chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Drug exposure during pregnancy, Neonatal disorder, Pregnancy test positive
Clinical narrative: Information has been received from a physician, from a completed questionnaire, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 1 day old male baby whose mother on 10-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) and a dose of MMR II (MSD), while she was pregnant. On 13-MAY-2010 the baby was born with a weight of 3360 gm and was normal. It was reported that he had elongated anterior fontanelle but soft not bulging. At the time of the report, the outcome of the baby was unknown. The mother's experience has been captured in WAES 0910USA02809. Additional information is not expected.
Sex: M
Vaccine: VARCEL, MMR, VARCEL
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a physician, from a completed questionnaire, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 1 day old male baby whose mother on 10-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) and a dose of MMR II (MSD), while she was pregnant. On 13-MAY-2010 the baby was born with a weight of 3360 gm and was normal. It was reported that he had elongated anterior fontanelle but soft not bulging. At the time of the report, the outcome of the baby was unknown. The mother's experience has been captured in WAES 0910USA02809. Additional information is not expected.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV, MMR, DTAP, HIBV, MMR
Symptoms: Excoriation, Injection site erythema, Injection site haemorrhage, Injection site induration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 15-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included HIB (non-gsk); non-GSK manufacturer given on 14 March 2011; MMR vaccine (non-gsk); non-GSK manufacturer given on 14 March 2011. On 14 March 2011 at 10:20 the subject received 4th dose of INFANRIX (unknown route, left arm). On an unspecified date in March 2011, less than one week after vaccination with INFANRIX, the subject experienced injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified.
Age: 1.28
Sex: F
Vaccine: DTAP, HIBV, MMR, DTAP, HIBV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 15-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included HIB (non-gsk); non-GSK manufacturer given on 14 March 2011; MMR vaccine (non-gsk); non-GSK manufacturer given on 14 March 2011. On 14 March 2011 at 10:20 the subject received 4th dose of INFANRIX (unknown route, left arm). On an unspecified date in March 2011, less than one week after vaccination with INFANRIX, the subject experienced injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified.
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Alanine aminotransferase increased, Alpha 1 foetoprotein normal, Aspartate aminotransferase increased, Blood albumin decreased, Blood creatinine normal
Clinical narrative: Information has been received from a registered nurse via medical records, concerning a female baby who was delivered at 36 weeks. On 10-SEP-2009 the baby's mother was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not provided). On the same day, the patient also received the first dose of MMR II (MSD). On 14-OCT-2009, the patient received the second dose of VARIVAX (Merck) and the second dose of MMR II (MSD) (lot # not provided). Concomitant therapy included vitamins (unspecified), PREVACID and ZOFRAN. Subsequently, the mother became pregnant, her LMP was 02-NOV-2009 and EDD was 09-AUG-2010. The mother delivered a normal, healthy female baby weighing 6 pounds 15 ounces at 36 weeks and had a 36 week induction. The reason for the 36 week induction was that the patient had elevated liver testing (ALT 108 and AST 75). The mother's experience has been captured in WAES#1001USA01169. Additional information is not requested. All available medical records will be provided upon request.
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Blood human chorionic gonadotropin positive, Blood urea decreased, Drug exposure during pregnancy, Eosinophil count increased, Haematemesis
Clinical narrative: Information has been received from a registered nurse via medical records, concerning a female baby who was delivered at 36 weeks. On 10-SEP-2009 the baby's mother was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not provided). On the same day, the patient also received the first dose of MMR II (MSD). On 14-OCT-2009, the patient received the second dose of VARIVAX (Merck) and the second dose of MMR II (MSD) (lot # not provided). Concomitant therapy included vitamins (unspecified), PREVACID and ZOFRAN. Subsequently, the mother became pregnant, her LMP was 02-NOV-2009 and EDD was 09-AUG-2010. The mother delivered a normal, healthy female baby weighing 6 pounds 15 ounces at 36 weeks and had a 36 week induction. The reason for the 36 week induction was that the patient had elevated liver testing (ALT 108 and AST 75). The mother's experience has been captured in WAES#1001USA01169. Additional information is not requested. All available medical records will be provided upon request.
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Haematocrit decreased, Labour induction, Liver function test abnormal, Lymphocyte count increased, Monocyte count increased
Clinical narrative: Information has been received from a registered nurse via medical records, concerning a female baby who was delivered at 36 weeks. On 10-SEP-2009 the baby's mother was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not provided). On the same day, the patient also received the first dose of MMR II (MSD). On 14-OCT-2009, the patient received the second dose of VARIVAX (Merck) and the second dose of MMR II (MSD) (lot # not provided). Concomitant therapy included vitamins (unspecified), PREVACID and ZOFRAN. Subsequently, the mother became pregnant, her LMP was 02-NOV-2009 and EDD was 09-AUG-2010. The mother delivered a normal, healthy female baby weighing 6 pounds 15 ounces at 36 weeks and had a 36 week induction. The reason for the 36 week induction was that the patient had elevated liver testing (ALT 108 and AST 75). The mother's experience has been captured in WAES#1001USA01169. Additional information is not requested. All available medical records will be provided upon request.
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Nausea, Neutrophil count increased, Premature delivery, Rash, Rash pruritic
Clinical narrative: Information has been received from a registered nurse via medical records, concerning a female baby who was delivered at 36 weeks. On 10-SEP-2009 the baby's mother was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not provided). On the same day, the patient also received the first dose of MMR II (MSD). On 14-OCT-2009, the patient received the second dose of VARIVAX (Merck) and the second dose of MMR II (MSD) (lot # not provided). Concomitant therapy included vitamins (unspecified), PREVACID and ZOFRAN. Subsequently, the mother became pregnant, her LMP was 02-NOV-2009 and EDD was 09-AUG-2010. The mother delivered a normal, healthy female baby weighing 6 pounds 15 ounces at 36 weeks and had a 36 week induction. The reason for the 36 week induction was that the patient had elevated liver testing (ALT 108 and AST 75). The mother's experience has been captured in WAES#1001USA01169. Additional information is not requested. All available medical records will be provided upon request.
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Ultrasound antenatal screen normal, Vomiting, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse via medical records, concerning a female baby who was delivered at 36 weeks. On 10-SEP-2009 the baby's mother was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not provided). On the same day, the patient also received the first dose of MMR II (MSD). On 14-OCT-2009, the patient received the second dose of VARIVAX (Merck) and the second dose of MMR II (MSD) (lot # not provided). Concomitant therapy included vitamins (unspecified), PREVACID and ZOFRAN. Subsequently, the mother became pregnant, her LMP was 02-NOV-2009 and EDD was 09-AUG-2010. The mother delivered a normal, healthy female baby weighing 6 pounds 15 ounces at 36 weeks and had a 36 week induction. The reason for the 36 week induction was that the patient had elevated liver testing (ALT 108 and AST 75). The mother's experience has been captured in WAES#1001USA01169. Additional information is not requested. All available medical records will be provided upon request.
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Drug exposure before pregnancy, Labour induction, Liver function test abnormal
Clinical narrative: Information has been received from a registered nurse via medical records, concerning a female baby who was delivered at 36 weeks. On 10-SEP-2009 the baby's mother was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not provided). On the same day, the patient also received the first dose of MMR II (MSD). On 14-OCT-2009, the patient received the second dose of VARIVAX (Merck) and the second dose of MMR II (MSD) (lot # not provided). Concomitant therapy included vitamins (unspecified), PREVACID and ZOFRAN. Subsequently, the mother became pregnant, her LMP was 02-NOV-2009 and EDD was 09-AUG-2010. The mother delivered a normal, healthy female baby weighing 6 pounds 15 ounces at 36 weeks and had a 36 week induction. The reason for the 36 week induction was that the patient had elevated liver testing (ALT 108 and AST 75). The mother's experience has been captured in WAES#1001USA01169. Additional information is not requested. All available medical records will be provided upon request.
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Premature delivery
Clinical narrative: Information has been received from a registered nurse via medical records, concerning a female baby who was delivered at 36 weeks. On 10-SEP-2009 the baby's mother was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not provided). On the same day, the patient also received the first dose of MMR II (MSD). On 14-OCT-2009, the patient received the second dose of VARIVAX (Merck) and the second dose of MMR II (MSD) (lot # not provided). Concomitant therapy included vitamins (unspecified), PREVACID and ZOFRAN. Subsequently, the mother became pregnant, her LMP was 02-NOV-2009 and EDD was 09-AUG-2010. The mother delivered a normal, healthy female baby weighing 6 pounds 15 ounces at 36 weeks and had a 36 week induction. The reason for the 36 week induction was that the patient had elevated liver testing (ALT 108 and AST 75). The mother's experience has been captured in WAES#1001USA01169. Additional information is not requested. All available medical records will be provided upon request.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: on 5/17 mother noticed redness and selling right upper thigh warm and cool compresses Motrin was given 5/18 redness and swelling increased since 5/17 entire thigh swollen, reddened and sore
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, mild swelling, itching/discomfort or right upper arm. No fevers or other illness. Treatment with Motrin/Tylenol and prn Benadryl
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1, RV1, DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Haematochezia
Clinical narrative: 3A noticed blood in the stool on 5/17/2011 and then a couple of times this A.M. 97.6 Ax. Pt had an appt at clinic.
Age: 0.35
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Diarrhoea, Screaming, Vomiting
Clinical narrative: Father states at about 8:15p 4/25, pt started crying/shrieking. Diarrhea x 3, 4/24 to 4/25. Vomited copius mass x 1 4/22/11. An hour after the crying started on 4/25, pt was smiling, seeming better. Parents think it was reaction to RV.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Grand mal convulsion
Clinical narrative: Immunization 2/22/11 DTaP, PREVNAR, Varicella - grand mal seizure 2/25/11. Immunization HIB given 5/12/11 - grand mal seizure 5/14/11.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Intussusception, Ultrasound scan
Clinical narrative: Information has been received from a physician concerning a 16 week old female patient who on 21-MAR-2011 was vaccinated orally with a dose of ROTATEQ (lot number 668951/1136Z). Concomitant therapy included oral vitamin D supplement. On 04-MAY-2011 the patient developed intussusception and was hospitalized but the intussusception resolved on its own without treatment the same day it was discovered on 04-MAY-2011. Diagnostic laboratory test ultrasound was performed, no result provided. A lot check has been initiated. Intussusception was considered to be immediately life-threatening. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Eye disorder, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient received Tdap in R Deltoid IM and Hepatitis B vaccine in L Deltoid. In approximately 5 minutes post vaccination, the patient complained that the right foot and leg was getting numb and tingling. Patient remained in clinic for approx. 30 minutes.  Vital signs were WNL.  Patient reported that he felt like his eye were dilated (pupils were not dilated). The numbness/tingling remained in the Rt. lower extremity and this did improve but did not fully resolve prior to his leaving the clinic. Nurse spoke with the patient on 5/12/11 and patient reported that symptoms fully resolved.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Abnormal behaviour, Anxiety, Decreased eye contact, Dissociation, Fatigue
Clinical narrative: Fever, felt sick and achy all over, behavior change, anxious, personality change, very anxious, upset, extremely tired.  Injection site VERY sore, and swollen.  Personality is not the same!!  Very shot with others, anti-social, trouble looking others in the eye.  Have NEVER had anything like this before.  Trouble organizing thoughts!!!  Calls to PCP, then on his recommendation went to ER on 5/17/2011.  Saw PA and Physician.  instruction was to take OTC pain killer/anti-inflammatory and wait until 10 days post vaccination for side effects to clear.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain, Personality change
Clinical narrative: Fever, felt sick and achy all over, behavior change, anxious, personality change, very anxious, upset, extremely tired.  Injection site VERY sore, and swollen.  Personality is not the same!!  Very shot with others, anti-social, trouble looking others in the eye.  Have NEVER had anything like this before.  Trouble organizing thoughts!!!  Calls to PCP, then on his recommendation went to ER on 5/17/2011.  Saw PA and Physician.  instruction was to take OTC pain killer/anti-inflammatory and wait until 10 days post vaccination for side effects to clear.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Social avoidant behaviour
Clinical narrative: Fever, felt sick and achy all over, behavior change, anxious, personality change, very anxious, upset, extremely tired.  Injection site VERY sore, and swollen.  Personality is not the same!!  Very shot with others, anti-social, trouble looking others in the eye.  Have NEVER had anything like this before.  Trouble organizing thoughts!!!  Calls to PCP, then on his recommendation went to ER on 5/17/2011.  Saw PA and Physician.  instruction was to take OTC pain killer/anti-inflammatory and wait until 10 days post vaccination for side effects to clear.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain
Clinical narrative: Chills, red sore injection site.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Blood glucose normal, Fatigue, Headache, Streptococcus test, Urine analysis normal
Clinical narrative: Fatigue & HA severe post MENACTRA.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: Patient reports a black spot, redness and pain lasting 1.5 yrs from where she believes her vaccination site occurred.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: Patient reports a black spot, redness and pain lasting 1.5 yrs from where she believes her vaccination site occurred.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Five erythematous rash on chest, back, arms & face appeared night of vaccine administration. - (+) itchy.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site mass, Pruritus
Clinical narrative: Imm Varicella (L) arm SQ given 4/27/11. Pt noticed red bump (Length 1 1/2 inches x 1in) Left - SQ area - of (L) arm today posterior c/o itching. No other adverse sx arm.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose normal, Dizziness, Presyncope
Clinical narrative: Patient became lightheaded after receiving vaccination, almost fainted.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 3" area on left deltoid, swollen, tender for over a month.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pain, Pruritus
Clinical narrative: Reddened raised area approx. 8 mm with swelling around area. Has pain and itching. Started after varicella shot on 3/29/11. Applied cold compress no other treatment.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pallor, Rash papular
Clinical narrative: Papular skin rash blanching, no pruritic, sparse. No fever. No other symptoms.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Macule, Rash, Urticaria
Clinical narrative: He broke out into rash within 1 to 2 min after the immunizations, on my exam he has 2 wheals about 1/2 inch on Rt forearm, few macules on (L) arm & back & neck, he was not wheezing, no intercostal retraction, we gave him 1/2 tsp of VERIPRED 20 mg/5ml, mom was advised to stay in the room to watch for allergic reaction, mom left against medical advise.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pyrexia, Rash, Swelling face
Clinical narrative: Imms. given at 1:30, child awoke from nap at 3:30 with fever on 104.2 (per mom), swelling in face, rash on face, neck & upper chest, gave child MOTRIN & was taken to ER at 5 pm. S/S improved by 5:30 pm when seen by MD in ER & no treatment needed.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Cellulitis at injection site (4.1 x 3.3 x about 0.3 cm). Red and hot without lymphatic streaking or enlarged regional nodes. No fever. Tx: clindamycin.
Age: 0.58
Sex: F
Vaccine: HEP, HIBV, IPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Went to ER 4/30/11 with hives, was tx with prednisone and BENADRYL, seen back in office 5/3/11 still having random hives advised to complete meds. Back to ER 5/5/11 with more hives and fever tx with prednisone, BENADRYL, TYLENOL. Seen 5/7/11 for follow up and advised to cont meds & follow up if worsens or persists.
Age: 1.44
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Mom called MD in mid-March concerned that patient's speech had decreased & he was not saying new words & maybe fewer words than before. She is not sure exactly when it started but feels it was after Nov 2010.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Pruritus
Clinical narrative: Immediately after vaccination with ZOSTAVAX, patient said her arm was "slightly itchy". She wasn't sure if she was having a reaction. She was observed for about 15 minutes - no signs of hives or trouble breathing. She left & called us later to let us know she was fine with no further reaction.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus
Clinical narrative: Immediately after vaccination with ZOSTAVAX, patient said her arm was "slightly itchy". She wasn't sure if she was having a reaction. She was observed for about 15 minutes - no signs of hives or trouble breathing. She left & called us later to let us know she was fine with no further reaction.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm began swelling at injection site and around entire upper arm with mild erythema and warmth to skin.
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: increased Pain, redness, swelling at site
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Localized reaction, redness, firm started to spread, treated for possible cellulitis 2nd to vaccine administration.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Severe swelling, redness & itching requiring several days treatment with BENADRYL & CLARITIN.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Mass, Rash
Clinical narrative: Pt came to pharmacy stating a mild rash on left arm, a lump in elbow crease area, redness where injection admin., warmth to area and mild swelling. She was going to call her physician as well.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt received MMR and Varicella vaccine 5/9/11, developed a fever 5/12/11 102.7, had 2 seizures, one last 10 minutes the other 7 minutes. Taken to nearest ER via rescue.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Dyspnoea, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Pt presented 5-16-11 reporting that evening after receiving vaccine (6-13-06), arm swollen and pain in arm & "throughout body". "My body was paralyzed." Also c/o weakness and shortness of breath. No documentation of adverse reaction when pt. returned 6-16-06 for MMR.
Age: 51.0
Sex: M
Vaccine: HEPAB
Symptoms: Paralysis
Clinical narrative: Pt presented 5-16-11 reporting that evening after receiving vaccine (6-13-06), arm swollen and pain in arm & "throughout body". "My body was paralyzed." Also c/o weakness and shortness of breath. No documentation of adverse reaction when pt. returned 6-16-06 for MMR.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Body temperature, Dizziness, Fatigue, Injection site pain, Pallor
Clinical narrative: Very dizzy, pale, temp at school, tired acting 5-9-11 through 5-11-11. Pain at injection site.
Age: 21.0
Sex: M
Vaccine: TD, TYP
Symptoms: Cold sweat, Fall, Head injury, Limb injury, Loss of consciousness
Clinical narrative: 5 min after admin patient lost consciousness & fell to floor in lobby of the Health Department. Hit head & (L) inner arm. Unconscious 1-2 min - B/P 110/82 pale clammy. Pupils react to light. Alert. Provided with ginger ale. Family member was notified - here to drive patient - advised evaluation by physician today.
Age: 21.0
Sex: M
Vaccine: TD, TYP
Symptoms: Pallor
Clinical narrative: 5 min after admin patient lost consciousness & fell to floor in lobby of the Health Department. Hit head & (L) inner arm. Unconscious 1-2 min - B/P 110/82 pale clammy. Pupils react to light. Alert. Provided with ginger ale. Family member was notified - here to drive patient - advised evaluation by physician today.
Age: 4.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: None - client received an extra dose of Polio & should have received a PCV instead.
Sex: M
Vaccine: SMALL
Symptoms: Chills, Decreased appetite, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Initial report received from the patient on 05 May 2011. A male patient (date of birth not provided) had received a dose of ACAM2000 (lot number, route and site of administration unknown) on 26 April 2011 and 9 days later on 04 May 2011 complained of flu-like symptoms of headache, chills, tiredness, lethargy, loss of appetite and dizziness. He also was feeling like he could not take a deep breath and that it seemed like he could only take in 70-80% of a breath. It was not reported whether the patient required medical evaluation or treatment. The patient had no concurrent illnesses, no known allergies and no use of other medications. He does however have a history of right bundle branch block. At the time of this report, the patient had not recovered. Documents held by sender: None.
Sex: M
Vaccine: SMALL
Symptoms: Headache, Influenza like illness, Lethargy
Clinical narrative: Initial report received from the patient on 05 May 2011. A male patient (date of birth not provided) had received a dose of ACAM2000 (lot number, route and site of administration unknown) on 26 April 2011 and 9 days later on 04 May 2011 complained of flu-like symptoms of headache, chills, tiredness, lethargy, loss of appetite and dizziness. He also was feeling like he could not take a deep breath and that it seemed like he could only take in 70-80% of a breath. It was not reported whether the patient required medical evaluation or treatment. The patient had no concurrent illnesses, no known allergies and no use of other medications. He does however have a history of right bundle branch block. At the time of this report, the patient had not recovered. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a now 13 year old male with no drug reaction/allergies and no pertinent medical history, who on 01-OCT-1998 was vaccinated with a first dose of VARIVAX (Merck) (dose, route and lot # not reported), a dose of DTP (unspecified) and dose MMR II (MSD). On 22-AUG-2008 the patient was vaccinated with a second dose of VARIVAX (Merck) (dose and route not reported, lot # 660671/0430X). After receiving doses of VARIVAX (Merck), the patient presented with a case of shingles. On 14-FEB-2011 the patient visited the office for this case and was given oral prednisone. No diagnostic laboratory tests were performed. At the time of the report, the patient's outcome was unknown. According to the reporter the patient's shingles was considered to be disabling with "a significant pain". Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test, Blister, Herpes zoster, Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 4 year old male patient with a history of bone marrow transplant from brother for Hemochromatosis (histiocytosis) in 2008 and no history of chickenpox who on an unspecified date was vaccinated with VARIVAX (Merck) (site of vaccination unknown). On 06-MAR-2011 the patient experienced herpes zoster (dermatome L2, 3, 4) from right thigh to generalized. There were about 50 vesicles lesions that distributed at right thigh, face and chest. The physician also added that she was unsure if the patient was vaccinated for chicken pox and the patient titer was .04; the brother was vaccinated and had a titer of 2.7 and 2.26 prior to treatment. 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. A skin lesion sample was collected on 08-MAR-2011. The final result was vaccine strain. On 09-MAR-2011, the patient had a fever of 102.0 F degrees. The patient was hospitalized briefly for antiviral therapy. The patient was treated with acyclovir. At the time of reporting, the patient was recovering. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 4 year old male patient with a history of bone marrow transplant from brother for Hemochromatosis (histiocytosis) in 2008 and no history of chickenpox who on an unspecified date was vaccinated with VARIVAX (Merck) (site of vaccination unknown). On 06-MAR-2011 the patient experienced herpes zoster (dermatome L2, 3, 4) from right thigh to generalized. There were about 50 vesicles lesions that distributed at right thigh, face and chest. The physician also added that she was unsure if the patient was vaccinated for chicken pox and the patient titer was .04; the brother was vaccinated and had a titer of 2.7 and 2.26 prior to treatment. 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. A skin lesion sample was collected on 08-MAR-2011. The final result was vaccine strain. On 09-MAR-2011, the patient had a fever of 102.0 F degrees. The patient was hospitalized briefly for antiviral therapy. The patient was treated with acyclovir. At the time of reporting, the patient was recovering. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a registered nurse concerning a patient who on an unknown date, was vaccinated with a dose of VARIVAX (Merck) (route and lot not reported). The nurse reported that on unspecified date the patient may had experienced a seizure after receiving VARIVAX (Merck). At the time of the report the outcome of the patient was unknown. Upon internal review, the patient may had experienced a seizure was considered to be an other important medical event. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Henoch-Schonlein purpura
Clinical narrative: Information has been received from a physician concerning a 3 year old female with sulfonamide and amoxicillin allergy and no pertinent medical history, who in December 1997, was vaccinated with a dose of VARIVAX (Merck) (lot # ). There was no concomitant medication. The physician reported that in January 1999, the patient developed severe Henoch-Shonlein purpura after administration of VARIVAX (Merck). The patient was hospitalized and treated with steroids. On an unknown date, the patient recovered from Henoch-Shonlein purpura. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Impaired work ability, Varicella post vaccine
Clinical narrative: Information has been received from an advanced nurse practitioner concerning a male patient who, on an unspecified date, was vaccinated with a dose of VARIVAX (Merck) (Lot # and expire date not reported), subcutaneously. The patient received the injection of VARIVAX (Merck) and came down with varicella 10 days later. Patient was not hospitalized, but went on Workman's Compensation. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Varicella was considered to be disabling by the advanced nurse practitioner. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Rash vesicular, Varicella virus test positive
Clinical narrative: Information has been received from a clinical laboratory director concerning a 12 month old male patient who on an unspecified date was vaccinated with "the standard dose" of VARIVAX (Merck) injection (Lot# not provided). It was reported that 2 months after receiving the vaccination shot, the patient developed a zoster rash. It was reported that a pediatric Vaccine HSA who works with the laboratory director had an isolate with a vaccine type virus. The lab director reported that the sample was DFA positive and PCR positive for varicella zoster virus (VZV). 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 mild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Zoster rash was considered to be disabling for the physician. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test, Rash vesicular
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 36 month old male (reported as 3 year old) with a history of eczema and never had chicken pox and was not exposed to chicken pox who in 2009 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported). The patient also had eczema before vaccination and was treated with corticosteroids (unspecified) "steroids" and antihistamines periodically (steroids and antihistamines also reported as concomitant medications). In August 2010, the patient experienced a zoster rash and resulting in hospitalization on 30-AUG-2010. He was discharged after a few days. The lab diagnostics studies reported as "isolated". At this time of reporting, the outcome of zoster rash was unknown. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Woke up with numbness on thorax region of torso.  Still present today.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Breast pain, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: MILD PAIN IN RIGHT ARM EVENING 5/16/11.  WENT TO WORK 6/17/11 NOTICED PAIN AND FEVER.  PAIN IN RIGHT LATERAL BREAST, NECK, SHOULDER, UPPER ARM.  VOMITED X 2 EVENING.  AREAS NOW TENDER TO TOUCH. NO REDNESS, SWELLING, WARMTH AT INJECTION SITE.  NO RIGHT AXILLA NODE SWELLING. ABLE TO MOVE ARM. HURTS TO LIFT ARM. REFERRED TO ER/URGENT CARE/MD. IF NO IMPROVEMENT OR INCREASED PAIN.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Tenderness, Vomiting
Clinical narrative: MILD PAIN IN RIGHT ARM EVENING 5/16/11.  WENT TO WORK 6/17/11 NOTICED PAIN AND FEVER.  PAIN IN RIGHT LATERAL BREAST, NECK, SHOULDER, UPPER ARM.  VOMITED X 2 EVENING.  AREAS NOW TENDER TO TOUCH. NO REDNESS, SWELLING, WARMTH AT INJECTION SITE.  NO RIGHT AXILLA NODE SWELLING. ABLE TO MOVE ARM. HURTS TO LIFT ARM. REFERRED TO ER/URGENT CARE/MD. IF NO IMPROVEMENT OR INCREASED PAIN.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: SWELLING AND REDNESS ON THE SIDE OF THE SHOT, SWELLING AND REDNESS ON BOTH UNCLES, BENADRYL 50MG IM WERE GIVEN TO THE PT. IN OUR OFF.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: hard to breathe
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: C-reactive protein normal, Mental status changes, Streptococcus test, Streptococcus test negative, Toxicologic test normal
Clinical narrative: significant acute mental status change, possible psychotic episode, required emergency room visit and short-stay observation
Age: 0.27
Sex: F
Vaccine: DTAPHEPBIP, HEP, PPV, RVX
Symptoms: Faeces discoloured, Haematochezia, Mucous stools
Clinical narrative: Approximately 48 hours after the rota virus vaccine, my daughter, an exclusive breastfed baby, had a bloody stool followed by green mucus stool. She has continued to have these types of diapers off and on for the past two months. We have tried eliminating dairy, soy, eggs, and nuts from my (the mother) diet. We tried to give her the Similac Alimentum formula, but she would not take it. Her diapers continue to have bloody and green mucus every couple days.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Patient developed a red mark surrounding injection site, tender to touch, warm, swollen. 5.5 x 6 centimeters on (L) deltoid - urticarial welt.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Throat irritation, Urticaria
Clinical narrative: Pt c/o itchy throat. Then developed hives all over. EPI-PEN Jr was administered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Pharyngeal oedema
Clinical narrative: Gave pt. shingles vaccine at 11:45 on 5-18-11. She came back to clinic at 2:27 with c/o mild throat swelling & generalized body weakness. Throat swelling resolved by dc. Weakness was resolving. Given 25mg BENADRYL rx'd.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: H/O swelling on 5/17/11 & itching - on Rt thigh. No pain. Itching (+).
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Allergy test negative, Urticaria
Clinical narrative: Recurrent urticaria for 8 wks after vaccination then resolved. Allergy MD agrees poss vaccine rxn.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 4 x 6 inch redness, swelling, (L) anterior thigh within 48 hours of vaccination.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Dermatitis, Erythema, Induration, Skin warm
Clinical narrative: Red, inflamed, tender, hot skin are with induration, marked the outer edges, almost 8cm long and 6 cm wide - going on for 7 days, looks like cellulitis --> prescribe antibiotics, hot compresses and follow up.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Red, inflamed, tender, hot skin are with induration, marked the outer edges, almost 8cm long and 6 cm wide - going on for 7 days, looks like cellulitis --> prescribe antibiotics, hot compresses and follow up.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Pt. held breath while receiving vaccines. She passed out & had a seizure lasting abt 10 sec. She came to with the ammonia salts - we kept her for over an hour - her pulse & resp were regular. Color good prior to sending her home. Dr was aware. She was fine when I called to check on her both that evening & the next morning. Pt. was also fine & parents said she had no further problems when she ret. 2 days later for TB reading.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Cellulitis, Herpes zoster, Infection, Infectious disease carrier, Pain
Clinical narrative: Information has been received from a physician concerning a 16 year old male with no pertinent medical history and no drug reactions/allergies who on 25-JUL-2008 was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot # 659952/0328X). Concomitant therapy included MENACTRA. On 04-MAR-2010 the patient experienced shingles "at spinal vertebrae L2 and L3". To treat the AE, the patient was given ZOVIRAX (manufacturer/description unspecified), an unspecified antibiotic and an unspecified steroid. At the time of the report, the patient recovered on an unspecified date. Follow up information has been received from a physician concerning a 16 year old male patient who on 25-JUL-2008 was vaccinated with second dose of VARIVAX (Merck) (lot # 659952/0328X) in his left arm. Concomitant therapy in the left arm included MENACTRA. In the afternoon of 04-MAR-2010 the patient developed shingles at L2 and L3 and got worse after 48 hours. The patient was given ZOVIRAX and ANH for secondary infection and steroids for infectious disease reaction confirmed by dermatologist. At the time of the report, the patient had recovered at unspecified date. Follow up information has been received from the physician who reported that she already sent in a form but would send it again. She did not think this qualified as an adverse event because the vaccine was given "a long time ago". She felt that this was not properly classified and thought it was being "lumped" with other reported adverse events. No additional AE information provided. Follow up information has been received from the physician concerning the patient who on 25-JUL-2008, was vaccinated with the second dose of VARIVAX (Merck) (lot # 659952/0328X) on the left. No rash occurred at the site of injection or elsewhere within 42 days of the vaccination. On 04-MAR-2010 the patient experienced herpes zoster at L2 and L3. Maximum temperature was 98.1degree F. The pain was quantified as 6 to 7. Other systemic symptoms included early cellulitis. There was not a history of chickenpox. There was no recent exposure to chickenpox or herpes zoster. Direct fluorescent antibody was not done. No specimen was collected for PCR. No photo was taken. The patient was referred to Dermatology who conferred and agreed with the diagnosis. The patient had recovered on unspecified date. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaemia, Delivery, Drug exposure during pregnancy, Ultrasound antenatal screen normal, Urine human chorionic gonadotropin positive
Clinical narrative: Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 25 year old female with no drug allergies and had recently immigrated from other country and a PPD had converted but a chest X-ray was negative so she had been referenced to the tuberculosis clinic (possible latent tuberculosis vs. exposure) who on 23-FEB-2010 was vaccinated at the health department with the first 0.5 mL dose of VARIVAX (Merck) (LOT# not reported). There was no concomitant medication. It was reported that the patient now was pregnant; and ultrasound had not been performed yet but was being scheduled. The pregnancy was confirmed by positive home pregnancy test and later confirmed by positive urine pregnancy test. The LMP was possibly on 20-JAN-2010; EDD is approximately on 27-OCT-2010. The patient would possibly need to be treated with isoniazid and vitamin B-6 for tuberculosis. Prenatal vitamins had started. Follow-up information has been received from a completed questionnaire, the physician concerning the female patient with none previous pregnancy history and positive for TB scan test before currently pregnancy (not on anti-TB medications for now) who during this pregnancy was taken prenatal vitamin with folic acid and pynoxide 1 tablet once a day from 09-APR-2010, and ferrous sulfate, 325 mg once a day indication for anemia from 10-SEP-2010. There was no complication during pregnancy or complication during labor/delivery or infections/illnesses during pregnancy. Monthly ultrasound for pregnancy performed on 22-APR-2010, 24-JUN-2010 and 08-OCT-2010 were normal. On 24-OCT-2010 at the 39 weeks from LMP, the patient delivered a male infant, weight 6 pounds and 6 ounces. The male infant was healthy with no congenital anomalies or other complications/abnormalities. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an about 3 year old male who in late 2008 was vaccinated with the second dose of VARIVAX (Merck) (LOT # not reported). In January 2009, the patient had shingles on his hand and forearm. There was no diagnosis nor lab study performed. Unspecified medical attention was sought. On an unspecified date, the patient recovered from shingles. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Herpes zoster, Pruritus, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female patient with no pertinent medical history, egg allergy and lactose intolerance who on 08-MAY-1999, was vaccinated SQ with the first 0.5ml dose of VARIVAX (Merck) and on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (Lot# 659360/1577U). Concomitant therapy included ZYRTEC. On 05-APR-2010, the patient developed shingles. The patient had a linear popular vesicular rash on her trunk and "a small line" on her buttocks and her upper leg. It was unspecified if the rash was one side or not. The patient had an office visit on 07-APR-2010 and she complained of itching but no pain. No medication was prescribed. The nurse had not heard back from the patient or her mother so she thought the patient was "fine" at the time of the report. No diagnostic tests were performed. Follow up information has been received from the registered nurse who indicated that the patient was a child with no adverse events following prior vaccinations (vaccinated during childhood) who on 05-MAR-2008, was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (Lot# 659360/1577U) into her right arm. No illnesses were reported at the time of vaccination. On 07-APR-2010, the patient presented with shingles, she had lesions for 3 days. The patient had 12 vesicles in total: 8 lesions on her abdomen, 3 on her buttocks and 1 on her neck, they were described as papular, vesicular, pink/red lesions. The shingles had a linear distribution. On a pain scale from 0 (least) to 10 (most), the patient reported pain of 1. No treatment was given, the patient was reported as afebrile (oral temperature 97.8) with itching. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. No diagnostic laboratory tests were performed. A specimen was not collected for PCR and no photos were taken. There was no direct fluorescent antibody done. On an unspecified date the patient  recovered. No further information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female patient with no pertinent medical history, egg allergy and lactose intolerance who on 08-MAY-1999, was vaccinated SQ with the first 0.5ml dose of VARIVAX (Merck) and on an unspecified date was vaccinated with the second dose of VARIVAX (Merck) (Lot# 659360/1577U). Concomitant therapy included ZYRTEC. On 05-APR-2010, the patient developed shingles. The patient had a linear popular vesicular rash on her trunk and "a small line" on her buttocks and her upper leg. It was unspecified if the rash was one side or not. The patient had an office visit on 07-APR-2010 and she complained of itching but no pain. No medication was prescribed. The nurse had not heard back from the patient or her mother so she thought the patient was "fine" at the time of the report. No diagnostic tests were performed. Follow up information has been received from the registered nurse who indicated that the patient was a child with no adverse events following prior vaccinations (vaccinated during childhood) who on 05-MAR-2008, was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (Lot# 659360/1577U) into her right arm. No illnesses were reported at the time of vaccination. On 07-APR-2010, the patient presented with shingles, she had lesions for 3 days. The patient had 12 vesicles in total: 8 lesions on her abdomen, 3 on her buttocks and 1 on her neck, they were described as papular, vesicular, pink/red lesions. The shingles had a linear distribution. On a pain scale from 0 (least) to 10 (most), the patient reported pain of 1. No treatment was given, the patient was reported as afebrile (oral temperature 97.8) with itching. There was no history of chickenpox and no recent exposure to chickenpox or herpes zoster. No diagnostic laboratory tests were performed. A specimen was not collected for PCR and no photos were taken. There was no direct fluorescent antibody done. On an unspecified date the patient  recovered. No further information is expected.