chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 literature marketed report as received from a other health professional refers to a 20 year old male patient with smoking. This is case 3 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization), rigors (hospitalization), presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 22.8K/microliter and Maximum temperature 103 degree F. The patient sought care within 2-3 d of vaccination and was admitted to the hospital for observation, with or without treatment of presumed cellulitis. Patient received full courses of antibiotics to cover for common skin flora as well as methicillin-resistant staphylococcus aureus. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. The outcome of the events localized inflammation, injection site erythema, warmth and swelling and presumed cellulitis was considered resolving and outcome of fever, leucocytosis, rigors and vomiting was considered as resolved. The reporter considered the events to be not related to influenza virus vaccine (manufacturer unknown). The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The author stated that "the 5 patients in this series all had leucocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Based on the known side effects of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and the patient 2's lack of influenza vaccine (manufacturer unknown) associated local symptoms we believe these reactions were due to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)". This case is linked to case # 1405USA008573, 1405USA007995, 1405USA008575 and 1405USA008576.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site warmth, Leukocytosis, Oedema, Pyrexia, Vomiting
Clinical narrative: This literature marketed report as received from a other health professional refers to a 20 year old male patient with smoking. This is case 3 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization), rigors (hospitalization), presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 22.8K/microliter and Maximum temperature 103 degree F. The patient sought care within 2-3 d of vaccination and was admitted to the hospital for observation, with or without treatment of presumed cellulitis. Patient received full courses of antibiotics to cover for common skin flora as well as methicillin-resistant staphylococcus aureus. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. The outcome of the events localized inflammation, injection site erythema, warmth and swelling and presumed cellulitis was considered resolving and outcome of fever, leucocytosis, rigors and vomiting was considered as resolved. The reporter considered the events to be not related to influenza virus vaccine (manufacturer unknown). The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The author stated that "the 5 patients in this series all had leucocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Based on the known side effects of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and the patient 2's lack of influenza vaccine (manufacturer unknown) associated local symptoms we believe these reactions were due to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)". This case is linked to case # 1405USA008573, 1405USA007995, 1405USA008575 and 1405USA008576.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: This literature marketed report as received from a other health professional refers to a 20 year old male patient with smoking. This is case 3 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization), rigors (hospitalization), presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 22.8K/microliter and Maximum temperature 103 degree F. The patient sought care within 2-3 d of vaccination and was admitted to the hospital for observation, with or without treatment of presumed cellulitis. Patient received full courses of antibiotics to cover for common skin flora as well as methicillin-resistant staphylococcus aureus. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. The outcome of the events localized inflammation, injection site erythema, warmth and swelling and presumed cellulitis was considered resolving and outcome of fever, leucocytosis, rigors and vomiting was considered as resolved. The reporter considered the events to be not related to influenza virus vaccine (manufacturer unknown). The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The author stated that "the 5 patients in this series all had leucocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Based on the known side effects of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and the patient 2's lack of influenza vaccine (manufacturer unknown) associated local symptoms we believe these reactions were due to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)". This case is linked to case # 1405USA008573, 1405USA007995, 1405USA008575 and 1405USA008576.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis, Chills, Erythema, Inflammation, Injection site erythema
Clinical narrative: This literature marketed report as received from a other health professional refers to a 20 year old male patient with smoking. This is case 3 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization), rigors (hospitalization), presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 22.8K/microliter and Maximum temperature 103 degree F. The patient sought care within 2-3 d of vaccination and was admitted to the hospital for observation, with or without treatment of presumed cellulitis. Patient received full courses of antibiotics to cover for common skin flora as well as methicillin-resistant staphylococcus aureus. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. The outcome of the events localized inflammation, injection site erythema, warmth and swelling and presumed cellulitis was considered resolving and outcome of fever, leucocytosis, rigors and vomiting was considered as resolved. The reporter considered the events to be not related to influenza virus vaccine (manufacturer unknown). The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The author stated that "the 5 patients in this series all had leucocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Based on the known side effects of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and the patient 2's lack of influenza vaccine (manufacturer unknown) associated local symptoms we believe these reactions were due to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)". This case is linked to case # 1405USA008573, 1405USA007995, 1405USA008575 and 1405USA008576.
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 literature marketed report as received from a other health professional refers to a 20 year old male patient with smoking. This is case 3 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization), rigors (hospitalization), presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 22.8K/microliter and Maximum temperature 103 degree F. The patient sought care within 2-3 d of vaccination and was admitted to the hospital for observation, with or without treatment of presumed cellulitis. Patient received full courses of antibiotics to cover for common skin flora as well as methicillin-resistant staphylococcus aureus. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. The outcome of the events localized inflammation, injection site erythema, warmth and swelling and presumed cellulitis was considered resolving and outcome of fever, leucocytosis, rigors and vomiting was considered as resolved. The reporter considered the events to be not related to influenza virus vaccine (manufacturer unknown). The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The author stated that "the 5 patients in this series all had leucocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Based on the known side effects of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and the patient 2's lack of influenza vaccine (manufacturer unknown) associated local symptoms we believe these reactions were due to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)". This case is linked to case # 1405USA008573, 1405USA007995, 1405USA008575 and 1405USA008576.
Age: 20.0
Sex: M
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: This literature marketed report as received from a other health professional refers to a 20 year old male patient with smoking. This is case 3 of 5 reports. Patient's medical history was not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose and frequency unknown) in the arm. Other suspect therapies included influenza virus vaccine (manufacturer unknown). Both the vaccination were received in the same arm. Patient's concomitant medication was not reported. On an unknown date the patient experienced large local inflammatory reactions (erythema, oedema and warmth) (hospitalization), fever (hospitalization), leucocytosis (hospitalization), rigors (hospitalization), presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 22.8K/microliter and Maximum temperature 103 degree F. The patient sought care within 2-3 d of vaccination and was admitted to the hospital for observation, with or without treatment of presumed cellulitis. Patient received full courses of antibiotics to cover for common skin flora as well as methicillin-resistant staphylococcus aureus. Within 5-7 days, the patient experienced improvement in the skin findings and resolution of the systemic symptoms. In one patient, the local swelling and erythema at the injection site lasted about 2 weeks. The outcome of the events localized inflammation, injection site erythema, warmth and swelling and presumed cellulitis was considered resolving and outcome of fever, leucocytosis, rigors and vomiting was considered as resolved. The reporter considered the events to be not related to influenza virus vaccine (manufacturer unknown). The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). The author stated that "the 5 patients in this series all had leucocytosis, fever and large local inflammatory reactions following influenza vaccine (manufacturer unknown) and Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Based on the known side effects of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), the lack of similar findings in patients who receive the influenza vaccine (manufacturer unknown) and the patient 2's lack of influenza vaccine (manufacturer unknown) associated local symptoms we believe these reactions were due to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown)". This case is linked to case # 1405USA008573, 1405USA007995, 1405USA008575 and 1405USA008576.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: Chills, Erythema, Feeling hot, Inflammation, Injection site reaction
Clinical narrative: Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512, and 2014SA063514. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experiencing this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 43-year-old female patient (referred to as "patient 4"), received the following vaccines on an unspecified date: a left arm injection of Influenza Vaccine (manufacturer and lot number not reported); a right arm injection of Tdap (manufacturer and lot number not reported); and a left arm injection of Pneumococcal (Polysaccharide) (23 Serotypes) Vaccine (manufacturer and lot number not reported) The patient had a history of asthma. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 102.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She sought medical care for her symptoms, and was found to have significant leukocytosis with white blood count of 22. She was not admitted to the hospital; treatment was not reported. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: Leukocytosis, Local reaction, Pyrexia, Swelling, White blood cell count increased
Clinical narrative: Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512, and 2014SA063514. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experiencing this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 43-year-old female patient (referred to as "patient 4"), received the following vaccines on an unspecified date: a left arm injection of Influenza Vaccine (manufacturer and lot number not reported); a right arm injection of Tdap (manufacturer and lot number not reported); and a left arm injection of Pneumococcal (Polysaccharide) (23 Serotypes) Vaccine (manufacturer and lot number not reported) The patient had a history of asthma. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 102.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She sought medical care for her symptoms, and was found to have significant leukocytosis with white blood count of 22. She was not admitted to the hospital; treatment was not reported. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: Cellulitis, Chills, Inflammation, Injection site erythema, Injection site oedema
Clinical narrative: Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512, and 2014SA063514. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experiencing this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 43-year-old female patient (referred to as "patient 4"), received the following vaccines on an unspecified date: a left arm injection of Influenza Vaccine (manufacturer and lot number not reported); a right arm injection of Tdap (manufacturer and lot number not reported); and a left arm injection of Pneumococcal (Polysaccharide) (23 Serotypes) Vaccine (manufacturer and lot number not reported) The patient had a history of asthma. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 102.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She sought medical care for her symptoms, and was found to have significant leukocytosis with white blood count of 22. She was not admitted to the hospital; treatment was not reported. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: Injection site warmth, Leukocytosis, Local reaction, Local swelling, Pyrexia
Clinical narrative: Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512, and 2014SA063514. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experiencing this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 43-year-old female patient (referred to as "patient 4"), received the following vaccines on an unspecified date: a left arm injection of Influenza Vaccine (manufacturer and lot number not reported); a right arm injection of Tdap (manufacturer and lot number not reported); and a left arm injection of Pneumococcal (Polysaccharide) (23 Serotypes) Vaccine (manufacturer and lot number not reported) The patient had a history of asthma. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 102.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She sought medical care for her symptoms, and was found to have significant leukocytosis with white blood count of 22. She was not admitted to the hospital; treatment was not reported. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: None.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, TDAP, FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512, and 2014SA063514. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experiencing this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 43-year-old female patient (referred to as "patient 4"), received the following vaccines on an unspecified date: a left arm injection of Influenza Vaccine (manufacturer and lot number not reported); a right arm injection of Tdap (manufacturer and lot number not reported); and a left arm injection of Pneumococcal (Polysaccharide) (23 Serotypes) Vaccine (manufacturer and lot number not reported) The patient had a history of asthma. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 102.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She sought medical care for her symptoms, and was found to have significant leukocytosis with white blood count of 22. She was not admitted to the hospital; treatment was not reported. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: None.
Age: 50.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site joint pain, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain at shoulder in a 50-year-old female subject who was vaccinated with DTPA (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included allergic reaction to Cymbalta, allergy to Biaxin, allergy to cephalexin, allergy to Cipro, Levaquin allergy, sulfa allergy, lexapro allergy and Wellbutrin allergy. Concurrent medications included Zolpidem, Sertraline, Mirapex, Magnesium aspartate, Glucosamine chondroitin complex and Iron salt. Subject's previous vaccinations went uncomplicated. In 2014 (5-6 weeks prior to the reporting time), the subject received unspecified dose of DTPA (with small D + P) (unknown route, left arm; lot number not provided). In 2014, 1 to 2 weeks after vaccination with DTPA (with small D + P), the subject experienced injection site reaction (left shoulder) described as: joint pain, swelling, hard spot and hot to touch. The consumer mentioned the side effects that she was experiencing to the doctor's office when she was there for an appointment for her daughter. The consumer considered the events were disabling and clinically significant. The subject stated that the events did not require medical attention. The consumer considered the events were disabling and clinically significant. At the time of reporting the events were unresolved.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: C-reactive protein increased, Chills, Erythema, Feeling hot, Inflammation
Clinical narrative: Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512 and 2014SA063513. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experienced this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described int he adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 3-3year-old female patient (referred to as "patient 5"), received the following vaccines on an unspecified date: INFLUENZA VACCINE (manufacturer and lot number not reported) and PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE (manufacturer and lot number not reported). The patient had a history of rheumatoid arthritis, treated with immunosuppressive therapy. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 101.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She was admitted to the hospital, and was found to have significant leukocytosis with white blood count of 19.2. Non-specific inflammatory markers were elevated, with erythrocyte sedimentation rate of 71 mm/hr and C-reactive protein of 14 mg/dl. While hospitalized, she received aggressive intravenous antibiotic therapy with several different antibiotics due to worsening erythema. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Inflammatory marker increased, Leukocytosis, Local reaction, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512 and 2014SA063513. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experienced this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described int he adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 3-3year-old female patient (referred to as "patient 5"), received the following vaccines on an unspecified date: INFLUENZA VACCINE (manufacturer and lot number not reported) and PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE (manufacturer and lot number not reported). The patient had a history of rheumatoid arthritis, treated with immunosuppressive therapy. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 101.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She was admitted to the hospital, and was found to have significant leukocytosis with white blood count of 19.2. Non-specific inflammatory markers were elevated, with erythrocyte sedimentation rate of 71 mm/hr and C-reactive protein of 14 mg/dl. While hospitalized, she received aggressive intravenous antibiotic therapy with several different antibiotics due to worsening erythema. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: none.
Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Swelling, White blood cell count increased
Clinical narrative: Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients are captured in case numbers 2014SA063502, 2014SA063511, 2014SA063512 and 2014SA063513. Verbatim from the abstract: Background: Fever, leukocytosis, and large local reactions following the pneumococcal polysaccharide vaccine (PS23) have been described only in isolated case reports in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experienced this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arms had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described int he adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. A 3-3year-old female patient (referred to as "patient 5"), received the following vaccines on an unspecified date: INFLUENZA VACCINE (manufacturer and lot number not reported) and PNEUMOCOCCAL (POLYSACCHARIDE) (23 SEROTYPES) VACCINE (manufacturer and lot number not reported). The patient had a history of rheumatoid arthritis, treated with immunosuppressive therapy. Within 24 hours of vaccination, she experienced systemic symptoms including fever of 101.8 degree Fahrenheit and rigors, with local inflammation including erythema, swelling, and warmth. Within three to four days post-vaccination the local reaction extended well beyond the immediate injection area. She was admitted to the hospital, and was found to have significant leukocytosis with white blood count of 19.2. Non-specific inflammatory markers were elevated, with erythrocyte sedimentation rate of 71 mm/hr and C-reactive protein of 14 mg/dl. While hospitalized, she received aggressive intravenous antibiotic therapy with several different antibiotics due to worsening erythema. Within five to seven days all systemic symptoms had resolved, and the patient experienced improvement of skin findings. Documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and unknown gender. The nurse reported that multiple unspecified patients were vaccinated with a dose of GARDASIL (lot# and dose/frequency unknown) on an unknown date which was improperly stored. No adverse effects reported. The outcome of the events were unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 19-FEB-2014, the patient was vaccinated with expired PNEUMOVAX 23, lot # 1947AA, expiry date 20-OCT-2013, dose (unknown) and route of administration (unknown), for unknown indication. No concomitant medications were reported. Pharmacist mentioned PNEUMOVAX 23 did not have any previous temperature excursions. No adverse symptoms reported. No product quality complaint was involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Anaphylactic reaction, Asthenia, Dizziness, Pallor
Clinical narrative: About 5 minutes after receiving Tdap, MENACTRA and GARDASIL, the patient felt dizzy and weak. He looked pale. BP 97/57. HR 62/min. Anaphylactic reaction to vaccines. Epinephrine and oxygen was administered. BP went up to 108/62 20 minutes later. Recovered.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Drug administered at inappropriate site
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself. The patient's medical history included breast cancer and removal of the lymph nodes under the arms (dates unspecified). On an unknown date the patient was vaccinated with a dose of influenza virus vaccine (manufacturer unknown) injection and with a dose of pneumonia vaccine (brand name and manufacturer unknown). The patient reported that the vaccines were administered in her hips. Dose number, dose, frequency and lot number were not specified for both vaccines. Concomitant medications were not specified. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-MAY-2014 the patient was vaccinated with a dose of VARIRAX that was exposed to temperatures outside of the recommended range (dose, route, indication and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Onset reported to occur within a few hours. Fever dizziness lightheadedness and nausea.
Age: 16.0
Sex: M
Vaccine: DTAP
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Patient reported within in a few hours, fever, dizziness and nausea.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-MAY-2014 the patient was vaccinated with a dose of PROQUAD that was exposed to temperatures outside of the recommended range (dose, route, indication and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: YF
Symptoms: Anaphylactic reaction, Dyspnoea, Urticaria
Clinical narrative: Anaphylactic reaction. About 20 to 30 minutes after receiving a Yellow Fever vaccination, she suddenly developed urticaria and difficulty breathing. She was taken by family to ER where she was successfully treated, but kept overnight for observation. Exact treatment is unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician reported an unspecified number of patients received improperly stored VARIVAX on unspecified dates. The physician was also unable to provide the lot#/exp for the VARIVAX in question. The physician mentioned the VARIRAX was exposed to minus 4.3C "since January 2013". No adverse symptoms reported. Physician inquired about the stability of VARIVAX exposed to minus 4.3C. Physician inquired if these patients need to be revaccinated or not. Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: HEPA, MMR
Symptoms: Acute disseminated encephalomyelitis, Blood test normal, Computerised tomogram normal, Immunoglobulin therapy, Lethargy
Clinical narrative: Fever, lethargy resulting in unconsciousness. Diagnosis of Acute Dissemination Encephalomyelitis. Treatment of steroids and IVIG needed along with inpatient and outpatient therapy.
Age: 1.31
Sex: F
Vaccine: HEPA, MMR
Symptoms: Loss of consciousness, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Ultrasound scan normal
Clinical narrative: Fever, lethargy resulting in unconsciousness. Diagnosis of Acute Dissemination Encephalomyelitis. Treatment of steroids and IVIG needed along with inpatient and outpatient therapy.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 4 year old patient. On an unspecified date, the patient was vaccinated with the 1st dose of VARIVAX (strength, dose and lot# not reported). On 02-MAY-2014 the patient was vaccinated with the 2nd dose of VARIVAX (lot # J009166, expiration date: 24-JUL-2015, strength and dose not reported) which was improperly stored at -11 Celsius degree for an unspecified number of hours. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.