chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Exposure during pregnancy, VIIth nerve paralysis
Clinical narrative: Case number PHHY2015US028985, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 556032) website on 05 Mar 2015, with the follow-up received on 12 Oct 2015. This report refers to a 28-year-old female patient. Her medical history and concomitant medication details were not provided. She was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown) into the left arm on 13 Oct 2014 while she was 23 weeks pregnant. On 24 Nov 2014, she was diagnosed with Bell's palsy in the 29th week of pregnancy in the emergency room. The final outcome of the events was not reported. The events were reported as non-serious. The causality assessment of the events was not reported. Seriousness assessment of Bell's palsy was based on information available in the source documents. Upon follow-up, it was reported that, reporter is anonymous and therefore due diligence cannot be pursued. No additional follow up received and case was considered lost to follow up. Follow-up received on 12 Oct 2015: Updated lost to follow-up information (reporter is anonymous).
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Herpes zoster, Liver function test normal
Clinical narrative: Case number PHHY2015US111137, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 558605) website on 10 Sep 2015, and with a follow-up report received from QA department on 22 Sep 2015. This report refers to a 53 year old female patient. Medical history included three week post upper respiratory tract infection. Concomitant medication was not provided. The patient was vaccinated with FLUVIRIN (batch number: unknown) intramuscular into right arm on 24 Nov 2014. Patient developed shingles on her right side on her back on 27 Dec 2014. Patient also had pain in liver area. Lab reports of liver panel were normal. No information was provided regarding treatment. The patient went to the emergency room. Outcome of the events reported as complete recovery. Case was reported to be non-serious and causality of the event was not reported. Seriousness of the event "shingles" was upgraded based on information available in the source document. QA reported that as it was not possible to determine the correct batch number, no investigation will be performed. Follow-up report received from QA department on 22 Sep 2015. Updated QA comments.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Face injury, Fall
Clinical narrative: Case number PHHY2015US110711, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 560029) received on 10 Sep 2015 with a follow up received from the quality assurance department on 21 Sep 2015. This report refers to a 57-year-old female patient. Historical conditions were not reported. Concomitant medication was none. The patient received FLUVIRIN (batch number: not reported) into the left arm on 20 Nov 2014. It was reported that approximately 15 minutes after vaccination the patient began feeling very dizzy, nauseous and fainted as the patient was going to lay down. Further when the patient was blacked out, the patient fell flat on face and had a cut on lower lip open and bit her tooth cutting through the skin. The patient's husband found her laying and helped her up and applied a compress to the lip. The patient's laid place has bleeding. The patient felt much weakened, shaky, ill, had chills and was feeling feverish which went on for about three hours. Final outcome was complete recovery. The events were reported as non-serious and causality was not reported. Seriousness of the event loss of consciousness was upgraded based on information available in the source document. The quality assurance department stated that the batch number: 90658 reported for FLUVIRIN was not a valid FLUVIRIN batch number and as it was not possible to determine the correct batch number, no standard quality investigation will be performed. Follow-up received from Quality Assurance Department on 21 Sep 2015: updated QA comment.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Lip injury, Loss of consciousness, Malaise, Nausea
Clinical narrative: Case number PHHY2015US110711, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 560029) received on 10 Sep 2015 with a follow up received from the quality assurance department on 21 Sep 2015. This report refers to a 57-year-old female patient. Historical conditions were not reported. Concomitant medication was none. The patient received FLUVIRIN (batch number: not reported) into the left arm on 20 Nov 2014. It was reported that approximately 15 minutes after vaccination the patient began feeling very dizzy, nauseous and fainted as the patient was going to lay down. Further when the patient was blacked out, the patient fell flat on face and had a cut on lower lip open and bit her tooth cutting through the skin. The patient's husband found her laying and helped her up and applied a compress to the lip. The patient's laid place has bleeding. The patient felt much weakened, shaky, ill, had chills and was feeling feverish which went on for about three hours. Final outcome was complete recovery. The events were reported as non-serious and causality was not reported. Seriousness of the event loss of consciousness was upgraded based on information available in the source document. The quality assurance department stated that the batch number: 90658 reported for FLUVIRIN was not a valid FLUVIRIN batch number and as it was not possible to determine the correct batch number, no standard quality investigation will be performed. Follow-up received from Quality Assurance Department on 21 Sep 2015: updated QA comment.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Syncope, Tremor
Clinical narrative: Case number PHHY2015US110711, is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 560029) received on 10 Sep 2015 with a follow up received from the quality assurance department on 21 Sep 2015. This report refers to a 57-year-old female patient. Historical conditions were not reported. Concomitant medication was none. The patient received FLUVIRIN (batch number: not reported) into the left arm on 20 Nov 2014. It was reported that approximately 15 minutes after vaccination the patient began feeling very dizzy, nauseous and fainted as the patient was going to lay down. Further when the patient was blacked out, the patient fell flat on face and had a cut on lower lip open and bit her tooth cutting through the skin. The patient's husband found her laying and helped her up and applied a compress to the lip. The patient's laid place has bleeding. The patient felt much weakened, shaky, ill, had chills and was feeling feverish which went on for about three hours. Final outcome was complete recovery. The events were reported as non-serious and causality was not reported. Seriousness of the event loss of consciousness was upgraded based on information available in the source document. The quality assurance department stated that the batch number: 90658 reported for FLUVIRIN was not a valid FLUVIRIN batch number and as it was not possible to determine the correct batch number, no standard quality investigation will be performed. Follow-up received from Quality Assurance Department on 21 Sep 2015: updated QA comment.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Case number PHHY2015US111774, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 560051) website on 10 Sep 2015, with a follow up report received from the Quality Assurance Department (QA, reference number: 1006394) on 22 Sep 2015. This report refers to a 60 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 146624) along with PNEUMOVAX (other manufacturer, batch number: K064552) both intramuscularly on 07 Dec 2014. On 10 Dec 2014, three days after vaccination, the patient developed redness, swelling and warmth in left arm. The patient was diagnosed with cellulitis by a physician. Treatment was rendered with BACTRIM and levofloxacin. Final outcome of the event was reported as complete recovery. Events were reported as non-serious. Seriousness assessment of the event cellulitis was upgraded (medically significant) as per Novartis important medical events list. Causality was not reported. Follow up report received from the QA on 22 Sep 2015: updated QA reference number and changed batch number.
Age: 15.0
Sex: M
Vaccine: JEV1, RAB, JEV1, RAB
Symptoms: Blood test normal, Computerised tomogram normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Nuclear magnetic resonance imaging normal
Clinical narrative: Case number PHHY2015US121733 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 580838) website on 05 Oct 2015 and a follow up report from the QA department (QA reference number: 396518) received on 12 Oct 2015. This report refers to a 15-year-old male patient. No medical history and concomitant medications were reported. On 14 Nov 2014, the patient was vaccinated with RABAVERT (batch number: 556011A) along with IXIARO (batch number: JEV13E37E), both intramuscularly in the left arm. On 21 Nov 2014, one week after vaccination the patient experienced an undiagnosed partial seizure and grand mal seizure. The patient visited the emergency room. The patient's blood work, CT scan, multiple EEG and multiple MRI were performed but nothing was found. The final outcome of the events reported as ongoing. The events reported as serious (life-threatening and disability) events. The causality of the events were not reported. Follow up report from the QA department received on 12 Oct 2015: Updated QA reference number 396518. The batch number 556011AA changed to 556011A as confirmed from the QA department.
Age: 15.0
Sex: M
Vaccine: JEV1, RAB, JEV1, RAB
Symptoms: Partial seizures
Clinical narrative: Case number PHHY2015US121733 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 580838) website on 05 Oct 2015 and a follow up report from the QA department (QA reference number: 396518) received on 12 Oct 2015. This report refers to a 15-year-old male patient. No medical history and concomitant medications were reported. On 14 Nov 2014, the patient was vaccinated with RABAVERT (batch number: 556011A) along with IXIARO (batch number: JEV13E37E), both intramuscularly in the left arm. On 21 Nov 2014, one week after vaccination the patient experienced an undiagnosed partial seizure and grand mal seizure. The patient visited the emergency room. The patient's blood work, CT scan, multiple EEG and multiple MRI were performed but nothing was found. The final outcome of the events reported as ongoing. The events reported as serious (life-threatening and disability) events. The causality of the events were not reported. Follow up report from the QA department received on 12 Oct 2015: Updated QA reference number 396518. The batch number 556011AA changed to 556011A as confirmed from the QA department.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dizziness, Headache, Muscular weakness, Oropharyngeal pain
Clinical narrative: Health system sent an email saying to schedule flu vaccine. That means to get it from them, a pharmacy, hospital, etc. I got the AFLURIA vaccine from an employee of my normal pharmacy...Pharmacy. During the vaccine, I felt it in my shoulder and neck immediately. Within hours I developed a cough, sore throat, swollen tongue, and bad headache..Since then (almost two weeks), arm mobility, stiffness and pain are worsening every day. It seems to go from my neck, down to my elbow. The shoulder is especially painful. I see my GP tomorrow.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Visual impairment
Clinical narrative: Health system sent an email saying to schedule flu vaccine. That means to get it from them, a pharmacy, hospital, etc. I got the AFLURIA vaccine from an employee of my normal pharmacy...Pharmacy. During the vaccine, I felt it in my shoulder and neck immediately. Within hours I developed a cough, sore throat, swollen tongue, and bad headache..Since then (almost two weeks), arm mobility, stiffness and pain are worsening every day. It seems to go from my neck, down to my elbow. The shoulder is especially painful. I see my GP tomorrow.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Headache, Immediate post-injection reaction, Mobility decreased, Musculoskeletal pain
Clinical narrative: Health system sent an email saying to schedule flu vaccine. That means to get it from them, a pharmacy, hospital, etc. I got the AFLURIA vaccine from an employee of my normal pharmacy...Pharmacy. During the vaccine, I felt it in my shoulder and neck immediately. Within hours I developed a cough, sore throat, swollen tongue, and bad headache..Since then (almost two weeks), arm mobility, stiffness and pain are worsening every day. It seems to go from my neck, down to my elbow. The shoulder is especially painful. I see my GP tomorrow.
Age: 58.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal stiffness, Oropharyngeal pain, Pain in extremity, Swollen tongue
Clinical narrative: Health system sent an email saying to schedule flu vaccine. That means to get it from them, a pharmacy, hospital, etc. I got the AFLURIA vaccine from an employee of my normal pharmacy...Pharmacy. During the vaccine, I felt it in my shoulder and neck immediately. Within hours I developed a cough, sore throat, swollen tongue, and bad headache..Since then (almost two weeks), arm mobility, stiffness and pain are worsening every day. It seems to go from my neck, down to my elbow. The shoulder is especially painful. I see my GP tomorrow.
Age: 0.76
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Autopsy, Death, Life support, Resuscitation, Unresponsive to stimuli
Clinical narrative: Initial unsolicited report received from a physician and pharmacist on 09-Oct-2015 and additional information received on 10-Oct-2015 from company representative. This case involves a nine-month-old female patient who was vaccinated with a first dose of 0.25 ml FLUZONE QIV (batch number- U5304FA, expiry date- 30-Jun-2016, route of administration was not reported) in left thigh on 08-Oct-2015 at 15:45 hours. Patient did not receive any other vaccinations within four weeks of current vaccination. Illness at the time of vaccination was reported as none. Patient had no known allergies and had ABO incompatibility and hyperbilirubinemia at the time of birth. Concomitant medications were not reported. On 08-Oct-2015, same day after vaccination it was reported that patient seemed to be fine but a bit fussy going to bed in the evening. Patient went to sleep at about 21:00 hours and when checked at 22:15 hours they found the baby was unresponsive and was not breathing. The parents began CPR and medics were called. She was transported to the Emergency room using full resuscitative measures. On 08-Oct-2015 at 22:50 hours (seven hours after vaccination), the resuscitative measures were stopped and patient was pronounced dead. The preliminary diagnosis was Sudden Infant Death Syndrome. Laboratory investigations were reported as not available. Autopsy was reported as pending. Outcome of the event irritable was not reported and rest other events (sudden infant death syndrome, unresponsive to stimuli and breathing arrested) were fatal. Documents held by sender: none.
Age: 0.76
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Autopsy, Death, Irritability, Respiratory arrest, Resuscitation
Clinical narrative: Initial unsolicited report received from a physician and pharmacist on 09-Oct-2015 and additional information received on 10-Oct-2015 from company representative. This case involves a nine-month-old female patient who was vaccinated with a first dose of 0.25 ml FLUZONE QIV (batch number- U5304FA, expiry date- 30-Jun-2016, route of administration was not reported) in left thigh on 08-Oct-2015 at 15:45 hours. Patient did not receive any other vaccinations within four weeks of current vaccination. Illness at the time of vaccination was reported as none. Patient had no known allergies and had ABO incompatibility and hyperbilirubinemia at the time of birth. Concomitant medications were not reported. On 08-Oct-2015, same day after vaccination it was reported that patient seemed to be fine but a bit fussy going to bed in the evening. Patient went to sleep at about 21:00 hours and when checked at 22:15 hours they found the baby was unresponsive and was not breathing. The parents began CPR and medics were called. She was transported to the Emergency room using full resuscitative measures. On 08-Oct-2015 at 22:50 hours (seven hours after vaccination), the resuscitative measures were stopped and patient was pronounced dead. The preliminary diagnosis was Sudden Infant Death Syndrome. Laboratory investigations were reported as not available. Autopsy was reported as pending. Outcome of the event irritable was not reported and rest other events (sudden infant death syndrome, unresponsive to stimuli and breathing arrested) were fatal. Documents held by sender: none.
Age: 0.76
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: Initial unsolicited report received from a physician and pharmacist on 09-Oct-2015 and additional information received on 10-Oct-2015 from company representative. This case involves a nine-month-old female patient who was vaccinated with a first dose of 0.25 ml FLUZONE QIV (batch number- U5304FA, expiry date- 30-Jun-2016, route of administration was not reported) in left thigh on 08-Oct-2015 at 15:45 hours. Patient did not receive any other vaccinations within four weeks of current vaccination. Illness at the time of vaccination was reported as none. Patient had no known allergies and had ABO incompatibility and hyperbilirubinemia at the time of birth. Concomitant medications were not reported. On 08-Oct-2015, same day after vaccination it was reported that patient seemed to be fine but a bit fussy going to bed in the evening. Patient went to sleep at about 21:00 hours and when checked at 22:15 hours they found the baby was unresponsive and was not breathing. The parents began CPR and medics were called. She was transported to the Emergency room using full resuscitative measures. On 08-Oct-2015 at 22:50 hours (seven hours after vaccination), the resuscitative measures were stopped and patient was pronounced dead. The preliminary diagnosis was Sudden Infant Death Syndrome. Laboratory investigations were reported as not available. Autopsy was reported as pending. Outcome of the event irritable was not reported and rest other events (sudden infant death syndrome, unresponsive to stimuli and breathing arrested) were fatal. Documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eye pruritus, Oral pruritus, Paraesthesia oral, Pruritus generalised
Clinical narrative: On 10/07/2015, I received the GSK-FLUARIX quadrivalent Lot number 43E97-expiration 6/30/2016 flu vaccine at 1430. At 1435, I started to feel a tingling sensation around my lips. I was at work, where I had received the vaccine provided by the employer, and administered by a nurse on my unit. I stayed with the other nurses for 15 minutes, and while the symptoms were not getting better, they were not getting worse, so I went home. I took 50 mg BENADRYL, ALLEGRA-D and ZANTAC 150mg, knowing that these were the medications I had received for an allergic reaction to cefazolin in 2011. The symptoms lessened slightly after taking these medications. I saw a member of the employee health staff at 1630, and she advised me to be seen in the ED at our hospital. At 1830, I did go to the ED. My symptoms at that point were a slight worsening of the tingling around the edge of my lips and itchy eyes. I did not feel short of breath, however, I could tell the OTC anti-allergy/anti-histamine medications were not going to be enough. They loaded me with prednisone 60 mg and sent me home on a prednisone taper. The peri-oral and eye itching continued until about midnight. 10/8/2015 at 0500 I took prednisone 60 mg, BENADRYL 25 mg, CLARITIN 5 mg and ZANTAC 150 mg, which all worked well to keep my symptoms to a minimum of oral and eye itching. Since approximately 1600 10/8, or just over 24 hours post exposure, additional BENADRYL 25mg, ALLEGRA-D and ZANTAC 150 mg is ineffective at relieving the itching. Beginning at approximately 2100 10/8, the itching has spread to the entire body. There is no rash or swelling of lips or eyelids at this time, just the pruritus. As a nurse, I have received the flu vaccine provided by my employer for the past 10+ years, and I have never had a reaction in the past. This is the first year I have received the GSK-FLUARIX, as my employer was unable to obtain it last year.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Eye pruritus, Paraesthesia oral, Pruritus generalised
Clinical narrative: On 10/07/2015, I received the GSK-FLUARIX quadrivalent Lot number 43E97-expiration 6/30/2016 flu vaccine at 1430. At 1435, I started to feel a tingling sensation around my lips. I was at work, where I had received the vaccine provided by the employer, and administered by a nurse on my unit. I stayed with the other nurses for 15 minutes, and while the symptoms were not getting better, they were not getting worse, so I went home. I took 50 mg BENADRYL, ALLEGRA-D and ZANTAC 150mg, knowing that these were the medications I had received for an allergic reaction to cefazolin in 2011. The symptoms lessened slightly after taking these medications. I saw a member of the employee health staff at 1630, and she advised me to be seen in the ED at our hospital. At 1830, I did go to the ED. My symptoms at that point were a slight worsening of the tingling around the edge of my lips and itchy eyes. I did not feel short of breath, however, I could tell the OTC anti-allergy/anti-histamine medications were not going to be enough. They loaded me with prednisone 60 mg and sent me home on a prednisone taper. The peri-oral and eye itching continued until about midnight. 10/8/2015 at 0500 I took prednisone 60 mg, BENADRYL 25 mg, CLARITIN 5 mg and ZANTAC 150 mg, which all worked well to keep my symptoms to a minimum of oral and eye itching. Since approximately 1600 10/8, or just over 24 hours post exposure, additional BENADRYL 25mg, ALLEGRA-D and ZANTAC 150 mg is ineffective at relieving the itching. Beginning at approximately 2100 10/8, the itching has spread to the entire body. There is no rash or swelling of lips or eyelids at this time, just the pruritus. As a nurse, I have received the flu vaccine provided by my employer for the past 10+ years, and I have never had a reaction in the past. This is the first year I have received the GSK-FLUARIX, as my employer was unable to obtain it last year.
Age: 24.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Blood test, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Case number PHEH2015US019074 is an initial spontaneous report received from a physician via medical affairs on 23 Sep 2015 with a follow up information received from a physician on 09 Oct 2015. This report refers to a 24-year-old female patient. Her current condition included immunodeficiency and her concomitant medications were prednisone 5 mg at a dose of 5 mg thrice daily via oral route  and PLAQUENIL 200 mg at a dose of 200 mg twice daily via oral route. The patient was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml from pre-filled syringe intramuscularly on 09 Sep 2015 at 6:21 pm. On the same date, after vaccination she experienced Guillain Barre Syndrome. On 21 Sep 2015, she had pain specified as headache, weakness of legs, paresthesia or anesthesia, unsteady gait, ataxia, shortness of breath, nausea and vomiting. The patient was hospitalized due to the event. Magnetic resonance imaging (MRI), Computed Tomogram (CT) and hematological or biological screening were done and results were not reported. The outcome of the events was reported as condition unchanged. The events were reported as life threatening and disabling. The causality of the events was not reported. Follow up information received from a physician on 09 Oct 2015: Updated patient demographics (initial, date of birth, height and weight), current condition, concomitant medications, suspect vaccine changed from FLUVIRIN to FLUCELVAX, batch number, dose and time of administration of suspect vaccination, events (headache, paresthesia or anesthesia, unsteady gait, ataxia weakness of legs, shortness of breath, nausea and vomiting), laboratory tests, outcome and seriousness.
Age: 24.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Anaesthesia, Ataxia, Computerised tomogram, Dyspnoea, Gait disturbance
Clinical narrative: Case number PHEH2015US019074 is an initial spontaneous report received from a physician via medical affairs on 23 Sep 2015 with a follow up information received from a physician on 09 Oct 2015. This report refers to a 24-year-old female patient. Her current condition included immunodeficiency and her concomitant medications were prednisone 5 mg at a dose of 5 mg thrice daily via oral route  and PLAQUENIL 200 mg at a dose of 200 mg twice daily via oral route. The patient was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml from pre-filled syringe intramuscularly on 09 Sep 2015 at 6:21 pm. On the same date, after vaccination she experienced Guillain Barre Syndrome. On 21 Sep 2015, she had pain specified as headache, weakness of legs, paresthesia or anesthesia, unsteady gait, ataxia, shortness of breath, nausea and vomiting. The patient was hospitalized due to the event. Magnetic resonance imaging (MRI), Computed Tomogram (CT) and hematological or biological screening were done and results were not reported. The outcome of the events was reported as condition unchanged. The events were reported as life threatening and disabling. The causality of the events was not reported. Follow up information received from a physician on 09 Oct 2015: Updated patient demographics (initial, date of birth, height and weight), current condition, concomitant medications, suspect vaccine changed from FLUVIRIN to FLUCELVAX, batch number, dose and time of administration of suspect vaccination, events (headache, paresthesia or anesthesia, unsteady gait, ataxia weakness of legs, shortness of breath, nausea and vomiting), laboratory tests, outcome and seriousness.
Age: 24.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Guillain-Barre syndrome, Haematology test, Headache, Laboratory test, Muscular weakness
Clinical narrative: Case number PHEH2015US019074 is an initial spontaneous report received from a physician via medical affairs on 23 Sep 2015 with a follow up information received from a physician on 09 Oct 2015. This report refers to a 24-year-old female patient. Her current condition included immunodeficiency and her concomitant medications were prednisone 5 mg at a dose of 5 mg thrice daily via oral route  and PLAQUENIL 200 mg at a dose of 200 mg twice daily via oral route. The patient was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml from pre-filled syringe intramuscularly on 09 Sep 2015 at 6:21 pm. On the same date, after vaccination she experienced Guillain Barre Syndrome. On 21 Sep 2015, she had pain specified as headache, weakness of legs, paresthesia or anesthesia, unsteady gait, ataxia, shortness of breath, nausea and vomiting. The patient was hospitalized due to the event. Magnetic resonance imaging (MRI), Computed Tomogram (CT) and hematological or biological screening were done and results were not reported. The outcome of the events was reported as condition unchanged. The events were reported as life threatening and disabling. The causality of the events was not reported. Follow up information received from a physician on 09 Oct 2015: Updated patient demographics (initial, date of birth, height and weight), current condition, concomitant medications, suspect vaccine changed from FLUVIRIN to FLUCELVAX, batch number, dose and time of administration of suspect vaccination, events (headache, paresthesia or anesthesia, unsteady gait, ataxia weakness of legs, shortness of breath, nausea and vomiting), laboratory tests, outcome and seriousness.
Age: 24.0
Sex: F
Vaccine: FLUC3, FLUC3
Symptoms: Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Vomiting
Clinical narrative: Case number PHEH2015US019074 is an initial spontaneous report received from a physician via medical affairs on 23 Sep 2015 with a follow up information received from a physician on 09 Oct 2015. This report refers to a 24-year-old female patient. Her current condition included immunodeficiency and her concomitant medications were prednisone 5 mg at a dose of 5 mg thrice daily via oral route  and PLAQUENIL 200 mg at a dose of 200 mg twice daily via oral route. The patient was vaccinated with FLUCELVAX (batch number: 173538) at a dose of 0.5 ml from pre-filled syringe intramuscularly on 09 Sep 2015 at 6:21 pm. On the same date, after vaccination she experienced Guillain Barre Syndrome. On 21 Sep 2015, she had pain specified as headache, weakness of legs, paresthesia or anesthesia, unsteady gait, ataxia, shortness of breath, nausea and vomiting. The patient was hospitalized due to the event. Magnetic resonance imaging (MRI), Computed Tomogram (CT) and hematological or biological screening were done and results were not reported. The outcome of the events was reported as condition unchanged. The events were reported as life threatening and disabling. The causality of the events was not reported. Follow up information received from a physician on 09 Oct 2015: Updated patient demographics (initial, date of birth, height and weight), current condition, concomitant medications, suspect vaccine changed from FLUVIRIN to FLUCELVAX, batch number, dose and time of administration of suspect vaccination, events (headache, paresthesia or anesthesia, unsteady gait, ataxia weakness of legs, shortness of breath, nausea and vomiting), laboratory tests, outcome and seriousness.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Abdominal pain, Constipation, Urticaria
Clinical narrative: Day 1 post FLUMIST: urticaria. Day 5 post FLUMIST: urticaria resolved. Day 7 post FLUMIST: severe abd. pain. Pt dbl'd over. Day 8 post FLUMIST: fever spike 102 degrees, vomit abd. pain. Day 9 post FLUMIST: fine AM, PM nausea, 101 temp, afebrile thereafter. Hives develop. Day 14 post FLUMIST: Hives.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Abdominal pain, Blood alkaline phosphatase increased, C-reactive protein, Differential white blood cell count normal, Full blood count
Clinical narrative: Day 1 post FLUMIST: urticaria. Day 5 post FLUMIST: urticaria resolved. Day 7 post FLUMIST: severe abd. pain. Pt dbl'd over. Day 8 post FLUMIST: fever spike 102 degrees, vomit abd. pain. Day 9 post FLUMIST: fine AM, PM nausea, 101 temp, afebrile thereafter. Hives develop. Day 14 post FLUMIST: Hives.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Laboratory test normal, Lymphocyte percentage increased, Nausea, Neutrophil percentage, Pyrexia
Clinical narrative: Day 1 post FLUMIST: urticaria. Day 5 post FLUMIST: urticaria resolved. Day 7 post FLUMIST: severe abd. pain. Pt dbl'd over. Day 8 post FLUMIST: fever spike 102 degrees, vomit abd. pain. Day 9 post FLUMIST: fine AM, PM nausea, 101 temp, afebrile thereafter. Hives develop. Day 14 post FLUMIST: Hives.
Age: 3.0
Sex: M
Vaccine: FLUN4, FLUN4
Symptoms: Urticaria, Vomiting
Clinical narrative: Day 1 post FLUMIST: urticaria. Day 5 post FLUMIST: urticaria resolved. Day 7 post FLUMIST: severe abd. pain. Pt dbl'd over. Day 8 post FLUMIST: fever spike 102 degrees, vomit abd. pain. Day 9 post FLUMIST: fine AM, PM nausea, 101 temp, afebrile thereafter. Hives develop. Day 14 post FLUMIST: Hives.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician via a field representative referring to a 12 month old male patient. The patient's pertinent medical history and drug allergies were not reported. On 27-JUL-2015 the patient was vaccinated with the first dose of M-M-R II (0.5  ml, subcutaneous) in his thigh. Approximately 30 min after the vaccination the patient developed a rash on his right arm. The patient sought medical attention and BENADRYL was given for the treatment. The outcome of the event was recovered on an unknown date in 2015. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician via a field representative referring to a 12 month old male patient. The patient's pertinent medical history and drug allergies were not reported. On 27-JUL-2015 the patient was vaccinated with the first dose of M-M-R II (0.5  ml, subcutaneous) in his thigh. Approximately 30 min after the vaccination the patient developed a rash on his right arm. The patient sought medical attention and BENADRYL was given for the treatment. The outcome of the event was recovered on an unknown date in 2015. Additional information has been requested.
Sex: U
Vaccine: FLUX, PNC13, VARZOS, FLUX, PNC13, VARZOS
Symptoms: Respiratory symptom
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This is the 1st of 2 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13 via an unspecified route of administration single dose, ZOSTAVAX via an unspecified route of administration, flu vaccine, all on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced respiratory symptoms on unknown date which required hospitalization. It was unknown if the patient was in the hospital at the time of this report.
Sex: U
Vaccine: FLUX, PNC13, VARZOS, FLUX, PNC13, VARZOS
Symptoms: Respiratory symptom
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. The physician reported for two patients, this is the second of two cases. A patient of unspecified age, gender and ethnicity received PREVNAR 13 at single dose, ZOSTAVAX at an unknown dose and flu vaccine (manufacturer unknown) at an unknown dose all via an unspecified route of administration, on unknown date. Relevant medical history and concomitant medications were not reported. The patient experienced respiratory symptoms on unknown date which required hospitalization. It was unknown if the patient was in the hospital at the time of this report.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Chills, Nausea
Clinical narrative: Chills, abdominal cramps, nausea, lack of energy.
Age: 31.0
Sex: M
Vaccine: FLUN4
Symptoms: VIIth nerve paralysis
Clinical narrative: Right sided face paralysis, Bell's Palsy.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: There were no adverse effects or symptoms at time of the event. Pt has been advised to f/u if there are any effects or side effects to the vaccination.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site reaction, Injection site scar
Clinical narrative: Huge red welts at injection site. Arm continues to get red and sensitive to touch. Knot or scarred tissue at injection site.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness, Urticaria
Clinical narrative: Huge red welts at injection site. Arm continues to get red and sensitive to touch. Knot or scarred tissue at injection site.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Wife reported that shortly after administration, patient experienced approximately 12 hours of wheezing and shortness of breath.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchitis, Cough, Headache, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Sore throat within hour for receiving vaccine, head ache, coughing congestion, bronchitis symptoms a few days later.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Pyrexia, Rash macular, Tremor
Clinical narrative: Severe, uncontrolled shaking from chills, Fever, Angry red blotch (12cm x 13cm) on arm at the point of vaccination.  Vaccination site became hot to touch, EXTREMELY painful and redness continued to increase in size for following 3-4 days.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Vaccination site pain, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Severe, uncontrolled shaking from chills, Fever, Angry red blotch (12cm x 13cm) on arm at the point of vaccination.  Vaccination site became hot to touch, EXTREMELY painful and redness continued to increase in size for following 3-4 days.
Age: 63.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site cellulitis, Injection site erythema, Injection site rash, Pain
Clinical narrative: Severe, uncontrolled shaking from chills, Fever, Angry red blotch (12cm x 13cm) on arm at the point of vaccination.  Vaccination site became hot to touch, EXTREMELY painful and redness continued to increase in size for following 3-4 days.
Age: 1.03
Sex: M
Vaccine: HEP, HEPA, HIBV, MMRV, PNC13
Symptoms: Interstitial lung disease, Laboratory test normal, Pyrexia, Sudden death, Toxicologic test normal
Clinical narrative: Pt. received physical and shots on 10/5/15 and passed 10/8/15. Per family he had a fever x2d, no fever on 3rd day or 4th day and then died suddenly on 10/8/15. The coroner's preliminary slides show viral myocarditis and interstitial pneumonia.
Age: 1.03
Sex: M
Vaccine: HEP, HEPA, HIBV, MMRV, PNC13
Symptoms: Viral myocarditis
Clinical narrative: Pt. received physical and shots on 10/5/15 and passed 10/8/15. Per family he had a fever x2d, no fever on 3rd day or 4th day and then died suddenly on 10/8/15. The coroner's preliminary slides show viral myocarditis and interstitial pneumonia.
Age: 47.0
Sex: F
Vaccine: FLUC3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient stated immediate pain right deltoid after vaccine; two weeks later presented to health center with right shoulder pain for 2 weeks.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Rash
Clinical narrative: Rash under arms and on chest.  Flu like symptoms.  Went to Health Services and they treated with OTC cold and flu medicine and cortisone.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Participant was vaccinated with influenza/ Novartis injection while stating she is pregnant. No Adverse reaction occurred.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Disorientation, Dizziness, Erythema, Influenza like illness
Clinical narrative: Chills, nausea, disoriented, dizzy, flu like symptoms that lasted 5-6 days, arm stayed red for six days, arm still has knot at injection site.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Nausea
Clinical narrative: Chills, nausea, disoriented, dizzy, flu like symptoms that lasted 5-6 days, arm stayed red for six days, arm still has knot at injection site.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Gastrointestinal pain, Pain, Pain in extremity
Clinical narrative: Gastro intestinal pain and diarrhea with arm pain especially with movement.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site which proceeded to entire upper arm.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Nodule, Oedema, Pruritus
Clinical narrative: Redness and edema with hard knot in center and hives onset within 24 hours while sleeping. Seen today 10/19/2015 @ 0845. Redness approx. 10 cm x 6 cm at this time. Client c/o itching. Caladryl lotion applied with partial relief of itching. Client reports was worse Friday and some better today.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Redness and edema with hard knot in center and hives onset within 24 hours while sleeping. Seen today 10/19/2015 @ 0845. Redness approx. 10 cm x 6 cm at this time. Client c/o itching. Caladryl lotion applied with partial relief of itching. Client reports was worse Friday and some better today.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, redness and itching that began approximately 20 hour post-vaccination.  The swelling and itching were gone by 40 hours post-vaccination but there was still residual inflammation.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Muscle twitching, Ultrasound scan abnormal
Clinical narrative: Developed redness, swelling, itchiness of right deltoid. Given Benadryl and compresses, then started developing muscle twitching in arm, back and neck. Seen in ER. No scans of brain done, no EEG, referred to Neurology. Placed on antibiotics for possible abscess.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia
Clinical narrative: Deltoid muscle pain especially when raising arm over head.  Pain has been chronic since onset.
Age: 1.35
Sex: M
Vaccine: DTP, HIBV
Symptoms: Agitation, Balance disorder, Clumsiness, Developmental regression, Dysstasia
Clinical narrative: Excessive sleepiness, extreme clumsiness, regression of skills, difficulty staying upright, difficulty gathering balance (taking five or six times to stand up after falling for no reason), extreme agitation and pain, non contagious rash appearing everywhere except chest and back lasting 2+ weeks (not bacterial, allergy related or viral).
Age: 1.35
Sex: M
Vaccine: DTP, HIBV
Symptoms: Fall, Pain, Rash generalised, Somnolence
Clinical narrative: Excessive sleepiness, extreme clumsiness, regression of skills, difficulty staying upright, difficulty gathering balance (taking five or six times to stand up after falling for no reason), extreme agitation and pain, non contagious rash appearing everywhere except chest and back lasting 2+ weeks (not bacterial, allergy related or viral).
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Nerve injury, Pain, Pain in extremity
Clinical narrative: Increasing stiffness, pain --pt described as "bone on bone feeling" "like nerve damage" and pain down arm to hand--but has full use of hand.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal discomfort, Asthenia, Dehydration, Diarrhoea, Dizziness
Clinical narrative: I developed a moderate continuous frontal headache all afternoon on 10/17/2015.  I felt as though I was feverish, but temperature was normal. As the day progressed, I developed generalized aching in my legs and neck (but I also have arthritis and am on a steroid burst).  In the evening developed abdominal feeling of impending diarrhea.  Had a loose stool before bedtime.  By 5am on 10/18/2015 I was having hourly or less episodes of moderate diarrhea.  I was unable to eat or drink, slept all day except to get up to have diarrhea. I wasn't in pain, just so sleepy.  I felt cold and used heated blankets.  I did NOT have fever or shaking chills throughout any of this.  I was dizzy and felt so weak on 10/18/2015 from the continuous diarrhea episodes.  My last episode was 8pm 10/18/15.  Today, 10/19/15, I awoke feeling just a slight headache (may be from slight dehydration and caffeine withdrawal of yesterday).  I had one soft loose BM this am, but can tell by my body that this will not be diarrhea.  I am drinking coffee and fluids and feel stronger with totally resolving symptoms.  My major side effect not listed in your symptoms article was significant diarrhea, with potential for dehydration.  I am a nurse, did not need treatment.  MD office not imformed, as it was a weekend.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Feeding disorder, Feeling cold, Fluid intake reduced, Headache, Neck pain
Clinical narrative: I developed a moderate continuous frontal headache all afternoon on 10/17/2015.  I felt as though I was feverish, but temperature was normal. As the day progressed, I developed generalized aching in my legs and neck (but I also have arthritis and am on a steroid burst).  In the evening developed abdominal feeling of impending diarrhea.  Had a loose stool before bedtime.  By 5am on 10/18/2015 I was having hourly or less episodes of moderate diarrhea.  I was unable to eat or drink, slept all day except to get up to have diarrhea. I wasn't in pain, just so sleepy.  I felt cold and used heated blankets.  I did NOT have fever or shaking chills throughout any of this.  I was dizzy and felt so weak on 10/18/2015 from the continuous diarrhea episodes.  My last episode was 8pm 10/18/15.  Today, 10/19/15, I awoke feeling just a slight headache (may be from slight dehydration and caffeine withdrawal of yesterday).  I had one soft loose BM this am, but can tell by my body that this will not be diarrhea.  I am drinking coffee and fluids and feel stronger with totally resolving symptoms.  My major side effect not listed in your symptoms article was significant diarrhea, with potential for dehydration.  I am a nurse, did not need treatment.  MD office not imformed, as it was a weekend.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I developed a moderate continuous frontal headache all afternoon on 10/17/2015.  I felt as though I was feverish, but temperature was normal. As the day progressed, I developed generalized aching in my legs and neck (but I also have arthritis and am on a steroid burst).  In the evening developed abdominal feeling of impending diarrhea.  Had a loose stool before bedtime.  By 5am on 10/18/2015 I was having hourly or less episodes of moderate diarrhea.  I was unable to eat or drink, slept all day except to get up to have diarrhea. I wasn't in pain, just so sleepy.  I felt cold and used heated blankets.  I did NOT have fever or shaking chills throughout any of this.  I was dizzy and felt so weak on 10/18/2015 from the continuous diarrhea episodes.  My last episode was 8pm 10/18/15.  Today, 10/19/15, I awoke feeling just a slight headache (may be from slight dehydration and caffeine withdrawal of yesterday).  I had one soft loose BM this am, but can tell by my body that this will not be diarrhea.  I am drinking coffee and fluids and feel stronger with totally resolving symptoms.  My major side effect not listed in your symptoms article was significant diarrhea, with potential for dehydration.  I am a nurse, did not need treatment.  MD office not imformed, as it was a weekend.
Age: 20.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Dizziness, Flushing, Loss of consciousness, Presyncope
Clinical narrative: Vasovagal. Pt got flushed, dizzy & passed out.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Intense itching and hives all over both arms, both legs, and chest. This also happened with 2014's vaccine but at the time I atributed it to intense stress and possibly a detergent reaction. It took 8 months, numerous visits to the dermatologist and countless medications and creams to finally clear up.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Fatigue, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Pain swelling at injection site, extreme fatigue, I mean extreme! Mild fever, migraine headache, arm pain, neck pain, back pain. Sick overall feeling, one week and not getting better.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Migraine, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Pain swelling at injection site, extreme fatigue, I mean extreme! Mild fever, migraine headache, arm pain, neck pain, back pain. Sick overall feeling, one week and not getting better.