chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Approximately 10 minutes after vaccination, child C/O feeling "not right". While attempting to assist him from standing to sitting, he became limp, slumping to the floor, seated, then fell back hitting his head (back of the head) on the floor; was unaware of surroundings for 15 seconds or less; sits up on his own despite efforts to keep him lying down. Mom and nurse at his sides; C/O pain to occipital area at site of impact. No swelling noted, BP 80/60, P 120; mild twitching and muscle rigidity in arms while unaware of his surroundings. 10:45 - BP 80/60 P 100 R even unlabored; 911 call; mom states she believes his had seizure activity at least twice in his lifetime, unrelated to vaccination and undiagnosed. Ice pack to contusion; no meals eaten today, only a popsicle. 10:48 - EMS crew here; no other C/O of pain other than back of head; states he feels "normal". 11:05 - child walks himself to gurney; episode appears to be syncopal due to vasovagal response to injection. Transported for evaluation of head injury and reported history of seizure activity in the past. 11:30 - Reported incident to doctor. 12:45 - Spoke to mom; child released home with ice pack to head post fainting spell.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Urticaria
Clinical narrative: Patient reported hives on her body and bruising at the site of injection. I spoke to her today (12-27-16) and she said the hives and bruising are vanishing.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Missed the second part of immunization record which shows patient received already Flu shot 10/7/16 and was given the second FLUVIRIN 12/27/16.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction left deltoid was not reported until office visit 12/6/16.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Feeling abnormal, Headache, Injection site pain, Injection site reaction
Clinical narrative: Significant injection site soreness, felt bad, aching all over, low grade fever, facial swelling, red splotch at injection site, headache, dizziness - onset evening of injection.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Rash macular, Swelling face
Clinical narrative: Significant injection site soreness, felt bad, aching all over, low grade fever, facial swelling, red splotch at injection site, headache, dizziness - onset evening of injection.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Cyanosis, Erythema, Pallor, Rash macular
Clinical narrative: After giving 4 mo. vaccines about 10 min. later the baby was turning red and blotchy. Also would not stop crying. Dr. examined baby, gave BENADRYL / but she would not take so we gave epinephrine. He took a pulse ox and gave oxygen. I call 911 they arrive within minutes they took her to ER because she looked pale and blue. Advised to follow up after.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Allergy test, Blood immunoglobulin G, Malaise, Oropharyngeal pain, Rash
Clinical narrative: Pruritic rash trunk and extremities. Malaise, sore throat.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash trunk and extremities. Malaise, sore throat.
Age: 79.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Received flu and pneumonia vaccine 12/20/16 in right deltoid. Next day noticed redness, tenderness, warmth. Redness spread to shoulder, and down to elbow. Pt came to UC 12/22/16.
Sex: U
Vaccine: MMR
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report as received from a physician, via other company (manufacturer control# 2015341229), refers to a currently 57-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with M-M-R II (dose, route, lot# and expiry date were not reported). On an unknown date, the patient experienced allergy to M-M-R II. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (manufacturer unknown). This is one of several reports received from the same source concerning the same patient. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA012214: US-009507513-1612USA012215:
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Bone disorder, Condition aggravated, Cough, Decreased appetite
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Ear pain, Exposure during pregnancy
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Eyelid oedema, Fatigue, Feeling hot, Headache, Hot flush
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Increased upper airway secretion, Laziness, Malaise, Musculoskeletal discomfort, Musculoskeletal disorder
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain, Myalgia, Nasal congestion, Nausea, Neck pain
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Parosmia, Rhinorrhoea, Sneezing, Somnolence, Speech disorder
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Spinal disorder, Swelling face, Trismus, Yawning
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Arthralgia, Bone disorder, Cough, Decreased appetite, Disturbance in attention
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Dizziness, Dyspnoea, Ear pain, Exposure during pregnancy, Eye swelling
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Increased upper airway secretion, Joint dislocation, Laziness, Malaise, Musculoskeletal discomfort
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Myalgia, Nasal congestion, Nausea
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Neck pain, Parosmia, Rhinorrhoea, Schizoaffective disorder, Sneezing
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Somnolence, Speech disorder, Spinal disorder, Swelling face, Throat tightness
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Trismus, Yawning
Clinical narrative: Case number PHHY2016US038753, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 621910) website on 18 Mar 2016. This report refers to a pregnant female patient of an unknown age. Medical history was not reported. Concomitant medication included prenatal vitamins and many drugs (not specified). The patient was vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: not reported) on an unspecified date. After vaccination the patient felt drowsy and faint. The doctor said it will wear off in a matter of days. The patient experienced schizoaffective disorder and she was taking ABILIFY. The patient had nausea and treated with CLARITIN as needed, and she had frequent headache and she was taking TYLENOL. After weeks the patient symptoms got worse. The patient lost shortness of breath a lot making it hard to breath, her throat very clogged, nose picking up strange smells and being clogged plus running at times, face became swollen/puffy. She started to feel more nauseous frequently throughout the entire day, her eyes became more swollen shut, concentration worsen, she yawn entirely too much. The patient feel faint a lot, drowsy more, laziness/fatigue, muscle aches and pains, joint pains and discomfort, bones disconjointed, always hot/heat flash, lock jaw making it hard to speak clearly, neck pain, earache, spine distinction, hands and feet not functional. The patient had cough a lot and sneeze too much, her headaches became worse and more frequent, and appetite closed, her shoulders became very sore. The patient also was administered the whooping cough shot as well so she was not sure where she can go to report that. But the patient would like this case to court because she really felt sick. One month was over and the events have not been improved just for worse. Final outcome of the events were condition unchanged. Seriousness of the events was reported as non serious and causality was not reported. Seriousness assessment of the all events schizoaffective disorder, dyspnea, throat tightness, nasal congestion, rhinorrhea, eye swelling, syncope, swelling face were upgraded to serious based on the information available in the source documents. The case was assessed as lost to follow up at follow up. Follow up report received on 19 Dec 2016: updated lost to follow up information.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Vomiting
Clinical narrative: Started with stomach pain. Eventually vomited several times.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Oral herpes, Pain, Pain in extremity
Clinical narrative: Fever blister. I have never had a fever blister prior to injection. Also had burning shooting pain in nerves going down arm injected for 4 days like when I had shingles.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Feeling hot, Injection site urticaria, Pruritus generalised
Clinical narrative: 1st time receiving a flu shot. Broke out in hives on right arm at point of shot insertion. Hives spread down right arm, along chest, back and all over neck. Difficulty breathing, tightness in throat, sneezing constantly, wheezing cough, itchy all over body, body hot. Went to ER and had Epipen and steroid shot. Symptoms came back Sunday 12/11/16: hives breaking out again and difficulty breathing. Went to urgent care for treatment. 12/27/16: hives breaking out again same exact places as when flu shot originally administered. Called doctors office to report. Took allergy medicine to try and relieve symptoms.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Sneezing, Throat tightness, Urticaria, Wheezing
Clinical narrative: 1st time receiving a flu shot. Broke out in hives on right arm at point of shot insertion. Hives spread down right arm, along chest, back and all over neck. Difficulty breathing, tightness in throat, sneezing constantly, wheezing cough, itchy all over body, body hot. Went to ER and had Epipen and steroid shot. Symptoms came back Sunday 12/11/16: hives breaking out again and difficulty breathing. Went to urgent care for treatment. 12/27/16: hives breaking out again same exact places as when flu shot originally administered. Called doctors office to report. Took allergy medicine to try and relieve symptoms.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 5 year old male patient. The patient had no relevant medical history and no concomitant medications. On 28-NOV-2016, the patient was vaccinated with 0.5 ml dose of PROQUAD subcutaneously, lot # M022402, expiration date 01-NOV-2017, administered for a routine health care, which underwent a temperature excursion. To the best of the nurse's knowledge, the patient did not experience an adverse reaction and no treatment was provided. There was no relevant laboratory data. At the time of this report it was unknown if the patient continued to receive PROQUAD. Additional information has been requested. Sender's Comments: US-009507513-1612USA000174: US-009507513-1612USA000174.
Age: 0.75
Sex: U
Vaccine: MMR
Symptoms: Rubulavirus test positive
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 9 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and drug reactions or allergies was provided. On 15-MAY-2008, the patient was vaccinated with M-M-R II injection (lot#, expiration date, dose and route of administration were not reported). Information about the patient's concomitant therapies was not provided. On an unknown date, the serological testing was positive for mumps and rubella but negative for measles. The outcome of the event and the causality between the M-M-R II and the event were not reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report received from an office manager referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was administered an expired dose of M-M-R II (lot: K021152, expiry date: 02-NOV-2016) on 09-DEC-2016. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 year old male patient. Pertinent medical history and concomitant medications were not reported. On an unknown date, pharmacist realized that the patient was vaccinated with second dose of ZOSTAVAX lot # L036454 dose 2, .65 ml, subcutaneous for prophylaxis, there was one (dose) already in the system from December 2015 (extra dose administered). No adverse events (no adverse event) noted. The outcome of extra dose administered and no adverse event were unknown. No further information to report. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Information has been received from a pharmacist via Pfizer (Manufacturer Report # 2016546308) referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were unknown) for prophylaxis. On an unknown date (reported as about 3 to 5 days later), the patient experienced heaviness in the chest and difficulty breathing. The outcome of the events was unknown. The causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report received from a medical assistant referred to a 4 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was administered first dose of VARIVAX 0.5 ml subcutaneously on 20-NOV-2013, second dose on 19-NOV-2015 and third dose on 12-DEC-2016 (lot: M023495, expiry: 06-JUL-2018) (extra dose administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning  multiple unknown patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M032493, expiration date: 06-JUL-2018, lot # M034584, expiration date: 27-JUL-2018, lot # M024675, expiration date: 18-MAY-2018, as prophylaxis. (Strength, dose and route of administration were not reported), which experienced a temperature excursion of max 9 Fahrenheit degrees for 1 hour and 21 minutes. A previous temperature excursion was reported of max 12.8 Fahrenheit degrees for 4 hours and 2 minutes. Data logger was involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.; Sender's Comments: US-009507513-1612USA005584:
Age: 11.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a consumer regarding a 12 year old male patient. The patient's medical history was not reported. On 16-AUG-2016, the patient was vaccinated with PEDVAXHIB (strength, dose, frequency and  batch# were not reported) of lot # L051122 with an expiry date of 12-OCT-2018, intramuscularly for prophylaxis. The other suspect therapy included PREVNAR 13 (strength, dose, frequency and batch # were not reported) of lot # L99270 with an expiry date in March 2017 intramuscularly for prophylaxis. There were no concomitant therapies reported. On 16-AUG-2016, 1 month 18 days after onset of therapy the patient was administered PEDVAXHIB at the age of 12 instead of getting the vaccine administered before being 18 months. The reporter wanted to know if the patient needed to be revaccinated and what would be the next procedure to do. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients' were vaccinated with improperly stored PROQUAD (lot # M029598, expiry date 10-DEC-2017) for prophylaxis. The vaccine were exposed to a temperature of 21F at a time frame of 8 hours. No adverse effects reported. Additional information has been requested. This is one of the two cases received form the same reporter. Sender's Comments: US-009507513-1612USA011236.