chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Sensory loss
Clinical narrative: Case number PHHY2014US065672 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system website (VAERS reference number: 525858) on 28 May 2014. This report refers to a 28-years-old female patient. Her medical history included hypothyroidism. Her concomitant medications were levothyroxine. She was vaccinated with rabies vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 01 Sep 2000. On 01 Apr 2001, 212 days after vaccination, she woke up in the morning and had numbness and she had no sensation below the waist. She also had double vision. She went to the emergency room at the health center the next day and saw a physician. She was referred immediately to another physician for neurology consultation. Magnetic Resonance Imaging (MRI) of brain and spinal cord and lumbar puncture was done to analyze the cerebrospinal fluid (CSF). She also underwent Brain stem Auditory Evoked Response (BAER), Visual Evoked Potentials (VEP) and multiple blood and urine tests. It was reported that the testing quickly revealed multiple sclerosis. She was treated and was still under treatment with daily Copaxone injections. The final outcome was reported as condition unchanged. The event was reported as disabling. The causality was not reported.
Age: 28.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Urine analysis abnormal, Visual evoked potentials abnormal
Clinical narrative: Case number PHHY2014US065672 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system website (VAERS reference number: 525858) on 28 May 2014. This report refers to a 28-years-old female patient. Her medical history included hypothyroidism. Her concomitant medications were levothyroxine. She was vaccinated with rabies vaccine (manufacturer and batch number: not reported) intramuscularly in the right arm on 01 Sep 2000. On 01 Apr 2001, 212 days after vaccination, she woke up in the morning and had numbness and she had no sensation below the waist. She also had double vision. She went to the emergency room at the health center the next day and saw a physician. She was referred immediately to another physician for neurology consultation. Magnetic Resonance Imaging (MRI) of brain and spinal cord and lumbar puncture was done to analyze the cerebrospinal fluid (CSF). She also underwent Brain stem Auditory Evoked Response (BAER), Visual Evoked Potentials (VEP) and multiple blood and urine tests. It was reported that the testing quickly revealed multiple sclerosis. She was treated and was still under treatment with daily Copaxone injections. The final outcome was reported as condition unchanged. The event was reported as disabling. The causality was not reported.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: C-reactive protein increased, Cellulitis, Erythema, Inflammation, Injection site erythema
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 21-year old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine  injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. The vaccines were received in opposite arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 103.2 degree Fahrenheit. The patient also developed vomiting. She developed local erythema and edema at the site of PS 23 vaccine. The arm where the influenza vaccine was placed was normal. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 20.7 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 92 mm/hr and elevated C-reactive protein (CRP) at 20 mg/dl. The patient did not receive any antibiotics. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injection site oedema, Leukocytosis, Oedema, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 21-year old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine  injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. The vaccines were received in opposite arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 103.2 degree Fahrenheit. The patient also developed vomiting. She developed local erythema and edema at the site of PS 23 vaccine. The arm where the influenza vaccine was placed was normal. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 20.7 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 92 mm/hr and elevated C-reactive protein (CRP) at 20 mg/dl. The patient did not receive any antibiotics. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Skin warm, Swelling, Vomiting, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 21-year old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine  injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. The vaccines were received in opposite arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 103.2 degree Fahrenheit. The patient also developed vomiting. She developed local erythema and edema at the site of PS 23 vaccine. The arm where the influenza vaccine was placed was normal. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 20.7 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 92 mm/hr and elevated C-reactive protein (CRP) at 20 mg/dl. The patient did not receive any antibiotics. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injection site oedema, Leukocytosis, Local reaction, Local swelling, Pyrexia
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 21-year old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine  injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. The vaccines were received in opposite arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 103.2 degree Fahrenheit. The patient also developed vomiting. She developed local erythema and edema at the site of PS 23 vaccine. The arm where the influenza vaccine was placed was normal. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 20.7 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 92 mm/hr and elevated C-reactive protein (CRP) at 20 mg/dl. The patient did not receive any antibiotics. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Red blood cell sedimentation rate increased, Vomiting, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 21-year old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine  injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. The vaccines were received in opposite arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 103.2 degree Fahrenheit. The patient also developed vomiting. She developed local erythema and edema at the site of PS 23 vaccine. The arm where the influenza vaccine was placed was normal. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 20.7 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 92 mm/hr and elevated C-reactive protein (CRP) at 20 mg/dl. The patient did not receive any antibiotics. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: C-reactive protein increased, Erythema, Injection site oedema, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 21-year old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine  injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. The vaccines were received in opposite arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 103.2 degree Fahrenheit. The patient also developed vomiting. She developed local erythema and edema at the site of PS 23 vaccine. The arm where the influenza vaccine was placed was normal. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 20.7 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 92 mm/hr and elevated C-reactive protein (CRP) at 20 mg/dl. The patient did not receive any antibiotics. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 21-year old female patient who had a medical history of asthma. On an unspecified date, the patient received influenza vaccine  injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. The vaccines were received in opposite arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 103.2 degree Fahrenheit. The patient also developed vomiting. She developed local erythema and edema at the site of PS 23 vaccine. The arm where the influenza vaccine was placed was normal. The patient had local swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. The patient had a significant leucocytosis with white blood cell count at 20.7 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 92 mm/hr and elevated C-reactive protein (CRP) at 20 mg/dl. The patient did not receive any antibiotics. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Chills, Inflammation, Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 20-year-old male patient, who was a smoker. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. Both vaccines were received in the same arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. the patient had maximum temperature of 103 degree Fahrenheit. He developed vomiting, rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and severe redness and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. He had a significant leucocytosis with white blood cell count at 22.8 K/ul with the predominance of neutrophils. The patient received antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site warmth, Leukocytosis, Oedema, Pyrexia, Vomiting
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 20-year-old male patient, who was a smoker. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. Both vaccines were received in the same arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. the patient had maximum temperature of 103 degree Fahrenheit. He developed vomiting, rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and severe redness and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. He had a significant leucocytosis with white blood cell count at 22.8 K/ul with the predominance of neutrophils. The patient received antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 20-year-old male patient, who was a smoker. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. Both vaccines were received in the same arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. the patient had maximum temperature of 103 degree Fahrenheit. He developed vomiting, rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and severe redness and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. He had a significant leucocytosis with white blood cell count at 22.8 K/ul with the predominance of neutrophils. The patient received antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis, Chills, Erythema, Inflammation, Injection site erythema
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 20-year-old male patient, who was a smoker. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. Both vaccines were received in the same arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. the patient had maximum temperature of 103 degree Fahrenheit. He developed vomiting, rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and severe redness and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. He had a significant leucocytosis with white blood cell count at 22.8 K/ul with the predominance of neutrophils. The patient received antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site oedema, Injection site warmth, Leukocytosis, Local reaction, Local swelling
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 20-year-old male patient, who was a smoker. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. Both vaccines were received in the same arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. the patient had maximum temperature of 103 degree Fahrenheit. He developed vomiting, rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and severe redness and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. He had a significant leucocytosis with white blood cell count at 22.8 K/ul with the predominance of neutrophils. The patient received antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 20-year-old male patient, who was a smoker. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for asthma. Both vaccines were received in the same arms. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. the patient had maximum temperature of 103 degree Fahrenheit. He developed vomiting, rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling and severe redness and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within two to three days of vaccination. The patient was admitted to the hospital for the treatment of presumed cellulitis. He had a significant leucocytosis with white blood cell count at 22.8 K/ul with the predominance of neutrophils. The patient received antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: C-reactive protein increased, Cellulitis, Chills, Erythema, Inflammation
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 33-year-old female patient. The patient had a medical history of rheumatoid arthritis. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for immunosuppressive therapy in rheumatoid arthritis. Both vaccines were received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 101.8 degree Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling, severe redness and swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within 2-3 days of vaccination. The patient was admitted to the hospital for observation with or without treatment for presumed cellulitis. The patient received full course of antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. She had received several different antibiotics due to worsening of skin erythema despite aggressive intravenous antibiotic therapy. She had a significant leucocytosis with white blood cell count at 19.2 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 71 mm/hr and elevated C-reactive protein (CRP) at 14 mg/dl. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Leukocytosis, Local swelling
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 33-year-old female patient. The patient had a medical history of rheumatoid arthritis. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for immunosuppressive therapy in rheumatoid arthritis. Both vaccines were received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 101.8 degree Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling, severe redness and swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within 2-3 days of vaccination. The patient was admitted to the hospital for observation with or without treatment for presumed cellulitis. The patient received full course of antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. She had received several different antibiotics due to worsening of skin erythema despite aggressive intravenous antibiotic therapy. She had a significant leucocytosis with white blood cell count at 19.2 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 71 mm/hr and elevated C-reactive protein (CRP) at 14 mg/dl. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, White blood cell count increased
Clinical narrative: This medically confirmed literature report (initial receipt 15-May-2014) concerns a 33-year-old female patient. The patient had a medical history of rheumatoid arthritis. On an unspecified date, the patient received influenza vaccine injection (manufacturer and batch number not provided) and PS 23 injection (manufacturer and batch number not provided) for immunosuppressive therapy in rheumatoid arthritis. Both vaccines were received in the same arm. On an unspecified date, within 1 day of vaccination, the patient developed fever greater than 101.5 degree Fahrenheit. The patient had maximum temperature of 101.8 degree Fahrenheit. She developed rigors, erythema, edema and warmth of the pneumococcal and influenza injection site. The patient had local swelling, severe redness and swelling and large local inflammatory reaction. The local reaction expanded well beyond the immediate injection area by day 3-4 post vaccination. The patient sought care within 2-3 days of vaccination. The patient was admitted to the hospital for observation with or without treatment for presumed cellulitis. The patient received full course of antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus. She had received several different antibiotics due to worsening of skin erythema despite aggressive intravenous antibiotic therapy. She had a significant leucocytosis with white blood cell count at 19.2 K/ul with the predominance of neutrophils. She also had elevated erythrocyte sedimentation rate (ESR) at 71 mm/hr and elevated C-reactive protein (CRP) at 14 mg/dl. Within 5-7 days, the patient improved in the skin findings and there was resolution of the systemic symptoms. The outcome was reported as recovering. Reporter's comments: The reporter stated that the local reaction experienced by the patients who received both influenza vaccine and PS23 in the same arm was due to PS23 vaccine rather than the influenza vaccine. The patient experienced fever and systemic symptoms with local erythema within 24 hours of PS23 administration and this timing is not consistent with a secondary infection of the injection site. In addition, the patients who were treated with antibiotics did not improve as would be expected if these local reaction represented cellulitis infection.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Area pink and slightly painful.  Patient instructed to use warm compresses to area and use Motrin for pain.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Nuclear magnetic resonance imaging brain normal, Swelling face, Vision blurred
Clinical narrative: Headache, facial swelling, blurred vision, nausea.
Age: 71.0
Sex: F
Vaccine: DTAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Pain, swelling redness 8 inch area where shot was given. Chills, body aches, sore joints mild headache, mild nausea, extreme tiredness.
Age: 71.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Pain, swelling redness 8 inch area where shot was given. Chills, body aches, sore joints mild headache, mild nausea, extreme tiredness.
Age: 1.05
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever, T max of 102.0 rectal for 2 days. Still having fevers at time of report, expected to recover without difficulty.
Age: 21.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Hypoaesthesia oral, Paraesthesia, Tongue disorder
Clinical narrative: Patient CC: Numbness of lips, tingling of throat and thick heavy tongue with difficulty breathing. Vitals were stable, respirations were not labored, and her main complaint was that her tongue and lips felt funny and progessive thickening. Medical officer administered .3 Epi 1:1000SC and 50mg Benadryl deep IM.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives started at 7pm on 5/28/14 per mom. Resolved spontaneously after 3 hours.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Abdominal tenderness, C-reactive protein increased, Chest X-ray normal, Chest pain, Echocardiogram normal
Clinical narrative: (This case has been evaluated by agency) The pt. stated that he had received the SPV (primary) on 5/9/14 in his upper left arm. Additionally, he received a typhoid and AVA #1 on 5/8/14. The pt. was in his normal state of good health at the time of the vaccinations. The pt. reports that he has had constant, substernal chest pain (8/10) for 16 hours. He states that he applied "icy/hot" to his chest without improvement. The pain is made worse with lying down, taking a deep breath and leaning forward. The pain is improved when the pt. is in a "slouching" position. He denied SOB, radiation of the pain, diaphoresis, N, V or palpitations. The pt. reported that he basically had rested all day without improvement of his chest pain. He also related that the vaccination site was red, warm, swollen and tender and that the lymph nodes in his neck and armpit were also tender. The pt. was instructed to proceed to the ER for evaluation for possible myopericarditis. He was instructed to provide the ER staff with the number to the Cell Center so that a copy of the Clinical Guidelines for Post-Smallpox Vaccine Associated Myopericarditis could be provided. The pt. reported to Medical Center. His vital signs were stable 117/78, 73, 16, 98% SpO2; PE revealed: RRR, no murmur; Normal breath sounds, no respiratory distress/rales/wheezes, no chest wall tenderness. Labs showed normal Troponin T, BMP and CBC (see below). His also had a normal CXR and EKG (SR with ST elevation-probably early repolarization). The pt. was discharged with instruction to follow-up with his PCM on 5/19/14. This provider instructed the pt. to take MOTRIN 600-800 mg tid with food. Consulted with NP, provider on call. Requested that the pt. be evaluated with a repeat EKG, cardiac enzymes (Troponin I and CKMB), ESR, CRP and a possible echocardiogram (See note dated 5/18/14). The pt was seen at the Clinic on 5/20/14. The pt. reported "feeling better" but that his chest pain had not completely resolved - he complained of pain, N, V or diaphoresis. On PE it was noted that no murmurs, gallops or pericardial friction rub were heard. An ESR (wnl) and CRP (8.3H) were done. The EKG showed NSR with early repolarization. The pt. was placed on a light duty profile and given a medical temporary exemption for further vaccinations. The pt was seen by dr, cardiology and cardiovascular services, on 5/22/14. The pt. reported that the chest pain had resolved except for mild "epigastric and retrosternal chest tenderness". The PE was normal. The EKG showed NRS with diffuse ST elevation "most compatible with benign early repolarization. An echocardiogram was normal (EF 60%, no pericardial effusion) with the exception of mild mitral valve regurgitation. It was determined that the pt's chest pain was non-cardiac in nature; he was cleared to resume vigorous activity and to return to full employment.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram ST segment elevation, Full blood count normal, Injection site erythema, Lymph node pain, Metabolic function test normal
Clinical narrative: (This case has been evaluated by agency) The pt. stated that he had received the SPV (primary) on 5/9/14 in his upper left arm. Additionally, he received a typhoid and AVA #1 on 5/8/14. The pt. was in his normal state of good health at the time of the vaccinations. The pt. reports that he has had constant, substernal chest pain (8/10) for 16 hours. He states that he applied "icy/hot" to his chest without improvement. The pain is made worse with lying down, taking a deep breath and leaning forward. The pain is improved when the pt. is in a "slouching" position. He denied SOB, radiation of the pain, diaphoresis, N, V or palpitations. The pt. reported that he basically had rested all day without improvement of his chest pain. He also related that the vaccination site was red, warm, swollen and tender and that the lymph nodes in his neck and armpit were also tender. The pt. was instructed to proceed to the ER for evaluation for possible myopericarditis. He was instructed to provide the ER staff with the number to the Cell Center so that a copy of the Clinical Guidelines for Post-Smallpox Vaccine Associated Myopericarditis could be provided. The pt. reported to Medical Center. His vital signs were stable 117/78, 73, 16, 98% SpO2; PE revealed: RRR, no murmur; Normal breath sounds, no respiratory distress/rales/wheezes, no chest wall tenderness. Labs showed normal Troponin T, BMP and CBC (see below). His also had a normal CXR and EKG (SR with ST elevation-probably early repolarization). The pt. was discharged with instruction to follow-up with his PCM on 5/19/14. This provider instructed the pt. to take MOTRIN 600-800 mg tid with food. Consulted with NP, provider on call. Requested that the pt. be evaluated with a repeat EKG, cardiac enzymes (Troponin I and CKMB), ESR, CRP and a possible echocardiogram (See note dated 5/18/14). The pt was seen at the Clinic on 5/20/14. The pt. reported "feeling better" but that his chest pain had not completely resolved - he complained of pain, N, V or diaphoresis. On PE it was noted that no murmurs, gallops or pericardial friction rub were heard. An ESR (wnl) and CRP (8.3H) were done. The EKG showed NSR with early repolarization. The pt. was placed on a light duty profile and given a medical temporary exemption for further vaccinations. The pt was seen by dr, cardiology and cardiovascular services, on 5/22/14. The pt. reported that the chest pain had resolved except for mild "epigastric and retrosternal chest tenderness". The PE was normal. The EKG showed NRS with diffuse ST elevation "most compatible with benign early repolarization. An echocardiogram was normal (EF 60%, no pericardial effusion) with the exception of mild mitral valve regurgitation. It was determined that the pt's chest pain was non-cardiac in nature; he was cleared to resume vigorous activity and to return to full employment.
Age: 27.0
Sex: M
Vaccine: SMALL
Symptoms: Mitral valve incompetence, Non-cardiac chest pain, Painful respiration, Red blood cell sedimentation rate normal, Troponin T normal
Clinical narrative: (This case has been evaluated by agency) The pt. stated that he had received the SPV (primary) on 5/9/14 in his upper left arm. Additionally, he received a typhoid and AVA #1 on 5/8/14. The pt. was in his normal state of good health at the time of the vaccinations. The pt. reports that he has had constant, substernal chest pain (8/10) for 16 hours. He states that he applied "icy/hot" to his chest without improvement. The pain is made worse with lying down, taking a deep breath and leaning forward. The pain is improved when the pt. is in a "slouching" position. He denied SOB, radiation of the pain, diaphoresis, N, V or palpitations. The pt. reported that he basically had rested all day without improvement of his chest pain. He also related that the vaccination site was red, warm, swollen and tender and that the lymph nodes in his neck and armpit were also tender. The pt. was instructed to proceed to the ER for evaluation for possible myopericarditis. He was instructed to provide the ER staff with the number to the Cell Center so that a copy of the Clinical Guidelines for Post-Smallpox Vaccine Associated Myopericarditis could be provided. The pt. reported to Medical Center. His vital signs were stable 117/78, 73, 16, 98% SpO2; PE revealed: RRR, no murmur; Normal breath sounds, no respiratory distress/rales/wheezes, no chest wall tenderness. Labs showed normal Troponin T, BMP and CBC (see below). His also had a normal CXR and EKG (SR with ST elevation-probably early repolarization). The pt. was discharged with instruction to follow-up with his PCM on 5/19/14. This provider instructed the pt. to take MOTRIN 600-800 mg tid with food. Consulted with NP, provider on call. Requested that the pt. be evaluated with a repeat EKG, cardiac enzymes (Troponin I and CKMB), ESR, CRP and a possible echocardiogram (See note dated 5/18/14). The pt was seen at the Clinic on 5/20/14. The pt. reported "feeling better" but that his chest pain had not completely resolved - he complained of pain, N, V or diaphoresis. On PE it was noted that no murmurs, gallops or pericardial friction rub were heard. An ESR (wnl) and CRP (8.3H) were done. The EKG showed NSR with early repolarization. The pt. was placed on a light duty profile and given a medical temporary exemption for further vaccinations. The pt was seen by dr, cardiology and cardiovascular services, on 5/22/14. The pt. reported that the chest pain had resolved except for mild "epigastric and retrosternal chest tenderness". The PE was normal. The EKG showed NRS with diffuse ST elevation "most compatible with benign early repolarization. An echocardiogram was normal (EF 60%, no pericardial effusion) with the exception of mild mitral valve regurgitation. It was determined that the pt's chest pain was non-cardiac in nature; he was cleared to resume vigorous activity and to return to full employment.