chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye swelling, Eyelid oedema, Headache, Nausea
Clinical narrative: Case number PHHY2013US116706 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 481266) website on 15 Oct 2013. This case refers to 27-year-old female patient. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on 10 Jan 2013. On 10 Jan 2013, after the vaccinations, the patient developed headache, nausea, hacking cough, hives, swollen, red and puffy eyes. The patient's doctor was not convinced that the symptoms were related to flu vaccine, yet symptoms suddenly appeared after vaccination and stopped shortly after receiving vaccine. The outcome of events was reported as complete recovery. The seriousness of events was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Ocular hyperaemia, Urticaria
Clinical narrative: Case number PHHY2013US116706 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 481266) website on 15 Oct 2013. This case refers to 27-year-old female patient. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on 10 Jan 2013. On 10 Jan 2013, after the vaccinations, the patient developed headache, nausea, hacking cough, hives, swollen, red and puffy eyes. The patient's doctor was not convinced that the symptoms were related to flu vaccine, yet symptoms suddenly appeared after vaccination and stopped shortly after receiving vaccine. The outcome of events was reported as complete recovery. The seriousness of events was not reported.
Age: 1.3
Sex: F
Vaccine: DTAP, FLUX, HIBV, FLUX
Symptoms: Drug administered to patient of inappropriate age, Dyspnoea, Rash, Swelling face, Vaccine positive rechallenge
Clinical narrative: Case number PHHY2013US116713, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481742) website on 15 Oct 2013. This report refers to a 15-month-old female infant. Her vaccination history included vaccination with seasonal influenza vaccine (batch number and manufacturer: unknown) and experienced facial swelling, difficulty breathing and rash (see case: PHHY2013US118841). The patient was again vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown), DAPTACEL (other manufacturer, batch number: not reported) and ACTHIB (other manufacturer, batch number: not reported), all intramuscularly on 17 Jan 2013. On the same date (at 13:50), after vaccination she developed difficulty breathing, facial swelling and rash. The patient received BENADRYL and EPI-PEN. Then presented to the emergency department and also received steroids. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 1.3
Sex: F
Vaccine: DTAP, FLUX, HIBV, FLUX
Symptoms: Dyspnoea, Rash, Swelling face
Clinical narrative: Case number PHHY2013US116713, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 481742) website on 15 Oct 2013. This report refers to a 15-month-old female infant. Her vaccination history included vaccination with seasonal influenza vaccine (batch number and manufacturer: unknown) and experienced facial swelling, difficulty breathing and rash (see case: PHHY2013US118841). The patient was again vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown), DAPTACEL (other manufacturer, batch number: not reported) and ACTHIB (other manufacturer, batch number: not reported), all intramuscularly on 17 Jan 2013. On the same date (at 13:50), after vaccination she developed difficulty breathing, facial swelling and rash. The patient received BENADRYL and EPI-PEN. Then presented to the emergency department and also received steroids. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 14.0
Sex: M
Vaccine: FLUX
Symptoms: Convulsion, Syncope
Clinical narrative: Case number PHHY2013US116665 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 481743) website on 15 Oct 2013. This report refers to a 14-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 17 Jan 2013. On the same day, after vaccination, he fainted and had mild seizure. Outcome of the event was reported as recovered. Seriousness and causality of the events were not reported.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB, FLUX, HEP, PPV
Symptoms: Blood test, Computerised tomogram, Drug administered to patient of inappropriate age, Febrile convulsion, Urine analysis
Clinical narrative: Case number PHHY2013US116692 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 481928) website on 15 Oct 2013. This report refers to a 1.3 year (15 months) old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into left gluteal on 10 Jan 2013. On the same day she was also vaccinated with DTP/IPV/active HIB vaccine (manufacturer and batch number unknown), hepatitis B vaccine (manufacturer and batch number unknown) and pneumococcal vaccine (manufacturer and batch number unknown) into left gluteal. On 19 Jan 2013, she experienced febrile seizure. She went to emergency room and underwent CT scan, urine and blood tests (results not reported). Outcome of the events was reported as recovered. No seriousness and causality was reported for the events. After an internal review on 22 Oct 2013, of the information received on 15 Oct 2013, it was identified that inappropriate age at vaccine administration was not coded as an event and therefore this event was updated.
Age: 3.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Case number PHHY2013US117305, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 482044) website on 15 Oct 2013. This report refers to a 03-year-old male patient. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 18 Jan 2013. On 19 Jan 2013, he had diarrhea. It was reported that the patient had diarrhea for 3 days. On third day, he vomited. The outcome of the events reported as not recovered as of 22 Jan 2013. The seriousness and causality of the events were not reported.
Age: 0.7
Sex: F
Vaccine: FLUX
Symptoms: Convulsion, Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Case number PHHY2013US116862, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483140) website on 15 Oct 2013. This report refers to a 0.7-year-old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right leg on 29 Jan 2013. On 30 Jan 2013, her body temperature increased to 103.5 F which resulted in seizure. On an unknown date, she had fever of 102 F and she visited the emergency room. She was treated with MOTRIN for every 6 hours and TYLENOL for every 4 hours. It was reported that she did not have further seizures. The outcome of the event fever reported as not recovered as of 31 Jan 2013. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Cough, Oxygen saturation decreased, Throat tightness
Clinical narrative: Case number PHHY2013US116879, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 483323) website on 15 Oct 2013. This report refers to a 55-year-old female patient. Her medical history included allergic to erythromycin ethylsuccinate (EES) and latex, and had allergic asthmatic reaction. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 28 Jan 2013 in the left arm. On the same date, after vaccination she experienced severe tightness in throat and chest and had coughing. She took 25 mg of BENADRYL and got a little better and took another 25 mg and the events went away within 45 min to 1 hour. It was reported that after second dose of BENADRYL her oxygen saturation level dropped to 86% and then came back up to 98-100. The outcome of the events reported as recovered. The seriousness and causality of the events were not reported.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Lip disorder, Lip swelling, Paraesthesia oral
Clinical narrative: Case number PHHY2013US116903 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 483893) on 15 Oct 2013. This case refers to 26-year-old female patient. The patient was previously treated with IMITREX. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Feb 2013 in left arm. On 07 Feb 2013, after the vaccination, the patient developed swollen lips, bumps on lips and tingling lips. Treatment for the events was a shot of allergy medication (unspecified). The outcome of events was reported as condition unchanged as of 10 Feb 2013. The seriousness and causality of events were not reported.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2013US116910, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 484155) website on 15 Oct 2013. This report refers to a 59-year-old male patient. He had no known drug allergies. He was vaccinated with Seasonal Influenza vaccine INN (manufacturer and batch number: not reported), intramuscularly on 31 Oct 2012. On the same date, after vaccination he presented to emergency room with rash (bilateral) on arms and legs, chest, back and neck. His blood pressure was reported as 131/73, temperature as 98, pulse as 85 and respiration rate as 18. He received SOLU-MEDROL 125mg IV, PEPCID 20mg IV and BENADRYL 25mg IV as treatment drugs. He got discharged at 7:10 PM. The outcome of the event reported as recovered. The seriousness and causality of the event were not reported.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Mobility decreased, Pain, Vaccination site pain
Clinical narrative: Case number PHHY2013US116971, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 485620) website on 15 Oct 2013. This report refers to 47-year-old female patient. Her medical history included scoliosis, Raynaud's disease, allergies to penicillin and sulfa drugs. Her current conditions included hypothyroidism, neuropathy, and Hodgkin's lymphoma. Her concomitant medications included SYNTHROID and CELEXA. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in the left arm on 13 Nov 2012. On 28 Nov 2012, she experienced pain, tingling and numbness in left arm where vaccine was administered. She reported that pain had worsened considerably in the past three months. She found it difficult to raise and use her arm without excruciating pain. She had undergone an X-ray which failed to reveal any abnormalities. The event outcome was condition unchanged as on 26 Feb 2013. The seriousness and causality was not reported. No additional information was available.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray normal
Clinical narrative: Case number PHHY2013US116971, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 485620) website on 15 Oct 2013. This report refers to 47-year-old female patient. Her medical history included scoliosis, Raynaud's disease, allergies to penicillin and sulfa drugs. Her current conditions included hypothyroidism, neuropathy, and Hodgkin's lymphoma. Her concomitant medications included SYNTHROID and CELEXA. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) in the left arm on 13 Nov 2012. On 28 Nov 2012, she experienced pain, tingling and numbness in left arm where vaccine was administered. She reported that pain had worsened considerably in the past three months. She found it difficult to raise and use her arm without excruciating pain. She had undergone an X-ray which failed to reveal any abnormalities. The event outcome was condition unchanged as on 26 Feb 2013. The seriousness and causality was not reported. No additional information was available.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Case number PHHY2013US116972, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 485635) website on 15 Oct 2013. This report refers to 65-year-old female patient. Her historic drug included PRO-BANTHINE and hydrocodone. Her concomitant medications included VYTORIN, PAXIL, carbidopa. She was vaccinated with the 3rd dose of seasonal influenza vaccine (unknown manufacturer, batch number: not reported) and 1st dose of pneumococcal vaccine (unknown manufacturer, batch number: not reported) on 26 Feb 2013. In the same day after vaccination, she experienced dizziness, rapid heart rate, weakness, labored breathing and headache. The event outcome was condition unchanged as of 26 Feb 2013. The seriousness and causality was not reported. No additional information was available.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Hypersensitivity, Immediate post-injection reaction, Induration, Peripheral swelling
Clinical narrative: Case number PHHY2013US044409 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS Ref: 485964) web site on 06 May 2013: This report refers to a 11 year old male patient. His medical history and concomitant medication was not reported. He was healthy. He was vaccinated with MENVEO (batch number: X1105) into right arm and GARDASIL (batch number: H010649) on 01 Mar 2013. On the same day, the patient had allergic reaction in the right arm. Immediately turned red and 2-3hrs, later it was swollen and hard about 1/2 dollar size. Next day, it was red and swollen and hard about 3/4 dollar size. The events were treated with prednisone 5 mg and BENADRYL. She visited the emergency. The outcome of the events was condition unchanged. Seriousness and causality assessment was not reported.
Age: 1.3
Sex: F
Vaccine: FLUX
Symptoms: Acute disseminated encephalomyelitis
Clinical narrative: Case number PHHY2013US116977, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486088) website on 15 Oct 2013. This report refers to a 01 year and 3 months old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 03 Feb 2013. On 10 Feb 2013, she experienced acute disseminated encephalomyelitis. The patient visited the emergency room. The outcome of the event reported as not recovered as of 04 Mar 2013. The event was reported as serious (life threatening). The causality of the event was not reported.
Age: 14.0
Sex: M
Vaccine: HPVX, MNQ, VARCEL
Symptoms: Abdominal pain upper, Dyspnoea, Malaise, Pain, Paraesthesia
Clinical narrative: Case number PHHY2013US116980 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 486537) website on 15 Oct 2013. This case refers to 14-year-old male patient. He was vaccinated with meningococcal vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as MENVEO INN) in left arm, Varicella (other manufacturer) in left arm and HPV (other manufacturer) in right arm on 08 Mar 2013. On 08 Mar 2013, after the vaccination, the patient's skin on back started tingling and burning. He had difficulty breathing, fever, body aches, all over ill feeling and stomach ache. The outcome of events was reported as not yet recovered as of 10 Mar 2013. the seriousness and causality of events was not reported.
Age: 14.0
Sex: M
Vaccine: HPVX, MNQ, VARCEL
Symptoms: Pyrexia, Skin burning sensation
Clinical narrative: Case number PHHY2013US116980 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 486537) website on 15 Oct 2013. This case refers to 14-year-old male patient. He was vaccinated with meningococcal vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as MENVEO INN) in left arm, Varicella (other manufacturer) in left arm and HPV (other manufacturer) in right arm on 08 Mar 2013. On 08 Mar 2013, after the vaccination, the patient's skin on back started tingling and burning. He had difficulty breathing, fever, body aches, all over ill feeling and stomach ache. The outcome of events was reported as not yet recovered as of 10 Mar 2013. the seriousness and causality of events was not reported.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test, Pain, Pain in extremity
Clinical narrative: Case number PHHY2013US116981 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 486608) website on 15 Oct 2013. This case refers to 25-year-old female patient. She was vaccinated with flu vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unspecified date. On an unspecified date, after the vaccination, the patient developed aches and pains especially in left arm. The patient had numerous doctor visits for the tests for Guillain barre and lost numerous days off work. The patient had to visit emergency room for the event. The outcome of event was reported as condition unchanged. The seriousness and causality of event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Influenza, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2013US116922 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (reference number: 487074) on 15 Oct 2013: This report refers to a female patient of unknown age. She had no illness at the time of vaccination and had a history of multiple sclerosis (MS). Her concomitant medications were not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on 01 Jan 2013. On 14 Feb 2013, the patient experienced low grade fever, vomiting, diarrhea for which she was admitted to the hospital and was treated with intravenous fluids. She was diagnosed with "the flu" when in the hospital. By 15 Feb 2013, the patient started to "keep food down". On 16 Feb 2013, the patient was discharged. Symptoms completely resolved and the patient had no further problems. No further information about causality was reported.
Age: 16.0
Sex: M
Vaccine: FLUX, HEPA, HPV4
Symptoms: Abdominal pain, Blood test, Diarrhoea, Diplopia, Dizziness
Clinical narrative: Case number PHHY2013US116718 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487509) website on 15 Oct 2013. This report refers to 16-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with the seasonal influenza vaccine (manufacturer and batch number: not reported), Hepatitis A vaccine (unknown manufacturer, batch number: not reported) and GARDASIL (other manufacturer, batch number: not reported) intramuscularly on 20 Feb 2013. On the same day, he experienced migraines, severe pain in arms and legs, stabbing abdominal pain, diarrhea, double vision, dizziness, nausea, weakness in left arm. He visited the emergency room. Lab tests like electrocardiogram and blood tests were performed (results not provided). The event outcome condition unchanged as on 21 Mar 2013. The seriousness and causality were not reported. No additional information was available.
Age: 16.0
Sex: M
Vaccine: FLUX, HEPA, HPV4
Symptoms: Electrocardiogram, Migraine, Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Case number PHHY2013US116718 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 487509) website on 15 Oct 2013. This report refers to 16-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with the seasonal influenza vaccine (manufacturer and batch number: not reported), Hepatitis A vaccine (unknown manufacturer, batch number: not reported) and GARDASIL (other manufacturer, batch number: not reported) intramuscularly on 20 Feb 2013. On the same day, he experienced migraines, severe pain in arms and legs, stabbing abdominal pain, diarrhea, double vision, dizziness, nausea, weakness in left arm. He visited the emergency room. Lab tests like electrocardiogram and blood tests were performed (results not provided). The event outcome condition unchanged as on 21 Mar 2013. The seriousness and causality were not reported. No additional information was available.
Age: 17.0
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Dysarthria, Eyelid ptosis, Gait disturbance, Injected limb mobility decreased, Mobility decreased
Clinical narrative: Case number PHHY2013US116758, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488725) website on 15 Oct 2013. This report refers to a 17-year-old male patient. His current condition included ringworm and concomitant medications were not reported. He was vaccinated with the meningococcal vaccine (manufacturer and batch number: not reported. So, conservatively considered as MENVEO INN) and HPV (unknown manufacturer, batch number: not reported) both intramuscularly in the left arm on 05 Apr 2013. On 06 Apr 2013, he experienced high fever, droopy in both eyes and left cheek, slur in speech, and was unstable while walking. His neck, shoulder and left arm were very warm to touch and he was unable to move them. His parents reported that pain was very high. He visited the emergency room. The event outcome was condition unchanged as of 07 Apr 2013. The seriousness and causality were not reported. No additional information was available.
Age: 17.0
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Pain, Pyrexia, Skin warm, VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US116758, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488725) website on 15 Oct 2013. This report refers to a 17-year-old male patient. His current condition included ringworm and concomitant medications were not reported. He was vaccinated with the meningococcal vaccine (manufacturer and batch number: not reported. So, conservatively considered as MENVEO INN) and HPV (unknown manufacturer, batch number: not reported) both intramuscularly in the left arm on 05 Apr 2013. On 06 Apr 2013, he experienced high fever, droopy in both eyes and left cheek, slur in speech, and was unstable while walking. His neck, shoulder and left arm were very warm to touch and he was unable to move them. His parents reported that pain was very high. He visited the emergency room. The event outcome was condition unchanged as of 07 Apr 2013. The seriousness and causality were not reported. No additional information was available.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Case number PHHY2013US069358 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488946) website on 03 Jul 2013. This report refers to a 17-year-old male patient. His medical history was not reported and his concomitant medication PPD (P-Phenylenediamine). He was vaccinated with MENVEO (batch number: M12011) into left arm on 04 Apr 2013. On 09 Apr 2013, he developed bumps all over head, neck, and face. Mother called and reported to immunization nurse. Patient denied of itching, redness, fever (temperature 97.9 degrees) or warmth. Nurse instructed mother that this was not a common reaction to MENVEO and to follow up with primary care physician. The outcome of the event was reported as not recovered as of 10 Apr 2013. The event seriousness and causality were not reported.
Age: 46.0
Sex: M
Vaccine: DTP, FLUX, PPV
Symptoms: Arthralgia, Bed rest, Fatigue, Injection site pain
Clinical narrative: Case number PHHY2013US116763 is an initial report received from a pharmacist via vaccine adverse event reporting system (VAERS reference number: 489031) on 15 Oct 2013. This report refers to a 46-year-old male patient. His medical history included diabetes mellitus type 2. His concomitant medications were metformin, glyburide, diclofenac, Aspirin, simvastatin, Vitamin D (ergocalciferol), propranolol, PRILOSEC and FLOMAX. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and DTP (other manufacturer, batch number: not reported) intramuscularly in the right arm and pneumococcal polysaccharide vaccine (other manufacturer, batch number: not reported) intramuscularly in the left leg on 05 Dec 2012. On the same date he experienced right shoulder pain, joint pain and fatigue. He was on bed rest for three days. His right shoulder was hurt since vaccination and it got worse 4 months later. The outcome of the events was reported as condition unchanged.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Muscle rigidity, Musculoskeletal stiffness, Pallor
Clinical narrative: Case number PHHY2013US069249 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 489206) website on 03 Jul 2013. This report refers to an 11-year-old male patient. The patient was allergic to nuts and experienced rash with the treatment of BIAXIN and OMNICEF. He was vaccinated with ADACEL (batch number: C4137AA, other manufacturer) in the left arm on 09 Apr 2013 (at 2:15 pm). On the same date, after ADACEL he was vaccinated with MENVEO (batch number: X11072) in the right arm. Immediately after MENVEO vaccination, the child became rigid, stiffened up and lost consciousness for 3 seconds. It was reported that the child became pale. The child was made to lay down for 15 min. His vital signs included pulse rate: 66, respiratory rate: 20, blood pressure (BP): 100/56 and O2 saturation 97%. It was reported that his color came back, after 30 min and was able to go home. The outcome of the events was reported as recovered on the same date. The seriousness and causality of the events were not reported.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Case number PHHY2013US069281 is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 489382) website on 03 Jul 2013. This report refers to a 17-year-old male patient. He was vaccinated with MENVEO (batch number: M12013), HAVRIX (batch number: AHAVB515AA, other manufacturer), GARDASIL (batch number: H015030, other manufacturer), BOOSTRIX (batch number: AC52B081BA, other manufacturer), all given intramuscularly and VARIVAX (batch number: 0669AA, other manufacturer) subcutaneously on 16 Jan 2013. On an unknown date (one and half week) after vaccinations the patient passed out. On 28 Mar 2013, he was vaccinated with the second dose of GARDASIL (batch number: H013977) intramuscularly. On an unknown date, 12 days after second dose of GARDASIL he passed out again. The patient was seen by his physician and lab work was done. It was reported that his mother no longer wishes to complete the series. The outcome of the event was reported as recovered on an unknown date.
Age: 19.0
Sex: U
Vaccine: MNQ
Symptoms: Fall, Syncope
Clinical narrative: Case number PHHY2013US069288 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number: 489389) website on 03 Jul 2013. This report refers to a 19-year-old patient of an unknown gender. The patient had no known allergies and current illness. The patient was vaccinated with MENVEO (batch number: A11041) in the left arm on 08 Apr 2013. On the same date, 10 minutes after vaccination the patient fainted and fell. The patient recovered on unspecified date. The seriousness and causality of the events were not reported.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, CSF protein increased, Demyelinating polyneuropathy, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Case number PHHY2013US116941 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 489797) on 15 Oct 2013: This report refers to a 74-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Two days after vaccination, the patient experienced proximal and distal numbness and weakness. The patient was diagnosed with distal acquired demyelinating symmetric neuropathy. Relevant test results included: cerebrospinal fluid (CSF) protein: 166 mg/dL; nerve conduction studies were performed; slow conduction velocity and conduction block were observed; F waves were absent. The patient was treated with normal immunoglobulin (IVIG) and corticosteroids. At the time of reporting the outcome of the events was unspecified. Neuropathy after vaccination was a rare event. Chronic immune-mediated polyneuropathy developing in the post-vaccination period was distinctly unusual and not well described. Almost all such patients were reported as having typical chronic inflammatory demyelinating polyneuropathy. Distal acquired demyelinating symmetric neuropathy, unlike classic chronic inflammatory demyelinating polyneuropathy, was characterized by distally predominant sensory symptoms with no or mild distal weakness. Vaccine-associated distal acquired demyelinating symmetric neuropathy (DADS) might suggest a vaccine-triggered immunologic event directed against myelin associated glycoprotein below detectable concentrations. More likely, the authors suspected vaccination in this patient triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in the form of demyelinating symmetric neuropathy. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS neuropathy can occur after vaccine. Authors suggested consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Nerve conduction studies abnormal
Clinical narrative: Case number PHHY2013US116941 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 489797) on 15 Oct 2013: This report refers to a 74-year-old male patient. His medical history and concomitant medication was not reported. He was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Two days after vaccination, the patient experienced proximal and distal numbness and weakness. The patient was diagnosed with distal acquired demyelinating symmetric neuropathy. Relevant test results included: cerebrospinal fluid (CSF) protein: 166 mg/dL; nerve conduction studies were performed; slow conduction velocity and conduction block were observed; F waves were absent. The patient was treated with normal immunoglobulin (IVIG) and corticosteroids. At the time of reporting the outcome of the events was unspecified. Neuropathy after vaccination was a rare event. Chronic immune-mediated polyneuropathy developing in the post-vaccination period was distinctly unusual and not well described. Almost all such patients were reported as having typical chronic inflammatory demyelinating polyneuropathy. Distal acquired demyelinating symmetric neuropathy, unlike classic chronic inflammatory demyelinating polyneuropathy, was characterized by distally predominant sensory symptoms with no or mild distal weakness. Vaccine-associated distal acquired demyelinating symmetric neuropathy (DADS) might suggest a vaccine-triggered immunologic event directed against myelin associated glycoprotein below detectable concentrations. More likely, the authors suspected vaccination in this patient triggered an immune response against currently unrecognized antigens and manifested as restricted chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in the form of demyelinating symmetric neuropathy. Vaccine-associated CIDP is a rare but poorly characterized event that should not discourage at-risk individuals from being vaccinated. Nonetheless, vaccine safety and public reassurance rely on rapid detection and treatment of adverse outcomes. DADS neuropathy can occur after vaccine. Authors suggested consideration of this diagnosis for patients with new sensory symptoms after vaccination.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117315 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490365) on 15 Oct 2013. This case refers to 37-year-old female patient. She was vaccinated with flu vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unspecified date. On an unknown date, 21 days after the vaccination, the patient was diagnosed with Guillain Barre syndrome. The outcome of event was reported as condition unchanged. The seriousness and causality of event was not reported.
Age: 28.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117317 is an initial spontaneous report received from the Vaccine Adverse Event reporting System (the source of the case in VAERS is a literature publication, reference number: 490362) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 inactivated influenza vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case refers to 28-year-old male patient. He was vaccinated with flu vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unspecified date. On an unknown date, one day after the vaccination, the patient had onset of Guillain Barre Syndrome. The outcome of event was reported as condition unchanged. The seriousness and causality of event was not reported. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117318 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490368) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case refers to 57-year-old male patient. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unspecified date. On an unknown date, 21 days after the vaccination, the patient was diagnosed with Guillain Barre syndrome and was hospitalized. The outcome of event was not reported. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided.
Age: 74.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117321 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490369) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. This case refers to 74-year-old male patient. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unknown date. On an unknown date, 25 days after the vaccination, the patient was diagnosed with Guillain Barre syndrome and was hospitalized. The outcome of event was not reported. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low. No further information was provided
Age: 62.0
Sex: F
Vaccine: FLUX, TD
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117322 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (the source of the case in VAERS is a literature publication, reference number: 490370) on 15 Oct 2013. From the published article, the authors reviewed charts of patients who had been hospitalized with Guillain-Barre Syndrome (GBS) from 1995 through 2006. Using a case-centered design, they compared the odds of vaccination in the 6 and 10 weeks prior to onset of GBS to the odds of vaccination during the same time intervals in all vaccinated individuals in the entire hospital population. While cases of GBS had been reported following a wide range of vaccines, a clear association had only been established with the 1976 H1N1 vaccine. The authors confirmed 415 cases of which only 25 had received any vaccine in the six weeks prior to GBS onset. Vaccines received included TIV, 23-valent polysaccharide pneumococcal vaccine, tetanus-diphtheria combination vaccines, Hepatitis A and Hepatitis B. The large retrospective study did not find any association between influenza vaccine or any other vaccine and the development of GBS within 6 weeks following vaccination. This case refers to 62-year-old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported)and TD absorbed (other manufacturer, batch number: not reported) on an unknown date. On an unknown date, 12 days after the vaccination, the patient was diagnosed with Guillain Barre syndrome and was hospitalized. The outcome of event was not reported. According to the authors, the risk of GBS following any vaccine, including influenza vaccines, was extremely low.
Age: 49.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Angiogram abnormal, Back pain, Blood culture negative, Chest pain, Electrocardiogram
Clinical narrative: Case number PHHY2013US1116800 is an initial report received via vaccine adverse event reporting system (VAERS reference number 490374) on 15 Oct 2013. This report refers to a 49-year-old male patient. He was a former smoker and his medical history included diabetes type 2, hypertension and hyperlipidemia. Concomitant medications included aspirin, bivalirudin, unfractionated heparin, hydrochlorothiazide, oxycodone HCL/acetaminophen, fosinopril sodium, simvastatin, and gabapentin. He was hospitalized on 16 Feb 2012 at 08:57 and enrolled into the study and underwent a percutaneous coronary intervention (PCI). Prior to randomization he received aspirin 81 mg, unfractioned heparin (UFH) and bivalirudin. On 16 Feb 2012 at 10:54, an angiography revealed one vessel with greater than 50% stenosis. At 11:17 he received a loading dose of four capsules of blinded study medication (clopidogrel). At 11:20, he received a 10.3 ml bolus of study medication followed by an 82.2 ml/hour infusion of blinded medication from 11:21 to 13:30. At 11:20 he underwent a PCI via a radial catheter access site during which time the right coronary artery was treated with three non-drug eluting stents (total length of 71). He received four capsules of blinded study medication post infusion at 13:30. Post procedure, he was given clopidogrel 75 mg. At discharge, he received aspirin and clopidogrel 75 mg. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PNEUMOVAX 23 intramuscularly on 17 Feb 2012 at 9:22. He was discharged from hospital on 17 Feb 2012 at 10:55. He returned to the emergency room on 17 Feb 2012 at 18:29 with complaints of back pain, chest pain and fever of 103 degree F. He was admitted to hospital and was diagnosed with a possible drug fever at 21:05 (approximately 31 hours and 30 minutes after the last dose of the blinded study medication). Blood cultures obtained on 17 Feb 2012 were negative. An electrocardiogram (ECG) was obtained however, results were not reported. He was treated with intravenous vancomycin and LEVAQUIN. On 20 Feb 2012, he was discharged with 5 days oral LEVAQUIN treatment. The outcome was reported as resolved on 20 Feb 2012 at 11:18. The study drug dose was not changed due to the event. The investigator considered the event of possible drug fever to be possibly related to blinded study medication, the influenza virus immunization and PNEUMOVAX 23.
Age: 49.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pyrexia, Vascular stenosis
Clinical narrative: Case number PHHY2013US1116800 is an initial report received via vaccine adverse event reporting system (VAERS reference number 490374) on 15 Oct 2013. This report refers to a 49-year-old male patient. He was a former smoker and his medical history included diabetes type 2, hypertension and hyperlipidemia. Concomitant medications included aspirin, bivalirudin, unfractionated heparin, hydrochlorothiazide, oxycodone HCL/acetaminophen, fosinopril sodium, simvastatin, and gabapentin. He was hospitalized on 16 Feb 2012 at 08:57 and enrolled into the study and underwent a percutaneous coronary intervention (PCI). Prior to randomization he received aspirin 81 mg, unfractioned heparin (UFH) and bivalirudin. On 16 Feb 2012 at 10:54, an angiography revealed one vessel with greater than 50% stenosis. At 11:17 he received a loading dose of four capsules of blinded study medication (clopidogrel). At 11:20, he received a 10.3 ml bolus of study medication followed by an 82.2 ml/hour infusion of blinded medication from 11:21 to 13:30. At 11:20 he underwent a PCI via a radial catheter access site during which time the right coronary artery was treated with three non-drug eluting stents (total length of 71). He received four capsules of blinded study medication post infusion at 13:30. Post procedure, he was given clopidogrel 75 mg. At discharge, he received aspirin and clopidogrel 75 mg. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PNEUMOVAX 23 intramuscularly on 17 Feb 2012 at 9:22. He was discharged from hospital on 17 Feb 2012 at 10:55. He returned to the emergency room on 17 Feb 2012 at 18:29 with complaints of back pain, chest pain and fever of 103 degree F. He was admitted to hospital and was diagnosed with a possible drug fever at 21:05 (approximately 31 hours and 30 minutes after the last dose of the blinded study medication). Blood cultures obtained on 17 Feb 2012 were negative. An electrocardiogram (ECG) was obtained however, results were not reported. He was treated with intravenous vancomycin and LEVAQUIN. On 20 Feb 2012, he was discharged with 5 days oral LEVAQUIN treatment. The outcome was reported as resolved on 20 Feb 2012 at 11:18. The study drug dose was not changed due to the event. The investigator considered the event of possible drug fever to be possibly related to blinded study medication, the influenza virus immunization and PNEUMOVAX 23.