chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Rash
Clinical narrative: Case number PHHY2015US018063, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549281) website on 03 Feb 2015. This report refers to a 65 year old patient of unknown gender. Historical drug included clarithromycin. Concomitant medication included CRESTOR; lisinopril; PLAVIX and metoprolol. On 08 Oct 2014, patient was vaccinated with FLUVIRIN (batch number: unknown) and PNEUMOVAX (batch number: unknown, other manufacturer). On the same day post vaccination the patient developed great soreness at the injection site for 48 hours and significant rash on chest, stomach and arms for 72 hours. Final outcome of the events was recovered. Causality assessment was not reported. Events were reported as non-serious. Seriousness assessment of rash was upgraded based on information available in the source documents.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling, Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2015US014128, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549384) on 03 Feb 2015. This report refers to a 37 years old female patient. Concurrent condition included peanut allergy. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413101) intramuscularly on 23 Oct 2014. On the same day, after vaccination, she experienced hives, severe itching all over, difficulty breathing and felt like lips were swelling. She went to emergency room due to these events. The case was assessed as non-serious. Seriousness assessment of hives, itching all over, difficulty breathing, lips swelling was upgraded based on information in the source document. The outcome and causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Case number PHHY2015US015264, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549462) website on 03 Feb 2015. This report refers to a 29 years old female patient. She had no illnesses and allergies at the time of vaccination. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145223) intramuscularly into left arm on 16 Sep 2014. On 18 Sep 2014, she experienced tiny red spots and hives from neck to upper legs with no itching or other symptoms. She took BENADRYL and ATARAX as prescribed by physician which relieved symptoms. The red spots and hives returned on discontinuation of ATARAX after 1 month. Outcome of the events was recovered. The case was assessed as non-serious. Seriousness assessment of urticaria generalised was upgraded based on information in the source documents. She was currently evaluated by physician for other causes indicating that the events may not be due to vaccine.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Heart rate increased, Pharyngeal oedema
Clinical narrative: Case number PHHY2014US171133 is an initial spontaneous report received from a healthcare professional via the Vaccine Adverse Event Reporting System (VAERS ID: 549613) website on 29 Dec 2014. This report refers to a 57 year old male patient. His past medical history and concomitant medications were not reported. On 09 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 1412501) into his left arm. On the same day after the vaccination, he had swelling of throat and was flushed. His heart rate was 80 and he had no problems breathing with no wheezing. He was treated with EPIPEN at a dose of 0.30 mg into his left outer thigh at 01:03 PM. The patient already took BENADRYL and CLARITIN. Emergency medical services (EMS) arrived and he was recommended to visit a physician or emergency department. The patient refused EMS ride. The outcome of the events was complete recovery. The events were reported as non serious but the seriousness of swelling of throat and flushing was upgraded based on the information available in the source documents. Causality of the events was not reported.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypertension, Nervousness, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US015242, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549922) website on 03 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 351523) on 13 Mar 2015. This report refers to a 33-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 1410901) intramuscularly in the right arm on 25 Sep 2014. On the same date, at approximately 02:00 pm, she returned to the flu clinic and stated that she had hives at two small areas, one behind her left ear and one on her right jaw line. She was itching and her chest was a little tight. she took one BENADRYL pill at approximately 1:30 pm with no relief. She received 0.5 mL of epinephrine by intramuscular route in her left deltoid. Her blood pressure (BP) at 2:03 pm was 112/80 and pulse was 80. Her vitals at 2:15 pm were: BP 114/74 and pulse as 78. She opted not to have a second injection of epinephrine, as she felt a little better, but just shaky. She refused for any further medical care and left shortly. Her last vital signs were reported as BP 155/92, HR 60 and oxygen at 100%. The outcome of the events reported as recovered. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the events (chest tightness) was upgraded based on the available information in the source document. Based on the investigation performed, the QA department stated that, FLUVRIN vaccine (batch number: 1410901) 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: 351523) on 13 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Muscular weakness, Nuclear magnetic resonance imaging normal, Pain in extremity
Clinical narrative: Case number PHHY2015US013439, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550009) on 03 Feb 2015. This report refers to a 30 years old female patient. Concurrent conditions included hypothyroidism. Concomitant medications included SYNTHROID and CYMBALTA. On 08 Oct 2014, the patient was vaccinated with FLUVIRIN (batch number: 1451) intramuscularly into right. On 21 Oct 2014, the patient experienced pain in thigh and muscle weakness of lower extremities. The patient was admitted to hospital with presumed Guillain Barre Syndrome. The electromyogram (EMG) indicated abnormal studies with suggestive of Guillain Barre Syndrome. No progression of symptoms was reported. The patient was treated with prednisone. The case was assessed as serious (hospitalization). Outcome and causality of the events was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Pharyngeal oedema
Clinical narrative: Case number PHHY2015US013435, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550012) website on 03 Feb 2015. This report refers to a 36-year-old female patient. Current condition included food allergies to fresh vegetables and fruits. On 24 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1412601) intramuscularly in the right arm. On the same date, after vaccination she experienced swelling of airway and difficulty breathing. The outcome of the events reported as recovered. The events reported as serious (life-threatening). The causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oral mucosal blistering, Pharyngeal oedema, Urticaria
Clinical narrative: Case number PHHY2015US015320, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 550021) website on 03 Feb 2015. This report refers to a 29 year old female patient. Medical history was not reported. Concurrent conditions included clostridium difficile colitis. Concomitant medication included vancomycin. She was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly in right arm on 24 Oct 2014. On the same day (after vaccination), she experienced hives, swollen lips, swollen throat and blisters in mouth. She was taken to an emergency room at 07:15 hour. Treatment was rendered with BENADRYL and MEDROL injection. Final outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of swollen lips and swollen throat was upgraded based on the information available in the source document. Causality was not reported.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Erythema, Sinusitis, Swelling face
Clinical narrative: Case number PHHY2015US015265, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550273) website on 03 Feb 2015. This report refers to a 69 years old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1413801) intramuscularly into left arm on 07 Oct 2014. On the same day, within 12 hours of receiving vaccine, he experienced swelling and redness in left side of face and resulted in sinus infection. His skin was red and blistered on forehead. He went to emergency room due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Seriousness assessment of swelling of face was upgraded based on information in the source document. Causality of the events was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Pruritus, Vision blurred
Clinical narrative: Case number PHHY2015US015266, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550280) website on 03 Feb 2015. This report refers to a 32 years old female patient. Her concurrent condition included multiple allergies. Concomitant medication included "desmothaine acetate". She was vaccinated with FLUVIRIN (batch number: 1412001) intramuscularly on 17 Oct 2014. About 30 seconds after receiving vaccination, she experienced blurred vision, anxiety, increased heart rate then facial itching and some shortness of breath. She was treated with BENADRYL and TYLENOL.  Outcome of the events was recovered. The case was assessed as non-serious. Seriousness assessment of shortness of breath was upgraded based on information in the source document. Causality of the events was not reported.
Age: 36.0
Sex: U
Vaccine: FLU3
Symptoms: Condition aggravated, Seizure
Clinical narrative: Case number PHHY2015US015267, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550281) website on 03 Feb 2015. This report refers to a 36 years old patient of an unknown gender. Concurrent condition included seizure disorder. Concomitant medications included DEPAKOTE and lorazepam. The patient was vaccinated with FLUVIRIN (batch number: 145203) intramuscularly into left arm on 26 Oct 2014. On the same day, after vaccination, the patient had a seizure. Outcome of the event was recovered. The case was assessed as non-serious. Seriousness assessment of seizure was upgraded based on the NVS-IMS list. Causality of the event was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Case number PHHY2015US015966, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550328) website on 03 Feb 2015. This report refers 53-year-old female patient. Concomitant drugs included bupropion and fluoxetine. She was vaccinated with FLUVIRIN (batch number: 145404) intramuscularly in the right arm on 18 Oct 2014. On the same date, 3 hours after vaccination she experienced facial swelling around the left side by the eye area. There was no swelling at the site of the injection. The events started to get down and she felt better. The outcome of the event reported as recovered. The event reported as non-serious. The causality of the event was not reported. Seriousness assessment of the event (facial swelling) was upgraded based on the available information in the source document.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Swelling, Urticaria
Clinical narrative: Case number PHHY2015US013366 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 550367) on 03 Feb 2015. This report refers to a 31 years old male patient. His current condition included allergy to penicillin. His concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: Q2037) intramuscularly in the right arm on 24 Oct 2014. On 24 Oct 2014, he had extreme soreness in shoulder and arm where the shot was administered. It was reported that hives broke out in his arms, legs and back. He took ZYRTEC 10 mg as a histamine blocker to treat hives overnight. The events got worse and covered his entire body within 24 hours. He took BENADRYL 25 mg which reduced the swelling of the hives significantly. The outcome of hives was reported as condition improving and that of soreness in shoulder and arm where shot was administered was unknown. The events were reported as life threatening. The causality of the events was not reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Case number PHHY2015US016324 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550412) on 03 Feb 2015. This report refers to a 55 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 24 Oct 2014 approximately at 8:00 pm. On 25 Oct 2014, he woke up at 1:00 am with swollen cheek. He took aspirin at 3:00 am. He reported the event on 27 Oct 2014. The events outcome was unknown. The events were reported as non-serious, but the event cheek swelling was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Lip swelling
Clinical narrative: Case number PHHY2015US031623, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550490) website on 16 Mar 2015. This report refers to a 88-year-old female patient. Her historical conditions and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1412701) on 09 Oct 2014. On 10 Oct 2014, within 8 to 12 hrs of injection the patient's lips were swollen and her arm/injection site became red/tender. Final outcome of the events was unknown. Seriousness of the events reported as non-serious. Causality of the events was not reported. Seriousness of the event lip swelling was upgraded based on information available in the source document.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Case number PHHY2015US016779, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550527) website on 03 Feb 2015. This report refers to a 65-year-old female patient. Concurrent conditions included chronic obstructive pulmonary disease (COPD). Concomitant medications were none. She was vaccinated with FLUVIRIN (batch number: 145302) into the left arm, along with PNEUMOVAX (batch number: K009105) into the right arm intramuscularly on 06 Oct 2014. On the same day after vaccination, the patient experienced trouble breathing and rash that extended around the arm. It was reported that the trouble breathing may be associated with COPD. Further, the site of PNEUMOVAX injection was swollen, red and sore. The patient was advised to take antihistamines. The final outcome of the events was unknown. The events were reported as non-serious. the event 'trouble breathing' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Eyelid ptosis, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US016780, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550598) website on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 353027) on 19 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 353027) on 21 Mar 2015. This report refers to a 55-year-old female patient. Past medical history was none. The patient was fine at the time of vaccination. She was vaccinated with FLUVIRIN (batch number: 14585P) into the right arm, along with ZOSTAVAX (batch number: not reported) on 24 Oct 2014. On 26 Oct 2014, the patient's eyes and face appeared to be drooping which was noticed by the people she was working with. On 28 Oct 2014, the patient went to a physician and she was given a diagnosis of Bell's palsy. It was reported that on 26 Oct 2014, the patient had a prescription filled and the patient began to take the medications (no further details provided). The patient was not taking prescription filled medications at the time of vaccination. So the patient may be on medications that the reporter was unaware of as it was the first visit of the patient to the store. The final outcome of the event was unknown. The event was reported as non-serious. The event 'Bell's palsy' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 14585P) 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 (QA reference number: 353027) on 19 Feb 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 353027) on 21 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pharyngeal erythema, Pharyngeal oedema, Swelling face
Clinical narrative: Case number PHHY2014US170554, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550622) website on 29 Dec 2014. This report refers to a 44-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into left arm on 26 Sep 2014. On 27 Sep 2014, the patient experienced swelling and redness of face and throat. The patient went to emergency room due to these events. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of swelling of throat was upgraded based on the NVS-IMS list; swelling of face, redness of face and throat was upgraded based on information in the source document.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Headache, Migraine, Rash
Clinical narrative: Case number PHHY2014US170594, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550630) website on 29 Dec 2014. This report refers to a 48-year-old female patient. Concurrent condition included allergic to PROVERA. Concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 145201) intramuscularly into left arm on 28 Aug 2014. On 30 Aug 2014, the patient experienced shortness of breath, rashes, migraine and headache. Outcome of the events was recovered. The case was assessed as non-serious. Seriousness assessment of shortness of breath was upgraded based on information in the source document.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Case number PHHY2014US170604, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550689) website on 29 Dec 2014. This report refers to a 64-year-old male patient. Concurrent condition included chronic obstructive pulmonary disease (COPD). Concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 145404) along with PNEUMOVAX (batch number: K006681, other manufacturer) intramuscularly into right arm on 13 Oct 2014. On the same day, after vaccination, the patient experienced dizziness and shortness of breath which resolved in 20 minutes. Shortness of breath was treated with salbutamol. Final outcome of the events was recovered. The case was assessed as non-serious. Seriousness assessment of shortness of breath was upgraded based on information in the source document.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Dyspnoea, Rash
Clinical narrative: Case number PHHY2015US016787, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550711) website on 03 Feb 2015. This report refers to a 48-year-old female patient. Medical History was not reported. Concurrent conditions included asthma and sulfa allergy. Concomitant medications included fluticasone, methylphenidate, valacyclovir and fluoxetine. She was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly into the left arm on 28 Oct 2014. On the same day after vaccination, she experienced rash on the left arm and had slight trouble breathing described as similar to her asthma. The final outcome of the events was recovered. The events were reported as non-serious. The event 'trouble breathing' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal discomfort, Throat irritation, Throat tightness
Clinical narrative: Case number PHHY2015US015785, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 550969) website on 03 Feb 2015. This report refers to a 24 years old female patient. Medical history and concomitant medications were not reported. On 24 Oct 2014, she was vaccinated with FLUVIRIN (batch number: 1411501) intramuscularly into right arm. On the same day, after vaccination, she presented with some discomfort and a tickle in the back of her throat. She was told to wait another 10 minutes. Approximately 5 minutes later she stated that she felt like the back of her throat was closing. The nurse noticed that while she was talking she seemed short of breath. Epinephrine was administered and emergency was called. The hospital was directly next door to the facility, so they were there quickly and gave patient IV BENADRYL and took her to hospital. Final outcome of the events was unknown. The case was assessed as non-serious. Seriousness assessment of short of breath and throat closing was upgraded based on information in the source document. Causality of the events was not reported.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Guillain-Barre syndrome
Clinical narrative: Case number PHHY2015US016871 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 550985) on 03 Feb 2015. This report refers to a 41 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1410801) intramuscularly on 21 Oct 2014. On 21 Oct 2014, he felt tired and weak. The events were getting worse and he did not have energy to hold things. He waited for 3 to 4 days and then went to emergency room. He saw a doctor and was informed by the physician in Oct 2014 that he had Guillain Barre Syndrome (GBS). The outcome of the event was reported as recovering. The events were reported as non-serious, but the event GBS was upgraded as medically significant based on the information available in the NVS-IME list. The causality of the events was not reported.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Case number PHHY2015US016883 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551069) on 03 Feb 2015. This report refers to a 28 years old male patient. His medical history was not reported. His current condition included upper respiratory infection (URI). His concomitant medications included DAYQUIL. He was vaccinated with FLUVIRIN (batch number: 161207) intramuscularly in the right arm on 29 Oct 2014. On 29 Oct 2014, immediately after vaccination, he had syncope episode. He became alert in seconds and was laid on floor for 10 minutes and he was attended by 4 nurses. His blood pressure was within normal limits and oxygen at 8 L was administered. He was dizzy and fainted upon sitting. Emergency Medical Services (EMS) was called when he had second syncope episode and he was transferred to the emergency room of hospital. The events outcome of syncope (second episode) and dizziness was unknown. The events were reported as non-serious, but the event syncope was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Eye irritation, Hypoaesthesia
Clinical narrative: Case number PHHY2015US015362, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551156) website on 03 Feb 2015. This report refers to a 52 years old male patient. He had no medical history and concurrent conditions at the time of vaccination. Concomitant medications were not reported. On 24 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 146403) intramuscularly into right arm. On 25 Oct 2014, he woke up with left-sided facial numbness and eye irritation. He went to emergency room due to these events. The computerized tomogram (CT scan) performed indicated negative results. Outcome of the events was recovered. The case was assessed as non-serious. Seriousness assessment of facial numbness was upgraded based on information in the source document. Causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat irritation
Clinical narrative: Case number PHHY2015US016906 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551243) on 03 Feb 2015. This report refers to a 49 years old female patient. Her current condition included seasonal allergies. Her concomitant medications included an unspecified over the counter (OTC) allergy medication used for treatment of seasonal allergies. She was vaccinated with FLUVIRIN (batch number: 1414201A) intramuscularly in the right arm on 29 Oct 2014. On 29 Oct 2014, she had scratchy throat and she experienced shortness of breath (SOB). She was given 0.5 ml epinephrine intramuscularly. The events outcome was reported as complete recovery. the events were reported as non-serious, but the events SOB and throat irritation were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Chills, Dizziness, Dyspnoea, Erythema
Clinical narrative: Case number PHHY2015US016943 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551262) on 03 Feb 2015. This report refers to a 47 years old female patient. Her medical history and concomitant were not reported. She was vaccinated with FLUVIRIN (batch number: 14582P) intramuscularly in the right arm on 22 Oct 2014 in the afternoon. On 22 Oct 2014 afternoon after vaccination, she felt tired. The events moved slow with gradual worsening and peaked around 6 pm with intermittent headache which was graded as 4/10, lightheadedness, ear ringing, red ears and eyes and low pulse. Her blood pressure (BP) was fine. Her throat had a tingling feeling around 8 pm on the same day and she had difficulty in breathing that lasted for 1 to 2 minutes. She felt as though she might pass out. At 9 pm she had cold chills. She could not sleep and her arm was sore for a day. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event difficulty breathing was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Heart rate decreased, Insomnia, Ocular hyperaemia
Clinical narrative: Case number PHHY2015US016943 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551262) on 03 Feb 2015. This report refers to a 47 years old female patient. Her medical history and concomitant were not reported. She was vaccinated with FLUVIRIN (batch number: 14582P) intramuscularly in the right arm on 22 Oct 2014 in the afternoon. On 22 Oct 2014 afternoon after vaccination, she felt tired. The events moved slow with gradual worsening and peaked around 6 pm with intermittent headache which was graded as 4/10, lightheadedness, ear ringing, red ears and eyes and low pulse. Her blood pressure (BP) was fine. Her throat had a tingling feeling around 8 pm on the same day and she had difficulty in breathing that lasted for 1 to 2 minutes. She felt as though she might pass out. At 9 pm she had cold chills. She could not sleep and her arm was sore for a day. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event difficulty breathing was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pharyngeal paraesthesia, Tinnitus
Clinical narrative: Case number PHHY2015US016943 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551262) on 03 Feb 2015. This report refers to a 47 years old female patient. Her medical history and concomitant were not reported. She was vaccinated with FLUVIRIN (batch number: 14582P) intramuscularly in the right arm on 22 Oct 2014 in the afternoon. On 22 Oct 2014 afternoon after vaccination, she felt tired. The events moved slow with gradual worsening and peaked around 6 pm with intermittent headache which was graded as 4/10, lightheadedness, ear ringing, red ears and eyes and low pulse. Her blood pressure (BP) was fine. Her throat had a tingling feeling around 8 pm on the same day and she had difficulty in breathing that lasted for 1 to 2 minutes. She felt as though she might pass out. At 9 pm she had cold chills. She could not sleep and her arm was sore for a day. The events outcome was reported as complete recovery. The events were reported as non-serious, but the event difficulty breathing was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 63.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Pruritus, Rash generalised
Clinical narrative: Case number PHHY2015US016984, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 551364) website on 03 Feb 2015. This report refers to a 63 year old male patient. Historical condition and concomitant medication were not reported. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 1413601) in right arm, PNEUMOVAX (other manufacturer, batch number: K005797) in left arm and ADACEL (other manufacturer, batch number: C4565AA) in left arm on 20 Oct 2014. On the same day about 2 hours after vaccination, the patient began to develop itching and rash down his arm. On 21 Oct 2014 (one day after vaccination), the rash spread all over his body. He took BENADRYL which did not help. The patient denied any other symptoms such as difficulty breathing or swelling of the tongue/airway. He went to a physician who gave him DEPO-MEDROL. His rash started to clear up within 20 minutes. He also started taking MEDROL. On 22 Oct 2014 (two days after vaccination), the rash was clear and he had no complaints. Final outcome of the events was complete recovery. Events were reported as non-serious. Seriousness assessment of rash all over his body was upgraded (medically significant) based on the information available in source document. Causality was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oropharyngeal pain, Pruritus, Rash, Throat irritation
Clinical narrative: Case number PHHY2015US017359, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 551509) website on 03 Feb 2015. This report refers to a 66 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1414101) intramuscularly in left arm on 31 Oct 2014. On the same day (approximately 2 hours after vaccination), she experienced scratchy arms/body and rash. Approximately 3 hours after vaccination, she experienced shortness of breath (SOB). She also developed scratchy throat and sore throat. The patient denied swelling. Final outcome of the events was unknown. Events were reports as non-serious. Seriousness assessment of shortness of breath and scratchy arms/body was upgraded (medically significant) based on the information available in the source document. Causality was not reported.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood test, Chest X-ray, Computerised tomogram, Eye pain
Clinical narrative: Case number PHHY2015US014195 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551590) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 350953) on 10 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350953) on 11 Mar 2015. This report refers to a 32 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1414101) intramuscularly on 28 Oct 2014. Four hours after vaccination, on 29 Oct 2014 he had numbness in tongue. 48 hours later he had paralysis in whole right face, pain in eyes, mouth and head, loss of movement in closing eye and body weakness. He also had headaches. He went to emergency room and was placed on steroids. He had blood tests and chest X-ray. He also underwent computerised tomogram (CAT) scan, nuclear magnetic resonance imaging (MRI) for testing for Guillain Barre syndrome (GBS) or Bell's palsy. The outcome of event reported condition unchanged. The event was reported as disabling. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1414101) 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 (QA reference number: 350953) on 10 Feb 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 350953) on 11 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Eyelid function disorder, Headache, Hypoaesthesia oral, Nuclear magnetic resonance imaging, Oral pain
Clinical narrative: Case number PHHY2015US014195 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551590) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 350953) on 10 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350953) on 11 Mar 2015. This report refers to a 32 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1414101) intramuscularly on 28 Oct 2014. Four hours after vaccination, on 29 Oct 2014 he had numbness in tongue. 48 hours later he had paralysis in whole right face, pain in eyes, mouth and head, loss of movement in closing eye and body weakness. He also had headaches. He went to emergency room and was placed on steroids. He had blood tests and chest X-ray. He also underwent computerised tomogram (CAT) scan, nuclear magnetic resonance imaging (MRI) for testing for Guillain Barre syndrome (GBS) or Bell's palsy. The outcome of event reported condition unchanged. The event was reported as disabling. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1414101) 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 (QA reference number: 350953) on 10 Feb 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 350953) on 11 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US014195 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 551590) on 03 Feb 2015 and with follow up information received from the quality assurance department (QA reference number: 350953) on 10 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 350953) on 11 Mar 2015. This report refers to a 32 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1414101) intramuscularly on 28 Oct 2014. Four hours after vaccination, on 29 Oct 2014 he had numbness in tongue. 48 hours later he had paralysis in whole right face, pain in eyes, mouth and head, loss of movement in closing eye and body weakness. He also had headaches. He went to emergency room and was placed on steroids. He had blood tests and chest X-ray. He also underwent computerised tomogram (CAT) scan, nuclear magnetic resonance imaging (MRI) for testing for Guillain Barre syndrome (GBS) or Bell's palsy. The outcome of event reported condition unchanged. The event was reported as disabling. The causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1414101) 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 (QA reference number: 350953) on 10 Feb 2015: Updated QA reference number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 350953) on 11 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Electroneuromyography, Guillain-Barre syndrome, Laboratory test abnormal, Muscular weakness
Clinical narrative: Case number PHHY2015US013990, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 551686) website on 03 Feb 2015. The report refers to a 70-year-old male patient. He had no known allergies and no significant medical conditions. On 18 Sep 2014, he was vaccinated with FLUVIRIN (batch number: 1413601) intramuscularly. On 02 Oct 2014, he experienced lower and upper extremity weakness and dizziness. Upon electro-diagnostic testing it was diagnosed as inflammatory demyelinating poly neuropathy/ Guillain Barre Syndrome. He was hospitalized for 7 days. The outcome of the events was unknown. The causality of the events was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Case number PHHY2015US014293, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552070) website on 03 Feb 2015. This report refers to a 57-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 146501) in the left arm on 10 Oct 2014. On the same date, few hours after vaccination she experienced hives and then had trouble breathing. She went to hospital and got admitted for an unknown duration. The outcome of the events reported as recovered. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHHY2015US014126, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 552071) website on 03 Feb 2015. This report refers to a 41 year old female patient. Her medical history was not reported. Concurrent condition included soreness (no further details given). No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 146305) in left arm on 14 Oct 2014. On the same day, the patient experienced pain at time of vaccination. Since then, the pain became progressively worse. She went to emergency room to see an MD who gave antibiotic. The primary care physician also ordered a nuclear magnetic resonance imaging (MRI). Final outcome of the event was unknown. The event was reported as serious (permanent disability). Causality was not reported.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Case number PHHY2015US014173, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 552251) website on 03 Feb 2015. This report refers to a 67 year old female patient. Medical history included high blood pressure. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 1413201) intramuscularly in left arm on 05 Nov 2014. It was reported that the patient was fasting (did not have breakfast) at the time of vaccination as she was going to do a blood test. On the same day (after vaccination), the patient experienced seizure at a restaurant. The patient was hospitalized for the event. Final outcome of the event was unknown. Causality was not reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Pain, Peripheral swelling
Clinical narrative: Case number PHHY2015US017682, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552339) website on 03 Feb 2015. This report refers to a 36-year-old female patient. She was vaccinated with FLUVIRIN (batch number: not reported) on 30 Oct 2014. On the same date, after vaccination she experienced swelling of left arm up to upper shoulder above clavicle, pain, dizziness, loss of appetite and shortness of breath. She visited the emergency room. 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: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging brain, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US017734, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552498) website on 03 Feb 2015, and with a follow-up information received from Quality Assurance Department (reference number: 353136) on 20 Feb 2015, with the follow-up information received from Quality Assurance Department (reference number: 353136) on 21 Mar 2015. This report refers to a 80-year-old female patient. Medical history included chronic myeloid leukaemia (CML), colon cancer, aortic and mitral valve replacement. The patient had no acute illness. Concomitant medications included Aspirin, BYSTOLIC, CRESTOR and SPRYCEL, vitamin D and COQ 10. She was vaccinated with FLUVIRIN (batch number: 1411901) intramuscularly on 30 Oct 2014. On 31 Oct 2014, the patient experienced right facial palsy consistent with Bell's palsy. The patient underwent nuclear magnetic resonance imaging of brain (no results reported). The final outcome of the event was not reported. The event was reported as non-serious. The event 'right facial palsy consistent with Bell's palsy' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 1411901) 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: 353136) on 20 Feb 2015: Updated QA number. Non-significant follow-up information received from the Quality Assurance Department (reference number: 353136) on 21 Mar 2015: Updated FLUVIRIN vaccine batch review report.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Case number PHHY2015US016845, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 552561) website on 03 Feb 2015. This report refers to a 20 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1414001) intramuscularly into left arm on 01 Nov 2014. On the same day, 30 minutes after vaccination, she experienced swelling of tongue. She went to urgent care and treated with short course of steroids and swelling resolved. Outcome of the event was recovered. The case was assessed as non-serious. Seriousness assessment of swelling of tongue was upgraded based on information in the source document. Causality of the event was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Case number PHHY2015US014216, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 552666) website on 03 Feb 2015. This report refers to a 29 year old female patient. Historical condition and concomitant medication were unknown. The patient was vaccinated with FLUVIRIN (batch number: 142905) and PNEUMOVAX (other manufacturer, batch number: K007826) both intramuscularly in left arm on 09 Oct 2014. On 11 Oct 2014, she experienced fever, left arm pain, redness and swelling. She was taken to emergency room and then hospitalized. Final outcome of these events was unknown. Causality was not reported.