chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Eye discharge, Eye irritation, Headache
Clinical narrative: Red, burning eyes; presence of mucus secretion in eyes affected vision; severe headache; aches in back and shoulders, tightness and tingling and then pain in chest; slight fever.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Ocular hyperaemia, Pain, Paraesthesia, Pyrexia
Clinical narrative: Red, burning eyes; presence of mucus secretion in eyes affected vision; severe headache; aches in back and shoulders, tightness and tingling and then pain in chest; slight fever.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Visual impairment
Clinical narrative: Red, burning eyes; presence of mucus secretion in eyes affected vision; severe headache; aches in back and shoulders, tightness and tingling and then pain in chest; slight fever.
Age: 81.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pyrexia, Tremor, Wheezing
Clinical narrative: trembling, wheezing, severe chills, fever
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Extensive swelling of vaccinated limb, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Extensive swelling & itching at injection site. Large hard, hot, painful lump in upper arm where injected.
Age: 61.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site warmth
Clinical narrative: Extensive swelling & itching at injection site. Large hard, hot, painful lump in upper arm where injected.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Flank pain, Muscle tightness, Musculoskeletal chest pain, Musculoskeletal stiffness
Clinical narrative: Woke up 2 days after getting Influenza Vaccine with Right Forearm, Wrist, Flank-Rib area, Calf, Foot and Ankle Pain, muscle stiffness and tightness. Patient was seen at 10:55 on 8 Nov 2010 with the following Temp: 98.2, Pulse:80, BP:128/80. Treated with non-steroidal anti inflammatory drugs (NSAIDS); Ibuprofen 800mg and Cyclobenzaprine 10mg 1 tablet every 8 hours as needed for muscle pain.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Woke up 2 days after getting Influenza Vaccine with Right Forearm, Wrist, Flank-Rib area, Calf, Foot and Ankle Pain, muscle stiffness and tightness. Patient was seen at 10:55 on 8 Nov 2010 with the following Temp: 98.2, Pulse:80, BP:128/80. Treated with non-steroidal anti inflammatory drugs (NSAIDS); Ibuprofen 800mg and Cyclobenzaprine 10mg 1 tablet every 8 hours as needed for muscle pain.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Cough, Feeling cold, Pain, Pyrexia
Clinical narrative: Started with onset of fever, chills, couldn't get warm and all over body pain which seemed to be normal side effects and then progressed to develop a red body rash from the neck down to the ankles which made my skin hot and I had to run a fan to cool my skin and make clothing comfortable.  Lasted two and a half days.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Skin warm
Clinical narrative: Started with onset of fever, chills, couldn't get warm and all over body pain which seemed to be normal side effects and then progressed to develop a red body rash from the neck down to the ankles which made my skin hot and I had to run a fan to cool my skin and make clothing comfortable.  Lasted two and a half days.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Gingival pain, Glossodynia, Lip pain, Oral pain, Paraesthesia oral
Clinical narrative: Tingling/soreness inside upper and lower lip, on tongue, gums, and inside of cheeks.  Eruption of hundreds of tiny mouth sores.  Happens each year after flu shot is administered (3rd year).
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Stomatitis, Vaccine positive rechallenge
Clinical narrative: Tingling/soreness inside upper and lower lip, on tongue, gums, and inside of cheeks.  Eruption of hundreds of tiny mouth sores.  Happens each year after flu shot is administered (3rd year).
Age: 7.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Urticaria
Clinical narrative: Diffuse hives developed within 45 minutes of flu shot vaccination; no anaphylaxis.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Complaints of having a fever, sore throat and bodyache/weakness 3 hours after getting Influenza vaccine. Treated with Acetaminophen 325mg 2 tabs every 6 hours as needed for fever.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Feeling abnormal, Feeling drunk, Gastrointestinal disorder, Hyperhidrosis
Clinical narrative: About one hour after receiving the influenza vaccine, the patient's left arm began tingling and burning from the site of injection down to the elbow. About 30 minutes later, the patient began to feel "spacy". These symptoms progressed and the patient began to feel nauseous and broke out into a sweat. The patient stated that she basically felt drunk. She also describes experiencing "flashes" in her peripheral vision while driving home as well as GI distress and diarrhea which occurred 5-6 hours after vaccination. The patient stated that her "spaciness" had resolved by that same evening and the next morning she felt normal again. The patient stated that she did not take any medications for relief of these symptoms.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Nausea, Paraesthesia, Photopsia
Clinical narrative: About one hour after receiving the influenza vaccine, the patient's left arm began tingling and burning from the site of injection down to the elbow. About 30 minutes later, the patient began to feel "spacy". These symptoms progressed and the patient began to feel nauseous and broke out into a sweat. The patient stated that she basically felt drunk. She also describes experiencing "flashes" in her peripheral vision while driving home as well as GI distress and diarrhea which occurred 5-6 hours after vaccination. The patient stated that her "spaciness" had resolved by that same evening and the next morning she felt normal again. The patient stated that she did not take any medications for relief of these symptoms.
Age: 1.02
Sex: F
Vaccine: FLUX, HEPA, MMR
Symptoms: Rash
Clinical narrative: Mild rash covering the trunk of her body
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: The patient experienced fever, chills, myalgia, nausea, vomiting, generalized weakness and headache the day after receiving the flu vaccine.  The patient hadn't tried anything for relief, but did inquire about treatments.  I instructed the patient to stay hydrated and take ibuprofen.  I was unable to follow up with the patient regarding symptom duration and resolution of symptoms after this conversation.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: The patient experienced fever, chills, myalgia, nausea, vomiting, generalized weakness and headache the day after receiving the flu vaccine.  The patient hadn't tried anything for relief, but did inquire about treatments.  I instructed the patient to stay hydrated and take ibuprofen.  I was unable to follow up with the patient regarding symptom duration and resolution of symptoms after this conversation.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Haemoptysis, Incisional drainage
Clinical narrative: Started with flu-like symptoms, especially sore throat and slight fever. Continued the rest of the week with coughing, shortness of breath, bloody greenish sputum, and higher fever (On Saturday 11/06/2010, fever got to 103 degrees F). Thus, symptoms became pneumonia-like by Friday 11/05/2010. Went to ER on Monday 11/08/2010 and was diagnosed with incipient pneumonia and was prescribed antibiotics. Currently in treatment.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza like illness, Oropharyngeal pain, Pneumonia, Pyrexia, Sputum discoloured
Clinical narrative: Started with flu-like symptoms, especially sore throat and slight fever. Continued the rest of the week with coughing, shortness of breath, bloody greenish sputum, and higher fever (On Saturday 11/06/2010, fever got to 103 degrees F). Thus, symptoms became pneumonia-like by Friday 11/05/2010. Went to ER on Monday 11/08/2010 and was diagnosed with incipient pneumonia and was prescribed antibiotics. Currently in treatment.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pt states that after receiving H1N1/Seasonal flu (22degrees) she developed a localized raised rash from shoulder to elbow that was hot to touch & swollen. Denied any respiratory issues at that time.
Age: 63.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Activities of daily living impaired, Movement disorder, Neuralgia
Clinical narrative: Patient has experienced & is experiencing nerve pain traveling down upper arm and has difficulty lifting her right arm and has hard time to dress.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Heart rate increased, Muscular weakness, Pain in extremity
Clinical narrative: 11/6/10: Pt rec'd flu vaccine on (L) D about 10 am. Returned to clinic around 1250pm with c/o pain on (L) arm below elbow & (L) arm weakness. No redness/swollen noted at injection site. No respiratory distress noted, icepack applied to (L) arm. Pt's BP & P increased: 190/100, P:98. 911 was called at 135pm. Pt refused to go to ER. 11/8/10: Tel. f/u with pt. stated "feeling the same". Per pt, went to urgent care on 11/6/10 & d/c home with HTN medication. Will f/u with PMD per pt.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None known. Left message for patient to call.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Musculoskeletal chest pain, Pyrexia
Clinical narrative: Given flu shot on 11/2/10 at 122 pm. That night she reports her "ribs were hurting", hard to take a deep breath. Believes she had a fever, felt warm, temp not checked. Didn't seek medical treatment. Didn't feel better until 4pm the next day. Reports on 11/4/10 of feeling fine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Headache, Rash, Throat irritation
Clinical narrative: Bilateral puffy eyes, itchy throat headache, rash on chest 2 hrs post vaccine - no localized adverse reaction at injection site.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site warmth
Clinical narrative: Pt developed cellulitis around injection site (about 4 inch diameter), injection site area was also warm to touch.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient came in on Saturday (11/6) stating on Friday night her arm at the injection site had started to itch her. She also has a rash at the site I gave her some BENADRYL and HC 1% creams to apply to the area. I called her Sunday, the itching had stopped but rash still present.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Pt experienced one week after flu shot both upper/lower extremities were beet red, itchy. BENADRYL taken with improvement noticed per patient.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site reaction, Pain of skin, Pruritus
Clinical narrative: Rash and tremendous itching at the site of injection and spreaded to the other arm/per pt. Had flu shot on Nov 2nd & itching & rash started on the 3rd & it is painful from itching. Went to Emergency. On antihistamine & steroids.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash and tremendous itching at the site of injection and spreaded to the other arm/per pt. Had flu shot on Nov 2nd & itching & rash started on the 3rd & it is painful from itching. Went to Emergency. On antihistamine & steroids.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia facial, Sensory loss
Clinical narrative: Per patient after receiving flu shot her right side of face lost the sense (numb like). When again call on 11-8-10 she is feeling much better.
Age: 14.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Urticaria
Clinical narrative: 9/28/10 Hives to UC given steroid injection. 9/29/10 Hives entire body to UC, given SOLU-MEDROL inject & Prednisone syrup. 9/30/10 To allergy MD. Rx'd Loratadine, SINGULAIR & continue Prednisone syrup.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pain, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: Patient experienced fever, chills & body ache. She went to urgent care center 11/5/10 & they thought she had infection & gave her an antibiotic. She went to allergist on 11/8/10 & he said no infection but patient had arthus reaction. Patient received a 2 day course of steroids.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain
Clinical narrative: Pt. received flu shot 11/2/10. He is now experiencing (L) arm weakness not able to lift arm over his head. Also states periodic stabbing/throbbing at injection site. Getting progressively worse site was sore at time of injection then pain increased.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Sharp pain down arm. No redness/no temp.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Skin lesion
Clinical narrative: Left deltoid pain, 10 x 6cm erythematous raised lesion, 10 days post vaccination.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Contusion, Dizziness, Feeling hot, Headache
Clinical narrative: Started feeling hot, pain down both arms, shaking, extreme weakness, headache. Approximately 1 day later noticed bruising at injection site. Six days later still feel weak & slight headache & dizziness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tremor
Clinical narrative: Started feeling hot, pain down both arms, shaking, extreme weakness, headache. Approximately 1 day later noticed bruising at injection site. Six days later still feel weak & slight headache & dizziness.
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Oedema peripheral, Pleurisy
Clinical narrative: Swelling arm, pleurisy affect.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Bronchospasm, Cardiac enzymes normal, Coagulation test normal, Cough, Haematocrit decreased
Clinical narrative: Throat tightness, cough, phlegm then bronchospasm hours post vaccine dose.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Haemoglobin normal, Increased upper airway secretion, Influenza virus test negative, Metabolic function test normal, Mononucleosis heterophile test negative
Clinical narrative: Throat tightness, cough, phlegm then bronchospasm hours post vaccine dose.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Platelet count decreased, Throat tightness, White blood cell count increased
Clinical narrative: Throat tightness, cough, phlegm then bronchospasm hours post vaccine dose.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Bronchospasm, Cough, Increased upper airway secretion, Throat tightness
Clinical narrative: Throat tightness, cough, phlegm then bronchospasm hours post vaccine dose.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Headache, Hyperaesthesia, Neck pain
Clinical narrative: Vaccinated in the left arm. PLUA 11AM 10/29/10 - 7pm on 10/31/10 left side of head, ear, neck pain. No rash. Pain to the touch. Reported to family doctor on Monday. Was prescribed VALTREX, helped with pain. Reported to pharmacy on 11/2/10 and was recovering.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Varicella-form rash on extremities & trunk. Rx'd - Acyclovir 400 mg qid x 7d.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Activities of daily living impaired, Confusional state, Disorientation, Feeling abnormal, Headache
Clinical narrative: Got 5 shots in the morning, returned to school after getting shots. "Feel warm", "have a headache", & "not herself " in the afternoon. Had to sit aside for PE. Next day, still "disoriented", mixed up Wednesday, thought it's Thursday. TYLENOL given when having HA on the same date getting shots - 2x day after, still "not herself" 4 days after - increase sleep. To the doctor today 11/8/10.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Hypersomnia, Skin warm
Clinical narrative: Got 5 shots in the morning, returned to school after getting shots. "Feel warm", "have a headache", & "not herself " in the afternoon. Had to sit aside for PE. Next day, still "disoriented", mixed up Wednesday, thought it's Thursday. TYLENOL given when having HA on the same date getting shots - 2x day after, still "not herself" 4 days after - increase sleep. To the doctor today 11/8/10.
Age: 27.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 1.25
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash generalised, Rash papular, Rash pruritic
Clinical narrative: Mother of pt. phoned clinic 9/29/10 approx. 12:30pm and stated her child had immunizations here 9/28/10. She reports pt. woke up this am with red itchy bumps all over her body, without fever. Mom wanted to know was it from immun. Mom was told unsure and advised to take child to her pediatrician. Clinic supervisor informed of above.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting began about 2 hrs. after injection, on Weds, 9/29/2010, nausea and vomiting Weds-Friday, on Friday went to hospital, was given nausea meds and sent home, returned to hospital on Sunday and was admitted for fluids, in hospital as of 10/5/2010.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient given a 5th IPV erroneously. Patient came to office 9-30-10 for 4 yr old vaccine. Received DTAP, IPV, MMR, and VAR. This was documented in the wrong patients chart. When MA pulled up this child it showed him missing the "4 yr old shot series" so she drew up 4 shots. MA took vaccines in to give and mom informed her that patient had his shots on 9-30-10. MA still gave an IPV - that was not needed.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Oropharyngeal pain, Pyrexia
Clinical narrative: 9/11/10 - AM - onset of joint pain, fever and sore throat 9/13/10 - Seen by PMD; was given injection for inflammation; started feeling better after injection. 9/15/10 - went back to work 9/17/10 - called MD due to increased fever, max is 101 degrees F, was given Rx of ZITHROMAX. Allergic PCN.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site warmth, Pain
Clinical narrative: C/o redness & arm/skin hot to touch on (L) upper arm , sore & achy. No fever. Temp 98.9 except -> Azithromycin 250 mg x 5 days Rx'd. Improved in 48 hrs.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Feeling cold, Nausea, Pallor, Vision blurred
Clinical narrative: < 5 mins. after TDAP is given pt started feeling weak, nauseous, skin cold, blurry vision, looking pale. Had patient lay down immediately on the floor on his back, knees bent. Patient also had syncopal episode before during blood drawn.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Faeces discoloured
Clinical narrative: Green bowel movement.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Syncope, Vomiting
Clinical narrative: Fainted and vomited x 1.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Diet refusal
Clinical narrative: Refused to eat crying vigorously.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Decreased appetite, Headache, Myalgia
Clinical narrative: Diffuse myalgias, headaches, anorexia. Symptomatic supportive treatment.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Myalgia, Oedema peripheral
Clinical narrative: Right arm swelling, lymph node tenderness, generalized muscle aches 12 hrs following vaccine. No treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Erythema, Eyelid oedema, Swelling face, Wheezing
Clinical narrative: Pt has received her 4 y.o. vaccination 5 min later had SOB, swollen face and eye lids, redness of the skin, slight wheezing. Received: EPIPEN, BENADRYL, ORAPRED.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Contusion, Idiopathic thrombocytopenic purpura, Petechiae, Rash erythematous
Clinical narrative: On 9-7-10, mother called the Co. H.D. to report child had a "red rash" on legs, in bends of arms and wrists and abdomen. "Egg sized" bruises around waist. Was taken to Primary Care Provider who referred child to the hospital. Stayed one night.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Depression, Dizziness
Clinical narrative: Initial report received from a consumer (patient's wife) on 25 Oct 2010: This patient received FLUVIRIN (batch number: not reported), intramuscularly in Sep 2010 (date unspecified). On an unspecified date in Sep 2010, the patient felt light headed within 24 hours which was persisted at the time of report also. The patient stated that his emergency room doctor has reported these symptoms were related to a depressive episode. Final outcome of the patient was reported as condition unchanged.
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Influenza
Clinical narrative: Initial and follow up literature case received on 28 Sep 2010 and 11 Oct 2010: This child with an unknown medical history was vaccinated with H1N1 (manufacturer unknown, batch number unknown) on unknown date. The patient was hospitalized one week after vaccination on unknown date with H1N1 infection. The outcome was not reported.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Pt received VZV 9/28/10 pt/Mo states about 2 hr after receiving vaccine back of (L) arm started hurting, turned red & swollen - warm to touch. No fever/no resp problems. Back of arm still warm, swollen & red today. Recommended taking ADVIL/warm/cold compresses.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pain, swelling in left upper arm near injection site.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Malaise, Syncope
Clinical narrative: Monitored q 15 min. after vaccine given as child said "not feeling well." Child fainted in lobby, ice applied to neck, legs elevated, and monitored till able to stand. Child left with mom.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Oedema peripheral, Pain in extremity
Clinical narrative: Got shot 8:15 on 10/20/10. That afternoon arm got hot and started to swell, later it started to get red and hurt. Was worse Thurs 10/21/10. Went to Dr. Dr said good thing he saw him, could have gone to hospital a day or so.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Decreased appetite, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Tiredness, ache, headache, decreased appetite, fever.
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a male child who on an unspecified date (may be recently or several years ago) was vaccinated SC with the first dose of PROQUAD (Merck).  Subsequently, "within 24 hours of the vaccine being given", the patient developed a high fever.  The fever did go down.  It was unspecified if the patient sought medical attention or not.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a patient who "4 years ago" on approximately 28-JAN-2006 was vaccinated with the first 0.5ml dose of PROQUAD (Merck upgrade process) (lot# not provided). After the vaccination, the patient developed fever. The patient sought unspecified medical attention. At an unspecified date, the patient recovered from fever. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of PROQUAD (Merck upgrade process) (lot number not reported). On an unspecified date the patient's mother called the physician stated that her child was "a little weary". It was mentioned that this happened when the vaccine was still recommended as a single dose therefore the second dose was not administered. On an unspecified date the patient had recovered. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster, Polymerase chain reaction, Rash erythematous, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a Registered Nurse concerning a 9 year old female patient with allergy to sulfa and penicillin allergy and a history of attention deficit/hyperactivity disorder, who on 07-DEC-2001 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck).  On 14-AUG-2006, the patient was vaccinated with a dose of PROQUAD (MSD) (lot # 652332/1122R).  Concomitant therapy included methylphenidate.  On 19-APR-2010, the patient experienced a vesicular rash.  On 21-APR-2010, the patient was seen in the office with clusters of clear vesicles on erythematous bases.  The patient had three lesions on the right arm, four lesions on right leg, four lesions in the left hip and one lesion on the left hand.  No treatment was required.  The patient was diagnosed with shingles.  The patient was afebrile.  The patient had not been exposed to chickenpox or shingles.  A vesicular lesion sample was collected.  The sample was taken from a vesicular lesion.  Final PCR results indicated that the sample was negative, no VZV was identified.  The nurse had not heard from the patient's mother since the visit so she assumed the patient recovered.  "The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain."  No further information is available.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from a Registered Nurse concerning a 9 year old female patient with allergy to sulfa and penicillin allergy and a history of attention deficit/hyperactivity disorder, who on 07-DEC-2001 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck).  On 14-AUG-2006, the patient was vaccinated with a dose of PROQUAD (MSD) (lot # 652332/1122R).  Concomitant therapy included methylphenidate.  On 19-APR-2010, the patient experienced a vesicular rash.  On 21-APR-2010, the patient was seen in the office with clusters of clear vesicles on erythematous bases.  The patient had three lesions on the right arm, four lesions on right leg, four lesions in the left hip and one lesion on the left hand.  No treatment was required.  The patient was diagnosed with shingles.  The patient was afebrile.  The patient had not been exposed to chickenpox or shingles.  A vesicular lesion sample was collected.  The sample was taken from a vesicular lesion.  Final PCR results indicated that the sample was negative, no VZV was identified.  The nurse had not heard from the patient's mother since the visit so she assumed the patient recovered.  "The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain."  No further information is available.
Age: 1.01
Sex: M
Vaccine: MMRV
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 45 month old male patient with no pertinent medical history and no allergies who on 06-AUG-2007 was vaccinated subcutaneously with a 0.5ml dose of PROQUAD (Merck) (lot# 658186/0789U).  There was no concomitant medication.  On 28-MAY-2010 the patient developed chickenpox.  The patient had a generalized itchy rash on his trunk, arms and legs.  The patient visited the office on 01-JUN-2010.  No treatment had been prescribed.  There were no laboratory diagnostics studies performed.  The nurse stated that the vesicles had already started to crust.  At the time of this report, the patient was recovering.  No further information is available.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Information has been received from a medical assistant (MA) concerning a 4 year old male patient who on 24-MAY-2010 was vaccinated with a dose of PROQUAD (Merck upgrade process) (lot# 01862 was invalid) in a thigh. Concomitant therapy included DTAP (reported as "D-tap"). Subsequently the patient was brought back 2 days later (26-MAY-2010) experiencing rash and redness on the thigh that spread to the groin. The patient experienced no fever. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Follow-up information has been received from the MA. She reported that the patient was a 4 year old male with no illness or pre-existing conditions. On 24-MAY-2010 at 1:45 pm the patient was vaccinated SC into the right thigh with his first dose of PROQUAD (Merck upgrade process), and on the same time was also vaccinated IM into the left thigh with a second dose of DTAP (Sanofi Pasteur, lot# C3141AA). On 26-MAY-2010 at 12:00 pm the patient experienced redness and induration to right leg. On 27-MAY-2010 the patient was recovered. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction, Injection site swelling, Rash, Rash pustular
Clinical narrative: Information has been received from a physician concerning a 4 year old male with penicillin and shellfish allergies, and a history of reactive airways disease who on 20-SEP-2007 was vaccinated with a first dose of PROQUAD (Merck upgrade process) (SC), and on 29-JUN-2010 he received the second dose (SC, lot # 666885/0283Z). Concomitant therapy included montelukast sodium (MSD). On 30-JUN-2010 the patient developed swelling at the injection site, right triceps region. On 01-JUL-2010 the patient developed a vesicular rash with a 3-5" radius around the site of injection and smaller rashes scattered about his body. No acute treatment was rendered. The patient made an office visit on 02-JUL-2010 and he had no contact with the physician since then. The outcome was unknown. Follow up information received from a licensed practical nurse concerning a 4 year old male patient with penicillin allergy and 2/6 Systolic Ejection Murmur innocent quality, and no illness at time of vaccination, who on 20-SEP-2007 was vaccinated with a first dose of PROQUAD (Merck upgrade process) ( lot # 666885/0283Z) in the right arm, and on 29-JUN-2010 at 4:00 pm he received the second dose (lot # 666885/0283Z) in the right arm. On 30-JUN-2010, the patient developed large area of swelling vesicular rash especially on red area, pustules did form and drain from vesicular rash. The patient required emergency room/doctor visit. There were no labs or diagnostic tests performed. The patient recovered, date unknown. Additional information is not expected.
Age: 1.86
Sex: M
Vaccine: MMRV
Symptoms: Injection site reaction, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 22 month old male patient with no medical history and no drug reactions or allergies who on 01-JUL-2010, was vaccinated with the first dose of PROQUAD (Merck upgrade process) SC into the left tricep region (lot # 666885/0283Z). There was no concomitant medication. On 07-JUL-2010, a contact with the patient was a phone call where it was described that on 02-JUL-2010, the patient experienced 3-5 vesicular rash at the site of injection as well as rashes scattered about his body. At the time of reporting, the patient was not recovered. The patient had not been seen by the physician since the date of injection and no acute treatment had been rendered. Follow up information was received from the nurse who reported that on 01-JUL-2010 at 11:30, the 22 month old male patient (also reported as 21 month old) was vaccinated with the first dose of PROQUAD (Merck upgrade process) in the left arm (lot # 666885/0283Z). There was no illness at time of vaccination. On 07-JUL-2010 (previously reported as 02-JUL-2010), the patient reported vesicular rash much worse in radius around immunization injection area. Then it spread mildly all over body. No lab diagnostics study was performed. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning several patients, both male and female between 12 to 15 months old, who were vaccinated with PROQUAD (Merck). Subsequently the patients experienced seizures or high fever. At the time of reporting, the outcome was unknown. The patients did not seek medical attention. Upon internal review, seizures was determined to be an other important medical event. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful.
Age: 14.0
Sex: M
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 14 year old male who on an unspecified date was vaccinated with PROQUAD (Merck upgrade process) instead of his second scheduled dose of VARIVAX (Merck) (MSD). No medical attention was sought. Follow up information was received from the physician who reported that the nurses grabbed the wrong product off the shelf. She further stated that the nurses forgot the PROQUAD (Merck upgrade process) only went up to 12 years of age. They did not realize that the patient was over 12 years old and should have received MMR II (MSD) and VARIVAX (Merck) (MSD) separately. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 5 year old female patient who on 04-AUG-2010 was vaccinated inadvertently with a dose of PROQUAD (Merck upgrade process) and with a second dose of VARIVAX (Merck) (MSD) (lot number not provided) in different arms. The nurse reported that the patient was to receive the second dose of MMR II (MSD) as PROQUAD (Merck upgrade process) injection. Concomitant therapy included a dose of poliovirus vaccine and a dose of DTAP. No adverse symptoms were noted. The nurse reported that this was not a product confusion or quality assurance (QA). Additional information has been requested.
Age: 1.37
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 16 month old patient who on 05-AUG-2010 was vaccinated SC with a 0.5 ml dose of PROQUAD (Merck upgrade process) (lot number 666746/0190Z) and with a 0.5 ml dose of VARIVAX (Merck) (MSD) (lot number 665908/1606Y) SC. The nurse reported that the patient received a dose of PROQUAD (Merck upgrade process) instead of a dose of MMR II. The patient was not experiencing any known symptoms. Follow up information has been received from a registered nurse. It was reported that the male patient with no pertinent medical history and no drug or allergies reactions was vaccinated with a dose of PROQUAD (Merck upgrade process) (expiration date 15-JUL-2011) SC in the right arm and with a dose of VARIVAX (Merck) (MSD) (expiration date 13-JUL-2010) SC in the left arm on 05-AUG-2010. There were no concomitant medications. The nurse reported that it was not until approximately 5-10 minutes after the patient had left the facility that the nurse who administered the vaccine realized her mistake and that the PROQUAD (Merck upgrade process) had indeed been given instead of MMR II. The nurse reported that she spoke to the patient's mother in the morning on 26-AUG-2010 and she stated that the child did not have any adverse reactions after his vaccinations. No further information is expected.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning her 4 year old daughter with no known drug allergies and no pertinent medical history who on 16-AUG-2010 was vaccinated with a dose of PROQUAD (Merck upgrade process), SQ, 0.5 ml in the left upper arm.  There was no concomitant medication. On 17-AUG-2010 the patient developed fever as well as redness, induration, and swelling at the injection site. The nurse contacted the physician's office by phone and was suggested to use warm compresses and ibuprofen. There was no lab or diagnostic test performed. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Body temperature increased, Diarrhoea, Ear infection, Lethargy, Pyrexia
Clinical narrative: Information has been received from a female consumer concerning her 5 year old daughter with seasonal allergy who on 22-MAY-2006 was vaccinated with a dose of PROQUAD (Merck upgrade process). Four days after vaccination, on 26-MAY-2006 the patient presented with a fever of 104 degrees, severe diarrhea, a mild rash on her body, lethargy and an ear infection. The patient sought unspecified medical attention. The patient recovered on an unspecified date. This is one of several reports from the same source. It was also reported that the patient was vaccinated with a dose of MMR II and experienced an adverse event (WAES 1008USA03779). No further information is available.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Information has been received from a female consumer concerning her 5 year old daughter with seasonal allergy who on 22-MAY-2006 was vaccinated with a dose of PROQUAD (Merck upgrade process). Four days after vaccination, on 26-MAY-2006 the patient presented with a fever of 104 degrees, severe diarrhea, a mild rash on her body, lethargy and an ear infection. The patient sought unspecified medical attention. The patient recovered on an unspecified date. This is one of several reports from the same source. It was also reported that the patient was vaccinated with a dose of MMR II and experienced an adverse event (WAES 1008USA03779). No further information is available.
Age: 1.01
Sex: F
Vaccine: MMRV
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient with no pertinent medical history and no drug reactions/allergies who on 16-AUG-2010, was vaccinated SQ with a dose 0.5 ml once of PROQUAD (Merck upgrade process) (Lot# not reported). There was no concomitant medication. On 22-AUG-2010, the patient presented red raised rash covering her body. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles to face.
Age: 88.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain
Clinical narrative: The vaccine was given via subcutaneous route.  The patient complained of soreness.
Age: 88.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Incorrect route of drug administration, Pain
Clinical narrative: The vaccine was given via subcutaneous route.  The patient complained of soreness.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Patient is complaining of left arm achiness and soreness and decreased range of motion since getting her flu shot. Pain upon lifting arm over shoulder height, difficulty in carrying heavier items in left hand due to pain radiating in the arm at the injection site.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Patient is complaining of left arm achiness and soreness and decreased range of motion since getting her flu shot. Pain upon lifting arm over shoulder height, difficulty in carrying heavier items in left hand due to pain radiating in the arm at the injection site.
Age: 38.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Asthenia, Guillain-Barre syndrome
Clinical narrative: From the medical record: Pt was having mild nausea, subjective temperature, general malaise, body aches, double vision.
Age: 38.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Diplopia, Feeling hot, Malaise, Nausea, Pain
Clinical narrative: From the medical record: Pt was having mild nausea, subjective temperature, general malaise, body aches, double vision.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Paraesthesia, Sensory loss
Clinical narrative: I would like to report an adverse reaction that occurred with the use of ADACEL vaccine. This was not life or limb threatening and as such, I was somewhat confused about how to report it to you. I am reporting it as a matter of record and follow-through on my part. On September 21, 2010 a dose of ADACEL, .5ml, lot # C3490AA, ED 7/16/2012 was administered in our immunization clinic to a 31 year old female and was given in the left deltoid area. Within 15 minutes of receiving the injection the patient returned to the urgent care area complaining of numbness and tingling that was involving the entire shoulder and spreading upward and posteriorly to the scapula and to the base of the skull on the left, and downward, distally, to the hand. The sensation was involving the entire aspect of the left arm, not just a localized area. Her vital signs were stable and she was kept in the urgent care area for an extended time. There was some reduction of sharp and soft sensation in the arm, although  there was no motor dysfunction. The patient was seen back the following day and there was improvement in the symptoms but not resolution. As of October 12, 2010 the patient still has some tingling in the fingertips and the scapular area to the neck, but there is continuing overall improvement. She will be followed until this resolves. Because this seemed to encompass three dermatomal areas and followed a unilateral nerve distribution pattern of the entire left arm it was thought to be unusual. In our clinic our combined clinician experience is over 100 years and none of the clinicians had seen this sort of occurrence before.
Age: 31.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site reaction, Paraesthesia
Clinical narrative: I would like to report an adverse reaction that occurred with the use of ADACEL vaccine. This was not life or limb threatening and as such, I was somewhat confused about how to report it to you. I am reporting it as a matter of record and follow-through on my part. On September 21, 2010 a dose of ADACEL, .5ml, lot # C3490AA, ED 7/16/2012 was administered in our immunization clinic to a 31 year old female and was given in the left deltoid area. Within 15 minutes of receiving the injection the patient returned to the urgent care area complaining of numbness and tingling that was involving the entire shoulder and spreading upward and posteriorly to the scapula and to the base of the skull on the left, and downward, distally, to the hand. The sensation was involving the entire aspect of the left arm, not just a localized area. Her vital signs were stable and she was kept in the urgent care area for an extended time. There was some reduction of sharp and soft sensation in the arm, although  there was no motor dysfunction. The patient was seen back the following day and there was improvement in the symptoms but not resolution. As of October 12, 2010 the patient still has some tingling in the fingertips and the scapular area to the neck, but there is continuing overall improvement. She will be followed until this resolves. Because this seemed to encompass three dermatomal areas and followed a unilateral nerve distribution pattern of the entire left arm it was thought to be unusual. In our clinic our combined clinician experience is over 100 years and none of the clinicians had seen this sort of occurrence before.
Age: 35.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: Patient did not present to clinic until 11/03/2010 with symptoms of  body ache, right lower back pain, left foot pain with pressure/ swelling since Tdap on 10/26/2010, left upper chest pain associated with intermittent shortness of breath 2 days prior to presentation.  Had headache that resolved.
Age: 35.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Back pain, Chest pain, Dyspnoea, Headache, Limb discomfort
Clinical narrative: Patient did not present to clinic until 11/03/2010 with symptoms of  body ache, right lower back pain, left foot pain with pressure/ swelling since Tdap on 10/26/2010, left upper chest pain associated with intermittent shortness of breath 2 days prior to presentation.  Had headache that resolved.
Age: 35.0
Sex: F
Vaccine: TDAP, DTAP
Symptoms: Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Patient did not present to clinic until 11/03/2010 with symptoms of  body ache, right lower back pain, left foot pain with pressure/ swelling since Tdap on 10/26/2010, left upper chest pain associated with intermittent shortness of breath 2 days prior to presentation.  Had headache that resolved.
Age: 5.0
Sex: F
Vaccine: HBHEPB, DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Blood test, Henoch-Schonlein purpura, Hypersensitivity, Oedema peripheral
Clinical narrative: Initial report was received on 28 October 2010 from a consumer who is also the patient's parent. A five year-old female patient (also reported as six) who had no illness at the time of vaccination and a past history of "mild reactions" to other immunizations some of which were DTAP, MMR, IPV and Varicella, had received on 02 December 2009 an intramuscular arm injection of IPOL (lot number and specific site not reported), an intramuscular arm injection of DAPTACEL (lot number and specific site not reported), VARIVAX (Merck lot number, site and route of administration not reported) and MMR (manufacturer, lot number, site and route of administration not reported). On 09 December 2009 the patient had experienced swelling of both feet and ankles reported as "nearly two to three times their normal size". They were fluid filled, itchy, sore and blistered. She also reported to have had fluid filled blisters on her toes. The symptoms persisted for three weeks. According to the reporter the patient had a difficult time walking and was unable to wear shoes. Treatment included BENADRYL "nearly around the clock" for three weeks. The patient was seen by a vascular doctor who diagnosed her with Henoch-Schonlein purpura. However, an allergist believed the symptoms to be an allergic reaction. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: none.