chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Blood amylase, Blood immunoglobulin G, Blood immunoglobulin M, Mumps, Parotitis
Clinical narrative: Information has been received from a physician concerning an 19 year old male patient who on 27-MAY-1992 was vaccinated with the first dose of MMR II (route, site, dose and lot number not reported). On 14-OCT-1997, the patient was vaccinated with the second dose of MMR II (route, site, dose and lot number not reported). On 30-NOV-2009 the patient experienced mumps (date diagnosed was reported as 03-DEC-2009). The patient was afebrile and had parotitis. On 03-DEC-2009, the laboratory tests showed IgM <1:10, IgG 4.29 and serum amylase 273. The outcome for mumps was not reported. Follow up information has been received from the physician who reported that the 15 year old patient at symptoms onset date experienced mumps on 22-NOV-2009 (previously reported as 30-NOV-2009). The date diagnosed was reported as 23-NOV-2009 (previously reported as 03-DEC-2009). The patient was afebrile and had bilateral parotitis. On 23-Nov-2009, the blood work test showed IgM <1:10, IgG 3.94 and serum amylase 190. At the time of the report the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Blood amylase increased, Blood immunoglobulin G, Blood immunoglobulin M normal, Body temperature increased, Cough
Clinical narrative: Information has been received from a physician concerning a 16 year old male patient who on 08-MAY-1996 was vaccinated with the first dose of MMR II.  The patient received the second dose of MMR II on 18-JUN-1997.  On 13-NOV-2009 the patient experienced mumps, (the date diagnosed was reported as 28-DEC-2009).  The patient had fever of 103 and had parotitis.  The outcome for mumps was not reported.   Follow up information has been received concerning the 16 year old male patient who on 08-MAY-1996 and on 18-JUN-1997 was vaccinated with the first and second doses of MMR II (route and lot # unknown), respectively.  On 06-NOV-2009 the patient experienced mumps (he was diagnosed on 08-NOV-2009).  The patient had fever of 102 and had L parotitis.  The patient also had cough and headaches.  On 08-NOV-2009,  a first blood work was performed:  IgM was negative, IgG was 198 and serum amylase was 359.  At the time of the report the patient's outcome was unknown.  No  further information is available.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Headache, Mumps, Parotitis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 16 year old male patient who on 08-MAY-1996 was vaccinated with the first dose of MMR II.  The patient received the second dose of MMR II on 18-JUN-1997.  On 13-NOV-2009 the patient experienced mumps, (the date diagnosed was reported as 28-DEC-2009).  The patient had fever of 103 and had parotitis.  The outcome for mumps was not reported.   Follow up information has been received concerning the 16 year old male patient who on 08-MAY-1996 and on 18-JUN-1997 was vaccinated with the first and second doses of MMR II (route and lot # unknown), respectively.  On 06-NOV-2009 the patient experienced mumps (he was diagnosed on 08-NOV-2009).  The patient had fever of 102 and had L parotitis.  The patient also had cough and headaches.  On 08-NOV-2009,  a first blood work was performed:  IgM was negative, IgG was 198 and serum amylase was 359.  At the time of the report the patient's outcome was unknown.  No  further information is available.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Mumps, Neck pain, Parotitis
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 31-JUL-2000 was vaccinated with a first dose of MMR. On 03-DEC-2009 the patient was vaccinated with a third dose of MMR (lot # 664363/0554Y). On 25-DEC-2009 the patient experienced mumps (thought the date diagnosed was reported as 30-NOV-2009). Other symptoms presented by the patient included pain under both ears. On 04-DEC-2009 the patient had blood work done (results not reported). The patient was afebrile. The patient's outcome was unknown. Follow-up information was received from the physician reporting that the patient experienced mumps on 11-NOV-2009 (previously reported as 25-DEC-2009) and was diagnosed on 15-NOV-2009 (previously reported as 30-NOV-2009). The patient developed right parotitis and was afebrile. No further information is available.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Blood amylase normal, Blood immunoglobulin G, Blood immunoglobulin M, Body temperature normal, Dizziness
Clinical narrative: Information has been received from a physician concerning a 18 year old male who on 10-FEB-1993 was vaccinated with a first dose of MMR II. On 14-NOV-1996 the patient was vaccinated with a second dose of MMR II. On 09-DEC-2009 the patient experienced mumps (thought the date diagnosed was reported as 11-NOV-2009). Other symptoms presented by the patient included dizziness. The patient was afebrile. ON 11-NOV-2009 the patient had a serum immunoglobulin M test, which came back negative, serum immunoglobulin G test: 4.66 and a serum amylase test: 195. The patient's outcome was unknown. Follow up information has been received regarding the 18 year old male patient who on 09-NOV-2009 (previously reported as 09-DEC-2009) experienced mumps. On 11-NOV-2009, the patient was diagnosed with mumps, the patient was afebrile and developed right parotitis. On 11-NOV-2009 the first blood work was performed, the results were: IgM (<1:10); <1:10, IgG (>1.10); 5.48 and serum amylase: 106. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Mumps, Parotitis
Clinical narrative: Information has been received from a physician concerning a 18 year old male who on 10-FEB-1993 was vaccinated with a first dose of MMR II. On 14-NOV-1996 the patient was vaccinated with a second dose of MMR II. On 09-DEC-2009 the patient experienced mumps (thought the date diagnosed was reported as 11-NOV-2009). Other symptoms presented by the patient included dizziness. The patient was afebrile. ON 11-NOV-2009 the patient had a serum immunoglobulin M test, which came back negative, serum immunoglobulin G test: 4.66 and a serum amylase test: 195. The patient's outcome was unknown. Follow up information has been received regarding the 18 year old male patient who on 09-NOV-2009 (previously reported as 09-DEC-2009) experienced mumps. On 11-NOV-2009, the patient was diagnosed with mumps, the patient was afebrile and developed right parotitis. On 11-NOV-2009 the first blood work was performed, the results were: IgM (<1:10); <1:10, IgG (>1.10); 5.48 and serum amylase: 106. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Blood amylase, Blood immunoglobulin G, Blood immunoglobulin M, Mumps, Orchitis
Clinical narrative: Information has been received from a physician concerning an 18 year old male patient who on 14-SEP-1992 was vaccinated with the first dose of MMR II. On 14-OCT-1996, the patient received the second dose of MMR II. Laboratory diagnostic tests were performed on 03-DEC-2009: IgM: 0.23; IgG: 3.63 and serum amylase test: 34. On 03-DEC-2009, the patient was diagnosed. It was reported that on 22-DEC-2009 the patient experienced mumps. The outcome of the patient was not reported. Follow up information has been received regarding the 18 year old male patient who on 21-JAN-2010 (previously reported as 22-DEC-2009) experienced mumps. On 22-JAN-2010, the patient was diagnosed with mumps, the patient had swelling under the right ear and soar throat, the patient developed right parotitis. On 22-JAN-2010 the first blood work was performed, the results were: IgM (<1:10) : <1:10, IgG (>1.10): 5.99 and serum amylase: 49. It was noted that the patient did not receive a third dose of MMR II. It was unknown if the patient experienced orchitis, was exposed to others with mumps and or experienced any sequelae. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Parotitis
Clinical narrative: Information has been received from a physician concerning an 18 year old male patient who on 14-SEP-1992 was vaccinated with the first dose of MMR II. On 14-OCT-1996, the patient received the second dose of MMR II. Laboratory diagnostic tests were performed on 03-DEC-2009: IgM: 0.23; IgG: 3.63 and serum amylase test: 34. On 03-DEC-2009, the patient was diagnosed. It was reported that on 22-DEC-2009 the patient experienced mumps. The outcome of the patient was not reported. Follow up information has been received regarding the 18 year old male patient who on 21-JAN-2010 (previously reported as 22-DEC-2009) experienced mumps. On 22-JAN-2010, the patient was diagnosed with mumps, the patient had swelling under the right ear and soar throat, the patient developed right parotitis. On 22-JAN-2010 the first blood work was performed, the results were: IgM (<1:10) : <1:10, IgG (>1.10): 5.99 and serum amylase: 49. It was noted that the patient did not receive a third dose of MMR II. It was unknown if the patient experienced orchitis, was exposed to others with mumps and or experienced any sequelae. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Exposure to communicable disease, Mumps, Parotitis
Clinical narrative: Information has been received from a physician concerning a 6 year old male patient who on an unspecified date was vaccinated with a dose of MMR II. On 01-DEC-2009 the patient experienced mumps outbreak (date of diagnosed was reported as 24-DEC-2009). The patient was afebrile and had parotitis. The outcome of the patient was not reported. Follow-up information was received from a physician concerning the 6 year old patient (also reported as 22 years old) with previous exposure to mumps at school. It was reported that on 04-DEC-2009 (previously reported as 01-DEC-2009) the patient experienced a mumps outbreak. The patient had right parotitis. At the time of reporting the patient's final outcome remained unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 0.76
Sex: F
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 11-MAY-1998 and 01-AUG-2001 was vaccinated with the first and second doses of MMR II, respectively. On 17-NOV-2009 the patient experienced mumps. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 1.14
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Allergy test negative, Bite, Rash, Urticaria
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 13 month old male patient with no known drug allergies or medical history who on 13-APR-2009 was vaccinated with MMR II (lot # 659706/0266X). Concomitant suspect therapy included VARIVAX (lot # 661651/0989X). On 14-APR-2009 the patient developed hives. The patient was examined in the emergency room on 14-APR-2009 for the treatment for a bite from a bat and released that day. The patient was administered a rabies vaccine and rabies immune globulin (manufacturer unknown). The patient developed hives 20 minutes later and was treated with KENALOG, DECADRON 4 mg IV and BENADRYL. The next week the patient was administered a different brand of rabies vaccine and also developed hives 20 minutes later. Allergy tests were conducted on the patient and it was determined that he did not have an allergy to rabies vaccine. The patient was administered a third and fourth dose of rabies vaccine with out any reaction. The patient's mother did state that he had had recurrent rashes but rashes were not seen by physician. The mother stated one time the rash looked like hives and another time it appeared as red spots on his stomach. On an unknown date the patient recovered. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: MMR
Symptoms: Crohn's disease
Clinical narrative: Information has been received from a consumer concerning an 15 year old male who on an unspecified date was vaccinated with MMR II. The reporter stated that she read in a book (name unspecified) that a male had received a dose of MMR II at the age of 15 years old and then was diagnosed with Crohn's disease. This is one of several reports received from the same source. Additional information is not expected.
Age: 0.01
Sex: M
Vaccine: MMR
Symptoms: Asthma, Developmental delay, Hyperacusis, Sensory disturbance
Clinical narrative: Information has been received from a consumer concerning his son, a caesarean baby with penicillin allergy who "within 2 or 3 days of being born" on approximately 02-JAN-2003 was vaccinated with MMR II SQ.  On an unspecified date the patient had "sensory perception disorder".  The patient had "problems" with loud noise and rough textures."  The consumer reported that his son "was a little bit late with walking and talking, but started walking before crawling." "When the patient was 2 or 3 he had asthma attacks."  The patient had sought unspecified medical attention.  At the time of reporting the patient's "sensory perception disorder" and "problems with loud noise and rough textures" and "asthma attacks" persisted.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Injection site induration
Clinical narrative: Information has been received from a consumer who is a nurse concerning her 4 year old daughter who received "the normal immunization given prior to school entry including MMR II and others" (unspecified what the other vaccines were). On an unspecified date the patient developed black and blue arms in addition to firmness at the injection site areas. Several weeks later the patient recovered from black and blue arms and firmness at the injection site areas. Additional information has been requested.
Age: 1.52
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning an 18 months old female who on 15-APR-2009 was vaccinated subcutaneously with a 0.5mL dose of VARIVAX (Merck) (LOT# 662577/0047Y). Ten days after vaccination, on 25-APR-2009, the patient experienced injection site redness and swelling, her arm was immediately red and stayed red, then turned black. She required an emergency room visit and was put on antibiotics. She did not have any streaking and was not admitted. It was also reported that the patient was recovered. A lot check has been initiated. 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. (Complaint ID # 154667). Follow-up information has been received from a medical assistant who reported that the patient with possible diaper rash at time of vaccination and no known drug allergy, no known birth defect or medication conditions who on 15-APR-2009 at 10:30 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (LOT# 662577/0047Y) in right thigh. Concomitant therapy included MOTRIN and SEPTRA. On 15-APR-2009 (previous reported as 25-APR-2009) the site of shot was discolored, hot to touch and swollen shortly after shot was given. The patient developed a fever (>/=100 F) on Sunday 26-APR-2009, but was in great pain starting on Friday 24-APR-2009. Patient received antibiotic KEFLEX in emergency room and responded well to this treatment. The patient was recovered on 27-APR-2009. This is one of several reports received from the same source. No further information is available.
Age: 1.52
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning an 18 months old female who on 15-APR-2009 was vaccinated subcutaneously with a 0.5mL dose of VARIVAX (Merck) (LOT# 662577/0047Y). Ten days after vaccination, on 25-APR-2009, the patient experienced injection site redness and swelling, her arm was immediately red and stayed red, then turned black. She required an emergency room visit and was put on antibiotics. She did not have any streaking and was not admitted. It was also reported that the patient was recovered. A lot check has been initiated. 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. (Complaint ID # 154667). Follow-up information has been received from a medical assistant who reported that the patient with possible diaper rash at time of vaccination and no known drug allergy, no known birth defect or medication conditions who on 15-APR-2009 at 10:30 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (LOT# 662577/0047Y) in right thigh. Concomitant therapy included MOTRIN and SEPTRA. On 15-APR-2009 (previous reported as 25-APR-2009) the site of shot was discolored, hot to touch and swollen shortly after shot was given. The patient developed a fever (>/=100 F) on Sunday 26-APR-2009, but was in great pain starting on Friday 24-APR-2009. Patient received antibiotic KEFLEX in emergency room and responded well to this treatment. The patient was recovered on 27-APR-2009. This is one of several reports received from the same source. No further information is available.
Age: 1.52
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning an 18 months old male who on 15-APR-2009 was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (LOT# 662577/004Y). On an unspecified date after vaccination the patient experienced injection site redness and swelling. It also reported that unspecified medical attention was sought and the patient was recovered. A lot check has been initiated. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements and was released. (Complaint ID # 154668). This is one of several reports received from the same source. No further information is available.
Age: 1.08
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Rash, Skin lesion
Clinical narrative: Information has been received from a office manager concerning a 13 month old female patient who on 08-FEB-2010 was subcutaneously vaccinated in the right arm with the first dose of VARIVAX (Merck) (Lot#665201/1294Y) 0.5 mL and concomitantly received a dose of PREVENAR vaccine on the same day. The office manager reported that on 23-FEB-2010, the patient presented to the doctor office with redness, blister like lesions and swelling at the injection site that looked like the bottom of a soup can. It was unspecified if lab tests were performed. The patient was treated with triamcinolone cream and would have the follow up visit on 09-MAR-2010. At the time of the report the patient was unknown. A lot check has been initiated. Follow up information has been received from a medical assistant who reported that the patient was vaccinated in the right leg (previously reported as right arm) with a dose of VARIVAX (Merck) (Lot#665201/1294Y) and was vaccinated with PREVENAR (Lot E07228) (previously reported as PREVENAR in the left leg. On 09-MAR-2010, the patient was seen by the physician, the patient had a rash on her right leg. The patient's parents were instructed to contact the physician if the rash worsened. It was noted that the patient had a follow-up appointment with the physician scheduled for 19-APR-2010. At the time of the report the patient outcome was unspecified. Additional information has been requested. This is one of several cases reported by the same source.
Age: 1.01
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a licensed practical nurse concerning a four year old female patient with no pre-existing allergies or medical conditions and no illness at the time of vaccination who on 16-SEP-2009 was vaccinated with a fourth IM dose of PREVNAR (lot# B08657F) and on 19-SEP-2006 was vaccinated with a second SC dose of VARIVAX (Merck) (lot# 653516/0347F). On 25-FEB-2010 the patient developed 50-60 red papular lesions with a few purulent lesions and no fever; a large patch was first noted in her abdomen and then spread for three-four days. There was no fever. The patient did not seek medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a office manager concerning a 4 year old male patient with no known drug reaction or allergies or pertinent medical history who on 02-MAR-2010 was intramuscularly vaccinated in the right arm with the first dose of VARIVAX (Merck) (Lot#665201/1294Y) 0.5 mL. Concomitant vaccination included MMR II, IPOL, and DTP + IPV. The office manager reporter that on 03-MAR-2010, the patient experienced redness, heat, rash and a very large swelling at the injection site which was the size of the bottom of a large pineapple juice can. On 05-MAR-2010 the patient was seen in the physician office. The patient was treated with BENADRYL. At the time of the report the patient had not recovered. It was noted that the office manager requested a lot check. A lot check has been initiated. Follow up information has been received from a medical assistant who reported that the patient who on 02-MAR-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot #665201/1294Y). The patient was concomitant vaccinated with MMR II (Lot#663796/0423Y) in the left leg, IPOL (Lot#D0413-2) and (INFANRIX) (Lot#AC14B086AB). On an unspecified date, that patient had recovered. It was noted that the patient had a follow-up appointment with the physician on 12-MAR-2010. Additional information is not expected. This is one of several cases reported by the same source.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Chills, Injection site erythema, Malaise, Musculoskeletal stiffness
Clinical narrative: Information has been received from a pharmacist concerning a female in her 20's with no pertinent medical history and no drug reactions/allergeis who on 06-MAR-2010 was vaccinated with a dose of VARIVAX (Merck). On 06-MAR-2010, within hours of vaccination the patient developed a stiff neck. Later she developed a fever, malaise, chills, achiness and redness the size of a palm at the injection site. The patient also developed 3 bumps on her right arm and shoulder. Bumps are not fluid filled. The patient talked to pharmacist and would call physician today. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pyrexia, Rash papular
Clinical narrative: Information has been received from a pharmacist concerning a female in her 20's with no pertinent medical history and no drug reactions/allergeis who on 06-MAR-2010 was vaccinated with a dose of VARIVAX (Merck). On 06-MAR-2010, within hours of vaccination the patient developed a stiff neck. Later she developed a fever, malaise, chills, achiness and redness the size of a palm at the injection site. The patient also developed 3 bumps on her right arm and shoulder. Bumps are not fluid filled. The patient talked to pharmacist and would call physician today. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning a 36 year old female patient with Gilbert's syndrome who on 22-SEP-2009 and 20-OCT-2009 was vaccinated with the first and second dose of VARIVAX (Merck) (lot# for both vaccinations was 665191/1047Y) while she may have been pregnant. The registered nurse stated that the vaccine was given at another physician's office and was not given in their office. Concomitant therapy included prenatal vitamins. The registered nurse also reported that the patient had redness and swelling at the injection site after the first dose of VARIVAX (Merck) was given. There was no adverse reaction reported after the second dose of VARIVAX (Merck). Medical attention was sought, the patient had an office visit. It was unspecified if lab studies were performed. At the time of the report, the patient's status was unknown. It was noted that the patient would be followed by another physician's office for prenatal care. Additional information has been requested.
Age: 87.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 87 year old patient who on 01-DEC-2009 was suppose to receive ZOSTAVAX (Merck) (MSD) and was inadvertently administered VARIVAX (Merck). No adverse effect was reported. Follow-up information has been received from a receptionist who indicated that a registered nurse stated that the patient received VARIVAX (Merck) and ZOSTAVAX (Merck) (MSD). Additional follow up information had been received from a registered nurse who stated that on 01-DEC-2009 the patient received VARIVAX (Merck) (Lot # 662581/0058Y) instead of ZOSTAVAX (Merck) (MSD). The nurse also stated that this was due to a medication error and not product confusion. It was also reported that the patient after receiving the VARIVAX (Merck) vaccination received ZOSTAVAX (Merck) (Lot # 664630/0837Y). No adverse effect was reported. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male patient with no pertinent medical history who on 03-OCT-2007 was vaccinated with a dose of VARIVAX (lot# 658191/0853U). Concomitant vaccinations on the same day included a dose of TRIPEDIA and a dose of HAVRIX. On 12-NOV-2009 the patient developed "mild breakthrough" chicken pox. There were about 15-16 lesions. The patient was evaluated in an emergency room, but was not admitted to the hospital. There were no laboratory diagnostic studies performed. On an unspecified date, the patient recovered. No further information is available.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 23 month old female patient (23 lb. 12 oz / 33 inches) with no illness who about 1 year ago (also reported as on 12-DEC-2008), was vaccinated SQ into the left arm which the first dose of VARIVAX (lot# 661999/1279X). On 20-NOV-2009 the patient developed rash and about 10 blister lesions. The patient sought medical attention via doctor visit on 24-NOV-2009, the patient recovered from the events. There was no illness at the time of vaccination. Additional information is not expected.
Age: 1.54
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature normal, Herpes zoster, Injection site pain, Pain, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 10 year old male patient with no pertinent medical history or drug reactions who on 30-MAY-2001, at the age of 2 years old, was vaccinated with a dose of VARIVAX (Merck) (lot #, route and site of administration not reported).  There was no concomitant medication.  On 06-DEC-2009 ("2 days ago") the patient developed shingles at the C7-T1 dermatomes.  It was reported that the patient was having burning at the lesion sites.  Unspecified medical attention was sought via office visit.  There were no laboratory diagnostics studies performed.  At the time of this report, the patient had not recovered.  Follow up information has been received from the physician concerning the male patient who on 05-DEC-2009 developed shingles at the left C7 - T1 dermatomes.  It was reported that the patient was afebrile and he had no other systemic symptoms.  The patient reported his pain to be 6 on a scale of 1 to 10.  The patient had no recent exposure to chickenpox or shingles.  He did not have a direct fluorescent antibody done.  No photos had been taken.  At the time of this report, the patient had 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.  On 11-DEC-2009 vesicle lesion was collected and on 14-DEC-2009 the specimen was sent to laboratory.  On 15-DEC-2009 the samples arrived in laboratory, VZV DNA and B globin were amplified and the VAV strain identification showed adequate specimen which identified the presence of WT VZV.  Additional information is not expected.
Age: 1.54
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 10 year old male patient with no pertinent medical history or drug reactions who on 30-MAY-2001, at the age of 2 years old, was vaccinated with a dose of VARIVAX (Merck) (lot #, route and site of administration not reported).  There was no concomitant medication.  On 06-DEC-2009 ("2 days ago") the patient developed shingles at the C7-T1 dermatomes.  It was reported that the patient was having burning at the lesion sites.  Unspecified medical attention was sought via office visit.  There were no laboratory diagnostics studies performed.  At the time of this report, the patient had not recovered.  Follow up information has been received from the physician concerning the male patient who on 05-DEC-2009 developed shingles at the left C7 - T1 dermatomes.  It was reported that the patient was afebrile and he had no other systemic symptoms.  The patient reported his pain to be 6 on a scale of 1 to 10.  The patient had no recent exposure to chickenpox or shingles.  He did not have a direct fluorescent antibody done.  No photos had been taken.  At the time of this report, the patient had 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.  On 11-DEC-2009 vesicle lesion was collected and on 14-DEC-2009 the specimen was sent to laboratory.  On 15-DEC-2009 the samples arrived in laboratory, VZV DNA and B globin were amplified and the VAV strain identification showed adequate specimen which identified the presence of WT VZV.  Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Alpha 1 foetoprotein abnormal, Drug exposure during pregnancy, Unevaluable event, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product concerning a 19 year old female patient with no pertinent medical history and no drug reactions or allergies who on 20-AUG-2009, was vaccinated with a dose of VARIVAX (Merck) (lot # 664235/0642Y). At time of vaccination, the patient was about 4 weeks pregnant. Her last menstrual period was on approximately 23-JUL-2009, and estimated delivery date was approximately 29-APR-2010. Urine pregnancy test was performed which confirmed pregnancy. The patient had a maternal serum alpha fetoprotein test which came back positive for a risk of Down's syndrome 1 and 5. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 0.0
Sex: F
Vaccine: HPV4
Symptoms: Continuous positive airway pressure, Drug exposure during pregnancy, Intensive care, Laboratory test normal, Premature baby
Clinical narrative: Information has been received from a medical assistant concerning one of twin babies. The baby's 18 year old mother was vaccinated with the first and second 0.5 ml dose of GARDASIL by different provider and was vaccinated IM with the third 0.5ml dose of GARDASIL (lot #: 659962/1740U) on 01-DEC-2008. The mother's last menstrual period was 19-NOV-2008 and estimated delivery date was 05-SEP-2009. The medical assistant reported that the baby was born about 1 month early, in approximately August 2009, but as far as she knew, the baby was born normal and healthy. Follow-up information was received from a pediatrician via medical records. It was reported that the mother delivered twin babies (one male and one female). The baby girl was born, 32 2/7 weeks of gestation via C-section for breech position. The baby was transferred to neonatal intensive care unit (NICU) for 18 days, and on continuous positive airway pressure (CPAP) for three days. Active medications included vitamins (unspecified) (POLY-VI-SOL) 0.5 ml PO BID. On 13-AUG-2009, the baby's weight was 5 pounds, 15 ounces, length was 18.5 inch, and head circumference was 13 inch. Her body temperature was 98, pulse was 136, and respiratory rate was 40. Physical examination showed the baby was alert, premature and active. The assessment was the female baby was one month old, premature, was doing well, and breech of birth. The baby continued diet Neosure 22 kcal/ounce and vitamins (unspecified) (POLY-VI-SOL). An ultrasound for hips was scheduled. Barlow and Ortolani tests were negative. The baby would be arranged "for syringes, monthly injection". On 04-SEP-2009, the baby had hip click alignment check. Ultrasound infant hips with physician guided was performed which showed both hips were within normal limits. The mother's experience has been captured in WAES # 0904USA01164. The twin baby's experience has been captured in WAES # 0904USA01164B2. Additional information has been requested. All available medical records will be provided upon request.
Age: 0.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: Information has been received from a medical assistant concerning one of twin babies. The baby's 18 year old mother was vaccinated with the first and second 0.5 ml dose of GARDASIL by different provider and was vaccinated IM with the third 0.5ml dose of GARDASIL (lot #: 659962/1740U) on 01-DEC-2008. The mother's last menstrual period was 19-NOV-2008 and estimated delivery date was 05-SEP-2009. The medical assistant reported that the baby was born about 1 month early, in approximately August 2009, but as far as she knew, the baby was born normal and healthy. Follow-up information was received from a pediatrician via medical records. It was reported that the mother delivered twin babies (one male and one female). The baby girl was born, 32 2/7 weeks of gestation via C-section for breech position. The baby was transferred to neonatal intensive care unit (NICU) for 18 days, and on continuous positive airway pressure (CPAP) for three days. Active medications included vitamins (unspecified) (POLY-VI-SOL) 0.5 ml PO BID. On 13-AUG-2009, the baby's weight was 5 pounds, 15 ounces, length was 18.5 inch, and head circumference was 13 inch. Her body temperature was 98, pulse was 136, and respiratory rate was 40. Physical examination showed the baby was alert, premature and active. The assessment was the female baby was one month old, premature, was doing well, and breech of birth. The baby continued diet Neosure 22 kcal/ounce and vitamins (unspecified) (POLY-VI-SOL). An ultrasound for hips was scheduled. Barlow and Ortolani tests were negative. The baby would be arranged "for syringes, monthly injection". On 04-SEP-2009, the baby had hip click alignment check. Ultrasound infant hips with physician guided was performed which showed both hips were within normal limits. The mother's experience has been captured in WAES # 0904USA01164. The twin baby's experience has been captured in WAES # 0904USA01164B2. Additional information has been requested. All available medical records will be provided upon request.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN, TDAP, VARCEL
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
Clinical narrative: Information has been received from a licensed visiting nurse for GARDASIL, a Pregnancy Registry product, concerning a 17 years old female with some unspecified hypertension medication allergies and a history of normal pregnancy who on 01-JUN-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 661841/0653X) while she was pregnant. Concomitant therapy included VARIVAX (lot number 662373/0417Y), 0.5 ml, SQ on 01-JUN-2009. Other concomitant therapy included meningococcal vaccine (unspecified) and DTAP and BACTRIM for urinary tract infection on 01-JUN-2009. On 01-JUN-2009 a pregnancy test was conducted but the test was negative. No adverse reactions reported. Phone call was made for medical attention on 25-JUN-2009. The patient was referred to an obstetrician. The patient's LMP was 29-MAY-2009 and the EDD was 5-MAR-2010. At the time of the report, the patient's outcome was unknown. Follow up information was received from a nurse practitioner. It was reported that the 17 year old patient had one previous full term delivery. It was unknown if there were any birth defects or infant complications with her previous pregnancy. Follow up information was received from a nurse practitioner. It was confirmed that LMP for the pregnancy was 29-MAY-2009 and the patient did have a positive pregnancy test on 25-JUN-2009. On approximately September 2009 ("may be in the fall"), the patient had a miscarriage. The reporter did see the patient on 12-DEC-2009 and the patient reported that her LMP at that visit was 24-NOV-2009, so the miscarriage was prior to that time. The patient was not pregnant at  the December visit. The patient did not have a history of prior miscarriage and does have a 2 year old child. It was also reported that the patient did not have a history of drug abuse. It was not known who the patient saw for her pregnancy care. No further information is available.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Cyanosis, Drooling, Dyspnoea, Mental status changes, Protrusion tongue
Clinical narrative: Vomiting, drooling, tongue swollen and protruding out of mouth, blurry vision, mental status changes, and difficulty breathing with blue lips.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Swollen tongue, Vision blurred, Vomiting
Clinical narrative: Vomiting, drooling, tongue swollen and protruding out of mouth, blurry vision, mental status changes, and difficulty breathing with blue lips.
Age: 13.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Acupuncture, Autoimmune disorder, Binocular eye movement disorder, Central nervous system lesion, Convulsion
Clinical narrative: My 13 year old daughter received an Intra-nasal attenuated H1N1 vaccination on November 25, 2009. Roughly a week later on December 2, 2009, she had onset of constant muscle tremors, seizures, and myoclonic jerks. We took her to ER. After 6 hours, she was non-responsive to medication so she was ambulance transported to another hospital. After one week of hospitalization her condition was unimproved and non responsive to medication or treatment. Neurological and Psychiatric physician team evaluation differential diagnosis included, auto-immune reaction to H1N1 vaccine, serotonin "storm" reaction to medication, and convergence disorder. With further MRI and lumbar puncture testing, however, abnormal findings were noted on her brain MRI. She was released from the hospital back to her primary care provider. I filed a VAERS/CDC report on 12/5/09 just prior to this time frame when she was still in the hospital. Recommendations from physician's were Neurological follow up, Counseling, and Acupuncture for her continued tremors as she was non responsive to medication. Doctor concurred with these recommendations, however, based on MRI findings she "fast tracked" a Neurological referral for second opinion. Doctor obtained a second set of MRI studies and based on examination and comparative MRI findings was of the impression she experienced an auto-immune reaction to the H1N1 Intra-nasal vaccine. I updated VAERS/CDC via phone in regards of this as of 1/11/10. Doctor prescribed medication, recommended continued passive therapies and supportive counseling measures and planned to follow up on a quarterly bases with MRI studies and examination. She received Acupuncture treatment, and was referred to this physician initially by the physicians at the hospital, and subsequently referred by two other doctors. Objectively it was noticed during the course of acupuncture treatment that the severity of her tremors and myoclonic jerks reduced during the course of the treatment session. Doctor also prescribed homeopathic and naturopathic medications which also seemed to help. Her condition subjectively and objectively improved over a four month duration and I would now say that her symptoms have essentially resolved. However, her 20-30 punctate lesions in her brain noted on her MRI studies are troubling. Doctor's prognosis is good and anticipates continued improvement with the tincture of time. At this time he plans on continuing to follow her on a quarterly basis with continued MRI studies prior to follow up evaluation. With the exception of one doctor, she is currently not receiving any other follow ups or formal treatment related to the auto-immune reaction to the H1N1 vaccine at this time.
Age: 13.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Lumbar puncture, Myoclonus, Nuclear magnetic resonance imaging brain abnormal, Serotonin syndrome, Tremor
Clinical narrative: My 13 year old daughter received an Intra-nasal attenuated H1N1 vaccination on November 25, 2009. Roughly a week later on December 2, 2009, she had onset of constant muscle tremors, seizures, and myoclonic jerks. We took her to ER. After 6 hours, she was non-responsive to medication so she was ambulance transported to another hospital. After one week of hospitalization her condition was unimproved and non responsive to medication or treatment. Neurological and Psychiatric physician team evaluation differential diagnosis included, auto-immune reaction to H1N1 vaccine, serotonin "storm" reaction to medication, and convergence disorder. With further MRI and lumbar puncture testing, however, abnormal findings were noted on her brain MRI. She was released from the hospital back to her primary care provider. I filed a VAERS/CDC report on 12/5/09 just prior to this time frame when she was still in the hospital. Recommendations from physician's were Neurological follow up, Counseling, and Acupuncture for her continued tremors as she was non responsive to medication. Doctor concurred with these recommendations, however, based on MRI findings she "fast tracked" a Neurological referral for second opinion. Doctor obtained a second set of MRI studies and based on examination and comparative MRI findings was of the impression she experienced an auto-immune reaction to the H1N1 Intra-nasal vaccine. I updated VAERS/CDC via phone in regards of this as of 1/11/10. Doctor prescribed medication, recommended continued passive therapies and supportive counseling measures and planned to follow up on a quarterly bases with MRI studies and examination. She received Acupuncture treatment, and was referred to this physician initially by the physicians at the hospital, and subsequently referred by two other doctors. Objectively it was noticed during the course of acupuncture treatment that the severity of her tremors and myoclonic jerks reduced during the course of the treatment session. Doctor also prescribed homeopathic and naturopathic medications which also seemed to help. Her condition subjectively and objectively improved over a four month duration and I would now say that her symptoms have essentially resolved. However, her 20-30 punctate lesions in her brain noted on her MRI studies are troubling. Doctor's prognosis is good and anticipates continued improvement with the tincture of time. At this time he plans on continuing to follow her on a quarterly basis with continued MRI studies prior to follow up evaluation. With the exception of one doctor, she is currently not receiving any other follow ups or formal treatment related to the auto-immune reaction to the H1N1 vaccine at this time.
Age: 13.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Vaccination complication
Clinical narrative: My 13 year old daughter received an Intra-nasal attenuated H1N1 vaccination on November 25, 2009. Roughly a week later on December 2, 2009, she had onset of constant muscle tremors, seizures, and myoclonic jerks. We took her to ER. After 6 hours, she was non-responsive to medication so she was ambulance transported to another hospital. After one week of hospitalization her condition was unimproved and non responsive to medication or treatment. Neurological and Psychiatric physician team evaluation differential diagnosis included, auto-immune reaction to H1N1 vaccine, serotonin "storm" reaction to medication, and convergence disorder. With further MRI and lumbar puncture testing, however, abnormal findings were noted on her brain MRI. She was released from the hospital back to her primary care provider. I filed a VAERS/CDC report on 12/5/09 just prior to this time frame when she was still in the hospital. Recommendations from physician's were Neurological follow up, Counseling, and Acupuncture for her continued tremors as she was non responsive to medication. Doctor concurred with these recommendations, however, based on MRI findings she "fast tracked" a Neurological referral for second opinion. Doctor obtained a second set of MRI studies and based on examination and comparative MRI findings was of the impression she experienced an auto-immune reaction to the H1N1 Intra-nasal vaccine. I updated VAERS/CDC via phone in regards of this as of 1/11/10. Doctor prescribed medication, recommended continued passive therapies and supportive counseling measures and planned to follow up on a quarterly bases with MRI studies and examination. She received Acupuncture treatment, and was referred to this physician initially by the physicians at the hospital, and subsequently referred by two other doctors. Objectively it was noticed during the course of acupuncture treatment that the severity of her tremors and myoclonic jerks reduced during the course of the treatment session. Doctor also prescribed homeopathic and naturopathic medications which also seemed to help. Her condition subjectively and objectively improved over a four month duration and I would now say that her symptoms have essentially resolved. However, her 20-30 punctate lesions in her brain noted on her MRI studies are troubling. Doctor's prognosis is good and anticipates continued improvement with the tincture of time. At this time he plans on continuing to follow her on a quarterly basis with continued MRI studies prior to follow up evaluation. With the exception of one doctor, she is currently not receiving any other follow ups or formal treatment related to the auto-immune reaction to the H1N1 vaccine at this time.
Age: 31.0
Sex: M
Vaccine: ANTH, FLU(H1N1)
Symptoms: Muscle strain, Muscle tightness, Neck pain
Clinical narrative: Right side of his neck started to become tight and sore. No breathing difficulty or swelling noted.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy skin, Condition aggravated, Rash pruritic, Skin discolouration
Clinical narrative: Diffuse pruritic rash after first vaccination. Rash slowly worsened after the next two vaccinations in series. Resulted in discoloration of skin.