chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Cough, Myalgia, Oedema
Clinical narrative: 33yo female admitted to the Hospital Mother/Baby Unit secondary to an abdominal incision (post-cesarean section) infection and likely serum sickness reaction (fever, rash, chills, myalgias, arthralgias, cough, and edema) following DTap administration at another Hospital (3/7/11).  The patient was hospitalized from 12/27/10 to 3/10/11 due to recurrent vaginal bleeding, placenta previa (which later transitioned to vasa previa) and early contractions; she had a c-section on 3/4/11.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash, Serum sickness-like reaction
Clinical narrative: 33yo female admitted to the Hospital Mother/Baby Unit secondary to an abdominal incision (post-cesarean section) infection and likely serum sickness reaction (fever, rash, chills, myalgias, arthralgias, cough, and edema) following DTap administration at another Hospital (3/7/11).  The patient was hospitalized from 12/27/10 to 3/10/11 due to recurrent vaginal bleeding, placenta previa (which later transitioned to vasa previa) and early contractions; she had a c-section on 3/4/11.
Age: 9.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, C-reactive protein normal, Erythema, Pain in extremity, Swelling
Clinical narrative: Temperature 103 F Redness, Swelling, Arm Pain Tylenol Given Primary Care Physician seen 05/08/2011 IV Rocephin 05/08/11 13:36
Age: 9.0
Sex: F
Vaccine: TD
Symptoms: White blood cell count increased
Clinical narrative: Temperature 103 F Redness, Swelling, Arm Pain Tylenol Given Primary Care Physician seen 05/08/2011 IV Rocephin 05/08/11 13:36
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Nerve injury, Skin mass
Clinical narrative: unusual lump under skin that patient is complaining is causing nerve damage to hand
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Cough, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Fever 103, swollen glands, joint pain, headache, coughing
Age: 1.49
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Constipation, Crying, Developmental delay, Emotional distress, Irritability
Clinical narrative: Started with fever up to 105.6. Very irritable, inconsolable. Crying. Continued Fever for several days. On 05/31/2007, a rash developed all over his body. Doctor examination concluded he had measles induced by MMR vaccine. Rash and fever gone with 10 days. Chronic constipation followed, and developemental regression.
Age: 1.49
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Measles, Pyrexia, Rash generalised
Clinical narrative: Started with fever up to 105.6. Very irritable, inconsolable. Crying. Continued Fever for several days. On 05/31/2007, a rash developed all over his body. Doctor examination concluded he had measles induced by MMR vaccine. Rash and fever gone with 10 days. Chronic constipation followed, and developemental regression.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Erythema at site of injection lasting up to 5 days. MOTRIN OTC.
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Chills, Hyperhidrosis, Irritability, Myalgia, Pyrexia
Clinical narrative: Patient received oral typhoid vaccine x 4 doses. 48 hrs. after last dose developed chills, felt feverish with sweats, myalgias. Developed rash on trunk today - feels "irritated".
Age: 24.0
Sex: M
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Patient received oral typhoid vaccine x 4 doses. 48 hrs. after last dose developed chills, felt feverish with sweats, myalgias. Developed rash on trunk today - feels "irritated".
Age: 1.04
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema
Clinical narrative: (L) upper thigh with mild erythema, fine nodule, mild edema site (Varicella).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Large painful rash around the injection site.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash papular
Clinical narrative: Fever 2 days prior rash starting on trunk spreading to arms, neck and face (slightly erythematous papular rash).
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Chest pain, Full blood count normal, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: High fever, flu-like symptoms, chest hurt, muscle aches for 2 days. No treatment.
Age: 1.51
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event
Clinical narrative: For reporting purpose only. Pt was given KINRIX vaccine at 18 months of age. No problems noted on patient.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Tinnitus, Vertigo, Vision blurred
Clinical narrative: Dizziness where world is spinning around, blurred visions, ringing in ears, sees purple dots that began after 2nd dose of GARDASIL.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction
Clinical narrative: Herpes zoster PCR vaccine strain confirmed.
Age: 1.72
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Blood electrolytes, Blood magnesium, Convulsion, Culture throat, Full blood count
Clinical narrative: Patient received DTaP #4, HIB #4, Pneumococcal #4 and Hep A #2 on 5-13-11 (morning). Early 5-14-11 he had a prolonged seizure lasting about 20 minutes. Associated with fever 102.0 (F). Questionable febrile seizure vs. other etiology.
Age: 1.72
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Patient received DTaP #4, HIB #4, Pneumococcal #4 and Hep A #2 on 5-13-11 (morning). Early 5-14-11 he had a prolonged seizure lasting about 20 minutes. Associated with fever 102.0 (F). Questionable febrile seizure vs. other etiology.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Resident sustained erythema to lateral & posterior areas of left upper arm, adjacent to injection site. Also c/o pain & slight swelling observed by this writer.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The injection was received on 5/13/11 and the patient started experiencing swelling, warmth, itch, tenderness, and a pink ring around the injection site by 5/15/11. She applied BENADRYL cream on 5/16/11 with some relief.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Injection site pain, Lymphadenopathy, Sleep disorder
Clinical narrative: Lymphadenopathy (L) axilla (vaccine site (L) deltoid) pain awakened pt from sleep. No loss of use of arm, no loss of work.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Lymphadenopathy, Sleep disorder, Vaccination site pain
Clinical narrative: Lymphadenopathy (L) axilla (vaccine site (L) deltoid) pain awakened pt from sleep. No loss of use of arm, no loss of work.
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Cyanosis, Respiratory arrest
Clinical narrative: Child was at childcare - had a seizure in which he turned "blue" and stopped breathing. Childcare provider gave mouth-to-mouth ventilations with which child revived. Child was taken to hospital - CT of head negative, physician exam negative - diagnosed as reaction to MMR vaccine. (Information from mother). *No fever or illness prior to incident.*
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Resuscitation, Vaccination complication
Clinical narrative: Child was at childcare - had a seizure in which he turned "blue" and stopped breathing. Childcare provider gave mouth-to-mouth ventilations with which child revived. Child was taken to hospital - CT of head negative, physician exam negative - diagnosed as reaction to MMR vaccine. (Information from mother). *No fever or illness prior to incident.*
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with a history of reactive airways disease and no drug reaction or allergy who on 15-MAY-2006 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 649996/0907R) into his left arm when he was 12 month old. The patient had a reaction (specific type reaction unknown) 1 year ago to KINRIX (GlaxoSmithKline). On 13-MAY-2010, the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot# 665971/1563Y). There was no concomitant medication. 12 or 18 hours later, the patient had an injection site reaction. The injection site was warm, firm, swollen, red and pain when the area was touched. The patient was told to apply ice and cold compresses to the area and take BENADRYL and MOTRIN as needed. The patient sought medical attention via office visit. No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering. Follow-up information has been received from the registered nurse concerning the child with a history of febrile seizure in 2008 who has three siblings. On 13-MAY-2010, the patient was vaccinated SC with the second dose of VARIVAX (Merck) into his left arm at 3:00 PM. Concomitant vaccine therapy included the second dose of MMR II ( lot# 666318/1739Y) SC in the right arm at the same time. There was no illness at the time of vaccination. On 14-MAY-2010, patient saw a physician, it was reported when the patient woke up in the morning, he didn't notice anything but noticed throughout the day left upper arm hard, warm, red and swollen. The patient did not complain of pain to area (previously reported as the injection site pain). On physical exam the left arm was noted to have a 7 cm diameter erythematous slightly firm circular area at site of VARIVAX (Merck) injection. There was no drainage and was mildly tender to palpation. The patient did not have fever. The patient was not taken any medication. It was reported that it looked like a significant local reaction to VARIVAX (Merck). There were no signs of infection at this point. The patient was diagnosed with rash/other nonspecific skin eruption. The plan was to have the patient to take BENADRYL and MOTRIN as needed, the patient was also told to use ice or cool compress to the area. On 17-MAY-2010, the office got off a phone with the patient's mother. It was reported that the patient's arm was much better. His arm was still firm and red, but the area was more concentrated to the injection site and it was no longer warm to touch. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with a history of reactive airways disease and no drug reaction or allergy who on 15-MAY-2006 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 649996/0907R) into his left arm when he was 12 month old. The patient had a reaction (specific type reaction unknown) 1 year ago to KINRIX (GlaxoSmithKline). On 13-MAY-2010, the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot# 665971/1563Y). There was no concomitant medication. 12 or 18 hours later, the patient had an injection site reaction. The injection site was warm, firm, swollen, red and pain when the area was touched. The patient was told to apply ice and cold compresses to the area and take BENADRYL and MOTRIN as needed. The patient sought medical attention via office visit. No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering. Follow-up information has been received from the registered nurse concerning the child with a history of febrile seizure in 2008 who has three siblings. On 13-MAY-2010, the patient was vaccinated SC with the second dose of VARIVAX (Merck) into his left arm at 3:00 PM. Concomitant vaccine therapy included the second dose of MMR II ( lot# 666318/1739Y) SC in the right arm at the same time. There was no illness at the time of vaccination. On 14-MAY-2010, patient saw a physician, it was reported when the patient woke up in the morning, he didn't notice anything but noticed throughout the day left upper arm hard, warm, red and swollen. The patient did not complain of pain to area (previously reported as the injection site pain). On physical exam the left arm was noted to have a 7 cm diameter erythematous slightly firm circular area at site of VARIVAX (Merck) injection. There was no drainage and was mildly tender to palpation. The patient did not have fever. The patient was not taken any medication. It was reported that it looked like a significant local reaction to VARIVAX (Merck). There were no signs of infection at this point. The patient was diagnosed with rash/other nonspecific skin eruption. The plan was to have the patient to take BENADRYL and MOTRIN as needed, the patient was also told to use ice or cool compress to the area. On 17-MAY-2010, the office got off a phone with the patient's mother. It was reported that the patient's arm was much better. His arm was still firm and red, but the area was more concentrated to the injection site and it was no longer warm to touch. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Full blood count, Herpes zoster, Pain in extremity, Red blood cell sedimentation rate, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male patient with no known drug allergies/reactions and no pertinent medical history who on 08-MAY-2006, was vaccinated SQ with the first 0.5 ml dose of VARIVAX (Merck) (Lot # 652663/1032R) and on 08-MAY-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (lot # 663299/1774X). There were no concomitant medications. On 26-APR-2010, the patient developed shingles. It was reported that the pain and lesions developed on his legs. Diagnostic laboratory tests included CBC, sedimentation rate and x-ray (results not provided). At the time of the report the patient's outcome was not specified. The patient sought unspecified medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: X-ray
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male patient with no known drug allergies/reactions and no pertinent medical history who on 08-MAY-2006, was vaccinated SQ with the first 0.5 ml dose of VARIVAX (Merck) (Lot # 652663/1032R) and on 08-MAY-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (lot # 663299/1774X). There were no concomitant medications. On 26-APR-2010, the patient developed shingles. It was reported that the pain and lesions developed on his legs. Diagnostic laboratory tests included CBC, sedimentation rate and x-ray (results not provided). At the time of the report the patient's outcome was not specified. The patient sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Cellulitis, Local reaction
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified date, was vaccinated with a dose of VARIVAX (Merck) and a dose of MMR II (MSD) in the same arm. Subsequently the patient had "a localized reaction" in between where the two shots were given. The patient sought unspecified medical attention. On unspecified date, the patient recovered. Follow up information has been received from a licensed practical nurse concerning a 5 year old female with no known drug allergies and no illness at time of vaccination and no adverse events following prior vaccination who on 02-MAY-2010 was subcutaneously vaccinated with the second dose of VARIVAX (Merck) (lot # 665804/1300Y) in the left deltoid. Secondary suspected therapy on 03-MAY-2010 included a second dose of MMR II (MSD) by subcutaneous route into the left deltoid. Other concomitant therapy included a fifth dose of KINRIX (lot # reported as AC20B141BA) (IM) into right deltoid. On 04-MAY-2010 the patient experienced localized reaction and cellulitis which responded to antibiotics in the right arm. The patient visited a doctor. On 07-MAY-2010, the patient recovered from localized reaction and cellulitis. No further information is available.
Age: 3.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Abnormal behaviour, Accidental overdose, Pyrexia, Rash generalised, Wrong drug administered
Clinical narrative: This case was reported by a heathcare professional (the subject's mother) and described the occurrence of rash over body in a 3-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject had previously experienced fever following vaccination with MMR vaccine, (Unknown manufacturer) on an unspecified date. Concurrent vaccination included 5th dose of INFANRIX (unknown route, left arm) given on 28 April 2010 at 16:30; pneumococcal vaccine (non-gsk); WAL given on 28 April 2010. On 28 April 2010 at 16:30 the subject inadvertently received an additional dose of INFANRIX (.5 cc, unknown route, right arm) instead of Hepatitis A vaccine, and experienced accidental overdose and wrong vaccine administered. The lot number of INFANRIX was reported as C3084AA. On 30 April 2010, 2 days after vaccination with 2 doses of INFANRIX, the subject experienced rash over body, fever and change in behavior. At the time of reporting the events of rash over body and fever were improved, and the event of change in behavior was worse. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain, Drug exposure during pregnancy, Ultrasound antenatal screen normal, Vaginal discharge, Varicella virus test negative
Clinical narrative: Information has been received from a Registered Nurse, for VARIVAX (Merck) and MMR II, Pregnancy Registry products, concerning a 25 year old female with previously measles, mumps, rubella and varicella naive, who on 12-MAR-2010 was vaccinated with a first dose VARIVAX (Merck) and a first dose of MMR II. At her follow-up appointment on 26-MAR-2010, she was pregnant. The patient's Last Menstrual Period was 13-FEB-2010 and the Estimated Delivery Date was 20-Nov-2010. Between March and May of 2010, the patient was treated in unspecified hospital emergency rooms on multiple occasions for abdominal pain and vaginal discharge. On 20-MAY-2010 fetal ultrasound was performed and depicted a live, moving, single fetus. At the time of the report, the outcome of the events was unknown. Follow-up information was received from the registered nurse concerning a 25 year old pregnant female who on 12-MAR-2010 was vaccinated with 0.5 ml VARIVAX (Merck) (lot # 664900/0812Y). Concomitant therapy included albuterol inhaler and FLAGYL. The patient was tested for varicella antibodies before vaccination and the test revealed negative. The patient's last menstrual period was 05-FEB-2010 and estimated delivery date was 12-NOV-2010. On 20-MAY-2010, at 14 weeks 5 days pregnancy, ultrasound was done for abdominal pain. The ultrasound revealed the infant was single, live and movement. Since 20-MAY-2010 the patient has not returned for care in the healthy system. At the time of the report the outcome was unknown. Follow-up information has been received from the registered nurse. She reported that the patient had not returned for care in the health system since 20-MAY-2010 and that no information was available where the patient went for pre-natal care. The patient was now lost to follow-up. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash pustular, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 25-APR-2001 was vaccinated with the first dose of VARIVAX (Merck) (SC, lot # 636365/1339K), and on 28-JUL-2008 the patient received the second dose (SC, lot # 659955/1801U). On 23-JUN-2010 the patient presented with a breakthrough chickenpox with 25 varicella lesions out of which few were typical pustules. The patient had no systemic symptoms other than pruritic. The patient received unspecified medical attention. At the time of the reporting, the patient recovered. Additional information has been requested.
Age: 1.34
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Body temperature increased, Decreased appetite, Irritability, Rash
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 16 month old male patient with no medical history and no known allergies or drug reactions who on 29-JUN-2010, was vaccinated with a dose of a VARIVAX (Merck) (Lot # 1657Y, Expiration date: 25-NOV-2011), a dose of MMR II (MSD) (Lot # 1357Y, Expiration date: 24-SEP-2011) and a dose of INFANRIX (Lot # AC14B091AA, Expiration date: 30-JUN-2011). Child's mother reported that five hours after receiving the vaccinations, child developed a rash on his face and arms, had a temperature, became fussy and irritable and had a decrease in his appetite. On 01-JUL-2010, patient's mother felt rash worsened, she noted the rash spread to the child's torso and groin. Mother brought child to doctor's office. Mother reported bathing child in an oatmeal bath as per doctor's recommendation. Mother contacted doctor's office on 06-JUL-2010 and reported that child was improving, child no longer had temperature, child was not fussy or irritable and appetite had improved. She also reported that rash on face, arms, torso and groin had improved and was very faint. Patient sought medical attention by a visit to the doctor's office. Rash on face and arms, temperature, fussy and irritable, decrease in appetite, and rash on torso and groin were considered to be an other important medical event by the certified medical assistant. Follow-up information was received from the Certified Medical Assistant who reported that the 16 (also reported as 15) month old male patient with a birth weight of 7 pounds 11 ounces who on 29-JUN-2010, was vaccinated subcutaneously in the left arm with the first dose of VARIVAX (Merck) (Lot # 666344/1657Y), subcutaneously in the right arm with the first dose of MMR II (MSD) (Lot #665878/1357Y) and intramuscularly in the left deltoid with a fourth dose of INFANRIX (Lot # AC148091AA). The Certified Medical Assistant also reported that the child's mother stated that on 29-JUN-2009 afternoon, toddler broke out in severe rash from head face bottom torso. On 07-JUL-2010 the patient recovered and the Certified Medical Assistant did not considered any more the events as an other important medical events. No further information is expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 28 month old female patient with no pertinent medical history or no drug reaction or allergy who on 02-FEB-2009 was vaccinated with a dose of VARIVAX (Merck) (lot# 660334/1533X). Concomitant therapy included MIRALAX. On 13-JUN-2010 (also reported at approximately 13-JUN-2010) the patient had a rash and "looked normal for chickenpox". However, the patient continued to "get more and more spots, not vesicular, but hundreds of popular spots on torso, groin, and face". It was reported that the patient was sent to home from daycare, but the patient was not exhibiting signs of discomfort and was afebrile. The patient sought unspecified medical attention. No laboratory studies were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 1.39
Sex: M
Vaccine: DTAP
Symptoms: Anger, Confusional state, Cough, Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by the grandmother of a consumer and described the occurrence of confusion in a 16-month-old male subject who was vaccinated with Diphtheria tetanus acellular pertussis (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux. Previous vaccination included 1st dose of diphtheria and tetanus toxoids and acellular pertussis vaccine (manufacturer unspecified) given on 28 April 2010. On 7 May 2010 the subject received 2nd dose of Diphtheria tetanus acellular pertussis in the left thigh. At an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced confusion and fit of rage (consumer referred to as outrage). These events resolved within two weeks. Around the time of reporting, the subject had developed diarrhea and a chronic cough. Diarrhea was unresolved and the outcome of cough was not specified. The 2nd vaccination with INFANRIX was also considered to be an inappropriate schedule of drug administration. Follow-up received 02 August 2010 from a consumer (the subject's mother): The consumer reported that "no one can tell us (me) if [the subject] is or will be safe". Follow-up received 31 August 2010 from a healthcare professional: The healthcare professional stated "no reported adverse reaction to this date, per exam or verbal", and indicated that the reported adverse events were per the subject's mother. The healthcare professional reported the diagnosis as "dtap vaccine administered IM", and that the event could have been associated with erroneous administration "not given within recommended spacing from CDC". There were no relevant laboratory tests or investigations. The healthcare professional reported that "scheduled DTAP series per CDC. Parent request one vaccine at visit, does not want to follow CDC guideline".
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with a history of rectal prolapse who in 2001 was vaccinated with the first dose of VARIVAX (Merck) (0.5 ml, SC) and on 02-AUG-2010 he received the second dose (0.5ml, SC, lot # 666869/0469Z). There was no concomitant medication. On 03-AUG-2010 the patient developed redness and induration at the injection site of the right upper arm. The patient was evaluated in the office and was found to have a 3 inch by 2 inch area of redness and induration at the injection site surrounded by a 6 inch by 5 inch pink area. The patient was prescribed KEFLEX. There were no labs or diagnostic tests performed. At the time of the reporting, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male who on 02-AUG-2010 was vaccinated with his second dose of VARIVAX (Merck) (lot # 666869/0469Z). On 03-AUG-2010 the patient called the office to report redness and swelling at the injection site of the right upper arm. He was scheduled for an office evaluation later on 03-AUG-2010. At the time of reporting, the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Eyelid oedema, Loss of consciousness, Ocular hyperaemia, Swelling face
Clinical narrative: Information has been received from a physician concerning a 4 years old female patient who on approximately 30-JUL-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot number 666490/1659Y) (Expiration date: November 2011). Secondary suspect vaccine included MMR II (lot number 606576/1564V validated for Hepatitis B vaccine (Recombinant) (MSD). Concomitant vaccine included polio virus vaccine and DTaP. The physician stated that a couple hours after vaccination he experienced puffy red eyes, puffy face and lost consciousness. The patient was taken to emergency room (ER) but not admitted and was given diphenhydramine (manufacturer unknown). On an unspecified date the patient had recovered from puffy red eyes, puffy face and lost consciousness. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Convulsion, Gaze palsy
Clinical narrative: Information has been received from a physician concerning a 4 years old female patient who on approximately 30-JUL-2010 was vaccinated with the second dose of VARIVAX (Merck) (lot number 666490/1659Y) (Expiration date: November 2011). Secondary suspect vaccine included MMR II (lot number 606576/1564V validated for Hepatitis B vaccine (Recombinant) (MSD). Concomitant vaccine included polio virus vaccine and DTaP. The physician stated that a couple hours after vaccination he experienced puffy red eyes, puffy face and lost consciousness. The patient was taken to emergency room (ER) but not admitted and was given diphenhydramine (manufacturer unknown). On an unspecified date the patient had recovered from puffy red eyes, puffy face and lost consciousness. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Blood test normal, Chest X-ray normal, Convulsion, Febrile convulsion, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 25 month old female patient with a history of abnormal weight gain and no allergies who on 05-AUG-2010 was vaccinated subcutaneously with the first 0.5ml dose of VARIVAX (Merck) (lot# 666735/0065Z) and the first 0.5ml dose of MMR II (MSD), (lot# 665750/1564Y). There was no concomitant medication. On 13-AUG-2010 the patient developed a fever of 100 degrees F and had a seizure. The patient was taken to an emergency room and was observed (no treatment given). The patient had a follow-up appointment with her pediatrician on 16-AUG-2010 and the patient had no symptoms. At the time of this report, the patient had recovered. Follow up information has been received from the licensed practical nurse concerning this 25 months old (reported as 2 years old) female child who on 05-AUG-2010 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# 666735/0065Z) into the right anterior thigh, the first 0.5ml dose of MMR II (MSD), (lot# 665750/1564Y) into the left anterior thigh, the first dose of HAVRIX (lot # AHAVB379AA) into the right anterior thigh and the second dose of PENTACEL (lot #C3623AA) into the left anterior thigh. On 13-AUG-2010, 11 days post immunizations, the patient had febrile seizure and was seen in the emergency department (ED). Blood work and chest X-ray were all within normal limits. The patient was sent home. Upon internal review, febrile seizure was considered to be an important medical event. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Normal newborn, Premature delivery, Premature labour
Clinical narrative: Information has been received from a medical assistant for the Pregnancy Registry for VARIVAX (Merck) concerning a 15 year old female pregnant patient with no pertinent medical history, no drug reactions/allergies, who on 06-OCT-2009 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (Lot # 665030/0976Y). There was no concomitant medication. The patient sought unspecified medical attention. No adverse effect was reported. Her LMP was 15-AUG-2009 and EDD was 22-MAY-2010. Follow up information was received from a medical assistant via pregnancy questionnaire concerning a 15 year old female patient with 1 previous pregnancy (at 34 weeks of gestation), and no birth defects in any previous pregnancy who on 06-OCT-2009 was vaccinated subcutaneously with 0.5 ml dose of VARIVAX (Merck) (Lot # 665030/0976Y). There were no concomitant medications reported. The patient was no tested for varicella antibodies before vaccination. It was reported that an ultrasound was performed on 21-JAN-2010, 13-FEB-2010 and on 22-MAR-2010 (results not provided). On 21-JAN-2010, a serum alpha-fetoprotein test was performed and the result was negative. There were no infections or illnesses during pregnancy. The patient experienced pre-term labor (dates not reported). It was reported that on 03-APR-2010, (32 weeks plus 6 days gestation), the patient delivered a normal male baby (weighed 5 pounds, 7 oz). There were no other complications reported. At the time of the report the outcome of the patient was not reported. Follow up information was received from a physician who reported that the mother was their patient but they were not the infant's physicians. The baby's experience has been captured in WAES # 1001USA03546B1. No further information is available.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Ultrasound antenatal screen
Clinical narrative: Information has been received from a medical assistant for the Pregnancy Registry for VARIVAX (Merck) concerning a 15 year old female pregnant patient with no pertinent medical history, no drug reactions/allergies, who on 06-OCT-2009 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (Lot # 665030/0976Y). There was no concomitant medication. The patient sought unspecified medical attention. No adverse effect was reported. Her LMP was 15-AUG-2009 and EDD was 22-MAY-2010. Follow up information was received from a medical assistant via pregnancy questionnaire concerning a 15 year old female patient with 1 previous pregnancy (at 34 weeks of gestation), and no birth defects in any previous pregnancy who on 06-OCT-2009 was vaccinated subcutaneously with 0.5 ml dose of VARIVAX (Merck) (Lot # 665030/0976Y). There were no concomitant medications reported. The patient was no tested for varicella antibodies before vaccination. It was reported that an ultrasound was performed on 21-JAN-2010, 13-FEB-2010 and on 22-MAR-2010 (results not provided). On 21-JAN-2010, a serum alpha-fetoprotein test was performed and the result was negative. There were no infections or illnesses during pregnancy. The patient experienced pre-term labor (dates not reported). It was reported that on 03-APR-2010, (32 weeks plus 6 days gestation), the patient delivered a normal male baby (weighed 5 pounds, 7 oz). There were no other complications reported. At the time of the report the outcome of the patient was not reported. Follow up information was received from a physician who reported that the mother was their patient but they were not the infant's physicians. The baby's experience has been captured in WAES # 1001USA03546B1. No further information is available.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Paraesthesia, Rash
Clinical narrative: Information has been received from a physician concerning a 35 year old male patient with no pertinent medical history and no drug reaction or allergies, who on 16-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # and route not reported). There was no concomitant medication. The physician reported that on approximately 30-AUG-2010, two weeks after the patient received the vaccine, he developed a rash on his thigh and arm. As the rash resolved, on an unspecified day in August 2010, the patient developed paresthesia in the thigh and from the wrist to his elbow. At the time of the report, it was unknown if the patient's paresthesia in the thigh and from the wrist to his elbow had resolved. The patient sought unspecified medical attention. There were not laboratories test performed. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: FLUX, HEPA, MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia, Tremor, Vomiting
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient who on 11-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (MSD) (lot# 668252/0859Z), a dose of MMR II (MSD) (lot# 666832/0285Z), a dose of PREVNAR and a dose of influenza virus vaccine (unspecified) (name and manufacturer unspecified). On 11-OCT-2010 the patient was taken to the Emergency Room with a low grade fever and vomiting. Physician reported that the patient was given IV fluids and released from the Emergency Room (no hospital stay occurred). On 13-OCT-2010 the patient was taken to the Emergency Room for a "shaking episode". There was no hospital stay for this second incidence. At the time of this report, the patient's outcome was not reported. Follow up information has been received from the physician concerning 12 month old male patient with congenital heart defect who on 11-OCT-2010 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (MSD) (lot# 668252/0859Z) into the left thigh. The patient had Tetralogy of Fallot at time of vaccination. On 11-OCT-2010, at 17:00, the patient developed vomiting, fever, fussy and shaking episode lasting 2-3 days. At the time of this report, the patient's outcome was not reported. Follow-up information has been received from the physician concerning the 12 month old male patient with murmur at time of vaccination and a history of Tetralogy of Fallot (TOF) repaired in November 2009 who on 11-OCT-2010 10:00 AM was vaccinated SC with a 0.5ml dose of VARIVAX (Merck) (lot# 668252/0859Z) into the left thigh, a 0.5 ml dose of MMR II (lot# 666832/0285Z) (MSD) subcutaneously into the right thigh, a 0.5 ml dose of VAQTA (lot# 668579/0850Z) (MSD) IM into the left thigh. Other concomitant therapy included a 0.5 ml dose of PREVNAR 13 (lot# 913967) given IM into the right thigh. The patient experienced above adverse events at 5:00 PM on 11-OCT-2010. The patient did not follow up. The patient was transferred out of the physician's practices to another pediatrics office. The patient's outcome was unknown. No further information is available.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 11 year old male who on 12-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (route not specified) (Lot # and expire date unknown). The patient was given a Hepatitis A vaccine (manufacturer and appearance unspecified) and another vaccine shot (manufacturer and appearance unspecified) the same day. On 14-OCT-2010 the patient developed a large red spot that was warm to the touch at the injection site. The patient sought medical attention: "he had an office visit on 15-OCT-2010". On 18-OCT-2010, the patient recovered. Follow-up information has been received from a medical assistant concerning a 11 years old male with no known drug allergies, birth defects and no medical history reported who on 12-OCT-2010 was vaccinated with the second dose of VARIVAX (Merck) (Lot # 668402/0841Z), subcutaneously into the left arm. Concomitant therapies included a dose of MENACTRA (lot n. 43671AA), intramuscularly in the left arm deltoid and VAQTA (MSD) (lot n. 668912/1087Z), intramuscularly in the right deltoid. Reporter stated that on 15-OCT-2010, the patient went to the physician's office. He experienced redness and warm to the touch area surrounding where VARIVAX (Merck) was given. Diameter was 16x14 cm. Patient was given 40 mg SOLU-MEDROL and prednisone 50 mg, 1 tablet daily for 3 days and recovered on 18-OCT-2010. Additional information is not expected.
Age: 1.18
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Cerebellar ataxia, Fall, Gait disturbance, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning her 14 month old son with allergy to lanolin, milk allergy and eczema and a history of adenoidectomy (September 2010) and ear tubes placed bilaterally (September 2010) who was vaccinated with a dose of VAQTA, a dose of MMR II, a dose of VARIVAX (Merck), a dose of PREVNAR and a dose of influenza virus vaccine (unspecified) (manufacturer unknown) on 28-OCT-2010. On 03-NOV-2010 and 04-NOV-2010 (also reported as within 7-8 days) the patient experienced a fever as high as 105.5 F and extreme irritability. On 05-NOV-2010 and 06-NOV-2010 the patient experienced a red rash over his trunk and his fever was low grade. On 07-NOV-2010 the patient did not have a fever or rash but developed "ataxia" where he "was falling everywhere" and had difficulty ambulating without assistance. The physician reported that he was falling a lot, seemed not to be falling as much but was running into objects. When the patient moved his head he seemed to fall. The patient had a wide-based gait. The patient first saw a pediatrician and then was evaluated by a pediatric neurologist who believed that he had an acute cerebellar ataxia. The physician reported that the irritability and fever had subsided, but the ataxia persisted. The physician stated that the ataxia was worse when the patient stopped walking and when he "looks up". No lab diagnostics studies performed. The mother reported that it has been "two weeks" since the patient's ataxia started and she felt that he was not really improving. An acute cerebellar ataxia was considered to be disabling. Additional information has been requested.
Age: 1.18
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Information has been received from a physician concerning her 14 month old son with allergy to lanolin, milk allergy and eczema and a history of adenoidectomy (September 2010) and ear tubes placed bilaterally (September 2010) who was vaccinated with a dose of VAQTA, a dose of MMR II, a dose of VARIVAX (Merck), a dose of PREVNAR and a dose of influenza virus vaccine (unspecified) (manufacturer unknown) on 28-OCT-2010. On 03-NOV-2010 and 04-NOV-2010 (also reported as within 7-8 days) the patient experienced a fever as high as 105.5 F and extreme irritability. On 05-NOV-2010 and 06-NOV-2010 the patient experienced a red rash over his trunk and his fever was low grade. On 07-NOV-2010 the patient did not have a fever or rash but developed "ataxia" where he "was falling everywhere" and had difficulty ambulating without assistance. The physician reported that he was falling a lot, seemed not to be falling as much but was running into objects. When the patient moved his head he seemed to fall. The patient had a wide-based gait. The patient first saw a pediatrician and then was evaluated by a pediatric neurologist who believed that he had an acute cerebellar ataxia. The physician reported that the irritability and fever had subsided, but the ataxia persisted. The physician stated that the ataxia was worse when the patient stopped walking and when he "looks up". No lab diagnostics studies performed. The mother reported that it has been "two weeks" since the patient's ataxia started and she felt that he was not really improving. An acute cerebellar ataxia was considered to be disabling. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a health professional concerning an 11 year old male patient with no medical history and no illness at time of vaccination who on 01-NOV-2010 was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot number 668536/0971Z). On 01-NOV-2010 the patient experienced 3.5 cm erythema and 5 cm induration at injection site. On 09-NOV-2010, the patient recovered from 3.5 cm erythema and 5 cm induration at injection site. The patient did not require emergency room/doctor visit. No diagnostic laboratory tests performed. No further information is available.
Age: 1.26
Sex: M
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Information has been received from a health care worker and a physician concerning a 42 month old male patient with no allergies and no pertinent medical history, who on 28-JUL-2008 was vaccinated with a dose of VARIVAX (Merck) (Lot# 660341/0317X). There was no concomitant medication. The health care worker stated that on 17-NOV-2010 the patient tested positive for "varicella-zoster vaccine related rash" on 17-NOV-2010. The health care worker also stated that " the rash was all over his body", "It had crusted over now". Later, the physician reported that the patient was diagnosed with shingles after receiving VARIVAX (Merck), physician reported the lesions appeared on his hands and then spread to arms and chest. On 30-NOV-2010 the patient recovered from all these symptoms. Follow-up information has been received from the healthcare professional, who reported that the patient with no chickenpox history was vaccinated with a first dose of VARIVAX (Merck) (Lot# 660341/0317X), Right arm, unknown time, and a first dose of MMR II (lot# 661725/0916X), Right arm, unknown time, on 28-JUL-2008. The healthcare professional stated that on 17-NOV-2010 the patient experienced vesicular rash on his right hand, arm and chest for 2 weeks. The rash did not occur at the site of injection or elsewhere within 42 days of vaccination. A varicella PCR test was performed that showed vaccine related strain. No photo was taken. No further information is available.
Age: 1.26
Sex: M
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Herpes zoster, Rash vesicular, Skin lesion, Varicella virus test positive
Clinical narrative: Information has been received from a health care worker and a physician concerning a 42 month old male patient with no allergies and no pertinent medical history, who on 28-JUL-2008 was vaccinated with a dose of VARIVAX (Merck) (Lot# 660341/0317X). There was no concomitant medication. The health care worker stated that on 17-NOV-2010 the patient tested positive for "varicella-zoster vaccine related rash" on 17-NOV-2010. The health care worker also stated that " the rash was all over his body", "It had crusted over now". Later, the physician reported that the patient was diagnosed with shingles after receiving VARIVAX (Merck), physician reported the lesions appeared on his hands and then spread to arms and chest. On 30-NOV-2010 the patient recovered from all these symptoms. Follow-up information has been received from the healthcare professional, who reported that the patient with no chickenpox history was vaccinated with a first dose of VARIVAX (Merck) (Lot# 660341/0317X), Right arm, unknown time, and a first dose of MMR II (lot# 661725/0916X), Right arm, unknown time, on 28-JUL-2008. The healthcare professional stated that on 17-NOV-2010 the patient experienced vesicular rash on his right hand, arm and chest for 2 weeks. The rash did not occur at the site of injection or elsewhere within 42 days of vaccination. A varicella PCR test was performed that showed vaccine related strain. No photo was taken. No further information is available.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no pertinent medical history and no drug reactions or allergies who on 22-JAN-2011 was subcutaneously vaccinated with 0.5ml VARIVAX (Merck) (lot# 668469/1188Z). There was no concomitant medication. On 02-FEB-2011 the patient went to the office with a rash that was described as two lesions on her back that were flat and non-vesicular. On 09-FEB-2011, the patient returned to the office with multiple, red, itchy lesions some flat and some vesicular over her thorax, scalp and back. Physician planned to prescribe acyclovir (manufacturer unknown) to treat the rash. The patient had not had a fever. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash erythematous, Rash macular, Rash pruritic, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 27 year old female with no pertinent medical history and no drug reactions or allergies who on 22-JAN-2011 was subcutaneously vaccinated with 0.5ml VARIVAX (Merck) (lot# 668469/1188Z). There was no concomitant medication. On 02-FEB-2011 the patient went to the office with a rash that was described as two lesions on her back that were flat and non-vesicular. On 09-FEB-2011, the patient returned to the office with multiple, red, itchy lesions some flat and some vesicular over her thorax, scalp and back. Physician planned to prescribe acyclovir (manufacturer unknown) to treat the rash. The patient had not had a fever. No lab diagnostics studies were performed. At the time of reporting, the patient was recovering. Additional information has been requested.