chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Infertility female, Infertility tests, Laboratory test, X-ray of pelvis and hip
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 24 years old female patient with allergy to Prazosin. The patient's medical history included generalized anxiety disorder, impingement right shoulder, ethyl alcohol (ETOH) abuse, in remission, adjustment disorder with mixed emotional features, adult maltreatment, victim, adjustment disorder with anxiety, insomnia, headache syndromes, menorrhagia, post-traumatic stress disorder (PTSD), shoulder joint pain, underweight and depression. The patient was vaccinated IM on left arm with the fourth dose of GARDASIL (lot # 666929/0331Z) on 25-MAY-2012. On 01-FEB-2012 the patient was diagnosed with unexplained infertility after one year of trying and she had a previous child. Consultant record (reproductive endocrinology) on 01-FEB-2012 (DOS) revealed the diagnosis of female infertility, secondary. Diagnostic tests were scheduled. The patient was inability to conceive post 10-months of attempts. Fertility labs fertility x-ray with fluid and Clomid challenge test were performed. There was no illness at the time of vaccination. The outcome of infertility female was unknown. The listing indicated that infertility female was considered to be disabling. The original reporting source was not provided. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Infertility female, Infertility tests, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 24 years old female patient with allergy to Prazosin. The patient's medical history included generalized anxiety disorder, impingement right shoulder, ethyl alcohol (ETOH) abuse, in remission, adjustment disorder with mixed emotional features, adult maltreatment, victim, adjustment disorder with anxiety, insomnia, headache syndromes, menorrhagia, post-traumatic stress disorder (PTSD), shoulder joint pain, underweight and depression. The patient was vaccinated IM on left arm with the fourth dose of GARDASIL (lot # 666929/0331Z) on 25-MAY-2012. On 01-FEB-2012 the patient was diagnosed with unexplained infertility after one year of trying and she had a previous child. Consultant record (reproductive endocrinology) on 01-FEB-2012 (DOS) revealed the diagnosis of female infertility, secondary. Diagnostic tests were scheduled. The patient was inability to conceive post 10-months of attempts. Fertility labs fertility x-ray with fluid and Clomid challenge test were performed. There was no illness at the time of vaccination. The outcome of infertility female was unknown. The listing indicated that infertility female was considered to be disabling. The original reporting source was not provided. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site reaction, Muscle spasms
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female patient was vaccinated IM on the left arm with the second dose of GARDASIL on 17-APR-2012. Secondary suspect included the first dose of ADACEL, diclofenac, MENACTRA which were vaccinated on the same day, IM on the right arm. Concomitant therapies included ORTHO TRI-CYCLEN. On 18-APR-2012 about 12 hours later the patient awoke with severe pain/spasm on the right arm trapezius/deltoid and went to emergency room for evaluation and treatment. The original reporting source was not provided. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: HEPA, HPV4, IPV, TDAP, HEPA, HPV4, IPV, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 28 year old female patient with no medical history and pre-existing illness was vaccinated intramuscularly with a first dose of GARDASIL (Lot # 672193/1524AA) in her right arm on 23-APR-2012. Concomitant therapy included a dose of ADACEL (Lot # U3957BA) and a first dose of HAVRIX (Lot # AHAVB532AA) given intramuscularly in left arm, and a dose of IPOL (Lot# H1223) given subcutaneously in right arm. On 23-APR-2012 the patient fainted. No injury. Patient was assisted to supine position with legs elevated. Responded quickly. No lab diagnostic studies performed. It was not known if patient sought for medical attention. The original reporting source was not provided. The VAERS ID # is 454186-1. No further information is available.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Tinnitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 year old male with none of previous illness who on 18-AUG-2011 was vaccinated IM with first dose of GARDASIL (lot# 667930/1561Z). On 09-NOV-2011 the patient was vaccinated with second dose of GARDASIL (lot# unknown). Patient and his mom report and complained of ringing in ears which started later in evening after receiving vaccine - lasting about 1-2 weeks. Noticed mostly at NOL when quiet. Ringing in ears with both vaccines. No lab data provided. No conditions. At time of the report, the patient's outcome was unknown. No further information is available. The VAERS ID # is 456114.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 16 years old female patient with previous illness of cold and flu was vaccinated IM with the first dose of GARDASIL (lot # 670050/1229AA) on 01-JUN-2012. Concomitant medications included: medroxyprogesterone acetate. On 01-JUN-2012 the patient experienced fainting post injection. The patient was elevated feet and was given juice. It was also reported that took patient's blood pressure. The outcome of fainting post injection was unknown. The report was considered to be no conditions and not serious. No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unevaluable event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female patient with K.N.D.A. (no known drug allergy) and yearly physical exam treated intramuscularly into left arm with the first dose of GARDASIL (lot # 672653/1860AA) on an unspecified date. The patient experienced unevaluable event on an unspecified date. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 456940-1.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TD, DT, HPV4, MNQ
Symptoms: Erythema, Injection site pain, Muscle tightness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old male patient on 11-JUN-2012 was vaccinated with a dose of GARDASIL lot # (668985/0690AA12) into the left arm. No other co-suspects were reported. Concomitant vaccines given on the same day included a dose of DECAVAC (lot # C3921AA) into the right arm and a dose of MENACTRA (lot # V4022AA) into the left arm. On 12-JUN-2012, 1 days after onset of therapy, the patient experienced red spot, tightness in muscle and pain on site of injection. No treatment information was reported. At the time of the report, the patient's outcome was not reported. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457460. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient with sweet potato allergy and a history of menorrhagia, acne and no previous illness on 21-DEC-2011 was vaccinated with the first dose of GARDASIL (lot # dose and site of administration were not reported). On 22-FEB-2012, the patient was vaccinated IM with the second dose of GARDASIL lot # (669796/0840AA) into the left arm. No other co-suspects were reported. Concomitant medications included: ethinyl estradiol, ferrous fumarate, MICROGESTIN FE. The patient's mother called and reported that the patient fainted 3 weeks after the second dose of GARDASIL. This episode was for approximately 3 minutes. This episode occurred when the patient got out of the bed in AM. Also it was reported that the patient experienced same adverse event after the first dose of GARDASIL. At the time of the report, the patient's outcome was not reported. This report was considered non serious and no conditions by the agency. This was originally reported by a consumer. The VAERS ID # is 457474. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. An 15 years old female patient with no medical history and no previous illness on 08-JUN-2012 was vaccinated with a dose of GARDASIL (lot # 672834/0131AE) (site of administration and dose was not provided). No other co-suspects were reported. Concomitant vaccines given on the same day included a IM dose of ADACEL (lot # C4051AA) into the left arm and a IM dose of MENACTRA (lot # U4021AE) into right arm. On 14-JUN-2012, 6 days after onset of therapy, the patient well circumscribed areas of urticaria on bilateral arms and legs-specifically large areas on black of bilateral thighs, elbow, knees, lower legs above ankles. No treatment information was reported. No lab test was performed. At the time of the report, the patient's outcome was not reported. The patient required an emergency room visit. This report was considered non serious by the agency. The original reporting source was not provided. The VAERS ID# is 457550. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4, HPV4
Symptoms: Dizziness, Feeling hot, Vomiting
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient with no medical history and no previous illness on 15-JUN-2012 was vaccinated IM with the second dose of VAQTA on 15-JUN-2012 (lot # 672840/0215AE) into the left arm. Other suspect vaccines given on the same day included the third IM dose of GARDASIL (lot # reported as 1696AA). No concomitant medications were reported. On 15-JUN-2012, approximately 5 minutes after received vaccination, he stated he felt "hot and lightheaded". He vomited with the next five minutes. The patient remained in the clinic for 15 more minutes. He stated he "felt better and no longer lightheaded". No lab test was performed. Also, it was reported that the 17 years old patient's sibling on an unspecified date experienced lightheadedness with the first dose of GARDASIL (lot # was not reported) (case # 1208USA003992). This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457551. This is one of the several reports of the same source. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old male patient with no medical history and no previous illness on 15-JUN-2012 was vaccinated IM with the second dose of VAQTA on 15-JUN-2012 (lot # 672840/0215AE) into the left arm. Other suspect vaccines given on the same day included the third IM dose of GARDASIL (lot # reported as 1696AA). No concomitant medications were reported. On 15-JUN-2012, approximately 5 minutes after received vaccination, he stated he felt "hot and lightheaded". He vomited with the next five minutes. The patient remained in the clinic for 15 more minutes. He stated he "felt better and no longer lightheaded". No lab test was performed. Also, it was reported that the 17 years old patient's sibling on an unspecified date experienced lightheadedness with the first dose of GARDASIL (lot # was not reported) (case # 1208USA003992). This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457551. This is one of the several reports of the same source. Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: HEPA, HPV4, HEPA, HPV4, HPV4
Symptoms: Dizziness, Feeling hot, Vomiting
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old patient was vaccinated with dose 1 GARDASIL (lot #, dose and site of administration were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced light headed. No treatment information was reported. At the time of the report, the patient's outcome was not reported. Also, it was reported that the 13 years old brother's patient on 15-JUN-2012, experienced light headedness, felt hot and vomited with the third dose of GARDASIL (lot # reported as 1696AA) (case # 1207USA012942). This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457551. This is one of the several reports of the same source. Additional information is not expected.
Age: 17.0
Sex: U
Vaccine: HEPA, HPV4, HEPA, HPV4, HPV4
Symptoms: Dizziness
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 years old patient was vaccinated with dose 1 GARDASIL (lot #, dose and site of administration were not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced light headed. No treatment information was reported. At the time of the report, the patient's outcome was not reported. Also, it was reported that the 13 years old brother's patient on 15-JUN-2012, experienced light headedness, felt hot and vomited with the third dose of GARDASIL (lot # reported as 1696AA) (case # 1207USA012942). This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457551. This is one of the several reports of the same source. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Electrocardiogram normal, Headache, Wheezing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with asthma and allergic rhinitis was vaccinated on 15-MAY-2012 with the first dose of GARDASIL (lot # 1745AA), I.M., in the right arm (dose not reported). Concomitant medications included albuterol prn. On 16-MAY-2012, 12 hours after GARDASIL, the patient developed chest pain, wheezing and headache. At the time of the report, patient's outcome for all the events was unknown. This report was considered non-serious by the agency, it required ER visit. The original reporting source was not provided. The VAERS ID # is 457743. No further information is available.
Age: 27.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dizziness, Tinnitus, Vision blurred
Clinical narrative: This report was obtained on request by the Company from the FDA under the Freedom of Information Act. A 27 years old female patient on 19-JUN-2012 was vaccinated IM with dose 2 of GARDASIL (lot # reported as 1516AA) into the left arm. No other co-suspects were reported. No concomitant medications were reported. On 19-JUN-2012, the patient experienced blurred vision, ringing in the ears and dizziness. Symptoms started within 30 seconds and resolved within 5 minutes. No treatment information was reported. At the time of the report, the patient recovered from blurred vision, ringing in the ears and dizziness. This report was considered non serious and no conditions by the agency. The original reporting source was not provided. The VAERS ID# is 457747. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site reaction, Nodule, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old female patient with sulfa allergy, penicillin allergy and allergy to FELDEN and no pertinent medical history. The patient was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot# 01708AE in verification; expiration date 06-MAR-2013) on 21-JUL-2012. No other co-suspects were reported. Concomitant medications included: prednisone. On 22-JUL-2012 the patient developed a large, red area on her arm around the injection site. The red area was warm to touch, slightly itchy and measured approximately 6 by 2 inches. The pharmacist stated "it felt like there was a large knot in the center". The patient sought unspecified medical attention. No treatment information was reported. No laboratory diagnostic studies were performed. The outcome of the events was reported as recovering/resolving. The relatedness for the events is unknown for ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old female patient with sulfa allergy, penicillin allergy and allergy to FELDEN and no pertinent medical history. The patient was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot# 01708AE in verification; expiration date 06-MAR-2013) on 21-JUL-2012. No other co-suspects were reported. Concomitant medications included: prednisone. On 22-JUL-2012 the patient developed a large, red area on her arm around the injection site. The red area was warm to touch, slightly itchy and measured approximately 6 by 2 inches. The pharmacist stated "it felt like there was a large knot in the center". The patient sought unspecified medical attention. No treatment information was reported. No laboratory diagnostic studies were performed. The outcome of the events was reported as recovering/resolving. The relatedness for the events is unknown for ZOSTAVAX. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician refers to a 61 years old female with no pertinent medical history or drug reaction. The patient was vaccinated with dose 1, 0.65ml ZOSTAVAX (lot # reported as 0255AE) on 18-JUL-2012. There was none concomitant medications. On 21-JUL-2012, 4 days after onset of therapy, the patient experienced experienced red swelling a couple of inches around the injection site, and the area was hot to touch. The patient contacted pharmacist. The patient was treated with cold packs on area, BENADRYL and unspecified antibiotic ointment. The patient was recovering. This is one of 3 reports (1207USA009006 and 1207USA009001) received from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician refers to a 61 years old female with no pertinent medical history or drug reaction. The patient was vaccinated with dose 1, 0.65ml ZOSTAVAX (lot # reported as 0255AE) on 18-JUL-2012. There was none concomitant medications. On 21-JUL-2012, 4 days after onset of therapy, the patient experienced experienced red swelling a couple of inches around the injection site, and the area was hot to touch. The patient contacted pharmacist. The patient was treated with cold packs on area, BENADRYL and unspecified antibiotic ointment. The patient was recovering. This is one of 3 reports (1207USA009006 and 1207USA009001) received from the same source. Additional information is not expected.
Age: 1.32
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash, Rash papular, Upper respiratory tract infection
Clinical narrative: Papular rash arranged in a circular fashion at the site of administration of the vaccines (VZV, MMR, PCV 13). She also developed rash on the posterior neck, face, buttocks and upper extremities. She also had URI symptoms and a fever to 101F at the time of onset of the illness.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Hyperhidrosis, Presyncope
Clinical narrative: Sudden lightheaded, profuse sweating, nearly fainted.  Sat with head down and ice on forehead and back of neck, given ice water.  Symptoms passed within 5 minutes but came with no warning.  Barely made it 3 steps to a chair; hate to think if she was driving when this occurred.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Herpetiform rash left C4 distribution c/w shingles.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Urticaria
Clinical narrative: Developed urticarial rash on arm & trunk.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Ataxia, Chromosome analysis normal, Computerised tomogram head normal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Persistent ataxia.
Age: 11.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was seen for 11 yr physical. Discussed vaccines including Hep A, MENACTRA, Influenza, Tdap and HPV. Parent requested to wait on HPV while they looked more into the vaccine, this request was recorded and the vaccines Hep A, MENACTRA, Influenza & Tdap were ordered. All were given except MENACTRA in its place the declined HPV was given. No adverse reactions reported.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthenia, Feeling hot, Pallor, Presyncope
Clinical narrative: 5-10 minutes after receiving vaccines, she became pale, felt warm & weak. She was given a cool cloth, water & a lollipop. She did not actually have syncope, only near-syncope. Observed longer.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cervical vertebral fracture, Computerised tomogram abnormal, Fall, Loss of consciousness, Skull fracture
Clinical narrative: 10-15 minutes post immunization. Patient lost consciousness in the waiting area falling backwards. He was sent to our urgent care center. CT revealed fracture of right occiput and cervical vertebrae 1.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: 10-15 minutes post immunization the patient complained of dizziness at the reception desk where she briefly lost consciousness falling into her mothers arms. Observed 15 mins.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Cyanosis, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: 5-10 min after KINRIX, MMR, VARIVAX, pt -> cough, elevated WOB, vom x 1, redness & swelling both entire legs, wheezing -> blue lips, decreased air exchange -> epi/O2; XOPENEX/BENADRYL/SOLUMEDROL/XOPENEX again -> transport by ambulance to hosp for O2 sat 88 1 hour later still off O2 & pallor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Oxygen saturation decreased, Pallor, Vomiting, Wheezing
Clinical narrative: 5-10 min after KINRIX, MMR, VARIVAX, pt -> cough, elevated WOB, vom x 1, redness & swelling both entire legs, wheezing -> blue lips, decreased air exchange -> epi/O2; XOPENEX/BENADRYL/SOLUMEDROL/XOPENEX again -> transport by ambulance to hosp for O2 sat 88 1 hour later still off O2 & pallor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Cough, Cyanosis, Dyspnoea, Erythema, Hypersensitivity
Clinical narrative: 5-10 min after KINRIX, MMR, VARIVAX, pt -> cough, elevated WOB, vom x 1, redness & swelling both entire legs, wheezing -> blue lips, decreased air exchange -> epi/O2; XOPENEX/BENADRYL/SOLUMEDROL/XOPENEX again -> transport by ambulance to hosp for O2 sat 88 1 hour later still off O2 & pallor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL, DTAPIPV, MMR, VARCEL
Symptoms: Oedema peripheral, Oxygen saturation decreased, Vomiting, Wheezing
Clinical narrative: 5-10 min after KINRIX, MMR, VARIVAX, pt -> cough, elevated WOB, vom x 1, redness & swelling both entire legs, wheezing -> blue lips, decreased air exchange -> epi/O2; XOPENEX/BENADRYL/SOLUMEDROL/XOPENEX again -> transport by ambulance to hosp for O2 sat 88 1 hour later still off O2 & pallor.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Nausea
Clinical narrative: 15 minutes post immunization the patient experienced dizziness & nausea that was not relieved. He was sent to the ER for further evaluation.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Skin reaction at site of injection.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count normal, Petechiae, Platelet count normal
Clinical narrative: Onset small red asymptomatic bumps on left arm the evening after receiving first time ZOSTAVAX vaccine in left deltoid. Takes baby aspirin every other night, also on COZAAR, omeprazole, and ZOCOR. Examined on 07/20/2012 and noted to have non-palpable petechiae on left medial arm, dorsal forearm, and anterior lower legs. No ecchymoses. Afebrile. No other reports of bleeding including gums or GI. Remote history pancreatic cancer, pulmonary emboli in 2007 without any complications from anticoagulation treatments. CBC all normal, platelet count 156,000. Rechecked on 7/25/2012, all lesions resolved, no symptoms. Stopped taking aspirin as instructed on 07/20/2012.
Age: 74.0
Sex: U
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Medication suspected of leading to the adverse reaction: Pneumococcal Conjugate Vaccine- 0.5/IM- Result of the reaction on the level of care: Drug therapy initiated/changed Incident Description patient had PNEUMOVAX, shingles and Tdap vaccines on 6/5/12. Patient had some local soreness. 5-6 days after injection began to have warmth and redness at lateral arm site seen in office 6/12/12- +cellulitis at lateral arm site and begun on oral antibiotics.
Age: 60.0
Sex: F
Vaccine: RAB
Symptoms: Amylase increased, Lipase increased, Pancreatitis acute
Clinical narrative: Acute pancreatitis.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Abasia, Arthralgia, Back pain, Influenza A virus test, Influenza B virus test
Clinical narrative: 10 days after immunization patient developed flu like symptoms with pharyngitis, tonsillar exudate and injected scleras. On 6/1/12 patient woke up with multiple arthralgias. Unable to walk neck and back pain. Referred to ER for further eval.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Influenza like illness, Laboratory test, Neck pain, Pharyngeal exudate, Pharyngitis
Clinical narrative: 10 days after immunization patient developed flu like symptoms with pharyngitis, tonsillar exudate and injected scleras. On 6/1/12 patient woke up with multiple arthralgias. Unable to walk neck and back pain. Referred to ER for further eval.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Scleral hyperaemia, Streptococcus test
Clinical narrative: 10 days after immunization patient developed flu like symptoms with pharyngitis, tonsillar exudate and injected scleras. On 6/1/12 patient woke up with multiple arthralgias. Unable to walk neck and back pain. Referred to ER for further eval.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia, Pruritus generalised, Throat tightness
Clinical narrative: Patient 1st felt nauseous then her throat began to tighten & her face felt tingly & she was itching all over (no visible rash). Patient went to ER upon my recommendation (she called me from home) & was given IV steroids & a prednisone taper pack to use at home. She was discharged from the hospital after a few hours of observation.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV1
Symptoms: Cyanosis, Depressed level of consciousness, Peripheral coldness, Pyrexia
Clinical narrative: 3 hours after shots patient became very unalert, hands/feet blue & ice cold, nail beds blue, 102.2 fever, ER visit & transfer to hospital & admitted.
Sex: U
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Tremor
Clinical narrative: This case is a part of cluster report of 2 cases and is linked with the case# 2012-07268, (same reporter, ADACEL vaccine (lot no: U4329AA) and Varicella (lot no: 0591AE). Initial information received from a Health care professional on 26 July 2012. Two patients whose medical history and concomitant medications were not reported received dose of MENACTRA vaccine (lot no U4244AA), ADACEL vaccine (lot no: U4329AA) and VARIVAX (lot no: 0591AE) (Manufacturer was Merck) on an unspecified date. The two patients experienced fever and shaking. Laboratory test and Corrective treatment was not reported. The outcome of the event was recovered however the stop date of the events was not reported. Documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Headache. Initial report received from a health are professional on 02 July 2012.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt was given the pediatric/adolescent dose of the Hepatitis A vaccine, instead of the adult dose. This was discovered about 5 minutes after pt was given the dose, by another medical assistant. Pt was told what happened, and tolerated the injection fine without complications.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal distension, Abdominal pain, Barium enema normal, Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: 18-24 hours after vaccine administered child developed bloody diarrhea.  Child also had abdominal pain and irritability with fever to 104 degrees and bloating. She initially had one blood stool on 5/31/2012 at 1930 but no other symptoms.  Woke up at 400 am on 6/1/2012 screaming in pain.  Child taken to ER where she passed a second loose bloody stool.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia, Haematocrit decreased, Haemoglobin normal, Irritability, Nitrite urine absent
Clinical narrative: 18-24 hours after vaccine administered child developed bloody diarrhea.  Child also had abdominal pain and irritability with fever to 104 degrees and bloating. She initially had one blood stool on 5/31/2012 at 1930 but no other symptoms.  Woke up at 400 am on 6/1/2012 screaming in pain.  Child taken to ER where she passed a second loose bloody stool.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pain, Pyrexia, Screaming, White blood cell count normal, White blood cells urine positive
Clinical narrative: 18-24 hours after vaccine administered child developed bloody diarrhea.  Child also had abdominal pain and irritability with fever to 104 degrees and bloating. She initially had one blood stool on 5/31/2012 at 1930 but no other symptoms.  Woke up at 400 am on 6/1/2012 screaming in pain.  Child taken to ER where she passed a second loose bloody stool.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Tenderness, edema, erythema at injection site which started on 08/01/2012. Patient received vaccine on 07/30/2012.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fatigue, Headache, Pain, Vaccination site cellulitis
Clinical narrative: FEELING OF FATGUE, HEADACHES, BODYACHES, CHILLS, CELLULITIS TO AREA VACCINE WAS GIVEN IN.
Age: 82.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Injection site red, inflamed and erythematous, nontender to palpation in a 5 cm x 5 cm area.
Age: 13.0
Sex: M
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Dizziness, Slow response to stimuli, Tremor, Unresponsive to stimuli
Clinical narrative: Pt became dizzy, upper extremities shaking, non-responsive for 7 minute. Pt then intermittently would become less responsive to verbal demands - This occurring for about 1 1/2 hours in office. Pt then transferred to ER per ambulance.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Diarrhoea, Injection site erythema, Injection site nodule, Injection site swelling, Pyrexia
Clinical narrative: Fever ranging between 100.5-102 for 48 hours treated with ibuprofen. Diarrhea Vomiting Swollen and red area around injection site Knot at injection site that has remained until now (August 2012).
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Vomiting
Clinical narrative: Fever ranging between 100.5-102 for 48 hours treated with ibuprofen. Diarrhea Vomiting Swollen and red area around injection site Knot at injection site that has remained until now (August 2012).
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain, Somnolence
Clinical narrative: After receiving a Tdap injection, I experienced extreme fatigue and soreness at the injection site.  Fatigue lasted for 4 days requiring me to sleep through out the day for 4 days.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Infant was given Rotarix by injection instead of by oral route.
Age: 22.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness, swelling 4 inches x 4 inches, soreness and rash at the injection site.
Age: 22.0
Sex: F
Vaccine: VARCEL, PPV
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site hypersensitivity, Injection site pain
Clinical narrative: Redness, swelling 4 inches x 4 inches, soreness and rash at the injection site.
Age: 30.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: Edema and 8x6cm area of induration to area surrounding injection site.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Joint range of motion decreased, Pyrexia
Clinical narrative: Patient developed fever to 101 and Local swelling and warmth over his left thigh which spread to his hip and below the knee, leading to pain, decreased range of motion of his left hip and knee and refusal to bear weight on that leg.
Age: 2.0
Sex: M
Vaccine: PPV
Symptoms: Weight bearing difficulty, White blood cell count increased
Clinical narrative: Patient developed fever to 101 and Local swelling and warmth over his left thigh which spread to his hip and below the knee, leading to pain, decreased range of motion of his left hip and knee and refusal to bear weight on that leg.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was given Rotarix injection instead of oral.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Electrocardiogram, Pain, Paraesthesia, Pruritus
Clinical narrative: Member felt right arm tingling, chest pain, itching and aches the day she received smallpox until Sunday. Member saw PCM on 9 Aug 2012 and release with no restrictions.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Entire deltoid area is red, warm and hard. Affected site measures 60mm x 55mm in size. Child complains of pain to the touch. Parent first noticed the symptoms on the morning of 8/9/12. Approximately 44 hours post vaccination.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: C-reactive protein, Crying, Full blood count normal, Metabolic function test, Pain
Clinical narrative: Patient stated she had a fever for one day. Crying spells and severe body aches since recieving immunization.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient stated she had a fever for one day. Crying spells and severe body aches since recieving immunization.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Pyrexia, Vision blurred
Clinical narrative: Dizziness, blurry vision, high fever.
Age: 10.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Slight fever of 99.  Redness at the injection site.  Some itching at the injection site.
Age: 0.34
Sex: M
Vaccine: DTAPH, PER, RVX
Symptoms: Abdominal pain, Condition aggravated, Eczema, Nasal congestion
Clinical narrative: Eczema flared up intensely, stuffy nose, tummy hurting.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea
Clinical narrative: 15 minutes post immunization patient complained of nausea & dizziness. No loss of consciousness. Observed in office for 30 minutes & discharged.
Age: 41.0
Sex: F
Vaccine: IPV, YF
Symptoms: Lip swelling, Urticaria
Clinical narrative: 2 weeks after vaccination with yellow fever & IPV patient began to have hives in random places on her body, also experienced swelling of her lip. Saw GP, took ZYRTEC & given tapering pack of steroids which she has not taken as of 8/7/12 still having hives in random places. (thighs, etc).
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Convulsion, Dizziness, Gaze palsy, Joint hyperextension, Vision blurred
Clinical narrative: Vaccine Meningococcal, Menatra from Sanofi Pasteur Inc. Lot U4237AA, expiration date 17 AUG 13 was administered tp the client, and after that, while sitted, she had a bried (1 min.) seizure, stretching the right leg and both arms, and rolling her both eyes. Client complained of being dizzy with blurred eyes.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Feeling hot, Hypersomnia, Lymphadenopathy, Odynophagia
Clinical narrative: No recollection of going to bed, woke up very fatigued and hot. Four hrs later developed painful swallowing. Too fatigued to get out of bed to take Tylenol, etc. Slept until 4pm the next day. Continued with severe sore throat, swollen neck glands and a high fever (but didn't take temp. Reports cervical glands still swollen on 8/6/12. Pt called to report these sx on 8/6/12, was not evaluated prior to this.  Was not in NH where vaccine when she called to report her sx.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Oropharyngeal pain
Clinical narrative: No recollection of going to bed, woke up very fatigued and hot. Four hrs later developed painful swallowing. Too fatigued to get out of bed to take Tylenol, etc. Slept until 4pm the next day. Continued with severe sore throat, swollen neck glands and a high fever (but didn't take temp. Reports cervical glands still swollen on 8/6/12. Pt called to report these sx on 8/6/12, was not evaluated prior to this.  Was not in NH where vaccine when she called to report her sx.
Age: 58.0
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: Headache, fever, nausea and diarrhea.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Unresponsive to stimuli
Clinical narrative: Pt given HPV dose 1.  Approximately 2-3 minutes later she became unresponsive sitting in chair.  Ammonia capsule snapped and patient awoke, c/o nausea.  Applied ice pack to neck and administered juice.  Pt became more responsive, then moved to mat on the floor until she felt that she could sit in chair.
Age: 21.0
Sex: F
Vaccine: HPV4, MMR, MNQ
Symptoms: Convulsion, Dizziness, Dyspnoea, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: Post vaccine administration pt presented to the PSR desk with c/o dizziness and difficulty breathing.  Nurse immediately escorted pt to exam room and she was assessed by the Physician.  She was pale, diaphoretic and dyspneic.  VS - BP 145/93, pulse 104, O2 sat 83% - pt was put on oxygen.  3:48 the Code Team and 911 called. She then began seizure activity which subsided but she continue to be dyspneic.  EKG obtained - Normal Sinus Rhythm.  Normal Saline IV started - bolus of 250ml given, 25mg Benadryl given IV push.  VS - 121/77, pule 106, O2 100%, glucose 103.  Paramedics arrived, report given and patient transported to hospital.  Released same day.
Age: 21.0
Sex: F
Vaccine: HPV4, MMR, MNQ
Symptoms: Pallor
Clinical narrative: Post vaccine administration pt presented to the PSR desk with c/o dizziness and difficulty breathing.  Nurse immediately escorted pt to exam room and she was assessed by the Physician.  She was pale, diaphoretic and dyspneic.  VS - BP 145/93, pulse 104, O2 sat 83% - pt was put on oxygen.  3:48 the Code Team and 911 called. She then began seizure activity which subsided but she continue to be dyspneic.  EKG obtained - Normal Sinus Rhythm.  Normal Saline IV started - bolus of 250ml given, 25mg Benadryl given IV push.  VS - 121/77, pule 106, O2 100%, glucose 103.  Paramedics arrived, report given and patient transported to hospital.  Released same day.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Cough, Pneumonia, Wheezing
Clinical narrative: Cough, Wheezing, and Confirmed Pneumonia by chest x-ray.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Chills, Headache, Neck pain, Oropharyngeal pain
Clinical narrative: Sudden onset of fever, chills, headache, neck and back pain, shaking, sorethroat, and body aches.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Sudden onset of fever, chills, headache, neck and back pain, shaking, sorethroat, and body aches.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient complained of 2 x2 in. red, warm area on arm that itches at injection site. She noticed it on 8/4/12. I counseled her to apply a cold compress & BENADRYL & I paged MD & MD agreed w/ my advice.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Asthma, Condition aggravated, Pharyngeal oedema, Pruritus generalised
Clinical narrative: This case was reported by a consumer and described the occurrence of pruritus all over body in a 35-year-old female subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to eggs, asthma and sulfa allergy. Concurrent medications included CLARITIN. On 24 July 2012 at 11:00 the subject received unspecified dose of Hepatitis A vaccine (unknown, right arm). In July 2012, within a couple of days of vaccination with Hepatitis A vaccine, the subject experienced itching all over body, throat a little swollen and asthma symptoms acting up. At the time of reporting the outcome of the itching all over body, throat a little swollen, asthma symptoms acting up were unspecified. This case was assessed as medically serious by GSK.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site red, swollen warm to touch.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Basophil count, Basophil percentage, Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, C-reactive protein increased
Clinical narrative: 28 y/o patient calls at 4:30 PM on 11JUL12 reporting positional, pleuritic pain rt rib cage with deep breathing "I can't take a deep breath." Patient received his primary SPV, AVA#1 and Typhoid IM vaccines on 05JUL12- day #6 s/p SPV. Pain began on Saturday 07JUL12 around mid day while patient was sitting in car (no previous physical exertion). Pain progressed throughout day till it was an "8-9"/10 by Saturday evening. Describes pain as "constant, sharp, worse when breathing in, difficulty to exhale and a lot worse when lying down." Pain does not radiate to left chest, to jaw, throat or left arm. No diaphoresis. No sweating. No N, V. No pallor. Patient's pleuritic rt rib cage pain & SOB exacerbated again morning of 11JUL12, while patient was attempting to do his usual 2-mile run in PT. Patient could not finish run due to SOB & sharp pleuritic pain rt rib cage. Denies sensation of deep pressure in center of chest. States that pustule on left upper arm at SPV injection site is about the size of a dime. Denies red streaking, significant erythema or left axillary LAD. NP advises patient to get buddy to drive him to ER Immediately for further evaluation to r/o post-smallpox vaccine myopericarditis. Initial EKG in ER with ST elevation, otherwise normal. Normal CXRAY. Bedside echo ER with no evidence of pericardia effusion. Cardiac enzymes, ESR, CMP, CBC all WNL, with exception of elevated CRP. (SEE LABS / DIAGNOSTICS BELOW). Patient released from ER w/o limitations and instructed to f/u with Cardiology. Seen by Cardiology on 13JUL12. EKG and echocardiogram repeated (13JUL12). (SEE BELOW) VITALS BP: 120/76, HR: 72, T: 97.5 degrees F, HT: 72 in, WT: 170 lbs. BMI: 23.06, BSA: 1.988 square meters. A/P Last updated at 13 Jul 2012 1329 EDT 1. Chest pain: Pt with symptoms of CP increasing with exertion/laying breathing in the setting of recent vaccination. All of which is consistent with pericarditis. The location of his pain is a bit atypical on the other hand. He does not have an audible friction rub and none was reported in the typed portion of the ER note. Both his current and ER EKGs show subtle PR and ST changes, but they appear to be localized and not diffuse as is typical of pericarditis. Lastly there is no evidence of pericardial effusion on his echo. In the end the patient fails to meet the strict definition of pericarditis, however, that being said I feel that there is enough information to treat him with high dose NSAIDs and colchicine. He may in fact have pleuritis, but will likely benefit from pericarditis therapy. 2. Visit for: screening exam cardiovascular disorders Procedures(s): -ECG Interpretation And Report Only x 1 Medication(s): -Colchicine--PO 0.6MG TAB - TI PO BID #180 RFO Qt: 180 Rf: 0 Start Date: 07/12/2012. Disposition Last updated at 13 Jul 2012 1330 EDT. Released w/o Limitations Follow up: as needed with PCM.