chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: C-reactive protein normal, Cardiac enzymes normal, Chest X-ray normal, Coagulation test normal, Differential white blood cell count normal
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.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment elevation, Eosinophil count, Eosinophil percentage
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.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Full blood count normal, Injection site pustule, Lymphocyte count, Lymphocyte percentage decreased, Metabolic function test normal
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.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Monocyte count, Monocyte percentage increased, Neutrophil count, Neutrophil percentage increased, Pain
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.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Painful respiration, Pleuritic pain, Red blood cell sedimentation rate normal, Troponin T
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.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient walked to waiting room after vaccines administered, began to feel lightheaded, then fainted. Child unconscious for less than one minute. Patients vitals monitored, then moved to exam room, and continued to be monitored for more than 20 minutes. Child steadily improved from time of incident. Child released to mothers care.
Age: 39.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia
Clinical narrative: Increasing tingling in feet, legs and hands.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Varicella and MMR where given within 10 days of a previous MMR, no adverse reactions seen as of this time.
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, TD
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Client passed out seconds after receiving 3rd vaccination.  He was passed out for about 20 seconds.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Body temperature increased, Injection site reaction, Injection site vesicles, Rash vesicular
Clinical narrative: Temp > 100.6, small localized vessicular rash at site of injection 10 days after, also with fluid filled blisters s/p injection as well.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Injection site reaction, Oedema peripheral, Urticaria
Clinical narrative: Patient had topical reaction to right arm. Patient also had hives around her mouth. Hives have disappeared, arm is still very swollen and red.
Age: 1.06
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity, Injection site urticaria
Clinical narrative: Developed a large hive at injection site. Given Benadryl by nurse, waited at clinic for two hours to ensure no further allergic reaction. No further reaction happened.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Feeling hot, Hyperhidrosis
Clinical narrative: Recipient felt light headed, hot, sweaty, dizzy, short of breath.
Age: 30.0
Sex: M
Vaccine: TTOX
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness w/sx started after injection 8/9/12 and slight headache w/ice pack applied, legs, elevated, VS taken, and 20 oz of water.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Rash, Rash erythematous, Skin warm
Clinical narrative: HER ARM HAS A LARGE, HOT, RED RASH AND THERE IS A HARD LUMP AT THE INJECTION SITE.  IT IS NOT ITCHING OR BURNING.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Blood glucose increased, Hyperhidrosis, Injection site streaking, Pain
Clinical narrative: Swelling, tenderness, body aches, sweats, elevated blood sugars since injection.  Streak from the Left Lateral Deltoid toward the axilla and his axilla is sore.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling, tenderness, body aches, sweats, elevated blood sugars since injection.  Streak from the Left Lateral Deltoid toward the axilla and his axilla is sore.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain, Rotator cuff syndrome
Clinical narrative: She reports pain with elevation of her arm, tenderness and swelling at the injection site lasting for about 6 weeks now.
Age: 10.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Pt received a PCV 13 when he shouldn't have.  No adverse events to report!
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Abdominal pain, Chills, Dizziness, Hypoacusis, Nausea
Clinical narrative: Dizziness, chills, abdominal cramping, felt like i was going to throw up, temporary blurry vision, couldn't hear correctly temporarily.
Age: 18.0
Sex: F
Vaccine: HPV4, MEN
Symptoms: Vision blurred
Clinical narrative: Dizziness, chills, abdominal cramping, felt like i was going to throw up, temporary blurry vision, couldn't hear correctly temporarily.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster ophthalmic, Oedema peripheral, Tremor
Clinical narrative: Came in a few days after vaccine and showed redness and swelling in left arm. After one week, patient came in with big red area, but no swelling and no pain. Patient said she can't hold glass of water because her arm shakes.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Autoantibody test, Back pain, Blood test, Culture, Eye pain
Clinical narrative: Came in a few days after vaccine and showed redness and swelling in left arm. After one week, patient came in with big red area, but no swelling and no pain. Patient said she can't hold glass of water because her arm shakes.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster ophthalmic, Muscular weakness, Nuclear magnetic resonance imaging, Pharyngitis streptococcal, Staphylococcal infection
Clinical narrative: Came in a few days after vaccine and showed redness and swelling in left arm. After one week, patient came in with big red area, but no swelling and no pain. Patient said she can't hold glass of water because her arm shakes.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound scan
Clinical narrative: Came in a few days after vaccine and showed redness and swelling in left arm. After one week, patient came in with big red area, but no swelling and no pain. Patient said she can't hold glass of water because her arm shakes.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Left deltoid region with hot mildly erythematous area about 2 inches circumference. Temp 100.3. Patient c/o muscle aches since morning after vaccination.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site pruritus, Wheezing
Clinical narrative: Pt. returned to clinic 20-30 after immunization. Injection site Left arm with 1 inch erythema/itching and slight wheezing. Pt. given 50mg BENADRYL PO, followed by ATROVENT nebulizer Rx. VS BP 124/68, HR 84, R 16. Pt. reports feeling better, left arm erythema decreased. Pt. released to home with instructions to go to ED with further wheezing/SOB. Returned to ED for admission 6/28/12 at 1023 PM. Pt. c/o reoccurrence wheezing. Admitted and released 6/29/12. Hospitalization included nebulizer Rx and prednisone.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: Client received vaccines on 8-6-12 7pm on 8-8-12 woke up with headache & took TYLENOL. Later in afternoon developed temperature 101.6 with chills and headache returned. This was HPV #3 & Hep A #2. He had no reaction on prior doses.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: At 7:00 am patient's mother notice a red, raised, itchy area at site of injection. Applied BENADRYL gel at 9:00 am. Will give BENADRYL orally this pm, cont. CLARITIN tomorrow.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Very painful arm 8/7/2012 (more than normal vaccine pain) morning of 8/8/2012 patient woke up to redness on injection arm from elbow to shoulder, with swelling on tricep, patient took BENADRYL.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Gave ZOSTAVAX IM instead of subq and patient is experiencing injection site pain. Also increased stiffness/difficulty moving arm - severe at 1st but easing up with time & still sore in (R) shoulder girdle in office 8/7/12 but has full ROM & no redness/swelling.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Muscle spasms, Pain
Clinical narrative: Gave ZOSTAVAX IM instead of subq and patient is experiencing injection site pain. Also increased stiffness/difficulty moving arm - severe at 1st but easing up with time & still sore in (R) shoulder girdle in office 8/7/12 but has full ROM & no redness/swelling.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin tightness
Clinical narrative: Swelling of right thigh 9 cm x 10 cm slightly red, swollen and tight. Cetirizine 5mg/5ml oral Triamcinolone acetonide topically.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Altered state of consciousness, Dyskinesia, Musculoskeletal stiffness, Syncope
Clinical narrative: Fainting after HPV #2 was administered 10 am - helped to floor - altered level of consciousness 30 sec to 1 min. Jerky movements associated with fainting (body stiff) - regained full alertness within 1 min. layed on floor for 10 min - sat for 20 more min - felt fine to go home B/P 130/70.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall, Hunger, Immediate post-injection reaction
Clinical narrative: A few minutes after receiving vaccine, she fall down on the ground from standing. Her eyes started to close, but open right away when mom started calling her name and shake her body. When asked what's happen, she said that she felt dizzy and hungry. She was given water, cracker, and towel. 20 minutes after, she felt better and leave the pharmacy.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Varicella administered 8/7/12. Today site is reddened 5 cm area. Warm to touch, itches. To use cool compress, BENADRYL.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abasia, Activities of daily living impaired, Pain
Clinical narrative: Entire body is aching unable to pick anything up or walk.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Vomiting
Clinical narrative: 3 hours following receipt of Tdap and MENACTRA vaccines the patient developed a severe bifrontal headache and several episodes of vomiting. No prior history of migraine headaches. No fever. Improving several hours following above episode.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: 3 inch red, inflamed circle around injection site as of today, patient feels area is "getting better".
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pyrexia
Clinical narrative: H/A, chills, stomach ache, fever 103.6, nausea no vomiting. Received call from patient reporting symptoms above. Called at 415 pm. Has started taking ibuprofen q 6 hrs.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Full blood count, Lip haemorrhage, Mouth haemorrhage, Platelet count decreased
Clinical narrative: This spontaneous report was received from a very healthy 78 years old male consumer reporting on himself, with no pertinent medical history and no drug reactions or allergies, who on 10-JUN-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant medications included: ZOCOR for the treatment of cholesterol. The consumer reported that on 13-JUN-2012, he had a drop in his blood platelet count after receiving ZOSTAVAX vaccination. He stated that his blood platelet count dropped down to 9. He was treated with prednisone (manufacturer unknown) (80 mg daily) and his platelet count had come back to 315. At the time of the report, the patient was recovering since it was stated that the adverse experience improved. The patient sought unspecified medical attention. The relatedness for blood platelet dropped down to 9 after receiving ZOSTAVAX was unknown ZOSTAVAX. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Thrombocytopenia
Clinical narrative: This spontaneous report was received from a very healthy 78 years old male consumer reporting on himself, with no pertinent medical history and no drug reactions or allergies, who on 10-JUN-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant medications included: ZOCOR for the treatment of cholesterol. The consumer reported that on 13-JUN-2012, he had a drop in his blood platelet count after receiving ZOSTAVAX vaccination. He stated that his blood platelet count dropped down to 9. He was treated with prednisone (manufacturer unknown) (80 mg daily) and his platelet count had come back to 315. At the time of the report, the patient was recovering since it was stated that the adverse experience improved. The patient sought unspecified medical attention. The relatedness for blood platelet dropped down to 9 after receiving ZOSTAVAX was unknown ZOSTAVAX. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Platelet count decreased
Clinical narrative: This spontaneous report was received from a very healthy 78 years old male consumer reporting on himself, with no pertinent medical history and no drug reactions or allergies, who on 10-JUN-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant medications included: ZOCOR for the treatment of cholesterol. The consumer reported that on 13-JUN-2012, he had a drop in his blood platelet count after receiving ZOSTAVAX vaccination. He stated that his blood platelet count dropped down to 9. He was treated with prednisone (manufacturer unknown) (80 mg daily) and his platelet count had come back to 315. At the time of the report, the patient was recovering since it was stated that the adverse experience improved. The patient sought unspecified medical attention. The relatedness for blood platelet dropped down to 9 after receiving ZOSTAVAX was unknown ZOSTAVAX. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 months old female patient. The patient was vaccinated with VARIVAX (merck), 0.5 ml, on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 20-JUL-2012 the patient developed a mild case of chicken pox. The patient has sought unspecified medical attention. No treatment information was reported. The outcome of mild case of chicken pox was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event, Herpes zoster, Hypersensitivity, Pruritus, Rash
Clinical narrative: Information has been received from a receptionist at the physician's office reporting for the physician concerning a 73 year old male patient without any drug allergy, with chronic renal insufficiency and bladder cancer and a history of renal failure acute who on 26-APR-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # not reported) at a pharmacy (location unknown). Concomitant therapy included Furosemide, amlodipine, metoprolol, HECTOROL, diazepam, simvastatin (manufacturer unknown) and allopurinol. On 27-APR-2012 the patient developed a red raised extending down the back of the right leg to the foot. The patient saw another unspecified physician that same day who noted it was likely shingles. The patient saw the reporting physician on 01-MAY-2012 who confirmed the diagnosis of shingles. No treatment was given to the patient. No lab test was done. At the time of this report, the event outcome was unknown. Information has been received from medical records concerning a 73 year old male with a history of hyperuricaemia, who on 26Apr2012 was given a dose of ZOSTAVAX (Merck) vaccine administered in his right arm (lot # 16581AA, expiration date 21 Jan2013, not validated at this time). There was no perceived difficulty at the time of the injection. By the following day, he had developed a red raised rash extending down the back of his right leg to the foot. The upper edge was the right gluteal fold. The patient did seek medical attention on 27 Apr with a physician who felt it was shingles and that the development was a result of the patient's kidney issue. The patient was not given any medications as he was not having any pain. The patient was not certain if he ever had chickenpox as a child. Throughout there was some hypersensitivity to the area with minimal intermittent itch. Assessment included: adverse effect, NOS due to correct medicinal substance properly administered. The patient continued on his regular medications. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a receptionist at the physician's office reporting for the physician concerning a 73 year old male patient without any drug allergy, with chronic renal insufficiency and bladder cancer and a history of renal failure acute who on 26-APR-2012 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # not reported) at a pharmacy (location unknown). Concomitant therapy included Furosemide, amlodipine, metoprolol, HECTOROL, diazepam, simvastatin (manufacturer unknown) and allopurinol. On 27-APR-2012 the patient developed a red raised extending down the back of the right leg to the foot. The patient saw another unspecified physician that same day who noted it was likely shingles. The patient saw the reporting physician on 01-MAY-2012 who confirmed the diagnosis of shingles. No treatment was given to the patient. No lab test was done. At the time of this report, the event outcome was unknown. Information has been received from medical records concerning a 73 year old male with a history of hyperuricaemia, who on 26Apr2012 was given a dose of ZOSTAVAX (Merck) vaccine administered in his right arm (lot # 16581AA, expiration date 21 Jan2013, not validated at this time). There was no perceived difficulty at the time of the injection. By the following day, he had developed a red raised rash extending down the back of his right leg to the foot. The upper edge was the right gluteal fold. The patient did seek medical attention on 27 Apr with a physician who felt it was shingles and that the development was a result of the patient's kidney issue. The patient was not given any medications as he was not having any pain. The patient was not certain if he ever had chickenpox as a child. Throughout there was some hypersensitivity to the area with minimal intermittent itch. Assessment included: adverse effect, NOS due to correct medicinal substance properly administered. The patient continued on his regular medications. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: This report was received  from Sanofi Pasteur Inc. and was assigned manufacturer report number 72782, concerning a 29 year old female with no illness at time of vaccination or pre existing physician diagnosed allergies who on 19-JUN-2012 (at 8:10 am) was vaccinated with the 3rd dose of (Lot#672781/1706AA) IM in left deltoid. Concomitant therapy included EFFEXOR. The patient began with headache, dizziness and nausea 1.5 hours after receiving vaccine. No vomit or diarrhoea happened. At the time of reporting, the patient's outcome was unknown. The patient was seen "6 degree" after vaccine, she appeared fine. No other vaccinations within 4 weeks were used. No adverse event happened following prior vaccination. This was originally reported by a certified registered nurse practitioner. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient in her 60's who on 18-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#, dose and route not reported). Later in June 2012, the patient came back to see the pharmacist and was concerned because she had a rash at the injection site. There was also a small amount of bruising and the rash felt warm to the touch. The pharmacist suggested her to take some TYLENOL and BENADRYL for the symptoms. At the time of the report, the patient's outcome was unknown. Follow-up information was received from a pharmacist refers to a 62 years old female patient (also reported as 64) who on 18-JUN-2012 at 09:51 AM, was vaccinated with the first dose of ZOSTAVAX (Merck), subcutaneously (SQ.) (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that on 20-JUN-2012 PM (2 days after the injection), the patient experienced a circular rash about 3 inches diameter, center of which was bruised and felt warmth to touch. At the time of report, the patient's outcome was recovered. The related for the patient's events was not reported for ZOSTAVAX. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 60 years old female patient with no pertinent medical history and no drug reaction or allergies, who on 26-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 CYMBALTA and acyclovir. The pharmacist reported that on 28-JUL-2012, the patient stated on two-inch by two-inch red patch developed around the injection site. By 29-JUL-2012, that same two-inch patch was blistering and the redness had wrapped around her entire arm in a two-inch band. No labs diagnostics studies were performed. The patient took BENADRYL which helped. At the time of the report, the patient had not recovered. The patient sought medical attention by calling the pharmacist. The relatedness for a two-inch by two-inch red patch developed around the injection site was now blistering, and redness and wrapped around her entire arm in a two-inch band was unknown for ZOSTAVAX. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 70 years old patient with no pertinent medical history and no drug reactions or allergies who on 06-JUL-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that on 03-JUL-2012, the patient called to the pharmacy and stated that he had returned from a trip with a 12 inch long rash on the same arm as the ZOSTAVAX was administered. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by calling the nurse. The relatedness for 12 inch long rash on the same arm was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning an unknown number of patients with no known drugs reactions/allergies who on unknown dates might have received improperly stored GARDASIL (dose, route and lot # not provided) that was exposed to 30F for 12 hours. The nurse stated that this temperature excursion occurred during the 1st week of June 2012. Patients might have been exposed to GARDASIL after this time frame. There were no known adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Cyanosis, Rash
Clinical narrative: This spontaneous report was received from a consumer refers to her approximately 1 (currently 5 years old) years old daughter with no pertinent medical history and no drug reactions or allergies who about four years ago, in approximately 2008, was vaccinated with a dose of M-M-R II (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that about four years ago, in approximately 2008, when her daughter received M-M-R II, she turned purple had a bad rash and was sent to the hospital. At the time of the report, the patient's outcome was unknown. The relatedness for patient turned purple and had a bad rash was unknown for M-M-R II . Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: Information has been received from a currently 72 years old female consumer concerning herself with a history of recurrent cold sores and being prone to "fever blisters (prescribed valacyclovir) who on 25-MAR-2012 was vaccinated with a dose ZOSTAVAX (lot# not reported). Beginning around 01-JUL-2012 the patient had noticed that her left side of her lips felt "puffy." She reported that she had a history of being prone to "fever blisters," and she was prescribed valacyclovir by her dermatologist for "flare-ups." She was not taking valacyclovir at the time that she received ZOSTAVAX. She stated that since the beginning of July, when she noticed her lips feeling "puffy," she had consulted her primary physician. The patient started taking her valacyclovir when she began to experience the sensation of swelling of her lips. The doctor told the patient that the sensation she was experiencing in her lips could be as a result of ZOSTAVAX. The patient stated that she had not experienced a rash. No treatment was given for the event. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to an 84 years old female patients with active shingles and with none pertinent medical history and drug reactions/allergies. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX on 31-AUG-2011. No concomitant medications were reported. 2 months after the patient received ZOSTAVAX, In October 2011 the patient developed a rash. There were lidocaine, NEURONTIN and ZOVIRAX given for the AE. The outcome of rash was unknown at the time of reporting. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old male patient with no drug reactions/allergies. The patient was vaccinated SQ with 0.65 ml ZOSTAVAX (lot # 670614/0620AA) on 10-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient had a rash and "full blown shingles". The patient sought medical attention by visiting to pharmacy and physician office and was treated with valacyclovir and TYLENOL with codeine. The outcome of rash and full blown shingles was reported as recovering/resolving. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to vaccinated person, Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient's daughter was vaccinated with a dose of VARIVAX (Merck), 0.5ml on 05-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 15-JUL-2012 the patient experienced shingles. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse concerning a patient who on 31-AUG-2007, was vaccinated with the first dose of GARDASIL (lot # not provided). On 11-SEP-2008, the patient received the second dose of GARDASIL (lot # not provided). The nurse stated that the patient had not received dose three yet. There were no symptoms reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Menstrual disorder
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, route, dosage and injection site were not known) in June 2012. No other co-suspects were reported. No concomitant medications were reported. The patient has been experiencing headaches and a "wacky menstrual cycle" ever since one GARDASIL injection was administered. The patient was not recovered at the time of report. The patient had visited the physician's office for medical attention. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician's assistant refers to a 6 months old patient. The patient was inadvertently vaccinated with a 0.5 ml dose of VAQTA (Lot # not reported) intramuscularly in the left thigh on 03-AUG-2012. No adverse effects were reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist (R. Ph) refers to unknown number of patients who on an unknown date were vaccinated with zoster vaccine live which was improperly stored (exposed to 50 degrees F for unknown duration). No adverse effect reported. The outcome of received improperly stored zoster vaccine live was unknown. 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.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse (L.V.N.) refers to one of twin sisters who in February 2010 was vaccinated with first dose of GARDASIL. The patient's mother said her draughts might have received the second dose of GARDASIL. Vaccine in March or April 2011 but the office could not provide official documentation and twins might received additional dose of GARDASIL. Vaccine for second dose again. No adverse effects reported. At the time of report, the outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse (L.V.N.) refers to one of twin sisters who in February 2010 was vaccinated with first dose of GARDASIL. The patient's mother said her draughts might have received the second dose of GARDASIL on March or April 2011 but the office could not provide official documentation and twins might received additional dose of GARDASIL. Vaccine for second dose again. No adverse effects reported. At the time of report, the outcome was unknown. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was subcutaneously vaccinated with a dose of ZOSTAVAX (lot # 665215/1172Y, Exp 14-FEB-2011, dose unspecified) on 31-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. Reporter noted that the patient was administered an expired dose of ZOSTAVAX on 31-JUL-2012. No adverse effect reported. It was unspecified the patient had sought medical attention or not. No treatment information was reported. The outcome was unknown. This is one of several reports received from the same source. 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 Registered Nurse to a patient of unknown age. The nurse reported that "the patient was administered the first dose of GARDASIL (0.5mL, intramuscular, lot# was unknown) on 23-NOV-2009. The second dose of GARDASIL (0.5mL, intramuscular, lot # was unknown) on 21-DEC-2009, and the third dose of GARDASIL (0.5mL, intramuscular, lot# was unknown)on 22-APR-2010". No adverse event was reported. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report has been received from a pharmacist (R. Ph) refers to a 52 years old female patients who on 25-JUL-2012 was vaccinated SC with a 0.65 ml dose of zoster vaccine live (lot # unspecified). On 27-JUL-2012, the patient developed bumps and a rash all over their body after receiving zoster vaccine live. The patient contacted the pharmacist and received the treatment medications of ZYRTEC, but no lab diagnostics were performed. At the time of report, the patient had not recovered. Additional information has been requested.