chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Back pain, Blood culture negative, Chest pain, Electrocardiogram, Pyrexia
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: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Case number PHHY2013US069506 is an initial spontaneous report received from Vaccine Adverse Event Reporting System website (VAERS reference number: 490441) on 03 Jul 2013: This report refers to a 21-year-old male patient. His medical history included fainting in past during blood draws and vaccinations (unspecified). His concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11066) intramuscularly in to the right arm on 30 Apr 2013. On the same day, after vaccination, he fainted sitting in the chair. Nurse was able to support patient and used ice pack to help with recovery. Outcome of the event was reported as complete recovery on the same day. The causality was not reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram, Dyspnoea, Pulmonary function test
Clinical narrative: Case number PHHY2013US116802, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 490806) website on 15 Oct 2013 with a follow-up received on 25 Nov 2013. This report refers to a 56-year-old female patient. This poly medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on 08 Nov 2012 in the right arm. On the same date, after vaccination she was short of breath and had difficulty breathing. The patient was hospitalized until 22 Nov 2012 with long term and continuous ongoing care. The patient underwent pulmonary function and CT Scan tests (results not provided) in the hospital. The patient received many medications (unspecified) and the medications were ongoing. The outcome of the event reported as not recovered as of 06 May 2013. The event was reported as serious (life threatening and permanent disability). The causality of the event was not reported. Upon receipt of follow-up information from VAERS, the suspect influenza vaccine was confirmed to be FLULAVAL (other manufacturer, batch number: AFLLA732AA). Therefore, this case would be deactivated. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 490806) website on 25 Nov 2013: Updated information about manufacturer of the influenza vaccine and deactivation of case.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Fall, Lip swelling, Pallor, Scratch, Syncope
Clinical narrative: Case number PHHY2013US084153, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 491067) website on 06 Aug 2013. This report refers to 11-year-old male patient. The current status of the patient was reported as good. He was vaccinated with MENVEO (batch number: M12010) in the right arm and GARDASIL (other manufacturer, batch number: 0555AE) in the left arm on 30 Apr 2013. On the same date after vaccinations at 2:30 pm, his blood pressure was 124/70 and pulse rate was 63. At 2:40 pm he experienced syncope and fainted outside the clinic. His mother stated that, he had a fall and shaking to ground. He was carried into the clinic by other person. He was pale, alert and was laid down on exam table. His left upper lip was swollen and had a left elbow scrape. He was seen by the physician at 2:47pm and his blood pressure was 124/70 and pulse rate was 63. He was observed, cleaned and sent home. The outcome of the events reported as completely recovered. The causality and seriousness of the events were not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Tremor
Clinical narrative: Case number PHHY2013US084153, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 491067) website on 06 Aug 2013. This report refers to 11-year-old male patient. The current status of the patient was reported as good. He was vaccinated with MENVEO (batch number: M12010) in the right arm and GARDASIL (other manufacturer, batch number: 0555AE) in the left arm on 30 Apr 2013. On the same date after vaccinations at 2:30 pm, his blood pressure was 124/70 and pulse rate was 63. At 2:40 pm he experienced syncope and fainted outside the clinic. His mother stated that, he had a fall and shaking to ground. He was carried into the clinic by other person. He was pale, alert and was laid down on exam table. His left upper lip was swollen and had a left elbow scrape. He was seen by the physician at 2:47pm and his blood pressure was 124/70 and pulse rate was 63. He was observed, cleaned and sent home. The outcome of the events reported as completely recovered. The causality and seriousness of the events were not reported.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 08 may 2013. An 11-year-old female patient, had received first dose of ADACEL (lot number: C4385AA. expiry date: 09/17/2015) intramuscularly in the left deltoid and first dose of MENACTRA (lot number: U4593AB, expiry date: 11/10/2014) intramuscularly in the right deltoid on 06 May 2013. The patient's medical history included eczema, asthma and illness at time of vaccination included ear pain. The patent had no known allergies and concomitant medications were not reported. On 06 May 2013 (i.e. same day after vaccination), the patient experienced red, swollen, warm to touch area with induration at injection site on left deltoid which was the site for ADACEL vaccination. The patient had developed 5cmx7cm slightly red area at the injection site of left deltoid. Relevant diagnostic tests were not reported. Corrective treatment details included: Loratadine twice daily and ice to the vaccination area. The patient's outcome was not recovered. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Myelitis transverse
Clinical narrative: Case number PHEH2013US001365 is an initial spontaneous report received from a physician on 10 Jan 2013, with follow up received from the physician on 12 Mar 2013, with a follow-up received on 14 May 2013: This report refers to an adult female patient (around 30). Her medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date in 2012, she experienced transverse myelitis. No seriousness criteria was reported. The outcome and causality were not reported. No further information was provided. Upon follow-up, the physician confirmed that the mother (this female patient) experienced the event but not her children. Follow up received from the physician on 12 Mar 2013: No new medical information was updated. Follow-up was received on 14 May 2013: Physician statement was updated. Non-significant follow-up was received from Vaccine Adverse Event Reporting System (VAERS reference number: 491758) on 06 Aug 2013: Updated reference number only.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US116524, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 491761) website on 15 Oct 2013. This report refers to an adult male patient. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2003. On an unspecified date in 2003, after vaccination with influenza vaccine the patient experienced Bell's palsy. The outcome of the event was not reported. The seriousness and causality of the event were not reported.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Case number PHHY2013US083973 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 491799) web site on 06 Aug 2013. This report refers to an 18-year-old female patient. Her medical history included latex allergy and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11047) intramuscularly in to left arm on 16 May 2013. On 16 May 2013, 15 minutes after vaccination, she passed out at the grocery store. She lost consciousness for approximately 10 seconds. She returned to clinic for reporting an assessment. She stated that she was sent to a cardiologist for finding the reason. The patient recovered completely on the same day.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dyspnoea, Hypertension, Nausea, Vomiting
Clinical narrative: Case number PHHY2013US117150, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 492060) website on 15 Oct 2013. This report refers to a 68-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 12 Jan 2013. On the same day, she experienced nausea, high blood pressure, vomiting, and diarrhea. It was also reported that she was also unable to breathe. The event outcome was reported as completely recovered. The seriousness and causality was not reported. No additional information was available.
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tonic clonic movements
Clinical narrative: Case number PHHY2013US117161, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 492642) website on 15 Oct 2013. This report refers to 11-year-old female patient. Her medical history included respiratory syncytial virus infection as an infant and Adenotonsillectomy. Her concomitant medications were not reported. She was vaccinated with MENVEO INN (unknown manufacturer, batch number: not reported) intramuscularly in the left deltoid, tetanus diphtheria and pertussis vaccine (unknown manufacturer, batch number: not reported) in the left deltoid and GARDASIL (other manufacturer, batch number: not reported) and VARIVAX (other manufacturer, batch number: not reported) intramuscularly in the right deltoid on 23 May 2013. Immediately after vaccination with GARDASIL, she developed tonic clonic movements and passed out for ten seconds. The physician recommended for the patient to get something to eat and drink after she passed out. It was reported that she was better and went to school afterwards. The event outcome for the events was completely recovered. The seriousness and causality was not reported. No additional information was available.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Hemiparesis, VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US117166 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 492665) on 15 Oct 2013: This report refers to a 60-year-old female patient. The patient had an allergy to MSD. Her concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date, three years ago. Six weeks after vaccination, the patient developed Bell's palsy. The patient visited the emergency room but was not admitted to hospital. Three years later the patient had not fully recovered, she continued to experience right sided weakness. No further information about seriousness and causality was reported.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Throat tightness, Urticaria
Clinical narrative: Case number PHHY2013US084191 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 492756) website on 06 Aug 2013. This report refers to an 11-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A12024) intramuscularly into right arm and GARDASIL (batch number: 0420AE, other manufacturer) intramuscularly into right arm on 04 Feb 2013. On the same day, after vaccination, area of injection was red and itchy. She visited the emergency room and reported that she had throat tightness but no difficulty in breathing. She also had urticarial rash and was treated with five day steroid burst. On 05 Feb 2013, she had no symptoms except local redness therefore additional steroids were put on hold. She was seen by allergist with prolonged urticaria to vaccine. The outcome of the events was reported as recovered as of unspecified date. No seriousness and causality of the events were reported.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: This case is a part of cluster cases (same reporter, product and product batch number) and is linked to case numbers 2013-06328. Initial report received from healthcare professional on 23 May 2013. A 39-year-old female patient, had received an intramuscular first dose of ADACEL (lot number: C4385AA) in right deltoid on 20 May 2013. The patient had history of anxiety and ADHD and had sustained human bites to both upper extremities a week before report. Patient had received CYMBALTA and ADDERALL as concomitant medications. The patient had not received any dose of ADACEL previously. On 22 May 2013 i.e. 2 day after administration, the patient had developed site reaction of redness, swelling, itching and lumps, body aches, low grade fever, vomiting, legs and arms were tingly. The patient laboratory tests were not reported and had received ADVIL and BENADRYL as corrective treatments. At the time of this report, the outcome of event was unknown. Follow-up information received from a healthcare professional on 26 June 2013: On an unspecified date, the patient had recovered from the events. Documents held by sender were none.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Pyrexia, Vomiting
Clinical narrative: This case is a part of cluster cases (same reporter, product and product batch number) and is linked to case numbers 2013-06328. Initial report received from healthcare professional on 23 May 2013. A 39-year-old female patient, had received an intramuscular first dose of ADACEL (lot number: C4385AA) in right deltoid on 20 May 2013. The patient had history of anxiety and ADHD and had sustained human bites to both upper extremities a week before report. Patient had received CYMBALTA and ADDERALL as concomitant medications. The patient had not received any dose of ADACEL previously. On 22 May 2013 i.e. 2 day after administration, the patient had developed site reaction of redness, swelling, itching and lumps, body aches, low grade fever, vomiting, legs and arms were tingly. The patient laboratory tests were not reported and had received ADVIL and BENADRYL as corrective treatments. At the time of this report, the outcome of event was unknown. Follow-up information received from a healthcare professional on 26 June 2013: On an unspecified date, the patient had recovered from the events. Documents held by sender were none.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: This case is a part of cluster cases (same reporter, product and product batch number) and is linked to case numbers 2013-06329. Initial report received from healthcare professional on 23 May 2013. A 35-year-old female patient, had received an intramuscular first dose of ADACEL vaccine (lot number: C435AA) in left deltoid on 21 May 2013. The reporter refused to provide patients preexisting physician diagnosed allergies, birth defects, medical conditions, concomitant medications and illness at time of vaccination. Concomitant medications were not reported. The patient had not received any dose of ADACEL vaccine previously. On 23 May 2013 i.e. 2 day after administration, the patient had developed site reaction of redness, soreness and swelling the size of a baseball, lumps at injection site, fever and legs and arms tingling. The patient laboratory tests and corrective treatment were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender were none.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: This case is a part of cluster cases (same reporter, product and product batch number) and is linked to case numbers 2013-06329. Initial report received from healthcare professional on 23 May 2013. A 35-year-old female patient, had received an intramuscular first dose of ADACEL vaccine (lot number: C435AA) in left deltoid on 21 May 2013. The reporter refused to provide patients preexisting physician diagnosed allergies, birth defects, medical conditions, concomitant medications and illness at time of vaccination. Concomitant medications were not reported. The patient had not received any dose of ADACEL vaccine previously. On 23 May 2013 i.e. 2 day after administration, the patient had developed site reaction of redness, soreness and swelling the size of a baseball, lumps at injection site, fever and legs and arms tingling. The patient laboratory tests and corrective treatment were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender were none.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Rash, Rash pruritic
Clinical narrative: Case number PHHY2013US117176 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (reference number: 492982) on 15 Oct 2013: This report refers to a 28-year-old female patient. Medical history included high blood pressure, high cholesterol, high triglycerides, morbid obesity, scoliosis (idiopathic), diabetes, bipolar disorder, hypothyroidism, palmo-plantar pustular psoriasis, generalized anxiety disorder, poly cystic ovary syndrome and osteoarthritis. This polymedicated patient was vaccinated with seasonal Influenza vaccine (unknown manufacturer, batch number: not reported) intramuscularly into the left arm on 28 Sep 2012. On the same day after vaccination, she experienced a painful, itchy rash at the injection site (which was apparently a normal reaction), and over the course of a few weeks that rash mostly disappeared but left a 1/4 inch diameter rash that never went away. She still had it as of 31 May 2013. Some days it itched a lot. Other days the rash did not bother her. But it still did not go away. She had never had any rash from eating any eggs or other foods or taking any prescription or over the counter drugs. The event outcome was condition unchanged as of 31 May 2013. No further information about seriousness and causality was reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Fatigue, Gingival swelling
Clinical narrative: Case number PHHY2013US116559 is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 493103) website on 15 Oct 2013. This case refers to 43-year-old female patient. The patient's medical history included diabetes. This poly-medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Oct 2012, intramuscularly in left arm. On 21 Jan 2013, the patient developed enlarged lymph nodes, extreme tiredness, and sores in mouth, swollen gums, weight loss, nausea, abdominal pain, and painful knots all over body. It was reported that the patient came down with influenza and never recovered from symptoms. She had been to oncologist and had CAT scans and blood work. She was sent to doctor who thought that all of her side effects stem from flu vaccine that started a severe reaction in her body and had caused inflammation all over. The outcome of all events was reported as condition unchanged. The seriousness of events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Inflammation, Influenza, Lymphadenopathy, Nausea, Nodule
Clinical narrative: Case number PHHY2013US116559 is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 493103) website on 15 Oct 2013. This case refers to 43-year-old female patient. The patient's medical history included diabetes. This poly-medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Oct 2012, intramuscularly in left arm. On 21 Jan 2013, the patient developed enlarged lymph nodes, extreme tiredness, and sores in mouth, swollen gums, weight loss, nausea, abdominal pain, and painful knots all over body. It was reported that the patient came down with influenza and never recovered from symptoms. She had been to oncologist and had CAT scans and blood work. She was sent to doctor who thought that all of her side effects stem from flu vaccine that started a severe reaction in her body and had caused inflammation all over. The outcome of all events was reported as condition unchanged. The seriousness of events was not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Stomatitis, Weight decreased
Clinical narrative: Case number PHHY2013US116559 is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 493103) website on 15 Oct 2013. This case refers to 43-year-old female patient. The patient's medical history included diabetes. This poly-medicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 15 Oct 2012, intramuscularly in left arm. On 21 Jan 2013, the patient developed enlarged lymph nodes, extreme tiredness, and sores in mouth, swollen gums, weight loss, nausea, abdominal pain, and painful knots all over body. It was reported that the patient came down with influenza and never recovered from symptoms. She had been to oncologist and had CAT scans and blood work. She was sent to doctor who thought that all of her side effects stem from flu vaccine that started a severe reaction in her body and had caused inflammation all over. The outcome of all events was reported as condition unchanged. The seriousness of events was not reported.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Cold sweat, Feeling cold, Hyperhidrosis, Syncope, Vision blurred
Clinical narrative: Case number PHHY2013US084022 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493485) website on 06 Aug 2013. This report refers to an 18-year-old female patient. Her medical history and concomitant medications were not reported. On 05 Jun 2013, she was vaccinated with MENVEO (batch number: M11050), GARDASIL (batch number: 0131AE) both intramuscularly in the left arm and HAVRIX (batch number: AHAVB536BA) intramuscularly in the right arm. On the same day, she fainted twice after vaccinations. She was also diaphoretic, cool, clammy, and had blurred vision. The event outcome was reported as completely recovery as of 05 Jun 2013. The seriousness and causality were not reported.
Age: 25.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Mouth swelling, Pruritus generalised, Rash generalised, Swelling face
Clinical narrative: Case number PHHY2013US084029 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 493873) website on 06 Aug 2013. This report refers to a 25-year-old male patient. His medical history included asthma and his concomitant medication was not reported. He was vaccinated with MENVEO (batch number: M12097) intramuscularly into left arm on 10 Jun 2013. On the same day he also received HAVRIX (other manufacturer, batch number: AHAVB532AA) intramuscularly into left arm, IPOL (other manufacturer, batch number: H16041) via subcutaneous route into right arm, ADACEL (other manufacturer, batch number: C4365AA) intramuscularly into right arm, TYPHIM VI (other manufacturer, batch number: H14821) intramuscularly into right arm and YF-VAX (other manufacturer, batch number: UH668AA) via subcutaneous route into left arm. On the same day after vaccination, he experienced rash and itching all over the body. He had no breathing problems at that time. He was instructed to take BENADRYL. He was advised to go to emergency room (ER) if his symptoms worsened or signs of anaphylaxis appears. In the evening, he had mouth and facial swelling so he went to ER where he was given epinephrine and steroids. He stated that he was feeling better as of 11 Jun 2013. The final outcome of the events was reported as improved. No seriousness and causality were provided.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Case number PHEH2013US012492, is an initial spontaneous report received from the physician on 07 Jun 2013 with a follow up information received from vaccine adverse event reporting system (VAERS ID: 494062) on 05 Sep 2013. This report refers to a 17-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A12011) intramuscularly on 03 Jun 2013. On the morning of 04 Jun 2013, she began to experience intermittent dizziness and nausea that lasted for an hour at a time. It was reported that the events were debilitating to the patient. The event outcome was reported as condition unchanged. The seriousness and causality was not reported. No additional information was available. Follow up information received from vaccine adverse event reporting system on 05 Sep 2013: VAERS ID updated.
Age: 19.0
Sex: F
Vaccine: HEPA, MNQ, YF
Symptoms: Dizziness, Hypotension, Pallor, Syncope, Tremor
Clinical narrative: Case number PHHY2013US097320 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495112) website on 05 Sep 2013. This report refers to 19-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO (batch number: X122026) intramuscularly in the right arm, HAVRIX (other manufacturer, batch number: HAVB532AA) intramuscularly in the left arm and YF-VAX (batch number: UH598AA) subcutaneously in the right arm on 25 Jun 2013. On the same day at 11:29 AM, she turned white and she felt lightheadedness and was dizzy. She was asked to breathe after which she fainted and had muscle shakes. Blood pressure after fainting was as low as 79/50. After 10 minutes it was back to 110/60. She woke up 1 minute later and was given water and she rested comfortably in the chair for 45 minutes. It was reported that she felt better. The patient recovered on the same day. The seriousness and causality were not reported.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Presyncope
Clinical narrative: Case number PHHY2013US097635 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 495184) web site on 05 Sep 2013, with the follow-up received from Quality Assurance Department (reference number: 251452) on 03 Oct 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: M11052 and expiry date: Mar 2014) and GARDASIL (other manufacturer, batch number: 0555AE); both vaccines administered intramuscularly in the left arm and ADACEL (other manufacturer, batch number: U4383AA) intramuscularly in the right arm on 28 May 2013. On the same date, he had a vasovagal episode after receiving the vaccinations. The outcome was reported as complete recovery as of 26 Jun 2013. The seriousness and causality of the events were not reported. Based on the investigation performed, the QA department stated that, the concerned MENVEO (batch number: M11052) was manufactured in accordance with the approved internal procedures and is in compliance with the cGMP requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 251452) on 10 Sep 2013: Updated QA reference number only. Follow up received Quality Assurance Department (reference number: 251452) on 03 Oct 2013: Updated batch review report.
Age: 11.0
Sex: M
Vaccine: HPV4, MEN, TDAP
Symptoms: Nausea, Syncope
Clinical narrative: Case number PHHY2013US117490 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS, reference number: 495222) website on 15 Oct 2013. This report refers to an 11-year-old male patient. Preexisting condition included allergic to penicillin. His concomitant medications were not reported. He was vaccinated with meningococcal vaccine (manufacturer and batch number unknown) on right arm on 12 Nov 2012. On the same day, he was also vaccinated with BOOSTRIX (other manufacturer and batch number unknown) on right arm and GARDASIL (other manufacturer and batch number unknown) on left arm. It was reported that the patient was given the shot in one of the exam rooms. He was then sent back to the lab for blood work. As he approached the lab he became very nauseous. He went to the restroom where he fainted. One of the lab technician caught him and laid him down. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Feeling abnormal, Feeling cold, Loss of consciousness, Pallor
Clinical narrative: Case number PHHY2013US110864 is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS reference number: 495381) website on 04 Oct 2013. This report refers to a 17-year-old male patient. His medical history included ADHD (attention deficit hyperactivity disorder) and concomitant medication was not reported. He was vaccinated with MENVEO (batch number: A11042) intramuscularly into right arm on 24 Jun 2013. On the same day, he also received HAVRIX (other manufacturer, batch number: AHAVB692BA) intramuscularly into right arm and GARDASIL (other manufacturer, batch number: H021608) intramuscularly into left arm. After receiving the vaccines, he passed out on exam table for approximately 30 seconds. He became pale and complained of being cold when he woke up. Physician monitored his blood pressure and pulse. He left the clinic approximately 25 minutes later. The patient recovered on the same day. No causality and seriousness were reported.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The below narrative include initial report received from a healthcare professional on 15 August 2013 plus subsequent follow up: A 71 year-old female patient had received intramuscularly first dose of ADACEL vaccine, batch number: U4421AA in the left deltoid on 19 June 2013 at 02.30 PM. The patient had illness at the time of vaccination and no physician diagnosed allergies, birth defects or medical conditions. Other medications were reported as "N/A". On 19 June 2013, post vaccination the patient experienced redness and swelling at injection site. The patient was recommended to use BENADRYL, ice and Ibuprofen by physician. Laboratory investigations were not reported. The patient was scheduled for visit on 01 July 2013. At the time of this report, the patient had recovered from the event. Documents held by sender: none. Additional information received from a healthcare professional on 24 October 2013: Event outcome and corrective treatment added. Narrative and relevant field updated.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The below narrative include initial report received from a healthcare professional on 15 August 2013 plus subsequent follow up: A 71 year-old female patient had received intramuscularly first dose of ADACEL vaccine, batch number: U4421AA in the left deltoid on 19 June 2013 at 02.30 PM. The patient had illness at the time of vaccination and no physician diagnosed allergies, birth defects or medical conditions. Other medications were reported as "N/A". On 19 June 2013, post vaccination the patient experienced redness and swelling at injection site. The patient was recommended to use BENADRYL, ice and Ibuprofen by physician. Laboratory investigations were not reported. The patient was scheduled for visit on 01 July 2013. At the time of this report, the patient had recovered from the event. Documents held by sender: none. Additional information received from a healthcare professional on 24 October 2013: Event outcome and corrective treatment added. Narrative and relevant field updated.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report and follow-up information received from consumer (non-healthcare professional) on 09 July 2013. A 71-year-old female patient had received intramuscular dose of ADACEL vaccine (lot number not reported) in the deltoid on 19 June 2013. The patient had a received tetanus shot 12 years ago. The patient had a medical history of Hypertension and Sinusitis. The patient was on OTC (Over the Counter) medications Calcium, Vitamin D and unspecified multivitamins. The patient had no illness at the time of vaccination. It was reported that the 71-year-old patient received ADACEL outside age indication thus inappropriate age at vaccine administration. It was reported that patient experienced site reactions of redness which spread from injection site down to elbow, swelling which was hot to touch. No laboratory tests were performed. The patient was treated with ice packs and physician prescribed OTC medications ADVIL 400 mg orally twice daily and BENADRYL 25 mg PRN. The patient recovered from adverse events on an unspecified date. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug administered to patient of inappropriate age, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report and follow-up information received from consumer (non-healthcare professional) on 09 July 2013. A 71-year-old female patient had received intramuscular dose of ADACEL vaccine (lot number not reported) in the deltoid on 19 June 2013. The patient had a received tetanus shot 12 years ago. The patient had a medical history of Hypertension and Sinusitis. The patient was on OTC (Over the Counter) medications Calcium, Vitamin D and unspecified multivitamins. The patient had no illness at the time of vaccination. It was reported that the 71-year-old patient received ADACEL outside age indication thus inappropriate age at vaccine administration. It was reported that patient experienced site reactions of redness which spread from injection site down to elbow, swelling which was hot to touch. No laboratory tests were performed. The patient was treated with ice packs and physician prescribed OTC medications ADVIL 400 mg orally twice daily and BENADRYL 25 mg PRN. The patient recovered from adverse events on an unspecified date. List of documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor, Syncope
Clinical narrative: Case number PHHY2013US117495, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 495761) website on 15 Oct 2013. This report refers to 11-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with MENVEO INN (unknown manufacturer, batch number: not reported), GARDASIL (other manufacturer, batch number: not reported), Hepatitis A (unknown manufacturer, batch number: not reported) and Tdap vaccine (unknown manufacturer, batch number: not reported) on 01 Jul 2013. On the same day, she experienced dizziness, fainting and paleness. She visited the emergency room of the physician. The event outcome was completely recovered. The seriousness and causality was not reported. No additional information was available.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Case number PHHY2013US110799 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496071) website on 04 Oct 2013. This report refers to an 18-year-old female patient. She was vaccinated with MENVEO (batch number: A12008) and GARDASIL (batch number: H010649), both via intramuscular route in the right arm on 08 Jul 2013. On the same date, she also received HAVRIX (batch number: AHAVB515BA) via intramuscular route and VARIVAX (batch number: H0146287) via subcutaneous route, both in the left arm. On the same date, after vaccinations the patient became lightheaded and fainted. She was changed from a sitting to a lying position and her blood pressure was 90/57 and heart rate was 56. She was monitored for an additional 10-15 minutes and later she left the clinic in a stable condition. The patient recovered on the same day. The seriousness and causality of the events were not reported.
Age: 38.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2013US116687 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 496553) website on 15 Oct 2013. This case refers to 38-year-old female patient. The patient's medical history included allergy to eggs. She was vaccinated with flu vaccine (manufacturer and batch number: not reported). So, conservatively coded as Seasonal Influenza vaccine INN) on an unspecified date in 2005. On an unknown date in 2005, after vaccination, she had anaphylactic reaction to vaccine. The outcome was reported as unknown. The seriousness and causality of event were not reported.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US116709 is an initial incomplete report from nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 496569) website on 15 Oct 2013. This case refers to an unspecified number of patients. These patients were vaccinated with flu vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on an unknown date. At unspecified times after vaccinations with influenza vaccine, the patients developed Guillain Barre syndrome. The seriousness, outcome and causality of event were not reported.
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Case number PHHY2013US116714, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting system (VAERS reference number: 496571) on 15 Oct 2013. This report refers to a male patient of an unknown age. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 01 Nov 2012. On 01 Feb 2013, approximately three months after vaccination, the patient experienced influenza and vaccination failure. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 13.0
Sex: F
Vaccine: DTP, FLUX, HPV4
Symptoms: Fall, Scratch, Syncope
Clinical narrative: Case number PHHY2013US1116733, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496955) website on 15 Oct 2013. This report refers to a 13-year-old female patient. It was reported that the patient did not eat anything and was fasting before vaccinations. Concomitantly the patient underwent tuberculin purified protein derivative (PPD) test. She was vaccinated with seasonal influenza vaccine (manufacturer and batch: not reported), DTP (batch number: not reported) and second dose of GARDASIL (batch number: H017698, other manufacturer) on 28 Jun 2013. On the same date, after vaccinations the patient fainted and had a fall. The patient had a little scratch on her face or head area, after falling. The patient was given oxygen, elevated her legs and provided a sugar popsicle. No lab diagnostic tests were performed. The outcome of the events was unknown. The seriousness and causal relationship of the events were not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Back pain, Electromyogram, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHHY2013US117214 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 496982) on 15 Oct 2013. This report refers to a 48-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) intramuscularly on left arm on 01 Oct 2011. On 11 Dec 2011, she experienced severe back ache. She was hospitalized on 12 Dec 2011 and experienced progressive weakness. She remained hospitalized 11 days. Magnetic resonance imaging (MRI), Spinal Tap and Electromyography (EMG) was done and results were not reported. The outcome of the events was reported as ongoing.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Eye swelling, Swollen tongue
Clinical narrative: Case number PHHY2013US110821 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497136) website on 04 Oct 2013. This report refers to a 10-year-old male patient. His medical history and concomitant medication were not reported. On 11 Jul 2013, he was vaccinated with MENVEO (batch number: A12120) intramuscularly in the left arm, BOOSTRIX (other manufacturer, batch number: AC52B081BA) intramuscularly in the right arm and VARIVAX (other manufacturer, batch number: H020251) subcutaneously into the right arm. On 13 Jul 2013, he experienced swelling of the eyes and tongue and went to emergency room. He was treated with BENADRYL and ZYRTEC and he did not receive any steroid or epinephrines. He had no breathing difficulties. The event outcome was reported as completely recovery as of 18 Jul 2013. The seriousness and causality of the events were not reported.
Age: 16.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dyspnoea, Muscle spasms, Pyrexia
Clinical narrative: Case number PHHY2013US110829 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 497202) website on 04 Oct 2013. This report refers to a 16-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M11041) intramuscularly into left arm, ADACEL (other manufacturer, batch number: C4181AA) intramuscularly into right arm, VARIVAX (other manufacturer, batch number: H011963) subcutaneously into right arm on 28 Feb 2013. On the same day after vaccination the patient experienced serious difficulty in breathing, violent body spasm and presented with fever of 103.7 degree Fahrenheit. He was taken to emergency room and received treatment for difficulty in breathing. Body spasm lasted for several hours. Outcome for difficulty in breathing was reported as condition improving and for body spasm as complete recovery. The outcome was reported as condition ongoing for fever as of 11 Mar 2013. No more information was available.
Age: 19.0
Sex: M
Vaccine: HEPAB, MNQ, TD
Symptoms: Chills, Dyspnoea, Lacrimation increased, Myalgia, Pharyngeal oedema
Clinical narrative: Case number PHHY2013US110847 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497498) website on 04 Oct 2013. This report refers to a 19-year-old male patient. His medical history and concomitant medications were not reported. On 22 Jul 2013, the was vaccinated with MENVEO (batch number: not reported), Td vaccine (other manufacturer, batch number: not reported) and HepA/HepB vaccine (other manufacturer, batch number: not reported). On 23 Jul 2013, he experienced fever, chills/shivering, shortness of breath, watery eyes, and throat swelling accompanied with sniffles and sore muscles. The event outcome was reported as completely recovered as on 23 Jul 2013. The seriousness and causality of the events were not reported.
Age: 19.0
Sex: M
Vaccine: HEPAB, MNQ, TD
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Case number PHHY2013US110847 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 497498) website on 04 Oct 2013. This report refers to a 19-year-old male patient. His medical history and concomitant medications were not reported. On 22 Jul 2013, the was vaccinated with MENVEO (batch number: not reported), Td vaccine (other manufacturer, batch number: not reported) and HepA/HepB vaccine (other manufacturer, batch number: not reported). On 23 Jul 2013, he experienced fever, chills/shivering, shortness of breath, watery eyes, and throat swelling accompanied with sniffles and sore muscles. The event outcome was reported as completely recovered as on 23 Jul 2013. The seriousness and causality of the events were not reported.