chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Catheterisation cardiac abnormal, Chest pain, Chills, Decreased appetite, Implantable defibrillator insertion
Clinical narrative: On the evening of getting the shot, began to feel chilled. Over the next few days included body aches, loss of appetite, sore throat. On morning of 10/19 had to clean up a water spill. Afterward had chest pains - 911 was called - V-fib - flatline & resuscitation on route.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Oropharyngeal pain, Pain, Resuscitation, Ultrasound chest
Clinical narrative: On the evening of getting the shot, began to feel chilled. Over the next few days included body aches, loss of appetite, sore throat. On morning of 10/19 had to clean up a water spill. Afterward had chest pains - 911 was called - V-fib - flatline & resuscitation on route.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Ventricular fibrillation, X-ray
Clinical narrative: On the evening of getting the shot, began to feel chilled. Over the next few days included body aches, loss of appetite, sore throat. On morning of 10/19 had to clean up a water spill. Afterward had chest pains - 911 was called - V-fib - flatline & resuscitation on route.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt came into office with redness, swelling, tenderness, warmth to left thigh on 11-10-11. She had the shot on 11-8-11. Pt was given ZYRTEC b/c BENADRYL gives diarrhea.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: (L) deltoid area was red, hot and sore to the touch since 11.9.11. Rx for cephalexin 500 mg 1 QID given.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory tract infection
Clinical narrative: Respiratory illness 1 week after vaccine. Transported to hospital 10/31/11. Remains hospitalized to date.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a "little over 70 years old" male patient with heart disease who either in 2007 or 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and route not reported). The physician reported that either in 2007 or 2008 the patient developed shingles about 6 days after receiving the vaccine. The patient had some heart issues and had been hospitalized before getting the vaccine. Apparently the ZOSTAVAX (Merck) was given after the patient was released from the hospital but the physician did not know how soon after. Later on an unspecified date about 6 to 12 months after getting the vaccine the patient passed away. The physician reported that he thought the cause of death was the heart disease but he did not know for sure. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician assistant (PA) concerning an approximately 86 year old male patient with sulfa allergy and no other pertinent medical history who on an unspecified date was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not provided). There was no concomitant medication. The PA reported that approximately 2 weeks after the vaccination, the patient developed shingles. It was given VALTREX as a treatment for the adverse event. The patient went to the physician's office for medical attention. No lab diagnostic studies were performed. At the time of the report the patient's outcome was unknown. Shingles were considered to be disabling to the patient's vision by the reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness transient, Deafness transitory, Hyperhidrosis, Nausea, Presyncope
Clinical narrative: Information has been received from a Healthcare worker, a nurse practitioner and a clinical assistant concerning a 22 year old female with no pertinent medical history and no known drug reactions/allergies who on 03-NOV-2011 was vaccinated IM with the second 0.5mL GARDASIL (Lot#668554/0306AA). There was no concomitant medication. The nurse practitioner stated that on 03-NOV-2011, following the administration of the second dose of GARDASIL, the patient almost fainted, lost vision and hearing for a short period of time. The clinical assistant provided adverse event details and stated that following the administration of vaccination "today", the patient on check out, told her that she thought she was going to faint, was sweating, nauseous, and her vision was blurry and dark. There were no lab diagnostics studies performed. Treatments for AE included placing a cool rag on the patient's forehead, giving her apple juice, and laying her down in the back room. Patient was monitored and her eye sight returned. On 03-NOV-2011, the patient fully recovered before leaving the office. Upon internal review, lost hearing was considered to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Information has been received from a Healthcare worker, a nurse practitioner and a clinical assistant concerning a 22 year old female with no pertinent medical history and no known drug reactions/allergies who on 03-NOV-2011 was vaccinated IM with the second 0.5mL GARDASIL (Lot#668554/0306AA). There was no concomitant medication. The nurse practitioner stated that on 03-NOV-2011, following the administration of the second dose of GARDASIL, the patient almost fainted, lost vision and hearing for a short period of time. The clinical assistant provided adverse event details and stated that following the administration of vaccination "today", the patient on check out, told her that she thought she was going to faint, was sweating, nauseous, and her vision was blurry and dark. There were no lab diagnostics studies performed. Treatments for AE included placing a cool rag on the patient's forehead, giving her apple juice, and laying her down in the back room. Patient was monitored and her eye sight returned. On 03-NOV-2011, the patient fully recovered before leaving the office. Upon internal review, lost hearing was considered to be an other important medical event. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Feeling abnormal, Injection site swelling, Pain, Pyrexia
Clinical narrative: This case was obtained from a consumer and a health care professional via a non-scientific (Lay press) publication on 31 October 2011. A 77-year-old female patient received an injection (route and site not reported) of TETANUS TOXOID, manufacturer and lot number unknown, twelve years ago (date not provided). The patient was in good health. The patient had an Arthus reaction to tetanus vaccine twelve years ago. "There was considerable swelling at the injection site. I also had chills and fever, aches all over and just plain felt miserable". It was recommended to the patient by a newspaper doctor to not get another shot unless an allergist felt it is safe. She was urged to meticulously clean all puncture wounds that occurred in situations where soil of dirt could enter the wound. The outcome was recovered. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: TTOX
Symptoms: Type III immune complex mediated reaction
Clinical narrative: This case was obtained from a consumer and a health care professional via a non-scientific (Lay press) publication on 31 October 2011. A 77-year-old female patient received an injection (route and site not reported) of TETANUS TOXOID, manufacturer and lot number unknown, twelve years ago (date not provided). The patient was in good health. The patient had an Arthus reaction to tetanus vaccine twelve years ago. "There was considerable swelling at the injection site. I also had chills and fever, aches all over and just plain felt miserable". It was recommended to the patient by a newspaper doctor to not get another shot unless an allergist felt it is safe. She was urged to meticulously clean all puncture wounds that occurred in situations where soil of dirt could enter the wound. The outcome was recovered. Documents held by sender: None.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Nurse injected vaccine into upper arm..pain with injection, hurt all the way to fingers...thought it would be painful for a few days, now after 2 months, patient still cannot take off a shirt and it hurts when putting any pressure on it like push to get up out of a chair.  Saw Dr. - flu vaccine bursitis, now receiving physical therapy for it.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Frequent bowel movements, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: Started with mild headache which progressed over the weekend to severe aches across head, neck and shoulders. Fever 100 - 101 F. She also complained of diarrhea for 3 days approximately six stools per day.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Started with mild headache which progressed over the weekend to severe aches across head, neck and shoulders. Fever 100 - 101 F. She also complained of diarrhea for 3 days approximately six stools per day.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Oedema peripheral
Clinical narrative: Swelling in supraclavicular & axillary areas, enlarged lymph nodes all on R side.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large swelling of L deltoid, heat and pain in L deltoid. No bruising or hematoma noted.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic
Clinical narrative: Puritic rash on chest and neck areas.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dysarthria, Fatigue, Headache, Injection site swelling, Injection site warmth
Clinical narrative: Before having the vaccines patient also had had a nebulizer treatment which caused blood pressure to rise and made patient light headed.  Was feeling better before leaving the office about 2:30.  By 3:00 was feeling very tired and uneasy which got worse and continued into the evening. Took a 2 1/2 hour nap about 5:30 and woke up around 8:00 PM and had trouble speaking.  Patient had slurred speaking and stayed home from work because was very sluggish and couldn't speak clearly. Friday was fine. Saturday was very tired and right arm was warm and swollen when shot was given. Had a bad headache and was vey nauseous. Sunday was fine. Monday was broken out on back with insect bite hives mostly on the right side.  Same side as swollen arm.  Took Benadryl for three days and all symptoms disappeared.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Sluggishness, Urticaria
Clinical narrative: Before having the vaccines patient also had had a nebulizer treatment which caused blood pressure to rise and made patient light headed.  Was feeling better before leaving the office about 2:30.  By 3:00 was feeling very tired and uneasy which got worse and continued into the evening. Took a 2 1/2 hour nap about 5:30 and woke up around 8:00 PM and had trouble speaking.  Patient had slurred speaking and stayed home from work because was very sluggish and couldn't speak clearly. Friday was fine. Saturday was very tired and right arm was warm and swollen when shot was given. Had a bad headache and was vey nauseous. Sunday was fine. Monday was broken out on back with insect bite hives mostly on the right side.  Same side as swollen arm.  Took Benadryl for three days and all symptoms disappeared.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Excessive eye blinking
Clinical narrative: Excessive eye blinking.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site pain, Joint fluid drainage
Clinical narrative: Per patient report "Debilitating pain in right arm half way from elbow to shoulder, could not move arm, could not drive car taken to ER 3 1/2 hrs after vaccine administered. Discharged from ER. Later at 4 am went to hospital, had severe pain that could not be relieved by morphine. 50 cc fluid taken from shoulder."
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram head, Headache, Lip swelling
Clinical narrative: Stiff neck, fever, headache, puffiness in shoulders, face & lips.  Progressively got worse.  Sat 10/29/11 saw PMD and receives a cortisone shot. 10/31/11 seen by corporate health provider "some better" d/t right SCM contracted (torticollis) and painful with headache.  Sent to ER to r/o meningoencephalitis which it was ruled out.  Discharged to home.  Dx. neck pain/torticollis s/p flu shot and headache.  Checked with her on 11/11/11 and doing better, no headache, no pain, neck with less swelling, no numbness.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Lumbar puncture normal, Musculoskeletal stiffness, Neck pain, Neutrophil count increased
Clinical narrative: Stiff neck, fever, headache, puffiness in shoulders, face & lips.  Progressively got worse.  Sat 10/29/11 saw PMD and receives a cortisone shot. 10/31/11 seen by corporate health provider "some better" d/t right SCM contracted (torticollis) and painful with headache.  Sent to ER to r/o meningoencephalitis which it was ruled out.  Discharged to home.  Dx. neck pain/torticollis s/p flu shot and headache.  Checked with her on 11/11/11 and doing better, no headache, no pain, neck with less swelling, no numbness.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Swelling face, Torticollis
Clinical narrative: Stiff neck, fever, headache, puffiness in shoulders, face & lips.  Progressively got worse.  Sat 10/29/11 saw PMD and receives a cortisone shot. 10/31/11 seen by corporate health provider "some better" d/t right SCM contracted (torticollis) and painful with headache.  Sent to ER to r/o meningoencephalitis which it was ruled out.  Discharged to home.  Dx. neck pain/torticollis s/p flu shot and headache.  Checked with her on 11/11/11 and doing better, no headache, no pain, neck with less swelling, no numbness.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Dysphagia, Feeling cold, Headache, Nausea, Sensation of foreign body
Clinical narrative: At about 5:30 PM patient's throat starting feeling like it had a lump in it which made it hard to swallow.  About 10 minutes later started feeling nauseous and began vomiting.  That was followed by shaking and feeling very cold and a headache.  Vomited several times until patient's stomach was empty and then continued to feel nauseous. Did not have a fever but was shaking from feeling cold.  The nausea and vomiting subsided around 11:00 PM.  The feeling of tightness in throat also stopped at the same time as the nausea.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Throat tightness, Vomiting
Clinical narrative: At about 5:30 PM patient's throat starting feeling like it had a lump in it which made it hard to swallow.  About 10 minutes later started feeling nauseous and began vomiting.  That was followed by shaking and feeling very cold and a headache.  Vomited several times until patient's stomach was empty and then continued to feel nauseous. Did not have a fever but was shaking from feeling cold.  The nausea and vomiting subsided around 11:00 PM.  The feeling of tightness in throat also stopped at the same time as the nausea.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dizziness, Dyspnoea, Eye swelling, Hypoaesthesia
Clinical narrative: Fever, cold sweat, swollen tongue and face, numbness, trouble breathing. Light headed and dizzy. Had my teeth and jaw hurting, eyes were swollen, puffy and red.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pain in jaw, Pyrexia, Swelling face, Swollen tongue
Clinical narrative: Fever, cold sweat, swollen tongue and face, numbness, trouble breathing. Light headed and dizzy. Had my teeth and jaw hurting, eyes were swollen, puffy and red.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Toothache
Clinical narrative: Fever, cold sweat, swollen tongue and face, numbness, trouble breathing. Light headed and dizzy. Had my teeth and jaw hurting, eyes were swollen, puffy and red.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Electroencephalogram normal, Electromyogram abnormal, Guillain-Barre syndrome, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal
Clinical narrative: The patient developed progressive sensory deficits on face, arms, hand, and body over a period of 3 days.  She was diagnosed with pure sensory Guillain-Barre syndrome by the pediatric neurologist at Medical Center.  Her symptoms began resolving by day of illness 6, and she was not treated with IVIG.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Sensory loss
Clinical narrative: The patient developed progressive sensory deficits on face, arms, hand, and body over a period of 3 days.  She was diagnosed with pure sensory Guillain-Barre syndrome by the pediatric neurologist at Medical Center.  Her symptoms began resolving by day of illness 6, and she was not treated with IVIG.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Diplopia, Headache, Nuclear magnetic resonance imaging normal
Clinical narrative: Headache with diplopia.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Client came to the immunization clinic requesting Pneumovax per physician recommandation. 5 hours after receiving vaccine Left arm began to swell. Client started taking OTC Benadryl. Symptoms continued to worsen. 11-11-11 Left arm hard swelling "twice the size of arm". Center white with red circle around. Pain increasing. At 1:00 pm she went to ER. She was given Prednisone and pain med IM. She was discharged home with PO prednisone, antibiotic, and pain med. 11-14-2011 the client was interviewed. At present the swelling and pain are gone. However, she continues to take medication as prescribed. At the time of vaccine she had denied previous Pneumovax, but after side effects occurred she remembering having the Pneumovax 2009 when turned 65yo. She confirmed the year with clinic's record. She has a follow up appt with her physician 11-14-11.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Kept complaining of sore arm - felt that was normal because of the muscle ache sometimes felt at the site after shot. However on inspection had had a red patch a couple of inches over from the shot site, no clearly defined outer margins - a large blotchy mis-shapen patch. Very red and hot to the touch. Measuring proably about 2 inches by 2 inches or so.  Was larger in size on 11/14. Also complained of aching legs and muscles all over his body. Possible low-grade fever. Did not act well, and was very tired and irritable.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Myalgia, Pain in extremity, Rash macular
Clinical narrative: Kept complaining of sore arm - felt that was normal because of the muscle ache sometimes felt at the site after shot. However on inspection had had a red patch a couple of inches over from the shot site, no clearly defined outer margins - a large blotchy mis-shapen patch. Very red and hot to the touch. Measuring proably about 2 inches by 2 inches or so.  Was larger in size on 11/14. Also complained of aching legs and muscles all over his body. Possible low-grade fever. Did not act well, and was very tired and irritable.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia, Oedema peripheral
Clinical narrative: Patient is experiencing pain, primarily at the injection site and the arm is puffy or slightly swollen.  Patient is experiencing no itching, redness, or temperature at the area.  The pain is primarily at night and bedtime keeping the patient awake at night.  During the day, the pain is low or absent.  Patient has been taking Tylenol periodically for pain and will switch to ibuprofen to see if that helps more.  I, the pharmacist, recommended that she visit the doctor to check the area and see if there are any problems.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Myalgia, Nasopharyngitis
Clinical narrative: Patient received vaccine on 11/01/11 and had typical muscle soreness, which was resolved after 2 or 3 days.  The pain then came back on 11/10/11.  Pt reports muscle stiffness and pain in the same area as before.  Pt reports that pain is relieved by ibuprofen.  Pt reported having a cold a few days after vaccination that has since resolved.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Headache, Increased upper airway secretion, Nasal congestion, Oropharyngeal pain
Clinical narrative: Felt tickle in the back of throat and throat clearing which turned into a productive cough and felt like was "drowning".  Atrovent nebulizer given and an Albuterol inhaler--3 puffs.  Axid and Zyrtec were given orally.  Began 'flushing', but lasted only 45 minutes and throat clearing continued to be productive.  6-14 hours after injection nasal congestion started along with headache, feeling achy, and a sore throat.  All symptoms resolved 24 hours after injection and patient felt fine.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Productive cough, Throat irritation
Clinical narrative: Felt tickle in the back of throat and throat clearing which turned into a productive cough and felt like was "drowning".  Atrovent nebulizer given and an Albuterol inhaler--3 puffs.  Axid and Zyrtec were given orally.  Began 'flushing', but lasted only 45 minutes and throat clearing continued to be productive.  6-14 hours after injection nasal congestion started along with headache, feeling achy, and a sore throat.  All symptoms resolved 24 hours after injection and patient felt fine.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site induration, Injection site pain
Clinical narrative: Soreness and induration at injection site.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Face slightly swollen and puffy. Given Vistaril po. at that time.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Gastrointestinal pain, Vomiting
Clinical narrative: Woken by strong intestinal ache; continued until 3 AM when I vomited several times.  The next day was confined to couch with intestinal crampiness and achiness.
Age: 57.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Erythema, Flushing, Oedema peripheral, Pain in extremity
Clinical narrative: Lt upper arm redness swollen and painful on touch. As early morning as progression into the 12th of November, redness was spreading, more painful and patient felt chills and then felt flushed.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blister, Chills, Decreased appetite, Erythema
Clinical narrative: 10-29-11: Severe aching in lower extremity joints. 10-30-11: Achy, cold chills, small bump appeared on (R) arm - filled with clear fluid. That evening, noticed these bumps on lower extremities. 10-31-11: More bumps appeared (no itching). Severe pain in ankles, knees - all over. No appetite. MD visit to walk in clinic - not treatment. 11-1-11: Could hardly walk due to pain. Lower extremities swollen, red, MD visit.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Gait disturbance, Oedema peripheral, Pain, Rash
Clinical narrative: 10-29-11: Severe aching in lower extremity joints. 10-30-11: Achy, cold chills, small bump appeared on (R) arm - filled with clear fluid. That evening, noticed these bumps on lower extremities. 10-31-11: More bumps appeared (no itching). Severe pain in ankles, knees - all over. No appetite. MD visit to walk in clinic - not treatment. 11-1-11: Could hardly walk due to pain. Lower extremities swollen, red, MD visit.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: 10-29-11: Severe aching in lower extremity joints. 10-30-11: Achy, cold chills, small bump appeared on (R) arm - filled with clear fluid. That evening, noticed these bumps on lower extremities. 10-31-11: More bumps appeared (no itching). Severe pain in ankles, knees - all over. No appetite. MD visit to walk in clinic - not treatment. 11-1-11: Could hardly walk due to pain. Lower extremities swollen, red, MD visit.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Pain, Skin warm, Swelling
Clinical narrative: Swollen, burning, red, warm, painful.
Age: 1.3
Sex: M
Vaccine: FLU3, MMR, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Rash - 2 wks after shot. High fever.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous medically confirmed report (initial receipt 07-Oct-2011) concerns a 49 year old female patient,, who had no illness, pre-existing allergies, birth defects or medical condition at the time of vaccination. She was not taking any concomitant medication. On 26-Sep-2011 the patient received AFLURIA (batch number N55306) in left deltoid for vaccination. On 26-Sep-2011, the patient immediately developed arm soreness that developed over the next few days into a stabbing pain. She complained of extreme pain in injection site and radiating to shoulder. She had difficulty moving her shoulder. The patient went to her physician and was given anti-inflammatory. The patient was feeling better. The pain was less, but she had not completely recovered from the event. The reporter considered events to be serious as the events resulted in persistent or significant disability/incapacity. Follow up (03-Nov-2011): upgraded to serious, batch number, site of injection, additional AE terms, event outcome, treatment medications, medical history, reporter assessment.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Arrhythmia
Clinical narrative: Information has been received from a pharmacy student concerning a 15 year old male patient who 2 days ago (on 30-OCT-2011), was vaccinated with a dose of GARDASIL (lot number, dose and route not reported). The pharmacy student reported that the patient was now (on approximately 01-NOV-2011) reporting arrhythmias. The patient had been hospitalized. At the time of the report the patient was recovering from the event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram, Juvenile myoclonic epilepsy, Loss of consciousness
Clinical narrative: Information has been received from a medical assistant social worker concerning an approximately 13 year old female patient with no allergies or drug reactions and no pertinent medical history who "4 years ago" (in 2007) was vaccinated with the first dose of GARDASIL (route, dose and lot number not reported). "4 years ago" (in 2007) was vaccinated with the third dose of GARDASIL (route, dose and lot number not reported). Concomitant medication included KEPPRA. The social worker stated that she had received the report about the patient via phone conversation. The social worker stated that the reporter did not speak the language. "15 days after the first dose of GARDASIL" (in approximately 2007), the patient began with seizures. The patient experienced a seizure, lost consciousness and went to the emergency department. During the hospital stay the patient had a electroencephalography (EEG) conducted (results were not provided) (also reported as no laboratory diagnostic studies performed). The medical assistant stated that the patient was healthy before the GARDASIL was given. The patient was diagnosed with juvenile chronic epilepsy and had been seen by a neurologist. The patient did not receive any treatment for the event. The social worker stated that the reporter wanted the report to be kept confidential. The social worker refused to give any additional information concerning the patient. The physician was contacted and stated that he did not know the patient and was not able to give any additional information. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Abasia, Computerised tomogram head, Computerised tomogram normal, Headache, Muscular weakness
Clinical narrative: Severe headache, profound lower extremity weakness (pt too weak to walk), somnolence.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Somnolence
Clinical narrative: Severe headache, profound lower extremity weakness (pt too weak to walk), somnolence.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: SYMPTOMS: REDNESS AND WARMTH TO TOUCH AT RIGHT DELTOID. TREATMENT: SUPPORTIVE CARE, ICE AND TYLENOL PRN.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient describes soreness and radiating pain at injection site.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Injection site erythema, Injection site mass, Injection site warmth, Lip swelling
Clinical narrative: Initial report received from a health care professional on 08 November 2011. A 60-year-old female patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UT499AB, on 05 November 2011. Within 10 minutes of receiving the injection of FLUZONE, the patient had a funny taste in her mouth and tongue and her pallet felt funny. The next day she had a red, hot lump at the injection site with swelling of the lips and tongue and tingling in the hands, feet and legs that all persisted. The patient required a doctor visit. The outcome was reported as not recovered. The reporter refused to give any further information. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Palatal disorder, Paraesthesia, Paraesthesia oral, Swollen tongue
Clinical narrative: Initial report received from a health care professional on 08 November 2011. A 60-year-old female patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UT499AB, on 05 November 2011. Within 10 minutes of receiving the injection of FLUZONE, the patient had a funny taste in her mouth and tongue and her pallet felt funny. The next day she had a red, hot lump at the injection site with swelling of the lips and tongue and tingling in the hands, feet and legs that all persisted. The patient required a doctor visit. The outcome was reported as not recovered. The reporter refused to give any further information. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Differential white blood cell count normal, Erythema, Full blood count normal, Oedema peripheral, Pain in extremity
Clinical narrative: Pain & swelling covering 3/4 of the posterior aspect of (L) arm. No reaction at the injection site. Pain started 2nd day after injection; redness on 3rd day.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema induratum, Skin warm
Clinical narrative: One day after injection patient noticed an erythemic induration, warm to the touch which she believes to be the size of a half-dollar coin. She believes it to be spreading. I advised her to use cold compresses, anti-inflammatory meds and to mark the border of the swelling and if it spreads to seek medical attention.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Eye irritation, Fatigue, Headache, Lymph node pain
Clinical narrative: Extreme fatigue, burning eyes, swollen, painful lymph nodes a few days later on same side as vaccine, muscle aches, muscle weakness, headache, asthma.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Lymphadenopathy, Muscular weakness, Myalgia
Clinical narrative: Extreme fatigue, burning eyes, swollen, painful lymph nodes a few days later on same side as vaccine, muscle aches, muscle weakness, headache, asthma.
Age: 65.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Vaccine was administered too high on shoulder, hit bursa, arm pain got progessively worse, three weeks to date. Had MRI, probably need cortisone injection to stop inflammation.
Age: 65.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Contusion, Insomnia, Pain in extremity
Clinical narrative: Vaccine was administered too high on shoulder, hit bursa, arm pain got progessively worse, three weeks to date. Had MRI, probably need cortisone injection to stop inflammation.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Nerve conduction studies normal, Pain, Pain in extremity, Rotator cuff syndrome, Skin warm
Clinical narrative: Patient wanted to speak with someone regarding complications from the Flu Shot on 9/29/11. Thought the pain would pass. Right arm has been in great pain to the touch, to lift and move. Since patient taken the shots in previous years, figured the discomfort would pass a few days afterwards. The pain has progressively gotten worse and even warranted going to an urgent care facility on 10/22/11. The doctor said back shoulder, forearm and front part of shoulder felt warmer than normal & gave patient the following medications to take: Mobic (15 MG/once a day), Tylenol 3 (every six hours) & Clindamycin (300 MG/three times a day). Since then patient went to Dr. who said has Rotator Cuff Sprain, gave pain meds and scheduled Physical Therapy to start on 11/29/11. Today is 11/14/11 & patient has run out of pain meds. The doctor won't refill the prescription until patient starts P.T. on 11/29/11.  Patient is COMPLETELY out of meds. Nurse said the nerve test and X-Ray came out normal and the doctor won't do anything else until patient completes P.T. Again, patient is in great pain and the doctor treated it like it was nothing. Missed work due to this pain and all the doctors have done (basically) was told patient "it's nothing".
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: X-ray normal
Clinical narrative: Patient wanted to speak with someone regarding complications from the Flu Shot on 9/29/11. Thought the pain would pass. Right arm has been in great pain to the touch, to lift and move. Since patient taken the shots in previous years, figured the discomfort would pass a few days afterwards. The pain has progressively gotten worse and even warranted going to an urgent care facility on 10/22/11. The doctor said back shoulder, forearm and front part of shoulder felt warmer than normal & gave patient the following medications to take: Mobic (15 MG/once a day), Tylenol 3 (every six hours) & Clindamycin (300 MG/three times a day). Since then patient went to Dr. who said has Rotator Cuff Sprain, gave pain meds and scheduled Physical Therapy to start on 11/29/11. Today is 11/14/11 & patient has run out of pain meds. The doctor won't refill the prescription until patient starts P.T. on 11/29/11.  Patient is COMPLETELY out of meds. Nurse said the nerve test and X-Ray came out normal and the doctor won't do anything else until patient completes P.T. Again, patient is in great pain and the doctor treated it like it was nothing. Missed work due to this pain and all the doctors have done (basically) was told patient "it's nothing".
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular, Varicella
Clinical narrative: Fever, vesicular eruption, modified chicken pox.
Age: 15.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Death, Pain, Swelling
Clinical narrative: Initial soreness and swelling. Death 10/20/2011.
Age: 29.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Nausea, Skin discolouration, Syncope
Clinical narrative: Loss of color to skin, nausea, dizziness, syncope.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site erythema, Local reaction, Pyrexia
Clinical narrative: Local site reaction (arm turned red) and fever of 101-102 degrees for 4 days starting about 6 hours after receiving the vaccine.  She also had joint pain once the fever started that has continued a day since the fever broke.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe pain and restriction of range of motion in injection arm (left).
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Diet refusal, Stool analysis, Vaccination complication, Vomiting
Clinical narrative: Initially baby had vomited couple of times and refused take feeding for couple of days and then it turned into sever Diarrhea with 16-20 Poops a day for a week and baby is mostly on Pedialyte Electrolitic maintenance solution.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm pain and severe restriction of mobility.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pain in left arm down to finger tips, shoulder pain, neck pain.  Severe restriction of range of motion.  Treated with steroids with temporary improvement.  As soon as steroids stopped, symptoms returned.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Pain in upper left arm where vaccine administered later in evening same day. Pain continues now 3 weeks with decreased Range of Motion Left shoulder.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Dizziness, Dysphonia, Fatigue, Headache
Clinical narrative: Extreme pain and stiffness in arms at injection site; all over body aches, dizziness, weakness, headache, hoarseness, hot "flashes", rapid heart beat, extreme fatigue. Symptoms still present as of 11/14/2011.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Heart rate increased, Hot flush, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Extreme pain and stiffness in arms at injection site; all over body aches, dizziness, weakness, headache, hoarseness, hot "flashes", rapid heart beat, extreme fatigue. Symptoms still present as of 11/14/2011.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: Patient in to this office on 10/27/2011 to report problem. Patient complains of inability to lift right arm over head or to shoulder height without severe pain described as "deep muscle ache" since receiving flu vaccine. Patient also complains of pain when rolling onto arm. Patient reports seeing primary care physician regarding arm pain. Patient states "He said I should talk to you about it since I got the shot here". No redness, warmth, hardness, induration, or swelling noted to injection site of right deltoid; patient denies pain to the touch.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Immediate post-injection reaction, Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: Patient felt pain immediately when the shot was given. This pain radiated down her arm to her fingertips. Immediately afterwards, her arm was really sore and continued to be sore to present date. Patient states it is mostly her shoulder that is sore at night and when her arm is above her head. Today, she feels the pain is much better than when she first got the shot and can see improvements in her functionality/range of motion daily. She denies any other symptoms such as fever or chills. She did not seek the care of her physician after the shot and does not intend to seek medical care for this stating "it realy has gotten a lot better since."
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Very sore muscles from right lower shoulder blade, upper and lower arm. Holding arm out in front would make much worse. Ibuprofen helps.  4 week later much better but not completely gone.
Age: 66.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Abasia, Asthenia, Dysstasia, Fatigue, Immunoglobulin therapy
Clinical narrative: Early complaints of weakness and fatigue progressing to inability to ambulate or stand when he presented to the ED on 11/10/2011.  Is currently in ICU in a local tertiary hospital.  Underwent a partial nephrectomy on 10/25/2011.
Age: 66.0
Sex: M
Vaccine: FLU3, TD
Symptoms: Intensive care, Laboratory test normal, Lumbar puncture normal, Nephrectomy
Clinical narrative: Early complaints of weakness and fatigue progressing to inability to ambulate or stand when he presented to the ED on 11/10/2011.  Is currently in ICU in a local tertiary hospital.  Underwent a partial nephrectomy on 10/25/2011.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Pain in extremity, Tremor
Clinical narrative: Patient call on 11/11/2011 to report a reaction to the Pneumonia shot that was given on 11/10/2011.  Patient stated that within one hour of injection her arm was hurting and by 4:00PM she was shaking, chills and running a temp of 102 degrees.  Patient states that she is feeling better now and that everything lasted less than 24 hours.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: States she woke up and her arm at injection site was red and itchy, looked in mirror and had whelps all over body and face was bright red. States she took her epi pen and Benadryl, states that she still has whelps and is itchy, has doctors appt in the morning 11-15-11.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Depressed level of consciousness, Feeding disorder of infancy or early childhood, Gastrooesophageal reflux disease, Malaise, Pain
Clinical narrative: Was overly sleepy, not as alert, sucking issues (started to take the paci less and less milk via breast and pumped bottles). Started to consume 40% less ounces, drink one or two ounces than scream in pain. Feeds were exhausting.  Feedings declined and screamed in pain randomly. Reflux diagnosis at the same clinic on 2/7/2011. Reflux meds worked shortly. Had reflux issues for 2 to 4 months following vaccination. On 2/21/2011 baby had little rash on back, and seemed ill, went to emergency room to receive viral infection diagnosis, no treatment. On and off colds for 2 months post vaccination. Has not been vaccinated since, once recovered, no further adverse events.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Poor sucking reflex, Rash, Screaming, Somnolence, Viral infection
Clinical narrative: Was overly sleepy, not as alert, sucking issues (started to take the paci less and less milk via breast and pumped bottles). Started to consume 40% less ounces, drink one or two ounces than scream in pain. Feeds were exhausting.  Feedings declined and screamed in pain randomly. Reflux diagnosis at the same clinic on 2/7/2011. Reflux meds worked shortly. Had reflux issues for 2 to 4 months following vaccination. On 2/21/2011 baby had little rash on back, and seemed ill, went to emergency room to receive viral infection diagnosis, no treatment. On and off colds for 2 months post vaccination. Has not been vaccinated since, once recovered, no further adverse events.
Age: 1.51
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Conjunctival hyperaemia, Cough, Nasal congestion, Otitis media, Pyrexia
Clinical narrative: FEVER, COUGH, CONGESTION.
Age: 1.51
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Rhinorrhoea
Clinical narrative: FEVER, COUGH, CONGESTION.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Injection site pain, Middle insomnia, Pain
Clinical narrative: Patient's arm/shoulder (where the shot was administered) became so sore that patient could not lift arm above head without severe pain.  The pain persisted for at least 2 weeks.  Patient couldn't dress without help, and couldn't sleep on that side at all.  The pain woke patient up whenever they moved at night.  Took ibuprofen to control the pain.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Blood culture, Blood folate normal, Blood thyroid stimulating hormone normal, CSF culture, CSF lymphocyte count increased
Clinical narrative: 1 day of Upper motor neuron findings including hyperreflexia with clonus and 2-3 joint involvement, +Babinski with 2 joint involvement, lower>upper limb weakness, severe HA, nausea, vomiting.  Concern for postvaccinia encephalomyelitis.  Symptoms largely resolving on HD 2 with supportive care, without IVIG or corticosteroids.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: CSF white blood cell count increased, Clonus, Cytomegalovirus test, Encephalomyelitis, Enterovirus test
Clinical narrative: 1 day of Upper motor neuron findings including hyperreflexia with clonus and 2-3 joint involvement, +Babinski with 2 joint involvement, lower>upper limb weakness, severe HA, nausea, vomiting.  Concern for postvaccinia encephalomyelitis.  Symptoms largely resolving on HD 2 with supportive care, without IVIG or corticosteroids.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Extensor plantar response, Full blood count normal, HIV test, Headache, Hyperreflexia
Clinical narrative: 1 day of Upper motor neuron findings including hyperreflexia with clonus and 2-3 joint involvement, +Babinski with 2 joint involvement, lower>upper limb weakness, severe HA, nausea, vomiting.  Concern for postvaccinia encephalomyelitis.  Symptoms largely resolving on HD 2 with supportive care, without IVIG or corticosteroids.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Metabolic function test normal, Muscular weakness, Nausea, Nuclear magnetic resonance imaging brain normal, Polymerase chain reaction
Clinical narrative: 1 day of Upper motor neuron findings including hyperreflexia with clonus and 2-3 joint involvement, +Babinski with 2 joint involvement, lower>upper limb weakness, severe HA, nausea, vomiting.  Concern for postvaccinia encephalomyelitis.  Symptoms largely resolving on HD 2 with supportive care, without IVIG or corticosteroids.
Age: 20.0
Sex: M
Vaccine: SMALL
Symptoms: Viral test, Vitamin B12 normal, Vomiting
Clinical narrative: 1 day of Upper motor neuron findings including hyperreflexia with clonus and 2-3 joint involvement, +Babinski with 2 joint involvement, lower>upper limb weakness, severe HA, nausea, vomiting.  Concern for postvaccinia encephalomyelitis.  Symptoms largely resolving on HD 2 with supportive care, without IVIG or corticosteroids.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Cellulitis, Chest X-ray normal, Erythema, Oedema peripheral
Clinical narrative: Red, hot, swollen and painful arm. Went to Hospital and was admitted for 3 days with cellulitis. On 3 or 4 different antibiotics.
Age: 45.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin warm, Ultrasound scan normal, Urine analysis normal
Clinical narrative: Red, hot, swollen and painful arm. Went to Hospital and was admitted for 3 days with cellulitis. On 3 or 4 different antibiotics.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site reaction, Insomnia, Joint range of motion decreased, Joint stiffness
Clinical narrative: Woken from sleep by painful shoulder. Pain is consistent with occasional throbbing in left shoulder joint and muscles above and around where vaccine was administered and does not respond to ibuprofen. Some response to naproxen @ 375mg per dose as needed per doctor visit on Sunday Nov. 13 when the pain became unbearable. Pain has led to sleeplessness, loss of range of motion, tingling in fingers, stiffness of joint and total loss of use of the left arm. A sling has been somewhat helpful.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia, Paraesthesia
Clinical narrative: Woken from sleep by painful shoulder. Pain is consistent with occasional throbbing in left shoulder joint and muscles above and around where vaccine was administered and does not respond to ibuprofen. Some response to naproxen @ 375mg per dose as needed per doctor visit on Sunday Nov. 13 when the pain became unbearable. Pain has led to sleeplessness, loss of range of motion, tingling in fingers, stiffness of joint and total loss of use of the left arm. A sling has been somewhat helpful.