chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Herpes zoster, Hypotonia, Insomnia, Lymphadenopathy, Malaise
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Mobility decreased, Muscle atrophy, Pain, Posture abnormal, Skin burning sensation
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Asthenia, Bone disorder, Cervical radiculopathy, Erythema, Fear
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Grip strength decreased, Hemiparesis, Herpes zoster, Hypotonia, Lymphadenopathy
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Malaise, Mobility decreased, Muscle atrophy, Pain, Posture abnormal
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Skin burning sensation, Sleep disorder, Urticaria, Viral infection
Clinical narrative: Information has been received from a 61 year old female patient referring to herself. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she started ZOSTAVAX, 1 dose subcutaneously one time on 09-AUG-2016. The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received a "bad vaccine" shot on 09-AUG-2016 from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she cannot sleep stating the pain was "unbelievable". She got some relief from EPSOM salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient was no longer received ZOSTAVAX and continued to experience the events. The patient could not sleep, and was continuing to get worse. The caller did not know the lot no or expiration date at the time of the call. The causality between the events and the ZOSTAVAX was not reported. Upon internal review, the events were considered as medically significant. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Balance disorder, Chills, Cough, Headache
Clinical narrative: Pneumonia and atrial fib. Hospitalized 24-Sept-16 til 4-Oct-16. I.V. antibiotics to cure pneumonia.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain
Clinical narrative: Pneumonia and atrial fib. Hospitalized 24-Sept-16 til 4-Oct-16. I.V. antibiotics to cure pneumonia.
Age: 68.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Atrial fibrillation, Pneumonia
Clinical narrative: Pneumonia and atrial fib. Hospitalized 24-Sept-16 til 4-Oct-16. I.V. antibiotics to cure pneumonia.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Diarrhoea, Dysphonia, Headache, Muscular weakness
Clinical narrative: Initial unsolicited report received from a consumer on 25 Oct 2016. This case involves a 68-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI642AC, expiry date: 03 Apr 2017, dose, dose in series, route and site of administration were not reported) on 09 Sep 2016. Illness at the time of vaccination was reported as none as per reporter and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies was not provided; medical history was respiratory issue, lung function test at 30%, heart block, anteroseptal infarct. The patient previously vaccinated with regular flu vaccines and did not experienced any adverse event. Concomitant medication was not provided. On 09 Sep 2016, 04 hours following the vaccination, the patient had experienced muscle soreness in chest area, all over muscle weakness- couldn't move to put on own clothes, projectile vomiting, severe diarrhea. On an unknown date, the patient taken to the hospital ER. On an unspecified date, the patient was hospitalized due to medical history. The patient's laboratory data and corrective treatment was not reported. The outcome of events was reported as unknown (also reported as symptoms resolved but not sure will not have a lasting effect on her health). List of documents held by sender: none. Sender's Comments: Patient had muscle soreness in chest area, all over muscle weakness-couldn't move to put on own clothes, projectile vomiting and severe diarrhea following FLUZONE HD. Time to onset is compatible but additional information regarding patient medical history, any infectious pathology, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Productive cough, Vomiting
Clinical narrative: Initial unsolicited report received from a consumer on 25 Oct 2016. This case involves a 68-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI642AC, expiry date: 03 Apr 2017, dose, dose in series, route and site of administration were not reported) on 09 Sep 2016. Illness at the time of vaccination was reported as none as per reporter and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies was not provided; medical history was respiratory issue, lung function test at 30%, heart block, anteroseptal infarct. The patient previously vaccinated with regular flu vaccines and did not experienced any adverse event. Concomitant medication was not provided. On 09 Sep 2016, 04 hours following the vaccination, the patient had experienced muscle soreness in chest area, all over muscle weakness- couldn't move to put on own clothes, projectile vomiting, severe diarrhea. On an unknown date, the patient taken to the hospital ER. On an unspecified date, the patient was hospitalized due to medical history. The patient's laboratory data and corrective treatment was not reported. The outcome of events was reported as unknown (also reported as symptoms resolved but not sure will not have a lasting effect on her health). List of documents held by sender: none. Sender's Comments: Patient had muscle soreness in chest area, all over muscle weakness-couldn't move to put on own clothes, projectile vomiting and severe diarrhea following FLUZONE HD. Time to onset is compatible but additional information regarding patient medical history, any infectious pathology, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Diarrhoea, Mobility decreased, Muscular weakness, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer on 25 Oct 2016. This case involves a 68-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI642AC, expiry date: 03 Apr 2017, dose, dose in series, route and site of administration were not reported) on 09 Sep 2016. Illness at the time of vaccination was reported as none as per reporter and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies was not provided; medical history was respiratory issue, lung function test at 30%, heart block, anteroseptal infarct. The patient previously vaccinated with regular flu vaccines and did not experienced any adverse event. Concomitant medication was not provided. On 09 Sep 2016, 04 hours following the vaccination, the patient had experienced muscle soreness in chest area, all over muscle weakness- couldn't move to put on own clothes, projectile vomiting, severe diarrhea. On an unknown date, the patient taken to the hospital ER. On an unspecified date, the patient was hospitalized due to medical history. The patient's laboratory data and corrective treatment was not reported. The outcome of events was reported as unknown (also reported as symptoms resolved but not sure will not have a lasting effect on her health). List of documents held by sender: none. Sender's Comments: Patient had muscle soreness in chest area, all over muscle weakness-couldn't move to put on own clothes, projectile vomiting and severe diarrhea following FLUZONE HD. Time to onset is compatible but additional information regarding patient medical history, any infectious pathology, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting projectile
Clinical narrative: Initial unsolicited report received from a consumer on 25 Oct 2016. This case involves a 68-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI642AC, expiry date: 03 Apr 2017, dose, dose in series, route and site of administration were not reported) on 09 Sep 2016. Illness at the time of vaccination was reported as none as per reporter and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergies was not provided; medical history was respiratory issue, lung function test at 30%, heart block, anteroseptal infarct. The patient previously vaccinated with regular flu vaccines and did not experienced any adverse event. Concomitant medication was not provided. On 09 Sep 2016, 04 hours following the vaccination, the patient had experienced muscle soreness in chest area, all over muscle weakness- couldn't move to put on own clothes, projectile vomiting, severe diarrhea. On an unknown date, the patient taken to the hospital ER. On an unspecified date, the patient was hospitalized due to medical history. The patient's laboratory data and corrective treatment was not reported. The outcome of events was reported as unknown (also reported as symptoms resolved but not sure will not have a lasting effect on her health). List of documents held by sender: none. Sender's Comments: Patient had muscle soreness in chest area, all over muscle weakness-couldn't move to put on own clothes, projectile vomiting and severe diarrhea following FLUZONE HD. Time to onset is compatible but additional information regarding patient medical history, any infectious pathology, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness bilateral, Deafness neurosensory, Sudden hearing loss
Clinical narrative: Patient presented for an appointment on 9/23/16 stating she had experienced sudden onset hearing loss approximately 4 hours prior to exam. She had total hearing loss on left side. Concerned flu vaccine might have caused the condition.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Deafness unilateral, Sudden hearing loss
Clinical narrative: Patient presented for an appointment on 9/23/16 stating she had experienced sudden onset hearing loss approximately 4 hours prior to exam. She had total hearing loss on left side. Concerned flu vaccine might have caused the condition.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactoid reaction
Clinical narrative: Initial unsolicited report received from a pharmacist on 24 October 2016. This case involves a 46-years-old of female patient who was vaccinated with dose of Fluzone QIV (lot number: UI693AB, expiry date: 30 Jun 2017) via intramuscular route in right deltoid on 20 October 2016. The illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions revealed that patient was allergic to shellfish and egg. The concomitant medications were not reported. On 20 October 2016, several hours following the vaccination, the patient experienced hives and "anaphylactic reaction". It was reported as patient had previously received flu vaccines for past four years without any reactions. The patient required ER/doctor visit. The lab test and corrective treatment was not reported. It was unknown if patient was recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event anaphylactic reaction. List of the documents held by sender: none. Sender's Comments: As with other vaccines, anaphylactic reaction is listed following INFLUENZA QUADRIVAL A-B VACCINE. Reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), any reaction to vaccine preservative, information regarding any drug or food intake during the period between vaccination and reaction and allergy testing to identify the culprit allergen are needed to further assess this case, in this case patient had history of egg allergy. Based on the available information, a role of the vaccine cannot be ruled out.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anaphylactic reaction, Urticaria
Clinical narrative: Initial unsolicited report received from a pharmacist on 24 October 2016. This case involves a 46-years-old of female patient who was vaccinated with dose of Fluzone QIV (lot number: UI693AB, expiry date: 30 Jun 2017) via intramuscular route in right deltoid on 20 October 2016. The illness at time of vaccination was reported as unknown and pre-existing physician diagnosed allergies, birth defects, medical conditions revealed that patient was allergic to shellfish and egg. The concomitant medications were not reported. On 20 October 2016, several hours following the vaccination, the patient experienced hives and "anaphylactic reaction". It was reported as patient had previously received flu vaccines for past four years without any reactions. The patient required ER/doctor visit. The lab test and corrective treatment was not reported. It was unknown if patient was recovered from the events. Upon internal review, the company decided to consider the event serious because of important medical event anaphylactic reaction. List of the documents held by sender: none. Sender's Comments: As with other vaccines, anaphylactic reaction is listed following INFLUENZA QUADRIVAL A-B VACCINE. Reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), any reaction to vaccine preservative, information regarding any drug or food intake during the period between vaccination and reaction and allergy testing to identify the culprit allergen are needed to further assess this case, in this case patient had history of egg allergy. Based on the available information, a role of the vaccine cannot be ruled out.
Age: 28.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Adverse event, Seizure
Clinical narrative: Seizure activity post administration. Provided documentation from provider to employee health today 11-7-16.
Age: 28.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Computerised tomogram, Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Seizure activity post administration. Provided documentation from provider to employee health today 11-7-16.
Age: 58.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Nausea
Clinical narrative: Nausea - starter about 11/2 hrs after Flu shot given. Lasted about 12 hrs.
Age: 69.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3
Symptoms: Erythema, Inflammation, Pruritus, Skin warm
Clinical narrative: Case number PHEH2016US028155, is an initial spontaneous report received from a pharmacist on 26 Oct 2016. This report refers to a 69 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 166002) at a dose of 0.5 ml intramuscularly on 17 Oct 2016. On an unknown date, the patient experienced cellulitis in the same arm where she received FLUAD and other vaccine (unspecified). The patient was treated with antibiotics (unspecified). The outcome of event was unknown. The seriousness and causality of event were not reported. The seriousness assessment of the event cellulitis was upgraded to medically significant based on the Novartis Important Medical Event list.
Age: 69.0
Sex: F
Vaccine: FLUA3, PNC13, FLUA3
Symptoms: Cellulitis
Clinical narrative: Case number PHEH2016US028155, is an initial spontaneous report received from a pharmacist on 26 Oct 2016. This report refers to a 69 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 166002) at a dose of 0.5 ml intramuscularly on 17 Oct 2016. On an unknown date, the patient experienced cellulitis in the same arm where she received FLUAD and other vaccine (unspecified). The patient was treated with antibiotics (unspecified). The outcome of event was unknown. The seriousness and causality of event were not reported. The seriousness assessment of the event cellulitis was upgraded to medically significant based on the Novartis Important Medical Event list.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV, TTOX, FLU4, PPV, TDAP
Symptoms: Erythema, Fatigue, Headache, Mobility decreased, Nausea
Clinical narrative: Redness at injection site. Hot to the touch. Couldn't move arm upon awakening.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV, TTOX, FLU4, PPV, TDAP
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: Redness at injection site. Hot to the touch. Couldn't move arm upon awakening.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV, TTOX, FLU4, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site warmth
Clinical narrative: Redness at injection site. Hot to the touch. Couldn't move arm upon awakening.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Contusion, Muscle spasms, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a consumer on 24-Oct-2016. This case involves a 68-year-old female patient, who was vaccinated FLUZONE HD via intramuscular route (batch number and expiry date, dose and dose in series not reported) in left deltoid on 23-Sep-2016. Patient's illness at time of vaccination was reported as no. The pre-existing physician diagnosed allergies, and birth defects, medical conditions were reported as GERD. Concomitant medications were not reported. On 24-Sep-2016, one day following the vaccination, the patient's left arm was sore and tender at the injection site and the area was black and blue. Symptoms had progressed, patient had stiffness, swelling and increased pain in the whole left arm. As of 21-Oct-2016 patient having spasms in the left arm. Patient required ER/doctor visit. Lab test and concomitant medication was not reported. Outcome of the events were reported as not recovered. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site discolouration, Injection site pain, Muscle spasms, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 24-Oct-2016. This case involves a 68-year-old female patient, who was vaccinated FLUZONE HD via intramuscular route (batch number and expiry date, dose and dose in series not reported) in left deltoid on 23-Sep-2016. Patient's illness at time of vaccination was reported as no. The pre-existing physician diagnosed allergies, and birth defects, medical conditions were reported as GERD. Concomitant medications were not reported. On 24-Sep-2016, one day following the vaccination, the patient's left arm was sore and tender at the injection site and the area was black and blue. Symptoms had progressed, patient had stiffness, swelling and increased pain in the whole left arm. As of 21-Oct-2016 patient having spasms in the left arm. Patient required ER/doctor visit. Lab test and concomitant medication was not reported. Outcome of the events were reported as not recovered. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer on 24-Oct-2016. This case involves a 68-year-old female patient, who was vaccinated FLUZONE HD via intramuscular route (batch number and expiry date, dose and dose in series not reported) in left deltoid on 23-Sep-2016. Patient's illness at time of vaccination was reported as no. The pre-existing physician diagnosed allergies, and birth defects, medical conditions were reported as GERD. Concomitant medications were not reported. On 24-Sep-2016, one day following the vaccination, the patient's left arm was sore and tender at the injection site and the area was black and blue. Symptoms had progressed, patient had stiffness, swelling and increased pain in the whole left arm. As of 21-Oct-2016 patient having spasms in the left arm. Patient required ER/doctor visit. Lab test and concomitant medication was not reported. Outcome of the events were reported as not recovered. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Haemorrhage, Human chorionic gonadotropin decreased, Pregnancy test positive, Thrombosis, Vaginal haemorrhage
Clinical narrative: Bleeding that started off as spotting then progressed to heavier bleeding producing blood clots and passing tissue.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pyrexia, Vomiting
Clinical narrative: Weakness and throwing up. Fever of 102.5 and blood pressure of 173/115.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Anti-glomerular basement membrane antibody positive, Biopsy kidney abnormal, Blood creatinine increased, Dialysis, Fatigue
Clinical narrative: 2-3 days after vaccine developed flu like symptoms, then progressive fatigue. 5-7 days later rise in creatinine noticed in a Urgent care. Pt underwent to kidney biopsy bc rapid renal function deterioration. Biopsy showed severe Anti GBM (Godd Pasture disease). Pt currently on dialysis and plasmapheresis, without signs of improvement.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Goodpasture's syndrome, Influenza like illness, Plasmapheresis, Renal impairment
Clinical narrative: 2-3 days after vaccine developed flu like symptoms, then progressive fatigue. 5-7 days later rise in creatinine noticed in a Urgent care. Pt underwent to kidney biopsy bc rapid renal function deterioration. Biopsy showed severe Anti GBM (Godd Pasture disease). Pt currently on dialysis and plasmapheresis, without signs of improvement.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Acute kidney injury, Anti-glomerular basement membrane antibody, Autoimmune disorder, Blood creatine increased, Blood urine present
Clinical narrative: 2-3 days after vaccine developed flu like symptoms, then progressive fatigue. 5-7 days later rise in creatinine noticed in a Urgent care. Pt underwent to kidney biopsy bc rapid renal function deterioration. Biopsy showed severe Anti GBM (Godd Pasture disease). Pt currently on dialysis and plasmapheresis, without signs of improvement.
Age: 44.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Cold sweat, Decreased appetite, Glomerulonephritis rapidly progressive, Lethargy
Clinical narrative: 2-3 days after vaccine developed flu like symptoms, then progressive fatigue. 5-7 days later rise in creatinine noticed in a Urgent care. Pt underwent to kidney biopsy bc rapid renal function deterioration. Biopsy showed severe Anti GBM (Godd Pasture disease). Pt currently on dialysis and plasmapheresis, without signs of improvement.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Upper respiratory tract infection, Vaccine positive rechallenge
Clinical narrative: For the 3rd year in a row, I have developed a severe sore throat and URI within 36 to 48 hours after "high dose flu vaccine."  And I have not been around anyone with known URI!
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site erythema, Pain, Swelling
Clinical narrative: Soreness, swelling, burning sensation, growing redness at injection site.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: Arm hurt after shot, woke up and it was very sore, red, swollen, tender,  Now itchy.  Getting better.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersomnia, Pain
Clinical narrative: Initial unsolicited report received from a nurse via other company, Pfizer (under the reference number:2016336790) on 24 October 2016. This case involves a 64-years-old of female patient who was vaccinated with INFLUENZA VACCINE (Flu shot) (lot number, expiration date, dose, dose in series, route of administration and site of administration were not reported) on an unspecified day. The medical history was reported as arthritic and stomach ulcer (that causes stomach to hurt) and the previous medication were reported as prevacid equivalent for stomach ulcer. Concomitant medication was not reported. On 07 Oct 2016, following vaccination, the patients developed body aches all over the body and sleepy whole day. The laboratory test and corrective treatment was not reported. The outcome of the events was not reported. List of the documents held by sender: none.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Bursa injury, Injection site pain, Nerve injury, Pain
Clinical narrative: Initial unsolicited report received from a physician on 24 October 2016. This case involves an 80-years-old of male patient who was vaccinated with first dose of FLUZONE HD (lot number: UI636AA, expiry date: 27 Mar 2017, route of administration and dose were not reported) in left deltoid on 05 October 2016. The illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. The concomitant medications were not reported. On 07 October 2016, two days following the vaccination, the patient developed pain at the injection site, even when lifting the arm (patient can't lay on left side) and neurological or bursa damage. The patient required ER/doctor visit. The lab test was reported as none. Corrective treatment was reported as ibuprofen. Patient was not recovered from the events. List of the documents held by sender: none.
Sex: U
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site discomfort, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Initial unsolicited report received from a pharmacist on 24 October 2016. This case involves six patients (age and gender were not reported) who were vaccinated with Fluzone QIV (lot number: UI693AB, expiry date: 30 Jun 2017, route, site of administration, dose and dose in series were not reported) and dose of Pneumovax vaccines (lot number, expiry date, route, site of administration, dose and dose in series were not reported) on 20 October 2016. The medical history and concomitant medications were not reported. The illness at the time of vaccination was reported as none. On 20 October 2016 i.e, on same day of following vaccination, the patients experienced redness, swelling discomfort at injection site, and chills and body aches (Reported as after several hours of vaccination). On 21 October 2016, post vaccination, the patient "didn't feel well". The laboratory test and the corrective treatment were not reported. The outcome of the events was reported as unknown. List of the documents held by sender: none.
Sex: U
Vaccine: FLU4, PPV
Symptoms: Pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 24 October 2016. This case involves six patients (age and gender were not reported) who were vaccinated with Fluzone QIV (lot number: UI693AB, expiry date: 30 Jun 2017, route, site of administration, dose and dose in series were not reported) and dose of Pneumovax vaccines (lot number, expiry date, route, site of administration, dose and dose in series were not reported) on 20 October 2016. The medical history and concomitant medications were not reported. The illness at the time of vaccination was reported as none. On 20 October 2016 i.e, on same day of following vaccination, the patients experienced redness, swelling discomfort at injection site, and chills and body aches (Reported as after several hours of vaccination). On 21 October 2016, post vaccination, the patient "didn't feel well". The laboratory test and the corrective treatment were not reported. The outcome of the events was reported as unknown. List of the documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Initial unsolicited report received from a consumer on 24 October 2016. This case involves a patient (age and gender was not reported) who was vaccinated with INFLUENZA VACCINE (Flu Shot) (lot number, expiration date of product, route of administration, site of administration, dose and dose in series were not reported) on 23 September 2016. The medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had an adverse reaction- had stiffness and spasms. Patient's lab data was not reported. It was reported that patient's doctor told that the patient needed physical therapy as treatment which the patient could not afford. The outcome of the events was not reported. List of the documents held by sender: none.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Cerebral haemorrhage, Computerised tomogram normal, Hemiparesis, Herpes simplex encephalitis
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 28 October 2016. This case involves 84-year-old (also reported as 85-year-old) female who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration was not reported) on 29 September 2016. Illness at time of vaccination includes possible bladder Infection and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported mild dementia and hypertension. Concomitant medication reported as none. On 01 October 2016, two days following the vaccination, patient became very groggy. On an unspecified date, (a week later) following vaccination patient become more lethargic. On an unspecified date, following vaccination patient was diagnosed with inflammation and bleeding of the right side of her brain and herpes simplex encephalitis. Patient required emergency visit. On an unspecified date patient was hospitalized. Lab data reported as magnetic resonance imaging (MRI), computerized axial tomography (CAT) Scan, Spinal tap Corrective treatment reported as acyclovir. Outcome of events reported as unknown. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with FLUZONE HD, 2 days after patient was groggy, become lethargic, unable to walk, and left side weakness. Patient was then had undergone CAT scan and spinal tap which she was diagnosed with Herpes Simplex Encephalitis and inflammation and bleeding of the Right side of her brain. Time to onset is compatible, but additional information regarding patient medical history like hypertension, past history of stroke or any other nervous system disorder, infectious history of any herpes infection, any recent history of trauma is needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Lumbar puncture abnormal, Noninfective encephalitis, Nuclear magnetic resonance imaging, Somnolence
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 28 October 2016. This case involves 84-year-old (also reported as 85-year-old) female who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route and site of administration was not reported) on 29 September 2016. Illness at time of vaccination includes possible bladder Infection and pre-existing physician diagnosed allergies, birth defects, a medical condition was reported mild dementia and hypertension. Concomitant medication reported as none. On 01 October 2016, two days following the vaccination, patient became very groggy. On an unspecified date, (a week later) following vaccination patient become more lethargic. On an unspecified date, following vaccination patient was diagnosed with inflammation and bleeding of the right side of her brain and herpes simplex encephalitis. Patient required emergency visit. On an unspecified date patient was hospitalized. Lab data reported as magnetic resonance imaging (MRI), computerized axial tomography (CAT) Scan, Spinal tap Corrective treatment reported as acyclovir. Outcome of events reported as unknown. List of documents held by sender: none. Sender's Comments: Patient was vaccinated with FLUZONE HD, 2 days after patient was groggy, become lethargic, unable to walk, and left side weakness. Patient was then had undergone CAT scan and spinal tap which she was diagnosed with Herpes Simplex Encephalitis and inflammation and bleeding of the Right side of her brain. Time to onset is compatible, but additional information regarding patient medical history like hypertension, past history of stroke or any other nervous system disorder, infectious history of any herpes infection, any recent history of trauma is needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: VARZOS
Symptoms: Oesophageal carcinoma, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a physician and a nurse (who was also the patient's wife) refers to a 60-70 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in approximately 2014 (reported as "2 years ago"), the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On an unknown date, the patient experienced esophageal cancer and received an unspecified treatment. On an unknown date, (reported as "recently"), the patient developed ophthalmic zoster following the treatment for esophageal cancer. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not provided. Upon internal review, the events of ophthalmic zoster and esophageal cancer were determined to be medically significant. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Patient has experienced neuropathy since the vaccine.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Diarrhoea, Fatigue, Headache
Clinical narrative: Passing out, extreme weakness, vomiting, fever, cool sweat, extreme fatigue, diarreah, skin rash, 4 day headache.  Considered calling 911 but I was on the floor too weak to get to the phone.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Pyrexia, Rash, Vomiting
Clinical narrative: Passing out, extreme weakness, vomiting, fever, cool sweat, extreme fatigue, diarreah, skin rash, 4 day headache.  Considered calling 911 but I was on the floor too weak to get to the phone.
Age: 46.0
Sex: F
Vaccine: DTAP
Symptoms: Lymphadenopathy
Clinical narrative: Vaccine was given in the left arm.  Lymph nodes under left arm and under left collar bone are swollen.