chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 5 year old male well child with no medical history who on 10/11/2006 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 646814/0629R). On 10/11/2006 the pt experienced an anti epileptic reaction. The pt was given epinephrine and subsequently recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from a medical assistant who reported that the pt was being seen for a physical on 10/11/06 when he was vaccinated with a dose of Varicella vaccine. Immediately after vaccination, the site was red, he complained of pain, and there was swelling at the injection site. The reporter confirmed that Epinephrine was not given because they did not have any in the office. The pt was treated with Ibuprofen (Motrin), ice and Triaminic cold and Allergy with diphenhydramine hydrochloride. the physician considered this a vaccine reaction. Before the pt left the office he felt better and had relief after the Motrin and ice. The pt was seen two days later for a routine check up and had recovered. The pts experiences were considered to be an other important medical events by the reporter (OMIC). Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site oedema, Injection site pain, Pain
Clinical narrative: Information has been received from a 53 year old female registered nurse with diabetes and thyroid disorder who on 10/12/2006 was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (0.5 ml), IM in the left deltoid. Concomitant therap0y included insulin and Synthroid. Subsequently, her left arm was in a lot of pain and she could not move her entire arm or lift the arm on the evening of 10/12/2006. The nurse was told by the physician to ice the arm and take medication for the pain. The nurse took Motrin 800 and two tablets of Vicodin. The nurse was very scared that there was a lot of pain with her arm and that she could not move her arm. The nurse mentioned on 10/13/06 the arm was achy but she could move it, but it was swollen and sore. At the time of the report, the pt had recovered. The nurse considered her experience to be an other medical event (OMIC)( and disabling. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, MNQ, VARCEL
Symptoms: Abdominal pain, Anaemia, Arthralgia, Asthma, Blood disorder
Clinical narrative: Information has been received from a school nurse and physician office nurse concerning a 13 year old male with no known allergies, a blood transfusion in June 2006, sickle cell anaemia, and asthma, who on 10/3/06 was vaccinated SC in the left arm with a one time 0.5ml dose of varicella virus vaccine lot (654129/0919F). Concomitant therapy included folic acid, penicillin V potassium (PEN VEE K) and amoxicillin. The pt had cold symptoms for two weeks prior to vaccination. On 10/5/06 the pt presented to the ER with knee, ankle pain, abdominal pain, vomiting, nausea, and decreased appetite, he had been taking Tylenol with codeine 3 and was admitted to the hospital for sickle cell crisis. It was reported that this was the pts normal presentation and were the symptoms for his sickle cell crisis and that the pt is frequently (monthly) admitted to the hospital in crisis. During the pts hospital stay, on 10/8/06, he received a blood transfusion. The pt also received fluids, a morphine drip for pain and unspecified antibiotics, he was treated with nothing out of the ordinary. The pts chest X ray was fine and his pertussis swab was neg (the nurse reported that there was a pertussis outbreak in the area. The pt was discharged on 10/9/06, though an actual recovery date was not reported. The pts discharge diagnosis was asthma and sickle cell crisis. There was no product quality complaint involved. It was reported that the sickle cell crisis may have been triggered by stress, the pt had been suspended from school on 10/4/06. It was also reported that the pt may have been hospitalized with a sickle cell crisis from 9/19/06 to 9/22/06, again after being suspended from school and that the pt was frequently hospitalized when he had problems at school. The pts events were considered to be other important medical events (OMIC) and serious for hospitalization. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL, MNQ, VARCEL
Symptoms: Condition aggravated, Decreased appetite, Nausea, Vomiting
Clinical narrative: Information has been received from a school nurse and physician office nurse concerning a 13 year old male with no known allergies, a blood transfusion in June 2006, sickle cell anaemia, and asthma, who on 10/3/06 was vaccinated SC in the left arm with a one time 0.5ml dose of varicella virus vaccine lot (654129/0919F). Concomitant therapy included folic acid, penicillin V potassium (PEN VEE K) and amoxicillin. The pt had cold symptoms for two weeks prior to vaccination. On 10/5/06 the pt presented to the ER with knee, ankle pain, abdominal pain, vomiting, nausea, and decreased appetite, he had been taking Tylenol with codeine 3 and was admitted to the hospital for sickle cell crisis. It was reported that this was the pts normal presentation and were the symptoms for his sickle cell crisis and that the pt is frequently (monthly) admitted to the hospital in crisis. During the pts hospital stay, on 10/8/06, he received a blood transfusion. The pt also received fluids, a morphine drip for pain and unspecified antibiotics, he was treated with nothing out of the ordinary. The pts chest X ray was fine and his pertussis swab was neg (the nurse reported that there was a pertussis outbreak in the area. The pt was discharged on 10/9/06, though an actual recovery date was not reported. The pts discharge diagnosis was asthma and sickle cell crisis. There was no product quality complaint involved. It was reported that the sickle cell crisis may have been triggered by stress, the pt had been suspended from school on 10/4/06. It was also reported that the pt may have been hospitalized with a sickle cell crisis from 9/19/06 to 9/22/06, again after being suspended from school and that the pt was frequently hospitalized when he had problems at school. The pts events were considered to be other important medical events (OMIC) and serious for hospitalization. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: Information has been received from a physician concerning a newborn male (less than 24 hours old) with a normal newborn heart murmur who on 10/12/06 was vaccinated IM with 0.5ml first and second dose of Hep B vaccine at 18:00 and 20:00 respectively. No fever was reported and no other symptoms were noted. It was reported that the pt was hospitalized, pt is newborn. No further information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Pruritus, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 24 year old female pt with no known allergies or reportable medical history who on 10/6/06 was vaccinated IM with a 0.5ml dose of HPV. Several hours later, on 10/6/06 the pt called the office with complaints of swollen puffy eyes, some itching but no rash and blurry vision. The pt was seen in the office that evening on 10/6/06 and was given a dose of Benadryl and was sent home. The pt took a nap for the blurry vision and upon awakening the next morning the pt fully recovered. Blurry vision was considered to be disabling according to the physician since the pt was unable to perform her normal task. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Confusional state, Hypokinesia, Hypoxia, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 65 year old male pt with coronary artery disease, congestive heart failure, type II diabetes, and kidney stones and a history of gastric banding who on 10/17/06 was vaccinated on left shoulder with his first dose of Pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). The pt also received influenza virus vaccine on the right shoulder. Concomitant therapy included Altace, Elavil, Lasix, potassium, Coreg and Keflex. Within 3 hours the pt had localized pain left arm and shivering. An hour later he had sluggish speech, was confused, and was taken to the ER with a systolic blood pressure of 129 and sat oxygen of 100%. He was confused, and slurred speech, and severe shivering. Warm blanket and oxygen administered. The pt had severe left shoulder pain, especially with movement, with a heavy sensation in arm. The physician indicated that blood tests including cardiac enzymes were performed, and that the events did not appear to be cardiac related. The pt was not able to raise his arm but was able to move his fingers, there was severe pain with passive movement of arm. Additional vital signs included systolic blood pressure 109, pulse 55, temp 97.7. The physician stated that he may need to transfer the pt to a larger facility for treatment, evaluation, and possible admission. The reporter also indicated that previous doses of influenza virus vaccine have not resulted in adverse symptoms. the physician considered the events to be immediately life threatening, and other important medical events (OMIC). A product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Sensation of pressure, Shoulder pain, Speech disorder
Clinical narrative: Information has been received from a physician concerning a 65 year old male pt with coronary artery disease, congestive heart failure, type II diabetes, and kidney stones and a history of gastric banding who on 10/17/06 was vaccinated on left shoulder with his first dose of Pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). The pt also received influenza virus vaccine on the right shoulder. Concomitant therapy included Altace, Elavil, Lasix, potassium, Coreg and Keflex. Within 3 hours the pt had localized pain left arm and shivering. An hour later he had sluggish speech, was confused, and was taken to the ER with a systolic blood pressure of 129 and sat oxygen of 100%. He was confused, and slurred speech, and severe shivering. Warm blanket and oxygen administered. The pt had severe left shoulder pain, especially with movement, with a heavy sensation in arm. The physician indicated that blood tests including cardiac enzymes were performed, and that the events did not appear to be cardiac related. The pt was not able to raise his arm but was able to move his fingers, there was severe pain with passive movement of arm. Additional vital signs included systolic blood pressure 109, pulse 55, temp 97.7. The physician stated that he may need to transfer the pt to a larger facility for treatment, evaluation, and possible admission. The reporter also indicated that previous doses of influenza virus vaccine have not resulted in adverse symptoms. the physician considered the events to be immediately life threatening, and other important medical events (OMIC). A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: MEA
Symptoms: Autism
Clinical narrative: It was reported in a published article, title as stated above that the physician has seen a pt with Autism induced by a lactation mother who received Measles virus vaccine live prior to lactation. No further information was provided. Upon internal review autism was determined to be an other important medical event (OMIC). A copy of the published article is attached as further documentation of the pts experience.
Sex: M
Vaccine: MEA
Symptoms: Abnormal behaviour, Antisocial behaviour, Autism, Hyperacusis, Speech disorder
Clinical narrative: It was reported in a published article, title as stated above that a breast feeding woman, on unspecified dates within one month, was vaccinated with three doses of MMR II as an employment requirement. Subsequently, after vaccination, she noted that her infant son, a product of a full term uncomplicated pregnancy, who she was breast feeding seemed listless and stopped saying the few words he had previously spoken. It was reported that the infant has one sister, 2 years older than him who was in good health. When the infant was seen by the physician at the age of 17 months he had no speech, avoided being touched, even by his parents, mad repetitive motions, and exhibited all 8 of the typical signs of typical infantile autism. There was some hyperacusis in the sound of high pitch. The infants attention span could not be measured. Prior test had included comprehensive gastrointestinal analysis, which was normal. Specifically, no bacteria, yeast, or parasites were found in the pts stool. The pts parents refused further testing, other than testing mercury levels in red blood cells, because of lack of funds. The parents stated that in their native city, air and ground levels of mercury, lead and other toxic elements were very high. The infants mother had discontinued nursing at 17 months, as she realized what had happened. The pt gradually improved over 9 months but plateaued and was still subnormal at 24 months. He was placed on oral chelation, and has slowly gained speech during the last 7 months. no further information was provided. Upon internal review, the pts autism was considered to be an other important medical event (OMIC). A copy of the published article is attached as further documentation of the pts experience.
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Anaphylactic reaction, Angioneurotic oedema, Candidiasis, Dermatitis, Erythema
Clinical narrative: Patient developed swelling of face and body with redness-had swelling at eyes.  10/30/06 Received medical records from reporter/provider which reveal patient seen for well child vs on day of vax.  Only finding on exam was nasal congestion & URI symptoms.  Patient then seen in ER for allergic reaction on 10/16/06.  Next office visit was 10/17/06 & patient was much improved but still had periorbital swelling.  Patient was to continue on steroids & zantac.  Next vs was 10/24 after completed steroid.  Now dx: dermatitis on face & oral thrush.   11/16/06 Received medical records from hospital which reveal patient seen in ER 10/16/06 early AM with swelling of face & lips w/rhonchorous breath sounds.  Received Epi per EMTs & IV solumedrol in ER.  Observed in ER for approx 8 hours & d/c to home on oral steroids. D/C DX: anaphylaxis/angioedema.
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Eye swelling, Swelling
Clinical narrative: Patient developed swelling of face and body with redness-had swelling at eyes.  10/30/06 Received medical records from reporter/provider which reveal patient seen for well child vs on day of vax.  Only finding on exam was nasal congestion & URI symptoms.  Patient then seen in ER for allergic reaction on 10/16/06.  Next office visit was 10/17/06 & patient was much improved but still had periorbital swelling.  Patient was to continue on steroids & zantac.  Next vs was 10/24 after completed steroid.  Now dx: dermatitis on face & oral thrush.   11/16/06 Received medical records from hospital which reveal patient seen in ER 10/16/06 early AM with swelling of face & lips w/rhonchorous breath sounds.  Received Epi per EMTs & IV solumedrol in ER.  Observed in ER for approx 8 hours & d/c to home on oral steroids. D/C DX: anaphylaxis/angioedema.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: Fever secondary to smallpox vaccine DC DX for DOS: 8/16-8/17/06 Fever fever likely secondary to small pox immunization. Treated with IV fluids and Toradol. Temp on admission 102.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Syncope vasovagal
Clinical narrative: Few minutes after receiving Gardasil vaccine patient had vaso vagal type reaction, weak, dizzy, hot, sweaty. Felt like she was going to faint.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Hypoaesthesia, Pain
Clinical narrative: Received Fluvirin 0.5cc IM left deltoid. Within 15 minutes of receiving shot, developed severe pain and numbness down arm. Ached all over, anxiety. Denied SOB or chest tightness.
Age: 32.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Erythema, Injection site abscess, Lymphadenopathy, Pain
Clinical narrative: Patient received smallpox vaccine 10/10/06. Vaccine site read 10/17 - major reaction. Reported to clinic 10/20with body aches, axillary and supraclavicular LA, afebrile, pustule draining moderate amounts clear fluid, 2" surrounding erythema with streaking pattern toward anterior axilla. 12x with Levaquin 750mg x5. Follow up visit 10/23/06, cellulitis resolved, no LA, afebrile.
Age: 32.0
Sex: F
Vaccine: SMALL
Symptoms: Skin striae
Clinical narrative: Patient received smallpox vaccine 10/10/06. Vaccine site read 10/17 - major reaction. Reported to clinic 10/20with body aches, axillary and supraclavicular LA, afebrile, pustule draining moderate amounts clear fluid, 2" surrounding erythema with streaking pattern toward anterior axilla. 12x with Levaquin 750mg x5. Follow up visit 10/23/06, cellulitis resolved, no LA, afebrile.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Influenza like illness, Nausea, Pain, Tongue oedema
Clinical narrative: Swollen tongue, sore on tongue. Flu symptoms - nausea, diarrhea, body aches, temp 98.6. Flu symptoms lasted for 1 week. Swollen tongue and sores lasted for 2 days.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Tongue ulceration
Clinical narrative: Swollen tongue, sore on tongue. Flu symptoms - nausea, diarrhea, body aches, temp 98.6. Flu symptoms lasted for 1 week. Swollen tongue and sores lasted for 2 days.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Mild case of painful to the touch feeling on buttocks and upper thigh of one leg. Lasted about 5 days, then went away. Caused me to wonder if I might come down with hives since I knew that was a symptom.
Age: 19.0
Sex: M
Vaccine: FLU3, TYP
Symptoms: Urticaria
Clinical narrative: Urticaria both elbows.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Site of pneumonia shot swollen, hot, red (4"x6"), fever 102.4, aches and chills, slight nausea. Next 4 days, arm hot, fever steady at 99. Used Naprosyn 230mg (2) BID, hot packs to arm.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Site of pneumonia shot swollen, hot, red (4"x6"), fever 102.4, aches and chills, slight nausea. Next 4 days, arm hot, fever steady at 99. Used Naprosyn 230mg (2) BID, hot packs to arm.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Hypoaesthesia, Injection site erythema, Myalgia, Nightmare
Clinical narrative: Myalgias, numbness, nightmare, anxiety, small ring redness around injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Dyskinesia
Clinical narrative: Within one hour after treatment, head jerking for 5 minutes.
Age: 19.0
Sex: M
Vaccine: FLUN3, HEPAB, TYP
Symptoms: Blister, Rash pustular, Skin ulcer
Clinical narrative: The clinical history is that of a 19 year old man who received a smallpox vaccine 8 days prior to presenting with numerous small pustular lesions over his entire body and scalp. The histologic findings of Intracorneal vesicles, basilar layer reduplication with prominent nucleoil, scattered keratinocyte cytoplasmic changes and the presence of moderate mixed (lymphocytic/neutrophilic0 perivascular.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: Malaise, weakness, dizziness, smallpox reaction.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Diarrhoea, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, myalgia, nausea, diarrhea, vaccine reaction.
Age: 29.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Malaise, Rash vesicular
Clinical narrative: Malaise, chicken pox like rash.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Erythema, Rash macular, Skin ulcer
Clinical narrative: Reaction locally spread to 2 other areas (macular erythematous lesion, small vesicle).
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Pt received pneumococcal vaccine into left deltoid concurrently with acetaminophen 650mg PO on 3/27/06 at 20:00. No adverse reaction noted until morning of 3/29/06 when pt noticed several scattered red raised hive like wheals, approx 1/2 cm in diameter to upper left arm. Pt experienced no other symptoms and vital signs were stable and unchanged from baseline treated with Acetaminophen 650mg PO and warm compresses.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, rash, approx 1 week.
Age: 7.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Rash pruritic
Clinical narrative: Positive rash on back of neck 3-5 hrs after Hep B immunization rash expanded unto chest and face, positive itchy.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site mass
Clinical narrative: Lump on arm from anthrax vaccines. Occurred after last shot and has never gone away. See DR on 6/15/06 at 8:45 hours for lump.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site abscess, Injection site erythema, Injection site oedema
Clinical narrative: Pts MD reported that infant came in for 6mo baby check on 10/17/06 and had abscess to right upper thigh. Mother informed MD that some redness and swelling was there following last shot. But had not had checked until 10/17/06. MD did incision and drainage of abscess which was 1cm x about 2cm deep and removed 50C fluid. Infant is on antibiotic and is having wound packed. MD anticipates no problems with recovery and no contraindications to further immunizations.
Age: 45.0
Sex: M
Vaccine: ANTH, HEPA, IPV, MMR, TD, TYP
Symptoms: Arthralgia, Gastrooesophageal reflux disease, Lacrimal disorder, Memory impairment, Muscle spasms
Clinical narrative: Ache joints, acid reflux, cramps legs, lacrimation disorder (tears probably sicca), increase in forgetfulness, runny nose, tachycardia, weight gain.
Age: 45.0
Sex: M
Vaccine: ANTH, HEPA, IPV, MMR, TD, TYP
Symptoms: Rhinorrhoea, Sicca syndrome, Tachycardia, Weight increased
Clinical narrative: Ache joints, acid reflux, cramps legs, lacrimation disorder (tears probably sicca), increase in forgetfulness, runny nose, tachycardia, weight gain.
Age: 34.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Migraine, Vomiting
Clinical narrative: Terrible Migraine like headache from 8:30pm 3am. Repeated every 5 minutes to 20 minutes vomiting from 10:30 to 3am. Both stopped only with IV medications.
Age: 73.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Pain, Sedation
Clinical narrative: Received Td and 2 days later arm pain. NO redness or swelling. 2 months after vaccine still has dull, achy arm pain. Difficulty raising arm. No fever. X ray ordered of humerus. Vicodin given.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Pt recieved a ppv-23 pneumovax on 10/18/06. On 10/20/06 pt returned to office with low grade fever, pain and swelling distally from injection site (SQ) in left upper extremity to the mid forearm.  Area warm to touch, erythematous and edematous.  Diagnosed as cellulitis, given Ciprofloxacin x 10 days.  To be seen for recheck in 2 weeks. Pt was co-administered Fluviron Flu Vaccine the same visit (10/18/06) in the Right upper extremity without adverse effect. The PPV-23 was  lot #0485F exp.5/5/07.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Pt recieved a ppv-23 pneumovax on 10/18/06. On 10/20/06 pt returned to office with low grade fever, pain and swelling distally from injection site (SQ) in left upper extremity to the mid forearm.  Area warm to touch, erythematous and edematous.  Diagnosed as cellulitis, given Ciprofloxacin x 10 days.  To be seen for recheck in 2 weeks. Pt was co-administered Fluviron Flu Vaccine the same visit (10/18/06) in the Right upper extremity without adverse effect. The PPV-23 was  lot #0485F exp.5/5/07.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Erythema, Injection site pain, Pyrexia
Clinical narrative: Patient received Pneumovax right deltoid intramuscular on 10/24/2006.  Patient had complaints of pain at injection site that night and a fever the following morning of 99.5 F.  Patient also developed "red streaks" on bicep of right arm with swelling and tenderness.  Patient has been taking Tylenol for pain.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Medical Asst. administered, in error, an "injectable" flu vaccine "intra-nasally". The precipating events are as follows:  1)On 10/23 at 0615a, vaccines were incorrectly dispensed by Pharmacist ; specifically, the correct 500 doses of injectable vaccine was correct but the 60 doses of  "Fluarix" was incorrect (correct vaccine is "FluMist").  2)MA administered the vaccine intranasally althougth she questioned is looked different there was a plastic valve that somewhat mirrored the one on the FluMist.   3)Employee/patient described the feeling of fluid down her throat not that of a mist which caused MA and her concern enough to discuss with writer who was adminstering other vaccines and TB Tests at the time.   4)MA states she examined the insert after and furthered questioned the vaccine administration but did not immediately recognize is was IM administration only. Potential Injury: Pharmacy contacted the manufacturer rep and confirmed there are no adverse reactions due to the injectable form of vaccine being administered/absorped into the nasal mucosa; no mild irration was noted by patient when contacted several hours later; no benefit of immunity is obtained by this method.  Readministration of injectable or intranasally was recommended.  Additional Comments:1) Pharmacy notified of error in dispensing of vaccine in order to determine process defects or procedural concerns. 2) Medical Assistants not considered qualified to make medical/clinical decisions that require judgement. MA did question the unusual container after the employee/patient commented after the the medical was administration, she did review the insert (per patient) and mentioned to writer that it looked different.  3) The RNs responsible for ensuring the vaccine is correct; RNs take some responsibility for not reading carefully the product packaging and/or insert. RN at the time of pick up from Pharmacy and writer after incorrect administration.  4) A 2nd occurrence happened several minutes later 5) VAERS report will be completed
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticaria on face, arms and trunk.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Medical Assistant administered, in error, an "injectable" flu vaccine "intra-nasally". The precipating events are as follows:  1) On 10/23 at 0615a, vaccines were incorrectly dispensed by Pharmacist; specifically, the correct 500 doses of injectable vaccine was correct but the 60 doses of "Fluarix" was incorrect (correct vaccine is "FluMist". 2)MA administered the vaccine intranasally after she questioned it looked different but there was a plastic valve that somewhat mirrored the one on the FluMist.   3) Patient described the feeling of fluid down her throat.   4)MA had just prevsious given one dose incorrectly to another patient and then states she examined the insert after and further questioned the vaccine administration but did not immediately recognize it was IM administration.   5) MA did showed injectable syringe to writer (RN) who was giving other vaccines and TB tests. It was after that the MA reviewed the packaging again and found this to be the injectable flu vaccine incorrectly dispensed by pharmacy and undetected by HS.  Potential Injury: Pharmacy contacted the manufacturer's rep and confirmed there are no adverse reactions due to the injectable form of vaccine being administered/absorped into the nasal mucosa; no mild irration was noted by patient when contacted several hours later; no benefit of immunity is obtained by this method. Readministration of injectable or intranasally was recommended.   Additional Comments: 1) Pharmacy notified of error in dispensing of vaccine in order to determine process defects or procedural concerns. 2) Medical Assistants not considered qualified to make medical/clinical decisions that require judgement. MA did question the unusually container after the employee/patient commented after the the medical was administration, she did review the insert (per patient) and mentioned to writer that it looked different.  3) The RNs responsible for ensuring the vaccine is correct; both RN and writer (RN) take some responsibility for not reading carefully the product packaging and/or insert. RN at the time of pick up from Pharmacy and writer after incorrect administration.  4) Further clinical judgement by MA and RN before or after 1st incident would have prevented this one. 5) VAERS report will be completed
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Had the PPV shot along wityh the influenza shot and with in 6 hours started running a high fever of 101 It lasted for at least 48 hours....the arm where the ppv was injected became extremly painful I could not move the arm at all and it was swollen and inflamed and a BIG red mark around the injection sight...It iwas so painful I couldnt move oreven touch my arm,...the aches and fever were unbarable as of today October 26th the arm is still swollen hot and tender to the touch and a big red mark where the shot was adminisered
Age: 58.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Had the PPV shot along wityh the influenza shot and with in 6 hours started running a high fever of 101 It lasted for at least 48 hours....the arm where the ppv was injected became extremly painful I could not move the arm at all and it was swollen and inflamed and a BIG red mark around the injection sight...It iwas so painful I couldnt move oreven touch my arm,...the aches and fever were unbarable as of today October 26th the arm is still swollen hot and tender to the touch and a big red mark where the shot was adminisered
Age: 21.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: Throbbing Headache that started 7 hours after Flu-mist and and lasted 4 days.  Seen in office visit.
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HIBV
Symptoms: Rash erythematous
Clinical narrative: RECIEVED DTap,HIB AND FLU ON OCT 19TH. MOM REPORTED YESTERDAY THAT SEE NOTICED RED RAISED BUMPS ON THE TRUCK OF HIS BODY AND BOTH ARMS AND LEGS. MOM REPORTS THAT CHILD HAD NO FEVER. HAS BEEN ON 9DAY THERAPY TREATMENT OF AMOXILLICIN, WHICH MOM REPORT THAT SHE IS ALLERGIC TO AMOXICILLIN.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Cough, Dysphagia, Flushing, Pruritus
Clinical narrative: 90 min after FluMist pt experienced flushing which progressed to cough and chest tightness.  progressed to throat tightness and itching, difficulty swallowing.  Eyes became red. Cough worsened.  Returned to clinic.  No wheezing.  Vitals stable.  No hives.  treated with Epi and Zyrtec.  Sx resolved.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Throat tightness
Clinical narrative: 90 min after FluMist pt experienced flushing which progressed to cough and chest tightness.  progressed to throat tightness and itching, difficulty swallowing.  Eyes became red. Cough worsened.  Returned to clinic.  No wheezing.  Vitals stable.  No hives.  treated with Epi and Zyrtec.  Sx resolved.
Age: 0.5
Sex: F
Vaccine: DTAP, FLU3, HEP, HIBV, PNC
Symptoms: Erythema
Clinical narrative: Blotches of redness over trunk and extremities. Otherwise stable.
Age: 0.12
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Constipation, Discomfort, Flatulence, Irritability, Oral intake reduced
Clinical narrative: Shots on October 3, then on 4th and 5th fever of 102.0F.  One the 3rd and 4th he would not eat anything.  Pedialyte given.  One or two bowel movements the rest of that week.  Gradually been getting worse, 48 or more hours between each bowel movement. On Oct 6 went to Dr., scheduled checkup.  Finally seen on the 16th for constipation.  Used suppositories 1/2 supp.  On the 23rd put on prescription colace stoolsoftner and x-ray done with mild gas build up noted.  Put infant on gas drops then.  No bowl movement since October 21, around 3PM, after warm bath.  No assistance needed at that time.  Very large and runny.  Mom feels that the baby is uncomfortable and gets fussy if his stomach is touched to much.  Seems happy but eating a lot less now.  Only on breast milk. No formula or diet change, no cereal.  Suppository tried today, but no BM as of yet.
Age: 0.12
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Shots on October 3, then on 4th and 5th fever of 102.0F.  One the 3rd and 4th he would not eat anything.  Pedialyte given.  One or two bowel movements the rest of that week.  Gradually been getting worse, 48 or more hours between each bowel movement. On Oct 6 went to Dr., scheduled checkup.  Finally seen on the 16th for constipation.  Used suppositories 1/2 supp.  On the 23rd put on prescription colace stoolsoftner and x-ray done with mild gas build up noted.  Put infant on gas drops then.  No bowl movement since October 21, around 3PM, after warm bath.  No assistance needed at that time.  Very large and runny.  Mom feels that the baby is uncomfortable and gets fussy if his stomach is touched to much.  Seems happy but eating a lot less now.  Only on breast milk. No formula or diet change, no cereal.  Suppository tried today, but no BM as of yet.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site reaction, Injection site vesicles, Pruritus
Clinical narrative: Aprroximately 0900 on 10/25/2006 received vaccination to right deltoid. Blisters noted this morning when itching began at site.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Cyanosis, Eye movement disorder, Grand mal convulsion, Irritability, Laboratory test abnormal
Clinical narrative: Patient presented fever and fussiness (7 hours after vaccine administered). Vomiting 15 times > (24 hours after loss of consciousness for seconds and stiffness. Repeated similar episodes 4 hours after. 12/22/06 Received medical records from hospital which reveal patient admitted 10/24/06-10/27/06 with fever & vomiting since receiving flu vax.  On day after vax had brief tonic-clonic episode with eyes rolling back, cyanosis & limpness afterward.  Fever 101 & had 2nd seizure.  Afebrile in hospital & no further seizures. Final DX: Febrile seizure s/p immunization w/flu vax; 2 brief febrile seizures.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Leukocytosis, Loss of consciousness, Musculoskeletal stiffness, Pyrexia, Vomiting
Clinical narrative: Patient presented fever and fussiness (7 hours after vaccine administered). Vomiting 15 times > (24 hours after loss of consciousness for seconds and stiffness. Repeated similar episodes 4 hours after. 12/22/06 Received medical records from hospital which reveal patient admitted 10/24/06-10/27/06 with fever & vomiting since receiving flu vax.  On day after vax had brief tonic-clonic episode with eyes rolling back, cyanosis & limpness afterward.  Fever 101 & had 2nd seizure.  Afebrile in hospital & no further seizures. Final DX: Febrile seizure s/p immunization w/flu vax; 2 brief febrile seizures.
Age: 1.07
Sex: M
Vaccine: FLU3, MMRV
Symptoms: Coordination abnormal, Fall, Pyrexia
Clinical narrative: 6 days after receiving influenza vaccine and ProQuad pt developed fever 101.7 and ataxia with frequent falling.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Confusional state, Pyrexia, White blood cell count increased
Clinical narrative: Fever to 105, confusion, WBC increase 26,000 within 24 hrs of receiving a flu vaccine and Pneumococcal vaccine. Required ER visit IV hydration.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Paraesthesia
Clinical narrative: Redness, swelling in right upper arm with tingling in fingers after pneumonia shot. Presented 10/26/06 to community clinic with improvement of signs and symptoms. States she had a bee sting (yellow jacket) RUA 1 week before her shot in the right axilla area.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site oedema, Malaise, Myalgia
Clinical narrative: 10/24/06 Pneumonia vaccine and influenza vaccine given left deltoid one inch apart per pt requested. 10/25/2006 2pm pt seen due to swelling, redness, burning left deltoid. Pt had 101 temp, malaise, myalgia, headache and sinus congestion. Pt stated he felt awful, I gm of Rocephin given right deltoid, pt request. Pt given RX for Keflex 500 mg P WID x 10 day. 2 325mg aspirin given for fever. 10/26/06 call from wife pt vomiting and temp came back last night at 102. Wife instructed to take pt to ER for evaluation and treatment.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Sinus congestion, Skin burning sensation, Vomiting
Clinical narrative: 10/24/06 Pneumonia vaccine and influenza vaccine given left deltoid one inch apart per pt requested. 10/25/2006 2pm pt seen due to swelling, redness, burning left deltoid. Pt had 101 temp, malaise, myalgia, headache and sinus congestion. Pt stated he felt awful, I gm of Rocephin given right deltoid, pt request. Pt given RX for Keflex 500 mg P WID x 10 day. 2 325mg aspirin given for fever. 10/26/06 call from wife pt vomiting and temp came back last night at 102. Wife instructed to take pt to ER for evaluation and treatment.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site pain, Joint range of motion decreased
Clinical narrative: Left arm Red, swollen arm shoulder to elbow, painful, ROM, started 10/24/06 afternoon. C/o feeling achy all over, chills that evening. Took TYLENOL improvement today 10/26/06.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain
Clinical narrative: Left arm Red, swollen arm shoulder to elbow, painful, ROM, started 10/24/06 afternoon. C/o feeling achy all over, chills that evening. Took TYLENOL improvement today 10/26/06.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Red welts on upper part of legs, itch, time approx 10am, given a shot of Benadryl.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pain
Clinical narrative: Extreme pain on right arm felt like it was dislocated. Had nausea from pain.  Tylenol did not help slept through Saturday, Sunday was able to move arm only from wrist to elbow, Monday had more movement on Wednesday was back to normal.
Age: 3.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain, Urticaria
Clinical narrative: 4-5 hours after immunization patient developed hives----> resolved after 1 dose BENADRYL; patient also complain of leg pain at injection site.  24 hours after immunization noted local reaction (erythema, warmth, induration) around injection site.  When measured at clinic 82.4 Fahrenheit immunization local reaction 10 x 7 cm.
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Tightness on upper leg muscles was not able to use these muscles to stand up.  Tightness gradually decreased over 4 days.  Only had residual soreness for 3 days specially on muscles above the knee towards the hip joint.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Injection given in left deltoid, left fore finger and left thumb presented with numbness within 10 minutes of injection.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Acne
Clinical narrative: Papules used BENADRYL and cortisone. Pt experienced severe case of hives over torso and legs ankle and feet. Hives lasted 4 days. Pt was given BENADRYL.
Age: 18.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site warmth, Swelling, Tenderness
Clinical narrative: Patient called after 2 days from receiving Tdap and Menactra both shots where given in left arm. Patient complained of redness, swelling, warmth, tenderness on arm as well as arm pit area underneath, prescription for KEFLEX given for precautionary measure.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Chest discomfort, Dizziness, Pain, Pallor
Clinical narrative: Temperature 103-104 degrees F, "pressure in chest" same day x 1, arm pain x 6 days, fever 10/10 --> 10/15, dizzy, pale, weak, side pain.
Age: 10.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Temperature 103-104 degrees F, "pressure in chest" same day x 1, arm pain x 6 days, fever 10/10 --> 10/15, dizzy, pale, weak, side pain.
Age: 39.0
Sex: F
Vaccine: HEPAB
Symptoms: Eye oedema, Rash
Clinical narrative: Complain of right eye swelling and right sided facial rash for 3 days.  No other symptoms, no complaints, symptoms or trace of initial reaction.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Was seen in office 3 weeks after Hep B injection with pain and numbness around the injection site about 3 inches around.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Sore arm then below injection site got bright, red, swollen, warm in area as big as palm of hand. Went to ER by midnight because redness spreading down arm. Given Benadryl. Next day doctor prescribed prednisone and Benadryl, alright. Today feeling much better but there is still some swelling and redness.
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Heart rate increased, Hypertension
Clinical narrative: Hep B at 3:30 p.m.  At 4:00 p.m. got dizzy, pulse 129.  Lasted one hour.  On 10-20-06 dizzy with blood pressure 224/105, pulse 121.  Lasted one hour.  Now 1:00 p.m. no further episodes
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Rash
Clinical narrative: Developed rash, knee pain and joint swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: LEFT ARM HARD,SWOLLEN AND WARM  BENADRYN LIQUID AND NIZORAL CREAM
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Dermatitis bullous, Viral infection
Clinical narrative: PATIENT DEVELOPED CHICKEN POX
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, MMR, PNC
Symptoms: Irritability, Muscle spasms
Clinical narrative: Extreme fussiness and muscle spasm
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Medication error
Clinical narrative: Two sets of shots drawn up at the same time, accidentally administered Pediarix instead of MMR by grabbing wrong syringe
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Muscle spasms, Pain
Clinical narrative: soreness, body aches, Muscle spasms entire left side of body  ( vaccine in left arm
Age: 45.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient developed rash, hives, and itching on arms, legs, and buttocks 2 days after receiving MMR and Td vaccines.  Patient treated rash with Gold Bond lotion but did not seek medical attention. Advised to see MD, but patient stated that symptoms had resolved by 9/15/06.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pruritus, Pyrexia
Clinical narrative: Patient described fever of 100.6, redness, swelling, itching at site of injection.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Dysgeusia, Erythema, Flushing
Clinical narrative: I first gave influenza vaccine in left deltoid, then immediately administered pneumonia vaccine in right deltoid. Patient said she immediately had "metallic taste" when given pneumonia shot.  She then began to flush bright red on face and extremities and said she "felt dizzy".  I gave her (2) diphenhydramine 25mg capsules.  Patient rested about ten minutes (her pulse was taken periodically) and then said she felt fine (skin color looked normal at that time, also). She called later in evening to report that she felt fine and we followed up with her again the next morning.
Age: 0.36
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood bicarbonate decreased, Dehydration, Haematochezia, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Intussusception resulting in surgical procedure and partial bowel resection. MR from pediatrician received which included hospital H&P from Oct. 16,2006 as well as a surgical pathology report dated Oct. 20, 2006.  Well baby exams at 6 days, 3 weeks, 2 and 4 months significant only for thrush and yeast rash in the diaper area. Breast fed. Vax given 10/11/06 include DTaP, Comvax, IPV, Prevnar, and Rotateq.  Bloody stools, fever, and vomiting began 10/15/2006 and infant was seen in the ER.   F/U with pediatrician 10/16/06 resulted in a direct admission to the hospital for rehydration, with an admission assessment of "Fever with bloody diarrhea and at least 5% dehydration."  Hospital MR received.  Infant had been hospitalized at a local hospital prior to admission to another hospital on 10/20/06 for surgery due to new onset of bilious emesis. (Exploratory Laparotomy and a Ladd Procedure).    Post-operatively, child became febrile on post-op day #3. Abd. X-ray negative.   Antibiotics and TPN continued. Post op day #7, CT of the abd/pevis done due to child being febrile since post-op day#3 and 90cc output from NG tube of greenish fluid. No evidence for leak or obstruction found. Improvement began 10/29/06 and the infant was discharged on 10/31/2006. No discharge diagnosis written on discharge summary. Lot number obtained for Rotateq ME0319F  exp. 1/11/2007 Per (FDA) "please add lot number to VAERS report if not yet done". Lot # added.
Age: 0.36
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intussusception, Laboratory test abnormal, Platelet count increased, Pyrexia, Vomiting
Clinical narrative: Intussusception resulting in surgical procedure and partial bowel resection. MR from pediatrician received which included hospital H&P from Oct. 16,2006 as well as a surgical pathology report dated Oct. 20, 2006.  Well baby exams at 6 days, 3 weeks, 2 and 4 months significant only for thrush and yeast rash in the diaper area. Breast fed. Vax given 10/11/06 include DTaP, Comvax, IPV, Prevnar, and Rotateq.  Bloody stools, fever, and vomiting began 10/15/2006 and infant was seen in the ER.   F/U with pediatrician 10/16/06 resulted in a direct admission to the hospital for rehydration, with an admission assessment of "Fever with bloody diarrhea and at least 5% dehydration."  Hospital MR received.  Infant had been hospitalized at a local hospital prior to admission to another hospital on 10/20/06 for surgery due to new onset of bilious emesis. (Exploratory Laparotomy and a Ladd Procedure).    Post-operatively, child became febrile on post-op day #3. Abd. X-ray negative.   Antibiotics and TPN continued. Post op day #7, CT of the abd/pevis done due to child being febrile since post-op day#3 and 90cc output from NG tube of greenish fluid. No evidence for leak or obstruction found. Improvement began 10/29/06 and the infant was discharged on 10/31/2006. No discharge diagnosis written on discharge summary. Lot number obtained for Rotateq ME0319F  exp. 1/11/2007 Per (FDA) "please add lot number to VAERS report if not yet done". Lot # added.