chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Irritable bowel syndrome, Lactose intolerance, Pneumonia, Pyrexia
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross reference to MEDI0005114). On 10/25/06, the pt was readmitted to the hospital for decreased in pulse rate. The pt was hospitalized for the following seven days with the rash on trunk. Diagnostic testing indicated that this pt had a complete heart block and the cardiac MRI showed that he had a myocarditis. The pt was discharged on 11/1/06 (cross referenced to MEDI0005133). On 11/6/06, fiver days after the discharge, the pt was readmitted to the hospital with a productive cough and trouble breathing. On 11/9/06, the pt was transferred to University medical center for worsening of the above symptoms. The pt was placed on a ventilator and on 11/13/06, he was given a diagnosis of heart failure. There is no past medical history of heart problems of disease. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block, Cardiac failure, Fatigue, Heart rate decreased, Myocarditis
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross reference to MEDI0005114). On 10/25/06, the pt was readmitted to the hospital for decreased in pulse rate. The pt was hospitalized for the following seven days with the rash on trunk. Diagnostic testing indicated that this pt had a complete heart block and the cardiac MRI showed that he had a myocarditis. The pt was discharged on 11/1/06 (cross referenced to MEDI0005133). On 11/6/06, fiver days after the discharge, the pt was readmitted to the hospital with a productive cough and trouble breathing. On 11/9/06, the pt was transferred to University medical center for worsening of the above symptoms. The pt was placed on a ventilator and on 11/13/06, he was given a diagnosis of heart failure. There is no past medical history of heart problems of disease. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Pneumonia, Rash
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross reference to MEDI0005114). On 10/25/06, the pt was readmitted to the hospital for decreased in pulse rate. The pt was hospitalized for the following seven days with the rash on trunk. Diagnostic testing indicated that this pt had a complete heart block and the cardiac MRI showed that he had a myocarditis. The pt was discharged on 11/1/06 (cross referenced to MEDI0005133). On 11/6/06, fiver days after the discharge, the pt was readmitted to the hospital with a productive cough and trouble breathing. On 11/9/06, the pt was transferred to University medical center for worsening of the above symptoms. The pt was placed on a ventilator and on 11/13/06, he was given a diagnosis of heart failure. There is no past medical history of heart problems of disease. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Atrioventricular block, Cardiac failure, Cough, Dyspnoea, Fatigue
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross reference to MEDI0005114). On 10/25/06, the pt was readmitted to the hospital for decreased in pulse rate. The pt was hospitalized for the following seven days with the rash on trunk. Diagnostic testing indicated that this pt had a complete heart block and the cardiac MRI showed that he had a myocarditis. The pt was discharged on 11/1/06 (cross referenced to MEDI0005133). On 11/6/06, fiver days after the discharge, the pt was readmitted to the hospital with a productive cough and trouble breathing. On 11/9/06, the pt was transferred to University medical center for worsening of the above symptoms. The pt was placed on a ventilator and on 11/13/06, he was given a diagnosis of heart failure. There is no past medical history of heart problems of disease. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 27.0
Sex: M
Vaccine: FLUN3, FLUN3, FLUN3
Symptoms: Heart rate decreased, Hypoxia, Myocarditis, Pneumonia, Rash
Clinical narrative: This is a 27 year old male, with a history of irritable bowel syndrome and lactose intolerance, who received FluMist for the first time on 10/5/06. Two days later, the pt was hospitalized for two days for pneumonia. For two weeks following the discharge, the pt returned to work despite having a persistent mild fatigue (cross reference to MEDI0005114). On 10/25/06, the pt was readmitted to the hospital for decreased in pulse rate. The pt was hospitalized for the following seven days with the rash on trunk. Diagnostic testing indicated that this pt had a complete heart block and the cardiac MRI showed that he had a myocarditis. The pt was discharged on 11/1/06 (cross referenced to MEDI0005133). On 11/6/06, fiver days after the discharge, the pt was readmitted to the hospital with a productive cough and trouble breathing. On 11/9/06, the pt was transferred to University medical center for worsening of the above symptoms. The pt was placed on a ventilator and on 11/13/06, he was given a diagnosis of heart failure. There is no past medical history of heart problems of disease. There is no family history of cardiac disorders or diseases. There is no history of smoking or alcohol substance abuse. The pt did not receive any other vaccines three months prior to receiving FluMist. There is no further information regarding course of events, lab diagnostic testing results, treatments, and event outcome. The reporter was requested to forward all pertinent pt medical information to product safety at manufacturer. The provided reporter causality is definite.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Lethargy, Muscle spasms, Neck pain, Pyrexia
Clinical narrative: Approx 12 hours later pain at site increased to level 10 and radiated to my neck. Temp elevated to 104 muscle spasms from legs to neck began every 10 mins lasted about 4-6 hours. Temp 102 next day very lethargic for 3 days. Temp 99.5. 01/02/07-records received and reviewed puncture wound to finger on 10/16/06, tetanus shot with pertussis on 10/18/06. Developed fever to 102, muscle aches without real arthralgias, headache,  seen on 10/15/06 impression acute serum sickness type reaction to tetanus shot, question whether it was the pertussis component. Developed cramping in legs and buttocks, RX with Prednisone. Visit 11/15/06 massive headache, visual disturbance.  will see in 2 weeks.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Patient was administered Fluzone and immediately a tonic seizure. 01/16/07-records received afrom doctor and reviewed. Seizure immediately following a flu shot, body stiffened, eyes rolled back and she was unresponsive. Patient's uncle has history of tonic clonic siezure. Patient has had asthma in 2002 and is on Advair. EEG:11/10/06. MRI: No acute intracranial pathology.  02/16/07-records received and reviewed from Dr. for DOS 11/10/06. Physical exam WNL; Seizure (GT type) within few seconds. Had generalized tonic spasm of body all 4 extremities and moving of eyballs within few second of injection of vaccine. Became fully concious and responsive in 2 minutes. Did not void.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Arthropathy, Back pain, Dehydration, Dry mouth, Muscle spasms
Clinical narrative: Dry mouth, pain lower back, dehydration, alert reaction, rash, skin itching, treatment at hospital.  MR received from the VA documenting 5 office visits between 01/2005 and 10/2006. HPIs:Ankle sprain 06/2005. C/o LBP in OV of 10/2005. Txd with Naproxen. Left shoulder tendonitis and ankle sprain 2' to a fall 03/2006. Txd with ibuprofen and steroids. C/o LBP in OV 10/2006.  Txd with PT. Assessment: LBP 2' to Lumbar Myositis and Spasms. No nerological deficits or radicular signs on PE.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Myositis, Pruritus, Rash, Tendonitis
Clinical narrative: Dry mouth, pain lower back, dehydration, alert reaction, rash, skin itching, treatment at hospital.  MR received from the VA documenting 5 office visits between 01/2005 and 10/2006. HPIs:Ankle sprain 06/2005. C/o LBP in OV of 10/2005. Txd with Naproxen. Left shoulder tendonitis and ankle sprain 2' to a fall 03/2006. Txd with ibuprofen and steroids. C/o LBP in OV 10/2006.  Txd with PT. Assessment: LBP 2' to Lumbar Myositis and Spasms. No nerological deficits or radicular signs on PE.
Age: 31.0
Sex: F
Vaccine: HEPAB
Symptoms: Hepatic enzyme increased
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of elevated liver enzymes in a 31 year old female subject who was vaccinated with Twinrix for prophylaxis. The subjects medical history included Hep C. There were no concurrent medications. On 4/27/06, the subject received 1st dose of Twinrix. On 8/29/06 4 months after vaccination with Twinrix, it was noted that the subject had developed elevated liver enzymes. As a result of this event, the immunization series with Twinrix was discontinued. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the event was unresolved.
Age: 50.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: This case was reported by a medical assistant and described the occurrence of dizziness in a 50 year old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent vaccination included Typhim VI given on 7/31/06. There were no concurrent medications. On 7/31/06, immediately following vaccination with Twinrix, the subject experienced dizziness, lightheadness and low blood pressure. The pt presented to the ER and it was unk if the pt was hospitalized. The reporter considered the events were clinically significant intervention required (OMIC). The events had improved before the subject left the physicians office. The reporter considered that the events were unrelated to the use of Twinrix. On 7/31/06 the subject received 1st dose of Twinrix IM, right deltoid.
Sex: M
Vaccine: HEPAB
Symptoms: Jaundice neonatal
Clinical narrative: A nurse prospectivity reported that a 26-year-old female subject received a dose of hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) during the first trimester of pregnancy.  Medical history was notable for no alcohol consumption and no tobacco use. The date of the last menstrual periods was 18 September 2004.  On an unspecified date in either October or November 2004, the mother of the subject received the first dose of Twinrix.  The nurse stated that, she "was four to five weeks pregnant when she received her first dose".  The immunization series with Twinrix was discontinued "until after the pregnancy". On 07 January 2005, at 16 weeks of gestation, the mother of the subject received Amoxicillin trihydrate + potassium clavulanate (Augmentin) and Phenergan with codeine to treat sinusitis.  ON 16 February 2005, at 21 weeks of gestation, the mother of the subject again received Augmentin to treat sinusitis.  The subject was born via cesarean section after a 40 week gestation.  The subject is a male and weighted 4.1 kg and was 21 inches in length.  No birth defects were noted .  Postnatally, on 29 June 2005, the subject was noted to be jaundiced.  The outcome of the jaundice was not reported.  Comment: Jaundice was assessed as medically serious.  (OMIC)
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Disorientation, Dizziness, Dry mouth, Headache
Clinical narrative: Dizzy, cotton mouth, disoriented, unable to stay awake, lower blood pressure, nauseated, headache.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Somnolence
Clinical narrative: Dizzy, cotton mouth, disoriented, unable to stay awake, lower blood pressure, nauseated, headache.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pain, Pyrexia, Swelling
Clinical narrative: Received Flu and Pneumovax around 2:30 pm.  That night awoke to pain in Pneumovax arm with swelling from shoulder to elbow, temperature 102, couldn't move due to pain.  Pain was "shooting"up neck and down side.  Went to the ER the next day as symptoms worsened.  ER gave her IV fluids/antibiotics and sent home.  Her regular physician was seen on Monday with no new treatment.  Over the course of her symptoms, she had taken ADVIL and TYLENOL.  As of 11-14-06 states her temperature is now 99.9 and her arm is still warm to touch and painful but the "swelling" has gone down.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Oedema, Pruritus
Clinical narrative: Pt developed raised red rash flexal area with pruritus of the arms, palms soles about 8 hours after administration of vaccine. Then developed mild pharyngeal swelling all SX resolved with self TX with Benadryl.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: Pt developed headache, fatigue and bilateral generalized lymphadenopathy, (cervical, axillary, and inguinal), that continues even 1 week after vaccination.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Received pneumonia vaccine 11/13/06.  Itching 1st day 11/14/06 left arm deltoid red, swollen.  Site of softball.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site vesicles, Oedema peripheral, Pyrexia
Clinical narrative: 11/14/06 Influenza vaccine.  11/15/06 Arm reddened and swollen, temperature 103.  11/16/06 Arm increased swelling and redness, clusters of blisters around injection site.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Oedema peripheral
Clinical narrative: Left arm swollen, "hard", very tender, abdominal pain.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pruritus, Rash papular, Shoulder pain
Clinical narrative: Pain along left scapula into shoulder beginning 2 days after vaccine and then out break papular rash with pain/itch pain relieved with NEURONTIN.  This is in follow-up to report(s) previously submitted on 12/14/2006. Information has been received from a physician concerning a 60 year old female with no known allergies or medical conditions who on 27-OCT-2006 in the AM was vaccinated SC in the right arm with a 0.65 mL first dose of VARIVAX (Merck) (lot # 652936/0981F). Concomitant vaccination on the same day included a first IM dose in the left deltoid of PNEUMOVAX (lot # 651320/1008P). There were no other concomitant vaccinations. There was no illness at the time of vaccination. After vaccination, on approximately 06-NOV-2006, the patient developed an atypical shingles rash with pain. Unspecified medical attention was sought and the patient was treated with NEURONTIN for the pain. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who reported that on 06-NOV-2006 the patient had pain along the left scapula into the shoulder beginning "two days after the vaccine" and then an outbreak of a papular rash with pain and itching. The pain was relieved with NEURONTIN. At the time of the report, the patient was recovering. No further information is expected.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Sensation of heaviness
Clinical narrative: 6 to 7 hours after receiving the flu vaccine he complained of heaviness in his arms and legs.  "They feel like they weigh too much".  Became very upset.  Mom had to calm him calm lasted about 20-30 minutes.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Fluvirin was given around 3pm. Per patient at about 8-9pm, patient started to feel very dizzy.  She can hardly stand, left side of her body numbness and she couldn't breath and had asthma attack use ALBUTEROL inhaler.  Went to sleep.  The signs and symptoms resolved after 3-4 days.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: 18 h after having Flu vaccine on left arm, pt developed erythema, swelling, induration at the area where she had vaccine, approx 11 x 9 cm; and some itching bearing to the area. Pt was treated with Benadryl 12.5 g/5 5ml even 6 h and Orapred PO daily x 3 days.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Pain, Rash
Clinical narrative: 2 cm area of induration in a 4 cm patch of erythema. Pain is improving, rash appears to be fading.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphonia, Dyspnoea, Throat tightness, Unintended pregnancy
Clinical narrative: A few hours after vaccine - developed tightness in throat, raspy hoarse voice, shortness of breath. Solumedrol IV (pt pregnant)
Age: 0.21
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Crying
Clinical narrative: Inconsolable crying x 6 hours after shots on day immunization, afebrile, finally fell asleep - slept 11 hrs.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Flu vaccine reaction. Vaccine administered to left deltoid on 10/23/06. Left arm pain and swelling fine 10/23/06 - got worse on 10/27. Went to ER. Treated with Benadryl 25 mg PO every 4-6 hrs prn and Predisone 40 mg PO daily x 4 days.
Age: 1.38
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Headache, Pyrexia, Viral infection
Clinical narrative: Dx varicella - fever and headache
Age: 58.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site oedema, Injection site pain, Tenderness
Clinical narrative: Local pain, swelling RUE near site Pneumovax within hours of injection. has improved but still some soreness, exam showed only tenderness.
Age: 1.68
Sex: M
Vaccine: DTAP, FLUX, PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives, fever no resp distress. MR and Vax record received. Healthy apprearing 20 month old male with 4 day hx. of diarrhea (improving) who received Dtap, Prevnar, and Flu vax on 11/15/2006, presented to MD with c/o rash which developed the evening of his vax. Assessment:  Urticaria-probably secondary to flu vaccine, but can be related to viral illness, tylenol admin., or other immunizations.
Age: 1.2
Sex: F
Vaccine: DTAPH, FLU3, HEPA, MMRV, PNC
Symptoms: Balance disorder
Clinical narrative: Poor balance within 24 hours after vaccines lasted 3-4 days, pt did not contact MD until symptoms resolved and was not examined.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Blood pressure decreased, Pharyngeal oedema
Clinical narrative: Pt had anaphylactic reaction 4-5 minutes after receiving in influenza vaccine, throat swelled up. Rn immediately gave client 0.cc epinephrine SQ and laid client down BP 80/40. Responded immediately BP increased 150/80 EMT to ER.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Throat tightness, Unintended pregnancy
Clinical narrative: Tightness of throat and dyspnea (pt pregnant) Solumedrol IV.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus generalised, Swelling, Throat irritation
Clinical narrative: Swelling of hands, redness of skin, generalized itching day of vaccine. Symptoms progressed over 3 days to swelling of hands and feet, redness of hands and feet, itchy throat, no difficulty swallowing. Feels puffy all over.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Total body itching
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus
Clinical narrative: Total body itching.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Rash maculo-papular, Rash pruritic
Clinical narrative: Maculo papular pruritic rash to abdomen, spread to cheeks, upper back, both elbows and both thighs. spread over 30 mins. Response good to antihistamines.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site oedema, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Swollen arm, stiffness, lump 16 days in area of injection. Throbbing pain radiating down arm.
Age: 0.76
Sex: M
Vaccine: FLU3
Symptoms: Sleep disorder, Urticaria
Clinical narrative: Urticaria (mild). MR received  revealing a 9 month old in for well-baby exam with only c/o mild diarrhea-resolving, otherwise normal. Flu shot given and infant developed hives that evening on face/trunk/back.  Seen 2 days s/p vax. because infant seemed uncomfortable, and was having trouble sleeping. DX: Urticaria, likely 2' to influenza vaccine, treated with Atarax PRN itching.
Age: 78.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Herpes zoster, Viral infection
Clinical narrative: Had Flu shot and Pneumonia shot on 10/27/06. Erythema, Cellulitis given Cephalexiro 500 mg 4x days. Had side effect after 13 doses. Two days later came down with shingles given Acyclovir by my own Dr. I seem to be on the mend after 18 days. I hope so.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema multiforme, Rash
Clinical narrative: Next day after flu vaccine noticed rash on legs. Next day rash spread trunk and extremities office visit 11/15/06 DX with Erythema multiforme. No treatment. Not sure if this is related or not to Fluzone.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Hot, Red, swollen arm 11/01/2006 administered, 11/07/06 presented at office with SX.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Cellulitis
Clinical narrative: Cellulitis like reaction to Pneumovax right arm.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Fluzone shot 10/27/2006 left arm. Within 12 hours axillary adenopathy left side. Feels well otherwise. No abnormality at site of shot.
Sex: U
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: Adacel is a new vaccination intended for adults under 65, which should replace Td for tetanus booster and will increase immunity to Pertussis. Daptacel is one of many brand names of the vaccine which is intended for infant use. The component antigens are the same, but the relative amounts are much greater for the infant vaccination. The nomenclature DTaP and Tdap is confusing and a potential source of error, which is further compounded by the similarity in the brand names. We have identified instances where adults and one adolescent have received the inappropriate infant vaccine.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Stomach discomfort, Vomiting
Clinical narrative: Rash on left deltoid area where inj administered stomach upset that evening and through next two days, then vomiting x 1 day.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Rash macular
Clinical narrative: 5 minutes of administration pts left arm above elbow red and warm to touch, redness extending around injection site and extending to above elbow. Red blotchy pattern to entire LUE. No other reaction. Benadryl IM given. Redness resolving. Benadryl given for home use.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Chest pain, Dysphonia
Clinical narrative: I got the flut shot on 25-OCT-2006 so I wouldn't get sick because I don't have a car for over 3 years and have to catch bus/cab which is expensive and dirty. For three weeks straight I've been sick with chest pains, sore ribs, hoarseness and I have to walk to the mail box 30 minutes in the snow/cold with that sickness. It snowed the day after (26-OCT-2006) when I got my shot. Last year the shot didn't make me sick. This year was my second time getting the flu shot. Barely recovered. The two 1-800 numbers didn't work to complain about the vaccine.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia
Clinical narrative: Vaccine given at 7:38am, at 7:45 pt complained of feeling weak going to pass out. Laid flat on cot, legs elevated. BP 12/57, HR 114, RR 16. 7:53 used ammonia pouch without relief, denies shortness of breath 7:58 BP 120/90, HR 100, RR 16 continues to complain of feeling weak. 911 called.
Age: 1.03
Sex: F
Vaccine: DTAP, FLU3, HIBV, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Rash macular, Rash pustular
Clinical narrative: Varicella like rash 9 days after vaccination. >50 red blotchy macule about 1/10 had pustular 1mm center. Not other wise ill. No treatment just reassurance.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Coma, Disorientation, Dizziness, Nausea
Clinical narrative: 3 1/2 hours after receiving vaccine, spouse found pt slouched and unresponsive. After arousing him, he was disoriented, nausea, dizzy,chilly, rapidly breathing x 30 minutes.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory rate increased
Clinical narrative: 3 1/2 hours after receiving vaccine, spouse found pt slouched and unresponsive. After arousing him, he was disoriented, nausea, dizzy,chilly, rapidly breathing x 30 minutes.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site oedema, Injection site warmth, Neuralgia
Clinical narrative: Red, swollen, hot at the site where shot was administered. Over 4 days, redness spread lower on arm, from left shoulder to elbow. Nerve pain, numbness in fingers followed initial reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: Right arm red, warm to touch, child c/o tenderness, slightly swollen 24-48 hours after vaccines administrated. Mom took him to MD, no treatment with antibiotics. Comfort measures only, DX was vaccine reaction.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Arm swollen and red 2 days after vaccines. Cellulitis, ice to affected area x 10-15 min. TID. OTC Motrin PRN Q 6.
Age: 1.29
Sex: M
Vaccine: MMR
Symptoms: Viral infection
Clinical narrative: Developed chicken pox 11/16/06
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: 9:00 am got shot, 11:00 am arm was red, hot, swelled, itched, hurt touch. 5:00 pm arm from shoulder to elbow was red like 3 degree burn. Still hot very swelled hurt, called DR office at 11:00. She said put ice on 20 min and off 20 min. Didn't help. Lasted 3 days with decreasing symptoms. Today 11/16/06 arm still hurt at times.
Age: 1.0
Sex: F
Vaccine: HBPV, MMR, VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Pt was diagnosed with shingles 11/07/06.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site oedema, Rash maculo-papular, Tenderness
Clinical narrative: Left arm with edema, broad area of erythema, tenderness, diffuse Maculo papular rash on both arms, both legs, abdomen.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Dehydration, Headache, Hypokinesia, Injection site erythema
Clinical narrative: The pain in right arm was unbearable could not move it at all. The area was red and very warm (Hot). It could not be touched massaged. Put me in bed for several days, very sick. Gave me generalized fever, body aches. I became weak. I felt dehydrated. Had headaches. I was so sick a relative wanted to take me to the ER.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Malaise, Pain, Pyrexia
Clinical narrative: The pain in right arm was unbearable could not move it at all. The area was red and very warm (Hot). It could not be touched massaged. Put me in bed for several days, very sick. Gave me generalized fever, body aches. I became weak. I felt dehydrated. Had headaches. I was so sick a relative wanted to take me to the ER.
Age: 0.39
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Agitation, Crying, Screaming
Clinical narrative: Pt developed high pitched screaming, cry approx four hours post immunization administration. Infant cried inconsolably for 45 minutes. Mother called ME office was told to return and infant was reexamined.
Age: 54.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Agitation, Amnesia, Confusional state, Depressed level of consciousness, Ear disorder
Clinical narrative: Encephalopathy, decreased consciousness, immediate warm rush sat. Syncope, (Slow moving, pressure on ears, unable to focus on task on hand, easily confused, short term memory loss, trouble focusing eyes, left whole let and foot tingling, personality change, agitated, back of head felt like it smacked hard as in a fall. Symptoms very bad x2 days, third better, ok in one week.
Age: 54.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Encephalopathy, Feeling hot, Head discomfort, Headache, Paraesthesia
Clinical narrative: Encephalopathy, decreased consciousness, immediate warm rush sat. Syncope, (Slow moving, pressure on ears, unable to focus on task on hand, easily confused, short term memory loss, trouble focusing eyes, left whole let and foot tingling, personality change, agitated, back of head felt like it smacked hard as in a fall. Symptoms very bad x2 days, third better, ok in one week.
Age: 54.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Personality disorder, Sensation of pressure, Sluggishness, Syncope, Vision blurred
Clinical narrative: Encephalopathy, decreased consciousness, immediate warm rush sat. Syncope, (Slow moving, pressure on ears, unable to focus on task on hand, easily confused, short term memory loss, trouble focusing eyes, left whole let and foot tingling, personality change, agitated, back of head felt like it smacked hard as in a fall. Symptoms very bad x2 days, third better, ok in one week.
Age: 40.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Erythema, Rash pruritic
Clinical narrative: Client states red rash covering both hands and intense itching (worse at night) approx 24 hours after vaccine with JE Vax and Rabies. Benadryl cream applied itching rash decreased after 2 days. On day 7 client returned for 2 JE Vax states itching less but observed scratching hands. Red dots remains bilaterally approx 10-15. No respiratory involvement.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Received Varicella vaccine (Varivax) on 11/05/06. Around 11/15/06 developed several small non itchy papules on hand, face x2. body x 1 and one on extremity.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Injection site discolouration, Pruritus
Clinical narrative: Blanching 1/2 circular areas erythema on anterior thighs and slightly below axillae, slightly itching. Began 2-3 days after Dtap and Hib were administered RX Benadryl 12.5 mg tsp 1tsp Q 6 hours PRN.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Pain and localized swelling, redness.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain in arm, redness, pt seen 11/3/06 Tylenol, ice PRN, symptoms resolved after few days. Pt contacted by office 11/06/06, symptoms were almost resolved.
Age: 0.43
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Hypersensitivity, Injection site erythema
Clinical narrative: 5 month 9/1/06 pt mother took baby to ER state left leg turned red, diagnosis was severe allergic local reaction.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis right upper arm. Started on Keflex 11/9/06 symptoms resolving.
Age: 78.0
Sex: F
Vaccine: HEPAB, IPV, TD, TYP
Symptoms: Rash, Swelling face
Clinical narrative: This case was reported by a nurse and described the occurrence of rash in a 78-year-old female subject who was vaccinated with TWINRIX for prophylaxis. Concurrent vaccinations administered on 06 September included IPV, diphtheria and tetanus toxoid adsorbed and TYPHIM VI. The subject was taking several other medications (unspecified). On 06 September 2006 the subject received an unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced a rash over her entire body except her feet and her lips were swollen. At the time of reporting the events were unresolved. The nurse considered the events were probably related to vaccination with TWINRIX.
Age: 32.0
Sex: M
Vaccine: HEPAB
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of diarrhea in a 32-year-old male subject who was vaccinated with TWINRIX for prophylaxis. On 14 September 2006 at 10:00 am. the subject received the 3rd dose of TWINRIX in the right arm. On 14 September 2006 at approximately 3:00 pm, 5 hours after vaccination with TWINRIX, the subject experienced diarrhea. The subject was seen at a physician's office and was treated with anti-diarrheal. The outcome of the event was not reported.
Sex: F
Vaccine: HEPAB
Symptoms: Myalgia
Clinical narrative: This case was reported by a physician and described the occurrence of arm soreness in a female subject of unspecified age who was vaccinated with Twinrix for prophylaxis. The subjects medical history, concurrent conditions and concurrent medications were not reported. On an unspecified date the subject received primary course of Twinrix (unknown dose). The lot number and expiration date were not provided. An unspecified amount of time after vaccination with Twinrix, the subject experienced arm soreness. The event resolved. No additional information is available.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Conjunctivitis, Feeling hot, Lacrimal disorder, Lacrimation increased, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of sensation of fever in a 38-year-old female subject who was vaccinated with TWINRIX (Glaxosmithkline). A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions an concurrent medication were not known. On 1o August 2006 at 12:40 the subject received 1st dose of TWINRIX at 1 ml. The lot number and expiration date were not reported. By the end of the day on 10 August 2006, the subject reported that she was feeling feverish. The following day, on 11 August 2006, the subject developed a runny nose, watery eyes and a fever. She took ADVIL and by the end of the day on 11 August 2006, her symptoms had resolved. Follow-up received on 17 July 2007 via a regulatory authority indicted that the subject experienced conjunctivitis, rhinitis and fever one day after vaccination with TWINRIX.
Age: 38.0
Sex: F
Vaccine: HEPAB
Symptoms: Rhinitis, Rhinorrhoea, Rhinorrhoea
Clinical narrative: This case was reported by a consumer and described the occurrence of sensation of fever in a 38-year-old female subject who was vaccinated with TWINRIX (Glaxosmithkline). A physician or other health care professional has not verified this report. The subject's medical history, concurrent conditions an concurrent medication were not known. On 1o August 2006 at 12:40 the subject received 1st dose of TWINRIX at 1 ml. The lot number and expiration date were not reported. By the end of the day on 10 August 2006, the subject reported that she was feeling feverish. The following day, on 11 August 2006, the subject developed a runny nose, watery eyes and a fever. She took ADVIL and by the end of the day on 11 August 2006, her symptoms had resolved. Follow-up received on 17 July 2007 via a regulatory authority indicted that the subject experienced conjunctivitis, rhinitis and fever one day after vaccination with TWINRIX.
Age: 34.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of hives in a 34-year-old male subject who was vaccinated with TWINRIX for prophylaxis. Concurrent medical conditions included penicillin allergy. There were no concurrent medications. The subject had no adverse events following previous vaccinations. On 14 Marhc 2006 the subject received the 2nd dose of TWINRIX (1 ml, right arm). On an unspecified date in March 2006, at an unspecified time after vaccination with TWINRIX the subject experienced hives. The subject presented to the emergency room two weeks after the 2nd dose of TWINRIX was given. There was no streaking or redness at the injection site. On an unspecified date in March 2006 the event was resolved.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis
Clinical narrative: This case was reported by a physician to a sales representative and described the occurrence of antigenemia in an adult subject of unspecified age and gender who was vaccinated with Twinrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. At the time of reporting, the subject was in an alcohol and drug treatment center. On an unspecified date prior to 21 July 2006, the subject received an unspecified dose of Twinrix (lot number unknown). Two days after the vaccination with Twinrix, the subject tested positive for hepatitis B. No additional information was reported.
Sex: M
Vaccine: HEPAB
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a male subject in his thirties who was vaccinated with Twinrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The reporting physician denied that the subject had experienced any adverse events following previous vaccinations. On an unspecified date prior to 24 July 2006, the subject received the 1st dose of Twinrix. One day after vaccination with Twinrix, the subject experienced fever of 104 degrees F, myalgia, fatigue and injection site tenderness. At the time of reporting the outcome of the events were unknown.
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis, Therapeutic response decreased
Clinical narrative: This case was reported by a nurse and described the occurrence of decreased therapeutic response in an adult male subject who was vaccinated with Twinrix for prophylaxis. On unspecified dates, the subject received the 1st, 2nd, and 3rd doses of Twinrix (unknown). Antibody levels were measured one to two months after the completion of the three dose series. The subject had hepatitis B antibody titers of less than 10mIU/mL.
Sex: M
Vaccine: HEPAB
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a nurse and described the occurrence of decreased therapeutic response in an adult male subject who was vaccinated with TWINRIX for prophylaxis. On unspecified dates, the subject received the 1st, 2nd and 3rd doses of TWINRIX (unknown). Antibody levels were measured one to two months after completion of the three dose series. The subject had hepatitis B antibody titers of less than 10 mIU/mL.
Age: 39.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis C virus, Urine analysis abnormal
Clinical narrative: This case was reported by a consumer and described the occurrence of positive urine test for marijuana in a 39 year old male subject who was vaccinated with Twinrix for prophylaxis. The reporter is the wife of the subject. A physician or other health care professional has not verified this report. Medical history included hepatitis C. The reporter stated that the subject, "is not a drug user." Concurrent medications included Ibuprofen. On an unspecified date in January 2006, the subject receive the 1st dose of Twinrix. On an unspecified date in January 2006, approximately "two weeks before the 2nd dose" of Twinrix, a "drug test was negative." On 12 February
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Feeling hot, Injection site erythema, Injection site inflammation
Clinical narrative: This case was reported by a physician and described the occurrence of swelling injection site in a 51 year old female subject who was vaccinated with Twinrix for prophylaxis.  Medical history included non-smoker and gastro-esophageal reflux disease. Concurrent medication included Nexium. On 22 September 2005 the subject received 1st dose of Twinrix. On 23 September 2005, 1 day after vaccination with Twinrix, the subject experienced swelling injection site, injection site redness and heat at injection site. The subject was treated with Benadryl. The events resolved on 24 September 2006. The physician considered the events to be related to vaccination with Twinrix.
Age: 20.0
Sex: M
Vaccine: HEPAB
Symptoms: Therapeutic response decreased
Clinical narrative: This case was reported by a nurse and described a 21 year old male subject who had a decreased antibody response to the hepatitis B component of immunization of Twinrix. On September 23, 2003, February 20, 2004, and August 03, 2004 the patient received three doses of Twinrix (lots HAB238B6, HAB276A, and HAB306A6) in his arm. Approximately 7 months after the last dose of Twinrix, on March 15, 2006, a hepatitis B surface antibody titer measured less than 8 UI/L. Protection is 10 (mIU/ml).
Age: 13.0
Sex: F
Vaccine: HEPAB, TTOX
Symptoms: Menstrual disorder
Clinical narrative: This case was reported by a nurse and described the occurrence of abnormal menstrual cycle in a 23 year old female subject who was vaccinated with hepatitis A inactivated and Twinrix plus a separate injection of Tetanus diphtheria toxoid. Medical history included smoker. Concurrent medications included Ortho Novum. On 10 February 2006, the subject received a dose of Twinrix (lot AHABB026AC) plus a separate injection of Tetanus and diphtheria toxoids (lot U13408A). On 13 February 2006, 3 days after receipt of the vaccinations, the subject "received her menstrual cycle." The event resolved on 03 March 2006. The nurse considered the event to possibly be related to vaccination with Twinrix and Tetanus and diphtheria toxoids.
Age: 37.0
Sex: F
Vaccine: HEPAB, TTOX
Symptoms: Menstrual disorder
Clinical narrative: This case was reported by a nurse and described the occurrence of abnormal menstrual cycle in a 37 year old female subject who was vaccinated with Twinrix plus a separate injection of tetanus and diphtheria toxoids adsorbed. Medical history included food allergies (non-egg), chronic asthma, fibromyalgia, non smoker, non drinker and no known drug allergies. Concurrent medications included Birth control pills. On 10 February 2006, the subject received 1st dose of Twinrix (lot AHABB026AC) plus a separate injection of Tetanus and diphtheria toxoids (lot U13408A). On 10 February 2006, at an unspecified time following receipt of the vaccinations, the subject "received her menstrual cycle." The subject was seen at a physician's office and was treated with progesterone. The menstrual cycle "stopped with the progesterone" on 14 March 2006. The nurse reported the outcome as resolved with sequelae. The nurse considered the event to possibly be related to vaccination with Twinrix and tetanus and diphtheria toxoids adsorbed.
Age: 33.0
Sex: F
Vaccine: HEPAB, TTOX
Symptoms: Menstrual disorder
Clinical narrative: This case was reported by a nurse and described the occurrence of abnormal menstrual cycle in a 33 year old female subject who was vaccinated with Twinrix plus a separate injection of tetanus and diphtheria toxoids adsorbed. Medical history included hypothyroidism and rosacea. Concurrent medications included Birth control pills. On 10 February 2006 the subject received 1st dose of Twinrix (lot AHABB026AC) plus a separate injection of Tetanus and diphtheria toxoids (lot U13408A). On 11 February 2006, one day after receipt of the vaccinations, the subject "received her menstrual cycle." The subject was seen at a physician's office. The event resolved on 16 February 2006. The nurse considered the event to possibly be related to vaccination with Twinrix tetanus and diphtheria toxoids adsorbed. Case A595775A and A595774A are duplicates of A0595765A. All further information will be entered into A0595765A.
Sex: U
Vaccine: HEPAB
Symptoms: Therapeutic response unexpected
Clinical narrative: This case was reported by a physician to a sales representative and described a subject of unspecified age and gender who did not respond to immunization to Twinrix for prophylaxis. On an unspecified date before 14 February 2006, the subject received 6th dose of Twinrix. At an unspecified time after vaccination with the 6th dose of Twinrix, on an unspecified date on or before 14 February 2006, titers to hepatitis A antibody and hepatitis B surface antibody were negative.
Age: 35.0
Sex: F
Vaccine: HEPAB, TTOX
Symptoms: Dermatitis allergic, Injection site urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of allergic skin reaction in a 35 year old female subject who was vaccinated with Twinrix for prophylaxis. The reporting physician is an allergist. The subject's medical history included depression, herpes simplex infection, migraine, mitral valve prolapse and sulfa allergy. Concurrent medications included Lexapro, Wellbutrin, and Acyclovir. On 16 February 2006 at 9:00am, the subject received 1st dose of Twinrix in the right arm. On 16 February 2006 at 9:00am, the subject also received an injection of tetanus toxoid (Aventis Pasteur) in the left arm. On 16 February 2006, at 10:15am approximately 75 minutes after vaccination with Twinrix, the subject experienced injection site hives on the right arm, at the site of the Twinrix injection. The hives,  "then spread" to a cutaneous systemic allergic reactionon 16 February 2006. The subject was seen at an allergist's office and was treated with adrenalline (Epinephrine) and steroid (Steroids). The immunization series with Twinrix was discontinued. At the time of initial reporting, 17 February 2006, the events were improved. The reporting physician stated that she, "thinks (the events) were probably with Twinrix since the tetanus vaccine was in the left arm and the reaction started in the right arm."