chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Swelling face, Testicular swelling
Clinical narrative: Case number PHHY2015US002131, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552803) website on 06 Jan 2015. This report refers to a 74-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of shingles vaccine in mid May 2014 and on 10 Jun 2014, the patient experienced severe shingles. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into the left arm on 06 Nov 2014. On the same day after vaccination, the patient experienced swelling of eyes and face. The patient's throat was sore, swollen and had cough. Additionally, the patient had swollen sinus. The patient took BENADRYL and on the next day, the patient went to the emergency room. The final outcome of the events was complete recovery. The events were reported as non-serious. The events 'swelling of eyes, face and throat' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: External ear pain, Eyelid function disorder, Headache, Hypoaesthesia, Injury
Clinical narrative: Case number PHHY2015US002195, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552878) website on 06 Jan 2015. This report refers to a 65-year-old male patient. The patient's past medical history included tremor and concurrent conditions included hypertension, diabetes mellitus and chronic constipation. Concomitant medications included amlodipine, simvastatin, lisinopril, metformin, glipizide, selegiline and linaclotide. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly on 10 Oct 2014. On 13 Oct 2014, the patient experienced left facial numbness, drooping left cheek and had an asymmetric smile. The patient was unable to close his left eye. The patient denied paralysis, numbness in other parts of the body, trauma, change in his headache pattern and lesions or pain around the left ear. There was no worsening of blood pressure or glucose level prior to the onset of the events. The patient went to the emergency room and the patient was evaluated for stroke as the patient had the risk factors of stroke like hypertension, diabetes mellitus and hyperlipidemia. The evaluation result for stroke was negative. The patient was given a diagnosis of Bell's palsy. The patient was on treatment with prednisone for seven days til 20 Oct 2014. The final outcome of the events was condition unchanged. The events were reported as non-serious. The event 'Bell's palsy' was internally upgraded as medically significant based on the NVD-key event list. Causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Skin lesion, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US002195, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552878) website on 06 Jan 2015. This report refers to a 65-year-old male patient. The patient's past medical history included tremor and concurrent conditions included hypertension, diabetes mellitus and chronic constipation. Concomitant medications included amlodipine, simvastatin, lisinopril, metformin, glipizide, selegiline and linaclotide. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly on 10 Oct 2014. On 13 Oct 2014, the patient experienced left facial numbness, drooping left cheek and had an asymmetric smile. The patient was unable to close his left eye. The patient denied paralysis, numbness in other parts of the body, trauma, change in his headache pattern and lesions or pain around the left ear. There was no worsening of blood pressure or glucose level prior to the onset of the events. The patient went to the emergency room and the patient was evaluated for stroke as the patient had the risk factors of stroke like hypertension, diabetes mellitus and hyperlipidemia. The evaluation result for stroke was negative. The patient was given a diagnosis of Bell's palsy. The patient was on treatment with prednisone for seven days til 20 Oct 2014. The final outcome of the events was condition unchanged. The events were reported as non-serious. The event 'Bell's palsy' was internally upgraded as medically significant based on the NVD-key event list. Causality was not reported.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Urticaria
Clinical narrative: Case number PHHY2015US002422, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552931) website on 06 Jan 2015. This report refers to a 7-year-old female patient. The patient's past medical history included asthma. The patient was allergic to cats and dogs. The patient was currently being treated for a smashed finger in the car door. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into the left arm on 07 Nov 2014. On the same day after the vaccination, the patient experienced hives all over the body. On 08 Nov 2014, the patient's whole face was swollen. The patient was treated with prednisone, ZANTAC and ZYRTEC. The final outcome of the events was unknown. The events were reported as non-serious. The events 'hives all over the body and whole face swollen' were internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 0.3
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US001671, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553263) website on 06 Jan 2015. This report refers to a 03 months old female patient. Current condition included microphthalmia and minor respiratory infection with no fever. Concomitant medications were not reported. On 11 Nov 2014, she was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into right leg. On the same day post vaccination at approximately 7:00 PM, she developed large number of hives, including a grouping of hives that was approximately 6 inches in length and 2-3 inches wide on her left inner thigh (opposite leg of injection site). She also developed hives on stomach, small groups on legs and left ankle. Consulted a physician on 12 Nov 2014, due to large amount of hives and he advised to administer BENADRYL if there was no fever and no difficulty breathing. Final outcome of the event was recovered. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of hives was upgraded based on information available in the source documents.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Aphasia, Dizziness, Musculoskeletal stiffness, Pruritus
Clinical narrative: Case number PHHY2015US001690, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553577) website on 06 Jan 2015. This report refers to a 42 year old female patient. Current condition included allergy to penicillin. Historical drug included BIAXIN. Concomitant medication was not reported. On 04 Nov 2014, she was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into right arm. On the same day post vaccination she developed itching and her head felt woozy and swimmy and the patient felt like she could not put words together. Itching started all over her face, head and body and neck was stiff. Final outcome of the event was unknown. Causality assessment was not reported. Event was reported as non-serious. Seriousness assessment of itching all over was upgraded based on information available in the source documents.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: Case number PHHY2015US001689, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553790) website on 06 Jan 2015. This report refers to a 50 year old female patient. Medical history was not reported. Concomitant medication included SYNTHROID. Previous vaccination included seasonal influenza vaccine INN (manufacturer and batch number unknown) on 13 Oct 2013 and no adverse event was reported. On 18 Oct 2014, she was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number unknown) intramuscular into left arm. On the same day post vaccination she developed radiating pain down arm into hand, throbbing nerve pain. Severe pain was going on for 1 and half weeks now. She went to the emergency room. Two doctors prescribed prednisone pack and narcotic pain relief. Final outcome of the event was unknown. Causality assessment was not reported. Event was reported as non-serious. Seriousness assessment of nerve pain was upgraded based on information available in the source documents.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face
Clinical narrative: Case number PHHY2015US027882 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 553840) website on 05 Mar 2015. This report refers to a 44 years old female patient. Her medical history was not reported. Her concomitant medications were ZOLOFT, ALDACTAZIDE and LOESTRIN. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 13 Nov 2014. On 13 Nov 2014, she had swelling on the sides of face from ear down. The outcome of the events was not reported. The event was reported non-serious, but the event face swelling was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site mass, Lip swelling, Oral discomfort, Oral mucosal eruption, Oral pruritus
Clinical narrative: Case number PHHY2015US028516, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 554309) website on 05 Mar 2015. This report refers to a 56-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had no known allergies. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 31 Oct 2014 in the afternoon. Immediately after the vaccination the patient had not developed any symptoms. On 01 Nov 2014, the patient developed rash around the mouth and a lump at the injection site. The patient's lips had swollen to three times of their size. The events reoccurred on 02 Nov 2014 and 03 Nov 2014 respectively with swelling, rash, itching and burning around the mouth area. After several days, the patient's symptoms had lessened. The final outcome of the events was not recovered. The events were reported as non-serious. The event 'lips swelled to three times their size' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Hypersensitivity, Induration, Pain, Pharyngeal oedema
Clinical narrative: Case number PHHY2015US028504, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 554410) website on 05 Mar 2015. This report refers to a 49 year old female patient. Historical condition was not reported. Concomitant medications included lisinopril, folic acid, estradiol and Triamterene-hydrochlorothiazide all once daily. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 10 Nov 2014. On 11 Nov 2014, she experienced large oversized swelling, itching, redness, hardness and soreness (all at unspecified site). She was taken to an emergency room due to throat swelling. In the ER the patient was diagnosed with allergic reaction. Treatment was rendered with BENADRYL at a dose of 25 mg, PEPCID at a dose of 20 mg, SOLU-MEDROL at a dose of 125 mg; all intravenously. Final outcome of the events was complete recovery.  Events were reported as non-serious. Seriousness assessment of allergic reaction was upgraded (medically significant) as per information available in source document. Causality was not reported.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Swelling
Clinical narrative: Case number PHHY2015US028504, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 554410) website on 05 Mar 2015. This report refers to a 49 year old female patient. Historical condition was not reported. Concomitant medications included lisinopril, folic acid, estradiol and Triamterene-hydrochlorothiazide all once daily. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in left arm on 10 Nov 2014. On 11 Nov 2014, she experienced large oversized swelling, itching, redness, hardness and soreness (all at unspecified site). She was taken to an emergency room due to throat swelling. In the ER the patient was diagnosed with allergic reaction. Treatment was rendered with BENADRYL at a dose of 25 mg, PEPCID at a dose of 20 mg, SOLU-MEDROL at a dose of 125 mg; all intravenously. Final outcome of the events was complete recovery.  Events were reported as non-serious. Seriousness assessment of allergic reaction was upgraded (medically significant) as per information available in source document. Causality was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye swelling, Lip swelling, Nasal congestion, Oral pruritus
Clinical narrative: Case number PHHY2015US028370, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 554478) on 05 Mar 2015. This report refers to a 63 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 18 Nov 2014. On the same day after vaccination, she experienced coughing, itchy mouth, swelling and tingling lips, swollen eyes and blocked nasal passages. Symptoms improved somewhat about one hour after taking BENADRYL. The patient took a total of three doses of BENADRYL. Final outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of lip swelling and eye swelling was upgraded (medically significant) as per information available in source document. Causality was not reported.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia oral
Clinical narrative: Case number PHHY2015US028370, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 554478) on 05 Mar 2015. This report refers to a 63 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) on 18 Nov 2014. On the same day after vaccination, she experienced coughing, itchy mouth, swelling and tingling lips, swollen eyes and blocked nasal passages. Symptoms improved somewhat about one hour after taking BENADRYL. The patient took a total of three doses of BENADRYL. Final outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of lip swelling and eye swelling was upgraded (medically significant) as per information available in source document. Causality was not reported.
Age: 13.0
Sex: F
Vaccine: FLUX, HEPA, HPV4
Symptoms: Headache, Loss of consciousness, Tremor
Clinical narrative: Case number PHHY2015US028804, is an initial spontaneous report received from a consumer (patient's mother) via Vaccine Adverse Event Reporting System (VAERS reference number: 554519) website on 05 Mar 2015. This report refers to a 13-year-old female patient. She was allergic to tree nuts. On 18 Nov 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in the right arm along with GARDASIL (other manufacturer, batch number: not reported) in the left arm and hepatitis A vaccine (other manufacturer, batch number: not reported) in the right arm. On the same date, few seconds after vaccination she passed out and while passing out she was shaking/trembling. She had terrible headaches afterwards. She visited the emergency room. The outcome of the events was unknown. The events reported as non-serious. Seriousness assessment of the event passed out was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Face oedema, Swelling face
Clinical narrative: Case number PHHY2015US029124, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 554763) website on 05 Mar 2015. This report refers to a 31-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her right arm on 30 Oct 2014. On the same date after vaccination, she had bilateral facial swelling/edema. The final outcome of the event was recovered. The event was reported as non serious. Causality of the event was not reported. Seriousness of event bilateral facial swelling/edema was upgraded based on available information in the source document.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphagia, Dysphonia, Eye irritation, Eyelid function disorder
Clinical narrative: Case number PHHY2015US029057, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 554963) website on 05 Mar 2015. This report refers to a 65-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into left arm on 19 Nov 2014. On the same date after vaccination, she had red scratchy eyes, sore throat, coughing and hoarseness. At 5:15 PM her throat was closing, had stuffy nose, headache and fatigue. At 5:45 PM had difficulty swallowing, body aches, eyes closing and severe headache. At 7:15 PM she had sore eyes, fatigue, body aches, hoarseness, coughing and her throat was slightly opening. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of events red scratchy eyes, eyes closing and throat closing was upgraded based on available information in the source document.    Case number PHHY2015US029057, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 554963) website on 05 Mar 2015. This report refers to a 65-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her left arm on 19 Nov 2014. On the same date after vaccination, she had red scratchy eyes, sore throat, coughing and hoarseness. At 5:15 PM her throat was closing, had stuffy nose, headache and fatigue, body aches, hoarseness, coughing and her throat was slightly opening. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of events red scratchy eyes, eyes closing and throat closing was upgraded based on available information in the source document.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Headache, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Case number PHHY2015US029057, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 554963) website on 05 Mar 2015. This report refers to a 65-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into left arm on 19 Nov 2014. On the same date after vaccination, she had red scratchy eyes, sore throat, coughing and hoarseness. At 5:15 PM her throat was closing, had stuffy nose, headache and fatigue. At 5:45 PM had difficulty swallowing, body aches, eyes closing and severe headache. At 7:15 PM she had sore eyes, fatigue, body aches, hoarseness, coughing and her throat was slightly opening. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of events red scratchy eyes, eyes closing and throat closing was upgraded based on available information in the source document.    Case number PHHY2015US029057, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 554963) website on 05 Mar 2015. This report refers to a 65-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her left arm on 19 Nov 2014. On the same date after vaccination, she had red scratchy eyes, sore throat, coughing and hoarseness. At 5:15 PM her throat was closing, had stuffy nose, headache and fatigue, body aches, hoarseness, coughing and her throat was slightly opening. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of events red scratchy eyes, eyes closing and throat closing was upgraded based on available information in the source document.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Throat tightness
Clinical narrative: Case number PHHY2015US029057, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 554963) website on 05 Mar 2015. This report refers to a 65-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into left arm on 19 Nov 2014. On the same date after vaccination, she had red scratchy eyes, sore throat, coughing and hoarseness. At 5:15 PM her throat was closing, had stuffy nose, headache and fatigue. At 5:45 PM had difficulty swallowing, body aches, eyes closing and severe headache. At 7:15 PM she had sore eyes, fatigue, body aches, hoarseness, coughing and her throat was slightly opening. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of events red scratchy eyes, eyes closing and throat closing was upgraded based on available information in the source document.    Case number PHHY2015US029057, is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 554963) website on 05 Mar 2015. This report refers to a 65-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) into her left arm on 19 Nov 2014. On the same date after vaccination, she had red scratchy eyes, sore throat, coughing and hoarseness. At 5:15 PM her throat was closing, had stuffy nose, headache and fatigue, body aches, hoarseness, coughing and her throat was slightly opening. The final outcome of the events was recovered. The events were reported as non serious. Causality of the events was not reported. Seriousness of events red scratchy eyes, eyes closing and throat closing was upgraded based on available information in the source document.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Chest pain, Computerised tomogram, Dyspnoea, Endoscopy, Laboratory test
Clinical narrative: Case number PHHY2015US027806 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 554978) website on 05 Mar 2015 with a follow up received from vaccine adverse event reporting system 20 Oct 2015. This report refers to a 14 years old female patient. Her medical history was not reported. Her concomitant medications were ZYRTEC and unspecified birth control medication. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) via unspecified site and GARDASIL (other manufacturer, batch number: not reported) in the left arm; both vaccines administered on 03 Oct 2014. On 03 Oct 2014, she had shortness of breath, chest pain and air in throat. She went to emergency room and did X-ray, computed tomography (CT) scan, esophageal study, pulmonary function test and throat camera scope. The outcome of the events was unknown. The events were reported life threatening. The causality of the events was not reported. It was reported that the patient was vaccinated with FLUMIST (other manufacturer, batch number: CH2022) and the case will be deactivated. Follow up received from vaccine adverse event reporting system (VAERS reference number: 582292) 20 Oct 2015: updated narrative (it was reported that the patient was vaccinated with FLUMIST (other manufacturer, batch number: CH2022) and the case will be deactivated).
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Pulmonary function test, X-ray
Clinical narrative: Case number PHHY2015US027806 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 554978) website on 05 Mar 2015 with a follow up received from vaccine adverse event reporting system 20 Oct 2015. This report refers to a 14 years old female patient. Her medical history was not reported. Her concomitant medications were ZYRTEC and unspecified birth control medication. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) via unspecified site and GARDASIL (other manufacturer, batch number: not reported) in the left arm; both vaccines administered on 03 Oct 2014. On 03 Oct 2014, she had shortness of breath, chest pain and air in throat. She went to emergency room and did X-ray, computed tomography (CT) scan, esophageal study, pulmonary function test and throat camera scope. The outcome of the events was unknown. The events were reported life threatening. The causality of the events was not reported. It was reported that the patient was vaccinated with FLUMIST (other manufacturer, batch number: CH2022) and the case will be deactivated. Follow up received from vaccine adverse event reporting system (VAERS reference number: 582292) 20 Oct 2015: updated narrative (it was reported that the patient was vaccinated with FLUMIST (other manufacturer, batch number: CH2022) and the case will be deactivated).
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Malaise, Muscle spasms, Paralysis
Clinical narrative: Case number PHHY2015US028312, is an initial spontaneous report received from a consumer (also patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 555218) website on 05 Mar 2015. This report refers to a 57-year-old female patient. Concurrent conditions included multiple sclerosis since 1998. The patient stated that she takes flu shots each year without incident. This polymedicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) along with pneumococcal vaccine (manufacturer and batch number unknown) on 21 Nov 2014. On the same day within one hour after vaccination, the patient was ill and went to bed. The patient woke up about two hours later with no voluntary movement except her head and had total body paralysis below her neck. The patient slowly began to achieve some movement. But, that was accompanied by violent total body spasms for about 2 hours. It took her 6 hours until she was finally able to sit on the bed. The patient was still very weak. The patient would consult the physician. The final outcome of the events was reported as recovery. The seriousness and causality was not reported. Seriousness assessment of paralysis was upgraded based on the NVS-IME list.
Age: 26.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Case number PHHY2015US028357, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555241) website on 05 Mar 2015. This report refers to a 26-year-old female patient. Current condition for the patient included slightly nauseous and sore at injection site. This patient was allergic to sulfa drugs. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into right arm and GARDASIL (batch number unknown) into left arm on 19 Nov 2014. On the same day, the patient experienced pins and needles in hands and feet. The patient went to emergency room and Guillain Barre Syndrome was suspected. No tests were done. The final outcome of the events was reported as condition unchanged. The events were assessed as non-serious. Causality was not reported. Seriousness assessment of Guillain Barre Syndrome was upgraded based on the NVS-IME list.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Case number PHHY2015US019131, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 555309) website on 05 Mar 2015. This report refers to a 37 year old female patient. Concurrent conditions included slight cold. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 20 Nov 2014. On the same day, after vaccination, the patient experienced pain at site of injection. Further the pain radiated down from arm and hand where her fingers and hand were sore. The patient also had a tingling and numbness sensation. Then about two hours later, these symptoms stopped and her heart began racing and had tightness in her chest/difficulty catching full breath for several hours. The patient consulted physician, who stated that he did not believe that was from the shot. The patient disagreed with physician and believed that her symptoms were an allergic reaction as she had not ever experienced this before. The outcome of the events was reported as recovery. The events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of chest tightness and difficulty breathing was upgraded based on information available in the source documents.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Case number PHHY2015US019131, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 555309) website on 05 Mar 2015. This report refers to a 37 year old female patient. Concurrent conditions included slight cold. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 20 Nov 2014. On the same day, after vaccination, the patient experienced pain at site of injection. Further the pain radiated down from arm and hand where her fingers and hand were sore. The patient also had a tingling and numbness sensation. Then about two hours later, these symptoms stopped and her heart began racing and had tightness in her chest/difficulty catching full breath for several hours. The patient consulted physician, who stated that he did not believe that was from the shot. The patient disagreed with physician and believed that her symptoms were an allergic reaction as she had not ever experienced this before. The outcome of the events was reported as recovery. The events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of chest tightness and difficulty breathing was upgraded based on information available in the source documents.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal behaviour, Asthenia, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: Case number PHHY2015US029144, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 555432) website on 05 Mar 2015. This report refers to a 42 year old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into the right arm on 24 Nov 2014. On the same day, after vaccination, the patient presented with hives, swelling, trouble breathing, dizziness, weakness, changes in behavior and an accelerated heartbeat. The events were reported as non-serious. Outcome and causality of the events was not reported. Seriousness assessment of trouble breathing was upgraded based on information available in the source documents.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling, Urticaria
Clinical narrative: Case number PHHY2015US029144, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 555432) website on 05 Mar 2015. This report refers to a 42 year old female patient. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into the right arm on 24 Nov 2014. On the same day, after vaccination, the patient presented with hives, swelling, trouble breathing, dizziness, weakness, changes in behavior and an accelerated heartbeat. The events were reported as non-serious. Outcome and causality of the events was not reported. Seriousness assessment of trouble breathing was upgraded based on information available in the source documents.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Case number PHHY2015US029159, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 555460) website on 05 Mar 2015. This report refers to an 11 year old male patient. Concurrent condition included allergy (environmental) induced asthma. Concomitant medication included montelukast. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into the right arm on 18 Nov 2014. On 20 Nov 2014, the patient experienced redness, pain and warm to touch at the area below the injection site. The patient went to ER and was diagnosed with cellulitis. The patient was prescribed with antibiotics for the same. It was reported that the patient's arm was still hurting where the vaccination was given. Final outcome of the events was reported as recovery. The events were assessed as non-serious. Causality was not reported. Seriousness assessment of cellulitis was upgraded based on the NVS-IMS list.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Culture, Lip blister, Lip swelling, Oral mucosal blistering, Rash macular
Clinical narrative: Case number PHHY2015US028987, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556302) website on 05 Mar 2015. This report refers to a 13-years-old female patient. Her medical history was not reported. Concomitant medication included ibuprofen. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 29 Oct 2014 at school flu clinic. On the same day, at bed time, the patient complained of lips feeling "silky" and her parent advised her to go to bed. When she awoke in the morning on 30 Oct 2014, her parent saw that her lips were swollen above nose and she had 8 blisters on top lip, 4 on bottom lip, blisters inside mouth and her skin was blotchy. She was given BENADRYL on 01 Nov 2014. She started vomiting all weekend and was taken to emergency room to primary care physician (PCP) on 03 Nov 2014. The PCP was uncertain of reaction and advised parent to notify HD. On 03 Nov 2014, culture test was done with dried blisters as per her mother. As of 24 Nov 2014, cultures were not obtained. The final outcome of the events was complete recovery. The events were reported as non-serious, but the events lip swelling and blisters of lip and mouth was upgraded as medically significant based on the information available in the source documents. The causality assessment of the events was not reported.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US028987, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556302) website on 05 Mar 2015. This report refers to a 13-years-old female patient. Her medical history was not reported. Concomitant medication included ibuprofen. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 29 Oct 2014 at school flu clinic. On the same day, at bed time, the patient complained of lips feeling "silky" and her parent advised her to go to bed. When she awoke in the morning on 30 Oct 2014, her parent saw that her lips were swollen above nose and she had 8 blisters on top lip, 4 on bottom lip, blisters inside mouth and her skin was blotchy. She was given BENADRYL on 01 Nov 2014. She started vomiting all weekend and was taken to emergency room to primary care physician (PCP) on 03 Nov 2014. The PCP was uncertain of reaction and advised parent to notify HD. On 03 Nov 2014, culture test was done with dried blisters as per her mother. As of 24 Nov 2014, cultures were not obtained. The final outcome of the events was complete recovery. The events were reported as non-serious, but the events lip swelling and blisters of lip and mouth was upgraded as medically significant based on the information available in the source documents. The causality assessment of the events was not reported.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness, Pain
Clinical narrative: Case number PHHY2015US028373, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556515) website on 05 Mar 2015. This report refers to a 56-year-old male patient. Historical conditions were not reported. Concomitant medications included balsalazide, amlodipine, hydrochlorothiazide, metoprolol, simvastatin and omeprazole. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 22 Oct 2014. On 24 Nov 2014, the patient experienced pain, tingling, paresthesia and proximal muscle weakness. The patient's electromyogram was consistent with Guillain Barre Syndrome. The patient was responding to treatment with intravenous immunoglobulin (IV IG). The final outcome of the events was not reported. The events were reported as serious (life threatening). Causality was not reported.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia
Clinical narrative: Case number PHHY2015US028373, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556515) website on 05 Mar 2015. This report refers to a 56-year-old male patient. Historical conditions were not reported. Concomitant medications included balsalazide, amlodipine, hydrochlorothiazide, metoprolol, simvastatin and omeprazole. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 22 Oct 2014. On 24 Nov 2014, the patient experienced pain, tingling, paresthesia and proximal muscle weakness. The patient's electromyogram was consistent with Guillain Barre Syndrome. The patient was responding to treatment with intravenous immunoglobulin (IV IG). The final outcome of the events was not reported. The events were reported as serious (life threatening). Causality was not reported.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Lip swelling, Peripheral swelling
Clinical narrative: Case number PHHY2015US030389, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556534) website on 05 Mar 2015. This report refers to a 45 year old female patient. Historical conditions and concomitant medications were not reported. On 20 Oct 2014, she was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day after vaccination, she experienced arm swelling and lip swelling. The outcome of the events was reported as recovered. The events were reported as non-serious. Causality assessment was not provided. Seriousness assessment of lip swelling was upgraded (medically significant) based on information available in the source document.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Dysphonia, Hypersensitivity, Pruritus, Rash
Clinical narrative: Case number PHHY2015US033742, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556797) website on 16 Mar 2015. This report refers to a female patient of an unknown age. She was allergic to egg and latex. She was vaccinated with seasonal Influenza vaccine (manufacturer and batch number: unknown) on an unknown date. On an unknown date, after vaccination the patient experienced anaphylaxis. Final outcome, seriousness and causality of the event were not reported. Seriousness of the event anaphylactic reaction was upgraded based on information available in the NVS-IME list. The patient received FLUCELVAX on 20 Oct 2014 and experienced dysphonia, hypersensitivity, pruritus and rash (see case: PHHY2015US034564).
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Acute motor-sensory axonal neuropathy, Dysarthria, Muscular weakness, Pain, Paraesthesia
Clinical narrative: Case number PHHY2015US028431, is an initial spontaneous report received from a consumer (patient) via the Vaccine Adverse Event Reporting System (VAERS reference number: 556985) website on 05 Mar 2015. This report refers to a 61 year old female patient. Historical conditions were not provided. Concurrent condition included depression. On an unknown date (reported as years ago), she was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported). On an unspecified date (shortly after vaccination), she developed sudden tingling in her cheeks, fingers, legs, nose which was on and off for months. The patient had 14 episodes of slurred speech. She went to the clinic three times. The patient had to use a walker due to lower limb muscle weakness. Later she developed symptoms of chronic severe pain. She was diagnosed with painful relapsing remitting axonal sensory-motor neuropathy. The pain was effectively treated with gabapentin (4200 mg) but she developed low white blood cell count (WBC count: 3.6). The outcome of the events was reported as not recovered. Events were reported as non-serious. Seriousness assessment of painful relapsing remitting axonal sensory-motor neuropathy was upgraded (medically significant) based on information available in the source documents. The reporter stated that her neurologist had told her that the condition was unrelated to the seasonal influenza vaccine INN but advised her not to receive flu vaccine in future.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Walking aid user, White blood cell count decreased
Clinical narrative: Case number PHHY2015US028431, is an initial spontaneous report received from a consumer (patient) via the Vaccine Adverse Event Reporting System (VAERS reference number: 556985) website on 05 Mar 2015. This report refers to a 61 year old female patient. Historical conditions were not provided. Concurrent condition included depression. On an unknown date (reported as years ago), she was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported). On an unspecified date (shortly after vaccination), she developed sudden tingling in her cheeks, fingers, legs, nose which was on and off for months. The patient had 14 episodes of slurred speech. She went to the clinic three times. The patient had to use a walker due to lower limb muscle weakness. Later she developed symptoms of chronic severe pain. She was diagnosed with painful relapsing remitting axonal sensory-motor neuropathy. The pain was effectively treated with gabapentin (4200 mg) but she developed low white blood cell count (WBC count: 3.6). The outcome of the events was reported as not recovered. Events were reported as non-serious. Seriousness assessment of painful relapsing remitting axonal sensory-motor neuropathy was upgraded (medically significant) based on information available in the source documents. The reporter stated that her neurologist had told her that the condition was unrelated to the seasonal influenza vaccine INN but advised her not to receive flu vaccine in future.
Age: 30.0
Sex: M
Vaccine: FLUX
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: Case number PHHY2015US027951, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 557212) website on 05 Mar 2015. This report refers to a 30 years old male patient. Concurrent condition included allergy to penicillin. Concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 12 Nov 2009. On the same day, after vaccination, the patient developed rash on left side of body covering neck and torso, fever around 102 degrees for 3 days and fits of vomiting. The patient did not consult doctor but was treated with fluids and ibuprofen. Outcome of the events was recovered. The events were assessed as serious (life-threatening). Causality of the events was not reported.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Dyspnoea, Pyrexia
Clinical narrative: Case number PHHY2015US029013, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557252) website on 05 Mar 2015. This report refers to a 30 year old female patient. Historical condition was not reported. Concurrent conditions include bicuspid aortic valve and aortic dysfunction. On 07 Dec 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown). On the same day (after vaccination), the patient developed joint pains, shortness of breath, fever and weakness. Outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of shortness of breath was upgraded as medically significant based on information available in the source documents. Causality assessment was not provided.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Case number PHHY2015US033378, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557933) website on 16 Mar 2015. This report refers to a 29-year-old female patient. Her historical and current conditions were none. Concomitant medications included DHA (docosahexaenoic acid) and Prenatal. She was vaccinated with AGRIFLU (batch number: 145004) intramuscularly on left arm on 20 Nov 2014. On 21 Nov 2014, the patient experienced big red bumps all over the body. Final outcome of the event reported as recovered. Seriousness of the event reported as non-serious. Causality of the event was not reported. Seriousness of the event rash erythematous was upgraded based on information available in the source document.