chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a Poison and Drug Center, refers to a 72 year old female patient. She had no relevant medical history and is not allergic to neomycin or gelatin, concomitant medications and past drug use are unknown. On 30-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J003796 exp date: 28-JUN-2014; 1 subcutaneous injection in the left arm) for prevention and PNEUMOVAX 23 (lot # H013581; exp date: 03-MAR-2014; 1 intramuscular injection in the left arm) for prevention. On 31-AUG-2013 the patient started to notice swelling in her left arm. On 01-SEP-2013 her left upper arm is red, and swelling from the site of the, 2 days after onset of the ZOSTAVAX around the arm to the outside, and states it is sore. It is unknown if there is any relevant laboratory data. As of 01-SEP-2013 it is unknown if she will have another ZOSTAVAX or PNEUMOVAX 23 and she continues to have redness, swelling and a sore upper left arm. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a physician via company representative refers to an unknown age female patient. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (lot # unspecified) injection (dose, route and location unspecified) for prevention of shingles. In May 2013, the patient experienced a "varicella-like" rash on her left arm after receiving ZOSTAVAX. The time between the onset of rash and administration of vaccine was unspecified. The patient had sought medical attention via physician appointment. No treatment was given for "varicella-like" rash. At the time of report, the outcome of the event was "improve on its own" as reported. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a 30 year old female patient regarding herself. On 16-SEP-2013, the patient who is seven-months pregnant was vaccinated with a dose of GARDASIL (lot number, expiry date and dose unspecified), intramuscularly in error at her physician office. No concomitant therapy was reported. The patient was scheduled to receive a Rhogam (unspecified) injection but was administered with GARDASIL. Gestational age was reported as 7 months. Due date was reported as 09-DEC-2013. The patient sought an unspecified medical attention. It was unspecified if any treatment was provided or if any lab tests were performed. No adverse effect was reported at the time of report. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 27-FEB-2012 the patient was vaccinated with the first dose of GARDASIL intramuscular injection (dose and site of administration were not reported) (lot # 1561AA; exp. date 26-AUG-2014). On 23-APR-2012 the patient was vaccinated with the second dose of GARDASIL intramuscular injection (dose and site of administration were not reported) (lot # 1561AA; exp. date 26-AUG-2014). Over one year after the second dose on 26-AUG-2013, the patient received her third dose of GARDASIL intramuscular injection (site and dose of administration were not reported) (lot # H021346; exp date 01-OCT-2015). No adverse effects were reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Anxiety, Cold sweat, Hyperhidrosis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 71 year old male patient, who on 25-AUG-2013, was vaccinated with a dose of ZOSTAVAX (lot # J002242, exp: 21-MAY-2014), 0.65 ml, subcutaneously for immunization. The patient received FLUZONE in the same vaccination session. On 25-AUG-2013, the patient experienced feeling clammy, sweaty and reported feeling anxiety. The patient reported that these symptoms began after receiving ZOSTAVAX and had not resolved as of 03-SEP-2013 (the day of reporting). The patient had not yet seen the physician, however he sought medical attention via calling pharmacy. No treatment was given for the events. No laboratory diagnostic studies were performed. The outcome of the events was reported as not recovered. The reporter did not rate the relatedness of the events to ZOSTAVAX. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Fatigue, Feeling abnormal, Headache
Clinical narrative: Wednesday, September 11, 2013 - I took ibuprofen immediately after injections (Influenza and Pneumococcal Polysaccharide). I received both injections in the upper part of the right arm. Soreness in upper right arm at injection site was present within 1 hour of injection time. During the evening, I developed chills, body aches, extreme tiredness, and a general "bad" feeling. These symptoms grew stronger throughout the night. The pain around the injection site intensified and the area of soreness grew across the outer part of my arm. I took TYLENOL and ibuprofen alternately every 6-8 hours throughout the night. Thursday, September 12, 2013 - I woke at the usual time and was feeling worse (the chills, body aches, extreme tiredness, and a general "bad" feeling, and extreme soreness in my upper right arm continued and I also developed a headache). I went to work hoping that the symptoms would subside. Instead of subsiding I was feeling worse within the first hour of the school day so I requested a substitute and took the remainder of the day off. Back at home I went to sleep immediately. Around midday I became very nauseated but did not vomit. I ran a fever throughout the day that ranged from 99.8 to 101.6. I woke up around 4:00 pm and the nausea had subsided but the other symptoms continued. Near 8:45 pm I noticed a and a red "blotch" approximately 2 inches in diameter was present at the injection sites and a red band had spread across my outer arm toward the front of my body. The red area was hot to touch and swollen. Even though my arm was extremely sore and sensitive to touch and movement I continued to move it to try to "work out" the soreness. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Thursday day and night. Friday, September 13, 2013 - I woke at the usual time symptoms had lessened except for the arm soreness to I went to work. The 1 inch band grew to approximately 3 1/2 to 4 inches wide and extended around my upper arm. It was swollen, hot to touch, extremely sore, and very red. Several people at different times described the redness as looking like a bad sunburn. My arm felt like it had a tight band around it. Throughout the day the other symptoms continued to subside. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Friday day and night. Friday night I took CLARITIN. Saturday, September 14, 2013 - Red band around my arm began to fade but the swelling, tightness and soreness remained. I continued to take CLARITIN. Sunday, September 15, 2013 - Red band around my arm continued to fade and the swelling, tightness and soreness began to subside, I continued to take CLARITIN. Monday, September 16, 2013 - Red band around my arm fading and the swelling, tightness and soreness continued to subside. I continued to take CLARITIN. Tuesday, September 17, 2013 - Symptoms no longer present. I continued to take CLARITIN.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hyperaesthesia, Injection site pain, Injection site reaction, Local swelling, Nausea
Clinical narrative: Wednesday, September 11, 2013 - I took ibuprofen immediately after injections (Influenza and Pneumococcal Polysaccharide). I received both injections in the upper part of the right arm. Soreness in upper right arm at injection site was present within 1 hour of injection time. During the evening, I developed chills, body aches, extreme tiredness, and a general "bad" feeling. These symptoms grew stronger throughout the night. The pain around the injection site intensified and the area of soreness grew across the outer part of my arm. I took TYLENOL and ibuprofen alternately every 6-8 hours throughout the night. Thursday, September 12, 2013 - I woke at the usual time and was feeling worse (the chills, body aches, extreme tiredness, and a general "bad" feeling, and extreme soreness in my upper right arm continued and I also developed a headache). I went to work hoping that the symptoms would subside. Instead of subsiding I was feeling worse within the first hour of the school day so I requested a substitute and took the remainder of the day off. Back at home I went to sleep immediately. Around midday I became very nauseated but did not vomit. I ran a fever throughout the day that ranged from 99.8 to 101.6. I woke up around 4:00 pm and the nausea had subsided but the other symptoms continued. Near 8:45 pm I noticed a and a red "blotch" approximately 2 inches in diameter was present at the injection sites and a red band had spread across my outer arm toward the front of my body. The red area was hot to touch and swollen. Even though my arm was extremely sore and sensitive to touch and movement I continued to move it to try to "work out" the soreness. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Thursday day and night. Friday, September 13, 2013 - I woke at the usual time symptoms had lessened except for the arm soreness to I went to work. The 1 inch band grew to approximately 3 1/2 to 4 inches wide and extended around my upper arm. It was swollen, hot to touch, extremely sore, and very red. Several people at different times described the redness as looking like a bad sunburn. My arm felt like it had a tight band around it. Throughout the day the other symptoms continued to subside. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Friday day and night. Friday night I took CLARITIN. Saturday, September 14, 2013 - Red band around my arm began to fade but the swelling, tightness and soreness remained. I continued to take CLARITIN. Sunday, September 15, 2013 - Red band around my arm continued to fade and the swelling, tightness and soreness began to subside, I continued to take CLARITIN. Monday, September 16, 2013 - Red band around my arm fading and the swelling, tightness and soreness continued to subside. I continued to take CLARITIN. Tuesday, September 17, 2013 - Symptoms no longer present. I continued to take CLARITIN.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pain in extremity, Pyrexia, Rash macular, Skin tightness
Clinical narrative: Wednesday, September 11, 2013 - I took ibuprofen immediately after injections (Influenza and Pneumococcal Polysaccharide). I received both injections in the upper part of the right arm. Soreness in upper right arm at injection site was present within 1 hour of injection time. During the evening, I developed chills, body aches, extreme tiredness, and a general "bad" feeling. These symptoms grew stronger throughout the night. The pain around the injection site intensified and the area of soreness grew across the outer part of my arm. I took TYLENOL and ibuprofen alternately every 6-8 hours throughout the night. Thursday, September 12, 2013 - I woke at the usual time and was feeling worse (the chills, body aches, extreme tiredness, and a general "bad" feeling, and extreme soreness in my upper right arm continued and I also developed a headache). I went to work hoping that the symptoms would subside. Instead of subsiding I was feeling worse within the first hour of the school day so I requested a substitute and took the remainder of the day off. Back at home I went to sleep immediately. Around midday I became very nauseated but did not vomit. I ran a fever throughout the day that ranged from 99.8 to 101.6. I woke up around 4:00 pm and the nausea had subsided but the other symptoms continued. Near 8:45 pm I noticed a and a red "blotch" approximately 2 inches in diameter was present at the injection sites and a red band had spread across my outer arm toward the front of my body. The red area was hot to touch and swollen. Even though my arm was extremely sore and sensitive to touch and movement I continued to move it to try to "work out" the soreness. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Thursday day and night. Friday, September 13, 2013 - I woke at the usual time symptoms had lessened except for the arm soreness to I went to work. The 1 inch band grew to approximately 3 1/2 to 4 inches wide and extended around my upper arm. It was swollen, hot to touch, extremely sore, and very red. Several people at different times described the redness as looking like a bad sunburn. My arm felt like it had a tight band around it. Throughout the day the other symptoms continued to subside. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Friday day and night. Friday night I took CLARITIN. Saturday, September 14, 2013 - Red band around my arm began to fade but the swelling, tightness and soreness remained. I continued to take CLARITIN. Sunday, September 15, 2013 - Red band around my arm continued to fade and the swelling, tightness and soreness began to subside, I continued to take CLARITIN. Monday, September 16, 2013 - Red band around my arm fading and the swelling, tightness and soreness continued to subside. I continued to take CLARITIN. Tuesday, September 17, 2013 - Symptoms no longer present. I continued to take CLARITIN.
Age: 57.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Skin warm
Clinical narrative: Wednesday, September 11, 2013 - I took ibuprofen immediately after injections (Influenza and Pneumococcal Polysaccharide). I received both injections in the upper part of the right arm. Soreness in upper right arm at injection site was present within 1 hour of injection time. During the evening, I developed chills, body aches, extreme tiredness, and a general "bad" feeling. These symptoms grew stronger throughout the night. The pain around the injection site intensified and the area of soreness grew across the outer part of my arm. I took TYLENOL and ibuprofen alternately every 6-8 hours throughout the night. Thursday, September 12, 2013 - I woke at the usual time and was feeling worse (the chills, body aches, extreme tiredness, and a general "bad" feeling, and extreme soreness in my upper right arm continued and I also developed a headache). I went to work hoping that the symptoms would subside. Instead of subsiding I was feeling worse within the first hour of the school day so I requested a substitute and took the remainder of the day off. Back at home I went to sleep immediately. Around midday I became very nauseated but did not vomit. I ran a fever throughout the day that ranged from 99.8 to 101.6. I woke up around 4:00 pm and the nausea had subsided but the other symptoms continued. Near 8:45 pm I noticed a and a red "blotch" approximately 2 inches in diameter was present at the injection sites and a red band had spread across my outer arm toward the front of my body. The red area was hot to touch and swollen. Even though my arm was extremely sore and sensitive to touch and movement I continued to move it to try to "work out" the soreness. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Thursday day and night. Friday, September 13, 2013 - I woke at the usual time symptoms had lessened except for the arm soreness to I went to work. The 1 inch band grew to approximately 3 1/2 to 4 inches wide and extended around my upper arm. It was swollen, hot to touch, extremely sore, and very red. Several people at different times described the redness as looking like a bad sunburn. My arm felt like it had a tight band around it. Throughout the day the other symptoms continued to subside. I continued to take TYLENOL and ibuprofen alternately every 6-8 hours Friday day and night. Friday night I took CLARITIN. Saturday, September 14, 2013 - Red band around my arm began to fade but the swelling, tightness and soreness remained. I continued to take CLARITIN. Sunday, September 15, 2013 - Red band around my arm continued to fade and the swelling, tightness and soreness began to subside, I continued to take CLARITIN. Monday, September 16, 2013 - Red band around my arm fading and the swelling, tightness and soreness continued to subside. I continued to take CLARITIN. Tuesday, September 17, 2013 - Symptoms no longer present. I continued to take CLARITIN.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Discomfort, Injection site erythema, Injection site nodule, Injection site pain, Pain in extremity
Clinical narrative: Soreness at injection site began before 2:30 on 9/11/13. Took Ibuprofen within an hour of getting injections. I had a red knot approximately 2 inches in diameter at the injection site. The red knot was evident about 8:30 PM on the 11th. My arm was really sore and very uncomfortable to move. I took some more Ibuprofen. Pain in left arm persisted thru 9/15/13. On 9/12/13 around 8 PM redness spread from the injection site all over my upper arm and shoulder. I contacted my doctor and was instructed to take BENADRYL or CLARITIN. I took a CLARITIN. The redness started getting better Friday (9/13/13) morning. Redness looked like hives all over my arm. The redness full went away by 9/15/13. The knot on my arm was evident until 9/17/13.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient (unknown gender). On 23-JUN-2010, the patient was vaccinated with the first dose of M-M-R (dose, route and lot # not reported) and VARIVAX (Merck) (dose, route and lot # not reported). On 15-AUG-2013, the patient should receive the second dose of M-M-R and VARIVAX (Merck), however received the second dose of PROQUAD (Merck) (dose, route and lot # not reported) and VARIVAX (Merck) (dose, route and lot # not reported) instead. No adverse effect reported. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Differential white blood cell count, Erythema, Full blood count, Headache
Clinical narrative: Patient given vaccine that same evening started with nausea and fever 102. Next morning with RUE soreness and trouble lifting arm. Since back in office 9/18/13 2 PM. Area erythema calor, tenderness at lateral aspect of the deltoid. Tenderness to any motion. She states unable to do her job. Treated for cellulitis. Given cephalexin 500 mg QID x 10 days and Hydrocodone/Acetaminophen 5/325 1 QID PRN. Pt returned 9/20/2013 to recheck states no change in symptoms. Pain, fever, erythema, decreased ROM with productive cough, sore throat, head congestion, headache. Patient using ice and Tylenol without relief. Advised continue ice, antibiotic. Use Ibuprofen and Hydrocodone/Acetaminophen as needed. CBC with Diff ordered today.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Mobility decreased, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Patient given vaccine that same evening started with nausea and fever 102. Next morning with RUE soreness and trouble lifting arm. Since back in office 9/18/13 2 PM. Area erythema calor, tenderness at lateral aspect of the deltoid. Tenderness to any motion. She states unable to do her job. Treated for cellulitis. Given cephalexin 500 mg QID x 10 days and Hydrocodone/Acetaminophen 5/325 1 QID PRN. Pt returned 9/20/2013 to recheck states no change in symptoms. Pain, fever, erythema, decreased ROM with productive cough, sore throat, head congestion, headache. Patient using ice and Tylenol without relief. Advised continue ice, antibiotic. Use Ibuprofen and Hydrocodone/Acetaminophen as needed. CBC with Diff ordered today.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Productive cough, Pyrexia, Sinus congestion, Tenderness
Clinical narrative: Patient given vaccine that same evening started with nausea and fever 102. Next morning with RUE soreness and trouble lifting arm. Since back in office 9/18/13 2 PM. Area erythema calor, tenderness at lateral aspect of the deltoid. Tenderness to any motion. She states unable to do her job. Treated for cellulitis. Given cephalexin 500 mg QID x 10 days and Hydrocodone/Acetaminophen 5/325 1 QID PRN. Pt returned 9/20/2013 to recheck states no change in symptoms. Pain, fever, erythema, decreased ROM with productive cough, sore throat, head congestion, headache. Patient using ice and Tylenol without relief. Advised continue ice, antibiotic. Use Ibuprofen and Hydrocodone/Acetaminophen as needed. CBC with Diff ordered today.
Sex: F
Vaccine: FLUN3
Symptoms: Wheezing
Clinical narrative: A report has been received from a health professional concerning a female patient. The patient's relevant medical history or concomitant medications were not reported. In the 2011-2012 season the patient received FLUMIST and was hospitalized for wheezing after taking the product. The action taken with FLUMIST and the outcome of the events was unknown. Assessment of the serious criteria by reporter for the report was as follows: hospitalised. Follow-up of insignificant information received by AstraZeneca/MedImmune on 20-Feb-2013 from health professional: new reporters added.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site haematoma
Clinical narrative: Extensive hematoma around injection site > 2 weeks.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient could not move her arm the next day and has pain to this day. Patient is worried of a long term problem and prevent mobility.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash
Clinical narrative: 1/2 inch red, itchy, hard rash at site of injection - right underside of arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. She had no relevant history. On 31-AUG-2013 the patient was vaccinated with a dose of PNEUMOVAX 23 1 injection, right arm, lot # 0653AE, exp. date 10-FEB-2014 (dose was not reported) for prevention. Her concomitant medications and past drug history were unknown. On 01-SEP-2013, the patient reported swelling that just started in her right arm. It was unknown if there was any relevant laboratory data. As of 01-SEP-2013 it was unknown if the patient would have another PNEUMOVAX 23 and she continued to have swelling in her right arm. The relatedness between therapy with PNEUMOVAX 23 and swelling that just started in her right arm was not reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 75 years old female patient. On 24-JUL-2013 th3e patient ws vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the right arm (lot number and expiration date not provided). There were no pertinent medical history or concomitant medications reported. In approximately 2013 the patient experienced an one inch pink/slight redness at the injection site. At the time of the report the patient still had a one inch pink/slight redness at the injection site. It was not hot to touch, no pain, no knotting. The patient sought medical attention and she contacted the pharmacist. The pharmacist stated that she recommended cool compress and TYLENOL as needed if the patient was uncomfortable. Client told to the pharmacist that she was not uncomfortable. The relatedness between the event of one inch pink/slight redness at the injection site and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Dec-2012. The reporter stated that the patient was given expired FLUMIST on 05-Dec-2012. The outcome of the event of GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiveing FLUMIST. FLUMIST started on 04-Dec-2012. The reporter stated that they had given expired FLUMIST to the patient on 04-DEC-2012. The outcome of the event of gave expired FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving nasal FLUMIST started on 04-DEC-2012. The patient experienced tested positive for influenza which started on 15-DEC-2012. The patient recovered from the event of Tested Positive for Influenza on an unspecified date. The report was considered to be non serious.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced EXPIRED FLUMIST GIVEN which started on 21-DEC-2012. The follow up reporter, stated the patient has not been back in the office and they have not heard from her. She was not re-dosed. The oucome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Dec-2012. The patient experienced EXPIRED FLUMIST GIVEN which started on 27-Dec-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious. Expired vaccine was used.
Age: 1.5
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: A consumer report has been received. The report concerns a 1 year old, male consumer, who had been receiving Nasal FLUMIST. The reporter stated that her 18 month old son received FLUMIST which started on 04-DEC-2012. She stated the pediatrician's office called her to notify her that he should have received the injection instead of the nasal spray. MD office told her there was nothing else that needed to be done. The outcome of the event of my 18 month old son received FLUMIST is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, male subject, who has been receiving Nasal FLUMIST. FLUMIST was started on 02-Jan-2013. The reporter stated that they GAVE EXPIRED FLUMIST on 02-JAN-2013. The outcome of the event of GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 1.56
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received from a Health Professional concerning a 1 year old, Female subject, who has been receiving Nasal FLUMIST. FLUMIST started on 21-DEC-2012. The Health professional reported that, 18 month old patient received FLUMIST on 21-DEC-2012. The outcome of the event of 18 month old received FLUMIST is unknown. The report was considered to be non-serious.
Age: 11.0
Sex: F
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A report has been received fr om a Physician concerning an 11 month old, Female subject who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter reported that FLUMIST was administered to 11 month old which started on 28-NOV-2012. The outcome of the event of FLUMIST ADMINISTERED TO 11 MONTH OLD is unknown. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 19-DEC-2012. The reporter reported that patient was administered expired FLUMIST on 19-DEC-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 18-Dec-2012. The patient experienced EXPIRED FLUMIST GIVEN which started on 18-Dec-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious by the company physician. Follow up of insignificant information received on 08-Apr-2013. The patient did not have any late occurring adverse events. Another immunization was offered one month later, but was declined. Narrative was updated.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Eye movement disorder, Facial paresis, Neurological examination normal, VIIth nerve paralysis
Clinical narrative: A report has been received from a health professional, concerning a three years old male patient. Patient's medical history and concomitant medications were not reported. There was no family history of Bell's palsy. The patient received nasal FLUMIST on 20-Nov-2012. The family noticed that the patient developed weakness on the left side of his face and the he was unable to close his eyes. The patient developed Bell's palsy on 16-Dec-2012. Action taken with influenza vaccine was not applicable. The patient recovered from the event of Bell's palsy on an unspecified date. He was given a brief course of prednisone (7 days steroid treatment with prednisone 10 mg, 3 tablets daily for 5 days, then 1 tablet daily for 5 days and also received VALTREX 500mg three-quarter tablet three times a day for 7 days) at that time. On 07-Feb-2013, on neurological exam, he was alert and cooperative. His running and jumping have been normal and he has had no double vision. There were no birthmarks and there were no cranial bruits. Easily closed his eyes bilaterally and they seen normal nasolabial creases bilaterally. Extraocular movements were intact and his fundus was normal. There was a normal walk and a normal run with good finger-nose testing. There have been no other neurological deficits. His head circumference was 48 cm. The reporter assessed the event of Bell's palsy to be serious with the seriousness criteria of important medical event. Follow up of insignificant information received by AstraZeneca/MedIummune 10-May-2013 from Physician: New reporter added. Form completed date updated. Summary of follow-up information received by AstraZeneca/MedImmune 20-May-2013 from physician: new reporters were added, start date of the event updated, outcome of the event updated, other diagnostic test was added, narrative updated.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST was given on 14-DEC-2012 later seen to be expired on 10-DEC-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious by reporting health professional.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The reporter stated that expired FLUMIST was given to the patient which started on 13-DEC-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered non-serious.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Dec-2012. The patient experienced EXPIRED FLUMIST GIVEN which started on 14-Dec-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The patient was given some expired doses of FLUMIST. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a registered nurse via medical representative concerning a female child. Her medical history was not reported. There was no information on her concomitant medication. On 13-NOV-2012 the child received FLUMIST. On 07-DEC-2012 she was tested positive for the flu after receiving FLUMIST. The outcome of the event was unknown. The report was considered to be non-serious. Corrected report 04-MAR-2013: event coding changed.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a registered nurse via medical representative concerning a female child. Her medical history was not reported. There was no information on her concomitant medication. On 13-NOV-2012 the child received FLUMIST. On 07-DEC-2012 she was tested positive for the flu after receiving FLUMIST. The outcome of the event was unknown. The report was considered to be non-serious. Corrected report 04-MAR-2013: event coding changed.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Influenza, Influenza virus test positive
Clinical narrative: A report has been received from a registered nurse via medical representative concerning a female child. Her medical history was not reported. There was no information on her concomitant medication. On 13-Nov-2012 the child received FLUMIST. On 7-Dec-2012 she was tested positive for the flu after receiving FLUMIST.  The outcome of the event was unknown. The report was considered to be non-serious. Corrected report 04-Mar-2013: event coding changed.
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Influenza virus test positive
Clinical narrative: A report has been received from a registered nurse via medical representative concerning a female child. Her medical history was not reported. There was no information on her concomitant medication. On 13-Nov-2012 the child received FLUMIST. On 7-Dec-2012 she was tested positive for the flu after receiving FLUMIST.  The outcome of the event was unknown. The report was considered to be non-serious. Corrected report 04-Mar-2013: event coding changed.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving FLUMIST. FLUMIST started on 02-Jan-2013. The patient experienced administered three patient expired FLUMIST/received expired FLUMIST which started on 02-Jan-2013. The outcome of the event of administered three patient expired FLUMIST/received expired FLUMIST is unknown. The report was considered to be non-serious by the reporter. Summary follow-up information received by AstraZeneca/MedImmune 02-Jan-2013 from a Health Professional: Patient's detail was added.
Age: 0.08
Sex: M
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 1 month old, Male subject who had been receiving Nasal FLUMIST. FLUMIST started on 11-DEC-2012. The patient reporter stated that GAVE A DOSE OF EXPIRED FLUMIST and GAVE FLUMIST TO A FOUR WEEK OLD which started on 11-DEC-2012. The outcome of the event of GAVE A DOSE OF EXPIRED FLUMIST and GAVE FLUMIST TO A FOUR WEEK OLD is unknown. The report was considered to be non-serious. Summary of follow-up information received 14-MAR-2013 from Health Professional Reporter's name was added. Form completed date was updated. Corrected report 19-MAR-2013: Action taken was correct from unknown to not applicable. Manufacturer name for suspect drug was added.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 1-Dec-2012. The reporter stated that they administered expired FLUMIST to a patient on 11-Dec-2012. RN reports the patient has not reported any side effects. The outcome of the event of ADMINISTERED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Agitation, Crying, Flushing, Injection site papule
Clinical narrative: Approximately 10:40 patient got 3 shots and oral Rotavirus. 1 minute later patient with flushed of legs bilaterally from toes to upper thigh. Diaper area and trunk and arms clear. Face flushed with incessant crying. Tried to calm and feed without success. Patient pulling hair. Given 6.25mgoral Diphenhydramine at 11:03 AM. Patient's skin flush improved within 3 minutes and resolved at 11:14 AM. Residual papules on legs. Photos taken on fathers cell phone. Patient arousable when discharged home. Mother to call later today. Referred to allergist.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Healthcare Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 11-Dec-2012. The patient RECEIVED EXPIRED FLUMIST which started on 11-Dec-2012. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The patient received expired FLUMIST. The report was considered to be non-serious.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 11-DEC-2012. The reporter stated that they GAVE A DOSE OF EXPIRED FLUMIST which started on 11-DEC-2012. The outcome of the event of GAVE A DOSE OF EXPIRED FLUMIST is unknown. According to the reporter the report was considered to be non-serious. Follow-up of insignificant information received on 29-JAN-2013 from a healthcare professional case opened during log step, no new information to add.
Age: 23.0
Sex: F
Vaccine: FLUN4, SMALL
Symptoms: Chest pain, Pericarditis
Clinical narrative: Pt came in at 0715 with chest pains since 0530. Was evaluated at clinic and was transported downtown to ER. Pt returned to clinic with diagnosis of pericarditis. Pt was given Indomethacin and omeprazole for medications.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: A report has been from a consumer via market research organization concerning a two year-old female patient with height: 95 centimeters and weight: 14 kilograms. The patient's concurrent disease was reported as asthma. The patient's medical history was not reported. On an unspecified date the patient received nasal FLUENZ. During Oct-2012 after the vaccination with FLUENZ she suffered from severe fever, severe chills and joint pain which lasted three days. During Oct-2012 the patient recovered from the events. The report was considered to be non-serous by the reporter.
Age: 1.0
Sex: U
Vaccine: FLUN3
Symptoms: Drug administered to patient of inappropriate age, Expired drug administered
Clinical narrative: As report has been received from a Health Professional concerning a 1 year old, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on 10-DEC-2012. The patient experienced GAVE EXPIRED FLUMIST which started on 10-Dec-2012 and TO ONE YEAR OLD. The outcome of the event of GAVE EXPIRED FLUMIST and TO ONE YEAR OLD is unknown. A dose of expired FLUMIST was given to a one year old patient. The report was considered to be non-serious.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old Other, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 10-Dec-2012. The patient experienced INADVERTENTLY ADMINISTERED EXPIRED FLUMIS which started on 10-Dec-2012. The outcome of the event of INADVERTENTLY ADMINISTERED EXPIRED FLUMIST is unknown. Administered expired FLUMIST to a 50 month old child. The report was considered to be non-serious.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Lichen planus, Pyrexia, Rash vesicular
Clinical narrative: Chickenpox like breakouts. Dermatologist diagnosed Lichen Planus as result of shingles vaccine. Within a few hrs. of shingles vaccine developed 101 degree fever for 2 days. Within 2 wks start to break out on chest with chickenpox type of pimples (no itch or pain). Tender to touch. Over several months it's gotten much worse. Dermatologist said I developed Lichen Planus from shot. (Have never had any auto immune disease of skin breakout before). Was told I could have it for 4 yrs and possibly for the remainder of my life. Have seen my primary care physician and another visit to his P.A. - all said it was from shingles shot. See photos - definitely herpes zoster blisters. Am permanently on Cortisone cream.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Chickenpox like breakouts. Dermatologist diagnosed Lichen Planus as result of shingles vaccine. Within a few hrs. of shingles vaccine developed 101 degree fever for 2 days. Within 2 wks start to break out on chest with chickenpox type of pimples (no itch or pain). Tender to touch. Over several months it's gotten much worse. Dermatologist said I developed Lichen Planus from shot. (Have never had any auto immune disease of skin breakout before). Was told I could have it for 4 yrs and possibly for the remainder of my life. Have seen my primary care physician and another visit to his P.A. - all said it was from shingles shot. See photos - definitely herpes zoster blisters. Am permanently on Cortisone cream.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Headache, Influenza A virus test positive, Pyrexia, Rhinitis
Clinical narrative: A report has been received from a physician concerning a 4 year old female child. No concomitant medication or medical history was reported. On 05-Dec-2012, the patient received vaccination with Nasal FLUENZ. Four days later, on 09-Dec-2012, the patient developed fever, rhinitis and headache. On 10-Dec-2012 a smear has been taken in order to distinguish an adverse event from influenza. The test was H1N1 positive. The child received symptomatic treatment. At the time of reporting the event of fever, rhinitis, and headache were ongoing. The reporting physician considered th events of fever, rhinitis and headache possibly related to FLUENZ. The events of fever, rhinitis and headache were considered to be non-serious by the reporter. Summary of follow-up information received on 20-Dec-2012: patient demography, event onset date, outcome of events were updated. Vaccine start date updated. Physician's assessment of casualty added. Diagnostic test result added. Narrative updated.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 03-Jan-2013. The patient experienced ADMINISTER EXPIRED FLUMIST which started on 03-Jan-2013. The outcome of the event of ADMINISTER EXPIRED FLUMIST is unknown. The report was considered to be non-serious. Expired vaccine used.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: A consumer report has been received. The report concerns a 4 year old male patient. No relevant history or concomitant medications reported. The patient received Nasal FLUENZ, once/single administration on an unknown date. The patient experienced mild fever 38/5 degrees. Therapy was an antipyretic drug. The patient recovered from the event of mild fever 38.5 degrees on an unspecified date. The report was considered to be non-serious by the company physician.
Age: 4.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 05-Dec-2012. The reported stated that they gave expired FLUMIST to patient that week, the FLUMIST expired on 03-DEC-2012 which started on 05-DEC-2012. The outcome of the event of GAVE EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Pharmacist concerning a child, subject of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced EXPIRED FLUMIST GIVEN. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. Clinic administered FLUMIST that had expired one day prior to administration. The report was considered to be non-serious.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Muscle spasms, Musculoskeletal pain, Pain in extremity
Clinical narrative: Swelling of throat. Cramp/numb/loss use of left arm - June 2012. Debilitating pain incapacitation - left shoulder arm. Presently 15 1/2 mos. 10-12 ER visits.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Pharyngeal oedema
Clinical narrative: Swelling of throat. Cramp/numb/loss use of left arm - June 2012. Debilitating pain incapacitation - left shoulder arm. Presently 15 1/2 mos. 10-12 ER visits.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness at site, 7 cm x 8 cm, tender to palpation, itching at site x 2 days. Treatment - KEFLEX 500mg 1 PO TID x 7 day, Hydrocortisone cream, BENADRYL 25mg PRN.
Sex: U
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A report has been received from a Physician concerning multiple patients with unknown age and gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. On the 2nd, rd, and 4th of January, the patients received FLUMIST, that expired at the end of December 2012. The outcome of the event of FLUMIST THAT EXPIRED IN END OF DECEMBER AND WE GAVE IT TO PATIENTS is unknown. The report was considered to be non-serious by the reporter.
Sex: F
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning, Female subject who had been receiving Nasal FLUMIST. The patient's medical history included VSA (Ventricular septal defect). FLUMIST started on 19-Nov-2012. The patient experienced tested positive for Influenza A which started on 13-Dec-2012. The patient recovered from the event of tested positive for Influenza A on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received 24-Jan-2013 from Health Professional: New reporter added as Health Professional. Event outcome was updated from unknown to recovered. Relevant history was added. Patient details added. Patient reporter deleted. Reporter's details updated. County of administration was added. Lab detail added. Corrected report 29-Jan-2013. Action taken corrected from Unknown to Not applicable. Associated case ID added. Medical rep reporter added.  Corrected report 01-March-2013: The coding of the event of "Tested positive for Influenza A" corrected from "Influenza A virus infection" to "Influenza A virus test positive".
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza A virus test positive
Clinical narrative: A report has been received from a Health Professional concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 29-Sep-2012. The patient experienced POSITIVE FOR INFLUENZA A which started on 31-Dec-2012. The outcome of the event of POSITIVE FOR INFLUENZA A is unknown. The report was considered to be non-serious.