chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Paraesthesia, Peak expiratory flow rate normal
Clinical narrative: Information has been received from a physician assistant concerning a 23 year old female patient with hypothyroidism who on 23-SEP-2009 was vaccinated with a dose of MMR II, 0.5 ml SC in upper right arm, (Lot # 663524/1727X).  Concomitant therapy included levothyroxine Na.  On 23-SEP-2009 night after receiving the vaccine, the patient's arm was tingling at the injection site and she was experiencing burning across the chest and shortness of breath.  Patient was seen for follow up on 24-SEP-2009 and she stated that she was experiencing decreased appetite, abdominal cramping and shortness of breath.  Injection site tingling was better but client was "still feeling crummy".  Physician assistant stated patient's peak flow measures were within normal limits.  At the time of the report, the patient's AE did not improve.  Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Injection site reaction, Laboratory test normal, Measles antibody negative, Mumps antibody test negative, Pain
Clinical narrative: Information has been received from a physician concerning a 30 year old female with cholesterol levels raised, asthma and allergies to CODEINE and penicillin who was vaccinated with two doses of MMR II (lot number not provided) as a child.  Now the patient had negative antibody titers for measles, mumps and rubella.  The patient recently received a flu vaccine, and now was experiencing achiness and a "mild injection site reaction" on her arm.  The patient visited the office and sought medical attention.  The outcome of the event was unknown.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Body temperature increased, Fatigue, Full blood count abnormal, Nausea, Pain
Clinical narrative: Information has been received from a pharmacist concerning a 36 year old female employee at her hospital with allergic to penicillin, sulfa drugs, fluoroquinolone antibiotics and macrolide antibiotics who on 04-AUG-2009 was vaccinated with a dose of MMR II.  "About 3 days after receiving MMR II on approximately 07-AUG-2009, the patient developed fatigue, achiness and a fever with a temperature of less than 100 degrees F.. The employee was also "now" on 25-AUG-2009 experiencing nausea along with the fatigue and achiness.  On 20-AUG-2009 the employee experienced a fever with a temperature of 102.7 degrees F.  Complete blood count (CBC) was performed showing elevated white blood cells.  The employee sought medical attention by phone call.  At the time of report, the employee had not recovered.  Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a pharmacist concerning a 36 year old female employee at her hospital with allergic to penicillin, sulfa drugs, fluoroquinolone antibiotics and macrolide antibiotics who on 04-AUG-2009 was vaccinated with a dose of MMR II.  "About 3 days after receiving MMR II on approximately 07-AUG-2009, the patient developed fatigue, achiness and a fever with a temperature of less than 100 degrees F.. The employee was also "now" on 25-AUG-2009 experiencing nausea along with the fatigue and achiness.  On 20-AUG-2009 the employee experienced a fever with a temperature of 102.7 degrees F.  Complete blood count (CBC) was performed showing elevated white blood cells.  The employee sought medical attention by phone call.  At the time of report, the employee had not recovered.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Diagnostic procedure, Dyslexia, Learning disability, Pyrexia
Clinical narrative: Information has been received from a nurse concerning her 12 month old son with no pertinent medical history and no drug allergies who in 1989 was vaccinated with a dose of MMR II (dose, route and LOT# not reported). There was no concomitant medication. Nurse reported that her son was found to have a learning disability after receiving MMR II. After he received MMR II, he developed very high fever. One year after the vaccination (in approximately 1990), he was diagnosed with dyslexia (via paper and pencil interview). The patient was not recovered. No further information was available at this time of the report. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Rubella antibody negative, Skin test
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old female patient with drug hypersensitivity and a history of childhood seizures who "probably" received MMR II as a child.  Concomitant therapy included LEXAPRO, MANTOUX SKIN TEST and unspecified oral contraceptives.  According to the reporter, on July 2009 the patient had negative antibody titer for measles and rubella. On 27-JUL-2009 one 0.5 ml intramuscularly dose of MMR II was given.  Subsequently, on 25-SEP-2009 this patient had a positive titer for measles, but continued to have a negative titer for rubella.  The patient sought medical attention by an office visit.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, No therapeutic response
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with two doses of MMR II as a child but still had negative titers to measles. No adverse reactions reported. The medical assistant stated this would be a new patient in their office and she did not have any information on the patient. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Wrong drug administered
Clinical narrative: Information has been received from a 72 year old female with no allergies who in the "end of February 2009" (approximately 28-FEB-2009), was vaccinated with VARIVAX (Merck) 0.5mL (lot # not reported) instead of ZOSTAVAX (Merck).  Concomitant therapy included SYNTHROID and LIPITOR.  On 07-MAR-2009 the patient developed rash on her arms and face.  Subsequently, the patient recovered from rash on her arms and face.  No lab diagnostic studies were performed.  Unspecified medical attention was sought.  No further information is available.
Age: 1.3
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 15 month old female with no medical history or concurrent condition who on 04-AUG-2009 was vaccinated subcutaneously with the first 0.5 mL dose of MMR II (lot # 663877/0356Y). Second suspect vaccine included a dose of VARIVAX (Merck) (MSD) on the same date. Concomitant therapy included a dose of DTAP on the same date. "About 13 days later (on 17-AUG-2009) the patient "developed a measles-like rash that covered about 80% of her body." The patient sought medical attention by visiting the physician's office. The outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a medical assistant concerning an 11 year old male who on 05-MAR-2009 was vaccinated SC in the left arm with a dose of VARIVAX (Merck) (Dose not reported, lot number 661988/1190X).  The medical assistant reported that on 05-MAR-2009 the patient had hives at the injection site.  The patient recovered from the event on an unspecified date.  The patient sought medical attention by speaking to the physician.  Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 5 year old female with no medical history or concurrent condition who on 10-AUG-2009 was vaccinated subcutaneously with the second 0.5 mL dose or MMR II (lot # 663877/0356Y).  Second suspect vaccine included a dose of VARIVAX (Merck) and a dose of VAQTA on the same date.  On 26-AUG-2009 the patient "developed a measles-like rash that covered about 80% of her body."  The patient sought medical attention by visiting the physician's office.  At the time of report the patient was recovering.  Additional information has been requested.
Age: 1.31
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a health professional concerning a 15 month old female who on 13-MAR-2009 was vaccinated SC in the left leg with a dose of VARIVAX (Merck) (dose not reported, lot number 661988/1190X).  Concomitant therapy included MMR II (dose and route not reported, lot number 660203/0452X) (rHA) (patient was given the vaccine in the right leg).  On 13-MAR-2009, the patient had hives at injection sites.  The patient recovered from the events on an unspecified date.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported).  The physician reported that the patient had a swollen arm after receiving the vaccine.  The patient recovered that the patient had a swollen arm after receiving the vaccine.  The patient recovered from the event on an unspecified date.  The patient was seen by the physician.  Follow up information has been received from a physician concerning a 12 year old female with no pertinent medical history reported, no known drug allergies and no illness at the time of vaccination who 09-MAR-2009 was vaccinated SC with a dose of VARIVAX (Merck) (dose not reported, lot number 660337/0098X).  The physician reported that the patient's arm was red and swollen on 11-MAR-2009.  On 12-MAR-2009, the patient called again and the symptoms persisted.  She was seen in office on 13-MAR-2009 and had minimal edema and erythema.  The patient recovered from the events on 20-APR-2009.  No lab studies were performed.  No further information is available.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 15 month old female with no medical history or concurrent condition who on 16-JUL-2009 was vaccinated subcutaneously with the first 0.5 mL dose of MMR II (lot # 663164/1583X).  Second suspect vaccine included a dose of VARIVAX (Merck) and a dose of VAQTA on the same date.  Concomitant therapy included a dose of PENTACEL and a dose of PREVNAR on the same date.  On 26-JUL-2009 the patient "developed a measles-like rash that covered about 80% of her body." The patient sought medical attention by visiting the physician's office.  The patient recovered on unspecified date.  Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old female patient who on 26-MAR-2009 was vaccinated subcutaneously with a dose of VARIVAX (Merck) (lot #: 657755/1863U) in the right leg.  On the same day the patient was vaccinated with a dose of MMR II (MSD) (lot # 662559/1370X) in the left leg.  Subsequently, the patient had hives at the injection sites for both vaccines.  On an unspecified date the patient recovered.  Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no medical history or allergies who on 11-MAR-2009 received the first dose of VARIVAX (Merck) (lot# not provided) in the leg. There was no concomitant medication. 10 days after vaccination, on 21-MAR-2009, the patient experienced fever for 24 hours. The patient also developed rash papular, which came out in crops over 3 days with over 200 lesions all over the body. On 26-MAR-2009, the patient recovered from fever and rash papular. The reporter considered the adverse events to be non-serious. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a mother concerning her 12 month old son with allergy to azithromycin who on 13-MAR-2009 was vaccinated with VARIVAX (Merck) (lot# not reported) and another vaccine (name and manufacturer unspecified). On the night of 15-MAR-2009 the patient developed a 103 F fever without medication and then on medication (name and manufacturer unspecified) the fever went down to 100 or 99 degrees that lasted until the afternoon of the 16-MAR-2009. On 18-MAR-2009 the patient developed a pimply rash on his inner thigh that resembled the chickenpox and then disappeared later that day. On the night of 19-MAR-2009 the patient developed a rash on his chest and then on 20-MAR-2009 the rash was on his body from head to toe, but it was not a full blown case of the chickenpox. The mother reported that the patient did see a physician and diagnosed the patient had having a reaction to VARIVAX (Merck). No lab diagnostics studies were performed. It was reported that the rash disappeared by 23-MAR-2009 and the patient had recovered. The mother also reported that "when the patient received his 9 month old vaccinations (name and manufacturer unspecified), the patient spiked a fever, loss of appetite for 48 hours." In follow-up, the physician indicated that the patient was not seen in the office but made phone calls. The physician had no idea who turned this case in. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who on 24-MAR-2009 was vaccinated SC with VARIVAX (Merck) (lot # 662459/1784X) into the right arm.  On 25-MAR-2009 the patient developed large red, swollen area at injection site and tenderness in right axilla.  The patient was examined on 27-MAR-2009 but symptoms were resolving without treatment.  It was unspecified if the patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes simplex serology negative, Herpes zoster, Hypophagia, Irritability
Clinical narrative: Information has been received from a physician via medical records concerning a 19 month old male with no prenatal exposure to chicken pox and a history of diaper rash one month ago who in August 2008, was vaccinated with the first dose of VARIVAX (Merck).  The patient was not exposed to chickenpox or herpes zoster recently and had no history of chickenpox.  On 27-MAR-2009 the patient experienced herpes zoster.  Clinic notes dated 30-MAR-2009 reported left upper buttock with crops of erythematous papules, no clear vesicles, some excoriated on top, no surrounding erythema or TTP.  Similar crops of erythematous papules in different stages of formation extending down left inner leg, onto medial surface of foot.  Additional office notes indicated that the rash was on the left buttock and left leg with vesicles at L4, L5.  The patient's mother had stated on 27-MAR-2009 the patient experienced rash on lower back, two days spread to trunk and legs.  The patient was himself except more fussy and irritable.  He had decreased PO, with wet diapers.  There was no fever and he would walk on leg.  The patient was treated with POLYSPORIN.  He also received ACYCLOVIR 80 mg/kg QID X 5 days beginning 31-MAR-2009.  Additionally, he received TYLENOL PRN for pain.  NYSTATIN topical cream 10000 units/gram was to be applied 4 times a day for 14 days.  He was to avoid contact with his infant sibling.  Follow-up was scheduled.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine VZV strain.  The sample of the lesion was collected on 30-MAR-2009.  The results from the lesion specimen identified the Vaccine strain.  No further information is available.
Age: 1.6
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Rash papular, Varicella virus test negative
Clinical narrative: Information has been received from a physician via medical records concerning a 19 month old male with no prenatal exposure to chicken pox and a history of diaper rash one month ago who in August 2008, was vaccinated with the first dose of VARIVAX (Merck).  The patient was not exposed to chickenpox or herpes zoster recently and had no history of chickenpox.  On 27-MAR-2009 the patient experienced herpes zoster.  Clinic notes dated 30-MAR-2009 reported left upper buttock with crops of erythematous papules, no clear vesicles, some excoriated on top, no surrounding erythema or TTP.  Similar crops of erythematous papules in different stages of formation extending down left inner leg, onto medial surface of foot.  Additional office notes indicated that the rash was on the left buttock and left leg with vesicles at L4, L5.  The patient's mother had stated on 27-MAR-2009 the patient experienced rash on lower back, two days spread to trunk and legs.  The patient was himself except more fussy and irritable.  He had decreased PO, with wet diapers.  There was no fever and he would walk on leg.  The patient was treated with POLYSPORIN.  He also received ACYCLOVIR 80 mg/kg QID X 5 days beginning 31-MAR-2009.  Additionally, he received TYLENOL PRN for pain.  NYSTATIN topical cream 10000 units/gram was to be applied 4 times a day for 14 days.  He was to avoid contact with his infant sibling.  Follow-up was scheduled.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine VZV strain.  The sample of the lesion was collected on 30-MAR-2009.  The results from the lesion specimen identified the Vaccine strain.  No further information is available.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 24 month old female patient who on 16-JUL-2009 was vaccinated subcutaneously with the first dose of 0.5 ml MMR II (lot # 663164/1583X).  Concomitant therapy included VAQTA, VARIVAX (MSD).  Other concomitant therapy included DTAP.  On 27-JUL-2009 the patient developed "a measles-like rash that covered about 80 percent of her body."  The patient had sought medical attention via office visit.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female who on 24-MAR-2009 was vaccinated SC with VARIVAX (Merck) (lot # 662459/1784X) into the left arm.  On 25-MAR-2009 the patient developed large area of redness at injection site.  The patient called the office on 26-MAR-2009 and was prescribed cool compresses, MOTRIN and BENADRYL.  This is one of several reports from the same source.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 23-MAR-2009 was vaccinated SC with VARIVAX (lot #662459/1784X) into the left arm. On 24-MAR-2009 the patient developed 2-3 inch area of redness, swelling, and warmth at injection site. The patient called the office and was prescribed cool compresses, MOTRIN and BENADRYL. This is one of several reports form the same  source. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 30-MAR-2009 was vaccinated with a dose of VARIVAX (Merck). Suspect therapy included a dose of ZOSTAVAX (Merck). The medical assistant reported that the patient who was scheduled to receive ZOSTAVAX (Merck). The patient had not experienced any known symptoms. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 16 year old female who in approximately 1998 (at age of 5) was vaccinated with VARIVAX (Merck). In March 2009 (within the last month), the patient was diagnosed with chickenpox. The patient presented with approximately 300 widespread lesions. The patient visited the office. The physician added that the patient had been exposed to a sibling with chickenpox. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning her 7 year old daughter who was vaccinated with two doses of VARIVAX (Merck). On unknown date, the patient developed a mild case of chicken pox. The patient was seen by the nurse practitioner. At the time of reporting, the patient's a mild case of chicken pox persisted. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who was vaccinated with the a first dose of  VARIVAX. On unknown date the patient experienced a severe local reaction (location of the upper part of the unspecified arm and around the injection). Unknown the specific type of reaction. The patient's titers done recently were shown then patient is not immune. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a male child of unknown age who was vaccinated with one dose of VARIVAX (Merck). The nurse reported that the patient acquired shingles within a year or two after received the vaccine. The nurse stated that she was trying to figure out whether the child needed two doses of vaccine. She wanted to know if the child needed a second dose of vaccine or whether the child is adequately protected against varicella. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction, Oedema peripheral
Clinical narrative: Information has been received from a nurse concerning a male who was vaccinated with a dose of VARIVAX (Merck). The patient experienced a serious local reaction and his arm blow up quite larger after receiving the dose of VARIVAX (Merck). The patient sought medical attention through a physician. The patient recovered. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccine positive rechallenge, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning her 14 her old daughter with mild asthma, who on 18-JAN-1997 and on 02-NOV-2007 was vaccinated with first dose (dose, route and lot number provided) and second dose (dose and route not provided lot number 658407/1176U) respectively of VARIVAX (Merck). The nurse reported that her daughter developed chickenpox after first vaccination and subsequently when after receiving the second dose she was experiencing chickenpox that began about two days ago (on approximately 31-MAR-2009). The second case is very mild and she had blisters on her legs and one blister in her mouth. She had been prescribed acyclovir. At the time of reporting patient had not recovered from the event. The patient was seen at the office. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, No therapeutic response, Rubella antibody negative
Clinical narrative: Information has been received from a registered nurse concerning an approximately 40 year old female who on an unknown date was vaccinated with a dose of MMR II (lot no., dose and route not reported). The nurse reported that the patient had negative rubella titers but positive titers for mumps and measles. No adverse effect was noted. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis atopic, Gastrooesophageal reflux disease, Varicella
Clinical narrative: Information has been received from a physician concerning an 18 month old male patient with gastro esophageal reflux and dermatitis atopic who on 17-SEP-2008 was vaccinated with a dose of VARIVAX (Merck) (lot# 661540/1015X) 0.5ml subcutaneously. On 26-MAR-2009 the patient developed chicken pox. Patient sought medical attention via an office visit. No lab diagnostic studies performed. At the time of this report the patient was still recovering. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Malaise
Clinical narrative: Information has been received from a consumer concerning a her son who was vaccinated with a dose of MMR II. The reported stated that the child "got really sick" after the MMR II. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 39 month old male with OMNICEF allergies who was vaccinated with the first and second (lot # 662201/1544X) dose of VARIVAX (Merck), SQ, 0.5ml on 14-JUN-2006 and 30-MAR-2009 respectively.  Concomitant therapy included DTAP on the left thigh, inactivated poliovirus vaccine on the right thigh.  On 02-APR-2009 the patient experienced red, warm and swollen in left thigh that looked like cellulitis.  The patient was treated with BENADRYL, BACTRIM and KEFLEX.  The patient had no lab diagnostics studies performed.  The physician saw the patient.  At the time of the report the patient was recovered.  Follow up information has been received from the licensed practical nurse concerning the patient with no illness at time of vaccination who received the second dose of VARIVAX (Merck) in left thigh on 30-MAR-2009 at 2:30 PM.  Subsequently the patient experienced cellulitis in left thigh, it was swollen, red and warm.  The patient was placed on KEFLEX and warm compress.  The event required emergency room/doctor visit.  At the time of the report the patient was recovered.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the Center of Biologics Evaluation and Research and was released.  No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old female with no medical history or drug allergies who was vaccinated with the first and the second (lot # 662201/1544X) dose of VARIVAX (Merck), SQ, 0.5ml on 24-JAN-2001 and 01-APR-2009 respectively. There was no concomitant medications. On 04-APR-2009 the patient experienced red thigh, swollen thigh that looked like cellulitis. The patient had no lab diagnostics studies performed. The physician saw the patient. At the time of the report the patient was recovering. A lot check has been initiated. Follow up information has been received from a licensed practical nurse concerning a patient with no illness at time of vaccination who was vaccinated with the second dose of VARIVAX (Merck) on 01-APR-2009 at 3:30 PM. She developed cellulitis left thigh. The patient was prescribed KEFLEX and warm compress. The event required emergency room/doctor visit. At the time of the report the patient was recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination error
Clinical narrative: Information has been received from a physician concerning her mother who on 06-APR-2009 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her now 18 year old son who on an unknown date when he was younger, was vaccinated with VARIVAX (Merck) (lot # not reported). Subsequently the patient developed chicken pox. Unspecified medical attention was sought. No further information was available.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Full blood count normal, Injection site erythema, Injection site induration, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female patient with penicillin allergy, sulfonamide allergy and cephalosporin allergy who on an unknown date was vaccinated with VARIVAX (Merck). Subsequently the patient experienced allergy to VARIVAX. The outcome of the adverse event was not reported. The patient experienced swelling of upper arm. Significant elevated levels of IgE and erythematous induration at site of injection while on therapy with GARDASIL, (WAES# 0902USA01435). Follow up information was received from a physician concerning the 15 year old female patient with penicillin allergy, sulfonamide allergy, allergy to cephalasporin and a history of adverse reaction to GARDASIL WAES#0902USA01435) who on 16-MAR-2009 was vaccinated intramuscularly in the left arm with the first dose of VARIVAX (Merck). There was no illness at the time of vaccination. On 15-JAN-2009 the patient developed 8.5 by 7.0 cm erythematous induration. Lab test showed that the patient's complete blood cell count (CBC) was normal but her erythrocyte sedimentation rate was greater than 31. The patient recovered 26-JAN-2009. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a female patient with penicillin allergy, sulfonamide allergy and cephalosporin allergy who on an unknown date was vaccinated with VARIVAX (Merck). Subsequently the patient experienced allergy to VARIVAX. The outcome of the adverse event was not reported. The patient experienced swelling of upper arm. Significant elevated levels of IgE and erythematous induration at site of injection while on therapy with GARDASIL, (WAES# 0902USA01435). Follow up information was received from a physician concerning the 15 year old female patient with penicillin allergy, sulfonamide allergy, allergy to cephalasporin and a history of adverse reaction to GARDASIL WAES#0902USA01435) who on 16-MAR-2009 was vaccinated intramuscularly in the left arm with the first dose of VARIVAX (Merck). There was no illness at the time of vaccination. On 15-JAN-2009 the patient developed 8.5 by 7.0 cm erythematous induration. Lab test showed that the patient's complete blood cell count (CBC) was normal but her erythrocyte sedimentation rate was greater than 31. The patient recovered 26-JAN-2009. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: Information has been received from a 38 year old female health care professional who in April 1999, 10 years ago, was vaccinated with VARIVAX (Merck) (lot # not reported).  Subsequently, on approximately 08-APR-2009, the patient experienced a negative varicella titer.  Unspecified medical attention was sought.  No further information is available.
Age: 68.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an adult patient who on 24-MAR-2009 was inadvertently vaccinated with VARIVAX (Merck) (lot # not reported).  The patient was intended to receive ZOSTAVAX (Merck).  The reporting nurse confirmed this was human error and not product confusion.  No problems reported.  It was unspecified if the patient sought medical attention.  Follow-up information was received from a registered nurse who confirmed that the 68 year old male patient did not experienced any adverse events.  There were no relevant diagnostic tests performed, no treatment was required and there was no illness at the time of vaccination.  The patient did not seek medical attention.  No further information is available.
Age: 69.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 69 year old patient who on 11-SEP-2009 was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck).  There was no adverse event reported.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Hypersensitivity
Clinical narrative: Information has been received from a consumer concerning child (sex and age not reported) who was placed on therapy with MMR II (dose number and vaccination date not reported).  The consumer heard about the patient through her sister about 3 years ago.  Subsequently the patient developed an "allergic reaction" after receiving MMR II.  It was unknown whether medical attention was sought.  The patient's out come was not reported.  This is one of two reports from the same source.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test negative, Nervous system disorder, Rubella antibody test
Clinical narrative: Information has been received from a consumer concerning a her 4 year old son with "neurological delay" who couple years ago was vaccinated with a dose MMR II (lot # not reported). Recently he had test for titer and the only one that was no longer active in the system was mumps virus. The patient did not sought medical attention. At the time on the report on 23-JUN-2009 the patient had not recovered. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 79 year old female patient who on 10-SEP-2009 inadvertently received a dose of VARIVAX (Merck) (subcutaneous injection, lot# 664327/0778Y) instead of ZOSTAVAX (Merck). No adverse effects reported. The patient did not seek medical attention. Follow-up information has been received from a pharmacist who explained that the patient received a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). It was a case of human error as the pharmacist was rushing and was distracted just prior to administering the vaccine. The pharmacist had no suggestions to improve packaging, labeling, storage, etc. The pharmacist could not confirm the lot number at the time of the report. The pharmacist did confirm that the patient had no adverse experiences as a result of the mistake and was due back in for vaccination with a dose of ZOSTAVAX (Merck) in 4 weeks. Additional information is not expected.
Age: 18.0
Sex: U
Vaccine: MMR
Symptoms: Measles antibody negative, No therapeutic response
Clinical narrative: Information has been received from a certified medical assistant concerning an 18 year old patient who had been vaccinated with two doses of MMR II, but still had negative titers to measles.  It was unknown if the patient sought medical attention.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was inadvertently vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). No adverse effect reported. Follow up information was received from a physician who indicated that the patient did not experience an adverse reaction. He stated that the error was caused by a novice medical assistant who was unfamiliar with the practices. The physician also provided the Lot # for VARIVAX (Merck) (Lot # 663323/0645Y). Follow up information was received from a physician concerning a 61 year old self-employed female patient with no known drug allergies/drug reactions who on 08-SEP-2009, at 10:00 am, was vaccinated with the first dose of VARIVAX (Merck) (Lot # 663323/0645Y) into her left deltoid. There were no illnesses at time of vaccination. It was reported that the patient received the wrong immunization. There was no adverse reaction. This is one of two cases from the same source. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning an unknown number of patients who on an unknown date were vaccinated with a dose of MMR II (lot no., dose and route not reported).  The nurse reported that the patient had negative antibody titers to one of the components of the vaccine.  She also stated that the patients did not have complete vaccination histories so it was unknown if one or more doses were administered.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 and a half year old female patient who on unspecified day was vaccinated with a second dose of VARIVAX. Subsequently the patient developed varicella like rash after getting the second dose of the vaccine. Lot # was not provided. The patient had sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been received from a nurse practitioner who reported that the patient received the second dose of VARIVAX (Lot # 664724/0927Y),  subcutaneous injection given in the right arm, on 26-AUG-2009 at 6:00 PM. The patient on 27-AUG-2009 at 7:00am experienced injection site reaction-large (8"), the red induration very pruritic and painful. Additional patient experienced generalized sparse vesicular eruption also pruritic. The patient recovered from AEs on 29-AUG-2009. No further information is available.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 and a half year old female patient who on unspecified day was vaccinated with a second dose of VARIVAX. Subsequently the patient developed varicella like rash after getting the second dose of the vaccine. Lot # was not provided. The patient had sought unspecified medical attention. At the time of this report, the patient had not recovered. Additional information has been received from a nurse practitioner who reported that the patient received the second dose of VARIVAX (Lot # 664724/0927Y),  subcutaneous injection given in the right arm, on 26-AUG-2009 at 6:00 PM. The patient on 27-AUG-2009 at 7:00am experienced injection site reaction-large (8"), the red induration very pruritic and painful. Additional patient experienced generalized sparse vesicular eruption also pruritic. The patient recovered from AEs on 29-AUG-2009. No further information is available.
Sex: U
Vaccine: MMR
Symptoms: Blood immunoglobulin G normal, No therapeutic response, Rubella antibody negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of MMR II. The patient had negative titers to rubella. The physician stated that the patient was immune against mumps and measles. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Body temperature increased, Rash
Clinical narrative: Information has been received from a health professional concerning a 34 month old male with penicillin allergy who in 07-NOV-2007, was vaccinated with the first dose of VARIVAX. In the morning of 09-SEP-2009, the patient developed 5 vesicles on the left shoulder. The patient's rash started on 09-SEP-2009, his body temperature was 100.3, not itchy or painful. The patient's outcome was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 4 year old female patient who on 19-JUN-2009 was vaccinated with a 0.5ml dose of MMR II (lot # 663667/0036Y) subcutaneously. There were no drug reactions, allergies, other medical history and concomitant medication. On 20-JUN-2009, one day after receiving vaccine, the patient developed redness and warmth at the injection site of the left upper arm. The patient was seen in a local unspecified emergency room on 20-JUN-2009 and was prescribed unspecified antibiotics to treat cellulitis. The patient was seen in follow-up in the office on 22-JUN-2009 and again on 25-JUN-2009. No lab diagnostics study was performed. At the time of report, the cellulitis was resolving. The lot number of sterile diluent was 4127X. The physician was concerned that the cellulitis might be related to the sterile diluent and requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number (4127X for sterile diluent) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluations and Research and was released. This one of several reports received from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 25 year old female with no pertinent medical history reported and no known drug allergies, who on 12-AUG-2009 was vaccinated SC with a 0.5mL dose of VARIVAX (Merck) (lot number 663943/0246Y) and SC with 0.5mL dose of MMR II (lot number 663928/0427Y). Concomitant therapy included TWINRIX and DTaP (manufacturer unknown). About three weeks after receiving the doses of VARIVAX (Merck) and MMR II, on approximately 02-SEP-2009, the patient developed a rash on her arms and chest. The rash lasted about 12 hours and then resolved. No lab studies were performed. The patient sought medical attention by contacting the office. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Varicella
Clinical narrative: Information has been received from a certified medical assistant via medical records concerning a 4 year old female who on 28-SEP-1995 was vaccinated with the first dose of MMR II. In approximately 1998 the patient developed chicken pox. The outcome was unknown. On 06-AUG-2007 the patient was vaccinated with the second dose of MMR II. Subsequently, the patient had inappropriate schedule of vaccination of GARDASIL (MSD) (WAES# 0905USA00732). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Information has been received from an office manager concerning a 14 year old female patient who in 1998 was vaccinated with the first dose of VARIVAX (Merck).  On 14-SEP-2009 the patient was vaccinated with the second 0.5 ml dose of VARIVAX (Merck) (Lot #664940/0884Y).  Subsequently the patient experienced pain and huge swelling at the injection site and all the way down to fingers and tingling in her fingers.  There were no adverse effects involved for the first dose of VARIVAX (Merck).  The patient had sought unknown medical attention.  At the time of report the patient's status was unknown.  Follow-up information has been received from a physician indicated that a 14 year old female student with no pre-existing allergies, birth defects, medical conditions who was vaccinated with the second dose of VARIVAX (Merck) (Lot # 664940/0884Y) subcutaneously in the right deltoid on 14-SEP-2009.  On 14-SEP-2009 at 21:00PM the patient had a red, indurated, tender area approximately 10 cm surrounding the injection site.  The patient was treated with BONADORM and cool packs.  At the time of report the patient had recovered.  Additional information is not expected.
Sex: M
Vaccine: MMR
Symptoms: Autoimmune disorder, Condition aggravated, Fall, Immune system disorder, Infection
Clinical narrative: Information has been received from a case in litigation via a case report concerning a male child patient who on approximately 06-JUN-2002 was vaccinated with a dose of MMR II (Lot number not reported). Subsequently, the patient experienced OMS. On 17-JUN-2002 approximately 11 days after the vaccination, the patient fell and cut his upper lip, according to the record. Twenty days after vaccination, his mother took him to the doctor because he had been falling frequently for the previous five days. A physician reported that the MMR vaccination triggered an autoimmune response in a child whose immune system was already under assault by a neuroblastoma and various infections. No further information is available.
Sex: M
Vaccine: MMR
Symptoms: Neuroblastoma, Opsoclonus myoclonus
Clinical narrative: Information has been received from a case in litigation via a case report concerning a male child patient who on approximately 06-JUN-2002 was vaccinated with a dose of MMR II (Lot number not reported). Subsequently, the patient experienced OMS. On 17-JUN-2002 approximately 11 days after the vaccination, the patient fell and cut his upper lip, according to the record. Twenty days after vaccination, his mother took him to the doctor because he had been falling frequently for the previous five days. A physician reported that the MMR vaccination triggered an autoimmune response in a child whose immune system was already under assault by a neuroblastoma and various infections. No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an approximately 11 year old male who on 04-NOV-1999 was vaccinated with a dose of VARIVAX (Merck).  The patient developed rashes recently and came to the clinic on 06-MAY-2009, the rashes were confirmed as chickenpox.  Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, Underweight
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old female who on 20-APR-2009 was vaccinated with MMR II that expired on March 2009. The nurse stated that the patient came in for a weight check on 29-JUN-2009 and was on the "lower percentile of weight". The nurse did not specify the patient's weight. Additional information has been requested.