chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash erythematous
Clinical narrative: Burning along waistline from navel to backbone on right side. Pain. Small red spots in area. Doctor confirmed shingles. Received Zostavax (Merck) shingles vaccine 8 days prior.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hypotension, Pharyngeal oedema, Pruritus, Rash
Clinical narrative: Hypotension. Headache. Itching/rash. Throat swelling.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection
Clinical narrative: This spontaneous report as received from a nurse refers to a two patients of unknown age and gender, who completed the series of ROTATEQ in 2013 (orally, dose frequency and indication were not provided). The nurse provided lot numbers: J004944 (expiration date: 12-NOV-2014); J001815 (expiration date: 06-JUL-2014); J001257 (expiration date: 27-AUG-2014); H016249 (expiration date: 27-MAR-12014); H012981 (expiration date: unknown); H011458 (expiration date: 04-DEC-2013). The lot number J010928 is an invalid lot number for ROTATEQ. In approximately March 2015 (reported as "in the last two weeks") the patient were diagnosed with rotavirus infection. The outcome of rotavirus infection was unknown. The relatedness between ROTATEQ was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown gender. The patients medical history was not reported. On an unknown date the unspecified number of patients were vaccinated with a supported dose of M-M-R II (Dose, route and lot number was unknown). No adverse effect was reported. No product quality complaint (PQC) was reported. This case is one of the several reports linked with same reporter  link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. It was reported that an unspecified number of unspecified patients received an unspecified number of improperly stored doses of RECOMBIVAX HB (intramuscularly, dose, frequency and lot # not reported) since an unspecified date in December 2014. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. It was reported that an unspecified number of unspecified patients received an unspecified number of improperly stored doses of GARDASIL (intramuscularly, dose, frequency and lot # not reported) since an unspecified date in December 2014. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. The patients pertinent medical history was not reported. On an unknown date the patients were vaccinated with a supported dose of (Oka/Merck) VARIVAX (Dose, route and lot number was unknown). No adverse effect was reported. No product quality complaint (PQC) was reported. This is one of the several reports linked with same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-MAR-2015 (also reported as "today") the patient was vaccinated with a second dose of GARDASIL (dose volume, route of administration, lot number were not reported). The patient was administered a first dose of GARDASIL (dose, volume, route of administration, lot number were not reported) on 01-JUL-2014. No adverse events were reported. Additional information is not expected because the reporter did not give a consent for the follow-up attempts.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. The patients pertinent medical history was not reported. On an unknown date unspecified patients were vaccinated with a supported dose of PROQUAD (Merck) (dose, lot number unknown). No adverse effect was reported. No product quality complaint (PQC) was reported for PROQAUD (Merck). This case is one of the several reports linked with same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with (Oka/Merck) VARIVAX (Lot#: J009987, Expiry: 12-AUG-2015), 0.5 ml, subcutaneous, which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This case is one of the several cases linked with the same reporter link. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients of unkonwn age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck) (Lot# K018142, Expiry:10-APR-2016), 0.5 ml, subcutaneous, which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports linked with the same reporter link. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot # not provided). On an unknown date, other unspecified pharmacist had been removing ZOSTAVAX from the freezer and let the vaccine sit out on the counter for 5 minutes before reconstituting, so it could thaw a little before administration. No adverse effect were reported. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist via field employee refers to a 52 year old male patient. The patient pertinent medical history and drug allergies were not reported. On 16-MAR-2015 the patient was vaccinated with ZOSTAVAX subcutaneously. On 16-MAR-2015, the patient experienced burning and redness at injection site, approximately the size of a circle (made by connecting his thumb an index finger). The pharmacist reported that the patient on an unspecified date saw an unspecified nurse, at the patient place of occupation and the nurse informed the patient, that the zoster vaccine live injection appeared to be an intramuscular injection. The pharmacist reported that the documentation recorded the patient received zoster vaccine live by subcutaneous route. The pharmacist saw the patient following day and the zoster vaccine live injection site was nothing out of the ordinary. The outcome of the events was unknown. The causality of the events was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck) (Lot@ K009473, Expiry:03-JAN-2016), 0.5 ml, subcutaneous, which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This is one of the several cases linked with the same reporter link. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unkonwn date the patients were vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous, which was improperly stored, temperature excursison. No addverse effects were reportd. No product quality complaint was involved. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored MMR II (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The patient received the first dose of GARDASIL intramuscular injection, 0.5 ml, on 25-MAR-2014, the second dose on 13-OCT-2014 and third dose on 13-DEC-2014 (which was slightly out of the recommended schedule). No adverse effects were reported. No concomitant therapies were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and unknown gender. The patients pertinent medical history was not reported. On an unknown date the patients were vaccinated with a supported dose of ZOSTAVAX (dose, route and lot number was unknown). No adverse effect was reported. No product quality complaint (PQC) was reported. This case is one of the several cases linked with the same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker also reported as a nurse assistant and refers to an unspecified number of patients of unknown age and gender. Information about patients' medical histories was not provided. On 09-FEB-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, lot number and expiry date were not reported) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker also reported as nurse assistant refers to group of patients of unknown demographics. Information about patients' medical histories was not provided. On 04-FEB-2015, the patients were vaccinated with VARIVAX (Merck) (dose, frequency, indication and lot # were not specified) which was improperly stored. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous, which was improperly stored, temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports linked with the same reporter link. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck) (Lot# K003411, Expiry: 06-MAR-2016), 0.5 ml, subcutaneous, which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This case is one of the several cases linked with the same reporter link. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck) (Lot# given as J014153, Expiry: 07-NOV-2015), 0.5 ml, subcutaneous, which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This is one of the several cases linked with the same reporter link. No additional information provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding 10 unspecified patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the 10 patients were vaccinated with VARIVAX (Merck) .5 milliliter (ml), product lot # reported as K011804, expiry date reported as 21-AUG-2016, subcutaneously after it was stored improperly. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site erythema
Clinical narrative: Redness of the left thigh, extending 22 cm by 14.5 cm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (Merck) (administration route, lot number and expiration date were not provided) that was exposed to a temperature outside of the recommended. No concomitant therapies were reported, neither was any adverse event. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Hepatitis A vaccine given while child had already two doses of Hepatitis A vaccine.
Age: 68.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swelling, severe itching at site of injection lasted for a week.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rhinorrhoea, Throat irritation
Clinical narrative: Patient reports redness and swelling at injection site.  Patient also experiencing runny nose and scratchy throat, but she believes it could be a cold unrelated to vaccine.
Age: 1.42
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Rash erythematous
Clinical narrative: Red spot where injection occurred on thigh. Also red bumps on knee. About three days later hard bump at injection site. Also rash still present.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Dull pain in area where shot was administered. Not always present, but comes back every week or so for about a day. Is more noticeable with physical exertion.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Inflammation, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Intense shoulder pain for several weeks. First week I was prescribed muscle relaxers and Ibuprofen. This had no impact on pain. Then I received an X-ray, which revealed to structural damage. I then was prescribed prednisone. After a week of prednisone, the pain had started to subside, but was still weak and pain when trying to use the arm. I then went to see a Orthopedic doctor and had an MRI. MRI showed inflammation, but no structural damage. Doctor prescribed 6 weeks of PT, 3 time a week. Weakness still impacting daily life after 3 weeks of therapy.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, X-ray normal
Clinical narrative: Intense shoulder pain for several weeks. First week I was prescribed muscle relaxers and Ibuprofen. This had no impact on pain. Then I received an X-ray, which revealed to structural damage. I then was prescribed prednisone. After a week of prednisone, the pain had started to subside, but was still weak and pain when trying to use the arm. I then went to see a Orthopedic doctor and had an MRI. MRI showed inflammation, but no structural damage. Doctor prescribed 6 weeks of PT, 3 time a week. Weakness still impacting daily life after 3 weeks of therapy.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area around injection site is raised, red and warm to the touch. PCP stated it may be cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Abnormal behaviour, Crying, Decreased eye contact, Immediate post-injection reaction, Speech disorder
Clinical narrative: Immediately after receiving vaccines he cried for more than four hours. After that he lost eye contact and the words he was saying and has never been the same child.
Sex: U
Vaccine: PPV
Symptoms: Antibody test, Antibody test negative, Immunoglobulins
Clinical narrative: Information has been received from the below mentioned literature article regarding 4 patients. The study used a retrospective electronic database chart review of all patients 18 years of age or older at a tertiary care. This review was approved by the Review Board of School of Medicine. Subjects met inclusion criteria if they had a visit at the allergy-immunology clinic between 2002 and 2009, received an International Classification of Diseases, Ninth Revision (ICD-9) diagnosis of Chronic rhinosinusitis (CRS), and underwent evaluation for immunodeficiency with a PPV. The treating physician made the decision to evaluate the individual patient with CRS for immunodeficiency. All subjects had normal IgG levels (>550 mg/dL). Subjects were included if they had a sinus CT scan documenting CRS and met criteria for CRS as defined by nationally recognized consensus statements. The presence of nasal polyposis was determined by rhinoscopy or surgical pathology specimens, and subjects were subsequently classified as chronic rhinosinusitis without nasal polyps (CRSsNP) or chronic rhinosinusitis with nasal polyps (CRSwNP). Atrophy was determined in all subjects via skin testing to pollens, dust mites, pets, molds, and cockroach using Hollister-Stier extracts. Asthma diagnosis and severity was determined in accordance with the 2007 NAEPP expert panel report 3 guidelines using % FEV1 values. Subjects were excluded if they had common variable immunodeficiency, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary ciliary dyskinesia, cystic fibrosis, malignancy, IgA deficiency, or any acquired immunodeficiencies (eg, HIV/AIDS or secondary to medications such as chemotherapy). Evaluation of subjects' characteristics, antipneumococcal antibody titers, and serum Ig levels was performed via Analysis of variance (ANOVA) with post hoc Tukey analysis. Analogous chi-square tests were used to compare percentage for categorical variables. Data are expressed as mean with standard deviation. A P-value less than 0.05 were considered statistically significant; such results have been marked with an asterisk in the table in which they appear. Total number of patients were 239. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dose, anatomical location and lot number was unknown). On an unknown date, the patients experienced specific antibody deficiency (had less than 50% of the pneumococcal serotypes greater than or equal to 1.3 mg/ml after PPV immunization). The outcome of the event was unknown. The author considered the event to the be related to PNEUNOVAX 23. A copy of published article was attached as further documentation of the patient's experience. This is one of the several reports received from the same literature article. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Antibody test negative, Immunoglobulins
Clinical narrative: Information has been received from the below mentioned literature article regarding 40 patients. The study used a retrospective electronic database chart review of all patients 18 years of age or older at a tertiary care. This review was approved by the Review Board School of Medicine. Subjects met inclusion criteria if they had a visit at the allergy-immunology clinic between 2002 and 2009, received an International Classification of Diseases, Ninth Revision (ICD-9) diagnosis of Chronic rhinosinusitis (CRS), and underwent evaluation for immunodeficiency by assessment of quantitative serum immunoglobulin levels and pneumococcal antibody titers pre- and post immunization with a PPV. The treating physician made the decision to evaluate the individual patient with CRS for immunodeficiency. All subjects had normal IgG levels (>550 mg/dL). Subjects were included if they had a sinus CT scan documenting CRS and met criteria for CRS as defined by nationally recognized consensus statements. The presence of nasal polyposis was determined by rhinoscopy or surgical pathology specimens, and subjects were subsequently classified as chronic rhinosinusitis without nasal polyps (CRSsNP) or chronic rhinosinusitis with nasal polyps (CRSwNP). Atrophy was determined in all subjects via skin testing to pollens, dust mite, pets, molds, and cockroach using Hollister-Stier extracts. Asthma diagnosis and severity was determined in accordance with the 2007 NAEPP expert panel report 3 guidelines using % FEV1 values. Subjects were excluded if they had common variable immunodeficiency, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary ciliary dyskinesia, cystic fibrosis, malignancy, IgA deficiency, or any acquired immunodeficiencies  (eg, HIV/AIDS or secondary to medications such as chemotherapy). Evaluation of subjects characteristics, antipneumococcal antibody titers, and serum Ig levels was performed via Analysis of variance (ANOVA) with post hoc Tukey analysis. Analogous chi-square tests were used to compare percentage for categorical variables. Data are expressed as mean with standard deviation. A P-value less than 0.05 were considered statistically significant; such results have been marked with an asterisk in the table in which they appear. Total number of patients were 239. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dose, anatomical location and lot number was unknown). On an unknown date, the patients experienced specific antibody deficiency (had less than 50% of the pneunococcal serotypes greater than or equal to 1.3 mg/ml after PPV immunization). The outcome of the event was unknown. The author considered the event to be related to PNEUMOVAX 23. A copy of published article was attached as further documentation of the patients' experience. This is one of the several reports received from the same literature article. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Antibody test, Antibody test negative, Immunoglobulins
Clinical narrative: Information has been received from a literature article regarding patient of unknown demographics. The study used a retrospective electronic database chart review of all patients 18 years of age or older at a tertiary care. This review was approved the Review Board. Subjects met inclusion criteria if they had a visit at the allergy-immunology clinic between 2002 and 2009, received an International Classification of Diseases, Ninth Revision (ICD-9) diagnosis of Chronic rhinosinusitis (CRS), and underwent evaluation for immunodeficiency by assessment of quantitative serum immunoglobulin levels and pneumococcal antibody titers pre-and post immunization with a pneumococcal polysaccharide vaccine (PPV). The treating physician made the decision to evaluate the individual patient with CRS for immunodeficiency. All subjects had normal IgG levels (>550 mg/dL). Subjects were included if they had a sinus CT scan documenting CRS and met criteria for CRS as defined by nationally recognized consensus statements. The presence of nasal polyposis was determined by rhinoscopy or surgical pathology specimens, and subjects were subsequently classified as chronic rhinosinusitis without nasal polyps (CRSsNP) or chronic rhinosinusitis with nasal polyps (CRSwNP). Atrophy was determined in all subjects via skin testing to pollens, dust mites, pets, molds, and cockroach using Hollister-Stier extracts. Asthma diagnosis and severity was determined in accordance with the 2007 National Asthma Education and Prevention Program (NAEPP) expert panel report 3 guidelines using % FEV1 values. Subjects were excluded if they had common variable immunodeficiency, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary ciliary dyskinesia, cystic fibrosis, malignancy, IgA deficiency, or any acquired immunodeficiencies (eg, HIV/AIDS or secondary to medications such as chemotherapy). Evaluation of subjects' characteristics, antipneumococcal antibody titers, and serum Ig levels was performed via Analysis of variance (ANOVA) with post hoc Tukey analysis. Analogous chi-square tests were used to compare percentages for categorical variables. Data are expressed as mean with standard deviation. A P-value less than 0.05 were considered statistically significant; such results have been marked with an asterisk in the table in which they appear. Total number of patients were 239. On an unknown date, the patient was vaccinated with PPV (manufacturer unknown) (dose, anatomical location and lot number was unknown). Concomitant medications were unspecified by reporter. On an unknown date, the patient experienced specific antibody deficiency (had less than 50% of the pneumococcal serotypes greater than or equal to 1.3 mg/ml after PPV immunization). The outcome of the event was unknown. The author considered the event to be related to PPV. This is one of the several reports received from the same literature article. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 18-MAR-2015 the patient was vaccinated with an expired dose of M-M-R II, 0.5 ml, subcutaneously, expiration date 12-MAR-2015 (lot# was not reported). The reporter stated that the dose was supported. No adverse experience was reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: Patient received shingles shot on 1-19-2015 3 days later had patches on right side, under ribs, by waistband area - were both internal and external and were bilateral - had increase of pain, rash, itchiness, tiredness for weeks after (approx 7 weeks). Note patient told me of this on March 25, 15.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, mild redness tender to injection site.
Sex: U
Vaccine: PPV
Symptoms: Antibody test, Antibody test negative, Immunoglobulins
Clinical narrative: Information has been received from the literature regarding 11 patients. The study used a retrospective electronic database chart review of all patients 18 years of age or older at a tertiary care. This review was approved by a Review Board. Subjects met inclusion criteria if they had a visit at the allergy-immunology clinic between 2002 and 2009, received an International Classification of Diseases, diagnosis of Chronic rhino sinusitis (CRS), and underwent evaluation for immunodeficiency by assessment of quantitative serum immunoglobulin levels and pneumococcal antibody titers pre- and post immunization with a PPV. The treating physician made the decision to evaluate the individual patient with CRS for immunodeficiency. All subjects had normal IgG levels (>550 mg/dL). Subjects were included if they had a sinus CT scan documenting CRS and met criteria for CRS as defined by nationally recognized consensus statements. The presence of nasal polyposis was determined by rhinoscopy or surgical pathology specimens, and subjects were subsequently classified as chronic rhino sinusitis without nasal polyps (CRSsNP) or chronic rhinosinusitis with nasal polyps (CRSwNP). Atrophy was determined in all subjects via skin testing to pollens, dust mites, pets, molds, and cockroach using Hollister-Stier extracts. Asthma diagnosis and severity was determined in accordance with the 2007 National Asthma Education and Prevention Program (NAEPP) expert panel report 3 guidelines using % FEV1 values. Subjects were excluded if they had common variable immunodeficiency, allergic bronchopulmonary aspergillosis, Churg-Strauss syndrome, primary cilliary dyskinesia, cystic fibrosis, malignancy, IgA deficiency, or any acquired immunodeficiencies (eg, HIV/AIDS or secondary to medications such as chemotherapy). Evaluation of subjects' characteristics, antipneumococcal antibody titers, and serum Ig levels was performed via Analysis of variance (ANOVA) with post hoc Tukey analysis. Analogous chi-square tests were used to compare percentage for categorical variables. Data are expressed as mean with standard deviation. A P-value less than 0.05 were considered statistically significant; such results have been marked with an asterisk in the table in which they appear. Total number of patients were 239. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (manufacturer unknown), (dose, anatomical location and lot number was unknown). Concomitant medications were unspecified by reporter. On an unknown date, the patients experienced specific antibody deficiency (had less than 50% of the pneumococcal serotypes greater than or equal to 1.3 mg/ml after PPV immunization). The outcome of the event was unknown. The author considered the event to be related to Pneumococcal vaccine. This is one of the several reports received from the same literature article. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: No R.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Aphasia, Blood test, Dysphagia, Dyspnoea
Clinical narrative: 10/9 numbness & tingling in hands & feet,could hardly get out of bed, fell walking.  10/10 Couldn't walk, cannot lift right arm, 10/11 Went to ER & was admitted, 10/12-went to MED ICU-paralyzed both hands & feet, difficulty breathing & swallowing, 10/13 put on ventilator, 10/14 reacted to IVIG treatment-started plasmapheresis- 5 treatments 10/16 EMG done -confirmed Guillain Barre syndrome,10/22-had tracheotomy & PEG tube - various complications-pneumonia, urinary infections, heart rate fluctuations, droopy eyes-hot/cold - could not talk-in a lot of pain all over 12/4-went to stepdown ICU-12/5-off vent for 24 hours-12/15-transported to rehab, 12/17-Trach & PEG Tube removed. 2/4/15-released - home OT & PT/Visiting nurse-in wheelchair-started using a walker-still has pain-3/15 started outpatient PT-cannot walk unassisted & still has pain...
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Eyelid ptosis, Fall, Feeling of body temperature change, Gastrostomy
Clinical narrative: 10/9 numbness & tingling in hands & feet,could hardly get out of bed, fell walking.  10/10 Couldn't walk, cannot lift right arm, 10/11 Went to ER & was admitted, 10/12-went to MED ICU-paralyzed both hands & feet, difficulty breathing & swallowing, 10/13 put on ventilator, 10/14 reacted to IVIG treatment-started plasmapheresis- 5 treatments 10/16 EMG done -confirmed Guillain Barre syndrome,10/22-had tracheotomy & PEG tube - various complications-pneumonia, urinary infections, heart rate fluctuations, droopy eyes-hot/cold - could not talk-in a lot of pain all over 12/4-went to stepdown ICU-12/5-off vent for 24 hours-12/15-transported to rehab, 12/17-Trach & PEG Tube removed. 2/4/15-released - home OT & PT/Visiting nurse-in wheelchair-started using a walker-still has pain-3/15 started outpatient PT-cannot walk unassisted & still has pain...
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Heart rate irregular, Hypoaesthesia, Immunoglobulin therapy, Intensive care
Clinical narrative: 10/9 numbness & tingling in hands & feet,could hardly get out of bed, fell walking.  10/10 Couldn't walk, cannot lift right arm, 10/11 Went to ER & was admitted, 10/12-went to MED ICU-paralyzed both hands & feet, difficulty breathing & swallowing, 10/13 put on ventilator, 10/14 reacted to IVIG treatment-started plasmapheresis- 5 treatments 10/16 EMG done -confirmed Guillain Barre syndrome,10/22-had tracheotomy & PEG tube - various complications-pneumonia, urinary infections, heart rate fluctuations, droopy eyes-hot/cold - could not talk-in a lot of pain all over 12/4-went to stepdown ICU-12/5-off vent for 24 hours-12/15-transported to rehab, 12/17-Trach & PEG Tube removed. 2/4/15-released - home OT & PT/Visiting nurse-in wheelchair-started using a walker-still has pain-3/15 started outpatient PT-cannot walk unassisted & still has pain...
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Mechanical ventilation, Mobility decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: 10/9 numbness & tingling in hands & feet,could hardly get out of bed, fell walking.  10/10 Couldn't walk, cannot lift right arm, 10/11 Went to ER & was admitted, 10/12-went to MED ICU-paralyzed both hands & feet, difficulty breathing & swallowing, 10/13 put on ventilator, 10/14 reacted to IVIG treatment-started plasmapheresis- 5 treatments 10/16 EMG done -confirmed Guillain Barre syndrome,10/22-had tracheotomy & PEG tube - various complications-pneumonia, urinary infections, heart rate fluctuations, droopy eyes-hot/cold - could not talk-in a lot of pain all over 12/4-went to stepdown ICU-12/5-off vent for 24 hours-12/15-transported to rehab, 12/17-Trach & PEG Tube removed. 2/4/15-released - home OT & PT/Visiting nurse-in wheelchair-started using a walker-still has pain-3/15 started outpatient PT-cannot walk unassisted & still has pain...
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Paralysis, Plasmapheresis, Pneumonia, Tracheostomy
Clinical narrative: 10/9 numbness & tingling in hands & feet,could hardly get out of bed, fell walking.  10/10 Couldn't walk, cannot lift right arm, 10/11 Went to ER & was admitted, 10/12-went to MED ICU-paralyzed both hands & feet, difficulty breathing & swallowing, 10/13 put on ventilator, 10/14 reacted to IVIG treatment-started plasmapheresis- 5 treatments 10/16 EMG done -confirmed Guillain Barre syndrome,10/22-had tracheotomy & PEG tube - various complications-pneumonia, urinary infections, heart rate fluctuations, droopy eyes-hot/cold - could not talk-in a lot of pain all over 12/4-went to stepdown ICU-12/5-off vent for 24 hours-12/15-transported to rehab, 12/17-Trach & PEG Tube removed. 2/4/15-released - home OT & PT/Visiting nurse-in wheelchair-started using a walker-still has pain-3/15 started outpatient PT-cannot walk unassisted & still has pain...
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection, Walking aid user, Wheelchair user
Clinical narrative: 10/9 numbness & tingling in hands & feet,could hardly get out of bed, fell walking.  10/10 Couldn't walk, cannot lift right arm, 10/11 Went to ER & was admitted, 10/12-went to MED ICU-paralyzed both hands & feet, difficulty breathing & swallowing, 10/13 put on ventilator, 10/14 reacted to IVIG treatment-started plasmapheresis- 5 treatments 10/16 EMG done -confirmed Guillain Barre syndrome,10/22-had tracheotomy & PEG tube - various complications-pneumonia, urinary infections, heart rate fluctuations, droopy eyes-hot/cold - could not talk-in a lot of pain all over 12/4-went to stepdown ICU-12/5-off vent for 24 hours-12/15-transported to rehab, 12/17-Trach & PEG Tube removed. 2/4/15-released - home OT & PT/Visiting nurse-in wheelchair-started using a walker-still has pain-3/15 started outpatient PT-cannot walk unassisted & still has pain...
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tachycardia in a 53-year-old female patient who received FLUARIX for allergy test. Previously administered products included FLUZONE (administered intramuscularly, 0.5 ml, batch number 4472BA which went uncomplicated) and FLUARIX with an associated reaction of urticaria (on 2013). On 4th February 2015, the patient received FLUARIX .05 ml. On 4th February 2015, an unknown time after receiving FLUARIX, the patient experienced off label use. On an unknown date, the patient experienced tachycardia and throat tightness. The patient was treated with BENADRYL allergy. On an unknown date, the outcome of the tachycardia and throat tightness were recovered/resolved and the outcome of the off label use was unknown. The reporter considered the tachycardia and throat tightness to be probably related to FLUARIX. It was unknown if the reporter considered the off label use to be related to FLUARIX. This case was linked to US2015003694 as it refers to the same patient. Additional details provided as follows: The allergy test was done by the allergist.
Age: 53.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Off label use, Tachycardia, Throat tightness
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tachycardia in a 53-year-old female patient who received FLUARIX for allergy test. Previously administered products included FLUZONE (administered intramuscularly, 0.5 ml, batch number 4472BA which went uncomplicated) and FLUARIX with an associated reaction of urticaria (on 2013). On 4th February 2015, the patient received FLUARIX .05 ml. On 4th February 2015, an unknown time after receiving FLUARIX, the patient experienced off label use. On an unknown date, the patient experienced tachycardia and throat tightness. The patient was treated with BENADRYL allergy. On an unknown date, the outcome of the tachycardia and throat tightness were recovered/resolved and the outcome of the off label use was unknown. The reporter considered the tachycardia and throat tightness to be probably related to FLUARIX. It was unknown if the reporter considered the off label use to be related to FLUARIX. This case was linked to US2015003694 as it refers to the same patient. Additional details provided as follows: The allergy test was done by the allergist.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Upon follow-up information received on 23 March 2015, the case was upgraded to serious due to the addition of the event intrauterine growth restriction. Initial unsolicited pregnancy report received from a healthcare professional on 22 January 2015. A 28-year-old female patient had received first dose of ADACEL, (batch number C4714AA, expiry date was 08 August 2017) and administered subcutaneously in left tricep on 19 January 2015. The patient had no illness at the time of vaccination and pre-existing allergies, birth defects and medical conditions were not reported. The patient was 31 weeks pregnant at the time of vaccination. The last menstrual period date was 26 May 2015 and expected date of delivery date is March 2015. The patient was in her third trimester of pregnancy. The patient did not receive any treatment for infertility. It was reported that the vaccine was administered subcutaneously instead of intramuscular route resulting in inappropriate route of vaccination. On 21 January 2015, 2 days after vaccination, the patient developed redness at the injection site. The patient was evaluated by the physician on 21 January 2015. Complementary investigations were not reported. The physician prescribed BENADRYL as corrective treatment. At the time of this report, the outcome was unknown. Follow-up information received for this unsolicited pregnancy case on 23 March 2015 from a healthcare professional. The route of administration for the dose of ADACEL received on 19 January 2015 was reported as intramuscular (previously reported as subcutaneous, inappropriate route of vaccination). The patient experienced local inflammation reaction that resolved with BENADRYL and icing of the area. The patient declined genetic testings. She gave birth to a single male live baby (vaginal delivery). Labor was induced for suspected intrauterine growth restriction at 38 weeks of gestation. The newborn's weight was 5 lbs and 8 oz. He did not present any congenital abnormality. Documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal growth restriction, Incorrect route of drug administration, Induced labour, Inflammation
Clinical narrative: Upon follow-up information received on 23 March 2015, the case was upgraded to serious due to the addition of the event intrauterine growth restriction. Initial unsolicited pregnancy report received from a healthcare professional on 22 January 2015. A 28-year-old female patient had received first dose of ADACEL, (batch number C4714AA, expiry date was 08 August 2017) and administered subcutaneously in left tricep on 19 January 2015. The patient had no illness at the time of vaccination and pre-existing allergies, birth defects and medical conditions were not reported. The patient was 31 weeks pregnant at the time of vaccination. The last menstrual period date was 26 May 2015 and expected date of delivery date is March 2015. The patient was in her third trimester of pregnancy. The patient did not receive any treatment for infertility. It was reported that the vaccine was administered subcutaneously instead of intramuscular route resulting in inappropriate route of vaccination. On 21 January 2015, 2 days after vaccination, the patient developed redness at the injection site. The patient was evaluated by the physician on 21 January 2015. Complementary investigations were not reported. The physician prescribed BENADRYL as corrective treatment. At the time of this report, the outcome was unknown. Follow-up information received for this unsolicited pregnancy case on 23 March 2015 from a healthcare professional. The route of administration for the dose of ADACEL received on 19 January 2015 was reported as intramuscular (previously reported as subcutaneous, inappropriate route of vaccination). The patient experienced local inflammation reaction that resolved with BENADRYL and icing of the area. The patient declined genetic testings. She gave birth to a single male live baby (vaginal delivery). Labor was induced for suspected intrauterine growth restriction at 38 weeks of gestation. The newborn's weight was 5 lbs and 8 oz. He did not present any congenital abnormality. Documents held by sender: none.