chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Echocardiogram, Lymphadenopathy, Nasopharyngitis, Non-Hodgkin's lymphoma, Positron emission tomogram abnormal
Clinical narrative: Information has been received from an 80 year old female patient with hip replacement, glaucoma and sulfonamide allergy who on 02-FEB-2009 was vaccinated at her upper left arm with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included alendronate sodium (MSD). Within a few weeks of the vaccination, the patient lost all of her hearing of her right ear. Then the patient was hearing impaired by utilizing a hearing aid, but the hearing aid did not work. On 13-APR-2009, the patient had severe swollen glands on both sides of her neck and an ear, nose and throat (ENT) physician was sought. A various number of testing was performed. A CAT scan indicated there was a growth on the patient's nasopharynx which was pressing against her Eustachian tube and robbed her hearing. There were three biopsies performed to confirm the diagnosis, diffuse large B-Cells Non-HODGKINS Lymphoma. On 28-MAY-2009, the patient started chemotherapy called R-CHOP and prednisone. The R-CHOP therapy included RITUXAN, adriamycin, VINCRISTINE. It was reported that the patient visited the emergency room 9 days after her first treatment of chemotherapy due to pain. The patient was admitted for 24 hours for pain relief and it was thought she was bleeding internally from chemotherapy. After two treatments, the patient's swelling was gone down, her hearing was back to former level and her hearing aid worked. At the time of the report, the patient had undergone 3 out of 6 treatments. Her physician told her that she was making progress. Upon internal review, hearing loss and diffuse large B-Cell non Hodgkins lymphoma were determined to be an other important medical event. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Surgery
Clinical narrative: Information has been received from an 80 year old female patient with hip replacement, glaucoma and sulfonamide allergy who on 02-FEB-2009 was vaccinated at her upper left arm with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included alendronate sodium (MSD). Within a few weeks of the vaccination, the patient lost all of her hearing of her right ear. Then the patient was hearing impaired by utilizing a hearing aid, but the hearing aid did not work. On 13-APR-2009, the patient had severe swollen glands on both sides of her neck and an ear, nose and throat (ENT) physician was sought. A various number of testing was performed. A CAT scan indicated there was a growth on the patient's nasopharynx which was pressing against her Eustachian tube and robbed her hearing. There were three biopsies performed to confirm the diagnosis, diffuse large B-Cells Non-HODGKINS Lymphoma. On 28-MAY-2009, the patient started chemotherapy called R-CHOP and prednisone. The R-CHOP therapy included RITUXAN, adriamycin, VINCRISTINE. It was reported that the patient visited the emergency room 9 days after her first treatment of chemotherapy due to pain. The patient was admitted for 24 hours for pain relief and it was thought she was bleeding internally from chemotherapy. After two treatments, the patient's swelling was gone down, her hearing was back to former level and her hearing aid worked. At the time of the report, the patient had undergone 3 out of 6 treatments. Her physician told her that she was making progress. Upon internal review, hearing loss and diffuse large B-Cell non Hodgkins lymphoma were determined to be an other important medical event. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chemotherapy, Computerised tomogram abnormal, Deafness unilateral, Diffuse large B-cell lymphoma, Haemorrhage
Clinical narrative: Information has been received from an 80 year old female patient with hip replacement, glaucoma and sulfonamide allergy who on 02-FEB-2009 was vaccinated at her upper left arm with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included alendronate sodium (MSD). Within a few weeks of the vaccination, the patient lost all of her hearing of her right ear. Then the patient was hearing impaired by utilizing a hearing aid, but the hearing aid did not work. On 13-APR-2009, the patient had severe swollen glands on both sides of her neck and an ear, nose and throat (ENT) physician was sought. A various number of testing was performed. A CAT scan indicated there was a growth on the patient's nasopharynx which was pressing against her Eustachian tube and robbed her hearing. There were three biopsies performed to confirm the diagnosis, diffuse large B-Cells Non-HODGKINS Lymphoma. On 28-MAY-2009, the patient started chemotherapy called R-CHOP and prednisone. The R-CHOP therapy included RITUXAN, adriamycin, VINCRISTINE. It was reported that the patient visited the emergency room 9 days after her first treatment of chemotherapy due to pain. The patient was admitted for 24 hours for pain relief and it was thought she was bleeding internally from chemotherapy. After two treatments, the patient's swelling was gone down, her hearing was back to former level and her hearing aid worked. At the time of the report, the patient had undergone 3 out of 6 treatments. Her physician told her that she was making progress. Upon internal review, hearing loss and diffuse large B-Cell non Hodgkins lymphoma were determined to be an other important medical event. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Lymphadenopathy, Mass, Non-Hodgkin's lymphoma, Pain
Clinical narrative: Information has been received from an 80 year old female patient with hip replacement, glaucoma and sulfonamide allergy who on 02-FEB-2009 was vaccinated at her upper left arm with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included alendronate sodium (MSD). Within a few weeks of the vaccination, the patient lost all of her hearing of her right ear. Then the patient was hearing impaired by utilizing a hearing aid, but the hearing aid did not work. On 13-APR-2009, the patient had severe swollen glands on both sides of her neck and an ear, nose and throat (ENT) physician was sought. A various number of testing was performed. A CAT scan indicated there was a growth on the patient's nasopharynx which was pressing against her Eustachian tube and robbed her hearing. There were three biopsies performed to confirm the diagnosis, diffuse large B-Cells Non-HODGKINS Lymphoma. On 28-MAY-2009, the patient started chemotherapy called R-CHOP and prednisone. The R-CHOP therapy included RITUXAN, adriamycin, VINCRISTINE. It was reported that the patient visited the emergency room 9 days after her first treatment of chemotherapy due to pain. The patient was admitted for 24 hours for pain relief and it was thought she was bleeding internally from chemotherapy. After two treatments, the patient's swelling was gone down, her hearing was back to former level and her hearing aid worked. At the time of the report, the patient had undergone 3 out of 6 treatments. Her physician told her that she was making progress. Upon internal review, hearing loss and diffuse large B-Cell non Hodgkins lymphoma were determined to be an other important medical event. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Aspiration biopsy, Aspiration bone marrow, Chemotherapy, Computerised tomogram abnormal, Deafness unilateral
Clinical narrative: Information has been received from an 80 year old female patient with hip replacement, glaucoma and sulfonamide allergy who on 02-FEB-2009 was vaccinated at her upper left arm with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included alendronate sodium (MSD). Within a few weeks of the vaccination, the patient lost all of her hearing of her right ear. Then the patient was hearing impaired by utilizing a hearing aid, but the hearing aid did not work. On 13-APR-2009, the patient had severe swollen glands on both sides of her neck and an ear, nose and throat (ENT) physician was sought. A various number of testing was performed. A CAT scan indicated there was a growth on the patient's nasopharynx which was pressing against her Eustachian tube and robbed her hearing. There were three biopsies performed to confirm the diagnosis, diffuse large B-Cells Non-HODGKINS Lymphoma. On 28-MAY-2009, the patient started chemotherapy called R-CHOP and prednisone. The R-CHOP therapy included RITUXAN, adriamycin, VINCRISTINE. It was reported that the patient visited the emergency room 9 days after her first treatment of chemotherapy due to pain. The patient was admitted for 24 hours for pain relief and it was thought she was bleeding internally from chemotherapy. After two treatments, the patient's swelling was gone down, her hearing was back to former level and her hearing aid worked. At the time of the report, the patient had undergone 3 out of 6 treatments. Her physician told her that she was making progress. Upon internal review, hearing loss and diffuse large B-Cell non Hodgkins lymphoma were determined to be an other important medical event. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diffuse large B-cell lymphoma, Echocardiogram, Laryngoscopy, Lymphadenopathy, Lymphoma
Clinical narrative: Information has been received from an 80 year old female patient with hip replacement, glaucoma and sulfonamide allergy who on 02-FEB-2009 was vaccinated at her upper left arm with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included alendronate sodium (MSD). Within a few weeks of the vaccination, the patient lost all of her hearing of her right ear. Then the patient was hearing impaired by utilizing a hearing aid, but the hearing aid did not work. On 13-APR-2009, the patient had severe swollen glands on both sides of her neck and an ear, nose and throat (ENT) physician was sought. A various number of testing was performed. A CAT scan indicated there was a growth on the patient's nasopharynx which was pressing against her Eustachian tube and robbed her hearing. There were three biopsies performed to confirm the diagnosis, diffuse large B-Cells Non-HODGKINS Lymphoma. On 28-MAY-2009, the patient started chemotherapy called R-CHOP and prednisone. The R-CHOP therapy included RITUXAN, adriamycin, VINCRISTINE. It was reported that the patient visited the emergency room 9 days after her first treatment of chemotherapy due to pain. The patient was admitted for 24 hours for pain relief and it was thought she was bleeding internally from chemotherapy. After two treatments, the patient's swelling was gone down, her hearing was back to former level and her hearing aid worked. At the time of the report, the patient had undergone 3 out of 6 treatments. Her physician told her that she was making progress. Upon internal review, hearing loss and diffuse large B-Cell non Hodgkins lymphoma were determined to be an other important medical event. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neoplasm, Non-Hodgkin's lymphoma, Positron emission tomogram abnormal, Surgery
Clinical narrative: Information has been received from an 80 year old female patient with hip replacement, glaucoma and sulfonamide allergy who on 02-FEB-2009 was vaccinated at her upper left arm with a dose of ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included alendronate sodium (MSD). Within a few weeks of the vaccination, the patient lost all of her hearing of her right ear. Then the patient was hearing impaired by utilizing a hearing aid, but the hearing aid did not work. On 13-APR-2009, the patient had severe swollen glands on both sides of her neck and an ear, nose and throat (ENT) physician was sought. A various number of testing was performed. A CAT scan indicated there was a growth on the patient's nasopharynx which was pressing against her Eustachian tube and robbed her hearing. There were three biopsies performed to confirm the diagnosis, diffuse large B-Cells Non-HODGKINS Lymphoma. On 28-MAY-2009, the patient started chemotherapy called R-CHOP and prednisone. The R-CHOP therapy included RITUXAN, adriamycin, VINCRISTINE. It was reported that the patient visited the emergency room 9 days after her first treatment of chemotherapy due to pain. The patient was admitted for 24 hours for pain relief and it was thought she was bleeding internally from chemotherapy. After two treatments, the patient's swelling was gone down, her hearing was back to former level and her hearing aid worked. At the time of the report, the patient had undergone 3 out of 6 treatments. Her physician told her that she was making progress. Upon internal review, hearing loss and diffuse large B-Cell non Hodgkins lymphoma were determined to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest pain, Pain in extremity
Clinical narrative: After vaccine started having severe shin pain (B), sternal pain-
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope, Vomiting
Clinical narrative: 1) Pt fainted / or passed out after vaccination 2) Vomiting (x1) afterwards.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Chest X-ray, Febrile convulsion, Full blood count
Clinical narrative: Febrile seizure the night after immunizations given.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dizziness, Fall
Clinical narrative: Before administering vaccine patient asked to lay down for shots for fear of needles. After giving vaccines patient sat up looked i felt fine, stood up and proceeded to walk out of room. I was talking w/ patients sister when she hit wall /side down but stared conscious she was dizzy stayed for 15min drank juice and felt fine upon leaving clinic.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood glucose increased, Dizziness, Headache, Hypothermia, Muscle rigidity
Clinical narrative: Within 1-2 minutes of administration, had syncope or possibly an akinetic seizure witnessed by MD.  Collapsed, somewhat tonic, prolonged recovery.  Observed in MD office for 3 hours and was still dizzy, shaking SL hypothermic.  May have been post-ictal for 30 minutes.  Had headache several hours later, and even the following day was dizzy.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Postictal state, Syncope, Tremor
Clinical narrative: Within 1-2 minutes of administration, had syncope or possibly an akinetic seizure witnessed by MD.  Collapsed, somewhat tonic, prolonged recovery.  Observed in MD office for 3 hours and was still dizzy, shaking SL hypothermic.  May have been post-ictal for 30 minutes.  Had headache several hours later, and even the following day was dizzy.
Age: 1.2
Sex: M
Vaccine: FLU3, HEPA, MMR
Symptoms: Herpes zoster
Clinical narrative: Shingles on 7/19/09.  - Acyclonir
Age: 11.2
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness and heat at vaccine sites. Silver dollars sized area of redness per mom @ VARIVAX site. Slight redness, hot and sore -  smaller area to R IM injection site, as well (MENACTRA). Hot packs advised and TYLENOL or MOTRIN.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Diarrhoea, Lethargy, Pyrexia, Somnolence
Clinical narrative: Child fever 102 degrees F, sleepy, lethargic, diarrhea X 3 da.  MOTRIN alternating with TYLENOL 9 4 - 6 9m.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: Parent stated RA swelled and reddened, area measured 3"x6" with said red streak in it." Took child to ER observed + reminded to not get Varicella #2. Parent stated area affected was where Varicella was placed.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: She got vaccinated on Monday 7/20/09 with ADACEL by LPN. Returned Tuesday 7/22/09 with redness & swollen on the injection site. Notified doctor.& order HYDROCORTISONE cream. To apply to until patient is okay.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blister, Erythema, Rash, Rash pruritic
Clinical narrative: Rash on left forearm and trunk, Sat & Sunday itched, red vesicles
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Pt developed shingles like rash across left cheek of face approximately 6 days after receiving vaccine.  Pt received 2 Rx's from Dr.  VALTREX and VICODIN.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Dyspnoea, Hypoaesthesia, Laboratory test normal, Nausea
Clinical narrative: 7 hours after GARDASIL (HPV) vaccine, awoke with leg pain, numbness, Tachycardia, orthopnea & nausea.  Developed shortness of breath.  Labs normal, CT scan negative for P.E.  Symptoms resolved.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Orthopnoea, Pain in extremity, Tachycardia
Clinical narrative: 7 hours after GARDASIL (HPV) vaccine, awoke with leg pain, numbness, Tachycardia, orthopnea & nausea.  Developed shortness of breath.  Labs normal, CT scan negative for P.E.  Symptoms resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Localized rxn with redness, warmth and swelling (about the size of golf ball).  We never saw rxn.  Spoke to mom on phone.  Instructed her to do warm compresses and call in 2 days if not better.  She hasn't called back.
Age: 0.3
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Irritability, Pyrexia, Rash, Swelling
Clinical narrative: c/o rash, fever, fussy x 1 day. c/o swelling- symptoms began last night.
Age: 6.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Injection site swelling, Skin warm
Clinical narrative: Mom called office and stated child was given immunizations in left thigh, stated leg swollen hip to knee, warm to touch.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Rash macular, Skin warm
Clinical narrative: Left arm (entire upper arm) edematous, warm to touch, Blotchy red patches- pt took BENADRYL.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Skin exfoliation, Swelling face
Clinical narrative: Face only. Swollen cheeks, hot and red cheeks - Peeling, itching cheeks on face. Shingles shot.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Sinusitis
Clinical narrative: Patient is allergic to AVELOX.  Developed sinus infection 2 days after vaccine administration, started 2 - pack.  The next day she noticed her arm was red and warm to the touch at administration site.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Back pain, Blister, Herpes simplex serology negative, Pain, Pyrexia
Clinical narrative: 9 days after ZOSTAVAX - began with low grade fever.  7/9 - backache & blisters on shoulder blade.  Blistering & pain continued with blisters moving around trunk.  Very painful.  VALTREX on 7/10.  Slight pain.  Blisters drying 7/23.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Varicella zoster serology negative
Clinical narrative: 9 days after ZOSTAVAX - began with low grade fever.  7/9 - backache & blisters on shoulder blade.  Blistering & pain continued with blisters moving around trunk.  Very painful.  VALTREX on 7/10.  Slight pain.  Blisters drying 7/23.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Chest discomfort, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: General malaise began day 1 followed by fever > 102 degrees F / Headache/ myalgnas & chest discomfort all day 7-22-09 - Took Ibuprofen 600 mg PO - better after - Mon will call us 7-23-09 for update.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Mom reported posterior right arm, 1 1/2 inch diameter, red, hard and itchy after receiving vaccines 7-15-09.  Onset of symptoms; 7/16/09.  Still with small redness today.  Reports having no pain.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Raised red area, long, around injection site, somewhat itchy.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Received 2 mo vaccines at 11 AM on 7/22/09. Returned to clinic at 6:15 PM stating "(R) leg swollen & painful when touched". Examined by NP who assessed a small lump under skin on upper (R) thigh without erythema or warmth.
Age: 46.0
Sex: M
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Cold sweat, Electrocardiogram abnormal, Heart rate decreased, Loss of consciousness, Pallor
Clinical narrative: Pt given 4 vaccines (Tdap, MMR, HEP B & A). blood drawn for lab work. Loss consciousness for 8-10 seconds. Pt pale & clammy. Pt to take deep breaths coke given. Waited 20 min in observation. Talking obey simple commands. B/P 110/62 feet elevated. Pulse 99% cool compressor applied to head & neck EKG done, Pulse 49, Bld sugar 115, B/P 128/78, EKG: sinus bradycardia. Pt left anb. with friend. Pt referred to ER for any further LDC, weakness, sweats.
Age: 46.0
Sex: M
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Sinus bradycardia
Clinical narrative: Pt given 4 vaccines (Tdap, MMR, HEP B & A). blood drawn for lab work. Loss consciousness for 8-10 seconds. Pt pale & clammy. Pt to take deep breaths coke given. Waited 20 min in observation. Talking obey simple commands. B/P 110/62 feet elevated. Pulse 99% cool compressor applied to head & neck EKG done, Pulse 49, Bld sugar 115, B/P 128/78, EKG: sinus bradycardia. Pt left anb. with friend. Pt referred to ER for any further LDC, weakness, sweats.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Blood pressure increased, Body temperature increased, Erythema, Heart rate increased, Skin warm
Clinical narrative: Temp. 101.2 B.P. elevated @ 160/98 H.R. elevated 125 skin site warm to touch, red, slightly swollen.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Swelling
Clinical narrative: Temp. 101.2 B.P. elevated @ 160/98 H.R. elevated 125 skin site warm to touch, red, slightly swollen.
Age: 1.3
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Bump on Left leg where vaccine was given redness on area, reaction on same day as vaccine was given, pt will put cold compresses for 10 min. 3-4 times a day return in 1 day to follow-up.
Age: 14.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Eyes sunken, Inflammation, Pyrexia, Vomiting
Clinical narrative: High fever 102 degrees, about 3 days.  Vomited, about 11 PM.  Shot was 3:00 ish. Body ws inflamed w/ redness about 3 days, eyes sunkin in.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Pt. with brief (< 1 minute) syncopal episode after receiving GARDASIL.  Had been given HEP A & HEP B prior to GARDASIL.
Age: 10.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Crying, Fall, Headache, Loss of consciousness, Mydriasis
Clinical narrative: Initial report received on 07 July 2009 from a health care professional in the country. A 10 year old female patient received ADACEL (lot number C3004) in the left deltoid and VARIVAX (manufacturer Merck, lot number 0655Y) on 07 July 2009. Two to three minutes post vaccination, the patient's head began to hurt. The patient fell back on the table and her eyes began to dilate. She began staring for about 10 seconds. The patient was monitored. No other reactions were noted besides crying at the time of the report. The patient's recovery status was unknown. The patient has a history of Rolandic epilepsy. The patient has been seizure free for 4 years and has been off medication for 1 year. Follow-up information was received 23 July 2009 from a health care professional in the country. ADACEL had been administered intramuscularly in the left deltoid. According to the reporter, they believed the patient lost consciousness for several seconds as the patient was unresponsive. The physician returned to the examination room to evaluate the patient; no treatments were prescribed and no laboratory testing had been performed. The event had been partially witnessed by the medical staff and according to the reporter, the patient recovered several seconds later. Due to this new information received, it was determined this case meets seriousness criteria and has been upgraded to serious. List of Documents held by Sender: none.
Age: 10.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Staring, Unresponsive to stimuli
Clinical narrative: Initial report received on 07 July 2009 from a health care professional in the country. A 10 year old female patient received ADACEL (lot number C3004) in the left deltoid and VARIVAX (manufacturer Merck, lot number 0655Y) on 07 July 2009. Two to three minutes post vaccination, the patient's head began to hurt. The patient fell back on the table and her eyes began to dilate. She began staring for about 10 seconds. The patient was monitored. No other reactions were noted besides crying at the time of the report. The patient's recovery status was unknown. The patient has a history of Rolandic epilepsy. The patient has been seizure free for 4 years and has been off medication for 1 year. Follow-up information was received 23 July 2009 from a health care professional in the country. ADACEL had been administered intramuscularly in the left deltoid. According to the reporter, they believed the patient lost consciousness for several seconds as the patient was unresponsive. The physician returned to the examination room to evaluate the patient; no treatments were prescribed and no laboratory testing had been performed. The event had been partially witnessed by the medical staff and according to the reporter, the patient recovered several seconds later. Due to this new information received, it was determined this case meets seriousness criteria and has been upgraded to serious. List of Documents held by Sender: none.
Sex: U
Vaccine: DTAP, HEP, IPV, RV5
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Information has been received from a physician who attended a program. The reporting physician stated that during the process of the discussion another physician revealed that a child received four vaccinations. The vaccinations were ROTATEQ, IPV (manufacturer not reported), RECOMBIVAX HB (unspecified) (manufacturer not reported) and DTaP (manufacturer not reported). Subsequently the patient developed STEVENS JOHNSON Syndrome or similar symptoms to that. It was unknown if the patient had sought medical attention. At the time of report the patient's status was unknown. This is considered to be an other medical event. Attempts are being made to verify the existence of a identifiable patient. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Agitation, Fatigue, Headache, Hypersensitivity, Insomnia
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old male who on 11-JUN-2009 was vaccinated with a first dose of ZOSTAVAX (Merck) (lot number 664223/0365Y) subcutaneously. There were no history of drug reactions and allergies. On approximately 13-JUN-2009, the patient "all weekend was tired, having headache and feeling kind of sick". The patient had sought medical attention by phone call. No lab diagnostics study was performed. At the time of the report, the patient did not recover. Follow-up information received the pharmacist and company representative stated that the patient developed an allergic reaction to ZOSTAVAX (Merck) in the form of a rash. Due to the rash, the patient was given cortisone (manufacturer unknown) shot 10 days after vaccination. Now the patient had hand tremors, agitation and insomnia. At the time of report, the patient did not recover. The reporter felt that an allergic reaction in form of a rash were related to therapy with ZOSTAVAX (Merck). Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Rash, Tremor
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old male who on 11-JUN-2009 was vaccinated with a first dose of ZOSTAVAX (Merck) (lot number 664223/0365Y) subcutaneously. There were no history of drug reactions and allergies. On approximately 13-JUN-2009, the patient "all weekend was tired, having headache and feeling kind of sick". The patient had sought medical attention by phone call. No lab diagnostics study was performed. At the time of the report, the patient did not recover. Follow-up information received the pharmacist and company representative stated that the patient developed an allergic reaction to ZOSTAVAX (Merck) in the form of a rash. Due to the rash, the patient was given cortisone (manufacturer unknown) shot 10 days after vaccination. Now the patient had hand tremors, agitation and insomnia. At the time of report, the patient did not recover. The reporter felt that an allergic reaction in form of a rash were related to therapy with ZOSTAVAX (Merck). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site reaction, Injection site urticaria, Injection site warmth
Clinical narrative: Received KINRIX on 7/23/09, grandparent noted localized reaction 24 hrs later. Came into the office on 7/26 for unrelated issue & showed us her arm; raised area (10cm x 5cm), warm to touch; mom notes it's improved". No impaired ROM* no fever did not receive treatment of any kind. Told family to call if worsening of injection site or other symptoms related to injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Received KINRIX on 7/21/09, parent noted localized reaction 24 hrs later.  Called to office 7/23/09 to report that arm was red, swollen, warm to touch, 0 fever, good ROM.  Recommended Motrin and cool compresses prn.  Call with fever worsening.  Symptoms rash, etc.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt experiencing erythema, warmth, and tenderness at injection site - R arm where varicella vaccination given. Sx x 3days not improving.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Menactra + varicella given wed.  7-22-09, + over course of the day patient presented to clinic on 7-24-09 with itching, swelling, + redness on both deltoids with palpable edges.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure decreased, Confusional state, Dizziness, Tonic convulsion
Clinical narrative: Immediately after shot pt felt light headed and dizzy when walking sat in chair and had a 5-10 sec long tonic seizure, afterwards pt was hypofebrile and confused for 2 hours.  BP normalized and he became responsive.
Age: 35.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Contusion, Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient began having swelling pain, bruising, and redness to right arm 3 days after TDAP given.  Bruising occurred July 6.  No fever.  Went to MD prescribed SEPTIA for 10 days.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Injection site mass, Injection site warmth, Nausea
Clinical narrative: Got injection on 07/24/09.   On 07/24/09 swelled.  On 07/25/09 severe HA, chills, site hot, nausea, hard lump size of tennis ball.   On 07/26/09 continued the same.  7/26/7-27/07-28 tried cold compress 07/28 really nauseated, chills.  Tried Tylenol x + during the day.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Got injection on 07/24/09.   On 07/24/09 swelled.  On 07/25/09 severe HA, chills, site hot, nausea, hard lump size of tennis ball.   On 07/26/09 continued the same.  7/26/7-27/07-28 tried cold compress 07/28 really nauseated, chills.  Tried Tylenol x + during the day.
Age: 61.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Referred to health dept. by Dr. for yellow fever and typhoid vaccines.  Stated after receiving typhoid shot on 7/20/09 she broke out in hives.  She book benadryl and hives got better.  Came to health dept late am with complaint of hives.  On exam, patient did have hives on extremities and back.  No complaint of shortness of breath or difficulty breathing.  She has appt with PMD at 3 pm today.  Instructed to go to ER if symptoms increase.  Talked to patient after PMD visit.  Started on prednisone.
Age: 24.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Headache, Injected limb mobility decreased, Pain in extremity
Clinical narrative: L arm pain for five days following vaccine.  Patient unable to raise arm above shoulder level due to pain.  Headache not responsive to conservative measures.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This child was given a Dtap instead of a Tdap.  This vaccine was given in the afternoon on 7/27/09.  The child was given the vaccine for preventative measure.  It was the 6th dose in this series.  No adverse effect reported by the parent.
Age: 5.0
Sex: U
Vaccine: DTAP, DTPIPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swollen and redness right leg dtap #5 was given and ipv #4 on right leg/ varicella mmr on left leg.    vacccines GIVEN ON: 07.20.2009   pt f/u on 7.22.2009.  Pt did recovered
Age: 5.0
Sex: U
Vaccine: DTAP, DTPIPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen and redness right leg dtap #5 was given and ipv #4 on right leg/varicella mmr on left leg.  vaccines GIVEN ON:  07.20.2009 on 7.22.2009.  Pt did recovered.
Age: 1.1
Sex: M
Vaccine: HEPA, PNC, VARCEL, HEPA, PNC, VARCEL
Symptoms: Blood culture positive, Cerebral infarction, Convulsion, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Patient developed fever, seizure, Left arm weakness the following morning and was hospitalized. MRI showed Right Middle Cerebral artery infarct. Pt was treated with antiseizure medications, antibiotics, and Lovenox.  8/10/09 Hospital records received DOS 6/6/09 to 7/06/09. Assessment: Right middle cerebral artery infact with occlusion, seizure, Staphylococcus bacteremia/endocarditis. Mother noted child child was 'not acting right', had poor head and body control jerking movements in left upper extremity, and the head jerking towards the left side. Child was partially responsive and found to have a fever or 102F. The movements lated for 10 - 15 minutes, after that he was lethargic and sleepy. It was noted that he had decreased mobility of the left extremity. Transient tremor left lower extremity. Hyperpigmented marks and nevi left heel/ankle. Hyperpigmentation right forehead and right shoulder.
Age: 1.1
Sex: M
Vaccine: HEPA, PNC, VARCEL, HEPA, PNC, VARCEL
Symptoms: Pyrexia, Staphylococcal bacteraemia
Clinical narrative: Patient developed fever, seizure, Left arm weakness the following morning and was hospitalized. MRI showed Right Middle Cerebral artery infarct. Pt was treated with antiseizure medications, antibiotics, and Lovenox.  8/10/09 Hospital records received DOS 6/6/09 to 7/06/09. Assessment: Right middle cerebral artery infact with occlusion, seizure, Staphylococcus bacteremia/endocarditis. Mother noted child child was 'not acting right', had poor head and body control jerking movements in left upper extremity, and the head jerking towards the left side. Child was partially responsive and found to have a fever or 102F. The movements lated for 10 - 15 minutes, after that he was lethargic and sleepy. It was noted that he had decreased mobility of the left extremity. Transient tremor left lower extremity. Hyperpigmented marks and nevi left heel/ankle. Hyperpigmentation right forehead and right shoulder.
Age: 1.1
Sex: M
Vaccine: HEPA, PNC, VARCEL, HEPA, PNC, VARCEL
Symptoms: Cerebral infarction, Cerebrovascular accident, Convulsion, Nuclear magnetic resonance imaging brain abnormal, Pyrexia
Clinical narrative: Patient developed fever, seizure, Left arm weakness the following morning and was hospitalized. MRI showed Right Middle Cerebral artery infarct. Pt was treated with antiseizure medications, antibiotics, and Lovenox.  8/10/09 Hospital records received DOS 6/6/09 to 7/06/09. Assessment: Right middle cerebral artery infact with occlusion, seizure, Staphylococcus bacteremia/endocarditis. Mother noted child child was 'not acting right', had poor head and body control jerking movements in left upper extremity, and the head jerking towards the left side. Child was partially responsive and found to have a fever or 102F. The movements lated for 10 - 15 minutes, after that he was lethargic and sleepy. It was noted that he had decreased mobility of the left extremity. Transient tremor left lower extremity. Hyperpigmented marks and nevi left heel/ankle. Hyperpigmentation right forehead and right shoulder.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Painful rash to abdomen. treatment Acycolvair, Valtrex
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, PPV
Symptoms: Anorexia, Headache, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Pain, swelling at site of injection on Rt. upper arm, lethargy, nausea , fever,body aches and pains, vomiting, loss of appetite,headache.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA, PPV
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pain, swelling at site of injection on Rt. upper arm, lethargy, nausea , fever,body aches and pains, vomiting, loss of appetite,headache.
Age: 36.0
Sex: M
Vaccine: UNK
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Discomfort to Left Arm. Constant pain for over 2 weeks. Pain still there but not as intense. Patient believes nerve was hit during reciept of shot.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness,swelling and tenderness 12x11cm on LD assessed by RN.Patient advised to place ice pack and motrin for pain.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Cold sweat, Nausea, Pallor
Clinical narrative: Tdap, Varicella, MCV4, & Gardasil were completely administered at approximately 1:50 p.m. on 7/28/09; When the family was checking out at the clerk's window, the patient told her mother she felt weak.  The patient leaned against the wall and the mother assisted her to the floor.  When the nurse arrived at the front, the patient was awake, alert, & oriented.  She was clammy and c/o nausea.  The nurse assisted her to the bathroom and the patient sat down.  B/P was 72/46, Respirations 14, regular;  Skin cool and damp, pale.  After about 15 minutes, patient began feeling better, color had returned.
Age: 14.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Headache, Hypersensitivity, Pain in extremity, Skin warm
Clinical narrative: Per patients mom, patient complained of Headache 10 mins postvaccination.  Developed Bilateral arm redness, sore and warm to touch getting larger the same day as vaccination. Patient applied ice to arms, took benadryl and motrin per mom.  Advised to have patient seen by family physician.  Pt saw family physician who per mom states patient is just having an allergic reaction, Dr. incresed patients benadryl dose.  On 7-28-09 phoned mom and she states patient is completely better headache is gone and arms are completely better no redness or swelling or soreness.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site atrophy
Clinical narrative: Dimple at injection site (left upper arm).  No treatment.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Eyelid oedema, Headache, Hypersensitivity, Injection site erythema
Clinical narrative: Localized allergic reaction to vaccine administration site approximately 10-12 hours after administration, impressive swelling, redness, warm and painful to touch; slight edema of the upper eyelids; Patient complains of Headache and dizziness as well.  Patient treated with Hydroxizine PRN; cool compresses to the area.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Localized allergic reaction to vaccine administration site approximately 10-12 hours after administration, impressive swelling, redness, warm and painful to touch; slight edema of the upper eyelids; Patient complains of Headache and dizziness as well.  Patient treated with Hydroxizine PRN; cool compresses to the area.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration
Clinical narrative: L lateral upper extremity with ~ 4 cm area of blanching erythema with smaller area firmness palpated subcutaneously directly below.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Pharyngeal hypoaesthesia, Pruritus, Urticaria
Clinical narrative: Pt developed systemic hives, pruritis, and throat numbness.  Pt was seen in the ER.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia facial, Injection site erythema
Clinical narrative: redness at site of injection; c/o left sided facial numbness approximately 20 minutes after injection, still with some numbness left upper lip and left side of face today (client also with history of polio as child and states has had similar episodes of facial numbness such as this in the past)No visual facial weakness on exam
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: vaccine related varicella (skin rash)
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Contusion, Petechiae, Platelet count decreased, Pyrexia
Clinical narrative: Child had fever for 2 weeks (intermittent), had fever 4 days before his one year immunizations June 29, 2009. Developed petechiae (July 11) on legs which spread to arm, face, and bottom. Bruising also developed in hands, face, legs. Child was taken to primary physicians office. CBC was performed. Total platelet count was 3000 so child was admitted to hospital.  8/10/09 Hospital records received DOS 7/11/09 to 7/11/09 and 7/20/09. Assessment: Severe thrombocytopenia and neutropenia. Patient presents with petechia on left lower leg this morning. Spread to both legs, arms, face, and bottom. Bruising on hands, face and legs. Intermittant fever over past 2 weeks. Plasmapheresis.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 0 adverse events.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Hyperaesthesia, Oedema peripheral
Clinical narrative: Feels warm though no fever.  Edema in hands / feet skin all over body was sensitive to touch.  Steroids started 7/28/09 and ZANTAC. 9/1/09 PCP records received for 7/27/09 to 7/29/09. WCC 7/27/09 with vax given.  Returned 7/28/09 with c/o allergic reaction to Gardasil.  Pt c/o dyspnea, pain and edema in hands and feet, chest pain,feels hot despite normal temp.  Also nausea, vomiting and diarrhea noted in ROS.  Pain with palpation to extremities. 7/29/09 reports knot at injection site. Skin improved. Tx: Benadryl and NSAIDS. 1/6/10:  PCP Record received for date of service 7/27/09.  Hx of Bee sting allergy, epi pen refill given.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Back pain, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Vaccine given: 7/21/09 - Fever day (1) 101.7 - MOTRIN q 6-8 hrs given - Child c/o soreness to arm - Headache, nausea, stomach aches and pain, diarrhea, decreased appetite - dizziness, lower back pain.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Vaccine given: 7/21/09 - Fever day (1) 101.7 - MOTRIN q 6-8 hrs given - Child c/o soreness to arm - Headache, nausea, stomach aches and pain, diarrhea, decreased appetite - dizziness, lower back pain.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Irritability, Vomiting projectile
Clinical narrative: Projectile vomiting  irritability Clingy.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Fatigue, Nasal congestion, Pain, Pyrexia
Clinical narrative: Began 7-25-09 with "mild achy".  Worsened on 7/27/09 -> fever (subjective), body aches, nasal congestion cough & chest congestion, arms & legs aches, fatigue.  No GI symptoms.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Respiratory tract congestion
Clinical narrative: Began 7-25-09 with "mild achy".  Worsened on 7/27/09 -> fever (subjective), body aches, nasal congestion cough & chest congestion, arms & legs aches, fatigue.  No GI symptoms.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: TDAP given instead of TD.  No adverse reaction.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial culture positive, Cellulitis, Injection site rash, Injection site vesicles
Clinical narrative: Vesicular eruption at injection site diagnosed cellulitis.
Sex: M
Vaccine: SMALL
Symptoms: Injection site discolouration, Injection site erythema, Musculoskeletal pain
Clinical narrative: Initial report received from a consumer on 29 March 2009 via the ACAM2000 Hotline. A male military service member who received smallpox vaccine (ACAM2000, lot number not reported) and anthrax vaccine (manufacturer and lot number not reported) experienced a reaction around the smallpox vaccination site. He reported a "dark line" around the vaccination site and redness surrounding the area. He also reported shoulder pain. He had not been seen by a health care provider but reported that he may visit the local Emergency Room for evaluation. List of documents held by sender: None. Followup report received from a consumer on 03 April 2009 via telephone contact. The patient reported that he went to an Ambulatory Care Center for evaluation. He could not recall the date he went. He was told that his smallpox vaccination site was healing normally. He reported that his symptoms of a "dark circle" around the vaccination site, redness and shoulder pain had resolved as of 28 March 2009. List of documents held by sender: None.
Age: 41.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Back pain, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: This case was received on 05 May 2009 from a consumer/patient. A 41 year old male patient received the following vaccinations on 27 April 2009: ACAM2000 (Sanofi Pasteur Biologics Co., lot number not reported) and ANTHRAX vaccine (trade name and manufacturer not reported). Five days following vaccination, the patient reported left-sided lower back pain, shoulder, wrist and left knee pain on bending. The patient's medical history reported a recent sprained ankle on 21 April 2009. The patient was seen in a clinic and had an x-ray and was scheduled to have an MRI of his back. The results of these tests were not reported. The patient reported no flu-like symptoms and no fever. The patient reported that the shoulder and wrist pain were improving at the time of the report but his joint pain was continuing. The patient's pain has not prevented him from working. List of documents hed by sender: None
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Dysphonia, Hallucination, Heart rate increased, Injection site rash, Pain
Clinical narrative: Had injections at 11:20 am on 7-27-09. Fever of 103.5, rapid heart rate, body aches, hallucinations, rapid speech in a high pitched voice, vomiting, and rash running the length of upper thigh at site of DTaP injection at 3:30 am 7-28-09.  Called on-call Dr. at 3:48 am and he told us to manage fever from home and call our Dr. in the morning.  Fever came down with Motrin and wrapping him in wet towels.  Saw Dr. at 11:00 am.  He assessed my son and told me to continue fever control for possibly the next 3 days. He told me what to watch for. And to bring my son back in, if the fever doesn't respond to Tylenol/Motrin.  My son had Varicella, DTaP, MMR and Polio vaccines administered at once on 7-27-09. We are still controlling his fever and watching for increased symptoms.  I don't know the manufacturer of the vaccine. You'll have to contact Dr's office for that.