chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Injection site pain, Malaise, Pharyngeal oedema, Respiratory tract congestion
Clinical narrative: Case number PHHY2014US160993, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546948) website on 28 Nov 2014. This report refers to a 60-year-old male patient. Medical history and concomitant medications were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date and developed flu like symptoms (see case: PHHY2014US160988). He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly into left arm on 01 Oct 2014. On 02 Oct 2014, the patient developed soreness at injection site arm; on 04 Oct 2014, gradual throat swelling, viscous saliva, malaise with no fever; on 05 Oct 2014, moderate congestion, runny nose, severe malaise; on 06 Oct 2014, severe chills with shivering for 12 hours. Outcome of the event of soreness at injection site was reported as recovered on 03 Oct 2014; throat swelling, viscous saliva, malaise, congestion, runny nose recovered on 06 Oct 2014; chills with shivering on an unknown date. The events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of throat swelling was upgraded based on the NVS-IMS list.
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Rhinorrhoea, Saliva altered
Clinical narrative: Case number PHHY2014US160993, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546948) website on 28 Nov 2014. This report refers to a 60-year-old male patient. Medical history and concomitant medications were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date and developed flu like symptoms (see case: PHHY2014US160988). He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly into left arm on 01 Oct 2014. On 02 Oct 2014, the patient developed soreness at injection site arm; on 04 Oct 2014, gradual throat swelling, viscous saliva, malaise with no fever; on 05 Oct 2014, moderate congestion, runny nose, severe malaise; on 06 Oct 2014, severe chills with shivering for 12 hours. Outcome of the event of soreness at injection site was reported as recovered on 03 Oct 2014; throat swelling, viscous saliva, malaise, congestion, runny nose recovered on 06 Oct 2014; chills with shivering on an unknown date. The events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of throat swelling was upgraded based on the NVS-IMS list.
Age: 60.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza like illness
Clinical narrative: Case number PHHY2014US160993, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 546948) website on 28 Nov 2014. This report refers to a 60-year-old male patient. Medical history and concomitant medications were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number unknown) on an unknown date and developed flu like symptoms (see case: PHHY2014US160988). He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) intramuscularly into left arm on 01 Oct 2014. On 02 Oct 2014, the patient developed soreness at injection site arm; on 04 Oct 2014, gradual throat swelling, viscous saliva, malaise with no fever; on 05 Oct 2014, moderate congestion, runny nose, severe malaise; on 06 Oct 2014, severe chills with shivering for 12 hours. Outcome of the event of soreness at injection site was reported as recovered on 03 Oct 2014; throat swelling, viscous saliva, malaise, congestion, runny nose recovered on 06 Oct 2014; chills with shivering on an unknown date. The events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of throat swelling was upgraded based on the NVS-IMS list.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Eyelid oedema
Clinical narrative: Case number PHHY2014US156231, is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 547110) website on 28 Nov 2014. This report refers to a 42-year-old female patient. The patient finished taking medicine for a sinus infection 2-3 days prior to vaccination. Concurrent conditions included allergic to gluten, chronic migraine and supraventricular tachycardia. This polymedicated patient received seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Oct 2014. 09 Oct 2014, the patient both eyes were swollen, when she woke up in the morning about half shut. They have been like this for about 48 hours now, despite taking multiple doses of BENADRYL. The outcome of the event was condition unchanged. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Swelling face
Clinical narrative: Case number PHHY2014US156245, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547115) website on 28 Nov 2014. This report refers to a 58-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 08 Oct 2014. On 09 Oct 2014, the patient face was swollen and the patient had weakness. The outcome of the events was complete recovery. Seriousness was not reported. The case was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site urticaria, Rash erythematous, Rash pruritic, Viral infection
Clinical narrative: Case number PHHY2014US161558, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547244) website on 28 Nov 2014. This report refers to a 41-year-old female patient. Medical history was not reported. Concurrent conditions included aspirin allergy and seasonal allergies. Concomitant medications included PROZAC, FLONASPRAY and Vitamin D3. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into right arm on 25 Sep 2014. On the same day, within 24 hours post vaccination, the patient developed large welt (over 2 inches in diameter) at vaccination site. The welt began to decline and red itchy rash began to spread, mostly across upper arms, chest, abdomen. The patient self-treated with oral BENADRYL and OTC antihistamines. Four days post vaccination, rash persisted and spread to lower arms and upper thighs. The patient was prescribed prednisone and topical ointment. Two weeks post vaccination, rash persisted and worsened despite completion of oral prednisone regimen. The patient then consulted allergies who prescribed ALLEGRA, PEPCID and ZYRTEC to treat itchy rash which was believed to be a viral reaction to the vaccine. Final outcome of the events was not reported. The events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of viral reaction to the vaccine was upgraded based on NVD key event list and red itchy rash and large welt at vaccination site was upgraded based on the information in the source document.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Lip swelling, Pruritus generalised, Urticaria
Clinical narrative: Case number PHHY2014US157380 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 547325) website on 28 Nov 2014. This report refers to a 65 years old female patient. Her current conditions included hypothyroidism, diabetes, high cholesterol and magnesium deficiency. Her concomitant medications were metformin 500 mg, Lisinopril 20 mg, Clopidogrel 75 mg, magnesium 400 mg, low dose Aspirin and levothyroxine 75 mcg. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 07 Oct 2014. After vaccination, approximately at 7:00 am on 07 Oct 2014, she broke out with hives and approximately at 8:00 am, her lower lip had severe swelling, about 3 to 4 times larger than normal. It was reported that she had major itching all night long on 07 Oct 2014 and whole day on 08 Oct 2014. She experienced itching in majority of her body, buttocks, inside thighs, feet, hands and arms. She called doctor's office and went to emergency room in the evening of 08 Oct 2014. The doctor diagnosed her with acute allergic reaction to the flu shot. She was administered famotidine, fexofenadine, and methylprednisolone intravenously and was given prescriptions for MEDROL 4 mg 21 tablets, PEPCID 20 mg 10 tablets and ALLEGRA 180 mg 30 package. The final outcome was reported as condition unchanged. The seriousness of events was not reported, but the event acute allergic reaction to the flu shot was upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Feeling abnormal, Productive cough, Pyrexia
Clinical narrative: Case number PHHY2014US157493 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 547359) website on 28 Nov 2014. This report refers to a 53 years old male patient. His current conditions included seasonal allergy. His concomitant medications included ZYRTEC taken 3 hours prior to the vaccination (24 hour). His vaccination history included administration of unspecified vaccines every year which were well tolerated. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 09 Oct 2014. On the same day after vaccination, he was fine for a minute. He reported that the next minute was miserable and he had sudden onset of uncontrollable sneezing and coughing (wet cough). He had rapid onset of copious amounts of nasal mucus and wheezing. His chest was tight and he had fluid in his chest. He took CLARITIN D which had minimal effect (24 hour). He experienced mild fever with a body temperature of 100 degrees. Five hours later he had troubled breathing, clogged sinuses, cough and his chest was still heavy. He took daily antihistamine and worked in home office. He stated that there was no environmental change and the only thing which was different was flu vaccination before the horrible respiratory reaction. The final outcome was reported as condition unchanged. The seriousness of events was not reported, but the event wheezing, trouble breathing and chest discomfort were upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sinus congestion, Sneezing, Wheezing
Clinical narrative: Case number PHHY2014US157493 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 547359) website on 28 Nov 2014. This report refers to a 53 years old male patient. His current conditions included seasonal allergy. His concomitant medications included ZYRTEC taken 3 hours prior to the vaccination (24 hour). His vaccination history included administration of unspecified vaccines every year which were well tolerated. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 09 Oct 2014. On the same day after vaccination, he was fine for a minute. He reported that the next minute was miserable and he had sudden onset of uncontrollable sneezing and coughing (wet cough). He had rapid onset of copious amounts of nasal mucus and wheezing. His chest was tight and he had fluid in his chest. He took CLARITIN D which had minimal effect (24 hour). He experienced mild fever with a body temperature of 100 degrees. Five hours later he had troubled breathing, clogged sinuses, cough and his chest was still heavy. He took daily antihistamine and worked in home office. He stated that there was no environmental change and the only thing which was different was flu vaccination before the horrible respiratory reaction. The final outcome was reported as condition unchanged. The seriousness of events was not reported, but the event wheezing, trouble breathing and chest discomfort were upgraded as medically significant based on the information available in the source document. The causality of the events was not reported.
Age: 31.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: Case number PHHY2014US157467 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 547395) website on 28 Nov 2014. This report refers to a 31 years old male patient. His medical history included post-traumatic stress disorder (PTSD) and combat related back injury. His concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Oct 2014. On the same day after vaccination, he experienced severe aching at joints of arms and legs, severe chills and fever with a body temperature of 104.3 degrees. The final outcome was reported as complete recovery. The seriousness of events was not reported, but the event fever with a body temperature of 104.3 degree was upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Pharyngeal oedema
Clinical narrative: Case number PHHY2014US157485 is an initial spontaneous report received via the Vaccine Adverse Event Reporting System (VAERS reference number: 547409) website on 28 Nov 2014. This report refers to a 61 years old female patient. Her medical history was not reported. Her concomitant medications included fluoxetine, pravastatin, CARDIA and isosorbide ER. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 30 Sep 2014. On the same day after vaccination, she experienced swelling of throat and gland; only on the left side. She gargled warm salt water and used hot and wet compress. She took Naproxen for swelling. The final outcome was reported as complete recovery. The seriousness of events was not reported, but the event throat swelling 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: FLUX
Symptoms: Antibody test, Borrelia test, VIIth nerve paralysis
Clinical narrative: Case number PHHY2014US157588, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547491) website on 28 Nov 2014. This report refers to a 47-year-old female patient. Concurrent conditions included hypertension, diabetes, herniated discs and post-traumatic stress disorder. Concomitant medications included NORVASC, EFFEXOR, AMBIEN and XANAX. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the right arm on 09 Oct 2014. On the same day after vaccination, she experienced Bell's palsy. She underwent lab test for Lyme disease titer (no results reported). The outcome of the event was not recovered. Seriousness was not reported. The case was internally upgraded as medically significant based on NVD key events. Causality was not reported.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Diarrhoea, Dizziness, Eyelid oedema, Headache
Clinical narrative: Case number PHHY2014US162664, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547492) website on 28 Nov 2014. This report refers to a 52 year old male patient. His medical history included mild asthma. Concomitant medications included fluticasone propionate nasal spray 50 mcg per daily spray and PULMICORT flexhaler 180 mcg one daily dose. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 09 Oct 2014. On the same day post vaccination at 1:00 pm, approximately 2 hours after vaccination he began feeling symptoms of weakness, dizziness, and mild muscle ache. By 3:30 pm, he felt overcome with paleness (others observed changing for a brief period to green, facial coloration, added weakness and dizziness, headache, mild swelling around the eyes, muscle ache, fever, nausea, and mildly loose bowels. The patient relaxed at home and drank fluids. On 10 Oct 2014, by 11:00 am headache and mildly cloudy thinking remained. These symptoms reduced steadily through the day. Events were reported as non-serious. Final outcome of the events was completely recovered. Causality assessment was not reported. Seriousness assessment of swelling of eyelid was upgraded based on information available in the source documents.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Myalgia, Nausea, Pallor, Pyrexia, Skin discolouration
Clinical narrative: Case number PHHY2014US162664, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547492) website on 28 Nov 2014. This report refers to a 52 year old male patient. His medical history included mild asthma. Concomitant medications included fluticasone propionate nasal spray 50 mcg per daily spray and PULMICORT flexhaler 180 mcg one daily dose. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 09 Oct 2014. On the same day post vaccination at 1:00 pm, approximately 2 hours after vaccination he began feeling symptoms of weakness, dizziness, and mild muscle ache. By 3:30 pm, he felt overcome with paleness (others observed changing for a brief period to green, facial coloration, added weakness and dizziness, headache, mild swelling around the eyes, muscle ache, fever, nausea, and mildly loose bowels. The patient relaxed at home and drank fluids. On 10 Oct 2014, by 11:00 am headache and mildly cloudy thinking remained. These symptoms reduced steadily through the day. Events were reported as non-serious. Final outcome of the events was completely recovered. Causality assessment was not reported. Seriousness assessment of swelling of eyelid was upgraded based on information available in the source documents.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Thinking abnormal
Clinical narrative: Case number PHHY2014US162664, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547492) website on 28 Nov 2014. This report refers to a 52 year old male patient. His medical history included mild asthma. Concomitant medications included fluticasone propionate nasal spray 50 mcg per daily spray and PULMICORT flexhaler 180 mcg one daily dose. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) on 09 Oct 2014. On the same day post vaccination at 1:00 pm, approximately 2 hours after vaccination he began feeling symptoms of weakness, dizziness, and mild muscle ache. By 3:30 pm, he felt overcome with paleness (others observed changing for a brief period to green, facial coloration, added weakness and dizziness, headache, mild swelling around the eyes, muscle ache, fever, nausea, and mildly loose bowels. The patient relaxed at home and drank fluids. On 10 Oct 2014, by 11:00 am headache and mildly cloudy thinking remained. These symptoms reduced steadily through the day. Events were reported as non-serious. Final outcome of the events was completely recovered. Causality assessment was not reported. Seriousness assessment of swelling of eyelid was upgraded based on information available in the source documents.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Swelling face, Throat irritation, Urticaria
Clinical narrative: Case number PHHY2014US157881, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 547885) website on 28 Nov 2014. This report refers to a 11-year-old male patient. He was allergic to foods like rice and barley. His concomitant drugs included FLOVENT 220 mg twice daily and PRILOSEC 20 mg. He was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 13 Oct 2014. On the same date, after vaccination he experienced red swollen hives on face and itchy throat. The patient visited the emergency room. The outcome of the events reported as not recovered. The events reported as non-serious. Seriousness assessment of the events (itchy throat, urticaria, swelling and redness) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 1.1
Sex: M
Vaccine: FLUX, HIBV, MMR
Symptoms: Fatigue, Inflammation, Lethargy, Malaise, Pyrexia
Clinical narrative: Case number PHHY2015US004980, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548412) website on 06 Jan 2015. This report refers to a 13-month-old male patient. The patient's current conditions included possible hand throat and mouth virus. Concomitant medications included amoxicillin. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) along with Hib vaccine (manufacturer unknown, batch number: not reported) and MMR vaccine (manufacturer unknown, batch number: not reported) on 22 Sep 2014. On 30 Sep 2014, the patient started to experience red spots on his forehead, then later that day the patient developed more red spots on his inner cheeks and nose. On 01 Oct 2014, the patient had developed red spots covering about 60 percent of his body from head down to feet. The patient was lethargic and he was not feeling well. On 02 Oct 2014, he was covered in raised red spots and a bigger reddened area covering about 85 percent of his body and the patient had low grade fever and was tired. On 03 Oct 2014, the red dots became raised reddened areas and started to turn pink in color. The patient began to feel better. The patient condition improved gradually from 04 Oct 2014 to 06 Oct 2014. The pink areas kept getting lighter in color than and not as raised as they were initially. The patient began feeling like himself until the inflammation on his body went away completely. The final outcome of the events was complete recovery. The events were reported as non-serious. The event 'red spots and a bigger reddened area covering about 85 percent' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 1.1
Sex: M
Vaccine: FLUX, HIBV, MMR
Symptoms: Rash, Rash erythematous, Rash generalised
Clinical narrative: Case number PHHY2015US004980, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548412) website on 06 Jan 2015. This report refers to a 13-month-old male patient. The patient's current conditions included possible hand throat and mouth virus. Concomitant medications included amoxicillin. He was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) along with Hib vaccine (manufacturer unknown, batch number: not reported) and MMR vaccine (manufacturer unknown, batch number: not reported) on 22 Sep 2014. On 30 Sep 2014, the patient started to experience red spots on his forehead, then later that day the patient developed more red spots on his inner cheeks and nose. On 01 Oct 2014, the patient had developed red spots covering about 60 percent of his body from head down to feet. The patient was lethargic and he was not feeling well. On 02 Oct 2014, he was covered in raised red spots and a bigger reddened area covering about 85 percent of his body and the patient had low grade fever and was tired. On 03 Oct 2014, the red dots became raised reddened areas and started to turn pink in color. The patient began to feel better. The patient condition improved gradually from 04 Oct 2014 to 06 Oct 2014. The pink areas kept getting lighter in color than and not as raised as they were initially. The patient began feeling like himself until the inflammation on his body went away completely. The final outcome of the events was complete recovery. The events were reported as non-serious. The event 'red spots and a bigger reddened area covering about 85 percent' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Impaired work ability
Clinical narrative: Case number PHHY2015US005040, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548447) website on 06 Jan 2015. This report refers to a 27-year-old female patient. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in fall of 2013. In 2013, less than a year after receiving influenza vaccine, the patient experienced severe headache for two weeks and numbness in fingers and was unable to work. The headache and numbness resolved after a couple weeks. It was reported that the patient was disabled because she had to miss her work due to the symptoms. The causality of the events was not reported.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Angioedema, Injection site pruritus, Injection site reaction
Clinical narrative: Case number PHHY2015US006079 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS ID: 550033) website on 06 Jan 2015. This report refers to a 74 year old female patient. Her current conditions included emphysema and asthma. The patient was polymedicated. On 15 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: 90662) into her left arm and with pneumococcal vaccine (other manufacturer, batch number: 90732) into her left arm. On 16 Oct 2014, about three inches below the puncture marks, she developed a giant itchy hive measuring about 4x6 inches. She contacted her physician who advised using a hot compress and a topical cream. The final outcome of the events was not reported. The events were reported as non serious but the seriousness of giant hive was upgraded based on the information available in the source document. Causality of the events was not reported.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Blood culture, Chills, Full blood count, Malaise, Metabolic function test
Clinical narrative: Case number PHHY2015US001854, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548632) website on 06 Jan 2015. This report refers to a 44-year-old female patient. The patient's current condition included allergies. Concomitant medications included SINGULAIR, PROVIGIL and TYLENOL. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into the right arm on 16 Oct 2014. On the same day after vaccination, the patient experienced fever with a body temperature of 104, severe nausea, malaise, chills, and body aches/pain. The patient underwent blood culture, urine analysis, comprehensive metabolic panel test and complete blood count. The results of the tests were not reported. The final outcome of the events was complete recovery. The events were reported as non-serious. The event 'fever (104)' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia, Urine analysis
Clinical narrative: Case number PHHY2015US001854, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548632) website on 06 Jan 2015. This report refers to a 44-year-old female patient. The patient's current condition included allergies. Concomitant medications included SINGULAIR, PROVIGIL and TYLENOL. She was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) intramuscularly into the right arm on 16 Oct 2014. On the same day after vaccination, the patient experienced fever with a body temperature of 104, severe nausea, malaise, chills, and body aches/pain. The patient underwent blood culture, urine analysis, comprehensive metabolic panel test and complete blood count. The results of the tests were not reported. The final outcome of the events was complete recovery. The events were reported as non-serious. The event 'fever (104)' was internally upgraded as medically significant based on the information available in the source document. Causality was not reported.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Diplegia, Hypoaesthesia, Paraesthesia, Presyncope, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US001262, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 548725) website on 06 Jan 2015. This report refers to a 40-year-old female patient. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 02 Oct 2014. On the same date, 15 minutes after vaccination she experienced numbness and tingling.  On 16 Oct 2014, she experienced near fainting and paralysis in arms, legs and face. The patient visited the emergency room. The outcome of the events was not reported. The events reported as non-serious. Seriousness assessment of the events (fainting and paralysis in arms, legs and face) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye irritation, Ocular hyperaemia, Swelling face, Throat irritation
Clinical narrative: Case number PHHY2015US001266, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548943) on 06 Jan 2015. This report refers to a 41 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly into right arm on 20 Oct 2014. On the same day, after vaccination, the patient developed swollen face, swollen red burning eyes, throat itching and cough. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of swollen face, swollen red burning eyes was upgraded based on information in the source document.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Electromyogram, Haematology test, Injection site pain, Laboratory test, Muscular weakness
Clinical narrative: Case number PHHY2015US001267, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548951) on 06 Jan 2015. This report refers to a 54 years old male patient. Medical history was not reported. Concomitant medication included Aspirin 81 mg daily. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly into left arm on 26 Sep 2014. On 07 Oct 2014, he experienced left acute brachial plexus neuritis and muscle weakness. He experienced severe left-sided neck, shoulder and arm pain for about 6 days which progressed to left hand and arm. He went to emergency room due to these events. He underwent magnetic resonance imaging (MRI), hematology, chemistry and serology tests (results not reported). Electromyogram (EMG) was pending. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of left acute brachial plexus neuritis was upgraded based on information in the source document.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Neck pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity, Serology test
Clinical narrative: Case number PHHY2015US001267, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 548951) on 06 Jan 2015. This report refers to a 54 years old male patient. Medical history was not reported. Concomitant medication included Aspirin 81 mg daily. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly into left arm on 26 Sep 2014. On 07 Oct 2014, he experienced left acute brachial plexus neuritis and muscle weakness. He experienced severe left-sided neck, shoulder and arm pain for about 6 days which progressed to left hand and arm. He went to emergency room due to these events. He underwent magnetic resonance imaging (MRI), hematology, chemistry and serology tests (results not reported). Electromyogram (EMG) was pending. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of left acute brachial plexus neuritis was upgraded based on information in the source document.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Palpitations, Paraesthesia oral, Swollen tongue
Clinical narrative: Case number PHHY2015US006623, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 549010) on 06 Jan 2015. This report refers to a 34 year old female patient. Medical history was not reported. Concurrent conditions included hyper-allergy to seafood, dairy and all nuts. No concomitant medication was reported. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm on 19 Oct 2014. On the same day after vaccination, she developed swollen tongue, tongue tingling, heart racing and felt faint. Final outcome of these events was complete recovery. Events were reported as non-serious. Seriousness assessment of swollen tongue was upgraded (medically significant) based on the information available in the source document. Causality of these events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Cough, Dyspnoea, Paraesthesia, Rash generalised
Clinical narrative: Case number PHHY2015US002208 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 549442) on 06 Jan 2015. This report refers to a 67 years old female patient. Her historical drug included CECLOR. Her concomitant medications were WELLBUTRIN, CELEXA, Vitamin B12, MIRAPEX, Vitamin D, omeprazole, ATIVAN PRN, SPIRIVA, ADVAIR and PROAIR. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 14 Oct 2014. On 15 Oct 2014 at 8:00 pm she experienced cough. On 16 Oct 2014, at 1:00 am, she had skin tingling all over. On the same date at 5:00 am, she experienced fine rash all over. Cough and rash continued until 17 Oct 2014 early in the am. She developed hives and her cough worsened on 17 Oct 2014. On an unknown date in Oct 2014 night to early morning, she experienced shortness of breath (SOB) twice and around 8:00 am, her face and tongue started to swell. She went to doctors on 21 Oct 2014 at 11:15 am and started on prednisone taper, cough medicine (unspecified) and hydrocortisone cream. On 23 Oct 2014, she had hives on 60% of her body and she lost a day of work. The events outcome was unknown. The events were reported as non-serious, but events SOB, rash all over, swelling of face and tongue were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Swollen tongue, Urticaria
Clinical narrative: Case number PHHY2015US002208 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS ID: 549442) on 06 Jan 2015. This report refers to a 67 years old female patient. Her historical drug included CECLOR. Her concomitant medications were WELLBUTRIN, CELEXA, Vitamin B12, MIRAPEX, Vitamin D, omeprazole, ATIVAN PRN, SPIRIVA, ADVAIR and PROAIR. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly in the left arm on 14 Oct 2014. On 15 Oct 2014 at 8:00 pm she experienced cough. On 16 Oct 2014, at 1:00 am, she had skin tingling all over. On the same date at 5:00 am, she experienced fine rash all over. Cough and rash continued until 17 Oct 2014 early in the am. She developed hives and her cough worsened on 17 Oct 2014. On an unknown date in Oct 2014 night to early morning, she experienced shortness of breath (SOB) twice and around 8:00 am, her face and tongue started to swell. She went to doctors on 21 Oct 2014 at 11:15 am and started on prednisone taper, cough medicine (unspecified) and hydrocortisone cream. On 23 Oct 2014, she had hives on 60% of her body and she lost a day of work. The events outcome was unknown. The events were reported as non-serious, but events SOB, rash all over, swelling of face and tongue were upgraded as medically significant based on the information available in the source documents. The causality of the events was not reported.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspnoea, Erythema, Injection site pain, Musculoskeletal pain, Nasopharyngitis
Clinical narrative: Case number PHHY2014US157915, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549568) website on 28 Nov 2014. This report refers to a 68-year-old female patient. Her current conditions included hypertension, hypercholesterolaemia and gastrooesophageal reflux disease. She was allergic to rice. On 06 Oct 2014, she was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) along with pneumococcal vaccine (manufacturer and batch number: not reported, other manufacturer), both in the left arm. On the same date, after vaccinations she experienced red swollen area on left arm which was about 3 inches in diameter, had lot of pain, cold symptoms, pain in shoulder area, fever, shortness of breath and throat closing. It was reported that the events red swollen area on left arm, pain and cold symptoms went on for 4 days. The patient visited the emergency room. The final outcome of the events was unknown. The events reported as non-serious. Seriousness assessment of the events (shortness of breath and throat closing) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Peripheral swelling, Pyrexia, Throat tightness
Clinical narrative: Case number PHHY2014US157915, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 549568) website on 28 Nov 2014. This report refers to a 68-year-old female patient. Her current conditions included hypertension, hypercholesterolaemia and gastrooesophageal reflux disease. She was allergic to rice. On 06 Oct 2014, she was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) along with pneumococcal vaccine (manufacturer and batch number: not reported, other manufacturer), both in the left arm. On the same date, after vaccinations she experienced red swollen area on left arm which was about 3 inches in diameter, had lot of pain, cold symptoms, pain in shoulder area, fever, shortness of breath and throat closing. It was reported that the events red swollen area on left arm, pain and cold symptoms went on for 4 days. The patient visited the emergency room. The final outcome of the events was unknown. The events reported as non-serious. Seriousness assessment of the events (shortness of breath and throat closing) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Migraine, Pain in extremity, Pain in jaw, Paraesthesia
Clinical narrative: Case number PHHY2015US000909, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 549715) website on 06 Jan 2015. This report refers to a 48-year-old female patient. Current conditions included acid reflux and seasonal allergies. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Sep 2014. On the same date, few hours after vaccination she experienced migraine headache, but not well feverish. On 25 Sep 2014, she had jaw pain and unusual sensations on left side of face, body, arm and fingers. She went to doctor and received antibiotics. On 04 Oct 2014, in the emergency room her tongue swelled and she could not breathe. She took allergy pills and more steroids. On an unknown date, 3 weeks later she still had the problems. She had pain in arm, swelling of tongue and tingling in face. The final outcome of the events reported as not recovered. The events reported as non-serious. Seriousness assessment of the events (swelling of tongue and could not breathe) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Sensory disturbance, Swollen tongue
Clinical narrative: Case number PHHY2015US000909, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 549715) website on 06 Jan 2015. This report refers to a 48-year-old female patient. Current conditions included acid reflux and seasonal allergies. She was vaccinated with Seasonal influenza vaccine (manufacturer and batch number: not reported) on 24 Sep 2014. On the same date, few hours after vaccination she experienced migraine headache, but not well feverish. On 25 Sep 2014, she had jaw pain and unusual sensations on left side of face, body, arm and fingers. She went to doctor and received antibiotics. On 04 Oct 2014, in the emergency room her tongue swelled and she could not breathe. She took allergy pills and more steroids. On an unknown date, 3 weeks later she still had the problems. She had pain in arm, swelling of tongue and tingling in face. The final outcome of the events reported as not recovered. The events reported as non-serious. Seriousness assessment of the events (swelling of tongue and could not breathe) was upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 0.5
Sex: M
Vaccine: DTAP, FLUX, HEP, IPV, MMR, PPV
Symptoms: Pyrexia, Seizure
Clinical narrative: Case number PHHY2015US000985, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS ID: 549960) on 06 Jan 2015. This report refers to a 6 months old male neonate. Medical history included possible atopic dermatitis. Concurrent conditions included congestion and rash. Concomitant medications were not reported. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) along with DTAP (manufacturer and batch number unknown), hepatitis B vaccine (manufacturer and batch number unknown), MMR (manufacturer and batch number unknown), pneumococcal vaccine polyvalent (manufacturer and batch number unknown) and poliovirus vaccine inactivated (manufacturer and batch number unknown) on 14 Oct 2014. On the same day, after vaccination, he experienced fever and seizure. He was taken to emergency room for treatment. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 8.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Erythema, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Case number PHHY2015US004304 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550101) website on 06 Jan 2015. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 24 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day, immediately after the vaccination, she had headache and stomach ache. She developed a fever with body temperature of 102.3, fatigue, red skin on face and vomiting. About three hours later, her fever rose with a body temperature of 103.6 with muscle pain and weakness. She was tired and her fever rose again with a body temperature of 104.2. She was treated with TYLENOL for fever which got the fever down to a body temperature of 103 but again rose to 104.6 within two hours. The patient visited the emergency room. She underwent flu and strep tests which were negative. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of fever was upgraded based on the information available in the source documents and causality of the events was not reported.    Case number PHHY2015US004304 is an initial spontaneous report received from a health care professional via the Vaccine Adverse Event Reporting System (VAERS ID: 550101) website on 06 Jan 2015. This report refers to an eight year old female patient. Her past medical history and concomitant medications were not reported. On 24 Oct 2014, she was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported). On the same day, immediately after the vaccination, she had head ache and stomach ache. She developed a fever with body temperature of 102.3, fatigue, red skin on face and vomiting. About three hours later, her fever rose with a body temperature of 103.6 with muscle pain and weakness. She was tired and her fever rose again with a body temperature of 104.2. She was treated with TYLENOL for fever which got the fever down to a body temperature of 103 but again rose to 104.6 within two hours. The patient then visited the emergency room. She underwent flu and strep tests which were negative. The final outcome of the events was complete recovery. The events were reported as non serious but the seriousness of fever was upgraded based on the information available in the source documents and causality of the events was not reported.