chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Hemiparesis, Hypoaesthesia, Hypoaesthesia oral, Laboratory test
Clinical narrative: Case number PHHY2015US017481 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 552779) on 03 Feb 2015. This report refers to a 25 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 28 Oct 2014. On 28 Oct 2014, a couple of hours after flu shot her left arm started going numb and it continued to stay numb. She went to work on 29 Oct 2014, but the arm was still numb. The numbness and tingling went down her left ribs and up the left side of her face. Her lips were numb when she was on her way home that night. On 30 Oct 2014, she went to emergency room. She had facial drooping and complete numbness and tingling in her left upper body, arm and face. She went to emergency room and was ordered blood work and conducted a neurological test which "determined her left side to be greatly decreased from her right side".  He consulted her primary and neuro doctors. They monitored her for a few hours and they agreed that it was a reaction to flu shot. She was started on prednisone for 10 days. She was to follow up with her primary physician if tingling and numbness was not better. She was instructed to not lift with her left arm and was told to go to emergency immediately in case of any burning or if her symptoms worsened. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the event facial drooping was upgraded as medically significant based on the information available in the source documents. No further information was provided.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, VIIth nerve paralysis, Vaccination complication
Clinical narrative: Case number PHHY2015US017481 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 552779) on 03 Feb 2015. This report refers to a 25 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the left arm on 28 Oct 2014. On 28 Oct 2014, a couple of hours after flu shot her left arm started going numb and it continued to stay numb. She went to work on 29 Oct 2014, but the arm was still numb. The numbness and tingling went down her left ribs and up the left side of her face. Her lips were numb when she was on her way home that night. On 30 Oct 2014, she went to emergency room. She had facial drooping and complete numbness and tingling in her left upper body, arm and face. She went to emergency room and was ordered blood work and conducted a neurological test which "determined her left side to be greatly decreased from her right side".  He consulted her primary and neuro doctors. They monitored her for a few hours and they agreed that it was a reaction to flu shot. She was started on prednisone for 10 days. She was to follow up with her primary physician if tingling and numbness was not better. She was instructed to not lift with her left arm and was told to go to emergency immediately in case of any burning or if her symptoms worsened. The events outcome was reported as condition unchanged. The events were reported as non-serious, but the event facial drooping was upgraded as medically significant based on the information available in the source documents. No further information was provided.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Flushing, Pruritus, Rash, Rash erythematous
Clinical narrative: Case number PHHY2015US017459, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 552921) website on 03 Feb 2015. This report refers to a 39 year old female patient. Medical history was not reported. Concurrent conditions included kidney stone (stage 3). She had no known drug allergy. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 146401) intramuscularly in right arm on 10 Nov 2014. On the same day after vaccination, she experienced flushing, itching, red rash spots on arm, back and stomach area. She also felt little tightness in throat and difficulty in breathing. Final outcome of the event was complete recovery. Event was reported as non-serious. Seriousness assessment of tightness in throat and difficulty in breathing was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Case number PHHY2015US017459, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 552921) website on 03 Feb 2015. This report refers to a 39 year old female patient. Medical history was not reported. Concurrent conditions included kidney stone (stage 3). She had no known drug allergy. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 146401) intramuscularly in right arm on 10 Nov 2014. On the same day after vaccination, she experienced flushing, itching, red rash spots on arm, back and stomach area. She also felt little tightness in throat and difficulty in breathing. Final outcome of the event was complete recovery. Event was reported as non-serious. Seriousness assessment of tightness in throat and difficulty in breathing was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Chest pain, Hypotension, Swollen tongue
Clinical narrative: Case number PHHY2015US013902, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552951) website on 03 Feb 2015. This report refers to a 31 year old female patient. Medical history included allergy to methylparaben and simethicone. She had a history of recurrent anaphylaxis. Concomitant medication included ADVAIR, ZYRTEC, SEROQUEL, ABILIFY, CYTOMEL, TOPAMAX and MIRENA. On 30 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1414201A) intramuscular into left arm. On the same day post vaccination she experienced chest pain, tongue swelling and low blood pressure. Treatment medication included EPIPEN (also in ambulance used). The patient was admitted in the hospital for anaphylaxis for 2 days. She went to the emergency room. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as serious (life threatening and hospitalization).
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mouth swelling, Swelling face
Clinical narrative: Case number PHHY2015US017469 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 552967) on 03 Feb 2015. This report refers to a 27 years old female patient. Her medical history was not reported. Her concomitant medications included ORTHO MICRONOR for birth control. She was vaccinated with FLUVIRIN (batch number: 1414001) intramuscularly in the left arm on 28 Oct 2014. On 28 Oct 2014, she had right sided facial swelling and numbness which began a few hours after flu vaccination. She noticed a little bit of swelling inside her right cheek. The symptoms started approximately 2 hours prior to been seeing in the emergency department. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event facial swelling was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2015US017443, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 553068) website on 03 Feb 2015. This report refers to a 49 year old male patient. Historical condition was not reported. Concomitant medications included LAMICTAL, trazodone, naproxen and cyclobenzaprine. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 07 Nov 2014. On the same day after vaccination, he developed rash over his entire body. He was taken to an emergency room where he was given Prednisone. Final outcome of the event was condition unchanged. Event was reported as non-serious. Seriousness assessment of rash over entire body was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Case number PHHY2015US017418, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 553158) website on 03 Feb 2015. This report refers to a 23 year old female patient. Medical history was not reported. Concurrent conditions included asthma and syncope after injection (needle). No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145402) intramuscularly on 11 Nov 2014. At the time of vaccination, she was seated on a chair. On the same day immediately after vaccination, she fainted on the chair (lost her consciousness for approximately for 10 seconds). She came back to consciousness and was fine. The patient was asked to wait for approximately 30 more minutes to make sure that no other event occurs. Final outcome of the event was reported as complete recovery. Event was reported as non-serious. Seriousness assessment of the event faint was upgraded (medically significant) based on the information available in source document. Causality was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysgeusia, Dyspnoea, Eye swelling, Nausea
Clinical narrative: Case number PHHY2015US017482, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553237) website on 03 Feb 2015. This report refers to a 43 years old female patient. Concurrent conditions included hypertension, sleep apnea and anxiety. She had no known drug allergy. Concomitant medication included lisinopril. She was vaccinated with FLUVIRIN (batch number: 14602P) intramuscular into left arm on 12 Nov 2014. On the same day, after vaccination, the patient felt light headedness then had trouble breathing with metallic taste in mouth. Later the patient experienced swelling and pressure in the right eye, then nauseous. The patient went to emergency care due to these events. Final outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of trouble breathing was upgraded based on the information in the source document. Causality assessment was not reported.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular discomfort
Clinical narrative: Case number PHHY2015US017482, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553237) website on 03 Feb 2015. This report refers to a 43 years old female patient. Concurrent conditions included hypertension, sleep apnea and anxiety. She had no known drug allergy. Concomitant medication included lisinopril. She was vaccinated with FLUVIRIN (batch number: 14602P) intramuscular into left arm on 12 Nov 2014. On the same day, after vaccination, the patient felt light headedness then had trouble breathing with metallic taste in mouth. Later the patient experienced swelling and pressure in the right eye, then nauseous. The patient went to emergency care due to these events. Final outcome of the events was unknown. Events were reported as non-serious. Seriousness assessment of trouble breathing was upgraded based on the information in the source document. Causality assessment was not reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Blood immunoglobulin E normal, Injection site erythema, Injection site pruritus, Macule, Radioallergosorbent test negative
Clinical narrative: Case number PHHY2015US017315, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553575) website on 03 Feb 2015. This report refers to a 54-year-old male patient. His medical history included left knee meniscus injury. Current conditions included thalassemia minor, G6PD (glucose-6-phosphate dehydrogenase) deficiency, lumber 4-5 compression issues, degenerative joint disease, enlarged prostate, 2 peptic ulcers, gastroesophageal reflux disease (GERD), sleep apnea, had bronchitis two times and back/knee issues. He uses reading glasses and had multiple environmental and seasonal allergies (dust, pollen, grass, mold, cats and dogs per allergy test as child). Concomitant drugs included FLEXERIL and naproxen for back/knee issues and MVA (unspecified), prostate medication (unspecified) twice, PEPCID for GERD, Multivitamins and Peppermint and Camellia tea when required. He was vaccinated with FLUVIRIN (batch number: 145605) intramuscularly in the left deltoid on 17 Oct 2014. On the same date, approximately 8-12 hours after vaccination he experienced itching and redness at the site. In the evening, he experienced red pimple like macules to his left arm and hand which progressed to his back, sides, chest, right arm/hand, legs and feet. There were no papules, vesicles or involvement at the soles of feet or palms of hands. He denied any fever, nausea, vomiting, headaches, myalgia, arthralgia or any systemic symptoms. He denied any recent illness or exposure and he did not take any new detergents, deodorants, soaps, linen, foods, clothing, etc. He self-treated this reaction with natural element called Candela gel. He had some relief and seeking medical care on 21 Oct 2014. He was diagnosed with allergic urticaria and he was placed on hydrocortisone 1% cream and oral BENADRYL. He showed relief of symptoms. He saw his physician on 27 Oct 2014 and underwent radioallergosorbent test (RAST) to the ingredients of vaccine and resulted in a negative IgE to egg white, egg whole, egg yolk, latex and aminoglycosides. The outcome of the events was reported as recovered. The events reported as non-serious. Seriousness assessment of the events (allergic urticaria) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Case number PHHY2015US017315, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553575) website on 03 Feb 2015. This report refers to a 54-year-old male patient. His medical history included left knee meniscus injury. Current conditions included thalassemia minor, G6PD (glucose-6-phosphate dehydrogenase) deficiency, lumber 4-5 compression issues, degenerative joint disease, enlarged prostate, 2 peptic ulcers, gastroesophageal reflux disease (GERD), sleep apnea, had bronchitis two times and back/knee issues. He uses reading glasses and had multiple environmental and seasonal allergies (dust, pollen, grass, mold, cats and dogs per allergy test as child). Concomitant drugs included FLEXERIL and naproxen for back/knee issues and MVA (unspecified), prostate medication (unspecified) twice, PEPCID for GERD, Multivitamins and Peppermint and Camellia tea when required. He was vaccinated with FLUVIRIN (batch number: 145605) intramuscularly in the left deltoid on 17 Oct 2014. On the same date, approximately 8-12 hours after vaccination he experienced itching and redness at the site. In the evening, he experienced red pimple like macules to his left arm and hand which progressed to his back, sides, chest, right arm/hand, legs and feet. There were no papules, vesicles or involvement at the soles of feet or palms of hands. He denied any fever, nausea, vomiting, headaches, myalgia, arthralgia or any systemic symptoms. He denied any recent illness or exposure and he did not take any new detergents, deodorants, soaps, linen, foods, clothing, etc. He self-treated this reaction with natural element called Candela gel. He had some relief and seeking medical care on 21 Oct 2014. He was diagnosed with allergic urticaria and he was placed on hydrocortisone 1% cream and oral BENADRYL. He showed relief of symptoms. He saw his physician on 27 Oct 2014 and underwent radioallergosorbent test (RAST) to the ingredients of vaccine and resulted in a negative IgE to egg white, egg whole, egg yolk, latex and aminoglycosides. The outcome of the events was reported as recovered. The events reported as non-serious. Seriousness assessment of the events (allergic urticaria) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Case number PHHY2015US017532, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553767) website on 03 Feb 2015. This report refers to a 47-year-old male patient. He denied any kind of illness before vaccination. He was vaccinated with FLUVIRIN (batch number: 146505) intramuscularly in the left arm on 10 Nov 2014. On the same date, after vaccination he experienced severe diaphoresis, dizziness, shortness of breath, nausea and vomiting, chills and rigors. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the event (shortness of breath) was upgraded based on the available information in the source document.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US017532, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553767) website on 03 Feb 2015. This report refers to a 47-year-old male patient. He denied any kind of illness before vaccination. He was vaccinated with FLUVIRIN (batch number: 146505) intramuscularly in the left arm on 10 Nov 2014. On the same date, after vaccination he experienced severe diaphoresis, dizziness, shortness of breath, nausea and vomiting, chills and rigors. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the event (shortness of breath) was upgraded based on the available information in the source document.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2015US031449, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 553873) website on 16 Mar 2015. This report refers to a 62-year-old female patient. Her medical history was not reported. Concomitant medications included CLARITIN and calcium. She was vaccinated with FLUVIRIN (batch number: 1413201) intramuscularly into the right arm on 10 Nov 2014. On 11 Nov 2014, in the morning at approximately at 6:00 AM, the patient experienced rash on face and arms. The patient went to a physician and the patient was started on steroid prednisone for six days. The final outcome of the event was complete recovery. The event was assessed as non-serious. The causality assessment of the event was not reported. Seriousness assessment of event rash was upgraded based on information available in source document.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pruritus, Throat irritation
Clinical narrative: Case number PHHY2015US032514, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 553874) website on 16 Mar 2015. This report refers to a 43-year-old female patient. Her medical history was not reported. The patient was allergic to penicillin and SEPTRA. Concomitant medications included XYZAL and LOESTRIN. She was vaccinated with FLUVIRIN (batch number 1413201) intramuscularly into the left arm 10 Nov 2014. On the same day after vaccination, the patient experienced shortness of breath, itching on arms, legs, torso and throat. At 06.00 PM, the patient was sent to a medical center due to the symptoms. She was treated at medical center with BENADRYL 50ml; BACTRIM once daily intravenously and prednisone 20mg for 6 days. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness assessment of events "shortness of breath itching on arms, legs, torso and throat" were upgraded based on information available in source document.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle rigidity, Posture abnormal, Seizure, Snoring
Clinical narrative: Case number PHHY2015US031209, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554144) website on 16 Mar 2015. This report refers to a 24 year old male patient. Historical conditions and concomitant medications were none. On 17 Nov 2014, he was vaccinated with FLUVIRIN (batch number: 1414201A) into left arm via intramuscular route. On the same date, post vaccination, when the patient was ready to leave, all of a sudden he slumped in chair. His head drooped to left and he snored briefly with his eyes open. His wife assisted him and asked to sit up. The patient struggled, then went rigid and briefly seized. He was brought to emergency room for medical support. Events were assessed as non-serious. The outcome of the events was reported as complete recovery. Causality assessment was not provided. Seriousness assessment for the event convulsion and its symptoms was upgraded as per available information in source document.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: Case number PHHY2015US028210 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554159) website on 05 Mar 2015. This report refers to a 64 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1414201) into left arm on 29 Oct 2014. On 31 Oct 2014, the patient developed diffuse maculopapular rash believed to be hives which was extensively covering the entire body. The patient visited emergency room and was treated with BENADRYL and ALLEGRA which were ineffective. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of hives was upgraded based on information in the source document.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Head discomfort, Hypoaesthesia, Hypoaesthesia oral, Red blood cell sedimentation rate normal
Clinical narrative: Case number PHHY2015US032695, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554330) website on 16 Mar 2015. This report refers to a 55 years old female patient. The patient had a history of suture tape, glue and penicillin allergy. Concurrent condition included psychiatric disorder. Concomitant medications included XANAX, ZYPREXA, QUESTRAN and NEXIUM. She was vaccinated with FLUVIRIN (batch number: 66521011702) into left arm on 30 Oct 2014. On 02 Nov 2014, the patient experienced numbness on both sides of face including lips and cheeks. Further the patient experienced squeezing of left temple in the head and body weakness. The patient consulted doctor and underwent blood work (sedimentation rate was normal). Outcome of the events was condition unchanged. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of numbness on both sides of face including lips and cheeks was upgraded based on information in the source document.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Optic neuritis, Optical coherence tomography, Ultrasound eye, Visual field tests
Clinical narrative: Case number PHHY2015US032588, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554368) website on 16 Mar 2015. This report refers to a 35 year old female patient. Current conditions included pseudotumor cerebri and migraine. Concomitant medications included labetalol and melatonin. On 26 Sep 2014, she was vaccinated with FLUVIRIN (batch number: 1412801) into left arm via intramuscular route. On 14 Nov 2014, 6 weeks after vaccination she developed neuroretinitis left eye. The patient underwent ultrasound eye, visual field test and optical coherence tomography (results not reported). The outcome of the event was unknown. Event was assessed as non-serious. Causality assessment was not provided. Seriousness assessment of event neuroretinitis was upgraded based on information available in the source documents.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye swelling, Rash, Urticaria
Clinical narrative: Case number PHHY2015US033490, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 554479) website on 16 Mar 2015. This report refers to a 39-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with FLUVIRIN (batch number: 14625P) intramuscularly into the left arm on 17 Nov 2014. On the same day about an hour after immunization, the patient broke out in hives all over her body (redness and tiny bumps) and in the following morning the patient woke up with swollen eyes. She had taken BENADRYL. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness of the event "eye swelling and broke out in hives all over body" was upgraded based on the information available in the source document.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Asthenia, Body temperature, Cough, Dyspnoea
Clinical narrative: Case number PHHY2015US032827, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555304) website on 16 Mar 2015. This report refers to a 60-year-old female patient. The patient had a pneumonia shot last year. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 13402P), along with PNEUMOVAX (other manufacturer, batch number: J001180) into the right arm on 10 Nov 2014. On an unknown date after vaccination, the patient developed swollen eyes and lips. Further, the patient had weakness and was not able to walk or get out of bed. The patient arm was red like a beehive from shoulder down to elbow for a week. She had temperature (no further details provided), blurred vision, deep cough, hard to breathe and swollen glands. She was given BENADRYL and antihistamines. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness assessment of the events "swollen eyes and lips and hard to breathe" were upgraded based information available in the source document.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Eye swelling, Lip swelling, Lymphadenopathy, Mobility decreased
Clinical narrative: Case number PHHY2015US032827, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555304) website on 16 Mar 2015. This report refers to a 60-year-old female patient. The patient had a pneumonia shot last year. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 13402P), along with PNEUMOVAX (other manufacturer, batch number: J001180) into the right arm on 10 Nov 2014. On an unknown date after vaccination, the patient developed swollen eyes and lips. Further, the patient had weakness and was not able to walk or get out of bed. The patient arm was red like a beehive from shoulder down to elbow for a week. She had temperature (no further details provided), blurred vision, deep cough, hard to breathe and swollen glands. She was given BENADRYL and antihistamines. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness assessment of the events "swollen eyes and lips and hard to breathe" were upgraded based information available in the source document.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vision blurred
Clinical narrative: Case number PHHY2015US032827, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555304) website on 16 Mar 2015. This report refers to a 60-year-old female patient. The patient had a pneumonia shot last year. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 13402P), along with PNEUMOVAX (other manufacturer, batch number: J001180) into the right arm on 10 Nov 2014. On an unknown date after vaccination, the patient developed swollen eyes and lips. Further, the patient had weakness and was not able to walk or get out of bed. The patient arm was red like a beehive from shoulder down to elbow for a week. She had temperature (no further details provided), blurred vision, deep cough, hard to breathe and swollen glands. She was given BENADRYL and antihistamines. The outcome of the events was complete recovery. The events were assessed as non-serious. The causality assessment of the events was not reported. Seriousness assessment of the events "swollen eyes and lips and hard to breathe" were upgraded based information available in the source document.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Pruritus, Swollen tongue
Clinical narrative: Case number PHHY2015US032127, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 555520) website on 16 Mar 2015. This report refers to a 27 year old male patient. Medical history was not reported. Concurrent condition included allergy to dog dander. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1414101) intramuscularly in left arm on 10 Nov 2014. On the same day after vaccination, he developed bright redness and itching at the arm. He also experienced breathing problems and swelling of tongue. The patient was taken to emergency room for medical support. Final outcome of the events was reported as complete recovery. Events were reported as non-serious. Seriousness assessment of breathing problems and swelling of tongue was upgraded (medically significant) based on the information available in source document. Causality was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspepsia, Eyelid oedema, Respiratory tract congestion
Clinical narrative: Case number PHHY2015US032617, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555997) website on 16 Mar 2015. This report refers to a 52-year-old female patient. Her historical conditions and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: unknown) on 10 Sep 2014. On the same day, approximately at 6:15 pm the patient began feeling heartburn. Approximately at 8:00 to 8:15 pm, she experienced severe congestion and swelling in both eyes and right eye was almost closed with swelling. She was prescribed with BENADRYL which relieved the congestion however eye swelling was not entirely gone until the second morning. Final outcome of the events reported as recovered. Seriousness of the events reported as non-serious. Causality of the events was not reported. Seriousness of the event eye swelling was upgraded based on the information available in the source document.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Vaccination site cellulitis
Clinical narrative: Case number PHHY2015US032594, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 555998) website on 16 Mar 2015 and with follow up information received from the quality assurance department (reference number: 359050) on 23 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 359050) on 17 Apr 2015. This report refers to a 74-year-old female patient. She was allergic to penicillin and codeine derivatives. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1413401) and PNEUMOVAX (other manufacturer and batch number: K010522) both intramuscularly on left arm on 10 Nov 2014. On 11 Nov 2014, the patient developed rash on the injection area and surrounding area including the inner part of the left arm and it was also painful, warm and swollen. The patient went to the physician on 12 Nov 2014 and was diagnosed with cellulitis and was prescribed with CIPRO 500 mg. Final outcome of the events was unknown. Seriousness of the events reported as non-serious. Causality of the events were not reported. Seriousness of the event vaccination site cellulitis and its symptoms was upgraded based on information available in NVS-IME list. Based on the investigation performed, the QA department stated that, FLUVIRIN vaccine (batch number: 1413401) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up information received from the quality assurance department (reference number: 359050) on 23 Mar 2015: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 359050) on 17 Apr 2015: Updated FLUVIRIN vaccine batch review report.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray, Drug screen, Fatigue, Full blood count, Seizure
Clinical narrative: Case number PHHY2015US033901, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556238) website on 16 Mar 2015. This report refers to an 10-year-old male patient. Medical history and concomitant medications were not reported. On 29 Nov 2014, he was vaccinated with FLUVIRIN (batch number: 145225) into left arm intramuscularly. On same day about 3-5 minutes after vaccination, he experienced seizure which lasted for about 30 seconds. No EPIPEN was required. The patient was lucid (was able to tell location and time). Further about 1 minute later, he was tired. Due to this patient was taken to ER. After the hospital observations, he was discharged on the same night. On 01 Dec 2014, his hospitalization details were reviewed and it was found that he had undergone urine analysis, CBC, drug test, and chest X-ray (results not provided). Outcome of the events reported as complete recovery. The events were assessed as non-serious. Causality of the events was not reported. Seriousness assessment of the event seizure was upgraded based on information available in the source documents.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: Case number PHHY2015US033901, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556238) website on 16 Mar 2015. This report refers to an 10-year-old male patient. Medical history and concomitant medications were not reported. On 29 Nov 2014, he was vaccinated with FLUVIRIN (batch number: 145225) into left arm intramuscularly. On same day about 3-5 minutes after vaccination, he experienced seizure which lasted for about 30 seconds. No EPIPEN was required. The patient was lucid (was able to tell location and time). Further about 1 minute later, he was tired. Due to this patient was taken to ER. After the hospital observations, he was discharged on the same night. On 01 Dec 2014, his hospitalization details were reviewed and it was found that he had undergone urine analysis, CBC, drug test, and chest X-ray (results not provided). Outcome of the events reported as complete recovery. The events were assessed as non-serious. Causality of the events was not reported. Seriousness assessment of the event seizure was upgraded based on information available in the source documents.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Dyspnoea, Headache, Injection site bruising, Injection site nodule
Clinical narrative: Case number PHHY2015US033362, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556252) website on 16 Mar 2015, with the follow-up information received from Quality Assurance Department on 25 Mar 2015. This report refers to a 61-year-old female patient. Medical history and concomitant medications were not reported. On 21 Nov 2014, she was vaccinated with FLUVIRIN (batch number: unknown) into left arm intramuscularly and PNEUMOVAX (other manufacturer, batch number 14575P) into right arm intramuscularly. On same day after vaccinations, she experienced lemon size bruising and knot at injection site of left arm. She also experienced breathing difficulties, cough and headache. The patient visited the emergency room. The patient was treated with Z-PAK and Albuterol. Outcome of the events was unknown. The events were assessed as non-serious. Causality of the events was not reported. Seriousness assessment of dyspnoea was upgraded based on the available information in the source document. Upon follow-up from QA department, it was stated that reported FLUVIRIN batch number: K004487 is not a valid batch number and batch investigation would not be performed. Follow-up information received from Quality Assurance Department on 25 Mar 2015: Updated QA comments (batch investigation would not be performed).
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Pruritus, Rash generalised
Clinical narrative: Case number PHHY2015US033380, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556711) website on 16 Mar 2015. This report refers to a 60 year old male patient. Historical conditions and concomitant medications were none.  On 26 Nov 2014, he was vaccinated with FLUVIRIN (batch number: 146505) via intramuscular route into left arm. On 27 Nov 2014, about one and a half day after vaccination, he experienced a generalized rash over entire body accompanied by non-severe itching and his eyes became bloodshot. On 03 Dec 2014, the rash was fading and itching had subsided. Eyes remain somewhat reddened. He did not seek any medical help. The outcome of the events was unknown. Events reported as non-serious. Causality assessment was not provided. Seriousness assessment of ocular hyperaemia, pruritic and rash generalized upgraded (medically significant) based on information available in the source documents.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Case number PHHY2015US033380, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556711) website on 16 Mar 2015. This report refers to a 60 year old male patient. Historical conditions and concomitant medications were none.  On 26 Nov 2014, he was vaccinated with FLUVIRIN (batch number: 146505) via intramuscular route into left arm. On 27 Nov 2014, about one and a half day after vaccination, he experienced a generalized rash over entire body accompanied by non-severe itching and his eyes became bloodshot. On 03 Dec 2014, the rash was fading and itching had subsided. Eyes remain somewhat reddened. He did not seek any medical help. The outcome of the events was unknown. Events reported as non-serious. Causality assessment was not provided. Seriousness assessment of ocular hyperaemia, pruritic and rash generalized upgraded (medically significant) based on information available in the source documents.
Age: 69.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Blood test, Electrocardiogram, Guillain-Barre syndrome, X-ray
Clinical narrative: Case number PHHY2015US032108, is an initial spontaneous from a consumer (also patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 556867) website received on 16 Mar 2015. This report refers to a 69-years-old male patient. Historical conditions were not reported. Concomitant medication included atenolol, CRESTOR, low-dose Aspirin and vitamin (details unspecified). Vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) and experienced tingling in body (see case: PHHY2015US032133). The patient was vaccinated with FLUVIRIN (batch number: 14515P) into left arm intramuscularly on 22 Oct 2014. On 29 Oct 2014, the patient experienced Guillain-Barre Syndrome. The patient went to emergency room and was hospitalized for one day. The patient saw his family doctor, cardiologist and neurologist. The patient underwent EKG (electrocardiogram), X-ray and blood work but the results were not reported. The outcome of the event was condition unchanged. The causality of the event was not reported.
Age: 69.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Paraesthesia
Clinical narrative: Case number PHHY2015US032108, is an initial spontaneous from a consumer (also patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 556867) website received on 16 Mar 2015. This report refers to a 69-years-old male patient. Historical conditions were not reported. Concomitant medication included atenolol, CRESTOR, low-dose Aspirin and vitamin (details unspecified). Vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) and experienced tingling in body (see case: PHHY2015US032133). The patient was vaccinated with FLUVIRIN (batch number: 14515P) into left arm intramuscularly on 22 Oct 2014. On 29 Oct 2014, the patient experienced Guillain-Barre Syndrome. The patient went to emergency room and was hospitalized for one day. The patient saw his family doctor, cardiologist and neurologist. The patient underwent EKG (electrocardiogram), X-ray and blood work but the results were not reported. The outcome of the event was condition unchanged. The causality of the event was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Rash, Throat irritation
Clinical narrative: Case number PHHY2015US032014, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS Reference number: 557201) website on 16 Mar 2015. This report refers to a 47 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412701) intramuscularly into left arm on 04 Dec 2014. Post vaccination she experienced difficulty breathing in the middle of the night and discovered a rash on trunk upon waking up next morning. Further she had a feeling of a rash in throat and throat pain. She was unable to get to the doctor but was cautioned to go to the emergency room if she experienced difficulty breathing again. Outcome of the events was unknown. The events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of difficulty breathing was upgraded based on information in the source document.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Throat tightness
Clinical narrative: Case number PHHY2015US032026, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557225) website on 16 Mar 2015. This report refers to a 40 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly into left arm on 17 Sep 2014. On the same day, after vaccination, the patient felt constriction in airway and tongue swelling. The patient took 4 doses of BENADRYL 25 mg and went to ER where she was given an epinephrine injection and steroids. Outcome of the events was recovered. The events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of constriction in airway and tongue swelling was upgraded based on information in the source document.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Hypersensitivity, Lip swelling, Paraesthesia, Urticaria
Clinical narrative: Case number PHHY2015US032027, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557284) website on 16 Mar 2015. This report refers to a 60 years old male patient. Medical history included insertion of 2 stents. Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1413801) intramuscularly and ZOSTAVAX (batch number: K010467, other manufacturer) subcutaneously; both into left arm on 06 Dec 2014. On the same day, at 05:00 PM, 7 hours after vaccination, the patient reported allergic reaction consisting of hives on head, swollen lips, and tingling in hands. The patient was treated with 2 tablets of BENADRYL as instructed. Outcome of the events was improving. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of allergic reaction was upgraded based on information in the source document.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHHY2015US033864, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557515) website on 16 Mar 2015. This report refers to a 12 year old female patient. Historical conditions and concomitant medications were none. On 02 Dec 2014, she was vaccinated with FLUVIRIN (batch number: 1414001) into right arm. On 03 Dec 2014, around 10.00 am, the patient woke up with rash from head to toe. In response to the event, her mother started treatment with BENADRYL, CLARITIN and ZANTAC. Event outcome reported as complete recovery. Event was reported as non-serious. Causality assessment was not provided. Seriousness assessment of rash generalised was upgraded (medically significant) based on information available in the source documents.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Guillain-Barre syndrome, Hypoaesthesia, Plasmapheresis
Clinical narrative: Case number PHHY2015US032184 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 557895) on 16 Mar 2015. This report refers to a 67 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 141200) on 05 Sep 2014. On 08 Sep 2014, he was unable to walk and his feet were numb. The numbness then moved upward and he was diagnosed with Guillain-Barre syndrome. It was reported that numbness rose to midsection. He was hospitalized for 30 days and underwent plasma exchange 5 times. The events outcome was reported as condition unchanged. The events were reported as serious. The causality of the events was not reported.