chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling
Clinical narrative: Case number PHHY2017US014397, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 667231) on 23 Jan 2017. This report refers to a 51 years old male patient. Historical condition was not reported. Current condition included various allergies (not to eggs). Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 18 Nov 2016. On same day after vaccination, the patient started with pain, redness, swelling quite a bit and hard feeling, progressed to become crazy itchy while also painful, from there it became body rash. After a couple of days the patient was taking BENADRYL. The outcome of the events was reported as unknown. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event rash generalized was upgraded to medically significant based on the information available in the source document.
Age: 0.5
Sex: F
Vaccine: DTAP, FLUX, HIBV, RVX
Symptoms: Cyanosis, Electroencephalogram abnormal, Eye movement disorder, Febrile convulsion, Foaming at mouth
Clinical narrative: Case number PHHY2017US010627, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 667509) on 23 Jan 2017. This report refers to a 06-month-old neonate female patient. The patient had no reported medical history and current conditions. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) and rotavirus; both administered into left leg and DTAP and HIB; both administered into right leg on 14 Nov 2016. It was reported that the patient who was a healthy child had received her regular 6 month vaccinations and at seventh month included the flu shot. On 15 Nov 2016, around 1:30 am, first seizure occurred. She blanked out and started foaming at the mouth. Emergency was called and nothing was really done and she was sent back home. On 15 Nov 2016, at 8 am, another seizure occurred. This time she was in a blank state and face and lips turned purple/ blue. Emergency was called again and her eyes began to roll back while in ambulance. They took an anal temperature and had a fever of 102. She was given MOTRIN and TYLENOL and had her go to her primary physician the same day. Her physician requested an electroencephalogram (EEG) and was told that she had abnormal results. She was put on KEPPRA 100 mg but was taken off and put on another type of medication that was a suppository (details not reported). It was reported that she had febrile seizure. The outcome of the events was unknown. The events were reported as non-serious by the reporter. The causality of the events was not reported. Seriousness assessment of the event febrile seizure were upgraded medically significant based on the information available in the source document.
Age: 0.5
Sex: F
Vaccine: DTAP, FLUX, HIBV, RVX
Symptoms: Loss of consciousness, Pyrexia, Seizure
Clinical narrative: Case number PHHY2017US010627, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 667509) on 23 Jan 2017. This report refers to a 06-month-old neonate female patient. The patient had no reported medical history and current conditions. Concomitant medications were not reported. The patient was vaccinated with seasonal influenza virus vaccine (manufacturer and batch number: not reported) and rotavirus; both administered into left leg and DTAP and HIB; both administered into right leg on 14 Nov 2016. It was reported that the patient who was a healthy child had received her regular 6 month vaccinations and at seventh month included the flu shot. On 15 Nov 2016, around 1:30 am, first seizure occurred. She blanked out and started foaming at the mouth. Emergency was called and nothing was really done and she was sent back home. On 15 Nov 2016, at 8 am, another seizure occurred. This time she was in a blank state and face and lips turned purple/ blue. Emergency was called again and her eyes began to roll back while in ambulance. They took an anal temperature and had a fever of 102. She was given MOTRIN and TYLENOL and had her go to her primary physician the same day. Her physician requested an electroencephalogram (EEG) and was told that she had abnormal results. She was put on KEPPRA 100 mg but was taken off and put on another type of medication that was a suppository (details not reported). It was reported that she had febrile seizure. The outcome of the events was unknown. The events were reported as non-serious by the reporter. The causality of the events was not reported. Seriousness assessment of the event febrile seizure were upgraded medically significant based on the information available in the source document.
Age: 44.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy, Blister, Full blood count, Urticaria
Clinical narrative: Case number PHHY2017US022324, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 667511) on 23 Jan 2017. This report refers to a  44-year-old male patient. Medical history was not reported. Past medication included Aspirin. The patient had no reported current condition. Concomitant medication included prednisone. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) administered subcutaneously into left arm on 14 Nov 2016. On 15 Nov 2016, the patient developed hives on legs, arms and back and blisters on both hands. On an unknown date, the patient had biopsy and also underwent the test for complete blood count (CBC). The patient visited the emergency room on an unknown date. The outcome of the events was reported as unknown. The events were reported as non-serious by the reporter. The causality of the events was not reported.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Fatigue, Headache, Pain
Clinical narrative: Case number PHHY2017US020619, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 667529) website on 23 Jan 2017. This report refers to a 59 years old female patient. Past medical history was not reported. Current conditions included as high blood pressure and allergies to mold. Concomitant medications included as high blood pressure medication (unspecified) and EFFEXOR. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm on 20 Nov 2016. On 21 Nov 2016, the patient experienced coughing, low fever, body achy, hoarseness, tired and sinus drainage. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Paranasal sinus hypersecretion, Pyrexia
Clinical narrative: Case number PHHY2017US020619, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 667529) website on 23 Jan 2017. This report refers to a 59 years old female patient. Past medical history was not reported. Current conditions included as high blood pressure and allergies to mold. Concomitant medications included as high blood pressure medication (unspecified) and EFFEXOR. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) into left arm on 20 Nov 2016. On 21 Nov 2016, the patient experienced coughing, low fever, body achy, hoarseness, tired and sinus drainage. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Hypersensitivity, Wheezing
Clinical narrative: Case number PHHY2017US013753, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 667576) website on 23 Jan 2017. This report refers to a 28 years old female patient. Past medical history included as pregnancy. Current conditions included as asthma and environmental allergies. Concomitant medication included as Albuterol. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) intramuscularly on 19 Sep 2016. On the same day after vaccination, the patient waking form her sleep because she was unable to breathe. On 19 Sep 2016, the patient had cough and wheezing several hours after the flu shot- which worsened overnight. Patient went to the emergency room. Patient had persistent shortness of breath (SOB)/wheezing and used her albuterol inhaler and did okay. next day patient feeling fine to primary care provider (PCP). On 19 Sep 2016, patient suffered with allergic reaction to the flu shot and she should never receive it again. The outcome of the events was reported as condition unchanged. The serious and causality of the events were not reported. The seriousness assessment to the event hypersensitivity was upgraded to serious (medically significant) based on the information available in the source document.
Age: 1.0
Sex: M
Vaccine: FLUX, HEPA, MMRV
Symptoms: Febrile convulsion
Clinical narrative: Case number PHHY2017US014527 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 667842) website on 23 Jan 2017. This report refers to 01 year old male patient. Medical history was not reported. Concomitant medication included cyproheptadine and MCT oil (medium chain triglycerides). This one year old patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number: not reported) on 15 Nov 2016. The patient was vaccinated with Hepatitis A vaccine (manufacturer unknown, batch number: not reported) and PROQUAD (manufacturer unknown, batch number: not reported) on 15 Nov 2016. After vaccination patient experienced febrile seizure, which occurred 80 hours after vaccination. Following the events the patient visited emergency room. The final outcome of the event febrile seizure was reported as complete recovery on an unknown date. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the event febrile convulsions (medically significant) was upgraded based on the information available in the source document.
Age: 13.0
Sex: F
Vaccine: FLUX, HPVX
Symptoms: Syncope
Clinical narrative: Case number PHHY2017US014608, is an initial spontaneous report received from a Vaccine Adverse Event Reporting System (VAERS reference number: 668030) website on 23 Jan 2017. This report refers to a 13 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer and batch number: not reported) on 23 Nov 2016. The patient also vaccinated with HPV vaccine (other manufacture and batch number: not reported) on 23 Nov 2016. On the same day after vaccination, the patient experienced syncope. The outcome of the event was reported as complete recovery on an unknown date. The seriousness and causality of the event were not reported. The seriousness assessment of syncope was upgraded to serious (medically significant) based on the information available in the source document.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Back pain, Blood test, Loss of personal independence in daily activities, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2017US020180, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668181) website on 23 Jan 2017. This report refers to a 55 years old female patient. Historical condition was not reported. Current condition was reported as none. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) and TDAP (unknown manufacturer, batch number not reported); on 20 Sep 2016. After vaccination, on 21 Sep 2016, she started to feel pain in her lower back. As time went by, she started feeling pain in her left leg. She stated it was painful, muscle tightening and stiffness. She could not take a shower, she had to take a wash up with a bucket, she was in her room sitting on bed and it was hard for her to get in and out of the car. She also had a hard time sitting on the toilet and getting off. She went to the emergency room on 07 Oct 2016 and they gave her an X-ray (details unspecified) and on 11 Oct 2016 they took her blood. They did not give her anything to take. She went to the doctor on 27 Oct 2016 and he took two X-rays. He gave her some gabapentin 300 mg and diclofenac 75 mg. It was reported that on 15 Nov 2016, she would seek further treatment. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 55.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Pain in extremity, X-ray
Clinical narrative: Case number PHHY2017US020180, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 668181) website on 23 Jan 2017. This report refers to a 55 years old female patient. Historical condition was not reported. Current condition was reported as none. Concomitant medication was not reported. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) and TDAP (unknown manufacturer, batch number not reported); on 20 Sep 2016. After vaccination, on 21 Sep 2016, she started to feel pain in her lower back. As time went by, she started feeling pain in her left leg. She stated it was painful, muscle tightening and stiffness. She could not take a shower, she had to take a wash up with a bucket, she was in her room sitting on bed and it was hard for her to get in and out of the car. She also had a hard time sitting on the toilet and getting off. She went to the emergency room on 07 Oct 2016 and they gave her an X-ray (details unspecified) and on 11 Oct 2016 they took her blood. They did not give her anything to take. She went to the doctor on 27 Oct 2016 and he took two X-rays. He gave her some gabapentin 300 mg and diclofenac 75 mg. It was reported that on 15 Nov 2016, she would seek further treatment. The outcome of the events was condition unchanged. The seriousness and causality of the events were not reported.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Allergy to vaccine, Feeling cold, Headache, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2016US031444, is an initial spontaneous report received from a pharmacist on 29 Nov 2016. This report refers to a 66-years-old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (manufacturer unknown and batch number: 165902) at a dose of 0.5 ml intramuscularly on 22 Nov 2016. On 28 Nov 2016, the patient visited physician and he said that patient was allergic to FLUAD. On an unknown date after vaccination, the patient experienced headache, pain at injection site, swelling at injection site, felt cold and a band of swelling around the arm where shot was given. The patient has had flu shots in the past with no problems. The patient did not have treatment for the symptoms. The outcome of the event allergic to FLUAD was unknown and for other events was not reported. The seriousness and causality of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Fatigue
Clinical narrative: Case number PHHY2017US022418, is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 669377) website on 23 Jan 2017. This report refers to a 66 years old female patient. Past medical history was not reported. Current condition included lower back stenosis. Concomitant medications included gabapentin, tramadol, CELEBREX, omeprazole, CRESTOR and amlodipine. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) on 30 Nov 2016. On 01 Dec 2016 after vaccination at 16:00, the patient experienced extreme fatigue and about 20:00 she experienced temperature of 103 degrees. By the next morning her temperature was normal and felt tired but okay. The outcome of the events was reported as complete recovery on an unspecified date. The seriousness and causality of the events were not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Body temperature decreased, Chills, Headache
Clinical narrative: Case number PHHY2017US021281 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 670430) website on 23 Jan 2017. This report refers to a 57 year old male patient. Prior vaccination history included vaccination with influenza vaccine (unknown whether seasonal or pandemic, other manufacturer) and patient experienced chills, low temperature, shivers, weakness and headache (see case: PHHY2017US021309). Historical condition included West Nile virus in 2003. On an unknown date in 2003 patient had been tested for the West Nile virus antibodies (results and normal range not specified). Current condition and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) into arm on 20 Sep 2015. On the same day after vaccination, patient experienced chills, low temperature, shivers, weakness and headache. It was also reported that patient experienced the same events every time flu shot had been administered for the past 6 years (time period for each season was not specified). The outcome of the events chills, body temperature decreased, asthenia and headache was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious and causality was not reported.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Body temperature decreased, Chills, Headache
Clinical narrative: Case number PHHY2017US021309 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 670430) website on 23 Jan 2017. This report refers to an adult male patient of unspecified age. Historical condition included West Nile virus in 2003. On an unknown date in 2003 patient had been tested for the West Nile virus antibodies (results and normal range not specified). Current condition and concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine INN (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unspecified date, it was reported that the patient experienced chills, low temperature, shivers, weakness and headache. The outcome, seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Grip strength decreased, Hypoaesthesia, Mobility decreased, Muscle spasms
Clinical narrative: Case number PHHY2017US020527, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 670535) website on 23 Jan 2017. This report refers to a 62 years old female patient. Past vaccination history included patient was received unspecified vaccines and never had any problems. Current condition included arthritis. Concomitant medication included oxybutynin, oxycodone, omeprazole, loratadine, nortriptyline, ATRAVANT, PROAIR, gabapentin, Baby aspirin, Calcium, Super B , Vitamin C, vitamin D and ammonium lactate. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) and PREVNAR 13 (other manufacturer, batch number: not reported); into left arm on 14 Oct 2016. After vaccination, on 15 Oct 2016, she experienced that her left arm felt stiff and sore. On 16 Oct 2015, she could not move arm and it bothered her ever since. She kept getting Charlie horse constantly at night and would wake her up in pain. On 27 Oct 2016, a doctor prescribed cortisone/steroids but she did not take it. She no longer had Charley horse but could not sleep well because of the pain. She could not trust movement in arm would drop things. She was not sure it hit a nerve or had a reaction. She experienced problems in arm, joint pain, limited movement, pain from shoulder down to arm, her arm went to sleep, and it was not as painful as Charley horse but still was nerve racking because she could not trust moment in arm. It was reported that she had a scheduled appointment on 30 Nov 2016 and 30 Dec 2016. She visited the emergency room. The outcome of Charley horse was reported as complete recovery on an unknown date and for other events it was not reported. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Musculoskeletal stiffness, Pain in extremity, Sleep disorder
Clinical narrative: Case number PHHY2017US020527, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 670535) website on 23 Jan 2017. This report refers to a 62 years old female patient. Past vaccination history included patient was received unspecified vaccines and never had any problems. Current condition included arthritis. Concomitant medication included oxybutynin, oxycodone, omeprazole, loratadine, nortriptyline, ATRAVANT, PROAIR, gabapentin, Baby aspirin, Calcium, Super B , Vitamin C, vitamin D and ammonium lactate. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) and PREVNAR 13 (other manufacturer, batch number: not reported); into left arm on 14 Oct 2016. After vaccination, on 15 Oct 2016, she experienced that her left arm felt stiff and sore. On 16 Oct 2015, she could not move arm and it bothered her ever since. She kept getting Charlie horse constantly at night and would wake her up in pain. On 27 Oct 2016, a doctor prescribed cortisone/steroids but she did not take it. She no longer had Charley horse but could not sleep well because of the pain. She could not trust movement in arm would drop things. She was not sure it hit a nerve or had a reaction. She experienced problems in arm, joint pain, limited movement, pain from shoulder down to arm, her arm went to sleep, and it was not as painful as Charley horse but still was nerve racking because she could not trust moment in arm. It was reported that she had a scheduled appointment on 30 Nov 2016 and 30 Dec 2016. She visited the emergency room. The outcome of Charley horse was reported as complete recovery on an unknown date and for other events it was not reported. The seriousness and causality of the events were not reported.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUX, MMR
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: Case number PHHY2017US015696, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 670771) website on 23 Jan 2017. This report refers to a 04 years old female patient. Past medical history was not reported. Concomitant medication included Ibuprofen. The patient was vaccinated with seasonal influenza virus vaccine INN (unknown manufacturer, batch number: not reported) 07 Dec 2016. The patient was also vaccinated with DTAP (manufacturer unknown, batch number: not reported) and MMR (unknown manufacturer, batch number: not reported) both on 07 Dec 2016. On 08 Dec 2016 after receiving the vaccine the patient experienced swelling, erythema, tenderness and streaking consistent with cellulitis within 24 hours. No abscess were reported at this time. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events were not reported. The seriousness assessment of the event cellulitis was upgraded (medically significant) based on the Novartis Important Medical Events list.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Pain in extremity, Pain of skin, Rash generalised, Skin exfoliation
Clinical narrative: Case number PHHY2017US015443, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 671656) on 23 Jan 2017. This report refers to a 51 years old male patient. Medical history was reported as none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 20 Sep 2016. On 23 Sep 2016 after vaccination, the patient developed hives and rash over body, hands and feet developed a shingles like pain, could barely walk or touch anything without severe pain, all the skin on hands and feet peeled off and was very, very painful. The patient visited emergency room on an unknown date. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events rash generalised, urticaria, were upgraded to medically significant based on the information available in the source document.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2017US015443, is an initial spontaneous report received from Vaccine Adverse Events Reporting System (VAERS reference number: 671656) on 23 Jan 2017. This report refers to a 51 years old male patient. Medical history was reported as none. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number: not reported) on 20 Sep 2016. On 23 Sep 2016 after vaccination, the patient developed hives and rash over body, hands and feet developed a shingles like pain, could barely walk or touch anything without severe pain, all the skin on hands and feet peeled off and was very, very painful. The patient visited emergency room on an unknown date. The outcome of the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the events rash generalised, urticaria, were upgraded to medically significant based on the information available in the source document.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site reaction
Clinical narrative: Case number PHHY2017US019303 is an initial spontaneous report received from consumer via Vaccine Adverse Event Reporting System (VAERS number: 672032) website on 23 Jan 2017. This report refers to a female patient of unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with Influenza virus vaccine (unknown whether seasonal or pandemic) on an unspecified date in 2015, and had similar vaccination site reaction. The outcome of the event was not reported, seriousness of the event was non serious and causality of the event was not reported.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2017US022410, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 672228) website on 23 Jan 2017. This report refers to a 61 years old female patient. Her medical history included shortness of breath, gastrointestinal reflux disease, gastric ulcer and ptosis of right eyelid. Current conditions included coronary artery disease, acute myocardial infarction, prediabetes, osteoarthritis, pulmonary emphysema and iron deficiency anaemia. Concomitant medications included Acetaminophen, Albuterol, Aspirin, atorvastatin, bumetanide, cetirizine, ezetimibe, fluticasone, hydralazine, magnesium oxide, metformin, montelukast, omeprazole, potassium chloride and ranitidine. She was vaccinated with seasonal influenza vaccine INN (manufacturer unknown, batch number not reported) and pneumococcal vaccine (unknown manufacturer, batch number: not reported); intramuscularly into the left deltoid on 31 Oct 2016. Within an hour of the combination vaccination, the patient developed significant swelling, redness, and pain spreading down the (L) arm and persisted for several days. She did not report anaphylactic symptoms and her arm pain and swelling improved with symptomatic management. The outcome of the redness was reported as condition unchanged while it was condition improving for arm pain and swelling. The seriousness and causality of the events were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Case number PHHY2017US021046, is an initial spontaneous report received from a health care professional via Vaccine Adverse Event Reporting System (VAERS: 672370) website on 23 Jan 2017. This report refers to a 37-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with seasonal influenza virus vaccine INN (manufacturer unknown, batch number not reported) on 15 Oct 2016. On the same day of vaccination the patient experienced soreness in left arm, reduced mobility, difficulty raising arm above shoulder or across the body and sharp pain. Outcome of the events were reported as condition unchanged. Seriousness of the events were reported as non serious and causality was not reported.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL, VARCEL
Symptoms: Ear infection, Rash, Rash vesicular, Varicella post vaccine
Clinical narrative: Patient woke up 3-11-17 w rash all over body and Mother noticed that throat swollen. Mother in contact with Primary Care Provider Dr. On 3-10-17 Amoxicillin started for ear infection with 2 doses on Friday. Had rash over most of body, not hives. Mostly lower legs, present on face, cheek and anterior chest.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL, VARCEL
Symptoms: Ear infection, Pharyngeal oedema, Rash generalised
Clinical narrative: Patient woke up 3-11-17 w rash all over body and Mother noticed that throat swollen. Mother in contact with Primary Care Provider Dr. On 3-10-17 Amoxicillin started for ear infection with 2 doses on Friday. Had rash over most of body, not hives. Mostly lower legs, present on face, cheek and anterior chest.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Crying, Culture urine, Differential white blood cell count, Dizziness, Fall
Clinical narrative: Patient received 3rd GARDASIL injection and became unconscious for less than one minute. Upon awakening the patient stated she could not hear.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Fear of injection, Full blood count, Human chorionic gonadotropin, Hypersensitivity, Hypoacusis
Clinical narrative: Patient received 3rd GARDASIL injection and became unconscious for less than one minute. Upon awakening the patient stated she could not hear.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Hypotension, Metabolic function test, Rash, Restlessness, Seizure
Clinical narrative: Patient received 3rd GARDASIL injection and became unconscious for less than one minute. Upon awakening the patient stated she could not hear.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Syncope, Tinnitus, Visual impairment
Clinical narrative: Patient received 3rd GARDASIL injection and became unconscious for less than one minute. Upon awakening the patient stated she could not hear.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Muscle rigidity, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient received 3rd GARDASIL injection and became unconscious for less than one minute. Upon awakening the patient stated she could not hear.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPVX
Symptoms: Deafness, Loss of consciousness
Clinical narrative: Patient received 3rd GARDASIL injection and became unconscious for less than one minute. Upon awakening the patient stated she could not hear.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Condition aggravated, Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Worsening of peripheral neuropathy with numbness and gait instability starting 3 days after influenza vaccine.  Electrodiagnostic findings consistent with Guillain-Barre syndrome.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Neuropathy peripheral
Clinical narrative: Worsening of peripheral neuropathy with numbness and gait instability starting 3 days after influenza vaccine.  Electrodiagnostic findings consistent with Guillain-Barre syndrome.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning to a patient of an unknown age or gender. There was no information about the patient's concurrent conditions, medical history, drug reactions, allergies or concomitant medications. On 30-JUN-2016, the patient was vaccinated with the first dose of ZOSTAVAX (lot # L039126 and expiration date of 08-JAN-2017) 0.65 ml, subcutaneously for prophylaxis. On 07-MAR-2017, the patient received the 2nd dose of ZOSTAVAX (lot # M035147 and expiration date of 25-OCT-2017) with the same dose, route and indication as the first dose. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a physician via medical records through Pfizer (manufacturer control #2017086232) refers to a currently 57-year-old female patient. No information on the patient's concurrent conditions, medical history and concomitant therapies was reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), reported as "pneumococcal polysaccharides". The outcome of the event was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. All available medical records will be provided upon request. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: This spontaneous report was received from a physician, via company representative concerning to a patient of an unknown age or gender. Information about the patient's medical history or concomitant medication was unknown by the reporter. The patient had alpha-gal allergy (Mammalian Meat Allergy). On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not reported) as immunization. On an unspecified date, the patient developed an unknown delayed reaction to the vaccine. At the time of reporting, the patient status was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA, HPV9, MMR, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medication were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored ROTATEQ, GARDASIL 9, PNEUMOVAX 23, M-M-R II and VAQTA (dose, route, lot numbers and expiration dates were not provided) for prophylaxis. No adverse effects were reported. The temperature for the vaccines stored was 32 degrees Fahrenheit to 35 degrees Fahrenheit with 143 hours and 27 minutes time frame. On the "28th" of an unspecified month and unspecified year, there was a previous temperature excursion (unknown temperature and time frame). The call was not because of a data logger. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses of VAQTA for prophylaxis, lot # M039202 with expiration date of 11-MAR-2018 (dose and route were not reported). No adverse effects were reported. The vaccine had an excursion during 5 hours 23 minutes with a temperature of  0°C to 1°C, no, data logger was involved. There was no previous temperature excursion. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA012670: US-009507513-1703USA012671: US-009507513-1703USA012672:
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician (also the patient's mother) via an employee from Pfizer concerning a 3 year old male patient. The patient was constantly sick with chronic sinusitis. On an unknown date when the patient was 12 month old, he received PREVNAR 13 and finished the four doses on time. On 29-DEC-2016, the patient had titer level test and the result showed he had no response to PREVNAR 13. On 12-JAN-2017, the patient was vaccinated with one dose of PNEUMOVAX23 (dose, route, lot# and expiration date were unknown) for prophylaxis. On 22-FEB-2017, the patient did a Titer level test. The result showed that the patient did respond to a few of the stereotypes in PNEUOMOVAX but there were still a lot of stereotypes which the patient did not respond to. The reporter considered PNEUMOVAX23 was not successful. The outcome of the event and the causality between the event and PNEUMOVAX23 were unknown.       Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient received a dose of with ZOSTAVAX vial 19400 PFU (dose, route of administration, lot number and expiration date were not provided) for prevention of shingles.  On an unspecified date in December 2016, the patient developed a case of shingles (herpes zoster) on an unknown location which was an unknown amount of time after receiving ZOSTAVAX. The patient visited the physician but it was unknown whether a treatment was given for the adverse event. At the time of the report, the outcome of herpes zoster was unknown. The causal relationship between herpes zoster and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from a Certified medical assistant, who also was reported to be the administrator, and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date, the patient received a dose of GARDASIL 9 for prophylaxis (formulation, strength, dose, frequency, route of administration, anatomical location, lot # and expiration date were not reported). On an unspecified date, the patient had an unspecified adverse event after the administration of GARDASIL 9 (adverse event following immunisation). At the time of reporting, the status of the patient was unknown by the reporter. The relationship between GARDASIL 9 and the event was not provided. Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information about concurrent conditions, medical history, concomitant medications and drug reactions or allergies was not provided. On 23-MAR-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M010476, expiration date 09-JAN-2017, dose and route of administration were not reported), for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 6 to 14 degrees Fahrenheit for 6 hours, 40 minutes; 15 to 46 degrees Fahrenheit for 8 hours, 30 minutes; and 47 to 77 degrees Fahrenheit for 1 hour, 40 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 23-MAR-2017, the patient was vaccinated with an expired dose of ZOSTAVAX 19,400 plaque-forming units (PFU) (Lot # L046897 and expiration date 23-MAR-2017) for prophylaxis (dose, frequency, route of administration and anatomical location were not reported) (expired product administered). There were no adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB, for prophylaxis, reported lot # M037248 expiration date 21-FEB-2019 (dose, frequency, anatomical location and route were not reported). The administered doses of the vaccine experienced a temperature excursion of 0°C to 1°degrees Celsius for 4 hours 39 min. It was also reported that the vaccine experienced  previous excursions of  0°C to 1°degrees Celsius for 5 hours 23 minutes. The temperature excursions were detected by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA012671: US-009507513-1703USA012672: US-009507513-1703USA007486.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot # M046134 (doses, route of administration, anatomical location and expiration date were not reported). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion between -1 degree Celsius to -2 degree Celsius which was detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1703USA014122: US-009507513-1703USA014120: US-009507513-1703USA014121:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the office manager and refers to multiple unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M014544, expiration date 27-NOV-2017; lot # M007125, expiration date 06-OCT-2017; lot #M007301, expiration date 19-NOV-2017, administered orally (dose was not reported) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 47°Fahrenheit (F) to 77°F (48F), for a time frame of 8 hours. There was a previous temperature excursion, the total time in the range 47°F to 77°F (55F) for 8 hours. There was no data logger. No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Vaccination site pain
Clinical narrative: This solicited report has been received from a nurse concerning a 46 year old female patient was enrolled in a market research program conducted by an agency.The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in July 2007 the patient was vaccinated with GARDASIL (dose, lot number and route of administration not provided) for prophylaxis. The patient reported that vaccination was painful but she continued with remaining doses on unknown dates in August 2007 and February 2008. The patient completed the series of vaccination. The outcome of painful experience was reported as recovered with sequelae on an unknown date in February 2008. The relationship between vaccination with GARDASIL and the event was unknown (also reported as not applicable). Additional information is not expected as the reporter did not give the consent to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the office manager and refers to multiple unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017; lot # L048459, expiration date 22-FEB-2018; lot # M028323; expiration date 26-SEP-2018; and lot # L037554, expiration date 25-DEC-2017 (dose and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 47° Fahrenheit (F) to 77°F (48F), for a time frame of 8 hours. There was a previous temperature excursion, the total time in the range 47°F to 77°F (55F) for 8 hours. There was no data logger. No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013155: US-009507513-1703USA013740: US-009507513-1703USA013741: US-009507513-1703USA013742.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the office manager and refers to multiple unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 lot # L019836, expiration date 24-MAR-2017; and lot # M004318, expiration date 12-OCT-2017 (dose and route of administration were not reported) for prophylaxis, which were exposed to temperature excursion, a total time in the range of 47°Fahrenheit (F) to 77°F (48F), for a time frame of 8 hours. There was a previous temperature excursion, the total time in the range 47°F to 77°F (55F) for 8 hours. There was no data logger. No adverse effects reported. No product quality complaint was involved. This is one of the several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013739: US-009507513-1703USA013155: US-009507513-1703USA013741: US-009507513-1703USA013742: