chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chickenpox looking red bumps all over body, stomach, back, neck, armpits, and face. Fever of 102.5.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Severe arm/shoulder pain at injection site weeks after received.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Colonoscopy, Computerised tomogram, Crohn's disease, Depression
Clinical narrative: Since the vaccine patient has been diagnosed with Endometriosis, Crohn's. Had 4 surgeries, MULTIPLE hospitalizations from generalized pain, abnormal Pap smear with pre-cancerous cells, depression, attempted suicide, and overall feeling of being sick.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Endometriosis, Endoscopy, Injection site haematoma, Laparoscopy, Malaise
Clinical narrative: Since the vaccine patient has been diagnosed with Endometriosis, Crohn's. Had 4 surgeries, MULTIPLE hospitalizations from generalized pain, abnormal Pap smear with pre-cancerous cells, depression, attempted suicide, and overall feeling of being sick.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Precancerous cells present, Smear cervix abnormal, Suicide attempt, Surgery
Clinical narrative: Since the vaccine patient has been diagnosed with Endometriosis, Crohn's. Had 4 surgeries, MULTIPLE hospitalizations from generalized pain, abnormal Pap smear with pre-cancerous cells, depression, attempted suicide, and overall feeling of being sick.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Muscular weakness, Oral herpes, Oropharyngeal blistering, Photophobia
Clinical narrative: Fever blisters on mouth....now extreme fatigue, light sensitivity, muscle weakness has presented in last 4 days.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dry eye, Dry throat, Dyspnoea, Eye irritation
Clinical narrative: Dry Throat; swollen, dry, burning, itchy eyes; rapid onset shortness of breath; Anaphylaxis.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Eye swelling
Clinical narrative: Dry Throat; swollen, dry, burning, itchy eyes; rapid onset shortness of breath; Anaphylaxis.
Age: 58.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Blood culture positive, Cardiac murmur, Catheterisation cardiac abnormal, Echocardiogram, General physical health deterioration
Clinical narrative: Right arm where injection was given became stiff and sore. Saw PCP and was told that inflammation was present. Was given Prednisone for inflammation and Hydrocodone for pain. Took medication for next 2 weeks. Health was worse. Went back to PCP on 09/26/2011 and was given antibiotic took blood cultures and had lost 10 lbs at this point. Went back to PCP 09/28/2011 lost 4 more lbs. heard heart murmur, had echo sent to PMC for catherization and TEE. Found Mitro Valve problems, came home 09/30/11. Saw Dr. on 10/18/11, had blood cultures, went back on 10/26/11 had TEE again. Found mitro valve needs to be replaced but will wait until health is better. Its 11/06/11 and health is beginning to deteriorate again. See PCP on 11/8/11.
Age: 58.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Infection, Inflammation, Injection site pain, Injection site reaction, Limb discomfort
Clinical narrative: Right arm where injection was given became stiff and sore. Saw PCP and was told that inflammation was present. Was given Prednisone for inflammation and Hydrocodone for pain. Took medication for next 2 weeks. Health was worse. Went back to PCP on 09/26/2011 and was given antibiotic took blood cultures and had lost 10 lbs at this point. Went back to PCP 09/28/2011 lost 4 more lbs. heard heart murmur, had echo sent to PMC for catherization and TEE. Found Mitro Valve problems, came home 09/30/11. Saw Dr. on 10/18/11, had blood cultures, went back on 10/26/11 had TEE again. Found mitro valve needs to be replaced but will wait until health is better. Its 11/06/11 and health is beginning to deteriorate again. See PCP on 11/8/11.
Age: 58.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Mitral valve disease, Musculoskeletal stiffness, Weight decreased
Clinical narrative: Right arm where injection was given became stiff and sore. Saw PCP and was told that inflammation was present. Was given Prednisone for inflammation and Hydrocodone for pain. Took medication for next 2 weeks. Health was worse. Went back to PCP on 09/26/2011 and was given antibiotic took blood cultures and had lost 10 lbs at this point. Went back to PCP 09/28/2011 lost 4 more lbs. heard heart murmur, had echo sent to PMC for catherization and TEE. Found Mitro Valve problems, came home 09/30/11. Saw Dr. on 10/18/11, had blood cultures, went back on 10/26/11 had TEE again. Found mitro valve needs to be replaced but will wait until health is better. Its 11/06/11 and health is beginning to deteriorate again. See PCP on 11/8/11.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Intense shoulder/arm main where shot was administered.  Pain continues and has gotten worse since then.  It has now been one month and patient can hardly move arm without extreme pain.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 9-16-11 patient went back to clinic, 2 days after pneu. injection received and reported redness, hard, mild itching, swelling and pain at injections site.  Follow up phone call with patient on 11-6-11, patient stated the symptoms lasted for approx 2 weeks. symptoms: swelling hard to the touch red 'not pink', 1" from injection site, to below her elbow. Pain rated as a 7-8 (Painscale 1<10). Patient denies fever.  Patient states she followed up with her PCP, and No treatment was rendered.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Oedema peripheral
Clinical narrative: 9-16-11 patient went back to clinic, 2 days after pneu. injection received and reported redness, hard, mild itching, swelling and pain at injections site.  Follow up phone call with patient on 11-6-11, patient stated the symptoms lasted for approx 2 weeks. symptoms: swelling hard to the touch red 'not pink', 1" from injection site, to below her elbow. Pain rated as a 7-8 (Painscale 1<10). Patient denies fever.  Patient states she followed up with her PCP, and No treatment was rendered.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Induration, Injection site swelling, Oedema peripheral, Skin warm
Clinical narrative: Adverse Event/symptoms started approx 12 hrs after receiving Pneumonia vaccine on 9/24/2011 and subsided by Wed 27Sept 2011.  Symptoms included red, swelling, hard to the touch, and hot to the touch. States swelling was from injection site to her elbow and 1/2 way around her arm. Denies systemic fever.  Treatment rendered warm compress to the site, and Tylenol. Treatment rendered by patient herself. Patient reports she received a previous Pneumonia vaccine 7 years ago.
Age: 3.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Patient had a seizure that night and didn't have a fever and never had that vaccine had MRI EEG and CAT scan and blood work all come back normal and the EEG had no seizure activity on it.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia
Clinical narrative: Muscle Pain in arm where patient received the shot.  Pain continues 2 weeks later, and has impaired use of the arm.
Age: 69.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Dizziness, Hyperhidrosis, Pain
Clinical narrative: Severe aching, sweats, chills, dizziness, lasted 48 hours after flu vaccine and pneumococcal vaccine shots.
Age: 30.0
Sex: F
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, Pain, Tendon injury, Tendonitis
Clinical narrative: SHOULDER INJURY DUE TO VACCINE ADMINISTRATION: GIVEN TOO HIGH INJURING TENDON CAUSING TENDONITIS. IN EXTREME PAIN.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's husband described that the patient's arm at the site of the injection had signs of bruising (black and blue coloration), and swelling. Slightly below the injection site there was also a 1 inch diameter red area.  The following day, this had grown to a 5 inch diameter red area.  Tenderness of the entire arm was seen, and the patient also experienced heat and swelling from the injection site.  The patient has been prescribed antibiotics, opioids, and antiemetics.  Currently the patient is resting at home.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: Patient's husband described that the patient's arm at the site of the injection had signs of bruising (black and blue coloration), and swelling. Slightly below the injection site there was also a 1 inch diameter red area.  The following day, this had grown to a 5 inch diameter red area.  Tenderness of the entire arm was seen, and the patient also experienced heat and swelling from the injection site.  The patient has been prescribed antibiotics, opioids, and antiemetics.  Currently the patient is resting at home.
Age: 23.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity, Tenderness
Clinical narrative: Week 1: Soreness, Tenderness Week 2: Severe arm/shoulder pain; Inability to lift arm; Rotator cuff pain (as diagnosed by Urgent Care doctor)
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash surrounding vaccine injection site.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscle tightness, Pain in extremity, Screaming
Clinical narrative: Patient said vaccine hurt and arm still hurt 3-4 hours later after taking TYLENOL. Patient screamed as soon as needle entered her arm. Her muscle was very tense and tight and she pulled away and grabbed my arm while I was pushing in the shot.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Loss of consciousness
Clinical narrative: Pt. received influenza vaccination by injection. Pt was ok immediately after injection but about 5 minutes later lost consciousness while standing and was helped to ground. Within 30 seconds pt. had regained consciousness and complained his "heart felt funny" before loss of consciousness. Pt. remained sitting until EMS arrived.
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope, Vomiting
Clinical narrative: Reported to us that patient had vomiting followed by syncope with loss of consciousness and transported to hospital.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tendon injury
Clinical narrative: Pt. called on 11-1-11 stating her arm was still sore after being given a flu shot on 10-18-11. Cx said she went to MD recently to find out why her arm was still sore. Cx stating she may have a ripped tendon b/c of flu shot.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Listless, Malaise
Clinical narrative: Pain/swelling at injection site, radiating down arm to inner elbow. Slight warmth on inner elbow area described "muscle soreness" malaise, listlessness. Symptoms began day of vaccine through 11/5/11 (4 days). Symptoms gradually subsided on their own.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Myalgia
Clinical narrative: Pain/swelling at injection site, radiating down arm to inner elbow. Slight warmth on inner elbow area described "muscle soreness" malaise, listlessness. Symptoms began day of vaccine through 11/5/11 (4 days). Symptoms gradually subsided on their own.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient experiencing pain and stiffness in shoulder and arm 8 days post-shot, but it has improved over last 2 days.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abortion spontaneous, Foetal heart rate abnormal, Maternal exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Initial report was received on 25 October 2011 from a consumer who is also the patient. A 36 year-old pregnant female patient who was five weeks gestation at the time of vaccination had received on 03 October 2011 an intramuscular injection of INFLUENZA VACCINE (lot number, route and site of administration not reported). On 20 October 2011, the patient was at her OB/GYN visit and it was discovered that she had a fetal death at five weeks gestation. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Intra-uterine death, Maternal exposure during pregnancy
Clinical narrative: Initial report was received on 25 October 2011 from a consumer who is also the patient. A 36 year-old pregnant female patient who was five weeks gestation at the time of vaccination had received on 03 October 2011 an intramuscular injection of INFLUENZA VACCINE (lot number, route and site of administration not reported). On 20 October 2011, the patient was at her OB/GYN visit and it was discovered that she had a fetal death at five weeks gestation. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old male who on 08-SEP-2011 was vaccinated with a dose of PNEUMOVAX 23 in the left arm. Concomitant therapy included an unspecified "Flu" vaccine in the right arm on 08-SEP-2011. On 08-SEP-2011 the patient experienced limited arm movement and soreness in his arm. The patient reported that the soreness in his arm dissipated after a "few days," but the limitation of his left arm movement had persisted. The patient reported that he had to use his other arm to lift his left arm. The patient called to the pharmacist to seek medical attention. The pharmacist did not believe that the patient had consulted his physician. Follow up information has been received from the pharmacist concerning the retired male patient with no illness at the time of vaccination, drug allergy or medical history who on 08-SEP-2011, at 10:30 AM was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot#: 667916/1066Z) in the left deltoid. Concomitant therapy included AGRIFLU (lot#: 1100101) in the right deltoid on 08-SEP-2011, at 10:30 AM. Two weeks after injection, the patient came back to pharmacy to complain soreness in the left arm, patient stated that he had been unable to lift his left arm without assistance from right arm on 09-SEP-2011. The pharmacist followed up with the patient a week later, who said there had been improvement but minimal, the patient refused to go to see and medical doctor. At the time of the report, the patient's outcome was unknown. All the symptoms were considered as disabling by the reporter. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Erythema, Eye swelling, Fatigue, Lip swelling
Clinical narrative: Initial report received from a health care professional on 28 October 2011. A 63-year-old female patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UT473AB, on 25 October 2011 at 6:30 PM. The patient had no medical history, no illness at the time of vaccination, no vaccines within four weeks prior to vaccination, no adverse events following prior vaccinations and took no concomitant medications. The patient had no previous doses of flu vaccine. On 25 October 2011 at 9:15 PM, the patient complained of "something stuck in throat" and "feeling tired". The patient self administered BENADRYL with no relief. In about 30 minutes her lips tingled, throat became tighter, eyes, lips and face became swollen. Her chest turned a bright red. The patient was driven to the Emergency Room (ER) by her daughter. At the ER, the patient had decreased in swallowing difficulty. The patient was administered ZANTAC, BENADRYL and steroids with relief. The patient was discharged at 4:30 AM on 26 October 2011 with a five day prescription of ZANTAC, steroid and BENADRYL. The outcome was reported as recovered. Documents held by sender: None.
Age: 62.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia oral, Sensation of foreign body, Swelling face, Throat tightness
Clinical narrative: Initial report received from a health care professional on 28 October 2011. A 63-year-old female patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UT473AB, on 25 October 2011 at 6:30 PM. The patient had no medical history, no illness at the time of vaccination, no vaccines within four weeks prior to vaccination, no adverse events following prior vaccinations and took no concomitant medications. The patient had no previous doses of flu vaccine. On 25 October 2011 at 9:15 PM, the patient complained of "something stuck in throat" and "feeling tired". The patient self administered BENADRYL with no relief. In about 30 minutes her lips tingled, throat became tighter, eyes, lips and face became swollen. Her chest turned a bright red. The patient was driven to the Emergency Room (ER) by her daughter. At the ER, the patient had decreased in swallowing difficulty. The patient was administered ZANTAC, BENADRYL and steroids with relief. The patient was discharged at 4:30 AM on 26 October 2011 with a five day prescription of ZANTAC, steroid and BENADRYL. The outcome was reported as recovered. Documents held by sender: None.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Agitation, Blindness, Crying, Fall, Head injury
Clinical narrative: Pt was sitting on exam table, received the flu shot left arm & GARDASIL Rt arm. Nurse turned back to document vaccine & pt passed out fell forward off table & hit head on counter then floor after few seconds awake & oriented c/o severe headache. Then stated couldn't see, then got agitated/crying, called ambulance pt transported to hospital pt has hx of 2 previous concussion.
Age: 14.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Headache, Loss of consciousness
Clinical narrative: Pt was sitting on exam table, received the flu shot left arm & GARDASIL Rt arm. Nurse turned back to document vaccine & pt passed out fell forward off table & hit head on counter then floor after few seconds awake & oriented c/o severe headache. Then stated couldn't see, then got agitated/crying, called ambulance pt transported to hospital pt has hx of 2 previous concussion.
Age: 43.0
Sex: F
Vaccine: YF
Symptoms: Asthenia, Blindness, Computerised tomogram normal, Hypoaesthesia, Influenza like illness
Clinical narrative: Day 1: Flu like symptoms/weakness, day 2-3-4 flu like symptoms got worse. Day 5 - Numbness in right side of face, including sense of swelling (not visible). Day 8 - Blurriness in left eye, loss of vision - after 3 weeks symptoms remain the same.
Age: 43.0
Sex: F
Vaccine: YF
Symptoms: Nuclear magnetic resonance imaging normal, Swelling face, Vision blurred
Clinical narrative: Day 1: Flu like symptoms/weakness, day 2-3-4 flu like symptoms got worse. Day 5 - Numbness in right side of face, including sense of swelling (not visible). Day 8 - Blurriness in left eye, loss of vision - after 3 weeks symptoms remain the same.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test, Pyrexia, Rash generalised, Rash morbilliform, Vaccination complication
Clinical narrative: Baby woke up with a rash of a bunch of small dots everywhere. Took her to the peds 2 days in a row, unable to get control of 104 fever so we went to hospital. They ran IV's and tests and ruled it as a reaction to MMR. I have pictures. Every inch of her body was covered, looked like regular measles. As of right now she still has rash just seems a little control with rx's er gave her.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Rash macular
Clinical narrative: Pt et sister very nervous about vaccine. Pt became blotchy after injection et. M.D. was called to the room. At that time her skin was almost cleared up and she was calm. She was D/C  with her Mom et Dad at that time.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram normal, Culture negative, Incontinence
Clinical narrative: Initial report received from a health care professional on 28 October 2011. A 75-year-old male patient received an intramuscular injection (site not reported) of FLUZONE No Preservative 2011-2012, lot number UT443AA, on 07 October 2011. The patient had a history of hypertension, stroke in 2009, hip replacement, and lung cancer. He had no adverse events following prior administration of vaccines and had no other vaccinations within 4 weeks of the FLUZONE. The patient's concomitant medications included NEURONTIN, atenolol, 'AGRINOX", terazosin and vitamins. The patient was in the hospital rehabilitation department for a complete physical and received the FLUZONE vaccine. A few days later he was transferred to the Intensive Care Unit (ICU). The patient was lethargic for ten days, could hardly keep his eyes open and was incontinent. The patient had a computed tomography scan, chest x-ray, blood work, cultures and a swallow test which were all negative. The outcome was reported as not recovered (improving). Documents held by sender: None.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Intensive care, Laboratory test normal, Lethargy, Somnolence
Clinical narrative: Initial report received from a health care professional on 28 October 2011. A 75-year-old male patient received an intramuscular injection (site not reported) of FLUZONE No Preservative 2011-2012, lot number UT443AA, on 07 October 2011. The patient had a history of hypertension, stroke in 2009, hip replacement, and lung cancer. He had no adverse events following prior administration of vaccines and had no other vaccinations within 4 weeks of the FLUZONE. The patient's concomitant medications included NEURONTIN, atenolol, 'AGRINOX", terazosin and vitamins. The patient was in the hospital rehabilitation department for a complete physical and received the FLUZONE vaccine. A few days later he was transferred to the Intensive Care Unit (ICU). The patient was lethargic for ten days, could hardly keep his eyes open and was incontinent. The patient had a computed tomography scan, chest x-ray, blood work, cultures and a swallow test which were all negative. The outcome was reported as not recovered (improving). Documents held by sender: None.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Initial report was received on 25 October 2011 from a health care professional. A cluster of unidentified patients had received a 0.5 mL injection of FLUZONE (lot numbers, routes, sites and dates of administration not reported) and an unspecified amount of time later, reports were made of local reaction of redness, slightly raised and warm to touch. One patient had increased redness measuring 40 mm by 50 mm in size two and three quarter inches below injection site and one patient within two hours of immunization experienced a thick tongue and shortness of breath. The patient was evaluated in the ED (emergency department), treated, release and was advised not to receive another influenza vaccine in the future. No further information was available at the time of the report. The patient's outcomes were not reported. The reporter for this case is the same as for case 2011-10408. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dyspnoea, Migraine, Myalgia, Nausea
Clinical narrative: Initial report was received from a health care professional on 25 October 2011. A female patient had received FLUZONE (lot number, route, site and date of administration not reported) and within two hours of immunization, experienced a migraine and severe muscle aches. Within four hours the patient developed nausea, vomiting, a temperature of 103, shortness of breath and an itchy rash on trunk. The patient reported that she does not use contact solution with timerosol (thimerosal) as she has an allergy to it. No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2011-10407. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash pruritic, Vomiting
Clinical narrative: Initial report was received from a health care professional on 25 October 2011. A female patient had received FLUZONE (lot number, route, site and date of administration not reported) and within two hours of immunization, experienced a migraine and severe muscle aches. Within four hours the patient developed nausea, vomiting, a temperature of 103, shortness of breath and an itchy rash on trunk. The patient reported that she does not use contact solution with timerosol (thimerosal) as she has an allergy to it. No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2011-10407. Documents held by sender: none.
Age: 0.92
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Hypersensitivity, Swelling face, Urticaria
Clinical narrative: Initial report received from a health care professional on 27 October 2011. An 11-month old male infant received an injection (route and site not reported) of FLUZONE, lot number UT4119AA, on 18 October 2011. The patient had a history of milk allergy. The patient's concomitant medications included ZYRTEC and BENADRYL. It was not known if the patient had any illnesses at the time of vaccination. On 19 October 2011, the next morning, the patient experienced "anaphylaxis reaction" of hives, facial swelling, and difficulty breathing. The patient was being seen as a consult for "allergic reaction" after receiving the FLUZONE vaccination. The outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Depression, Malaise, Pain
Clinical narrative: Initial case received from a consumer on 27 October 2011. A female senior citizen (age not reported) received an injection (route and site not reported) of FLUZONE HIGH-DOSE (lot number not reported) on 24 August 2011. The patient had no problems with the regular flu vaccine. The patient's medical history and concomitant medications were not reported. On an unknown date the patient became ill and developed enormous amount of pain and anxiety. She was prescribed an antibiotic by her doctor. The patient's doctor and pharmacist agreed that the patient's suffering was caused by the vaccine. She got better but the illness returned again. She was prescribed another series of antibiotics which she just finished. The patient complained that the shot made her very ill and she has become depressed. The outcome was reported as not recovered. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pruritus generalised
Clinical narrative: Initial report received from a health care professional on 28 October 2011. A 61-year-old female patient received an intramuscular injection (site not reported) of FLUZONE SV, sanofi pasteur lot number not reported, on 11 October 2011. The patient had an allergy to ZANTAC and penicillin. The patient's concomitant medications were reported as unknown. The patient had no illness at the time of vaccination. The patient reported redness and swelling at the injection site and was diagnosed with cellulitis. The next day after these symptoms appeared, the patient was itchy all over her body. The outcome was reported as unknown. Documents held by sender: None.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Paraesthesia oral, Pharyngeal oedema, Pyrexia
Clinical narrative: Initial report received from a health care professional on 28 October 2011. A 61-year-old female patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur lot number UH486AE, on 18 October 2011 at 10:00 AM. The patient had an allergy to penicillin. The patient's concomitant medications included hydrochlorothiazide, lisinopril and ezetimibe and VYTORIN. The patient's medical history was not reported. The patient received a flu vaccine every year. She had no illness at the time of vaccination and had no prior adverse events following previous vaccinations. On 18 October 2011, two hours after vaccination at 12:00 PM, the patient had tingling in the mouth, throat swelling, fever, and chills. She went to the Emergency Room (ER) and was given BENADRYL, prednisone and ZOFRAN. The patient was sent home a few hours later. The outcome was reported as recovered. Documents held by sender: None.
Age: 83.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema peripheral, Pruritus, Rash macular
Clinical narrative: TD placed 10/25/11 called 11/2/11 c/o arm swollen, blotchy & red, itching. Tx BENADRYL prn.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Biopsy stomach, Endoscopy gastrointestinal, Gastrectomy, Gastric haemorrhage, Gastric perforation
Clinical narrative: Information has been received from an physician concerning a 16 year old male patient with asthma, obesity, allergy to penicillin, amoxicillin, MOTRIN, BENADRYL and shellfish, the patient never had chickenpox. Who on 23-MAY-1997 was vaccinated with the first dose of VARIVAX (Merck) and on 10-OCT-2008 was vaccinated with the second dose of VARIVAX (Merck) (Lot numbers, routes and doses not reported). Concomitant therapy included albuterol and montelukast sodium (MSD). It was reported that on 21-SEP-2011, the patient developed severe gastritis and gastric perforation that required resection on his stomach, due uncontrollable bleeding. The physician stated that because there were several cases of gastritis reported due to varicella zoster virus (VZV) in immunocompromised patients, they looked at the patient's saliva for VZV DNA and found it positive. The patient was so ill afterwards he was transferred to another hospital. It was too late to treat him with an antiviral drug, but he did recovered from the surgery. He was now at home. On 26-OCT-2011, a gastric mucosa sample was obtained from endoscopy biopsy, results not reported. At the time of the report outcome of Severe gastritis, Uncontrollable bleeding and gastric perforation was unknown. Upon internal review gastric perforation and resection of his stomach were considered to be an other important medical events. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Gastritis, Saliva analysis abnormal, Varicella virus test positive
Clinical narrative: Information has been received from an physician concerning a 16 year old male patient with asthma, obesity, allergy to penicillin, amoxicillin, MOTRIN, BENADRYL and shellfish, the patient never had chickenpox. Who on 23-MAY-1997 was vaccinated with the first dose of VARIVAX (Merck) and on 10-OCT-2008 was vaccinated with the second dose of VARIVAX (Merck) (Lot numbers, routes and doses not reported). Concomitant therapy included albuterol and montelukast sodium (MSD). It was reported that on 21-SEP-2011, the patient developed severe gastritis and gastric perforation that required resection on his stomach, due uncontrollable bleeding. The physician stated that because there were several cases of gastritis reported due to varicella zoster virus (VZV) in immunocompromised patients, they looked at the patient's saliva for VZV DNA and found it positive. The patient was so ill afterwards he was transferred to another hospital. It was too late to treat him with an antiviral drug, but he did recovered from the surgery. He was now at home. On 26-OCT-2011, a gastric mucosa sample was obtained from endoscopy biopsy, results not reported. At the time of the report outcome of Severe gastritis, Uncontrollable bleeding and gastric perforation was unknown. Upon internal review gastric perforation and resection of his stomach were considered to be an other important medical events. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Pruritus generalised
Clinical narrative: 43 yr old F received flu shot 11/4/2011 at 1315 hrs, appeared red faced at 1320 & when questioned said she had generalized itching all over without SOB. EPIPEN injected at 1325 & 911 called. Progressed to SOB, EMTs intervened with IV BENADRYL, IV Epi & O2 & improved & taken to ED. Last flu shot 2009. Reports 3 day itching episode 6 mos ago after house hunting, cause unknown. Pruritus resolved. EPIPEN prescribed. PMH asthma 2009. Taking ADVAIR & controlled.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Condition aggravated, Immune system disorder, Injection site pain, Lethargy
Clinical narrative: Started to feel achy/lethargic after going to the gym following vaccination. After about 5 hours, started to feel really achy w/ cycles of fever and chills. High fever woke him up at about 2AM so he went to ER. Says ER MD told him vaccination brought down his immune system and made him more susceptible to a dormant respiratory infection patient had prior to vaccination. Note: patient said vaccination stung when he was injected.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Respiratory tract infection, White blood cell count increased
Clinical narrative: Started to feel achy/lethargic after going to the gym following vaccination. After about 5 hours, started to feel really achy w/ cycles of fever and chills. High fever woke him up at about 2AM so he went to ER. Says ER MD told him vaccination brought down his immune system and made him more susceptible to a dormant respiratory infection patient had prior to vaccination. Note: patient said vaccination stung when he was injected.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: About 5 minutes after administration, patient fainted. He was caught by father & I. We layed on floor with feet up. Regained consciousness in 1 minute. After 10 min sat in chair. Remained for 30 minutes till felt good & then left.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site nodule
Clinical narrative: A dime-sized knot developed under injection site immediately upon needle withdrawal, extending to the left within 5 minutes, knot had dissipated to small pinpoint.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Nervousness, Rash macular
Clinical narrative: Pt nervous. Pt skin became blotchy after injection and M.D. was called into the room. Skin had almost cleared by the time dr entered. Pt. calmed and was d/c with mom et dad.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Injection site cellulitis, Injection site induration, Injection site swelling, Vaccine positive rechallenge
Clinical narrative: Patient received PREVNAR vaccine on 8/12/11 (L) thigh. Went to ER on 8/14/11 with cellulitis (L) thigh. Was given ROCEPHIN injection for antibiotics and it did clear up. On 10/12/11 received PREVENAR injection in (R) leg. Same reaction. Was put on AUGMENTIN antibiotics and it did clear up. 3cm x 4cm red, hard, swollen area.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Swelling around eyes and bloodshot eyes, ZYRTEC and BENADRYL.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Information has been received from a medical assistant (also reported as healthcare worker) concerning a 20 year old male patient with no drug reactions or allergies who on 01-SEP-2011 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 670050/1229AA, expiration: November 2013). There was no concomitant medication. On 01-SEP-2011, post vaccination within one minute, the patient fell to the floor. The paramedics were called and the patient was administered oxygen. The patient was not hospitalized and went home "completely fine" a short while after the incident. The medical assistant also mentioned that the patient fainted with all (unspecified) injections and blood draws. There were no lab diagnostics studies performed. The follow-up information has been received from the medical assistant concerning the patient who on 01-SEP-2011 was vaccinated with the first dose of GARDASIL (lot # 670050/1229AA) on his left arm. The reporter stated that on 01-SEP-2011 after receiving GARDASIL the patient passed out and was given oxygen. 911 was called. The patient regained consciousness and recovered immediately on 01-SEP-2011. Emergency Medical Service (EMS) assisted. The follow-up information has been received from the medical assistant concerning the patient who on 01-SEP-2011 was vaccinated with the first dose of GARDASIL (lot # 670050/1229AA) on his left arm and the first dose of VAQTA (lot #671585/1005AA) on his right arm. The patient was given the GARDASIL and after receiving it the patient passed out. He was given oxygen. The patient fell to the floor was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLUN3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash generalised
Clinical narrative: Pt reports a full body rash appearing on 10/22/11. She did not report this to our office until 10/31/11. Stated she is on a MEDROL dose pak & still has a rash on her neck. Her physician is unsure if it is related to the flu shot.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome. Pt. admitted 11/4/11 to hospital.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain in shoulder. Pain when I lift arm for 1 week. Happen 2 years ago too.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Pat. laid down 15 min after the vaccine admin. when started walking experienced severe pain in upper arm extending to shoulder & started feeling dizzy. Laid down an extra 20 min & sxs resolved.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Insomnia, Nausea
Clinical narrative: One hour after injection: chills, headache, insomnia, nausea, vomiting, fatigue - continued over a 2 d. period.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: One hour after injection: chills, headache, insomnia, nausea, vomiting, fatigue - continued over a 2 d. period.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site erythema, Injection site urticaria, Nausea
Clinical narrative: Bad headache, worse than typical headache, lasted several days and associated with nausea.  Also experienced a red welt at the injection site.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram normal, Hypoaesthesia, Myelitis transverse, Nuclear magnetic resonance imaging normal
Clinical narrative: Cold sore started, lasted for a week, numbness to right side of face and scalp developed ten days later and is still ongoing. Hospitalized for 4 days, CT, MRI ruled out stroke. Transverse Myelitis has been diagnosed. Steroids are being taken.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Oral herpes
Clinical narrative: Cold sore started, lasted for a week, numbness to right side of face and scalp developed ten days later and is still ongoing. Hospitalized for 4 days, CT, MRI ruled out stroke. Transverse Myelitis has been diagnosed. Steroids are being taken.
Age: 1.11
Sex: M
Vaccine: FLU3
Symptoms: Erythema multiforme, Rash generalised
Clinical narrative: RASH RAISED ALL OVER BODY SOME WITH CENTRAL CLEARING, ERYTHEMA MULTIFORME.
Age: 36.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Allergy to vaccine
Clinical narrative: Took epipen she brought with her claimed to be allergic to flu shot.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Red and swollen eyes.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abasia, Feeling abnormal, Pain, Pyrexia
Clinical narrative: His entire body ached and he was saying he did not feel right. The next morning when he woke up to go to school his body ached so badly that he could not walk. He had a fever as well. This has been going on since and has been a week today. He has been back to the military hospital one time and they did not seem too concerned, I then took him to a civilian ER because he was just laying around saying he did not feel right or feel well at all. They as well did not seem too concerned.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Ocular hyperaemia
Clinical narrative: Short of breath, red eyes.
Age: 32.0
Sex: F
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: No adverse symptoms reported- Client pregnant at time of vaccine given. However, client did not report she was pregnant.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Urticaria
Clinical narrative: Became dizzy, nauseated, hives on face and neck.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Dyspnoea, Heart rate increased, Muscular weakness
Clinical narrative: Said she had muscle weakness was in bed from 830pm to 830AM (couldn't get out of bed) - layed in bed for 12 hours. Fast heart beat. Shortness of breath; also low blood sugar reading in the am, the next day.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Headache, towards back by neck and pulsated towards top of the head.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Pt call clinic 2 days after vaccination on 4 NOV 2011, complaining she is unable to move neck, pt was advised to present to the emergancy room.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Chills, Erythema
Clinical narrative: Patient called this a.m. to say she had a terrible reaction to the pneumonia shot she got here on Friday.  Said her arm was was swollen, sore and red.  Said she had chills and fever all weekend so bad that she had to stay in bed.  She said her joints ached too.  She has no fever today but is so weak that she can't go in to work.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Vaccination complication
Clinical narrative: Patient called this a.m. to say she had a terrible reaction to the pneumonia shot she got here on Friday.  Said her arm was was swollen, sore and red.  Said she had chills and fever all weekend so bad that she had to stay in bed.  She said her joints ached too.  She has no fever today but is so weak that she can't go in to work.
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Cardiac failure, Cardiomyopathy, Echocardiogram, Ejection fraction decreased
Clinical narrative: Weakness, excessive tiredness.  Later high blood pressure, preeclampsia.  Diagnosed with cardiomyopathy (heart failure) and ejection fraction of 18 following pregnancy. No health issues prior to the flu shot; however, experienced extreme fatigue following. Issues with pregnancy well documented. Eventual diagnosis of non-ischemic cardiomyopathy (no known cause).
Age: 41.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Electrocardiogram, Fatigue, Hypertension, Nuclear magnetic resonance imaging, Pre-eclampsia
Clinical narrative: Weakness, excessive tiredness.  Later high blood pressure, preeclampsia.  Diagnosed with cardiomyopathy (heart failure) and ejection fraction of 18 following pregnancy. No health issues prior to the flu shot; however, experienced extreme fatigue following. Issues with pregnancy well documented. Eventual diagnosis of non-ischemic cardiomyopathy (no known cause).
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Headache, Mass, Musculoskeletal pain
Clinical narrative: Extreme chills (uncontrollable shaking) fever of 102, dry heaves 3 times over period of only first 30 min., headache & dizziness. Fever (100-102) & intermittent spells of chilled shaking & headache lasted 48 hours. Fever (99-101) another 24 hours with no headache or chills. No intestinal or respiratory symptoms.  Extreme pain in shoulder/arm below injection site within 1 hour with lumps and redness developing 40 hours after injection.  Still some pain and redness, but decreasing.  Treated self with fluids and Tylenol & ibuprofen.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Pyrexia, Retching, Tremor
Clinical narrative: Extreme chills (uncontrollable shaking) fever of 102, dry heaves 3 times over period of only first 30 min., headache & dizziness. Fever (100-102) & intermittent spells of chilled shaking & headache lasted 48 hours. Fever (99-101) another 24 hours with no headache or chills. No intestinal or respiratory symptoms.  Extreme pain in shoulder/arm below injection site within 1 hour with lumps and redness developing 40 hours after injection.  Still some pain and redness, but decreasing.  Treated self with fluids and Tylenol & ibuprofen.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Reported that her arm was swollen, warm and red.  Took a month or so to go back to normal.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Progressive moderate pain in deltoid 2 days after injection was given which progressed on to severe pain with limited mobility.  Pain is worse with abduction and less with rest.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Patient didn't report any adverse events. Prior Tdap given 9/19/06.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Nausea, Oedema peripheral, Skin warm
Clinical narrative: Red, warm, swollen arm.  Chills and nausea.  Went to ED and Dr. for follow up and put on antibiotics.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Local reaction, Pain
Clinical narrative: SWELLING, REDNESS, WARM, PAINFUL, FEVER.  WAS SEEN BACK IN OFFICE AND AT EMERGENCY ROOM.  LOCAL ALLERGIC REACTION VERSES CELLULITIS.  GIVEN AUGMENTIN 875MG X7 DAYS, GIVEN ANTIHISTAMINE.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: SWELLING, REDNESS, WARM, PAINFUL, FEVER.  WAS SEEN BACK IN OFFICE AND AT EMERGENCY ROOM.  LOCAL ALLERGIC REACTION VERSES CELLULITIS.  GIVEN AUGMENTIN 875MG X7 DAYS, GIVEN ANTIHISTAMINE.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Mobility decreased
Clinical narrative: Left shoulder very painful first night, could barely take off shirt at night. It has been nearly 3 weeks and shoulder is still sore. Can hardly lift arm up.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Administration site warm, red, itchy.  Patient denied fever.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Incorrect drug administration duration, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: Patient experienced a lot of pain at time of flu shot vaccination. The nurse took a very long time to inject the solution. Not even 30 minutes afterwards, could barely move the arm because of the pain. Patient couldn't lift arm to dress and undress. Thought the pain was due to the shot but 4 days later, still in a lot of pain and can't use arm properly. Patient can't lift it without pain and feels tingling and ache in shoulder and upper arm. Patient read people can suffer nerve and/or muscle damage after any vaccination because of where the needle was inserted and is afraid that's what the patient has.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient experienced a lot of pain at time of flu shot vaccination. The nurse took a very long time to inject the solution. Not even 30 minutes afterwards, could barely move the arm because of the pain. Patient couldn't lift arm to dress and undress. Thought the pain was due to the shot but 4 days later, still in a lot of pain and can't use arm properly. Patient can't lift it without pain and feels tingling and ache in shoulder and upper arm. Patient read people can suffer nerve and/or muscle damage after any vaccination because of where the needle was inserted and is afraid that's what the patient has.