chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to an unknown patient of unknown age and unknown gender. Medical history and current conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, route, lot number, expiration date and anatomical location were unspecified). No concomitant therapies were reported. On an unknown date the patient developed a chickenpox-like rash after having ZOSTAVAX. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a register nurse, refers to an unknown age and gender patient. Medical history was not reported. On an unknown date the patient was vaccinated with M-M-R II lot number, route and dosage were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date the patient had titers drawn on an unspecified date and the patient's titers for mumps came back "low" for mumps immunity. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site warmth, Pain
Clinical narrative: This spontaneous report as received from a female Doctor of pharmacy of unknown age reporting on herself. On 13-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not reported) subcutaneously. The pharmacist reported that on 15-MAY-2014, she experienced a red area around the injection site that she described as warm and pink about three inches in diameter over the injection site. It felt like she got stung by a bee. The pharmacist also reported pain and heat. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. No medical history and no drug allergy were reported. On 03-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# J013135, expiration date 17-JAN-2015), 0.65 ml, subcutaneously for prevention of shingles. No concomitant therapy was reported. On 04-MAY-2014, the patient experienced injection site was swollen, warm and approximately four inches, in diameter, after patient received ZOSTAVAX. VZV packet was not sent as there was no rash or redness. No treatment was given. No lab diagnostics was performed. The patient sought medical attention by seeing pharmacist. The outcome of adverse event was not reported. The causality between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a male patient of unknown age. Medical history and current conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose, strength, route, lot number, expiration date and anatomical locations were unspecified). No concomitant therapies were reported. On an unknown date the patient developed shingles after received ZOSTAVX. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. Medical history and current conditions were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX, (dose, strength, route, lot number, expiration date and anatomical location were unspecified). No concomitant therapies were reported. On an unknown date the patient developed shingles after ZOSTAVAX. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Infection, Inflammation
Clinical narrative: Case number PHHY2014US045964 is an initial spontaneous report received from a consumer via Vaccine Adverse Event Reporting System (VAERS, reference number: 519588) website on 14 Apr 2014 and a follow up report from the QA department (QA reference number: 294988) received on 16 May 2014. This report refers to a 75-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 13373P) and PNEUMOVAX (other manufacturer, batch number: H022280) both intramuscularly on the same arm on 09 Jan 2014. Post vaccination she got infected inflamed (cellulitis) and was hospitalized for the same. The event was reported as serious (hospitalization). Outcome of the event was unknown. Causality of the event was not reported. Based on the batch review, it was stated that the FLUVIRIN batch number 13373P was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department (QA reference number: 294988) received on 16 May 2014: Updated QA number and batch review report.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Cellulitis, Joint swelling, Pain
Clinical narrative: Case number PHHY2014US046570, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520089) website on 14 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 294977) on 16 May 2014. This report refers to a 65-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309601) along with PNEUMOVAX (batch number: H022280, other manufacturer), intramuscularly in the arm on 13 Jan 2014. On 15 Jan 2014, she experienced pain and swelling of elbow. The patient could not raise her arm without pain. The patient visited the emergency room. It was reported that as per her MD she had severe cellulitis in her elbow. The final outcome of the events reported as not recovered. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1309601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 294977) on 16 May 2014: Updated batch review report.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Arthralgia, Cellulitis, Joint swelling, Mobility decreased, Pain
Clinical narrative: Case number PHHY2014US046570, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 520089) website on 14 Apr 2014, with the follow-up received from Quality Assurance Department (reference number: 294977) on 16 May 2014. This report refers to a 65-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309601) along with PNEUMOVAX (batch number: H022280, other manufacturer), intramuscularly in the arm on 13 Jan 2014. On 15 Jan 2014, she experienced pain and swelling of elbow. The patient could not raise her arm without pain. The patient visited the emergency room. It was reported that as per her MD she had severe cellulitis in her elbow. The final outcome of the events reported as not recovered. The events reported as non-serious; however the case was internally upgraded as medically significant by the agency. The causality of the events not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1309601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 294977) on 16 May 2014: Updated batch review report.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. The patient's pertinent medical history included eczema. The patient had no drug allergies. Concomitant medication was reported as none. On 12-MAY-2014 the patient was vaccinated with the 2nd dose of GARDASIL (strength and lot# not reported), 0.5 ml, intramuscularly. On 12-MAY-2014, the patient developed dizziness, blacked out and shaking shortly after receiving the scheduled second dose of GARDASIL. The patient was brought to the physician's office. No labs were performed. The physician had the patient took PEDIASURE and had patient sit up. The outcome of dizziness, blacked out and shaking was reported as recovered/resolved. Upon internal review, black out was considered to be medically significant. This is one of the several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient. The patient's pertinent medical history included eczema. The patient had no drug allergies. Concomitant medication was reported as none. On 12-MAY-2014 the patient was vaccinated with the 2nd dose of GARDASIL (strength and lot# not reported), 0.5 ml. intramuscularly. On 12-MAY-2014, the patient developed dizziness, blacked out and shaking shortly after receiving the scheduled second dose of GARDASIL. The patient was brought to the physician's office. No labs were performed. The physician had the patient took PEDIASURE and had patient sit up. The outcome of dizziness, blacked out and shaking was reported as recovered/resolved. Upon internal review, black out was considered to be medically significant. This is one of the several reports from the same source. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Inflammation, Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: This literature marketed report as received from the author refers to a 28 year old male patient with asplenia. This is case 1 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 (unspecified). 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) presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 29.7K/microliter, and maximum temperature of 104.5 degree F. The patient sought care within 2-3 days of vaccination and was admitted to the hospital for observation. 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. From the records available, it appeared that only patient 1 had received (manufacturer unknown) PS23 vaccine prior to this reaction. The indication for prior (manufacturer unknown) PS23 vaccination was the patient's asplenia. The date of this prior vaccination was not available as it occurred prior to the patient's enrollment in the healthcare system. The outcome of the events localized inflammation, injection site erythema, warmth and edema and presumed cellulitis was considered as resolving and outcome of fever, leucocytosis and vomiting was considered as resolved. The reporter considered the events to be related to Pneumococcal vaccine, Polyvalent (23-valent) (manufacturer unknown). This case is linked to case # 1405USA008574, 1405USA008573, 1405USA008575 and 1405USA008576 (same reporter link). Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Leukocytosis, Pyrexia, Vomiting, White blood cell count increased
Clinical narrative: This literature marketed report as received from the author refers to a 28 year old male patient with asplenia. This is case 1 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 (unspecified). 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) presumed cellulitis (hospitalization) and vomiting (hospitalization). The patient's laboratory results included WBC 29.7K/microliter, and maximum temperature of 104.5 degree F. The patient sought care within 2-3 days of vaccination and was admitted to the hospital for observation. 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. From the records available, it appeared that only patient 1 had received (manufacturer unknown) PS23 vaccine prior to this reaction. The indication for prior (manufacturer unknown) PS23 vaccination was the patient's asplenia. The date of this prior vaccination was not available as it occurred prior to the patient's enrollment in the healthcare system. The outcome of the events localized inflammation, injection site erythema, warmth and edema and presumed cellulitis was considered as resolving and outcome of fever, leucocytosis and vomiting was considered as resolved. The reporter considered the events to be related to Pneumococcal vaccine, Polyvalent (23-valent) (manufacturer unknown). This case is linked to case # 1405USA008574, 1405USA008573, 1405USA008575 and 1405USA008576 (same reporter link). Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash macular
Clinical narrative: Rash on arms and side of neck, big red blotch.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal discomfort, Pyrexia, Rash
Clinical narrative: Fever, rash, upset stomach.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Eye pain, Limb discomfort, Pyrexia, Rash generalised
Clinical narrative: Fever, eyes hurt, legs feels "weird when walking", rash started on face, rash on stomach, neck back.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: 16cm of warm slightly red and slightly indurated swelling at injection site.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Pt developed rash that was diagnosed as Erythema Multiforme Minor.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a physician refers to an adult patient of unknown age and gender. No information provided regarding concurrent conditions and medical history. On 14-MAY-2014 the patient was vaccinated with RECOMBIVAX HB, 5/0.5 microgram-milliliter intramuscular. No concomitant medications were reported. It was reported that on 14-MAY-2014, the adult patient received 0.5 ml pediatric dose and no adverse effects reported. PQC was not involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: Patient received the MMR vaccine, and was subsequently found to have a positive urine pregnancy test. The patient's last menstrual period was 3/14/2014. Otherwise, no adverse events occurred.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Patient received the MMR vaccine, and was subsequently found to have a positive urine pregnancy test. The patient's last menstrual period was 3/14/2014. Otherwise, no adverse events occurred.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Haematochezia, Hyperhidrosis
Clinical narrative: Sweating, low blood pressure, totally messed labs up from previously normal, pain in abdomen woke me, diarrhea, blood in stool, vertigo, can't sleep, nauseated, light headed.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Hypotension, Insomnia, Nausea, Vertigo
Clinical narrative: Sweating, low blood pressure, totally messed labs up from previously normal, pain in abdomen woke me, diarrhea, blood in stool, vertigo, can't sleep, nauseated, light headed.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dysphagia, Dyspnoea, Nausea, Oropharyngeal pain
Clinical narrative: Throat pain first, so I gargled and went to bed. Awoke around 11:30 PM with nausea/chills, difficulty breathing/swallowing/talking. Call nurseline. Was advised to go to ER. Went at 6:15 AM. Given a steroid shot and breathing therapy. Symptoms continued. Visited ENT on 5/19/14. Given steroid prescription. Today, 5/20/14, back at work and sore throat persists.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Streptococcus test negative
Clinical narrative: Throat pain first, so I gargled and went to bed. Awoke around 11:30 PM with nausea/chills, difficulty breathing/swallowing/talking. Call nurseline. Was advised to go to ER. Went at 6:15 AM. Given a steroid shot and breathing therapy. Symptoms continued. Visited ENT on 5/19/14. Given steroid prescription. Today, 5/20/14, back at work and sore throat persists.
Age: 20.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Inflammation, Injection site erythema, Injection site oedema, Injection site warmth
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, 2014SA063513 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 reported 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 the providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. Regarding this case which involves a 20-year-old male patient, with a medical history of smoking, who had received on an unspecified date the following vaccines: an injection of influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an injection of 23 valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) vaccine in the same arm. Within 1 day after the vaccination, the patient developed fever with a maximum of 103 degrees F, vomiting and rigors. The patient also developed local erythema, edema and warmth at the site of injection. The patient had significant leukocytosis with a white blood cell (WBC) of 22.8 K/uL. The patient was hospitalized (dates not reported). He received a corrective treatment with antibiotics in the hospital and post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Leukocytosis, Pyrexia, Vomiting, 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, 2014SA063513 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 reported 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 the providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. Regarding this case which involves a 20-year-old male patient, with a medical history of smoking, who had received on an unspecified date the following vaccines: an injection of influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an injection of 23 valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) vaccine in the same arm. Within 1 day after the vaccination, the patient developed fever with a maximum of 103 degrees F, vomiting and rigors. The patient also developed local erythema, edema and warmth at the site of injection. The patient had significant leukocytosis with a white blood cell (WBC) of 22.8 K/uL. The patient was hospitalized (dates not reported). He received a corrective treatment with antibiotics in the hospital and post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
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: 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 were captured in case numbers 2014SA063502, 2014SA063512, 2014SA063513 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." Regarding this case which involves a 21-year-old female with a history of asthma had received on an unspecified date the following vaccines: an arm injection of Influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an arm injection of 23-valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and within one day of vaccination developed a fever of 103.2 and vomiting. The patient who received both vaccines in opposite arms developed local erythema and edema at the site of the pneumococcal polysaccharide vaccine. The arm where the influenza vaccine was administered was normal. The patient had significant leukocytosis with a white blood cell (WBC) of 20.7 K/uL. The patient ESR was 92 mm/hr and CRP was 20 mg/dl. The patient was hospitalized (dates not reported). The patient did not receive any antibiotics in the hospital or post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
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: 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 were captured in case numbers 2014SA063502, 2014SA063512, 2014SA063513 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." Regarding this case which involves a 21-year-old female with a history of asthma had received on an unspecified date the following vaccines: an arm injection of Influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an arm injection of 23-valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and within one day of vaccination developed a fever of 103.2 and vomiting. The patient who received both vaccines in opposite arms developed local erythema and edema at the site of the pneumococcal polysaccharide vaccine. The arm where the influenza vaccine was administered was normal. The patient had significant leukocytosis with a white blood cell (WBC) of 20.7 K/uL. The patient ESR was 92 mm/hr and CRP was 20 mg/dl. The patient was hospitalized (dates not reported). The patient did not receive any antibiotics in the hospital or post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Skin warm, Swelling, Vomiting, 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 were captured in case numbers 2014SA063502, 2014SA063512, 2014SA063513 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." Regarding this case which involves a 21-year-old female with a history of asthma had received on an unspecified date the following vaccines: an arm injection of Influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an arm injection of 23-valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and within one day of vaccination developed a fever of 103.2 and vomiting. The patient who received both vaccines in opposite arms developed local erythema and edema at the site of the pneumococcal polysaccharide vaccine. The arm where the influenza vaccine was administered was normal. The patient had significant leukocytosis with a white blood cell (WBC) of 20.7 K/uL. The patient ESR was 92 mm/hr and CRP was 20 mg/dl. The patient was hospitalized (dates not reported). The patient did not receive any antibiotics in the hospital or post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Injection site oedema, 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 were captured in case numbers 2014SA063502, 2014SA063512, 2014SA063513 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." Regarding this case which involves a 21-year-old female with a history of asthma had received on an unspecified date the following vaccines: an arm injection of Influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an arm injection of 23-valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and within one day of vaccination developed a fever of 103.2 and vomiting. The patient who received both vaccines in opposite arms developed local erythema and edema at the site of the pneumococcal polysaccharide vaccine. The arm where the influenza vaccine was administered was normal. The patient had significant leukocytosis with a white blood cell (WBC) of 20.7 K/uL. The patient ESR was 92 mm/hr and CRP was 20 mg/dl. The patient was hospitalized (dates not reported). The patient did not receive any antibiotics in the hospital or post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
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: 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 were captured in case numbers 2014SA063502, 2014SA063512, 2014SA063513 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." Regarding this case which involves a 21-year-old female with a history of asthma had received on an unspecified date the following vaccines: an arm injection of Influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an arm injection of 23-valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and within one day of vaccination developed a fever of 103.2 and vomiting. The patient who received both vaccines in opposite arms developed local erythema and edema at the site of the pneumococcal polysaccharide vaccine. The arm where the influenza vaccine was administered was normal. The patient had significant leukocytosis with a white blood cell (WBC) of 20.7 K/uL. The patient ESR was 92 mm/hr and CRP was 20 mg/dl. The patient was hospitalized (dates not reported). The patient did not receive any antibiotics in the hospital or post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
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: 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 were captured in case numbers 2014SA063502, 2014SA063512, 2014SA063513 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." Regarding this case which involves a 21-year-old female with a history of asthma had received on an unspecified date the following vaccines: an arm injection of Influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an arm injection of 23-valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and within one day of vaccination developed a fever of 103.2 and vomiting. The patient who received both vaccines in opposite arms developed local erythema and edema at the site of the pneumococcal polysaccharide vaccine. The arm where the influenza vaccine was administered was normal. The patient had significant leukocytosis with a white blood cell (WBC) of 20.7 K/uL. The patient ESR was 92 mm/hr and CRP was 20 mg/dl. The patient was hospitalized (dates not reported). The patient did not receive any antibiotics in the hospital or post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV, FLUX, PPV
Symptoms: Vomiting, 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 were captured in case numbers 2014SA063502, 2014SA063512, 2014SA063513 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." Regarding this case which involves a 21-year-old female with a history of asthma had received on an unspecified date the following vaccines: an arm injection of Influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an arm injection of 23-valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and within one day of vaccination developed a fever of 103.2 and vomiting. The patient who received both vaccines in opposite arms developed local erythema and edema at the site of the pneumococcal polysaccharide vaccine. The arm where the influenza vaccine was administered was normal. The patient had significant leukocytosis with a white blood cell (WBC) of 20.7 K/uL. The patient ESR was 92 mm/hr and CRP was 20 mg/dl. The patient was hospitalized (dates not reported). The patient did not receive any antibiotics in the hospital or post discharge. According to the reporter, within 5-7 days all patients experienced improvement in the skin findings and resolution of the systemic symptoms. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.