chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHHY2013US117326 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: 490373) 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 59-year-old male patient. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, 31 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: 49.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Angiogram abnormal, Back pain, Blood culture negative, Chest pain, Electrocardiogram
Clinical narrative: Case number PHHY2013US117463 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (the source of the case in VAERS is a clinical study (non CSL clinical study), reference number: 490513) on 15 Oct 2013. This report refers to a 49-year-old polymedicated male patient. The patient's concurrent conditions included diabetes, former smoker, hypertension and hyperlipidaemia. On 16 Feb 2012 at 08:57 the patient was enrolled to a clinical study (non CSL clinical study) and underwent a percutaneous coronary intervention (PCI). Prior to randomization the patient received aspirin 81 mg unfractionated heparin and bivalirudin. At 10:54 an angiography revealed one vessel with greater than 50% stenosis. At 11:17 the patient received a loading dose of 4 capsules of clopidogrel (study medication). At 11:20 the patient received a 10.3 ml bolus of clopidogrel (study medication) followed by an 82.2 ml/hr. infusion of clopidogrel (study medication) from 11:21 to 13:30. At 11:20 the patient began to undergo a PCI via a radial catheter access site during which time the right coronary artery (RCA) was treated with three non-drug eluting stents (total length of 71). The patient received bivalirudin pre/during procedure. The PCI concluded at 12:19. The patient received 4 capsules of clopidogrel (study medication) post infusion at 13:30. Post procedure; the patient was given clopidogrel 75 mg. At discharge he received aspirin and clopidogrel 75 mg. On 17 Feb 2012 at 09:22 the patient received an influenza virus immunization (manufacturer and batch number unknown) at a dose of 45 ug once intramuscularly. At the same time, he also received PNEUMOVAX 23 (other manufacturer, batch number unknown) at a dose of 25 ug once intramuscularly. The patient was discharged from the hospital on 17 Feb 2012 at 10:55. On the same day at 18:59 the patient returned to the hospital via the emergency room with complaints of back pain, chest pain and a fever of 103 F (Fahrenheit). He was admitted to the hospital and diagnosed with possible drug fever at 21:05. Blood cultures obtained on 17 Feb 2012 were negative. An electrocardiogram (EKG) was obtained, however the results were not provided. Treatment included intravenous vancomycin and intravenous LEVAQUIN. On 20 Feb 2012 the patient was discharged home with oral LEVAQUIN (five days of treatment). The events resolved on 20 Feb 2012 at 11:18. The reporter's commented that the Investigator considered the event of "possible drug fever" to be possible related to clopidogrel (study medication), influenza virus immunization and PNEUMOVAX 23 immunizations. Causality of other events was not reported.
Age: 49.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pyrexia, Vascular stenosis
Clinical narrative: Case number PHHY2013US117463 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (the source of the case in VAERS is a clinical study (non CSL clinical study), reference number: 490513) on 15 Oct 2013. This report refers to a 49-year-old polymedicated male patient. The patient's concurrent conditions included diabetes, former smoker, hypertension and hyperlipidaemia. On 16 Feb 2012 at 08:57 the patient was enrolled to a clinical study (non CSL clinical study) and underwent a percutaneous coronary intervention (PCI). Prior to randomization the patient received aspirin 81 mg unfractionated heparin and bivalirudin. At 10:54 an angiography revealed one vessel with greater than 50% stenosis. At 11:17 the patient received a loading dose of 4 capsules of clopidogrel (study medication). At 11:20 the patient received a 10.3 ml bolus of clopidogrel (study medication) followed by an 82.2 ml/hr. infusion of clopidogrel (study medication) from 11:21 to 13:30. At 11:20 the patient began to undergo a PCI via a radial catheter access site during which time the right coronary artery (RCA) was treated with three non-drug eluting stents (total length of 71). The patient received bivalirudin pre/during procedure. The PCI concluded at 12:19. The patient received 4 capsules of clopidogrel (study medication) post infusion at 13:30. Post procedure; the patient was given clopidogrel 75 mg. At discharge he received aspirin and clopidogrel 75 mg. On 17 Feb 2012 at 09:22 the patient received an influenza virus immunization (manufacturer and batch number unknown) at a dose of 45 ug once intramuscularly. At the same time, he also received PNEUMOVAX 23 (other manufacturer, batch number unknown) at a dose of 25 ug once intramuscularly. The patient was discharged from the hospital on 17 Feb 2012 at 10:55. On the same day at 18:59 the patient returned to the hospital via the emergency room with complaints of back pain, chest pain and a fever of 103 F (Fahrenheit). He was admitted to the hospital and diagnosed with possible drug fever at 21:05. Blood cultures obtained on 17 Feb 2012 were negative. An electrocardiogram (EKG) was obtained, however the results were not provided. Treatment included intravenous vancomycin and intravenous LEVAQUIN. On 20 Feb 2012 the patient was discharged home with oral LEVAQUIN (five days of treatment). The events resolved on 20 Feb 2012 at 11:18. The reporter's commented that the Investigator considered the event of "possible drug fever" to be possible related to clopidogrel (study medication), influenza virus immunization and PNEUMOVAX 23 immunizations. Causality of other events was not reported.
Age: 49.0
Sex: M
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Back pain, Blood culture negative, Chest pain, Electrocardiogram, Pyrexia
Clinical narrative: Case number PHHY2013US117463 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (the source of the case in VAERS is a clinical study (non CSL clinical study), reference number: 490513) on 15 Oct 2013. This report refers to a 49-year-old polymedicated male patient. The patient's concurrent conditions included diabetes, former smoker, hypertension and hyperlipidaemia. On 16 Feb 2012 at 08:57 the patient was enrolled to a clinical study (non CSL clinical study) and underwent a percutaneous coronary intervention (PCI). Prior to randomization the patient received aspirin 81 mg unfractionated heparin and bivalirudin. At 10:54 an angiography revealed one vessel with greater than 50% stenosis. At 11:17 the patient received a loading dose of 4 capsules of clopidogrel (study medication). At 11:20 the patient received a 10.3 ml bolus of clopidogrel (study medication) followed by an 82.2 ml/hr. infusion of clopidogrel (study medication) from 11:21 to 13:30. At 11:20 the patient began to undergo a PCI via a radial catheter access site during which time the right coronary artery (RCA) was treated with three non-drug eluting stents (total length of 71). The patient received bivalirudin pre/during procedure. The PCI concluded at 12:19. The patient received 4 capsules of clopidogrel (study medication) post infusion at 13:30. Post procedure; the patient was given clopidogrel 75 mg. At discharge he received aspirin and clopidogrel 75 mg. On 17 Feb 2012 at 09:22 the patient received an influenza virus immunization (manufacturer and batch number unknown) at a dose of 45 ug once intramuscularly. At the same time, he also received PNEUMOVAX 23 (other manufacturer, batch number unknown) at a dose of 25 ug once intramuscularly. The patient was discharged from the hospital on 17 Feb 2012 at 10:55. On the same day at 18:59 the patient returned to the hospital via the emergency room with complaints of back pain, chest pain and a fever of 103 F (Fahrenheit). He was admitted to the hospital and diagnosed with possible drug fever at 21:05. Blood cultures obtained on 17 Feb 2012 were negative. An electrocardiogram (EKG) was obtained, however the results were not provided. Treatment included intravenous vancomycin and intravenous LEVAQUIN. On 20 Feb 2012 the patient was discharged home with oral LEVAQUIN (five days of treatment). The events resolved on 20 Feb 2012 at 11:18. The reporter's commented that the Investigator considered the event of "possible drug fever" to be possible related to clopidogrel (study medication), influenza virus immunization and PNEUMOVAX 23 immunizations. Causality of other events was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy test, Allergy test negative, Blood test normal, Computerised tomogram abnormal, Nasopharyngitis
Clinical narrative: Case number PHHY2013US116504 is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 491204) website on 15 Oct 2013. This case refers to 63-year-old female patient. Her current conditions included slight cold and sore throat. The patient stated that nurse had listened to her lungs and stated it was fine to take the vaccine. She was vaccinated with Flu vaccine (manufacturer and batch number: not reported. So, conservatively coded as Seasonal Influenza vaccine INN) on 21 Dec 2012 intramuscularly in left arm. On 26 Dec 2012, the patient experienced sore throat. It later turned into a bad cold and then severe sinus infections that lasted for 6 weeks. On 04 Apr 2013, same symptoms occurred. She was treated with AUGMENTIN which got rid of dark mucus but patient still had non-allergic rhinitis and could not get rid of it. Axial non-contrast computed tomography (CT) Scan of paranasal sinuses using lab protocol that revealed inflammatory changes in the paranasal sinuses. Also the patient had full panel of allergy tests, by skin prick and by blood and all showed up as negative. Also there was localized inflammation at the site of the injection that lasted for about a week. The patient had emergency visit due to the events. The final outcome of events sinus infection, cold and rhinitis was reported as condition unchanged as of 08 May 2013. The seriousness of events was not reported. The patient never had sinus infection before the Influenza vaccination and hence patient strongly believed it was related to Flu vaccine.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Rhinitis, Secretion discharge, Sinusitis, Skin test negative
Clinical narrative: Case number PHHY2013US116504 is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 491204) website on 15 Oct 2013. This case refers to 63-year-old female patient. Her current conditions included slight cold and sore throat. The patient stated that nurse had listened to her lungs and stated it was fine to take the vaccine. She was vaccinated with Flu vaccine (manufacturer and batch number: not reported. So, conservatively coded as Seasonal Influenza vaccine INN) on 21 Dec 2012 intramuscularly in left arm. On 26 Dec 2012, the patient experienced sore throat. It later turned into a bad cold and then severe sinus infections that lasted for 6 weeks. On 04 Apr 2013, same symptoms occurred. She was treated with AUGMENTIN which got rid of dark mucus but patient still had non-allergic rhinitis and could not get rid of it. Axial non-contrast computed tomography (CT) Scan of paranasal sinuses using lab protocol that revealed inflammatory changes in the paranasal sinuses. Also the patient had full panel of allergy tests, by skin prick and by blood and all showed up as negative. Also there was localized inflammation at the site of the injection that lasted for about a week. The patient had emergency visit due to the events. The final outcome of events sinus infection, cold and rhinitis was reported as condition unchanged as of 08 May 2013. The seriousness of events was not reported. The patient never had sinus infection before the Influenza vaccination and hence patient strongly believed it was related to Flu vaccine.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Optic neuritis, Vaccine positive rechallenge
Clinical narrative: Case number PHHY2013US120302 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: 491225) on 15 Oct 2013: This report refers to a 59-year-old female patient. Her medical history and concomitant medication was not reported. Her vaccination history included administration of a seasonal influenza vaccine following which she experienced optic neuritis (see related case: PHHY2013US117558). She was vaccinated with another dose of seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date and experienced optic neuritis. No further information about seriousness and outcome was reported. The authors considered the event was almost certainly related to vaccination.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Optic neuritis
Clinical narrative: Case number PHHY2013US120302 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: 491225) on 15 Oct 2013: This report refers to a 59-year-old female patient. Her medical history and concomitant medication was not reported. Her vaccination history included administration of a seasonal influenza vaccine following which she experienced optic neuritis (see related case: PHHY2013US117558). She was vaccinated with another dose of seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date and experienced optic neuritis. No further information about seriousness and outcome was reported. The authors considered the event was almost certainly related to vaccination.
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Optic neuritis, Vaccine positive rechallenge
Clinical narrative: Case number PHHY2013US117558 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: 491225) on 15 Oct 2013: This report refers to a 59-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Two weeks after vaccination she experienced optic neuritis. There was no evidence of neuroretinitis, syphilis or systemic lupus erythematosus. At the time of reporting, the outcome of the event was unspecified. Laboratory test done included antinuclear antibody examination, blood examinations, blood biochemistry examinations, neuro-ophthalmological examinations, nuclear magnetic resonance and Treponema pallidum antibody examination; however, results for them were not reported. The authors considered the event was almost certainly related to vaccination. No further information about seriousness was reported. The patient was vaccinated with another dose of influenza vaccine and presented with optic neuritis again (see related case: PHHY2013US120302).
Age: 59.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Optic neuritis
Clinical narrative: Case number PHHY2013US117558 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: 491225) on 15 Oct 2013: This report refers to a 59-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Two weeks after vaccination she experienced optic neuritis. There was no evidence of neuroretinitis, syphilis or systemic lupus erythematosus. At the time of reporting, the outcome of the event was unspecified. Laboratory test done included antinuclear antibody examination, blood examinations, blood biochemistry examinations, neuro-ophthalmological examinations, nuclear magnetic resonance and Treponema pallidum antibody examination; however, results for them were not reported. The authors considered the event was almost certainly related to vaccination. No further information about seriousness was reported. The patient was vaccinated with another dose of influenza vaccine and presented with optic neuritis again (see related case: PHHY2013US120302).
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Oral herpes, Pain
Clinical narrative: Case number PHHY2014US116824 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 491414) website on 15 Oct 2013. This report refers to a 39-year-old female patient. Her medical history included "allergy to Sulfa". Her concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly into left arm on 13 Sep 2012. On 14 Sep 2012, she felt; achy throughout the right of her self and then next morning she woke up with cold sore. Outcome of the events was reported as recovered. No seriousness and causality was reported for the events.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US117508 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 491762) on 15 Oct 2013: This report refers to a male patient of unknown age. 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, approximately 10 years ago. On an unknown date after vaccination he experienced Bell's palsy. No further information about outcome, seriousness and causality was reported.
Age: 11.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Blood aluminium increased, Rash erythematous, Rash pruritic, Skin test positive, Vaccination site erythema
Clinical narrative: Case number PHHY2013US117563 is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS was a scientific literature publication, reference number: 492115) on 15 Oct 2013. This report refers to an 11-year-old female patient. She had no known egg allergy. Her medical history included Von Willebrand disease. Her family history included hay fever and atopic dermatitis. Her concomitant medications were not reported. She received DTaP (other manufacturer, batch number: not reported) on an unknown date. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. 14 months after DTaP vaccine and 6 months after influenza vaccine, she experienced swelling, erythema, and pruritus at the vaccination site. She also had concurrent pruritic erythematous eruptions of arms and legs. She had a positive patch test and increased aluminum chloride hexahydrate on an unknown date with reaction results grade 2. She was presented for evaluation of pruritic eruptions after vaccine administration and the event was reported as partially relieved by oral antihistamines. The final outcome of the event was not reported.
Age: 11.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Case number PHHY2013US117563 is an initial spontaneous report received via vaccine adverse event reporting system (the source of the case in VAERS was a scientific literature publication, reference number: 492115) on 15 Oct 2013. This report refers to an 11-year-old female patient. She had no known egg allergy. Her medical history included Von Willebrand disease. Her family history included hay fever and atopic dermatitis. Her concomitant medications were not reported. She received DTaP (other manufacturer, batch number: not reported) on an unknown date. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. 14 months after DTaP vaccine and 6 months after influenza vaccine, she experienced swelling, erythema, and pruritus at the vaccination site. She also had concurrent pruritic erythematous eruptions of arms and legs. She had a positive patch test and increased aluminum chloride hexahydrate on an unknown date with reaction results grade 2. She was presented for evaluation of pruritic eruptions after vaccine administration and the event was reported as partially relieved by oral antihistamines. The final outcome of the event was not reported.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Areflexia, Drug administered at inappropriate site, Erythema, Headache, Hypoaesthesia
Clinical narrative: Case number PHHY2013US116554 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS, reference number: 492725) web site on 15 Oct 2013. This report refers to a 51-year-old female patient. Her medical history included neck injury from a past motor vehicle accident (road traffic accident) and no history of hypersensitivity. She use to receive the flu shot vaccine every year. Her vaccination history included administration of hepatitis B vaccine (manufacturer and batch number unknown) in 1990. In May 2011, she was vaccinated with tetanus/diphtheria absorbed vaccine (manufacturer and batch number unknown) where she did not have a response. In middle of Dec 2012, she was vaccinated with ZOSTAVAX (other manufacturer, batch number: unknown) subcutaneously into right arm (right posterior aspect part of the arm). At the same time, she was also vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into deltoid of the left arm. On an unspecified date, within days from getting the vaccination, she had a pretty big response which described as "got redness", a large, huge egg sized bump that was red, swelling and itching and did get a headache. In Jan 2013, three weeks later, she had scapular pain, numbness of the right hand, then excruciating pain which explained as numbness in the thumb, index finger and middle finger of the right hand. On an unknown date, she went to emergency room and undergone MRI (magnetic resonance imaging) where result was not reported. She reported that she did tell her neurosurgeon that she had received the ZOSTAVAX and where it was injected. Neurosurgeon said that it could have irritated. Since 23 Jan 2013, she had been miserable as she lost her reflexes in the right arm which further described as flaccid arm. On 16 May 2013, the physician stated that it was an "odd" spot to put the injection, reporting that it was close to the "brachial plexus" under the arm or the "bat wing" area, not far from the armpit. On 16 May 2013, she stated that her symptoms had gotten better, as she received steroid MEDROL dose packs, physical therapy and has avoided had any neurosurgical intervention. She explained that she had a "bad neck" and had scapular pain in the location of the C-5, C-6 and C-7 (cervical vertebra). Her posterior arm had some pain and numbness and also the index finger was described as "neuropathic" pain. The grasp strength of the middle finger was better and her reflexes had come back. As of 16 May 2013, it was unknown if the physician had any relevant laboratory data, it was unknown if she would continue to receive the ZOSTAVAX or the flu vaccination and it was unknown if she continued to have a headache, a large, huge egg sized bump that was red, swelling and itching. Outcome of the events was reported as not recovered as of 27 May 2013. No causality and seriousness was reported for the events.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Hypotonia, Musculoskeletal pain, Neuralgia, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Case number PHHY2013US116554 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS, reference number: 492725) web site on 15 Oct 2013. This report refers to a 51-year-old female patient. Her medical history included neck injury from a past motor vehicle accident (road traffic accident) and no history of hypersensitivity. She use to receive the flu shot vaccine every year. Her vaccination history included administration of hepatitis B vaccine (manufacturer and batch number unknown) in 1990. In May 2011, she was vaccinated with tetanus/diphtheria absorbed vaccine (manufacturer and batch number unknown) where she did not have a response. In middle of Dec 2012, she was vaccinated with ZOSTAVAX (other manufacturer, batch number: unknown) subcutaneously into right arm (right posterior aspect part of the arm). At the same time, she was also vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into deltoid of the left arm. On an unspecified date, within days from getting the vaccination, she had a pretty big response which described as "got redness", a large, huge egg sized bump that was red, swelling and itching and did get a headache. In Jan 2013, three weeks later, she had scapular pain, numbness of the right hand, then excruciating pain which explained as numbness in the thumb, index finger and middle finger of the right hand. On an unknown date, she went to emergency room and undergone MRI (magnetic resonance imaging) where result was not reported. She reported that she did tell her neurosurgeon that she had received the ZOSTAVAX and where it was injected. Neurosurgeon said that it could have irritated. Since 23 Jan 2013, she had been miserable as she lost her reflexes in the right arm which further described as flaccid arm. On 16 May 2013, the physician stated that it was an "odd" spot to put the injection, reporting that it was close to the "brachial plexus" under the arm or the "bat wing" area, not far from the armpit. On 16 May 2013, she stated that her symptoms had gotten better, as she received steroid MEDROL dose packs, physical therapy and has avoided had any neurosurgical intervention. She explained that she had a "bad neck" and had scapular pain in the location of the C-5, C-6 and C-7 (cervical vertebra). Her posterior arm had some pain and numbness and also the index finger was described as "neuropathic" pain. The grasp strength of the middle finger was better and her reflexes had come back. As of 16 May 2013, it was unknown if the physician had any relevant laboratory data, it was unknown if she would continue to receive the ZOSTAVAX or the flu vaccination and it was unknown if she continued to have a headache, a large, huge egg sized bump that was red, swelling and itching. Outcome of the events was reported as not recovered as of 27 May 2013. No causality and seriousness was reported for the events.
Age: 51.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Case number PHHY2013US116554 is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS, reference number: 492725) web site on 15 Oct 2013. This report refers to a 51-year-old female patient. Her medical history included neck injury from a past motor vehicle accident (road traffic accident) and no history of hypersensitivity. She use to receive the flu shot vaccine every year. Her vaccination history included administration of hepatitis B vaccine (manufacturer and batch number unknown) in 1990. In May 2011, she was vaccinated with tetanus/diphtheria absorbed vaccine (manufacturer and batch number unknown) where she did not have a response. In middle of Dec 2012, she was vaccinated with ZOSTAVAX (other manufacturer, batch number: unknown) subcutaneously into right arm (right posterior aspect part of the arm). At the same time, she was also vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into deltoid of the left arm. On an unspecified date, within days from getting the vaccination, she had a pretty big response which described as "got redness", a large, huge egg sized bump that was red, swelling and itching and did get a headache. In Jan 2013, three weeks later, she had scapular pain, numbness of the right hand, then excruciating pain which explained as numbness in the thumb, index finger and middle finger of the right hand. On an unknown date, she went to emergency room and undergone MRI (magnetic resonance imaging) where result was not reported. She reported that she did tell her neurosurgeon that she had received the ZOSTAVAX and where it was injected. Neurosurgeon said that it could have irritated. Since 23 Jan 2013, she had been miserable as she lost her reflexes in the right arm which further described as flaccid arm. On 16 May 2013, the physician stated that it was an "odd" spot to put the injection, reporting that it was close to the "brachial plexus" under the arm or the "bat wing" area, not far from the armpit. On 16 May 2013, she stated that her symptoms had gotten better, as she received steroid MEDROL dose packs, physical therapy and has avoided had any neurosurgical intervention. She explained that she had a "bad neck" and had scapular pain in the location of the C-5, C-6 and C-7 (cervical vertebra). Her posterior arm had some pain and numbness and also the index finger was described as "neuropathic" pain. The grasp strength of the middle finger was better and her reflexes had come back. As of 16 May 2013, it was unknown if the physician had any relevant laboratory data, it was unknown if she would continue to receive the ZOSTAVAX or the flu vaccination and it was unknown if she continued to have a headache, a large, huge egg sized bump that was red, swelling and itching. Outcome of the events was reported as not recovered as of 27 May 2013. No causality and seriousness was reported for the events.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Case number PHHY2013US116563, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 494050) website on 15 Oct 2013. This report refers to a 65-year-old female patient. Her medical history included hypertension and poor compliance with 800 mg ibuprofen. Concomitant drugs included prednisone, ibuprofen and steroids. She was vaccinated with Seasonal influenza vaccine INN (manufacturer and batch number: not reported) intramuscularly on 01 Oct 2013. On 02 Oct 2013, she presented with pain left upper extremity (LUE), persistent ache in deltoid muscle which has limited her range of motion and ability to raise her left arm laterally above her left shoulder. The patient visited the emergency room. The outcome of the events reported as recovered. The seriousness and causality of the event were not reported.
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Headache, Pain, Pyrexia, Swelling
Clinical narrative: Case number PHHY2013US117187 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 494060) on 15 Oct 2013: This report refers to a male patient of an unspecified age. His medical history and concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 03 Dec 2003. On the same day, he also vaccinated with BIOTHRAX (other manufacturer and batch number: FAV077). On an unknown date after vaccination, he experienced fever, headaches, aches in body and swelling. Outcome of the events was reported as recovered as of 30 May 2013. Seriousness and causality was not reported for the events.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2013US117593 is an initial spontaneous report from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 494738) website on 15 Oct 2013. This case refers to a 52-year-old male patient. His medical history included allergy to penicillin. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination the patient developed anaphylactic reaction. The outcome, seriousness and causality assessment of the event was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Electrocardiogram abnormal, Tachycardia
Clinical narrative: Case number PHHY2013USA116647, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496008) website on 15 Oct 2013. This report refers to an elderly male patient. He was vaccinated with Seasonal Influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, following vaccination the patient experienced tachycardia. He went to the emergency room and had an abnormal EKG (electrocardiogram). The patient sought medical attention via emergency room visit. The event outcome reported as recovered. The seriousness and causality of the event were not reported.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Discomfort, Feeling abnormal, Malaise
Clinical narrative: Case number PHHY2013US116679, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496541) website on 15 Oct 2013. This report refers to a 43-year-old female patient. Her vaccination history included influenza vaccation and no adverse events were reported. It was reported that no adverse events were reported by the patient following receipt of prior immunizations. On 23 Oct 2003, the patient Flu vaccine (manufacturer and batch number: unknown, so conservatively coded as Seasonal Influenza vaccine INN) in the left arm. On the same date, less than one day after vaccination, the patient was not feeling well, had discomfort and felt something was wrong (but unsure what it was). The patient reported she had treatment in ambulance. At the clinic they observed her and no Epinephrine shot was administered. The patient consulted her healthcare provider regarding the events. On the same date, the patient recovered from the events. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHHY2013US117475 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 496599) on 15 Oct 2013: This report refers to an adult female patient. Her medical history and concomitant medication was not reported. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date, approximately in 2005. On an unknown date after vaccination she experienced anaphylaxis. No further information about outcome, seriousness and causality was reported.
Sex: U
Vaccine: FLUX
Symptoms: Hypersensitivity, Swelling, Urticaria
Clinical narrative: Case number PHHY2013US116705, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496565) website on 15 Oct 2013. This report refers to a patient of an unknown age and gender. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination the patient experienced allergic reactions like welt and swelling. At the time of reporting the outcome of the events was not reported. The seriousness and causality of the events were not reported. No other information was provided.
Age: 12.0
Sex: F
Vaccine: FLUX, HEPA, HPV4, IPV, VARCEL
Symptoms: Abdominal pain, Exposure during pregnancy, Human chorionic gonadotropin positive, Pregnancy test urine positive, Sinusitis
Clinical narrative: Case number PHHY2013US117207, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 496582) web site on 15 Oct 2013. This report refers to a 12-year-old female patient. She had no pertinent medical history and no allergies or drug reactions. She was vaccinated with Seasonal Influenza vaccine (manufacturer and batch number: not reported), HAVRIX (batch number: B492BA), GARDASIL (batch number: 669308/0636AA), Polio virus vaccine, inactivated (manufacturer and batch number: not reported) and VARIVAX (batch number: 669602/0023AA) on 30 Sep 2011. On an unknown date, after vaccination the patient experienced abdominal pain and was evaluated in the emergency room and discharged home. On 10 Nov 2011, the patient had a positive urine pregnancy test with last menstrual period on 23 Sep 2011 and due date on 29 Jun 2012. The physician reported that the patient had currently being treated for a sinus infection with ZITHROMAX. At the time of the report the outcome of the patient was unknown. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Muscular weakness, Nonspecific reaction
Clinical narrative: Case number PHHY2013US116719 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 496590) website on 15 Oct 2013. This case refers to an adult female patient. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on 19 Nov 2012. On 19 Nov 2012, less than one day after vaccination with influenza vaccine, the patient experienced insomnia, muscle weakness and nonspecified reaction. She stated that she developed a severe reaction (unspecified) after receiving a flu vaccine. The severe reaction eventually resolved after many months, specific dates were unknown. She had visited emergency room for the events. The outcome of all events was reported as complete recovery. The seriousness and causality of events was not reported.
Sex: U
Vaccine: FLUX
Symptoms: Back pain, Neck pain, Pruritus
Clinical narrative: Case number PHHY2013US116722 is an initial spontaneous report from nurse via Vaccine Adverse Event Reporting System (VAERS reference number: 496596) website on 15 Oct 2013. This case refers to multiple patients (number unspecified). The patients were vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) intramuscularly on an unspecified date in 2012. On an unspecified date(s) in 2012, less than one week after vaccination with influenza vaccine, an unspecified number of patients developed neck pain and back pain. Less than one year after vaccination with influenza vaccine, an unspecified number of patients experienced itching. The healthcare professional reported that several patients had made complaints regarding neck and back pains almost a week after the flu shot was given intramuscularly. There were a few who complained of itching. At the time of reporting the outcome of the events was unspecified.
Age: 28.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Aphasia, Asthenia, Confusional state, Cytomegalovirus test positive, Encephalitis
Clinical narrative: Case number PHHY2013US117541 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: 496794) on 15 Oct 2013. This report refers to a 28-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with seasonal trivalent influenza vaccine (manufacturer and batch number unknown) and TDAP vaccine (manufacturer, batch number unknown) on an unspecified date. on an unspecified date, five days after vaccination with TDAP vaccine and 10 days after vaccination with flu vaccine, she experienced nausea, vomiting and headache. She was hospitalized for photophobia, progressive weakness, and acute change in mental status, confusion, expressive aphasia, neck pain and stiffness. She was finally diagnosed with acute meningoencephalitis with encephalopathy with encephalopathy. She underwent cytomegalovirus serology test (IgG and IgM) which resulted as positive. At the time of reporting, the events were resolved. No causality was reported for the events.
Age: 28.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Encephalopathy, Headache, Mental status changes, Musculoskeletal stiffness, Nausea
Clinical narrative: Case number PHHY2013US117541 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: 496794) on 15 Oct 2013. This report refers to a 28-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with seasonal trivalent influenza vaccine (manufacturer and batch number unknown) and TDAP vaccine (manufacturer, batch number unknown) on an unspecified date. on an unspecified date, five days after vaccination with TDAP vaccine and 10 days after vaccination with flu vaccine, she experienced nausea, vomiting and headache. She was hospitalized for photophobia, progressive weakness, and acute change in mental status, confusion, expressive aphasia, neck pain and stiffness. She was finally diagnosed with acute meningoencephalitis with encephalopathy with encephalopathy. She underwent cytomegalovirus serology test (IgG and IgM) which resulted as positive. At the time of reporting, the events were resolved. No causality was reported for the events.
Age: 28.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Neck pain, Photophobia, Vomiting
Clinical narrative: Case number PHHY2013US117541 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: 496794) on 15 Oct 2013. This report refers to a 28-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with seasonal trivalent influenza vaccine (manufacturer and batch number unknown) and TDAP vaccine (manufacturer, batch number unknown) on an unspecified date. on an unspecified date, five days after vaccination with TDAP vaccine and 10 days after vaccination with flu vaccine, she experienced nausea, vomiting and headache. She was hospitalized for photophobia, progressive weakness, and acute change in mental status, confusion, expressive aphasia, neck pain and stiffness. She was finally diagnosed with acute meningoencephalitis with encephalopathy with encephalopathy. She underwent cytomegalovirus serology test (IgG and IgM) which resulted as positive. At the time of reporting, the events were resolved. No causality was reported for the events.
Age: 9.0
Sex: M
Vaccine: FLUX
Symptoms: Local reaction
Clinical narrative: Case number PHHY2013US116770 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 498306) website on 15 Oct 2013. This case refers to 09-year-old male patient. He was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) on 18 Jan 2013. On 18 Jan 2013, after the vaccination, the patient had a local reaction of the size of a softball. He had no other reactions or complaints. The patient's mother did not have patient checked at the time of reaction. The outcome of event was reported as complete recovery. The seriousness and causality of event was not reported.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Injection site mass, Peripheral swelling
Clinical narrative: Case number PHHY2013US116570 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 498634) website on 15 OCT 2013. This report refers to a 60-year-old female patient. Concomitant medications included theophylline, Ventolin  HFA and SYNTHROID. She had prior allergy shots which always had a reaction (not further specified). She was vaccinated with seasonal influenza (manufacturer and batch number unknown) on 16 JUL 2013. Next day she experienced arm swollen, red and site was slightly lumpy. Outcome of the events was reported as recovered as of 06 AUG 2013. Seriousness and causality was not reported for the events.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2013US117221 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 498788) on 15 OCT 2013. This report refers to a 62-year-old female patient. She had egg allergies, penicillin allergy and sulfa allergy. Concomitant medications were none. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date. She was also vaccinated with pneumococcal vaccine (manufacturer and batch number unknown) on an unknown date. On an unknown date, after vaccinations, she developed similar adverse reactions with both vaccinations. She developed fatigue as well as swelling of the arm that received th injection accompanied by bright redness, achiness and heat in the arm. The patient explained that the reactions lasted for a period of about 2 weeks following both vaccinations. The patient received these vaccines at different times and did not receive multiple vaccines during administration. The patient stated that her reaction to the flu vaccine was less severe than the reaction caused by the pneumonia vaccine. The patient r4eceived the pneumonia vaccine approximately 10 months ago and received flu vaccine (reported as the flu season before last). There was not treatment rendered for the events.  There was no laboratory diagnostic tests performed. On an unknown date (reported as after a couple of weeks) the patient recovered from the reported events. The patient sought medical attention. No additional information was available.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Irritability, Rash generalised, Urticaria
Clinical narrative: Case number PHHY2013US116584 is an initial spontaneous report from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 499039) website on 15 Oct 2013. This case refers to 8-year-old female patient. She was vaccinated with influenza vaccine (unknown manufacturer, batch number: not reported, so conservatively coded as Seasonal Influenza vaccine INN) intramuscularly in left leg on 09 Aug 2013. On the same date, the patient developed full body rash, hives, irritability and minor cough. The outcome of events was reported as condition unchanged. The seriousness and causality of events was not reported.