chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: Information has been received from a consumer concerning her daughter, a female who in approximately 1998 (about 10 years ago) was vaccinated with a dose of VARIVAX (Merck). Recently, the patient had blood work and it showed that she did not have any immunity. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: No therapeutic response
Clinical narrative: Information has been received from a pharmacist concerning a 25 year old female employee of the hospital who was vaccinated with two doses of VARIVAX (Merck) and does not have immunity. The two doses were given 6 weeks apart. The patient contacted the nurse in employee health. No further information is available.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered pharmacist concerning her son, a 14 month old male with no pertinent medical history and no known drug reactions/allergies who in July 2008, was vaccinated subcutaneously with the 0.5ml dose of VARIVAX (Merck). There was no concomitant medication. About a week after the vaccination, the patient developed a mild case of chicken pox. Subsequently, the patient recovered from chickenpox. Unspecified medical attention was sought. No further information is available.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Body temperature, Injection site vesicles, Rash, Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a 9 year old female, weight 78lb, height 58 inches, with attention deficit/hyperactivity disorder (ADHD) and no history of drug reactions or allergies who on 22-MAY-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot#: 660042/1899U) 0.5 ml subcutaneously in the right arm and HAVRIX (lot#: AHAVB268EA) in the left arm. Concomitant therapy included CONCERTA. On 02-JUN-2008 the patient experienced a rash. She was seen in the office on 03-JUN-2008 with 6-8 vesicles at the injection site on her upper right arm spreading toward her elbow, her temperature was 99.4 F. The patient was diagnosed with chicken pox. The patient was treated with BENADRYL if needed for itching. Subsequently, the patient recovered. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 22-AUG-2000 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) 0.5ml (Lot number not reported). In Sep 2006 the patient was vaccinated subcutaneously with the second dose of VARIVAX (Merck) 0.5ml (Lot number not reported). On the last week of May 2008(approximately 26-MAY-2008) the patient developed over 100 varicella like lesions and fever. The patient was seen in the office and treated with ZOVIRAX. As of the time of the report the patient is recovering. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant and a nurse concerning a 70 year old female who on 18-AUG-2008 was vaccinated with VARIVAX vaccine (Merck) instead of ZOSTAVAX vaccine (Merck) by accident. The wrong vial was grabbed. It was human error but not a case of product confusion. The patient didn't experience any known symptoms. It was unspecified if the patient sought medical attention. No further information is available.
Age: 85.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 85 year old male who on 08-APR-2008 was vaccinated with a "regular dose" of VARIVAX vaccine (Merck) instead of ZOSTAVAX vaccine (Merck) for prevention of shingles. This was a medical error by the medical assistant. The physician reported that the medical assistant though they (varicella virus vaccine and zoster vaccine) were the same thing. The patient was not experiencing any known symptoms. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a physician concerning her 8.5 year old daughter who on 24-JUL-2007 was vaccinated in the right arm with a dose of VARIVAX (Merck) (Lot number 657100/0454U). On 24-JUL-2007, the patient experienced a large, warm swollen area to the upper right arm. It is not known if the patient sought medical attention. As of the date of this report, the patient's outcome was unknown. Additional information was received from the patient's mother (the physician). The mother did not report the reaction to the physician who "ordered the shot - as a lab only visit now a year ago". This is one of two reports from the same source. No further information as expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male with no drug allergies who on 14-MAY-2003 was vaccinated with VARIVAX vaccine (Merck) (Lot # unspecified), 0.5 ml, subcutaneous. Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) VARIVAX vaccine (Merck upgrade process) (Lot# 657535/05441U) received on 07/17/2007. On 24-MAY-2008 the patient developed chickenpox. He was seen by his physician on 28-MAY-2008 and the diagnosis was confirmed. The nurse mentioned that "the severity level was a 2."  Meaning that the patient experienced between 50-500 lesions. On 06-JUN-2008 a call was received from the nurse. She explained that the patient never really had full blown pustules. Per mother, it was more pimple-like. Subsequently, there were no scabs and the patient recovered from the event. No further information is available.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who on 03-JUN-2008 was inadvertently vaccinated subcutaneosly with a 0.5 ml dose of VARIVAX (Merck) (Lot #658053/1009U) instead of ZOSTAVAX (Merck). This was a human error. The VARIVAX (Merck) and ZOSTAVAX (Merck) were in the same location and the R.N. said that she just picked the wrong vaccine. No adverse events reported. Later that day (on 03-JUN-2008) the patient also received a dose of ZOSTAVAX (Merck) with no ill effects. The patient was seen at office. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Biopsy, Chapped lips, Cheilitis, Influenza like illness
Clinical narrative: Information has been received from a physician concerning a male in his 40's with a past medical history significant for a thyroid disorder treated with "thyroid hormone" since the age of 15 years old. There was no history of immuno compromise or drug allergies. There was no other concomitant medication. In May 2008, the patient was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient developed mild "flu-like symptoms" including cold symptoms and muscle acne. In June 2008, the patient was vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced mild "flu-like symptoms", rash described as purple patches (1/2-2 cm firm macules) on his face, arms, back, neck that were itchy, fever , a mouth felt inflamed and swollen without lesions, red/ chapped lips that bled when touched, redness around the eyes and joint pain. On approximately 11-Aug-2008, "last week", the patient experienced fever and redness around the eyeballs. On approximately 15-Aug-2008, "last Friday", the patient was seen by a dermatologist. Rash was biopsied with results showing "fixed drug reaction". The healthcare physician questioned possible HSP or vasculitis. The patient currently continued with the rash, although the rest of the symptoms had subsided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Lip haemorrhage, Myalgia, Nasopharyngitis, Ocular hyperaemia, Oedema mouth
Clinical narrative: Information has been received from a physician concerning a male in his 40's with a past medical history significant for a thyroid disorder treated with "thyroid hormone" since the age of 15 years old. There was no history of immuno compromise or drug allergies. There was no other concomitant medication. In May 2008, the patient was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient developed mild "flu-like symptoms" including cold symptoms and muscle acne. In June 2008, the patient was vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced mild "flu-like symptoms", rash described as purple patches (1/2-2 cm firm macules) on his face, arms, back, neck that were itchy, fever , a mouth felt inflamed and swollen without lesions, red/ chapped lips that bled when touched, redness around the eyes and joint pain. On approximately 11-Aug-2008, "last week", the patient experienced fever and redness around the eyeballs. On approximately 15-Aug-2008, "last Friday", the patient was seen by a dermatologist. Rash was biopsied with results showing "fixed drug reaction". The healthcare physician questioned possible HSP or vasculitis. The patient currently continued with the rash, although the rest of the symptoms had subsided. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash macular, Rash pruritic, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a male in his 40's with a past medical history significant for a thyroid disorder treated with "thyroid hormone" since the age of 15 years old. There was no history of immuno compromise or drug allergies. There was no other concomitant medication. In May 2008, the patient was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient developed mild "flu-like symptoms" including cold symptoms and muscle acne. In June 2008, the patient was vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced mild "flu-like symptoms", rash described as purple patches (1/2-2 cm firm macules) on his face, arms, back, neck that were itchy, fever , a mouth felt inflamed and swollen without lesions, red/ chapped lips that bled when touched, redness around the eyes and joint pain. On approximately 11-Aug-2008, "last week", the patient experienced fever and redness around the eyeballs. On approximately 15-Aug-2008, "last Friday", the patient was seen by a dermatologist. Rash was biopsied with results showing "fixed drug reaction". The healthcare physician questioned possible HSP or vasculitis. The patient currently continued with the rash, although the rest of the symptoms had subsided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 year old white female with no pre-existing allergies, birth defects, or medical conditions who on 07-AUG-2008, was vaccinated with the second dose of VARIVAX (Merck) (lot # 660495/0431X) subcutaneous route, left arm.  There was no illness at the time of vaccination.  On 08-AUG-2008, the patient experienced swelling and redness at the site of injection.  The patient was told to use ice MOTRIN and TYLENOL for comfort.  Was told to call back in 24 hours if not going down and they never called back.  On 09-AUG-2008, the patient recovered from swelling and redness.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a vaccine provider concerning a 9 year old  female minor with no pre-existing allergies, birth defects or medical conditions who on 28-MAY-2008, at 3:30 p.m., was vaccinated subcutaneosly in the left arm with a second dose of VARIVAX (Merck) (Lot #658408/1177U). On the same day, the patient also received a first dose of concomitant vaccination HAVRIX (Lot #AHAVBZ35BA). There was no illness at time of vaccination. On 29-MAY-2008 the patient developed cellulitis in the left arm, left upper arm dorsal aspect erythema patch with induration around the injection site (from shoulder to elbow). On 05-JUN-2008 the patient recovered from the events. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 10 year old male with allergy to OMNICEF who on 22-APR-1999 was vaccinated with a first dose of VARIVAX vaccine (Merck). On 10-AUG-2008 the patient experienced break-through chickenpox after infant dose of vaccine and had at least 50 lesions. The patient sought medical attention of the physician. Outcome was unknown. The patient did not receive other vaccines within 4 weeks. Additional information was received from a medical assistant. On 20-AUG-2008, the patient recovered. No further information is available.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 4 year old female with no history of recent exposure to Chicken pox who on 05-JUN-2005 was vaccinated with a first dose of VARIVAX (Merck) (route not reported) on her left upper lateral thigh.  Concomitant therapy included MMR II (Wistar RA 27/3) (MSD), PREVNAR and PURIVAX.  On 04-JUN-2008 the patient developed shingles on her left upper lateral thigh where originally the vaccine was given.  No other systemic symptoms were noted.  The patient sought medical attention.  Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse and a consumer concerning a 12 year old male with atopic dermatitis on leg behind knee at time of vaccination and asthma, allergies and eczema who on 12-AUG-2008 was vaccinated with the second dose of VARIVAX (Merck) (Lot # 660079/0331X), subcutaneous, left arm and on the same day received a dose of VAQTA inactivated in left deltoid. On 13-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 15-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 of the Center for Biologics Evaluation and Research and was released. This is one of several patient provided by the same reporter. No additional information is expected.
Age: 68.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old female patient with no pertinent medical history or known allergies or drug reaction who was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck).  No further information was available at the time of this report.  The patient had no illness at the time of vaccination.  Follow up information was received from the physician which reported that there was no adverse event.  No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Laboratory test, Vaccination complication
Clinical narrative: This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A patient experienced an extremely bad reaction to a second shot of VARIVAX vaccine (Merck). This was originally reported by a physician. No further information is available.
Age: 69.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 69 year old female who on 11-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 0319X) instead of ZOSTAVAX (Merck).  It was nurse error not product confusion.  No adverse effect reported.  No product quality complaint was involved.  Follow up information was received from a registered nurse (R.N.) which reported that this case was not a case of product confusion.  It was a case of human error.  The reporter did not elaborate on this.  The reporter simply said that the nurse made an error and offered no feedback or suggestions to help prevent this happening in the future.  The patient had not experienced any adverse events, and she would return in 28 days to be vaccinated with ZOSTAVAX (Merck).  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Swelling
Clinical narrative: Information has been received from a nurse practitioner, concerning to "couple of youngsters", who were vaccinated with the second dose of VARIVAX vaccine (Merck). The patient experienced itching and large swelling after the second dose of VARIVAX vaccine (Merck). The patient sought medical attention. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow-up information has been received from a Licensed Practical Nurse, concerning a 12 year old female patient, who was vaccinated with VARIVAX vaccine (Merck) (Lot # 660671/0430X). The patient experienced itching and large swelling after the second dose of VARIVAX vaccine (Merck). Subsequently, the patient recovered. Additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Rash, Varicella post vaccine, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX vaccine (Merck). On an unspecified date, 10 days post vaccination, the patient developed a rash. The rash was found to be positive for the vaccine strain VZV by PCR performed at CDC. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second doe AEs, particularly rashes in patients who have received a second dose of VARIVAX vaccine (Merck). She indicated that the other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first dose. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX vaccine (Merck) were stored and administered appropriately, and all patients involved were normal healthy children. This is one of several reports received from the same source. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: Information has been received from a physician concerning a 9 year old male who in approximately 2000, "8 years ago", was vaccinated subcutaneously with a 0.5ml dose of VARIVAX (Merck). On 12-Aug-2008 the patient came to the office with a case of shingles. At the time of this report, the patient's shingles persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a licensed practical nurse and a consumer concerning a 12 year old male who on an unspecified date was vaccinated with the first dose of VARIVAX (Oka/Merck) and was well tolerated. On 4-AUG-2008, was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 660079/0331X) (in follow-up, the lot 3 was reported as 661445/0525X). On 04-AUG-2008, the patient was vaccinated with a second dose of VAQTA in the deltoid (OKA/MERCK). There were no illness at 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 have 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 of the government and was released. This is one of several reports provided by the same source. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX (Oka/Merck). On an unspecified date, 10 days post vaccination, the patient developed a rash. The rash was found to be positive for the vaccine strain VZV by PCR performed at the CDC. At the the time of the report the patient's status was unknown. A product quality complained was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX (Oka/Merck). She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first dose. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoke with the reporting healthcare providers and all doses of VARIVAX (Oka/Merck) were stored and administered appropriately, and all patients involved were normal healthy children. This is one of several reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with asthma and penicillin allergy which caused breath shortness and hives and with no illness at time of vaccination, who on 04-AUG-2008 at 15:10 was vaccinated with 0.5 mL of VARIVAX vaccine (Merck) (Lot #660402/0271X) SQ in the left upper arm. Concomitant therapy was not reported. On 13-AUG-2008 at 12:30 pm, nine days post subcutaneous vaccination, the patient experienced tenderness in the administered site. The reporter stated that the patient had difficulties with sleep that the previous night and also reported a patient's headache and generalized achiness. The patient developed a 4-5 cm indurated erythema area into the left medial aspect of left upper extremity, it was warm to touch with faint blue tinged approximately 1 cm surrounding area. She experienced pain and itching in the left medial aspect upper extremity, approximately a hand, breadth under left acromion process. The reported stated that on 14-AUG-2008 the patient developed signs and symptoms late night at 23:30, nine days post injection, the patient had signs and symptoms similar to insect sting/bite. The registered nurse stated that the patient recently sprayed the house and did not think it was an insect. The reporter called the pharmacist who stated that she did not think it was the vaccine related with the incident. Also, the reporter spoke with other registered nurse who also stated she did not think it was vaccine related. On 05-SEP-2008, the patient was vaccinated with the second dose of 0.5 mL of VARIVAX vaccine (Merck) SQ, without any difficulty but had a previous incident thought to have been an insect sting. The registered nurse suggested to follow up with the primary care physician for the signs and symptoms of infection, purulent drainage, worsening pain, tissue necrosis, systemic symptoms and signs of fever. The patient stated that she was used an over the counter medication, cortisol cream, for symptoms management. On 18-AUG-2008, the patient recovered. The patient did seek medical attention at office visit. Additional information is expected.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site warmth, Pain, Sleep disorder
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female patient with asthma and penicillin allergy which caused breath shortness and hives and with no illness at time of vaccination, who on 04-AUG-2008 at 15:10 was vaccinated with 0.5 mL of VARIVAX vaccine (Merck) (Lot #660402/0271X) SQ in the left upper arm. Concomitant therapy was not reported. On 13-AUG-2008 at 12:30 pm, nine days post subcutaneous vaccination, the patient experienced tenderness in the administered site. The reporter stated that the patient had difficulties with sleep that the previous night and also reported a patient's headache and generalized achiness. The patient developed a 4-5 cm indurated erythema area into the left medial aspect of left upper extremity, it was warm to touch with faint blue tinged approximately 1 cm surrounding area. She experienced pain and itching in the left medial aspect upper extremity, approximately a hand, breadth under left acromion process. The reported stated that on 14-AUG-2008 the patient developed signs and symptoms late night at 23:30, nine days post injection, the patient had signs and symptoms similar to insect sting/bite. The registered nurse stated that the patient recently sprayed the house and did not think it was an insect. The reporter called the pharmacist who stated that she did not think it was the vaccine related with the incident. Also, the reporter spoke with other registered nurse who also stated she did not think it was vaccine related. On 05-SEP-2008, the patient was vaccinated with the second dose of 0.5 mL of VARIVAX vaccine (Merck) SQ, without any difficulty but had a previous incident thought to have been an insect sting. The registered nurse suggested to follow up with the primary care physician for the signs and symptoms of infection, purulent drainage, worsening pain, tissue necrosis, systemic symptoms and signs of fever. The patient stated that she was used an over the counter medication, cortisol cream, for symptoms management. On 18-AUG-2008, the patient recovered. The patient did seek medical attention at office visit. Additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX (Merck). On an unspecified date, 10 days post vaccination, the patient developed a rash. The rash was found to be positive for the vaccine strain VZV by PCR performed at the CDC. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX (Merck). She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first dose. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX (Merck) were stored and administered appropriately, and all patients involved were normal healthy children. This is one of several reports received from 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 registered pharmacist concerning a patient who on 13-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). This was a human error. No adverse experience reported. The patient sought medical attention, consulted with pharmacist. There was no product quality complaint. Follow-up information has been received. The pharmacist was unable and could not provide details for the product confusion. A family practice office had called in to ask the pharmacist if there was a waiting period between the time VARIVAX (Merck) was given and the time ZOSTAVAX could be given to the patient. Additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date was vaccinated with a second dose of VARIVAX (Merck). On an unspecified date, following the second dose, the patient developed a rash on both upper arms. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX (Merck). She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first dose. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX (Merck) were stored and administered appropriately, and all patients involved were normal healthy children. This is one of several reports received from the same source. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning three patients who on an unspecified date, were vaccinated with a dose of VARIVAX (Merck) (Lot number not reported).  The patients developed an injection site reaction.  Subsequently, the patient's recovered.  There was no product quality complaint.  (Also refer to WAES # 0808USA04427).  Follow-up information has been received from a Licensed Practical Nurse, concerning an 8 year old female patient who was vaccinated with a dose of VARIVAX (Merck) (Lot # 660402/0271X).  The patient experienced red and swollen upper arm from injection site and had blisters around the injection site.  Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning an adult male, without a reported history of chickenpox and who was VZV negative, who on an unknown date was vaccinated with a first dose of VARIVAX (Merck). On an unspecified date, 3 weeks post vaccination, the patient developed a rash. The rash was found to be positive for the vaccine strain VZV by PCR performed at the CDC. At the time of the report the patient's status was unknown. A product quality complaint was not involved. The reporting physician stated she believes there has been an increase in the frequency of calls to the local health department regarding second dose AEs, particularly rashes in patients who have received a second dose of VARIVAX (Merck). She indicated that other physicians in the region also felt they were seeing an increase in second dose rashes as compared to what they observed following the first dose. With respect to specific types of AEs, the physician stated she saw reports of generalized rashes, injection site reactions and cellulitis. She has spoken with the reporting healthcare providers and all doses of VARIVAX (Merck) were stored and administered appropriately, and all patients involved were normal healthy children. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 3 year old female with no known drug allergies and no pertinent medical history, who on 28-JUL-2008 was vaccinated with VARIVAX (Merck) (lot # 652873/0433F), 0.5 mL, subcutaneously. On approximately 10-AUG-2008 (3 days ago) after receiving her first and only dose, the patient experienced chickenpox. The patient had more than 50 lesions all over the body including in her throat inside of her mouth. Most of the lesions were either fluid filled or scabbed. The physician saw the patient. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaemia, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse for the pregnancy registry for VARIVAX (Merck) concerning a 15 year old female with no pertinent medical history and no allergies who was vaccinated with the first dose of VARIVAX (Merck) as a child. On 07-MAR-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 659355/1518U) 0.5 ml SC and then discovered that she was pregnant. There was no concomitant medication. The last menstrual period was 03-JAN-2008. The estimated due date is 09-OCT-2008. No adverse effects reported. The prenatal ultrasound showed no problems. The baby was breech at this time and a C-section was scheduled soon (dates not provided). The patient sought medical attention in the office visit. Follow-up information was received. On 13-AUG-2008 and 17-SEP-2008 ultrasounds were performed with no problems. Other medication use during pregnancy included FeSO4 325mg twice a day for anemia on 25-AUG-2008. The serum alpha fetoprotein test (MSAFP) was performed too late. The patient with a history of 0 pregnancies 0 and 0 pre-term births on 24-OCT-2008 delivered a male baby weighing 7 pounds 11 ounces at 41 weeks. There was no complication during pregnancy and labor/delivery. There was no feature of congenital varicella zoster syndrome. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with a dose of VARIVAX (Merck). Subsequently the patient experienced shingles. Unspecified medical attention was sought. No further information is available.
Age: 11.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Erythema, Injection site nodule, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse and a consumer concerning an 11 year old female who on 13-Aug-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot# 660079/0331X), in the right upper arm. On the same day, the patient received the first dose of (ADACEL lot# 02995AA), subcutaneous route, in the right deltoid and The patient was vaccinated with a second dose of MMR II, lot# 658931/0239X, subcutaneous route in the right upper arm. On 14-Aug-2008, the patient experienced redness, itching and swelling on back of her R arm and a large bump the size of a quarter at the injection site. The patient may have also experienced fever and / or pain and burning while getting injected with the vaccine. At the time of reporting , the patient sought medical attention by calling the office. This is one of several reports provided by the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a patient who on 04-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 661443/0528X) subcutaneous into his leg, 0.5 mL. The patient experienced a rash after vaccination. This is one of two reports from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 11-12 year old female who was vaccinated with VARIVAX (Merck) (lot no., route and site of administration were not reported) 6-8 months ago.  At the same time the patient was vaccinated with GARDASIL (lot no., route and site of administration were not reported).  The vaccinations were given in the same arm.  The day after the patient received the vaccinations, the patient developed redness and swelling at the injection site.  It was reported that these events had an onset date of 6-8 months ago (approximately October 2007).  All symptoms resolved in a few days.  The patient sought unspecified medical attention.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck) 0.5 ml SQ. The patient experienced a severe localized reaction (not further specified). Subsequently, the patient recovered from the localized reaction. The patient sought unspecified medical attention. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a nurse concerning an 11-12 year old female who was vaccinated with VARIVAX (Merck) (lot no., route and site of administration were not reported) 6-8 months ago. At the same time the patient was vaccinated with HPV (lot no., route and site of administration were not reported). The vaccinations were given in the same arm. The day after the patient received the vaccinations, the patient developed redness and swelling at the injection site. It was reported that these events had an onset date of 6-8 months ago (approximately October 2007). All symptoms resolved in a few days. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse cornering an 11-12 year old female who was vaccinated with VARIVAX (Merck) (lot no., route and site of administration were not reported) 6-8 months ago.  At the same time the patient was vaccinated with GARDASIL (lot no., route and site of administration were not reported).  The vaccinations were given in the same arm.  The day after the patient received the vaccinations, the patient developed redness and swelling at the injection site.  It was reported that these events had an onset date of 6-8 months ago (approximately October 2007).  All symptoms resolved in a few days.  The patient sought unspecified medical attention.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a nurse concerning an 11-12 year old female who was vaccinated with VARIVAX (Merck) (lot no., route and site of administration were not reported) 6-8 months ago. At the same time the patient was vaccinated with HPV (lot no., route and site of administration were not reported. The vaccinations were given in the same arm. The day after the patient received the vaccinations, the patient developed redness, swelling and welt 3 inches diameter at the injection site. It was reported that these events had an onset date of 6-8 months ago (approximately October 2007). All symptoms resolved in a few days. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on an unspecified date was vaccinated with a second dose of VARIVAX (Merck). There was no concomitant medication. "Soon after the second vaccination", the patient developed an injection site reaction which was described as a warm, swollen injection site arm and vesicles around the injection site (time frame not reported). The patient returned to the physician for treatment of reaction. The physician used symptomatic treatment. At the time of the report, it was unknown if the patient had recovered from the events. Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician's assistant (P.A.) concerning a approximately 23 month old white male with no other medical history and no drug allergies who in February 2008, was vaccinated with the first dose of VARIVAX (Merck).  There was no concomitant medication.  There was no illness at the time of vaccination.  Five weeks after vaccination in March 2008, the patient experienced VARICELLA rash.  The VARICELLA rash persisted through June 2008, when the lesions gradually resolved.  Never any fever or illness.  No product quality complaint was involved.  Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with the first dose of VARIVAX (Merck).  Subsequently the patient experienced chickenpox.  No product quality complaint was involved.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash papular
Clinical narrative: Information has been received from a health professional concerning a 12 year old male with a history of rash for 2 days who on 19-SEP-2003 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot # 644974/0196N). On 21-JUN-2008 on exam the patient had scattered red papules on an erythematous flare over anterior neck, chest, abdomen and few on back and posterior thighs, over 80 lesions. The patient was treated with BENADRYL, every 6 hours, PRN, and AVEENO ANTI ITCH. The patient did not recover. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who was vaccinated with the first dose of VARIVAX (Merck). Subsequently the patient experienced chickenpox. On an unspecified date, the patient recovered from chickenpox. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient, his child, who was vaccinated with a dose of VARIVAX (Merck) (lot no., route and site of administration were not reported). Subsequently the patient developed a slight case of chicken pox. The outcome was not reported. The patient sought unspecified medical attention. 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 physician concerning a 10 year old male, weight 107.8lb height 52.5 inches, who on 03-AUG-2005 was vaccinated with the second dose of VARIVAX (Merck) subcutaneously in the right arm. There was no concomitant medication. On 27-AUG-2007 the patient developed varicella infection. Subsequently, the patient recovered from varicella infection. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site urticaria, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 year old male with no pertinent medical history and drug reactions/allergies who on 25-FEB-1999 was vaccinated with a first dose of VARIVAX (Merck) 0.5ml subcutaneous in his left arm. On 04-JUN-2008 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 657106/1891U) 0.5ml subcutaneous in his left arm. There was no concomitant medication. There was no illness at time of vaccination. Immediately post vaccination on 04-JUN-2008 the patient developed hives around the injection site and itching at injection site. The symptoms lasted a few hours. The patient was monitored and recovered, no treatment. The patient sought medical attention in office. Nurse was requesting lot 1891U check to see if there have been other reports of this happening with this same lot number. This is one of several reports from the same source. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Headache, Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
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.