chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Case number PHHY2013US000694, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471560) website (QA report no: 202323) on 02 Jan 2013. This report refers to a 47-year-old female patient. Her medical history included high blood pressure (BP), hyperthyroidism and allergy to sulfa antibiotics. Her concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 122102) and PNEUMOVAX (other manufacturer, batch number: 0813AA) on 19 Sep 2012. Both the vaccines were given intramuscularly. On 20 Sep 2012 (at 7 PM), she started developing chills and fever. On the same day (at 9.20 PM), the area (undetermined) was swollen, red and felt hot/warm to touch. On 21 Sep 2012, she had consulted the physician (emergency visit) and blood test was done for infection. The blood test result was abnormal and she was diagnosed with cellulitis. The outcome of the events was reported as recovered. The causality and seriousness of the events were not reported. Batch review report (reference number 202323) received from quality assurance department on 30 Jan 2013: Based on the document review, it was stated that the concerned FLUVIRIN, batch number 122102 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from QA department received on 30 Jan 2013: Updated the batch review report.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Fatigue, Lymphangitis, Nausea
Clinical narrative: Case number PHHY2013US000786, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471629) web site on 02 Jan 2013 with a follow up received from QA department on 04 Feb 2013: This report refers to a 47-year-old polymedicated male patient. Current condition of this patient include depression, insomnia, "HTN" and "CAD". He was vaccinated with FLUVIRIN (batch number: 1206901) and PNEUMOVAX (batch number; H013581) intramuscularly to left arm on 18 Oct 2012. On 19 Oct 2012 patient experienced nausea, vomiting, fever, fatigue, chills, cellulitis, lymphangitis. Patient was treated with KEFLEX and BACTRIM. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. The quality assurance department stated that based on the batch review report it was concluded that the concerned FLUVIRIN batch 1206901 was manufactured in accordance with approved internal procedures and it is in compliance with cGMP requirements. Follow up received from QA department on 04 Feb 2013. Batch review report updated.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Case number PHHY2013US000786, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 471629) web site on 02 Jan 2013 with a follow up received from QA department on 04 Feb 2013: This report refers to a 47-year-old polymedicated male patient. Current condition of this patient include depression, insomnia, "HTN" and "CAD". He was vaccinated with FLUVIRIN (batch number: 1206901) and PNEUMOVAX (batch number; H013581) intramuscularly to left arm on 18 Oct 2012. On 19 Oct 2012 patient experienced nausea, vomiting, fever, fatigue, chills, cellulitis, lymphangitis. Patient was treated with KEFLEX and BACTRIM. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. The quality assurance department stated that based on the batch review report it was concluded that the concerned FLUVIRIN batch 1206901 was manufactured in accordance with approved internal procedures and it is in compliance with cGMP requirements. Follow up received from QA department on 04 Feb 2013. Batch review report updated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Pain in extremity
Clinical narrative: Case number PHHY2013US000914 is an initial spontaneous report from Vaccine Adverse Event Reporting System (VAERS reference number 472747) received on 02 Jan 2013, with a follow-up received from a Quality Assurance department (202608) on 01 Feb 2013. This report refers to a 70-year-old female patient. She was vaccinated with FLUVIRIN (batch number 1205301) intramuscularly on 16 Oct 2012. On 16 Oct 2012 her arm was painful the night after immunization. She visited her doctor next day (ER visit) who diagnosed with cellulitis around administration site and prescribed antibiotic (unspecified). The outcome of the events was reported as condition unchanged as of 20 Oct 2012. The seriousness and causality assessment of the events was not reported. Based on the document review, it was stated that the concerned FLUVIRIN (batch number: 1205301) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up was received from quality assurance department on 01 Feb 2013: Batch review report was updated.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Headache, Injection site swelling, Nausea, Pyrexia, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Oct-2012) concerns a 23-year-old female patient, who had a medical history of depression, anxiety disorder, asthma, attention deficit-hyperactivity disorder and allergy to cefixime. Concomitant medications included bupropion, topiramate, budesonide; formoterol fumarate combination and unspecified oral contraceptive. On 27-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) intradermally (unapproved route of administration, not explicitly reported) in the left arm. On the same day the patient also received PNEUMOVAX 23 (batch number: 1850AA) at dose of 0.5 mL intramuscularly in the right deltoid. On 27-Sep-2012 the patient developed a headache, fever, nausea and vomiting, and extreme swelling of her right arm at the PNEUMOVAX 23 injection site. The patient had swelling, redness at injection site, GI (gastrointestinal upset) and migraine. The patient went to the Emergency Room due to severity of the reaction where she was treated with an unspecified pain medication and was released after about 3 hours. Lab diagnostic study performed showed unspecified elevated white blood cell count. CBC (complete blood count) showed leukocytosis. The event outcome was recovered. Reporter's comments: The reporter considered events serious as it required intervention. Follow up (22-Jan-2013): upgraded to serious, additional AE terms, patient outcome, administration site, reporter's comments.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: White blood cell count increased
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Oct-2012) concerns a 23-year-old female patient, who had a medical history of depression, anxiety disorder, asthma, attention deficit-hyperactivity disorder and allergy to cefixime. Concomitant medications included bupropion, topiramate, budesonide; formoterol fumarate combination and unspecified oral contraceptive. On 27-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) intradermally (unapproved route of administration, not explicitly reported) in the left arm. On the same day the patient also received PNEUMOVAX 23 (batch number: 1850AA) at dose of 0.5 mL intramuscularly in the right deltoid. On 27-Sep-2012 the patient developed a headache, fever, nausea and vomiting, and extreme swelling of her right arm at the PNEUMOVAX 23 injection site. The patient had swelling, redness at injection site, GI (gastrointestinal upset) and migraine. The patient went to the Emergency Room due to severity of the reaction where she was treated with an unspecified pain medication and was released after about 3 hours. Lab diagnostic study performed showed unspecified elevated white blood cell count. CBC (complete blood count) showed leukocytosis. The event outcome was recovered. Reporter's comments: The reporter considered events serious as it required intervention. Follow up (22-Jan-2013): upgraded to serious, additional AE terms, patient outcome, administration site, reporter's comments.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Abdominal discomfort, Full blood count abnormal, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Oct-2012) concerns a 23-year-old female patient, who had a medical history of depression, anxiety disorder, asthma, attention deficit-hyperactivity disorder and allergy to cefixime. Concomitant medications included bupropion, topiramate, budesonide; formoterol fumarate combination and unspecified oral contraceptive. On 27-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) intradermally (unapproved route of administration, not explicitly reported) in the left arm. On the same day the patient also received PNEUMOVAX 23 (batch number: 1850AA) at dose of 0.5 mL intramuscularly in the right deltoid. On 27-Sep-2012 the patient developed a headache, fever, nausea and vomiting, and extreme swelling of her right arm at the PNEUMOVAX 23 injection site. The patient had swelling, redness at injection site, GI (gastrointestinal upset) and migraine. The patient went to the Emergency Room due to severity of the reaction where she was treated with an unspecified pain medication and was released after about 3 hours. Lab diagnostic study performed showed unspecified elevated white blood cell count. CBC (complete blood count) showed leukocytosis. The event outcome was recovered. Reporter's comments: The reporter considered events serious as it required intervention. Follow up (22-Jan-2013): upgraded to serious, additional AE terms, patient outcome, administration site, reporter's comments.
Age: 23.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Leukocytosis, Migraine, Nausea, Pyrexia, Vomiting
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 02-Oct-2012) concerns a 23-year-old female patient, who had a medical history of depression, anxiety disorder, asthma, attention deficit-hyperactivity disorder and allergy to cefixime. Concomitant medications included bupropion, topiramate, budesonide; formoterol fumarate combination and unspecified oral contraceptive. On 27-Sep-2012 the patient received a flu vaccine (manufacturer, brand name and batch number were not provided) intradermally (unapproved route of administration, not explicitly reported) in the left arm. On the same day the patient also received PNEUMOVAX 23 (batch number: 1850AA) at dose of 0.5 mL intramuscularly in the right deltoid. On 27-Sep-2012 the patient developed a headache, fever, nausea and vomiting, and extreme swelling of her right arm at the PNEUMOVAX 23 injection site. The patient had swelling, redness at injection site, GI (gastrointestinal upset) and migraine. The patient went to the Emergency Room due to severity of the reaction where she was treated with an unspecified pain medication and was released after about 3 hours. Lab diagnostic study performed showed unspecified elevated white blood cell count. CBC (complete blood count) showed leukocytosis. The event outcome was recovered. Reporter's comments: The reporter considered events serious as it required intervention. Follow up (22-Jan-2013): upgraded to serious, additional AE terms, patient outcome, administration site, reporter's comments.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Skin reaction
Clinical narrative: Case number PHHY2013US000942, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 472856) website on 02 Jan 2013 and a follow up report from the quality assurance department received on 01 Feb 2013. This was also a quality complaint report (QA reference number: 202604). This report refers to a 48-year-old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 121523) and PNEUMOVAX (batch number: H014283) both IM into left arm on 11 Oct 2012. On an unspecified date, the patient developed localized redness and cellulitis on left upper arm. Patient was advised by the doctor to apply ice pack and prescribed pain reliever. Patient also received antibiotics (unspecified) for cellulitis. The final outcome of the events was recovered. The seriousness and causality assessment was not reported. Based on the document review, it was stated that the batch number (121523) was not a FLUVIRIN batch number, so batch review was performed as an unknown batch number. It was reported that without the batch number, a batch specific review could not be carried out. Therefore, this review was based on general review of the quality requirements for FLUVIRIN. The stability data for the multi-dose presentation indicated that the batch would have complied with the product specification at the time of vaccination. Follow up report from the quality assurance department received on 01 Feb 2013: The QA investigation number and summary were updated.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Rash, Rash erythematous, Skin warm
Clinical narrative: Case number PHHY2013US000626, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 473723) website on 02 Jan 2013 with non-significant follow up received from the Quality Assurance Department (reference number: 202366) on 04 Jan 2013: This report refers to a 66-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1205001) and PNEUMOVAX (batch number: H009826) both intramuscularly to left arm on 24 Oct 2012. On 25 OCT 2012 (approximately after 12 to 24 hours of vaccination) patient experienced red warm rash encircle her arm. Patient reported rash on 26 Oct 2012 and was instructed to take BENADRYL and to go to emergency room in case the rash got larger or didn't regress. The patient later went to ER and was diagnosed with cellulitis and was started on antibiotics. The outcome of the events was reported as complete recovery. Seriousness and causality were not reported. Batch review report (reference number 202366) received from quality assurance department on 30 Jan 2013: Based on the document review, it was stated that the concerned FLUVIRIN batch number 1205001 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices requirements. Non-significant follow up received from Quality Assurance Department on 04 Jan 2013: Updated QA reference number only. Follow up report from QA department received on 30 Jan 2013: Updated the batch review report.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Dizziness, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter a 12 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with first dose of GARDASIL (lot number unspecified) on 29-JAN-2013. No other co-suspects were reported. Concomitant medications included an unspecified generic product which started a couple of weeks ago. The reporter stated that the patient received GARDASIL and immediately began having dizziness, nausea, fatigue, headache, and issues with her muscles to the point that she was unable to walk and had to be wheeled out of the physician's office in a wheel chair. No treatment was given for the adverse event. No lab diagnostics studies performed. The patient had sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. The relatedness for the events was unknown for GARDASIL. Unable to walk was considered to be disability. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Muscle disorder, Nausea, Wheelchair user
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter a 12 years old female patient with no pertinent medical history or drug reactions/allergies. The patient was vaccinated with first dose of GARDASIL (lot number unspecified) on 29-JAN-2013. No other co-suspects were reported. Concomitant medications included an unspecified generic product which started a couple of weeks ago. The reporter stated that the patient received GARDASIL and immediately began having dizziness, nausea, fatigue, headache, and issues with her muscles to the point that she was unable to walk and had to be wheeled out of the physician's office in a wheel chair. No treatment was given for the adverse event. No lab diagnostics studies performed. The patient had sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. The relatedness for the events was unknown for GARDASIL. Unable to walk was considered to be disability. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Urticaria
Clinical narrative: Pt. received FLUZONE ID on 1-6-13. Upon activating the safety device, a lot of liquid squirted out we contacted the manufacturer the next day 1-7-13 at 9:40 AM & they said to re-vaccinate. Second dose administered - PM. Pt. then called a couple of hours later stated hives around the mouth & swollen lips. She took BENADRYL and saw her doctor who gave her a steroid shot & 5 day supply of steroid.
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age(gender unspecified). On 11-MAY-2011, the patient was vaccinated with first dose of GARDASIL, (lot number, expiration date and route was intramuscularly) and would be administered the second dose of GARDASIL, (lot number, expiration date and route was not reported) on 31-JAN-2013. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a registered nurse via company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (lot#, expiration date and route not reported). No concomitant medications were reported. On an unknown date the patient experienced vomiting and nausea post vaccination of GARDASIL. No lab diagnostic studies were performed. No treatment was given for the events. Medical attention was not sought for the events. Outcome of the reported events were unknown. Additional information is not expected.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 80 year (reported as patient in his 80s) old male patient. The patient was vaccinated with ZOSTAVAX, (lot number, expiration date and route was not reported) on 23-JAN-2013. No concomitant medications were reported. On 23-JAN-2013, the patient experienced intermittent loss of vision after receiving ZOSTAVAX, within the same day of administration. The outcome of the event was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 69 year old male patient. The patient has DARVON allergy, coronary artery disease, hypertension, depression, benign prostatic hyperplasia, osteoarthritis, lumbar stenosis and ZOCOR allergy. On 22-JAN-2013, the patient was vaccinated with a dose of live ZOSTAVAX, (lot number, expiration date and route was not reported). Concomitant medications included LIPITOR, PROSCAR, COZAAR, acetaminophen, LORCET, atenolol, aspirin, temazepam, bupropion hydrochloride, RAPAFLO and VIAGRA. On 22-JAN-2013, the patient received live ZOSTAVAX, from a local pharmacy and developed shingles. On 24-JAN-2013, the patient experienced severe right hip pain. On 29-JAN-2013, the patient developed a rash that looked like clusters. It had a dermatomal pattern that was on his right inner leg. There was also a rash on his right buttock. Treatment rendered for the events were VALTREX and PERCOCET. There were no laboratory diagnostics performed. The outcome of the events were reported as not recovered. The patient sought medical attention (office visit). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to an elderly female patient of unknown age. On 31-JAN-2013 at 09:00 a.m. the patient was vaccinated with ZOSTAVAX (lot #, expiration date and route not reported). No concomitant medications were reported. Physician stated that he reconstituted ZOSTAVAX on 30-JAN-2013 at 8 PM, kept it on ice and administered the ZOSTAVAX to the patient on 31-JAN-2013 (reported as this morning at 9 AM. No adverse effects reported. Physician stated he had no other information for this patient. Additional information is not expected.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a 0.5 milliliter (ml) of an improperly stored VAQTA (lot number H010437 and expiry date 28-FEB-2015) on the left thigh intramuscularly. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date route and dose were not reported). No concomitant medications were reported. On an unknown date, the patient developed shingles 2 years after receiving a dose of ZOSTAVAX. The outcome of shingles was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 12 years old male patient with asthma. The patient was vaccinated with lot # (H019034) ZOSTAVAX on 21-JAN-2013 (lot number H019034 with exp date 17-JAN-2014). No other co-suspects were reported. No concomitant medications were reported. On 21-JAN-2013 the patient received ZOSTAVAX instead of VARIVAX. It was unknown if the patient experienced any symptoms. No treatment information was reported. The outcome of wrong drug administration was unknown. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Injection site abscess, Injection site cellulitis, Injection site pain, Injection site swelling
Clinical narrative: Fever, myalgias, arthralgias, nausea, vomiting. Pain & swelling at site (R) arm. Cellulitis & abscess at injection site (R) arm.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, myalgias, arthralgias, nausea, vomiting. Pain & swelling at site (R) arm. Cellulitis & abscess at injection site (R) arm.
Age: 12.0
Sex: M
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Acute disseminated encephalomyelitis, Blood culture negative, Borrelia test negative, CSF culture negative, CSF glucose normal
Clinical narrative: Patient developed headache and neck pain for 4-5 days. Went to the ER, initially diagnosed with viral meningitis. Symptoms continued with also some confusion and lethargy.  Respiratory panel revealed patient Mycoplasma pneumoniae positive and MRI revealed picture consistent with (ADEM) Acute Disseminated Encephalo Myelitis.
Age: 12.0
Sex: M
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: CSF protein increased, CSF test, CSF white blood cell count increased, Confusional state, Culture urine negative
Clinical narrative: Patient developed headache and neck pain for 4-5 days. Went to the ER, initially diagnosed with viral meningitis. Symptoms continued with also some confusion and lethargy.  Respiratory panel revealed patient Mycoplasma pneumoniae positive and MRI revealed picture consistent with (ADEM) Acute Disseminated Encephalo Myelitis.
Age: 12.0
Sex: M
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Enterovirus test negative, Epstein-Barr virus test, HIV test negative, Headache, Lethargy
Clinical narrative: Patient developed headache and neck pain for 4-5 days. Went to the ER, initially diagnosed with viral meningitis. Symptoms continued with also some confusion and lethargy.  Respiratory panel revealed patient Mycoplasma pneumoniae positive and MRI revealed picture consistent with (ADEM) Acute Disseminated Encephalo Myelitis.
Age: 12.0
Sex: M
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Meningitis viral, Mycoplasma test, Mycoplasma test positive, Neck pain, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Patient developed headache and neck pain for 4-5 days. Went to the ER, initially diagnosed with viral meningitis. Symptoms continued with also some confusion and lethargy.  Respiratory panel revealed patient Mycoplasma pneumoniae positive and MRI revealed picture consistent with (ADEM) Acute Disseminated Encephalo Myelitis.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Deafness bilateral, Ear, nose and throat examination normal, Fatigue, Rhinorrhoea
Clinical narrative: Extreme fatigue, rhinorrhea, bi-lateral hearing loss that is ongoing at this time.  Visited ENT, checked for wax/fluid build up, no significant findings.  Course of Prednisone given with no improvement.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Eustachian tube dysfunction, Fatigue, Hypersensitivity, Hypoacusis, Influenza
Clinical narrative: Extreme fatigue, rhinorrhea, bi-lateral hearing loss that is ongoing at this time.  Visited ENT, checked for wax/fluid build up, no significant findings.  Course of Prednisone given with no improvement.
Age: 73.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lacrimation increased, Rhinorrhoea
Clinical narrative: Extreme fatigue, rhinorrhea, bi-lateral hearing loss that is ongoing at this time.  Visited ENT, checked for wax/fluid build up, no significant findings.  Course of Prednisone given with no improvement.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Rash on both sides of body; itchy, pink, raised with no vesicles.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Erythema, Injection site pruritus, Swelling
Clinical narrative: Patient c/o R arm itiching at the site of injection.  Some redness noted about palm size with swelling.  Checked 1/31/13 2:30 p.m states swelling decreasing. Patient did not go to Primary MD or ER.
Age: 51.0
Sex: F
Vaccine: DTAP
Symptoms: Axillary pain, Joint range of motion decreased, Muscular weakness
Clinical narrative: Axillary pain just after injection.  The next day noted decrease left shoulder range of motion.
Age: 1.54
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 103, development of rash on head and torso 2 days after fever.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site warmth
Clinical narrative: This spontaneous report as received from a 65 years old male consumer with high cholesterol and no drug reactions or allergies reporting on himself. The consumer was vaccinated with a dose of live ZOSTAVAX (Lot # not reported) SQ on 29-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 31-JAN-2013, the patient experienced a knot about half dollar sized around the injection site. He also stated it had fever around the site. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. The consumer stated it had not gone away, but had subsided. The relatedness for know about half dollar sized around the injection site and fever around the site was unknown for live ZOSTAVAX. Additional information is not expected.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Decreased appetite, Hypersomnia, Pyrexia
Clinical narrative: Low grade fever 99.7, decrease appetite, increase in sleeping.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Rash papular
Clinical narrative: C/O rash posterior thorax no hx egg allergy no hx problems eating eggs. Denies S.O.B. Pt took antihistamine. Fine erythematous papular rash mostly posterior thorax today 1/27/13.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Oedema peripheral
Clinical narrative: Arm was swollen for several days, swelling resolved on its own.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Sx: pt reported rash/hives starting 01-25-13 (Lips, forearm, upper thigh, groin, waist, back of (R) leg) rash would come and go every 30 min to 2 hrs Tx - antihistamines.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram abnormal, Condition aggravated, Dizziness, Nausea, Nephrolithiasis
Clinical narrative: Flu vaccine 11/9/12. 11/10 & 11/11 -> had nausea, dizziness & vomiting. 11/12/13 - presented to ER and was diagnosed with a kidney stone.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Flu vaccine 11/9/12. 11/10 & 11/11 -> had nausea, dizziness & vomiting. 11/12/13 - presented to ER and was diagnosed with a kidney stone.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Influenza like illness, Injected limb mobility decreased
Clinical narrative: Flu-like symptoms on 1-30-2013 & unable to lift her left arm. Low grade temp. Severe joint pain on 1-31-2013 with pain level of a 10 on a scale of 1-10. Unable to work because of the incredible joint pain.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Fatigue, Neck pain, Pain in extremity
Clinical narrative: Fever & chills the next day. Fatigue 2 days after. Redness on left arm after 3 days with pain. Also has neck pain.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever & chills the next day. Fatigue 2 days after. Redness on left arm after 3 days with pain. Also has neck pain.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Gait disturbance, Injection site swelling, Pyrexia, Viral infection
Clinical narrative: DTaP & Varicella 1/29/13, 1/30/13 fever onset 101-104 degrees comes decreased with MOTRIN to 102. Rt swollen, hard to walk on it. Advised to use MOTRIN, Epsom salt baths 2x daily, vitamin C 500 mg q 2 hours during phone call 1/31/13. Leg swelling resolved 2/4/13-came down with viral illness.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Hypersensitivity
Clinical narrative: 2-3 cm red allergic rxn. Loratadine 10 mg q hr x 7 days. Ibuprofen 600 mg TID x 10 days.
Age: 0.53
Sex: M
Vaccine: HIBV
Symptoms: Convulsion
Clinical narrative: Initial report received on 23 January 2013 from another manufacturer who had received the original report from nurse. A 6-month old male patient experienced a systemic reaction of seizure 2 days after receiving a 3rd dose of ACTHIB vaccination (also reported as DTP vaccine) on 06 October 1999 (lot number 0970100, which is an invalid lot number for ACTHIB). Immunization series was discontinued. Information regarding other vaccines given the same day were unknown. The event was reported as not being life threatening, but the patient was hospitalized. It was thought the seizure was due to the pertussis containing vaccination. The outcome was resolved. Concomitant medications, relevant medical history, and adverse events with prior vaccinations were unknown. The patient subsequently received a dose of BOOSTRIX vaccine (GlaxoSmithKline) on 15 January 2013, which was the first pertussis containing vaccine the patient had received since the seizure in 1999. It was noted the patient weighed 13 pounds at 3 months of age. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness
Clinical narrative: Reported lightheadedness within 15 minutes of receiving vaccine; resolved within approximately 3 hours.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia, Swelling
Clinical narrative: Severe muscle pain & swelling after. One left arm & other one right arm.
Age: 42.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site (left arm) is swollen (fist size) red, hard & painful (throbbing).
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Blood glucose normal, Presyncope
Clinical narrative: Patient had a vasovagal response.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site urticaria, Local reaction
Clinical narrative: Hive (local) rxn to immunizations (L) thigh 5 x7 cm. DaPT, IPV, given on LT.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 2 unspecified patients of unknown age. The patients were vaccinated with a dose of MMR II (doses, routes not reported) (lot number reported as 0686AE, expiration date 02-APR-2014) on 28-JAN-2013, that was exposed to 60F for 19 hours on 27-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Pruritus generalised, Rash, Swelling face
Clinical narrative: FULL BODY ITCHING, RASH, C/O FEELING LIKE FACE SWELLING.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red, warm hard induration at right thigh which is painful to touch.
Age: 36.0
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Left deltoid, at the site of injection: edema, erythema, mild pruritus, slightly warmer comparing with comparing with surrounding skin. The edema increased in size from 2cm diameter to 6x7 cm diameter with demarcated erythematous margins and central clearing. No pain. No systemic symptoms, no wheezing or dyspnea, no cough, no swallowing difficulties, no neurological symptoms, no other skin lesions.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Crying, Decreased appetite, Hyperacusis, Insomnia, Irritability
Clinical narrative: Projectile vomiting once, but irritable for the next couple days and mild fever 99.0. Sensitive to noise and environment with loss of appetite and sleep. Sleeping pattern were short, about 2 hours  during the night with excessive crying which is not normal for her. These were the 6 month shots.
Age: 0.54
Sex: F
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Pyrexia, Sleep disorder, Vomiting projectile
Clinical narrative: Projectile vomiting once, but irritable for the next couple days and mild fever 99.0. Sensitive to noise and environment with loss of appetite and sleep. Sleeping pattern were short, about 2 hours  during the night with excessive crying which is not normal for her. These were the 6 month shots.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Bone pain, Hyperhidrosis, Oedema peripheral, White blood cell count
Clinical narrative: Client received both flu and pneumonia shots in left arm.  Client states that around 1030pm he experienced heavy sweating, aches into his bones, a "bad" headache, and his left arm swelled up.  By 8am he sought assistance at ER where he received IV fluids, antibiotics and a breathing treatment.  Client states that Dr. was concerned about his blood work (WBC's per client) and wanted him to remain in the hospital but the client does not have insurance and wanted to leave.  Client reports that symptoms have subsided and he is "feeling better".
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Muscular weakness, Vomiting
Clinical narrative: Received vaccine on (1/29/13, 1 pm). The evening of 1/29 I vomited twice. Wed morning (1/30) when getting up I still felt like my stomach was at a stage where I felt like not eating. At this point my legs were very weak to the point I had to be very careful going up and down stairs. As of now 3:50 pm 2/1 the strength is returning to the legs.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The nurse practitioner reported that in October 2011, the patient was vaccinated intramuscularly with her first dose of 0.5 ml GARDASIL (lot # and expiration date not reported) and in April 2012 received intramuscularly her second dose of 0.5 ml GARDASIL (lot # and expiration date not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome for the patient events is unknown. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to a 68 years old female patient. The physician reported that after receiving on an unspecified date a dose of ZOSTAVAX subcutaneously, the patient developed "a localized reaction" which consisted of "redness about 2 to 3 inches in diameter around the injection site (date unspecified). It was reported that the patient did not receive treatment for the adverse event. The event lasted 3 weeks and the redness at the injection site disappeared. The patient recovered (date unspecified).
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a pediatric patient. The physician reported that the patient was vaccinated on an unspecified date with the second dose of RECOMBIVAX HB after only 24 days of receiving the first dose of vaccine (date unspecified). Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Asthma, Condition aggravated, Cough, Upper respiratory tract irritation
Clinical narrative: Upper respiratory symptoms, cough, asthma exacerbation roughly 5 days after 1st and 2nd dose of vaccine given.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Arthralgia, Chest X-ray normal, Dyspnoea, Full blood count normal, Headache
Clinical narrative: Patient is 29-year-old male who presents with a headache. Two days ago he had typhoid and anthrax vaccines. Later on that evening he developed headache, arthralgias, nausea, myalgias, photophobia, and intermittent difficulty breathing. He was seen in this emergency department and had a negative chest x-ray, negative CT, negative BMP, and normal CBC. He was given IV fluids and TORADOL with some improvement in his symptoms, today he was seen by the doctor and a chest x-ray was repeated which was negative. He also had negative labs note is unclear as to what those labs were. He was given XANAX and VICODIN. His symptoms did not improve he presents tonight. He was unable to take the VICODIN due to vomiting.
Age: 29.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Laboratory test normal, Myalgia, Nausea, Photophobia
Clinical narrative: Patient is 29-year-old male who presents with a headache. Two days ago he had typhoid and anthrax vaccines. Later on that evening he developed headache, arthralgias, nausea, myalgias, photophobia, and intermittent difficulty breathing. He was seen in this emergency department and had a negative chest x-ray, negative CT, negative BMP, and normal CBC. He was given IV fluids and TORADOL with some improvement in his symptoms, today he was seen by the doctor and a chest x-ray was repeated which was negative. He also had negative labs note is unclear as to what those labs were. He was given XANAX and VICODIN. His symptoms did not improve he presents tonight. He was unable to take the VICODIN due to vomiting.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Client reports allergy to eggs and declines flu vaccine.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Erythema
Clinical narrative: Child's bilateral cheeks became red. No treatment given, child observed by MD for 15 minutes.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Axillary pain, Chills, Erythema, Headache, Mass
Clinical narrative: Employee states, "I felt pain & tenderness on my armpits on touch. I also felt chills and checked for fever but no fever. Had headaches in the afternoon. Later that night, I felt hard lumps with pain and saw redness at my armpits. I took Ibuprofen and applied ice last night and this morning when I woke up. That is when I called Employee Health."
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pyrexia
Clinical narrative: Employee states, "I felt pain & tenderness on my armpits on touch. I also felt chills and checked for fever but no fever. Had headaches in the afternoon. Later that night, I felt hard lumps with pain and saw redness at my armpits. I took Ibuprofen and applied ice last night and this morning when I woke up. That is when I called Employee Health."
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Back pain, Chills, Crying, Decreased appetite, Haematemesis
Clinical narrative: Fever over 104, severe chills, severe lower back pain, vomiting (emesis contained frank blood), lethargy, prolonged crying, complete loss of appetite.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Lethargy, Pyrexia
Clinical narrative: Fever over 104, severe chills, severe lower back pain, vomiting (emesis contained frank blood), lethargy, prolonged crying, complete loss of appetite.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Computerised tomogram abdomen abnormal, Intussusception, Surgery, Volvulus
Clinical narrative: Pt received ROTATEQ plus DTAP plus ACTHIB plus Polio on 12/29/12, Intussusception Volvulus diagnosed 1/25/13.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Computerised tomogram, Intestinal resection, Intussusception
Clinical narrative: Pt received ROTATEQ plus DTAP plus ACTHIB plus Polio on 12/29/12, Intussusception Volvulus diagnosed 1/25/13.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 years old patient (gender was not reported) who on 01-FEB-2013, was vaccinated with, 0.65 ml ZOSTAVAX subcutaneously in right deltoid (Lot number reported as 0150Z) that expired on 01-APR-2011. No other co-suspects were reported. No concomitant medications were reported. No adverse effect has been observed or reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Regurgitation
Clinical narrative: This spontaneous report was received from a registered nurse refers to an infant of an unknown age who on 01-FEB-2013, was vaccinated with a dose of ROTATEQ (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that within 30 seconds of administration on 01-FEB-2013, the infant regurgitated the dose of ROTATEQ. No adverse effects were reported. The relatedness for within 30 seconds of administration the infant regurgitated the dose of ROTATEQ was unknown for ROTATEQ. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Patient states his arm hurt since he received the injection. Right upper arm red from mid forearm to upper arm to arm pit, area not tender touch. Patient states he receive inject to back of arm.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus, Vaccination complication
Clinical narrative: Patient came into the clinic stating he thought he might have a few satellite lesions from his smallpox vaccination.  The possible lesions were located just above and below the left elbow. The patient noticed them first thing at around 0600 on 5 Feb 2013. He immediatly covered them with bandages provided to conver the smallpox site. During examination of the site the patient stated "they itched a little but other than that felt great."  Patient was instructed to continue covering the smallpox site and the additional lesion, as well as, monitoring each lesion.  Patient was given additional bandages and some non-adhesive pads and coban to prevent irritation.  Patient was instructed to contact the immunizations clinic in a week to follow up and/or if he had any questions.  Patient understood all instructions.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting and diarrhea.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Convulsion, Electroencephalogram normal, Irritability, Laboratory test normal, Musculoskeletal stiffness
Clinical narrative: Fever & irritable on days 12-113 - on 6-14-12 tonic seizure lasting 5 minutes approximately 12N - another seizure at 4pm - 'seen' at ER labs normal - transferred to hospital - febrile seizure ruled out - Third seizure occurred 6/21/12 - body aching stiffening & tremors lasting 1-2 minutes - Neurologist saw patient 6-21-12 - DIASTAT prescribed - diagnosed - reaction to pertussis no further pertussis vaccine to be given - stagger vaccines.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pain, Pyrexia, Tonic convulsion, Tremor, Vaccination complication
Clinical narrative: Fever & irritable on days 12-113 - on 6-14-12 tonic seizure lasting 5 minutes approximately 12N - another seizure at 4pm - 'seen' at ER labs normal - transferred to hospital - febrile seizure ruled out - Third seizure occurred 6/21/12 - body aching stiffening & tremors lasting 1-2 minutes - Neurologist saw patient 6-21-12 - DIASTAT prescribed - diagnosed - reaction to pertussis no further pertussis vaccine to be given - stagger vaccines.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Patient had severe nausea, vomiting and headache. She was treated at the hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Localized reaction to right thigh.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Intensive care, Ocular hyperaemia, Oral mucosal blistering, Oropharyngeal pain
Clinical narrative: Mouth was full of blisters and had a sore throat, eye was all red, went to ER room and they told me to go home and it will work its course, nothing to worry about, 2 days later I went back to ER within 2 hours I was intensive care.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Influenza virus test negative, Injection site erythema, Pyrexia, Vaccination site induration, Vaccination site warmth
Clinical narrative: High fever to 104, sight of vaccine red, hot, indurated.