chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site urticaria, Injection site warmth, Pain, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a consumer concerning her son who on 19-JUN-2008 was vaccinated with his booster VARIVAX (Merck), 0.5 ml, SQ. Concomitant therapy included tetanus toxoid shot in the same arm. The next day, he developed a 1.5" x 1.5" "a raised red mark" at the injection site. "Over the course of a week" it turned purple and was "yellow beneath the skin." It became "hard" and "hot". On 19-Jun-2008, he developed a headache. Yesterday, he was "achy all over his body." Today, the spot is "a pinkish reddish color", it is no longer hot or hard and there is "no longer any yellow." It was reported that when the patient got his first VARIVAX shot he "felt a little yucky, but it didn't last that long." Unspecified medical attention was sought. At this time, it was reported that he is recovering. No product quality complaint. Follow-up information was received on 22-SEP-2008 from a registered nurse (R.N.) concerning an approximately 10 year old male who on 19-JUN-2008 was vaccinated subcutaneously with a second dose of VARIVAX (Merck) (Lot #659427/1586U). On the same day the patient was also vaccinated intramuscularly with the sixth dose of BOOSTRIX (Lot #AL52B012AA). Follow-up information was received on 23-DEC-2008 from the R.N. indicating that the "family" had reported the "unusual vaccine reaction beyond a minor local reaction" prior to contacting their office. Their office did not "generate a separate report". It was also reported that the patient had not been in contact since 30-JUN-2008. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 11 year old male patient with no known allergies or pertinent medical history who on 16-Jun-2008 was vaccinated SQ with 0.5ml of VARIVAX (Merck). Concomitant vaccination included MENACTRA and ADACEL. Subsequently, on 16-June-2008, within several hours of the vaccination the patient developed an injection site reaction where the vaccine was given that included warmth, swelling and redness. The patient also had a headache. Medical attention was sought in the office. There were no lab studies performed. It was reported that all symptoms resolved within 4 days. The patient was recovered on 20-Jun-2008. There was no product quality complaint involved. Follow-up information has been received from the physician's office concerning this 11 year old male child with seasonal allergies who on 16-Jun-2008 at 12:30 was vaccinated in the left thigh with a second dose of VARIVAX (Merck) (lot# 660054/1857U). Concomitant vaccinations on the same day at 12:30 included MENACTRA (lot# U2519AA) in the right and ADACEL (lot# C2937AA) in the right thigh. There was no illness at the time of vaccination and no concomitant medications. Subsequently, on 16-Jun-2008 the patient developed swelling, erythema, and induration of the injection site. The patient also had a headache, myalgia, and low grade fever. There were no lab studies performed. The patient was treated symptomatically with Motrin, heat, and topical steroid cream. It was noted that the patient improved in 72 hours. At the time of the report, the patient recovered on 20-Jun-2008. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 11 year old male patient with no known allergies or pertinent medical history who on 16-Jun-2008 was vaccinated SQ with 0.5ml of VARIVAX (Merck). Concomitant vaccination included MENACTRA and ADACEL. Subsequently, on 16-June-2008, within several hours of the vaccination the patient developed an injection site reaction where the vaccine was given that included warmth, swelling and redness. The patient also had a headache. Medical attention was sought in the office. There were no lab studies performed. It was reported that all symptoms resolved within 4 days. The patient was recovered on 20-Jun-2008. There was no product quality complaint involved. Follow-up information has been received from the physician's office concerning this 11 year old male child with seasonal allergies who on 16-Jun-2008 at 12:30 was vaccinated in the left thigh with a second dose of VARIVAX (Merck) (lot# 660054/1857U). Concomitant vaccinations on the same day at 12:30 included MENACTRA (lot# U2519AA) in the right and ADACEL (lot# C2937AA) in the right thigh. There was no illness at the time of vaccination and no concomitant medications. Subsequently, on 16-Jun-2008 the patient developed swelling, erythema, and induration of the injection site. The patient also had a headache, myalgia, and low grade fever. There were no lab studies performed. The patient was treated symptomatically with Motrin, heat, and topical steroid cream. It was noted that the patient improved in 72 hours. At the time of the report, the patient recovered on 20-Jun-2008. Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 14 month old male on 05-JUN-2008 was vaccinated subcutaneously in the right leg with a 0.5 ml dose of VARIVAX (Merck) (lot # 657106/1891U).  He was vaccinated concomitantly in his left leg with a dose of PREVNAR and a dose of MMRII.  On 05-JUN-2008 immediately post vaccination the patient experienced hives around the injection site of right leg.  The patient was treated with BENADRYL and monitored.  Subsequently, the patient recovered from hives around the injection site of right leg.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 month old male patient who on 05-JUN-2008 was vaccinated with a dose of VARIVAX (Merck) (lot# 657106/1891U) 0.5 ml subcutaneous in the right leg. Concomitant therapy included PREVENAR and MMR II, both given in the left leg. Immediately post vaccination the patient experienced hives around the injection site of right leg. The patient was monitored with no treatment. Subsequently, the patient recovered from hives around the injection site of right leg. The patient sought medical attention in office. This is one of several reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 11 year old female who in April 2008, was vaccinated with second dose of VARIVAX (Merck). The patient had a chicken pox outbreak. The patient's chicken pox persisted. The patient sought medical attention. She went to the physician. Additional information has been requested. The patient's brother also had an adverse experience after vaccination with VARIVAX (Merck). (WAES0805USA05950).
Age: 1.53
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature, Herpes zoster, Rash, Rash vesicular, Viral DNA test negative
Clinical narrative: Information has been received for a physician assistant concerning a 8 year old male patient who on 11-SEP-2001, was vaccinated with VARIVAX (Merck).  Concomitant therapy included DIGITEK.   The physician assistant reported that on 02-MAY-2008, the patient developed herpes ZOSTER.  The patient had a rash under his left eye, which had happened 4 times.  His temperature was 97.7 F.  The patient did not have a rash at the site of the injection post-vaccination.  The patient had no recent exposure to chickenpox and there was no recent exposure to shingles.  At the time of the report, the patient had recovered.  The patient sought medical attention, was seen by the physician.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if is associated with the wild-type (WT) VZV strain or with the MERCK vaccine VZV strain.  The sample of the lesion was collected on 10-JUL-2008.  The sample was taken from dry - crusted vesicular lesions.  The results showed no amplified VZN DNA.  The interpretation indicated inadequate lesion, negative for B-globin, no strain I.D.  No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye disorder
Clinical narrative: Information has been received from a physician concerning a 9 year old male patient with a history of seizures who was vaccinated with a dose of VARIVAX (Merck) (route and dose not reported). The patient came back in the office with eye issues on an unspecified date. The outcome of eye issues was not reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning an approximately 8 year old male who "about 10 years ago" in approximately 1998 was vaccinated with VARIVAX (Merck). It was reported that the now 11 year old boy received VARIVAX (Merck). The nurse reported that "about 3 years ago" in approximately 2005 the patient experienced mild breakthrough chickenpox (some lesions on his back). On an unspecified date the patient recovered from mild breakthrough chickenpox. The patient sought medical attention; contacted Physician. There was no product quality complaint. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Gingivitis, Oral herpes, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a healthcare worker concerning an approximately 7 year old female with no known allergies and a history of streptococcal infection several time who on 16-MAY-2001 was vaccinated SQ with a dose of VARIVAX (Merck).  0.5ml.  There was no concomitant medication.  The healthcare worker reported that the patient had developed "streptococcus" on several occasions (dates of infections are not known).  In February 2007, the patient developed a moderate  case of chickenpox followed by acute herpetic stomatitis and gingivitis.  The patient was seen in the emergency room for IV hydration, but was not admitted.  The incident lasted 6 days.  On unspecified date the patient recovered from moderate chickenpox, acute herpetic stomatitis and gingivitis.  There was no product quality complaint.  Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 59 year old male patient who on 15-APR-2008 was prescribed and vaccinated with a first dose of VARIVAX (Merck) (lot #658405/1076U) instead of ZOSTAVAX (Merck) on his 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 (Merck) in the prescription instead of ZOSTAVAX (Merck) and the nurse gave the patient VARIVAX (Merck). The patient do not have any adverse experience and they refused to be vaccinated with ZOSTAVAX (Merck) now. This is one of several reports received from the same source. No further information is requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a patient who in 1998 was vaccinated with a dose of VARIVAX (Merck) (lot no., route and site of administration were not reported).  The patient experienced a mild chicken pox outbreak two weeks after VARIVAX (Merck) was given.  The patient called physician's office and sought unspecified medical attention.  On unspecified date the patient recovered from chicken pox.  No product quality complain was involved.  No further information available from the nurse.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old female patient with no pertinent medical history and drug reactions/allergies who in January 2003, was vaccinated with the first dose of VARIVAX (Merck) (lot number, route and site of administration not reported). In April 2007, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 656572/0115U) (route and site of administration not reported). On an unspecified date the patient had a breakthrough of VARIVAX. The patient had about 12 lesions. The patient had completely recovered from this event. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician assistant (P.A) concerning a patient who was vaccinated with a dose of VARIVAX (Merck) years ago. Recently the patient experienced shingles. The patient came to the office and was currently being treated with an antiviral. At the time of this report, the patient's shingles persisted. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with a history of dermatitis, rhinitis allergic and latex allergy who on 31-MAR-2008 was vaccinated with a second dose of VARIVAX (Lot#659723/1659U) SQ in right arm (Merck). On the same date, concomitant vaccines included first dose of HAVRIX (unspecified) (AHAV52124) IM in RA, MENACTRA (Lot #V25594A) IM in LA and human papillomavirus vaccine (659182/1757U) IM in LA. On 31-MAR-2008 the patient experienced swollen area and itchy. 1/2 dollar sized red, swollen, itchy area on right arm, times one week. The patient required a Doctor visit. The patient recovered on 01-APR-2008. Subsequently, the patient recovered from swollen area and itchy. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Eye infection, Urticaria, Vaccination failure, Varicella zoster serology negative
Clinical narrative: Information has been received from a 40 year old female with hypercholesterolaemia and a history of female genital operation concerning on 04-SEP-2007 she was vaccinated with the first dose of VARIVAX (Merck) (lot no. not reported) via intramuscular route.  Site of injection was not reported.  On 24-OCT-2007, she was vaccinated with the second dose of VARIVAX (Merck) (lot no. not reported) via intramuscular route, site of injection was not reported.  Concomitant therapy included LOVASTATIN (manufacturer unknown), vitamin D (unspecified), Omega fatty acids (unspecified) and calcium (unspecified).  On 22-NOV-2007 the patient experienced unspecified hives that were treated by numerous unspecified medical personnel with unspecified medications.  The patient fully recovered from the hives in several weeks.  In December 2007, the patient experienced eye infection.  The outcome of eye infection was unknown.  On 05-JUN-2008 the varicella titer was negative and the reporter considered this to be vaccine failure.  The patient went to physician's office and sought unspecified medical attention.  No other symptoms or treatment  reported.  No product quality complaint involved.  No other information available from the reporter.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Varicella, Varicella post vaccine
Clinical narrative: Information has been received healthcare provider concerning a 9-year-old male who on 16-AUG-2002 was vaccinated with a dose of VARIVAX (Merck). On 01-JUN-2008 the patient developed an itchy rash times 1 day that was described as multiple lesions (over 60) in various stages. On 02-JUN-2008 the patient was diagnosed with varicella. The patient was treated with acyclovir 400 mg QID for 5 days, BENADRYL and CALAMINE LOTION. No diagnostic labs were performed. On an unspecified date, the patient recovered from varicella. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old male who on an unspecified date was vaccinated with her first dose of VARIVAX (Merck) and was well tolerated. On 04-Aug-2008, was vaccinated with the second dose of VARIVAX SQ in the left arm (Merck) (lot# 660079/0331X) (in follow up reported as 661445/0525X). On 04-Aug-2008, was vaccinated with the second dose of Hepatitis A virus vaccine inactivated in the left deltoid (Merck). There were no illness at the time of vaccination. On 05-Aug-2008, the patient experienced redness, itching and swelling at the injection site. the patient may have also experienced fever and /or pain and burning while getting injected with the vaccine. On 07-Aug-2008, the patient recovered. The reporter has requested a lot check due the patients having adverse experiences. The patient sought medical attention by calling the office. 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 and was released. This is one of several reports provided by the same source. No additional information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old male who on an unspecified date was vaccinated with her first dose of VARIVAX (Merck) and was well tolerated. On 04-Aug-2008, was vaccinated with the second dose of VARIVAX SQ in the left arm (Merck) (lot# 660079/0331X) (in follow up reported as 661445/0525X). On 04-Aug-2008, was vaccinated with the second dose of Hepatitis A virus vaccine inactivated in the left deltoid (Merck). There were no illness at the time of vaccination. On 05-Aug-2008, the patient experienced redness, itching and swelling at the injection site. the patient may have also experienced fever and /or pain and burning while getting injected with the vaccine. On 07-Aug-2008, the patient recovered. The reporter has requested a lot check due the patients having adverse experiences. The patient sought medical attention by calling the office. 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 and was released. This is one of several reports provided by the same source. No additional information is expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who on 03-APR-2001, 4 day early prior to the patient's first year birthday, was vaccinated with a dose of VARIVAX (Merck) (lot number, injection site and route not reported) and MMR II. No AE was reported. No product quality complain was involved. Follow-up information was received from the R.N. on 15-JUL-2008. She reported that there was "no adverse reaction". The patient simply got shingles after having had the vaccine. He recovered without incident. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning an 11 year old male who on 05-JUN-2008 was vaccinated subcutaneously in left with a second dose of VARIVAX (Merck) (Lot#659344/1776U). On 06-JUN-2008 the patient experienced redness and swelling of upper arm. At the time of the report, it was unspecified the patient's outcome. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 46 year old female with history of morphine allergy who on 09-JUN-2008 was vaccinated with a dose of VARIVAX (Merck) (lot# 658182/1559U) 0.5ml SQ. Concomitant therapy included Lisinopril-HCTZ (manufacturer unknown), pravastatin Na, omega-3 marine trglycerides (Omega-3), vitamins (unspecified), vitamin D (unspecified) and ginkgo. On 10-JUN-2008 the patient experienced an injection site reaction consisting of slight swelling, induration, warmth to the touch, and pruritus at the injection site. The pharmacist has requested a lot check to see if there were any similar reports made with this lot. The patient was recovering. The patient sought medical attention at the practice. A lot check has been initiated. A standard lot check investigation was performed. All in-process quality checks for the number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 63.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 63 year old patient who on 04-JUN-2008 was vaccinated with a dose of VARIVAX (Merck) (route and administrating site not reported) instead of ZOSTAVAX (Merck). This was not due to product confusion. No adverse event was reported. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: MEN, TTOX, VARCEL
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Musculoskeletal chest pain, Pain
Clinical narrative: Information has been received from a consumer concerning her son a male patient who on 10-JUN-2008 at 11:00 was vaccinated with VARIVAX (Merck) (route and site of administration was not reported), TETANUS TOXOID (manufacturer unknown) (route and site of administration not reported) and MENINGOCOCCAL (unspecified) (route and site of administration not reported). On 10-JUN-2008 in the middle of the night the patient experienced fever, body aches, rib pain, stomach, dizzy, weak and felt "faintish". The patient did not like to sit because of the pain in his stomach. Mom is treating the ADVIL and was calling the doctor office for follow up with the advice nurse. The patient's fever and body aches and rib pain and stomach pain and dizzy and weak and felt faintish persisted. The reporter felt that fever, body aches, rib pain, stomach pain, dizzy, weak and felt faintish were related to therapy with VARIVAX (Merck). No further information is available.
Sex: M
Vaccine: MEN, TTOX, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her son a male patient who on 10-JUN-2008 at 11:00 was vaccinated with VARIVAX (Merck) (route and site of administration was not reported), TETANUS TOXOID (manufacturer unknown) (route and site of administration not reported) and MENINGOCOCCAL (unspecified) (route and site of administration not reported). On 10-JUN-2008 in the middle of the night the patient experienced fever, body aches, rib pain, stomach, dizzy, weak and felt "faintish". The patient did not like to sit because of the pain in his stomach. Mom is treating the ADVIL and was calling the doctor office for follow up with the advice nurse. The patient's fever and body aches and rib pain and stomach pain and dizzy and weak and felt faintish persisted. The reporter felt that fever, body aches, rib pain, stomach pain, dizzy, weak and felt faintish were related to therapy with VARIVAX (Merck). No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a consumer concerning her son who was vaccinated with VARIVAX (Merck) (Injection site, dose/ frequency and lot# unspecified). Subsequently the patient experienced seizures. No additional information was provided. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Induration, Rash generalised
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning that during the past few months a few patient who were vaccinated with a second dose of VARIVAX (Merck) (lot number, injection site and route not reported).  Subsequently the patients experienced generalized rashes.  One patient had cellulitis and was treated with an unnamed antibiotic.  Unspecified medical attention was sought for these events.  All children were about 4 years old.  Follow-up information was received from the R.N. on 07-JUL-2008 concerning a 17 year old female student with asthma and no known allergies who on 18-OCT-2001 and 14-MAY-2008 was vaccinated subcutaneously in the left arm with first and second 0.5ml doses, respectively, of VARIVAX (Merck) (Lot number of second dose 659357/1567U, expiration date 28-SEP-2009).  Concomitant medication included ALBUTEROL.  On 15-MAY-2008 the patient developed arm redness and warmth to touch.  On 17-MAY-2008 the patient developed red, raised and itchy rash which was about palm size.  On 18-MAY-2008 the patient developed left upper arm induration and was seen in office.  The patient was treated with KEFLEX.  Subsequently the patient recovered from the events.  Follow-up information was received via telephone call or 21-JUL-2008 from a nurse.  She reported that the patient recovered from all adverse events reported.  This is one of several reports from the same source.  Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning that during the past few months a few patient who were vaccinated with a second dose of VARIVAX (Merck) (lot number, injection site and route not reported).  Subsequently the patients experienced generalized rashes.  One patient had cellulitis and was treated with an unnamed antibiotic.  Unspecified medical attention was sought for these events.  All children were about 4 years old.  Follow-up information was received from the R.N. on 07-JUL-2008 concerning a 17 year old female student with asthma and no known allergies who on 18-OCT-2001 and 14-MAY-2008 was vaccinated subcutaneously in the left arm with first and second 0.5ml doses, respectively, of VARIVAX (Merck) (Lot number of second dose 659357/1567U, expiration date 28-SEP-2009).  Concomitant medication included ALBUTEROL.  On 15-MAY-2008 the patient developed arm redness and warmth to touch.  On 17-MAY-2008 the patient developed red, raised and itchy rash which was about palm size.  On 18-MAY-2008 the patient developed left upper arm induration and was seen in office.  The patient was treated with KEFLEX.  Subsequently the patient recovered from the events.  Follow-up information was received via telephone call or 21-JUL-2008 from a nurse.  She reported that the patient recovered from all adverse events reported.  This is one of several reports from the same source.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N) concerning a patient who on 11-JUN-2008 was inadvertently vaccinated with a dose of VARIVAX (Merck). No symptoms were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a nurse concerning her child, 4 year old male, with a history of prior immunizations (unspecified) who on 10-JUN-2008 was vaccinated with the second dose of VARIVAX (Merck). It was reported that on 10-JUN-2008 the patient experienced fever of 103 F. The patient was treated with TYLENOL (dose, route and duration unspecified). The nurse reported that the patient never had a reaction to other vaccines before. It was reported that the nurse sought medical attention by speaking with another nurse at the facility where the vaccine was given. The outcome is reported as recovering. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a 36 month old male who in approximately 2006 was vaccinated with a single dose of VARIVAX (Merck). Subsequently on an unspecified date the patient developed shingles. The rash appeared on his legs and butt. The physician saw the patient. The patient was recovering. No product quality complaint was involved. Follow-up information was received from a physician which reported that this was a 42 month old male whom was previously vaccinated by his previous primary physician (PCP) with VARIVAX (Merck) in 2005 whom we treated for shingles 05-JUN-2008. At the time of reporting, the patient recovered from shingles. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a 12 year old female with no pertinent medical history or known drug allergies who on 26-JUN-2008 was vaccinated subcutaneously in the right arm with a second dose of VARIVAX (Merck) (Lot #659432/1918U).  On the same day the patient was vaccinated higher up in the right arm with concomitant HAVRIX.  On 27-JUN-2008 the patient was in office with injection site blister like bump with fluid underneath.  The patient had no adverse event after receiving the first dose of VARIVAX (Merck).  At the time of the report, the patient had not recovered from injection site blister.  The patient was seen in office.  This is one of several reports from the same source.  Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old patient who on 27-JUN-2008 was inadvertently vaccinated with a single dose of VARIVAX (Merck) SQ instead of ZOSTAVAX (Merck) (MSD) due to human error.  The pharmacist confirmed this was not a case of product confusion.  No problems reported.  No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 30-Jan-2008 was inadvertently vaccinated with a dose of VARIVAX (Merck) (route and administrating site not reported) instead of ZOSTAVAX (Merck). Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a male with no known pertinent medical history who on 26-JUN-2008 was vaccinated with a first dose of VARIVAX (Merck) 0.5 ml SQ. There was no concomitant medication. The patient developed a rash after he received the vaccine on an unspecified date. The patient sought medical attention by calling the nurse. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 60 year old male who on approximately 30-MAY-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). The patient had no reaction. The patient's outcome was unknown. No further information is available.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 4 year old female with no medical history or drug allergies who on 12-APR-2005 was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (Merck) (lot # 648318/0440P) and on 08-MAY-2008 was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot # 659939/1788U). Secondary suspected therapy included MMR II. Other concomitant therapy included Poliovirus vaccine (manufacturer unknown), HAVRIX and DTaP (unspecified) (+) Tetanus toxoid. Prior vaccination included PREVENAR (12-APR-2005). On 01-JUL-2008 the patient developed chicken pox. On 01-JUL-2008, the patient was seen in the office and had about 20 lesions on her back. The patient's mother reported that the patient had been running a fever, but was afebrile at the time of the office visit. At the time of this report, the patient's chicken pox persisted. No product quality complaint was involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient in his (or her) 70's with no pertinent medical history, drug reactions or allergies who on 01-JUL-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). There was no concomitant medication. The reporter stated that she did not double check the vial and made the mistake. It was no product confusion. No adverse events reported. Follow-up information was received on 04-SEP-2008 from the C.M.A. concerning a 73 year old retired female who was administered a dose of VARICELLA (Merck) instead of ZOSTAVAX (Merck). The reporter confirmed that there was no adverse event. This is one of several reports from the same source. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Rash pruritic
Clinical narrative: Information has been received from a veterinarian concerning his 24 year old pregnant daughter with a history of chickenpox as infant. The patient's 18 month old daughter was vaccinated about a month ago (in approximately May 2008) with a dose of VARIVAX (Merck) (WAES # 0806USA03425). On 12-JUN-2008 the patient experienced spots all over her body such as on the face, arms and legs. It was most noticeable on the stomach and thighs. She was not being treated with any medication and had a follow-up appointment next week. She has a conception date of 20-MAY-2008. Estimated due date is 10-FEB-2009. At the time of reporting the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received from the patient's father who reported that his granddaughter had an itchy rash after vaccination (WAES # 0806USA03425). His daughter then developed a rash with hard bumps that itches and was seen by her dermatologist. The reporter stated that his daughter was not seen by her obstetrician/gynecologist yet, but had an appointment scheduled. Additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning her daughter who was vaccinated with a dose of VARIVAX (Merck). On an unspecified date the patient broke out in chickenpox. Subsequently, the patient recovered, unspecified medical attention was sought. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Scar, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning her approximately 12 month old daughter with allergies who in August 2005 was vaccinated with the first dose of VARIVAX (Merck) single dose subcutaneously. Subsequently the patient developed wide-spread chicken pox with some scarring. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified dates was vaccinated with the two doses of VARIVAX (Merck). The physician reported that the patient experienced a large area of arm severely swollen, 5-7 inches in length, pain and erythema. The treating physician gave an antibiotic to the patient since he has not sure what kind of reaction it was. The reporting physician stated that it was from their private and public stock (Vaccines for Children stock). The patient sought medical attention. This is one of two reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a Merck employee concerning a 6 year old female who last week (between 23-JUN-2008 to 29-JUN-2008) was vaccinated with the second dose of VARIVAX (Merck). Subsequently, the patient developed swelling, redness and a poc mark at the site. The patient went to the emergency room and was treated with antibiotics. The outcome of the adverse events was not reported. No further information is available.
Age: 77.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) concerning a patient in his (or her) 70's with no pertinent medical history, drug reactions or allergies who on 01-JUL-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). There was no concomitant medication. The reporter stated that she did not double check the vial and made the mistake. It was not product confusion. No adverse events reported. Follow-up information was received on 04-SEP-2008 from the C.M.A. concerning a 77 year old retired male who was administered a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). The reporter confirmed that no adverse event occurred. This is one of several reports from the same source. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test normal, Varicella zoster serology negative
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old female patient with no pertinent medical history who on 17-MAY-2007 was vaccinated with the first dose of VARIVAX (Merck). On 17-AUG-2007 the patient was vaccinated with the second dose of VARIVAX (Merck). There was no concomitant medication. The recent VZV antibody titer was negative for the patient. No further information is available.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Inappropriate schedule of drug administration, Varicella zoster serology negative
Clinical narrative: Information has been received from a nurse concerning a 25 year old female with no pertinent medical history or history of drug allergies or reaction who in June 2006, was vaccinated with the first dose of VARIVAX (Merck). In April 2008, the patient was vaccinated with the second dose of VARIVAX (Merck). The vaccinations were affiliated with another practice. There was no concomitant medication. In May 2008, antibody titers were drawn and were found to be negative. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 6 or 7 years old male who was vaccinated with at least two doses of VARIVAX (Merck). The nurse reported that the patient had chicken pox every time when he was exposed to it in the community. The physician believed that it was not breakthrough, but rather an exposure to the wild type. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 13 month old female with no medical history or no drug allergies who on 30-MAY-2008 was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included PREVNAR and MMR II (MSD). On 24-JUN-2008 the patient developed a rash resembling chickenpox and a low grade fever. The patient came back to the office to seek medical attention. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 07-JUL-2008 was vaccinated with "one vial" of VARIVAX (Merck) instead of ZOSTAVAX (Merck). The reason for error was unknown. The patient did not experience any known symptoms. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 4 year old female with no pre-existing allergies, birth defects or medical conditions who on 01-Jul-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot#660062/0091X) in her left arm. There was no illness at the time of vaccination. On 03-Jul-2008 the patient experienced swelling and redness which size was of a quarter at site of injection. The patient was treated with Tylenol/ Motrin and ice. At the time of report, the outcome was unknown. The reporter indicated that the adverse events were non-serious. No further information is available.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health care professional concerning an 8 year old female with no pre-existing allergies, birth defects or medical conditions who on 26-JUN-2008 was vaccinated with a second dose of VARIVAX (Merck) in her left arm (lot #654281/1890U). There was no illness at the time of vaccination. Subsequently the patient experienced swelling and redness at site of injection. The patient was treated with TYLENOL/MOTRIN and ice. Subsequently, the reaction went away between 24-48 hours after first appeared. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a patient who on unspecified dates was vaccinated with the two doses of VARIVAX (Merck).  The physician reported that the patient experienced injection site reaction such as swelling, pain and erythema.  The reporting physician stated that it was from their private and public stock (Vaccines for Children stock).  The patent sought medical attention.   This is one of two reports received from the same source.  Attempts are being made to obtain additional identifying information to distinguish the individual patients.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a healthcare worker and a physician concerning an 11 year old white female with no pertinent medical history and no known drug reactions/allergies who on 18-AUG-1997 was vaccinated with the first dose of VARIVAX (Merck) (LOT # 623125/0546E).  On 14-AUG-2007 the patient was vaccinated with the second dose of VARIVAX (MERCK).  Concomitant vaccination on 14-AUG-2007 included a dose of GARDASIL (MSD) and a dose of HEPATITIS A virus vaccine (unspecified) (manufacturer unknown).  It was reported that the patient received two doses of VARIVAX (Merck) "by mistake".  There was no illness at time of vaccination and no rash was occurred at the site of injection within 42 days of the vaccination.  On 08-JUL-2008 the patient developed shingles.  Multiple cluster of vesicular was erythematic painful base along left shoulder and around hand with pain (the child was crying).  On 22-JUL-2008, the patient recovered from shingles.  No medical attention was sought.  Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a 63 year old female who on 08-JUL-2008 was vaccinated in her left arm with a dose of VARIVAX (Merck) (LOT# 659603/1903U) instead of ZOSTAVAX (Merck) (MSD). No symptoms reported. The patient's outcome was unknown. The patient did not seek medical attention. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abdominal pain, Alanine aminotransferase normal, Aspartate aminotransferase normal, Blood albumin normal, Blood alkaline phosphatase normal
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 5 year old male with no relevant medical history or allergies who on 02-JUL-2008 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot number 660282/1897U) subcutaneously in the left deltoid, and a dose of MMR (MSD) subcutaneously in the right deltoid. There was no concomitant medication. On approximately 04-JUL-2008, also reported as 2 days later, the patient experienced abdominal pain. The pain persisted and he awakened at night crying from the pain. The patient was given MOTRIN for the discomfort, results are not known. The patient did not experience any nausea, vomiting, diarrhea, or constipation. On 09-JUL-2008, it was confirmed that the patient had mesentery adenitis. On 10-JUL-2008, laboratory tests were performed which showed that platelet count and serum albumin abnormal. Abdominal ultrasound showed that "matted lymph nodes in the right lower quadrant and periumbilical area. Finding may be consistent with mesentery adenitis." Unspecified medical attention was sought. At the time of reporting, the outcome of the patient was unknown. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose abnormal
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 5 year old male with no relevant medical history or allergies who on 02-JUL-2008 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot number 660282/1897U) subcutaneously in the left deltoid, and a dose of MMR (MSD) subcutaneously in the right deltoid. There was no concomitant medication. On approximately 04-JUL-2008, also reported as 2 days later, the patient experienced abdominal pain. The pain persisted and he awakened at night crying from the pain. The patient was given MOTRIN for the discomfort, results are not known. The patient did not experience any nausea, vomiting, diarrhea, or constipation. On 09-JUL-2008, it was confirmed that the patient had mesentery adenitis. On 10-JUL-2008, laboratory tests were performed which showed that platelet count and serum albumin abnormal. Abdominal ultrasound showed that "matted lymph nodes in the right lower quadrant and periumbilical area. Finding may be consistent with mesentery adenitis." Unspecified medical attention was sought. At the time of reporting, the outcome of the patient was unknown. Additional information is not expected.