chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Rash, Rash pruritic
Clinical narrative: Developed swollen red ring with rash at injection site.  Shortly after, developed rash which itched in the middle top of my back. Shortly after this the rash has continued to appear at different places on my body: shoulders, neck, arms, legs, etc.  It has been 4 weeks since the vaccine was administered and little spots continue to appear at various places on my body.
Age: 1.86
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Gait disturbance, Induration, Skin warm
Clinical narrative: Per mom, quarter size red spot on right leg.  Mom stated spot was warm and hard to touch.  Mom states no fever, child not favoring the leg. Per mom, child acting okay.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Mother reports patient had mild swelling, pain & redness at injection sight the first 2 days after administration. The evening of 7-25-12 his condition worsened. Mother states patient's left arm was painful, swollen & red from the elbow to the shoulder & firm to the touch, states also that there was some swelling into the left side of the neck & reports swollen tonsils. She notified child's doctor & was told to come to their office at 11:30 AM the next morning. FNP-C reported to HD that patient had local reaction to Tdap vaccine & is improving witn no loss of motion or use & no fever. Tx recommended by NP was OTC loratidine & cool compress. 7-27-12 @ 4:00 PM this nurse called patient's mother, & she reported that child is slowly improving, still without serious s/s.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Local swelling, Oropharyngeal swelling
Clinical narrative: Mother reports patient had mild swelling, pain & redness at injection sight the first 2 days after administration. The evening of 7-25-12 his condition worsened. Mother states patient's left arm was painful, swollen & red from the elbow to the shoulder & firm to the touch, states also that there was some swelling into the left side of the neck & reports swollen tonsils. She notified child's doctor & was told to come to their office at 11:30 AM the next morning. FNP-C reported to HD that patient had local reaction to Tdap vaccine & is improving witn no loss of motion or use & no fever. Tx recommended by NP was OTC loratidine & cool compress. 7-27-12 @ 4:00 PM this nurse called patient's mother, & she reported that child is slowly improving, still without serious s/s.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Pyrexia
Clinical narrative: Low grade fever, bloody stool.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Wrong drug administered
Clinical narrative: Patient Recieved Pentacel instead of Daptacel.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: Child had rash started on back of legs, back, hands and face and child c/o itching. Dad states it did improve but now worse 2 days after vaccines.
Age: 50.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Injection site erythemic, edematous, and moderately tender. Baseball size.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Angiogram pulmonary abnormal, Computerised tomogram thorax abnormal, Dyspnoea, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: Dyspnea. Patient came to ED on 26 July 2012 and was admitted. Work-up disclosed large bilateral pulmonary emboli. There was also a Right thyroid lobe complex nodule of about 4 cm diameter.
Age: 85.0
Sex: F
Vaccine: TDAP
Symptoms: Thyroid neoplasm, Troponin
Clinical narrative: Dyspnea. Patient came to ED on 26 July 2012 and was admitted. Work-up disclosed large bilateral pulmonary emboli. There was also a Right thyroid lobe complex nodule of about 4 cm diameter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed a red mark about 2 inches by 4 inches at the injection site the day after vaccination.  Still red 3 days after vaccine.  She has taken Tylenol and denies pain unless she touches it.  No itching.
Age: 1.28
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Acidosis, Acute myeloid leukaemia, Anaemia, Aspiration bone marrow abnormal, Bacterial test negative
Clinical narrative: The patient had a screening CBC done the same day as vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was diagnosed with AML by bone marrow aspirate. She also started having fever and was started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and received intrathecal cytarabine. She had postoperative respiratory issues, which was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning 7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening desaturations. She progressed over the course of the day on 7/22/12 despite increasing respiratory support from high flow nasal cannula oxygen to bilevel positive airway pressure, to endotracheal intubation with mechanical ventilation. The team caring for her was unable to increase oxygenation, improve carbon dioxide retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from blood and urine did not grow bacteria. An autopsy is being done.
Age: 1.28
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Bilevel positive airway pressure, Blast cells present, Blood culture, Central venous catheterisation, Culture urine
Clinical narrative: The patient had a screening CBC done the same day as vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was diagnosed with AML by bone marrow aspirate. She also started having fever and was started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and received intrathecal cytarabine. She had postoperative respiratory issues, which was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning 7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening desaturations. She progressed over the course of the day on 7/22/12 despite increasing respiratory support from high flow nasal cannula oxygen to bilevel positive airway pressure, to endotracheal intubation with mechanical ventilation. The team caring for her was unable to increase oxygenation, improve carbon dioxide retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from blood and urine did not grow bacteria. An autopsy is being done.
Age: 1.28
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Death, Diarrhoea, Endotracheal intubation, Full blood count abnormal, Hypercapnia
Clinical narrative: The patient had a screening CBC done the same day as vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was diagnosed with AML by bone marrow aspirate. She also started having fever and was started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and received intrathecal cytarabine. She had postoperative respiratory issues, which was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning 7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening desaturations. She progressed over the course of the day on 7/22/12 despite increasing respiratory support from high flow nasal cannula oxygen to bilevel positive airway pressure, to endotracheal intubation with mechanical ventilation. The team caring for her was unable to increase oxygenation, improve carbon dioxide retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from blood and urine did not grow bacteria. An autopsy is being done.
Age: 1.28
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Leukocytosis, Mechanical ventilation, Oxygen saturation decreased, Postoperative respiratory distress, Pyrexia
Clinical narrative: The patient had a screening CBC done the same day as vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was diagnosed with AML by bone marrow aspirate. She also started having fever and was started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and received intrathecal cytarabine. She had postoperative respiratory issues, which was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning 7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening desaturations. She progressed over the course of the day on 7/22/12 despite increasing respiratory support from high flow nasal cannula oxygen to bilevel positive airway pressure, to endotracheal intubation with mechanical ventilation. The team caring for her was unable to increase oxygenation, improve carbon dioxide retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from blood and urine did not grow bacteria. An autopsy is being done.
Age: 1.28
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Tachycardia, Tachypnoea, Thrombocytopenia, Vomiting
Clinical narrative: The patient had a screening CBC done the same day as vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was diagnosed with AML by bone marrow aspirate. She also started having fever and was started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and received intrathecal cytarabine. She had postoperative respiratory issues, which was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning 7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening desaturations. She progressed over the course of the day on 7/22/12 despite increasing respiratory support from high flow nasal cannula oxygen to bilevel positive airway pressure, to endotracheal intubation with mechanical ventilation. The team caring for her was unable to increase oxygenation, improve carbon dioxide retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from blood and urine did not grow bacteria. An autopsy is being done.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Blood test normal, Computerised tomogram head normal, Convulsion, Lumbar puncture normal, Urine analysis normal
Clinical narrative: Generalized seizure x 20 seconds. Unknown if fever present at the time of seizures.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Left upper arm with edema & very slight erythema s/p injections of ADACEL & MENACTRA. Entire circumference of upper arm 1-1.5 inch larger than right arm.
Age: 1.02
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 5 X 5 cm wheal at site of either PENTACEL or MMR.
Age: 1.02
Sex: M
Vaccine: DTAP, MMR, PNC13, VARCEL, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: 5 X 5 cm wheal at site of either PENTACEL or MMR.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Body temperature increased, Rash generalised, Rash papular
Clinical narrative: Temp 102 degrees for 48 hours. Papular rash to entire body - confluent, raised. No intra oral lesions. Non blanching.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Feeling abnormal, Pallor
Clinical narrative: Pt. received vaccine at approximately 1:10pm on 7-26-12. Pt. reacted to the vaccine 5 minutes later and was feeling dazed, pale, weak. Treatment with epinephrine .2mL. Pt. recovered 20 minutes after injection of epinephrine. Site was the deltoid of the left arm.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is approximately 48 hours after injection, she is experiencing redness & swelling at injection site.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: Local redness, swelling, itching, heat, rash, pain "sore throat".
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Local redness, swelling, itching, heat, rash, pain "sore throat".
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Local swelling, Pruritus
Clinical narrative: Local redness, itching, swelling and heat.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Pain, red rash (L) shoulder/inner arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt had arm swelling about the size of a dollar bill, sore & warm to touch, sore and swollen for 4-5 days. Now resolved. Trted w/cool packs & antihistamine.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Allergy test negative, Antinuclear antibody negative, Blood bilirubin normal, Blood creatinine normal, Full blood count normal
Clinical narrative: Developed papular, raised lesions with linearity on (R) arm, chest, upper lags and chest c/o itching. Treated with OTC BENADRYL, CLARITIN and prednisone.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Rash, Rash papular, Red blood cell sedimentation rate normal, Skin lesion
Clinical narrative: Developed papular, raised lesions with linearity on (R) arm, chest, upper lags and chest c/o itching. Treated with OTC BENADRYL, CLARITIN and prednisone.
Age: 49.0
Sex: M
Vaccine: HEP
Symptoms: Treponema test negative
Clinical narrative: Developed papular, raised lesions with linearity on (R) arm, chest, upper lags and chest c/o itching. Treated with OTC BENADRYL, CLARITIN and prednisone.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Staring, Trismus
Clinical narrative: See attached. Within 5 minutes of administration, clients entire body began to stiffen, her eyes were fixated and her jaw clamped down. This activity lasted approximately 30 seconds. Client recovered from this incident within 15 minutes. The client was observed for 30 minutes before being released to her mother. Referred to family physician. Clients mother stated that she does have a prior history of seizure activity on 4/26/2011 unrelated to vaccine administration. She was evaluated by a physician at that time.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Chills, Cough, Influenza like illness, Respiratory tract congestion
Clinical narrative: About 24 hours after receiving HBV dose #3 he had congestion, weakness, chills, cough - flu like symptoms which continued and then began to lessen 7/26 when he called Employee Health. Today 7/27 he has continued to improve. His physician recommended MUCINEX which he said was helpful.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Papule
Clinical narrative: Marked erythema, induration, around injection site 5.5 x 6 in; scattered papules diaper area.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) deltoid 6 X ^6 in swelling and redness. No breathing difficulty.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 7/27/12 Patient came to pharmacy stating she had a reaction to ZOSTAVAX injection which consisted of redness and swelling at injection site. Approximate diameter was 4 inches. Pt had seen MD who advised ice packs & CLARITIN, Vaccine administered 7/24/12.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) deltoid 3.5 X 4 inches, redness, swelling, warm to touch. No breathing difficulty.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt required vaccines on 7/25/12. Mom states (L) arm has been red, swollen and hot to the touch for 3 days. Advised to call PCP today and have child seen. Mom states child has discomfort.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Pain, Swelling
Clinical narrative: Cellulitis like reaction which began the evening of the PNEUMOVAX administration progressing to moderate pain and swelling of the lower half of the posterior area prompting an ER visit 2 days after the vaccine way administered.
Age: 33.0
Sex: F
Vaccine: HEPAB, MMR, PPV, TDAP, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site rash, Injection site swelling
Clinical narrative: Developed fever 102 degrees F - swelling, bump (hard to touch) & erythema to (L) arm where varicella was place - went to urgent care & "cellulitis" (vaccine) had been diagnosed - tx - BACTRIM DS 2xdAYX10 days.
Age: 33.0
Sex: F
Vaccine: HEPAB, MMR, PPV, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Developed fever 102 degrees F - swelling, bump (hard to touch) & erythema to (L) arm where varicella was place - went to urgent care & "cellulitis" (vaccine) had been diagnosed - tx - BACTRIM DS 2xdAYX10 days.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist technician refers to a 85 years old female patient with sulfa allergy, silver allergy and hypersensitivity to alpha blocker quinazolines. The patient was vaccinated subcutaneously with a dose of lot # (672612/1653AA; exp date 21-JAN-2013) ZOSTAVAX on 18-JUN-2012 (dose not reported). No other co-suspects and no concomitant medications were reported. On a subsequent date sometime before 29-JUN-2012, she had an outbreak of shingles on the right flank and abdomen (hospitalization). The patient was admitted to the hospital on 29-JUN-2012 for the shingles. She was discharged from the hospital on 03-JUL-2012. Treatment was given but the type of treatment was unknown. At the time of the report the patient was still recovering from outbreak of shingles on the right flank and abdomen. The relatedness for outbreak of shingles on the right flank and abdomen was not provided for ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Bone pain, Food allergy, Headache, Latex allergy, Milk allergy
Clinical narrative: Information was received on 18-JUL-2012, from a patient's mother regarding conditions her son experienced after immunizations. The mother reported her son's immunization history as: hepatitis B Vaccine (30-AUG-2006, 25-OCT-2006, 03-JAN-2007, 04-JUN-2007), Meningococcal Protein Conjugate (25-OCT-2006, 03-JAN-2007), ROTATEQ (25-OCT-2006), poliovirus vaccine inactivated (unspecified) (25-OCT-2006, 03-JAN-2007 04-JUN-2007), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (25-OCT-2006, 03-JAN-2007, 04-JUN-2007), VARIVAX (Merck) (09-OCT-2007), hepatitis A vaccine, inactivated (07-OCT-2007, 19-AUG-2008, 09-OCT-2007), measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (09-OCT-2007, influenza virus A vaccine (unspecified) (H1N1) (09-OCT-2007), PNEUMOVAX 23 (25-OCT-2006, 03-JAN-2007, 04-JUN-2007, 13-FEB-2008) and unspecified skin test (13-FEB-2008, 19-AUG-2008). The mother reported that starting on 25-OCT-2006, her son was introduced to the new 5 in 1 vaccine, PEDIARIX. The mother reported the following experienced by her son: sun hurts his head when outside playing and severe headache, overheat his skin making him very uncomfortable. The bright or flashing light hurts his eyes causing headache, the cold ache his bones, any medical service with x-ray or injections of pharmaceutical drugs caused him to pull his hair away from the left side of his head. Every other month he is stricken with head cold, severe headache and inflamed throat. He has allergy to food and fruits including fish, shell fish, milk, cheese, chocolate, tomatoes, strawberry, blueberry, raspberry, blackberry, lemon and oranges. Allergy to latex gloves and perfume burn at his skin. See adverse experience information for ROTATEQ, MARRS #1207USA008778. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Nasopharyngitis, Perfume sensitivity, Pharyngeal inflammation, Photophobia, Photosensitivity reaction
Clinical narrative: Information was received on 18-JUL-2012, from a patient's mother regarding conditions her son experienced after immunizations. The mother reported her son's immunization history as: hepatitis B Vaccine (30-AUG-2006, 25-OCT-2006, 03-JAN-2007, 04-JUN-2007), Meningococcal Protein Conjugate (25-OCT-2006, 03-JAN-2007), ROTATEQ (25-OCT-2006), poliovirus vaccine inactivated (unspecified) (25-OCT-2006, 03-JAN-2007 04-JUN-2007), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (25-OCT-2006, 03-JAN-2007, 04-JUN-2007), VARIVAX (Merck) (09-OCT-2007), hepatitis A vaccine, inactivated (07-OCT-2007, 19-AUG-2008, 09-OCT-2007), measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (09-OCT-2007, influenza virus A vaccine (unspecified) (H1N1) (09-OCT-2007), PNEUMOVAX 23 (25-OCT-2006, 03-JAN-2007, 04-JUN-2007, 13-FEB-2008) and unspecified skin test (13-FEB-2008, 19-AUG-2008). The mother reported that starting on 25-OCT-2006, her son was introduced to the new 5 in 1 vaccine, PEDIARIX. The mother reported the following experienced by her son: sun hurts his head when outside playing and severe headache, overheat his skin making him very uncomfortable. The bright or flashing light hurts his eyes causing headache, the cold ache his bones, any medical service with x-ray or injections of pharmaceutical drugs caused him to pull his hair away from the left side of his head. Every other month he is stricken with head cold, severe headache and inflamed throat. He has allergy to food and fruits including fish, shell fish, milk, cheese, chocolate, tomatoes, strawberry, blueberry, raspberry, blackberry, lemon and oranges. Allergy to latex gloves and perfume burn at his skin. See adverse experience information for ROTATEQ, MARRS #1207USA008778. Additional information has been requested.
Sex: M
Vaccine: HEPA
Symptoms: Skin discomfort, Throat irritation, Trichotillomania
Clinical narrative: Information was received on 18-JUL-2012, from a patient's mother regarding conditions her son experienced after immunizations. The mother reported her son's immunization history as: hepatitis B Vaccine (30-AUG-2006, 25-OCT-2006, 03-JAN-2007, 04-JUN-2007), Meningococcal Protein Conjugate (25-OCT-2006, 03-JAN-2007), ROTATEQ (25-OCT-2006), poliovirus vaccine inactivated (unspecified) (25-OCT-2006, 03-JAN-2007 04-JUN-2007), diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (25-OCT-2006, 03-JAN-2007, 04-JUN-2007), VARIVAX (Merck) (09-OCT-2007), hepatitis A vaccine, inactivated (07-OCT-2007, 19-AUG-2008, 09-OCT-2007), measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live (09-OCT-2007, influenza virus A vaccine (unspecified) (H1N1) (09-OCT-2007), PNEUMOVAX 23 (25-OCT-2006, 03-JAN-2007, 04-JUN-2007, 13-FEB-2008) and unspecified skin test (13-FEB-2008, 19-AUG-2008). The mother reported that starting on 25-OCT-2006, her son was introduced to the new 5 in 1 vaccine, PEDIARIX. The mother reported the following experienced by her son: sun hurts his head when outside playing and severe headache, overheat his skin making him very uncomfortable. The bright or flashing light hurts his eyes causing headache, the cold ache his bones, any medical service with x-ray or injections of pharmaceutical drugs caused him to pull his hair away from the left side of his head. Every other month he is stricken with head cold, severe headache and inflamed throat. He has allergy to food and fruits including fish, shell fish, milk, cheese, chocolate, tomatoes, strawberry, blueberry, raspberry, blackberry, lemon and oranges. Allergy to latex gloves and perfume burn at his skin. See adverse experience information for ROTATEQ, MARRS #1207USA008778. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Post vaccination syndrome, Tic
Clinical narrative: This spontaneous report as received from a physician refers to an 11 years old male patient with seasonal allergies and no pertinent medical history. The patient was vaccinated with dose 1 of GARDASIL (Lot # not reported) in January 2012 and dose 2 of GARDASIL (Lot # not reported) in April 2012. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient developed motor tics post vaccination with GARDASIL. The physician stated that mother of child told her that 5 days after child received the first and second dose of GARDASIL in January 2012 and April 2012, he developed motor tics, which wax and wane. The physician reported that the patient had motor tics of the face, shoulder, hands. The third dose of GARDASIL had not yet been administered. The physician stated there was incapacity due to medication treatment was needed. The patient was prescribed topiramate on 18-JUL-2012. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: This spontaneous report as received from a doctor of pharmacy refers to a 61 years old male patient who on 01-JUL-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant medications included "statin". It was reported that on an unknown date, the patient experienced nerve pain. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by calling the pharmacist. Nerve pain was considered to be disabling by the reporter. The relatedness for patient experienced nerve pain was unknown for ZOSTAVAX. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner concerning a 30 years old female patient with cephalexin and codeine allergy and codeine allergy who was vaccinated SQ with a first dose of (Merck) VARIVAX (lot # 673078/0261AE) (dose not reported) on 19-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse practitioner stated that on 23-JUN-2012, the patient experienced localized area reaction in right deltoid approximately 3 inches in diameter "big and red", which lasted two approximately two weeks approximately on 07-JUL-2012. There was not treatment given for the event. There were no labs performed. The outcome of localized area reaction in reaction in right deltoid approximately 3 inches in diameter "big and red" was reported as recovering/resolving. The relatedness for localized area reaction in right deltoid approximately 3 inches in diameter "big and red" was unknown for (Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information received from a published article, concerning a group of 149 patients from an analysis study that were vaccinated with a dose of zoster vaccine live (manufacturer unknown) Context: Based on limited data, the live attenuated herpes zoster (HZ) vaccine is contraindicated in patients taking anti-tumor necrosis factor (anti-TNF) therapies or other biologics commonly used to treat immune-mediated diseases. The safety and effectiveness of the vaccine are unclear for these patients. Objective: To examine the association between HZ vaccination and HZ incidence within and beyond 42 days after vaccination in patients with selected immune-mediated diseased and in relation to biologics and other therapies used to treat these conditions. Herpes Zoster (HZ) Incidence Rate Within 42 days: A total of 7780 vaccinated patients contributed person-time within 42 days after vaccination; fewer than 11 HZ cases were observed, resulting in an overall incidence rate of 7.8 cases per 1000 person-years (95% C1, 3.716.5). HZ Incidence Rate after 42 days: During the period of more than 42 days after vaccination, the authors observed 138 HZ cases during 20639 person-years (6.7 cases per 1000 person-years; 95% C1, 5.7.9), resulting in a ration of 0.58 when compared with the incidence rate during unvaccinated person time (11.6 cases per 1000 person-years; 95% C1, 11.4-11.9; P< .001). A limitation relevant to the safety results was not that for HZ cases shortly after vaccination, the authors were unable to determine whether the HZ cases were caused by the vaccine virus strain or the wild-type virus strain, which is possible if biological samples from skin lesions were available for analysis. Another limitation was that the actual vaccine administration dates were unknown for 59% of the author's patients which resulted in the exclusion of these patients from safety (but the effectiveness) analyses. In conclusion, the author's data suggested that the live zoster vaccine may not be associated with increased risk of HZ shortly after vaccination in patients currently treated with biologics and that it was possibly associated with a significantly reduced longer-term HZ risk in patients with immune-mediated disease. The authors' data called into question the current recommendations that HZ vaccine was contraindicated in patients receiving biologics. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a currently 20 years female patient with prednisone allergy and no pertinent medical history. The patient was vaccinated with dose 1 GARDASIL (Lot # not reported) "a few years ago". No other co-suspects were reported. No concomitant medications were reported. The physician reported that within 24 hours after GARDASIL dose was given, the patient experienced muscle aches. vomiting and nausea. The patient did not seek medical attention. No treatment was received for the adverse events. There were no lab diagnosis or studies performed. The patient recovered within 2 days of adverse events onset. No further information is available.
Sex: F
Vaccine: HEP, RV5
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 21 day old patient who had already a birth dose of hepatitis B virus vaccine rHBsAg (manufacturer unknown), on 20-JUN-2012, the patient was inadvertently vaccinated orally with the first dose of ROTATEQ (lot number not reported) and the second dose of hepatitis B virus vaccine rHBsAg 5 mcg/0.5 ml (route and lot number not reported). The registered nurse stated that there was no adverse effect reported. Follow up information has been received from a registered nurse refers to a 21 days (reported also as 3 week) old female patient. The patient was vaccinated with a first dose of ROTATEQ to early on 20-JUN-2012. Other suspect therapies included RECOMBIVAX HB with dosage information as (UNK ml, UNK), (dose not reported, Lot #1466AA during validation process) on 20-JUN-2012. No concomitant medications were reported. No adverse events followed. Parents were contacted the next day. On 20-JUN-2012 the patient experienced mild fever (it did not need medications). Mother was told to contact doctor if any problems and bring shot card. At the time of the report the patient's status was recovered (recovery date was 21-JUN-2012). Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative, Therapy responder
Clinical narrative: This spontaneous report as received from  a Licensed Practical Nurse refers to an approximately 22 years old female patient who on an 17-JUN-1990 was vaccinated SC with 0.5 ml with the first dose of MMR II (lot number not reported). On 05-NOV-1990, the patient was vaccinated SC with 0.5 ml with the second dose of MMR II (lot number not reported). On 22-JUN-2012, the patient was vaccinated SC with 0.5 ml with the third dose of MMR II, (lot: 671685/1873AA; Exp date: 30-NOV-20123). No other co-suspects were reported, Concomitant medications included NUVARING. On an unknown date, the patient's titer for mumps was negative. No treatment was given for the adverse event. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. The relatedness for titer for mump was negative is unknown for MMR II. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 years old female patient. The patient was vaccinated with lot # (669863/0365AA expiration date 09-JUN-2012) of ZOSTAVAX on 07-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 07-JUN-2012, the patient experienced an injection site reaction that was red, itchy and painful after the ZOSTAVAX injection. The patient visited the physician's office. At the time of the report, the patient's outcome was unknown. No further information is available.
Sex: M
Vaccine: RV5
Symptoms: Constipation, Intestinal obstruction, Overfeeding of infant
Clinical narrative: Information has been received from a case (MARRS # 1207USA003929) regarding a male who received a dose of ROTATEQ on 30-AUG-2003 and experienced "obstructed bowel movements." It was also noted that the physician reported that the patient was constipated because the mother was feeding him too much. No additional information was received.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from consumer concerning her 13 year old grand daughter with no pertinent medical history and no drug reactions/allergies who on an unspecified date when she was a child was vaccinated with a dose of VARIVAX (Merck) (route and lot# not provided). The consumer stated that her grand daughter developed shingles over this past weekend on 12-JUL-2012. Her grand daughter came down with a rash around her neck, face, ear and eye and first it was thought to be impetigo and was prescribed antibiotic (unspecified) by her family physician, but her symptoms did not improve and came down with more rash. Her grand daughter was taken to a dermatologist and was diagnosed with shingles and prescribed an antiviral medication (name unspecified). As of today 17-JUL-2012, the patient's condition was improving with no new rash appearing. At the time of the report, the patient was recovering. The patient sought medical attention. The relatedness for shingles is unknown for (Merck) VARIVAX. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient who on 25-JUN-2012 was vaccinated with a 0.5mL dose of Hib conj vaccine (OMPC) and PENTACEL together. It was unknown if the patient was sought medical attention. No adverse effects reported. Follow up information has been received from the physician concerning the 9 weeks male patient, who was vaccinated with the first dose of PEDVAXHIB and PENTACEL. The patient was perfect, did not have symptoms. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Information has been received concerning a female who on 07-APR-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Upon investigation of an allergic reaction, it was determined that the customer was given an influenza virus vaccine (unspecified, manufacturer unknown) by a pharmacist. The influenza vaccine was administered correctly and according to protocol. The customer stated that she had an allergic reaction to the vaccine (not specified to which vaccine the reaction occurred). She did seek medical treatment (unspecified). The outcome of the allergic reaction was not provided. Information was received from a telephone call. On 03-MAY-2012, it was verified that the patient was vaccinated with ZOSTAVAX (Merck), not the flu vaccine. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 years old female patient. The patient's medical history included hypertension. The patient was vaccinated intramuscularly in left arm, with an expired 0.5 ml dose of PNEUMOVAX 23, (lot # 667912/0933Z, expired date 25-FEB-2012) on 14-JUL-2012. Concomitant medications included: digoxin. Any adverse effects reported. Additional information has been requested,
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was received three doses  of (Merck) VARIVAX, 0.5ml. First dose was given sometimes in September-2005, the second dose was given in May-2010 and the third dose was given on 16-JUL-2012. First dose and second dose had been given subcutaneously. Third dose had been intramuscularly. No lot number was provided. The nurse reported that the patient was younger than 12 months of age when he received first dose. The patient was given first dose for post-exposure prophylaxis because he was exposed to varicella. No symptoms was reported, The outcome of patient was unknown. Whether the patient sought medical attention was unspecified. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: MMR
Symptoms: Body temperature increased, Injection site erythema, Injection site rash, Local reaction
Clinical narrative: This spontaneous report as received from a physician refers to an 18 months and 6 days old male patient with no concomitant medication, pertinent medical history or drug reactions/allergies. The patient was vaccinated with first dose of MMR II and (Merck) VARIVAX intramuscularly on unspecified date approximately 3 months ago in April 2012 and developed a localized reaction. No concomitant medications were reported. The patient's mother described the rash as red, raised rash around the injection site, which looked like sores and covered approximately a 5cm area. The patient's mother also mentioned the patient had a 100-101 temperature for 10 days after the administration. The patient's mother did not seek medical attention for the patient. No laboratory diagnostics studies or treatment were performed. The outcome was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with first dose of GARDASIL on 20-DEC-2010, the second dose on 16-JAN-2012 and the third dose on 20-FEB-2010. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was subcutaneously vaccinated with lot # (667741/0811Z), Exp Date(10-JUN-2012), 0.5 ml MMR II (dose number was unspecified) on 19-JUL-2012, No other co-suspects were reported. No concomitant medications were reported. It was reported that on 19-JUL-2012 the patient was inadvertently administered MMR II that had expired on 10-JUN-2012. No adverse effects reported. It was unspecified whether the patient had sought medical attention or not. The outcome were unknown. This is one of several reports received from the same source. Additional information is not expected
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was subcutaneously vaccinated with lot # (667741/0811Z), Exp Date (10-JUN-2012), 0.5 ml MMR II (dose number was unspecified) on 19-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on19-JUL-2012 the patient was inadvertently administered MMR II that had expired on 10-JUN-2012. No adverse effects reported. It was unspecified whether the patient had sought medical attention or not. The outcome were unknown. This is one of several reports received from the same source. Additional information is not expected.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with GARDASIL (intramuscular, 0.5ml a dose, Lot# unspecified). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was received her first dose of GARDASIL on approximately 2008 or 2009 ("3 or 4 years ago") and was administered second dose of 23-JUL-2012. No adverse effect reported. It was unspecified whether the patient had sought medical attention. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with 0.65 ml ZOSTAVAX (Lot #Exp, dose number were not unspecified) on 18-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that an unspecified pharmacist might have administered ZOSTAVAX in loose skin area and not in subcutaneous tissue area, no adverse effect reported. The outcome was unknown. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Oedema peripheral, Pain in extremity
Clinical narrative: Swollen arm size of small apple, deep, deep intense pain.   As of today 7/28/12, seven weeks later, swelling has subsided but pain has spread to both arms and joints all over body, taking many strong pain pills;  oxycodone with Acetaminophen.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Fever, chills, fatigue, dizziness, headache, generalized weakness, shaking, muscle soreness at injection site, swollen injection site, from onset until AM of 07/28/2012.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Injection site reaction, Injection site swelling, Myalgia, Pyrexia, Tremor
Clinical narrative: Fever, chills, fatigue, dizziness, headache, generalized weakness, shaking, muscle soreness at injection site, swollen injection site, from onset until AM of 07/28/2012.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Electroencephalogram normal, Gaze palsy, Petit mal epilepsy, Rash generalised, Vaccination complication
Clinical narrative: Rash on trunk, arms, neck, cheek and legs.  Administered Benadryl for rash.  Two weeks post-vaccination, episodes of petit mal seizures daily, eyes rolling back into head, for two weeks. Noted MMR vaccine reaction by LPN on 4/25/08.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site rash, Myalgia
Clinical narrative: Patient reported shingles-like rash on left arm at injection site.  Rash covered an area about the size of her hand.  Patient also reported muscle and joint soreness in her neck, shoulders, and arms.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Influenza, Injection site pain, Lethargy, Mobility decreased, Oedema peripheral
Clinical narrative: Began w/pain in arm at injection site which turned into severe pain lasting 30 hours, low-grade temperature, temporary loss of mobility in arm, fever, severe flu symptoms, lethargy & swelling and heat in affected arm.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Began w/pain in arm at injection site which turned into severe pain lasting 30 hours, low-grade temperature, temporary loss of mobility in arm, fever, severe flu symptoms, lethargy & swelling and heat in affected arm.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Blood test, Computerised tomogram, Convulsion, Electroencephalogram abnormal, Loss of consciousness
Clinical narrative: Syncope followed by seizure or seizure like activity. She was in the car with me on the way home.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Syncope followed by seizure or seizure like activity. She was in the car with me on the way home.
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Aphasia, Computerised tomogram normal, Dizziness, Muscle contracture, Posture abnormal
Clinical narrative: Syncope followed by seizure or seizure like activity. She was in the car with me on the way home.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to a patient. The nurse mentioned that on 06-JUN-2012 the patient was given the 1st dose of GARDASIL that was drawn up into a syringe and stored this way in the fridge for no more than 1 week and exposed to light when the fridge door is opened. The patient is not experiencing any known symptoms. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site induration, Injection site rash
Clinical narrative: 1st day - deltoid "hard lump" which subsided. Sometime into day 2-3 a rash began along backside of injected arm, spread around arm, under deltoid area of vaccine & down to elbow.
Age: 1.28
Sex: F
Vaccine: DTAP, HEP, MMR
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a other health professional refers to 5 patients of unknown age. the patients were vaccinated with a dose of lot # (665425/1017Y: exp date 15-JUL-2011) MMR II (dose and route not reported) on unspecified dates. No other co-suspects and no concomitant medications were reported. The reporter stated that the patients were vaccinated with expired vaccines. The reporter did not have exact dates of vaccination but thought the patients were vaccinated within the last couple of months. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.