chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 3 year old male patient with no pertinent medical history and no drugs reactions or allegies who on 28-MAR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot #658525/1255U; expiration date: 07-AUG-2009). There was no concomitant medication. The nurse reported that on 17-SEP-2010 the patient developed possibly shingles on his leg down to his foot and on the right side of his back. "The lesions were in small clusters but the patient had no pain or itchy". No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering from possibly shingles. The patient sought unspecified medical attention. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pustular, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an approximately 4 year old male patient (now 6 years old) who in approximately August 2005, at the age of 15 months old, was vaccinated with the first dose of VARIVAX (Merck) (lot number 651043/0215R). In approximately May 2008, at the age of 4 year old, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 658935/1349U). After receiving VARIVAX (Merck), the patient presented with pustules on his arms, legs, and trunk. Patient was seen by the physician for this symptom on 13-SEP-2010 and at this time the pustules had started to crust over. At the time of report the patient's status was unknown. Follow-up information has been received from the physician concerning the patient, a 4 year old male child (now 6 years old, last year height around 46 inches). The physician reported that the patient was "well child" when "given at 4 and half years" with the second dose of VARIVAX (Merck) (lot number 658935/1349U), subcutaneously in the right thigh on 14-AUG-2008 (previously reported as approximately May 2008). On 10-SEP-2010 the patient was seen in ER with pustules on his arms, legs, and trunk. Diagnosis was chicken pox. No lab test was performed. The patient was put on CEFZIL. On 13-SEP-2010, the patient was seen in office. Physician confirmed diagnosis. There were many crusted lesions on arms and thighs. No new ones and no signs of infection. The patient was still on CEFZIL. He was out of school for 7 days. The patient recovered from the event within 2 weeks. No further information is available.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 11 year old patient who on an unspecified date was vaccinated with at least one dose of VARIVAX (Merck) (Lot # and route no reported). The nurse reported that the patient on an unspecified date came down with chickenpox. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning an 8 year old patient who on an unspecified date was vaccinated with at least one dose of VARIVAX (Merck) (Lot # and route no reported). The nurse reported that the patient on an unspecified date came down with chickenpox. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 24 month old patient who on an unspecified date was vaccinated with at least one dose of VARIVAX (Merck) (Lot # and route no reported). The nurse reported that the patient on an unspecified date came down with chickenpox. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Rash
Clinical narrative: Information has been received from a physician concerning a 6 year old male who "at 15 months old" (in approximately August 2005), was vaccinated with the first dose of VARIVAX (Merck) (LOT# 647960/0070R) and the second dose (LOT# 658935/1349U) "at age 4" (in approximately May 2008). On approximately 20-SEP-2010 the patient experienced scattered rash on his trunk and extremities. The physician stated that the patient developed a scattered rash on his trunk and extremities after receiving VARIVAX (Merck). On 20-SEP-2010, patient was seen by the physician for the symptom. No specific dates were provided for administration of the doses. No further AE information provided. Follow up information was received from a nurse who reported that the 6 year old male student on 22-MAY-2008 was vaccinated subcutaneously into the right thigh with a second dose of VARIVAX (Merck) (LOT# 658935/1349U). There was no illness at the time of the vaccination. On 20-SEP-2010 the school nurse called the patient's guardian to come to get the patient at school. The patient was broke out in a rash and not feeling well at 14:15. The patient was brought straight to the physician's office. No relevant laboratory data was reported. The patient didn't go to school for 1 week. On an unspecified date, the patient recovered. No further information is available.
Age: 7.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pharyngitis streptococcal, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a currently 7 year old male patient who on 25-FEB-2004 was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). On 17-SEP-2010 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# not reported) and a dose of MMR vaccine. Other concomitant therapy included DTaP and poliovirus vaccine. Subsequently the patient developed severe chickenpox. He also developed "strep" throat along with chickenpox lesions all over his scalp. The patient has no fever and was prescribed with AUGMENTIN and BACTROBAN. There were no diagnostic laboratory studies performed. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pruritic, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 10 year old female patient who on 31-AUG-2010 was vaccinated with her second dose of VARIVAX (Merck) (Lot number 667293/0640Z). Concomitant medication included "allergy shots". The nurse reported that on 18-SEP-2010 the patient developed an itchy rash all over her body. At the time of report, the patient had not recovered from itchy rash all over her body. The patient sought medical attention by an office visit. Follow up information has been received from the registered nurse who stated that the female patient with not illness at the time of vaccination on 31-AUG-2010 in the afternoon received subcutaneously into the right arm the second dose of VARIVAX (Merck). The nurse reported that on 21-SEP-2010 the child had full varicella outbreak with multiple pox spread thought her body. On an unspecified date, the patient had recovered. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pharyngitis streptococcal, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old male patient who on 13-OCT-2005 was vaccinated with the first dose of VARIVAX (Merck). On 12-AUG-2010 the patient was vaccinated with the second dose of VARIVAX (Merck). Secondary suspect therapy included: MMR. In approximately September 2010 after receiving two doses of VARIVAX (Merck), the patient developed severe chickenpox. He also developed "strep" throat along with chickenpox lesions all over his scalp. The patient had no fever. The patient sought unspecified medical attention. There was no lab diagnostic test performed. The patient was prescribed with AUGMENTIN and BACTROBAN. At the time of report the patient's status was recovering. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: HEPA, HIBV, VARCEL
Symptoms: Cellulitis, Rash generalised, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a medical assistant concerning a 27 month old female patient with no pertinent medical history or drug reactions/allergies who on 18-SEP-2009 was vaccinated with a dose of VARIVAX (Merck) (lot number 665110/1014Y). There was no concomitant therapy. On 17-SEP-2010, 4 days ago, the patient developed a papular, vesicular rash. The rash was all over her body but worse on her legs. The patient sought medical attention by seeing in office. There was no lab diagnostic test performed. The patient was treated with TYLENOL and BENADRYL. At the time of report the patient's status was not recovered. Follow-up information has been received from the medical assistant concerning the female patient (birth weight 8 lb and 4 ounce, no siblings) with no medical history, birth defects or allergies, and no illness at the time of report who on 18-SEP-2009 was vaccinated SQ with the first dose of VARIVAX (Merck) (lot # 665110/1014Y) into the right arm. Secondary suspect therapy included VAQTA (MSD) (lot # 663914/0267Y) IM into the left arm on 18-SEP-2009. Other concomitant therapy included ACTHIB. On 19-SEP-2010 (also reported as 20-SEP-2010), the patient developed rash papular vesicular lesions (worse on her legs) which scattered all over. The patient also developed cellulitis in her left forearm. The medical assistant also reported that on 20-OCT-2010 the patient developed scattered vesicles from legs to the arms and cellulitis on arm. The patient was given KEFLEX. The patient was seen by a dermatologist. On an unspecified date in 2010, the patient recovered. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning an approximately 16 year old female patient who on an unspecified date in the past was vaccinated with a dose of VARIVAX (Merck) (Lot# 658936/1350U). It was reported that the patient was recently found to have negative varicella antibody titers. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Exposure to vaccinated person, Rash
Clinical narrative: Information has been received from a certificated medical assistant concerning a male patient whose 12 year old male brother on 28-JUN-2010 at 11:30 am was vaccinated with the second dose of VARIVAX (Merck) (lot # 665575/1229Y, in the left deltoid) IM. His brother's concomitant therapy included the first dose of MENACTRA (unspecified, sanofi, lot # U3465AA, IM) in the right deltoid and the sixth dose of BOOSTRIX (lot # AC52B061EA, IM) in the left deltoid on 28-JUN-2010 at 11:30 am. On 26-JUN-2010 the patient had rash. He and his brother were both in hot tub during the previous week. The outcome was not reported. Additional information is not expected. The patient's brother's information has been captured in WAES # 1006USA04371.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a Registered Pharmacist concerning her daughter who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) (Lot number not reported). In 2001 the patient experienced a break through varicella. It was unknown if the patient sought medical attention. At the time of the report the patient's status was unknown. Follow-up information has been received from a registered pharmacist concerning his approximately 36 months female patient who in 1999 was vaccinated with a dose of VARIVAX (Merck) (Lot # not provided). The pharmacist reported that her daughter, 1-2 years later, got mild case of chicken pox back in 2001. The patient recovered on an unspecified date. The patient did not seek medical attention. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with the first and second doses of VARIVAX (Merck) (Lot # and routed no reported). On an unspecified date, a serum antibody test was performed which showed that the patient had not developed any antibodies. The physician reported that the patient was given a third dose of VARIVAX (Merck) (Lot # and route no reported). The patient did no experience a negative event. At the time of the report, the outcome of the patient was unknown. No further information is available.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 8 year old male patient with no known drug allergies or pertinent medical history who on 10-OCT-2002 (at the age of one) was vaccinated with the first dose of VARIVAX (Merck) (lot number not provided). There was no concomitant medication. The physician reported that on 10-JUL-2010 the patient developed shingles prior to receiving his second VARIVAX (Merck) vaccination. The child was treated with acyclovir and recovered on an unspecified date. The patient was seen by the physician. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: CSF test abnormal, Cardiac murmur, Rash erythematous, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning two patients who were vaccinated with a 0.5 mL dose of VARIVAX (Merck) (lot number 664717/0807Y). The nurse stated that the patients had a reported case of chickenpox. The patients did not seek medical attention. Follow up information received from the registered nurse via medical records indicated that the patient was a 12 months old female, with no illness at the time of vaccination and not known allergies, who on 03-MAR-2010 was vaccinated with a first dose of VARIVAX (Merck) (lot number 664717/0807Y), subcutaneously in her right thigh. Concomitant therapy included first doses of hepatitis A virus vaccine inactivated (manufacturer unknown) and MMR II (manufacturer unknown). The patient's past vaccination therapy included first doses of hepatitis B virus vaccine (unspecified) (manufacturer unknown), DTaP and Hib conj vaccine (unspecified carrier) on 04-MAY-2009. The patient received the second doses of hepatitis B virus vaccine (unspecified) (manufacturer unknown), DTaP and Hib conj vaccine (unspecified carrier) on 28-JUL-2009. A third dose of Hib conj vaccine (unspecified carrier) was given on 27-OCT-2009 along with the first doses of PREVNAR, ROTATEQ and PEDIARIX. A fourth dose of Hib conj vaccine (unspecified carrier) was given on 21-JUN-2010, on the same date the patient received the third dose of DTaP and the second dose of PREVNAR. On 01-SEP-2010 the patient had a visit to the physician's office where she was diagnosed with varicella zoster; (VZV AB IGG test performed on the same date was positive for VZV IgG antibody (3.65)), the patient had multiple vesicular erythematous reddish lesions, especially in her face, scalp and neck. The patient's physical examination was normal, the patient was alert. The patient's plan was treatment with acyclovir w5 ml, PO, QID v5d, CALADRYL lotion OTC topically and hydrocortisone cream. The reporter stated that the rash started in the left side of the face and was spreading; it started over the weekend. It was also reported that the patient had nasal drainage and congestion, was irritable and warm. At the 15-SEP-2010 visit the vesicular lesions were resolved, only reddish papules noted. It was reported that the patient was doing much better. During the cardiovascular examination the patient was noted to have a heart murmur (S1 S2 harsh). The rest of the physical examination was normal, the patient was alert. At the patient's 18 month visit on 23-SEP-2010, the varicella symptoms were resolving. For the heart murmur a follow up ped cardio was recommended. Flu vaccination was scheduled in one month. At the 26-OCT-2010 visit the varicella was completely resolved, the patient was doing fine, eating and drinking well, physical examination was normal. The patient had the second doses of influenza virus vaccine (unspecified) and hepatitis A virus vaccine inactivated (manufacturer unknown). The heart murmur outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella virus test positive
Clinical narrative: Information has been received from a registered nurse concerning two patients who were vaccinated with a 0.5 mL dose of VARIVAX (Merck) (lot number 664717/0807Y). The nurse stated that the patients had a reported case of chickenpox. The patients did not seek medical attention. Follow up information received from the registered nurse via medical records indicated that the patient was a 12 months old female, with no illness at the time of vaccination and not known allergies, who on 03-MAR-2010 was vaccinated with a first dose of VARIVAX (Merck) (lot number 664717/0807Y), subcutaneously in her right thigh. Concomitant therapy included first doses of hepatitis A virus vaccine inactivated (manufacturer unknown) and MMR II (manufacturer unknown). The patient's past vaccination therapy included first doses of hepatitis B virus vaccine (unspecified) (manufacturer unknown), DTaP and Hib conj vaccine (unspecified carrier) on 04-MAY-2009. The patient received the second doses of hepatitis B virus vaccine (unspecified) (manufacturer unknown), DTaP and Hib conj vaccine (unspecified carrier) on 28-JUL-2009. A third dose of Hib conj vaccine (unspecified carrier) was given on 27-OCT-2009 along with the first doses of PREVNAR, ROTATEQ and PEDIARIX. A fourth dose of Hib conj vaccine (unspecified carrier) was given on 21-JUN-2010, on the same date the patient received the third dose of DTaP and the second dose of PREVNAR. On 01-SEP-2010 the patient had a visit to the physician's office where she was diagnosed with varicella zoster; (VZV AB IGG test performed on the same date was positive for VZV IgG antibody (3.65)), the patient had multiple vesicular erythematous reddish lesions, especially in her face, scalp and neck. The patient's physical examination was normal, the patient was alert. The patient's plan was treatment with acyclovir w5 ml, PO, QID v5d, CALADRYL lotion OTC topically and hydrocortisone cream. The reporter stated that the rash started in the left side of the face and was spreading; it started over the weekend. It was also reported that the patient had nasal drainage and congestion, was irritable and warm. At the 15-SEP-2010 visit the vesicular lesions were resolved, only reddish papules noted. It was reported that the patient was doing much better. During the cardiovascular examination the patient was noted to have a heart murmur (S1 S2 harsh). The rest of the physical examination was normal, the patient was alert. At the patient's 18 month visit on 23-SEP-2010, the varicella symptoms were resolving. For the heart murmur a follow up ped cardio was recommended. Flu vaccination was scheduled in one month. At the 26-OCT-2010 visit the varicella was completely resolved, the patient was doing fine, eating and drinking well, physical examination was normal. The patient had the second doses of influenza virus vaccine (unspecified) and hepatitis A virus vaccine inactivated (manufacturer unknown). The heart murmur outcome was unknown. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Adverse event, Blood culture negative, Hallucination, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 45 month old female with no pertinent medical history and no drug reactions/allergies who on 15-SEP-2010 was vaccinated with the first 0.5 mL dose of VARIVAX (Merck). There was no concomitant medication. On 16-SEP-2010, 24 hours after receiving VARIVAX (Merck), the patient experienced fever of 104.9 and had an onset of hallucination with the fever. The nurse practitioner reported that the patient came to the office and received a blood culture that came back negative. The nurse practitioner reported that the patient had had on therapy and recovered. Follow up information has been received concerning the patient with no brothers or sisters who was vaccinated the first dose of VARIVAX (Merck) via intramuscularly route at left thigh. There was no concomitant therapy. Within 24 hours the patient had fever onset post shot, 104.9 degree C, and episode of hallucination, complain of ST. The patient was no illness at time of vaccination. On an unspecified date, the patient recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Crohn's disease, Varicella virus test negative
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 11 year old female patient with irritable bowel syndrome and no drug reactions or allergies who on 06-MAY-2004, was vaccinated with the first dose of VARIVAX (Merck) (Lot# not reported, expire date 27-OCT-2010)). On 31-AUG-2010, the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot# not reported). On an unspecified date, the patient was diagnosed with Crohn's disease after receiving VARIVAX (Merck). There was not concomitant medication. It was also reported that the patient's varicella titer was found to be negative. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. On follow up information received on 22-NOV-2010, the medical assistant reported that the patient's Crohn's Disease was unrelated to the dose of VARIVAX (Merck). Follow up information has been received from the medical assistant concerning the female patient who on 06-MAY-2004, was vaccinated with the first dose of VARIVAX (Merck) (Lot# 647259/1137N). On 31-AUG-2010, the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot# 662450/1385X). It was reported that there was no adverse reaction. The GI doctor wanted to know if having Crohn's disease was going to effect the VARIVAX (Merck) from working. Patient had Crohn's had nothing to do with VARIVAX (Merck). GI doctor did not feel Crohn's was from the VARIVAX (Merck). No further information is available.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an approximately 4 year old female patient with a history of previous immunization with a dose of PROQUAD (Merck upgrade process) (some time in 2006) at the age of one who in February 2010, was vaccinated with a 0.5 mL dose of VARIVAX (Merck) (lot # not reported). About six months after received VARIVAX (Merck), in approximately August 2010, the patient developed chickenpox. The patient was treated with VALTREX. At the time of the report, the physician reported that the patient still had some visible lesions but she was recovering. The patient sought unspecified medical attention. Additional information has been requested. This is one of two reports received from the same source.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning 9 year old male with no pertinent medical history who on 08-OCT-2002 was vaccinated with the first dose of VARIVAX (Merck). On 28-SEP-2010, the patient received another dose of VARIVAX (Merck). The patient may had received a dose of VARIVAX (Merck) on 03-AUG-2010. There was incomplete documentation and the office and parents were not sure. After the dose of 28-SEP-2010 the patient developed redness and soreness at the injection site. There was no lab diagnostics studies performed. The patient had sought medical attention by calling the healthcare professional. The Medical assistant said that patient often develop a mild injection site reaction after the second dose of VARIVAX (Merck). At this time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 year old male who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) injection. Concomitant therapy included acyclovir. Then the patient obtained the chickenpox shortly after. The patient sought unspecified medical attention. At the time of report, the patient's outcome was unknown. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a patient who on 01-OCT-2010, was vaccinated with VARIVAX (Merck) (Lot # not reported) instead of MMR II. No adverse effects were known. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an approximately 14 or 15 year old female patient who approximately three weeks ago, on approximately 13-SEP-2010 was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included GARDASIL (MSD) and MENACTRA. Within hours of immunization, the patient had a bad reaction of cellulitis at the site of injection probably around 8 cm with pain, swelling, tenderness, warmth and redness around the injection site. The patient was treated with BENADRYL, however her symptoms did not go away. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male patient with a history of previous immunization with a dose of PROQUAD (Merck upgrade process) (in 2007) who sometime in 2010, was vaccinated with a dose of VARIVAX (Merck) (lot # not reported). The physician reported that after received VARIVAX (Merck), in September 2010, the patient developed chickenpox. At the time of the report, the patient was still recovering. Additional information has been requested. This is one of two reports received from the same source.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who on unspecified dates was vaccinated with two doses of VARIVAX (Merck) (Lot # not reported). The physician reported that he examined the patient on 29-SEP-2010 and diagnosed chickenpox. The patient had been exposed to a grandfather with shingles. The patient's outcome was not reported. Follow-up information was received from a medical assistant who stated that they did not know who the patient was. No further information is available.
Age: 50.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning an approximately 50 year old "about 50" male patient with a history of depression and no drug reactions or allergies who on 14-SEP-2010, was vaccinated SQ with a dose of VARIVAX (Merck) (Lot# not reported). On 30-SEP-2010, the patient began to have fever, malaise and then a rash on the chest, upper arms, and back. Lab diagnostics studies were not performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information was received on 14-OCT-2010, from a physician who stated that at that time the patient was extremely itchy and the patient would need medical attention. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Herpes zoster, Laboratory test, Secondary transmission, Varicella
Clinical narrative: Information has been received from a 51 year old female consumer with (BACTRIM DS reported as BACTRUM DS) allergy, bronchitis and heavy smoker who on 01-OCT-2010 came-down with shingles because of her daughter's vaccination in 21-SEP-2010 with a 0.5 ml (also reported as 0.5 mg) dose of VARIVAX (Merck) (Lot# unknown), IM. There was no concomitant medication. The patient reported that on 01-OCT-2010, she developed chickenpox. The patient said "is had bronchitis and is a heavy smoker, which is believes is why she developed shingles". On an unspecified date, annual check-ups tests and blood work test were performed (results not provided). At the time of the report, the patient had not recovered. No further information is available.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse (R.N) concerning an approximately 36 months old (reported as "at 3 age") patient who on an unspecified date received unknown varicella vaccination at age one. The patient developed mild chickenpox at age 3. The caller was unsure if the first vaccination was with VARIVAX (Merck) brand or another. At the time of reporting, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a 25 year old female patient with no known drug allergies and hyperthyroidism who was vaccinated SC with a first 0.5ml dose of VARIVAX (Merck) on 22-MAR-2002 and a second 0.5ml dose on 7-JUN-2002 (lot # 639778/0981L). Concomitant therapy included thyroid medication. On 08-AUG-2009, laboratory test revealed that varicella titer level was 1.07. The patient did not have protective titer levels after vaccination. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a physician concerning her adult niece who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot# not reported). It was reported that a few years ago, but at some time after the immunization she had a negative varicella titer. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning a 13 year old female patient who on 05-OCT-2010 was vaccinated SQ with a 0.5 ml dose of VARIVAX (Merck) (Lot# 667240/0675Z) (Expiration date: 05-MAY-2012). The nurse reported that on 05-OCT-2010, the patient experienced localized injection site reaction of redness and pain of the left arm. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Follow up information was received from a Medical Assistant (M.A) who provided patient's information. It was reported that on 05-OCT-2010, the patient was administered the second dose of VARIVAX (Merck) (Lot# 667240/0675Z) and concomitantly received the first dose of VAQTA (Lot # 668912/1087Z). The patient did not receive the FLUZONE because it was not available at that time. The patient was not hospitalized. It was reported that the patient had recovered from injection site erythema and pain in extremity. Follow up information was received indicating that on 05-OCT-2010, the male patient was administered at 18: 15 subcutaneously into the left arm the second dose of VARIVAX (Merck) and concomitantly received intramuscularly into the left arm the first dose of VAQTA. It was reported that on 06-OCT-2010 (previously reported as 05-OCT-2010) the patient experienced a 5/3 cm redness and mild swelling with moderate pain at the site of the vaccine. The patient was treated with KEFLIN. The patient's sibling experienced an Adverse Event with VARIVAX (Merck) (WAES# 1010USA00826). Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Herpes zoster, Rash, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male patient with drug reactions or allergies to OMNICEF, amoxicillin and BACTRIM and no pertinent medical history who on 24-MAR-2010 was vaccinated subcutaneously into the left deltoid with a dose of VARIVAX (Merck) (Lot # 665644/1205Y, expiration date: 21-AUG-2011). There was no concomitant medication. The nurse reported that on 22-SEP-2010, the patient developed a rash, "shingles" on his forehead. Child was seen by physician and he prescribed him acyclovir and fluids. Rash resolved on an unknown date. Follow up information has been received from a physician concerning the male patient with no illness at time of vaccination. It was reported that on 24-MAR-2010 at 13:23, the patient also received a second dose of MMR II (Lot# 662560/1252X) in the left upper deltoid. On 22-SEP-2010, the patient experienced rash-red erythematous area 3 to 4 cm with broken open vesicles. At the time of the report, the patient had recovered. The patient sought medical attention by a doctor visit. No further information is available.
Age: 1.01
Sex: F
Vaccine: HEP, HIBV, VARCEL
Symptoms: Herpes zoster, Injection site rash, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 22 months old female patient with no pertinent medical history and no drugs reactions or allergies who on 17-NOV-2009 was vaccinated subcutaneously in left arm with a dose of VARIVAX (Merck) (Lot number 665191/1047Y). Concomitant therapy included ENGERIX-B, IM in right arm; and ACTHIB. The nurse reported that on 11-OCT-2010 the patient had an outbreak of chickenpox on the left arm and back. No laboratory diagnostics studies were performed. The patient sought medical attention. She was given acyclovir 200mg/5mL (1/2 teaspoonful 4 times daily for 5 days) and ZORIVAX OINTMENT (3 times daily for 5 to 7 days). At the time of report, the patient had not recovered from chickenpox on the left arm and back. Follow up information has been received from a registered nurse concerning a 22 months old female patient with no pre-existing allergies, birth defects or medical conditions and no illness at time of vaccination who on 17-NOV-2009 received a first dose of VARIVAX (Merck) (Lot number 665191/1047Y), SC in the left arm. Concomitant therapy included a fourth dose of ACTHIB (Lot # UF707AB), IM in the left thigh, and a third dose of ENGERIX-B (Lot # AHBVB708BA), IM in the right thigh (The registered nurse reported that the vaccines were given at p.m). It was reported that on 11-OCT-2010 the patient developed a rash on left arm and left side of back. It was diagnosed as shingles. At the time of the report, the outcome of the patient was not reported. Follow up information has been received from the registered nurse who reported that on an unspecified date, the patient had recovered from shingles. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a female consumer who on 10-OCT-2010 was vaccinated intramuscularly with a booster of VARIVAX (Merck) (Lot# unknown). The patient stated that on 11-OCT-2010, she had a red spot where she got the shot. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. No further information is available.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Pallor, Rash maculo-papular, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 12 months old female with diarrhoea and with no adverse events following prior vaccination who on 24-SEP-2010 was vaccinated SC in right thigh with the first dose of VARIVAX (Merck) (lot# 662575/0045Y). On the same day, the patient concomitantly was vaccinated with the first dose of MMR II (MSD) (lot#665976/0155Z, SC in left thigh), the first dose of VAQTA (lot# 667859/0569Z, IM in left thigh) (MSD) and the first dose of FLUZONE (lot# UT3562BA, IM in right thigh). On 02-OCT-2010, the patient experienced rash status post vaccines within 11 days on chest, back and legs, blanching 3 mm red macules and papules, not vesicular. There were approximately 50 lesions. The outcome of the patient was not reported. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: No therapeutic response, Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse concerning a currently 29 year old male patient with asthma and no known reactions or allergies who on 26-SEP-2008, was vaccinated with the first dose of VARIVAX (Merck) and on an unspecified date was vaccinated with the second dose of VARIVAX (Merck). It was reported that the patient had failed to seroconvert post vaccination. The patient did not seek medical attention. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a male patient who on 23-SEP-2010 went to physician's office to receive an injection of ZOSTAVAX (Merck), and was given VARIVAX (Merck) instead. There were no adverse reactions to the injection of VARIVAX (Merck). It was unspecified if the patient sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available. This is one of several reports received from the same source.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, No therapeutic response, Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse (R.N.), for VARIVAX (Merck), a Pregnancy Registry product, concerning a female patient in her late 30's who in October 2005 "five years ago", was vaccinated with her first dose of VARIVAX (Merck) (lot number unknown) and then was given her a booster dose on approximately November 2005 "approximately one month later". The nurse stated that a recent titer was drawn because the patient was pregnant, and the patient's titer showed she failed to seroconvert. No adverse effects were reported. The patient sought unspecified medical attention. Last menstrual period and estimated delivery date were not reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 11-AUG-2010 was vaccinated with a 0.5ml dose of VARIVAX (Merck) (lot# 666694/1710Y). Mother of child reported that on 14-OCT-2010 the patient developed a rash on his upper body and had a fever. No medical attention was sought. The patient's rash on his upper body and a fever persisted. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an approximately 14 or 15 year old male patient who approximately three weeks ago, on approximately 13-SEP-2010 was vaccinated with a dose of VARIVAX (Merck) and with hours of immunization he had a bad reaction of cellulitis at the site of injection probably around 8 cm with pain, swelling, tenderness, warmth and redness around the injection site. The patient was treated with BENADRYL, however his symptoms did not go away. At the time of the report the patient had not recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female patient who on 23-SEP-2010 went to physician's office to receive an injection of ZOSTAVAX (Merck), and was given VARIVAX (Merck) instead. There were no adverse reactions to the injection of VARIVAX (Merck). It was unspecified if the patient sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available. This is one of several reports received from the same source.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician assistant concerning an approximately 12 months year old female who unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot#Unknown). The medical assistant stated that "the patient broke out in rash about five days after she was receiving dose of VARIVAX (Merck). At the time of the report the patient's outcome was recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of VARIVAX (Merck) (lot#unknown). Pharmacist reported that the patient was administered with a dose of VARIVAX (Merck) instead that a dose of ZOSTAVAX (Merck). No adverse effect was reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a nurse concerning a male patient between the age of 11-13 who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (Lot# unknown). It was reported that the patient also received a dose of influenza virus vaccine (unspecified) (Lot# unknown) (manufactured unknown). The nurse reported that the patient experienced a localized reaction after receiving the dose of VARIVAX (Merck). The nurse stated that the patient had called the physician to report the events. On 19-OCT-2010, the patient had recovered. The patient sought unspecified medical attention. The health care professional contacted during telephone follow up could not supply the following information: patient name, date of birth, dates of vaccination, lot number. This is one of several reports from the same source. No further information is available.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Excessive eye blinking
Clinical narrative: Information has been received from a nurse concerning a 10 year old male child who on 05-AUG-2010 was vaccinated with VARIVAX (Merck). Concomitant therapy included ZYRTEC. On 05-AUG-2010 the patient started having excessive, continued blinking and lasted for 5days, ending on 09-AUG-2010. The patient sought unspecified medical attention. Follow-up information has been received from the registered nurse indicating that the patient with no illness at the time of vaccination (sports physical routine) and allergic rhinitis and peanut allergy and allergy to walnuts, oak trees, timothy grass, june grass, cocklebur, cashew nut, maple trees, pecan trees, birch, white ash, orchard, red top, sweat vernal, alternaria, dust mite and a history of eczema and headache who on 05-AUG-2010 10:00 AM received the second dose of VARIVAX (Merck) (lot # 661554/0435Z). On "12-AUG-2010", the patient experienced blinking, thought to be tic. On 09-AUG-2010, the patient had recovered. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a first dose of VARIVAX (Merck) (Lot # and route not reported) and in October 2006, "four years ago", was vaccinated with a second dose of VARIVAX (Merck) (Lot # not reported). The nurse reported a low titer result with the patient who had administered two doses of VARIVAX (Merck) (Lot # not reported). Titer was performed in September 2010. The patient sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. Follow up information has been received from the register nurse who stated that there were not adverse events. No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 4 year old male patient, with no pertinent medical history and no drug reactions or allergies, who on 22-OCT-2010 was vaccinated with a dose of VARIVAX (Merck), (lot # 666917/0550Z, expire date not reported), 0.5 ml, subcutaneously. Concomitant therapy included PREVNAR. On 24-OCT-2010 the patient developed an injection site reaction. The patient received the VARIVAX on his thigh and it became red and swollen. The red and swollen area was about 37 cm in diameter. It was not tender. There were no laboratory diagnostics performed. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient "over 60 years of age", who on 27-OCT-2010 was vaccinated with VARIVAX (Merck) (Lot # unknown) instead of ZOSTAVAX (Merck). No adverse event was reported. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient who on an unspecified date might be vaccinated with a dose of VARIVAX (Merck) (lot # not reported) in place of a dose of ZOSTAVAX (Merck). No adverse effect was reported. It was unspecified if the patient sought medical attention. Follow-up information has been received from the pharmacist who reported that VARIVAX (Merck) might have been given instead of ZOSTAVAX (Merck) because their vials were similar in appearance. No one had reported any adverse event. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number. Additional information is not expected.