chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Received MMR 8/17/06. 3 days after injection had fever x 1D. Then since 8/22/06 has c/o arthralgia, chest and face rash, adenopathy walked into office 8/28/06 with above complaints. Referred to Dr (Infectious diseases).
Age: 32.0
Sex: M
Vaccine: HEP, IPV, MMR
Symptoms: Back pain, Erythema, Headache, Pyrexia, Rash
Clinical narrative: Had fever, hives 8/24. Still has rash, no blisters but red bumps on about every inch of my body. Ha head and back pain, skin hurt everywhere. Saw Dr on the 28th and 29th, Started in Prednisone 28th and feel better already. Dr gave me a dose pack. Recommended no more MMR. Continue Hep A and B vaccines. Trip in Nov Abroad. Wait until rash clears before beginning oral Typhoid. VAERS completed.
Age: 32.0
Sex: M
Vaccine: HEP, IPV, MMR
Symptoms: Skin irritation, Urticaria
Clinical narrative: Had fever, hives 8/24. Still has rash, no blisters but red bumps on about every inch of my body. Ha head and back pain, skin hurt everywhere. Saw Dr on the 28th and 29th, Started in Prednisone 28th and feel better already. Dr gave me a dose pack. Recommended no more MMR. Continue Hep A and B vaccines. Trip in Nov Abroad. Wait until rash clears before beginning oral Typhoid. VAERS completed.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Chorea, Dyskinesia, Hypokinesia
Clinical narrative: Jerking movements to both upper extremities, upper trunk and face. Unable to pick up objects. Symptoms concerning for chorea. Rheumatic fever work up negative.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema
Clinical narrative: The morning after immunizations, child woke up with redness and swelling lt deltoid that progressed to neckline and down to elbow. Mother took child to PMD the following day Friday 7/28/06, Diagnosis allergic reaction. Treatment. Prednisone 3mg QD PO x 3 days. Resolved by 7/30/06.
Age: 19.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Injection site rash, Pruritus
Clinical narrative: Patient states that approximately 20-30 minutes after injection of MMR she noticed a rash around injection site. She described it as "spider bites", said it was very itchy.  States it lasted 1 week but never sought medical attention.  States she did have a mild rash on right arm as well but not as much as on the left arm around MMR site.  Did not take any medication such as BENADRYL.
Age: 0.95
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site rash, Urticaria
Clinical narrative: Large Circle rash at injection site right thigh hives all over body.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Erythema, Hypersensitivity, Intestinal obstruction, Rectal haemorrhage
Clinical narrative: Developed rectal bleeding (red blood) about 18 hours after immunization. Now on 9/5/06, she still have some bleeding.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Skin ulcer, Viral infection
Clinical narrative: On 8/29/06 pt came in with a rash child has positive chicken pox. About 30 lesions.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: 8/24/06 3:45 erythema, swelling, about 8cm diameter outer aspect right upper arm, warm and tender to touch. Also about 10 papules over lower back, 1 on right leg, erythematous patches 1cm, localized reaction to DTaP right arm, papules early varicella vs insect bites.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash papular, Tenderness, Viral infection
Clinical narrative: 8/24/06 3:45 erythema, swelling, about 8cm diameter outer aspect right upper arm, warm and tender to touch. Also about 10 papules over lower back, 1 on right leg, erythematous patches 1cm, localized reaction to DTaP right arm, papules early varicella vs insect bites.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash, Rash papular
Clinical narrative: Began with rash on legs. More than 50 papules on thighs, lower abdomen and arms. Calamine lotions and Atarax for itching.
Age: 5.0
Sex: F
Vaccine: BCG, IPV, MMR
Symptoms: Eye oedema, Urticaria
Clinical narrative: Development swelling of eyes and urticaria 5 mins after administration MMR, DTap, IPV.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Symptoms started on 8/27/06 with a swelling (silver dollar) redness and warmth along with tenderness.  Patient came in on 8/31/06 with redness to injection site.  Patient was treated with Loratadine 10mg 1 tab po qd #30 no refills.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Shoulder pain, Swelling
Clinical narrative: Sharp pain in neck, back, upper shoulder and little finger.Pain extends to finger when moving hand. Arm "swollen, tight" no redness. Client states Tylenol does not help.  Suggested use of anti-inflammatory and alternating use of heat and cold. Also recommended client see physician.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Shoulder pain
Clinical narrative: With movement of arm has pain in shoulder and middle of back with difficulty sleeping.  States Tylenol ineffective.  Suggested use of anti-inflammatory and alternating use of cold and heat to site. Recommended client see physician.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Erythema, Oedema, Pruritus
Clinical narrative: 17X14.5 CM RED PATCH ON LEFT OUTER UPPER ARM. MILDLY EDEMATOUS. NO WARMTH. NO TENDERNESS, SOME ITCHING. NO FEVER.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Facial palsy
Clinical narrative: Developed Bell's Palsy 8-28-06 9/12/06-note from 08/30/06-mom contacted office, daughter lost feeling in tongue earlier in day. Mom observed that face was drooping on one side when she speaks. advise nurse directed patient to ER-where patient was DX with Bell's palsy. RX with Prednisone. Visit on 9/1/06-symptoms remain with drooping of face to right side. Lyme lab work negative. Office visit 9/11/06-drooping remains on right side of face. R ear with redness and drying with oozing. Possible cellulitis of right auricle. RX with Duricef . Additional lab tests 8/28/06-Hct 36.2 repeat on 8/30/06 35.8, neutrophils 30, lymph 62, UA negative, Drug screen negative.  Will follow up with physician office in 2 weeks to check on status of symptoms related to Bell's Palsy.
Age: 16.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Facial palsy
Clinical narrative: Developed Bell's Palsy 8-28-06 9/12/06-note from 08/30/06-mom contacted office, daughter lost feeling in tongue earlier in day. Mom observed that face was drooping on one side when she speaks. advise nurse directed patient to ER-where patient was DX with Bell's palsy. RX with Prednisone. Visit on 9/1/06-symptoms remain with drooping of face to right side. Lyme lab work negative. Office visit 9/11/06-drooping remains on right side of face. R ear with redness and drying with oozing. Possible cellulitis of right auricle. RX with Duricef . Additional lab tests 8/28/06-Hct 36.2 repeat on 8/30/06 35.8, neutrophils 30, lymph 62, UA negative, Drug screen negative.  Will follow up with physician office in 2 weeks to check on status of symptoms related to Bell's Palsy.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: LEFT ARM WHERE DTAP#5 WAS GIVEN HAS REDNESS SWELLING AND THREE BLISTERS. RIGHT ARM WHERE MMRV WAS GIVEN HAD SLIGHT REDNESS AND SWELLING.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Hyperaesthesia, Myalgia, Night sweats
Clinical narrative: Average temp of 102.5 for 3 days Severe Body aches/joint aches/muscle aches Severe headache Pain on scalp (sensitiev to touch) Profuse nighttime sweating Dizziness
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Average temp of 102.5 for 3 days Severe Body aches/joint aches/muscle aches Severe headache Pain on scalp (sensitiev to touch) Profuse nighttime sweating Dizziness
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever up to 103 on set 1 day after vaccine administration.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness, swelling, pain after injection.
Age: 25.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Erythema, Injection site warmth, Joint range of motion decreased, Pain, Swelling
Clinical narrative: Patient said right deltoid area, became red, swollen, quarter size hard knot, achy, painful to raise arm.  Knot was hot to touch.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Abscess bacterial, Lymphadenitis, Parotid gland enlargement, Parotitis, Pyrexia
Clinical narrative: A 1 year old presenting with high fever and swelling of the right side of the neck, Cefazolin given IV.  10/24/06 Received medical records from hospital which reveal patient admitted to hospital from 9/9/06 to 9/16/06 with Admit dx: fever, right neck swelling of unknown etiology.  D/C dx: Lymphadenitis resolving, parotitis. Hosp Course:  Started IV antibiotics but developed abscess within the swelling.  ENT consulted & I&D done 9/15.  Surgical drain removed on 9/16. D/C to continue on oral antibiotics for 7 additional days & f/u with ENT & PCP.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Swelling
Clinical narrative: A 1 year old presenting with high fever and swelling of the right side of the neck, Cefazolin given IV.  10/24/06 Received medical records from hospital which reveal patient admitted to hospital from 9/9/06 to 9/16/06 with Admit dx: fever, right neck swelling of unknown etiology.  D/C dx: Lymphadenitis resolving, parotitis. Hosp Course:  Started IV antibiotics but developed abscess within the swelling.  ENT consulted & I&D done 9/15.  Surgical drain removed on 9/16. D/C to continue on oral antibiotics for 7 additional days & f/u with ENT & PCP.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Proctalgia
Clinical narrative: Edema 13 cm by 19 cm, erythema 5 cm by 6 cm, unable to bear weight secondary to pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Blister, Crying, Erythema, Injection site warmth
Clinical narrative: Area of approximately 10 cm, intense erythema, warmth, and induration with weepiness and vesicles surrounding injection site.  Nontender, afebrile, no streaking, no lymphadenopathy.  Treated with KEFLEX.
Age: 3.0
Sex: F
Vaccine: DTAP, HBHEPB, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Left deltoid with redness, mild swelling 2-3 cm, non tender.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: Chest pain, Laryngeal oedema, Oedema, Swelling, Urticaria
Clinical narrative: On 7/4/06 he had a sting.  He had local swelling.  He was treated in the emergency room 7/5/06.  He was given Prednisone 60 mg a day for 3 days and BENADRYL.  He also was given a tetanus shot.  I can not tell you for sure which form, but it would have been an adult form.  On 7/12/06 he had some chest pain and a feeling.  The patient was admitted to the hospital with urticaria, etiology not well documented. Did have an episode of bee sting treated for a few days with steroids.  Doctor did not feel this could be a late reaction to that but the patient id have impression urticaria and some laryngeal edema when seen in the emergency room.  The patient came back to the emergency room, was seen, admitted and left due to the fact that he had improved significantly and signed out against medical advice.  On this admission, returned again with hives and edema and stayed for more complete workup and consult to doctor.  The patient improved significantly with steroids, was adjusted to 30 mg and additional follow-up on an outpatient basis to find an etiology of same.  Did have some hives as a child but no specific etiology was found at that time and had not been followed up with an allergist for similar symptoms through is adult life.  The patient discharged in good condition in care of family on steroids.  BENADRYL and TAGAMET.  Follow up in the office.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Nystagmus, Vaccine positive rechallenge
Clinical narrative: One week following 1st series of vaccines, Subject developed nystagmus with episodes lasting 1 1/2- 2 weeks.  Within 24 hours of 2nd series of vaccines, subject had several episodes of nystagmus.  After 1st series, subject had reportedly normal MRI and EEG.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Nystagmus
Clinical narrative: One week following 1st series of vaccines, Subject developed nystagmus with episodes lasting 1 1/2- 2 weeks.  Within 24 hours of 2nd series of vaccines, subject had several episodes of nystagmus.  After 1st series, subject had reportedly normal MRI and EEG.
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning an 82 year old male with spinal stenosis, benign prostatic hypertrophy, osteoporosis, hypertension and no known drug reactions/allergies who on 31-JUL-2006 was vaccinated subcutaneously with a dose of varicella-zoster virus vaccine live (lot#652925/0621F).  Concomitant therapy included hydrochlorothiazide, aspirin, finasteride, lorazepam, alendronate sodium, calcium (unspecified), vitamin d (unspecified), omeprazole (PRILOSEC) and "zalecton (vitamin supplement)" and a cortisone injection 5 days prior to vaccination.  On 31-JUL-2006 in the evening, the patient developed a herpetic like rash found at the thoraces 10 dermatome.  The rash got more red on 01-AUG-2006 and by 03-AUG-2006a the rash was fading.  No pain or itching was mentioned by the patient.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning an 82 year old male with spinal stenosis, benign prostatic hypertrophy, osteoporosis, hypertension and no known drug reactions/allergies who on 31-JUL-2006 was vaccinated subcutaneously with a dose of varicella-zoster virus vaccine live (lot#652925/0621F).  Concomitant therapy included hydrochlorothiazide, aspirin, finasteride, lorazepam, alendronate sodium, calcium (unspecified), vitamin d (unspecified), omeprazole (PRILOSEC) and "zalecton (vitamin supplement)" and a cortisone injection 5 days prior to vaccination.  On 31-JUL-2006 in the evening, the patient developed a herpetic like rash found at the thoraces 10 dermatome.  The rash got more red on 01-AUG-2006 and by 03-AUG-2006a the rash was fading.  No pain or itching was mentioned by the patient.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 0.29
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Bacterial infection, CSF test abnormal, Irritability, Leukocytosis, Nuchal rigidity
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 15 week old male, with no medical history and no allergies, who on 17-AUG-2006, at 4:30 pm, was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#"0577").  There was no illness at the time of vaccination and no adverse events following prior vaccination.  Concomitant vaccine administered at the same time included a second dose in the right thigh of Hib conj vaccine (Lot#652229/0404F) and a second dose in the right thigh of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B065AA).  On 18-AUG-2006 the patient experienced a febrile illness and was hospitalized for three days.  It was reported that the patient recovered.  Additional information has been requested.
Age: 0.29
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 15 week old male, with no medical history and no allergies, who on 17-AUG-2006, at 4:30 pm, was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#"0577").  There was no illness at the time of vaccination and no adverse events following prior vaccination.  Concomitant vaccine administered at the same time included a second dose in the right thigh of Hib conj vaccine (Lot#652229/0404F) and a second dose in the right thigh of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B065AA).  On 18-AUG-2006 the patient experienced a febrile illness and was hospitalized for three days.  It was reported that the patient recovered.  Additional information has been requested.
Age: 0.29
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 15 week old male, with no medical history and no allergies, who on 17-AUG-2006, at 4:30 pm, was vaccinated with a first oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#"0577").  There was no illness at the time of vaccination and no adverse events following prior vaccination.  Concomitant vaccine administered at the same time included a second dose in the right thigh of Hib conj vaccine (Lot#652229/0404F) and a second dose in the right thigh of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX) (Lot#AC21B065AA).  On 18-AUG-2006 the patient experienced a febrile illness and was hospitalized for three days.  It was reported that the patient recovered.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes simplex, Malaise, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old female with hypertension, hypothyroidism, allergies to sulfonamide, benzocaine, and the angiotensin converting enzyme inhibitors and a history of colon cancer, anemia, hypokalemia and esophageal cancer who on 23-AUG-2006 was vaccinated subcutaneously in the right arm with a 0.65 ml dose of varicella-zoster virus vaccine live (LOT#652965/0622F).  Concomitant therapy included blood pressure medication (unspecified) and hormone medication (unspecified).  It was noted that the patient was vaccinated since her husband had a history of shingles.  On an unspecified date after vaccination, in August 2006, the patient developed zoster-like lesions.  The two locations of the lesions included the right shoulder and the right finger.  The size of the lesion on the right shoulder was two to three centimeters.  There was no reaction near or around the injection site on the right arm.  Unspecified medical attention was sought.  Laboratory tests included a "CBC" and a basic metabolic profile (both routine) (results not provided).  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 64 year old female with hypertension, hypothyroidism, allergies to sulfonamide, benzocaine, and the angiotensin converting enzyme inhibitors and a history of colon cancer, anemia, hypokalemia and esophageal cancer who on 23-AUG-2006 was vaccinated subcutaneously in the right arm with a 0.65 ml dose of varicella-zoster virus vaccine live (LOT#652965/0622F).  Concomitant therapy included blood pressure medication (unspecified) and hormone medication (unspecified).  It was noted that the patient was vaccinated since her husband had a history of shingles.  On an unspecified date after vaccination, in August 2006, the patient developed zoster-like lesions.  The two locations of the lesions included the right shoulder and the right finger.  The size of the lesion on the right shoulder was two to three centimeters.  There was no reaction near or around the injection site on the right arm.  Unspecified medical attention was sought.  Laboratory tests included a "CBC" and a basic metabolic profile (both routine) (results not provided).  At the time of the report, the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Lip swelling
Clinical narrative: 09/06/2006 at 10 AM:  Administered DTaP IM to left leg; IPV, MMR SQ to left leg. ER phoned health department at 4pm on 09/06/2006 to state that child had swollen lips.  Given epi and benadryl with good response.  No respiratory problems.  No other symptoms other than swollen lips. Follow-up Information 20-OCT-2006: Observed 30min post vaccination.
Age: 32.0
Sex: M
Vaccine: ANTH, HEP, HEPA
Symptoms: Arthralgia, Hypertension, Migraine, Rash
Clinical narrative: RASH IN NECK AND BETWEEN MY HANDS, MIGRAINE, BLOOD PRESURE, JOINT PAIN.
Age: 70.0
Sex: M
Vaccine: YF, HEPA, YF
Symptoms: Chills, Chromaturia, Laboratory test abnormal, Pain, Pyrexia
Clinical narrative: Approximately one week after vaccine receipt, had fever up to 102 and chills. Fever lasted for about a week. Also had aches, pain, and pt. stated had dark urine. Office visit on 8/28/06 showed essentially normal physical exam.
Age: 70.0
Sex: M
Vaccine: YF, HEPA, YF
Symptoms: Anaemia, Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: Approximately one week after vaccine receipt, had fever up to 102 and chills. Fever lasted for about a week. Also had aches, pain, and pt. stated had dark urine. Office visit on 8/28/06 showed essentially normal physical exam.
Age: 53.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, Diarrhoea, Dizziness, Headache, Lethargy
Clinical narrative: 8/31/06 Complain of severe headache, dizziness, muscle aches.  9/01/06 Dizziness, muscle aches, neck pain, headache, flew to state mentioned.  9/02/06 4:00 am fainted in bathroom, diarrhea, sore neck, vomiting.  9/3/06 Lethargic, complained of headache.  Seen in hospital center, emergency room.  9/04/06 headache continued, felt weak.    10/28/09:  Hospital Records and Discharge Summary received for dates of service 10/19/09 to 10/20/09.  Dx:  Migraines. Assessment:  Presented with sudden onset left-sided facial paresthesia shortly after receiving a flu shot.  Denies fever, chills, night sweats, vomiting or diarrhea.  Has chronic left leg numbness which is unchanged this episode.  No facial droop.  When numbness started pt. felt a "fluttery feeling" in her heart. A 2D echo was done, and was normal.  Stroke was ruled out.  Neurology consulted, comfortable with dx. of migraine and discharge to home.
Age: 53.0
Sex: M
Vaccine: YF
Symptoms: Myalgia, Neck pain, Syncope, Vomiting
Clinical narrative: 8/31/06 Complain of severe headache, dizziness, muscle aches.  9/01/06 Dizziness, muscle aches, neck pain, headache, flew to state mentioned.  9/02/06 4:00 am fainted in bathroom, diarrhea, sore neck, vomiting.  9/3/06 Lethargic, complained of headache.  Seen in hospital center, emergency room.  9/04/06 headache continued, felt weak.    10/28/09:  Hospital Records and Discharge Summary received for dates of service 10/19/09 to 10/20/09.  Dx:  Migraines. Assessment:  Presented with sudden onset left-sided facial paresthesia shortly after receiving a flu shot.  Denies fever, chills, night sweats, vomiting or diarrhea.  Has chronic left leg numbness which is unchanged this episode.  No facial droop.  When numbness started pt. felt a "fluttery feeling" in her heart. A 2D echo was done, and was normal.  Stroke was ruled out.  Neurology consulted, comfortable with dx. of migraine and discharge to home.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: 4 1/2 month healthy infant died 4/12 days after vaccinations. Autopsy said "SIDS" which mean nothing. I have copy or report if you want copy.
Age: 22.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Chest pain, Electrocardiogram abnormal, Laboratory test abnormal, Pericarditis
Clinical narrative: On 28 Aug 06, patient came to clinic with chest pain, noted to have stress test elevations in leads II, III, AVF.  Transferred to local emergency room, then transferred to a hospital in other state for ICU admission.  Underwent cardiac catheterization , no evidence of coronary artery disease.  Echocardiogram-normal limits.  Diagnosed with pericarditis.  Doing well. 10/26/06-DX: probably acute myopericarditis associated with the administration of the smallpox vaccine.  Assessment: pericarditis currently on minimum of a 4 week profile of light duty. He may return to full duty on 9/25/06 as long as he continues to be pain free.
Age: 15.0
Sex: F
Vaccine: HEP, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out fell out of chair onto floor bumped head after receiving meningococcal and Hep B vaccines.  Regained consciousness within 30 seconds
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Urticaria
Clinical narrative: 5 small wheals left forearm surrounded by erythema.
Age: 18.0
Sex: F
Vaccine: MMR, MNQ, TD
Symptoms: Dizziness, Headache, Neck pain, Pyrexia, Vomiting
Clinical narrative: Woke up 4 am 8/31 severe headache and dizziness.  Fever and neck ache.  Vomiting occurred around 7 am blood pressure and heart rate stable.  Headache lasted for a couple of days.
Age: 20.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Asthenia, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, diarrhea, fever, headache, weakness.
Age: 20.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, fever, headache, weakness.
Age: 14.0
Sex: F
Vaccine: TD
Symptoms: Cyanosis, Pallor, Syncope
Clinical narrative: Patient fainted after walking out exam room after immunization, turned blue and pale was unable to get up.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: Awake at midnight with extreme chills, awoke again at 0430 am with diaphoresis, feeling feverish, "horrible" headache,a nd vomited small amount.  Took Ibuprofen and later in morning had fever of 100 degrees F felt "lousy" and slept all day.  Felt better 9/1/06.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: vomiting day 2,3 and 4 after given vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Immediately after vaccine administration patient had syncopal episode with tonic posturing fell from table.  Responded with gentle stimulation versus normal 5 minutes post regaining full consciousness.
Age: 17.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Convulsion, Eye movement disorder, Facial palsy, Hyperhidrosis, Loss of consciousness
Clinical narrative: Within 5 seconds of 3rd injection, client fell over to side and passed out.  Seizure activity was noted twice which included eyes rolling back, facial drooping, and upper body tremors.  Pulse 60, weak, thready; blood pressure 80/50 and faint, pale, diaphoretic.  Ambulance transferred to emergency room.
Age: 17.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Pallor, Syncope, Tremor
Clinical narrative: Within 5 seconds of 3rd injection, client fell over to side and passed out.  Seizure activity was noted twice which included eyes rolling back, facial drooping, and upper body tremors.  Pulse 60, weak, thready; blood pressure 80/50 and faint, pale, diaphoretic.  Ambulance transferred to emergency room.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Streaks/flecks of blood in stool for 3 days after vaccine given, stool were soft, loose, not formed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning his wife who was vaccinated with a dose of varicella-zoster virus vaccine live.  Within the last month, in July 2006, the patient experienced a varicella like rash.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/8/2006.  Information has been received from a physician concerning his 60 year wife with no known medical history who was vaccinated in the left deltoid with a first dose of ZOSTAVAX (Merck) (dilulent Lot # 0581F).  There was no illness at the time of vaccination.  Within the last month, in July 2006, the patient experienced a varicella like rash.  Unspecified medical attention was sought.  Additional information from the physician and a registered nurse indicated the patient was vaccinated on 12-JUL-2006 and the next day on 13-JUL-2006 she developed a rash of 5 small pox on her right lower waist and abdomen.  Subsequently the patient recovered and was "doing fine".  No laboratory tests were performed.  There was no product quality complaint involved.  No further information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a health professional concerning female over 60 years of age who on 02-AUG-2006 was vaccinated with a dose of varicella-zoster virus vaccine live.  Subsequently on 02-AUG-2006, the patient developed a red line at the injection site.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Oedema, Pruritus, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 70 year old female with allergies to sulfa and dairy products who on 02-AUG-2006 was vaccinated subcutaneously with one dose of varicella-zoster virus vaccine live (lot#652925/0621F).  Within 15 minutes of vaccinations on 02-AUG-2006, the patient experienced edema, redness, itching, injection site was warm to touch and a welt developed within minutes.  At the time of the report the patient had not recovered.  The reporter expressed a concern with the lot.  The office reported that the gave 10 vials previously with no problems.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards and was released.  The reporter indicated that another patient had a similar experience following vaccination with varicella-zoster virus vaccine live (lot#652925/0621F).  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Information has been received from pharmacist concerning a 75-80 year old male with elevated cholesterol and no known allergies who was vaccinated with a dose of varicella-zoster virus live.  Concomitant therapy included finasteride and pravastatin Na (PRAVACHOL).  Subsequently four weeks after vaccination the patient developed flu like symptoms.  The patient saw his physician and was treated with an unspecified antibiotic.  Subsequently, the patient recovered.  There was no product quality complaint involved.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Heart rate increased, Nausea, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 78 year old female with diabetes, high blood pressure, gastroesophageal reflux disease, arthritis and codeine and sulfonamide allergies who on 18-JUL-2006 was vaccinated with a dose of varicella-zoster virus vaccine.  It was reported that the patient was vaccinated because she had "shingles 3 times a day".  Concomitant therapy included valacyclovir HCL (VALTREX), amlodipine besylate (+) benazepril hydrochloride (LOTREL), amlodipine besylate (NORVASC), nitroglycerin, donepezil hydrochloride (ARICEPT), risperidone (RISPERDAL), fluconazole (DIFLUCAN), tramadol HCL, LANSOPRAZOLE (PREVACID), hydrocodone bitartrate and furosemide (LASIX).  On approximately 21-JUL-2006, "three to four days" after vaccination, the patient experienced nausea and vomiting.  She also felt very weak and her heart rate had been fluctuating.  She was treated with promethazine hydrochloride (PHENERGAN) for nausea and ordered to stay in bed.  On 11-AUG-2006 the patient was seen by the physician, GERD was noted.  Her heart rate was 81 and regular.  She was also given a new prescription of glimepiride (AMARYL) for her diabetes.  The patient thought her stomach problems were related to vaccination, however she stopped her donepezil hydrochloride (ARICEPT) and felt much better.  Subsequently the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a female whose 82 year old husband was vaccinated SC with a dose of varicella zoster virus vaccine live on 7/28/06. the vaccinee did not have a post vaccination rash. On 8/4/06 the pt began having pain and on 8/5/06 the pts rash appeared and was considered to be herpes zoster. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 82 year old female who on 8/3/06 was vaccinated SC with one dose of varicella zoster virus virus vaccine live (lot 652925/0621F). Within 15 minutes of vaccination on 8/3/06, the pt experienced edema, redness, itching, injection site was warm to touch and a welt developed within minutes. At the time of the report the pt had not recovered. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The office reported that he gave 10 vials previously with no problems. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards and was released. The reporter indicated that another pt (WAES0608USA01091) had a similar experience following vaccination with varicella Zoster virus vaccine live (lot 652925/0621F). Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning a 82 year old female who on 8/3/06 was vaccinated SC with one dose of varicella zoster virus virus vaccine live (lot 652925/0621F). Within 15 minutes of vaccination on 8/3/06, the pt experienced edema, redness, itching, injection site was warm to touch and a welt developed within minutes. At the time of the report the pt had not recovered. Unspecified medical attention was sought. The reporter expressed a concern with the lot. The office reported that he gave 10 vials previously with no problems. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards and was released. The reporter indicated that another pt (WAES0608USA01091) had a similar experience following vaccination with varicella Zoster virus vaccine live (lot 652925/0621F). Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male pt, 59 years old at the time of the report, who was vaccinated with a dose of varicella zoster virus vaccine live. Subsequently the pt experienced a diffuse rash. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/8/2006. Information has been received from a physician concening a 59 year old Caucasian male patient with no known medical history who was vaccinated with a dose of ZOSTAVAX. There was no illness at the time of vaccinatin. Subsequently the patient experienced a diffuse rash. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information indicated that on 11-AUG-2006 the patient developed a diffuse rash which did not improve with PREDNISONE and FEXOFENADINE. The patient was given ACYCLOVIR. Additional information has been requested.
Age: 1.23
Sex: M
Vaccine: PNC, VARZOS
Symptoms: Incorrect dose administered, Medication error, Rash erythematous, Wrong drug administered
Clinical narrative: This is in follow-up to report(s) previous submitted on 9/8/2006. Information has been received from a pharmacist concerning his 14 month old son with no known medical history or allergies who on 7/26/06 was vaccinated in the right thigh with a dose of varicella zoster virus vaccine live (Merck) (lot # 652966/0623F) instead of a dose of varicella virus vaccine live (Merck). Concomitant vaccination included a fourth dose of PREVNAR in the left thigh. There was no concomitant medication. During the weekend after the dose, on approximately 7/29/06, the patient's grandmother noticed a "pock" and red spots on the child. She applied camphor + eucalyptus oil + menthol vicks vapor rub on the pock. Unspecified medical attention was sought. It was reported that the pock and the spots have resolved. The pharmacist was told that his son was administered an "adult dose of the chicken pox vaccine". There was no product quality complaint involved. Additional information has been requested. Additional information from the office manager indicated that the practice was not aware of the child experiencing a "pock" or red spots after vaccination. She explained that the patient has since switched to another practice and no further contact has been made to their office. The patient was supposed to receive PROQUAD (Merck) and not VARIVAX (Merck) as previously reported. She reported that the packaging for the ZOSTAVAX (Merck) and PROQUAD (Merck) were similar. The vaccine are now taken out of there original boxes and placed in individual trays labeled with the trade names and marked pediatric or adult vaccines. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician office concerning a male pt who in Aug 2006 was vaccinated with a dose of varicella zoster virus vaccine live. On 8/23/06 the physician reported that sometime this week, the pt was vaccinated and had an outbreak of chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 71 year old female who on 8/27/06 was vaccinated with a 0.65 ml dose of varicella zoster virus vaccine live. On 8/31/06 the pt experienced a shingles like rash on her mid torso. The physician treated her with the anti viral Famciclovir (Famvir). There was no product quality complaint involved. The physician considered the pts shingles like rash to be an other important medical event (OMIC). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a medical assistant concerning an unknown number of pts who were vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) at greater than 12 weeks of age. It was unknown if any medical attention was sought. The medical assistant indicated, via a telephone call, that she had no information with regards to specific identifiers for any of the pts involved. No further information is available.
Sex: M
Vaccine: RV5
Symptoms: Abdominal pain, Muscle spasms
Clinical narrative: Information has been received from a registered nurse concerning an unknown number of pts who were vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) The pts mother reported that, 5-7 days post vaccination, her son developed severe cramping for a couple of days. The patient's pediatrician thought he had colic and it was not the vaccine. Subsequently, the patient recovered.  No further information is available.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a patient who on 04-JUN-2006 was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that in 2006, the patient developed diarrhea.  Unspecified medical attention was sought.  Stool samples were obtained for testing (results not provided).  Three weeks after onset, the patient's diarrhea resolved.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning a baby who was vaccinated with an oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Subsequently the patient vomited.  It was reported that the nurse then repeated the dosage.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Faeces pale
Clinical narrative: Information has been received from a physician concerning an 18-week-old underweight infant who on 17-JUL-2006, at 1500, was vaccinated by mouth with the second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653754/0139F).  Concomitant vaccinations administered on that same day and time included the second intramuscular dose of hepatitis B vaccine rHBsAg (yeast) (+) Hib conj vaccine (Lot#653274/1072R), the second intramuscular dose of diphtheria toxoid (+) pertussis acellular (unspecified) (+) tetanus toxoid (Lot#C2431AA), the second intramuscular dose of poliovirus vaccine inactivated (IPOL) (Lot#X1166) and the second intramuscular dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot#B08683A).  There was no other concomitant therapy or illness at the time of vaccination.  The physician reported that the on 18-JUL-2006, the patient developed severe diarrhea that was bright green and watery with a foul odor.  It was noted that the patient was having about 1-2 episodes per day. The patient was seen by the physician, but no laboratory/diagnostic tests were performed.  At a follow-up on 07-AUG-2006, the patient was still having problems.  On 09-AUG-2006, the patient was noted to be recovered.  Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Somnolence
Clinical narrative: Information has been received from a  physician concerning a 2-month-old female who on approximately 15-JUL-2006 was vaccinated by mouth with a dose of rotavirus G1 G2 G3 G4 P1 reassortant  vaccine live (human-bovine).  Concomitant vaccinations at that time included a dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg  (yeast) (+) pertussis acellular 3-component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (PEDIARIX), a dose of Hib conj vaccine (manufacturer unknown) and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR).  The physician reported that on approximately 15-JUL-2006, three hours after receiving rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine), the patient experienced high levels of drowsiness.  Unspecified medical attention was sought.  After at least sight hours, the patient's drowsiness resolved.  Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Information has been received from a  nurse practitioner (NP) concerning a 2-month-old male who on 31-JUL-2006 was vaccinated by mouth with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653661/0146F).  The NP reported that in 2006, the patient developed a slight fever and diarrhea.  Unspecified medical attention was sought, the patient recovered from the slight fever and diarrhea.  Additional information has been requested.
Age: 0.16
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Erythema multiforme, Rash
Clinical narrative: Information has been received from a physician concerning an 8-week-old patient who on 03-AUG-2006 was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (unspecified), a dose of Hib conj vaccine (manufacturer unknown) and a dose of pneumococcal 4 6B 9V 14 18C 23F conj vaccine (CRM197) (PREVNAR).  The physician reported that on 05-AUG-2006, the patient experienced rash.  It was unknown if medical attention was sought.  It was noted that the patient had no other known exposure to a rash or illness at home and there were no new foods or soaps introduced due to the patient's age.  As of 11-AUG-2006, the patient's rash persisted.  Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/8/2006.  Information has been received from a physician concerning an 8-week-old female with no medical history who on 03-AUG-2006, at 1130, was vaccinated PO with the first dose of ROTATEQ (Lot #653754/0139F).  Concomitant vaccinations administered on that same day included the first IM dose in the left lower thigh of TRIPEDIA (Lot #U1615AA), the first IM dose in the left upper thigh of ACTHIB (Lot #UE902AA), the first IM dose in the right lower thigh of PREVNAR (Lot #B02657B) and the first IM dose in the right upper thigh of IPOL (Lot #Y0991).  There was no illness at the time of vaccination.  Vaccinations given within four weeks of ROTATEQ included the second IM dose in the right thigh of hepatitis B virus vaccine (Lot #652093) at 0930 on 10-JUL-2006.  The physician reported that on 05-AUG-2006, the patient developed a rash.  On 11-AUG-2006, the patient presented to the office with 2mm red macules scattered on her arms, legs and torso.  By 12-AUG-2006, the patient had developed erythema multiforms minor.  It was noted that the patient had no other known exposure to a rash or illnesses at home and there were no new foods or soaps introduced due to the patient's age.  On 15-AUG-2006, the patient was changed from ENFAMIL to soy (PROSOBEE).  The patient's rash gradually faded and by approximately 18-AUG-2006 or 19-AUG-2006 the erythema multiforme minor had resolved.  Follow-up information contained the following adverse experience: upper respiratory infection (URI) (12-AUG-2006).  Additional information is not expected.