chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fatigue, Immediate post-injection reaction, Loss of consciousness, Muscle twitching, Nausea
Clinical narrative: Case number PHHY2013US110740, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497655) website on 04 Oct 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12011) intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: 0475AE) intramuscularly in the right arm on 23 Jul 2013. On the same day immediately after receiving MENVEO, he fainted and was unconscious for 5-10 seconds and his shoulders started to twitch. After some time the patient was alert but was very tired and complained of nausea and ringing in the ears. The symptoms lasted for 5 minutes and he was back to normal in 5 minutes. The event outcome was completely recovered as on 25 Jul 2013. The seriousness and causality were not reported. No additional information was available.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope, Tinnitus
Clinical narrative: Case number PHHY2013US110740, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497655) website on 04 Oct 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12011) intramuscularly in the left arm and GARDASIL (other manufacturer, batch number: 0475AE) intramuscularly in the right arm on 23 Jul 2013. On the same day immediately after receiving MENVEO, he fainted and was unconscious for 5-10 seconds and his shoulders started to twitch. After some time the patient was alert but was very tired and complained of nausea and ringing in the ears. The symptoms lasted for 5 minutes and he was back to normal in 5 minutes. The event outcome was completely recovered as on 25 Jul 2013. The seriousness and causality were not reported. No additional information was available.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Case number PHHY2013US110743 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497785) website on 04 Oct 2013. This report refers to 11-year-old female patient. She was vaccinated with MENVEO (batch number: A12127) in the left arm and ADACEL (batch number: C4453BA) in the right arm, both via intramuscular route on 25 Jul 2013. On 26 Jul 2013, she experienced vomiting, temperature between 101.8 and 102.8, sweating, chills, achy body, she was unable to keep liquids down and had extreme fatigue. It was reported that her symptoms were persisting till an unknown date. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Case number PHHY2013US110743 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497785) website on 04 Oct 2013. This report refers to 11-year-old female patient. She was vaccinated with MENVEO (batch number: A12127) in the left arm and ADACEL (batch number: C4453BA) in the right arm, both via intramuscular route on 25 Jul 2013. On 26 Jul 2013, she experienced vomiting, temperature between 101.8 and 102.8, sweating, chills, achy body, she was unable to keep liquids down and had extreme fatigue. It was reported that her symptoms were persisting till an unknown date. The seriousness and causality of the events were not reported.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Areflexia, Guillain-Barre syndrome, Laboratory test
Clinical narrative: Case number PHHY2013US117222 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 497835) on 15 Oct 2013. This report refers to a 68-year-old female patient. Her vaccination history included vaccination with ZOSTAVAX and Tdap on 13 Jun 2012. She was vaccinated with PNEUMOVAX 23 (other manufacturer, batch number: not reported) and an unspecified seasonal influenza vaccine (manufacturer and batch number: unknown) on 18 Oct 2012. On 01 Jul 2013, she experienced unexplained loss of function in reflexes and lower extremity ascending paralysis. She was still confined to a wheelchair and was not recovered but was seeing a neurologist. She initially sought medical attention for this adverse experience at the emergency room, where she was afterwards admitted and hospitalized for an unspecified number of days and received unspecified treatment and lab tests. At the time of reporting, the patient had not recovered. The nurse practitioner considered events to be significant disability. No additional information was available.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion, Syncope
Clinical narrative: Case number PHHY2013US110756, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497878) website on 04 Oct 2013. This report refers to a 19-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with the first dose of MENVEO (batch number: A12011) intramuscularly in the left arm on 28 Jul 2013. On the same day after the vaccination, he fainted and experienced seizure for approximately for 15 seconds. The event outcome was completely recovered as on 29 Jul 2013. The seriousness and causality were not reported. No additional information was available.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Dizziness postural, Seizure like phenomena
Clinical narrative: Case number PHHY2013US110758 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497945) website on 04 Oct 2013. This report refers to 12-year-old female patient. Her medical history included convulsion and fainting. The patient was being followed by neurology and cardiology department. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12097) intramuscularly in the right arm and 1st dose of VARIVAX (batch number: J001174) subcutaneously in the right arm and ADACEL (batch number: U4618AA) intramuscularly in the left arm on 29 Jul 2013. On the same day after vaccination, she began to get lightheaded and dizzy. She was laid down and feet were elevated. She began to have beginning signs of a seizure, but her mom intervened by talking with patient and she responded by. It was reported that she was unable to stand without being lightheaded. So, she was sent to the emergency room. No testing was done in the ER. The patient recovered on the same day. The seriousness and causality were not reported. No additional information was available.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Case number PHHY2013US117226 is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 498537) on 15 Oct 2013. This case refers to a 62-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PNEUMOVAX (other manufacturer, batch number: not reported) on 19 Oct 2012. On the same day after vaccination the patient developed chills, fever, systemic itching and injection site swelling. Following the events she visited emergency room (ER). She was treated with ZYRTEC, prednisone, cephalexin, PRAMOSONE and CLARITIN. Injection site swelling resolved by four weeks later. The outcome of systemic itching was reported as condition unchanged as of 22 Jul 2013, and for the remaining events it was not reported. The seriousness and causality assessment of the events was not reported.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Feeling abnormal, Injection site swelling, Lethargy, Throat tightness
Clinical narrative: Case number PHHY2013US127778 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498551) website on 11 Nov 2013. This report refers to an 11-year-old male patient. His family history included Guillain-Barre Syndrome and asthma and his medical history included nickel sensitivity and nut allergy. He was vaccinated with MENVEO (batch number: M12113) intramuscularly in the left arm and HAVRIX (batch number: AHAVB527EA, other manufacturer) intramuscularly in the left arm on 26 Jul 2013. On the same day, after vaccination, he experienced tight throat, abnormal swelling at injection site left upper arm and "felt out of it/lethargic". She went to emergency room because of these events. His mother gave him BENADRYL at home. Outcome of the events was reported as recovered as of 30 Jul 2013. No seriousness and causality was reported for these events.
Age: 19.0
Sex: M
Vaccine: HEPA, HPVX, MNQ
Symptoms: Convulsion, Dizziness, Pallor, Syncope
Clinical narrative: Case number PHHY2013US116567 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 498631) on 15 Oct 2013: This report refers to a 19-year-old male patient. His medical history included upper respiratory infection and his concomitant medications were not reported. He was vaccinated with a meningococcal vaccine (manufacturer and batch number: unknown, therefore conservatively taken as MENVEO INN) along with a hepatitis A vaccine (manufacturer and batch number: unknown) and with a human papilloma vaccine (manufacturer and batch number: unknown) on 08 May 2013. Hepatitis A vaccine was given in the left arm; the other two vaccines were administered in the right arm. On the same day after vaccinations, he fainted and experienced convulsion type movements for about a one minute duration. Cold compresses were applied and SPRITE was provided to the patient. He was made to lie down until dizziness and pallor subsided. Final outcome of the events was reported as complete recovery. No additional information about seriousness and causality was reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US110898 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498868) website on 04 Oct 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. On 06 Aug 2013, she was vaccinated with MENVEO (batch number: M12097) intramuscularly in the left arm and ADACEL (other manufacturer, batch number: AC52B110CA) intramuscularly in the right arm. On 7 Aug 2013 at 5 pm, her left arm became red, swollen and hot to touch. She went to emergency room with complaint of breathing difficulties. She was treated with epinephrine, methylprednisolone, ranitidine, Albuterol and diphenhydramine. After an overnight monitoring (not hospitalized), she was released the next day. On an unknown date, she had completely recovered from the events. The seriousness and causality of the events was not reported.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Case number PHHY2013US110902, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498874) website on 04 Oct 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. On 08 Aug 2013, she was vaccinated with MENVEO (batch number: M11050) intramuscularly in the left arm, BOOSTRIX (other manufacturer, batch number: AC52B088AA) intramuscularly in the right arm and VARIVAX (other manufacturer, batch number: J000191) intramuscularly into the left arm. On the same day after vaccination, she became dizzy, pale, diaphoretic and fainted. The patient recovered on the same day. The seriousness and causality of the events were not reported.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope
Clinical narrative: Case number PHHY2013US110903 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 498875) website on 04 Oct 2013. This report refers to a 12-year-old male patient. His medical history and concomitant medications were not reported. On 01 Aug 2013 he was vaccinated with MENVEO (batch number: M11050) and GARDASIL (other manufacturer, batch number: 0131AE) both intramuscularly in the right arm, HAVRIX (other manufacturer, batch number: 5449M) and BOOSTRIX (other manufacturer, batch number: AC52B088AA) both intramuscularly in the left arm. He was also vaccinated with VARIVAX (other manufacturer, batch number: J000192) subcutaneously into the left arm on the same day. After vaccination he became pale, dizzy and diaphoretic and then fainted. Outcome for these events was reported as complete recovery as of 08 Aug 2013. The causality and seriousness were not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Fall, Gait disturbance, Limb injury, Nausea
Clinical narrative: Case number PHHY2013US127809 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499160) website on 11 Nov 2013. This report refers to an 18-year-old female patient. Her medical history was not reported. Her concomitant medication included MONONESSA as oral contraceptive. She was vaccinated with MENVEO (batch number: M12009) into left arm on 07 Aug 2013. After five minutes of vaccination, she began to feel nauseous. She stumbled on the way to bathroom (although she was told not to get up if she felt ill) and fell faint on the way resulting in falling and hitting her arm. Outcome of the events was reported as not recovered as of 07 Aug 2013. No seriousness and causality was reported for the events.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Defaecation urgency, Loss of consciousness, Nausea
Clinical narrative: Case number PHHY2013US127824 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499241) website on 11 Nov 2013. This report refers to a 12-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: M11051) intramuscularly into right arm, INFANRIX (other manufacturer, batch number: AC52B110DA) intramuscularly into right arm, GARDASIL (other manufacturer, batch number: H021346) intramuscularly into left arm and VARIVAX (other manufacturer, batch number: J001182) subcutaneously into left arm on 15 Jul 2013. On the same day after vaccination, she passed out. She was laid down and her feet were elevated. Upon rising, she was nauseated and felt the need to have a BM (bowel movement). Outcome of the events was reported as recovered as of 13 Aug 2013. No seriousness and causality was reported for the events.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hunger, Nausea, Syncope
Clinical narrative: Case number PHHY2013US127713, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499338) website on 11 Nov 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A12097) and BOOSTRIX (batch number: AC52B092BA), both intramuscularly in the left arm on 12 Aug 2013. On the same date, after receiving vaccines he fainted on his way home. He was out for first few seconds only and then was nauseous, but no vomiting. He was hungry shortly there after and he was fine without other symptoms. He received no treatment. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Pallor, Syncope, Vomiting
Clinical narrative: Case number PHHY2013US127790, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 499652) website on 11 Nov 2013. This report refers to a 16-year-old male patient. His medical history included anxiety disorder and attention deficit/ hyperactivity disorder. He was vaccinated with MENVEO (batch number: M12131) and HAVRIX (batch number: AHAVB552CA), in the left arm on 14 Aug 2013. On the same date, he also received GARDASIL (batch number: J002641) in the right arm. On the same date, after third vaccination he became very pale and his eyes closed and started to lean over the nurse. The nurse grabbed him and hollered for help. He was then lowered to the ground and his feet elevated and couple of fans was kept in front of him to increase air flow. He then vomited and he was turned to his side and cleaned up. He remained at the facility for about one hour with his feet elevated and air blowing on him. The outcome of the events reported as recovered on same day. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: Initial report received from a nonhealthcare professional (patient) on 13 September 2013. A patient (whose age and gender were not reported) had received a dose of ADACEL vaccine (lot number 43979AA, dose number, route and site of administration was not reported) on 15 August 2013. The patient's medical history and concomitant medications were not reported. On 15 August 2013, the patient experienced an adverse reaction (details were not specified). Laboratory details and corrective medications were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Oropharyngeal blistering, Pharyngeal erythema, Pharyngeal oedema, Urticaria
Clinical narrative: Case number PHHY2013US127837, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 500140) website on 11 Nov 2013. This report refers to a 16-year-old male patient. His medical history included asthma. Concomitant drug included PRILOSEC as needed. He was vaccinated with MENVEO (batch number: M12124) intramuscularly in the right arm on 21 Aug 2013. On the same date, after vaccination he experienced swollen throat, hives on neck, red blisters on back of throat and headache. The patient visited the emergency room and was given ZYRTEC. The outcome of the events was reported as recovered as of 22 Aug 2013. The seriousness and causality of the events were not reported.
Age: 12.0
Sex: F
Vaccine: DTAP, HPV4, MNQ, VARCEL
Symptoms: Somnolence, Syncope
Clinical narrative: Case number PHHY2013US135203 is an initial spontaneous report received from a nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 500232) website on 25 Nov 2013. This report refers to a 12-year-old female patient. The medical history and concomitant medications of the patient were not reported. It was reported that the patient had no drug reaction/allergies. The patient was vaccinated with first dose of GARDASIL (other manufacturer, batch number: H021346, expiry date: 01 Oct 2015) intramuscularly, meningococcal vaccine (manufacturer and batch number unknown. Hence, conservatively coded as MENVEO INN), DTAP vaccine (manufacturer and batch number unknown) and VARIVAX (other manufacturer, batch number: unknown) on 15 Jul 2013. On the same day, after receiving vaccinations, the patient experienced syncope. The nurse reported that she made the patient to lie down after experiencing syncope, and it took 15 seconds for the patient to wake up. The patient had sought medical attention (emergency visit) and the patient was in physician office when the adverse reaction happened. No treatment was received and no lab tests were performed. Outcome of the event was reported as recovered as of 15 Jul 2013. No seriousness and causality was reported for the event.
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Initial report received from a healthcare professional on 28 Augusst 2013. A 74-year-old female patient had received a dose of ADACEL (batch number-U4325AB, expiry date-08/18/2014) intramuscularly in the left arm on 15 August 2013. The patient had no illness at time of vaccination. The patient's drug allergies included-Codeine. Medical history, birth defects and concomitant medications were not reported. On 21 August 2013, the patient had develoed swollen, red, itchy left arm from the vaccination site down to the elbow. The corrective treatments and laboratory investigations were not reported. At the time of this report, the patient had not recovered from the events. Documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial pregnancy report received from a consumer on 22 August 2013. An 18-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of MENACTRA (batch number, site and route of administration were not reported) and Varicella vaccine (manufacturer: unknown, batch number, site and route of administration were not reported) on an unspecified date in August 2013). The patient was healthy at the time of vaccination. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 16 July 2014. The estimated date of delivery was reported as 01 April 2014. At the time of the report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from a healthcare professional on 11 October 2013. The patient had received intramuscularly first dose of MENACTRA (lot number U4601BA) in the right arm, received subcutaneously second dose of varicella (manufacturer other, lot number: J003539) in left arm, and had received intramuscularly first dose of Hepatitis A vaccine (4735D) in the right arm on 16 August 2013. The patient had intramuscularly received first dose of Tap (lot number: C4327AA) in the left arm and had intramuscularly received first dose of HPV vaccine (manufacturer other, lot number: H021194) in the left arm on an unspecified date. The patient had received a dose of Varicella vaccine on 02 June 2000. The patient was diagnosed with West Nile Virus on 31 July 2013, otherwise the patient was healthy. The patient did not receive any treatment for infertility and had no previous pregnancy. The estimated date of delivery was 23 March 2014. The prenatal testing was unknown as the patient was going to a different facility for prenatal care and delivery. The patient was diagnosed with West Nile virus on 31 July 2013, otherwise the patient was healthy. The patient did not receive any treatment for infertility and had no previous pregnancy. The estimated date of delivery was 23 March 2014. The prenatal testing ws unknown as the patient was going to a different facility for prenatal care and delivery.
Age: 20.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Pyrexia, Syncope, Vaccination site pain, Vaccination site swelling
Clinical narrative: Case number PHHY2013US127863 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 500510) web site on 11 Nov 2013. This report refers to a 20-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12023) intramuscularly in right arm and MMR II (other manufacturer, batch number: H012572) subcutaneously in the right arm on 23 Aug 2013. On the same day, she fainted for about 20 minutes after receiving the vaccine. Later that night she developed fever and her body temperature was over 102F. She was taken to emergency room on the night of vaccination. It was reported that later she also had pain and swelling at vaccination site on 26 Aug 2013. The outcome of the events was reported as complete recovery as of 26 Aug 2013. The seriousness and causality of the events were not reported.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Presyncope, Syncope
Clinical narrative: Case number PHHY2013US135258 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 500722) website on 25 Nov 2013. This report refers to a 12-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with hepatitis A vaccine (manufacturer and batch number unknown) intramuscularly, meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as MENVEO INN) and first dose of GARDASIL (other manufacturer, batch number: unknown) intramuscularly on 06 Aug 2013. On the same day, after vaccination, she experienced syncope and nearly fainting about 20-25 minutes. She recovered on-site with rest and with a cold pack and also the staff continued observing for another 20 minutes after her recovery. Outcome of syncope and nearly fainting was reported as fully recovered/resolved. No seriousness and causality was reported for the events.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Throat tightness
Clinical narrative: Case number PHHY2013US127880 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 500741) web site on 11 Nov 2013. This report refers to an 18-year-old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of MENACTRA (other manufacturer, batch number: not reported) in 2009. He was vaccinated with MENVEO (batch number: A12123) intramuscularly in left arm and GARDASIL (other manufacturer, batch number: 0022AE) intramuscularly in the right arm on 20 Aug 2013. On the same day, approximately 30 minutes after vaccination, he felt that his throat was tight. His vital signs were stable. He was given BENADRYL 50 mg. The outcome of the events was reported as complete recovery on the same day. The causality was not reported.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal pain upper, Contusion, Dizziness, Dizziness postural, Immediate post-injection reaction
Clinical narrative: Case number PHHY2013US127881, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 500882) website on 11 Nov 2013. This report refers to 17-year-old female patient. Her medical history included allergy to macadamia nuts. Her concomitant medications were not reported. She was vaccinated with the first dose of MENVEO (batch number: M12127) intramuscularly in the left arm on 26 Aug 2013. Immediately after vaccination, she fainted and was laid down to avoid injury until she responded. After a few minutes, she noticed that her ankle was bruised and began to swell. She also felt lightheaded, dizzy and had a stomach ache. She ate some food when she got home. She visited a walk-in-clinic for her bruised ankle. The physician assessed her throat, heart and ankle and diagnosed as sprain. The physician did not feel any allergic reaction had taken place. She continued to feel lightheaded and dizzy when upright in the next day. Her mother reported that she had no fever, redness at injection site or hives. She felt normal and went to school on 28 Sep 2013. The event outcome was completely recovered as of 29 Sep 2013. The seriousness and causality were not reported. No additional information was available.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Joint swelling, Ligament sprain, Syncope
Clinical narrative: Case number PHHY2013US127881, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 500882) website on 11 Nov 2013. This report refers to 17-year-old female patient. Her medical history included allergy to macadamia nuts. Her concomitant medications were not reported. She was vaccinated with the first dose of MENVEO (batch number: M12127) intramuscularly in the left arm on 26 Aug 2013. Immediately after vaccination, she fainted and was laid down to avoid injury until she responded. After a few minutes, she noticed that her ankle was bruised and began to swell. She also felt lightheaded, dizzy and had a stomach ache. She ate some food when she got home. She visited a walk-in-clinic for her bruised ankle. The physician assessed her throat, heart and ankle and diagnosed as sprain. The physician did not feel any allergic reaction had taken place. She continued to feel lightheaded and dizzy when upright in the next day. Her mother reported that she had no fever, redness at injection site or hives. She felt normal and went to school on 28 Sep 2013. The event outcome was completely recovered as of 29 Sep 2013. The seriousness and causality were not reported. No additional information was available.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, TDAP
Symptoms: Condition aggravated, Syncope
Clinical narrative: Case number PHHY2013US127882, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501019) website on 11 Nov 2013. This report refers to an 11-year-old female patient. Her medical history included fainting upon seeing blood. Her concomitant medications were not reported. She was vaccinated with MENVEO (batch number: M12024) intramuscularly in the right arm, BOOSTRIX (batch number: AC52B110DA) intramuscularly in the left arm and FLUMIST quadrivalent (batch number: BH2174) intranasal on 28 Aug 2013. It was reported that she was sitting in her mother's lap while receiving BOOSTRIX and MENVEO vaccines and she fainted after receiving the second vaccine. She was roused immediately and was placed in the supine position with cold compress to vaccination sites and was given popsicle. She recovered without any incident. The event outcome was completely recovered as of 28 Aug 2013. The seriousness and causality was not reported. No additional information was available.
Sex: M
Vaccine: MNQ
Symptoms: Abasia, Loss of consciousness, Syncope, Visual impairment
Clinical narrative: Case number PHHY2013US135437 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 501654) website on 25 Nov 2013. This report refers to a male patient of an unknown age. His medical history and concomitant medication were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as MENVEO INN) on an unspecified date. On an unspecified date, after vaccination, he felt like he was losing his vision, was unable to walk, passed out and then fainted. He went to the emergency room due to these events. Outcome of the events was reported as not recovered. No causality and seriousness was reported for these events.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Chills, Pyrexia
Clinical narrative: Initial report received on 01-Oct-2013 from consumer. A 63-years-old female (patient's medical history and concomitant medications were not reported) received ADACEL (lot number, expiration date unknown) intramuscular at right deltoid for prophylactic vaccination on 02-Sep-2013. Patient had fever and chills the day after the vaccine (03-Sep-2013) and then started to feel off balance for a few weeks. On 17-Sep-2013, the feeling of imbalance got worse and she was having feverish chilled feeling. Outcome of the events were not recovered at the time of this report. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: ADEN_4_7, DTP, HEPAB, MNQ
Symptoms: Allergy to arthropod sting, Anaphylactic shock, Hypersensitivity
Clinical narrative: Case number PHHY2013US135599 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502423) website on 25 Nov 2013. This report refers to an 18-year-old male patient. He was enrolled in a study and this report was based on data abstracted from a retrospective review. His medical history and concomitant medication were not reported. His medical condition included no alcohol or tobacco use within 30 days prior to vaccination. He was vaccinated with Adenovirus vaccine (other manufacturer, batch number: unknown), DTP vaccine (manufacturer and batch number: unknown), TWINRIX (other manufacturer, batch number: unknown) and meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as MENVEO INN) on 12 Jul 2012. On 13 Jul 2012, he experienced anaphylactic shock. On the same day he started treatment with ZANTAC, BENADRYL, unknown steroid and diphenhydramine orally. On 16 Jul 2012, he experienced allergic reaction. He received treatment with epinephrine on 16 Jul 2012. He had an emergency visit due to these events. On 18 Jul 2012, he had wasp venom anaphylaxis. The events were treated at outpatient visit (OTC medication). Severity of the events was not assessed but seriousness was reported as disability/incapacity. Outcome of anaphylactic shock was reported as not resolved, outcome of allergic reaction was resolved and outcome of wasp venom anaphylaxis was not reported. The medical monitor has assessed the causal relationship of the event as possibly related to the Adenovirus Vaccine.
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHHY2013US135666 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 502557) website on 25 Nov 2013. This report refers to a male patient of an unknown age. His medical history and concomitant medication were not reported. He was vaccinated with a dose of meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as MENVEO INN) on an unspecified date. On an unspecified date, after vaccination, he fainted and was taken to the emergency room. Outcome of the event was reported as not recovered. No seriousness and causality was reported for the event.
Age: 11.0
Sex: M
Vaccine: DTAP, HPVX, MNQ
Symptoms: Abdominal pain upper, Chills, Urticaria
Clinical narrative: Case number PHHY2013US135757 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502846) website on 25 Nov 2013. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with a meningococcal vaccine (manufacturer and batch number: unknown, therefore conservatively taken as MENVEO INN) along with a diphtheria, tetanus and acellular pertussis vaccine (manufacturer and batch number: unknown) and with human papilloma virus vaccine (manufacturer and batch number: unknown) on 17 Jul 2013. On 22 Jul 2013, his body was covered in hives; he experienced chills and stomach pain. Final outcome of the events was reported as complete recovery on an undetermined date. No further information about causality and seriousness was reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Case number PHHY2013US140066 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 503928) website on 03 Dec 2013. This report refers to an 11-year-old female patient. She was vaccinated with MENVEO (batch number: M12128) intramuscularly into right arm and BOOSTRIX (other manufacturer, batch number: AC52B092PA) intramuscularly into left arm on 19 Sep 2013. On the same day, after receiving vaccinations she stood up and fainted. She recovered quickly and waited 15 minutes in the clinic. Seriousness and causality were not reported for the event.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pruritus, Rash generalised, Rash papular
Clinical narrative: Case number PHHY2013US140110 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 504035) on 03 Dec 2013. This report refers to an 11-year-old male patient. He was vaccinated with MENVEO (batch number: M11066) intramuscularly into right arm on 17 Sep 2013. On the same day, he also received HAVRIX (other manufacturer, batch number: AHAVB692CA) and ADACEL (other manufacturer, batch number: C4247AA) both intramuscularly into left arm. On 18 Sep 2013, he developed a flesh colored papular rash on neck and face, which spread intermittently to trunk and legs. He received CLARITIN due to pruritus. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Sex: M
Vaccine: FLUN4, HPV4, MNQ, TDAP
Symptoms: Feeling hot, Pruritus, Rash generalised
Clinical narrative: Case number PHHY2013US140162 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system (VAERS reference number: 504134) on 03 Dec 2013. This report refers to an 11 years-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M12120) intramuscularly in the right arm, FLUMIST (other manufacturer, batch number: BJ2013) via intranasal route, GARDASIL (other manufacturer, batch number: J008423) intramuscularly in the left leg and BOOSTRIX (other manufacturer, batch number: AC52B090BA) intramuscularly in the right leg on 23 Sep 2013. On 23 Sep 2013, approximately 20 minutes after vaccine administration, he complained of feeling warm and itchy and he had rash on back and armpits. He was given BENADRYL, oatmeal bath and hydrocortisone topically. Later he had rash from head to toe including scalp and private area. He was taken to emergency room and was prescribed prednisone and ATARAX. The outcome was reported as condition unchanged. Seriousness and causality were not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Tonic clonic movements
Clinical narrative: Case number PHHY2014US000774, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 506021) website on 06 Jan 2014. This report refers to an 11-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: X12126) intramuscularly into the right arm, GARDASIL (other manufacturer, and batch number: H020002) intramuscularly into the right arm and ADACEL (other manufacturer, batch number: U4567AA) intramuscularly into the left arm on 02 Oct 2013. On the same day 10 to 15 minutes after vaccination, he experienced tonic/clonic activity. The event lasted for few seconds. The outcome of the event was complete recovery. The seriousness and causality of the event were not reported.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US001016 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 508154) website on 06 Jan 2014. This case refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number M12119) in her left arm and GARDASIL (other manufacturer, batch number J006236) in her right arm on 03 Oct 2013. On the same date after vaccination approximately 15 minutes of sitting following vaccine administration, she stood, walked several steps and fainted. Her vitals were stable. The outcome of the events was reported as complete recovery. The seriousness and causality assessment of the events was not reported.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Pruritus, Rash erythematous
Clinical narrative: Initial report received from health care professional on 18 October 2013. A 30-years-old female patient having medical history of allergy to sulfa (concomitant medications was not reported) received FLUZONE (lot number: UT4722BA, expiration date unknown) intramuscular at right arm on 11-Oct-2013. Patient had itching, she felt hot rash red noted on chest/upper chest neck on 11-Oct-2013. Outcome of the events were recovered at the time of this report. List of documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: HEPAB, MNQ, PPV, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Somnolence, Syncope
Clinical narrative: Case number PHHY2014US012604, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 510582) website on 03 Feb 2014. This report refers to a 40-year-old male patient. His medical history and concomitant medication were reported. He was vaccinated with MENVEO (batch number: M13011) intramuscularly into the right arm, BOOSTRIX (other manufacture, batch number: 2RY59) intramuscularly into the right arm, TWINRIX (other manufacturer, batch number: not reported) intramuscularly into the left arm and PNEUMOVAX (other manufacturer, batch number: H017759) intramuscularly in left arm on 29 Oct 2013. He fainted and passed out approximately 4-5 minutes. He was alert but groggy about 5 more minutes. He had a sweaty forehead without fever or clammy skin and was alert after 5 minutes. The final outcome of the events was reported as complete recovery as of 29 Oct 2013. The seriousness and causality of the events were not reported. No additional information was available.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: Initial report received on 05 November 2013 from a health care professional. a 43-year-old female patient whose medical history and concomitant medications were not reported, received a dose of ADACEL (lot number C4424AA, Expiration date unknown and site of vaccination was left deltoid) administered intramuscularly on 31-Oct-2013. It was reported that a 43-year-old female patient have received the ADACEL. On 31-Oct-2013, a few minutes after vaccination, patient developed a reddened area the size of a quarter, 1/4 to 1/2 inch thick. Symptoms were worsened and BACTRIM prescribed, advised to use warm compress. On 11-May-2013 affected area was 2cm by 4cm, less red and not as hard. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Heart rate increased
Clinical narrative: Initial report received from a consumer on 03-November-2013. A female patient whose age, medical history was not reported, received a dose of ADACEL (lot number: C4456AA, expiry date and site of administration was unknown) via intramuscular route on 27 October 2013. Patient experienced symptoms of feeling of general weakness, fast heart beat and light headedness persisting one week after the vaccine. She had also stopped running for this week. Concomitant medications included DILANTIN. The events were not resolved. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Erythema, Fall, Head injury, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2014US012649 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 513568) on 03 Feb 2014. This report refers to a 12-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A13011) and FLUARIX (other manufacturer, batch number: L4CP9) intramuscularly in the right arm and HAVRIX (other manufacturer, batch number: 55P24) and GARDASIL (other manufacturer, batch number: J003727) intramuscularly in the left arm; all vaccines were administered on 21 Oct 2013. On 21 Oct 2013, she passed out. Her face turned white and she fainted off the examination table bumping her forehead. It was reported that ice was applied on the small red spot. She was given oxygen 3L by nasal canula (NC). It was reported that her oxygen saturation became 95-98% at room air approximately within a minute after the oxygen was off. Her oxygen saturation was at baseline before leaving. The outcome was reported as complete recovery. The seriousness and causality of the event were not reported.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Case number PHHY2014US012649 is an initial spontaneous report received from the vaccine adverse event reporting system (VAERS reference number: 513568) on 03 Feb 2014. This report refers to a 12-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A13011) and FLUARIX (other manufacturer, batch number: L4CP9) intramuscularly in the right arm and HAVRIX (other manufacturer, batch number: 55P24) and GARDASIL (other manufacturer, batch number: J003727) intramuscularly in the left arm; all vaccines were administered on 21 Oct 2013. On 21 Oct 2013, she passed out. Her face turned white and she fainted off the examination table bumping her forehead. It was reported that ice was applied on the small red spot. She was given oxygen 3L by nasal canula (NC). It was reported that her oxygen saturation became 95-98% at room air approximately within a minute after the oxygen was off. Her oxygen saturation was at baseline before leaving. The outcome was reported as complete recovery. The seriousness and causality of the event were not reported.
Age: 16.0
Sex: F
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2014US012832, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 513906) website on 03 Feb 2014. This report refers to a 16-year-old female patient. Her medical history included hypothyroidism. Concomitant drug included Levothyroxine. On 19 Nov 2013, she was vaccinated with MENVEO (batch number: A12099), GARDASIL (batch number: J002423) intramuscularly and also with FLUMIST (batch number: BH2174). On an unknown date, after vaccination she felt dizzy and passed out for 5 seconds. It was reported that with jerky moves of her arm, she regained consciousness. She also became pallor and this was observed by her parent. No treatment was given to the patient. The patient's complete blood count, Vitamin D, T2, T3 levels, comprehensive metabolic panel and Tibe tests were ordered. The final outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 11.0
Sex: F
Vaccine: MEN, TD
Symptoms: Dyskinesia, Heart rate decreased, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2014US006162 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 515723) on 20 Jan 2014. This report refers to an 11-year-old female patient. Allergies of this patient include allergic to amoxicillin and congenital hypothyroidism. Concomitant medication of this patient levothyroxine. She was vaccinated with meningococcal vaccine (unknown manufacturer) and tetanus diphtheria vaccine (other manufacturer; batch number: not reported) on 05 Dec 2013. On the same day the patient presented with fainting, jerking, loss of consciousness, low blood pressure (73/34) and low heart rate (30s). Patient laid down and took rest. Ice was applied. Outcome of the events were reported as complete recovery. Seriousness and causality were not reported.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Rash
Clinical narrative: Initial report received from a health care professional on 10 January 2014. A 76-year-old female patient had received a first dose of ADACEL (lot number 2029685, intramuscularly in the left arm) on 2 January 2014 at 2:42 PM. The patient had hypertension, asthma, gout and cholesterol. On 03 January 2014, the patient had rash approximately 4 inches in diameter around hand and soreness. The patient does not have any illness at the time of vaccination. Corrective treatment was not reported. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none. Follow-up information received from healthcare professional on 24 February 2014. It was reported that, the patient visited to the private doctor's office on 10 January 2014 and received course of oral antibiotics cephalexin as a corrective treatment. On 15 January 2014, the patient was recovered from the event.