chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Pyrexia, White blood cell count increased
Clinical narrative: Initial report received on 25 October 2011 from a nurse. This case involved 1 of a cluster of 4 patients who had received the same vaccine FLUZONE HIGH-DOSE with the same lot number (UH459A), that was from the same reporter. Information regarding the other 3 patients is captured in case numbers 2011-09291, 2011-10381, and 2011-10382. An 84-year-old male patient with no concurrent illnesses had received a first intramuscular right deltoid injection of FLUZONE HIGH-DOSE (full lot number UH459AC) on 14 September 2011 at 09:36 am and approximately 15 minutes later experienced fever, chills, sweats, cramping in the LE's (lower extremities), pain in his shoulders, and confusion with hallucinations. Diagnostic tests and laboratory data performed included a CBC (complete blood count) that revealed elevated WBCs of 12.5; and the patient also had a test to rule out Lyme disease, urine culture, CMP (complete metabolic panel), and lipid profile, all of which were negative. The patient was subsequently treated with doxycycline 5 days after onset of symptoms and all symptoms resolved on 19 September 2011. Per the reporter, the patient had not been back to the office for re-evaluation. It was noted the patient is allergic to PCN (penicillin), and had medical history of CAD (Coronary Artery disease), hyperlipidemia, HTN (Hypertension), BPH (benign prostatic hypertrophy), and DM ? (question - diabetes Mellitus, word illegible). Concomitant medications were not provided. Documents held by sender: None.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Dyspnoea, Fall, Pneumonia
Clinical narrative: Initial report received on 25 October 2011 from a nurse. This case involves 1 of a cluster of 4 patients who had received the same vaccine (FLUZONE HIGH-DOSE) with the same lot number (UH459A), and was from the same reporter. Information regarding the other 3 patients is captured in case numbers 2011-09291, 2011-10381, and 2011-10383. A 78-year-old male patient who had dizziness and tinnitus had received a first intramuscular left deltoid injection of FLUZONE HIGH-DOSE (full lot number UH459AC) on 29 August 2011 at 15:40 pm and that same afternoon went to the ER (emergency room) with weakness, SOB (shortness of breath) and complaint of falling, but no complaints of pain. The patient was hospitalized for an unknown number of days and diagnosed with pneumonia. Treatments received and diagnostic tests/laboratory data performed were not reported. It was noted the patient had medical history of allergy to PCN (Penicillin) and BUSPAR, CAD (Coronary Artery Disease), hyperlipidemia, cancer of the throat, COPD (Chronic Obstructive Pulmonary disease), HTN (hypertension), Hypothyroidism and GERD (Gastroesophageal Reflux disease). Concomitant medications were not reported. The patient recovered on an unspecified date. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Culture, Full blood count, Injection site cellulitis
Clinical narrative: Discomfort to site - had PNEUMOVAX/Flu shot administered same area. Pain, swelling, could not lift arm, redness "streaking" to health services - IV antibiotics.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Injection site discomfort, Mobility decreased, Pain, Swelling
Clinical narrative: Discomfort to site - had PNEUMOVAX/Flu shot administered same area. Pain, swelling, could not lift arm, redness "streaking" to health services - IV antibiotics.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Tachycardia, Urticaria
Clinical narrative: Initial report was received from a health care professional on 25 October 2011. A female patient (name and date of birth not reported) had received FLUZONE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an allergic reaction requiring an emergency room evaluation. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersensitivity
Clinical narrative: Initial report was received from a health care professional on 25 October 2011. A female patient (name and date of birth not reported) had received FLUZONE (lot number, route, site and date of administration not reported) and an unspecified amount of time later experienced an allergic reaction requiring an emergency room evaluation. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Influenza like illness, Laboratory test normal, Malaise, Oropharyngeal pain, Streptococcus test
Clinical narrative: Client started experiencing very painful throat; bumps on back of throat on 10/13/11. Client stated began to had felt this way before other than the first time she got the HPV vaccine. Client started to experience nasal congestion, sneezing and general malaise on 10/15/11. On 10-18-11 client stated to be feeling a little better but she now was experiencing "cramps or chest pains". Client went to see a doctor on 11-19-11. Ct stated Dr was unable to tell her what the problem was. Strep throat was negative 11-24-11. Client started to be feeling much better, almost 100% back to normal.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Malaise, Muscle spasms, Nasal congestion, Oropharyngeal pain
Clinical narrative: Client started experiencing very painful throat; bumps on back of throat on 10/13/11. Client stated began to had felt this way before other than the first time she got the HPV vaccine. Client started to experience nasal congestion, sneezing and general malaise on 10/15/11. On 10-18-11 client stated to be feeling a little better but she now was experiencing "cramps or chest pains". Client went to see a doctor on 11-19-11. Ct stated Dr was unable to tell her what the problem was. Strep throat was negative 11-24-11. Client started to be feeling much better, almost 100% back to normal.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Sneezing, Streptococcus test negative, Throat irritation, Vaccine positive rechallenge
Clinical narrative: Client started experiencing very painful throat; bumps on back of throat on 10/13/11. Client stated began to had felt this way before other than the first time she got the HPV vaccine. Client started to experience nasal congestion, sneezing and general malaise on 10/15/11. On 10-18-11 client stated to be feeling a little better but she now was experiencing "cramps or chest pains". Client went to see a doctor on 11-19-11. Ct stated Dr was unable to tell her what the problem was. Strep throat was negative 11-24-11. Client started to be feeling much better, almost 100% back to normal.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Evening after receiving the flu shot pt developed a fever of 103 degrees F. This lasted through the night with some residual fever the following morning.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Post dog bite, received Tdap vaccine on 10-31-2011. Developed redness, fever and hardness at site 24 hours later after vaccination.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Chills, Cough, Decreased activity, Fatigue
Clinical narrative: About 12 hours after receiving the shot patient started having flu like symptoms, starting with a dry cough, chills and fever.  The symptoms considerably worsened over the course of the following weeks, the cough becoming so intense patient had trouble sleeping at night or functioning during the day.  Tiredness was also a symptom, causing patient to spend 2 to 3 weeks with hardly any physical activity.  Went to a Doctors assistant after a week of this and said it was a shot reaction & viral. Gave an antibiotic to prevent a secondary infection, but it did no good.  Now, a month later patient still has horrible coughing spells.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Insomnia, Pyrexia, Vaccination complication, Viral infection
Clinical narrative: About 12 hours after receiving the shot patient started having flu like symptoms, starting with a dry cough, chills and fever.  The symptoms considerably worsened over the course of the following weeks, the cough becoming so intense patient had trouble sleeping at night or functioning during the day.  Tiredness was also a symptom, causing patient to spend 2 to 3 weeks with hardly any physical activity.  Went to a Doctors assistant after a week of this and said it was a shot reaction & viral. Gave an antibiotic to prevent a secondary infection, but it did no good.  Now, a month later patient still has horrible coughing spells.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Soreness & pain in left arm then moving into shoulder area by morning -pain getting progressively worse 3 days later. Ice & NSAIDs for pain relief.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Macule
Clinical narrative: Developed 1-5 mm darkly pigmented macules multiple in number all over face. No erythematous, non tender, no discharge, no pruritis.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, heat, induration, soreness at injection site radiating down entire upper arm.
Age: 34.0
Sex: F
Vaccine: MEN
Symptoms: Pain in extremity, Skin warm
Clinical narrative: Hot, swollen, pain down to elbow, up to shoulder - shot given 10/24/11 - symptoms started 10/25/11 - came to practice 10/27/11 - tx'd with Abx today (10/27/11) & filed report.
Age: 3.0
Sex: F
Vaccine: FLUN3, PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 36-month-old, female patient received a dose of PREVNAR 13 intramuscularly laterally on the left thigh at 13:40 on 18Oct2011 for immunization. The patient had no relevant medical history. The patient's 13-month-old sister received a fourth dose of PREVNAR 13 in Sep2011 and did not experience any adverse event. Relevant concomitant medication included Poly-Vitamin with Fluoride from 2010 and ongoing. Vaccine given on the same day included FLUMIST intranasally. Relevant past vaccine history included PREVNAR on an unknown date and an unspecified childhood vaccine. On 19Oct2011, the patient developed swelling, hardness and redness on the lateral side of the left thigh, which required an emergency room or doctor visit. The patient was diagnosed with cellulitis in the lateral side of the left thigh. Therapeutic measures taken as a result of the event included treatment with AUGMENTIN in Oct2011. There was no relevant lab data. At the time of the report, the outcome of the event was unknown.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling
Clinical narrative: Pt to clinic today & reported rx to vaccine on 8/5/11. GARDASIL admin. to pt on 8/5/11 in the am. Pt awoke on 8/6/11 with swollen lips. Denies other sx. Pt states she took BENADRYL p.o. & swelling resolved. Pt did not see a doctor for her symptoms.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Abdominal pain upper, Blood urine present, Chills, Malaise, Muscle spasms
Clinical narrative: 10/28/11 here for 5yr check - 4pm had Dtap # 5 LA & IPV # 4 LA upper -- 10/29/11 - 1AM - 103.5 fever. Chills, fever, sore throat, stomach ache, malaise, c/o cramp (R) neck/back - legs. ER - did Strep test (-). Pt to office. WBC=32.8. 10/29/11 1pm admitted hosp.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Oropharyngeal pain, Pyrexia, Streptococcus test negative, Urine analysis abnormal, White blood cell count increased
Clinical narrative: 10/28/11 here for 5yr check - 4pm had Dtap # 5 LA & IPV # 4 LA upper -- 10/29/11 - 1AM - 103.5 fever. Chills, fever, sore throat, stomach ache, malaise, c/o cramp (R) neck/back - legs. ER - did Strep test (-). Pt to office. WBC=32.8. 10/29/11 1pm admitted hosp.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Urticarial rash on bil upper extremities and on the trunk. No SOB, no angioedema. Treated with prednisone oral, BENADRYL oral and to ER.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral
Clinical narrative: Patient c/o swelling of the arm and redness. Temp 104.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Influenza like illness, Malaise, Musculoskeletal discomfort
Clinical narrative: Patient had severe discomfort from neck down to shoulder on right side. Did not feel well, and had flu-like symptoms for 4 days after receiving vaccine. Receives flu shots every year - this is first reaction.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Vaccination complication
Clinical narrative: Patient experienced leg swelling in the back of her knees. Time to event unknown; however, she went to an orthopedic to have the legs evaluated on 10/24 and 10/26. The doctor highly suspected the vaccine to be the issue because there were no signs from anything else.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Borrelia test negative, Condition aggravated, Fatigue, Joint fluid drainage
Clinical narrative: Patient experienced leg swelling in the back of her knees. Time to event unknown; however, she went to an orthopedic to have the legs evaluated on 10/24 and 10/26. The doctor highly suspected the vaccine to be the issue because there were no signs from anything else.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint swelling, Musculoskeletal pain, Synovial fluid analysis
Clinical narrative: Patient experienced leg swelling in the back of her knees. Time to event unknown; however, she went to an orthopedic to have the legs evaluated on 10/24 and 10/26. The doctor highly suspected the vaccine to be the issue because there were no signs from anything else.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Pt. receive PNEUMO-PS in Rt. deltoid on 10/25/11. In the evening of the 25th arm appeared swollen, red and tender to the touch. Rt deltoid continues to have the same appearance two days later.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Pt. receive PNEUMO-PS in Rt. deltoid on 10/25/11. In the evening of the 25th arm appeared swollen, red and tender to the touch. Rt deltoid continues to have the same appearance two days later.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Pt. presented to the after hours care clinic on 10/03/11 with raised red rash (hives) to back, neck, arms & buttocks. States she received flu shot same day at 0930 a.m.
Age: 65.0
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: Body aches and pains, especially in my legs. Weakness followed by a bad cold.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site urticaria, Pyrexia, Rash
Clinical narrative: Fever 104 degrees & rash (hives at injection site).
Age: 24.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Extreme pain at site of injections with rash 2"x4" at injection site - progressively getting worse.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: 7 hrs after injection - arthralgias, chills, fever, arm swelling, redness, temp up to 104 degrees, lightheaded, vomiting, diarrhea. She also had shortness of breath and hives. Arm where vaccine given swollen 3 times it's size, heat, redness at site.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: 7 hrs after injection - arthralgias, chills, fever, arm swelling, redness, temp up to 104 degrees, lightheaded, vomiting, diarrhea. She also had shortness of breath and hives. Arm where vaccine given swollen 3 times it's size, heat, redness at site.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: 7 hrs after injection - arthralgias, chills, fever, arm swelling, redness, temp up to 104 degrees, lightheaded, vomiting, diarrhea. She also had shortness of breath and hives. Arm where vaccine given swollen 3 times it's size, heat, redness at site.
Age: 16.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Back pain, Blood creatine phosphokinase increased, Blood creatinine normal, Blood urea normal, Pain in extremity
Clinical narrative: Information has been received from a physician via patient's mother concerning a 16 year old female with asthma who on 31-AUG-2011 was vaccinated with the second dose of GARDASIL (lot# not reported). Concomitant therapy included ALLEGRA and montelukast sodium. The mother reported that she had a total of two doses and the date of the first dose is unknown. On 31-AUG-2011 the patient experienced pain in her back, heaviness in her legs and pain ascending from her legs go up or down stairs. Therapy with human papillomavirus vaccine was discontinued. The patient's pain in her back and heaviness in her legs and pain ascending from her legs go up or down stairs persisted. On 31-AUG-2011 she started having pain in her back and experienced a heaviness in her legs that is described as a feeling of "weight on her feet." She had pain ascending from her legs upward through her back. She was unable to go up or down stairs. Her doctor had her go to the emergency room (ER). She was seen in the ER on 31-AUG-2011, after the onset of the symptoms. The ER doctors thought she may have Guillain-Barre syndrome, and that was ruled out as a cause because she had reflexes. She was an athlete. They also thought it may be related to "athletic pain" but she says it feels different than athletic pain. She was given one liter of unknown IV fluids as a treatment in the ER. During the ER visit she had a Creatinine Kinase (CK) level of "around 1000," BUN and Creatinine "within normal levels." On 31-AUG-2011 she was discharged from the ER with orders to take MOTRIN and TYLENOL. From 31-AUG-2011 to 03-SEP-2011, she has been taking 600 mg of MOTRIN and 500 mg of TYLENOL, in alternating doses as needed for pain. As of 03-SEP-2011, she has not fully recovered from her pain and heaviness in her legs and she was no longer receiving doses of GARDASIL. Follow-up information was received from a physician indicating that he treated the patient (a doctor's adolescent daughter) in the Emergency Room. It was reported that the patient had received GARDASIL and the flu vaccine (manufacturer unknown) on an unspecified date. The patient presented to the Emergency Room with pain in her thighs and had difficulty walking. The patient's CK level was elevated. The patient was diagnosed with Rhabdomyolysis. The patient was treated with IV fluids and sent home. The patient was not admitted to the hospital. The physician stated that the patient had recovered. Upon internal review, rhabdomyolysis was determined to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Reflex test normal, Rhabdomyolysis, Sensation of heaviness
Clinical narrative: Information has been received from a physician via patient's mother concerning a 16 year old female with asthma who on 31-AUG-2011 was vaccinated with the second dose of GARDASIL (lot# not reported). Concomitant therapy included ALLEGRA and montelukast sodium. The mother reported that she had a total of two doses and the date of the first dose is unknown. On 31-AUG-2011 the patient experienced pain in her back, heaviness in her legs and pain ascending from her legs go up or down stairs. Therapy with human papillomavirus vaccine was discontinued. The patient's pain in her back and heaviness in her legs and pain ascending from her legs go up or down stairs persisted. On 31-AUG-2011 she started having pain in her back and experienced a heaviness in her legs that is described as a feeling of "weight on her feet." She had pain ascending from her legs upward through her back. She was unable to go up or down stairs. Her doctor had her go to the emergency room (ER). She was seen in the ER on 31-AUG-2011, after the onset of the symptoms. The ER doctors thought she may have Guillain-Barre syndrome, and that was ruled out as a cause because she had reflexes. She was an athlete. They also thought it may be related to "athletic pain" but she says it feels different than athletic pain. She was given one liter of unknown IV fluids as a treatment in the ER. During the ER visit she had a Creatinine Kinase (CK) level of "around 1000," BUN and Creatinine "within normal levels." On 31-AUG-2011 she was discharged from the ER with orders to take MOTRIN and TYLENOL. From 31-AUG-2011 to 03-SEP-2011, she has been taking 600 mg of MOTRIN and 500 mg of TYLENOL, in alternating doses as needed for pain. As of 03-SEP-2011, she has not fully recovered from her pain and heaviness in her legs and she was no longer receiving doses of GARDASIL. Follow-up information was received from a physician indicating that he treated the patient (a doctor's adolescent daughter) in the Emergency Room. It was reported that the patient had received GARDASIL and the flu vaccine (manufacturer unknown) on an unspecified date. The patient presented to the Emergency Room with pain in her thighs and had difficulty walking. The patient's CK level was elevated. The patient was diagnosed with Rhabdomyolysis. The patient was treated with IV fluids and sent home. The patient was not admitted to the hospital. The physician stated that the patient had recovered. Upon internal review, rhabdomyolysis was determined to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Back pain, Blood creatine phosphokinase increased, Gait disturbance, Pain in extremity, Rhabdomyolysis
Clinical narrative: Information has been received from a physician via patient's mother concerning a 16 year old female with asthma who on 31-AUG-2011 was vaccinated with the second dose of GARDASIL (lot# not reported). Concomitant therapy included ALLEGRA and montelukast sodium. The mother reported that she had a total of two doses and the date of the first dose is unknown. On 31-AUG-2011 the patient experienced pain in her back, heaviness in her legs and pain ascending from her legs go up or down stairs. Therapy with human papillomavirus vaccine was discontinued. The patient's pain in her back and heaviness in her legs and pain ascending from her legs go up or down stairs persisted. On 31-AUG-2011 she started having pain in her back and experienced a heaviness in her legs that is described as a feeling of "weight on her feet." She had pain ascending from her legs upward through her back. She was unable to go up or down stairs. Her doctor had her go to the emergency room (ER). She was seen in the ER on 31-AUG-2011, after the onset of the symptoms. The ER doctors thought she may have Guillain-Barre syndrome, and that was ruled out as a cause because she had reflexes. She was an athlete. They also thought it may be related to "athletic pain" but she says it feels different than athletic pain. She was given one liter of unknown IV fluids as a treatment in the ER. During the ER visit she had a Creatinine Kinase (CK) level of "around 1000," BUN and Creatinine "within normal levels." On 31-AUG-2011 she was discharged from the ER with orders to take MOTRIN and TYLENOL. From 31-AUG-2011 to 03-SEP-2011, she has been taking 600 mg of MOTRIN and 500 mg of TYLENOL, in alternating doses as needed for pain. As of 03-SEP-2011, she has not fully recovered from her pain and heaviness in her legs and she was no longer receiving doses of GARDASIL. Follow-up information was received from a physician indicating that he treated the patient (a doctor's adolescent daughter) in the Emergency Room. It was reported that the patient had received GARDASIL and the flu vaccine (manufacturer unknown) on an unspecified date. The patient presented to the Emergency Room with pain in her thighs and had difficulty walking. The patient's CK level was elevated. The patient was diagnosed with Rhabdomyolysis. The patient was treated with IV fluids and sent home. The patient was not admitted to the hospital. The physician stated that the patient had recovered. Upon internal review, rhabdomyolysis was determined to be an other important medical event. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, FLU3, HPV4
Symptoms: Sensation of heaviness
Clinical narrative: Information has been received from a physician via patient's mother concerning a 16 year old female with asthma who on 31-AUG-2011 was vaccinated with the second dose of GARDASIL (lot# not reported). Concomitant therapy included ALLEGRA and montelukast sodium. The mother reported that she had a total of two doses and the date of the first dose is unknown. On 31-AUG-2011 the patient experienced pain in her back, heaviness in her legs and pain ascending from her legs go up or down stairs. Therapy with human papillomavirus vaccine was discontinued. The patient's pain in her back and heaviness in her legs and pain ascending from her legs go up or down stairs persisted. On 31-AUG-2011 she started having pain in her back and experienced a heaviness in her legs that is described as a feeling of "weight on her feet." She had pain ascending from her legs upward through her back. She was unable to go up or down stairs. Her doctor had her go to the emergency room (ER). She was seen in the ER on 31-AUG-2011, after the onset of the symptoms. The ER doctors thought she may have Guillain-Barre syndrome, and that was ruled out as a cause because she had reflexes. She was an athlete. They also thought it may be related to "athletic pain" but she says it feels different than athletic pain. She was given one liter of unknown IV fluids as a treatment in the ER. During the ER visit she had a Creatinine Kinase (CK) level of "around 1000," BUN and Creatinine "within normal levels." On 31-AUG-2011 she was discharged from the ER with orders to take MOTRIN and TYLENOL. From 31-AUG-2011 to 03-SEP-2011, she has been taking 600 mg of MOTRIN and 500 mg of TYLENOL, in alternating doses as needed for pain. As of 03-SEP-2011, she has not fully recovered from her pain and heaviness in her legs and she was no longer receiving doses of GARDASIL. Follow-up information was received from a physician indicating that he treated the patient (a doctor's adolescent daughter) in the Emergency Room. It was reported that the patient had received GARDASIL and the flu vaccine (manufacturer unknown) on an unspecified date. The patient presented to the Emergency Room with pain in her thighs and had difficulty walking. The patient's CK level was elevated. The patient was diagnosed with Rhabdomyolysis. The patient was treated with IV fluids and sent home. The patient was not admitted to the hospital. The physician stated that the patient had recovered. Upon internal review, rhabdomyolysis was determined to be an other important medical event. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Initial report received on 24 October 2011 from the patient's daughter who is a health care professional. A 79-year-old female patient who had an URI (upper respiratory infection) at the time, had received an intramuscular left deltoid injection of FLUZONE HIGH-DOSE (lot number UH444AB) on 23 October 2011 at 19:00 pm and 3.5 hours later on the same day at 22:30 pm the patient experienced swelling of the tongue. Another of the patient's daughters who is a nurse, and who had administered the flu vaccine, administered the patient 100 mg of BENADRYL (route not reported). The patient did not required a physician visit and no relevant diagnostic tests or laboratory data were performed. It was noted the patient had medical history of HTN (hypertension) that was currently being treated with NORVASC and CARDURA, but KNA (no known allergies). The patient had received a flu vaccination last year, but it was not reported whether she had experienced any adverse events with that vaccination. At the time of this report, it was unknown if the patient had recovered. Documents held by sender: None.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Cough, Pharyngeal oedema, Similar reaction on previous exposure to drug, Wheezing
Clinical narrative: 3 hrs after receiving FLUZONE developed cough, wheezing, "film" in eyes, swelling in throat. No other sxs. Recovered by following morning. Similar episode 5 yrs ago after flu shot.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Influenza A virus test positive, Oropharyngeal pain, Pain
Clinical narrative: Initial report received on 24 October 2011 from a physician. A 6-year-old male patient, who had no concurrent illnesses had received an intramuscular left deltoid injection of FLUZONE (lot number UH475AA) on 19 October 2011 and 3 days later experienced fever, sore throat, chills, and body aches that required a physician visit. The patient had a flu test that was positive for influenza A and he was started on TAMIFLU. The patient subsequently developed a hive like rash on the right ankle, both legs and trunk, and a severe cough that had started on 23 October 2011. It was noted the patient has medical history of asthma that is treated with PULMICORT and albuterol as needed, and an allergy to Penicillin. At the time of this report the patient had not recovered. Documents held by sender: None.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Initial report received on 24 October 2011 from a physician. A 6-year-old male patient, who had no concurrent illnesses had received an intramuscular left deltoid injection of FLUZONE (lot number UH475AA) on 19 October 2011 and 3 days later experienced fever, sore throat, chills, and body aches that required a physician visit. The patient had a flu test that was positive for influenza A and he was started on TAMIFLU. The patient subsequently developed a hive like rash on the right ankle, both legs and trunk, and a severe cough that had started on 23 October 2011. It was noted the patient has medical history of asthma that is treated with PULMICORT and albuterol as needed, and an allergy to Penicillin. At the time of this report the patient had not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Chest pain, Coeliac disease, Condition aggravated
Clinical narrative: Initial report was received 24 October 2011 from a health care professional, who is also the patient. A female patient (age and date of birth not reported) who had a history of Celiac disease and severe chest pain, had received an injection of INFLUENZA VACCINE (manufacturer unknown, lot number, route and site of administration not reported) on 19 October 2011 and several hours after vaccination, she developed a severe Celiac reaction consisting of severe chest pain which lasted more than 36 hours. The patient also had to take time off from work. The patient had not altered anything in her diet or what she had touched (the patient also has a history of reacting to tactile gluten) on the day of vaccination. According to the patient, their reaction to any gluten product consists of severe chest pain that could last anywhere from 24 to 96 hours. The patient's son also had a history of Celiac disease. Outcome was not reported. The reporter for this case is the same as for case number 2011-10377. Documents held by sender: None.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Hypoaesthesia, Oedema peripheral, Pain in extremity
Clinical narrative: (L) arm swelling, pain and redness with numb spots. Pt also c/o headache x 4 days. Several inches in length and width.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt reported red, swollen, extremely painful arm x3 day. Pts states "arm swelled up twice the size of normal". BENADRYL and compresses given.
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: Initial report received on 24 October 2011 from a health care professional via the company's web site. A male patient had received a dose of FLUZONE (lot number not reported) on an unspecified date and at an unspecified amount of time later had an anaphylactic response to the injection. The patient had no egg allergies. Recovery status was not reported. No further information was provided. Documents held by sender: none.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Severe (R) thigh swelling, redness, induration, pain. Pt was exquisitely tender and induration and redness 6 cm x 7 cm. Red line 3cm long also developed lateral to immunization site. Treated with TYLENOL, ice. 6 cm x 7 cm are resolved, red line 1mm thick, 3 cm long persists.
Age: 1.16
Sex: M
Vaccine: FLU3
Symptoms: Encephalitis, Fall, Gait disturbance
Clinical narrative: Initial report was received on 25 October 2011 from a health care professional. A one year-old patient who was well at the time of vaccination had received on 17 October 2011 an intramuscular right arm injection of FLUZONE, lot number U4159BB and an unspecified amount of later, experienced difficulty walking and would drop to the floor. The patient was diagnosed with cerebellitis, possibly from vaccination. Treatments and diagnostic tests were not reported. The patient had received on 13 September 2011 an intramuscular left arm injection of PREVNAR 13, Pfizer lot number 916973. The patient's pre-existing conditions and adverse events following prior vaccinations were reported as none. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Convulsion, Pyrexia
Clinical narrative: Initial report was received on 25 October 2011 from a health care professional. An "above 65" year-old patient (name, exact date of birth and gender not reported) had received a dose of FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, experienced a seizure and was hospitalized with a high fever. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: (L) arm pain, soreness worse in AM & trouble raising arm over head painful, creaky/Ibuprofen helps.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Erythema, Hypersensitivity, Injection site reaction, Rash papular
Clinical narrative: Had 3 - 4 cm papular rash at MMR site. Had multiple 1 - 2 cm red w/central blister -> pustule d #1 of rash (10/27). Has erythema/swelling c/w allergic response.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Rash pustular, Swelling
Clinical narrative: Had 3 - 4 cm papular rash at MMR site. Had multiple 1 - 2 cm red w/central blister -> pustule d #1 of rash (10/27). Has erythema/swelling c/w allergic response.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: About 1 hr after admin, erythema developed at site of VARIVAX injection 10cm diameter - sore. Saw Dr given antibiotic - told to take TYLENOL or Ibuprofen.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Extreme exhaustion, achy joints/muscles.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort
Clinical narrative: The actual poke didn't hurt, but the actual vaccine entering my arm was uncomfortable, it felt like it was expanding, w/in a few minutes my arm felt like I had "dead arm". I have had vaccines before & never had that strong of a reaction, the discomfort lasted all day, tapered off quickly over the weekend & is much better today.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Within an hour of receiving the vaccine, I felt pressure & pain at the injection site. It was difficult to raise my hand to eat. I felt intense pain for several hours after injection.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pain and weakness in right arm for 2-3 days.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Numbness of arm, at 6:25 am next morning, went to doctors office, took Tylenol.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Body temperature increased, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: In evening pt told mom arm hurt and warm, tender to touch. Temp 100.4. Mom gave Tylenol every 6  hours. Came to clinic in AM. Upper left outer arm is swollen slighlty and warm and tender to touch. Temp 97.1.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Skin warm, Tenderness
Clinical narrative: In evening pt told mom arm hurt and warm, tender to touch. Temp 100.4. Mom gave Tylenol every 6  hours. Came to clinic in AM. Upper left outer arm is swollen slighlty and warm and tender to touch. Temp 97.1.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, DTAPHEPBIP, FLU3
Symptoms: Hallucination, visual
Clinical narrative: Visual Hallucinations.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, FLU3, DTAPHEPBIP, FLU3
Symptoms: Chills, Discomfort, Hallucination, Pyrexia
Clinical narrative: Visual Hallucinations.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain, Pain of skin
Clinical narrative: Extreme muscle soreness and tenderness to the touch, sore with movement and lifting; ached in whole arm at times; took TYLENOL at approx 2:00 am.
Age: 0.21
Sex: M
Vaccine: HIBV, PNC
Symptoms: Allergy test, Crying, Faeces discoloured, Faeces hard, Mobility decreased
Clinical narrative: Slight fever treated with children's Tylenol.  He immediately stopped passing stools and his stools became hard and black.  He stopped smiling and started crying after no previous "colic" behaviors.  He started staring out into space and stopped moving or noticing things in front of him.
Age: 0.21
Sex: M
Vaccine: HIBV, PNC
Symptoms: Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: Slight fever treated with children's Tylenol.  He immediately stopped passing stools and his stools became hard and black.  He stopped smiling and started crying after no previous "colic" behaviors.  He started staring out into space and stopped moving or noticing things in front of him.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nervousness, Throat tightness
Clinical narrative: CLIENT C/O FEELING FAINT AND SHAKY AND LIKE "MY THROAT IS CLOSING UP."  911 called.  Vital signs stable.  Refused transport to ER.  Husband took her home.  She was called the next day and said that she took a Benadryl, had something to eat, slept, and then felt tine.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Pruritus
Clinical narrative: Redness at site of injection, patient began to itch, redness noted on side of neck and on bottom of leg that shot was administered. Pt was given 25 mg Benadryl IM. Itching stopped and redness did not worsen.
Age: 1.16
Sex: M
Vaccine: HIBV
Symptoms: Convulsion, Foaming at mouth, Full blood count normal, Laboratory test normal, Respiratory rate decreased
Clinical narrative: Seizure activity, foam coming from mouth, decreased respirations noted by mother.  Baby had good color and respirations upon arrival to ER.  NSR, O2 sat 99%, T98.3. No treatment.  No further seizure activity since.
Age: 1.16
Sex: M
Vaccine: HIBV
Symptoms: Urine analysis normal
Clinical narrative: Seizure activity, foam coming from mouth, decreased respirations noted by mother.  Baby had good color and respirations upon arrival to ER.  NSR, O2 sat 99%, T98.3. No treatment.  No further seizure activity since.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Extreme chills, moderate muscle aches in arms and legs, weakness in legs, periods of fever of 100.8 degrees Fahrenheit.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Nasal congestion, Pain
Clinical narrative: Fever, Chills, body aches, Nasal congestions.  The following day experienced extreme fatigue and a severe headache.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever, Chills, body aches, Nasal congestions.  The following day experienced extreme fatigue and a severe headache.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Condition aggravated
Clinical narrative: 5 months after getting the last shot patient lost all hair all over the body it happened over a matter of 2 days. Alopecia prior to the shot was never this bad patient would get a bald spot in their head here or there and then it would grow right back. Still had a full head of hair prior to the shots after the 3rd shot patient started to lose hair and then all of a sudden lost all hair in 2 days.
Age: 49.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, TDAP
Symptoms: Pain, Pain in extremity, Swelling
Clinical narrative: Ppatient presents to immunizations clinic on 2 November 2011.  She reports that she has had pain above the injection site of left arm since the day of injection.  She notes that it is worse over the past few days and now she has pain in her whole arm.  She also notes swelling above her injection site on that side.  No redness or induration.  No fevers.  No systemic symptoms suggestive of anaphylactic event.  According to shot record, pt was given MMR and Tdap in that arm. Pt was referred to flight medicine for acute evaluation and treatment.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dysphonia, Myalgia, Oropharyngeal pain, Palpitations
Clinical narrative: Severe chills, shaking, heart racing, fever of 102, muscle aches, hoarseness and sore throat, excessive thirst.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Thirst, Tremor
Clinical narrative: Severe chills, shaking, heart racing, fever of 102, muscle aches, hoarseness and sore throat, excessive thirst.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Maternal exposure during pregnancy
Clinical narrative: No known adverse events.  Patient was pregnant when she was given Flumist.
Age: 53.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: First 18 hours arm was extremely painful. Next day arm was swollen, red, hot and painful. The pain extended to shoulder.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Nausea, Pruritus, Rash
Clinical narrative: Started itching on various parts of body.  Itching progressed and that evening the spots scratched were red, raised, and bumpy.  Hives???  This lasted several days and was helped by taking Benedryl or Allegra.  10 days later, still itchy.  On 10/31/2011 patient also started feeling very nauseous, and that has lasted until today, 11/3/2011.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Pain
Clinical narrative: Received Fluarix vaccine.  Approx 1 1/2 hours later felt achy from head to toe; had chills; no fever. No discomfort at injection site.  At home at 5:15 took Tylenol and went to bed.  At 10:00 PM woke up; still achy and cold; took another Tylenol.  10/21/11 at 5:00 AM awoke felt better; but achy all over for about 48 hours.  Acute stage = 12 hours.  Had taken the flu vaccine all of her adult life without problem.
Age: 40.0
Sex: F
Vaccine: FLUN3
Symptoms: Erythema, Pruritus
Clinical narrative: ITCHY NOSE, MOUTH & FOREHEAD WITH REDNESS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Local redness and tenderness. 5 cm diameter. Local firmness developed over next day.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Dyskinesia, Syncope
Clinical narrative: Syncope with 5 - 6 seconds of limb movements.  Entire event lasted less than 1 minute and the patient recovered completely.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site urticaria
Clinical narrative: Large red welt (4cmx3cm) at site of shingles vaccine and 8cm x 8cm red are with central clearing and central bruising at the site of the pneumonia vaccine.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Laboratory test normal, Tremor
Clinical narrative: Patient presents to the ER with fine tremor of the arms. She states that she was sent by employee health. She states that she had the flu shot earlier today. She states she has a history of migraines and feels like she is about to get a migraine. She denies any numbness, tingling, weakness. She denies a history of tremor. She denies any chest pain or abdominal pain. She has no other complaints at this time.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: Patient started to experience swelling of the tongue approximately 5 mins after the vaccine was given. 50 mg of diphenhydramine was given. a few mins later, patient started experiencing shortness of breath.  0.15 mg of epi were given. The dose was repeated again approximately 20 mins later.  15 mins later, NC was put on the patient for about 10 mins.  Later on that night, patient went to an emergency department where steroids, albuterol nebs, and another 50 mg of Benadryl were administered.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture negative, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Complement factor C4, Complement factor normal
Clinical narrative: 24+ hrs after vaccine fever 101.8. 36 hrs after vaccine significant swelling hip to knee - hot to touch, painful (right leg) left leg. Golf ball size swelling at injection site. Also 1-2cm mobile inguinal lymph nodes on (R) side. Admitted to hospital. IV CLEOCIN. No more fever. Redness improved but non-pitting swelling increased below knee. Started SOLUMEDROL - well in 24 hrs.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Lymph node palpable
Clinical narrative: 24+ hrs after vaccine fever 101.8. 36 hrs after vaccine significant swelling hip to knee - hot to touch, painful (right leg) left leg. Golf ball size swelling at injection site. Also 1-2cm mobile inguinal lymph nodes on (R) side. Admitted to hospital. IV CLEOCIN. No more fever. Redness improved but non-pitting swelling increased below knee. Started SOLUMEDROL - well in 24 hrs.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: 24+ hrs after vaccine fever 101.8. 36 hrs after vaccine significant swelling hip to knee - hot to touch, painful (right leg) left leg. Golf ball size swelling at injection site. Also 1-2cm mobile inguinal lymph nodes on (R) side. Admitted to hospital. IV CLEOCIN. No more fever. Redness improved but non-pitting swelling increased below knee. Started SOLUMEDROL - well in 24 hrs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abscess, Burning sensation, Cellulitis, Erythema, Induration
Clinical narrative: 50 mm redness, induration circle. Burning & itching feeling. Denies SOB, any other swelling or pain. Urgent care - Dx cellulitis & abscess - Rx. BACTRIM DS & BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus
Clinical narrative: 50 mm redness, induration circle. Burning & itching feeling. Denies SOB, any other swelling or pain. Urgent care - Dx cellulitis & abscess - Rx. BACTRIM DS & BENADRYL.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Per mom, 1 hr after admin, developed erythema at site of varicella injection. Increased in size x 1 day. Saw DR 11/2/11 - given antibiotic & told to give TYLENOL or Ibuprofen.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site oedema, Injection site reaction, Joint stiffness
Clinical narrative: Left thigh edema mid thigh to knee joint firmness to lateral thigh, no erythema, no warmth no fluctuance.