chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, IPV, VARCEL
Symptoms: Diarrhoea, Herpes zoster, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 41 month old male with autism, speech delay and encopresis who on 02-SEP-2005 was vaccinated subcutaneous in left with a first dose of VARIVAX (Merck) (LOT# 647535/0824P) and was vaccinated intramuscular in right with the fourth dose of RECOMBIVAX HB (+) Hib conj vaccine (OMPC) (LOT# 648809/0145P). Patient was also vaccinated intramucular in deltoid with the fourth dose of INFANRIX  (unspecified) (GSK - LOT# AC14A056BA) and was vaccinated subcutaneous in right with the third dose of IPOL (unspecified) (Aventis - LOT# X12313-2). At the time of vaccination, the patient had a slight fever. On 31-JUL-2007 the patient developed zoster on right hip and diarrhea. Acyclovir 200 per 5 was prescribed. The patient sought medical attention in physician's office. At the time of the report, it was unknown if patient had recovered or not Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular, Rash pruritic, Scab, Skin lesion
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female with amoxicillin allergy who on 21-NOV-1997 was vaccinated subcutaneously with a first dose of VARIVAX (Merck). The licensed practical nurse reported that on 07-APR-2008 the patient experienced scincitial lesions 20-30, few scabbed, some milky vesicular papules, fever + pruritic. At the time of the report the patient status was unknown. No further information is available.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old male who was vaccinated with a dose VARIVAX (Merck). On 09-Apr-2008 the patient had chickenpox. No documentation of the child's vaccination with the vaccine because the child could have received the vaccine from another doctor's practice. Unspecified medical attention was sought, in the doctor's office. There was no product quality complaint. Follow up information received 08-APR-2008. The patient did not have any adverse event after he received  VARIVAX (Merck). Follow up information received on 14-Apr-2008. Someone from the physician office indicated that, they did not have records of the patient receiving VARIVAX (Merck). The mother did not provide immunization records for the patient. Follow-up information received from the physician it was reported "No adverse events after vaccine". Additional information is not expected.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Immunology test abnormal
Clinical narrative: Information has been received from a nursing student concerning herself, a 42 year old female with no history of drug reactions or allergies and possibly may have had chickenpox as a child, who on 20-AUG-2003 was vaccinated with the first dose of VARIVAX (Merck) (lot # 642682/0481M) and on 21-OCT-2003 was vaccinated with the second dose of (lot # 646141/0540N) for working in hospital (titers not detected). There was no concomitant medication. A couple of months after the second dose was given, she had a titer of 3.54. In Sep-2006 her titer was 1.25. The nursing student stated now her test from Mar-2008 says she was not immune, less than 0.91. The patient was not recovered as of 15-Apr-2008. The patient sought medical attention with a telephone call and physician office visit. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner and consumer concerning a patient who in March 2008, was vaccinated with a dose of VARIVAX (Merck).  After administration, the patient developed a swollen, red an sore arm.  It was unknown whether medical attention was sought.  The  outcome was unknown.  There was no product quality complaint.  Additional information has been requested.  This is one of several reports from the same source.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male with asthma and seasonal allergies who on 15-JAN-1996 was vaccinated with VARIVAX (Merck) (lot # 610248/0446B), 0.5 ml via subcutaneous administration. Concomitant therapy included SYMBICORT, MAXAIR, Montelukast sodium, ZYRTEC and FLONASE. On 15-APR-2008 the patient experienced red pimple like rash, and was afebrile. On 16-APR-2008, he was seen in the office with 30 pustules and diagnosed with chicken pox. He was treated with VALTREX, calamine lotion and antihistamines. At the time of report, the event persisted. The patient's mother reported that other students in his school have also recently experienced chicken pox. Additional information is not expected as the nurse is unable to provide additional details.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a patient who on 17-JUN-2008 was vaccinated with VARIVAX (Merck).  The nurse reported that on 17-JUN-2008 the patient inadvertently received VARIVAX (Merck) instead of ZOSTAVAX (Merck).  No symptoms reported. There was no product quality complaint.  Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Injection site swelling, Rash
Clinical narrative: Information has been received from a physician concerning a male between 12 and 15 years of age with obesity who in 2008 was vaccinated SC with his second dose of  VARIVAX (Merck). Suspect vaccinations administered within the same visit included a dose of MENACTRA and a dose of DTaP. In 2008, within the last couple of months, the patient developed severe swelling at the injection site and a rash that ran down their arm. The patient sought unspecified medical attention. Subsequently, the rash cleared on its own and the patient recovered. This is one of several reports fro the same source.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 10 year old female with allergic reaction to ZITHROMAX who on 17-JUN-1998 was vaccinated with the first dose of VARIVAX (Merck) and on 14-APR-2008 received the second dose of VARIVAX (Merck) (lot # 660082/1977U).  There was no concomitant medication.  The medical assistant reported that on 16-APR-2008, the patient's mother called the doctor's office because the patient developed swelling, redness and tightness at the VARIVAX injection site.  The entire upper right arm was warm to the touch and indurated.  The patient sought medical attention in the physician's office. The physician stated to be alarm that it had happened with VARIVAX (Merck) 3 times that month.  The physician reported that it looked like cellulitis but could be an immunogenic reaction.  At the time of the report.  The patient had not recovered.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a veterinarian concerning his 18 month old granddaughter with no medical history or allergies, who about a month ago (in approximately May 2008), was vaccinated with a dose of VARIVAX (Merck). There was no concomitant medication. The veterinarian reported that his granddaughter developed a bump near the injection site a week after receiving VARIVAX (Merck). On 10th day after vaccination, she had an itchy rash all over her body. The rash lasted for about 5 days. The child was not treated with any medications and the symptoms resolved. A chickenpox titer was performed (results not reported). There was no product quality complaint. Follow up information was received from the patient's grandfather who reported that his granddaughter had an itchy rash after vaccination. His daughter then developed a rash with hard bumps that itches and was seen by her dermatologist (WAES # 0807USA00666). The reporter was "pretty sure" his granddaughter had no scabs remaining and she had recovered. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male with ringworm of scalp who was vaccinated with first and second doses of VARIVAX (Merck) on 26-JUN-2003 (lot# 644567/1151M) and 08-MAR-2007 (lot # 656123/1310F) respectively. Concomitant therapy included Griseofulvin. On 17-APR-2008 the patient was diagnosed with chickenpox in the office, the patient had less than 50 lesions on his upper chest, upper arms and neck. There was no fever. The patient outcome was not reported. There was no product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 7 year old female who on 14-APR-2008 was vaccinated with the second dose of VARIVAX (Merck) (lot# 660280/1997U). The date of the first dose was unspecified. There was no concomitant medication. Subsequently the patient developed an injection site reaction in the left arm. The arm developed a 5/10th of an inch diameter area that is hot, very red and swollen surrounded by a 4 inch in diameter area of pink, tender and swollen area. The patient was seen by the physician on 16-APR-2008 and was placed on therapy with KEFLEX prophylactically. As the time of the report it was unknown if the patient had recovered fro the injection site reaction. The nurse also mentioned that this patient is the third patient that had developed an injection site reaction after the second dose. No information on other patients mentioned. This is one of the several reports received from the same source. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 12 month old female with a ear infection and with no pertinent medical history or drug reactions/allergies reported who on 9:50 am on 06-OCT-2003 was vaccinated with a dose of VARIVAX (Merck) (lot# 645163/0205N) 0.5ml SQ in 4-5 cm posterior aspect of her left thigh and a dose of MMR II (dose and administering site not reported). Concomitant therapy included antimicrobial (unspecified) for the ear infection. Within 5 days after the vaccination the patient developed a maculopapular rash over her upper extremities, most of lower extremities, trunk and face. No lab diagnostic were performed. The physician defined the rash as "eruptions likely from the vaccination with a urticarial component". Subsequently, the patient recovered. The patient sought medical attention in the office. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 15 month old male who on 15-APR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 659942/1797U) in his left arm. Concomitant therapy included vaccination with a dose of HAVRIX (lot #AHAVB200BA) in his right arm on 15-APR-2008. Within 15 minutes of vaccination the patient broke out in hives. The patient was given an unspecified antihistamine and fully recovered 15 minutes later. There was no product quality complaint involved. No further information is expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a nurse practitioner concerning a 33 year old female who in approximately June 2004, was vaccinated with VARIVAX (Merck). In June 2008, the patient had a negative titer for varicella (less than 0.91). The nurse practitioner was not sure if the dose 4 years ago was the first dose. No problems reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a female patient who entered an unspecified study and was vaccinated with VARIVAX (Merck) on an unspecified date. (Lot #, and dosing information was not provided). The patient did not seroconvert to the vaccine. No further information is available.
Age: 75.0
Sex: M
Vaccine: VARCEL
Symptoms: Medication error, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 75 year old male patient who at 2 pm on 18-JUN-2008 inadvertently received a first dose of VARIVAX (Merck) (lot# 65875/1270U) in his left arm. The patient was intended to receive ZOSTAVAX (Merck). This was an administration error and not product confusion. No adverse symptoms reported. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 6 year old male with epilepsy and seizure disorder, and no drug reactions or allergies who on 26-MAR-2001 was vaccinated with VARIVAX (Merck). Concomitant therapy included unspecified seizure medication. In April 2006 the patient developed shingles. Unspecified medical attention was sought, which included an office visit. The patient subsequently recovered on an unspecified date. No lab diagnostic studies were performed. It was noted that the physician was not interested in VZV analysis at this time. There was no product quality complaint. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, MEN, TTOX, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a company representative concerning her 11 year old son with no pertinent medical history, drug reactions or allergies who on 16-JUN-2008 was vaccinated in the arm with a second dose of VARIVAX (Oka/Merck). On the same day the patient also received a dose of secondary suspect VAQTA. Other concomitant therapy included Meningococcal vaccine (unspecified) and Tetanus toxoid booster. On an unspecified date the patient developed large red patch on his arm at the injection site. It was reported that no reaction was reported with the first dose of VARIVAX (Oka/Merck). The patient was treated with KEFLEX. At the time of the report, it was unknown if the patient had recovered from the event. The patient went to physician. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a patient with reactive airways disease and a history of rhinitis allergic and otitis media chronic who on 25-AUG-2004 was vaccinated with VARIVAX (Oka/Merck) SQ (Lot # 646363/0574N). On 05-NOV-2005 the patient experienced zoster on chest and abdomen. The patient was treated with OMNICEF 250 mg daily, ZOVIRAX 200 mg, and RONDEX DM. On 08-MAY-2008, the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 656819/0172U). Concomitant therapy included TRIPEDIA (Lot # C2569AA). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Cellulitis, Herpes zoster
Clinical narrative: Information has been received from an employee at a physician's office concerning a 4 year old male patient with no pre-existing allergies, birth defects or medical conditions who on 10-AUG-2000 was vaccinated IM in left anterior thigh with a first dose of VARIVAX (Oka/Merck) (LOT# 632612/1851J) and was vaccinated IM in right "VL" with a third dose of ENGERIX-B (LOT# 3142AZ). Concomitant therapy included BENADRYL and mejoralita. On 25-JAN-2004 the patient developed zoster, left leg and cellulitis. It was to late for Acyclovir. Cephalexin 250/5 (KEFLEX) was prescribed. At the time of the report, it was unknown if the patient had recovered. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a healthcare worker concerning a 12 year old male with no known allergies who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck). the patient received the first dose at another location. on 16-JUN-2008 at 9:00 AM the patient was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot no. 659434/1911U) 0.5ml via subcutaneous route in the left leg. On the same day, the patient also received DTAP and MENACTRA. Concomitant therapy included ADDERALL TABLETS. The vaccines were all given in the left leg at the patient's and mother's request. All injections were spaced from one another. On 18-JUN-2008 the patient developed a very strong local reaction with swelling, redness and pain at the injection site. The patient was treated with MOTRIN (anti-inflammation) and resolved. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from an office worker in a physician's office concerning a 8 year old male with a history of adenotansillectomy (16-MAR-2005) who on 05-JAN-2000 was vaccinated subcutaneous in left anterior thigh with a first dose of VARIVAX (Oka/Merck) and was vaccinated subcutaneous in the right with the third dose of poliovirus vaccine inactivated (unspecified). Concomitant therapy included BENADRYL. On 25-MAY-2007 the patient developed zoster with a rash on the leg and back. The patient was treated with Acyclovir 200/per 5cc. At the time of the report, it was unknown if the patient had recovered. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Otitis media
Clinical narrative: Information has been received from a health professional concerning a 4 year old male with rhinitis allergic and asthma and a history of otitis media who on 22-MAR-2005 was vaccinated with VARIVAX (Oka/Merck) (lot# 647245/0898N) and MMR II. Concomitant therapy included HIBOR and DTAP-IPV. On 05-MAR-2008 the patient developed zoster in right arm and otitis media. The patient was placed on therapy with Acyclovir and VALDREX, 500 mg, three times a day for the treatment of zoster. It was unknown if the patient had recovered from zoster and otitis media. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Herpes zoster, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 16-JUL-2001 was vaccinated with VARIVAX (Oka/Merck) (lot# 638647/0232L). Concomitant therapy included ENGERIX-B and PREVNAR. On 29-AUG-2005 the patient developed zoster, vomiting and diarrhoea. The patient was placed on therapy with Acyclovir for the treatment of zoster. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a healthcare worker concerning a 9 year old female with no known allergies who on 17-OCT-2000 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 16-JUN-2008 at 11:00 AM the patient was vaccinated subcutaneously into the right leg with the second 0.5 ml dose of VARIVAX (Oka/Merck) (lot no. 659434/1911U). There was no concomitant medication. On an unspecified date the patient developed local reaction with erythematic, swelling and pain at the injection site. And the patient complained of fever. The local reaction progressed over 48 hours to induration. The patient was treated with antibiotics for a cellulitis. At the time of report, the patient was not recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 45 month old female patient with a history of premature twin birth who on 01-SEP-2004 was vaccinated with a dose of VARIVAX (Oka/Merck). Concomitant therapy included DTAP-IPV. The health professional reported that the patient experienced zoster on left arm and wrist, which was treated with BENADRYL. On 01-OCT-2007 the patient was vaccinated with PROQUAD. No further information is available.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 5 year old male who on 18-JUN-2008, today, was inadvertently vaccinated with two doses of VARIVAX (Oka/Merck) (lot no., route and site of administration were not reported), instead of one dose of VARIVAX (Oka/Merck) and one dose of MMR II. It was reported that this was staff error only. The patient sought unspecified medical attention in office. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: HBHEPB, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an employee at a physician's office concerning an 8 year old girl with allergic rhinitis who on 26-AUG-1999 was vaccinated with VARIVAX (Oka/Merck) and COMVAX. Other concomitant therapy included POLIO vaccine (manufacturer unknown). On 06-APR-2007 the patient developed zoster around left leg and thigh. The patient was treated with Acyclovir 400 mg. The symptoms lasted for 6 days. A strep screen was performed (results not reported). The patient's outcome was not reported. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received concerning a 10 year old male with allergic rhinitis, asthma and allergy to peanut butter who on 22-MAR-2001 was vaccinated with a dose of VARIVAX (Oka/Merck), lot Number # 635463/1147K). On 13-MAR-2005 the patient developed rash (1) side underarm. He was treated with Acyclovir 200 mg per 5cc. On 24-Mar-08, the adverse event was resolving. No further information is expected.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Decreased appetite, Erythema, Pyrexia, Somnolence
Clinical narrative: Initial information has been received from a registered nurse and follow up information was received from the physician concerning a 12 month old female with no pertinent medical history and no known drug reactions/allergies who on 09-JUN-2008 at 09:00AM was vaccinated subcutaneously in her right anterior thigh with the first dose of VARIVAX (Oka/Merck) (LOT# 660659/0174X). Suspect vaccination included MMR II (MSD) (LOT# 658581/0264X). Concomitant vaccination included HAVRIX (LOT# AHAVB3S5BA). There was no illness at time of vaccination. On 11-JUN-2008 the patient's mother reported that the patient started with a couple of red spots (reported to be chickenpox) around the right leg. Within 1 day the red spots became yellow fluid filled and were crusted over. On 17-JUN-2008 (2 days ago), clusters of red spots appeared on the left thigh and right leg and 1 spot on the knee which were fluid filled. On 18-JUN-2008 the patient also had a low grade temperature of 99-100 deg F. The patient was more sleepy, "not herself" and appetite had decreased slightly but she was still drinking fine. On 19-JUN-2008, there was a red spot that appeared on the right knee which was red and raised. subsequently, the patient recovered. Medical attention was sought by phone. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Swelling, Varicella post vaccine
Clinical narrative: Initial information has been received from a registered nurse and follow up information was received from the physician concerning a 12 month old female with no pertinent medical history and no known drug reactions/allergies who on 09-JUN-2008 at 09:00AM was vaccinated subcutaneously in her right anterior thigh with the first dose of VARIVAX (Oka/Merck) (LOT# 660659/0174X). Suspect vaccination included MMR II (MSD) (LOT# 658581/0264X). Concomitant vaccination included HAVRIX (LOT# AHAVB3S5BA). There was no illness at time of vaccination. On 11-JUN-2008 the patient's mother reported that the patient started with a couple of red spots (reported to be chickenpox) around the right leg. Within 1 day the red spots became yellow fluid filled and were crusted over. On 17-JUN-2008 (2 days ago), clusters of red spots appeared on the left thigh and right leg and 1 spot on the knee which were fluid filled. On 18-JUN-2008 the patient also had a low grade temperature of 99-100 deg F. The patient was more sleepy, "not herself" and appetite had decreased slightly but she was still drinking fine. On 19-JUN-2008, there was a red spot that appeared on the right knee which was red and raised. subsequently, the patient recovered. Medical attention was sought by phone. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning an 18 year old female who on 02-JUN-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot number 660077/1898U) (injection site and route not reported). On 16-JUN-2008, exactly 2 weeks after vaccination, the patient developed breakthrough chicken pox. The case was less than 50 lesions but caused her to miss her prom and high school graduation. Unspecified medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 4 year old male with hypersensitivity and atopy who on 29-JAN-2004 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). On an unspecified date the patient was vaccinated with a second dose of VARIVAX (Oka/Merck) 0.5 ml by subcutaneous injection (injection site not reported). After the second dose, on 18-JUN-2008, the patient experienced an outbreak of the chickenpox. The patient's chickenpox persisted. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Body temperature increased, Full blood count, Neutropenia
Clinical narrative: Information has been received form a physician concerning a 12 month old patient who was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). Within 24 hours the patient developed severe neutropenia and a high fever. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning a 17 month old female with heart disease and asthma who on 16-SEP-2003 was vaccinated subcutaneously with the first dose of VARIVAX (Oka/Merck) (Lot #644145/0327N). Secondary suspect vaccination included MMR II (LOT #644843/1229M), DTAP, ACT HIB and PREVNAR. The health professional reported that the patient experienced zoster on chin and cheeks and mostly in the temporal region, for which the patient received no treatment. The patient did not seek medical attention. This is one of several reports received from the same source. No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a women from a pediatric office concerning an 11 year old female who on 02-JUN-2008 was vaccinated subcutaneously in the "right" with a second dose of VARIVAX (Oka/Merck) (Lot #660279/1895U). "24 hours post injection:, on 03-JUN-2008 the patient experienced injection site pain, tenderness, redness, swelling and warm to touch. The diameter of the area was 5-6 cm. The patient also experienced fever and cellulitis. The patient's body temperature was up to 101. the patient was treated with TYLENOL, MOTRIN and possible antibiotics for cellulitis. At the time of the report, it was unknown if the patient had recovered from the events. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a women from a pediatric office concerning an 11 year old female who on 02-JUN-2008 was vaccinated subcutaneously in the "right" with a second dose of VARIVAX (Oka/Merck) (Lot #660279/1895U). "24 hours post injection:, on 03-JUN-2008 the patient experienced injection site pain, tenderness, redness, swelling and warm to touch. The diameter of the area was 5-6 cm. The patient also experienced fever and cellulitis. The patient's body temperature was up to 101. the patient was treated with TYLENOL, MOTRIN and possible antibiotics for cellulitis. At the time of the report, it was unknown if the patient had recovered from the events. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a male dentist with a history of being given 2 doses of pneumococcal 23v polysaccharide vaccine close together (WAES# 0805USA04877) who reported that on 08-APR-2008 he was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) due to human error. No adverse effects reported. The patient's lady friend also received VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) due to human error. (WAES#: 0805USA04876). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Drug exposure during pregnancy, No adverse event
Clinical narrative: information has been received from a physician concerning a female who was vaccinated with a first dose of VARIVAX (Oka/Merck) prior to pregnancy. The patient did not receive the second dose. The patient is 4 months pregnant and has tested for a negative titer as 0.91. The patient had no symptoms. No further information was available. There was no product quality complaint. The is one report of several from the same source. In follow up the warned mother, reporting physician stated "Patient was pregnant and warned about unborn baby." The patient did not want to report, neither did the patient;s physician (reporting physician was covering person). reporting physician left the group and has no further contact with patient. No further information is available.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pruritus, Rash vesicular, Scab, Varicella post vaccine
Clinical narrative: Initial and follow-up information has been received from registered nurse concerning an 8 year old male child with no known allergies who on 16-APR-2008 at 4:00 pm was vaccinated SQ in the right arm with a second dose of 0.5ml of VARIVAX (Oka/Merck) (lot # 659698/1770U). The first dose of VARIVAX (Oka/Merck) (lot # 635452/0768K) was administered on 14-MAR-2007. Concomitant vaccination on 16-APR-2008 included HAVRIX (lot # AHAVB264BA) IM in the right arm at 4:00 pm. The patient had a skin infection from a scraped knee at the time of vaccination of the second dose. Concomitant therapy at the time of the second dose included KELFLEX for 10 days. Subsequently, on 23-APR-2008 the patient developed some chickenpox lesions from head to toe and was taken to the emergency room. There were no lab studies performed. The emergency room counted 73 vesicles. On 28-APR-2008 the patient has a follow-up appointment in the office and had over 250 lesions all over his body. The vesicles were itchy and the majority were scabbing. At the time of the report the patient recovered on an unspecified date. There was product quality complaint involved. A lot check has been requested (lot # 659698/1770U). Additional information is not expected. This is one of several reports from the same source. 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 agency and was released.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a female who was vaccinated with a dose of VARIVAX (Oka/Merck). On 09-APR-2008 the patient had shingles. Unspecified medical attention was sought, at the doctor's office. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Erythema, Rash, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female with exercise induced asthma and no known allergies, who on 20-SEP-2002 and 08-APR-2008 was vaccinates subcutaneous with a first and second 0.5 ml dose of VARIVAX (Oka/Merck) (lot # 659698/1770U 2nd dose). Concomitant therapy included Albuterol and HAVRIX (GSK - LOT# AHAVB2250A). There was no reported illnesses at the time of the vaccinations. On 26-ARP-2008 the patient developed a rash that started on the face, neck and chest. There were skin vesicles with surrounding erythema with less than 50 lesions. The patient presented to the physician's office on 28-APR-2008 with the chickenpox. Subsequently, the patient recovered from chickenpox. The reporter requested a lot check on (lot # 659698/1770U). 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 agency and was released. This is one of several reports received from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Incorrect route of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 5 year old female with no history of allergies (including neomycin or gelatin) who on 29-APR-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot #660283/1971U). The nurse states the patient received 0.1 ml varicella virus vaccine live intradermally in error. The nurse intended to administer an intradermal tuberculin test and made an administration error. The patient was given the intradermal injection in the left inner aspect of the forearm. Within 1/2 hour the are formed an intradermal bleb and was reddened. No other symptoms. Subsequently, the patient recovered. Follow up information was from the registered nurse reported that on 29-APR-2008 the patient was erroneously administered VARIVAX (Oka/Merck) was thought to be PPD that was also drawn up for administration). The patient was examined by the physician immediately post the error. Bleb was noted at surrounding red flat blotchiness. After 40minutes later, local reaction was noted, 3.5 times 2.5 cm surrounding redness, 1 times 1.5 cm central mild swelling, no other symptoms. On 30-APR-2008 the patient's mom reported that area looked fine, no redness (area seemed almost resolved). On 01-MAY-2008 the patient was examined again as redness returned to area. Local erythema and undulation was observed in the mild ventral aspect of right forearm, 20 times 15 mm undulation and 30 times 20 mm erythema. On 02-MAY-2008 the patient's mom reported the area was less red, no other symptoms, the patient recovered. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 4 year old female who in the afternoon of 19-APR-2007 was vaccinated in the left arm with a second dose of VARIVAX (Oka/Merck) (Lot #656572/0115U). There was no illness at time of vaccination. At 11:30 p.m., on 05-JUN-2008, the patient developed one dozen of vesiculopapular scattered on her trunk and extremities. The lesions of varying ages appeared over 48 hours. The patient had no fever. She was diagnosed with chickenpox. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with Amoxicillin allergy who on 21-MAY-2003 was vaccinated subcutaneously into the left thigh with the first dose of VARIVAX (Oka/Merck) ( lot # 643592/0807M). Concomitant therapy included a fourth dose of PREVNAR intramuscularly into the right thigh. On 15-JUN-2007 the patient was vaccinated subcutaneously into the left arm with the second dose of VARIVAX (Oka/Merck) (Lot # 657449/0597U). On 08-APR-2008 the patient sought medical attention and was seen in physician office. The patient reported he had a 3 day history of rash with multiple erythematous papules 3-5 mm and many with clear or yellow vesicular lesions on trunk, buttock and on face, non on the extremities. The patient was diagnosed with varicella. Subsequently, the patient recovered. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a healthcare worker concerning a 14 month old male with no pertinent medical history who on 14-APR-2008 was vaccinated with VARIVAX (Oka/Merck) (LOT# 658575/1270U). There was no concomitant medication. On 28-APR-2008 the patient experienced chickenpox. The patient was seen by the physician and there was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male with no pertinent medical history who on 30-MAR-2004 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot #647521/1108N) in his left thigh SC. There were no illnesses at the time of the vaccination. On 14-APR-2008 the patient was seen in office with a four day history of a rash (onset 11-APR-2008). They were found to be diffuse papules of varying sizes, mostly on trunk, extremities with several overlying vesicles crusted over. The number of lesions was more than 50. There were no diagnostic or laboratory tests performed. As of 22-APR-2008 the rash was still ongoing. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 15 to 18 month old child patient out of 20 who was vaccinated with VARIVAX (Oka/Merck, lot #659345/1915U). Approximately 13 to 15 days post vaccination, the patient have developed red, raised knot at the injection site. The child was seen at the office for follow up was given a prescription for KEFLEX. At the time of report, the event persisted. The nurse also reported that there were another 2 patients who had a similar experience with the same lot number (refer to WAES #s 0805USA04398 and 0805USA05445). A lot check has been initiated. Additional information is not expected as the nurse is unable to provide any additional details regarding the three patients. On 05-JUN-2008 adverse event lot check completion information was received. 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 agency and was released. No further information is expected.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 57 year old female patient who on 15-APR-2008 was prescribed and vaccinated with a first dose of VARIVAX (Oka/Merck) (lot #658405/1076U) instead of ZOSTAVAX (Oka/Merck) on her left arm for shingles prevention. It was noted that no symptoms were reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow up information was received which reported that the medical assistance indicated that doctor inadvertently wrote VARIVAX (Oka/Merck) in the prescription instead of ZOSTAVAX (Oka/Merck) and the nurse gave the patient VARIVAX (Oka/Merck). The patient did not have any adverse experience and they refused to be vaccinated with ZOSTAVAX (Oka/Merck) now. No further information is requested.
Age: 77.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old male who on 23-JAN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) and then on 29-APR-2008 was vaccinated with VARIVAX (Oka/Merck) inadvertently. No adverse effect reported. The nurse had no specific reason and/or recommendation for this medication error and was unable to provide the lot # for VARIVAX (Oka/Merck). Additional information from the R.N. indicated that the patient had forgotten that he had already received ZOSTAVAX (Oka/Merck) and come back to received the vaccine. It was a medication error that he received VARIVAX (Oka/Merck). The office followed their protocol and notified the doctor. The patient is fine and has no adverse experience. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old female with allergy to pertussis vaccine (limplegs) and ZYRTEC and autism who on 29-AUG-2002 was vaccinated subcutaneously in right thigh with a 0.5 ml first dose of VARIVAX (Oka/Merck) and on 11-APR-2008 was vaccinated subcutaneously in right thigh with a 0.5 ml second dose of VARIVAX (Oka/Merck) (LOT# 659353/1778U). There was no concomitant medication. On 12-APR-2008 the patient developed redness and swelling at the injection site of the right thigh (Size of 50 cent piece). The patient was examined in the office on 17-APR-2008 and the injection site reaction was resolved. No therapy was prescribed. There was no product quality complaint. Additional information is not expected.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Heart rate increased, Pyrexia, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 18 month old daughter with no pertinent medical history or drug allergies who on 04-OCT-2005 was vaccinated with a dose of VARIVAX (Oka/Merck). There was no concomitant medications. On that same day 12 hours after vaccination, the patient experienced fever, vomiting and rapid heartbeat. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. The symptoms lasted for about 1 week and the patient subsequently recovered. No further information was reported. There was no product quality complaint. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rash papular, Varicella post vaccine
Clinical narrative: Information has been received from 2 nurses concerning a 6 year old boy, 66 pounds weight and 47 inches height, with seasonal allergies who on 26-MAR-2003 was vaccinated with varicella vaccine("OMNI") (manufacturer unknown) as stated by his medical documentation. The vaccine was administered by previous provider's office and there is no indication, lot number, dose, route of administration, or administration site. There was no concomitant medication. On 29-APR-2008, the patient was diagnosed with chickenpox by the reporting nurse practitioner with symptoms of itching with a chickenpox rash to the abdomen, arms, and face; itching scattered papules; and small crusted face and neck. The nurse practitioner ordered a urine analysis and blood work (results not reported). No other symptoms were reported. The patient was treated with BENADRYL and AVEENO. The patient sought medical attention with a physician office visit and was considered to be recovered. Additional information is not expected.
Age: 2.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 30 month old male who on 21/NOV/2006 was vaccinated with a single dose of VARIVAX (Oka/Merck) (LOT# 654530/1046F). On 30-Apr-2008 the patient broke out with a full blown case of chicken pox. The patient's symptom persisted. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 9 year old boy with no history of drug reactions or allergies who on 30-MAR-2000 was vaccinated with the first dose of VARIVAX  0.5 ml subcutaneous (Oka/Merck) (lot # 632371/1464J), and on 06-Dec-2006 with the second dose of VARIVAX 0.5 ml subcutaneous (Oka/Merck) (lot # 655065/1142F). On 13-APR-2008 the patient was diagnosed with shingles after he had received the two doses of VARIVAX (Oka/Merck). The patient's outcome was not reported. No further information is available.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Pruritus, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no pertinent medical history who on 10-JAN-2001 was vaccinated with the first dose of VARIVAX "standard dose" (Oka/Merck) and on 01-Oct-2007 was vaccinated with a second dose of VARIVAX (Oka/Merck). Subsequently the patient developed chickenpox lesions when she was exposed to chickenpox over a sleep over with her friends. The patient developed 4 lesions on her chest. 1 lesion on her stomach, and 4 lesions on her legs. She has no fever, but the lesions were itching. As of 30-APR-2008, the patient was recovering. The patient was sought medical attention at the physician's office. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Cellulitis, Erythema, Induration, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a mother and a physician concerning a 13 year old boy with asthma, allergy to penicillin and severe allergies to milk, beef and pork, who on an unspecified date was vaccinated with the first dose of  VARIVAX (Oka/Merck) and on 15-APR-2008 was vaccinated with the second dose 0.5 ml injection. Concomitant therapy included montelukast sodium (MSD). The patient's mother reported her son experienced cellulitis infection after getting the second dose of  VARIVAX (Oka/Merck). The patient did not experience an adverse event from the first dose The physician called afterwards and mentioned the patient had enormous red indurated area on the left thigh. The area was tender and went from the "puncture towards the feet". There was an expanded levels of redness and dependent edema. The physician initially thought this reaction was cellulitis but the physician now thinks it was an allergic reaction. The patient had no anaphylaxis and no hives. The physician mentioned pork was recently reintroduced and the patient did not experience any7 problems. As of 29-APR-2008, the patient's allergic reaction to varivax persisted. Additional information has been requested.