chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Diarrhoea, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Initial report received from the consumers' parents on 28 June 2011. An 11-year-old male patient with a history of seasonal allergies, received an intramuscular injection site (site not reported) of MENACTRA, sanofi pasteur lot number U3839AA, and an injection (route and site not reported) of TUBERSOL 5 TU, sanofi pasteur lot number not reported. The patient had a reaction to ADACEL at age 10 on 10 June 2010. The patient had no illness at the time of vaccination and no other vaccines within 4 weeks of the MENACTRA and TUBERSOL. The patient took no concomitant medications. On 24 June 2011, the patient developed a fever of 102 (oral), sore throat and a runny nose with clear drainage. The patient was seen by a physician and tested negative for strep. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 02 August 2011. The patient had received MENACTRA in the left deltoid and TUBERSOL 5 TU, lot number C3373AA in the left forearm. The patient's parent called on 24 June 2011 to report the patient had a fever, sore arm and body aches. It was recommended that the patient taken MOTRIN and limit activity. On 27 June 2011, the patient was evaluated and he continued to have a fever, body aches, runny nose and diarrhea. No treatments were prescribed at that time. The patient has not been seen and no calls have been received since 27 June 2011. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Rhinorrhoea, Streptococcus test negative
Clinical narrative: Initial report received from the consumers' parents on 28 June 2011. An 11-year-old male patient with a history of seasonal allergies, received an intramuscular injection site (site not reported) of MENACTRA, sanofi pasteur lot number U3839AA, and an injection (route and site not reported) of TUBERSOL 5 TU, sanofi pasteur lot number not reported. The patient had a reaction to ADACEL at age 10 on 10 June 2010. The patient had no illness at the time of vaccination and no other vaccines within 4 weeks of the MENACTRA and TUBERSOL. The patient took no concomitant medications. On 24 June 2011, the patient developed a fever of 102 (oral), sore throat and a runny nose with clear drainage. The patient was seen by a physician and tested negative for strep. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 02 August 2011. The patient had received MENACTRA in the left deltoid and TUBERSOL 5 TU, lot number C3373AA in the left forearm. The patient's parent called on 24 June 2011 to report the patient had a fever, sore arm and body aches. It was recommended that the patient taken MOTRIN and limit activity. On 27 June 2011, the patient was evaluated and he continued to have a fever, body aches, runny nose and diarrhea. No treatments were prescribed at that time. The patient has not been seen and no calls have been received since 27 June 2011. No further information was provided at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Feeling hot
Clinical narrative: Shot administered at 3:50, patient said he felt lightheaded then he laid on floor & complained that he was hot then complained of difficulty breathing. Call 911 & gave EPIPEN shot at 3:55. A few minutes later & he said he was breathing OK & had him lay there for awhile then sat up & EMS arrived. He refused to go to ER.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Pt (L) upper arm broke out in hives on 3/8/12 in am. Pt stated she noticed it when she got up in the morning because it itched. Pt came to office, red raised areas noted to (L) upper arm. DECADRON 10 mg IM given, MEDROL dose pak ordered and pt instructed to take BENADRYL 50 mg. Spoke to pt on 3/9/12 and she was feeling better.
Age: 2.0
Sex: F
Vaccine: MMR, PNC
Symptoms: Rash
Clinical narrative: Rash on back of neck & face.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Convulsion, Loss of consciousness, Presyncope
Clinical narrative: Upon completion of vaccine administration, patient passed out into arms of medical assistant. Patient was assisted into supine position on bed where she seemed to convulse for 1-2 seconds. Patient slowly became more alert and oriented within 1-2 minutes of presumed vasovagal reaction. Patient remained in office and monitored for approximately 15 more minutes at which time the doctor examined her and cleared her to leave.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Mother noticed redness at Rt. deltoid injection site on evening of vaccination. On Tues. 3/6/12 Rt. deltoid was red, swollen and hard.  Symptoms continued on Wednesday 3/7/12 and by Thursday morning redness on Rt. deltoid had increased in size and area felt warm to touch.  Mother took child to nurse practitioner.  Treated with antibiotic due to cellulitis per mother's report.  Child is to follow up with NP if signs and symptoms are not relieved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Leg pain with swelling and redness. 1 day after receiving vaccines exam showed a large circular area of redness 7-8cm in diameter, some warmth centrally, mild firm to palpatation-no induration. Cephalexin 250/5ml was Rx alone with to increase Benadryl to 2 tsp q6h.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash on upper chest and upper back, feeling feverish.
Age: 6.0
Sex: M
Vaccine: RAB
Symptoms: Chest pain
Clinical narrative: Mother reported on 3/12 that 45 minutes after 3/8 rabies vaccine, child c/o chest hurting. Resolved without intervention 3 hours later.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Injection site erythema, Injection site pruritus
Clinical narrative: 0.65ML OF ZOSTAVAX VACCINE WAS ADMINISTERED INTO PATIENTS RIGHT ARM SUBQ @ 12:55PM. Patient complained of itching at administration site after 5 minutes. Area was red with small scratched. Patient denied any other symptoms. After another 5 minutes patient complained of tightness in chest and some difficulty breathing with sweating. Epi Pen 0.3mg administered into patients Right thigh lateral aspect. Patient them escorted to Emergency Room via wheelchair.
Age: 23.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Hypoaesthesia
Clinical narrative: Pt has had intermittent intensity of numbness but still has from and normal strength in (R) deltoid where pt was given Hep A.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Incorrect dose administered, Pain, Pyrexia
Clinical narrative: Initial case was received on 10 September 2010 from a consumer/patient. A 35 year old female patient received at 11:00 a.m. on 08 September 2010 an injection of either "ADACEL" or a "DTaP" (manufacturer "sanofi pasteur", lot number unknown). The patient was not sure which vaccine was given to her. On 08 September 2010, the patient also received a tuberculin (TB) test (manufacturer and lot number unknown). Five hours after the injections (also reported as 5 p.m.), she experienced body aches, headache and a fever. The patient had no illness at the time of the vaccination. She received TdaP in May 2009. Her medical history included seasonal allergies and migraine headache. As of this report, the headache had resolved but, the patient had not recovered from the fever and body aches. Follow-up information was received from a health care professional on 09 October 2010. The patient received on 08 September 2010 a left deltoid injection of ADACEL, lot number C3491AA and a left forearm placement of TUBERSOL 5 TU, lot number C3371AA. The patient did not inform that she already had a "Tdap" in May 2009. The outcome was reported as recovered. Follow-up information was received from a healthcare professional on 06 December 2010. The patient did not require treatment, and was not seen by a physician. ADACEL was administered intramuscularly, and TUBERSOL was administered intradermally. The reporter had no additional information to provide. Follow-up information was received from a healthcare professional on 04 February 2011. The patient was evaluated by a physician (previously reported as not being seen by a physician). The credentials for the vaccine administrator were also reported. No further information was provided at the time of the report. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient was seen in our office due to right deltoid red, swollen. Patient was rx KEFLEX 250mg, twice a day for 10 days.
Age: 55.0
Sex: M
Vaccine: DT, TYP
Symptoms: Rash, Swollen tongue
Clinical narrative: Client c/o rash on arm and tongue swelling after taking 3rd dose of oral typhoid. PCP encouraged ER visit where client was monitored and dc'd home with instructions to use oral BENADRYL on 3-6-12. Spoke with client on 3-8-12; symptoms resolving & doing well.
Age: 20.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Condition aggravated, Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Approximately 5 minutes after vaccines administered (Gardasil and intradermal flu) pt felt faint on way to waiting room. Skin very pale and sweaty. Sat then laid down in waiting room. BP 100/50. Cool cloth given along with juice. Client monitored by staff. After approximately 10 minutes pt states he is feeling better. Color is noticeably better and BP 105/60 with HR 76. Client sat for an additional 5 minutes before leaving and stated that he felt fine and had a friend to drive him home.  After client feeling better he did tell staff that he has a history of feeling faint after things such as ear piercing.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Injection site swelling, Injection site warmth, Neck pain, Pain
Clinical narrative: Client reports soreness began 3-9-12. Next day noted "some" swelling. Now c/o R arm at site of injection with 3 inch diameter swelling and c/o "hot" to touch . Also states had neck pain and headache over the weekend after vaccines received. Denies any hives or Resp distress at any time after vaccines. States has "normal" temperature now and denies any drainage at site. Advised client to see his private MD or urgent care facility to assess above area and C/o of headache and neck pain.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Client reports soreness began 3-9-12. Next day noted "some" swelling. Now c/o R arm at site of injection with 3 inch diameter swelling and c/o "hot" to touch . Also states had neck pain and headache over the weekend after vaccines received. Denies any hives or Resp distress at any time after vaccines. States has "normal" temperature now and denies any drainage at site. Advised client to see his private MD or urgent care facility to assess above area and C/o of headache and neck pain.
Age: 57.0
Sex: M
Vaccine: IPV, TDAP, TYP, YF
Symptoms: Activities of daily living impaired, Cataract, Decreased appetite, Malaise, Myalgia
Clinical narrative: Acute decrease in vision started hours after vaccine. Saw ophtho and reported this is just cataract (but he had never had symptoms from it before). They saw no evidence of neuritis/uveitis. Then 3 days later didn't feel well. Day 4 - fever (102), myalgia, anorexia. Fever resolved by day 5 and myalgias and anorexia slowly improving (currently day 7). Patient has remained out of work this whole week.
Age: 57.0
Sex: M
Vaccine: IPV, TDAP, TYP, YF
Symptoms: Pyrexia, Visual acuity reduced
Clinical narrative: Acute decrease in vision started hours after vaccine. Saw ophtho and reported this is just cataract (but he had never had symptoms from it before). They saw no evidence of neuritis/uveitis. Then 3 days later didn't feel well. Day 4 - fever (102), myalgia, anorexia. Fever resolved by day 5 and myalgias and anorexia slowly improving (currently day 7). Patient has remained out of work this whole week.
Age: 0.93
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Irritability, Pyrexia, Rash erythematous, Vaccination complication
Clinical narrative: The next morning when she woke up mom said she had a red rash to her forehead, cheeks, stomach and back. Had a low grade temp. of 99.8, and was fussy. Mom called ER and they told her to give her Benadryl and if it doesn't get any better to bring her in to be seen. She took her in to ER that evening, and they told her it was a reaction to the vaccines she received the day before. She cont to give her Benadryl for 2-3 days and it went away.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Abdominal pain upper, Erythema, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient had Pediarix injected into his left upper arm and that evening his arm started to swell. The following day his injected arm was twice the size of his other arm from swelling and the redness extended over his shoulder into his upper back all the way down to his elbow. He complained of pain and itching. We saw the doctor and was given Zyrtec (antihistamine) and Advil. Neither medicines seemed to help swelling but helped control his fever. Patient had a low grade fever 100 F. for most of the time his arm was swollen. Saturday 03.03.2012 patient complained of stomach pain and vomited twice, no other signs of illness. His arm started to decrease in swelling the day after he had vomited. Arm swelling has now, as of 03.13.2012, considerably decreased.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pruritus, Pyrexia
Clinical narrative: Patient had Pediarix injected into his left upper arm and that evening his arm started to swell. The following day his injected arm was twice the size of his other arm from swelling and the redness extended over his shoulder into his upper back all the way down to his elbow. He complained of pain and itching. We saw the doctor and was given Zyrtec (antihistamine) and Advil. Neither medicines seemed to help swelling but helped control his fever. Patient had a low grade fever 100 F. for most of the time his arm was swollen. Saturday 03.03.2012 patient complained of stomach pain and vomited twice, no other signs of illness. His arm started to decrease in swelling the day after he had vomited. Arm swelling has now, as of 03.13.2012, considerably decreased.
Age: 1.16
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Localized redness to injection site right upper arm with low grade fever up to 100.4.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site mass, Rash macular
Clinical narrative: Patient's left arm where injections were given developed a lump approximately 1 1/2 inches and her arm started turning red and blotchy. Dr was notified and she saw the patient and ordered 9ml of BENADRYL. Patient's heart rate and respirations were monitored for 30 mins after onset of reaction. Signs didn't progress/worsen over the 30 minutes.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hive at injection site.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Lethargy, Oedema peripheral, Pyrexia, Spinal myelogram
Clinical narrative: Redness, swelling, fever, tenderness (R) arm. Lethargic. Had myelogram on 3-12-12 AM.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Redness, swelling, fever, tenderness (R) arm. Lethargic. Had myelogram on 3-12-12 AM.
Age: 63.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Blister, Condition aggravated, Fibromyalgia
Clinical narrative: Patient comes back in January 2012 complaining of blisters on his leg he believes were shingles blisters from ZOSTAVAX vaccine. Patient comes back today (3/13/12) complaining ZOSTAVAX shot exacerbated his fibromyalgia. No treatment.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Breath holding, Convulsion, Cyanosis, Hypokinesia, Hypotonia
Clinical narrative: 11:45am, 3/13/12. Called to exam room 1 secondary to patient having an unresponsive episode after the vaccine was given. After the two shots (Hib and PREVNAR) given, patient held breath for prolonged period of time with bluish discoloration noted especially around the mouth and bridge of nose. Patient became unconscious and unresponsive. Episode lasted approximately 5 minutes. Noted to reawaken to drowsiness and some fussiness afterwards. No fever noted. No shaking noted--still and limp. Patient breastfed intermittently. Patient noted to have normal respirations, normal pulse ox of 97% on room air, and normal heart rate in 80's. Normal coloration returned. Patient assessed as having a breathholding spell with seizure. Mother given information and reassurance about breathholding spells. Mother concerned about possible future seizures, brain damage. Reassurance provided. Mother given Dr's phone number for an appointment.
Age: 1.01
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Irritability, Loss of consciousness, Platelet count, Somnolence, Unresponsive to stimuli
Clinical narrative: 11:45am, 3/13/12. Called to exam room 1 secondary to patient having an unresponsive episode after the vaccine was given. After the two shots (Hib and PREVNAR) given, patient held breath for prolonged period of time with bluish discoloration noted especially around the mouth and bridge of nose. Patient became unconscious and unresponsive. Episode lasted approximately 5 minutes. Noted to reawaken to drowsiness and some fussiness afterwards. No fever noted. No shaking noted--still and limp. Patient breastfed intermittently. Patient noted to have normal respirations, normal pulse ox of 97% on room air, and normal heart rate in 80's. Normal coloration returned. Patient assessed as having a breathholding spell with seizure. Mother given information and reassurance about breathholding spells. Mother concerned about possible future seizures, brain damage. Reassurance provided. Mother given Dr's phone number for an appointment.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU3, PNC13
Symptoms: Grand mal convulsion, Unresponsive to stimuli
Clinical narrative: Child had tonic/ clonic seizure, unresponsive x 4-5 minutes, Taken to hospital via ambulance.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Severe shoulder pain lasting over 5 months now.   Lots of PT and ibuprofen did not completely remove pain.   Better now, but still hurts.   MRI done 3/8/2012 revealed bursitis.  Not sure what to try next.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Cellulitis, Erythema, Hypersensitivity, Injection site erythema
Clinical narrative: 3/2/17 arm swelling, redness and streaking down her arm from injection site. Malaise, nausea & redness for 4-5 days. 3/13/12 limited upper right hand, elbow pain, can't lay on that arm. She has hypersensitive pain to touch down to forearm.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Nausea, Oedema peripheral
Clinical narrative: 3/2/17 arm swelling, redness and streaking down her arm from injection site. Malaise, nausea & redness for 4-5 days. 3/13/12 limited upper right hand, elbow pain, can't lay on that arm. She has hypersensitive pain to touch down to forearm.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature, Chills, Gait disturbance, Hyperhidrosis, Malaise
Clinical narrative: I became very ill, chills/sweats with body aches & temp. Also could not walk very well. Legs were weak and stiff. Severe migraine headache that lasted for 3-4 days with no relief. Total of 8 days before symptoms stopped.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: I became very ill, chills/sweats with body aches & temp. Also could not walk very well. Legs were weak and stiff. Severe migraine headache that lasted for 3-4 days with no relief. Total of 8 days before symptoms stopped.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Cardiac stress test normal, Computerised tomogram normal, Laboratory test normal, Mental status changes
Clinical narrative: Presented to ER for sudden weakness, mental status changes which improved over 1-2 days.
Age: 33.0
Sex: M
Vaccine: ANTH, TDAP
Symptoms: Chills, Dizziness, Headache, Myalgia, Sensation of heaviness
Clinical narrative: Chills, myalgias. Followed about 5 hours later by "heavy" sensation in left leg, brief episodes of lightheadedness and bitemporal HA.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Headache, Pain
Clinical narrative: Headache, body aches.
Age: 6.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Reaction began Fri 9 March, redness & warmth at the site & increased over the weekend, painful to touch or move. Treated with BENADRYL & observed closely & continued to enlarge. Initiated antibiotics KEFLEX 250 mg/5ml to give 8.5 ml twice daily x 10 days.
Age: 30.0
Sex: F
Vaccine: HPV2
Symptoms: Abdominal pain, Exploratory operation, Hepatic mass, Hepatic neoplasm malignant non-resectable, Jaundice
Clinical narrative: On 8/30/2011 subject reported by phone that she had started on 6/5/2011 with diffuse abdominal pain of moderate-to-severe intensity, nausea, vomits, generalized pruritus, and jaundice. Abdominal sonogram on 7/22/2011 showed a mass in the liver. Local hospital admission (7/23/2011) and testing led to referral to national hospital and exploratory laparotomy (8/8/2011), and discovery of liver tumor (5 cm diameter) in the portal vein bifurcation with infiltration of the extrahepatic bile duct. Tumor was unremovable. She was discharged 8/11/2011 with treatment against pruritus and referral to Oncology (appt 9/7/2011). On 12/22/2011 subject was in terminal phase, receiving palliative care at home; diagnosis was liver cancer.
Age: 30.0
Sex: F
Vaccine: HPV2
Symptoms: Laboratory test, Laparotomy, Nausea, Palliative care, Pruritus generalised
Clinical narrative: On 8/30/2011 subject reported by phone that she had started on 6/5/2011 with diffuse abdominal pain of moderate-to-severe intensity, nausea, vomits, generalized pruritus, and jaundice. Abdominal sonogram on 7/22/2011 showed a mass in the liver. Local hospital admission (7/23/2011) and testing led to referral to national hospital and exploratory laparotomy (8/8/2011), and discovery of liver tumor (5 cm diameter) in the portal vein bifurcation with infiltration of the extrahepatic bile duct. Tumor was unremovable. She was discharged 8/11/2011 with treatment against pruritus and referral to Oncology (appt 9/7/2011). On 12/22/2011 subject was in terminal phase, receiving palliative care at home; diagnosis was liver cancer.
Age: 30.0
Sex: F
Vaccine: HPV2
Symptoms: Terminal state, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: On 8/30/2011 subject reported by phone that she had started on 6/5/2011 with diffuse abdominal pain of moderate-to-severe intensity, nausea, vomits, generalized pruritus, and jaundice. Abdominal sonogram on 7/22/2011 showed a mass in the liver. Local hospital admission (7/23/2011) and testing led to referral to national hospital and exploratory laparotomy (8/8/2011), and discovery of liver tumor (5 cm diameter) in the portal vein bifurcation with infiltration of the extrahepatic bile duct. Tumor was unremovable. She was discharged 8/11/2011 with treatment against pruritus and referral to Oncology (appt 9/7/2011). On 12/22/2011 subject was in terminal phase, receiving palliative care at home; diagnosis was liver cancer.
Age: 28.0
Sex: F
Vaccine: HPV2
Symptoms: Chemotherapy, Colitis, Hysterectomy, Mass excision, Metastasis
Clinical narrative: Between June-August 2010, subject started with pain/discomfort in pelvic region. She consulted her local primary care center and was diagnosed and treated for colitis. After symptomology progressively worsened she was given a sonogram (8/25/2010) that showed "shadows on ovaries". Following readmission (8/30/2010), surgeons on 9/1/2010 removed a mass apparently started in the stomach; they told subject's sister it was invasive cancer. Hospital admission and multiple chemotherapy courses took place in 9/2010 and 10/2010, then total hysterectomy (1/28/2011) and more chemo (5/2011). On 6/22/2011 she was admitted with diagnosis of ovarian cancer stage III C. Was taking Hyoscine, methadone, and bisacodyl as necessary.
Age: 28.0
Sex: F
Vaccine: HPV2
Symptoms: Ovarian cancer stage III, Ovarian disorder, Pelvic discomfort, Pelvic pain, Stomach mass
Clinical narrative: Between June-August 2010, subject started with pain/discomfort in pelvic region. She consulted her local primary care center and was diagnosed and treated for colitis. After symptomology progressively worsened she was given a sonogram (8/25/2010) that showed "shadows on ovaries". Following readmission (8/30/2010), surgeons on 9/1/2010 removed a mass apparently started in the stomach; they told subject's sister it was invasive cancer. Hospital admission and multiple chemotherapy courses took place in 9/2010 and 10/2010, then total hysterectomy (1/28/2011) and more chemo (5/2011). On 6/22/2011 she was admitted with diagnosis of ovarian cancer stage III C. Was taking Hyoscine, methadone, and bisacodyl as necessary.
Age: 28.0
Sex: F
Vaccine: HPV2
Symptoms: Ultrasound ovary abnormal
Clinical narrative: Between June-August 2010, subject started with pain/discomfort in pelvic region. She consulted her local primary care center and was diagnosed and treated for colitis. After symptomology progressively worsened she was given a sonogram (8/25/2010) that showed "shadows on ovaries". Following readmission (8/30/2010), surgeons on 9/1/2010 removed a mass apparently started in the stomach; they told subject's sister it was invasive cancer. Hospital admission and multiple chemotherapy courses took place in 9/2010 and 10/2010, then total hysterectomy (1/28/2011) and more chemo (5/2011). On 6/22/2011 she was admitted with diagnosis of ovarian cancer stage III C. Was taking Hyoscine, methadone, and bisacodyl as necessary.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Urticarial lesions noted on legs, feet and one on face by parents and MA within 2 minutes of all vaccines. Pt observed and no new lesions noted after 15 minutes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Small area of erythema (2cm) to LUE - no induration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Complaints of pains in legs where vaccine was administered. Woke in the morning with fever that lasted for about 14 hours.
Age: 1.22
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Erythema, Febrile convulsion, Irritability, Pharyngeal erythema
Clinical narrative: Awoke with temperature of 101, fussy, did not act like she felt well.  Taken to MD on 3/6/12 and prescribed Augmentin for "red ear and red throat". On 3/9/12 fever 104 and red rash appeared on chest, abdomen, faintly noted on extremities.  Febrile seizure x1.  Taken to ER for evaluation.  Advised to continue Augmentin.
Age: 1.22
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Awoke with temperature of 101, fussy, did not act like she felt well.  Taken to MD on 3/6/12 and prescribed Augmentin for "red ear and red throat". On 3/9/12 fever 104 and red rash appeared on chest, abdomen, faintly noted on extremities.  Febrile seizure x1.  Taken to ER for evaluation.  Advised to continue Augmentin.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: A purple welt several inches in area at the injection site was discovered by my wife last night -- actual onset may have been earlier.  Area was swollen and tender/sore.  This morning (3/14), the color had changed to red.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Urticaria
Clinical narrative: A purple welt several inches in area at the injection site was discovered by my wife last night -- actual onset may have been earlier.  Area was swollen and tender/sore.  This morning (3/14), the color had changed to red.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Patient developed a rash on her face and her trunks, the next morning it had spread into a total body rash.  It looked like she had the measles all over her body.  It lasted for a day, then the next day the trunk faded, the following day the arms improved.  When she gets hot, you can still see a little residual on her face and arms/legs.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: REDNESS, SWELLING, PAIN, WARMTH.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Dizziness, Hypoaesthesia oral
Clinical narrative: Feeling dizziness with intermittent numbness of lips after receiving immunizations. No syncope. Vitals normal. Pt. alert and oriented.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Croup infectious, Herpes zoster, Influenza like illness, Mucosal discolouration
Clinical narrative: Initial report was received on 06 March 2012 from a consumer who is also the patient. A 58 year-old male patient with a past medical history of congestive heart failure and diabetes had received on 20 December 2011 FLUZONE (lot number, route and site of administration not reported) and an unspecified amount of time later had "several bouts of flu like symptoms. In mid-February 2012, the patient had a sinus problem with white mucous, cough and sneezing. The patient reported he had "cruddy croup". A few days after the sinus problem resolved. The patient developed shingles. The patient stated "felt as though it (the vaccine) didn't work". According to the report, the patient had the croup for 15 days and then "got" shingles for 13 days which he continued to have. The patient was evaluated by a physician. Treatments were not reported. The patient had received the influenza vaccine every year for 30 years. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Secretion discharge, Sinus disorder, Sneezing
Clinical narrative: Initial report was received on 06 March 2012 from a consumer who is also the patient. A 58 year-old male patient with a past medical history of congestive heart failure and diabetes had received on 20 December 2011 FLUZONE (lot number, route and site of administration not reported) and an unspecified amount of time later had "several bouts of flu like symptoms. In mid-February 2012, the patient had a sinus problem with white mucous, cough and sneezing. The patient reported he had "cruddy croup". A few days after the sinus problem resolved. The patient developed shingles. The patient stated "felt as though it (the vaccine) didn't work". According to the report, the patient had the croup for 15 days and then "got" shingles for 13 days which he continued to have. The patient was evaluated by a physician. Treatments were not reported. The patient had received the influenza vaccine every year for 30 years. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture, Computerised tomogram head, Culture urine, Mental status changes, Pyrexia
Clinical narrative: Fever 102.9 3-8-12 at 1400 (TYLENOL 650mg PO, IV antibiotics, IV fluids). Altered mental status (CT of brain). (Fever came down to 101.7 degrees then 98.2 at 1900; PO fluids encouraged; IV fluids - antibiotics initiated; mentation remains altered though pt appears to be improving).
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Cough, Death, Dyspnoea
Clinical narrative: Admitted 12/16/10 for cough x 3 days, and SOB. Found to be in CHF. Hospitalized for approximately 8 days and released to hospice. Patient expired 12/26/10. Patient had ZOSTAVAX 10 days prior to admission.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: Got shingles shot at 2 PM at health dept. on Mar. 2, 2012. Went in hot tub approx. 5 PM & felt pressure on chest, followed by walking resulting in breathing problems, fatigue & chest pressure, subsided after rest.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEP, HIBV, MMR, VARCEL
Symptoms: Pallor, Vomiting
Clinical narrative: Pt developed vomiting and paleness of approximately 30 minutes after vaccines administration that persisted for approximately 6 hours. No fever, no rash, no hives, no seizures, no diarrhea or other complaints. Advised to consult PCP and/or ER -> next day mother reports no problems & no medical follow-up.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Within fifteen min. pt c/o rash on chest & localized rash around injection site. Pt sent home with Rx (antihistamine).
Sex: F
Vaccine: TDAP, FLU3, TDAP
Symptoms: Local reaction
Clinical narrative: Localized reaction to LUE from Tdap reaction.
Sex: F
Vaccine: TDAP, FLU3, TDAP
Symptoms: Diarrhoea, Injection site erythema, Malaise, Pain in extremity
Clinical narrative: Localized reaction to LUE from Tdap reaction.
Age: 33.0
Sex: F
Vaccine: TDAP, FLU3, TDAP
Symptoms: Local reaction
Clinical narrative: Sore (L) arm x 6 days. Redness about 10 cm Tdap. Had malaise & diarrhea 1 day after Tdap & FLUZONE
Age: 33.0
Sex: F
Vaccine: TDAP, FLU3, TDAP
Symptoms: Diarrhoea, Injection site erythema, Malaise, Pain in extremity
Clinical narrative: Sore (L) arm x 6 days. Redness about 10 cm Tdap. Had malaise & diarrhea 1 day after Tdap & FLUZONE
Sex: U
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 0.82
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient received PENTACEL, PREVNAR 13, hepatitis B vaccine, flu vaccine on 3/9/12 in am. After about 12-15 hours, pt developed fever 1-3.5 and generalized seizures for about 2 mins. brought to ER, diagnosed w/ febrile seizure, possible side affect of vaccines; discharged home in few hours; no further seizures since then.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: No adverse event
Clinical narrative: None.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Arm (left) swollen, hot to the touch.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Diarrhoea, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Both deltoids swollen - on day vaccine was given. Fever - 104 degree F - for 7 days. (night given vaccines. Diarrhea & vomiting - started - <24 hrs after (the next day.. reported by Mom. Did not call or go to medical facility.
Age: 4.0
Sex: U
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: R arm really swollen and hot to the touch.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Approximately 2 days after vaccine was given, the patient stated the place where the vaccine was given became very red, hard, and slightly painful to the touch. The mark is approximately 1" by 2" rectangular with a larger red area about 5" in diameter.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Wheezing
Clinical narrative: Vaccines administered at 1535. Patient discharged, but returned at 1555 with fine red rash from head to toe. Bilateral wheezes. BENADRYL administered, pulse ox check = 96-97%. Albuterol administered MDI, transferred to ER for further observation. Discharged to home at 1830.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Lip swelling, Nausea, Pain, Periorbital oedema
Clinical narrative: Swelling of lips mild periorbital edema ha, body aches, nausea.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: None.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Pt returned to pharmacy 3-5-12 complaining of muscle soreness in right arm still from injection of FLUVIRIN on 1-13-12.
Age: 28.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Antibody test, Loss of consciousness, Mycobacterium tuberculosis complex test, Syncope
Clinical narrative: He had titers drawn, TB skin test & vaccines for INFLUENZA & Tdap a part of his orientation to company. He fainted in completion of these tasks. He regained consciousness before we got him from chair to the floor. Once he was on the floor with his legs elevated he was coherent. He states he has fainted in the past after a cortisone injection to his shoulder. I saw him 3/8/12 no further problem.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration
Clinical narrative: Redness, induration 2 x 2.5 inches. No fever, pain, itching or limitation in range of motion of left arm.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Chills, Influenza like illness, Musculoskeletal discomfort, Pain, Pyrexia
Clinical narrative: Youth reports flu-like symptoms the day after vaccines given: fever, chills, body aches. Then had generalized upper body pain/tenderness with movement x5 days; raising arms to shoulder level is painful. Ibuprofen 600mg prn for muscle discomfort.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Tenderness
Clinical narrative: Youth reports flu-like symptoms the day after vaccines given: fever, chills, body aches. Then had generalized upper body pain/tenderness with movement x5 days; raising arms to shoulder level is painful. Ibuprofen 600mg prn for muscle discomfort.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Erythema, Local swelling
Clinical narrative: Localized swelling & erythema.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Urticaria that started at injection site, and spread throughout body, 5 days after immunization.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Headache, Injection site pain
Clinical narrative: About 8pm on 3-12-12, began to have chills and a headache. She also began to have soreness at injection site that began about 12pm on 3-12-12. On the morning of 3-13-12 she woke up feeling weak with headache. Chills ended during the night.
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Pertussis
Clinical narrative: Initial report was received from a health care professional on 29 February 2012. A male patient had received an injection of ADACEL, sanofi pasteur Ltd. lot number C3058AA (route and site not reported) on 14 March 2009 and approximately 3 years later, the patient tested positive for Pertussis. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Bordetella test positive, Culture, Feeling abnormal
Clinical narrative: Initial case received from a healthcare professional on 01 March 2012. A 15-year-old female patient received an intramuscular injection of DTAP, manufacturer and lot number unknown, (site not reported) on 12 June 2006. The patient's past medical history was reported as Attention Deficit Disorder (ADD) and hypothyroidism, and the patient was taking ADDERALL, (reported as ATAROL) and EFFEXOR medications concomitantly. The patient had no illness at time of vaccination and had no known drug allergies. The reporter stated that the now 21-year-old patient received DTAP (Tdap) at age 15 years, and now the patient has a possible case of pertussis. The patient was seen in the local emergency room (ER) on 25 February 2012, and culture results were pending. On 01 Mar 2012, the reporter stated that the patient's nasal swab tested positive for pertussis. The patient did not require hospitalization, but was given an antibiotic. The patient was currently feeling better and without fever. The patient's outcome was not recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: 3/13/12 Pneumonia vaccine given in left arm. In the evening of 3/13/12 pt developed pain. On 3/14/12 pt developed erythema about 5 inches round, painful and warm to touch. Doctor evaluated pt, apply ice, TYLENOL and Loratadine, erythema outlined and if sx/sx worsen to call for further treatment.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Dizziness, Incontinence, Pain in extremity, Syncope
Clinical narrative: After pt was given immunizations, he c/o his arm hurt and he was light-headed. While lying pt in supine position, he experienced a syncope episode which lasted approx. 30-45 sec. Pt continued lying down, cool wash cloth applied to forehead, vitals taken, evaluated by MD, given Gatorade. After being monitored x 30 min. pt assisted to sitting position and noted to be stable with BP 108/64. He was then discharged home with his mother. Pt did experience incontinence during episode.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Feeling jittery, Hyperhidrosis, Syncope
Clinical narrative: Pt. stated that he had to go the bathroom, as he walked down the hallway he fainted. He also appeared jittery and diaphoretic. The patient had their feet elevated shortly after and was then given water and some cookies, since it was learned that the patient had not eaten this morning. Blood pressure and pulse were checked and bothe were WNL. Patient was instructed (with mother) to wait for 15 minutes before leaving and was then escorted back to their vehicle.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Injection site erythema, Injection site swelling, Local reaction, Pyrexia, Vaccination complication
Clinical narrative: Lcalized vaccine reaction, redness, swelling R thigh at injection site, low grade fever, transient.
Age: 64.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm to touch, redness and swelling at injection site and just below site.  Size approx 10 cm by 8 cm.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Activities of daily living impaired, Computerised tomogram, Confusional state, Electroencephalogram, Headache
Clinical narrative: We are not sure if this is the exact date that symptoms first occurred, as daughter didn't tell us right away.  Started with a headache which worsened as the days went on. She started experiencing confusion and forgetfulness of tasks that she could do before. She forgot how to do a simple x y graph. Read notes incorrectly during a concert; which she had been playing for at least 2 months. Couldn't figure out how to change the channels on a tv remote.  Couldn't open a small carton of milk.  Nor could she count backwards from 100 by sevens.  This is a student who takes all honors classes and is ranked 22 out of 485 in her class.  We took her to the local ER where they started an IV an gave her Trdal, Reglan, and Benadryl with some relief of headache and was discharged. 3/8/2012 ER then admitted.
Age: 16.0
Sex: F
Vaccine: TYP
Symptoms: Memory impairment
Clinical narrative: We are not sure if this is the exact date that symptoms first occurred, as daughter didn't tell us right away.  Started with a headache which worsened as the days went on. She started experiencing confusion and forgetfulness of tasks that she could do before. She forgot how to do a simple x y graph. Read notes incorrectly during a concert; which she had been playing for at least 2 months. Couldn't figure out how to change the channels on a tv remote.  Couldn't open a small carton of milk.  Nor could she count backwards from 100 by sevens.  This is a student who takes all honors classes and is ranked 22 out of 485 in her class.  We took her to the local ER where they started an IV an gave her Trdal, Reglan, and Benadryl with some relief of headache and was discharged. 3/8/2012 ER then admitted.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Patient reports significant circumferential upper arm swelling lasting several weeks, fevers lasting several days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Otitis media, Pharyngeal erythema, Rash erythematous, Rash pruritic
Clinical narrative: Red raised itchy rash that started around the neck and ears.  By next morning rash was over chest, abdomen, back and some on extremities 3/14/2012 - given Pediapred 15/5 one-half tsp/day.  Also using Benedryl otc. Throat was red and mild Right OM - given Zithromax 200/5 at usual dose.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hyperaesthesia, Nausea, Tremor
Clinical narrative: Diffuse headache, tremulousness, fatigue, skin hyperalgesia, nausea.
Age: 1.5
Sex: F
Vaccine: MMRV
Symptoms: Ear infection, Eye infection, Herpes zoster, Rash
Clinical narrative: She got shingles.  One can only get shingles if one is exposed to the chickenpox virus.  This leads me to believe that the Varicella vaccine itself caused this.  Now she permanently has the shingles virus.  She had an ear and eye infection, which allegedly caused the shingles on her lower back to "pop out".
Age: 34.0
Sex: M
Vaccine: TTOX
Symptoms: Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: Pain to right arm, not able to left more than five pounds, and not able to move right arm with full range of motion.
Age: 1.03
Sex: F
Vaccine: HIBV
Symptoms: Cholangitis, Cyanosis, Eczema, Erythema, Hypotonia
Clinical narrative: 7/26/11. Received multiple vaccines. Had cholangeritis two days later, turned blue, and has had now hypotonia. Vaccine on 3/13/12 with acute exacerbation of erythema with eczema.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin warm, Upper extremity mass
Clinical narrative: Pt. received vaccine on 3/10/12 and presented to pharmacy on 3/16/12 that her arm was red, swollen, hot to touch, & had a lump. Pt. contacted MD & he said must be a side effect & to use warm compress.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site induration
Clinical narrative: 10mm induration at injection site.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Patient had a fever, swelling, redness at injection site as well as swelling in forearm. Patient took BENADRYL 50mg x 2 doses 6 hours apart and felt much better. Sxs were 12 hours after administration.
Age: 26.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Maternal exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Client in for clinic, pregnancy test indicated positive per doctor's orders. Administration of shot was already given, although client reported not pregnant et last menses 2.18.12. No adverse effect currently present.
Age: 1.49
Sex: F
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia
Clinical narrative: High fever to 105 & seizure. ER visit to hospital.