chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: FLU VACCINE RECEIVED AT PLACE OF EMPLOYMENT.  ACTUAL INJECTION WS NON-EVENTFUL HOWEVER, THE ADMINSTRATION OF THE VACCINATION MEDICATION WAS QUITE PAINFUL.  APPROXIMATELY TWO (2) HOURS AFTER INJECTION ARM STARTED BECOMING QUITE SORE.  HAVING RECEIVED FLU VACCINATIONS YEARLY FOR MANY YEARS, IT WAS NOT UNUSUAL TO EXPERIENCE SOME TENDERNESS IN THE HOURS AFTER THE INJECTION. THAT EVENING, I EXPERIENCED EXTREME PAIN IN THE ARM AND WAS BARELY ABLE TO MOVE IT.  THIS CONTINUED THROUGHOUT THE NIGHT KEEPING ME AWAKE MOST OF THE NIGHT.  AFTER A FEW DAYS IT DAYS IT WAS FEELING BETTER.  A LITTLE SORE BUT NOTHING SEVERE SO I ASSUMED MY ARM WAS RECOVERING.  HOWEVER, JUST AS I THOUGHT IT WAS IMPROVING, THE PAIN AGAIN BECAME QUITE SEVERE (THIS OCCURRED APPROX SEVEN (7) DAYS AFTER THE INJECTION.  OVER THE FOLLOWING WEEKS, THE LEVEL OF PAIN FLUCTUATED BETWEEN MILD (TOLERABLE) AND SEVERE (MOVEMENT CAUSED ME TO GASP).  ON DECEMBER 14, 2005, I VISITED MY PRIMARY CARE PHYSICIAN.  HE TOLD ME HE FELT THAT THE SYMPTOMS WERE NOT CAUSED BY NEEDLE, BUT DIAGNOSED IT AS A NEURITIS CAUSED BY THE VACCINE.  HE PRESCRIBED NEUROTININ (GABAPENTIN 300 MG TWICE DAILY FOR TWO WEEKS).  I WAS UNABLE TO CONTINUE WITH THAT TREATMENT BECAUSE IT CAUSED SEVERE DIARRHEA AND GAS.  I HAVE AN APPOINTMENT SCHEDULED WITH AN ORTHOPAEDIC SPECIALIST FOR DECEMBER 30, 2005.
Age: 5.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Abnormal behaviour, Antisocial behaviour, Hypoacusis, Irritability
Clinical narrative: MMR given in June of 2003. Parents brought patient to my office in Nov of 2003 and at that time he had a documented sensorineural hearing loss. However parents noted behavioral changes in the summer and feel that hearing loss started then. They are concerned about a possible link with MMR.
Age: 5.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Abnormal behaviour, Hypoacusis
Clinical narrative: MMR given in June of 2003. Parents brought patient to my office in Nov of 2003 and at that time he had a documented sensorineural hearing loss. However parents noted behavioral changes in the summer and feel that hearing loss started then. They are concerned about a possible link with MMR.
Age: 11.0
Sex: M
Vaccine: PPV, MMR
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 10 year old male with chronic hay fever, no serious underlying medical conditions, and no illness at time of vaccination who on Oct 18 2005 at 4:30pm was vaccinated IM in the left arm with a 0.5 ml first dose of pneumococcal 23 polysaccharide vaccine (lot 649914/0578P). On Oct 18 2005 the patient complained of extreme pain in left arm after vaccination. There was only minor redness at the site. It was reported that the patient had a high fever for the past two days that would not go away even after treatment with ibuprofen (Motrin) and ketorolac tromethamine (Toradol). The doctor would like an investigation into this lot number. Unspecified medical attention was sought. No laboratory diagnostic test were performed. There was no product quality complaint involved. A lot check has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards and was released. Additional information was received from the physician who reported that within an hour of vaccination, which was done after preparing the syringe warm with aseptic technique, the site became extremely tender along with nausea, headache, and fever. The physician examined him on Oct 19 2005 and found extreme tenderness but no swelling or erythema to the area concentric to the injection site. His fever at the time was 104. By Oct 21 2005, his fever, nausea, and pain were severe enough he could neither eat nor drink. He was admitted to the hospital for 3 days for analgesia and IV fluids. By Oct 22 2005, the patient was afebrile, and the pain which had extended beyond his arm was improved. The patient was discharged home and made a full recovery on Oct 22 2005. The physician reported that he suspected that the patient had an episode of acute pneumococcal pneumonia. This illness suspected to be a pneumococcal infection was the reason why the patient was vaccinated with pneumococcal vaccine polyvalent (MSD). No additional information is expected.
Age: 11.0
Sex: M
Vaccine: PPV, MMR
Symptoms: Anorexia, Headache, Injection site hypersensitivity, Injection site pain, Nausea
Clinical narrative: Information has been received from a health professional concerning a 10 year old male with chronic hay fever, no serious underlying medical conditions, and no illness at time of vaccination who on Oct 18 2005 at 4:30pm was vaccinated IM in the left arm with a 0.5 ml first dose of pneumococcal 23 polysaccharide vaccine (lot 649914/0578P). On Oct 18 2005 the patient complained of extreme pain in left arm after vaccination. There was only minor redness at the site. It was reported that the patient had a high fever for the past two days that would not go away even after treatment with ibuprofen (Motrin) and ketorolac tromethamine (Toradol). The doctor would like an investigation into this lot number. Unspecified medical attention was sought. No laboratory diagnostic test were performed. There was no product quality complaint involved. A lot check has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards and was released. Additional information was received from the physician who reported that within an hour of vaccination, which was done after preparing the syringe warm with aseptic technique, the site became extremely tender along with nausea, headache, and fever. The physician examined him on Oct 19 2005 and found extreme tenderness but no swelling or erythema to the area concentric to the injection site. His fever at the time was 104. By Oct 21 2005, his fever, nausea, and pain were severe enough he could neither eat nor drink. He was admitted to the hospital for 3 days for analgesia and IV fluids. By Oct 22 2005, the patient was afebrile, and the pain which had extended beyond his arm was improved. The patient was discharged home and made a full recovery on Oct 22 2005. The physician reported that he suspected that the patient had an episode of acute pneumococcal pneumonia. This illness suspected to be a pneumococcal infection was the reason why the patient was vaccinated with pneumococcal vaccine polyvalent (MSD). No additional information is expected.
Age: 11.0
Sex: M
Vaccine: PPV, MMR
Symptoms: Pneumonia, Pyrexia, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 10 year old male with chronic hay fever, no serious underlying medical conditions, and no illness at time of vaccination who on Oct 18 2005 at 4:30pm was vaccinated IM in the left arm with a 0.5 ml first dose of pneumococcal 23 polysaccharide vaccine (lot 649914/0578P). On Oct 18 2005 the patient complained of extreme pain in left arm after vaccination. There was only minor redness at the site. It was reported that the patient had a high fever for the past two days that would not go away even after treatment with ibuprofen (Motrin) and ketorolac tromethamine (Toradol). The doctor would like an investigation into this lot number. Unspecified medical attention was sought. No laboratory diagnostic test were performed. There was no product quality complaint involved. A lot check has been requested. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards and was released. Additional information was received from the physician who reported that within an hour of vaccination, which was done after preparing the syringe warm with aseptic technique, the site became extremely tender along with nausea, headache, and fever. The physician examined him on Oct 19 2005 and found extreme tenderness but no swelling or erythema to the area concentric to the injection site. His fever at the time was 104. By Oct 21 2005, his fever, nausea, and pain were severe enough he could neither eat nor drink. He was admitted to the hospital for 3 days for analgesia and IV fluids. By Oct 22 2005, the patient was afebrile, and the pain which had extended beyond his arm was improved. The patient was discharged home and made a full recovery on Oct 22 2005. The physician reported that he suspected that the patient had an episode of acute pneumococcal pneumonia. This illness suspected to be a pneumococcal infection was the reason why the patient was vaccinated with pneumococcal vaccine polyvalent (MSD). No additional information is expected.
Age: 13.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Asthenia, CSF test abnormal, Chills, Diarrhoea, Headache
Clinical narrative: A 13 year old male patient was vaccinated with the third dose of RabAvert (batch no 355011) on Dec 6 2005. Later on vaccination day the patient experienced diarrhea and vomiting. On Dec 12 2005 in the evening, the patient presented at a hospital with vomiting, chills, fever, severe headache, and generalised muscle aches with neck weakness. A lumbar puncture was performed. The patient was diagnosed with aseptic meningitis and was put into the pediatric intensive care unit. On Dec 13 the patient had improved. We are  awaiting further data preliminary company assessment Seriousness criterion hospitalisation, causality pending. The reported symptoms are expected, except for aseptic meningitis and neck weakness, after vaccination with RabAvert. On a case level, the case is considered unexpected. Addendum 12/16/2005. We received further information. On the day of the third RabAvert administration (i.m. Dec 6 2005) patient experienced vomiting persisting for three days, Diarrhea started on Dec 9 2005 (not on 12/6/2005 as reported earlier). On Dec 10 2005 patient seemed better, but then developed, still on that day, generalized rash and in the evening after sleeping all day, fever, and chills. Where as the rash resolved on Dec 11 2005, chills and fever continued through  12/12/2005, when he was hospitalized, presenting with severe headache, generalized muscle aches, weakness and being feverish. He spoke clearly. Ear, nose, throat exam suggested meningismus, probable meningitis was noted in the patient chart. He was admitted to the intensive care unit on 12/12/2005, but moved out to a regular ward the next day. He was stable by 12/14/2005. Lab test showed increased white blood cell count in cerebrospinal fluid (547/ul normal <5/ul), CSF was cloudy and white, white blood cell count in blood was low (2.600 normal: 4.500-13000 ul), bands in differential blood count went from 34% (12/12/2005) to 10% (12/13/2005) and 6% (12/14/2005). Red blood count, hemoglobin, hematocrit and platelets were all low. CSF and blood culture were still negative by 12/14/2005. MRI on 12/13/2005 was negative, meningitis was diagnosed. Patient was put on antibiotics. Patient is wearing teeth braces (possible place of entry for bacteria). Seriousness criteria hospitalisation, medically significant (OMIC). causality not related. The described symptoms, except for diarrhea, vomiting, rash, headache, chills, fever, muscle aches and weakness, are unexpected after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
Age: 13.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Laboratory test abnormal, Leukopenia, Meningitis, Myalgia, Neutropenia
Clinical narrative: A 13 year old male patient was vaccinated with the third dose of RabAvert (batch no 355011) on Dec 6 2005. Later on vaccination day the patient experienced diarrhea and vomiting. On Dec 12 2005 in the evening, the patient presented at a hospital with vomiting, chills, fever, severe headache, and generalised muscle aches with neck weakness. A lumbar puncture was performed. The patient was diagnosed with aseptic meningitis and was put into the pediatric intensive care unit. On Dec 13 the patient had improved. We are  awaiting further data preliminary company assessment Seriousness criterion hospitalisation, causality pending. The reported symptoms are expected, except for aseptic meningitis and neck weakness, after vaccination with RabAvert. On a case level, the case is considered unexpected. Addendum 12/16/2005. We received further information. On the day of the third RabAvert administration (i.m. Dec 6 2005) patient experienced vomiting persisting for three days, Diarrhea started on Dec 9 2005 (not on 12/6/2005 as reported earlier). On Dec 10 2005 patient seemed better, but then developed, still on that day, generalized rash and in the evening after sleeping all day, fever, and chills. Where as the rash resolved on Dec 11 2005, chills and fever continued through  12/12/2005, when he was hospitalized, presenting with severe headache, generalized muscle aches, weakness and being feverish. He spoke clearly. Ear, nose, throat exam suggested meningismus, probable meningitis was noted in the patient chart. He was admitted to the intensive care unit on 12/12/2005, but moved out to a regular ward the next day. He was stable by 12/14/2005. Lab test showed increased white blood cell count in cerebrospinal fluid (547/ul normal <5/ul), CSF was cloudy and white, white blood cell count in blood was low (2.600 normal: 4.500-13000 ul), bands in differential blood count went from 34% (12/12/2005) to 10% (12/13/2005) and 6% (12/14/2005). Red blood count, hemoglobin, hematocrit and platelets were all low. CSF and blood culture were still negative by 12/14/2005. MRI on 12/13/2005 was negative, meningitis was diagnosed. Patient was put on antibiotics. Patient is wearing teeth braces (possible place of entry for bacteria). Seriousness criteria hospitalisation, medically significant (OMIC). causality not related. The described symptoms, except for diarrhea, vomiting, rash, headache, chills, fever, muscle aches and weakness, are unexpected after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
Age: 13.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Platelet count decreased, Pyrexia, Rash, Thrombocytopenia, Vomiting
Clinical narrative: A 13 year old male patient was vaccinated with the third dose of RabAvert (batch no 355011) on Dec 6 2005. Later on vaccination day the patient experienced diarrhea and vomiting. On Dec 12 2005 in the evening, the patient presented at a hospital with vomiting, chills, fever, severe headache, and generalised muscle aches with neck weakness. A lumbar puncture was performed. The patient was diagnosed with aseptic meningitis and was put into the pediatric intensive care unit. On Dec 13 the patient had improved. We are  awaiting further data preliminary company assessment Seriousness criterion hospitalisation, causality pending. The reported symptoms are expected, except for aseptic meningitis and neck weakness, after vaccination with RabAvert. On a case level, the case is considered unexpected. Addendum 12/16/2005. We received further information. On the day of the third RabAvert administration (i.m. Dec 6 2005) patient experienced vomiting persisting for three days, Diarrhea started on Dec 9 2005 (not on 12/6/2005 as reported earlier). On Dec 10 2005 patient seemed better, but then developed, still on that day, generalized rash and in the evening after sleeping all day, fever, and chills. Where as the rash resolved on Dec 11 2005, chills and fever continued through  12/12/2005, when he was hospitalized, presenting with severe headache, generalized muscle aches, weakness and being feverish. He spoke clearly. Ear, nose, throat exam suggested meningismus, probable meningitis was noted in the patient chart. He was admitted to the intensive care unit on 12/12/2005, but moved out to a regular ward the next day. He was stable by 12/14/2005. Lab test showed increased white blood cell count in cerebrospinal fluid (547/ul normal <5/ul), CSF was cloudy and white, white blood cell count in blood was low (2.600 normal: 4.500-13000 ul), bands in differential blood count went from 34% (12/12/2005) to 10% (12/13/2005) and 6% (12/14/2005). Red blood count, hemoglobin, hematocrit and platelets were all low. CSF and blood culture were still negative by 12/14/2005. MRI on 12/13/2005 was negative, meningitis was diagnosed. Patient was put on antibiotics. Patient is wearing teeth braces (possible place of entry for bacteria). Seriousness criteria hospitalisation, medically significant (OMIC). causality not related. The described symptoms, except for diarrhea, vomiting, rash, headache, chills, fever, muscle aches and weakness, are unexpected after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
Age: 13.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Asthenia, CSF test abnormal, Chills, Diarrhoea, Haematocrit decreased
Clinical narrative: A 13 year old male patient was vaccinated with the third dose of RabAvert (batch no 355011) on Dec 6 2005. Later on vaccination day the patient experienced diarrhea and vomiting. On Dec 12 2005 in the evening, the patient presented at a hospital with vomiting, chills, fever, severe headache, and generalised muscle aches with neck weakness. A lumbar puncture was performed. The patient was diagnosed with aseptic meningitis and was put into the pediatric intensive care unit. On Dec 13 the patient had improved. We are  awaiting further data preliminary company assessment Seriousness criterion hospitalisation, causality pending. The reported symptoms are expected, except for aseptic meningitis and neck weakness, after vaccination with RabAvert. On a case level, the case is considered unexpected. Addendum 12/16/2005. We received further information. On the day of the third RabAvert administration (i.m. Dec 6 2005) patient experienced vomiting persisting for three days, Diarrhea started on Dec 9 2005 (not on 12/6/2005 as reported earlier). On Dec 10 2005 patient seemed better, but then developed, still on that day, generalized rash and in the evening after sleeping all day, fever, and chills. Where as the rash resolved on Dec 11 2005, chills and fever continued through  12/12/2005, when he was hospitalized, presenting with severe headache, generalized muscle aches, weakness and being feverish. He spoke clearly. Ear, nose, throat exam suggested meningismus, probable meningitis was noted in the patient chart. He was admitted to the intensive care unit on 12/12/2005, but moved out to a regular ward the next day. He was stable by 12/14/2005. Lab test showed increased white blood cell count in cerebrospinal fluid (547/ul normal <5/ul), CSF was cloudy and white, white blood cell count in blood was low (2.600 normal: 4.500-13000 ul), bands in differential blood count went from 34% (12/12/2005) to 10% (12/13/2005) and 6% (12/14/2005). Red blood count, hemoglobin, hematocrit and platelets were all low. CSF and blood culture were still negative by 12/14/2005. MRI on 12/13/2005 was negative, meningitis was diagnosed. Patient was put on antibiotics. Patient is wearing teeth braces (possible place of entry for bacteria). Seriousness criteria hospitalisation, medically significant (OMIC). causality not related. The described symptoms, except for diarrhea, vomiting, rash, headache, chills, fever, muscle aches and weakness, are unexpected after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
Age: 13.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Haemoglobin decreased, Headache, Laboratory test abnormal, Meningism, Meningitis
Clinical narrative: A 13 year old male patient was vaccinated with the third dose of RabAvert (batch no 355011) on Dec 6 2005. Later on vaccination day the patient experienced diarrhea and vomiting. On Dec 12 2005 in the evening, the patient presented at a hospital with vomiting, chills, fever, severe headache, and generalised muscle aches with neck weakness. A lumbar puncture was performed. The patient was diagnosed with aseptic meningitis and was put into the pediatric intensive care unit. On Dec 13 the patient had improved. We are  awaiting further data preliminary company assessment Seriousness criterion hospitalisation, causality pending. The reported symptoms are expected, except for aseptic meningitis and neck weakness, after vaccination with RabAvert. On a case level, the case is considered unexpected. Addendum 12/16/2005. We received further information. On the day of the third RabAvert administration (i.m. Dec 6 2005) patient experienced vomiting persisting for three days, Diarrhea started on Dec 9 2005 (not on 12/6/2005 as reported earlier). On Dec 10 2005 patient seemed better, but then developed, still on that day, generalized rash and in the evening after sleeping all day, fever, and chills. Where as the rash resolved on Dec 11 2005, chills and fever continued through  12/12/2005, when he was hospitalized, presenting with severe headache, generalized muscle aches, weakness and being feverish. He spoke clearly. Ear, nose, throat exam suggested meningismus, probable meningitis was noted in the patient chart. He was admitted to the intensive care unit on 12/12/2005, but moved out to a regular ward the next day. He was stable by 12/14/2005. Lab test showed increased white blood cell count in cerebrospinal fluid (547/ul normal <5/ul), CSF was cloudy and white, white blood cell count in blood was low (2.600 normal: 4.500-13000 ul), bands in differential blood count went from 34% (12/12/2005) to 10% (12/13/2005) and 6% (12/14/2005). Red blood count, hemoglobin, hematocrit and platelets were all low. CSF and blood culture were still negative by 12/14/2005. MRI on 12/13/2005 was negative, meningitis was diagnosed. Patient was put on antibiotics. Patient is wearing teeth braces (possible place of entry for bacteria). Seriousness criteria hospitalisation, medically significant (OMIC). causality not related. The described symptoms, except for diarrhea, vomiting, rash, headache, chills, fever, muscle aches and weakness, are unexpected after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
Age: 13.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Meningitis aseptic, Myalgia, Platelet count decreased, Pyrexia, Rash
Clinical narrative: A 13 year old male patient was vaccinated with the third dose of RabAvert (batch no 355011) on Dec 6 2005. Later on vaccination day the patient experienced diarrhea and vomiting. On Dec 12 2005 in the evening, the patient presented at a hospital with vomiting, chills, fever, severe headache, and generalised muscle aches with neck weakness. A lumbar puncture was performed. The patient was diagnosed with aseptic meningitis and was put into the pediatric intensive care unit. On Dec 13 the patient had improved. We are  awaiting further data preliminary company assessment Seriousness criterion hospitalisation, causality pending. The reported symptoms are expected, except for aseptic meningitis and neck weakness, after vaccination with RabAvert. On a case level, the case is considered unexpected. Addendum 12/16/2005. We received further information. On the day of the third RabAvert administration (i.m. Dec 6 2005) patient experienced vomiting persisting for three days, Diarrhea started on Dec 9 2005 (not on 12/6/2005 as reported earlier). On Dec 10 2005 patient seemed better, but then developed, still on that day, generalized rash and in the evening after sleeping all day, fever, and chills. Where as the rash resolved on Dec 11 2005, chills and fever continued through  12/12/2005, when he was hospitalized, presenting with severe headache, generalized muscle aches, weakness and being feverish. He spoke clearly. Ear, nose, throat exam suggested meningismus, probable meningitis was noted in the patient chart. He was admitted to the intensive care unit on 12/12/2005, but moved out to a regular ward the next day. He was stable by 12/14/2005. Lab test showed increased white blood cell count in cerebrospinal fluid (547/ul normal <5/ul), CSF was cloudy and white, white blood cell count in blood was low (2.600 normal: 4.500-13000 ul), bands in differential blood count went from 34% (12/12/2005) to 10% (12/13/2005) and 6% (12/14/2005). Red blood count, hemoglobin, hematocrit and platelets were all low. CSF and blood culture were still negative by 12/14/2005. MRI on 12/13/2005 was negative, meningitis was diagnosed. Patient was put on antibiotics. Patient is wearing teeth braces (possible place of entry for bacteria). Seriousness criteria hospitalisation, medically significant (OMIC). causality not related. The described symptoms, except for diarrhea, vomiting, rash, headache, chills, fever, muscle aches and weakness, are unexpected after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
Age: 13.0
Sex: M
Vaccine: RAB, RAB
Symptoms: Red blood cell count decreased, Somnolence, Vomiting, White blood cell count decreased
Clinical narrative: A 13 year old male patient was vaccinated with the third dose of RabAvert (batch no 355011) on Dec 6 2005. Later on vaccination day the patient experienced diarrhea and vomiting. On Dec 12 2005 in the evening, the patient presented at a hospital with vomiting, chills, fever, severe headache, and generalised muscle aches with neck weakness. A lumbar puncture was performed. The patient was diagnosed with aseptic meningitis and was put into the pediatric intensive care unit. On Dec 13 the patient had improved. We are  awaiting further data preliminary company assessment Seriousness criterion hospitalisation, causality pending. The reported symptoms are expected, except for aseptic meningitis and neck weakness, after vaccination with RabAvert. On a case level, the case is considered unexpected. Addendum 12/16/2005. We received further information. On the day of the third RabAvert administration (i.m. Dec 6 2005) patient experienced vomiting persisting for three days, Diarrhea started on Dec 9 2005 (not on 12/6/2005 as reported earlier). On Dec 10 2005 patient seemed better, but then developed, still on that day, generalized rash and in the evening after sleeping all day, fever, and chills. Where as the rash resolved on Dec 11 2005, chills and fever continued through  12/12/2005, when he was hospitalized, presenting with severe headache, generalized muscle aches, weakness and being feverish. He spoke clearly. Ear, nose, throat exam suggested meningismus, probable meningitis was noted in the patient chart. He was admitted to the intensive care unit on 12/12/2005, but moved out to a regular ward the next day. He was stable by 12/14/2005. Lab test showed increased white blood cell count in cerebrospinal fluid (547/ul normal <5/ul), CSF was cloudy and white, white blood cell count in blood was low (2.600 normal: 4.500-13000 ul), bands in differential blood count went from 34% (12/12/2005) to 10% (12/13/2005) and 6% (12/14/2005). Red blood count, hemoglobin, hematocrit and platelets were all low. CSF and blood culture were still negative by 12/14/2005. MRI on 12/13/2005 was negative, meningitis was diagnosed. Patient was put on antibiotics. Patient is wearing teeth braces (possible place of entry for bacteria). Seriousness criteria hospitalisation, medically significant (OMIC). causality not related. The described symptoms, except for diarrhea, vomiting, rash, headache, chills, fever, muscle aches and weakness, are unexpected after vaccination with RabAvert. On a case level, the case is considered unexpected. No change in benefit risk ratio. No measures necessary.
Age: 66.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Injection site mass, Injection site pain, Paraesthesia
Clinical narrative: This citizen sent a letter to her local health department on December 13th to report this AE. The letter was also sent to CDC OD on December 14th and the letter was then forwarded to this reporter who is entering the information on behalf of this citizen, whom i spoke with on the phone today.  The letter and today's phone conversation both involve the citizen describing severe pain upon movement and loss of mobility in the left arm.  The arm pain extends from the left shoulder and neck down to the wrist area and also involves numbness and tingling of the middle finger.  She now also reports feeling "small lumps" at the injection site.  She is beginning physical therapy at 2PM on 12/27/05.  I asked her for permission to fill out this report on her behalf. I also told her that she would be receiving a follow-up letter from the VAERS system which would ask her if her symptoms had resolved.  I have given her my phone number to contact me directly if she desires to contact me to discuss.
Age: 66.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Hypokinesia, Injection site mass, Pain, Paraesthesia
Clinical narrative: This citizen sent a letter to her local health department on December 13th to report this AE. The letter was also sent to CDC OD on December 14th and the letter was then forwarded to this reporter who is entering the information on behalf of this citizen, whom i spoke with on the phone today.  The letter and today's phone conversation both involve the citizen describing severe pain upon movement and loss of mobility in the left arm.  The arm pain extends from the left shoulder and neck down to the wrist area and also involves numbness and tingling of the middle finger.  She now also reports feeling "small lumps" at the injection site.  She is beginning physical therapy at 2PM on 12/27/05.  I asked her for permission to fill out this report on her behalf. I also told her that she would be receiving a follow-up letter from the VAERS system which would ask her if her symptoms had resolved.  I have given her my phone number to contact me directly if she desires to contact me to discuss.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Dizziness, Influenza like illness, Stomach discomfort
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of flu like symptoms in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The healthcare professional reported that "four adults" experienced  flu like symptoms following administration of Fluarix, however, subject identifiers were not reported. On an unspecified date on or after 01 September 2005 and on or before 16 September 2005, the subject received 1st dose of Fluarix (lot number not provided). On an unspecified date on or before 16 September 2005, less than one week after vaccination with Fluarix, the subject experienced flu like symptoms, upset stomach, lightheadedness, dizziness, and chills. At the time of initial reporting, 16 September 2005, the events were ongoing.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: This case was reported by a nurse and described the occurrence of a needle stick injury in a 77 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Follow-up was received by an office manager. There were no concurrent medications. On 03 October 2005 the subject received 1st dose of Fluarix in an unspecified arm. The nurse reported that she, "attached a 25 gauge, 5/8 inch needle to the prefilled syringe of Fluarix. Upon pulling back on the dose, the needle released form the hub of the syringe and stayed in the patient's arm. The needle did not break." The subject was "taken to the emergency room." At the emergency room, "a specialist was called in and had to make a cut" to remove the needle from the subject's arm. The procedure was completed in the emergency room and the subject was discharged from the emergency room on the same day. It was not reported if the subject received any of the Fluarix. The event was ongoing at the time of follow-up reporting, 25 October 2005. The office manager reported that it was determined that the incident was caused by a fault with the needle, not any problem with the Fluarix syringe.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Medication error, Pruritus
Clinical narrative: This case was reported by a nurse and described the occurrence of chest tightness in a 37 year old female subject who was accidentally exposed to influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. Medical history included a "severe" egg allergy. The nurse also reported that she is "not latex sensitive." On 03 October 2005 the subject was removing a label from a used Fluarix viral. She reported that she "did not use gloves when handling the vaccine." "Within minutes" on 03 October 2005, the subject "noticed that her mouth and lips were itching and she was coughing." "Later that day," on 03 October 2005, the subject administered a Fluarix dose to a patient and she "noticed the same symptoms." On 03 October 2005, the subject "took a desloratadine (Clarinex) and within 30 minutes, the events resolved." On 04 October 2005, the subject was again accidentally exposed to Fluarix when a small drop of the vaccine was expelled from a syringe. "Shortly" after the accidental exposure to Fluarix, on 04 October 2005, the subject again experienced itching of the mouth and lips, coughing and "slight chest tightness." The subject state that, "these symptoms never happened when she administered Fluzone (influenza virus vaccine)."
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of generalized rash in an adult male subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The subject is a physician. On 05 October 2005 the subject received 1st dose of Fluarix. At an unspecified time following the administration of Fluarix, on 05 October 2005, the subject experienced a generalized rash. The generalized rash resolved on an unspecified date on or after 05 October 2005 and on or before 07 October 2005.
Age: 12.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site soreness in a 12 year old subject of unspecified gender who was inadvertently vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the mother of the subject. On an unspecified date in 2005, on or before 14 October 2005, the subject received 1st dose of Fluarix at an unspecified site of administration (lot number not provided). Fluarix is recommended for immunizing individuals 18 years of age and older. At an unspecified time following the administration of Fluarix, on or before 14 October 2005, the subject experienced injection site soreness. At the time of reporting 14 October 2005, the outcome of the injection site soreness was not provided. Follow-up to the case will not be available.
Age: 14.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Medication error, Myalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site soreness in a 14 year old subject of unspecified gender who was inadvertently vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the mother of the subject. On an unspecified date in 2005, on or before 14 October 2005, the subject received 1st dose of Fluarix at an unspecified site of administration (lot number not provided). Fluarix is recommended for immunizing individuals 18 years of age and older. At an unspecified time following the administration of Fluarix, on or before 14 October 2005, the subject experienced injection site soreness. At the time of reporting, 14 October 2005, the outcome of the injection site soreness was not provided. Follow-up to the case will not be available.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: This case was reported by a nurse and described the occurrence of dizziness to a 53 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 28 October 2005 the subject received 1st dose of Fluarix in the left arm (lot AFLUA151BA). "Approximately 20 minutes after receiving Fluarix," on 28 October 2005, the subject experienced dizziness, nausea, and "felt like fainting." The subject was seen at a physician's office. The events had improved as of the time of initial reporting 28 October 2005. The nurse considered the events to possibly be related to vaccination with Fluarix.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of vomiting in a 42 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 28 October 2005 the subject received 1st dose of Fluarix in the right arm (lot AFLUA151BA). At an unspecified time following receipt of Fluarix, on 28 October 2005, the subject experienced vomiting and nausea. The subject "rested at home." The events were ongoing at the time of initial reporting, 28 October 2005. The nurse considered the events to possibly be related to vaccination with Fluarix.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: This case reported by a pharmacist and described the occurrence of shingles in a 50 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. On 10/20/05 the subject received a dose of Fluarix. The pharmacist reported that the suject received influenza virus vaccine, "in the past without incident." At an unspecified time following the administration of Fluarix, on 10/20/05, the subject "did not feel well." The subject was seen at a physician's office on 10/21/05 and was diagnosed with shingles. The subject was treated with anti-viral medication. The events had improved as of the time of initial reporting. 10/05 the pharmacist considered the events to possibly be related to vaccination with fluarix. On follow up received 11/22/05, the pharmacist reported the events had resolved with treatment unspecified anti-viral medication. The pharacist considered the events to be unrelated to vaccination with Fluarix.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of itchy rash in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2005, on or before 04 November 2005, the subject received 1st dose of Fluarix (lot AFLUA154BA). At an unspecified time after vaccination with Fluarix, on or before 04 November 2005, the subject experienced a "generalized itchy rash." The subject was seen at a physician's office. The outcome of the event was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Fatigue, Lymphadenopathy, Viral infection
Clinical narrative: This case was reported by a consumer and described the occurrence of viral illness in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. On 02 November 2005 the subject received a dose of Fluarix. The subject did not provide information regarding previous immunization with influenza virus vaccine. On an unspecified date on or before 08 November 2005, within days of vaccination with Fluarix, the subject experienced tiredness On 06 November 2005, she experienced swollen glands and difficulty swallowing. On an unspecified date on or before 08 November 2005, the subject was seen at a physician's office. The subject reported that the physician told that she had, "a non-specific viral illness." The swollen glands and difficulty swallowing resolved on or after 06 November 2005 and on or before 08 November 2005. The viral illness and tiredness were ongoing at the time of initial reporting, 08 November 2005. Follow-up will not be available.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site pain in a 57 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. There were no concurrent medications. On 28 October 2005 the subject received a dose of Fluarix in the left deltoid (lot AFLUA131BA). The nurse reported that the subject, "had been getting her flu vaccine" in previous years and "never reacted to the flu shot like she did with Fluarix." On 28 October 2005, less than one day after vaccination with Fluarix, the subject experienced injection site pain in the left arm. The nurse reported that, on 29 October 2005, "within 24 hours of injection' of Fluarix, the pain "went to her left arm, then to the neck, and subsequently to the right side of the body. The pain was so severe that the patient could not lift her left arm up." Approximately five days after injection of Fluarix, on 02 November 2005, the subject was seen at a physician's office "to treat a sinus infection." At the time of initial reporting the events were improved. The nurse considered the sinus infection to be unrelated and all the other events to probably be related to vaccination with Fluarix.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of arm pain at the injection site in a 48 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. On 10/26/05, the subject received the first dose of Fluarix. Information regarding previous immunization with influenza virus vaccine was not provided. On 10/26/05, at an unspecified time after vaccination with Fluarix, the subject experienced arm pain at the injection site. As of 11/10/05, the event remained unresolved. In the reporting nurse's opinion, the event was probably related to vaccination with Fluarix.  At the time of follow-up reporting, December 19, 2005, the event had improved. In the nurse's opinion, the event was related to vaccination with Fluarix. The nurse also reported that the injection of Fluarix was "possibly administered too high".
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Vaccination complication, X-ray limb
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of arm pain at the injection site in a 49 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 25 October 2005, the subject received the first dose of Fluarix (lot AFLUA154AA). Information regarding previous immunization with influenza virus vaccine was not provided. One day later, on 26 October 2005, the subject experienced arm pain at the injection site. As of 10 November 2005, the event remained unresolved. In the reporting nurse's opinion, the event was probably related to vaccination with Fluarix. The nurse also reported the injection of Fluarix was "possibly administered too high."
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of raised area injection site in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The pharmacist reported that, "50 percent of the patients," experienced a raised area at the injection site, however, a specific number of subjects was not provided. On an unspecified date in 2005, on or before 09 November 2005, the subject received a dose of Fluarix (lot AFLUA148BA). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time following vaccination with Fluarix, on or before 09 November 2005, the subject experienced a red, raised area at the injection site. The subject was taken to the emergency room. The outcome of the injection site reaction was not provided. The pharmacist considered the injection site reaction to probably be related to vaccination with Fluarix.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Headache, Paraesthesia
Clinical narrative: This case was reported by a nurse and described the occurrence of chest heaviness in a 36 year old female subject who was vaccinated with influenza virus vaccine for prophyylaxis. On 11/07/2005 at 1:05 pm, the subject received 1st dose of Fluarix in the left deltoid. On 11/07/2005 at 1:10 pm, 5 minutes after vaccination with Fluarix, the subject experienced chest heaviness, tingling body and headache. At 1:10 pm, the subject's blood pressure was 104/70 mm Hg, heart rate was 80 and respiratory rate was 14. The subject was "observed for 1/2 hour." At approximately 1:40 pm on 11/07/05, the chest heaviness and body tingling resolved, blood pressure was 108/70 mm Hg, heart rate was 76, respiratory rate was 12 and temperature was 98.2  degrees F. The headache "lasted for 4 hours" and resolved at approximately 5:10 pm on 11/07/05.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist to a sales representative and described the occurrence of injection site irritation in an elderly subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2005 on or before 10 November 2005, the subject received a dose of Fluarix (lot number not provided). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time following the administration of Fluarix, on or before 10 November 2005, the subject experienced injection site irritation "that required a trip to the emergency room." The outcome of the injection site irritation was not reported.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse to a sales representative and described the occurrence of arm pain at the injection site in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 25 October 2005, the subject received the first dose of Fluarix (lot AFLUA154AA). Information regarding previous immunization with influenza virus vaccine was not provided. One day later, on 26 October 2005, the subject experienced arm pain at the injection site. As of 10 November 2005, the event remained unresolved. In the reporting nurse's opinion, the event was probably related to vaccination with Fluarix. Follow up - This case was reported by a nurse and described the occurrence of arm pain at the injection site in a 54-year-old female subject who was vaccinated with FLUARIX, GlaxoSmithKline. On 25 October 2005, the subject received a dose of FLUARIX in the right arm (lot AFLUA154AA). Information regarding previous immunization with influenza viruenza virus vaccine was not provided. At an unspecified time following the administration of FLUARIX. On 25 October 2005, the patient experienced arm pain at the injection site. The subject was seen at a physician's office. On an unspecified date in 2005, after 25 October 2005, the subject underwent "a CT scan and ultrasound." The results of these tests were not provided. The event was ongoing as of 19 December 2005. In the reporting nurse's opinion, the event was probably related to vaccination with FLUARIX. The nurse also reported that the injection of FLUARIX was "possibly administered too high."
Sex: M
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of an allergic reaction in an adult male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis. On an unspecified date in 2005, the subject received a dose of influenza virus vaccine (manufacturer and dose number unspecified). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time after vaccination with flu vaccine, the subject experienced "an allergic reaction which was possible due to thimerosal." At the time of reporting on 10 November 2005, the outcome of the event was unspecified. Follow-up information received on 15 November 2005 indicated that the reporter had no additional details regarding this event. No further follow-up will be conducted.