chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on 16-JUN-2009 was vaccinated with the second dose of VARIVAX (Merck) on her left arm, 0.5ml. Concomitant therapy included polio virus vaccine inactivated (unspecified) on the left arm. Other concomitant therapy included MMR II (MSD) and DTAP on the right arm. On 16-JUN-2009 the patient experienced blister at the injection site of the left arm. The first dose of VARIVAX (Merck) was unspecified. The patient sought medical attention. As of 18-JUN-2009, the patient had not recovered. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: Information had been received from a certified medical assistant concerning a 12 month old female with no pertinent medical history reported and no known drug allergies who on 14-MAY-2009 was vaccinated SQ with a 0.5mL dose of VARIVAX (Merck) (lot number 663941/0262Y). Concomitant therapy included MMR II (MSD) and HAVRIX (manufacturer unknown). The certified assistant reported that in May 2009, the patient developed chickenpox after receiving VARIVAX (Merck). The patient sought medical attention by making an office visit. Follow up information has been received from a certified medical assistant concerning a 12 month old female who on 14-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) subcutaneously in the left thigh, the first dose of MMR II (Lot: 660317/0481X) subcutaneously in the right thigh and the first dose of HAVRIX (Lot AHA0B31) intramuscularly in the right thigh. On 19-MAY-2009, in the afternoon, the patient developed rash consistent with mild varicella. On an unspecified date the patient recovered. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Swelling, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 10 year old patient who was vaccinated with the second dose of VARIVAX (Merck) (lot # 664662/0698Y).  The patient had injection site reactions after vaccinations.  Symptoms were described as welt-like swelling and "more than normal".  The patient was being treated with ice, BENADYLE and TYLENOL.  At the report time the outcome was unknown.  Follow-up information has been received from the nurse concerning a 10 year old male with no pre-existing physician-diagnosed allergies, birth defects nor medical conditions who on 13-JUL-2009 at 09:50, was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot# reported as 0295Y, previously reported as 664662/0698Y) in his right leg.  There was no concomitant therapy.  There was no illness at the time of vaccination.  On 14-JUL-2009 at 10:00, at the patient's injection site a mild erythema appeared as approximately 4cm circle.  No treatment needed.  At the time of the report, the patient had recovered.  No further information is available.  This is one of several reports received from the same source.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Measles antibody positive, Rash
Clinical narrative: Information has been received from a physician concerning a 13 month old male patient with no illness at the time of vaccination and no allergies, birth defects or medical conditions, who on 15-JUN-2009 was vaccinated subcutaneously with the first dose of MMR II (lot # 663164/1583X) at 12:00 pm. The same day was vaccinated with the first dose of VARIVAX (MSD) subcutaneously (lot # 663321/0049Y) and the first dose of HAVRIX intramuscularly. There was no other concomitant therapy. On 08-JUL-2009 at 10:00 am, the patient presented with complains of rash all over the body and was seen at emergency room. On 10-JUL-2009 Measles IgM and IgG titer were sent from emergency room "(+u)". On follow up at physician office, two days later, rash had subsided and due to suspected measles IgG and IgM titers were repeated and sent on 15-JUL-2009 which resulted on IgG positive titers. Additionally, rubella IgM and IgG titers were performed (results not reported). At the time of the report the patient had recovered. No further information is available.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Measles, Measles antibody positive, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 13 month old male patient with no illness at the time of vaccination and no allergies, birth defects or medical conditions, who on 15-JUN-2009 was vaccinated subcutaneously with the first dose of MMR II (lot # 663164/1583X) at 12:00 pm. The same day was vaccinated with the first dose of VARIVAX (MSD) subcutaneously (lot # 663321/0049Y) and the first dose of HAVRIX intramuscularly. There was no other concomitant therapy. On 08-JUL-2009 at 10:00 am, the patient presented with complains of rash all over the body and was seen at emergency room. On 10-JUL-2009 Measles IgM and IgG titer were sent from emergency room "(+u)". On follow up at physician office, two days later, rash had subsided and due to suspected measles IgG and IgM titers were repeated and sent on 15-JUL-2009 which resulted on IgG positive titers. Additionally, rubella IgM and IgG titers were performed (results not reported). At the time of the report the patient had recovered. No further information is available.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Measles antibody positive, Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient who on 15-JUN-2009 was vaccinated with the first dose of MMR II (lot # 663164/1583X). Secondary suspect therapy included VARIVAX which the patient received concomitantly with HAVRIX on 15-JUN-2009. On 08-JUL-2009 the patient with rash all over his body and a fever so the patient sent to the Emergency Room (ER). At the ER the patient had and IGM and IGA titer test done; results were not reported. On 10-JULY 2009 the patient was able to leave the hospital. Two days later, the patient had a follow-up at his physician's office and the rash was diminishing and his fever had subsided. The physician reported that patient was suspected to have measles but it was not possible to tell if it was diseased related or vaccine related. At the time of reporting the physician stated that the patient recovered. Follow up information has been received via telephone call from a medical assistant who reported that on 15-JUN-2009 concomitant to MMR II the patient received VARIVAX (lot # 663321/0049Y) and HAVRIX (lot # AHAVB247AA). On 08-JUL-2009 the patient was seen by the physician due to rash. At that time the patient's temperature was 98.8 degrees F. On 10-JUL-2009, the patient was taken to the hospital. The patient had IgG and IgM drawn on 10-JUL-2009. The result for the IgG was 2.11 (positive) and the result for IgM was 2.80 (positive). The patient was not admitted to the hospital. The patient was seen by the physician on 10-JUL-2009, for a rash. On 15-JUL-2009, the patient's IgG was 3.86 (positive). The physician stated that the laboratory results were non conclusive. The patient had positive antibodies. The patient could have concurrent exposure to measles or past exposure to measles or an immunization. The CDC was not calling this a measles case but felt that the rash was due to the vaccine. The physician stated that the rash did not look like measles rash . The patient had fully recovered. Follow up information has been received via medical record from the physician who reported on 15-JUL-2009 measles (rubeola) antibody, IgM: 1.59 AU (positive) and measles (rubeola) antibody. IgG: 3.86 (positive) were performed.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Measles, Measles antibody positive, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 12 month old male patient who on 15-JUN-2009 was vaccinated with the first dose of MMR II (lot # 663164/1583X). Secondary suspect therapy included VARIVAX which the patient received concomitantly with HAVRIX on 15-JUN-2009. On 08-JUL-2009 the patient with rash all over his body and a fever so the patient sent to the Emergency Room (ER). At the ER the patient had and IGM and IGA titer test done; results were not reported. On 10-JULY 2009 the patient was able to leave the hospital. Two days later, the patient had a follow-up at his physician's office and the rash was diminishing and his fever had subsided. The physician reported that patient was suspected to have measles but it was not possible to tell if it was diseased related or vaccine related. At the time of reporting the physician stated that the patient recovered. Follow up information has been received via telephone call from a medical assistant who reported that on 15-JUN-2009 concomitant to MMR II the patient received VARIVAX (lot # 663321/0049Y) and HAVRIX (lot # AHAVB247AA). On 08-JUL-2009 the patient was seen by the physician due to rash. At that time the patient's temperature was 98.8 degrees F. On 10-JUL-2009, the patient was taken to the hospital. The patient had IgG and IgM drawn on 10-JUL-2009. The result for the IgG was 2.11 (positive) and the result for IgM was 2.80 (positive). The patient was not admitted to the hospital. The patient was seen by the physician on 10-JUL-2009, for a rash. On 15-JUL-2009, the patient's IgG was 3.86 (positive). The physician stated that the laboratory results were non conclusive. The patient had positive antibodies. The patient could have concurrent exposure to measles or past exposure to measles or an immunization. The CDC was not calling this a measles case but felt that the rash was due to the vaccine. The physician stated that the rash did not look like measles rash . The patient had fully recovered. Follow up information has been received via medical record from the physician who reported on 15-JUL-2009 measles (rubeola) antibody, IgM: 1.59 AU (positive) and measles (rubeola) antibody. IgG: 3.86 (positive) were performed.
Age: 1.03
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: Information has been received from a nurse concerning a 12 month old patient who was vaccinated with the first dose of VARIVAX (Merck) (lot# 664662/0698Y). The patient had injection site reactions after vaccinations. Symptoms were described as welt-like swelling and "more than normal". The patient was being treated with ice, BENADRYL and TYLENOL. At the report time the outcome was unknown. Follow-up information has been received from the nurse concerning a 12 month old female with no medical history who on 06-JUL-2009 at 09:15, was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 664662/0698Y) in her left thigh. Concomitant therapy included VAQTA  (MSD) (lot# reported as 1718X) in her right leg and (CRM197) PREVNAR in right leg. There was no illness at the time of vaccination. On 06-JUL-2009 at 14:00 the injection site started to become red and became the size of a nickle. The site was red, no tenderness, slight warmth, no pus and did not appear infected upon examination. At the time of the report , the patient had recovered. No further information is available. This is one of several reports received from the same source.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 9 year old patient who was vaccinated with the second dose of VARIVAX (Merck) (lot number was reported as "0295Y). The patient had injection site reactions after vaccinations. Symptoms were described as welt-like swelling and "more than normal". The patient was being treated with ice, BENADRYL and TYLENOL. At the report time the outcome was unknown. Follow-up information has been received from the registered nurse concerning a 9 year old female with no pre-existing physician-diagnosed allergies, birth defects or medical conditions who on 21-JUL-2009 at 11:20, was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot # 664692/0694Y) in her right arm. Concomitant therapy included BENADRYL. There was no illness at the time of vaccination. On 21-JUL-2009 at 17:00, the patient's injection site became red, painful and hard. The patient came to the office for the physician to see and was prescribed an antibiotic (ABX) to start if not better in 24 hours. At the time of the report, the patient recovered on an unspecified date. No further information is available. This is one of several reports from the same source.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a nurse concerning a 9 year old patient who was vaccinated with the second dose of VARIVAX (Merck) (lot number was reported as "0295Y). The patient had injection site reactions after vaccinations. Symptoms were described as welt-like swelling and "more than normal". The patient was being treated with ice, BENADRYL and TYLENOL. At the report time the outcome was unknown. Follow-up information has been received from the registered nurse concerning a 9 year old female with no pre-existing physician-diagnosed allergies, birth defects or medical conditions who on 21-JUL-2009 at 11:20, was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (lot # 664692/0694Y) in her right arm. Concomitant therapy included BENADRYL. There was no illness at the time of vaccination. On 21-JUL-2009 at 17:00, the patient's injection site became red, painful and hard. The patient came to the office for the physician to see and was prescribed an antibiotic (ABX) to start if not better in 24 hours. At the time of the report, the patient recovered on an unspecified date. No further information is available. This is one of several reports from the same source.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Information has been received from a nurse concerning her daughter, a 10 year old female who received the first dose of VARIVAX (Merck) when she was 12 to 15 months old, in approximately 2000. The patient received her second dose of VARIVAX (Merck) on an unspecified date. Concomitant therapy included DTAP and HAVRIX. On 02-JUL-2009 the patient developed rashes that started on her trunk and they were not bumpy but under the skin. The rashes looked like measles and they spread to the patient's arms and legs but not on her palms or soles. The rashes were warm to touch and they itched. It was not verified if it was chickenpox related. At the report time the outcome was unknown. Follow up information was received from a nurse concerning her daughter, a 10 year old patient with seasonal allergies received the second dose of VARIVAX (Merck) (Lot# 662445/1328X) on her left arm on 02-JUL-2009. Concomitant therapy included DTAP (lot # C2997AA, site:  left arm) and HAVRIX (lot# AHAV319AA, site: left arm). On 07-JUL-2009 (previously reported as 02-JUL-2009) the patient had a rash across her upper back that within the next 2 days was covering her trunk. The rash went to her upper arms and legs. It went to her lower arms and legs (plus hands and feet). It itched at times. No other symptoms. On 03-JUL-2009 (previously reported as 02-JUL-2009) when chickenpox vaccine was given, it was red swollen and warm to touch for 1 week. At the report time the rash on her trunk was gone, but the patient still had rash. No further information is available.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth, Pallor
Clinical narrative: Information has been received from a nurse concerning a 15 year old patient with a history of hepatitis a who on 22-JUL-2009 was vaccinated with a second dose of VARIVAX (lot # 664692/0694Y) 0.5 ml.  Concomitant therapy include HEPATITIS A virus vaccine inactivated.  On 22-JUL-2009 after getting the vaccine the patient experienced blanching and cellulites.  On 24-JUL-2009 the patient was seen in the office.  On unspecified date the patient recovered.  Follow up information received on 21-AUG-2009 from a registered nurse indicated that the patient was a female student who on 22-JUL-2009 at 14:30 was vaccinated with the second dose of VARIVAX (Merck) (lot # 664692/0694Y), subcutaneously into the right arm.  On 24-JUL-2009 at 13:35, 48 hours after vaccination the patient developed a 2 X 2.5 inches firm, erythematous, warm area at injection site.  One or more of the events required an emergency room / doctor visit.  The patient recovered on an unspecified date.  This is one of three reports from the same source.  Follow up information has been received on 20-OCT-2009 via telephone call from a registered nurse who reported that the patient experienced cellulitis previously reported as cellulites.  No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 11 year old patient who was vaccinated with the second dose of VARIVAX (Merck) (lot# 664620/0797Y). The patient had injection site reactions after vaccinations. Symptoms were described as welt-like swelling and "more than normal". The patient was being treated with ice, BENADRYL and TYLENOL. At the report time the outcome was unknown. Follow-up information has been received from the registered nurse concerning an 11 year old male with no pre-existing allergies, birth defects or medical conditions who at 15:00 on 27-JUL-2009, was vaccinated with the second dose of VARIVAX (Merck) (SC, lot# 664620/0797Y) in his right arm. There was no illness at the time of vaccination. There was no concomitant medication. In the afternoon of 28-JUL-2009 the patient's mother called the office stating that where the patient received the injection was raised and about the size of a silver dollar at 08:00. The patient was told to apply ice and take BENADRYL as needed. There was no lab studies performed. At the time of the report, the patient recovered on an unspecified date. No further information is available. This is one of several reports received from the same source.
Age: 14.0
Sex: M
Vaccine: DTP, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 14 year old patient who was vaccinated with the second dose of VARIVAX (Merck) (lot# 664620/0797Y). The patient had injection site reactions after vaccinations. Symptoms were described as welt-like swelling and "more than normal". The patient was being treated with ice, BENADRYL and TYLENOL. At the report time the outcome was unknown. Follow-up information has been received from the nurse concerning a 14 year old male with Penicillin allergy who at 13:00 on 27-JUL-2009 was vaccinated with the second dose of VARIVAX (Merck) (SC, lot# 664620/0797Y) in his right leg. Concomitant vaccine therapy included the fifth dose of diphtheria toxoid (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (lot # UF484BA) (no trade name) intramuscularly in his right leg and the first dose of MENACTRA (lot # U2919) intramuscularly in his right leg. There was no illness at the time of vaccination. On 28-JUL-2009 at 08:00, the injection site became red and swollen to the size of approximately a half dollar. The patient was told to apply ice and take TYLENOL as needed for pain. At the time of the report, the patient had recovered. No further information is available. This is one of several reports received from the same source.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Arthralgia, Ataxia
Clinical narrative: Information has been received from a physician and a nurse concerning a 3 year old female patient who on 19-JUN 2009 was vaccinated with the first dose of MMR II (dose not reported, lot number: 663929/0511Y)in the right arm. Concomitant therapy included DTaP on 19-JUN-2009. On 26-JUL-2009, the patient was seen in the emergency room of a hospital (with complaints if knee pain) and was discharged that same day. The patient was diagnosed with sudden ataxia following MMR II by the pediatric infectious disease doctor and the doctor stated the knee pain was caused by MMR II. The outcome of the patient was recovered. Additional information has been received from a physician concerning a 37 month old female patient with reactive disease who on 19-JUN-2009 was vaccinated IM with a first dose of MMR II (lot number: 663929/0511Y) IM in the right arm. Concomitant vaccine included a fourth dose of INFANRIX (lot number: AC14B066AA) IM into the left arm on the same day. Subsequently on 22-JUL-2009 (also previously reported as 26-JUL-2009) the patient complained of knee pain for one week, then the patient went to Emergency Room and she was diagnosed with ataxia. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 13 year old patient who was vaccinated with the second dose of VARIVAX (Merck) (lot # 664692/0694Y).  The patient had injection site reactions after vaccinations.  Symptoms were described as welt-like swelling and "more than normal".  The patient was being treated with ice, BENADRYL and TYLENOL.  At the report time the outcome was unknown.  Follow-up information has been received from the registered nurse concerning a 13 year old (also reported as 14 year old) female patient who on 27-JUL-2009, was vaccinated with the second dose of VARIVAX (Merck) (SC, lot # 664620/0797Y) (lot # previously reported as 664692/0694Y) in her right thigh.  There were no other medications.  On 29-JUL-2009 the patient's mother called to report that on 28-JUL-2008, the injection site was red and raised to the size of a pong pong ball.  There were no lab studies performed.  The patient was treated with ice and BENADRYL.  At the time of the report, the patient recovered on an unspecified date.  No further information is available.  This is one of several reports received from the same source.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with AMOXIL and CEFZIL allergy and no illness at the time of vaccination who on 27-JUL-2009 at approximately 03:30 p.m. was vaccinated SC into the left arm with second dose of VARIVAX (Merck) (lot number reported as 663936/0508Y) valid for PNEUMOVAX. Concomitant therapy included multivitamins. In the evening of 29-JUL-2009, the patient experienced headache and was nauseated. On 30-JUL-2009, the patient continued with headache and complained "not feeling well". He had a 2 inch red swollen area at injection site with itching and vesicle the size of a pencil eraser at injection site. The patient was prescribed BENADRYL every 6 to 8 hours and TYLENOL every four to six hours. In a follow up call made on 31-JUL-2009, the patient was feeling much better. He had no headache, redness, swelling, blister and no scab. No lab studies were performed. The patient did not seek medical attention. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Nausea
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with AMOXIL and CEFZIL allergy and no illness at the time of vaccination who on 27-JUL-2009 at approximately 03:30 p.m. was vaccinated SC into the left arm with second dose of VARIVAX (Merck) (lot number reported as 663936/0508Y) valid for PNEUMOVAX. Concomitant therapy included multivitamins. In the evening of 29-JUL-2009, the patient experienced headache and was nauseated. On 30-JUL-2009, the patient continued with headache and complained "not feeling well". He had a 2 inch red swollen area at injection site with itching and vesicle the size of a pencil eraser at injection site. The patient was prescribed BENADRYL every 6 to 8 hours and TYLENOL every four to six hours. In a follow up call made on 31-JUL-2009, the patient was feeling much better. He had no headache, redness, swelling, blister and no scab. No lab studies were performed. The patient did not seek medical attention. No further information is available.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Beta globulin normal, Biopsy skin, Herpes zoster
Clinical narrative: Initial and follow up information has been received from a licensed visiting nurse concerning a 37 year old male who on 22-JUN-2009 was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX (Merck) (lot #, site of administration not reported) and other unnamed vaccines.  On 02-AUG-2009 (42 days later) the patient developed what may be shingles.  The physician was not sure if that was associated with VARIVAX (Merck).  On 12-AUG-2009 two swabs of the lesions were obtained and one sample was sent to a local laboratory.  They were awaiting the results.  It was reported that there was still one swab remaining in the refrigerator and they would sent the sample to Merck on 20-AUG-2009.  The event was improved when the patient was on therapy.  On an unspecified date, the patient recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild type (WT) VZV strain or with the Merck vaccine strain.  Follow up information has been received from the licensed visiting nurse concerning the 37 year old male with no past medical history nor allergies who on 22-JUN-2009 (also reported as 22-JUL-2009), at 1:30 P.M., was vaccinated subcutaneously with the first 0.5ml dose of VARIVAX (Merck) (lot #  663301/1776X) into the left arm.  Concomitant therapy included PAXIL, (reported as FAXIL).  The patient had no recent exposure to chickenpox or shingles.  It was reported that the patient had mild anxiety for about 10 years at the time of vaccination.  On 04-AUG-2009 the patient developed herpes zoster at the right lateral trunk area.  There were approximately 6 lesions by 12-AUG-2009.  The patient reported his pain to be a 7 or 8 on a scale of 1 to 10.  He had no fever or other systemic symptoms.  No rash occurred at the site of injection post-vaccination.  The patient did not have a direct fluorescent antibody done.  Photos had been taken.  On 07-AUG-2009 the patient was diagnosed with shingles.  On 12-AUG-2009 the patient recovered from herpes zoster.  On 12-AUG-2009, a dry lesion specimen was collected and on 20-AUG-2009 the specimen was sent to the laboratory.  PCR analysis of the specimen revealed it was inadequate (no beta-globin).  Additional information is not expected.
Age: 1.11
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 4 year old female patient with no reported drug reactions/allergies and with no pertinent medical history who on 04-AUG-2006 was vaccinated SQ with the first 0.5 ml dose of VARIVAX (Merck) (lot #650221/0431R) and on 10-AUG-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (dose not reported, lot number: 644719/0804Y). Concomitant therapy included MMR II, TWINRIX and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on 09-AUG-2009 (doses, routes and lot numbers not reported). The nurse reported that the patient developed redness and swelling in the injection site about 58 cm by 40 cm in size after administration of VARIVAX (Merck) on 10-AUG-2009. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664719/0804Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 5 year old female patient with no known drug reactions/allergies and with no pertinent medical history who on 10-AUG-2009 was vaccinated SQ with 0.5 ml of a dose of VARIVAX (Merck) (dose not reported, lot number: 664719/0804Y) in the left arm.  There was no concomitant medication.  The nurse reported the patient developed an injection site reaction of redness and swelling 5 minutes after vaccination.  The affected area was about 80 mm.  The patient was treated with an ice pack for 20 minutes.  At the time of the report the outcome of the patient was unknown.  The patient sought unspecified medical attention by phone call.  A standard lot check investigation has been finalized.  All in-process quality checks for the lot number 664719/0804Y were satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  This is one of several reports received from the same source.  No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 11 year old male who on 20-JUL-2009 was vaccinated with a second dose of VARIVAX (Merck) (lot # 663946/0225Y), 0.5 ml, SQ.  There was no concomitant medication.  It was reported that on 20-JUL-2009 or 21-JUL-2009, the patient went to the physician's office with a "red ring on his arm at the injection site.  It was red, painful, swollen and about the size of a half dollar.  The doctor gave the patient BENADRYL as a treatment.  At the time of reporting, the spot was not as painful and the circle was not as bad as it was when it first appeared".  There were no lab diagnostics studies performed.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 36 month old male patient who on an unspecified date was vaccinated with a "first doses of series" of VARIVAX (Merck) (route and lot not reported).  The physician reported that after receiving the vaccine the patient developed spots on his face, legs and thighs.  The physician believed the experience was some form of breakthrough.  The patient sought medical attention by seeing the physician.  On an unspecified date, the patient recovered.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash pruritic, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on an unspecified date was vaccinated with her first dose of VARIVAX (Merck) (route and lot number not reported).  "After the patient received VARIVAX (Merck) they had developed lesions on her abdomen, groin and buttocks".  The physician reported that the patient had recovered and believed that the experience was some form of breakthrough.  The patient sought medical attention by contacting the physician.  Follow-up information was received from a Physician who reported that the patient without a pertinent medical history or drug reaction or allergies on 10-MAY-2006 was vaccinated in her left arm with her first dose of VARIVAX (Merck) (Lot # 651283/0916R).  It was mentioned that on 13-AUG-2009 the patient was seen by the physician at office at 3 pm for fever (T degrees Max 102 degrees F) for 3 days followed by pruritic crops of lesions consisting of granular vesicles and was diagnosed chickenpox that was considered to be nonserious.  No laboratory or test diagnostics were performed.  The physician reported that the patient recovered 3 weeks later approximately on 03-SEP-2009.  No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on an unspecified date was vaccinated with her first dose of VARIVAX (Merck) (route and lot number not reported).  "After the patient received VARIVAX (Merck) they had developed lesions on her abdomen, groin and buttocks".  The physician reported that the patient had recovered and believed that the experience was some form of breakthrough.  The patient sought medical attention by contacting the physician.  Follow-up information was received from a Physician who reported that the patient without a pertinent medical history or drug reaction or allergies on 10-MAY-2006 was vaccinated in her left arm with her first dose of VARIVAX (Merck) (Lot # 651283/0916R).  It was mentioned that on 13-AUG-2009 the patient was seen by the physician at office at 3 pm for fever (T degrees Max 102 degrees F) for 3 days followed by pruritic crops of lesions consisting of granular vesicles and was diagnosed chickenpox that was considered to be nonserious.  No laboratory or test diagnostics were performed.  The physician reported that the patient recovered 3 weeks later approximately on 03-SEP-2009.  No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 11 year old male patient with allergic reaction to AUGMENTIN who on 08-JUN-2000 was vaccinated with first dose of VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously. On 19-AUG-2009 he received second dose of VARIVAX (Merck) (lot # not reported) 0.5ml, subcutaneously. Concomitant therapy include unspecified inhaler. On 19-AUG-2009 while receiving his second dose of vaccine he developed hives on his arm, near the injection site. The patient sought medical attention office visit. At the time on the report on 19-AUG-2009 the patient had not recovered. There were no laboratories diagnostics studies performed. Follow-up information received from a licensed practical nurse indicated that the patient was a male with no known allergies or medical conditions (previously reported with allergy reaction to amoxicillin) who on 19-AUG-2009 was vaccinated with his second dose of VARIVAX (Merck) (Lot # 664623/0805Y) subcutaneously in his right arm at 08:25. There were no illnesses at time of vaccination. It was reported that he had hives, red and swollen "at site". According to the practical nurse ice was applied, Blood pressure and pulse were taken periodically and he was observed for 45 minutes. The patient recovered after 1-2 hours. There were no diagnostic tests performed. No further information is available.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Disability, Dyspnoea, Endotracheal intubation, Hypoaesthesia, Intensive care
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old male who on 12-AUG-2009 was vaccinated SQ but was unknown if this was the first or second dose of VARIVAX (Merck) (lot number: 664621/0851Y) into the left arm. The patient was admitted on the hospital on 29-AUG-2009 and she was diagnosed with transverse myelitis on the same day (29-AUG-2009). It was reported that the patient is in the (intensive care unit) ICU on an respirator. At the time of the report, the outcome of the patient was not recovered. Follow up information has been received from a registered nurse who reported that the patient's received the first dose of VARIVAX (Merck) (route not reported, lot number: 619672/0838D) on 17-DEC-1996. On 12-AUG-2009, the patient received the second dose of VARIVAX (Merck) (lot number: 664621/0851Y) and concomitantly received HAVRIX (date and route not reported, lot number: AHAVB326A) on an unspecified date. The registered nurse stated that the patient's mother call the physician to state that the patient had a numbness and difficulty breathing (date not reported). On 29-AUG-2009, the patient was admitted to the hospital and the patient was intubated and transferred to Pediatric ICU to be extubated. The registered nurse did not know if the patient was extubated and she did not know if the patient had recovered. The physician had consulted a pediatric neurologist and Infectious disease Specialist. The reporter considered the patient's transverse myelitis to be immediately life-threatening and was considered to be disabling, an other important medical event. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from physician who stated that some laboratories were performed and the results were pending. The patient was concomitantly vaccinated with HAVRIX on 12-AUG-2009. The patient was still on respirator. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Myelitis transverse
Clinical narrative: Information has been received from a pharmacist concerning a 13 year old male who on 12-AUG-2009 was vaccinated SQ but was unknown if this was the first or second dose of VARIVAX (Merck) (lot number: 664621/0851Y) into the left arm. The patient was admitted on the hospital on 29-AUG-2009 and she was diagnosed with transverse myelitis on the same day (29-AUG-2009). It was reported that the patient is in the (intensive care unit) ICU on an respirator. At the time of the report, the outcome of the patient was not recovered. Follow up information has been received from a registered nurse who reported that the patient's received the first dose of VARIVAX (Merck) (route not reported, lot number: 619672/0838D) on 17-DEC-1996. On 12-AUG-2009, the patient received the second dose of VARIVAX (Merck) (lot number: 664621/0851Y) and concomitantly received HAVRIX (date and route not reported, lot number: AHAVB326A) on an unspecified date. The registered nurse stated that the patient's mother call the physician to state that the patient had a numbness and difficulty breathing (date not reported). On 29-AUG-2009, the patient was admitted to the hospital and the patient was intubated and transferred to Pediatric ICU to be extubated. The registered nurse did not know if the patient was extubated and she did not know if the patient had recovered. The physician had consulted a pediatric neurologist and Infectious disease Specialist. The reporter considered the patient's transverse myelitis to be immediately life-threatening and was considered to be disabling, an other important medical event. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from physician who stated that some laboratories were performed and the results were pending. The patient was concomitantly vaccinated with HAVRIX on 12-AUG-2009. The patient was still on respirator. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old male patient with no pertinent medical history and no known drug allergies who on 02-SEP-2009 was vaccinated with a dose of VARIVAX (Merck). Concomitant vaccines included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of IPOL and a dose of MMR II. On 03-SEP-2009 the patient experienced an injection site reaction after he received VARIVAX (Merck). The injection site was red, swollen and warm to touch. The patient came into the office on 03-SEP-2009. There were no lab diagnostic studies performed. The caller is requesting a lot check of VARIVAX (Merck) due to the patient's adverse experiences. At the time of this report, patient had not recovered. Follow-up information has been received from the medical assistant concerning the patient who on 02-SEP-2009 was vaccinated with a dose of VARIVAX (Merck) (the lot number was confirmed as 663797/0424Y). Concomitant vaccination therapy on the same day included a dose of MMR II (lot number 665596/0934Y). Follow-up information has been received from a medical assistant concerning the patient who on 02-SEP-2009 at 15:11 was vaccinated with the second dose of VARIVAX (Merck) (lot# 663797/0424Y valid), MMR II and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (U2472CA) in right thigh and MMR II (665596/0934Y) and IPOL (B1090.2) in left thigh. On 03-SEP-2009 the patient returned to the office. The patient's thigh was red and swollen and tender to touch around the injection site. The size of the area was 2 inches. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 12 year old male who on 31-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) 0.5mL, subcutaneously, Lot #664904/0914Y. Concomitant therapy included HAVRIX. On 01-SEP-2009, the patient experienced injection site reaction. The injection site area was red, swollen and warm to the touch. The patient was recovering from injection site reaction. The patient sought medical attention. The reporter was requesting a lot check of this vaccine due to patients had adverse experience. Follow-up information has been received from a physician indicated that a male patient with obesity and no illness at the time of vaccination who on 31-AUG-2009 at 9:20am was vaccinated with the second dose of VARIVAX (Merck) 0.5mL, subcutaneously at right arm, Lot #664904/0914Y, and the patient was also vaccinated IM with the first dose of HAVRIX at left arm, Lot #AHAVB357CA. On 02-SEP-2009 the patient was swollen at the right arm and had injection site "itchy with warm to touch". The patient had sought medical attention, doctor visit. Shortly after 04-SEP-2009 the patient was recovered. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received from the physician's office which reported that on 31-AUG-2009 the patient had vaccines and on 02-SEP-2009 the patient returned to office. On 02-SEP-2009 at 10:40 AM, the patient's right arm was swollen and tender to touch, feverish around injection site. Subsequently, the patient recovered from the events. Additional information is not expected.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Asthenia, Chills, Facial palsy, Fatigue, Hypoaesthesia
Clinical narrative: Information has been received from an epidemiologist concerning a 38 year old male patient who on 26-Aug-2009 was vaccinated with a dose of MMR II. Concomitant therapy included tetanus toxoid and tuberculin administered one week prior (approx 19-AUG-2009). On 26-Aug-2009, after administration of MMR II, the patient experienced "mild" symptoms of fever and chills. The consumer then reported that within days of receiving MMR II he also experienced Bells palsy, numbness, aches, pains, sore throat, spasms and fatigue. He reported that it took away his energy for the past week. By 31-Aug-2009, he felt worse and also experienced swollen testicles. The patient reported that he is in great shape and has never smoked or drank and is shocked that this vaccine has affected him this severely at the hospital where the vaccine was administered. Laboratory diagnostic studies have been performed which showed normal platelet numbers. He has sought medical attention. At the time of report, the patient had not recovered. No further information is available.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Muscle spasms, Oropharyngeal pain, Pain, Platelet count normal, Pyrexia
Clinical narrative: Information has been received from an epidemiologist concerning a 38 year old male patient who on 26-Aug-2009 was vaccinated with a dose of MMR II. Concomitant therapy included tetanus toxoid and tuberculin administered one week prior (approx 19-AUG-2009). On 26-Aug-2009, after administration of MMR II, the patient experienced "mild" symptoms of fever and chills. The consumer then reported that within days of receiving MMR II he also experienced Bells palsy, numbness, aches, pains, sore throat, spasms and fatigue. He reported that it took away his energy for the past week. By 31-Aug-2009, he felt worse and also experienced swollen testicles. The patient reported that he is in great shape and has never smoked or drank and is shocked that this vaccine has affected him this severely at the hospital where the vaccine was administered. Laboratory diagnostic studies have been performed which showed normal platelet numbers. He has sought medical attention. At the time of report, the patient had not recovered. No further information is available.
Age: 38.0
Sex: M
Vaccine: MMR
Symptoms: Testicular swelling
Clinical narrative: Information has been received from an epidemiologist concerning a 38 year old male patient who on 26-Aug-2009 was vaccinated with a dose of MMR II. Concomitant therapy included tetanus toxoid and tuberculin administered one week prior (approx 19-AUG-2009). On 26-Aug-2009, after administration of MMR II, the patient experienced "mild" symptoms of fever and chills. The consumer then reported that within days of receiving MMR II he also experienced Bells palsy, numbness, aches, pains, sore throat, spasms and fatigue. He reported that it took away his energy for the past week. By 31-Aug-2009, he felt worse and also experienced swollen testicles. The patient reported that he is in great shape and has never smoked or drank and is shocked that this vaccine has affected him this severely at the hospital where the vaccine was administered. Laboratory diagnostic studies have been performed which showed normal platelet numbers. He has sought medical attention. At the time of report, the patient had not recovered. No further information is available.