chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Arm pain in upper left arm 5 days post vaccination. LEVAQUIN, Ibuprofen on 10/12 then Propoxyphene/APAP, methylprednisolone on 10/18.
Age: 3.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Cough, Feeling abnormal, Hallucination, visual, Pharyngeal erythema, Pyrexia
Clinical narrative: Son said in car he didn't feel good. Felt yucky. Came home and he played and ate. Later that evening he threw up in bed and told me that he saw people walking around his room. Later in the evening he threw up again. Next morning he was ok. Later that day he spiked a fever after his nap. Called Physician and told him about night before and then. Told to give Tylenol, fluids and rest. Next day broke out in hives which continued a few days. Called physician, told to watch what he eats. Hives left in few days then a dry hacking cough started. Only at night when sleeping. Then post nasal drip. Month later received 2nd shot, no reaction. Four days later return to doc for cough, son has sinus infection and given antibiotic (first time ever) for 14 days. My son has been sick for a month now and this is a child that is NEVER sick, and I believe it stemmed from the flu shot. This was his first time getting it due to nursery school.
Age: 3.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Sinusitis, Upper-airway cough syndrome, Urticaria, Vomiting
Clinical narrative: Son said in car he didn't feel good. Felt yucky. Came home and he played and ate. Later that evening he threw up in bed and told me that he saw people walking around his room. Later in the evening he threw up again. Next morning he was ok. Later that day he spiked a fever after his nap. Called Physician and told him about night before and then. Told to give Tylenol, fluids and rest. Next day broke out in hives which continued a few days. Called physician, told to watch what he eats. Hives left in few days then a dry hacking cough started. Only at night when sleeping. Then post nasal drip. Month later received 2nd shot, no reaction. Four days later return to doc for cough, son has sinus infection and given antibiotic (first time ever) for 14 days. My son has been sick for a month now and this is a child that is NEVER sick, and I believe it stemmed from the flu shot. This was his first time getting it due to nursery school.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives down left arm and into back some
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Electroencephalogram, Multiple sclerosis, Muscle spasms, Nuclear magnetic resonance imaging
Clinical narrative: My daughter began with having seizure type spasms in her arm and leg in late January 2008 (had an mri on 1/30/08) and was diagnosed on February 4, 2008 with Multiple Sclerosis.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Clonus, Dyspnoea, Hyperventilation, Tardive dyskinesia, Tongue disorder
Clinical narrative: Clonic posturing, tardive dyskenesia, "frozen tongue" hyperventilations SOB. Treatment = Epinephrine, IV, observation in emergency room
Age: 84.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Malaise
Clinical narrative: Patient received both Flu & Pneumo vaccine. Reported very sore arm where Pneumo vaccine given. Did not feel well. Had to lay down. Overused arm while cleaning.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Bone pain, Pain, Pain in extremity
Clinical narrative: Reaction previously (local) to flu vaccine. Soreness increased - was advised by HD 10-21-10 to call physician, try ice or heat. Heat caused increased pain. C/o vertebrae involvement -> pain radiating down arm to elbow & to back. 10-26-10 Advised again to call physician. Explained report & that we would report.
Age: 1.21
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash
Clinical narrative: Patient had FLUZONE immunization 10/21/2010. Onset of red patchy rash approximately 6 hours later on chest. Increasing in size & covering upper and lower extremity. Resolved with OTC BENADRYL.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: 1 small urticarial lesion with 1/10th dose Novartis brand in pt with hx of egg allergy who tolerates baked goods with egg. He was give BENADRYL. He had no other symptoms. Had tolerated Sanofi Pasteur last year.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm swelling 13cm x 10cm with erythema.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Breath holding, Crying, Culture urine negative, Cyanosis
Clinical narrative: Pt. received rotavirus the PCV-13 - cried but was fine. Then given PENTACEL and immediately screamed and turned purple then pallor with peri-oral cyanosis and went rigid and hyporesponsive after 3 to 5 minutes, color returned with HR - 130, pulse Ox 98% (unable to get HR or pulse ox prior to this). During episode pt. was staring with fixed gaze, increased extremity tone, and grunting. After resolution, fell asleep and had twitching of LLE and (L) wrist and s beats, also myoclonic jerks. Nurse administered ROTATEQ, then PCV-13 and baby cried but appeared to be fine. Then, at approximately 12:30 p.m., the nurse administered PENTACEL and the baby immediately started to scream and turned purple then developed pallor with peri-oral cyanosis. The nurse had Dr. come to check pt. At this time she was rigid and hyporesponsive. Her gaze was fixed and staring. Her extremity tone was increased and she was grunting. Heart rate and pulse ox were unobtainable although patient was breathing. The episode resolved 3 to 5 minutes. Heart rate was 130, T 97.8 temporal, and pulse ox was 99%. After resolution, the baby fell asleep and was observed to have twitching of the left lower extremity and left wrist of 1 to 5 beats lasting only a few seconds. She also had myoclonic jerks during sleep. On the advice of the emergency room physician, 911 was called and baby was transported to another hospital via ambulance then transferred to 2nd hospital where she was admitted for observation. Pt was discharged from hospital on the evening of the 23rd of October. I spoke with her mother today by phone. She told me that pt had a similar episode at Hospital when her IV was being inserted and that staff there felt it was a breath holding episode. Shortly after arrival at hospital she developed a fever of 38.2 Celsius. After being transported to 2nd hospital, she underwent a septic work-up including spinal tap, blood cultures, and urine cultures. The results are negative so far per patient's mother but are still pending final results. Mother told me that patient appears to be doing fine since returning home. She is scheduled for a follow up visit in our office with Dr. tomorrow.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Gaze palsy, Grunting, Hypertonia, Immediate post-injection reaction, Lumbar puncture normal
Clinical narrative: Pt. received rotavirus the PCV-13 - cried but was fine. Then given PENTACEL and immediately screamed and turned purple then pallor with peri-oral cyanosis and went rigid and hyporesponsive after 3 to 5 minutes, color returned with HR - 130, pulse Ox 98% (unable to get HR or pulse ox prior to this). During episode pt. was staring with fixed gaze, increased extremity tone, and grunting. After resolution, fell asleep and had twitching of LLE and (L) wrist and s beats, also myoclonic jerks. Nurse administered ROTATEQ, then PCV-13 and baby cried but appeared to be fine. Then, at approximately 12:30 p.m., the nurse administered PENTACEL and the baby immediately started to scream and turned purple then developed pallor with peri-oral cyanosis. The nurse had Dr. come to check pt. At this time she was rigid and hyporesponsive. Her gaze was fixed and staring. Her extremity tone was increased and she was grunting. Heart rate and pulse ox were unobtainable although patient was breathing. The episode resolved 3 to 5 minutes. Heart rate was 130, T 97.8 temporal, and pulse ox was 99%. After resolution, the baby fell asleep and was observed to have twitching of the left lower extremity and left wrist of 1 to 5 beats lasting only a few seconds. She also had myoclonic jerks during sleep. On the advice of the emergency room physician, 911 was called and baby was transported to another hospital via ambulance then transferred to 2nd hospital where she was admitted for observation. Pt was discharged from hospital on the evening of the 23rd of October. I spoke with her mother today by phone. She told me that pt had a similar episode at Hospital when her IV was being inserted and that staff there felt it was a breath holding episode. Shortly after arrival at hospital she developed a fever of 38.2 Celsius. After being transported to 2nd hospital, she underwent a septic work-up including spinal tap, blood cultures, and urine cultures. The results are negative so far per patient's mother but are still pending final results. Mother told me that patient appears to be doing fine since returning home. She is scheduled for a follow up visit in our office with Dr. tomorrow.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Muscle rigidity, Muscle twitching, Myoclonus, Pallor, Pyrexia
Clinical narrative: Pt. received rotavirus the PCV-13 - cried but was fine. Then given PENTACEL and immediately screamed and turned purple then pallor with peri-oral cyanosis and went rigid and hyporesponsive after 3 to 5 minutes, color returned with HR - 130, pulse Ox 98% (unable to get HR or pulse ox prior to this). During episode pt. was staring with fixed gaze, increased extremity tone, and grunting. After resolution, fell asleep and had twitching of LLE and (L) wrist and s beats, also myoclonic jerks. Nurse administered ROTATEQ, then PCV-13 and baby cried but appeared to be fine. Then, at approximately 12:30 p.m., the nurse administered PENTACEL and the baby immediately started to scream and turned purple then developed pallor with peri-oral cyanosis. The nurse had Dr. come to check pt. At this time she was rigid and hyporesponsive. Her gaze was fixed and staring. Her extremity tone was increased and she was grunting. Heart rate and pulse ox were unobtainable although patient was breathing. The episode resolved 3 to 5 minutes. Heart rate was 130, T 97.8 temporal, and pulse ox was 99%. After resolution, the baby fell asleep and was observed to have twitching of the left lower extremity and left wrist of 1 to 5 beats lasting only a few seconds. She also had myoclonic jerks during sleep. On the advice of the emergency room physician, 911 was called and baby was transported to another hospital via ambulance then transferred to 2nd hospital where she was admitted for observation. Pt was discharged from hospital on the evening of the 23rd of October. I spoke with her mother today by phone. She told me that pt had a similar episode at Hospital when her IV was being inserted and that staff there felt it was a breath holding episode. Shortly after arrival at hospital she developed a fever of 38.2 Celsius. After being transported to 2nd hospital, she underwent a septic work-up including spinal tap, blood cultures, and urine cultures. The results are negative so far per patient's mother but are still pending final results. Mother told me that patient appears to be doing fine since returning home. She is scheduled for a follow up visit in our office with Dr. tomorrow.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming, Slow response to stimuli, Staring
Clinical narrative: Pt. received rotavirus the PCV-13 - cried but was fine. Then given PENTACEL and immediately screamed and turned purple then pallor with peri-oral cyanosis and went rigid and hyporesponsive after 3 to 5 minutes, color returned with HR - 130, pulse Ox 98% (unable to get HR or pulse ox prior to this). During episode pt. was staring with fixed gaze, increased extremity tone, and grunting. After resolution, fell asleep and had twitching of LLE and (L) wrist and s beats, also myoclonic jerks. Nurse administered ROTATEQ, then PCV-13 and baby cried but appeared to be fine. Then, at approximately 12:30 p.m., the nurse administered PENTACEL and the baby immediately started to scream and turned purple then developed pallor with peri-oral cyanosis. The nurse had Dr. come to check pt. At this time she was rigid and hyporesponsive. Her gaze was fixed and staring. Her extremity tone was increased and she was grunting. Heart rate and pulse ox were unobtainable although patient was breathing. The episode resolved 3 to 5 minutes. Heart rate was 130, T 97.8 temporal, and pulse ox was 99%. After resolution, the baby fell asleep and was observed to have twitching of the left lower extremity and left wrist of 1 to 5 beats lasting only a few seconds. She also had myoclonic jerks during sleep. On the advice of the emergency room physician, 911 was called and baby was transported to another hospital via ambulance then transferred to 2nd hospital where she was admitted for observation. Pt was discharged from hospital on the evening of the 23rd of October. I spoke with her mother today by phone. She told me that pt had a similar episode at Hospital when her IV was being inserted and that staff there felt it was a breath holding episode. Shortly after arrival at hospital she developed a fever of 38.2 Celsius. After being transported to 2nd hospital, she underwent a septic work-up including spinal tap, blood cultures, and urine cultures. The results are negative so far per patient's mother but are still pending final results. Mother told me that patient appears to be doing fine since returning home. She is scheduled for a follow up visit in our office with Dr. tomorrow.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Headache, Pneumonia
Clinical narrative: Severe headache vomiting dyspnea , cough
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Severe headache vomiting dyspnea , cough
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Eye discharge, Eye swelling, Fatigue
Clinical narrative: PATIENT BEGAN TO FEEL TIRED ABOUT AN HOUR LATER, BY 5:00 PM WAS IN BED COUGHING, IT WAS HARD FOR HER TO SWALLOW, HEADACHE, EYES WERE SWOLLEN, RED AND HAD A WHITISH DISCHARGE, NASAL CONGESTION.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Nasal congestion
Clinical narrative: PATIENT BEGAN TO FEEL TIRED ABOUT AN HOUR LATER, BY 5:00 PM WAS IN BED COUGHING, IT WAS HARD FOR HER TO SWALLOW, HEADACHE, EYES WERE SWOLLEN, RED AND HAD A WHITISH DISCHARGE, NASAL CONGESTION.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Blood pressure orthostatic, Blood test, Chest X-ray
Clinical narrative: Joint pain, lower back pain, fever, chills, dizziness, tunnel vision, muscle weakness, cold sweats, orthostatic blood pressure, patient collapsed and was taken to ER; prolonged joint pain; headache, soreness and pain in neck/throat muscles.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cold sweat, Computerised tomogram head, Dizziness, Headache
Clinical narrative: Joint pain, lower back pain, fever, chills, dizziness, tunnel vision, muscle weakness, cold sweats, orthostatic blood pressure, patient collapsed and was taken to ER; prolonged joint pain; headache, soreness and pain in neck/throat muscles.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Myalgia, Pyrexia, Syncope, Tunnel vision
Clinical narrative: Joint pain, lower back pain, fever, chills, dizziness, tunnel vision, muscle weakness, cold sweats, orthostatic blood pressure, patient collapsed and was taken to ER; prolonged joint pain; headache, soreness and pain in neck/throat muscles.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis
Clinical narrative: Joint pain, lower back pain, fever, chills, dizziness, tunnel vision, muscle weakness, cold sweats, orthostatic blood pressure, patient collapsed and was taken to ER; prolonged joint pain; headache, soreness and pain in neck/throat muscles.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Drug administered at inappropriate site, Injection site pain, Pain
Clinical narrative: Pain in left arm shoulder.  Employee felt it was placed to high, felt crunching, has had burning, aching since time of vaccination.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sensation of heaviness
Clinical narrative: PATIENT FELT HEAVINESS IN THE ARM.  IT HAS BEEN 2 DAYS SINCE THE VACCINATION AND SHE IS STILL EXPERIENCING THE PAIN/HEAVINESS IN ARM.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Feeling abnormal, Limb discomfort, Musculoskeletal discomfort, Neck pain, Pain in extremity
Clinical narrative: Patient said he had soreness and discomfort in his arm and traveled up to his neck and just does not feel right.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from a physician concerning a 15 year old male with asthma and "cardiac history" (unspecified) who on 30-AUG-2010 was vaccinated with GARDASIL (Lot number 665607/1333Y). Concomitant therapy included LIPITOR. On 27-SEP-2010 the patient died while playing hockey. The physician reported "awaiting autopsy results". At the time of report no further information was available. The reporter considered death to be life-threatening. A lot check has been initiated. Additional information has been requested.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Report received from a nurse on 18-OCT-2010 (received via Merck WAES 1010UA01764). A 30 or 31 year old female patient (date of birth unknown) received flu vaccine (brand and batch unknown) on 12-OCT-2010. The patient had a medical history of pneumonia and a history of MA. The patient also received additional suspect drug PNEUMOVAX 23 (batch unknown) on the same day to prevent pneumonia. On 12-OCT-2010, the day of vaccination with the suspect drug, the patient said the injection really hurt. On 14-OCT-2010, the patient developed a high fever of 103 degrees. The patient went to the doctor on 14-OCT-2010. The nurse said the doctor stated this might be an infection; it is red and swollen with induration at the injection site. The patient required hospitalisation. Her white blood cell count was extremely elevated. The nurse reporter that the infectious disease doctor said it was the vaccine. The nurse also reported that she thought it was the pneumovax vaccine because that was the arm that was swollen. The patient had received the flu vaccine in the other arm at the same time. The event outcome was recovering. The case was reported as serious due to hospitalisation. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Sex: F
Vaccine: FLU3, PPV
Symptoms: White blood cell count increased
Clinical narrative: Report received from a nurse on 18-OCT-2010 (received via Merck WAES 1010UA01764). A 30 or 31 year old female patient (date of birth unknown) received flu vaccine (brand and batch unknown) on 12-OCT-2010. The patient had a medical history of pneumonia and a history of MA. The patient also received additional suspect drug PNEUMOVAX 23 (batch unknown) on the same day to prevent pneumonia. On 12-OCT-2010, the day of vaccination with the suspect drug, the patient said the injection really hurt. On 14-OCT-2010, the patient developed a high fever of 103 degrees. The patient went to the doctor on 14-OCT-2010. The nurse said the doctor stated this might be an infection; it is red and swollen with induration at the injection site. The patient required hospitalisation. Her white blood cell count was extremely elevated. The nurse reporter that the infectious disease doctor said it was the vaccine. The nurse also reported that she thought it was the pneumovax vaccine because that was the arm that was swollen. The patient had received the flu vaccine in the other arm at the same time. The event outcome was recovering. The case was reported as serious due to hospitalisation. The company considered events possible in relation to the suspect drug. Information derived from this AE report does not change the current safety profile of the product.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Dizziness, Dyspnoea, Headache
Clinical narrative: This patient is one of a cluster of 2 patient's with the same reporter and same vaccine administered; however lot number was not reported. Initial report received from a patient on 19 October 2010. A 61-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number not reported) at 9:30 am on 18 October 2010, and within 15-20 minutes later, she complained of a sore throat, SOB (shortness of breath) and coughing. The patient subsequently developed severe headache, dizziness, nausea, diarrhea, and complained of numbness and tingling in her hands and feet. It was also reported the patient had pain (not described) and that 90 minutes after vaccination the patient was sick. The patient has no known allergies and denied any pre-existing medical conditions or concurrent illnesses at the time of vaccination; however the patient was taking concomitant medications of PREMPRO and "MDV". She had not experienced any other adverse events with prior vaccinations in the past. The patient does receive the flu vaccine annually. At the time of this report, the patient was feeling better but still complained of a headache although not as severe. Documents held by sender: None. The reporter for this case is the same as for non-serious case 2010-06028.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Malaise, Nausea, Oropharyngeal pain, Pain
Clinical narrative: This patient is one of a cluster of 2 patient's with the same reporter and same vaccine administered; however lot number was not reported. Initial report received from a patient on 19 October 2010. A 61-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number not reported) at 9:30 am on 18 October 2010, and within 15-20 minutes later, she complained of a sore throat, SOB (shortness of breath) and coughing. The patient subsequently developed severe headache, dizziness, nausea, diarrhea, and complained of numbness and tingling in her hands and feet. It was also reported the patient had pain (not described) and that 90 minutes after vaccination the patient was sick. The patient has no known allergies and denied any pre-existing medical conditions or concurrent illnesses at the time of vaccination; however the patient was taking concomitant medications of PREMPRO and "MDV". She had not experienced any other adverse events with prior vaccinations in the past. The patient does receive the flu vaccine annually. At the time of this report, the patient was feeling better but still complained of a headache although not as severe. Documents held by sender: None. The reporter for this case is the same as for non-serious case 2010-06028.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: This patient is one of a cluster of 2 patient's with the same reporter and same vaccine administered; however lot number was not reported. Initial report received from a patient on 19 October 2010. A 61-year-old female patient had received a dose of FLUZONE HIGH-DOSE (lot number not reported) at 9:30 am on 18 October 2010, and within 15-20 minutes later, she complained of a sore throat, SOB (shortness of breath) and coughing. The patient subsequently developed severe headache, dizziness, nausea, diarrhea, and complained of numbness and tingling in her hands and feet. It was also reported the patient had pain (not described) and that 90 minutes after vaccination the patient was sick. The patient has no known allergies and denied any pre-existing medical conditions or concurrent illnesses at the time of vaccination; however the patient was taking concomitant medications of PREMPRO and "MDV". She had not experienced any other adverse events with prior vaccinations in the past. The patient does receive the flu vaccine annually. At the time of this report, the patient was feeling better but still complained of a headache although not as severe. Documents held by sender: None. The reporter for this case is the same as for non-serious case 2010-06028.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Hypotension, Laboratory test normal, Pain, Syncope
Clinical narrative: Initial report was received 21 October 2010 from a health care professional, who is also the patient. A 47-year-old male patient had received an intramuscular left deltoid injection of FLUZONE SV, lot number UH214AC on 08 October 2010, and on the evening of vaccination he felt achy and weak and progressively felt weaker and weaker. The next morning, the patient fainted and experienced a hypotensive episode. His blood pressure was reported to have been below 100 which was low for him. He had no concurrent illness at the time of vaccination. The patient was evaluated by his physician and laboratory results were normal. Past medical history included high blood pressure, GERD (gastroesophageal reflux disease), asthma, hyperlipidemia and ADHD. He had no known allergies. He had been taking NORVASC, ZOLOFT, RITALIN, "Simvastatin", ASA, Acyclovir and ZYRTEC concomitantly. The patient also reported they had received Influenza vaccinations annually. At the time of the report, the patient was still not 100% and had not recovered. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Alpha 1 foetoprotein normal, Caesarean section, Drug exposure during pregnancy, Laboratory test normal, Labour complication
Clinical narrative: Initial report received on 06 October 2009 from a health care professional. A 17-year-old female patient, who has asthma and no prior obstetrical history or allergies, had received a 0.5 mL intramuscular right deltoid injection of ADACEL (lot number C3248AA); a 0.5 mL intramuscular right deltoid injection of MENACTRA (lot number U2686AA); and an intramuscular left deltoid injection of GARDASIL (manufacturer Merck, lot number 1446U) on 24 August 2009. The patient was taking PYRIDOXINE for nausea (etiology not reported) at the time of this report; however the reporter indicated the patient had not experienced any adverse events since being vaccinated on 24 August 2009. The patient denied being sexually active at the time of the vaccinations, but was subsequently found to be pregnant with a last menstrual period date of 19 August 2009. Expected date of delivery was not reported. The patient has denied any smoking, alcohol use, or recreational drug use during this pregnancy. The recovery status for the event of nausea was not reported. Follow-up information received 30 October 2009 from a health care professional who provided contact information for the obstetrician overseeing the patient's care. No additional information was provided, and the patient's recovery status was not reported. Follow-up information received 14 December 2009 from a health care professional. The patient's last menstrual period was 18 August 2009. Estimated date of delivery is 25 May 2010. An ultrasound on 05 November 2009 was normal. Prenatal labs on 19 November 2009 were within normal limits. The reporter indicated that the patient was a healthy 17-year-old who had not experienced any adverse events. Follow-up information received from a physician on 27 September 2010. The patient delivered a single live male baby on 18 May 2010 at 39 weeks gestation via Cesarean section. The baby weighed 3 Kg (also reported as 87 3/4?) and his Apgar scores were 7 at one minute and 9 at five minutes. The baby had no congenital anomalies. All prenatal testing was normal. There were no complications of pregnancy and or labor and delivery. Per the reporter, the patient did not experience any adverse events. The patient recovered from the nausea (date not reported). Follow-up information was received from a physician on 22 October 2010. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. The patient was reported to have had pre-eclampsia. The cesarean section was performed due to the "failure on descent" of the fetal head. No further information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: None.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea, Pre-eclampsia, Ultrasound scan normal
Clinical narrative: Initial report received on 06 October 2009 from a health care professional. A 17-year-old female patient, who has asthma and no prior obstetrical history or allergies, had received a 0.5 mL intramuscular right deltoid injection of ADACEL (lot number C3248AA); a 0.5 mL intramuscular right deltoid injection of MENACTRA (lot number U2686AA); and an intramuscular left deltoid injection of GARDASIL (manufacturer Merck, lot number 1446U) on 24 August 2009. The patient was taking PYRIDOXINE for nausea (etiology not reported) at the time of this report; however the reporter indicated the patient had not experienced any adverse events since being vaccinated on 24 August 2009. The patient denied being sexually active at the time of the vaccinations, but was subsequently found to be pregnant with a last menstrual period date of 19 August 2009. Expected date of delivery was not reported. The patient has denied any smoking, alcohol use, or recreational drug use during this pregnancy. The recovery status for the event of nausea was not reported. Follow-up information received 30 October 2009 from a health care professional who provided contact information for the obstetrician overseeing the patient's care. No additional information was provided, and the patient's recovery status was not reported. Follow-up information received 14 December 2009 from a health care professional. The patient's last menstrual period was 18 August 2009. Estimated date of delivery is 25 May 2010. An ultrasound on 05 November 2009 was normal. Prenatal labs on 19 November 2009 were within normal limits. The reporter indicated that the patient was a healthy 17-year-old who had not experienced any adverse events. Follow-up information received from a physician on 27 September 2010. The patient delivered a single live male baby on 18 May 2010 at 39 weeks gestation via Cesarean section. The baby weighed 3 Kg (also reported as 87 3/4?) and his Apgar scores were 7 at one minute and 9 at five minutes. The baby had no congenital anomalies. All prenatal testing was normal. There were no complications of pregnancy and or labor and delivery. Per the reporter, the patient did not experience any adverse events. The patient recovered from the nausea (date not reported). Follow-up information was received from a physician on 22 October 2010. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. The patient was reported to have had pre-eclampsia. The cesarean section was performed due to the "failure on descent" of the fetal head. No further information was available at the time of the report. The patient's outcome remained recovered. Documents held by sender: None.
Sex: U
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning someone that one of his patients knew who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # not reported). Subsequently the patient had a experienced seizure post vaccination. The physician stated that the patient was not his patient and the adverse experience was hear say. Attempts are being made to verify the existence of an identifiable patient. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Myalgia, Pyrexia
Clinical narrative: Patient/employee received flu vaccination on 10/27/10 at 13:30PM within 2 1/2 hours after vaccination experienced symptoms of: cough, fever and muscle aches. Symptoms subsiding this morning 10/28/10.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: Pt. came on 10/20/2010 for flu shot. Received Flu shot IM (L) deltoid. Called c/o dizziness, vomiting, diarrhea. T.C, called x 2 - feeling ?, C x 1 - left a message.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Myalgia, Pyrexia, Sneezing
Clinical narrative: Patient/employee received Flu vaccination on 10/26/10 at 1445PM. At 0300 (10/27) awoke with fever 38.1 degrees C dry cough sneezing nose and muscle aches which have continued through this morning 10/28/10 at 9:30 AM.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Induration, Oedema peripheral, Skin warm
Clinical narrative: Parent reported (R) arm became swollen, hard & hot to elbow. Seen in ER with Dx cellulitis & placed on KELFEX. Family MD follow up D/C KEFLEX & placed on BENADRYL & referred to Pediatric allergist for further evaluation.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Dizziness, Faeces discoloured, Pyrexia
Clinical narrative: Dizzy, light headed, broke out in cold sweat, completely wet, weak, extremely, fever, dark stools & possible blood.
Age: 22.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site urticaria, Platelet count decreased
Clinical narrative: 24 hours after shot - bruise at exact site of vaccines (due to low platelets). Raised, red hives in a circular pattern around deltoid. From shoulder to just above elbow. Painful.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Paraesthesia
Clinical narrative: Within 1 minute of receiving vaccine, patient reported tingling in upper body & arms, also headache in (L) temporal region (pain level 2). Initial BP 140/90, BP in 10 minutes 180/80, HR 80. Tingling subsided within 2 hours. Headache subsided that evening. No treatment needed.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Paraesthesia
Clinical narrative: A few minutes after injection, patient complained of tingling in both arms and upper body and a headache.  No chest pain or shortness of breath.  BP140/90, pulse reg.  Observed at clinic for about 10 minutes. Patient stated tingling less, no SOB, no rash.  BP 132/80 (usual 130/78).
Age: 3.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood test normal, Bradycardia, Lethargy, Pallor
Clinical narrative: After patient left and was in parking lot, patient became lethargic. Mom brought him in. He was not alert but awake, lethargic. Initially bradycardic, not hypoxic, pale. Administered O2 and BENADRYL. 15 min later was completely himself, paramedics took him to ER - blood work normal and was released home.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Aching on right side - everywhere. 10/22/10 aching & rash on right side - increasing each day even into today 10/27/10. Has been to Dr. several times. Dx: Shingles. On Acyclovir & Prednisone.
Age: 45.0
Sex: M
Vaccine: FLUX, HEPAB, IPV, TDAP, TYP
Symptoms: Arthralgia, Laboratory test normal, Red blood cell sedimentation rate increased
Clinical narrative: Profound joint pain, diffuse.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: Swelling of lips & tongue given BENADRYL, methylprednisone and epi. SQ.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Pt received GARDASIL and Influenza, waited ten minutes after shots. Was feeling fine. Free to go. Ambulated to parking lot with Mom. Felt ill, fell in parking lot. Experienced LOC-not sure of time frame. Paramedic on hand, transported to ER via ambulance.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Grip strength decreased, Laboratory test normal, Myalgia, Pain in extremity
Clinical narrative: After 3 days of flu shot, patient developed muscle aches on the other arm, pain moved to the arm (flu shot) after 7 days. Pt had chest pain after 5 days of shot -> all tests came out -UE. After 1 week pt still has pain cannot grip anything with the hand (flu shot was given)
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Erythema & swelling, 10cm x 10cm, (R) deltoid, 24-48 hours after Flu immunization. Pain, decreased mobility x 24 hours; resolving at 48 hours. No fever, no joint pain, no other rash.
Age: 35.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Injection site pain, Lymphadenopathy, Pruritus, Rash
Clinical narrative: Left deltoid soreness for 2 days, follow by lymph node swelling behind left chest wall for 2 days. Mild rash on chest with itching followed for 2 days, now all resolved.
Age: 0.76
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Pyrexia, Urine analysis
Clinical narrative: Fever for 3 days - T-max 102, since FLUZONE give.
Age: 4.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Pyrexia
Clinical narrative: Vaccine given at 12 noon at 3:00 school called Dad patient had fever, dad got there and took her to ER.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Mass, Tenderness
Clinical narrative: Awoke morning after vaccine with grape size lump left next to left clavicle at nape of neck with tenderness. Had similar reaction in 2006, but was not reported.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness
Clinical narrative: Light-headed; dizzy spells (3-4 x during day continuing through following day.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Chills, Pyrexia
Clinical narrative: Overnight chills and fever, took Motrin, fever resolved.  Lost a day of work catching up on sleep.
Age: 0.56
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RVX
Symptoms: Convulsion, Muscle twitching, Pyrexia
Clinical narrative: Fever to 105 per history and twitching felt to be seizure activity by Mom
Age: 0.89
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme rash
Age: 22.0
Sex: F
Vaccine: PER, TD
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: high fever up to 103 nausea stiff neck joint pain sever headache - shooting pain and pressure chills  fatigue muscle soreness loss of appetite difficulty sleeping diarrhea over a five day period
Age: 22.0
Sex: F
Vaccine: PER, TD
Symptoms: Headache, Insomnia, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: high fever up to 103 nausea stiff neck joint pain sever headache - shooting pain and pressure chills  fatigue muscle soreness loss of appetite difficulty sleeping diarrhea over a five day period
Age: 22.0
Sex: F
Vaccine: PER, TD
Symptoms: Pain, Pyrexia
Clinical narrative: high fever up to 103 nausea stiff neck joint pain sever headache - shooting pain and pressure chills  fatigue muscle soreness loss of appetite difficulty sleeping diarrhea over a five day period
Age: 27.0
Sex: F
Vaccine: YF
Symptoms: Urticaria
Clinical narrative: Hives from head to toe.  Advised pt to take Benadryl per package directions.  Hives lasted approximately 24 hrs.
Age: 26.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood creatine phosphokinase increased, Chills, Full blood count normal, Metabolic function test, Muscle disorder
Clinical narrative: 27 yo male with reported muscle failure within 12 hours of getting Flumist last year.  He reports sudden onset, no preceding myalgias prior to "failure".  Was not ascending, was all over, immediately.  He thinks he may have played football that day but cannot recall for sure.  He is a weight-lifter but says he wasn't lifting weights during that time of the year.  Denies any medications or supplements at that time.  Reports he went to ED within 24 hours (although ED labs dated 5 days after getting Flumist) and received IVFs, discharged to home on 24 or 36 hours quarters.  Slowly resolved over 3-4 days.  Pt reports chills but no fever, no emesis/diarrhea, no skin rash, hematuria.  Received the H1N1 later in the season without any other reactions.  No previous vaccination reactions ever.  No known drug allergies.
Age: 26.0
Sex: M
Vaccine: FLUN3
Symptoms: Urine analysis normal
Clinical narrative: 27 yo male with reported muscle failure within 12 hours of getting Flumist last year.  He reports sudden onset, no preceding myalgias prior to "failure".  Was not ascending, was all over, immediately.  He thinks he may have played football that day but cannot recall for sure.  He is a weight-lifter but says he wasn't lifting weights during that time of the year.  Denies any medications or supplements at that time.  Reports he went to ED within 24 hours (although ED labs dated 5 days after getting Flumist) and received IVFs, discharged to home on 24 or 36 hours quarters.  Slowly resolved over 3-4 days.  Pt reports chills but no fever, no emesis/diarrhea, no skin rash, hematuria.  Received the H1N1 later in the season without any other reactions.  No previous vaccination reactions ever.  No known drug allergies.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: High Fever, Severe Body aches
Age: 37.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Injection site rash, Local swelling, Swelling face, Throat irritation
Clinical narrative: Upon arising noted some facial and neck swelling and rash at site of pneumonia vaccine.  As AM progressed, complained of single episode of SOB and scratchy throat which responded without treatment.  Had taken a Zyrtec on 10/21/10 and took another late AM on 10/22/10.  Reported this happened x2 before following Mexican food. Had been seen by allergist for testing in past and no allergies noted upon testing. Reports no history of allergy to eggs, latex or other ingredients in either vaccine.  BP 106/78, HR 80 and regular, chest clear, no wheezing or congestion noted.  Called primary physician and was referred to her allergist.  Seen by allergist on 10/22/10.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX, FLUX(H1N1)
Symptoms: Back pain, Dizziness, Dyspnoea, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Patient presented to office on 10/18/10 with bilateral leg weakness with numbness. Bilateral numbness in arms and hands. Unsteady gait. SOB with exertion. Dizziness. Back pain. No respiratory distress. Dr.  consulted with hospitalist and agreed to direct admit patient with working diagnosis Gullien Barre Syndrome.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX, FLUX(H1N1)
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient presented to office on 10/18/10 with bilateral leg weakness with numbness. Bilateral numbness in arms and hands. Unsteady gait. SOB with exertion. Dizziness. Back pain. No respiratory distress. Dr.  consulted with hospitalist and agreed to direct admit patient with working diagnosis Gullien Barre Syndrome.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX, FLUX(H1N1)
Symptoms: Asthenia, Blood culture, Computerised tomogram, Culture urine, Dyspnoea
Clinical narrative: Patient presented to office on 10/18/10 with bilateral leg weakness with numbness. Bilateral numbness in arms and hands. Unsteady gait. SOB with exertion. Dizziness. Back pain. No respiratory distress. Dr.  consulted with hospitalist and agreed to direct admit patient with working diagnosis Gullien Barre Syndrome.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX, FLUX(H1N1)
Symptoms: Electromyogram, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intensive care
Clinical narrative: Patient presented to office on 10/18/10 with bilateral leg weakness with numbness. Bilateral numbness in arms and hands. Unsteady gait. SOB with exertion. Dizziness. Back pain. No respiratory distress. Dr.  consulted with hospitalist and agreed to direct admit patient with working diagnosis Gullien Barre Syndrome.
Age: 73.0
Sex: F
Vaccine: FLU3, FLUX, FLUX(H1N1)
Symptoms: Lumbar puncture abnormal, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, X-ray
Clinical narrative: Patient presented to office on 10/18/10 with bilateral leg weakness with numbness. Bilateral numbness in arms and hands. Unsteady gait. SOB with exertion. Dizziness. Back pain. No respiratory distress. Dr.  consulted with hospitalist and agreed to direct admit patient with working diagnosis Gullien Barre Syndrome.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: noted local erythema at injection site
Age: 63.0
Sex: M
Vaccine: FLU3, PNC10
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Started feeling extremely fatigued, then muscle aches and fever of 101.8.  Severe symptoms continued until this morning 10/28/10.  Still fatigued, but fever has gone down - not normal yet - but getting better.  Injection site got huge - red, swelling covered entire upper arm. PLEASE NOTE:  received both the flu vaccination AND pnuemonia shot.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Chills, Insomnia, Nasopharyngitis
Clinical narrative: I woke at 11 PM with severe chills and shaking so bad, I could not get out of bed.  I also was extremely nauseous, although I did not vomit.  As the evening wore on, I could not fall back to sleep and felt very restless.  I then became extremely cold and added two more blankets to my bed.  By morning, my fever was 102 degrees.  The shaking had stopped.  As the day progressed, I felt weak but not shaky.  I did not leave the house all day.  The next day, I was almost fully recovered.  I took 2 extra-strength Tylenol every 4 hours during this episode.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Restlessness, Tremor
Clinical narrative: I woke at 11 PM with severe chills and shaking so bad, I could not get out of bed.  I also was extremely nauseous, although I did not vomit.  As the evening wore on, I could not fall back to sleep and felt very restless.  I then became extremely cold and added two more blankets to my bed.  By morning, my fever was 102 degrees.  The shaking had stopped.  As the day progressed, I felt weak but not shaky.  I did not leave the house all day.  The next day, I was almost fully recovered.  I took 2 extra-strength Tylenol every 4 hours during this episode.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Feeling hot, Headache, Nasopharyngitis, Pharyngeal oedema
Clinical narrative: Patient felt feverish, started coughing, had cold like symptoms, severe headache. Stated that face swelled and felt swelling of the tongue and throat. Now feels like she has a sinus infection.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Patient felt feverish, started coughing, had cold like symptoms, severe headache. Stated that face swelled and felt swelling of the tongue and throat. Now feels like she has a sinus infection.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Exceptional amount of pain at injection site with weakness and tingling radiating down arm to middle finger.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Flushing, Hypoaesthesia, Hypoaesthesia oral, Thirst
Clinical narrative: Flushing, numbness of mouth tongue, neck.  Thirst, Chills
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site pain, Nausea
Clinical narrative: Nauseated, severe pain in arm where received both flu and Pneumovax shots, couldn't lift arm, developed cellulitis about 4 inches above affected elbow but not at injection sites.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Pharyngeal oedema
Clinical narrative: Started to feel her throat, lips and eyes swelling.  No breathing problems.  Went to ER at 7:58 PM and got subcut epinephrine, 125 mg IV solumedrol, and 25 mg IV Benadryl.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site atrophy, Muscular weakness, Pain in extremity
Clinical narrative: After injection arm was sore for ~ 3 days then soreness changed into weakness. Weakness gradually increased. Before vaccination could do 35 push-ups. As of 10/28/10 can only do 3 due to weakness of left arm. Divot noticed in left deltoid area of injection 10/27/10. Pain "2" on 0 - 10 scale.