chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Pain in extremity, Pruritus, Rash papular, Rash vesicular
Clinical narrative: Started with itching at my left wrist (same arm where vaccine given). The itchy area became a papular rash. Several patches of papular rash measuring up to 3-4 cm then appeared over the next 24 hours in the C5 and C6 dermatomal distribution. Then the rash became more sensitive/painful, with pain and dysesthesia throughout my left arm and hand. The rash is now becoming more vesicular with spreading erythema.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Throat tightness
Clinical narrative: Patient reported itching on left forearm, then throat closing.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: BP 10:05 89/52, Pulse 112 10:15 151/104 Pulse 98 10:25 163/105 Pulse 120 10:30 174/114 Pulse 124 10:40 am 137/95 Pulse 118 Patient received influenza vaccine at around 9:55am. Started feeling nauseous BP & pulse rate taken & monitored as listed above. Paramedic called, pt refused to go to hospital, continue to monitor.
Age: 36.0
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Pt. received 2 T-DAP injections within 12 hours.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Fever 102.5 degrees, severe headache, severe muscle pain, redness and swelling at the site of injection (10x20 cm area on the left upper arm, where pneumonia and flu shot - seasonal+H1N1 were given), extreme fatigue, dizziness. Symptoms continued for 72 hrs. Tylenol, ibuprofen, antihistamine were used, but they could not control fever for 48 hrs.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever 102.5 degrees, severe headache, severe muscle pain, redness and swelling at the site of injection (10x20 cm area on the left upper arm, where pneumonia and flu shot - seasonal+H1N1 were given), extreme fatigue, dizziness. Symptoms continued for 72 hrs. Tylenol, ibuprofen, antihistamine were used, but they could not control fever for 48 hrs.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt inadvertly received TDAP instead of Td.  No adverse events noted at time of vaccination.
Age: 36.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Arthralgia, Migraine, Musculoskeletal stiffness, Myalgia, Nasal congestion
Clinical narrative: 4pm nasal congestion; 10pm neck pain & stiffness, muscle & joint pain, nausea; 5:45am all the above symptoms and photosensitive migraine
Age: 36.0
Sex: F
Vaccine: FLU3, MEN
Symptoms: Nausea, Neck pain, Photosensitivity reaction
Clinical narrative: 4pm nasal congestion; 10pm neck pain & stiffness, muscle & joint pain, nausea; 5:45am all the above symptoms and photosensitive migraine
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Injection site pain, Musculoskeletal stiffness
Clinical narrative: I began to feel dizzy and light-headed about an hour after the shot. I also began to feel a stiffness all through my left shoulder and up the left side of my neck (the shot was given in my left arm). I sat in a quiet room for about 30 minutes and then took a shower to alleviate the stiffness. Within an hour, all symptons were gone, besides a soreness just at the injection site.
Age: 11.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Chills, Headache, Pallor, Vomiting
Clinical narrative: vomiting, chills, paleness, weakness, headache
Age: 23.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever of 102, severe chills, head pain. Motrin and Tylenol given alternately every 4 hours.
Age: 51.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives
Age: 0.24
Sex: M
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Chills, Dizziness, Loss of consciousness, Nausea
Clinical narrative: Very nauseous, light headedness, passed out, Chills for the entire night. Had to call 911 to be seen by paramedics.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema, Musculoskeletal pain, Vomiting
Clinical narrative: One incident of diarrhea, vomited once overnight. Her shoulder had been quite red and sore.  May be unrelated of course, but felt that reporting should be done.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Decreased appetite, Headache, Hypersomnia, Pain
Clinical narrative: Patient began feeling achey and developed a high fever with severe headache, the fever reached 103.7 and would not come down. Her Dr.'s office advised if her fever reached 104 to take her to ER. I gave her ibuprofen and acetaminophen, rotating between the 2, every 4 hours. This kept her fever from rising, but did not reduce it. She missed a whole week of school and was, I felt close to death, which was very distressful for me. All she did was sleep and sleep. She was extremely thirsty and was able to keep down the small amount of food she ate, she had no appetite.
Age: 10.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Thirst
Clinical narrative: Patient began feeling achey and developed a high fever with severe headache, the fever reached 103.7 and would not come down. Her Dr.'s office advised if her fever reached 104 to take her to ER. I gave her ibuprofen and acetaminophen, rotating between the 2, every 4 hours. This kept her fever from rising, but did not reduce it. She missed a whole week of school and was, I felt close to death, which was very distressful for me. All she did was sleep and sleep. She was extremely thirsty and was able to keep down the small amount of food she ate, she had no appetite.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles, buttocks, treated with acyclovir
Age: 50.0
Sex: F
Vaccine: FLUX, FLUX(H1N1)
Symptoms: Chills, Discomfort, Pain, Pyrexia
Clinical narrative: 102.5 fever all night long, uncontrollable shakes (like shivering, but greater) for about an hour, then subsided into regular fever symptoms (aches, temperature, discomfort, shivers)
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site pain, Malaise, Pain
Clinical narrative: Very painful at injection site. I could not move my left arm without severe pain. My arm could not be moved for 2 days. I also became very ill the day after with flu-like symptoms.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Condition aggravated, Cough, Dyspnoea, Pyrexia
Clinical narrative: Pt states he developed fever and chills in the evening, following flu and pneumovax administration. He additionally developed a croupy cough and dyspnea that lasted a week, with exacerbation of his underlying COPD/emphysema. He reported that symptoms were improving at the time of his visit on Oct 18, 2010. Patient was also unaware that he should report an adverse event and how to do so.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Felt flu-like symptoms: full-body aching, chills, fatigue, shortness of breath and headache.  Developed significant rash/bruising over left deltoid/upper arm.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Injection site haematoma, Injection site rash, Pain
Clinical narrative: Felt flu-like symptoms: full-body aching, chills, fatigue, shortness of breath and headache.  Developed significant rash/bruising over left deltoid/upper arm.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness, swelling
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Could not breathe
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Biopsy brain, Dysarthria, Gastrointestinal tube insertion, Laboratory test
Clinical narrative: Speech was slurring. At this date patient can not talk, or move her muscles. Patient eats through a feeding tube.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Movement disorder, Nuclear magnetic resonance imaging
Clinical narrative: Speech was slurring. At this date patient can not talk, or move her muscles. Patient eats through a feeding tube.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Computerised tomogram, Headache, Insomnia, Migraine
Clinical narrative: Severe headache began, and continued for several days through today, 11/07/2010.  It was like a migraine, and similar to headaches I get when I have a reaction to medication.  I tried Excedrin to relieve it but had to end up taking Maxalt.  Had difficulty sleeping, as headache would go away and then come back when time for medication again.
Age: 35.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site haematoma, Pain
Clinical narrative: Woke with a huge bruise on my arm where I recieved the injection. It hurt to move my arm above my shoulder. It still does almost 3 weeks later.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Oedema peripheral
Clinical narrative: Entire left upper arm shoulder to elbow 20 cm was red, hot and tender. Mom came in clinic next day, I saw it and sent her to ER to evaluate for possible cellulitis. They gave RX for antibiotics just in case of infection-they were not sure either if it was just vaccine reaction or infection, his arm swelling is gone per father per phone report.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Asthenia, Chest discomfort, Chills, Cough, Dysphonia
Clinical narrative: vac site was LARGE and red; sore throat, chills, cough, headache, itchy hives, weakness, hoarseness, tightness of chest, tiredness, weakness.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Fatigue, Headache, Injection site erythema, No reaction on previous exposure to drug, Oropharyngeal pain
Clinical narrative: vac site was LARGE and red; sore throat, chills, cough, headache, itchy hives, weakness, hoarseness, tightness of chest, tiredness, weakness.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: vac site was LARGE and red; sore throat, chills, cough, headache, itchy hives, weakness, hoarseness, tightness of chest, tiredness, weakness.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest discomfort, Chills, Dysphonia, Eye pruritus, Fatigue
Clinical narrative: vac site was LARGE and red; sore throat, chills, cough, headache, itchy hives, weakness, hoarseness, tightness of chest, tiredness, weakness.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Headache, Malaise, Ocular hyperaemia, Pain, Pruritus
Clinical narrative: vac site was LARGE and red; sore throat, chills, cough, headache, itchy hives, weakness, hoarseness, tightness of chest, tiredness, weakness.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Pyrexia
Clinical narrative: vac site was LARGE and red; sore throat, chills, cough, headache, itchy hives, weakness, hoarseness, tightness of chest, tiredness, weakness.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Biopsy, Chills, Erythema, Pruritus, Pyrexia
Clinical narrative: Started like red ant bites, spread all over my body, severe itching, chills and fever. Over the counter ointments to no avail, skin on hands peels and splits. About 10 days before seeing a doctor, rx to no avail. Biospy 10/26/2010 drug related. Referred to dermatologist 11/05/2010.
Age: 75.0
Sex: M
Vaccine: FLUX
Symptoms: Skin exfoliation
Clinical narrative: Started like red ant bites, spread all over my body, severe itching, chills and fever. Over the counter ointments to no avail, skin on hands peels and splits. About 10 days before seeing a doctor, rx to no avail. Biospy 10/26/2010 drug related. Referred to dermatologist 11/05/2010.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Impaired work ability, Pain, Somnolence, Vaccination site pain
Clinical narrative: Very sore vaccination site, whole body aches, including head, fatigue; Motrin was helpful; attempted work next day but incr aches; slept off & on most of day, w/ Motrin in between.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Epidural anaesthesia, Gallbladder operation, Headache
Clinical narrative: INTENSE UNCONTROLABE HEADACHE PAIN PROGRESSING TO BACK & HIP. GALL BLADDER REMOVAL AND A SPINAL EPIDURAL FOR PAIN CONTROL.
Age: 7.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Oropharyngeal pain
Clinical narrative: Started out with red area at injection site and was sore. Developed high fever (103.2 orally), headache, chills, sore throat, and very pale in middle of the night. Will take her to the doctor in the morning if not better. Treating with Ibuprofen and Tylenol.
Age: 7.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pallor, Pyrexia
Clinical narrative: Started out with red area at injection site and was sore. Developed high fever (103.2 orally), headache, chills, sore throat, and very pale in middle of the night. Will take her to the doctor in the morning if not better. Treating with Ibuprofen and Tylenol.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Insomnia, Movement disorder, Pain in extremity
Clinical narrative: Severe pain in right arm (injection arm). Unable to extend arm in any direction. Unable to sleep due to pain. No swelling, no temp, no redness. Just awful pain and inability to use arm. Took Advil with no relief. Used warm compresses.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: For the past month, my shoulder has experienced pain, especially when lifting anything or moving arm (like putting on a jacket). Wakes me up at night, especially if I roll over on my left arm.  Pain was noticable almost immediately after injection.  Nothing like this has EVER been experienced before and there was no physical activity or other explanation for this pain.  A month later, this pain is still present and not improving.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Back pain, Gait disturbance, Hypoaesthesia, Joint range of motion decreased
Clinical narrative: 27OCT10-Left shoulder pain-unable to get full ROM, neck & back pain.  Right 3rd digit joint pain unable to close fist. Right 2nd digit numb and nausea. 31Oct10-severe heel pain causing difficulty walking, bilateral knee pain, above s/s still present. 8Nov10-right 2nd digit numb, all other s/s gone.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Musculoskeletal pain, Nausea, Neck pain, Pain in extremity
Clinical narrative: 27OCT10-Left shoulder pain-unable to get full ROM, neck & back pain.  Right 3rd digit joint pain unable to close fist. Right 2nd digit numb and nausea. 31Oct10-severe heel pain causing difficulty walking, bilateral knee pain, above s/s still present. 8Nov10-right 2nd digit numb, all other s/s gone.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Crying inconsolably tender, red & swollen left thigh tx with acetaminophen.
Sex: M
Vaccine: MEA, RUB
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her son with milk allergy, banana allergy, wheat and dairy, who on 08-FEB-2008 was vaccinated with a dose of with MERUVAX II. On an unspecified date the patient experienced fever which lasted for 3 days. Subsequently, the patient recovered from fever. The patient had a history of fever while on therapy with ATTENUVAX (MSD, WAES 0906USA03384). This is one report of several from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Lip swelling, Oxygen saturation normal, Pruritus, Respiratory distress, Swelling face
Clinical narrative: Information has been received from a nurse concerning a 5 year old male patient who on 28-JUN-2010, was vaccinated with a dose of PROQUAD (Merck upgrade process) (dose, route and lot number not provided). Other vaccines administered the same day included PREVNAR 13. On 28-JUN-2010, the patient experienced an anaphylactic reaction 15 minutes after administration of the vaccines. The patient developed a rash, started vomiting and had trouble breathing on the way home from the physician's office. The patient was brought to the office and was administered an EPIPEN, prednisone and BENADRYL. The patient was then transferred to a hospital via ambulance, treated in emergency room and then released the same day. The patient's outcome was unknown at the time of reporting. Follow up information has been received concerning the now 6 year old male patient, with no pre-existing allergies/birth defects and no illness at the time of vaccination, who on 28-JUN-2010 was vaccinated subcutaneously in the right thigh with the first dose of PROQUAD (Merck upgrade process) (dose and lot # not provided). On the same day, at 10:00 am,  the patient received intramuscularly on the right thigh the first dose of PREVNAR 13. The patient started vomiting, developed respiratory distress, hives, swollen face, lips swelling, itchiness. The oxygen saturation taken was 48%. The patient was brought to the office and was administered an EPIPEN, ORAPRED and BENADRYL. The patient was then transferred to a hospital via ambulance, treated in emergency room. The nurse reported that on 28-JUN-2010 the patient had recovered. A oxygen saturation exam performed was normal. Upon internal review, "administered an EPI-PEN" was considered to be an other important medical event. This is a corrected report, the therapy date and the AE onset date in the narrative has been changed to 28-JUN-2010. The AE stop date (28-JUN-2010) was also added to the AE screen. No further information is available.
Age: 5.0
Sex: M
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Urticaria, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 5 year old male patient who on 28-JUN-2010, was vaccinated with a dose of PROQUAD (Merck upgrade process) (dose, route and lot number not provided). Other vaccines administered the same day included PREVNAR 13. On 28-JUN-2010, the patient experienced an anaphylactic reaction 15 minutes after administration of the vaccines. The patient developed a rash, started vomiting and had trouble breathing on the way home from the physician's office. The patient was brought to the office and was administered an EPIPEN, prednisone and BENADRYL. The patient was then transferred to a hospital via ambulance, treated in emergency room and then released the same day. The patient's outcome was unknown at the time of reporting. Follow up information has been received concerning the now 6 year old male patient, with no pre-existing allergies/birth defects and no illness at the time of vaccination, who on 28-JUN-2010 was vaccinated subcutaneously in the right thigh with the first dose of PROQUAD (Merck upgrade process) (dose and lot # not provided). On the same day, at 10:00 am,  the patient received intramuscularly on the right thigh the first dose of PREVNAR 13. The patient started vomiting, developed respiratory distress, hives, swollen face, lips swelling, itchiness. The oxygen saturation taken was 48%. The patient was brought to the office and was administered an EPIPEN, ORAPRED and BENADRYL. The patient was then transferred to a hospital via ambulance, treated in emergency room. The nurse reported that on 28-JUN-2010 the patient had recovered. A oxygen saturation exam performed was normal. Upon internal review, "administered an EPI-PEN" was considered to be an other important medical event. This is a corrected report, the therapy date and the AE onset date in the narrative has been changed to 28-JUN-2010. The AE stop date (28-JUN-2010) was also added to the AE screen. No further information is available.
Age: 5.0
Sex: M
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Anaphylactic reaction, Blood gases normal, Dyspnoea, Lip swelling, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 5 year old male patient who on 28-JUN-2010, was vaccinated with a dose of PROQUAD (Merck upgrade process) (dose, route and lot number not provided). Other vaccines administered the same day included PREVNAR 13. On 28-JUN-2010, the patient experienced an anaphylactic reaction 15 minutes after administration of the vaccines. The patient developed a rash, started vomiting and had trouble breathing on the way home from the physician's office. The patient was brought to the office and was administered an EPIPEN, prednisone and BENADRYL. The patient was then transferred to a hospital via ambulance, treated in emergency room and then released the same day. The patient's outcome was unknown at the time of reporting. Follow up information has been received concerning the now 6 year old male patient, with no pre-existing allergies/birth defects and no illness at the time of vaccination, who on 28-JUN-2010 was vaccinated subcutaneously in the right thigh with the first dose of PROQUAD (Merck upgrade process) (dose and lot # not provided). On the same day, at 10:00 am,  the patient received intramuscularly on the right thigh the first dose of PREVNAR 13. The patient started vomiting, developed respiratory distress, hives, swollen face, lips swelling, itchiness. The oxygen saturation taken was 48%. The patient was brought to the office and was administered an EPIPEN, ORAPRED and BENADRYL. The patient was then transferred to a hospital via ambulance, treated in emergency room. The nurse reported that on 28-JUN-2010 the patient had recovered. A oxygen saturation exam performed was normal. Upon internal review, "administered an EPI-PEN" was considered to be an other important medical event. This is a corrected report, the therapy date and the AE onset date in the narrative has been changed to 28-JUN-2010. The AE stop date (28-JUN-2010) was also added to the AE screen. No further information is available.
Age: 5.0
Sex: M
Vaccine: MMRV, PNC13, MMRV, PNC13
Symptoms: Rash, Respiratory distress, Swelling face, Urticaria, Vomiting
Clinical narrative: Information has been received from a nurse concerning a 5 year old male patient who on 28-JUN-2010, was vaccinated with a dose of PROQUAD (Merck upgrade process) (dose, route and lot number not provided). Other vaccines administered the same day included PREVNAR 13. On 28-JUN-2010, the patient experienced an anaphylactic reaction 15 minutes after administration of the vaccines. The patient developed a rash, started vomiting and had trouble breathing on the way home from the physician's office. The patient was brought to the office and was administered an EPIPEN, prednisone and BENADRYL. The patient was then transferred to a hospital via ambulance, treated in emergency room and then released the same day. The patient's outcome was unknown at the time of reporting. Follow up information has been received concerning the now 6 year old male patient, with no pre-existing allergies/birth defects and no illness at the time of vaccination, who on 28-JUN-2010 was vaccinated subcutaneously in the right thigh with the first dose of PROQUAD (Merck upgrade process) (dose and lot # not provided). On the same day, at 10:00 am,  the patient received intramuscularly on the right thigh the first dose of PREVNAR 13. The patient started vomiting, developed respiratory distress, hives, swollen face, lips swelling, itchiness. The oxygen saturation taken was 48%. The patient was brought to the office and was administered an EPIPEN, ORAPRED and BENADRYL. The patient was then transferred to a hospital via ambulance, treated in emergency room. The nurse reported that on 28-JUN-2010 the patient had recovered. A oxygen saturation exam performed was normal. Upon internal review, "administered an EPI-PEN" was considered to be an other important medical event. This is a corrected report, the therapy date and the AE onset date in the narrative has been changed to 28-JUN-2010. The AE stop date (28-JUN-2010) was also added to the AE screen. No further information is available.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Concussion, Convulsion, Dyskinesia, Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with GARDASIL (lot #, route and injection site not reported) and experienced an unspecified AE. Outcome was not reported. Follow-up information has been received from a physician concerning the patient, a 16 year old female student with no known pertinent medical history and allergies. On 20-AUG-2010, at 5:30 PM, the patient was vaccinated with the third dose of GARDASIL (lot # 665768/1354Y, Exp: 29-JUN-2010) IM in the left deltoid and also the second dose of VAQTA (lot # 661566/0912Y, Exp: 20-MAY-2010) IM in the left deltoid. Concomitant therapy was not reported. Five seconds after the shots, the patient, who was seated on mother's lap, had syncope and seizure like movements on upper extremities for 10 seconds. She was put lying down position on mother's lap. Blood pressure, heart rate and pulse were monitored without findings. She remained oriented and responding to questions. She also felt dizzy. She was observed for an hour. No laboratory tests were needed. Subsequently the patient recovered from the event on 20-AUG-2010. Upon internal review, seizure like movements on upper extremities was considered to be an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Adverse event, Dizziness, Movement disorder, Syncope
Clinical narrative: Information has been received from a medical assistant concerning a patient who was vaccinated with GARDASIL (lot #, route and injection site not reported) and experienced an unspecified AE. Outcome was not reported. Follow-up information has been received from a physician concerning the patient, a 16 year old female student with no known pertinent medical history and allergies. On 20-AUG-2010, at 5:30 PM, the patient was vaccinated with the third dose of GARDASIL (lot # 665768/1354Y, Exp: 29-JUN-2010) IM in the left deltoid and also the second dose of VAQTA (lot # 661566/0912Y, Exp: 20-MAY-2010) IM in the left deltoid. Concomitant therapy was not reported. Five seconds after the shots, the patient, who was seated on mother's lap, had syncope and seizure like movements on upper extremities for 10 seconds. She was put lying down position on mother's lap. Blood pressure, heart rate and pulse were monitored without findings. She remained oriented and responding to questions. She also felt dizzy. She was observed for an hour. No laboratory tests were needed. Subsequently the patient recovered from the event on 20-AUG-2010. Upon internal review, seizure like movements on upper extremities was considered to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Generalised erythema, Throat tightness
Clinical narrative: Patient developed generalized redness and stated "throat was closing up."  Became anxious and complained of seeing spots.  No stridor, breath sounds clear, but erythematous rash on face/trunk/extremities.  Symptoms slowly subsided after Diphenhydramine 50 mg IM given at 12:00 pm.
Age: 12.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anxiety, Generalised erythema, Rash, Rash erythematous, Throat tightness
Clinical narrative: Patient developed generalized redness and stated "throat was closing up."  Became anxious and complained of seeing spots.  No stridor, breath sounds clear, but erythematous rash on face/trunk/extremities.  Symptoms slowly subsided after Diphenhydramine 50 mg IM given at 12:00 pm.
Age: 12.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Visual impairment
Clinical narrative: Patient developed generalized redness and stated "throat was closing up."  Became anxious and complained of seeing spots.  No stridor, breath sounds clear, but erythematous rash on face/trunk/extremities.  Symptoms slowly subsided after Diphenhydramine 50 mg IM given at 12:00 pm.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Herpes zoster, Injection site nodule
Clinical narrative: Initial report received from a registered pharmacist on 25 Oct 2010: This patient was vaccinated with FLUVIRIN vaccine (batch 111851P1, expiry date: Apr 2011), 0.5 ml intramuscularly on 04 Oct 2010. Around 11 Oct 2010, the patient developed shingles. The outcome of this event was reported as ongoing. Symptoms were persistent to date.
Age: 71.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Herpes zoster
Clinical narrative: Initial report received from a registered pharmacist on 25 Oct 2010: This patient was vaccinated with FLUVIRIN vaccine (batch 111851P1, expiry date: Apr 2011), 0.5 ml intramuscularly on 04 Oct 2010. Around 11 Oct 2010, the patient developed shingles. The outcome of this event was reported as ongoing. Symptoms were persistent to date.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Asthenia, Chest discomfort, Chills, Cough, Dysphonia
Clinical narrative: Possible hives, itchy spots, hoarseness, aches, fevers, very ill, red eyes with lots of itchiness, tight chest, headache, chills, fatigue.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Fatigue, Headache, Injection site erythema, No reaction on previous exposure to drug, Oropharyngeal pain
Clinical narrative: Possible hives, itchy spots, hoarseness, aches, fevers, very ill, red eyes with lots of itchiness, tight chest, headache, chills, fatigue.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Possible hives, itchy spots, hoarseness, aches, fevers, very ill, red eyes with lots of itchiness, tight chest, headache, chills, fatigue.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chest discomfort, Chills, Dysphonia, Eye pruritus, Fatigue
Clinical narrative: Possible hives, itchy spots, hoarseness, aches, fevers, very ill, red eyes with lots of itchiness, tight chest, headache, chills, fatigue.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Headache, Malaise, Ocular hyperaemia, Pain, Pruritus
Clinical narrative: Possible hives, itchy spots, hoarseness, aches, fevers, very ill, red eyes with lots of itchiness, tight chest, headache, chills, fatigue.
Age: 72.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Pyrexia
Clinical narrative: Possible hives, itchy spots, hoarseness, aches, fevers, very ill, red eyes with lots of itchiness, tight chest, headache, chills, fatigue.
Age: 1.72
Sex: F
Vaccine: FLU3
Symptoms: Abnormal faeces, Allergy test negative, Cough, Crying, Dark circles under eyes
Clinical narrative: Patient was in the carseat while I drove, so I could not observe the onset of the reaction. She was very quiet and around 12:30 PM she started coughing and then vomiting. She coughed and vomited profusely - at least 5 large projectile vomits and then began to retch and became pale and lethargic. The corners of her eyes were red.  I gave her an epipen (per food allergy action plan) and she began to improve very quickly - she began to cry & scream. She threw up twice more about 30-60 seconds after the epi and continued to cry. The ambulance arrived and took her to Hospital. She had tachycardia and a fever in the ambulance of 101.8 F, (no fever prior to the vaccine) but her fever was gone by the time we arrived at the hospital. She was given steroids, Zantac and Benadryl at the hospital and observed for 5 hours. Her heart rate went down but was still slightly elevated upon release. That evening she pulled at her mouth and tongue and was given more Benadryl. On 11/2/10 she had dark purple circles under her eyes and had two very mucousy stools, one loose, one normal. She was seen by her pediatrician and determined to be healthy and I had a follow up phone call with her allergist.  She had normal stools for two days, but has had soft, greasy, foul smelling, floating stools from 11/4 to 11/7 (day of the report) and developed a diaper rash on 11/7.  It is unknown if these delayed conditions are related to the vaccine. They have been seen following prior allergic reactions.
Age: 1.72
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis diaper, Diarrhoea, Glossitis, Heart rate increased, Lethargy
Clinical narrative: Patient was in the carseat while I drove, so I could not observe the onset of the reaction. She was very quiet and around 12:30 PM she started coughing and then vomiting. She coughed and vomited profusely - at least 5 large projectile vomits and then began to retch and became pale and lethargic. The corners of her eyes were red.  I gave her an epipen (per food allergy action plan) and she began to improve very quickly - she began to cry & scream. She threw up twice more about 30-60 seconds after the epi and continued to cry. The ambulance arrived and took her to Hospital. She had tachycardia and a fever in the ambulance of 101.8 F, (no fever prior to the vaccine) but her fever was gone by the time we arrived at the hospital. She was given steroids, Zantac and Benadryl at the hospital and observed for 5 hours. Her heart rate went down but was still slightly elevated upon release. That evening she pulled at her mouth and tongue and was given more Benadryl. On 11/2/10 she had dark purple circles under her eyes and had two very mucousy stools, one loose, one normal. She was seen by her pediatrician and determined to be healthy and I had a follow up phone call with her allergist.  She had normal stools for two days, but has had soft, greasy, foul smelling, floating stools from 11/4 to 11/7 (day of the report) and developed a diaper rash on 11/7.  It is unknown if these delayed conditions are related to the vaccine. They have been seen following prior allergic reactions.
Age: 1.72
Sex: F
Vaccine: FLU3
Symptoms: Mucous stools, Ocular hyperaemia, Pallor, Pyrexia, Retching
Clinical narrative: Patient was in the carseat while I drove, so I could not observe the onset of the reaction. She was very quiet and around 12:30 PM she started coughing and then vomiting. She coughed and vomited profusely - at least 5 large projectile vomits and then began to retch and became pale and lethargic. The corners of her eyes were red.  I gave her an epipen (per food allergy action plan) and she began to improve very quickly - she began to cry & scream. She threw up twice more about 30-60 seconds after the epi and continued to cry. The ambulance arrived and took her to Hospital. She had tachycardia and a fever in the ambulance of 101.8 F, (no fever prior to the vaccine) but her fever was gone by the time we arrived at the hospital. She was given steroids, Zantac and Benadryl at the hospital and observed for 5 hours. Her heart rate went down but was still slightly elevated upon release. That evening she pulled at her mouth and tongue and was given more Benadryl. On 11/2/10 she had dark purple circles under her eyes and had two very mucousy stools, one loose, one normal. She was seen by her pediatrician and determined to be healthy and I had a follow up phone call with her allergist.  She had normal stools for two days, but has had soft, greasy, foul smelling, floating stools from 11/4 to 11/7 (day of the report) and developed a diaper rash on 11/7.  It is unknown if these delayed conditions are related to the vaccine. They have been seen following prior allergic reactions.
Age: 1.72
Sex: F
Vaccine: FLU3
Symptoms: Screaming, Skin test, Stomatitis, Tachycardia, Vomiting projectile
Clinical narrative: Patient was in the carseat while I drove, so I could not observe the onset of the reaction. She was very quiet and around 12:30 PM she started coughing and then vomiting. She coughed and vomited profusely - at least 5 large projectile vomits and then began to retch and became pale and lethargic. The corners of her eyes were red.  I gave her an epipen (per food allergy action plan) and she began to improve very quickly - she began to cry & scream. She threw up twice more about 30-60 seconds after the epi and continued to cry. The ambulance arrived and took her to Hospital. She had tachycardia and a fever in the ambulance of 101.8 F, (no fever prior to the vaccine) but her fever was gone by the time we arrived at the hospital. She was given steroids, Zantac and Benadryl at the hospital and observed for 5 hours. Her heart rate went down but was still slightly elevated upon release. That evening she pulled at her mouth and tongue and was given more Benadryl. On 11/2/10 she had dark purple circles under her eyes and had two very mucousy stools, one loose, one normal. She was seen by her pediatrician and determined to be healthy and I had a follow up phone call with her allergist.  She had normal stools for two days, but has had soft, greasy, foul smelling, floating stools from 11/4 to 11/7 (day of the report) and developed a diaper rash on 11/7.  It is unknown if these delayed conditions are related to the vaccine. They have been seen following prior allergic reactions.
Age: 55.0
Sex: M
Vaccine: DTP, FLUX
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain and weakness in left arm where DPT (diphtheria, pertussis, tetanus) vacination was administered. Still painful and weak after 20 days (Nov. 7, 2010).  Also received seasonal flu vaccine at same time.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lip swelling, Local swelling, Malaise, Vomiting
Clinical narrative: Pt called Saturday morning to inform me that after receiving Flu vaccine Friday she felt very sick that evening & throughout night. She said swollen lips/neck, vomiting, chills, she didn't go to hospital and was fine by Saturday. She never received H1N1 before.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Paraesthesia
Clinical narrative: Describes tingling at injection site still 3 1/2 months later. Not severe, just noticeable.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph glands under left arm (same as shot). Went to physician who prescribed Naproxen.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Received a call from Medical Center informing us that the patient has developed Guillain Barre Syndrome.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autonomic nervous system imbalance, Demyelination, Electromyogram abnormal, Guillain-Barre syndrome, Hypertension
Clinical narrative: Received a call from Medical Center informing us that the patient has developed Guillain Barre Syndrome.
Age: 63.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nerve conduction studies abnormal, Nuclear magnetic resonance imaging abnormal, Reversible posterior leukoencephalopathy syndrome, Sensory loss
Clinical narrative: Received a call from Medical Center informing us that the patient has developed Guillain Barre Syndrome.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Eye discharge, Ocular hyperaemia
Clinical narrative: Red eyes, excess production of mucous like substance at eye.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Conjunctivitis, Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: 4" redness, swelling, tender to touch, itchy. Secondary conjuctivitis developed in left eye at same time as reaction. Patient had been exposed to conjuctivitis previously.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Hemiplegia, Pulmonary congestion
Clinical narrative: (actual time unk)  1 day after vaccine severe lung congestion.  5 days after vaccine total paralyzation on right side of body, diagnosed as "stroke."
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eyelid function disorder, Muscular weakness, Ocular hyperaemia, Vision blurred
Clinical narrative: Redness of the eyes, blurred vision, difficulty opening eyes. Severe cough and weakness of the legs. Patient recovered 48 hours after.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Antiacetylcholine receptor antibody positive, Computerised tomogram normal, Diplopia, Erythema, Eyelid ptosis
Clinical narrative: Patient is a critical care physician who received inactivated flu shot 18 OCT who awakened 27 OCT with left eye ptosis, erythema, and double vision. Diagnosed with ocular myasthenia gravis. MRI and CT normal. Ach receptor binding antibody titer very high. Symptoms persist and are worse at end of day. Prior flu vaccines have been Flumist.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Myasthenia gravis, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient is a critical care physician who received inactivated flu shot 18 OCT who awakened 27 OCT with left eye ptosis, erythema, and double vision. Diagnosed with ocular myasthenia gravis. MRI and CT normal. Ach receptor binding antibody titer very high. Symptoms persist and are worse at end of day. Prior flu vaccines have been Flumist.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Fall
Clinical narrative: Child waited around after recieving injection and she toppled over and seized for 3 seconds, then opened her eyes and was able to speak and answer questions. Paramedics came and checked her vitals and she was fine. Mother made a Dr. appointment and took her home.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Tingling started in legs.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Eye irritation, Feeling of body temperature change, Headache
Clinical narrative: Patient described reaction as chills, alternating hot and cold sensation, fever (unknown - patient did not measure), muscle pain (especially calves and thighs), felt like "lying on bed of pins and needles," eyes watering and burning, sweating.  Patient reported this to the dispensing clinic in AM on 10/27/10 and saw her Primary Care Provider 10/27/10 at 2:30 PM.  She stated no treatment was received.  She was told by her PCP she could return to work when she felt better.  She returned to the clinic on 10/28/10 feeling "85%" and ready to work.  "Slight" muscle aches, headache" were still present.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Lacrimation increased, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Patient described reaction as chills, alternating hot and cold sensation, fever (unknown - patient did not measure), muscle pain (especially calves and thighs), felt like "lying on bed of pins and needles," eyes watering and burning, sweating.  Patient reported this to the dispensing clinic in AM on 10/27/10 and saw her Primary Care Provider 10/27/10 at 2:30 PM.  She stated no treatment was received.  She was told by her PCP she could return to work when she felt better.  She returned to the clinic on 10/28/10 feeling "85%" and ready to work.  "Slight" muscle aches, headache" were still present.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: itching, hives to both forearms and legs
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dyspnoea, Oedema peripheral, Pain in extremity
Clinical narrative: Arm was swollen and sore. Patient said she was having problems breathing 2 days later and went to Dr. Dr told her not to get Tetanus shot again.
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC, VARCEL
Symptoms: Anaemia, Chest X-ray, Full blood count, Lethargy, Leukaemia
Clinical narrative: 1 week after administration, pt. presented with pallor, lethargy, neck mass, anemia, thrombocytopenia. Pt. admitted to hospital. Dx leukemia.
Age: 1.27
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC, VARCEL
Symptoms: Neck mass, Pallor, Thrombocytopenia
Clinical narrative: 1 week after administration, pt. presented with pallor, lethargy, neck mass, anemia, thrombocytopenia. Pt. admitted to hospital. Dx leukemia.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Dysgeusia
Clinical narrative: Received flu vaccine 10/27/10. 10/28/10 complaints of upset stomach with funny taste in mouth. 10/29/10 feels better but funny taste still present on tongue.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Vaccine administered on Wed. 10/20/10. When I had occasion to raise arm (L) to shoulder height it felt like it was sprained. Lasted at least 7 days.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: My arm are very sore in joint (especially at night).
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt. states arm hurt when she got the injection. States she can't raise or lift her (L) arm. The pain is in her (L) shoulder. States she has to take two ALEVE q 12 hrs. Pt. denies any external redness, swelling or warmth.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Herpes zoster, Rash, Tenderness
Clinical narrative: Within 24hours tenderness & sensitivity to left side of stomach area. Next day rash developed & continued to develop for next several days around middle to back (left side). Diagnosed with shingles on Nov 1.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Pyrexia, Refusal of treatment by relative, Staring
Clinical narrative: Above vaccine given 11/4 that evening spell of staring for 2 min. Mom did not attempt to stimulate child. 2nd staring spell Mom stimulated & child "came out of it". TYLENOL 5pm. Child woke 2:45 am Temp 103.9 responded to mom, no pallor, no abnormal movements. Family called 911 pt taken to ED. There exam ok except fever. ED Dr recommended labs, sepsis eval family declined. Pt seen by me 11/5 3:20pm. Normal exam. Most likely fever secondary to vaccine. No seizure.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Polymerase chain reaction, Rash vesicular, Varicella virus test positive
Clinical narrative: Zoster on leg and back treated with 7-day course of acyclovir & vesicular swab obtained on 9/4/10 was positive for VZV by PCR. Rash lasted 10 days, good outcome.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Back pain, Loss of consciousness
Clinical narrative: After receiving immunizations the patient passed out for a period <2min. Due to this she fell off the exam table. Was slow to respond immediately following incident. Only complaint was back pain, she was sent to ED for evaluation.
Age: 11.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received Hep A & Var 11/5/10 am. Pt. c/o pain back of (L) upper arm with some itching. 11/6/10 am - (L) upper arm swollen, very red & hot to the touch with 2 prominent raised red areas size of quarter & nickel-painful. Mom gave MOTRIN.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Local reaction, Malaise
Clinical narrative: Fever, local reaction - swelling, malaise -> redness at injection site with swelling. Chills with fever. Seen office - 11/1/2010. Clear lungs and no swelling to tongue.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever, local reaction - swelling, malaise -> redness at injection site with swelling. Chills with fever. Seen office - 11/1/2010. Clear lungs and no swelling to tongue.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: We discovered that my son's left arm at injection site was very red and swollen, swelled like a baseball size. It hurt and was very sore. The swelling has continued and is still red and swollen today 3 days later. It hurts to move his arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Experience severe nausea with vomiting and diarrhea. Called fire department ambulance and was taken to Hospital. Adm. 11/2 to 11/4/10 for monitoring and fluids IV.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: 2-3 hours post vaccination and after eating lunch, c/o nausea, vomiting, and later diarrhea. Resolved 48 hours later.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Lacrimation increased, Swelling face
Clinical narrative: Eyes starting swelling and watering.  Then facial swelling.  No Shortness of breath.