chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Patient reported weakness in arm, 7 weeks after vaccination.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Respiratory distress, Wheezing
Clinical narrative: First episode of wheezing with severe respiratory distress 20-24 hrs after MMR vaccine. Treated with albuterol & oral steroids. Responded well. Very mild runny nose at time of vaccine administration but no other signs of illness.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Itching all over body & rash x 2 weeks after vaccine administration (pt returned to clinic for eval & given steroid dose pack).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient developed right upper arm redness/swelling/itching after Dtap & IPV immunizations given 3/4/13. Afebrile. Dx cellulitis - Rx Clindamycin 150 mg P.O. TID x 10d. Cool compresses 2-3xday until swelling decreases. ZYRTEC 10 mg P.O. qd prn. Borders drawn at reaction site to reveal 24-48 hours if reaction worsens or fever. Follow up appointment scheduled 3/11/13.
Age: 29.0
Sex: M
Vaccine: JEV1, TYP
Symptoms: Activities of daily living impaired, Chills, Pain in extremity
Clinical narrative: Friday afternoon received Typhoid and Japanese Encephalitis vaccines. Saturday night, my legs felt achy while lying down. Sunday, my legs felt achy thru Monday morning. Also, Saturday night, I had chills. Monday morning pain was worse pain at lower extremities. Affected running.
Age: 52.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis several hours after administration.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: None at this time. First Hep A on 9-25-12. Second on 3-5-13 3 weeks too soon.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Localized erythema within 24 hrs; possible cellulitis -> given antibiotics.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Croup infectious, Pyrexia, Urticaria
Clinical narrative: Pt got vaccines on 2.25.13 that night pt developed a fever. The next day pt developed hives and now has a croupy cough.
Age: 62.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt's arm hurt x several months.
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 17-JAN-2013 the patient was vaccinated with VARIVAX (merck) (lot number not provided) dose 1. On 31-JAN-2013, two weeks after receiving the vaccine, the patient developed chickenpox. She had multiple lesions on her face and body. The patient was treated with acyclovir. On an unknown date in 2013 the patient recovered. The relatedness for chickenpox was not provided. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Inflammation, Skin warm
Clinical narrative: Pt received pneumonia vaccine on 3/4/13 after routine exam, along with influenza and TDAP. Only pneumococcal given in RT arm. On 3/6 pt came to urgent care with red, inflamed area on (R) arm 29 x 16 cm, hot to touch. No fever, but positive for fatigue and chills. Given Cephalexin 500 mg QID.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt received pneumonia vaccine on 3/4/13 after routine exam, along with influenza and TDAP. Only pneumococcal given in RT arm. On 3/6 pt came to urgent care with red, inflamed area on (R) arm 29 x 16 cm, hot to touch. No fever, but positive for fatigue and chills. Given Cephalexin 500 mg QID.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Cellulitis, Erythema, Myalgia, Oedema peripheral, Pain in extremity
Clinical narrative: Pt received pneumonia vaccine on 3/4/13 after routine exam, along with influenza and TDAP. Only pneumococcal given in RT arm. On 3/6 pt came to urgent care with red, inflamed area on (R) arm 29 x 16 cm, hot to touch. No fever, but positive for fatigue and chills. Given Cephalexin 500 mg QID.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: CSF protein increased, Fatigue, Gait disturbance, Gastrostomy tube insertion, Guillain-Barre syndrome
Clinical narrative: Patient hospitalized Jan, 2011 for Guillain-Barre Syndrome. She was hospitalized for several months and required extensive rehabilitation. Required PEG tube placement. Received IVIG. Residual fatigue, neuropathic pain, gait change.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Neuralgia
Clinical narrative: Patient hospitalized Jan, 2011 for Guillain-Barre Syndrome. She was hospitalized for several months and required extensive rehabilitation. Required PEG tube placement. Received IVIG. Residual fatigue, neuropathic pain, gait change.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Balance disorder, Muscular weakness, Nausea
Clinical narrative: Severe burning stinging in muscles in back.  Weakness in left arm.  Painful tingling pin pricks in feet, moving to include hands and now systemic.  Nauseous. Balance is off.  Doing some detox with my Naturopath doctor.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Neurological examination, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe burning stinging in muscles in back.  Weakness in left arm.  Painful tingling pin pricks in feet, moving to include hands and now systemic.  Nauseous. Balance is off.  Doing some detox with my Naturopath doctor.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Blood pressure increased, Burning sensation, Chest pain, Choking sensation, Dysphagia
Clinical narrative: I received the T Tap (plain tetanus) at 7:10 AM. At 8 AM at home I felt a sharp pain from my pelvis and nearly wet my pants. That night I was running fever of appx. 101* and had shooting leg pain. By 1/18/2013, I had shooting pain in my jaw. By 1/20/13 my lymph nodes in my neck were swelling and I felt choked, along with a fever and blurred vision in my right eye. My neck also shook when I tried to look down, in a palsied state. On 1/23/2013 my doctor took me off doxycycline I was also taking, but this only abated a little nausea in the following days. On January 27 my neck, face, and ear started burning; I could and cannot stand for a shirt collar to touch it at all.That night the abject sharp pain across my lymph nodes and larynx began, along with difficulty swallowing, and speaking in a low tone to my 4 year old daughter. February 7 Dr. prescribed prednisone, which I took 10mg of on Feb. 8, 2013, and that tiny bit had me in the cardiac ward of the ER by 8 AM the next morn. All tests came back normal, but the symptoms from the tetanus toxoid remained. I was there all day. At this point, chest pain began. I saw Dr. again on 02/13/2013, and he ran more tests; also kidney tests due to my frequent urination, but all tests were normal. On February 28 I was back in the ER with all symptoms and severe pain, also very elevated blood pressure, but tests came back normal. At this time I still have severe neck (laryngeal and lymph) pain, jaw pain, arm pain at injection sight, slightly bllurred vision on right side (the shot was on my left), chest muscular wall pain, ear pain, burning sensation, and horrible, continual pressure. I am widowed with 4 children, and this has RUINED my life!!! How dare the doctors not give us all the facts on booster shots!! I am seeing a specialist tomorrow, can't afford it, and may lose my home now.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Ear pain, Injection site pain, Laboratory test normal, Laryngeal pain, Lymph node pain
Clinical narrative: I received the T Tap (plain tetanus) at 7:10 AM. At 8 AM at home I felt a sharp pain from my pelvis and nearly wet my pants. That night I was running fever of appx. 101* and had shooting leg pain. By 1/18/2013, I had shooting pain in my jaw. By 1/20/13 my lymph nodes in my neck were swelling and I felt choked, along with a fever and blurred vision in my right eye. My neck also shook when I tried to look down, in a palsied state. On 1/23/2013 my doctor took me off doxycycline I was also taking, but this only abated a little nausea in the following days. On January 27 my neck, face, and ear started burning; I could and cannot stand for a shirt collar to touch it at all.That night the abject sharp pain across my lymph nodes and larynx began, along with difficulty swallowing, and speaking in a low tone to my 4 year old daughter. February 7 Dr. prescribed prednisone, which I took 10mg of on Feb. 8, 2013, and that tiny bit had me in the cardiac ward of the ER by 8 AM the next morn. All tests came back normal, but the symptoms from the tetanus toxoid remained. I was there all day. At this point, chest pain began. I saw Dr. again on 02/13/2013, and he ran more tests; also kidney tests due to my frequent urination, but all tests were normal. On February 28 I was back in the ER with all symptoms and severe pain, also very elevated blood pressure, but tests came back normal. At this time I still have severe neck (laryngeal and lymph) pain, jaw pain, arm pain at injection sight, slightly bllurred vision on right side (the shot was on my left), chest muscular wall pain, ear pain, burning sensation, and horrible, continual pressure. I am widowed with 4 children, and this has RUINED my life!!! How dare the doctors not give us all the facts on booster shots!! I am seeing a specialist tomorrow, can't afford it, and may lose my home now.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Lymphadenopathy, Musculoskeletal chest pain, Nausea, Neck pain, Pain
Clinical narrative: I received the T Tap (plain tetanus) at 7:10 AM. At 8 AM at home I felt a sharp pain from my pelvis and nearly wet my pants. That night I was running fever of appx. 101* and had shooting leg pain. By 1/18/2013, I had shooting pain in my jaw. By 1/20/13 my lymph nodes in my neck were swelling and I felt choked, along with a fever and blurred vision in my right eye. My neck also shook when I tried to look down, in a palsied state. On 1/23/2013 my doctor took me off doxycycline I was also taking, but this only abated a little nausea in the following days. On January 27 my neck, face, and ear started burning; I could and cannot stand for a shirt collar to touch it at all.That night the abject sharp pain across my lymph nodes and larynx began, along with difficulty swallowing, and speaking in a low tone to my 4 year old daughter. February 7 Dr. prescribed prednisone, which I took 10mg of on Feb. 8, 2013, and that tiny bit had me in the cardiac ward of the ER by 8 AM the next morn. All tests came back normal, but the symptoms from the tetanus toxoid remained. I was there all day. At this point, chest pain began. I saw Dr. again on 02/13/2013, and he ran more tests; also kidney tests due to my frequent urination, but all tests were normal. On February 28 I was back in the ER with all symptoms and severe pain, also very elevated blood pressure, but tests came back normal. At this time I still have severe neck (laryngeal and lymph) pain, jaw pain, arm pain at injection sight, slightly bllurred vision on right side (the shot was on my left), chest muscular wall pain, ear pain, burning sensation, and horrible, continual pressure. I am widowed with 4 children, and this has RUINED my life!!! How dare the doctors not give us all the facts on booster shots!! I am seeing a specialist tomorrow, can't afford it, and may lose my home now.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Pain in extremity, Pain in jaw, Pelvic pain, Pollakiuria, Pyrexia
Clinical narrative: I received the T Tap (plain tetanus) at 7:10 AM. At 8 AM at home I felt a sharp pain from my pelvis and nearly wet my pants. That night I was running fever of appx. 101* and had shooting leg pain. By 1/18/2013, I had shooting pain in my jaw. By 1/20/13 my lymph nodes in my neck were swelling and I felt choked, along with a fever and blurred vision in my right eye. My neck also shook when I tried to look down, in a palsied state. On 1/23/2013 my doctor took me off doxycycline I was also taking, but this only abated a little nausea in the following days. On January 27 my neck, face, and ear started burning; I could and cannot stand for a shirt collar to touch it at all.That night the abject sharp pain across my lymph nodes and larynx began, along with difficulty swallowing, and speaking in a low tone to my 4 year old daughter. February 7 Dr. prescribed prednisone, which I took 10mg of on Feb. 8, 2013, and that tiny bit had me in the cardiac ward of the ER by 8 AM the next morn. All tests came back normal, but the symptoms from the tetanus toxoid remained. I was there all day. At this point, chest pain began. I saw Dr. again on 02/13/2013, and he ran more tests; also kidney tests due to my frequent urination, but all tests were normal. On February 28 I was back in the ER with all symptoms and severe pain, also very elevated blood pressure, but tests came back normal. At this time I still have severe neck (laryngeal and lymph) pain, jaw pain, arm pain at injection sight, slightly bllurred vision on right side (the shot was on my left), chest muscular wall pain, ear pain, burning sensation, and horrible, continual pressure. I am widowed with 4 children, and this has RUINED my life!!! How dare the doctors not give us all the facts on booster shots!! I am seeing a specialist tomorrow, can't afford it, and may lose my home now.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Renal function test normal, Sensation of pressure, Speech disorder, Tenderness, Tremor
Clinical narrative: I received the T Tap (plain tetanus) at 7:10 AM. At 8 AM at home I felt a sharp pain from my pelvis and nearly wet my pants. That night I was running fever of appx. 101* and had shooting leg pain. By 1/18/2013, I had shooting pain in my jaw. By 1/20/13 my lymph nodes in my neck were swelling and I felt choked, along with a fever and blurred vision in my right eye. My neck also shook when I tried to look down, in a palsied state. On 1/23/2013 my doctor took me off doxycycline I was also taking, but this only abated a little nausea in the following days. On January 27 my neck, face, and ear started burning; I could and cannot stand for a shirt collar to touch it at all.That night the abject sharp pain across my lymph nodes and larynx began, along with difficulty swallowing, and speaking in a low tone to my 4 year old daughter. February 7 Dr. prescribed prednisone, which I took 10mg of on Feb. 8, 2013, and that tiny bit had me in the cardiac ward of the ER by 8 AM the next morn. All tests came back normal, but the symptoms from the tetanus toxoid remained. I was there all day. At this point, chest pain began. I saw Dr. again on 02/13/2013, and he ran more tests; also kidney tests due to my frequent urination, but all tests were normal. On February 28 I was back in the ER with all symptoms and severe pain, also very elevated blood pressure, but tests came back normal. At this time I still have severe neck (laryngeal and lymph) pain, jaw pain, arm pain at injection sight, slightly bllurred vision on right side (the shot was on my left), chest muscular wall pain, ear pain, burning sensation, and horrible, continual pressure. I am widowed with 4 children, and this has RUINED my life!!! How dare the doctors not give us all the facts on booster shots!! I am seeing a specialist tomorrow, can't afford it, and may lose my home now.
Age: 44.0
Sex: F
Vaccine: TTOX
Symptoms: Vision blurred
Clinical narrative: I received the T Tap (plain tetanus) at 7:10 AM. At 8 AM at home I felt a sharp pain from my pelvis and nearly wet my pants. That night I was running fever of appx. 101* and had shooting leg pain. By 1/18/2013, I had shooting pain in my jaw. By 1/20/13 my lymph nodes in my neck were swelling and I felt choked, along with a fever and blurred vision in my right eye. My neck also shook when I tried to look down, in a palsied state. On 1/23/2013 my doctor took me off doxycycline I was also taking, but this only abated a little nausea in the following days. On January 27 my neck, face, and ear started burning; I could and cannot stand for a shirt collar to touch it at all.That night the abject sharp pain across my lymph nodes and larynx began, along with difficulty swallowing, and speaking in a low tone to my 4 year old daughter. February 7 Dr. prescribed prednisone, which I took 10mg of on Feb. 8, 2013, and that tiny bit had me in the cardiac ward of the ER by 8 AM the next morn. All tests came back normal, but the symptoms from the tetanus toxoid remained. I was there all day. At this point, chest pain began. I saw Dr. again on 02/13/2013, and he ran more tests; also kidney tests due to my frequent urination, but all tests were normal. On February 28 I was back in the ER with all symptoms and severe pain, also very elevated blood pressure, but tests came back normal. At this time I still have severe neck (laryngeal and lymph) pain, jaw pain, arm pain at injection sight, slightly bllurred vision on right side (the shot was on my left), chest muscular wall pain, ear pain, burning sensation, and horrible, continual pressure. I am widowed with 4 children, and this has RUINED my life!!! How dare the doctors not give us all the facts on booster shots!! I am seeing a specialist tomorrow, can't afford it, and may lose my home now.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 103.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness, redness and swelling at the site of injection.
Age: 1.86
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: No symptoms to report, no treatment.
Age: 9.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Oedema peripheral, Rash pustular, Urticaria
Clinical narrative: Patient's left arm swollen on Sunday AM. Whelp present size of a silver dollar. Monday, 8/27/12, mom took child to MD, as child had "pus filled" pockets on arm and did not want to raise the arm. Was told area may have to be lanced. MD treated with 2 antibiotics and per mother said it was from the needle used to vaccinate.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash pustular
Clinical narrative: Itchy and pustular.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Itchy and pustular.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mother and child presented to the Health Dept 8-31-2011 after child received vaccines on 8-29-11. Mom reports child had redness and swelling in left arm just below varicella site. Swollen, red area above elbow and in mid area. Counseled re reactions to expect following following Dtap and varicella. Provided VIS and counseled.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Upon getting the HPV vaccination, he syncopized with some tonic-clonic movements. The reaction was very soon after the vaccination was given. He does remember the entire episode. It lasted approximately 20 seconds per his mother's reports. He laid down for approximately 15 to 20 minutes afterwards. He felt fine at that time. He then sat down for another 10 to 15 minutes and then he was discharged to home with instructions for followup if any symptoms recur or begin. Menactra was not given to him. He had a similar reaction to Menactra in the past, but it was not as severe. He has had influenza in the past year with no reaction. He has no history of other reactions to vaccinations. He does have a likely allergy to penicillin from his infancy. This was likely HPV-related syncope. I advised them against getting future vaccinations given the response to these last two vaccinations. Flu vaccination will be reasonable to continue given his past tolerance of this, but will need to have adequate coverage and would not recommend him getting this any where, but a physician's office. I did inform them that I would be happy to complete any documentation if others feel that vaccination would be required
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Convulsion, Dyskinesia, Electroencephalogram normal, Gaze palsy, Unresponsive to stimuli
Clinical narrative: 30 minute seizure with vomiting, child unresponsive, eyes rolling, uncoordinated limb movement and mouth movements. Spent night in pediatric ER for observation, had EEG and given rectal Valium for treatment of subsequent seizures.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Vomiting
Clinical narrative: 30 minute seizure with vomiting, child unresponsive, eyes rolling, uncoordinated limb movement and mouth movements. Spent night in pediatric ER for observation, had EEG and given rectal Valium for treatment of subsequent seizures.
Age: 21.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Extreme pain at injection site, slight redness. Pain reached peak two hours after onset and decreased in intensity 24 hours after onset. Pain disappeared 48 hours after onset.
Age: 1.54
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: MOTHER STATED CHILD'S RIGHT LEG WAS SWOLLEN AND WARM TO TOUCH.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Muscle spasms, Pain, Pain in extremity
Clinical narrative: On going since 1/13/2013. Both lower legs and feet numb. Shocking sensation in toes. Both forearms hurt, feel like they are on fire. Cramping in both calf muscles. tingling in both hands. Sensations in lower arms and legs like pins / needles, cold hands, shooting pains. Getting worse by the week.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Peripheral coldness, Shock
Clinical narrative: On going since 1/13/2013. Both lower legs and feet numb. Shocking sensation in toes. Both forearms hurt, feel like they are on fire. Cramping in both calf muscles. tingling in both hands. Sensations in lower arms and legs like pins / needles, cold hands, shooting pains. Getting worse by the week.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Injection site nodule, Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever, flu like symptoms, and body aches. Also large knot on the arm at injection site. Warm to touch.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site vesicles, Injection site warmth
Clinical narrative: Shoulder swelling with vesicular itchy red rash surrounding site.  Site hot to touch.  Advised to ice for swelling, Benadryl for itching, Motrin or Tylenol for pain.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Joint swelling
Clinical narrative: Shoulder swelling with vesicular itchy red rash surrounding site.  Site hot to touch.  Advised to ice for swelling, Benadryl for itching, Motrin or Tylenol for pain.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: The patient was seen in the ambulatory care clinic for a vaccine follow-up. A pregnancy test was performed, however the patient was administered a Hepatitis A vaccine, HPV vaccine, and a medroxyprogesterone injection prior to the results of the pregnancy test. The pregnancy test was later confirmed to be positive.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Diarrhoea, Dysstasia, Hypersomnia, Hypokinesia
Clinical narrative: Stated she wasnt feeling well. I thought it was from dialysis treatment. She went to sleep, slept longer than normal, tried to eat, vomiting, couldn't move or stand without assistance. Refused to go to hospital, diarrhea on herself, sleeping, couldn't move off couch to bed, could walk, kept saying she was sick wanted. Very lethargic, no fever, got help from two sons to help move to wash off diarrhea & vomit.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Intensive care, Lethargy, Malaise, Vomiting
Clinical narrative: Stated she wasnt feeling well. I thought it was from dialysis treatment. She went to sleep, slept longer than normal, tried to eat, vomiting, couldn't move or stand without assistance. Refused to go to hospital, diarrhea on herself, sleeping, couldn't move off couch to bed, could walk, kept saying she was sick wanted. Very lethargic, no fever, got help from two sons to help move to wash off diarrhea & vomit.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Death, Diarrhoea, Dysstasia
Clinical narrative: Stated she wasnt feeling well. I thought it was from dialysis treatment. She went to sleep, slept longer than normal, tried to eat, vomiting, couldn't move or stand without assistance. Refused to go to hospital, diarrhea on herself, sleeping, couldn't move off couch to bed, could walk, kept saying she was sick wanted. Very lethargic, no fever, got help from two sons to help move to wash off diarrhea & vomit.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersomnia, Intensive care, Lethargy, Malaise, Mobility decreased
Clinical narrative: Stated she wasnt feeling well. I thought it was from dialysis treatment. She went to sleep, slept longer than normal, tried to eat, vomiting, couldn't move or stand without assistance. Refused to go to hospital, diarrhea on herself, sleeping, couldn't move off couch to bed, could walk, kept saying she was sick wanted. Very lethargic, no fever, got help from two sons to help move to wash off diarrhea & vomit.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Product quality issue, Vomiting
Clinical narrative: Stated she wasnt feeling well. I thought it was from dialysis treatment. She went to sleep, slept longer than normal, tried to eat, vomiting, couldn't move or stand without assistance. Refused to go to hospital, diarrhea on herself, sleeping, couldn't move off couch to bed, could walk, kept saying she was sick wanted. Very lethargic, no fever, got help from two sons to help move to wash off diarrhea & vomit.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age at an assisted living facility. Medical history was not provided. On an unknown date the patient was possibly vaccinated with ZOSTAVAX (indication not provided) last year, but was not able to confirm this. Lot number and route of administration was not provided. Concomitant medication was not provided. On an unknown date the patient recently developed chickenpox. The outcome of chickenpox was reported as not recovered. The relatedness for chickenpox was not reported for ZOSTAVAX. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 15 year old female patient. On an unknown date the patient was vaccinated with an extra dose of GARDASIL. Dosage, route of administration and lot number were not provided. 4th dose of GARDASIL was administered 3 months after the third dose was given on an unspecified date. No further information was available. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Abnormal behaviour, Activities of daily living impaired, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: High fever, shaking, changing behavior, red spot on site, rash, difficulty breathing, heart speeding up, dizzy. Was taken to ER and kept overnight. Pt given medication to control allergic reaction and for pain. Arm started hurting, couldn't move it due to swelling of the joint. Given hydrocodone-acetaminophen. Pain increasing, comes and goes. Pt. followed up with orthopedic doctor who specified it is an inflammation of the muscle and gave her more pain medicine. Today patient still has pain at injection site and can't perform daily activities since range of motion is limited.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site erythema, Injection site pain, Joint range of motion decreased
Clinical narrative: High fever, shaking, changing behavior, red spot on site, rash, difficulty breathing, heart speeding up, dizzy. Was taken to ER and kept overnight. Pt given medication to control allergic reaction and for pain. Arm started hurting, couldn't move it due to swelling of the joint. Given hydrocodone-acetaminophen. Pain increasing, comes and goes. Pt. followed up with orthopedic doctor who specified it is an inflammation of the muscle and gave her more pain medicine. Today patient still has pain at injection site and can't perform daily activities since range of motion is limited.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Joint swelling, Myositis, Pain, Pain in extremity, Pyrexia
Clinical narrative: High fever, shaking, changing behavior, red spot on site, rash, difficulty breathing, heart speeding up, dizzy. Was taken to ER and kept overnight. Pt given medication to control allergic reaction and for pain. Arm started hurting, couldn't move it due to swelling of the joint. Given hydrocodone-acetaminophen. Pain increasing, comes and goes. Pt. followed up with orthopedic doctor who specified it is an inflammation of the muscle and gave her more pain medicine. Today patient still has pain at injection site and can't perform daily activities since range of motion is limited.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Tremor
Clinical narrative: High fever, shaking, changing behavior, red spot on site, rash, difficulty breathing, heart speeding up, dizzy. Was taken to ER and kept overnight. Pt given medication to control allergic reaction and for pain. Arm started hurting, couldn't move it due to swelling of the joint. Given hydrocodone-acetaminophen. Pain increasing, comes and goes. Pt. followed up with orthopedic doctor who specified it is an inflammation of the muscle and gave her more pain medicine. Today patient still has pain at injection site and can't perform daily activities since range of motion is limited.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate increased, Hyperhidrosis
Clinical narrative: High fever, shaking, changing behavior, red spot on site, rash, difficulty breathing, heart speeding up, dizzy. Was taken to ER and kept overnight. Pt given medication to control allergic reaction and for pain. Arm started hurting, couldn't move it due to swelling of the joint. Given hydrocodone-acetaminophen. Pain increasing, comes and goes. Pt. followed up with orthopedic doctor who specified it is an inflammation of the muscle and gave her more pain medicine. Today patient still has pain at injection site and can't perform daily activities since range of motion is limited.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypersensitivity, Hypoaesthesia, Pain in extremity, Pallor, Ultrasound scan
Clinical narrative: High fever, shaking, changing behavior, red spot on site, rash, difficulty breathing, heart speeding up, dizzy. Was taken to ER and kept overnight. Pt given medication to control allergic reaction and for pain. Arm started hurting, couldn't move it due to swelling of the joint. Given hydrocodone-acetaminophen. Pain increasing, comes and goes. Pt. followed up with orthopedic doctor who specified it is an inflammation of the muscle and gave her more pain medicine. Today patient still has pain at injection site and can't perform daily activities since range of motion is limited.
Age: 71.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Urticaria, Wheezing, X-ray
Clinical narrative: High fever, shaking, changing behavior, red spot on site, rash, difficulty breathing, heart speeding up, dizzy. Was taken to ER and kept overnight. Pt given medication to control allergic reaction and for pain. Arm started hurting, couldn't move it due to swelling of the joint. Given hydrocodone-acetaminophen. Pain increasing, comes and goes. Pt. followed up with orthopedic doctor who specified it is an inflammation of the muscle and gave her more pain medicine. Today patient still has pain at injection site and can't perform daily activities since range of motion is limited.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Injection site pain, Injection site warmth, Pain
Clinical narrative: Temp - 100.5 F, chills, body aches, injection site sore & warm. Pt. called 3/7/13 to report symptoms. He continues on 3/7/13 with symptoms described.
Age: 0.21
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Gave 2nd dose PENTACEL too early (was supposed to get PCV13).
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Chills, Cold sweat, Headache, Nausea, Pain
Clinical narrative: Aches, chills, headache, clammy, nausea.
Age: 28.0
Sex: F
Vaccine: HEP, HPV2
Symptoms: Abortion spontaneous, Exposure during pregnancy, Metrorrhagia, Pregnancy test urine positive, Uterine contractions during pregnancy
Clinical narrative: Subject was enrolled in Study from 5/18/2011 to 12/20/2011, and received 2 doses of CERVARIX and ENGERIX B vaccines. Per protocol, patient received negative urine pregnancy tests prior to each vaccination. Following closeout from Study, patient continued in the Extended Follow-up Study (since 11/25/2010). At study visit on 3/4/2013, patient reported she took a urine pregnancy test on 1/15/2012 that was positive and later the same day started spotting and contractions. Patient went to the ER and was told by a doctor she had had a complete miscarriage. Patient had IV solution (not specified), and was released the same day with rest indicated. Patient reported she was fully recovered by 1/22/2012.
Age: 53.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a 53 year old patient of unknown gender. On an unknown date 5 years ago in approximately 2008, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number provided) before ZOSTAVAX was indicated for patients to receive at 50 years of age or older. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontanoeus report as received from a registered nurse concerning a patient of unknown age who on an unknown date was vaccianted with a dose of MMR II. (lot # H012139. Exp 29-JUN-2014) that was exposed to 70 F for 600 hours (25 days) no stability to support this excursion (dose and route not provided). The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist concerning a 62 year old female patient with mastocytosis who on 26-FEB-2013 was vaccinated with ZOSTAVAX (lot # H019092, Exp 09-FEB-2014) subcutaneous (dose not provided). Concomitant therapies included pravastatin sodium, MOBIC and FIORICET. The pharmacist stated that on 01-MAR-2013, the patient developed 3 inch wide, red, swollen rash at the site of ZOSTAVAX injection. There was no treatment given for the events. There were no labs performed. The outcome of 3 inch wide, red, swollen rash at the site of ZOSTAVAX injection was reported as not recovered/not resolved. Additional information has been requested.
Age: 0.52
Sex: M
Vaccine: IPV
Symptoms: Rash
Clinical narrative: Rash diffuse over chest, abdomen, upper & lower extremities. All observed one week after administration in the medical office. No other adverse noted & mom had not observed any other symptoms.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blood culture, Body temperature increased, Chills, Differential white blood cell count, Fatigue
Clinical narrative: Flu vaccine admin 3-1-13 Rt delt per new hire protocol. Evening following vac. admin pt began feeling tired, developed chills, Rt arm increasing painful, red, swollen over weekend. Temp 101. plus Sun. 3/3/13. Three irregular, red, swollen, tender patches Rt upper arm.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Full blood count, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Flu vaccine admin 3-1-13 Rt delt per new hire protocol. Evening following vac. admin pt began feeling tired, developed chills, Rt arm increasing painful, red, swollen over weekend. Temp 101. plus Sun. 3/3/13. Three irregular, red, swollen, tender patches Rt upper arm.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: Flu vaccine admin 3-1-13 Rt delt per new hire protocol. Evening following vac. admin pt began feeling tired, developed chills, Rt arm increasing painful, red, swollen over weekend. Temp 101. plus Sun. 3/3/13. Three irregular, red, swollen, tender patches Rt upper arm.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Nausea, Pain, Paraesthesia
Clinical narrative: Received vaccine 3/5/13 evening & had nausea & weakness that night. Developed red ring about 2 inches across over injection site next am and had it itching over both arms and up to neck & scalp, progressed to tingling and achiness by evening of 3/6/13. Dr treated w/VALTREX on 3/7/13.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Received vaccine 3/5/13 evening & had nausea & weakness that night. Developed red ring about 2 inches across over injection site next am and had it itching over both arms and up to neck & scalp, progressed to tingling and achiness by evening of 3/6/13. Dr treated w/VALTREX on 3/7/13.
Sex: U
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: This literature marketed report as received from a physician, referred to 11 patients (age of 1-25 years old) who were diagnosed with blood malignancies (leukemias and lymphomas). Multiple studies indicated loss of immunity after chemotherapy and bone marrow transplant among pediatric cancer patients. Due to high probability of transfusions and reactivation of hepatitis B, some protocols recommend prc-screening of patients for hepatitis Bs antigen and antibody prior to the first dose of chemotherapy. We have noted that many cancer patients had negative prechemotherapy hepatitis Bs antibody even after standard immunization, while healthy controls mount a 90% response with detectable antibodies. This pilot study was developed to test the hypothesis that children with oncologic diagnoses have an a priori defective immune response to standard immunization. All patients with a new malignant diagnosis from the institution over the last 2 years were included in this retrospective study. Physicians have found 44 cases from which they excluded 2 with infantile acute lymphoblastic leukemia diagnosed before one year old. All had received their full immunizations (lot #, dose/frequency and route were unspecified) prior to diagnosis. From the included cases (age of 1-25 years old), 15/42 were found to have mounted an immune response to hepatitis B immunization, 16/42 were not reactive and 11/42 were not tested, resulting in an approximately 50% lack of immunity towards hepatitis B from the evaluated patients. When the diagnoses were analyzed, it was noted that there were 24 blood malignancies (leukemias and lymphomas) and 18 solid tumors (including brain tumors). For the blood malignancies: 11/24 had positive Hepatitis Bs antibodies, 11/24 had negative and 2/24 were not tested. For the solid tumors: 4/18 were reactive, 5/18 non-reactive and 9/18 were not tested. Even though half of solid tumors patients were not evaluated for immunity status, still the numbers show that a similar lack of immunity. This pilot study revealed that 50% of children with new cancer diagnosis have no immune response to standard hepatitis B immunization, compared with 10% of normal controls. Above data brings a different perspective on the current belief that chemotherapy results in loss of immunity suggesting a pre-existent deficiency in the immune response. A larger study would be developed shortly to confirm the pilot data and infer the significant implications of current findings. This was one of several reports that derived from the same literature link. A copy of the published article was attached as further documentation of the patient's experience. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chills, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Generalized weakness, body aches, chills, nausea. Swelling at injection site with redness, soreness, pain and warmth. PCP diagnosed me with cellulitis at injection site.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain
Clinical narrative: Generalized weakness, body aches, chills, nausea. Swelling at injection site with redness, soreness, pain and warmth. PCP diagnosed me with cellulitis at injection site.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site urticaria, Myalgia
Clinical narrative: (L) arm hive like reaction - large located by injection site. Largest approx. 7 x 4 1/2 cm & 4 x 2 1/2 cm & scattered hives around. Axilla soreness reported & bicep tenderness.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Abdominal pain upper, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Pt c/o of vomiting & stomach ache x 1 day. Local redness and swelling x 60x70 mm at injection site, left deltoid.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt sts 4-5 hours after injection developed pain, redness, swelling at site, T max 102. Pt presents to office no fever, 5 inch diam erythema to post upper (L) arm w/ 1 inch center hard area. Provider advised ibuprofen prn.
Age: 1.25
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Developed redness with welt to center within 2 min of injection on right leg BENADRYL 12.5 mg given, monitor x 20 min.
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, IPV, TDAP, VARCEL
Symptoms: Erythema, Injection site rash, Pallor, Skin hypertrophy
Clinical narrative: Localized rash on upper lft thigh & erythema spreading to max of 3" x 4" with small area of fine rash & dense tissue.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Electromyogram normal, Lumbar puncture normal, Muscular weakness, Paraesthesia
Clinical narrative: TINGLING IN THE LOWER LIMBS PROGRESSED TO WEAKNESS.
Age: 68.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Hypoaesthesia, Lumbar puncture normal, Muscular weakness, Nerve conduction studies abnormal, Paraesthesia
Clinical narrative: TINGLING IN THE LOWER LIMBS PROGRESSED TO WEAKNESS.
Age: 20.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Syringe issue, Underdose
Clinical narrative: Patient presented to Health Center with complaint of arm pain after receiving flu vaccine that was administered at local pharmacy. She reports receiving 2 vaccines due to malfunction of syringe. X-Rays were obtained, MOBIC was prescribed. Pt later went to orthopedist in town and had more X-rays & physical therapy. She continues to complain of lt arm pain.
Age: 20.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Syringe issue, X-ray limb normal
Clinical narrative: Patient presented to Health Center with complaint of arm pain after receiving flu vaccine that was administered at local pharmacy. She reports receiving 2 vaccines due to malfunction of syringe. X-Rays were obtained, MOBIC was prescribed. Pt later went to orthopedist in town and had more X-rays & physical therapy. She continues to complain of lt arm pain.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, HPV4
Symptoms: Amnesia, Fall, Gaze palsy, Muscle twitching, Pallor
Clinical narrative: After blood draw and immunization done, mom states patient was twitching, shaking, eyes rolling upwards while the body fell backwards on chair. Also noted extreme pallor, residual twitching while the patient sat up after the incident. Patient unable to recall the incident when asked.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, HPV4
Symptoms: Tremor
Clinical narrative: After blood draw and immunization done, mom states patient was twitching, shaking, eyes rolling upwards while the body fell backwards on chair. Also noted extreme pallor, residual twitching while the patient sat up after the incident. Patient unable to recall the incident when asked.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, HPV4
Symptoms: Fall, Gaze palsy, Muscle twitching, Pallor, Tremor
Clinical narrative: After blood draw and immunization done, mom states patient was twitching, shaking, eyes rolling upwards while the body fell backwards on chair. Also noted extreme pallor, residual twitching while the patient sat up after the incident. Patient unable to recall the incident when asked.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: Patient was administered the Fluarix (0.5mL) and Pneumovax 23 (0.5mL) vaccines IM, both in the right deltoid muscle (not in same syringe) approximately 1 inch apart. Approximately 43 hours after the administration of the vaccines, the patient first reported that his upper right arm was red, warm, swollen and tender. Physician was notified and ordered warm compresses and an ID consult. ID saw the patient and the impression was that the patient's persistent fever was probably due to an infection in the deltoid, but due to the possibility of an abscess, a CT of the arm was ordered and the antibiotics changed.  CT of the arm revealed soft tissue stranding consistent with swelling as well as a small amount of fluid and associated air in the musculature of the right upper arm. As the patient continued to have fevers and an elevated WBC while on antibiotics, Surgery was consulted and saw the patient. It was felt that the patient had a cellulitis that would improve with continued antibiotic management and no surgical intervention was required. The patient continued on antibiotics with marked improvement in the cellulitis and was able to be discharged home and continued on oral antibiotics.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site abscess sterile, Injection site cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient was administered the Fluarix (0.5mL) and Pneumovax 23 (0.5mL) vaccines IM, both in the right deltoid muscle (not in same syringe) approximately 1 inch apart. Approximately 43 hours after the administration of the vaccines, the patient first reported that his upper right arm was red, warm, swollen and tender. Physician was notified and ordered warm compresses and an ID consult. ID saw the patient and the impression was that the patient's persistent fever was probably due to an infection in the deltoid, but due to the possibility of an abscess, a CT of the arm was ordered and the antibiotics changed.  CT of the arm revealed soft tissue stranding consistent with swelling as well as a small amount of fluid and associated air in the musculature of the right upper arm. As the patient continued to have fevers and an elevated WBC while on antibiotics, Surgery was consulted and saw the patient. It was felt that the patient had a cellulitis that would improve with continued antibiotic management and no surgical intervention was required. The patient continued on antibiotics with marked improvement in the cellulitis and was able to be discharged home and continued on oral antibiotics.