chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.19
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Rash papular
Clinical narrative: Patient received vaccines on 3/8/13. Mom reported fever and rash within the next day. Very itchy. Fever resolved within 2 days but still had papular rash with pruritis on both legs, mostly. Also some on both arms. Patient will follow up 3 days from visit. Treated patient with children's BENADRYL TID (q 6 hours) when awake. Follow up in 3 days from visit.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified other health professional refers to a patient of unknown age and gender. On 21-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # 1601AA. The route of administration and anatomical location was not provided. The expiry date of the ZOSTAVAX was 13-JAN-2013, while it was administered on 21-FEB-2013. No adverse symptoms were reported. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old patient. On 05-MAR-2013 the patient was vaccinated with expired ZOSTAVAX (lot # 1657AA, expiration date 21-JAN-2013). Route of administration was not provided. The patient experienced no adverse effect. 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 health care worker refers to a patient of unknown age and gender. The patient received the first dose of GARDASIL (lot number, expiry date, route and dose were not reported) series on 06-NOV-2012, the second dose on 21-NOV-2012 and the third dose on 22-JAN-2013. No adverse effects reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous report as received from a n unspecified nurse in a doctor's practice via company representative refers to a female patient of an unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# not reported). On an unknown date, within 24 hours following administration of the first dose in the GARDASIL vaccination series the patient experienced nausea and extreme dizziness. The outcome of the events was reported as recovered on an unspecified date. The relatedness for the events with the therapy was not provided. The patient sought medical attention, unspecified how. This is one of several reports received from the same source. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration
Clinical narrative: 4.5 x 4.5 area of induration at site of administered. Given TEMOVATE ointment with relief.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was not pregnant. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot # H014196; Expiration unspecified) (dose, route and injection site were not reported). On an unknown date the patient had a lump as well as a red area around the injection site. The outcome was unknown at the time of report. Action taken and causality were not provided. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blood glucose normal, Dizziness, Hypotonia, Loss of consciousness
Clinical narrative: Ten minutes after vaccines, father of pt. reported pt. felt lightheaded then went limp and passed out. Doctor immediately went in room and pt. was awake. Blood sugar was checked and normal. Pt. sat up and within ten minutes fell back to normal.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Anticonvulsant drug level decreased, Blood test, Cerebral cyst, Chest pain, Condition aggravated
Clinical narrative: Case number PHEH2013US005840, is an initial spontaneous report received from a consumer via Taro pharmaceuticals Inc. on 12 Mar 2013. This report refers to an adult female patient. Her medical history included hysterectomy in the past. Concomitant medications included estradiol 2 mg, Taro phenytoin sodium extended capsules USP 300 mg qd in Nov 2012 for seizures and started KEPPRA in Dec 2012 by her neurologist, but this did not affect the frequency of her seizures. KEPPRA dose was increased to 1000 mg twice daily but this did not affect the frequency of her seizures. She was vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown) on 20 Feb 2013 at around 11:00 am. At around 1 pm, she developed itchy, red eyes and an elevated heart rate. She started vomiting at about 2 or 3 pm. She went to the emergency room at about 4 pm. She had a heart rate of 150, was shaking, vomiting, had trouble breathing and had chest pain due to the difficulty breathing. Her blood pressure was 162/100, her "lips were white"; she was flushed and had vertigo. EPIPEN, BENADRYL IV, ZOFRAN 4 mg, DILAUDID 1 or 2 mg and ATIVAN 1 mg were administered. She had received other medications also, but does not have her medical records now. While in hospital she had two seizures. Her "DILANTIN level" was tested. It was 0, not just close to zero such as zero point something, it was actually 0. She was administered a bag of CEREBYX IV. Blood work and EEG were performed but the results were not reported. She also had an MRI previously on an unspecified date. The only abnormality on the MRI was a small cyst in the "back of her head" which the doctor stated was not likely causing her seizures. The patient was not hospitalized for the events. The symptoms she developed after flu shot were resolved. She was discharged at about 10 pm on 20 Feb 2013. Causality of the events was not reported.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Convulsion, Dyspnoea, Electroencephalogram, Eye pruritus, Flushing
Clinical narrative: Case number PHEH2013US005840, is an initial spontaneous report received from a consumer via Taro pharmaceuticals Inc. on 12 Mar 2013. This report refers to an adult female patient. Her medical history included hysterectomy in the past. Concomitant medications included estradiol 2 mg, Taro phenytoin sodium extended capsules USP 300 mg qd in Nov 2012 for seizures and started KEPPRA in Dec 2012 by her neurologist, but this did not affect the frequency of her seizures. KEPPRA dose was increased to 1000 mg twice daily but this did not affect the frequency of her seizures. She was vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown) on 20 Feb 2013 at around 11:00 am. At around 1 pm, she developed itchy, red eyes and an elevated heart rate. She started vomiting at about 2 or 3 pm. She went to the emergency room at about 4 pm. She had a heart rate of 150, was shaking, vomiting, had trouble breathing and had chest pain due to the difficulty breathing. Her blood pressure was 162/100, her "lips were white"; she was flushed and had vertigo. EPIPEN, BENADRYL IV, ZOFRAN 4 mg, DILAUDID 1 or 2 mg and ATIVAN 1 mg were administered. She had received other medications also, but does not have her medical records now. While in hospital she had two seizures. Her "DILANTIN level" was tested. It was 0, not just close to zero such as zero point something, it was actually 0. She was administered a bag of CEREBYX IV. Blood work and EEG were performed but the results were not reported. She also had an MRI previously on an unspecified date. The only abnormality on the MRI was a small cyst in the "back of her head" which the doctor stated was not likely causing her seizures. The patient was not hospitalized for the events. The symptoms she developed after flu shot were resolved. She was discharged at about 10 pm on 20 Feb 2013. Causality of the events was not reported.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Nuclear magnetic resonance imaging brain abnormal, Ocular hyperaemia, Pallor, Tremor
Clinical narrative: Case number PHEH2013US005840, is an initial spontaneous report received from a consumer via Taro pharmaceuticals Inc. on 12 Mar 2013. This report refers to an adult female patient. Her medical history included hysterectomy in the past. Concomitant medications included estradiol 2 mg, Taro phenytoin sodium extended capsules USP 300 mg qd in Nov 2012 for seizures and started KEPPRA in Dec 2012 by her neurologist, but this did not affect the frequency of her seizures. KEPPRA dose was increased to 1000 mg twice daily but this did not affect the frequency of her seizures. She was vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown) on 20 Feb 2013 at around 11:00 am. At around 1 pm, she developed itchy, red eyes and an elevated heart rate. She started vomiting at about 2 or 3 pm. She went to the emergency room at about 4 pm. She had a heart rate of 150, was shaking, vomiting, had trouble breathing and had chest pain due to the difficulty breathing. Her blood pressure was 162/100, her "lips were white"; she was flushed and had vertigo. EPIPEN, BENADRYL IV, ZOFRAN 4 mg, DILAUDID 1 or 2 mg and ATIVAN 1 mg were administered. She had received other medications also, but does not have her medical records now. While in hospital she had two seizures. Her "DILANTIN level" was tested. It was 0, not just close to zero such as zero point something, it was actually 0. She was administered a bag of CEREBYX IV. Blood work and EEG were performed but the results were not reported. She also had an MRI previously on an unspecified date. The only abnormality on the MRI was a small cyst in the "back of her head" which the doctor stated was not likely causing her seizures. The patient was not hospitalized for the events. The symptoms she developed after flu shot were resolved. She was discharged at about 10 pm on 20 Feb 2013. Causality of the events was not reported.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo, Vomiting
Clinical narrative: Case number PHEH2013US005840, is an initial spontaneous report received from a consumer via Taro pharmaceuticals Inc. on 12 Mar 2013. This report refers to an adult female patient. Her medical history included hysterectomy in the past. Concomitant medications included estradiol 2 mg, Taro phenytoin sodium extended capsules USP 300 mg qd in Nov 2012 for seizures and started KEPPRA in Dec 2012 by her neurologist, but this did not affect the frequency of her seizures. KEPPRA dose was increased to 1000 mg twice daily but this did not affect the frequency of her seizures. She was vaccinated with seasonal influenza vaccine (batch number and manufacturer: unknown) on 20 Feb 2013 at around 11:00 am. At around 1 pm, she developed itchy, red eyes and an elevated heart rate. She started vomiting at about 2 or 3 pm. She went to the emergency room at about 4 pm. She had a heart rate of 150, was shaking, vomiting, had trouble breathing and had chest pain due to the difficulty breathing. Her blood pressure was 162/100, her "lips were white"; she was flushed and had vertigo. EPIPEN, BENADRYL IV, ZOFRAN 4 mg, DILAUDID 1 or 2 mg and ATIVAN 1 mg were administered. She had received other medications also, but does not have her medical records now. While in hospital she had two seizures. Her "DILANTIN level" was tested. It was 0, not just close to zero such as zero point something, it was actually 0. She was administered a bag of CEREBYX IV. Blood work and EEG were performed but the results were not reported. She also had an MRI previously on an unspecified date. The only abnormality on the MRI was a small cyst in the "back of her head" which the doctor stated was not likely causing her seizures. The patient was not hospitalized for the events. The symptoms she developed after flu shot were resolved. She was discharged at about 10 pm on 20 Feb 2013. Causality of the events was not reported.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: MNQ
Symptoms: Asthenia, Chills, Dizziness, Headache, Pain
Clinical narrative: Initial report received from a healthcare professional on 01 February 2013. This is an invalid case as patient identifiers were missing. Cluster of 2 patients who had no illness at the time of vaccination and concomitant medication were not reported, had received a dose of MENACTRA (dose, number in series and site of administration were not reported) intramuscularly on an unspecified date. On an unspecified date (within 24 hrs. of vaccination) the patients developed fever, chills, headache, body aches, dizziness, and generalized weakness. It was reported as symptoms lasted 48-72 hrs. One patient had improved and the other patient still has a few lingering symptoms, but has improved. Corrective treatment details were not reported. No laboratory investigations were done. The patient's outcome was not recovered. List of Documents held by sender: None.
Sex: U
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 01 February 2013. This is an invalid case as patient identifiers were missing. Cluster of 2 patients who had no illness at the time of vaccination and concomitant medication were not reported, had received a dose of MENACTRA (dose, number in series and site of administration were not reported) intramuscularly on an unspecified date. On an unspecified date (within 24 hrs. of vaccination) the patients developed fever, chills, headache, body aches, dizziness, and generalized weakness. It was reported as symptoms lasted 48-72 hrs. One patient had improved and the other patient still has a few lingering symptoms, but has improved. Corrective treatment details were not reported. No laboratory investigations were done. The patient's outcome was not recovered. List of Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 28 February 2013. A 56-year-old female patient had received first dose of MENACTRA vaccine (lot number U4585AB) intramuscularly in right deltoid and first dose of ADACEL (batch number U4431AA) intramuscularly in left deltoid on 25 February 2013. The patient had no illness at the time of vaccination, no pre-existing physician diagnosed allergies, birth defects, medical conditions and no concomitant medications. On 26 February 2013 at 2:00 pm, the patient experienced chills, achy and tiredness. At 06:00 pm, the patient came home and had felt worse. At 08:00 pm, the patient had a temperature of 102. The patient started feeling like going to faint and had vomited once. The patient laid down for the rest of the evening. No laboratory investigations were performed and corrective treatment details were not reported. It was reported that following day (i.e. on 27 February 2013), the fever broke and there was no more vomiting and the patient ate breakfast. The patient's outcome was recovered on 27 February 2013. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: Initial report received from a healthcare professional on 28 February 2013. A 56-year-old female patient had received first dose of MENACTRA vaccine (lot number U4585AB) intramuscularly in right deltoid and first dose of ADACEL (batch number U4431AA) intramuscularly in left deltoid on 25 February 2013. The patient had no illness at the time of vaccination, no pre-existing physician diagnosed allergies, birth defects, medical conditions and no concomitant medications. On 26 February 2013 at 2:00 pm, the patient experienced chills, achy and tiredness. At 06:00 pm, the patient came home and had felt worse. At 08:00 pm, the patient had a temperature of 102. The patient started feeling like going to faint and had vomited once. The patient laid down for the rest of the evening. No laboratory investigations were performed and corrective treatment details were not reported. It was reported that following day (i.e. on 27 February 2013), the fever broke and there was no more vomiting and the patient ate breakfast. The patient's outcome was recovered on 27 February 2013. Documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysgeusia, Ear infection, Ear infection fungal, Ear pain
Clinical narrative: 11/9/12 Within 1 hour of vaccination I could taste a metallic taste. Reported to nurse on site & was advised may be from preservative in vaccine. Taste remained throughout the day. Arm very sore. 11/11/12 Developed a severe cold with persisting cough for the rest of month. 12/1/12 Developed (L) ear pain/ache. 12/10/12 Continuing ear pain with decreased hearing & moist feeling with continuing unproductive cough. 12/17/12 To clinic with dx of ear infection. (L) ear cleaned with prescription for ear drops and 10 day antibiotic. Continued with underlying cold symptoms with unproductive cough and (L) ear pain with decreased hearing. 2/18/13 Went to specialist and dx with fungal ear infection. Ear cleaned and fungal powder used. 2/28/13 Follow up with Dr. Improved with follow as needed. 3/6/13 Another cold like symptoms with ear ache in both ears. I have never had this many medical issues in the winter. I have not had an ear infection (prior to now) since I was a child. Have never been sick off and on like this.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoacusis, Nasopharyngitis, Pain in extremity
Clinical narrative: 11/9/12 Within 1 hour of vaccination I could taste a metallic taste. Reported to nurse on site & was advised may be from preservative in vaccine. Taste remained throughout the day. Arm very sore. 11/11/12 Developed a severe cold with persisting cough for the rest of month. 12/1/12 Developed (L) ear pain/ache. 12/10/12 Continuing ear pain with decreased hearing & moist feeling with continuing unproductive cough. 12/17/12 To clinic with dx of ear infection. (L) ear cleaned with prescription for ear drops and 10 day antibiotic. Continued with underlying cold symptoms with unproductive cough and (L) ear pain with decreased hearing. 2/18/13 Went to specialist and dx with fungal ear infection. Ear cleaned and fungal powder used. 2/28/13 Follow up with Dr. Improved with follow as needed. 3/6/13 Another cold like symptoms with ear ache in both ears. I have never had this many medical issues in the winter. I have not had an ear infection (prior to now) since I was a child. Have never been sick off and on like this.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a nurse refers to two patients of unknown age. The patients were not pregnant. On an unknown date the two patients were vaccinated with PNEUMOVAX23 (lot# H014196; expiration unspecified) (dose, route and injection site were not reported). On an unknown date the two patients developed a red area around the injection site. The outcome of was unknown at the time of report. Action taken and causality were not provided. The patient had sought unspecified medical attention. This is one of several reports received 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 was received from a licensed practical nurse concerning a patient of unknown age and gender. On an unknown date in November 2011, the patient was vaccinated with the first dose of GARDASIL (lot number, expiry date, dose and route unspecified) and on 12-MAR-2013, the patient was in the office for the second dose of GARDASIL (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. The patient was not experiencing any known symptoms at the time of reporting. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 70 year old male patient. On 06-MAR-2013 the patient was vaccinated with ZOSTAVAX dose 1 (therapy route not reported). The patient explained that he developed pain around his injection site. The pain went unnoticed until he happened to be receiving an electric massage from his wife, and when the massaging apparatus went over the injection site the pain occurred. The patient explained that at this point the pain is gone. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: This spontaneous report as received from an unspecified nurse in a doctor's practice via company representative refers to a female patient of an unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# not reported). On an unknown date, within 24 hours following administration of the first dose in the GARDASIL vaccination series the patient experienced nausea and extreme dizziness. The outcome of the events was reported as recovered on an unspecified date. The relatedness for the events with the therapy was not provided. The patient sought medical attention, unspecified how. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age and gender. Unknown number of patients might have been administered M-M-R II (lot number, expiry date, route and dose were not reported) since 08-FEB-2013, that had been improperly stored. No adverse effects reported. The reporter was unable to confirm the exact number or the identities of the patients involved at the time of this report. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from a 65 year old female patient regarding herself. On 10-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). Approximately on an unknown date in March 2013, the patient experienced itching. The patient sought no medical attention and no treatment was given for the event. The outcome of itching was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. In October 2012 the patient was vaccinated with ZOSTAVAX dose 1. Lot number, expiration date, route and anatomical location were not reported. In March 2013 the patient was vaccinated with ZOSTAVAX dose 2, 0.65 ml, subcutaneous. Lot number and expiration date were not reported. The second dosage was reported as an accidental administration. On MAR-2013. Treatment information was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On 04-MAR-2013 the patient was vaccinated with ZOSTAVAX (lot # reported as J000433, Exp. Date: 10-APR-2014) exposed to 68 F for 66 hours. The pharmacist also reported that patient obtained this ZOSTAVAX in question and transported it to the physician's office for administration, no further temperature details are available during this transport time. No adverse symptoms reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PNC
Symptoms: Asthenia, Injection site erythema, Injection site oedema
Clinical narrative: Injection site edema/redness. Pt went to ER was given Abx but got worsening redness & weakness and went to ER a second time. Antibiotics switched.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal pain, Antibody test negative, Antigliadin antibody positive, Blood immunoglobulin E increased, Blood immunoglobulin G increased
Clinical narrative: This literature marketed report as received from a healthcare professional, refers to a 17 year old male patient with recurrent intermittent abdominal pain and diarrhea 4 years ago, since 2008, and eczematous skin rash. The patient's pertinent medical history included perennial allergy, seasonal allergic rhinitis, eczema, vernal conjunctivitis, recurrent herpetic infection and drug allergy. It was reported that patient's symptoms worsened with milk. Gluten and milk avoidance improved symptoms but reintroduction caused exacerbation. Physician reported that a stool culture in the past (date not specified) grew Blastocystis hominis. On an unknown date, previous PNEUMOVAX 23 vaccination, the patient underwent a serotype test which revealed only 1 positive serotype. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (lot # and expiration date were not reported). Concomitant therapies included montelukast sodium (manufacturer unknown). On an unknown date, a post vaccination test was performed which revealed only 9 out of 23 positive serotypes. On unspecified dates the following lab tests were also performed: Physical examination (date not reported): normal, except for boggy nasal turbinates and patches of eczema. Allergy skin test (date not reported): positive to various molds and slgE=class I positive to corn, soybean, wheat and peanut. Class II to potato, but negative to egg white and milk. Elevated lgG: gliadin antibody>100 units/ml tTGIA.lgG: negative, decreased lgG: 456 mg/dL, IgA: 50 mg/dL. Healthcare professional reported that childhood hypogammaglobulinemia may be secondary to cow milk allergy since immunoglobulin and cells leak through the inflamed mucosa. Progression from lgAD to common variable immunodeficiency (CVID) with impaired antibody response could occur with immune mediated gastrointestinal disease such as nodular lymphoid hyperplasia or atrophic gastritis. Common variable immunodeficiency (CVID) was associated with poor response to PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. The patient's antibody test negative was reported to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Blood immunoglobulin G normal, Colonoscopy normal, Diarrhoea, Eczema, Gastritis atrophic
Clinical narrative: This literature marketed report as received from a healthcare professional, refers to a 17 year old male patient with recurrent intermittent abdominal pain and diarrhea 4 years ago, since 2008, and eczematous skin rash. The patient's pertinent medical history included perennial allergy, seasonal allergic rhinitis, eczema, vernal conjunctivitis, recurrent herpetic infection and drug allergy. It was reported that patient's symptoms worsened with milk. Gluten and milk avoidance improved symptoms but reintroduction caused exacerbation. Physician reported that a stool culture in the past (date not specified) grew Blastocystis hominis. On an unknown date, previous PNEUMOVAX 23 vaccination, the patient underwent a serotype test which revealed only 1 positive serotype. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (lot # and expiration date were not reported). Concomitant therapies included montelukast sodium (manufacturer unknown). On an unknown date, a post vaccination test was performed which revealed only 9 out of 23 positive serotypes. On unspecified dates the following lab tests were also performed: Physical examination (date not reported): normal, except for boggy nasal turbinates and patches of eczema. Allergy skin test (date not reported): positive to various molds and slgE=class I positive to corn, soybean, wheat and peanut. Class II to potato, but negative to egg white and milk. Elevated lgG: gliadin antibody>100 units/ml tTGIA.lgG: negative, decreased lgG: 456 mg/dL, IgA: 50 mg/dL. Healthcare professional reported that childhood hypogammaglobulinemia may be secondary to cow milk allergy since immunoglobulin and cells leak through the inflamed mucosa. Progression from lgAD to common variable immunodeficiency (CVID) with impaired antibody response could occur with immune mediated gastrointestinal disease such as nodular lymphoid hyperplasia or atrophic gastritis. Common variable immunodeficiency (CVID) was associated with poor response to PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. The patient's antibody test negative was reported to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: PPV
Symptoms: Laboratory test normal, Oesophagogastroduodenoscopy abnormal, Skin test positive, Streptococcus test positive
Clinical narrative: This literature marketed report as received from a healthcare professional, refers to a 17 year old male patient with recurrent intermittent abdominal pain and diarrhea 4 years ago, since 2008, and eczematous skin rash. The patient's pertinent medical history included perennial allergy, seasonal allergic rhinitis, eczema, vernal conjunctivitis, recurrent herpetic infection and drug allergy. It was reported that patient's symptoms worsened with milk. Gluten and milk avoidance improved symptoms but reintroduction caused exacerbation. Physician reported that a stool culture in the past (date not specified) grew Blastocystis hominis. On an unknown date, previous PNEUMOVAX 23 vaccination, the patient underwent a serotype test which revealed only 1 positive serotype. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported) (lot # and expiration date were not reported). Concomitant therapies included montelukast sodium (manufacturer unknown). On an unknown date, a post vaccination test was performed which revealed only 9 out of 23 positive serotypes. On unspecified dates the following lab tests were also performed: Physical examination (date not reported): normal, except for boggy nasal turbinates and patches of eczema. Allergy skin test (date not reported): positive to various molds and slgE=class I positive to corn, soybean, wheat and peanut. Class II to potato, but negative to egg white and milk. Elevated lgG: gliadin antibody>100 units/ml tTGIA.lgG: negative, decreased lgG: 456 mg/dL, IgA: 50 mg/dL. Healthcare professional reported that childhood hypogammaglobulinemia may be secondary to cow milk allergy since immunoglobulin and cells leak through the inflamed mucosa. Progression from lgAD to common variable immunodeficiency (CVID) with impaired antibody response could occur with immune mediated gastrointestinal disease such as nodular lymphoid hyperplasia or atrophic gastritis. Common variable immunodeficiency (CVID) was associated with poor response to PNEUMOVAX 23. At the time of the report, the patient's outcome was unknown. The patient's antibody test negative was reported to be related to PNEUMOVAX 23. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 3 inch x 3 inch red, firm, hot swollen area on deltoid surrounded by 1 inch pink area (total area 4 inch x 4 inch). Tx cold compress, BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Mother reported child c/o pain in right upper arm, noticed swelling, reddness.  Gave Tylenol and this AM noticed it was worse, and swelling around to side of arm.  Tylenol did not help pain and swelling is getting worse.  Instructed to put ice on it and mother stated she had been.  Instructed to call physician.  Mother stated she would.  Called back and mother reported she was taking child into clinic.  Reported to mother that child had received Dtap/IPV and MMRV both in the right arm.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Hard knot on injection side, spreading over next days to 13cm diameter circle, all red and hard; tender, no meds given.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Woke up with arm extremely swollen, red, painful, fingers and hands tingling and numbness. Notified plant hosp. Asked to come in, told normal side effects, use ice pack, arm still sore, numbness in hand and fingers continue.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mild redness, mild swelling and mild pain at the injection site. Redness is 1.5 inches in diameter.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Chills, Headache, Vomiting
Clinical narrative: CHIEF COMPLAINT: Chest pain, headache, vomiting. OTHER SYMPTOMS: HA, chills. Patient is currently admitted to hospital.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Myopericarditis, Vaccination complication
Clinical narrative: CHIEF COMPLAINT: Chest pain, headache, vomiting. OTHER SYMPTOMS: HA, chills. Patient is currently admitted to hospital.
Age: 21.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Patient complained of right arm swelling, itching and redness one day after vaccine administration.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Asthenia, Diarrhoea, Pain, Pyrexia
Clinical narrative: Just wanted to drop you a line to advise that I believe I had a reaction to the Hep- A shot administered on Thursday, March 7th. Reaction started Friday evening late around 11pm, and peaked on Saturday around 4pm, with vomiting, joint pain, and a low grade fever 99.8. By late Saturday night I was feeling better, but still had the joint pain and mild diarrhea. Sunday morning, felt good enough to eat a bland breakfast, oatmeal and dry toast. Monday still slightly sore from vomiting episode, and a little weak. Everything else is all good.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Just wanted to drop you a line to advise that I believe I had a reaction to the Hep- A shot administered on Thursday, March 7th. Reaction started Friday evening late around 11pm, and peaked on Saturday around 4pm, with vomiting, joint pain, and a low grade fever 99.8. By late Saturday night I was feeling better, but still had the joint pain and mild diarrhea. Sunday morning, felt good enough to eat a bland breakfast, oatmeal and dry toast. Monday still slightly sore from vomiting episode, and a little weak. Everything else is all good.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to the injection site. Instructed parent to apply a cold pack to area for 20 minutes at a time and if it doesnt go away becomes worse or is painful to call her medical home.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Fairly severe chills and muscle ache in lower back. Body temperature was normal and no local irritation at injection site or any other symptoms. Treatment was (1) covered myself with an electric blanket on high and (2) 600 mg of ibuprofen which resolved both problems within 1 hour. To date, no return of these symptoms or any other problem.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Dysstasia, Fall, Gait disturbance, Syncope
Clinical narrative: Morning after receiving MMR shot, my son is having trouble walking. He can not stand still for long.  He trips and falls and collapses on the floor.  He will just sit all day and now will not even attempt to walk.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Hot flush, Injection site erythema, Injection site pain
Clinical narrative: Tired not feeling well, cold, hot flashes since 3/12/2013 10:00pm; swelling, soreness and redness at injection site 03/12/2013 10:00pm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Malaise
Clinical narrative: Tired not feeling well, cold, hot flashes since 3/12/2013 10:00pm; swelling, soreness and redness at injection site 03/12/2013 10:00pm.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Depression, Dizziness, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection site, feeling faint, nauseated, injury to right shoulder, X-rays, MRI, decreased range of motion, inability to use arm to push, pull or lift; trouble sleeping, depression, bursitis, tendonitis, rotator cuff tear; physical therapy, cortisone shot, likely surgery will be needed.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Joint injury, Joint range of motion decreased, Nausea, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Pain at injection site, feeling faint, nauseated, injury to right shoulder, X-rays, MRI, decreased range of motion, inability to use arm to push, pull or lift; trouble sleeping, depression, bursitis, tendonitis, rotator cuff tear; physical therapy, cortisone shot, likely surgery will be needed.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome, Tendonitis, X-ray
Clinical narrative: Pain at injection site, feeling faint, nauseated, injury to right shoulder, X-rays, MRI, decreased range of motion, inability to use arm to push, pull or lift; trouble sleeping, depression, bursitis, tendonitis, rotator cuff tear; physical therapy, cortisone shot, likely surgery will be needed.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, C-reactive protein, Diplegia, Dyspnoea, Facial pain
Clinical narrative: 2 weeks after flu shot client states she began with pain & tingling at her knees, progressed to arms & face. Oct 22nd hospitalized for 3 days discharged hospitalized again on Dec 3rd for 3 days - difficulty breathing not ever intubated - paralyzed arms.
Age: 48.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate
Clinical narrative: 2 weeks after flu shot client states she began with pain & tingling at her knees, progressed to arms & face. Oct 22nd hospitalized for 3 days discharged hospitalized again on Dec 3rd for 3 days - difficulty breathing not ever intubated - paralyzed arms.
Age: 1.6
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Asthenia, Dyspnoea, Grunting, Heart rate increased, Pallor
Clinical narrative: 3-6-13 started with wheezing. 3-7-13 got worse as day went on wheezing, weakness, paleness, fast heartbeat, difficulty breathing. Hospital stay started 3-7-13 with oxygen/warm vapor mist, ended 3-11-13. As of 3-14-13 still wheezing, periods of "grunt" breathing.
Age: 1.6
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Wheezing
Clinical narrative: 3-6-13 started with wheezing. 3-7-13 got worse as day went on wheezing, weakness, paleness, fast heartbeat, difficulty breathing. Hospital stay started 3-7-13 with oxygen/warm vapor mist, ended 3-11-13. As of 3-14-13 still wheezing, periods of "grunt" breathing.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV2, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pink firm induration measuring 1.5 inches long by 2 inches wide on Left upper outer aspect of arm (SC area).
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Back pain, Immediate post-injection reaction, Injection site pain, Lethargy, Myalgia
Clinical narrative: Pt experienced lethargy immediately following the vaccinations on 11/20/12.  The patient reported mild soreness in the upper arms at the end of November 2012 through the beginning of January 2013.  She stated that the soreness increased and progressed to the legs and back.  She reported that the pain became so unbearable that she went to the ER on 2/1/13.  The patient was put on a 10 day course of prednisone by the ER doctor and instructed to follow up with her PCP.  Patients PCP put her on a 30 day course of prednisone 10 mg daily and referred her to a rheumatologist.  Patient was diagnosed with polymyalgia by rheumatologist on 3/12/13 and started on 12.5 mg of prednisone daily.
Age: 71.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pt experienced lethargy immediately following the vaccinations on 11/20/12.  The patient reported mild soreness in the upper arms at the end of November 2012 through the beginning of January 2013.  She stated that the soreness increased and progressed to the legs and back.  She reported that the pain became so unbearable that she went to the ER on 2/1/13.  The patient was put on a 10 day course of prednisone by the ER doctor and instructed to follow up with her PCP.  Patients PCP put her on a 30 day course of prednisone 10 mg daily and referred her to a rheumatologist.  Patient was diagnosed with polymyalgia by rheumatologist on 3/12/13 and started on 12.5 mg of prednisone daily.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Lethargy
Clinical narrative: Infant lethargic.
Age: 0.13
Sex: M
Vaccine: HEP, OPV
Symptoms: Lethargy, Respiratory disorder
Clinical narrative: Upper respiratory, lethargy.
Age: 0.3
Sex: F
Vaccine: OPV
Symptoms: Eye discharge, Vaginal discharge, Vulvovaginal erythema
Clinical narrative: Eye discharge, green vaginal DC, mild labial erythema.
Age: 0.65
Sex: F
Vaccine: HEP
Symptoms: Cough, Poor quality sleep, Respiratory tract congestion
Clinical narrative: Congested with cough, sleepig poorly.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Diplegia, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient admitted in mid October 2012 for GBS, paralysis involved LEs and distal UEs. Treated with 5 days of IVIG.
Age: 18.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: DONOR STATES HE DID NOT EAT ALL DAY, HE THEN DONATED PLASMA AFTER DONATING; HE RECEIVED A TETANUS VACCINATION. WE FINISHED THE CENTERS PAPER WORK FOR THE VACCINATION AND AS HE WAS LEAVING THE EXAM ROOM HE BECAME LIGHT HEADED AND PASSED OUT FOR 2-3 SEC (HE NEVER FELL TO THE FLOOR HE WAS CAUGHT AND ASSISTED TO EXAM TABLE). HE WAS GIVEN 500ML NORMAL SALINE BY IV AND RECOVERED.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Similar reaction on previous exposure to drug
Clinical narrative: Redness approx. 3 inch across injection site area, pt. says feels warm to the touch. Now she admits that she gets same reaction with DPT inj.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 3/7 shot given (L) arm SQ. 3/8 presents with red swollen area, mild pain, warm at injection site size of orange, with a knot - pt advised to see PCP. 3/11 called pt. PCP gave pt ABX, BENADRYL, area had expanded to entire back of arm-now subsiding.
Age: 36.0
Sex: U
Vaccine: MMR, TD
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: TD vaccine was administered on the 11th of March 2013. She started having redness and swelling of the (Rt) arm by Tuesday the 12th of March 2013. Ran a low grade fever x1 day up to 100.8 (F).
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Balance disorder, Breath holding, Dyskinesia, Fall, Nausea
Clinical narrative: Roughly 4 minutes after receiving 2nd Hep. B immunization, patient dropped to the floor from a standing position. Patient eyes open, unresponsive, and upper body started to have a rhythmic jerking movement. Patient appeared to hold breath for 5 seconds while jerking occurred. Seizure like activity lasted about 7 seconds and then stopped. Patient then resumed consciousness, sat up and became oriented. Pediatrician called. Paramedics called. Orthostatic were performed. Unsteady on feet it appeared when walked to exam room. In exam room nauseated & small emesis. Patient taken to ER via ambulance.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Seizure like phenomena, Unresponsive to stimuli, Vomiting
Clinical narrative: Roughly 4 minutes after receiving 2nd Hep. B immunization, patient dropped to the floor from a standing position. Patient eyes open, unresponsive, and upper body started to have a rhythmic jerking movement. Patient appeared to hold breath for 5 seconds while jerking occurred. Seizure like activity lasted about 7 seconds and then stopped. Patient then resumed consciousness, sat up and became oriented. Pediatrician called. Paramedics called. Orthostatic were performed. Unsteady on feet it appeared when walked to exam room. In exam room nauseated & small emesis. Patient taken to ER via ambulance.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a 69 year old female consumer with no pertinent medical history or drug reactions/allergies refers to herself. On 26-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot number unspecified). Concomitant therapies included ADALAT. The consumer reported an AE after getting ZOSTAVAX. One day after getting the shot, on 27-DEC-2012, the injection site was swollen and itchy. That reaction recovered two days after shots, on 28-DEC-2012. No treatment was given for the events. No lab diagnostics studies performed. The patient did not seek any medical attention. The relatedness for the events to ZOSTAVAX was unknown. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: Pt received MENVEO about 3;10 pm and pt left the waiting room. Soon thereafter, the pt's mother was knocking on the door and said her son blacked out for a second. He felt like he was going to black out and she guided him to a chair in waiting area. He felt hot and dizzy for about 10 minutes but felt better after sitting. Did not fall to ground/no injuries.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Sleep disorder
Clinical narrative: Hotness, hardness, soreness at injection site. Onset 3/9/13. Still present 3/14/13. Improving slightly. Unable to sleep on left side.
Sex: M
Vaccine: HPV4
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a male patient of unknown age. On 15-FEB-2013 the patient was vaccinated with a dose of CERVARIX instead of a dose of GARDASIL (dose, route, lot number not provided). No product confusion discovered, just medication error. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Patient received BOOSTRIX vaccine 2/26/13 around 3 pm. Patient had miscarriage on 03/06/13.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Started with redness & swelling to (L) upper arm from top of arm to elbow & under arm to medical surface on 3-13-14. Still red & swollen to elbow on 3-14-14. Hot to touch - no pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Local induration on left thigh redness; heat 7.5 cm in diameter.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local swelling, Skin warm
Clinical narrative: Patient receive 5 vaccines on 3/12/13. 3 in right arm and 2 in left arm. On 3/14/13 patient present with 2 inch x 3.5 inch red, warm and swollen area on right arm. Patient treated with SINGULAIR 5mg x 21 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Cough, Herpes zoster, Injection site swelling
Clinical narrative: Pt observed swelling of (R) upper arm - elbow to shoulder day following vaccination, remained swollen x 2 wks mid Feb developed severe URI symptom: fever, cough, nasal cong. Treated 2/24/13 with AUGMENTIN. 3/1 significant (L) sided mid back pain wrapping to (L) chest seen 3/4 urgent care & treated for shingles. Visible light rash, no vesicles (L) lower thoracic.