chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Discrete papular vesicular rash present one day, pruritic 20 plus spots
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Medication error
Clinical narrative: Pt was asked if she had received pneumovax in past. She stated "no". When reviewing chart found pt had shot in 2003. Pt received shot she did not need.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling at injection site, noticed the day following immunization, 11/09/05.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Medication error, Pruritus, Pyrexia, Skin warm
Clinical narrative: Returned to clinic 10/18 c/o fever 99 degrees F - seen by med provider L shoulder to elbow red, swollen - warm to touch and tender without erythema and edema. Dx as arthus reaction. Rx - tylenol and cool pack to area 10/99 referred to clinic - swelling resolved - given Benadryl for itching
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling, Tenderness
Clinical narrative: Returned to clinic 10/18 c/o fever 99 degrees F - seen by med provider L shoulder to elbow red, swollen - warm to touch and tender without erythema and edema. Dx as arthus reaction. Rx - tylenol and cool pack to area 10/99 referred to clinic - swelling resolved - given Benadryl for itching
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Aphasia, Dry throat, Dysphonia, Tongue disorder
Clinical narrative: Throat felt dry and hoarse after 15 min progressed to tongue feeling thick and hard to talk. Benadryl 50 mg IM, called, all sent to ER.
Age: 1.29
Sex: F
Vaccine: IPV, MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Pt had a febrile seizure (temp 104 degrees) 10 days after MMR and IPV. No other symptoms.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Pain, Swelling
Clinical narrative: Upper arm became swollen and hard and hurt. Then a day later it became red. Now soft - reaction about gone.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Hyperhidrosis, Sensation of heaviness
Clinical narrative: Immediately after shot c/o "feeling funny". Had her recline on table with cool air, cloth. After several minutes c/o dizzy, sweating, "arms feel heavy". v/s 120/70, resp 20, pulse 76. After 25 min Benadryl given. After 25 min pt still c/o of heavy feeling. Taken to ER by EMT. BP 110/60 pulse 116 resp 24. Pt observed in ER then released at 7pm.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Intense pain in left deltoid area after pneumovax for 48 hours, improved by 72 hours
Age: 1.48
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Child developed a rash within 10 days of vaccine.
Sex: F
Vaccine: HEP
Symptoms: Unintended pregnancy
Clinical narrative: Soldier is 6 weeks pregnant. Was administered Hepatitis B vaccine Lot AHBVB131AA Exp. 12/09/06.
Age: 33.0
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Headache, Pyrexia
Clinical narrative: Nausea, vomiting, diarrhea, headache, low grade fever 11/14 - 11/18/05 No treatment
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye pain, Feeling hot, Headache, Injection site erythema, Shoulder pain
Clinical narrative: Received Varivax vaccine #2 11/16/2005. Redness started 11/16/05 evening. Awoke this am with enlarging redness induration, warmth at site of injection area enlarging at 3:15 pm 2.75 inches x 3 inches. Also r shoulder pain, headache, left eye pain with pressure.
Age: 64.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Patient received Pneumonia Vaccine in Rt Deltoid, and Influenza vaccine in Left Deltoid on 10/27/05.  By AM of 10/28/05 Rt. Arm had edema and redness below site to elbow.  Patients Privent MD instructed to talk Tylenol every 3 hours and apply ice for next 24-48 hours.       By 10/31/05 Redness relieved edema minimal.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Erythema, Urticaria
Clinical narrative: Pt broke out in hives/redness cheek area of face which progressed to pt back
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia, Oedema peripheral, Pain
Clinical narrative: LEFT ARM BECAME PAINFUL, INFLAMMED, RED, WARM TO TOUCH WITHIN 12 HOURS AFTER VACCINATION. MUSCLE PAIN TRAVELED DOWN CHEST WALL AND THRU SHOULDER BLADE BY DAY 2 FOLLOWING VACCINATION. PT WENT TO PHYSICIAN 24 HOURS AFTER VACCINATION AND WAS PUT ON NUPIRIN FOR INFLAMMATION. TWO DAYS LATER SYMPTOMS ARE RESOLVING.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Terrible fatigue, headache, low grade fever, nausea , excruciating joint and muscle pain. Missede day of work
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Terrible fatigue, headache, low grade fever, nausea , excruciating joint and muscle pain. Missede day of work
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Rash pruritic
Clinical narrative: 11/15 - Pt presented with red, itchy rash on face x 3 days; some small spots on arms.  Rash just erupted.  Pt took OTC claritin and topical hydrocortisone with little relief.  No new detergents, soaps, animals, pillow, bedding, towels or food.  Symptoms have never happened before.  Treated with methylprednisolone Dose-Pack.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Ear pain, Fatigue, Headache, Increased bronchial secretion
Clinical narrative: After receiving vaccination at 11:15am 11/14/05, patient developed sore throat 11/16/05 am.  Patient began OTC throat lozenges with menthol on her way to work.  During the day, headache and mild earache presented.  Patient took anacin (aspirin/caffeine).  In the evening, patient took Robotussin with expectorant and gargled with salt water.  Sleeping elevated was ok.  On 11/17 am, patient visualized yellow phlegm in back of throat and sore throat was worse.  Patient gargled with salt water.  Patient again had headache during the day.  Robotussin was continued throughout the day.  In the evening, voice was deminished.  At night, dissolving OTC product with decongestant and acetominophen was taken but sleep (elevated) was poorer and coughing began.  Today, third day of symptoms, patient has sore throat, mild upper back aches, fatigue and mild cough.  Overall, nasal symptoms have been insignificant.  Patient considers effects to throat and the level of fatigue significant and in the moderate range.  Patient is concerned that the reason to get a flu shot (two children at home under the age of three, one only 15month old) has now put her children at risk of acquiring the flu strain from her, as local supplies of thermosil free vaccine are limited and her children have not yet been vaccinated this year. This information is solely for the purpose of evaluating the safety of this lot of vaccine, not for the purpose of pursuing compensation or reimbursement for health care expenses.  Contrary to the rep, I believe that the purpose of this form is not to presume an association but to provide you with information you can combine with hundreds of other peoples' data to make that determination.  My assumption is that "inactivated (killed)" is not 100.00% effective.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain
Clinical narrative: After receiving vaccination at 11:15am 11/14/05, patient developed sore throat 11/16/05 am.  Patient began OTC throat lozenges with menthol on her way to work.  During the day, headache and mild earache presented.  Patient took anacin (aspirin/caffeine).  In the evening, patient took Robotussin with expectorant and gargled with salt water.  Sleeping elevated was ok.  On 11/17 am, patient visualized yellow phlegm in back of throat and sore throat was worse.  Patient gargled with salt water.  Patient again had headache during the day.  Robotussin was continued throughout the day.  In the evening, voice was deminished.  At night, dissolving OTC product with decongestant and acetominophen was taken but sleep (elevated) was poorer and coughing began.  Today, third day of symptoms, patient has sore throat, mild upper back aches, fatigue and mild cough.  Overall, nasal symptoms have been insignificant.  Patient considers effects to throat and the level of fatigue significant and in the moderate range.  Patient is concerned that the reason to get a flu shot (two children at home under the age of three, one only 15month old) has now put her children at risk of acquiring the flu strain from her, as local supplies of thermosil free vaccine are limited and her children have not yet been vaccinated this year. This information is solely for the purpose of evaluating the safety of this lot of vaccine, not for the purpose of pursuing compensation or reimbursement for health care expenses.  Contrary to the rep, I believe that the purpose of this form is not to presume an association but to provide you with information you can combine with hundreds of other peoples' data to make that determination.  My assumption is that "inactivated (killed)" is not 100.00% effective.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pain, Paraesthesia
Clinical narrative: Within 24 - 48 hours developed overall body muscle pain, aches, stiff neck, tingling in arms to finger tips, upset stomach, head aches.  Lasting 1 week. Contacted Health District and was told to contact Dr. if symptoms worsen.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Stomach discomfort
Clinical narrative: Within 24 - 48 hours developed overall body muscle pain, aches, stiff neck, tingling in arms to finger tips, upset stomach, head aches.  Lasting 1 week. Contacted Health District and was told to contact Dr. if symptoms worsen.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: At the site of injection, left Deltoid, patient has a red, raised, local reaction.  The affected area is oval in shape and about 3 inches by 2 inches.  Patient reports no other syptoms or problems.  Patient reported to the pharmacy 24 hours after receiving her vaccine.  Patient was instructed to contact her MD for treatment.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Nausea
Clinical narrative: Pt Reports Chills, Fever 101 F, headache, Nausea, Drowsiness by 9PM the day the vaccination was given. Redness and induration at injection site increased through day of report.  Took Alieve in the AM of !1/17. Seen in ER at 4:30 PM 11/17/05. ER physician perscribed tylenol and Benadryl every 4 hours and intermitent ice and heat to injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Somnolence
Clinical narrative: Pt Reports Chills, Fever 101 F, headache, Nausea, Drowsiness by 9PM the day the vaccination was given. Redness and induration at injection site increased through day of report.  Took Alieve in the AM of !1/17. Seen in ER at 4:30 PM 11/17/05. ER physician perscribed tylenol and Benadryl every 4 hours and intermitent ice and heat to injection site.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Drug toxicity
Clinical narrative: RECEIVED VACCINE 10//18/05 P.M. FAMILY STATES NO UNTOWARD AFFECTS NOTD PAST IMMUNIZATION.  FOUND IN BED DEAD THE 11/19/2005 A.M. Drug Toxicity added from Autopsy report rec'd 12/08/2005 was + for methadone & ETOH.  Parent admitted to administering adult strength Tylenol to patient./sr
Age: 45.0
Sex: F
Vaccine: FLUN3
Symptoms: Feeling jittery, Paraesthesia
Clinical narrative: Chest pain approx. 20 minutes after recieving the flumist, ear lobes tingley and very jittery  I gave her benadryl, she called her doctor and went home to rest.  The synmptoms disapeared within 30 min of taking the benadryl.
Age: 4.0
Sex: M
Vaccine: IPV, UNK
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Received 2 vaccines in upper arms Fri 11/14/05. Sunday 11/16/05 right arm swelled from shoulder to elbow, with demarcation, deep red color, warm to touch, significant pain.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient developed hardness, swelling, redness at the deltoid injection site, and the redness traveled down to the armpit over then next several hours.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: c/o dizziness, hives after 3 days of receiving influenza vaccine. The patient cont. to c/o of hives sporadically appearing/disappearing on arms, torso, neck and behind knees. c/o pruritis. The size of Hives range from size of a pencil eraser to golf ball size.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: PATIENT EXPERIENCED RASH ON FACE AND HAS NOT BEEN TREATED. RASH IS STILL PRESENT, BUT IMPROVING (PER THE PATIENT) ON 11/18/05. ADVISED TO TREAT ALLERGY WITH BENDADRYL TABLETS ON 11/18/05.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Asthenia, Encephalopathy, Palpitations, Speech disorder
Clinical narrative: Altered mental status and generalized weakness. Discharge summary states encephalopathy. msv Medical records state abnormal vision, palpitations, anxiety, speech disorder. msv.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Stupor, Visual disturbance
Clinical narrative: Altered mental status and generalized weakness. Discharge summary states encephalopathy. msv Medical records state abnormal vision, palpitations, anxiety, speech disorder. msv.
Age: 71.0
Sex: F
Vaccine: FLUX
Symptoms: Face oedema, Urticaria
Clinical narrative: I recieved the shot at 12 noon Monday and I woke up Tuesday with Hives and swollen eyes. This is Friday and I still have it.This was a flu shot
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Laryngeal oedema, Laryngospasm, Pharyngeal oedema
Clinical narrative: Patient is my wife and a Russian immigrant (with fair English language skills). I am a PharmD (clinical pharmacist) and thus filing this report for my wife.  On the evening of Thurs, Nov 17 2005, at an employee & family "flu vaccination clinic" onsite my wife recived an IM flu shot, and approximately 2 hrs later, she experienced  laryngeal spasm and edema and difficulty breathing.  Throat felt swollen inside and out.  This persisted for about 3 hrs (from 10 pm to 1am, disrupting sleep) and gradually faded away by 3am. No treatment administered, but was seconds away from going to hospital.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Dyspnoea, Headache, Pyrexia
Clinical narrative: Vaccine given at 9.30 am. Chills at 4.pm,weakness,headache,chough,sneezing and fever of 103.01 by 5pm.At 9pm,temp.102.02. Difficulty breathing,I have Asthma and COPD and use Oxygen.By morning felt much better.rough night of trying to sleep.Am doing OK now.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Vaccine given at 9.30 am. Chills at 4.pm,weakness,headache,chough,sneezing and fever of 103.01 by 5pm.At 9pm,temp.102.02. Difficulty breathing,I have Asthma and COPD and use Oxygen.By morning felt much better.rough night of trying to sleep.Am doing OK now.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Heart rate increased, Pain, Pyrexia, Rash
Clinical narrative: Right after Flu shot, felt very fatigued which got worse throughout the day- developed fever and internal pain all over body- had difficulty breathing and experienced pain in lungs, very weak/no energy and fast heart rate. A few days later, broke out with rash all over arms and spreading to neck area.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Ear pain, Facial palsy
Clinical narrative: 112 days after receiving vaccine developed left ear area pain and loss of sense of taste on left side of tongue. On day 6 after vaccine administration I expereinced the gradual onset of a loss of motor function on left side of face (peripheral VIIth nerve distribution, which was mild at first and progressed to a complete paralysis of motor function over the next 18 hours. The systems have persisted, now 9 days after receiving the vaccine. (Bell's Palsy)
Age: 80.0
Sex: M
Vaccine: FLUX
Symptoms: Face oedema, Oedema peripheral, Rash
Clinical narrative: Patient broke out in a rash over most of his body. There was also swelling in the hands, feet and face.  This was treated in Urgent Care with an antihistimine shot followed by a course of Benadryl and the application of Triamcinolone Acetonide Ointment USP (0.1%).
Age: 31.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Asthenia, Headache, Lethargy, Lymphadenopathy, Malaise
Clinical narrative: Information has been received from a pharmacist concerning a 31 year old female who on Aug 18 2005 was vaccinated SC with a 0.5ml dose of rubella virus vaccine live (Wistar RA 27/3) (lot 649072/1094P). Subsequently the patient experienced a rash. It was noted that the patients husband developed a rash about the same time. The patient is recovering. It was unknown if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 31 year old female who on Aug 18 2005 was vaccinated SC with a 0.5ml dose of rubella virus vaccine live (Wistar RA 27/3) (lot 649072/1094P). Subsequently the patient experienced a rash. It was noted that the patients husband developed a rash about the same time. The patient is recovering. It was unknown if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 31 year old female who on Aug 18 2005 was vaccinated SC with a 0.5ml dose of rubella virus vaccine live (Wistar RA 27/3) (lot 649072/1094P). Subsequently the patient experienced a rash. It was noted that the patients husband developed a rash about the same time. The patient is recovering. It was unknown if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Dyspnoea, Erythema, Pain, Rales
Clinical narrative: Information has been received from a pharmacist and daughter of the consumer concerning an 84 year old female who on Oct 23 2005 was vaccinated IM with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). The patients daughter called the pharmacist to report that on Oct 24 2005 her mother developed redness and swelling in the arm she received pneumococcal 23v polysaccharide vaccine. The patient was hospitalized on the evening of Nov 2 2005 with shortness of breath, rales, and pneumonia. The pharmacist reported that he pulled all of his pneumococcal 23v polysaccharide vaccine off his shelf and requested a lot check be done. At the time of the report the patient was reported as not recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. 11/16/05 additonal terms -- chest pain, fever, chills, nausea/sr
Age: 84.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Chest pain, Chills, Drug ineffective, Dyspnoea, Erythema
Clinical narrative: Information has been received from a pharmacist and daughter of the consumer concerning an 84 year old female who on Oct 23 2005 was vaccinated IM with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). The patients daughter called the pharmacist to report that on Oct 24 2005 her mother developed redness and swelling in the arm she received pneumococcal 23v polysaccharide vaccine. The patient was hospitalized on the evening of Nov 2 2005 with shortness of breath, rales, and pneumonia. The pharmacist reported that he pulled all of his pneumococcal 23v polysaccharide vaccine off his shelf and requested a lot check be done. At the time of the report the patient was reported as not recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. 11/16/05 additonal terms -- chest pain, fever, chills, nausea/sr
Age: 84.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Infection, Injection site hypersensitivity, Injection site oedema, Nausea, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist and daughter of the consumer concerning an 84 year old female who on Oct 23 2005 was vaccinated IM with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). The patients daughter called the pharmacist to report that on Oct 24 2005 her mother developed redness and swelling in the arm she received pneumococcal 23v polysaccharide vaccine. The patient was hospitalized on the evening of Nov 2 2005 with shortness of breath, rales, and pneumonia. The pharmacist reported that he pulled all of his pneumococcal 23v polysaccharide vaccine off his shelf and requested a lot check be done. At the time of the report the patient was reported as not recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. 11/16/05 additonal terms -- chest pain, fever, chills, nausea/sr
Age: 84.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Pneumonia, Pyrexia, Rales
Clinical narrative: Information has been received from a pharmacist and daughter of the consumer concerning an 84 year old female who on Oct 23 2005 was vaccinated IM with a second 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). The patients daughter called the pharmacist to report that on Oct 24 2005 her mother developed redness and swelling in the arm she received pneumococcal 23v polysaccharide vaccine. The patient was hospitalized on the evening of Nov 2 2005 with shortness of breath, rales, and pneumonia. The pharmacist reported that he pulled all of his pneumococcal 23v polysaccharide vaccine off his shelf and requested a lot check be done. At the time of the report the patient was reported as not recovered. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. 11/16/05 additonal terms -- chest pain, fever, chills, nausea/sr
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site induration, Injection site oedema, Pruritus
Clinical narrative: 1 hour after vaccination, developed hives around injection site with itching. Site red, hard, warm, swollen. Induration 2 in x 1 in 1/2 hour later developed generalized itching lasting 24 to 48 hours. Took Zyrtec for 4 days. 3 days less swelling. Still hard, slightly red, slightly itchy.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 1 hour after vaccination, developed hives around injection site with itching. Site red, hard, warm, swollen. Induration 2 in x 1 in 1/2 hour later developed generalized itching lasting 24 to 48 hours. Took Zyrtec for 4 days. 3 days less swelling. Still hard, slightly red, slightly itchy.
Age: 39.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Dyspnoea, Feeling hot, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Pt called 10/17 stated her rt arm at YF injection site was red warm and swollen to touch. Later that night after the injections she had wheezing difficulty breathing and began itching at midnight and broke out in hives on her abdomen. She did not go to a Dr. She took tylenol allergy sinus felt bad the whole weekend. Hives went away on Monday and breathing was better.
Age: 39.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Urticaria, Wheezing
Clinical narrative: Pt called 10/17 stated her rt arm at YF injection site was red warm and swollen to touch. Later that night after the injections she had wheezing difficulty breathing and began itching at midnight and broke out in hives on her abdomen. She did not go to a Dr. She took tylenol allergy sinus felt bad the whole weekend. Hives went away on Monday and breathing was better.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Eye disorder, Hypoacusis, Hypokinesia, Influenza like illness
Clinical narrative: Information has been received from a 54 year old female registered nurse with an allergy to pentazocine lactate (Talwin), arrhythmias, and high cholesterol who on Oct 18 2005 vaccinated herself SC in the right thigh with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol and pravastatin NA (Pravachol). The nurse noted that she was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine about a week ago, on approximately Oct 13 2005, and nothing happened after the first dose. She reported that they messed up and gave it to her again because she was supposed to get a flu vaccine but they gave her pneumococcal 23v polysaccharide vaccine instead. On Oct 18 2005, she went to a physicians office to pick up a flu shot for her patient. The physician stated that the nurse could have one also and she was given two filled syringes. Later that she gave herself the vaccination and saw that the label on the syringe indicated that  it was  pneumococcal 23v polysaccharide vaccine. The other syringe said the same. The nurse reported that within a few hours of getting the second dose, her right eye was drooping and she could not hear out of her left ear. She also reported that her legs hurt and she had flu like symptoms (exact onset date not reported). On Oct 19 2005, she had red lumps on both of her legs and they were gone on Oct 20 2005. On Oct 20 2005, she reported that she could hardly hear out of both ears but her eye was better. She had pain in her right thigh where she received the injection and it was hot and swollen (exact onset not reported). She noted that she could hardly walk on it (exact onset not reported). She took naproxen sodium (Aleve) for the pain. She noted that she would be seeing a physician on Oct 20 2005. No diagnostic laboratory test were performed. A product quality complaint was not involved. Follow up information was received on Nov 10 2005 from the registered nurse who reported that she was still experiencing effects from the vaccination. She had a rash at the injection site on her thigh. She was hospitalized for a vaginal ulceration believed to be related to therapy with pneumococcal 23v polysaccharide vaccine. She noted that she had upcoming appointments with an internist, dermatologist, and an otolaryngologist. She was given methylprednisolone acetate (Depo Medrol) and cephalexin (Keflex). Additional information has been requested. Medical records state otitis, puritis, rash. msv
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site pain, Injection site rash, Injection site warmth, Medication error
Clinical narrative: Information has been received from a 54 year old female registered nurse with an allergy to pentazocine lactate (Talwin), arrhythmias, and high cholesterol who on Oct 18 2005 vaccinated herself SC in the right thigh with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol and pravastatin NA (Pravachol). The nurse noted that she was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine about a week ago, on approximately Oct 13 2005, and nothing happened after the first dose. She reported that they messed up and gave it to her again because she was supposed to get a flu vaccine but they gave her pneumococcal 23v polysaccharide vaccine instead. On Oct 18 2005, she went to a physicians office to pick up a flu shot for her patient. The physician stated that the nurse could have one also and she was given two filled syringes. Later that she gave herself the vaccination and saw that the label on the syringe indicated that  it was  pneumococcal 23v polysaccharide vaccine. The other syringe said the same. The nurse reported that within a few hours of getting the second dose, her right eye was drooping and she could not hear out of her left ear. She also reported that her legs hurt and she had flu like symptoms (exact onset date not reported). On Oct 19 2005, she had red lumps on both of her legs and they were gone on Oct 20 2005. On Oct 20 2005, she reported that she could hardly hear out of both ears but her eye was better. She had pain in her right thigh where she received the injection and it was hot and swollen (exact onset not reported). She noted that she could hardly walk on it (exact onset not reported). She took naproxen sodium (Aleve) for the pain. She noted that she would be seeing a physician on Oct 20 2005. No diagnostic laboratory test were performed. A product quality complaint was not involved. Follow up information was received on Nov 10 2005 from the registered nurse who reported that she was still experiencing effects from the vaccination. She had a rash at the injection site on her thigh. She was hospitalized for a vaginal ulceration believed to be related to therapy with pneumococcal 23v polysaccharide vaccine. She noted that she had upcoming appointments with an internist, dermatologist, and an otolaryngologist. She was given methylprednisolone acetate (Depo Medrol) and cephalexin (Keflex). Additional information has been requested. Medical records state otitis, puritis, rash. msv
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Otitis media, Pain, Pruritus, Rash, Vulvovaginal disorder
Clinical narrative: Information has been received from a 54 year old female registered nurse with an allergy to pentazocine lactate (Talwin), arrhythmias, and high cholesterol who on Oct 18 2005 vaccinated herself SC in the right thigh with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol and pravastatin NA (Pravachol). The nurse noted that she was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine about a week ago, on approximately Oct 13 2005, and nothing happened after the first dose. She reported that they messed up and gave it to her again because she was supposed to get a flu vaccine but they gave her pneumococcal 23v polysaccharide vaccine instead. On Oct 18 2005, she went to a physicians office to pick up a flu shot for her patient. The physician stated that the nurse could have one also and she was given two filled syringes. Later that she gave herself the vaccination and saw that the label on the syringe indicated that  it was  pneumococcal 23v polysaccharide vaccine. The other syringe said the same. The nurse reported that within a few hours of getting the second dose, her right eye was drooping and she could not hear out of her left ear. She also reported that her legs hurt and she had flu like symptoms (exact onset date not reported). On Oct 19 2005, she had red lumps on both of her legs and they were gone on Oct 20 2005. On Oct 20 2005, she reported that she could hardly hear out of both ears but her eye was better. She had pain in her right thigh where she received the injection and it was hot and swollen (exact onset not reported). She noted that she could hardly walk on it (exact onset not reported). She took naproxen sodium (Aleve) for the pain. She noted that she would be seeing a physician on Oct 20 2005. No diagnostic laboratory test were performed. A product quality complaint was not involved. Follow up information was received on Nov 10 2005 from the registered nurse who reported that she was still experiencing effects from the vaccination. She had a rash at the injection site on her thigh. She was hospitalized for a vaginal ulceration believed to be related to therapy with pneumococcal 23v polysaccharide vaccine. She noted that she had upcoming appointments with an internist, dermatologist, and an otolaryngologist. She was given methylprednisolone acetate (Depo Medrol) and cephalexin (Keflex). Additional information has been requested. Medical records state otitis, puritis, rash. msv
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Confusional state, Difficulty in walking, Disorientation, Dizziness, Erythema
Clinical narrative: Information has been received from a 54 year old female registered nurse with an allergy to pentazocine lactate (Talwin), arrhythmias, and high cholesterol who on Oct 18 2005 vaccinated herself SC in the right thigh with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol and pravastatin NA (Pravachol). The nurse noted that she was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine about a week ago, on approximately Oct 13 2005, and nothing happened after the first dose. She reported that they messed up and gave it to her again because she was supposed to get a flu vaccine but they gave her pneumococcal 23v polysaccharide vaccine instead. On Oct 18 2005, she went to a physicians office to pick up a flu shot for her patient. The physician stated that the nurse could have one also and she was given two filled syringes. Later that she gave herself the vaccination and saw that the label on the syringe indicated that  it was  pneumococcal 23v polysaccharide vaccine. The other syringe said the same. The nurse reported that within a few hours of getting the second dose, her right eye was drooping and she could not hear out of her left ear. She also reported that her legs hurt and she had flu like symptoms (exact onset date not reported). On Oct 19 2005, she had red lumps on both of her legs and they were gone on Oct 20 2005. On Oct 20 2005, she reported that she could hardly hear out of both ears but her eye was better. She had pain in her right thigh where she received the injection and it was hot and swollen (exact onset not reported). She noted that she could hardly walk on it (exact onset not reported). She took naproxen sodium (Aleve) for the pain. She noted that she would be seeing a physician on Oct 20 2005. No diagnostic laboratory test were performed. A product quality complaint was not involved. Follow up information was received on Nov 10 2005 from the registered nurse who reported that she was still experiencing effects from the vaccination. She had a rash at the injection site on her thigh. She was hospitalized for a vaginal ulceration believed to be related to therapy with pneumococcal 23v polysaccharide vaccine. She noted that she had upcoming appointments with an internist, dermatologist, and an otolaryngologist. She was given methylprednisolone acetate (Depo Medrol) and cephalexin (Keflex). Additional information has been requested. Medical records state otitis, puritis, rash. msv
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Eye disorder, Eye pain, Fatigue, Headache, Hypoacusis
Clinical narrative: Information has been received from a 54 year old female registered nurse with an allergy to pentazocine lactate (Talwin), arrhythmias, and high cholesterol who on Oct 18 2005 vaccinated herself SC in the right thigh with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol and pravastatin NA (Pravachol). The nurse noted that she was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine about a week ago, on approximately Oct 13 2005, and nothing happened after the first dose. She reported that they messed up and gave it to her again because she was supposed to get a flu vaccine but they gave her pneumococcal 23v polysaccharide vaccine instead. On Oct 18 2005, she went to a physicians office to pick up a flu shot for her patient. The physician stated that the nurse could have one also and she was given two filled syringes. Later that she gave herself the vaccination and saw that the label on the syringe indicated that  it was  pneumococcal 23v polysaccharide vaccine. The other syringe said the same. The nurse reported that within a few hours of getting the second dose, her right eye was drooping and she could not hear out of her left ear. She also reported that her legs hurt and she had flu like symptoms (exact onset date not reported). On Oct 19 2005, she had red lumps on both of her legs and they were gone on Oct 20 2005. On Oct 20 2005, she reported that she could hardly hear out of both ears but her eye was better. She had pain in her right thigh where she received the injection and it was hot and swollen (exact onset not reported). She noted that she could hardly walk on it (exact onset not reported). She took naproxen sodium (Aleve) for the pain. She noted that she would be seeing a physician on Oct 20 2005. No diagnostic laboratory test were performed. A product quality complaint was not involved. Follow up information was received on Nov 10 2005 from the registered nurse who reported that she was still experiencing effects from the vaccination. She had a rash at the injection site on her thigh. She was hospitalized for a vaginal ulceration believed to be related to therapy with pneumococcal 23v polysaccharide vaccine. She noted that she had upcoming appointments with an internist, dermatologist, and an otolaryngologist. She was given methylprednisolone acetate (Depo Medrol) and cephalexin (Keflex). Additional information has been requested. Medical records state otitis, puritis, rash. msv
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Influenza, Oedema, Pain, Pneumoconiosis, Pyrexia
Clinical narrative: Information has been received from a 54 year old female registered nurse with an allergy to pentazocine lactate (Talwin), arrhythmias, and high cholesterol who on Oct 18 2005 vaccinated herself SC in the right thigh with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol and pravastatin NA (Pravachol). The nurse noted that she was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine about a week ago, on approximately Oct 13 2005, and nothing happened after the first dose. She reported that they messed up and gave it to her again because she was supposed to get a flu vaccine but they gave her pneumococcal 23v polysaccharide vaccine instead. On Oct 18 2005, she went to a physicians office to pick up a flu shot for her patient. The physician stated that the nurse could have one also and she was given two filled syringes. Later that she gave herself the vaccination and saw that the label on the syringe indicated that  it was  pneumococcal 23v polysaccharide vaccine. The other syringe said the same. The nurse reported that within a few hours of getting the second dose, her right eye was drooping and she could not hear out of her left ear. She also reported that her legs hurt and she had flu like symptoms (exact onset date not reported). On Oct 19 2005, she had red lumps on both of her legs and they were gone on Oct 20 2005. On Oct 20 2005, she reported that she could hardly hear out of both ears but her eye was better. She had pain in her right thigh where she received the injection and it was hot and swollen (exact onset not reported). She noted that she could hardly walk on it (exact onset not reported). She took naproxen sodium (Aleve) for the pain. She noted that she would be seeing a physician on Oct 20 2005. No diagnostic laboratory test were performed. A product quality complaint was not involved. Follow up information was received on Nov 10 2005 from the registered nurse who reported that she was still experiencing effects from the vaccination. She had a rash at the injection site on her thigh. She was hospitalized for a vaginal ulceration believed to be related to therapy with pneumococcal 23v polysaccharide vaccine. She noted that she had upcoming appointments with an internist, dermatologist, and an otolaryngologist. She was given methylprednisolone acetate (Depo Medrol) and cephalexin (Keflex). Additional information has been requested. Medical records state otitis, puritis, rash. msv
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Urticaria, Vision blurred
Clinical narrative: Information has been received from a 54 year old female registered nurse with an allergy to pentazocine lactate (Talwin), arrhythmias, and high cholesterol who on Oct 18 2005 vaccinated herself SC in the right thigh with a second dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included atenolol and pravastatin NA (Pravachol). The nurse noted that she was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine about a week ago, on approximately Oct 13 2005, and nothing happened after the first dose. She reported that they messed up and gave it to her again because she was supposed to get a flu vaccine but they gave her pneumococcal 23v polysaccharide vaccine instead. On Oct 18 2005, she went to a physicians office to pick up a flu shot for her patient. The physician stated that the nurse could have one also and she was given two filled syringes. Later that she gave herself the vaccination and saw that the label on the syringe indicated that  it was  pneumococcal 23v polysaccharide vaccine. The other syringe said the same. The nurse reported that within a few hours of getting the second dose, her right eye was drooping and she could not hear out of her left ear. She also reported that her legs hurt and she had flu like symptoms (exact onset date not reported). On Oct 19 2005, she had red lumps on both of her legs and they were gone on Oct 20 2005. On Oct 20 2005, she reported that she could hardly hear out of both ears but her eye was better. She had pain in her right thigh where she received the injection and it was hot and swollen (exact onset not reported). She noted that she could hardly walk on it (exact onset not reported). She took naproxen sodium (Aleve) for the pain. She noted that she would be seeing a physician on Oct 20 2005. No diagnostic laboratory test were performed. A product quality complaint was not involved. Follow up information was received on Nov 10 2005 from the registered nurse who reported that she was still experiencing effects from the vaccination. She had a rash at the injection site on her thigh. She was hospitalized for a vaginal ulceration believed to be related to therapy with pneumococcal 23v polysaccharide vaccine. She noted that she had upcoming appointments with an internist, dermatologist, and an otolaryngologist. She was given methylprednisolone acetate (Depo Medrol) and cephalexin (Keflex). Additional information has been requested. Medical records state otitis, puritis, rash. msv
Age: 80.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Cough, Oedema, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 80 year old male patient, with an unknown medical history and unknown drug reaction/allergies, who on Oct 12 2005 was vaccinated (route unknown) in his right arm with a dose of pneumococcal 23v polysaccharide vaccine (650453/1791P). Concomitantly he was vaccinated in his left arm with a dose of influenza virus vaccine (unspecified). Subsequently, on an unspecified date, the patient developed chills, swelling of his arm, fever, and coughing. The patient was treated with gatifloxacin (Tequin), 400 mg, daily for 7 days. On an unknown date the patient recovered. The patients experiences were considered to be other medical events by the reporter (OMIC). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMRV, PNC
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 12-month-old female who on 28-Oct-2005 was vaccinated in the right thigh with a dose of measles virus vaccine live plus mumps virus vaccine live plus rubella virus vaccine live plus varicella virus vaccine live. Concomitant vaccinations on the same day include a dose of hepatitis B virus vaccine rHBsAg (yeast) plus Hib conj vaccine (OMPC) and a dose of pneumococcal 4 6B 9V 18C 19F 23F conj vaccine (CRM197) (Prevnar). On 10-Nov-2005, the patient had a seizure at home. She was taken to the hospital and had two more seizures that same day in the emergency room. She was subsequently admitted to the hospital. There was no fever involved. A spinal tap showed no white cells so the physician ruled out aseptic meningitis. At the time of the report, the patient remained hospitalized. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: HEP
Symptoms: Apparent life threatening event, Dyspnoea, Oropharyngeal swelling
Clinical narrative: information has been received from a physician concerning a male at risk patient in his mid sixties who, a couple of years ago, in approximately 2003, was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). A couple of years ago, in approximately 2003, the patient experienced a swelling of the air passage and breathing trouble. The patient went to the emergency room and was treated. It was reported that the patient recovered. No other information was provided. Swelling of the air passage and breathing trouble were considered to be immediately life threatening and disabling by the reporter. Additional information has been requested. This is an amended report, tracheal oedema has been changed to oropharyngeal swelling. This is a corrected report as amended. Oropharyngeal swelling is considered an expected event, and as a result the report no longer meets the criteria for expedited submission.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning a child who was vaccinated with a dose of measles virus vaccine live plus mumps virus vaccine live plus rubella virus vaccine live. Subsequently, a few days after vaccination, the patient started to act differently. It was noted that the child was diagnosed with autism. No further information was available. There was no product quality complaint. Upon internal review, autism was considered another important medical event (OMIC). Additional information has been requested
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Oedema
Clinical narrative: Information has been received from a physician who reported to a company representative concerning a 65 year old female who received her first dose pneumococcal 23v polysaccharide vaccine (lot not provided) on an unknown date in approximately 2000. On Oct 31 2005 the patient was vaccinated with her second dose of pneumococcal 23v polysaccharide vaccine (650327/0792P). The same day the patients left arm became red and swollen. The patient was seen by the physician on Nov 1 2005 in his office and was diagnosed with an allergic reaction that was considered to be an other medical event (OMIC). The physician prescribed fexofenadine hydrochloride (Allergra), ice and elevation. Subsequently, on an unknown date the patient recovered from the allergic reaction without complication. Additional information has been requested.