chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Initial information has been received from a registered nurse concerning her 5 year old daughter who on 27-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) in the right arm (lot number 660568/0507X) (injection route not reported) and a dose of DTaP (manufacturer unknown) in the right arm, a dose of MMR II (MSD) in the left arm and a dose of poliovirus vaccine (manufacturer unknown) in the left arm. On 27-AUG-2008 night, the patient had a slight fever. On 28-AUG-2008, also reported as the following day, the patient developed severe swelling (approximately 3 x size of her left arm) of her right arm. The patient's right arm also became hot and red. The reporter noted that it "looked like cellulitis". The swelling, redness and warmth extended from the top of the patient's shoulder to her elbow. The patient was seen in the physician's office on 28-AUG-2008 and was treated with BENADRYL and TYLENOL. It was also reported that the patient had no adverse events following prior vaccination (she previously had all routine vaccinations). The patient's mother was going to monitor the patient's arm. If the patient did not improve she planned on taking her to the emergency room. Follow-up information was received from the registered nurse also the patient's mother which reported that the patient's symptoms had improved significantly on 31-AUG-2008. The patient went for a follow-up appointment on 02-SEP-2008 with the physician. According to the patient's mother, the physician thought that this was not an adverse reaction to vaccine, but a possible error in technique with the administration of IM injection of DTaP or the patient moved during administration. The patient's mother indicated that the physician stated that he thought it was a collection of blood due to this that caused the events. The physician also told the patient's mother that he did not agree that the patient shouldn't receive vaccine in the future. The patient's mother did not have lot number available but she still requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 5 year old female with no allergies and no medical history reported, who on 08-JAN-2002 was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot# 640468/0796L) and on 07-FEB-2008 was vaccinated with the second dose of VARIVAX  (Lot # 651177/0428R). There was no concomitant medication. In September 2006, the patient developed a "full blown case of chickenpox" after administration of two doses of VARIVAX (Oka/Merck). On an unknown date, the patient recovered from "full blown case of chickenpox". The patient sought medical attention at the office. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No therapeutic response, Varicella zoster serology negative
Clinical narrative: Information has been received from a pharmacist concerning a patient who an unspecified date was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). The Pharmacist reported that a physician called and reported that the patient who received a dose of VARIVAX (Oka/Merck) was now non-immune to VARIVAX. It was unknown if the patient sought any medical attention. The outcome of the patient was unspecified. No further information is available.
Age: 1.4
Sex: M
Vaccine: DTP, HIBV, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a 5 year old male with dextromethorphan hypersensitivity who on 08-OCT-1996 was vaccinated with VARIVAX (Oka/Merck) (617313/0769D) S.Q. Concomitant therapy included HIB (manufacturer unspecified) and DTP (unspecified). Four years after the patient's first and only dose of VARIVAX, in approximately 2000 the patient developed shingles. Subsequently, the patient recovered from shingles. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 11-15 year old female who was vaccinated with a second dose of VARIVAX (Oka/Merck). Subsequently the patient experienced chickenpox type lesions after the second dose of VARIVAX (Oka/Merck). This is one of two reports from the same source. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an allergist/ immunologist concerning a 7-9 year old male "sometime in mid-July 2008", on approximately 15-Jul-2008 was vaccinated with a dose of VARIVAX (Oka/Merck). "About two weeks" after vaccination, the patient developed a severe case of Zoster. The Zoster rash covered the back from shoulder blade. The patient was treated in the emergency room for the rash (date unspecified) and prescribed Augmentin and Prednisone for two weeks. The rash did not improve with treatment. No other symptoms or treatment available. HCP was interested in VZV anylasis by PCR and wanted to send viral isolates. At the time of this report, the event persisted. Follow up information was received which indicated that 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 or with the Oka/Merck vaccine VZV strain. On 10-Sep-2008 the specimen was taken from a vesicle lesion on the patient's back and sent to the laboratory on a piece of gauze. The result indicated that the sample was inadequate, negative for B-globin, no strain I.D. . VZV  DNA could not be amplified. The reporter stated, "piece of gauze soaked for many days". Additional information has been requested.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Agitation, Irritability, Pruritus, Pyrexia, Urticaria
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 16 month old female with a history of allergic atopic dermatitis who in June 2008, also reported as three months ago, was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). Subsequently, approximately 5 days after the administration of the vaccine, the patient developed generalized urticaria which lasted 3-4 weeks. On approximately 20-AUG-2008, also reported as two weeks ago, the patient was inadvertently vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and  route not reported) instead of MMR due to human error. One week ago, also reported as within 48 hours of vaccination, the patient developed more severe urticaria than after the first dose. It was reported that the urticaria was with generalized presentation of skin lesion which were pruritic and increased agitation of child. The patient was also irritable with a little fever and vomiting after the second dose (also reported not associated with fever, joint pain or vomiting). The patient was on steroids for 5 days and was on antihistamines at time of reporting. The patient was recovering from the events. No further information is expected.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Vaccine positive rechallenge, Vomiting, Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 16 month old female with a history of allergic atopic dermatitis who in June 2008, also reported as three months ago, was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). Subsequently, approximately 5 days after the administration of the vaccine, the patient developed generalized urticaria which lasted 3-4 weeks. On approximately 20-AUG-2008, also reported as two weeks ago, the patient was inadvertently vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and  route not reported) instead of MMR due to human error. One week ago, also reported as within 48 hours of vaccination, the patient developed more severe urticaria than after the first dose. It was reported that the urticaria was with generalized presentation of skin lesion which were pruritic and increased agitation of child. The patient was also irritable with a little fever and vomiting after the second dose (also reported not associated with fever, joint pain or vomiting). The patient was on steroids for 5 days and was on antihistamines at time of reporting. The patient was recovering from the events. No further information is expected.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 12 month old female with no pertinent medical history or allergies who on 23-AUG-2008 was vaccinated with a dose of VARIVAX vaccine (Oka/Merck). Secondary suspect therapy included a dose of MMR II vaccine. "13 days later", on 07-SEP-2008 the patient developed a rash on the abdomen which spread to the chest, back and abdomen. The rash was described as little red dots and not a typical chickenpox rash. The rash had gotten progressively worse since starting, but since 09-SEP-2008 it had stayed the same. On 10-SEP-2008 the patient visited the office. No laboratory or diagnostics tests were performed. The vaccine was administered at another facility. At the time of this report, the event persisted. Follow up information received from the L.P.N. who reported that the 13 month old female with no known allergies who in September 2008 developed rash approximately 10-12 days after shots. The rash disappeared, no fever and other problems. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 5 year old male patient (birth weight was 7 pounds, 11 ounces) with allergy to AMOXIL who was previously vaccinated on 05-AUG-2008 with the second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), Lot number 659704/0667, intramuscularly into the right thigh and fifth dose of DAPTACEL, Lot number C29343A, intramuscularly into the left thigh. On 08-SEP-2008, was vaccinated with the second dose of VARIVAX vaccine (Oka/Merck), Lot # 660671/0403X, 0.5 mL, subcutaneously into the right thigh and a fourth dose of IPOL (previously reported as poliovirus vaccine, unspecified), Lot number A04914, subcutaneously into the left thigh. On 08-SEP-2008 the patient experienced hives and redness after receiving the second dose of VARIVAX vaccine (Oka/Merck). The patient experienced the hives shortly after receiving the dose followed by redness in the area as the hives resolved. The lot number for the first dose was not available. In follow-up information the physician reported that the patient had no hives and the patient recovered from redness at site of VARIVAX vaccine (Oka/Merck) injection. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on an unspecified date was vaccinated with a second dose of VARIVAX (Oka/Merck) (route and administration site not reported). Subsequently, 10 days after the vaccination, the patient developed a mild case of chickenpox on her trunk. The patient was treated with loratadine. The patient was recovering from the chickenpox. The patient sought medical attention via a phone call. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rhinorrhoea
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 16 year old male who on 22-JUL-1997 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 18-AUG-2008 at 2:57 pm, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) Lot number 660673/0332X, 0.5 mL, subcutaneously in the right thigh and the patient was also vaccinated with the first dose of HAVRIX IM into the left thigh, Lot # B264AA. It was reported that on 06-SEP-2009 the patient was experiencing fever and runny nose. In follow-up information the nurses reported that the patient's mother called on 10-SEP-2008, approximately 3 weeks post vaccination stating that on 06-SEP-2008, child's rash appeared on 3-4 locations on his chest, then several more appeared on his face. It appeared as spider bites. At the time of the initial information reported the patient was recovering. It was also reported in follow-up information that when the patient's mother reported the rash, the patient had no fever. At the time of the follow-up information reported, the outcome of the patient's rash was not reported. The patient sought medical attention, called the practice. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 11-15 year female who was vaccinated with a second dose of VARIVAX (Oka/Merck). Subsequently the patient experienced chickenpox type lesions after the second dose of VARIVAX (Oka/Merck). This is one of  two reports from the same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Rash generalised, Rash macular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 6 year old female with a history of otitis media in February 2004 (treated with amoxicillin) who on 07-FEB-2004 and 16-FEB-2007 was vaccinated subcutaneously with her first and second doses of VARIVAX (Oka/Merck) (lot #647266/1098N and 655995/130F) in her arm, respectively. Concomitant therapy included 4th dose of PNEUMO on 07-FEB-2004, 5th dose of Tdap and 4th dose of POLIO on 16-FEB-2007. On 11-AUG-2008 the patient developed a varicella like rash. The patient developed a rash over the whole body including the scalp. On 15-AUG-2008 the patient was seen in the office and the rash was at least 25 lesions and was vesicular and had some early stage macular. No laboratory or diagnostics tests were performed. On 19-AUG-2008 the patient recovered. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 15 year old male patient with AMOXICILLIN allergy who on 08-SEP-2008 was vaccinated with VARIVAX (Oka/Merck) (lot number 659603/1903U, site and route not reported) at a clinic associated with the hospital.  Subsequently, two days after the vaccination, the patient's parent called to report the injection site reaction which was described as swelling and warmth at the injection site that involved the whole upper arm.  The area was warm to touch, but the patient did not have a fever.  There was no other information.  The patient sought medical attention.  The patient sought medical attention.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  Further information has been requested.
Age: 11.0
Sex: F
Vaccine: TTOX, VARCEL
Symptoms: Inappropriate schedule of drug administration, Rash
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 11 year old female who on 20-AUG-2008 was vaccinated with the first dose of VARIVAX vaccine (Oka/Merck). Concomitant therapy included "tetanus" vaccine (manufacturer unspecified). It was reported that on 20-AUG-2008, at 8:30 am, the patient got a rash on her right arm after receiving VARIVAX vaccine (Oka/Merck) and tetanus vaccine (manufacturer unspecified). In follow-up information it was reported that the rash was circular (2-3 cm). The patient sought medical attention, saw the doctor. It was also reported that on 10-SEP-2008, at 8:30 a.m., the patient was vaccinated with a second dose of VARIVAX vaccine (Oka/Merck), Lot number 661636/0535X in the right upper arm. At the time of the report the patient's outcome was unknown. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 9 year old female who was vaccinated with VARIVAX vaccine (Oka/Merck) (route, lot number and site not reported). Subsequently the mother of the patient told the physician that the patient experienced a 4 inch by 5 inch softball size swelling at the injection site of the arm within 24 hours. There is no information of which arm. The patient was treated with oral diphenhydramine hydrochloride and has recovered. This was a recent occurrence, but unknown date. There is no other information. The patient sough medial attention. Further information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 29 year old female who on 09-Sep-2008 was vaccinated IM with VARIVAX (Oka/Merck) (lot number and site not reported). Concomitant therapy included Poliovirus vaccine (manufacture unknown). On the morning of 11-Sep-2008 the patient experienced redness and swelling at the injection site. The reaction was about the size of quarter to fifty cents coin. The patient sought medical attention. No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received form a physician's assistant student concerning an 11 year old male with no known allergies, who on 18-APR-2000 was vaccinated with a first dose of VARIVAX (Oka/Merck) (Lot # 632052/1463J) and on 23-MAY-2007 was vaccinated with a second dose of VARIVAX (Oka/Merck) (Lot # 656172/1498F). The physician's assistant student reported that the child developed an itchy, red, rash on his trunk, legs and arms on 04-SEP-2008. No other symptoms were noted. At the time of reporting the patient was recovering. The patient sought medical attention: in office. There was no product quality complaint. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Herpes zoster, Pyrexia, Vomiting
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a 7 year old female with allergy to OMNICEF (rash) and no previous significant history who on 04-AUG-1998 was vaccinated with the first dose of VARIVAX (Merck). There were no concurrent medications. On 19-DEC-2004 (also reported as 21-DEC-2004) the patient developed shingles (also reported as vesicular rash) and vomiting. There was no rash at the injection site. The lesions were distributed to left lower and upper arm posteriorly left scapula (left side of upper back and neck) over night. On 21-DEC-2004 the patient was seen in office with complaint of fever 102.9- 99.9 for 48 hours. No lab tests or diagnostics were performed. Subsequently, the patient was recovered from shingles and vomiting. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year old male patient who on 21-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 660499/0132X). On 09-SEP-2008 the patient was seen in the physician's office with the complaint of chicken pox. The patient's brother also developed chicken pox after vaccination with VARIVAX (Merck) (WAES # 0809USA02379). Additional information hs been requested. This is one of several reports from the same source.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Irritability, Rash
Clinical narrative: Information has been received from a consumer her 12 months daughter with allergy to gelatin, who on 04-Sep-2008 was vaccinated with VARIVAX (Oka/Merck) and developed a rash on her face and chest and became very irritable. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. No further information is available.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician's assistant concerning a female patient who received two doses two of VARIVAX (Merck) at unstated schedule.  After an unknown period of time she developed Herpes Zoster on one side of her trunk on 03-SEP-2008.  No additional information at the time of report.  VZVID offered and Representative will call the office that day, 12-SEP-2008. The patient sought medical attention in the office.  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with no pertinent medical history and no history of drug reactions or allergies who on 04-AUG-2008 was vaccinated with the second dose of VARIVAX (Merck) (lot#: 659606/1905U) 0.5ml SQ. There was no concomitant medication. Within 48 hours from getting the vaccine, on 06-AUG-2008, the patient complained of redness, swelling and soreness to a touch at the injection site. On 07-AUG-2008, the swelling and soreness resolved. The redness was getting less. The patient was treated with heat therapy. The patient was seen in the office. A lot check has been requested. This is one of several reports from the same source. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Oka/Merck) (lot number and injection site not reported). Subsequently the patient developed chickenpox. It was unknown if the patient sought any medical attention. The outcome was unspecified. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 5 year old patient who had been vaccinated with a dose of VARIVAX (Merck) in the past, and had been diagnosed with shingles. The physician was not interested in VZV analysis by PCR (Polymerase Chain Reaction) as the patient was completely recovered. The patient sought medical attention at the office. No lab diagnostic studies were performed. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Initial and follow-up information has been received from a nurse concerning her 6 year old male grandson with no pertinent medical history and no drug reactions/allergies, who on an unknown date was vaccinated with a first dose of VARIVAX (Merck) as an infant and on 16-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck). There was no concomitant medication. On 06-SEP-2008 the patient experienced chickenpox. The patient developed a couple of lesions on his skin and some in his mouth. He had less lesions than his brother (WAES # 0809USA02576). The child was treated with Ibuprofen and Tylenol. He was not seen by the physician because his mother is a nurse. The patient was able to return to school on 12-SEP-2008. There were no lab diagnostics studies performed. In further communication, the nurse reported that the patient did not see the physician and had a mild case with no adverse reactions, only fever and multiple sores in mouth and body (mostly buttocks and legs). This is one of two sibling reports from the same source. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 9 year old female who on 10-SEP-2008 was vaccinated with a booster dose of VARIVAX (Merck) (lot no., route, injection site not reported). After receiving the vaccination the patient developed a reddened area and cellulitis of arm. On 09-AUG-2000 the patient was vaccinated with the first dose of VARIVAX (Merck) (lot no., route, injection site not reported). She has no fever but experienced itchiness in the arm. The patient's symptoms persisted. The patient visited office and sought medical attention. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 9-year-old female patient who on 30-AUG-2008 received the second dose of 0.5ml VARIVAX (Merck) (lot # 658176/1011U) via subcutaneous route in her left arm. Subsequently, the patient developed "two ruddy discolored patches" with uneven borders which were not elevated above the injection site. The patient came to the office to seek medical attention on 02-SEP-2008 with "two ruddy discolored patches" still presented. At the time of reporting, the patient was not recovered. The patient received the first dose of VARIVAX (Merck) on 19-APR-2008. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 08-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 661443/0528X) 0.5 mL subcutaneously and a dose of MMRII (lot # 656864/0412U).  Concomitant vaccination included a dose of PREVNAR.  On 08-SEP-2008 the patient was diagnosed with erythema multiforme.  The patient had lesions on the face, neck, upper back and chest.  At time of reporting, the patient was recovering.  No labs or diagnostic studies were performed.  The patient sought medical attention with an office visit.  Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash, Viral DNA test negative
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 23-JAN-2001 was vaccinated with the first dose of VARIVAX (Merck) (lot # 632366/1458J). On 07-SEP-2008 (also reported as Saturday) the patient started with spots and vesicles appeared. On 08-SEP-2008 the specimen of the patient's lesion hand was sent for culture of varicella. Varicella zoster virus culture results showed that there was no virus isolated. At the time of this report, the outcome was unknown. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (lot number and injection site not reported). Subsequently the patient developed chickenpox. It was unknown if the patient sought any medical attention. The outcome was unspecified. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 11 year old male patient who on 21-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 660499/0132X). On 09-SEP-2008 the patient was seen in the physician's office with the complaint of chicken pox. The patient's brother also developed chicken pox after vaccination with VARIVAX (Merck) (WAES# 0809USA01837). Additional information has been requested. This is one of several reports from the same source.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 9 year old male patient who on 21-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 660499/0132X). On 09-SEP-2008 the patient was seen in the physician's office with the complaint of chicken pox. The patient's sister also developed chicken pox after vaccination with VARIVAX (Merck) (WAES# 0809USA02381). Additional information has been requested. This is one of several reports from the same source.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient who on 21-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 660499/0132X).  On 09-SEP-2008 the patient was seen in the physician's office with the complaint of chicken pox.  The patient's brother also developed chicken pox after vaccination with VARIVAX (Merck) (WAES# 0809USA02380).  Additional information has been requested.   This is one of several reports from the same source.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 67 year old female with hypertension who on 16-SEP-2008 was vaccinated inadvertently with VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD).  Concomitant therapy included DYAZIDE, aspirin and multi vitamins.  The nurse reported that it was a combination of events that led to the human error.  The physician's assistant took the vaccine out of the freezer and handed it to the nurse to administer.  The office was very busy.  The vials had the term "VARICELLA" on the label.  The formulations were similar in that one is HERPES ZOSTER and the other is HERPES SIMPLEX.  And both were stored in the same refrigerator/ freezer.  The nurse suggested that it might be helpful if the label was easier to read to distinguish the two vaccines as the names were similar.  But she admitted it was more an issue of two people handling the vaccine and the very busy conditions in the office that day.  No adverse effect reported.  On 23-SEP-2008, "today", the patient was scheduled to follow up later.  On 29-SEP-2008, it was reported that the patient was contacted and denied any problems/symptoms after vaccination.  This is one of several reports received from the same source.  Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning her 7 year old male grandson with no pertinent medical history and no drug reactions/allergies, who on an unknown date was vaccinated with a first dose of VARIVAX (Merck) as an infant. There was no concomitant medication. On 06-SEP-2008 the patient experienced chickenpox. The patient developed lesions on his buttocks, legs, neck and in his mouth. He had more lesions than his brother (WAES # 0809USA01980). The child was treated with Ibuprofen and Tylenol. He was not seen by the physician because his mother is a nurse. The patient was not able to return to school yet. There were no lab diagnostics studies performed. This is one of two sibling reports from the same source. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 68 year old male with hyperlipidemia who on 16-Sep-2008 was vaccinated inadvertently with VARIVAX (Merck) instead of ZOSTAVAX (Merck). Concomitant therapy included Lipitor, aspirin and multi vitamins. The nurse reported that it was a combination of events that led to the human error. The physician's assistant took the vaccine out of the freezer and handed it to the nurse to administer. The office was very busy. The vials had the term "Varicella" on the label. The formulations were similar in that one is Herpes Zoster and the other is Herpes Simplex. And both were stored in the same refrigerator/freezer. The nurse suggested that it might be helpful if the label was easier to read to distinguish the two vaccines as the names were similar. But she admitted it was more an issue of two people handling the vaccine and the very busy conditions in the office that day. No adverse effect reported. On 23-SEP-2008, "today", the patient was scheduled to follow up later. On 29-SEP-2008, it was reported that the patient was contacted and denied any problems/ symptoms after vaccination. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on an unknown date was vaccinated with a second dose of VARIVAX (Merck) (lot number 0974X) (injection site and route not reported). Ten to twelve days after vaccination, the patient developed a varicella like reaction. The reaction started on both arms and spread to the whole body numbering 250 pox. It was unknown if the patient sought any medical attention. The outcome of the patient was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant (C.M.A) concerning a 20 year old female, weight 168lb, height 67 inches, with no pertinent medical history and no history of drug reactions or allergies. Who in 1999 was vaccinated with the first dose of VARIVAX (Merck). In the afternoon of 17-JUL-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 659114/1361U). Concomitant medication included unspecified birth control medication. On 18-JUL-2008 the patient broke out in a rash at the injection site but no fever. On 19-JUL-2008 the patient was seen physician's office and was diagnosed with varicella disease. The patient was prescribed VALTREX, ZOVIRAX and sulfa in case it was cellulitis. On 29-JUL-2008 the patient recovered. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Condition aggravated, Immunodeficiency common variable
Clinical narrative: Information has been received via literature article regarding a case in litigation concerning a now 54 year old female with common variable immunodeficiency disorder (CVID) and a 30 years earlier history, given by her to a gastroenterologist, of chronic uncontrolled diarrhea from spastic colon, who on 07-MAR-2001 was vaccinated with a dose of VARIVAX (Merck) in connection with a clinical research study.  Concomitant medication was not reported.  The patient experienced aggravating of her common variable immunodeficiency disorder after receiving VARIVAX (Merck) and the patient hypothesized that VARIVAX (Merck) aggravated her condition.  However a preponderance of the evidence does not support the existence of a preexisting immunologist disorder, CVID, prior to immunizations.  The reporter stated the patient's theory must fail since the vaccine could not aggravate that which was not proven to exist.  Follow up information was received via literature article regarding a case in litigation which reported that the patient was in regular contact with study staff who were following a protocol for collecting information about vaccine side-effects, and there was no contemporaneous record of the symptoms that the patient reports.  The judge said "she also was in regular contact with the primary physician, and had other medical treatments in 2001, yet non of the contemporaneous records before the chief special master mentioned the severe post-vaccination symptoms that are now alleged by the patient to have occurred in 2001".  This is a consolidation of two reports concerning the same patient.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a physician concerning a 24 year old female who on was vaccinated with two doses of VARIVAX (Merck) and failed to seroconvert. The patient was vaccinated with her first dose on 25-FEB-2008 and her second dose in April 2008. Titer was drawn recently showed zero seroconversion. No product quality complaint. No further information is available.
Age: 6.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning an over 6 years old male who on approximately 21-JUL-2008 was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot # 660219/0154X) (route and administration site not reported).  Concomitant therapy included other vaccines (unspecified) which were not administered at the same site.  Within hours of the shots the patient experienced a reaction of "unusually large swelling, redness and fever at the injection site".  The swelling worsened the day after the vaccination.  His sister received VARIVAX (Oka/Merck) from the same lot and had no adverse event.  The patient sought medical attention by calling the doctor.  Additional information has been requested.  This is one of several reports from the same source.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no medical history or no drug allergies who was vaccinated with a dose of VARIVAX (Merck) (lot # 660084/0333X). Five days after vaccination, the patient developed vaccine related chicken pox. The patient had no fever but had a lot of vesicles. The patient was seen in the office and had a lot of vesicles. The patient was seen in office and physician suggested to treat the patient with over the counter BENADRYL. On an unspecified date, the patient recovered from vaccine related chicken pox. No product quality complaint was involved. The reporter felt that chicken pox was related to therapy with VARIVAX (Merck). Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella zoster serology negative
Clinical narrative: Information has been received from a pharmacist concerning a male who was vaccinated with VARIVAX (Oka/Merck).  The patient failed to SEROCONVERT for VARICELLA ZOSTER virus antibodies after receiving two doses of VARICELLA VIRUS vaccine live 8 weeks apart.  No adverse symptoms reported.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on 29-MAY-2008 was a dose of vaccinated with VARIVAX (Merck) (lot # 659169/1500U) on right thigh. Subsequently the patient developed vaccine related shingles. The mother brought the patient into the office on 24-JUL-2008 where the doctor diagnosed a patch of shingles near injection site on right thigh. At the time of this report, the patient was recovering. The reporter felt that vaccine related shingles was related to therapy with VARIVAX (Merck). No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old male who on 14-MAY-2008 was vaccinated with VARIVAX (Merck), 0.5 ml, SC instead of ZOSTAVAX (Merck) (human error, no product quality complaint involved).  The prescribing physician just wrote "Varicella" on the orders.  It was dispensed as a VARIVAX (Merck) dose not ZOSTAVAX (Merck) dose because they failed to look at the patient's age being 70 year old.  No adverse effects reported.  A telephone call to the pharmacist reaffirmed that the wrong vaccine given was human error and did not involve a quality complaint.  Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year old male who was vaccinated with the second dose of VARIVAX (Merck). One year after the second dose of VARIVAX (Merck), the patient developed full blown chicken pox, characterized by 500 lesions. The patient did received two doses of vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from the physician reported that there was no need to report the event since there was no adverse reaction. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old boy who on 06-JAN-2005 was vaccinated subcutaneously into left arm with first dose of VARIVAX 0.5ml (Merck), and in 17-JUL-2007 was vaccinated subcutaneously into left arm with the second dose of VARIVAX 0.5ml (Merck). There was no concomitant medication. On 13-MAY-2008 the patient developed chicken pox. On 14-MAY-2008 the patient was seen by the physician where the diagnosis was made. The patient's chicken pox was recovering. The nurse also mentioned that the patient's grandmother recently had a case of shingles. The patient sought medical attention with a physician office visit. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 60 year old patient who on 30-JUL-2008 was inadvertently vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) (MSD).  The medication error did not result in any adverse symptoms.  The physician confirmed it was a human error but not a product confusion.  It was unspecified if the patient sought medical attention.  Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an approximately 10 year old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck). The physician reported that the patient received the chickenpox on 15-MAY-2008. At the time of the report the patient was recovering. No further information is available.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 13 month old female with no pertinent medical history and no allergies who on 30-APR-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (LOT # 659938/1787U9).  Secondary suspect vaccinations included MMR II, HAEMOPHILUS B vaccine (manufacturer unknown) and HEPATITIS B virus vaccine (manufacturer unknown).  The physician reported that on 11-MAY-2008, the patient experienced fever and a mild case of chickenpox.  The patient had less that 15 chickenpox lesions.  The patient was seen by a physician.  At the time of the report the patient was recovering.  Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 16 month old female with no known allergies or pertinent medical history who on 21-APR-2008 was vaccinated with a single dose of VARIVAX (Merck) (lot # 659432/1918U).  There was no concomitant medication.  The physician reported that on 09-MAY-2008 the patient developed a rash at the injection site and soon after developed chickenpox.  Viral count was performed (result was not provided).  The patient's rash at the injection site and chickenpox persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood glucose increased, Drug exposure during pregnancy, Glucose tolerance test normal, Pregnancy test positive, Ultrasound scan normal
Clinical narrative: Information has been received from a nurse practitioner through a pregnancy registry concerning a 29 year old female with asthma and a possible Tylenol allergy, who on 01-APR-2008 and 05-MAY-2008 was vaccinated with VARIVAX (Merck). Concomitant therapy included Advair and Mucinex. The patient is pregnant with LMP of 01-APR-2008 and an EED of 22-JAN-2009. No adverse effect reported. Pregnancy test fetal ultrasound was performed. There was no product quality complaint. Follow up information received on 27-FEB-2009 from an initial and a outcome pregnancy questionaries. The patient had a live born normal female on 23-JAN-2009, who weighed 7+6 LBS. There were no complications during pregnancy and during labor. It was also reported that there were no infections or illness during pregnancy and no concurrent medical conditions. During the pregnancy the patient's primary glucose was elevated. During the pregnancy the patient had a tertiary glucose tolerance test (GTT) within normal limits. Four ultrasounds test were performed to the patient, the first one on 24-JUN-2008, the second one on 31-JUL-2008, the third one on 02-SEP-2008 and the fourth one on 16-NOV-2008, all of them within normal limits. No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood lead, Blood test, Full blood count, Nuclear magnetic resonance imaging, Spinocerebellar ataxia
Clinical narrative: Information has been received from a consumer's mother concerning her 24 month old daughter with no pertinent medical history or drug allergies who on 20-DEC-2007 was vaccinated with a first dose of VARIVAX (Merck), 0.5 ml, SC.  There was no concomitant medication.  A week after receiving VARIVAX (Merck) (on 27-DEC-2007) the patient was diagnosed with acute spinocerebella ataxia.  Blood work, lead test, CBC and MRI were performed (no results provided).  The patient's acute spinocerebellar ataxia persisted.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old male who on 19-Jan-2008 was on 19-Jan-2008 was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot# 654128/1147F) 0.5ml subcutaneously and a dose of MMRII (MSD) (lot# 654983/1168F). The patient had been diagnosed with chicken pox which developed the week of 21-Jul-2008. The patient sought medical attention: office visit. At the time of this report, the patient was recovering. There was no product quality complaint. Additional information has been requested.