, swelling and induration. On 27-JAN-2016, patient developed headache, nausea and stomach ache. Patient had reflux but no vomiting, was tired and had chills without fever. Patient visited the doctor's office on 29-JAN-2016. Patient was mildly ill while appearing for exam and was tired and could not focus on the exam. Patient's right upper arm had induration with a serpiginous rash and resolving hives. There was no discrete wheal and flare. Patient was treated with supportive care. The outcome of abdominal pain upper, urticaria, swelling, pruritus, nausea, injection site swelling, injection site rash, injection site induration, injection site erythema, induration, headache, gastrooesophageal reflux disease, fatigue and chills was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
Symptoms: Headache, Injection site erythema, Injection site pain, 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 (VAERS # 625266) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient's medical history included acne and had no known allergies, birth defects or medical conditions. Prior vaccinations included HAVRIX, dose 1 at 17:00 and TRUMENBA, dose 1 at 17:00. Other medications were reported as Erythromycin topical 2 % after Hepatitis A and Meningococcal B vaccinations and youth ran a temperature and had a headache but was not reported to the VAERS. On 01-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L020015, dose 3, intramuscularly in the left arm for prophylaxis. Other suspect therapies included TRUMENBA (dose number: 2, vaccinated date: 01-MAR-2016, intramuscularly in the left arm, lot# L013514; dose and expiration date unknown). On 02-MAR-2016, the patient experienced headache, injection site warmth, injection site pain and injection site erythema. Redness was observed in upper arm and shoulder and was warm to touch but no swelling was noted. The outcome of headache, injection site warmth, injection site pain and injection site erythema were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: FLUN4, HEP, HEPA, HPV9, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor
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# 625476) and refers to a 13 year old male patient. Patient's current illnesses, medical history and other medication was reported as none. No details about lab data and prior vaccination was provided. On 04-MAR-2016, the patient was vaccinated with GARDASIL 9, lot # L023230, dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 04-MAR-2016, lot # L024266, subcutaneous in the right arm for prophylaxis), VARIVAX (administered on 04-MAR-2016, lot # L037563, subcutaneous in the left arm for prophylaxis), HAVRIX (administered on 04-MAR-2016, lot # 2PC5H, intramuscular in the left arm for prophylaxis), BOOSTRIX (administered on 04-MAR-2016, lot # B4SD9, intramuscular in the right arm for prophylaxis), FLUMIST QUADRIVALENT (administered on 04-MAR-2016, lot # FN2127, intranasal for prophylaxis), ENGERIX-B (administered on 04-MAR-2016, lot # CB544, intramuscular in the left arm for prophylaxis) and MENACTRA (administered on 04-MAR-2016, lot # U5172BA, intramuscular in the right arm for prophylaxis). On 04-MAR-2016, patient began feeling faint after vaccines were given. Patient was sweaty and pale, told patient to sit and put legs up on another chair. Patient's blood pressure was checked and it was 88/62 (unit unknown). Patient was given some water to drink and was told patient to eat the peanut butter crackers he was given. Patient was asked if he was dizzy or feeling better after five minutes. Patient stated he was feeling better. Blood pressure was rechecked and it was 98 over 78 (unit unknown). The outcome of dizziness, pallor and hyperhidrosis was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Hypoacusis, Immediate post-injection reaction
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 # 627482) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included seasonal allergies. Information on other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 11-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L020015, dose 2, intramuscularly in the right arm for prophylaxis. On the same day, the patient experienced dizziness, immediate post-injection reaction, hypoacusis and headache. Patient reported that her head and ears were "muffled". Patient had bilateral feet elevated and cold rag given to patient or ice water (per patient's request after 15 minutes from injection). Patient was in exam room 30 minutes after injection for registered nurse (RN) to observe. Patient stated she was no longer dizzy and her head "was feeling better". Patient reported she was fine. The outcome of dizziness, immediate post-injection reaction, hypoacusis and headache was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis
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 # 627553) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 29-FEB-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L016429, dose 3, via unknown route in the left arm for prophylaxis. On 02-MAR-2016, the patient experienced cellulitis. The outcome of cellulitis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
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 (VAERS # 628093). This spontaneous report refers to a 18 year old male patient. Patient had no concurrent illnesses, medical history and other medications. On 26-JUN-2015, the patient was vaccinated with GARDASIL 9, lot # K026246, dose 3, intramuscularly in the left arm for prophylaxis. On the same day, patient was also vaccinated with TRUMENBA lot # J29203, dose 1, intramuscularly in the right arm for prophylaxis. On 27-JUN-2015 (within 24 hours after vaccination), the patient developed hives externally. The outcome of the event was reported as unknown. The causality assessment for the event with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MEN, TDAP
Symptoms: Influenza virus test, Injection site swelling, Pyrexia, 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 (VAERS # 628123). This spontaneous report refers to a 11 year old male patient. Patient had no concurrent illnesses, medical history and other medications. On 15-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with VAQTA lot # L045713, dose 1, intramuscularly in the right arm; ADACEL lot # UI568AA, dose 1, intramuscularly in the left arm; MENOMUNE lot # 5228BB, dose 1, intramuscularly in the left arm for prophylaxis. On 15-MAR-2016, the patient experienced swelling to site, fever, rash to the body and had influenza virus test. Lab data included flu test. The outcome of the events was reported as not recovered. The causality assessment for all the events with respect to GARDASIL 9 and VAQTA was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site swelling, Injection site warmth, Paraesthesia
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 # 629452) on 18-APR-2017 This spontaneous report as received from a regulatory authority refers to a 25 year old female patient. The patient's medical history included seasonal depression. The patient had no known drug allergies (NKDA). Other medications were reported as wellbutrin. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. On 23-MAR-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L044475, dose 3, intramuscularly in the left arm for prophylaxis. On 24-MAR-2016, the patient experienced injection site erythema, injection site swelling, injection site warmth and paraesthesia which required emergency visit. The patient's left deltoid had 4 x 5 red, warm, swollen area, distal to injection site. Symptoms started one day post injection, and worsened overnight into day 2 post injection. Patient also experienced some tingling in fingers with certain positions. Patient was recommended ice, evaluation, ibuprofen, and BENADRYL. The outcome of injection site erythema, injection site swelling,  injection site warmth and paraesthesia were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Lip swelling, Throat irritation, Urticaria, 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 # 629931) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included attention deficit/hyperactivity disorder. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 07-MAR-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L019297, via unknown route in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 07-MAR-2016, via unknown route in the right arm, lot# 34EB5; dose and expiration date unknown) and MENVEO (vaccinated date: 07-MAR-2016, via unknown route in the right arm, lot# A15017; dose and expiration date unknown). On 11-MAR-2016, the patient experienced lip swelling, vomiting, urticaria and throat irritation and also reported having hives on face that occurred post vaccination. The outcome of lip swelling, vomiting, urticaria and throat irritation is unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TD
Symptoms: Drug administered to patient of inappropriate age, 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 (HA# 630766) and refers to a 11 year old female patient. No details about medical history, prior vaccination and other medications were provided. Patient had no current illnesses. On 05-APR-2016 the patient was vaccinated with M-M-R II lot # L026553, dose 2, subcutaneous in the right arm for prophylaxis. Other suspect therapies included vaccination with GARDASIL 9 (administered on 05-APR-2016, lot # L043213, intramuscular in the left arm for prophylaxis), TENIVAC (administered on 05-APR-2016, lot # C4736CA, intramuscular in the left arm for prophylaxis), ENGERIX-B (administered on 05-APR-2016, lot # A9LB7, intramuscular in the right arm for prophylaxis) and IPOL (administered on 05-APR-2016, lot # L11301, subcutaneous in the right arm for prophylaxis). It was reported that on 04-MAY-2016, an adult dose of Hep B vaccine was administered to pediatric 11 year old patient. Patient was contacted following day and no adverse event was noted to date. Lab data was reported as NA and none needed. No complications reported during call follow up. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pruritus, 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 (VAERS # 631291) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. Information on patient's medical history, other medications, current illness were reported as none. Information on patient's prior vaccinations was not reported. On 13-APR-2016, the patient was vaccinated with GARDASIL 9 lot # M004116, dose 1, via intramuscular route, in the right arm for prophylaxis (dose, frequency and lot expiration date were not reported). Other suspect therapies included VAQTA lot # L041676, dose 1, via intramuscular route, in the left arm for prophylaxis (dose, frequency and lot expiration date were not reported). On 13-APR-2016, 10 minutes after the vaccination administered the patient broke out in hives on the left arm and chest. Patient felt itchy and was given with Benadryl 25 mg. The outcome of pruritus and urticaria was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Seizure, 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 # 631835) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 9 year old female patient. The patient concurrent illnesses included anxiety. The patient's medical history included seizure. Information on the patient's prior vaccinations and other medications were not reported. On 15-APR-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L019297 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 15-APR-2016 after patient received shot, she stood up, moved around and proceeded to collapse. The patient mother caught her and laid her on the ground and bumped her head. The patient went into a seizure lasting approximately 20-30 seconds, signs of breathing and pulse were turned to her side. Ambulance was called and the patient was taken to Hospital. The outcome of head injury, syncope and seizure was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram, Face injury, Fall, Loss of consciousness
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 # 634972). This spontaneous report refers to a 12 year old female patient. Information on patient's concurrent illnesses, medical history and other medications were not reported. On 08-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L018351, dose 3, route: unknown in the left arm for prophylaxis. On 08-APR-2016, the patient had loss of consciousness and fell from exam table post GARDASIL 9 injection and had face injury. Patient also underwent computerized tomogram (CT) scan. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 20.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, 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 # 635080). This spontaneous report refers to a 20 year old female patient. Information on patient's concurrent illnesses, medical history and other medications were not reported. On 05-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L048459, dose 3, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # 54283, dose 2, intramuscularly in the right arm and MENVEO lot # X15069, subcutaneously in the right arm for prophylaxis. On 05-MAY-2016 after injection, patient got dizzy and had a very brief two second syncope possibly vaso-vagal. Doctor monitored her for 15 minutes and patient laid down and drank water. The outcome of the events dizziness and syncope was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MMR, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor
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# 635120) and refers to a 16 year old female patient. Patient had no current illnesses, medical history and other medications was reported as none. No details about lab data and prior vaccination was provided. On 11-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L044475, dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 11-MAY-2016, lot # L028273, subcutaneous in the right arm for prophylaxis), ENGERIX-B (administered on 11-MAY-2016, lot # CB544, intramuscular in the left arm for prophylaxis), MENACTRA (administered on 11-MAY-2016, lot # U5180AA, intramuscular in the right arm for prophylaxis), FLUARIX QUADRIVALENT (administered on 11-MAY-2016, lot # 3L9LD, intramuscular in the right arm for prophylaxis), HAVRIX (administered on 11-MAY-2016, lot # A2X9E, intramuscular in the left arm for prophylaxis), and BOOSTRIX (administered on 11-MAY-2016, lot # E735A, intramuscular in the right arm for prophylaxis). On 11-MAY-2016, patient looked pale and passed out in chair after last vaccine (HPV) was given. Patient legs were elevated up in another chair, began fanning patient and also patient was given cookies to eat. Patient was asked how she was feeling and she stated she was dizzy. Patient's blood pressure was checked and it was 110/70 (unit unknown). After 10 minutes, asked patient if she was alright and she stated she was not dizzy anymore. Patient and her family was told to wait another 10 minutes before leaving. The outcome of dizziness, loss of consciousness and pallor was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 22.0
Sex: M
Vaccine: HPV9, TYP, YF
Symptoms: Skin papilloma
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 # 635601). This spontaneous report refers to a 22 year old male patient. Patient had no concurrent illnesses, medical history and other medications. On 08-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # K026246, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with TYPHIM VI lot # K0331, dose 2, intramuscularly in the right arm and YF-VAX lot # UI084AA, dose 1, subcutaneously in the right arm for prophylaxis. On 23-DEC-2015, the patient stated that two warts developed, one on the top side of his right index finger on the middle/second knuckle and the other on top side of his left thumb between his knuckles. He said that the warts developed prior to his travel when he left on 28-DEC-2015. The outcome of the event was reported as recovered. The causality assessment for the event with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Dizziness, 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 # 636114). This spontaneous report refers to a 10 year old female patient. Information on patient's concurrent illnesses, medical history and other medications were not reported. On 10-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # M004116, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with VARIVAX lot # M000765, dose and site: unknown, via subcutaneous route; VAQTA lot # M009377, dose 1, intramuscularly in the right arm; ADACEL lot # U5316AA, dose 1, intramuscularly in the left arm and MENACTRA lot # U5187AA, dose 1, intramuscularly in the left arm for prophylaxis. On 10-MAY-2016 after vaccination, the patient waited for 15 to 20 minutes before leaving and complained of feeling dizzy and she fainted briefly. The provider reassessed the patient and found no injuries. No treatment was required. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9, VARIVAX and VAQTA was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dysphemia, Muscle twitching, Neurological examination normal, Seizure
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 # 638856). This spontaneous report refers to a 15 year old female patient. Information on patient's concurrent illnesses and other medications were not reported. The patient's medical history included depression, anxiety and asthma-exercise induced. On 01-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L024993, dose 3, intramuscularly in the left arm for prophylaxis. On 01-JUN-2016, right after administration patient had five second seizure. After that she had a normal neuro exam and vitals were stable. Day after that, patient complained of twitching in arms, stuttered vocabulary and sometimes she was unable to get words out. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9, MMR, TDAP, VARCEL
Symptoms: No adverse event, Wrong drug administered
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# 639505) and refers to a 18 year old male patient. Patient had no current illnesses. No details about medical history, lab data, prior vaccination and other medications were provided. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9, lot # M004116, dose 2, intramuscular in the right arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 14-JUN-2016, lot # L030162, subcutaneous in the left arm for prophylaxis), VARIVAX (administered on 14-JUN-2016, lot # L041207, subcutaneous in the right arm for prophylaxis), and BOOSTRIX (administered on 14-JUN-2016, lot # 54LS7, intramuscular in the left arm for prophylaxis). On 14-JUN-2016, after vaccine administration it was identified that BOOSTRIX was given instead of HBV. No adverse reaction. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Ear discomfort, Malaise, Nausea, Syncope, Tinnitus
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 # 639599). This spontaneous report refers to a 11 year old male patient. Patient had no concurrent illnesses and medical history. Information on patient's lab data and other medications were not reported. On 15-JUN-2016, the patient was vaccinated with GARDASIL 9 dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL dose and lot # not reported, intramuscularly in the left arm and meningococcal polysaccharide vaccine (unspecified) (manufacturer unknown) dose and lot # not reported, intramuscularly in the right arm for prophylaxis. On 15-JUN-2016, the patient reported about ringing/popping in ears and that he was not feeling well. Patient reached parking lot and reported that he was still not feeling well but couldn't describe how he was feeling. He also reported nausea, fuzzy vision and ended up fainting in the parking lot of doctors clinic. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 639599). This spontaneous report refers to a 11 year old male patient. Patient had no concurrent illnesses and medical history. Information on patient's lab data and other medications were not reported. On 15-JUN-2016, the patient was vaccinated with GARDASIL 9 dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL dose and lot # not reported, intramuscularly in the left arm and meningococcal polysaccharide vaccine (unspecified) (manufacturer unknown) dose and lot # not reported, intramuscularly in the right arm for prophylaxis. On 15-JUN-2016, the patient reported about ringing/popping in ears and that he was not feeling well. Patient reached parking lot and reported that he was still not feeling well but couldn't describe how he was feeling. He also reported nausea, fuzzy vision and ended up fainting in the parking lot of doctors clinic. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea
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 # 640152). This spontaneous report refers to a 16 year old female patient. Patient had no concurrent illnesses. Patient's other medications included ADVIL and history was reported as cats. On 20-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L043213, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, patient was also MENACTRA lot # U5049AA, dose 3, intramuscularly in the right arm for prophylaxis. On 20-JUN-2016, the patient felt lightheaded, nauseous and sweaty. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Abnormal behaviour, Agitation, Anxiety, Back pain, Cognitive disorder
Clinical narrative: Flu-like symptoms, sick in bed for a week - loss of appetite, disrupted sleep pattern, back pain, rash, agitation, anxiety, depression, weight loss, incontinence, exhaustion, destructive behavior, emotional outbursts, loss of cognitive function
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Decreased appetite, Depression, Emotional disorder, Fatigue, Incontinence
Clinical narrative: Flu-like symptoms, sick in bed for a week - loss of appetite, disrupted sleep pattern, back pain, rash, agitation, anxiety, depression, weight loss, incontinence, exhaustion, destructive behavior, emotional outbursts, loss of cognitive function
Age: 73.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Influenza like illness, Malaise, Rash, Sleep disorder, Weight decreased
Clinical narrative: Flu-like symptoms, sick in bed for a week - loss of appetite, disrupted sleep pattern, back pain, rash, agitation, anxiety, depression, weight loss, incontinence, exhaustion, destructive behavior, emotional outbursts, loss of cognitive function
Age: 14.0
Sex: F
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Fall, Head injury, Nausea
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# 643474) and refers to a 14 year old female patient. There were no known current illnesses, other medications, medical history and pre-existing conditions. No details about lab data and prior vaccinations were provided. On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L024993, dose 1, intramuscular in the right arm for prophylaxis. Other suspect therapies included vaccination with VARIVAX (administered on 05-JUL-2016, lot # L024993, Subcutaneous in the right arm for prophylaxis), M-M-R II, (administered on 05-JUL-2016, lot # L035674, Subcutaneous in the left arm for prophylaxis), TENIVAC, (administered on 05-JUL-2016, lot # US2S1AA, intramuscular in the left arm for prophylaxis) IPOL (administered on 05-JUL-2016, lot # L1S97, subcutaneous in the left arm for prophylaxis) and ENGERIX-B. On 5-JUL-2016, at approximately 2:10 pm, and several minutes after the patient received her last vaccination (a HPV9 vaccination) she leaned forward in her chair, fell out of the chair, and bumped her head on the floor. Patient was laid flat on the floor. Patient felt nauseous and sat up to try and vomit, but was unsuccessful. Patient was laid back down on mat with her legs elevated. A call was placed to 911 at approximately 2:20. Patient recovered and was evaluated by the paramedics. As a precautionary follow-up the patient was transported to hospital. The outcome of fall, nausea and head injury was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.