chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Blood pressure increased, Chest pain, Dysphonia, Fatigue
Clinical narrative: Case number PHHY2015US157084, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 600954) website on 24 Nov 2015. This report refers to a 31 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Oct 2015. On the same day after vaccination, the patient experienced sudden nausea followed with throat swelling which restricted the airway, this lasted for approximately 3 to 5 minutes, blood pressure elevated then dropped to 101/53, after a minute rest in standing position blood pressure was 99/68. Throughout the day patient experienced fatigue, exhaustion and at around 2:00 PM patient body began shaking and heart rate ranged from 103 to 117 beats per minutes, patient was treated in the emergency room for an allergic reaction around 3:00 PM, heart rate remained elevated ranging from 92 to 111 beats per minute throughout the evening, patient experienced back pain while in the emergency room and that went away around 4:00 am the next morning. On 07 Oct 2015 at 6:30 am heart rate was 77 beats per minute, patient had a sore wind pipe, mild hoarseness, and chest that feels sore. The outcome of the events sudden nausea with throat swelling which restricted the airway (lasted for approximately 3 to 5 minutes), blood pressure elevated, back pain (4:00 am the next morning), heart rate elevated (on 07 Oct 2015 at 6:30 am) was completely recovered and for other events it was not reported. Seriousness of the events was reported as non serious and causality was not reported. Seriousness of the event allergic reaction was upgraded based on information available in source document.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Hypersensitivity, Hypotension, Nausea, Obstructive airways disorder
Clinical narrative: Case number PHHY2015US157084, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 600954) website on 24 Nov 2015. This report refers to a 31 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Oct 2015. On the same day after vaccination, the patient experienced sudden nausea followed with throat swelling which restricted the airway, this lasted for approximately 3 to 5 minutes, blood pressure elevated then dropped to 101/53, after a minute rest in standing position blood pressure was 99/68. Throughout the day patient experienced fatigue, exhaustion and at around 2:00 PM patient body began shaking and heart rate ranged from 103 to 117 beats per minutes, patient was treated in the emergency room for an allergic reaction around 3:00 PM, heart rate remained elevated ranging from 92 to 111 beats per minute throughout the evening, patient experienced back pain while in the emergency room and that went away around 4:00 am the next morning. On 07 Oct 2015 at 6:30 am heart rate was 77 beats per minute, patient had a sore wind pipe, mild hoarseness, and chest that feels sore. The outcome of the events sudden nausea with throat swelling which restricted the airway (lasted for approximately 3 to 5 minutes), blood pressure elevated, back pain (4:00 am the next morning), heart rate elevated (on 07 Oct 2015 at 6:30 am) was completely recovered and for other events it was not reported. Seriousness of the events was reported as non serious and causality was not reported. Seriousness of the event allergic reaction was upgraded based on information available in source document.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Tremor
Clinical narrative: Case number PHHY2015US157084, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 600954) website on 24 Nov 2015. This report refers to a 31 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 06 Oct 2015. On the same day after vaccination, the patient experienced sudden nausea followed with throat swelling which restricted the airway, this lasted for approximately 3 to 5 minutes, blood pressure elevated then dropped to 101/53, after a minute rest in standing position blood pressure was 99/68. Throughout the day patient experienced fatigue, exhaustion and at around 2:00 PM patient body began shaking and heart rate ranged from 103 to 117 beats per minutes, patient was treated in the emergency room for an allergic reaction around 3:00 PM, heart rate remained elevated ranging from 92 to 111 beats per minute throughout the evening, patient experienced back pain while in the emergency room and that went away around 4:00 am the next morning. On 07 Oct 2015 at 6:30 am heart rate was 77 beats per minute, patient had a sore wind pipe, mild hoarseness, and chest that feels sore. The outcome of the events sudden nausea with throat swelling which restricted the airway (lasted for approximately 3 to 5 minutes), blood pressure elevated, back pain (4:00 am the next morning), heart rate elevated (on 07 Oct 2015 at 6:30 am) was completely recovered and for other events it was not reported. Seriousness of the events was reported as non serious and causality was not reported. Seriousness of the event allergic reaction was upgraded based on information available in source document.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Case number PHHY2015US153934, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601205) website on 24 Nov 2015. This report refers to a 46 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157229) intramuscularly into left arm on 28 Sep 2015. On the same day after vaccination the patient developed severe bruising and sore arm around the flu vaccine. Outcome of the events was not recovered. Seriousness and causality of the events were not reported.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Dyspnoea, Vomiting
Clinical narrative: Case number PHHY2015US155858, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601240) website on 24 Nov 2015. This report refers to a 73 years old female patient. Concurrent conditions included hypertension, sleep apnea, allergic to PERCOSET, Lisinopril and Niacin. Concomitant medications included Atenenol, Aspirin, D3, estradiol, simvastatin, fish oil and alprazolam. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 04 Oct 2015. On the same day after vaccination the patient could not breathe and had chills which were abated at 08:00 PM. The patient had a violent vomiting at about 09:00 PM. The patient experienced diarrhea at about 02:00 AM which stopped at 03:00 AM. The patient again had vomiting at about 02:30 AM. Final outcome of the events were recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "dyspnea", "chills", "diarrhea" and "vomiting" was upgraded based on information in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Chest pain, Dyspnoea, Hypersensitivity, Hyperventilation
Clinical narrative: Case number PHHY2015US157742, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 601292) website on 24 Nov 2015. This report refers to a 33 years old female patient. Past medical history included anxiety, Kiwi food allergy and mitral valve prolapse. Historical drug included gluten (manufacturer unknown). Vaccination history included administration of RECOMBIVAX HB and after vaccination patient experienced swollen and inflamed left arm. Concomitant medication included LEXAPRO at a dose of 10 mg once daily. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm, intramuscularly on 06 Oct 2015. On the same day after vaccination, the patient experienced burning in neck, hives, shortness of breath, chest spasms and pain. The patient reported that, she was urinating on herself when she experienced projectile vomiting. The patient visited the emergency room on an unknown date. Lab investigation revealed that, the patient had allergic reaction to flu vaccine. Diagnostics and other lab tests were all normal with the exception of the hyperventilation. It was stated that chest X-ray and cardiac work up should be performed and SOLUMEDROL, BENADRYL, prednisone (manufacturer unknown), EPIPEN should be given in case needed in future. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non-serious and causality of the events was not reported. Seriousness of the events burning in neck, hyperventilation chest pain and projectile vomiting was upgraded to medically significant based on the information available in the source document.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Laboratory test normal, Muscle spasms, Urinary incontinence, Urticaria, Vomiting projectile
Clinical narrative: Case number PHHY2015US157742, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 601292) website on 24 Nov 2015. This report refers to a 33 years old female patient. Past medical history included anxiety, Kiwi food allergy and mitral valve prolapse. Historical drug included gluten (manufacturer unknown). Vaccination history included administration of RECOMBIVAX HB and after vaccination patient experienced swollen and inflamed left arm. Concomitant medication included LEXAPRO at a dose of 10 mg once daily. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in left arm, intramuscularly on 06 Oct 2015. On the same day after vaccination, the patient experienced burning in neck, hives, shortness of breath, chest spasms and pain. The patient reported that, she was urinating on herself when she experienced projectile vomiting. The patient visited the emergency room on an unknown date. Lab investigation revealed that, the patient had allergic reaction to flu vaccine. Diagnostics and other lab tests were all normal with the exception of the hyperventilation. It was stated that chest X-ray and cardiac work up should be performed and SOLUMEDROL, BENADRYL, prednisone (manufacturer unknown), EPIPEN should be given in case needed in future. Outcome of the events was reported as complete recovery. Seriousness of the events was reported as non-serious and causality of the events was not reported. Seriousness of the events burning in neck, hyperventilation chest pain and projectile vomiting was upgraded to medically significant based on the information available in the source document.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Throat irritation, Urticaria
Clinical narrative: Case number PHHY2015US166078, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 601358) website on 14 Dec 2015. This report refers to a 44-year-old female patient. Family history (sibling) included local reactions to a vaccine (not specified). Past medical history include difficult pregnancy (17 years ago), angioedema and one idiopathic urticaria and since then the patient was in remission. Past medication history include XOLAIR for two years. The patient was allergic to sulfa, codeine, Oxycodone, DILAUDID, COMPAZINE, SUDAFED and Fentanyl. Concomitant medications included Albuterol, ADDERALL XR, ZOLOFT and EPIPEN. The patient was vaccinated with FLUCELVAX (batch number: 174084) intramuscularly into the arm on 06 Oct 2015. On the same day, two hours after vaccination, the patient developed hives. The patient was treated with BENADRYL 25 mg and ZYRTEC with some relief. Four hours later the patient developed rebound reaction with generalized urticaria and itchy throat. The patient was treated with BENADRYL 50 mg. 15 minutes later, after a consultation with immunologist, the patient received EPIPEN. The patient had near complete resolution of the events and now only has one or two small hives. Final outcome of the events was complete recovery. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document. Based on the investigation performed, the QA department stated that, FLUCELVAX (batch number: 174084) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. No anomalies were noted during this review. Non significant follow-up received from Quality Assurance Department (QA, reference number: 1010432) on 21 Dec 2015: updated QA reference number. Non-significant follow-up information received from quality assurance department on 05 Jan 2016: Updated batch review report.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Cough, Diarrhoea, Eye swelling, Fatigue
Clinical narrative: Case number PHHY2015US160753 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 601541) on 24 Nov 2015. This report refers to a 71 year old female patient. She had no medical history and current conditions. Her concomitant medications were TRICOR, PREMARIN, fish oil, calcium and Aspirin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 05 Oct 2015. On the same day after vaccination, she experienced fatigue, abdominal pains, itchy hands, red swollen eyes, nausea, cough, diarrhea and hives. The event outcome was unknown. The event was reported as non-serious, but the event red swollen eyes was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Ocular hyperaemia, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US160753 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 601541) on 24 Nov 2015. This report refers to a 71 year old female patient. She had no medical history and current conditions. Her concomitant medications were TRICOR, PREMARIN, fish oil, calcium and Aspirin. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 05 Oct 2015. On the same day after vaccination, she experienced fatigue, abdominal pains, itchy hands, red swollen eyes, nausea, cough, diarrhea and hives. The event outcome was unknown. The event was reported as non-serious, but the event red swollen eyes was upgraded as medically significant based on the information available in the source documents. The causality of the event was not reported.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Case number PHHY2015US165472, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 601592) website on 14 Dec 2015. This report refers to a 54 years old polymedicated male patient. Concurrent condition included COPD. The patient was vaccinated with FLUVIRIN (batch number: 1514701) into left arm along with PNEUMOVAX (batch number: K009876, other manufacturer) intramuscularly into right arm on 29 Sep 2015. On 30 Sep 2015 the patient reports feeling tired, shortness of breath and stumbling. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 27.0
Sex: F
Vaccine: FLUC3
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Case number PHHY2015US164679 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601617) website on 14 Dec 2015. This report refers to a 27 years old female patient. Medical history and concurrent illness were none. Concomitant medication included SPRINTEC. The patient was vaccinated with FLUCELVAX (batch number: 174085) intramuscularly into left arm on 06 Oct 2015. On 07 Oct 2015 the patient developed tongue swelling and hives on tongue and face. The patient went to emergency room due to these events. The patient was treated with PEPCID, SOLUMEDROL, BENADRYL and MEDROL. Outcome of the events was recovered. The case was assessed as serious (life-threatening). Causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: Case number PHHY2015US157786, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 601631) website on 24 Nov 2015. This report refers to a 52 years old female patient. Medical history and current illness were none. Concomitant medication included NATAZIA. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 08 Oct 2015. On the same day at 03:30 PM the patient noticed body aches mostly in legs followed by sudden onset headache. Further the headache progressed. Around 5:15 PM the patient experienced vomiting, diarrhea, fever and body aches. The patient took ibuprofen 800 mg. At around 06:15 PM to 07:00 PM the patient experienced difficulty breathing and nausea. No rash or swelling of throat, lips or tongue. By 08:00 PM the symptoms slowly improved so the patient did not seek medical treatment. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "difficulty breathing", "diarrhea", "vomiting" and "nausea" was upgraded based on information in the source document.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US157786, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 601631) website on 24 Nov 2015. This report refers to a 52 years old female patient. Medical history and current illness were none. Concomitant medication included NATAZIA. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 08 Oct 2015. On the same day at 03:30 PM the patient noticed body aches mostly in legs followed by sudden onset headache. Further the headache progressed. Around 5:15 PM the patient experienced vomiting, diarrhea, fever and body aches. The patient took ibuprofen 800 mg. At around 06:15 PM to 07:00 PM the patient experienced difficulty breathing and nausea. No rash or swelling of throat, lips or tongue. By 08:00 PM the symptoms slowly improved so the patient did not seek medical treatment. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "difficulty breathing", "diarrhea", "vomiting" and "nausea" was upgraded based on information in the source document.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Paraesthesia, Swelling face, Urticaria
Clinical narrative: Case number PHHY2015US156413, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601680) website on 24 Nov 2015. This report refers to a 30-year-old female patient. Concomitant drugs included LEXAPRO 20 mg daily and NEXPLANON implant. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 05 Oct 2015. On the same date, after vaccination the patient experienced hives, swelling on left side of face and numbness/tingling left side of face. The patient received BENADRYL 25 mg orally as a treatment. The outcome of the events reported as recovered. The events reported as non-serious. Seriousness assessment of the event face swelling upgraded based on the available information in the source document. The causality of the events was not reported.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, FLUX, HEPA, MMR, PPV
Symptoms: Angioedema, Erythema, Pruritus, Respiratory distress, Urticaria
Clinical narrative: Case number PHHY2015US157282 is an initial spontaneous report received via Vaccine Adverse Events Reporting System (VAERS reference number: 601738) on 24 Nov 2015. This report refers to a 4 year old female patient. Her current conditions included Ebstein anomaly, pulmonary valve atresia status post Glenn and Fontan and pulmonary artery stenosis status post stent. Her concomitant medications were not reported. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported), PEDIARIX (other manufacturer, batch number: not reported), hepatitis A vaccine (other manufacturer, batch number: not reported), pneumococcal vaccine (other manufacturer, batch number: not reported) and MMR vaccine (other manufacturer, batch number: not reported); all vaccines administered on 07 Oct 2015. On 07 Oct 2015, 10 minutes after vaccination, she experienced pruritic hives, diffuse redness, angioedema and respiratory distress. She went to emergency room. The outcome of the events was reported as complete recovery. The events were reported as non-serious, but the events angioedema and respiratory distress were upgraded as medically significant based on NVS-IME list and the event urticaria was upgraded as medically significant based on the information available in the source documents. The causality of events was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Pain
Clinical narrative: Case number PHHY2015US169353, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 601816) website on 14 Dec 2015. This report refers to a 47-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 157021) intramuscularly in left arm on 10- Sep 2015,/ On 10 Sep 2015, she felt like pharmacist injected too high, when injected felt a great pressure in arm and arm was hard to move without pain. She was taken to emergency room. The outcome of the events was unknown. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Eyelid oedema, Lip swelling, Pruritus, Urticaria
Clinical narrative: Case number PHHY2015US160735, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 601853) website on 24 Nov 2015. This report refers to a 35-year-old female patient. Past medical history included thyroid disease, anxiety, bulging disc and vitamin deficiency. The patient was allergic to LEXAPRO and sulfa. Concomitant medications included SYNTHROID, PAXIL, COLAC, iron vitamin B12, BUSPAR, vitamin D, melatonin and Probiotic. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 09 Oct 2015. On 10 Oct 2015, the patient experienced swollen eye lids, swollen lips, red itchy hives on neck, face, lips, arms butt and vaginal area. The patient was treated with BENADRYL 50 mg every 8 hours but the events did not get better. Further the patient had more swelling, hives persisted and the patient was forced to seek help on 11 Oct 2015 at urgent care center. The patient received a cortisone shot and week worth of steroids and would continue with BENADRYL 50 mg every 8 hours. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported. Seriousness of the events was upgraded based on information available in the source document.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Dyspnoea, Ear discomfort, Palpitations, Sneezing
Clinical narrative: Case number PHHY2015US157230, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602019) website on 24 Nov 2015. This report refers to a 78 years old male patient. Medical history and concurrent illness were none. Concomitant medication included Baby aspirin. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 12 Oct 2015. On the same day after vaccination the patient complained of sneezing, hard to breathe, forehead and ears on fire and heart pounding. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported. Seriousness assessment of "hard to breathe, sneezing and heart pounding were upgraded based on information in the source document.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, Dyskinesia, Eyelid function disorder, Facial paralysis, Headache
Clinical narrative: Case number PHHY2015US158254, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 602032) website on 24 Nov 2015. This report refers to a 29-year-old female patient. Medical history and current illness were none. Concomitant medication included Prenatal vitamins. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 25 Sep 2015. On 08 Oct 2015, the patient noticed that her tongue felt like burned and started to lose taste. On 09 Oct 2015, the patient developed pain on the left side of head under the ear. The patient thought it was a headache and took TYLENOL. On 10 Oct 2015, when the patient tried eating breakfast, the patient could not open the mouth all the way. The patient felt like she had gone to the dentist and she lost all feeling on the left side of the face. The patient thought she was experiencing a stroke because she could not close the left eye and could not smile or open mouth all the way. The left side of the patient's face was paralyzed. The patient could only experience taste on the right side of the tongue. the patient quickly called the doctor and was told to go to Urgent Care. The patient was then diagnosed with Bell's palsy in the emergency room and was prescribed Valacyclovir and Prednisone. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported. Seriousness of the event was upgraded based on information available in the source document.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Sensory loss, Tongue discomfort
Clinical narrative: Case number PHHY2015US158254, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 602032) website on 24 Nov 2015. This report refers to a 29-year-old female patient. Medical history and current illness were none. Concomitant medication included Prenatal vitamins. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) into the left arm on 25 Sep 2015. On 08 Oct 2015, the patient noticed that her tongue felt like burned and started to lose taste. On 09 Oct 2015, the patient developed pain on the left side of head under the ear. The patient thought it was a headache and took TYLENOL. On 10 Oct 2015, when the patient tried eating breakfast, the patient could not open the mouth all the way. The patient felt like she had gone to the dentist and she lost all feeling on the left side of the face. The patient thought she was experiencing a stroke because she could not close the left eye and could not smile or open mouth all the way. The left side of the patient's face was paralyzed. The patient could only experience taste on the right side of the tongue. the patient quickly called the doctor and was told to go to Urgent Care. The patient was then diagnosed with Bell's palsy in the emergency room and was prescribed Valacyclovir and Prednisone. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported. Seriousness of the event was upgraded based on information available in the source document.
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Nausea, Syncope, Tremor
Clinical narrative: Case number PHHY2015US161968, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 602146) website on 24 Nov 2015. This report refers to a 24-year-old female patient. Medical history was not reported. Vaccination history included administration of ENGERIX-B (batch number: not reported) which caused Vomiting and fainting. Patient had no current illness. Concomitant medication included LUTERA. The patient was vaccinated with FLUVIRIN (batch number: 157105) intramuscularly into left arm on 13 Oct 2015. On same day about 10 minutes after vaccination, the patient stared to feel hot, nauseous, dizzy and a little shaky. The patient rested for a few minutes and started to feel a little bit better so she went back to work, then started to feel even worse and about 10 minutes later she vomited for the first time. Patient then rested for 10 minutes then vomited a second time. The patient was laid down and fanning was started because she was still feeling the same symptoms. About 30 minutes after that, the patient vomited a third time. The patient was taken to the company nurse and she suggested taking the patient to the urgent care for a checkup. The outcome of the events was not reported. Seriousness of the events was reported as non serious and causality not reported.
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Case number PHHY2015US161968, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 602146) website on 24 Nov 2015. This report refers to a 24-year-old female patient. Medical history was not reported. Vaccination history included administration of ENGERIX-B (batch number: not reported) which caused Vomiting and fainting. Patient had no current illness. Concomitant medication included LUTERA. The patient was vaccinated with FLUVIRIN (batch number: 157105) intramuscularly into left arm on 13 Oct 2015. On same day about 10 minutes after vaccination, the patient stared to feel hot, nauseous, dizzy and a little shaky. The patient rested for a few minutes and started to feel a little bit better so she went back to work, then started to feel even worse and about 10 minutes later she vomited for the first time. Patient then rested for 10 minutes then vomited a second time. The patient was laid down and fanning was started because she was still feeling the same symptoms. About 30 minutes after that, the patient vomited a third time. The patient was taken to the company nurse and she suggested taking the patient to the urgent care for a checkup. The outcome of the events was not reported. Seriousness of the events was reported as non serious and causality not reported.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Case number PHHY2015US164273, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602151) website on 14 Dec 2015. This report refers to a 47 years old female patient. Medical history included fibromyalgia. Concomitant medication included CYMBALTA. The patient was vaccinated with FLUVIRIN (batch number: 157904) intramuscularly into right arm on 13 Oct 2015. On the same day, 10 minutes after vaccination, the experienced black vision around the edges. Symptom subsided about 1 hour after onset. The case was assessed as non-serious. Causality of the event was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Grip strength decreased, Hypoaesthesia, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2015US169235, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602163) website on 14 Dec 2015. This report refers to a 62-years-old female patient. Past medical history was not reported. Concomitant medications included Alendronate, naproxen (manufacturer unknown), tramadol (manufacturer unknown) and VAGIFEM. The patient was vaccinated with FLUVIRIN (manufacturer unknown and batch number: 1514601) intramuscularly in right arm on 22 Sep 2015. The patient was also vaccinated with ZOSTAVAX (manufacturer unknown and batch number: K020186) subcutaneously in left arm on 22 Sep 2015. On 27 Sep 2015, the patient experienced pain in right arm and could not hold pen, arm was numb and could not move. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLUC3
Symptoms: Eye pruritus, Fatigue, Pruritus
Clinical narrative: Case number PHHY2015US165493, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 602171) website on 14 Dec 2015. This report refers to a 53-year-old female patient. Historical condition was not reported. Vaccination history included administration of Varicella vaccine and unsure if it caused adverse reaction. Current conditions included allergy to clonazepam, sulfa, iodine, varicella virus vaccine live, cats and dogs and current illness reported as none. Concomitant medication included ranitidine (manufacturer unknown) 150mg, SINGULAIR 10 mg, budesonide (manufacturer unknown) 0.25 mg/2 ml, doxycycline (manufacturer unknown) 100mg, TYLENOL, Acidophilus, atorvastatin (manufacturer unknown) 20mg, biotin (manufacturer unknown), CLARITIN, cyclobenzaprine (manufacturer unknown), DEPAKOTE, fish oil, losartan potassium (manufacturer unknown) 100mg, MUCINEX ER, NASONEX, PRO-AIR, progesterone (manufacturer unknown). The patient was vaccinated with FLUCELVAX (batch number: 173538) intramuscularly in to left arm on 06 Oct 2015. On same day after vaccination, the patient experienced body itching, itchy eyes and fatigue. The patient was treated with BENADRYL every 6 hours and she would start treatment regimen which included antihistamines and MEDROL dose pack. The patient was advised to visit emergency room if the symptoms worsen. The outcome of the events was reported as complete recovery. Seriousness of the events was reported as non serious and causality not reported. Seriousness assessment of the events pruritus generalised was upgraded based on information available in the source document.
Age: 17.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Pyrexia
Clinical narrative: Case number PHHY2015US171369 is an initial spontaneous report received from a consumer via Vaccine Adverse Events Reporting System (VAERS reference number: 602663) on 29 Dec 2015. This report refers to a 17 year old male patient. Past medical history, current condition and concomitant medications were unknown. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date after vaccination, the patient experienced fever and chills. He was hospitalized due to the events. No laboratory investigations were reported. The patient was treated with TYLENOL and BENADRYL and was discharged from the hospital. The final outcome of the events was unknown. The causality of the events was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Nodule, Scan with contrast abnormal
Clinical narrative: Case number PHHY2016US009766, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602796) website on 18 Jan 2016. This report refers to a 54-years-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 157605) intramuscularly in left arm on 18 Sep 2015. On 21 Sep 2015, she experienced lymph nodes swelling on left side, same as injection site. It was also reported that, contrast dye indicated nodule. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Cough, Generalised erythema, Injection site urticaria, Nasal pruritus
Clinical narrative: Case number PHHY2015US171214 is an initial spontaneous report via Vaccine Adverse Events Reporting System (VAERS reference number: 602837) on 29 Dec 2015. This report refers to a 31 year old female patient. Her medical history included tachycardia. Her current conditions included nonessential hand tremors, migraine, asthma and juvenile myoclonic epilepsy. Her concomitant medications were XANAX 0.5 mg via oral route at bedtime whenever required before sleep, melatonin 10 mg via oral route at bed time whenever required before sleep and MAXALT 10 mg for the treatment of migraine at a dose of 10 mg via oral route when required. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 10 Oct 2015. On the same day after vaccination, she started with hives at the vaccination site. She then had itching all over and her entire body turned red. Her throat and nose became itchy and she was feeling them as swollen. She also had wheezing, cough and it was reported that she had anaphylactic reaction. She went to emergency room. The final outcome of the event was reported as complete recovery. The events were reported as life threatening. The causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema, Pruritus generalised, Swelling, Throat irritation, Wheezing
Clinical narrative: Case number PHHY2015US171214 is an initial spontaneous report via Vaccine Adverse Events Reporting System (VAERS reference number: 602837) on 29 Dec 2015. This report refers to a 31 year old female patient. Her medical history included tachycardia. Her current conditions included nonessential hand tremors, migraine, asthma and juvenile myoclonic epilepsy. Her concomitant medications were XANAX 0.5 mg via oral route at bedtime whenever required before sleep, melatonin 10 mg via oral route at bed time whenever required before sleep and MAXALT 10 mg for the treatment of migraine at a dose of 10 mg via oral route when required. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on 10 Oct 2015. On the same day after vaccination, she started with hives at the vaccination site. She then had itching all over and her entire body turned red. Her throat and nose became itchy and she was feeling them as swollen. She also had wheezing, cough and it was reported that she had anaphylactic reaction. She went to emergency room. The final outcome of the event was reported as complete recovery. The events were reported as life threatening. The causality of the event was not reported.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Body temperature increased, Chest X-ray, Electrocardiogram, Full blood count
Clinical narrative: Case number PHHY2015US171512, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602848) website on 29 Dec 2015. This report refers to a 26-year-old female patient. Current illness was none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the left arm on 14 Oct 2015. On the same day two minutes after vaccination the patient experienced throat swelling. Further, the patient developed severe body aches, including muscles, skin and joints. The patient had a syncopal episode and temperature rose to a maximum of 102.5. The patient underwent chest X ray, electrocardiogram, complete blood count, metabolic function test and flu swab tests (results not reported). Final outcome of the events was recovered.  Events were reported as non-serious. Causality was not reported. Seriousness of the event was upgraded based on information available in the source document.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza virus test, Metabolic function test, Myalgia, Pain, Pain of skin
Clinical narrative: Case number PHHY2015US171512, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602848) website on 29 Dec 2015. This report refers to a 26-year-old female patient. Current illness was none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the left arm on 14 Oct 2015. On the same day two minutes after vaccination the patient experienced throat swelling. Further, the patient developed severe body aches, including muscles, skin and joints. The patient had a syncopal episode and temperature rose to a maximum of 102.5. The patient underwent chest X ray, electrocardiogram, complete blood count, metabolic function test and flu swab tests (results not reported). Final outcome of the events was recovered.  Events were reported as non-serious. Causality was not reported. Seriousness of the event was upgraded based on information available in the source document.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema, Syncope
Clinical narrative: Case number PHHY2015US171512, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 602848) website on 29 Dec 2015. This report refers to a 26-year-old female patient. Current illness was none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly into the left arm on 14 Oct 2015. On the same day two minutes after vaccination the patient experienced throat swelling. Further, the patient developed severe body aches, including muscles, skin and joints. The patient had a syncopal episode and temperature rose to a maximum of 102.5. The patient underwent chest X ray, electrocardiogram, complete blood count, metabolic function test and flu swab tests (results not reported). Final outcome of the events was recovered.  Events were reported as non-serious. Causality was not reported. Seriousness of the event was upgraded based on information available in the source document.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2016US009844, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 602904) on 18 Jan 2016. This report refers to a 70 years old female patient. Past medical history was not reported. Current conditions included mental retardation, congestive heart failure, hypertension and diabetes. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1515701) into the right arm and PNEUMOVAX (other manufacturer) (batch number: L012215) into the right arm; both intramuscularly on 13 Oct 2015. After vaccination, on 16 Oct 2015, she experienced warm to touch down to her elbow and it was red and swollen. Outcome of the events was reported as unknown. The events were assessed as non serious and causality was not reported. Following an internal review done on 27 Jan 2016 for the data received on MRD 18 Jan 2016: A significant case correction was done. Changed coding of verbatim warm to touch down to her elbow and it was red and swollen to arm swelling instead of swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Drug administered at inappropriate site, Extra dose administered, Wrong drug administered
Clinical narrative: Case number PHHY2016US009665, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602930) website on 18 Jan 2016. This report refers to a 04-years-old male patient. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 15722P) subcutaneously in right leg, DAPTACEL (manufacturer unknown and batch number: C4457AA) intramuscularly in arm, MMR II (manufacturer unknown and batch number: L003859) subcutaneously in leg, IPOL (manufacturer unknown and batch number: L11301) intramuscularly in leg and VARIVAX (manufacturer unknown and batch number: L011083) intramuscularly in arm on 15 Oct 2015. On the same day, the medical assistant drew 2 wrong shots from wrong pockets and administered to patient. He was given 3 flu shots by accident. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Case number PHHY2016US009723, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 602964) website on 18 Jan 2016. This report refers to a 20 years old female patient. Past medical history included as IGA deficiency. Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514901) into right arm, intramuscularly on 08 Oct 2015. On the same day (reported as 24 hours after vaccination) after vaccination, the patient experienced numbness on the right side of her face. The patient visited to the emergency room. The patient treated with prednisone (manufacturer unknown). The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non-serious. The causality of the events was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Case number PHHY2016US011272, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603006) website on 18 Jan 2016. This report refers to a 48 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) intramuscularly in left arm at a dose of 1 ml on 14 Oct 2015. No adverse event was reported following this maladministration (overdose).
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2016US011326, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603007) website on 18 Jan 2016. This report refers to a 42 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) intramuscularly in right arm on 14 Oct 2015. It was reported the patient received 1 ml of FLUVIRIN instead of the recommended 0.5 ml dose. No adverse event was reported following this maladministration.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHHY2016US011231, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 603010) on 18 Jan 2016. This report refers to a 44 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515601) at a dose of 1 ml intramuscularly into left arm on 14 Oct 2015. It was reported that over dosage of FLUVIRIN was administered in error. The case was assessed as non-serious. No adverse event was reported.