chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Infectious mononucleosis, Laboratory test normal, Rash, Staphylococcal infection
Clinical narrative: Information has been received from a registered nurse concerning her 11 year old granddaughter with a haemangioma who in 1999 at 14 months of age was vaccinated with VARIVAX (Merck) (Lot number was not reported).  There was a family history of autoimmune problems and problems after VARIVAX (Merck).  In 2009, the patient had a hemangioma removed and developed a staph infection this was followed by mononucleosis.  In 2009 the entire summer was "an autoimmune nightmare for the child".  It was reported that polymerase chain reaction test (PCR testing) was not needed.  The patient's rash spread to both sides and no longer resembled zoster.  The child was taken to hospital where a rapid antigen test showed that the rash was not zoster.  The patient was treated with a lidocaine gel.  Emergency Room physician confirmed that the rash was not zoster.  The patient's events persisted.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site pain, Injection site swelling, Scar
Clinical narrative: Information has been received from a nurse concerning a 24 month patient who on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (lot # 664719/0804Y). On an unspecified date the patient experienced a large area of swelling and pain at the injection site and may have developed some blistering which may have scarred. It was unknown if the patient sought medical attention. The outcome was not reported. This is one of several reports from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Drug Evaluation and Research and was released. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Eye pain, Facial pain, Lethargy, Ophthalmological examination normal
Clinical narrative: Information has been received from a registered nurse concerning a 3 year old male patient with no known drug allergies or pertinent medical history who on 05-AUG-2009 was vaccinated subcutaneously in his left arm with the dose of 0.5 mL VARIVAX (Merck) (Lot # was 663810/0476Y). There was no concomitant medication. On 12-AUG-2009 the patient was lethargic with a fever of up to 102.8F off and on for 2 days after administration VARIVAX (Merck). The patient was treated with TYLENOL. After the patient was afebrile his right side of his mouth, eye and face hurt for 4 days. The patient sought medical attention and made an office visit. The result of dilated eye examination with Fluorescein staining was normal. On 18-AUG-2009, the patient recovered from these events. Follow-up information has been received from the nurse concerning the male patient with one sibling. It was reported that the patient developed a fever of 102.8 degrees F for 2 1/2 days. Subsequently the fever subsided then the patient complained of his right eye hurting and right side of his face/mouth possible tic type behavior. Symptoms lasted four days then resolved on 20-AUG-2009 (previously reported as 18-AUG-2009). No other family members developed fever/illness. These events required emergency room/doctor visit. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Oral pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 3 year old male patient with no known drug allergies or pertinent medical history who on 05-AUG-2009 was vaccinated subcutaneously in his left arm with the dose of 0.5 mL VARIVAX (Merck) (Lot # was 663810/0476Y). There was no concomitant medication. On 12-AUG-2009 the patient was lethargic with a fever of up to 102.8F off and on for 2 days after administration VARIVAX (Merck). The patient was treated with TYLENOL. After the patient was afebrile his right side of his mouth, eye and face hurt for 4 days. The patient sought medical attention and made an office visit. The result of dilated eye examination with Fluorescein staining was normal. On 18-AUG-2009, the patient recovered from these events. Follow-up information has been received from the nurse concerning the male patient with one sibling. It was reported that the patient developed a fever of 102.8 degrees F for 2 1/2 days. Subsequently the fever subsided then the patient complained of his right eye hurting and right side of his face/mouth possible tic type behavior. Symptoms lasted four days then resolved on 20-AUG-2009 (previously reported as 18-AUG-2009). No other family members developed fever/illness. These events required emergency room/doctor visit. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypersensitivity, Rash
Clinical narrative: Information has been received from a grandmother concerning her 2 year old granddaughter who "about 2 months ago" (in approximately June 2009), was vaccinated with a 0.5mL dose of VARIVAX (Merck) (LOT# not reported). In approximately June 2009, after receiving the vaccine the patient experienced "an allergic reaction and 5 days later broke out in a rash". The grandmother also stated that the patient's physician told them that the rash was from the vaccine virus "because the outbreak wasn't that bad and a virus outbreak from the vaccine looks different that when you've been exposed to the wild virus." The patient sought unspecified medical attention and had recovered on an unspecified date. No further information is available.
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an unknown number of older adult patients who on an unspecified date were vaccinated with VARIVAX (Merck) (dose and lot number not provided). The patients experienced local injection site reactions. Follow up call information was received from a physician and a registered medical assistant concerning a 70 year old male patient who on 06-MAR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 659724/1660U). The patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). This event was not a case of product confusion, but a result of human error. No further information is available. This is one of two reports from the same source.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a nurse at a country health department concerning a 4 year old female patient with no previous medical history reported who on 13-APR-2009 was vaccinated with VARIVAX (Merck) SQ in the left arm and concomitantly at the same time with MMR (MSD), hepatitis B virus vaccine (unspecified) and diphtheria toxoid + pertussis acellular vaccine (unspecified) (+) poliovirus vaccine inactivated (unspecified) (+) tetanus toxoid. Subsequently, the patient came back, she experienced injection site reaction. The injection was red, itchy and hot (no rash reported). The patient sought unspecified medical attention. Information has been received from a Registered Nurse concerning a 4 year old white female patient who on 13-APR-2009 at 16:00 was vaccinated with the second dose of VARIVAX (Merck) (660334/1533X) subcutaneously into her left arm. Concomitant vaccines given on the same day at 16:00 included the second dose of MMR (Lot # 663162/1579X) subcutaneoulsy into her right arm, the fourth dose of ENGERIX-B (Lot # AHBVB582HA) intramuscularly into her right deltoid and the last dose of KINRIX (Lot # AC20B116AB) intramuscularly into her left deltoid. It was reported that on 13-APR-2009 in the afternoon the patient experienced arm red, itchy and warm to touch at the injection site. It was reported that approximately on 18-APR-2009 the patient had recovered. This is one of several cases from the same source. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from a nurse concerning an approximately 10 year old female patient, with no pertinent medical history, who on 13-APR-2009, was vaccinated subcutaneously with VARIVAX (Merck) (Lot # 660334/1533X). There was no concomitant medication. The nurse reported that the patient came back experiencing injection site reaction. On approximately 13-APR-2009, the patient's injection site was red, itchy, hot and painful to the touch (no rash reported). The patient recovered on an unspecified date. The patient sought unspecified medical attention. Follow up information was received from a Registered Nurse (R.N.) concerning a 10 year old female student who on 13-APR-2009 was vaccinated with the second dose of VARIVAX (Merck) (Lot # 660334/1533X) subcutaneously into her left arm at 15:40. It was reported that on 13-APR-2009 in the afternoon the patient experienced injection site red, itchy, warm to touch. The upper portion of the back left arm was solid, red and had a patch (2 1/2 inches for 2 1/2 inches). It was also reported an irregular shape square and induration along edges of redness. It was reported that approximately on 17-APR-2009 the patient had recovered. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Skin warm
Clinical narrative: Information has been received from a nurse concerning an approximately 10 year old female patient, with no pertinent medical history, who on 13-APR-2009, was vaccinated subcutaneously with VARIVAX (Merck) (Lot # 660334/1533X). There was no concomitant medication. The nurse reported that the patient came back experiencing injection site reaction. On approximately 13-APR-2009, the patient's injection site was red, itchy, hot and painful to the touch (no rash reported). The patient recovered on an unspecified date. The patient sought unspecified medical attention. Follow up information was received from a Registered Nurse (R.N.) concerning a 10 year old female student who on 13-APR-2009 was vaccinated with the second dose of VARIVAX (Merck) (Lot # 660334/1533X) subcutaneously into her left arm at 15:40. It was reported that on 13-APR-2009 in the afternoon the patient experienced injection site red, itchy, warm to touch. The upper portion of the back left arm was solid, red and had a patch (2 1/2 inches for 2 1/2 inches). It was also reported an irregular shape square and induration along edges of redness. It was reported that approximately on 17-APR-2009 the patient had recovered. No further information is available.
Age: 67.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who was schedule to receive ZOSTAVAX (Merck) was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). There was no product confusion involved. The patient had not experienced any known symptoms. Follow up information was received from a registered nurse. It was reported the 67 year old patient was inadvertently vaccinated with VARIVAX (Merck) (lot # 661980/1145X, exp.: 12-AUG-2010) due to human error. The reporter explained that their medical center policy no longer permitted the office to order ZOSTAVAX (Merck) (MSD). The office could only administer ZOSTAVAX  (Merck) (MSD) if a patient purchased the vaccine from his/her pharmacy. The nurse who administered the VARIVAX (Merck) thought that the office still ordered and stocked ZOSTAVAX (Merck) (MSD) and did not pay attention. The reporter stated that there was no problem with the label that led to the product confusion. The reporter indicated that the physician confirmed that the patient did not have any adverse experiences. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypovitaminosis, Liver disorder, Malaise, Mineral deficiency, Renal disorder
Clinical narrative: Information has been received from a patient's mother concerning her daughter (with a twin sister) with coeliac disease who on an unspecified date, at the age of 13 months was vaccinated with a dose of VARIVAX (Merck). Secondary suspect therapy included a dose of MMR II that was given 3 months after the VARIVAX (Merck) (when the patient was 16 months of age). It was reported that the patient was sick for a year after vaccination with  "post viral syndrome", "vitaminosis", and vitamin and mineral deficiencies for a year. It was also reported that the patient had kidney and liver problems and low white blood cell counts. It was reported that the patient recovered on an unspecified date. It was reported that the patient's twin sister experienced the same adverse experiences following vaccination (WAES # 0904USA03573). This is on of several cases from the same source. No further information is available.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection, White blood cell count decreased
Clinical narrative: Information has been received from a patient's mother concerning her daughter (with a twin sister) with coeliac disease who on an unspecified date, at the age of 13 months was vaccinated with a dose of VARIVAX (Merck). Secondary suspect therapy included a dose of MMR II that was given 3 months after the VARIVAX (Merck) (when the patient was 16 months of age). It was reported that the patient was sick for a year after vaccination with  "post viral syndrome", "vitaminosis", and vitamin and mineral deficiencies for a year. It was also reported that the patient had kidney and liver problems and low white blood cell counts. It was reported that the patient recovered on an unspecified date. It was reported that the patient's twin sister experienced the same adverse experiences following vaccination (WAES # 0904USA03573). This is on of several cases from the same source. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 6 year old male who at the age of 15 months, on 23-JAN-2004 was vaccinated with a first dose of VARIVAX (lot # 647520/1106N) subcutaneously in arm.  On 31-OCT-2007 the patient was vaccinated with a second dose of VARIVAX (lot #658596/1333U).  Last week the patient experienced a fever.  On 20-APR-2009 the patient was diagnosed with mild varicella with less than 50 lesions.  At the time of reporting, the patient's mild varicella with less than 50 lesions persisted, but the fever had since resolved (date not specified).  The patient sought unspecified medical attention.  Follow up information was received from a registered nurse.  It was reported the patient was vaccinated with a first dose of VARIVAX (lot # 647520/1106N) (exp. date: September 2005) into the left arm by subcutaneous route and a second dose of VARIVAX (lot # 658596/1333U) (exp. date August 2009?) into right arm by subcutaneous route.  At 08:42 am on 20-APR-2009 the patient was diagnosed with mild varicella with less than 50 lesions.  There was no illness at time of vaccination.  The patient had no pre-existing allergies, birth defects or medical conditions.  There were no relevant diagnostic tests performed.  Subsequently, on an unspecified date, the patient recovered.  No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Varicella
Clinical narrative: Information has been received from a health professional concerning an 8 year old male at approximately 12 moths of age, who on 02-OCT-2001 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (lot # 657408/0517U) and on 19-Dec-2007 was vaccinated subcutaneously with a second dose of VARIVAX (Merck) (lot # 659358/1568U).  On 02-APR-2009 the patient called the office to complain of red, itchy rash and was seen in the office on the same day.  The patient had pink papules on chest, neck, arms and legs and one clear vesicle on trunk.  Nothing had ever been crushed over yet.  The patient was diagnosed with chicken pox.  At the time of reporting, the outcome was not reported.  No further information is available.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer concerning her approximately 4 year old son with seasonal allergy and a history of developmental delay, sickness, breathing difficulty, abnormal behavior (spinning in circles, "acted autistic") after prior therapy with all of his shots (names and manufacturers unspecified) that are required the first year of life (WAES # 0904USA03747) who on an unspecified date was vaccinated with VARIVAX (Merck). Subsequently, on an unspecified date, the patient experienced seizures. The patient sought unspecified medical attention. At the time of reporting, the outcome was unknown. Follow up information was received from a medical assistant. On 26-SEP-2006 the patient was vaccinated with VARIVAX (Merck) (lot # 649740/0221R). It was reported the patient was first seen in their office on 21-NOV-2006. Upon internal review, seizures was determined to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypovitaminosis, Liver disorder, Malaise, Renal disorder, Viral infection
Clinical narrative: Information has been received from a patient's mother concerning her daughter (with a twin sister) with coeliac disease who on an unspecified date, at the age of 13 months was vaccinated with a dose of VARIVAX (Merck). Secondary suspect therapy included a dose of MMR II that was given 3 months after the VARIVAX (Merck) (when the patient was 16 months of age). It was reported that the patient was sick for a year after vaccination with "post viral syndrome", "vitaminosis" and vitamin and mineral deficiencies for a year. It was also reported that the patient had kidney and liver problems and low white blood cell counts. It was reported that the patient recovered on an unspecified date. It was reported that the patient's twin sister experienced the same adverse experiences following vaccination (0904USA03169). This is one of several cases from the same source. No further information is available.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: White blood cell count decreased
Clinical narrative: Information has been received from a patient's mother concerning her daughter (with a twin sister) with coeliac disease who on an unspecified date, at the age of 13 months was vaccinated with a dose of VARIVAX (Merck). Secondary suspect therapy included a dose of MMR II that was given 3 months after the VARIVAX (Merck) (when the patient was 16 months of age). It was reported that the patient was sick for a year after vaccination with "post viral syndrome", "vitaminosis" and vitamin and mineral deficiencies for a year. It was also reported that the patient had kidney and liver problems and low white blood cell counts. It was reported that the patient recovered on an unspecified date. It was reported that the patient's twin sister experienced the same adverse experiences following vaccination (0904USA03169). This is one of several cases from the same source. No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old male who was vaccinated with the first and the second (lot # 657941/0851U) dose of VARIVAX (Merck), 0.5ml on 06-DEC-2001 and 10-AUG-2007 respectively. On 22-APR-2009 the patient experienced a case of chicken pox even though he had received 2 doses of VARIVAX (Merck). The patient's case of chicken pox persisted. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with VARIVAX (Merck) instead of ZOSTAVAC (Merck) due to an office error. The VARIVAX (Merck) was given in the physician's office. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with a second dose of VARIVAX (Merck) 0.5 mL. More than 42 days post vaccination of the second dose, the patient experienced chicken pox. The patient did receive both doses of VARIVAX (Merck) and this occurred after the second dose. There were other chicken pox information in the community. This is one of several reports from the same source. Additional information has been requested.
Age: 1.06
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient with no medical history or drug allergy who on 16-JUL-2002 was vaccinated with VARIVAX (Merck). There was no concomitant medication. Subsequently the patient developed chickenpox on face, arm, and legs. The patient did not have any lab diagnostics studies performed. The patient was seen by a physician. At the time of the report the patient was recovering. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Varicella
Clinical narrative: Information has been received from a nurse concerning a male with attention deficit disorder who on 05-AUG-1999 was vaccinated with his first dose of VARIVAX (SQ, 0,5ml, lot number: 631065/0445J) and on 13-JAN-2009, the patient received his second dose of the vaccine (SQ, 0,5ml, lot number:).  Concomitant therapy included ADDERALL TABLETS (manufacturer unknown).  The nurse reported the patient developed chicken pox on 9-APR-2009.  The patient was examined in the office on 14-APR-2009 and a diagnosis of chicken pox was confirmed.  The patient presented with a heavy distribution of orangish papules on the chest, back, upper and lower extremities.  No treatment was advised.  The patient sought medical attention visited physician's office.  The outcome of the patient was unspecified.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ataxia, Condition aggravated, Developmental delay, Immune system disorder, Nervous system disorder
Clinical narrative: Information has been received from a published report concerning a 12 month old female with ganglioneuroblastoma, and a malignant cancer of the spinal cord, numerous viral infections, and overloaded immune system who on 22-DEC-2004, when she was 1, was vaccinated with a dose of MMR II.  Secondary suspect vaccine given on the same day included a dose of VARIVAX (Merck) (MSD).  It was reported that the patient presented to her pediatrician's office for her scheduled examination and to receive the vaccines and she had a runny nose and an upper respiratory infection.  It was reported that the patient awoke in the morning with full body tremors (also reported as a shaking episode) three days after receipt of the vaccinations lasting 15 or 20 minutes and she developed a noticeable ataxic gait nine days after she received the vaccines.  It was felt that the vaccinations further "up-regulated" her already "up-regulated" immune system to cause a self-directed attack on her nervous system.  It was reported that the immune system activity initiated by the vaccinations exacerbated her already overloaded immune system, leading to opsoclonus myoclonus syndrome (OMS), a disorder of muscle control of the eyes.  It was reported that the vaccinations were causal factors that substantially contributed to her neurological condition.  It was reported that the patient's earliest symptoms of OMS occurred within the medically appropriate time frame for an autoimmune type reaction triggered by the received vaccinations.  It was also reported that her development and neurological condition worsened on a variety of fronts until the discovery of the tumor and its removal on 09-SEP-2005.  After that, she began to improve, although she suffered relapses.  At age 4, according to her mother, she was doing well but was "a little behind".  No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Opsoclonus myoclonus, Tremor
Clinical narrative: Information has been received from a published report concerning a 12 month old female with ganglioneuroblastoma, and a malignant cancer of the spinal cord, numerous viral infections, and overloaded immune system who on 22-DEC-2004, when she was 1, was vaccinated with a dose of MMR II.  Secondary suspect vaccine given on the same day included a dose of VARIVAX (Merck) (MSD).  It was reported that the patient presented to her pediatrician's office for her scheduled examination and to receive the vaccines and she had a runny nose and an upper respiratory infection.  It was reported that the patient awoke in the morning with full body tremors (also reported as a shaking episode) three days after receipt of the vaccinations lasting 15 or 20 minutes and she developed a noticeable ataxic gait nine days after she received the vaccines.  It was felt that the vaccinations further "up-regulated" her already "up-regulated" immune system to cause a self-directed attack on her nervous system.  It was reported that the immune system activity initiated by the vaccinations exacerbated her already overloaded immune system, leading to opsoclonus myoclonus syndrome (OMS), a disorder of muscle control of the eyes.  It was reported that the vaccinations were causal factors that substantially contributed to her neurological condition.  It was reported that the patient's earliest symptoms of OMS occurred within the medically appropriate time frame for an autoimmune type reaction triggered by the received vaccinations.  It was also reported that her development and neurological condition worsened on a variety of fronts until the discovery of the tumor and its removal on 09-SEP-2005.  After that, she began to improve, although she suffered relapses.  At age 4, according to her mother, she was doing well but was "a little behind".  No further information is available.
Age: 1.27
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male with no pertinent medical history reported, no known drug allergies and no illness at the time of vaccination, who on 19-MAR-2009 was vaccinated SC in left upper thigh with first dose of MMR II (dose not reported, lot number 658339/0985X). Concomitant vaccinations received on the same day included VARIVAX (route SC right upper thigh, lot number 662374/1405X), PREVNAR (route IM left upper thigh, lot number D21051) and ACTHIB (route IM right upper thigh, lot number UF618AA). On 29-MAR-2009 the patient experienced a rash all over his body. He presented to office on 31-MAR-2009. The rash was spreading, non itchy, non vesicular. It was a maculopapular blanching erythematous rash that was generalized to whole body. The patient had no fever. Follow up information has been received from a physician concerning a 15 month old male who on 19-MAR-2009, at 1:59 PM, was vaccinated SC in left upper thigh with first dose of MMR II (dose not reported, lot number 658339/0985X). The physician reported that on 29-MAR-2009 the patient experienced maculopapular blanching erythematous rash generalized to entire body, non itchy and non vesicular The symptoms lasted for five to seven days. No treatment was given to the patient, only supportive care and reassurance.. The patient recovered from maculopapular blanching erythematous rash generalized to entire body on 05-APR-2009. This is an amended report. The manufacturer for the concomitant vaccine ACTHIB now reads Sanofi-Pasteur instead of Aventis Pasteur. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Pallor, Pharyngeal erythema, Rash maculo-papular
Clinical narrative: Information has been received from a nurse concerning a 12 month old female with no pertinent medical history who on 17-MAR-2009 at 13:00 was vaccinated with a first dose of VARIVAX (Merck) (lot # 662374/1405X) into her right thigh and a first dose of MMR II (lot # 662348/1506X) into her left thigh. Concomitant therapy included a fourth dose of PREVNAR (lot # D15050) into the left thigh. There was no illness at time of vaccination. On 27-MAR-2009 at 8:00, 10 days after vaccination, the patient developed a bright red maculo papular rash to face, neck, arms, chest, abdomen, back and groin. Blanching and non vesicular. The patient was not itchy, was afebrile and there was no vomiting or diarrhea. The patient also had posterior pharynx redness/tunsils grade 2. There were no relevant diagnostic tests or laboratory data. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N.)concerning a 9 year old female who on 06-APR-2009 was vaccinated which a dose of VARIVAX (Merck) (lot # 663823/0221Y) through the Vaccines for Children program. It was reported  that the patient had injection site reaction. The patient recovered. This is one of several reports from the same source. No further information is available.
Age: 1.28
Sex: F
Vaccine: DTAP, MMRV, VARCEL
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a nurse concerning her 22 month old daughter who in September 2008, was vaccinated SC 0.5ml in the left arm with VARIVAX (Merck) (lot# not reported). On 21-MAR-2009 the patient was diagnosed with shingles, affecting her left shoulder, down her arm to her fingers. The patient sought medical attention in the office and was treated with pain medication and antiviral medication. At the time of the report, 31-MAR-2009, the patient was recovering from the shingles. Follow up information was received from the physician which reported that the patient with no medical history or known allergies was vaccinated with VARIVAX (Merck) (lot no. 660404/0101X) 0.5 ml SC into the left deltoid, on 2-SEP-2008 at 16:45. On the same date, The patient was also administered a dose of PROQUAD (Merck) SC into the left arm and a dose of DAPTACEL (lot no. C29568A) IM into the right arm. It was reported that the patient developed Herpes Zoster (vesicles type-rash) dermatome C5, along her arm, forearm and hand. The patient had less than 10 lesions. The patient also experienced pain of 7 in a 1 to 10 scale. On an unknown date, the patient recovered. The patient had no history of Chickenpox or previous exposure to herpes zoster or chickenpox. The patient had no illness at the time of vaccination. The patient was enrolled at the time of vaccination. 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 OKA/Merck vaccine VZV strain. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 10 year old female who on 08-APR-2009 was vaccinated with a dose of VARIVAX (Merck) (lot # 663823/0221Y) through the Vaccines for Children program. It was reported that the patient had injection site reaction. The patient recovered. This is one of several reports from the same source. No further information is available.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Chest X-ray normal, Decreased appetite, Malaise, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with a history of pneumonia and "RSP" and no allergies who on 24-MAR-2009 was vaccinated SC with the first dose of VARIVAX (Merck) (lot# 661971/1394X, expiration date 27-OCT-2010) in the left arm. Concomitant therapy included HAVRIX (lot# 1258U, expiration date 26-JUL-2010) IM in the left deltoid. On 24-MAR-2009 the patient developed a fever of 101F that had lasted for 7 days, general malaise and loss of appetite. The mother gave the patient TYLENOL sporadically for the fever. The patient had a negative chest X-ray and would take complete blood cell count and streptococcus test. The patient's symptoms persisted. The patient sought medical attention by office visit. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture negative, Body temperature increased, Drooling, Febrile convulsion, Full blood count normal
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no known drug reactions/allergies and medical history, who on 07-MAY-2009 was vaccinated with: MMR II, HEP A (manufacturer unknown), VARIVAX (Merck) (routes and lot numbers unspecified). The physician mentioned that on 07-MAY-2009, the patient experienced seizure one hour after receiving the vaccinations. The infant had the seizure in the car and was taken back to the physician's office and found to have a temperature between 104F-105F. The fever lasted 2 days and he was fine now. The patient's twin brother also experienced adverse event of fever following vaccinations, reported in WAES#0905USA02439 by the same reporter. Upon internal review, seizure was determined to be an other important medical event. Follow up information has been received from a physician concerning the 12 month old male, who was born prematurely at 34 weeks and 6/7 gestation with mild hypospadias and a mild kidney reflux, who on 07-MAY-2009 was vaccinated with: MMR II (lot # 663524/1727X). Secondary suspect vaccinations also administered on 07-MAY-2009 included, HEP A (manufacturer unknown) (lot # AHAVB262AA) and VARIVAX (Merck) (lot# 660566/0729X). Concomitant therapy included amoxicillin 2 cc, orally, once daily. The physician stated that on 7-MAY-2009, the patient was seen in the office along with his twin brother (WAES # 0905USA02439) for their 12 month visit. The exam was within normal limits. Approximately 1 hour after vaccination the mother noticed that the patient was twitching in his legs, seemed to be staring off into space, drooling and was unresponsive. She was driving at the time and pulled over. This lasted for approximately 4 minutes. After the child regained responsiveness the mother reported that he was very fussy and cranky. The mother returned to the Pediatrician's office for the patient to be evaluated. At approximately 1.5 hours after vaccination he was seen and his temperature was measured 104.3 degrees. The Pediatrician came to the conclusion that the patient experienced a febrile seizure. The mother was instructed to treat the child's symptoms with TYLENOL or MOTRIN. Laboratory tests were performed to rule out the other scenarios. The patient's complete blood cell count (CBC) was normal and blood culture was negative. The patient was seen again 7-9 days after the fever, he exhibited no rashes, no fever and did not have any recurrence of the seizure. Upon internal review, febrile seizure was determined to be an other important medical event. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Muscle twitching, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no known drug reactions/allergies and medical history, who on 07-MAY-2009 was vaccinated with: MMR II, HEP A (manufacturer unknown), VARIVAX (Merck) (routes and lot numbers unspecified). The physician mentioned that on 07-MAY-2009, the patient experienced seizure one hour after receiving the vaccinations. The infant had the seizure in the car and was taken back to the physician's office and found to have a temperature between 104F-105F. The fever lasted 2 days and he was fine now. The patient's twin brother also experienced adverse event of fever following vaccinations, reported in WAES#0905USA02439 by the same reporter. Upon internal review, seizure was determined to be an other important medical event. Follow up information has been received from a physician concerning the 12 month old male, who was born prematurely at 34 weeks and 6/7 gestation with mild hypospadias and a mild kidney reflux, who on 07-MAY-2009 was vaccinated with: MMR II (lot # 663524/1727X). Secondary suspect vaccinations also administered on 07-MAY-2009 included, HEP A (manufacturer unknown) (lot # AHAVB262AA) and VARIVAX (Merck) (lot# 660566/0729X). Concomitant therapy included amoxicillin 2 cc, orally, once daily. The physician stated that on 7-MAY-2009, the patient was seen in the office along with his twin brother (WAES # 0905USA02439) for their 12 month visit. The exam was within normal limits. Approximately 1 hour after vaccination the mother noticed that the patient was twitching in his legs, seemed to be staring off into space, drooling and was unresponsive. She was driving at the time and pulled over. This lasted for approximately 4 minutes. After the child regained responsiveness the mother reported that he was very fussy and cranky. The mother returned to the Pediatrician's office for the patient to be evaluated. At approximately 1.5 hours after vaccination he was seen and his temperature was measured 104.3 degrees. The Pediatrician came to the conclusion that the patient experienced a febrile seizure. The mother was instructed to treat the child's symptoms with TYLENOL or MOTRIN. Laboratory tests were performed to rule out the other scenarios. The patient's complete blood cell count (CBC) was normal and blood culture was negative. The patient was seen again 7-9 days after the fever, he exhibited no rashes, no fever and did not have any recurrence of the seizure. Upon internal review, febrile seizure was determined to be an other important medical event. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture negative, Body temperature increased, Full blood count normal, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no known drug reactions/allergies and medical history, who on 07-MAY-2009 was vaccinated with MMR II, hepatitis A virus vaccine (manufacturer unknown), VARIVAX (Merck) (dates, routes and lot numbers unspecified). The physician mentioned that on 07-MAY-2009, the infant was taken back to the physician's office and found to have a temperature between 104F-105F. The fever lasted 2 days and he was fine now. The patient's twin brother also experienced adverse event of fever following vaccinations, reported in WAES#0905USA01996 by the same reporter. Follow up information has been received from a physician concerning the 12 month old male, who was born prematurely at 34 weeks and 6/7 gestation with mild hypospadias who on 07-MAY-2009 was vaccinated with MMR II (lot#: 663524/1727X (rHA)). Secondary suspect vaccinations also administered on 07-MAY-2009 included, hepatitis A virus vaccine (manufacturer unknown) (lot# AHAVB262AA) and VARIVAX (Merck) (lot# 660566/0729X). The physician state that on 7-MAY-2009, the patient was seen in the office along with his twin brother (WAES # 0905USA01996) for their 12 month visit. The exam was within normal limits. The mother returned to the Pediatrician's office for the patient to be evaluated. At approximately 1.5 hours after vaccination he was seen and his temperature was measured 104.6 degrees. The physician drew blood cultures to rule out other scenarios and they came back negative. Complete blood count was normal. The patient was seen again 7-9 days after the fever, he exhibited no rashes, no fever did not experienced seizure. Additional information is not expected.
Age: 1.09
Sex: M
Vaccine: HEPA, PNC, VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 13 month male with no illness at time of vaccination, who on 29-MAY-2009 at 10:00 am was vaccinated with the first dose of VARIVAX (Merck) (Lot No 660663/1534X), subcutaneous in the left arm. Secondary suspect include the first dose of VAQTA vaccine. Concomitant therapy included PREVENAR. The physician reported that on 07-MAY-2009, the patient developed red raised itchy rash without illness or fever. Additional information has been requested.
Age: 1.34
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Information has been received from a physician concerning a female with history of seizures who was vaccinated with VARIVAX (Merck) no lot number was provided). Subsequently the patient experienced a febrile seizure. Subsequently, the patient recovered from febrile seizure. The patient sought medical attention. Upon internal review, febrile seizure was determined to be an other important medical event. Follow up information has been received from a physician concerning a 16 month old female who on 25-MAR-2009 at 02:30 PM was vaccinated with the first dose of VARIVAX (Merck) SC. The patient had no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions. Concomitant therapy included the fourth dose of PREVNAR (lot # D15050) on 25-MAR-2009 at 2:30 PM. Within 20 hours after receiving the vaccine (on 26-MAR-2009 at 1:30 PM), the patient developed a high fever and subsequently had a seizure which lasted 1-2 minutes. No relevant diagnostic tests or laboratory was performed. Treatment was supportive only. The event required emergency room/doctor visit. The patient was recovered on 26-MAR-2009. No further information is available.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Pruritus, Rash erythematous, Rash papular, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female patient who on 29-APR-2009 was vaccinated subcutaneously with 0.5 ml of the second dose of VARIVAX (Merck) (Lot:663546/0125Y). On the same day the patient received VAQTA (MSD) (lot # 663548/1604X), intramuscularly in her left arm, GARDASIL (MSD) (lot # 661846/1312X), MENACTRA and ADACEL. On an unspecified date the patient presented to the office with a diagnosis of chicken pox located behind her one ear. At the time of reporting, on 05-MAY-2009, the patient's chicken pox persisted. Follow-up information was received from registered nurse who reported that on 05-MAY-2009 experienced a rash and first noticed it behind her ears, now on her stomach and her arms. The rash behind her ear was a fine red rash. The patient developed a papular rash scattered at her thorax and extremities. The nurse suggested to keep her skin clean and dry and the patient took BENADRYL for pruritus. The patient was given hydrocortisone for behind her ears only. The outcome of the patient was unknown. No further information is available.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Diarrhoea, Mumps antibody test negative, Myalgia, Nausea
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 43 year old female patient with asthma (but not medicated) and history of palpitations and wheezing who on 11-MAY-2009 was vaccinated with the first documented 0.5 ml dose of MMR II subcutaneously in deltoid region. It was reported that on 11-MAY-2009 the patient experienced nausea and diarrhea about 1 and 1/2 hours post dose. It was also reported that the patient experienced weakness and aches for the week following. It was reported that the palpitations and wheezing were made worse by the vaccine. The patient saw two different physicians with no diagnosis. It was reported that the patient received MMR II because of a lack of proper childhood documentation and a mumps titer that was drawn (prior to vaccination) which was negative. It was reported that the patient felt the vaccine was given intramuscularly but nurse confirmed subcutaneous by the needle length and nurse that administered. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning three patients who on an unspecified date were vaccinated with a dose of VARIVAX (Merck) (Lot # 663819/0336Y). It was reported that the three patients had injection site reactions from VARIVAX (Merck). The patients sought medical attention with an office visit. It was reported that the patients had recovered after two weeks. In follow up the nurse reported that this case concerned a 12 month old male patient who received through the Vaccines for Children program on 29-APR-2009. The patient recovered. This is one of several cases from the same source. No further information is available.
Age: 1.05
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning three patients who on an unspecified date were vaccinated with a dose of VARIVAX (Merck) (Lot # 663819/0336Y). It was reported that the three patients had injection site reactions from VARIVAX (Merck). The patients sought medical attention with an office visit. It was reported that the patients had recovered after two weeks. In follow up the nurse reported that this case concerned a 12 month old male patient who received through the Vaccines for Children program on 29-APR-2009. The patient recovered. This is one of several cases from the same source. No further information is available.
Age: 1.05
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from an office manager concerning a 12 month old male who on 29-APR-2009 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (LOT# 663819/0336Y). On the same day the patient experienced injection site reaction: "redness, swelling and induration at the injection site". The patient was sought medical attention in the office and was diagnosed with cellulitis. It was reported that the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 12 month old male who on 29-APR-2009 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (LOT# 663819/0336Y). On the same day the patient experienced injection site reaction: "redness, swelling and induration at the injection site". The patient was sought medical attention in the office and was diagnosed with cellulitis. It was reported that the patient was recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.01
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 12 month old female who on 01-MAY-2009 was vaccinated with a dose of VARIVAX (Merck) (lot# 663819/0336Y) through the Vaccines for Children program . It was reported that the patient had injection site reaction. The patient recovered. This is one of several reports from the same source. No further information is available.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning a 12 month old male who on 04-MAY-2009 was vaccinated with a dose of VARIVAX (Merck) (lot # 663819/0336Y) through the vaccine program. It was reported that the patient had injection site reaction. The patient recovered. This is one of several reports from the same source. No further information is available.