chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Joint swelling, Laboratory test, Lactose intolerance, Lipase normal, Lymphocyte count normal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Monocyte count normal, Monocyte percentage, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Nausea, Neutrophil count normal, Neutrophil percentage, Nuclear magnetic resonance imaging abnormal, Oesophagogastroduodenoscopy abnormal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Ophthalmological examination normal, Osteoarthritis, Pain in extremity, Paraesthesia, Parasite stool test negative
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Peripheral swelling, Platelet count normal, Polymerase chain reaction, Poor quality sleep, Protein total normal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal, Rheumatoid arthritis, Rotavirus test negative
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Salmonella test negative, Sleep study normal, Spondylitis, Spondyloarthropathy, Stool analysis
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: Systemic lupus erythematosus, Ultrasound abdomen abnormal, Viral test negative, White blood cell count normal, X-ray abnormal
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 36.0
Sex: F
Vaccine: ANTH, TYP, ANTH, TYP
Symptoms: X-ray limb abnormal, X-ray limb normal, Yersinia test negative
Clinical narrative: GI Issues: IBS, Rheumatology: autoimmune disorder.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Patient developed a fever and a little vomiting. She also developed a rash on the back of her neck. The great grandmother stated "we put her in a warm shower and used cold compresses to bring the fever down." She also applied over the counter anti itch cream meds to bring fever of 105 down. When she asked pediatrician about it they were not concerned.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Rec'd. varicella on 5-9-17 at 11:23. Noticed next AM after removing BAND-AID. Red swollen, hot to touch. Measures 30 x 34 cm. Called Dr. at 9:35 Recommendations: warm moist compressed, MOTRIN or ibuprofen - pain, BENADRYL or ZYRTEC, monitor diameter and report.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Pt received TDaP vaccine during PCP appointment on 4/21. Shortly after receiving vaccination, patient began to notice rash on his face and trunk. Pt took OTC diphenhydramine at home w/o any improvement in rash. Pt then presented to urgent care on 4/27/17 for evaluation of rash and received KENALOG IM x 1, Medrol dose pack, diphenhydramine, and ranitidine.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Rash pruritic
Clinical narrative: Patient was seen in our office on April 26th for a sore throat. After a positive throat culture came back on April 28th she was started on AMOXIL 400 MG/5ML suspension for 10 days. She came back on May 2nd for a school physical and was given a TDaP and a Meningococcal Conjugate. On May 6th her parents called our doctors line. This is the note from that phone call: Returned call from emergency line for complaint of a diffuse, pruritic rash x 1 day. Mother states that the patient was seen in clinic on 5/2/17. She was given vaccinations for meningitis and TDaP. The patient subsequently developed injection site pain and redness, which developed into a diffuse rash today. Additional, the patient was recently given a 10 day course of amoxicillin for strep throat starting on 4/28/17. Mother reports that the rash is very itchy. She gave 10 mL of Benadryl x 1 for this. The mother states the child is afebrile, in no distress, and is eating and drinking normally. Mother assures me that the child is having no difficult breathing. I instructed the mother to give the child BENDADRYL 10mL q4-6 hours if these are any concerning symptoms such as fever, lethargy, decreased PO intake, or signs of airway compromise, then she should bring the child to the ER right away. If the rash improves with BENDRAYL, patient should follow up with family medicine on Monday. Patient able to repeat back plan and agreeable. All questions answered. I will forward this note to the primary. When patient followed up followed up with us on May 10th her father informed us that they did take her to ER for her rash. They did not bring any paper work regarding that visit so we sent ER a request for her medical records.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, MMR, PNC13, VARCEL
Symptoms: Seizure
Clinical narrative: The next day (4-05-17) at approx. 12:00 pm - 2:00 pm child appeared to have a seizure in daycare. An ambulance was called. Guardian denied she had a fever in the morning, but the daycare personnel said she was "hot" when she was taking her nap. Pt. discharged home.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Limb mass, Streptococcal infection
Clinical narrative: Small palpable lump on (L) upper arm. Dx with strep at todays visit.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Nuclear magnetic resonance imaging, Rotator cuff syndrome, X-ray
Clinical narrative: Notified of condition by the state 5-8-17 Pt states was Dx with cellulitis on 2-9-17 by MD. Was Tx with KEFLEX. States was in (Rd) where received PNEUMOVAX. States did not get better and has been under the care of ortho. States has a torn rotator cuff as a result of the PNEUMOVAX vaccine. States is scheduled to see MD at ortho to have schedule surgery. Health Department has records of MRI/Xrays and cellulitis Tx.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Took 4th dose of oral Typhoid (VIVOTIF) 4/28/17 hives appeared on backs of arms and back cleared Saturday 4/29/17. Reappeared and worsened Sunday AM 4/30/17.-All over body and lips/face, saw doctor - was given BENADRYL - Re-appeared again on Monday. (worsened)
Age: 65.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Patient received TDaP and PCV 13 vaccines on 5/10/17. Patients daughter called 5/11/17 to report her father had fever 101.4 with chills, headache, body aches. She gave TYLENOL at 6:00 and symptoms resolved.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Injection site swollen and painful. Feverish, fatigued and achy.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Agitation, Crying, Hyporesponsive to stimuli, Hypotonia, Pallor
Clinical narrative: Approx. 5 min after vaccine administration, pt became agitated, crying, vomited multiple times. He was noted to have splotchy rash on his trunk. Shortly after that he developed respiratory distress, wheezing, became pale, limp and minimally responsive. Oxygen applied, epinephrine 0.15mg given at 1617, pt transported by EMS to Hospital.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash, Rash macular, Respiratory distress, Vomiting, Wheezing
Clinical narrative: Approx. 5 min after vaccine administration, pt became agitated, crying, vomited multiple times. He was noted to have splotchy rash on his trunk. Shortly after that he developed respiratory distress, wheezing, became pale, limp and minimally responsive. Oxygen applied, epinephrine 0.15mg given at 1617, pt transported by EMS to Hospital.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Arm is inflamed and very red. Pt will see Dr.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion
Clinical narrative: Pt. states to have a bruise a day or two after injection. She came back 5-11-17 and still has a bruise. She said it never faded or went away. Stayed the same.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: 2 days after receiving vaccination red spot appeared 3 in x 7 in size, warm to touch.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Diarrhoea, Rash macular
Clinical narrative: Received PEDIARIX and ROTATEQ on 5/8/17. Mom called today stating pt has red blotches that are flat over chest and back. Watery stool.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, 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 # 621215) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were reported as none. On 26-JAN-2016 the patient was vaccinated with 3rd GARDASIL 9 lot # L027282 (dose, frequency and lot expiration date were not reported), via intramuscular route, in the left arm for prophylaxis. On 26-JAN-2016, patient experienced rash with hives on thigh, right/left ankle and neck. Patient had no redness or rash on the injection site. Patient was not exposed to anything new except the HPV 9. The patient required an emergency room visit. The outcome of rash and urticaria were unknown. Causality assessment for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Dizziness
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 # 621592). This spontaneous report refers to a 12 year old female patient. Information on patient's concurrent illnesses was not reported. The patient's medical history included asthma and other medications included albuterol HFA inhaler. On 27-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L019297, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX dose 1, intramuscularly in the right arm; FLUMIST QUADRIVALENT dose 1, via intranasal route and MENACTRA dose 1, intramuscularly in the right arm for prophylaxis. On 27-JAN-2016, approximately 1 minute after receiving injections, patient complained of feeling dizzy. Patient laid down on exam table and propped up lower legs with blankets. She was given a cup of water and crackers as she hadn't eaten breakfast. Patient felt better in approximately 5 minutes. The outcome of dizziness was reported as recovered. The causality assessment for the event dizziness 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: FLU3, HEPA, HPV9, IPV, MMRV, VARCEL
Symptoms: Extra dose 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 (VAERS # 621904) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 19-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L020015, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included PROQUAD (dose number: 1, vaccinated date: 19-JAN-2016, subcutaneously in the right arm, lot# L02634; dose and expiration date unknown), VARIVAX (dose number: 2, vaccinated date: 19-JAN-2016, subcutaneously in the left arm , lot# L032394; dose and expiration date unknown), VAQTA (dose number: 1, vaccinated date: 19-JAN-2016, subcutaneously in the right arm , lot# L023936; dose and expiration date unknown), FLUZONE (dose number: 1, vaccinated date: 19-JAN-2016, intramuscularly in the left arm , lot# U5310D; dose and expiration date unknown) and IPOL (dose number: 2, vaccinated date: 19-JAN-2016, subcutaneously in the left arm , lot# 11442; dose and expiration date unknown).  It was reported that the patient was given PROQUAD and VARIVAX on the same day (extra dose administered). No issues were noted from vaccine. The outcome of extra dose administered 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: 14.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Chest pain, Injection site pain, Mobility decreased, Musculoskeletal stiffness, 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 # 622149). This spontaneous report refers to a 14 year old female patient. Patient had no concurrent illnesses, medical history and other medications. On 06-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L045711, dose 3, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUMIST QUADRIVALENT lot # FL2117, dose 2, via intranasal route for prophylaxis. On 02-FEB-2016, the patient experienced pain at injection site, stiffness and pain was worse. Patient had pain down her arm and into shoulder/chest and was unable to lift her arm above the shoulder. 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: 14.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: 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 # 622149). This spontaneous report refers to a 14 year old female patient. Patient had no concurrent illnesses, medical history and other medications. On 06-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L045711, dose 3, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUMIST QUADRIVALENT lot # FL2117, dose 2, via intranasal route for prophylaxis. On 02-FEB-2016, the patient experienced pain at injection site, stiffness and pain was worse. Patient had pain down her arm and into shoulder/chest and was unable to lift her arm above the shoulder. 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, TDAP, VARCEL
Symptoms: Disorientation, Eye movement disorder, Immediate post-injection reaction, Muscle rigidity, 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 (HA# 623298) and refers to a 11 year old female patient. Her current illnesses was reported as none. Medical history was none known as per her mother. No details about prior vaccinations and other medication were provided. On 22-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L019297, dose 1, intramuscularly in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with MENACTRA, VARIVAX and ADACEL. The patient was given GARDASIL 9 and ADACEL in the right deltoid, followed by MENACTRA in the left deltoid region. Immediately following third vaccine, patient's eyes rolled back in head and she became unresponsive. This was followed by extremity rigidity, both arms and some visible tremors. Within 2-3 minutes, patient relaxed and eyes began to focus. She appeared disoriented and did not respond verbally, but looked at provider when her name was called. She gradually became more alert and oriented, able to give her name and age. She was evaluated by physician on site. BP was 123/79 (unit unknown), P78, R18. Patient was given juice and crackers, as she had not eaten since breakfast. At the onset of the event, 911 was called. The EMT squad arrived and also evaluated vital signs and level of consciousness. No visible injuries were sustained. The mother declined transport to the hospital. On further questioning with the mother, it was determined that the patient had fainted previously when she had gone long periods without eating. The patient continued to be observed for 20 -30 minutes and then left ambulatory with mother. The outcome of disorientation, immediate post-injection reaction, unresponsive to stimuli, tremor, muscle rigidity and eye movement disorder 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, MNQ, TDAP, VARCEL
Symptoms: Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 623298) and refers to a 11 year old female patient. Her current illnesses was reported as none. Medical history was none known as per her mother. No details about prior vaccinations and other medication were provided. On 22-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L019297, dose 1, intramuscularly in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with MENACTRA, VARIVAX and ADACEL. The patient was given GARDASIL 9 and ADACEL in the right deltoid, followed by MENACTRA in the left deltoid region. Immediately following third vaccine, patient's eyes rolled back in head and she became unresponsive. This was followed by extremity rigidity, both arms and some visible tremors. Within 2-3 minutes, patient relaxed and eyes began to focus. She appeared disoriented and did not respond verbally, but looked at provider when her name was called. She gradually became more alert and oriented, able to give her name and age. She was evaluated by physician on site. BP was 123/79 (unit unknown), P78, R18. Patient was given juice and crackers, as she had not eaten since breakfast. At the onset of the event, 911 was called. The EMT squad arrived and also evaluated vital signs and level of consciousness. No visible injuries were sustained. The mother declined transport to the hospital. On further questioning with the mother, it was determined that the patient had fainted previously when she had gone long periods without eating. The patient continued to be observed for 20 -30 minutes and then left ambulatory with mother. The outcome of disorientation, immediate post-injection reaction, unresponsive to stimuli, tremor, muscle rigidity and eye movement disorder 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: HEPA, HPV9, MNQ
Symptoms: 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 (HA# 623389) and refers to a 17 year old male patient. His current illnesses were reported as none. He had no known drug allergies. No details about lab data, other medications and prior vaccination was provided. On 09-SEP-2015, the patient was vaccinated with GARDASIL 9, intramuscularly in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with MENACTRA and HAVRIX. On 11-OCT-2015, the patient experienced seizure, which needed Emergency Room visit. There was no specific correlation, however neurology can also not explain the sudden seizure. The outcome of seizure 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: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Induration, Lymphadenopathy, Migraine, 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 #623542) and refers to a 12 year old female patient. Her current illness included tender lymph node from November 2015 after first round of HPV Vaccine. On 01-FEB-2016, the patient was vaccinated with GARDASIL 9, dose 2, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). On 01-FEB-2016, the patient experienced migraine, nausea and within 12 hours all lymph nodes became swollen hard again like in November after first round of HPV Vaccine. Throwing up started by day 2 after vaccination and continued for 2 weeks. She lost 4 lbs body weight. No lab tests were performed other than the Doctor checked patient on 22-FEB-2016, when patient resumed throwing up and abdominal pain again for 3rd time after receiving second round of HPV vaccine. The outcome of abdominal pain, weight decreased, vomiting, nausea, migraine and lymphadenopathy was reported as not recovered/not resolved. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting, Weight decreased
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 #623542) and refers to a 12 year old female patient. Her current illness included tender lymph node from November 2015 after first round of HPV Vaccine. On 01-FEB-2016, the patient was vaccinated with GARDASIL 9, dose 2, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). On 01-FEB-2016, the patient experienced migraine, nausea and within 12 hours all lymph nodes became swollen hard again like in November after first round of HPV Vaccine. Throwing up started by day 2 after vaccination and continued for 2 weeks. She lost 4 lbs body weight. No lab tests were performed other than the Doctor checked patient on 22-FEB-2016, when patient resumed throwing up and abdominal pain again for 3rd time after receiving second round of HPV vaccine. The outcome of abdominal pain, weight decreased, vomiting, nausea, migraine and lymphadenopathy was reported as not recovered/not resolved. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site erythema, 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 ID-624639)  on 18-APR-2017. This spontaneous report refers to a 19 year old female patient. The patient's medical history, concurrent conditions and concomitant medications and prior vaccinations were not reported. On 29-JAN-2016 the patient was vaccinated with GARDASIL 9 (lot # I007560) dose 1 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On 03-FEB-2016, the patient experienced arthralgia, pain in extremity (pain in left arm extending down into wrist) and injection site erythema. The patient had no fever, swelling and head/neck pain. The outcome of arthralgia, pain in extremity and injection site erythema was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Migraine, New daily persistent 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 # 625230). This spontaneous report refers to a 13 year old female patient. The patient had no concurrent illnesses, medical history and other medications. On 19-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L036245, dose 1, route: unknown in the left arm for prophylaxis. On 21-JAN-2016, 2 days after vaccination, the patient experienced chronic daily migrainous headache and had no past medical history of recurrent headaches. The outcome of the events was reported as not 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: MNQ
Symptoms: 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 (VAERS # 625402). This spontaneous report refers to a 15 year old male patient. The patient had no concurrent illnesses and medical history. Information on other medications and prior vaccinations were not reported. On 09-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L025737, dose 2, intramuscularly in the right arm for prophylaxis. On 04-MAR-2016, patient was wrongly administered with MENVEO lot # M15019, dose 1, intramuscularly in the left arm, but patient's mother had expected patient to get meningococcal B. The outcome of the event was reported as recovered. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site warmth, 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 # 625477). This spontaneous report refers to a 21 year old female patient. Patient had no concurrent illnesses and other medications. The patient's medical history included allergies: AUGMENTIN, VICODIN TUSS and sulfa, migraine and generalised anxiety. On 02-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L036245, dose 1, intramuscularly in the right arm and PNEUMOVAX lot # K019386, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated BOOSTRIX lot # 7XR47, intramuscularly in the left arm and FLUARIX lot # 7HR72, intramuscularly in the left arm for prophylaxis. Patient reported that her left arm became painful in the evening on 02-MAR-2016 (also reported as 03-MAR-2016). On 03-MAR-2016, patient's deltoid was reddened, hard and warm to touch. On 04-MAR-2016 (also reported as 03-MAR-2016), patient stated that it was difficult to move her left arm. The outcome of the events was not reported. The causality assessment for all the events with respect to GARDASIL 9 and PNEUMOVAX was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 21.0
Sex: F
Vaccine: HPV9, MENB, MNQ, TD
Symptoms: Unevaluable 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 # 626212) and refers to a 21 year old female patient. Her current illness was cold and medical history included Asplenia. No details about lab data, other medications and prior vaccination was provided. On 25-FEB-2016 the patient was vaccinated with GARDASIL 9, lot # L026602, dose 2, via unknown route in the right arm for prophylaxis. Other suspect therapies included vaccination with MENACTRA, TENIVAC and BEXSERO. It was reported that the drug was administered to patient of inappropriate age. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 626976) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 19 year old female patient. The patient had no known allergies in the past. The patient had no other medications or concurrent illnesses. On 04-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L024993 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day 1 hour post vaccination, the patient felt fatigued which was followed by body aches, fever and headache. The symptoms lasted for 2 days. There were no signs and symptoms of injection site reaction reported. The outcome for the events fatigue, pyrexia, pain and headache were 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, IPV, MMR, VARCEL
Symptoms: Unevaluable 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 (VAERS # 627054) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 15 year old female patient. The patient's medical history included dust allergy, weather change allergy and pregnancy test was positive. Information on concomitant therapies, concurrent illness, lab data and prior vaccinations were not reported. On 14-MAR-2016, the patient was vaccinated with first dose of GARDASIL 9 injection, lot # L043213, (dose and lot expiration date unknown) intramuscularly in the right arm for prophylaxis. Other suspect therapies included VARIVAX (Vaccinated date: 14-MAR-2016, dose number 1, (dose and lot expiration date unknown) lot # L40419, subcutaneously in the left arm), M-M-R II ((Vaccinated date: 14-MAR-2016, dose number 2, (dose and lot expiration date unknown) lot # L020189, subcutaneously in the left arm) and IPOL (Manufacturer: Sanofi Pasteur, Vaccinated date: 14-MAR-2016, dose number 5, (dose and lot expiration date unknown) lot # L043213, subcutaneously in the right arm) for prophylaxis. On an unknown date, the patient experienced an unevaluable adverse event. The outcome of the event was unknown. The 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: Dizziness, Pallor, Pharyngeal oedema
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 # 627064) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 14 year old female patient. The patient had no concurrent illnesses and medical history included type 1 diabetes mellitus. The patient's other medications included insulin pump. On 11-MAR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L038917 (dose number: 3, frequency and lot expiration date were not reported) for prophylaxis. On the same day, the patient complained of throat swelling, became pale and felt lightheaded. The throat problem had lasted for 5 minutes and the patient had faintness for half an hour. Her vitals were within normal limits and had laid down for half an hour. The patient was offered BENADRYL and prednisone which she declined. She was to take BENADRYL (oral) and ZANTAC as soon as she got home. The patient's mother was in attendance and verbalized understanding. The outcome for the events dizziness, pharyngeal oedema and pallor 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: M
Vaccine: HPV9, MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site warmth, 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 # 627294). This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses, medical history and other medications. On 07-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L028083, dose 3, intramuscularly in the left deltoid for prophylaxis. On the same day the patient was also vaccinated with MENVEO lot # A15009, dose 1, intramuscularly in the left deltoid for prophylaxis. Patient received both immunizations in the same left deltoid. Later in the evening on 07-MAR-2016, patient developed redness over his entire deltoid along with warmth at the site, soreness, fever at home and headache. He was given cool compress and ibuprofen. No other treatment was given and it took several days to resolve. 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: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Mass
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# 629928) and refers to a 37 year old female patient. Current illnesses and medical history was reported as none. No details about lab data, other medications, and prior vaccination was provided. On 30-NOV-2015, the patient was vaccinated with GARDASIL 9, lot # L019286, dose 2, intramuscular in the left arm for prophylaxis (strength and dosing details unknown). On 01-DEC-2015 the patient developed a pea size lump under the skin that lasted 2 months and was fatigue since vaccination. The outcome of mass and fatigue 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: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Limb mass, Pain in extremity, Peripheral 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 (HA# 630298) and refers to a 14 year old male patient. Patient's current illnesses, medical history, lab data and other medications were reported as none. No details about prior vaccination was provided. On 11-MAR-2016 the patient was vaccinated with GARDASIL 9, lot # L038917, dose 1, intramuscularly in the left arm for prophylaxis (strength and dosing detail unknown). On 04-APR-2016, the patient experienced pain in extremity, limb mass and peripheral swelling. The arm still has a persistent swelling/lump, and is still sore. It did not look like an infection. The patient's arm swelling and soreness was not yet 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: HEPA, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 630316) and refers to a 13 year old male patient. No details about current illnesses, medical history, lab data and other medications were provided. His prior vaccination included HSP Influenza (Seasonal) (no brand name) vaccine at the age of 5 year. On 30-MAR-2016, Wednesday, the patient was vaccinated with GARDASIL 9 lot # L040164, intramuscular in the right arm for prophylaxis (strength and dosing details unknown). Other suspect therapy included vaccination on 30-MAR-2016, with VAQTA, lot#C7252, intramuscular in the left arm for prophylaxis. On 31-MAR-2016, Thursday, his right arm began to turn red and swollen at injection site. Then developed a lump and was also itchy and painful when lifting. On 01-APR-2016, Friday, the arm was no longer red and swelling was decreased. The outcome of injection site erythema, injection site swelling, injection site pruritus, injection site mass and pain 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: 5.0
Sex: M
Vaccine: HPV9, MMR
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 (VAERS # 632084). This spontaneous report refers to a 5 year old male patient. The patient had no concurrent illnesses, medical history and other medications. Information on patient's prior vaccinations was not reported. On 07-APR-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (dosage, dose number, lot #, route and site of administration were unspecified). On the same day, the patient was also vaccinated with M-M-R II batch# L051102, dose 2 via subcutaneous route in the right arm for prophylaxis (dosage unspecified). Immunization given was incorrect, GARDASIL 9 was given instead of KINRIX. Wrong drug administered and no adverse event was reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Fall, Tooth fracture
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 # 634210) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old male patient with prophylaxis. The patient had no other medications, current illnesses, medical history and the prior vaccinations was not reported. On 03-MAY-2016, the patient was vaccinated with the third dose of GARDASIL 9 (route of administration: unknown) in the right arm, lot # L016429: expiration date: 09-AUG-2017, (dose and frequency was not reported) and with a second dose of VAQTA (route of administration: unknown) in the left arm, lot # L023936, (dose, frequency and expiration date were not reported) for prophylaxis and on the same day after receiving both vaccines the patient stood up to exit, fell forward brushing nurse shoulder then to floor. The patient had small chip to (L) left front tooth. This was notified by patient mother. The patient was provided with ice and Tylenol. The patient's grandma was there to take home the patient. The patient went to dentist. On an unknown date, patient had emergency room (ER) visit. The outcome of fall and tooth fracture 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: Blepharospasm, Condition aggravated, Dyskinesia, Electroencephalogram, Tic
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 # 635244) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old female patient with prophylaxis. The patient's other medications included clonidine. The patient's current illnesses included, mother stated that patient told her she had a really bad headache the day the vaccine was administered. When asked before immunizing if she was sick patient replied no. The patient medical history included vocal ticks treated with clonidine. The patient's prior vaccinations were not reported. On 03-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L043213 (dose, frequency and lot expiration date were not reported) for prophylaxis. Lab data included: EEG (electroencephalogram): results not back yet. As per patient's mother, on 04-MAY-2016, the patient stated she had significant increase of vocal ticks (approximately. 50) which started that morning and the same day the patient had blepharospasm, dyskinesia, underwent electroencephalogram and had condition aggravated. On 05-MAY-2016, patient's mother called neurologist doctor who increased her clonidine to 0.1 mg, BID. On 06-MAY-2016, increase on vocal ticks persist despite of increase in clonidine. On 10-MAY-2016, the patient woke up with her eyes twitching and her head jerking. Later that day, her mouth started jerking and was shown to neurologist that day and EEG was done. The doctor also ordered Klonopin 0.5 mg, BID to patient. On 11-MAY-2016, vocal ticks persists and head and mouth are still jerking. On an unknown date, patient had emergency room (ER) visit. The outcome of blepharospasm, tic, electroencephalogram, dyskinesia and condition aggravated was reported as not recovered.  Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Agitation, Feeling abnormal, Hyperventilation, 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 # 636436). This spontaneous report refers to a 11 year old male patient. Patient had no concurrent illnesses and medical history. On 09-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 1, intramuscularly in the left arm for prophylaxis. On 09-MAY-2016, patient started to feel weird right after the shot was given. He hyperventilated and was very agitated for 90 minutes. 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: F
Vaccine: HPV9
Symptoms: Dizziness, Hypotension
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 # 636687). This spontaneous report refers to a 37 year old female patient. Patient had no concurrent illnesses. The patient's medical history included occasional migraines and intolerance to neomycin to eye drops. Patient's other medication included Flonase. On 23-MAY-2016, the patient was vaccinated with GARDASIL 9 dose 1, intramuscularly in the left arm for prophylaxis. On 23-MAY-2016, immediately after administration of vaccine by the nurse, patient felt like she was going to faint and she felt the blood drain from her face and got dizzy. The patient stated that " I have fainted in the past and know what it feels like and i believe if i had stood or even remained sitting upright i would likely have fainted". The nurse made patient lie down and checked her blood pressure, which she said was low (which was normal earlier that day). Patient felt that feeling come and go for the next 20 minutes or so before she was finally okay to sit up. Then probably after 15 more minutes she felt normal enough to stand. 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, MMR, VARCEL
Symptoms: Dizziness, 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 # 637694) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old female patient. Information on patient's concomitant therapies and prior vaccinations were not reported. Patient's medical history included wellness examination. Patient's other medications included omeprazole 20 mg, one daily, ibuprofen 600 mg, one daily as needed. Patient had no current illness. On 01-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L020015, dose 1, via intramuscular route, in the left arm for prophylaxis (dose, frequency and lot expiration date were not reported). Other suspect therapies included VARIVAX lot# M000756, dose 2, via subcutaneous route, in the right arm and M-M-R II lot# L027431, dose 2, via subcutaneous route in the right arm for prophylaxis (dose, frequency and lot expiration date were not reported). On 01-JUN-2016, the patient began to feel faint and passed out. The outcome of dizziness and loss of consciousness 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: 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 # 638340). This spontaneous report refers to a 15 year old female patient. Patient had no concurrent illnesses and other medications. The patient's medical history included asthma-exercise induced. On 02-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L026602, dose 1, intramuscularly in the left arm for prophylaxis. On 03-JUN-2016, approximately 20-24 hours post-administration, the patient developed diffuse urticaria. Patient had no associated wheezing, difficulty in swallowing, fever and arthralgia. She was taken to urgent care and received injectable corticosteroid, loratadine and diphenhydramine. The outcome of the event urticaria was reported as not recovered. The causality assessment of the event urticaria 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: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, 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 # 638403) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 25 year old female patient. Patient had no concurrent illness. The patient's medical history included fibromyalgia and allergy to fluorescein. Patient's other medications included lyrica 100 mg and ambien 10 mg. On 21-JAN-2016 the patient was vaccinated with second dose of GARDASIL 9 (dose, frequency, lot and lot expiration date were not reported) (route reported as needle and syringe-not specified further) in the left arm for prophylaxis. On the same day, the patient experienced severe body pain and fatigue which lasted about a week. The outcome of fatigue and pain were reported as recovered. Causality assessment for the events were not reported.   Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
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-638412). This spontaneous report refers to a 17 year old male patient. The patient's current illness included dizziness. The patient had no medical history. The patient's other medications and prior vaccinations were not reported. On 08-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # M005714 dose 1 (unspecified dose and frequency), intramuscularly in the left arm for prophylaxis. On the same day, the patient had dizziness for 20 minutes after vaccination. The outcome of dizziness was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.