chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, TD
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Patient here for immunization visit. Received 5 vaccines total. Received three vaccines in left arm. First vaccine given in left arm was IPV, second was Hep A and last vaccine administered in left arm was HPV. Patient immediately fainted after HPV injection. Was sitting on exam table at this time, RN was able to lead patient down to exam table and patient layed down and was not injured. Syncopal episode lasted only about 5 seconds. Patient awoke and was advised to continue to lay down. Patient's head of bed elevated. Vital signs taken. All vital signs stable. Provided with cups of water and a pedialyte popsicle. Evaluated by RNP. Monitored in office for 45-60 mins after syncope. Patient stable to go home 60 mins after incident occurred.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Lip swelling
Clinical narrative: Swelling of the upper lip.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Lymphadenopathy, Pharyngeal oedema, Tonsillar hypertrophy
Clinical narrative: Patient was given vaccine in pharmacy. At the time of the injection (and 20 minutes after administration, pt had no s/sx of allergy. Four days after immunization, Patient states they have swelling of throat/lymph nodes/ tonsils. However, delayed onset (4 days), so it is unclear if it is bacterial/viral pharyngitis or reaction to vaccine components. I referred patient to ER/urgent care to be evaluated for allergy or other causes, however patient still has not gone to urgent care/hospital for evaluation despite recommendation.
Age: 67.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Erythema
Clinical narrative: Redness of the upper arm.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain
Clinical narrative: Patient reported soreness and redness. She said that the soreness has improved some, but she is still experiencing some. She said the redness was larger than a quarter size. Patient was counseled to begin aspirin and benadryl regimen.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Pyrexia, Rash, Rash erythematous
Clinical narrative: Headache, fever, red/pink dots on stomach and legs.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received ZOSTAVAX in 2015 and then received in 2017 again.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis bacterial, Arthroscopic surgery, Aspiration joint, Infection, Injection site joint infection
Clinical narrative: Severe shoulder pain; fluid drawn, infection confirmed, arthroscopic surgery performed, shoulder "lavaged".
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Therapeutic procedure
Clinical narrative: Severe shoulder pain; fluid drawn, infection confirmed, arthroscopic surgery performed, shoulder "lavaged".
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a adult female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. On an unknown date, the patient received 1st dose of Hepatitis B vaccine (intramuscular) 1 ml, the 2nd dose of Hepatitis B vaccine 1 ml, the 3rd dose of Hepatitis B vaccine 1 ml and 4th dose of Hepatitis B vaccine 1ml. On an unknown date, several years after receiving Hepatitis B, Hepatitis B, Hepatitis B and Hepatitis B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B, Hepatitis B, Hepatitis B  and Hepatitis B. Additional details were provided as follows: The age at vaccination was not reported. The patient with a history of 4 doses of hepatitis B vaccine in childhood had a no response titer in adulthood for hepatitis B antibodies. The patient subsequently received 1 challenge dose of ENGERIX-B in April 2016 and would be having a titer drawn in the next few weeks from the date of reporting. It was reported that the manufacturer of first 4 doses of Hepatitis B vaccine was unknown and lot number and expiry of challenge dose was unknown.
Age: 68.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Erythema, Induration
Clinical narrative: Redness, induration of skin.
Age: 68.0
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, induration of skin.
Sex: M
Vaccine: HEPA
Symptoms: Hepatomegaly
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of hepatomegaly in a 38-year-old male patient who received HAVRIX. Previously administered products included ENGERIX-B (administered at the same clinic with no problems) and FLULAVAL (administered at the same clinic with no problems). On an unknown date, the patient received HAVRIX (intramuscular). On an unknown date, unknown after receiving HAVRIX, the patient experienced hepatomegaly. On an unknown date, the outcome of the hepatomegaly was not recovered/not resolved. The reporter considered the hepatomegaly to be probably related to HAVRIX. Additional details were reported as follows: This report was reported by the owner of a vaccine clinic to a field representative. The age at vaccination was not reported. The patient's concomitant medications were unknown. The patient received HAVRIX in right arm. The patient experienced hepatomagalia after receiving HAVRIX. The patient saw his personal doctor, not the one at the clinic, who believed the problem was caused by the vaccine. The reporter thought the HAVRIX series was completed and this occurred after the 2nd dose, but was not certain.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in an unspecified number of patient who received BEXSERO. On an unknown date, the patients received the 1st dose of BEXSERO. On an unknown date, 3 days after receiving BEXSERO, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter state that several patients returned for their second dose of BEXSERO complained of pain at injection site following their initial dose. The patients reported that the pain began about 3 to 5 days after receiving the first dose. The reporter stated that due to previous complaints of pain at injection site, patients were then given the second dose in the thigh. No further information was available or reported regarding the events.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site papule, Injection site swelling, Local reaction
Clinical narrative: Left mid thigh, circular area of erythema 14 mm diameter with central papule. No edema. Left lateral thigh, 3 x 4 cm of erythema and swelling. Acetaminophen and diphenhydramine recommended for local reaction.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site pain, Mobility decreased, Pyrexia, Swelling
Clinical narrative: Very bad pain at injection site day of vaccine. Could hardly move arm. Day 2 redness started with swelling and fever spike up to 103. Controlled with TYLENOL, MOTRIN and BENADRYL. Feeling better by day 4.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Crying, Eye movement disorder, Hypotonia
Clinical narrative: After 3rd injection (MMR) patient cried. Mom picked him up and his eyes rolled back and felt limp. No cyanosis or apnea. Last approximately 5 sec to 30 sec and self resolved. Subdued after, but returned to baseline.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Nausea, Neurological examination normal, Pain in extremity
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 # 624743). This spontaneous report refers to a 13 year old female patient. The patient had no concurrent illnesses and other medications. The patient had no history of headache in the past. On 08-DEC-2015 the patient was vaccinated with the first dose of GARDASIL 9 lot # L020015 (expiration date 16-AUG-2017) intramuscularly in the left arm  for prophylaxis. On 09-DEC-2015, the patient experienced sore arm (pain in extremity) and headache. Headache lasted for about 3 weeks, daily, throbbing and self-limited. On 17-DEC-2015 some dizziness and nausea was observed and no vomiting in office. Neurological examination was found to be normal. It was unsure if to give more HPV vaccine to the patient. The outcome of dizziness, pain in extremity, nausea and headache was reported as recovered. The causality assessment was not reported. Additional information is not expected from  the agency as follow up information cannot be obtained.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Headache, Pain in extremity, 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 (VAERS # 631867) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 23 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. Other medications included Terzol 3 and Tinidazole. On 12-APR-2016 the patient was vaccinated with the third dose of GARDASIL 9 lot # L040164, (dose, frequency and lot expiration date were not reported) via unknown route of administration in the left arm for prophylaxis. On 13-APR-2016, the patient experienced arm soreness (pain in extremity), chills, fever and headache. The outcome of chills, pyrexia, pain in extremity 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.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site swelling, Lymph node pain, Lymphadenopathy, Pain in extremity, 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, and refers to an 11-year-old male patient. The patient did not have any medical history or current illnesses reported. No patient's medical history was provided. On 19-APR-2016, the patient was vaccinated with GARDASIL 9 (lot # L037339 , expiration date not reported), intramuscularly, in the right arm in an unspecified private medical facility (reported as PVT). Other suspect vaccines included BOOSTRIX and MENVEO. On 21-APR-2016 (reported as 48 hours after administration), swelling in upper left arm and armpit after administration of MENVEO and BOOSTRIX (reported as Tdap) in that location was reported. The patient was able to use his arm but it was painful. The patient was afebrile. There was a one inch tender left axillary lymph node with two pea sized mobile nodes adjacent reported. No laboratory data or prior vaccinations were reported. The outcome of the events and the relatedness between the suspect therapies and the events were not reported. The agency considered the events to be non-serious. Additional information is not expected as no more information can be obtained from the regulatory authority.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Limb discomfort, Loss of consciousness, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #635897) and refers to a 17 year old male patient. No details about current illnesses, medical history, lab data, prior vaccination and other medications were provided. On 17-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L026602, dose 2, intramuscularly in the right arm for prophylaxis (strength and dosing details unknown).  Other suspect therapies included vaccination with VAQTA, VARIVAX and MENVEO. On 17-MAY-2016, the patient developed syncope which lasted about 5-10 seconds after GARDASIL 9 and VARIVAX vaccination. Patient fainted momentary, she was held up in the chair and her head aligned. Patient regained consciousness a few seconds later. She wanted to lay down. The patient wasn't stable on her feet yet. She mentioned "passing out" before during a blood draw and other similar circumstances. She also hadn't had any breakfast, so she was given with a bar/granola and apple juice. Patient stayed in clinic for 10-15 min and said she was ready to leave and felt much better, she mentioned her arm felt heavy right after HPV9 vaccination. The patient was asked to come back another day for VAQTA and MENVEO. But after a discussion about vaccination and the adverse events she had just experienced, patient decided to go ahead and received the remaining vaccines. Patient stayed in bed after receiving those vaccine for another 5-10 min to make sure no Adverse Event would occur. Patient reported feeling good. Patient left at around 10:50 am. No other S/S reported by patient or observed. The outcome of limb discomfort, syncope and loss of consciousness was reported as recovered/resolved. Reporter causality was not reported. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Discomfort, Lip blister, Oral disorder, Oropharyngeal pain, 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 (HA # 636996) and refers to a 17 year old female patient. Patient had no current illnesses and medical history. Lab data and Other medications were reported as none. No prior vaccinations details were provided. On 18-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L007560, dose 1, intramuscular in the right arm for prophylaxis (strength and dosing details were unknown). The patient experienced fever of 103 (unit unknown) on Friday and Saturday evening of May 20-21, 2016, Complained of body aches. The patient came to clinic on Monday 23-MAY-2016, complaining of sore throat and blisters on lips. In the next follow up visit, she had no fever for 24 hours with less throat pain. She has new crust covered lesions to lower lip and fine papules to tongue. Itching and pustular with some discomfort. The events were treated with cephalexin(KEFLEX) given on 25-MAY-2016. The outcome of discomfort, tongue eruption, scab, rash pustular, pruritus, pain, oropharyngeal pain and lip blister was reported as recovered/resolved. Reporter causality was not reported. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Pyrexia, Rash pustular, Scab, Tongue eruption
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 # 636996) and refers to a 17 year old female patient. Patient had no current illnesses and medical history. Lab data and Other medications were reported as none. No prior vaccinations details were provided. On 18-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L007560, dose 1, intramuscular in the right arm for prophylaxis (strength and dosing details were unknown). The patient experienced fever of 103 (unit unknown) on Friday and Saturday evening of May 20-21, 2016, Complained of body aches. The patient came to clinic on Monday 23-MAY-2016, complaining of sore throat and blisters on lips. In the next follow up visit, she had no fever for 24 hours with less throat pain. She has new crust covered lesions to lower lip and fine papules to tongue. Itching and pustular with some discomfort. The events were treated with cephalexin(KEFLEX) given on 25-MAY-2016. The outcome of discomfort, tongue eruption, scab, rash pustular, pruritus, pain, oropharyngeal pain and lip blister was reported as recovered/resolved. Reporter causality was not reported. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, 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 #639958) and refers to a 17 year old female patient. Patient's current illnesses, medical history and other medications were reported as none. No details about prior vaccination was provided. On 15-JUN-2016 the patient was vaccinated with GARDASIL 9, lot # L019286, dose 1, route: needle and syringe (not specified further) in the left arm for prophylaxis. On 16-JUN-2016, patient experienced Fever of temperature 102 (Unit unknown), felt very tired. Fever continued for next day of temperature 101 (unknown unit), symptoms ongoing as of time of this report. The outcome of fatigue and pyrexia was unknown. Reporter causality was not reported. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: FLU3, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Injection site pruritus, Injection site 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 (HA # 646072) and refers to a 12 year old male patient. Patient had no current illnesses and medical history. No details about lab data, prior vaccination and other medications were provided. On 27-JUN-2016 the patient was vaccinated with GARDASIL 9, lot # L019297 dose 1, intramuscular in the right arm for prophylaxis (strength and dosing details unknown). Other suspect therapies included vaccination on 27-JUN-2016, with HAVRIX, IPOL, M-M-R II, MENACTRA, BOOSTRIX, FLUZONE, ENGERIX-B and VARIVAX. On 27-JUN-2016, the patient developed itching at the site of vaccine. There were 50-100 pinpoint raised welts at SQ site. Patient was given 50 mg Diphenhydramine for the treatment. The outcome of injection site pruritus and injection site urticaria 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: M
Vaccine: HPV9, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
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 ID-647463). This spontaneous report refers to a 22 year old male patient. The patient's historical conditions included type 1 diabetes mellitus. The patient had no current illness. Other medications included HUMALOG and LANTUS. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 dose 1 (unspecified dose frequency and lot number), intramuscularly in the left arm for prophylaxis and PNEUMOVAX 23 dose 1 (unspecified dose frequency and lot number), intramuscularly in the right arm for prophylaxis. On the same day, the patient had decreased injected limb mobility (unable to use right arm), insomnia and severe injection site pain in the right shoulder. The outcome of the events was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MMR, MNQ
Symptoms: Chest X-ray, Chills, Cough, Glossitis, 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 #651275) and refers to a 18 year old male patient. His current illnesses and medical history was reported as none. No details about other medication and prior vaccinations was provided. On 17-AUG-2016 the patient was vaccinated with GARDASIL 9, lot # L038503, dose 1, via unknown route in the right arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 17-AUG-2016, lot # L028273, dose 1, via unknown route in the left arm for prophylaxis) and MENACTRA. On 23-AUG-2016, about 6 days after M-M-R II, patient developed low grade fever, chills, congestion, cough, glossitis. On 30-AUG-2016, a chest X-ray was performed and the result was not provided. The outcome of the events were 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: M
Vaccine: HPV9, MMR, MNQ
Symptoms: Respiratory tract congestion
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 #651275) and refers to a 18 year old male patient. His current illnesses and medical history was reported as none. No details about other medication and prior vaccinations was provided. On 17-AUG-2016 the patient was vaccinated with GARDASIL 9, lot # L038503, dose 1, via unknown route in the right arm for prophylaxis. Other suspect therapies included vaccination with M-M-R II (administered on 17-AUG-2016, lot # L028273, dose 1, via unknown route in the left arm for prophylaxis) and MENACTRA. On 23-AUG-2016, about 6 days after M-M-R II, patient developed low grade fever, chills, congestion, cough, glossitis. On 30-AUG-2016, a chest X-ray was performed and the result was not provided. The outcome of the events were 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, MMR, VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA # 654774) and refers to a 17 year old pregnant female patient. The patient's medical history was reported as positive pregnancy test. Patient's current illnesses, Other medications were unknown. No details about prior vaccination was provided. On 13-SEP-2016 the patient was vaccinated with GARDASIL 9, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with M-M-R II and VARIVAX. On 13-SEP-2016, the patient experienced exposure during pregnancy and human chorionic gonadotropin positive. On an unspecified date rapid HCG test performed was positive. The outcome of exposure during pregnancy and human chorionic gonadotropin positive was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 8.0
Sex: M
Vaccine: FLU3, HPV9, MENB
Symptoms: Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
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 # 669244) on 10-MAY-2017. This spontaneous report refers to 8 year old male patient. The patient's allergies included allergy to bee stings. Other medications were unknown. The patient had no current illnesses. On 28-NOV-2001, the patient was vaccinated with GARDASIL 9 (lot # M032650) dose 2, intramuscularly in the left arm, FLUZONE (lot# UI669AC), intramuscularly in the right arm and TRUMENBA (lot# M37315) dose 1, intramuscularly in the left arm for prophylaxis. On 30-NOV-2016, the patient informed the nurse that his arm was very sore, involving the entire shoulder. He cancelled his usual activities due to that pain. The patient was advised to use ice/cool therapy at site, and could take over the counter (OTC) mild pain reliever. At the time of this report, the outcome of loss of personal independence in daily activities, pain in extremity and musculoskeletal pain was unknown. The causality of loss of personal independence in daily activities, pain in extremity and musculoskeletal pain with respect to GARDASIL 9, FLUZONE and TRUMENBA was not reported. Additional information is not expected as follow up information cannot be obtained from the Agency.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Bradycardia, Brain death, Brain oedema, Cerebral haemorrhage, Cerebrovascular accident
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 # 669596) refers to a 11 year old male patient. The patient's current condition included asthma. No medical history and concomitant therapies were reported. On 25-OCT-2016, the patient was vaccinated with second dose of GARDASIL 9 (lot number: M017983, expiry date: not provided) via intramuscular route in the left arm for prophylaxis. On 27-OCT-2016, the patient experienced headaches, seizures, strokes, swelling of the brain, blood pooling in the brain, repetitive speech, fainting, tachycardia, fever, lethargy, emotional, bradycardia, incontinence, and brain death. The patient was hospitalized. Outcome of brain death was reported as fatal and all other events were not recovered. It was unknown if autopsy was performed. Causality assessment was not provided. The agency considered all the events to be serious due to hospitalization and life threatening. The event brain death was considered to be serious due to hospitalization, life threatening and death. Additional information is not expected, because no further information can be obtained from the local regulatory authority.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Death, Emotional disorder, Headache, Incontinence, Lethargy
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 # 669596) refers to a 11 year old male patient. The patient's current condition included asthma. No medical history and concomitant therapies were reported. On 25-OCT-2016, the patient was vaccinated with second dose of GARDASIL 9 (lot number: M017983, expiry date: not provided) via intramuscular route in the left arm for prophylaxis. On 27-OCT-2016, the patient experienced headaches, seizures, strokes, swelling of the brain, blood pooling in the brain, repetitive speech, fainting, tachycardia, fever, lethargy, emotional, bradycardia, incontinence, and brain death. The patient was hospitalized. Outcome of brain death was reported as fatal and all other events were not recovered. It was unknown if autopsy was performed. Causality assessment was not provided. The agency considered all the events to be serious due to hospitalization and life threatening. The event brain death was considered to be serious due to hospitalization, life threatening and death. Additional information is not expected, because no further information can be obtained from the local regulatory authority.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia, Repetitive speech, Seizure, Syncope, 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 # 669596) refers to a 11 year old male patient. The patient's current condition included asthma. No medical history and concomitant therapies were reported. On 25-OCT-2016, the patient was vaccinated with second dose of GARDASIL 9 (lot number: M017983, expiry date: not provided) via intramuscular route in the left arm for prophylaxis. On 27-OCT-2016, the patient experienced headaches, seizures, strokes, swelling of the brain, blood pooling in the brain, repetitive speech, fainting, tachycardia, fever, lethargy, emotional, bradycardia, incontinence, and brain death. The patient was hospitalized. Outcome of brain death was reported as fatal and all other events were not recovered. It was unknown if autopsy was performed. Causality assessment was not provided. The agency considered all the events to be serious due to hospitalization and life threatening. The event brain death was considered to be serious due to hospitalization, life threatening and death. Additional information is not expected, because no further information can be obtained from the local regulatory authority.
Age: 26.0
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Muscle rigidity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 672613) under the Freedom of Information Act (FOI) and concerns a 26 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-JUL-2016, the patient was vaccinated with a dose of GARDASIL 9 injection, in his left arm, by intramuscular route, lot number L045711 (strength, dose and expiration date were not reported) for prophylaxis. On the same date, blood draw started and in the middle of drawing patient's blood at the nursing station, the patient started jerking with his eyes close long with rigid arms and fingers that lasted for about 15 seconds. Code blood was initiated and the doctor arrived. The causality between the events and the GARDASIL 9 was not reported. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 11.0
Sex: M
Vaccine: HPV9, IPV, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Agency # 674236) under the Freedom of Information Act (FOI) and concerns a 11 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-DEC-2016, the patient was vaccinated with GARDASIL 9 injection, in his left arm, by intramuscular route, lot number M018810 (strength, dose and expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA, by intramuscular route, left arm, lot number U5415AA and poliovirus vaccine inactivated (Vero) (IPOL), by intramuscular route, right arm, lot number 970150, both for prophylaxis. On the same date at 15:30, the patient experienced hives and itching (urticaria/pruritus). The patient was treated with prednisone (manufacturer unknown) 30 mg and cetirizine, orally by physician assistant - Certified (PA-C) with additional tablets of both to be taken for the next 3 days. At the time of the report, the patient had recovered from the events. The causality between the events and the GARDASIL 9 was not reported. Additional information is not expected as no follow-up can be obtained from the agency.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood culture negative, C-reactive protein increased, Chills, Cytomegalovirus test positive, Hypotension
Clinical narrative: This spontaneous report was received from a line listing obtained on request by the Company from the FDA (VAERS No. 675671) under the Freedom of information Act, referring to a to a 14 year old female patient. The patient had no concurrent conditions. The patient's medical history included allergic rhinitis, gastrooesophageal reflux disease (GERD) and Vocal cord dysfunction. The patient has no active problems at time of vaccination. The patient's prior vaccinations included hives-measles, mumps and rubella (manufacturer unknown). The patient's other medications included ZANTAC, ALLEGRA and NASACORT. On 21-DEC-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L037554 (expiration date was not reported), intramuscularly in the left arm for prophylaxis.  Additionally, other suspect therapies included the third dose of FLUZONE lot# U5691AA (expiration date was not reported), intramuscularly in the left arm, also for prophylaxis (dose and frequency were unspecified for both vaccines). On 21-DEC-2016, the patient developed fever (maximum temperature 103 (units were not reported)) and chills, blood culture negative, white blood cell count normal, viral test negative, tachycardia, streptococcus test negative, red blood cell sedimentation rate normal, influenza virus test negative, hypotension, cytomegalovirus test positive,  and C-reactive protein increased. On 22-DEC-2016, the patient was admitted to the hospital due to near-syncope episode in office and because of tachycardia and hypotension despite fluids were administered. At the time of the report, the outcome of blood culture negative, white blood cell count normal, viral test negative, tachycardia, streptococcus test negative, red blood cell sedimentation rate normal, pyrexia, presyncope, influenza virus test negative, hypotension, cytomegalovirus test positive, chills and C-reactive protein increased was reported as recovered on an unspecified date. The relatedness assessment of the aforementioned adverse events with GARDASIL 9 was not provided. Additional information is not expected since no follow up can be obtained from the regulatory authority.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Influenza virus test negative, Presyncope, Pyrexia, Red blood cell sedimentation rate normal, Streptococcus test negative
Clinical narrative: This spontaneous report was received from a line listing obtained on request by the Company from the FDA (VAERS No. 675671) under the Freedom of information Act, referring to a to a 14 year old female patient. The patient had no concurrent conditions. The patient's medical history included allergic rhinitis, gastrooesophageal reflux disease (GERD) and Vocal cord dysfunction. The patient has no active problems at time of vaccination. The patient's prior vaccinations included hives-measles, mumps and rubella (manufacturer unknown). The patient's other medications included ZANTAC, ALLEGRA and NASACORT. On 21-DEC-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L037554 (expiration date was not reported), intramuscularly in the left arm for prophylaxis.  Additionally, other suspect therapies included the third dose of FLUZONE lot# U5691AA (expiration date was not reported), intramuscularly in the left arm, also for prophylaxis (dose and frequency were unspecified for both vaccines). On 21-DEC-2016, the patient developed fever (maximum temperature 103 (units were not reported)) and chills, blood culture negative, white blood cell count normal, viral test negative, tachycardia, streptococcus test negative, red blood cell sedimentation rate normal, influenza virus test negative, hypotension, cytomegalovirus test positive,  and C-reactive protein increased. On 22-DEC-2016, the patient was admitted to the hospital due to near-syncope episode in office and because of tachycardia and hypotension despite fluids were administered. At the time of the report, the outcome of blood culture negative, white blood cell count normal, viral test negative, tachycardia, streptococcus test negative, red blood cell sedimentation rate normal, pyrexia, presyncope, influenza virus test negative, hypotension, cytomegalovirus test positive, chills and C-reactive protein increased was reported as recovered on an unspecified date. The relatedness assessment of the aforementioned adverse events with GARDASIL 9 was not provided. Additional information is not expected since no follow up can be obtained from the regulatory authority.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Tachycardia, Viral test negative, White blood cell count normal
Clinical narrative: This spontaneous report was received from a line listing obtained on request by the Company from the FDA (VAERS No. 675671) under the Freedom of information Act, referring to a to a 14 year old female patient. The patient had no concurrent conditions. The patient's medical history included allergic rhinitis, gastrooesophageal reflux disease (GERD) and Vocal cord dysfunction. The patient has no active problems at time of vaccination. The patient's prior vaccinations included hives-measles, mumps and rubella (manufacturer unknown). The patient's other medications included ZANTAC, ALLEGRA and NASACORT. On 21-DEC-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L037554 (expiration date was not reported), intramuscularly in the left arm for prophylaxis.  Additionally, other suspect therapies included the third dose of FLUZONE lot# U5691AA (expiration date was not reported), intramuscularly in the left arm, also for prophylaxis (dose and frequency were unspecified for both vaccines). On 21-DEC-2016, the patient developed fever (maximum temperature 103 (units were not reported)) and chills, blood culture negative, white blood cell count normal, viral test negative, tachycardia, streptococcus test negative, red blood cell sedimentation rate normal, influenza virus test negative, hypotension, cytomegalovirus test positive,  and C-reactive protein increased. On 22-DEC-2016, the patient was admitted to the hospital due to near-syncope episode in office and because of tachycardia and hypotension despite fluids were administered. At the time of the report, the outcome of blood culture negative, white blood cell count normal, viral test negative, tachycardia, streptococcus test negative, red blood cell sedimentation rate normal, pyrexia, presyncope, influenza virus test negative, hypotension, cytomegalovirus test positive, chills and C-reactive protein increased was reported as recovered on an unspecified date. The relatedness assessment of the aforementioned adverse events with GARDASIL 9 was not provided. Additional information is not expected since no follow up can be obtained from the regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Blood test, Electroencephalogram abnormal, Eye movement disorder, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging brain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report was received from the FDA (VAERS# 676104) and refers to an 11-year-old female patient. The patient had no current illnesses. The patient's prior vaccinations included measles virus vaccine live (unspecified) (+) mumps virus vaccine live (unspecified) (+) rubella virus vaccine live (unspecified) (manufacturer unknown) (febrile seizure reaction) (it was also reported that the patient had no medical history). On 04-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M011117, dose and expiration date were not reported), intramuscularly in the right arm. Other suspect therapies included MENACTRA (1st dose, lot# U5244AA, intramuscular, in the left arm) and ADACEL (1st dose, lot# U5378AA, intramuscular, in the left arm). On 25-SEP-2016, the patient woke up complaining that her hand couldn't stop shaking, the eyes were rolled to back of her head, followed by a major grand mal seizure (which was lasting roughly 45 minutes). 911 has been called, the patient had another focal seizure then (this one lasted 30 seconds). Paramedics took her to a hospital for evaluation. The patient was observed in an emergency room, her blood was drawn and she was released. On 26-SEP-2016 (reported as next day), the following tests were performed: electroencephalogram (EEG) of brain (abnormal results), nuclear magnetic resonance imaging brain (results were not provided), neurology consult and orthopedic spine consult. The outcome of blood test, tremor, specialist consultation, partial seizures, nuclear magnetic resonance imaging brain, generalised tonic-clonic seizure, eye movement disorder and electroencephalogram abnormal was reported as not recovered. The FDA considered all aforementioned events as life threatening. The causality was not assessed by the FDA. Additional information is not expected.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Partial seizures, Specialist consultation, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report was received from the FDA (VAERS# 676104) and refers to an 11-year-old female patient. The patient had no current illnesses. The patient's prior vaccinations included measles virus vaccine live (unspecified) (+) mumps virus vaccine live (unspecified) (+) rubella virus vaccine live (unspecified) (manufacturer unknown) (febrile seizure reaction) (it was also reported that the patient had no medical history). On 04-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # M011117, dose and expiration date were not reported), intramuscularly in the right arm. Other suspect therapies included MENACTRA (1st dose, lot# U5244AA, intramuscular, in the left arm) and ADACEL (1st dose, lot# U5378AA, intramuscular, in the left arm). On 25-SEP-2016, the patient woke up complaining that her hand couldn't stop shaking, the eyes were rolled to back of her head, followed by a major grand mal seizure (which was lasting roughly 45 minutes). 911 has been called, the patient had another focal seizure then (this one lasted 30 seconds). Paramedics took her to a hospital for evaluation. The patient was observed in an emergency room, her blood was drawn and she was released. On 26-SEP-2016 (reported as next day), the following tests were performed: electroencephalogram (EEG) of brain (abnormal results), nuclear magnetic resonance imaging brain (results were not provided), neurology consult and orthopedic spine consult. The outcome of blood test, tremor, specialist consultation, partial seizures, nuclear magnetic resonance imaging brain, generalised tonic-clonic seizure, eye movement disorder and electroencephalogram abnormal was reported as not recovered. The FDA considered all aforementioned events as life threatening. The causality was not assessed by the FDA. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 676304) under the Freedom of Information Act referring to an 11 year old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant medication included PROAIR HFA. On 29-DEC-2016, the patient was vaccinated with the second dose of GARDASIL 9 in the right arm, route of administration was reported as unknown (lot # M018810, expiration date was not provided), for prophylaxis. On the same day, the patient was also vaccinated with the second dose of MENVEO in the left arm, route of administration was reported as unknown (lot #M16005, expiration date was not provided), for prophylaxis, and with second dose of BOOSTRIX in the left arm, route of administration was reported as unknown (lot #92S2S, expiration date was not provided), for prophylaxis. On the same day, patient allegedly fainted for less than 5 second. By the time the examiner entered the exam room, the patient was conscious. The causality relationship between syncope and GARDASIL 9, and MENVEO, and BOOSTRIX was not provided by the reporter. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 20.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Chest discomfort, Chest pain, Injection site pruritus, Pruritus
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 # 679890) refers to a 20 years old male patient. The patient had no medical history and concurrent conditions. On 10-DEC-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M026306, expiry date not provided)  in the left arm for prophylaxis. On 10-DEC-2016, the patient experienced chest discomfort, injection site pruritus and chest pain. The outcome of the events was reported as recovered. The agency did not provide the causality assessment for the events. Additional information is not expected since no further information can be obtained from the regulatory authority
Age: 20.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Paraesthesia, Urticaria
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 # 679890) refers to a 20 years old male patient. The patient had no medical history and concurrent conditions. On 10-DEC-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M026306, expiry date not provided)  in the left arm for prophylaxis. On 10-DEC-2016, the patient experienced chest discomfort, injection site pruritus and chest pain. The outcome of the events was reported as recovered. The agency did not provide the causality assessment for the events. Additional information is not expected since no further information can be obtained from the regulatory authority
Age: 20.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Chest discomfort, Chest pain, Injection site pruritus
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 # 679890) refers to a 20 years old male patient. The patient had no medical history and concurrent conditions. On 10-DEC-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M026306, expiry date not provided)  in the left arm for prophylaxis. On 10-DEC-2016, the patient experienced chest discomfort, injection site pruritus and chest pain. The outcome of the events was reported as recovered. The agency did not provide the causality assessment for the events. Additional information is not expected since no further information can be obtained from the regulatory authority
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Full blood count, Rash, 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 # 677535) on 10-MAY-2017. This spontaneous report refers to 11 year old female patient. The patient had no medical history or concurrent illnesses. On 03-JAN-2017, the patient was vaccinated with GARDASIL 9 (lot # M031557) dose 1, intramuscularly in the left arm, BOOSTRIX (lot# J2NH5) dose 1, intramuscularly in the right arm, FLUZONE (lot# UT5673NA) dose 1, intramuscularly in the right arm and MENVEO (lot# M16075) dose 1, intramuscularly in the left arm for prophylaxis. The patient's mother referred that, the patient started two days after vaccination (05-JAN-2017) with rash on face (also reported as 03-JAN-2017). On 04-JAN-2017 (reported as the next day), she had rash all over body and her mother gave her cetirizine (ZYRTEC). She referred that on 08-JAN-2017 (Sunday), the rash was too much for patient and took her to a nearby health clinic. The attending doctor took a complete blood count (CBC) and explained to patient's mother that they understand she had a reaction to the vaccines administered. Later, full blood count, rash and rash generalized resolved. The causality of full blood count, rash and rash generalized with respect to GARDASIL 9, BOOSTRIX, FLUZONE and MENVEO was not reported. Additional information is not expected as follow up information cannot be obtained from the Agency.